WO2014010086A1 - Implant - Google Patents

Implant Download PDF

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Publication number
WO2014010086A1
WO2014010086A1 PCT/JP2012/067992 JP2012067992W WO2014010086A1 WO 2014010086 A1 WO2014010086 A1 WO 2014010086A1 JP 2012067992 W JP2012067992 W JP 2012067992W WO 2014010086 A1 WO2014010086 A1 WO 2014010086A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant
belt
state
connector
implant according
Prior art date
Application number
PCT/JP2012/067992
Other languages
French (fr)
Japanese (ja)
Inventor
政克 川浦
奈央 横井
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to PCT/JP2012/067992 priority Critical patent/WO2014010086A1/en
Publication of WO2014010086A1 publication Critical patent/WO2014010086A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045Support slings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482Needle or suture guides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066Needles, e.g. needle tip configurations
    • A61B17/06109Big needles, either gripped by hand or connectable to a handle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42Gynaecological or obstetrical instruments or methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00805Treatment of female stress urinary incontinence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B2017/06052Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0007Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting length

Definitions

  • the present invention relates to an implant.
  • 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.
  • An object of the present invention is to provide an implant capable of performing a procedure with minimal invasiveness when performing a procedure on an implant placed in a living body.
  • An elongated main body having a first portion on one end side and a second portion on the other end side, and having flexibility, Regulating means for regulating the distance of the implant body between the first part and the second part; It is constituted separately from the restricting means, and comprises a releasing means for releasing the restriction by the restricting means so that the first part and the second part can be separated from each other. Implant.
  • the implant main body has a belt-like shape and includes at least two belt-like members arranged along the longitudinal direction, and one of the two belt-like members is the first portion. And the other band-shaped member is the second part,
  • the implant according to (1) wherein when the restriction is released by the releasing means, the one band-shaped member and the other band-shaped member are separated.
  • the restricting means is configured by a suture that is sewn in a state where the end of the one band-shaped member and the end of the other band-shaped member are overlapped. Implants.
  • the suture has a folded portion that is folded halfway in the longitudinal direction
  • the restricting means is attached to an end portion of the one belt-like member, and is attached to an end portion of the other belt-like member, the first connector having a protrusion formed so as to protrude, and the protrusion is And a second connector having a pair of elastically deformable clamping pieces to be clamped, In the sandwiched state in which the protrusion is sandwiched by the pair of sandwiching pieces, the one strip member and the other strip member are connected, The implant according to (2) or (3), wherein the connection between the one band-shaped member and the other band-shaped member is released in a separated state in which the pair of sandwiching pieces are elastically deformed and separated from the protrusion. .
  • the release means is detachably attached to at least the second connector of the first connector and the second connector, and prevents elastic deformation of the pair of clamping pieces in the attached state. Composed of members, In the attached state attached to the second connector, the elastic deformation of the pair of holding pieces is prevented, and the holding state is maintained.
  • the implant body has a belt-like shape, and has at least three belt-like members arranged along the longitudinal direction thereof.
  • limiting means connects the edge parts of the said strip
  • the implant body includes a connecting thread that is laid between the ends of the adjacent strip-shaped members and that is bent while being regulated by the regulating means.
  • the implant body is formed of a single band-shaped member having a band shape and having at least one deformable portion that is deformable to be stretchable in the middle of the longitudinal direction.
  • the restricting means is configured to maintain a contracted state of the deforming portion, The implant according to (1), wherein when the restriction is released by the release means, the deformed portion is changed from the contracted state to an extended state, and the entire length of the implant body is extended.
  • FIG. 1 is a partial longitudinal sectional side view showing a puncture device.
  • FIG. 2 is a side view showing the puncture device.
  • 3 is a cross-sectional view taken along line AA in FIG.
  • Fig. 4 is an enlarged detailed perspective view showing the implant of the present invention provided in the puncture device in Fig. 1.
  • FIG. 5 is a diagram for explaining the procedure of the procedure using the puncture apparatus shown in FIGS. 1 and 2.
  • FIG. 6 is a diagram for explaining the procedure of the procedure using the puncture apparatus shown in FIGS. 1 and 2.
  • FIG. 7 is a diagram for explaining the procedure of the procedure using the puncture apparatus shown in FIGS. 1 and 2.
  • FIG. 8 is a diagram for explaining the procedure of the procedure using the puncture device shown in FIGS. 1 and 2.
  • FIG. 5 is a diagram for explaining the procedure of the procedure using the puncture apparatus shown in FIGS. 1 and 2.
  • FIG. 6 is a diagram for explaining the procedure of the procedure using the puncture apparatus shown in FIG
  • FIG. 9 is a diagram for explaining the procedure of the procedure using the puncture apparatus shown in FIGS. 1 and 2.
  • FIG. 10 is a diagram for explaining the procedure of the procedure using the puncture apparatus shown in FIGS. 1 and 2.
  • FIG. 11 is a diagram for explaining a procedure for separating the implant placed in the living body by the procedure performed in the procedure of FIGS.
  • FIG. 12 is a diagram for explaining a procedure for separating the implant placed in the living body by the procedure performed in the procedure of FIGS.
  • FIG. 13 is a diagram for explaining a procedure for separating the implant placed in the living body by the procedure performed in the procedure of FIGS.
  • FIG. 14 is a diagram for explaining the procedure for separating the implant placed in the living body by the procedure performed in the procedure of FIGS.
  • FIG. 15 is an enlarged detailed perspective view showing a second embodiment of the implant of the present invention.
  • FIG. 16 is a diagram for explaining a procedure for separating the implant shown in FIG. 15.
  • FIG. 17 is a view for explaining a procedure for separating the implant shown in FIG. 15.
  • FIG. 18 is a view for explaining a procedure for separating the implant shown in FIG. 15.
  • FIG. 19 is a diagram for explaining a procedure for separating the implant shown in FIG. 15.
  • FIG. 20 is a plan view and a side view showing a third embodiment of the implant of the present invention.
  • FIG. 21 is a diagram for explaining a procedure for separating the implant shown in FIG. 20.
  • FIG. 22 is a view for explaining a procedure for separating the implant shown in FIG. 20.
  • FIG. 21 is a diagram for explaining a procedure for separating the implant shown in FIG. 20.
  • FIG. 23 is a diagram for explaining a procedure for separating the implant shown in FIG. 20.
  • FIG. 24 is a plan view showing a fourth embodiment of the implant of the present invention.
  • FIG. 25 is a plan view showing a state in which the length of the implant shown in FIG. 24 is adjusted.
  • FIG. 26 is a side view showing a fifth embodiment of the implant of the present invention.
  • FIG. 27 is a side view showing a state in which the length of the implant shown in FIG. 26 is adjusted.
  • FIGS. 1, 4 and 5 to 14 are diagrams for explaining the procedure of the procedure using the puncture device shown in FIG. 1 and FIG. 2, and FIG. 11 to FIG.
  • FIG. 11 is a diagram for explaining a procedure for separating an implant placed in a living body by the procedure performed in the procedure of FIGS. 5 to 10;
  • the left side of FIGS. 1, 4 and 5 to 14 is “one end” or “tip”, and the right side is “other end” or
  • base end “upper” or “upper” on the upper side and “lower” or “lower” on the lower side.
  • a puncture apparatus 1 shown in FIGS. 1 and 2 is an apparatus used when an implant (in-vivo indwelling device) 2 for treatment of female urinary incontinence is embedded in a living body.
  • the puncture device 1 includes a first device 17 shown in FIG. 1 and a second device 18 shown in FIG.
  • the implant 2 is a device that pulls the urethra 100 in a direction away from the vagina wall 300 between the vagina 200 or supports the urethra 100 so as not to approach the vagina wall 300.
  • the urethra 100 is pressed by the support force of the implant 2 and urinary incontinence can be prevented.
  • the first device 17 includes a puncture needle assembly 9 and a support member 10.
  • the puncture needle assembly 9 includes an outer tube 91 configured by a tube body curved in an arc shape, and an implant 2 as an inner structure inserted into the outer tube 91.
  • the puncture needle assembly 9 includes an assembled state in which the outer tube 91 and the implant 2 are assembled (see FIGS. 1, 6, and 7), and an exploded state in which the outer tube 91 and the implant 2 are separated from the assembled state. (See FIGS. 8 to 10).
  • the outer tube 91 has one end opening 911 having one end opened, and a grip 912 at the other end.
  • the needle body 7 of the implant 2 is detachably attached to the one end opening 911.
  • the grip portion 912 is a portion to be gripped when the outer tube 91 is pulled out from the living tissue 600 as will be described later.
  • center angle of the arc-shaped outer tube 91 is preferably 135 to 210 degrees, and more preferably 150 to 180 degrees.
  • constituent material of the outer tube 91 is not particularly limited, and examples thereof include metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy.
  • the implant 2 includes an implant body 3 having an elongated overall shape, a needle body 7 provided at the distal end portion of the implant body 3, a regulating means 4, and a releasing means 5. is doing.
  • the configuration of each part will be described after the description of the support member 10 and the second device 18.
  • the support member 10 is provided with a support portion 101, a guide portion 102 arranged at a position different from the support portion 101, that is, spaced apart from the support portion 101, and the support portion 101 and the guide. It has the connection part 103 which connects the part 102.
  • the support portion 101 is a member formed of a rectangular parallelepiped or a cubic block body, and a through hole 104 penetrating the block body is formed.
  • the through-hole 104 can be inserted with the puncture needle assembly 9 (outer tube 91) in an assembled state, and is curved with the same curvature as the outer tube 91.
  • the puncture needle assembly 9 in an assembled state is supported by the through-hole 104 so as to be rotatable about an axis having the center O of the arc of the outer tube 91 as a central axis (see FIGS. 6 and 7).
  • the lower surface 105 in FIG. 1 of the support portion 101 functions as a contact portion addressed to the body surface 700.
  • the support part 101 is not limited to a block body, For example, the shape containing a curved surface may be sufficient.
  • the guide portion 102 is a member that is configured by a rectangular parallelepiped or a cubic block body and is positioned in a direction in which the needle tip 71 of the needle body 7 is directed when the assembled puncture needle assembly 9 is rotated.
  • the lower surface 106 of the guide portion 102 in FIG. 1, that is, the surface facing the needle tip 71 functions as an abutting portion addressed to the body surface 700.
  • the guide part 102 is not limited to a block body, For example, the shape containing a curved surface may be sufficient.
  • the surface 106 of the guide portion 102 is provided with a restriction portion 8 having a function of restricting the rotation (movement) of the assembled puncture needle assembly 9.
  • the restricting portion 8 includes a concave portion 107 formed by being recessed in the surface 106.
  • the shape of the recess 107 is the same as or slightly larger than the outer shape from the needle tip 71 to the stepped portion 72 of the needle body 7.
  • the connecting portion 103 is formed of a long body, and supports the support portion 101 and the guide portion 102 at both ends thereof. Thereby, the support part 101 and the guide part 102 are connected via the connection part 103.
  • the second device 18 includes a longitudinal urethral insertion member 30 inserted into the urethra 100, a longitudinal vagina insertion member 40 inserted into the vagina 200, and the urethral insertion member 30. And a connecting member 50 that connects the vaginal insertion member 40.
  • the urethral insertion member 30 and the vagina insertion member 40 are each composed of a rod-shaped body having a circular cross-sectional shape. Further, the diameter of the urethral insertion member 30 is smaller than the diameter of the vaginal insertion member 40.
  • the distal end surface 301 of the urethral insertion member 30 is rounded. Thus, when the urethra insertion member 30 is inserted into the urethra 100, it is possible to reliably prevent the inside of the urethra 100 from being damaged by the distal end surface 301, and thus the safety during insertion is high.
  • the distal end surface 401 of the vaginal insertion member 40 is rounded. Therefore, when inserting the vagina insertion member 40 into the vagina 200, it is possible to reliably prevent the inside of the vagina 200 from being damaged by the distal end surface 401. Therefore, the safety at the time of insertion is high.
  • the connecting member 50 is a member that separates the urethral insertion member 30 and the vagina insertion member 40 from each other and connects them in a parallel state.
  • the connection member 50 is comprised so that adjustment of the separation distance of the urethral insertion member 30 and the vagina insertion member 40 is possible.
  • the constituent materials of the urethral insertion member 30, the vaginal insertion member 40, the connection member 50, the support portion 101, the guide portion 102, and the connection portion 103 are not particularly limited.
  • Metal materials such as Other constituent materials include, for example, polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer (EVA), cyclic polyolefin, modified polyolefin, polyvinyl chloride, polyvinylidene chloride, Polystyrene, polyamide, polyimide, polyamideimide, polycarbonate, poly- (4-methylpentene-1), ionomer, acrylic resin, polymethyl methacrylate, acrylonitrile-butadiene-styrene copolymer (ABS resin), other fluorine resins, Various thermoplastics such as styrene, polyolefin, poly
  • the implant 2 has the implant body 3, the needle body 7, the restricting means 4, and the releasing means 5.
  • the implant body 3 is composed of a first belt-like member (one belt-like member) 31 having a belt shape and a second belt-like member (the other belt-like member) 32 having a belt shape. Has been.
  • the first belt-like member 31 (first portion) and the second belt-like member 32 (second portion) are arranged along the longitudinal direction, and the first belt-like member 31 is located on one end side, The 2nd strip
  • the proximal end portion 311 of the first belt-shaped member 31 and the distal end portion 321 of the second belt-shaped member 32 are overlapped, and the portion is an overlapping portion 33.
  • the overlapping portion 33 is stitched with a suture thread 41 constituting the regulating means 4.
  • Each of the first belt-like member 31 and the second belt-like member 32 has flexibility, and as its constituent material, various resin materials having biocompatibility such as polyethylene and polypropylene, and other biological materials Resin materials such as compatible polyglycolic acid, polydioxanone, polylactic acid and the like can be used.
  • belt-shaped member 32 can be comprised by making such a resin material into a fiber form, and knitting or twisting together.
  • each of the first belt-like member 31 and the second belt-like member 32 has a mesh shape, and the opening is not particularly limited, and is preferably 0.1 to 3.0 mm, for example. More preferably, it is 0.2 to 1.0 mm.
  • the total length of the first strip member 31 and the second strip member 32 is preferably 30 to 150 mm, and more preferably 50 to 100 mm.
  • belt-shaped member 32 may differ, it is preferable that it is the same.
  • the overlap part 33 is located in the center part of the longitudinal direction. Thereby, the urethra 100 can be reliably supported by the overlapping part 33 having relatively high strength in the implant body 3.
  • the widths of the first strip member 31 and the second strip member 32 are each preferably 3 to 15 mm, and more preferably 5 to 10 mm.
  • belt-shaped member 32 may differ, it is preferable that it is the same.
  • each of the first belt member 31 and the second belt member 32 is preferably 0.1 to 2.0 mm, and more preferably 0.2 to 1.0 mm.
  • belt-shaped member 32 may differ, it is preferable that it is the same.
  • the needle body 7 is connected and fixed to the distal end portion of the first belt-like member 31.
  • the fixing method is not particularly limited, and examples thereof include a method using adhesion (adhesion using an adhesive or a solvent), a method using fusion (thermal fusion, high frequency fusion, ultrasonic fusion, etc.), and the like.
  • the needle body 7 has a mushroom shape, and a top portion thereof is a rounded non-sharp needle tip 71 that punctures the living tissue 600. Further, a stepped portion 72 whose outer diameter changes sharply is formed at the proximal end portion of the needle body 7, that is, the portion opposite to the needle tip 71.
  • the constituent material of the needle body 7 is not particularly limited, and for example, the same constituent material as that of the outer tube 91 can be used.
  • the puncture needle assembly 9 can be operated in a state where the surface 106 of the guide portion 102 is directed to the body surface 700 (hereinafter, this state is referred to as “use state”). During this operation, the living tissue 600 is punctured from the needle tip 71 of the needle body 7 toward the guide portion 102 side from the support portion 101 side (see FIG. 7).
  • the needle tip 71 When the needle tip 71 approaches the guide portion 102, a part of the living tissue 600 is pressed toward the guide portion 102 by the needle tip 71 and enters the concave portion 107 and becomes hard. At this time, the operator can feel that the puncture resistance of the puncture needle assembly 9 to the living tissue 600 has sharply increased in his hand, and can stop the operation of pushing the puncture needle assembly 9. Thereby, the puncture hole formed in the biological tissue 600 is a puncture of the biological tissue 600 to a predetermined depth, that is, a hole that does not penetrate the biological tissue 600. Such puncture has a low burden on the patient and high patient safety. In addition, since the needle body 7 is prevented from protruding outside the body, it is possible to prevent the needle body 7 from puncturing the fingertip, which is safe.
  • the regulating means 4 regulates the distance in the longitudinal direction of the implant body 3 between the first belt-like member 31 and the second belt-like member 32.
  • This regulating means 4 is constituted by a suture thread 41.
  • the suture thread 41 sews the overlapping portion 33 where the base end portion 311 of the first belt-like member 31 and the tip portion 321 of the second belt-like member 32 overlap each other. Thereby, edge parts are connected, Therefore The said distance can be controlled reliably.
  • This restriction also restricts the extension of the implant 2 (implant body 3) as a whole. Therefore, the implant 2 is reliably prevented from extending and sagging even when the urethra 100 is supported, and the urinary incontinence function is ensured. It can be demonstrated.
  • the suture thread 41 in a state where the distance is regulated is “sew stitch”. Further, the suture thread 41 is formed with a folded portion 411 that is folded halfway in the longitudinal direction. One end portion 412 and the other end portion 413 of the suture thread 41 are collectively inserted into the folded portion 411. Thereby, the suture thread 41 is prevented from being loosened and unwound until the pulling thread 51 constituting the release means 5 is pulled.
  • the release means 5 releases the restriction by the suture thread 41 (the restriction means 4).
  • the release means 5 is composed of a pulling thread 51 that is formed separately from the suture thread 41. As shown in FIG. 1, the traction thread 51 is disposed along the longitudinal direction of the implant 2 in the outer tube 91.
  • the pulling thread 51 has a folded portion 511 that is folded halfway in the longitudinal direction.
  • the folded portion 511 is inserted through the folded portion 411 of the suture thread 41 and engaged with the folded portion 411.
  • the suture 41 can be reliably pulled toward the folded portion 411 and the suture by the suture 41 can be easily released (see FIG. 11 to 14).
  • the release operation can be performed by a simple operation called a pulling operation.
  • the suture thread 41 is released, that is, when the regulation by the suture thread 41 is released by the traction thread 51 (release means 5), the first belt member 31 and the second belt member 32 are separated, It will be in the state which can be spaced apart in the mutually opposite direction.
  • the operation for setting the separated state is performed when the tension acting on the implant 2 is excessive and complications such as urinary retention occur, as will be described later.
  • a grip portion 512 that is gripped when a pulling operation is performed on the traction thread 41 is provided on a portion of the traction thread 51 on the side opposite to the folded portion 511.
  • the grip portion 512 has a ring shape and is disposed on the second belt-like member 32 side.
  • constituent materials of the suture thread 41 and the traction thread 51 are not particularly limited, and for example, the same material as that of the first belt-like member 31 and the second belt-like member 32 can be used.
  • the puncture hole formed by the puncture device 1 becomes a non-through hole formed from the left closing hole 400 toward the right closing hole 400.
  • the puncture device 1 is put into use. That is, the surface 105 of the support portion 101 of the support member 10 of the first device 17 is in contact with the body surface 700, and the surface 106 of the guide portion 102 is in contact with the body surface 700.
  • the urethral insertion member 30 of the second apparatus 18 is inserted into the urethra 100, and the vagina insertion member 40 is inserted into the vagina 200.
  • the support portion 101 is directed to the corresponding portion (upper portion) of the left closing hole 400 of the body surface 700
  • the guide portion 102 is corresponding to the corresponding portion (upper portion) of the right closing hole 400 of the body surface 700. Address.
  • the assembled puncture needle assembly 9 is inserted into the through hole 104 of the support portion 101 from the needle tip 71 side.
  • the puncture needle assembly 9 is pushed in as it is and rotated from the support portion 101 side toward the guide portion 102 side.
  • the needle tip 71 passes the distal side (lower side in FIG. 7) from the center O of the arc of the outer tube 91 with respect to the urethra insertion member 30, that is, the needle tip 71 is inserted into the urethra insertion member 30 and the vagina.
  • the positional relationship among the puncture needle assembly 9, the urethral insertion member 30, and the vaginal insertion member 40 is regulated by the support portion 101 so as to pass between the members 40.
  • the puncture hole formed by the puncture needle assembly 9 passes through a very thin layer of the living tissue 600 between the urethra 100 and the vagina 200, that is, the vaginal wall 300.
  • the puncture needle assembly 9 continues to rotate, a part of the living tissue 600 is pressed toward the guide portion 102 by the needle tip 71 and enters the recess 107 as described above. At this time, the surgeon can feel that the puncture resistance of the puncture needle assembly 9 to the living tissue 600 sharply increases in his / her hand. Thereby, before the needle tip 71 is exposed to the body surface 700 on the guide portion 102 side, the turning operation of the puncture needle assembly 9 can be stopped. In this way, the puncture hole formed in the living tissue 600 is obtained by reliably puncturing the living tissue 600 to a predetermined depth.
  • the support member 10 is removed from the body surface 700.
  • the length of the second band-shaped member 32 of the implant 2 is adjusted to such an extent that the urethra 100 can be supported from the lower side in the figure.
  • This part is excised, and a predetermined suture is performed to complete the procedure.
  • tension is applied to the implant 2 in the longitudinal direction, and the urethra 100 can be reliably compressed from the lower side in the figure to prevent urinary incontinence.
  • the length of the traction thread 51 is adjusted so as to be embedded in the living body before suturing.
  • the implant 2 is in the state shown in FIG. That is, in the implant 2, the first band-shaped member 31 and the second band-shaped member 32 are connected by the suture thread 41, and the distance between these band-shaped members is regulated. Further, as described above, in the suture thread 41, one end portion 412 and the other end portion 413 are collectively inserted into the folded portion 411.
  • the grasping portion 512 of the traction thread 51 of the implant 2 is searched for, for example, by palpation. Thereafter, the part in which the living body holding part 512 is embedded is cut open, and the holding part 512 is taken out from the living body.
  • the grip part 512 is gripped, and the pulling thread 51 is pulled toward the right side in the figure as shown in FIG.
  • the suture thread 41 is pulled from the folded-back portion 411 side, and the one end portion 412 and the other end portion 413 come out of the folded-back portion 411, and the suture with the suture thread 41 starts to be released.
  • the first strip member 31 and the second strip member 32 are separated, that is, when performing a procedure on the implant 2 placed in the living body,
  • the smallest possible incision site for pulling out the traction thread 51 is sufficient.
  • the procedure can be performed with minimal invasiveness, and the burden on the patient can be reliably reduced.
  • FIG. 15 is an enlarged detailed perspective view showing a second embodiment of the implant of the present invention
  • FIGS. 16 to 19 are views for explaining a procedure for separating the implant shown in FIG.
  • This embodiment is the same as the first embodiment except that the configuration of the release means is different.
  • the releasing means 5A further includes a fixing means 52 in addition to the traction thread 51.
  • the fixing means 52 performs fixing to the suture thread 41 and releasing the fixing.
  • the fixing means 52 includes a tube 53 through which the traction thread 51 is inserted and a gripping member 54 that is gripped when a pulling operation is performed on the traction thread 51.
  • the tube 53 extends from the overlapping portion 33 of the implant body 3 to the vicinity of the proximal end portion of the second belt-like member 32.
  • a first engagement portion 531 and a second engagement portion 532 each formed of a through hole penetrating the tube wall are formed at the proximal end portion of the tube 53.
  • the first engaging portion 531 and the second engaging portion 532 are arranged along the longitudinal direction of the tube 53, and the first engaging portion 531 is located on the distal end side, and the second engaging portion The part 532 is located on the proximal end side. Note that the length of the second engagement portion 532 along the longitudinal direction of the tube 53 is longer than the length of the first engagement portion 531 along the longitudinal direction of the tube 53.
  • the gripping member 54 includes a main body 541 and an elastic piece 542 formed to protrude from the main body 541.
  • the main body portion 541 is composed of small pieces, and one end portion 513 and the other end portion 514 of the traction thread 51 are connected to the tip portion thereof. Thereby, the pulling thread 51 can be reliably pulled.
  • the main body portion 541 has a fitting portion 543 that is fitted to the proximal end portion of the tube 53 from the inside at the distal end portion thereof. Then, as shown in FIG. 16, in the fitting state where the fitting portion 543 is fitted to the proximal end portion of the tube 53, between the outer peripheral portion of the fitting portion 543 and the proximal inner peripheral portion of the tube 53, One end 412 and the other end 413 of the suture thread 41 can be clamped together. Thereby, fixation to the suture thread 41 is performed, and therefore, the suture thread 41 is unintentionally pulled, and it is reliably prevented that the suture with respect to the overlapping portion 33 is released.
  • the elastic piece 542 is formed to protrude from the fitting portion 543 toward the distal end.
  • a claw 544 protrudes from the tip of the elastic piece 542.
  • the claw 544 can engage with the first engaging portion 531 and the second engaging portion 532 of the tube 53, respectively.
  • the 1st state (refer to Drawing 15 and Drawing 16) where claw 544 engaged with the 1st engagement part 531, the above-mentioned fitting state is maintained.
  • the second state in which the claw 544 is engaged with the second engaging portion 532, the fitting state is released, and as a result, the suture thread 41 is also fixed. Canceled.
  • the tube 53 can be pulled together with the pulling thread 51.
  • belt-shaped member 32 can be used.
  • a part 414 on the one end part 412 side and a part 415 on the other end part 413 approach each other in the width direction of the implant body 3 via the folded part 411.
  • the overlapping portion 33 is stitched in the direction. Further, at least one of the one end 412 and the other end 413 is inserted through the folded portion 411.
  • the implant 2 is in the state shown in FIG. That is, in the implant 2, the first band-shaped member 31 and the second band-shaped member 32 are connected by the suture thread 41, and the distance between these band-shaped members is regulated. Further, the releasing means 5A is in the first state, thereby preventing the suture 41 from being unintentionally unraveled as described above.
  • the grasping member 54 of the implant 2 is searched for by palpation, for example. Thereafter, the part in which the living body grasping member 54 is embedded is cut open, and the grasping member 54 is taken out from the living body.
  • the gripping member 54 is gripped, and the gripping member 54 is pulled toward the right side in the drawing as shown in FIG. 17 while pressing the claw 544 of the elastic piece 542 downward.
  • the release means 5A enters the second state, and thus the fixation to the suture thread 41 is released as described above.
  • the suture thread 41 is pulled from the folded-back portion 411 side, and the suture with the suture thread 41 starts to be released.
  • the implant 2 of the present embodiment when performing a procedure on the implant 2 placed in the living body, the smallest possible incision portion for pulling out the releasing means 5A is sufficient for the living body. For this reason, the procedure can be performed with minimal invasiveness, and the burden on the patient can be reliably reduced.
  • FIG. 20 is a plan view and a side view showing a third embodiment of the implant of the present invention
  • FIGS. 21 to 23 are views for explaining a procedure for separating the implant shown in FIG.
  • This embodiment is the same as the first embodiment except that the configurations of the restricting means and the releasing means are different from each other.
  • the restricting means 4B includes a first connector 42 attached to the proximal end portion 311 of the first belt-like member 31, and a second belt-like member.
  • the second connector 43 is attached to the distal end portion 321 of 32.
  • the first connector 42 and the second connector 43 can take the connected state shown in FIGS. 20 and 21 and the disconnected state shown in FIGS. 22 and 23.
  • the first connector 42 includes a main body 420 having a flat plate shape, and a protrusion 421 formed to protrude from the front end surface of the main body 420.
  • the main body 420 has a pair of insertion holes 424 formed so as to penetrate from both side surfaces to the front end surface.
  • the front end surface 422 of the protrusion 421 is rounded.
  • a stepped portion 423 whose width is sharply reduced is formed in the middle of the protruding portion 421 in the protruding direction (longitudinal direction).
  • the second connector 43 is constituted by a main body portion 430 having a flat plate shape and a pair of sandwiching pieces 431 formed to protrude from the main body portion 430.
  • a recess 432 is formed in the front end surface of the main body 430 so as to be recessed.
  • a pair of clamping pieces 431 are disposed opposite to each other inside the recess 432.
  • Each clamping piece 431 is elastically deformable. Further, as shown in FIG. 21, the protruding portions 421 of the first connector 42 can be held between the holding pieces 431. And in this clamping state, the 1st strip
  • the release means 5 ⁇ / b> B has a pair of long members 55 that are flexible and have a long shape (band shape).
  • Each long member 55 passes through the insertion hole 424 of the first connector 42 and reaches the recess 432 of the second connector 43. Thereby, each long member 55 is attached to the first connector 42 and the second connector 43 in the connected state.
  • each long member 55 is inserted between the inner peripheral portion that defines the recess 432 and each holding piece 431 to prevent elastic deformation of each holding piece 431. be able to.
  • the said clamping state can be maintained and it can prevent reliably that the 1st strip
  • each long member 55 is removed from the connected first connector 42 and second connector 43, respectively. That is, leave.
  • each clamping piece 431 can be elastically deformed, and thus is in a separated state separated from the protrusion 421 of the first connector 42.
  • belt-shaped member 32 can isolate
  • the implant 2 is in the state shown in FIG. That is, in the implant 2, the first belt-like member 31 and the second belt-like member 32 are connected via the first connector 42 and the second connector 43 in the connected state, and the band-like members are connected to each other. The distance is regulated. Further, each of the long members 55 is in a mounted state, and as described above, the elastic deformation of each sandwiching piece 431 is prevented, and the first connector 42 and the second connector 43 are disconnected. It is prevented from becoming a state.
  • each long member 55 of the implant 2 is searched for by palpation, for example.
  • each long member 55 is grasped, and each long member 55 is pulled and removed from the connected first connector 42 and second connector 43 as shown in FIG.
  • each sandwiching piece 431 can be elastically deformed. Therefore, as shown in FIG. 23, the first strip member 31 and the second strip member 32 are separated. Can do. By this separation, the tension acting on the implant 2 is released, and the compression force on the urethra 100 is also released, thereby alleviating symptoms due to complications.
  • the living body can be cut as small as possible in order to pull out the long members 55. That's it. For this reason, the procedure can be performed with minimal invasiveness, and the burden on the patient can be reliably reduced.
  • belt-shaped member 32 is used. be able to.
  • each of the long members 55 is attached to the first connector 42 and the second connector 43 that are in a connected state, but the present invention is not limited to this.
  • the first connector 42 is provided. If the insertion hole 424 is omitted from the above and the width is reduced by that amount, the insertion hole 424 may be attached only to the second connector 43.
  • the number of the long members 55 is two in this embodiment, but may be one.
  • FIG. 24 is a plan view showing a fourth embodiment of the implant of the present invention
  • FIG. 25 is a plan view showing a state in which the length of the implant shown in FIG. 24 is adjusted.
  • This embodiment is the same as the first embodiment except that the configuration of the implant body is different.
  • the implant body 3C has at least three belt-shaped members 34a, 34b, 34c (seven are shown in the figure) forming a belt-like shape. , 34d, 34e, 34f, and 34g. These belt-like members 34a to 34g are arranged at intervals along the longitudinal direction thereof.
  • the implant body 3C includes a pair of connecting threads 35a installed between the ends of the adjacent first set of band-shaped members 34a and 34b and the ends of the adjacent second set of band-shaped members 34b and 34c.
  • a pair of connecting yarns 35b laid between the parts, a pair of connecting yarns 35c laid between the ends of the adjacent third set of strip members 34c, 34d, and an adjacent fourth set A pair of connecting yarns 35d laid between the ends of the belt-like members 34d, 34e and a pair of connecting yarns 35e laid between the ends of the adjacent fifth set of belt-like members 34e, 34f.
  • Each of the connecting yarns 35a to 35e has flexibility and is bent while being regulated by the regulating means 4C. Note that the lengths of the connecting yarns 35a to 35e may be the same or different.
  • the regulating means 4C includes a pair of connecting threads 44a for connecting the ends of the first set of band-like members 34a, 34b so as to be disengaged, and a second set of band-like members 34b, 34c.
  • the release means 5C includes a traction thread 56a configured separately from each connection thread 44a, a traction thread 56b configured separately from each connection thread 44b, and a connection thread 44c.
  • the traction thread 56c is configured as follows, the traction thread 56d is configured separately from each connection thread 44d, and the traction thread 56e is configured separately from each connection thread 44e.
  • the traction yarns 56a and 56b each extend toward the left side in the figure, and the traction yarns 56c to 56e each extend toward the right side in the figure.
  • connection thread 44c when it is desired to release the connection by the connection thread 44c, the connection thread 44c is also pulled in that direction by pulling the pulling thread 56c, and the connection by the connection thread 44c is released. Is done. Thereby, the strip
  • the traction threads 56a, 56b, 56d, 56e can be released independently at a desired timing.
  • the same materials as those of the first belt member 31 and the second belt member 32 can be used.
  • FIG. 26 is a side view showing a fifth embodiment of the implant of the present invention
  • FIG. 27 is a side view showing a state in which the length of the implant shown in FIG. 26 is adjusted.
  • This embodiment is the same as the first embodiment except that the configuration of the implant body is different.
  • the implant body 3D is composed of a single band-shaped member 36 having a band shape.
  • the implant main body 3D has a deforming portion 361 that deforms in a stretchable manner in the middle in the longitudinal direction.
  • the deformed portion 361 is folded by forming two bent portions 362 that are bent in opposite directions. Further, in the extended state shown in FIG. 27, the deforming part 361 is unfolded by spreading each bent part 362 in the opposite direction.
  • the suture thread 41 that is the restricting means 4 stitches the deformable portion 361 so as to maintain the contracted state of the deformable portion 361.
  • the implant main body 3D regulates the distance between its one end and the other end, that is, the total length of the implant main body 3D.
  • the deforming portion 361 is changed from the contracted state to the extended state.
  • the suture of the suture thread 41 is released, and the entire length of the implant body 3D is extended.
  • the tension acting on the implant 2 is reduced, and thus the pressing force on the urethra 100 is also suppressed. As a result, symptoms due to complications are alleviated.
  • transformation parts 361 formed is one in this embodiment, it is not limited to this, For example, two or more may be sufficient.
  • the present invention is not limited to this, and each part constituting the implant is replaced with an arbitrary structure that can exhibit the same function. can do. Moreover, arbitrary components may be added.
  • the implant of the present invention may be a combination of any two or more configurations (features) of the above embodiments.
  • the implant of the present invention is not limited to use in the treatment of female urinary incontinence, but can also be used in the treatment of male urinary incontinence.
  • the first device and the second device may be connected so as to be close to each other.
  • a marker that can confirm the position of the gripping part may be attached to the gripping part of the traction thread, for example, under ultrasound or X-ray contrast.
  • the connecting thread constituting the restricting means and the pulling thread constituting the releasing means can be constituted by a single continuous linear body.
  • the implant of the present invention has an elongated shape, and has a first part on one end side and a second part on the other end side, and has a flexible implant body, the first part, A restricting means for restricting the distance of the implant body from the second part; and a separate member from the restricting means, the restriction by the restricting means being released, and the first part and the second part Is provided with release means for separating each other from each other.
  • tension is acting along the longitudinal direction of the implant body of the implant placed in the living body. If this tension is excessive, a procedure may be performed on the implant body to release the tension. In this case, if the restriction of the distance in the longitudinal direction between the first part and the second part of the implant body by the restricting means is released, the tension is released. Therefore, according to the present invention, when performing this release operation, the incision site as small as possible is sufficient for the living body to the extent that the release means can be operated. For this reason, the procedure can be performed with minimal invasiveness, and thus the burden on the patient can be reliably reduced.
  • the implant of the present invention has industrial applicability.

Abstract

According to the present invention, an implant (2) is provided with: a flexible main implant body (3), the overall shape of which is elongated and which includes a first strip member (31) at one end and a second strip member (32) at the other end; a regulating means (4) for regulating the distance in the longitudinal direction of the main implant body (3) between the first strip member (31) and the second strip member (32); and a releasing means (5) for releasing the regulation imparted by the regulating means (4) and enabling the first strip member (31) and the second strip member (32) to be separated from one another toward mutually opposite directions, the releasing means (5) being configured separately from the regulating means (4).

Description

インプラントImplant
 本発明は、インプラントに関する。 The present invention relates to an implant.
 尿失禁、特に、腹圧性尿失禁になると、通常の運動中や、笑い、咳、くしゃみ等により腹圧がかかることで、尿漏れが生じる。この原因は、例えば、出産等により、尿道を支える筋肉である骨盤底筋が緩むこと等が挙げられる。 Urinary incontinence, particularly stress urinary incontinence, urine leakage occurs due to abdominal pressure applied during normal exercise, laughing, coughing, sneezing, etc. The cause of this is, for example, that the pelvic floor muscle, which is a muscle that supports the urethra, is loosened due to childbirth and the like.
 尿失禁の治療には、例えばテープ状のインプラントを用いた外科的療法が有効である。この外科的療法では、1本のインプラントを体内に留置し、そのインプラントで尿道を支持する(例えば、特許文献1参照)。インプラントを体内に留置するには、術者がメスで膣を切開し、尿道と膣との間を剥離し、穿刺針等を用いて、その剥離した部位と外部とを閉鎖孔を介し連通させる。そして、このような状態で、インプラントを体内に留置する。このインプラントには、その長手方向に張力が作用している。 For the treatment of urinary incontinence, for example, surgical therapy using a tape-like implant is effective. In this surgical therapy, one implant is placed in the body, and the urethra is supported by the implant (see, for example, Patent Document 1). In order to place the implant in the body, 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 site and the outside through a closed hole. . In such a state, the implant is placed in the body. A tension acts on the implant in its longitudinal direction.
 しかしながら、この張力が過剰であった場合には、排尿困難もしくは尿閉等の合併症が生じることがある。このような合併症が発生すると、再度膣を切開して、尿道と膣との間のインプラントを切断する手術が実施される。この手術は、インプラントの留置時に切開した箇所を再度切開するため、侵襲が大きく、患者への負担が大きいという問題があった。 However, if this tension is excessive, complications such as difficulty in urination or urinary retention may occur. When such complications occur, an operation is performed in which the vagina is opened again and the implant between the urethra and the vagina is cut. This operation has a problem in that the incision is incised again at the time of placement of the implant, so that the invasion is large and the burden on the patient is large.
特表2004-535835号公報JP-T-2004-535835
 本発明の目的は、生体に留置されたインプラントに対して手技を行なう際、その手技を低侵襲で行なうことができるインプラントを提供することにある。 An object of the present invention is to provide an implant capable of performing a procedure with minimal invasiveness when performing a procedure on an implant placed in a living body.
 このような目的は、下記(1)~(14)の本発明により達成される。 Such an object is achieved by the present invention as described in (1) to (14) below.
 (1) 長尺状をなし、その一端側の第1の部分と他端側の第2の部分とを有し、可撓性を有するインプラント本体と、
 前記第1の部分と前記第2の部分との前記インプラント本体の距離を規制する規制手段と、
 前記規制手段と別体で構成され、該規制手段による規制を解除して、前記第1の部分と前記第2の部分とが互いに離間可能な状態とする解除手段とを備えることを特徴とするインプラント。
(1) An elongated main body having a first portion on one end side and a second portion on the other end side, and having flexibility,
Regulating means for regulating the distance of the implant body between the first part and the second part;
It is constituted separately from the restricting means, and comprises a releasing means for releasing the restriction by the restricting means so that the first part and the second part can be separated from each other. Implant.
 (2) 前記インプラント本体は、帯状をなし、その長手方向に沿って配置された少なくとも2枚の帯状部材で構成され、該2本の帯状部材のうちの一方の帯状部材が前記第1の部分となり、他方の帯状部材が前記第2の部分となっており、
 前記解除手段により前記規制が解除された際、前記一方の帯状部材と前記他方の帯状部材とが分離する上記(1)に記載のインプラント。
(2) The implant main body has a belt-like shape and includes at least two belt-like members arranged along the longitudinal direction, and one of the two belt-like members is the first portion. And the other band-shaped member is the second part,
The implant according to (1), wherein when the restriction is released by the releasing means, the one band-shaped member and the other band-shaped member are separated.
 (3) 前記規制手段は、前記一方の帯状部材の端部と前記他方の帯状部材の端部とを連結するよう構成されている上記(2)に記載のインプラント。 (3) The implant according to (2), wherein the restriction means is configured to connect an end of the one band-shaped member and an end of the other band-shaped member.
 (4) 前記規制手段は、前記一方の帯状部材の端部と前記他方の帯状部材の端部とを重ねた状態で縫合する縫合糸で構成されている上記(2)または(3)に記載のインプラント。 (4) In the above (2) or (3), the restricting means is configured by a suture that is sewn in a state where the end of the one band-shaped member and the end of the other band-shaped member are overlapped. Implants.
 (5) 前記縫合糸には、その長手方向の途中が折り返された折り返し部が形成されており、
 前記解除手段は、前記折り返し部に係合し、前記縫合糸を牽引して該縫合糸による縫合を解く牽引糸を有する上記(4)に記載のインプラント。
(5) The suture has a folded portion that is folded halfway in the longitudinal direction,
The implant according to (4), wherein the release means includes a pulling thread that engages with the folded portion and pulls the suture to release the suture by the suture.
 (6) 前記解除手段は、前記縫合糸に対する固定と、該固定の解除とを行なう固定手段を有する上記(5)に記載のインプラント。 (6) The implant according to (5), wherein the releasing means includes fixing means for fixing the suture and releasing the fixation.
 (7) 前記規制手段は、前記一方の帯状部材の端部に装着され、突出形成された突部を有する第1のコネクタと、前記他方の帯状部材の端部に装着され、前記突部を挟持する、弾性変形可能な一対の挟持片を有する第2のコネクタとで構成され、
 前記一対の挟持片により前記突部を挟持した挟持状態では、前記一方の帯状部材と前記他方の帯状部材とが連結され、
 前記一対の挟持片が弾性変形して前記突部から離間した離間状態では、前記一方の帯状部材と前記他方の帯状部材との連結が解除される上記(2)または(3)に記載のインプラント。
(7) The restricting means is attached to an end portion of the one belt-like member, and is attached to an end portion of the other belt-like member, the first connector having a protrusion formed so as to protrude, and the protrusion is And a second connector having a pair of elastically deformable clamping pieces to be clamped,
In the sandwiched state in which the protrusion is sandwiched by the pair of sandwiching pieces, the one strip member and the other strip member are connected,
The implant according to (2) or (3), wherein the connection between the one band-shaped member and the other band-shaped member is released in a separated state in which the pair of sandwiching pieces are elastically deformed and separated from the protrusion. .
 (8) 前記解除手段は、前記第1のコネクタおよび前記第2のコネクタのうちの少なくとも前記第2のコネクタに着脱自在に装着され、その装着状態で前記一対の挟持片の弾性変形を阻止する部材で構成され、
 前記第2のコネクタに装着された装着状態では、前記一対の挟持片の弾性変形を阻止して、前記挟持状態を維持し、
 前記第2のコネクタから離脱した離脱状態では、前記一対の挟持片の弾性変形により、離間状態となる上記(7)に記載のインプラント。
(8) The release means is detachably attached to at least the second connector of the first connector and the second connector, and prevents elastic deformation of the pair of clamping pieces in the attached state. Composed of members,
In the attached state attached to the second connector, the elastic deformation of the pair of holding pieces is prevented, and the holding state is maintained.
The implant according to (7), wherein in the detached state separated from the second connector, the separated state is caused by elastic deformation of the pair of sandwiching pieces.
 (9) 前記インプラント本体は、帯状をなし、その長手方向に沿って配置された少なくとも3本の帯状部材を有し、
 前記規制手段は、隣接する各組の前記帯状部材の端部同士を連結解除可能に連結し、該各組の連結がそれぞれ前記解除手段により独立して解除され得る上記(1)に記載のインプラント。
(9) The implant body has a belt-like shape, and has at least three belt-like members arranged along the longitudinal direction thereof.
The said restriction | limiting means connects the edge parts of the said strip | belt-shaped member of each adjacent group so that connection cancellation | release is possible, The implant of each said group can be independently cancelled | released by the said cancellation | release means respectively. .
 (10) 前記インプラント本体は、隣接する各組の前記帯状部材の端部同士の間に架設され、前記規制手段による規制が行われている間、撓んでいる連結糸を有する上記(7)に記載のインプラント。 (10) In the above (7), the implant body includes a connecting thread that is laid between the ends of the adjacent strip-shaped members and that is bent while being regulated by the regulating means. The described implant.
 (11) 前記インプラント本体は、帯状をなし、その長手方向の途中が伸縮自在に変形する少なくとも1つの変形部を有する1本の帯状部材で構成され、
 前記規制手段は、前記変形部の収縮状態を維持するよう構成されており、
 前記解除手段により前記規制が解除された際、前記変形部が前記収縮状態から伸長状態となり、前記インプラント本体の全長が伸長する上記(1)に記載のインプラント。
(11) The implant body is formed of a single band-shaped member having a band shape and having at least one deformable portion that is deformable to be stretchable in the middle of the longitudinal direction.
The restricting means is configured to maintain a contracted state of the deforming portion,
The implant according to (1), wherein when the restriction is released by the release means, the deformed portion is changed from the contracted state to an extended state, and the entire length of the implant body is extended.
 (12) 前記変形部は、前記収縮状態では、折り畳まれており、前記伸長状態では、展開する上記(11)に記載のインプラント。 (12) The implant according to (11), wherein the deformed portion is folded in the contracted state and expands in the extended state.
 (13) 前記解除手段による解除操作は、前記インプラント本体の長手方向に沿って行なわれる上記(1)ないし(12)のいずれか1項に記載のインプラント。 (13) The implant according to any one of (1) to (12), wherein the release operation by the release means is performed along a longitudinal direction of the implant body.
 (14) 尿失禁の治療に用いられる上記(1)ないし(13)のいずれか1項に記載のインプラント。 (14) The implant according to any one of (1) to (13), which is used for treatment of urinary incontinence.
図1は、穿刺装置を示す部分縦断面側面図である。FIG. 1 is a partial longitudinal sectional side view showing a puncture device. 図2は、穿刺装置を示す側面図である。FIG. 2 is a side view showing the puncture device. 図3は、図2中のA-A線断面図である。3 is a cross-sectional view taken along line AA in FIG. 図4は、図1中の穿刺装置が備える本発明のインプラントを示す拡大詳細斜視図である。Fig. 4 is an enlarged detailed perspective view showing the implant of the present invention provided in the puncture device in Fig. 1. 図5は、図1および図2に示す穿刺装置を用いた手技の手順を説明するための図である。FIG. 5 is a diagram for explaining the procedure of the procedure using the puncture apparatus shown in FIGS. 1 and 2. 図6は、図1および図2に示す穿刺装置を用いた手技の手順を説明するための図である。FIG. 6 is a diagram for explaining the procedure of the procedure using the puncture apparatus shown in FIGS. 1 and 2. 図7は、図1および図2に示す穿刺装置を用いた手技の手順を説明するための図である。FIG. 7 is a diagram for explaining the procedure of the procedure using the puncture apparatus shown in FIGS. 1 and 2. 図8は、図1および図2に示す穿刺装置を用いた手技の手順を説明するための図である。FIG. 8 is a diagram for explaining the procedure of the procedure using the puncture device shown in FIGS. 1 and 2. 図9は、図1および図2に示す穿刺装置を用いた手技の手順を説明するための図である。FIG. 9 is a diagram for explaining the procedure of the procedure using the puncture apparatus shown in FIGS. 1 and 2. 図10は、図1および図2に示す穿刺装置を用いた手技の手順を説明するための図である。FIG. 10 is a diagram for explaining the procedure of the procedure using the puncture apparatus shown in FIGS. 1 and 2. 図11は、図5~図10の手順で行なわれた手技により生体に留置されたインプラントを分離する手順を説明するための図である。FIG. 11 is a diagram for explaining a procedure for separating the implant placed in the living body by the procedure performed in the procedure of FIGS. 図12は、図5~図10の手順で行なわれた手技により生体に留置されたインプラントを分離する手順を説明するための図である。FIG. 12 is a diagram for explaining a procedure for separating the implant placed in the living body by the procedure performed in the procedure of FIGS. 図13は、図5~図10の手順で行なわれた手技により生体に留置されたインプラントを分離する手順を説明するための図である。FIG. 13 is a diagram for explaining a procedure for separating the implant placed in the living body by the procedure performed in the procedure of FIGS. 図14は、図5~図10の手順で行なわれた手技により生体に留置されたインプラントを分離する手順を説明するための図である。FIG. 14 is a diagram for explaining the procedure for separating the implant placed in the living body by the procedure performed in the procedure of FIGS. 図15は、本発明のインプラントの第2実施形態を示す拡大詳細斜視図である。FIG. 15 is an enlarged detailed perspective view showing a second embodiment of the implant of the present invention. 図16は、図15に示すインプラントを分離する手順を説明するための図である。FIG. 16 is a diagram for explaining a procedure for separating the implant shown in FIG. 15. 図17は、図15に示すインプラントを分離する手順を説明するための図である。FIG. 17 is a view for explaining a procedure for separating the implant shown in FIG. 15. 図18は、図15に示すインプラントを分離する手順を説明するための図である。FIG. 18 is a view for explaining a procedure for separating the implant shown in FIG. 15. 図19は、図15に示すインプラントを分離する手順を説明するための図である。FIG. 19 is a diagram for explaining a procedure for separating the implant shown in FIG. 15. 図20は、本発明のインプラントの第3実施形態を示す平面図および側面図である。FIG. 20 is a plan view and a side view showing a third embodiment of the implant of the present invention. 図21は、図20に示すインプラントを分離する手順を説明するための図である。FIG. 21 is a diagram for explaining a procedure for separating the implant shown in FIG. 20. 図22は、図20に示すインプラントを分離する手順を説明するための図である。FIG. 22 is a view for explaining a procedure for separating the implant shown in FIG. 20. 図23は、図20に示すインプラントを分離する手順を説明するための図である。FIG. 23 is a diagram for explaining a procedure for separating the implant shown in FIG. 20. 図24は、本発明のインプラントの第4実施形態を示す平面図である。FIG. 24 is a plan view showing a fourth embodiment of the implant of the present invention. 図25は、図24に示すインプラントの長さが調整された状態を示す平面図である。FIG. 25 is a plan view showing a state in which the length of the implant shown in FIG. 24 is adjusted. 図26は、本発明のインプラントの第5実施形態を示す側面図である。FIG. 26 is a side view showing a fifth embodiment of the implant of the present invention. 図27は、図26に示すインプラントの長さが調整された状態を示す側面図である。FIG. 27 is a side view showing a state in which the length of the implant shown in FIG. 26 is adjusted.
 以下、本発明のインプラントを添付図面に示す好適な実施形態に基づいて詳細に説明する。 Hereinafter, the implant of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.
 <第1実施形態>
 図1および図2は、それぞれ、穿刺装置を示す部分縦断面側面図および側面図、図3は、図2中のA-A線断面図、図4は、図1中の穿刺装置が備える本発明のインプラントを示す拡大詳細斜視図、図5~図10は、それぞれ、図1および図2に示す穿刺装置を用いた手技の手順を説明するための図、図11~図14は、それぞれ、図5~図10の手順で行なわれた手技により生体に留置されたインプラントを分離する手順を説明するための図である。なお、以下では、説明の都合上、図1、図4および図5~図14中(図15~図27についても同様)の左側を「一端」または「先端」、右側を「他端」または「基端」とし、また、上側を「上」または「上方」、下側を「下」または「下方」として説明を行なう。
<First Embodiment>
1 and 2 are a partial longitudinal sectional side view and a side view, respectively, showing a puncture device, FIG. 3 is a sectional view taken along line AA in FIG. 2, and FIG. 4 is a book provided in the puncture device in FIG. FIG. 5 to FIG. 10 are diagrams for explaining the procedure of the procedure using the puncture device shown in FIG. 1 and FIG. 2, and FIG. 11 to FIG. FIG. 11 is a diagram for explaining a procedure for separating an implant placed in a living body by the procedure performed in the procedure of FIGS. 5 to 10; In the following, for convenience of explanation, the left side of FIGS. 1, 4 and 5 to 14 (the same applies to FIGS. 15 to 27) is “one end” or “tip”, and the right side is “other end” or The description will be made with “base end”, “upper” or “upper” on the upper side and “lower” or “lower” on the lower side.
 図1、図2に示す穿刺装置1は、女性の尿失禁の治療用のインプラント(生体内留置器具)2を生体内に埋設する際に用いられる装置である。この穿刺装置1は、図1に示す第1の装置17と、図2に示す第2の装置18とで構成されている。 A puncture apparatus 1 shown in FIGS. 1 and 2 is an apparatus used when an implant (in-vivo indwelling device) 2 for treatment of female urinary incontinence is embedded in a living body. The puncture device 1 includes a first device 17 shown in FIG. 1 and a second device 18 shown in FIG.
 なお、インプラント2は、尿道100を、膣200との間にある膣壁300から離間する方向へ引張る、あるいは、尿道100を膣壁300へ接近させないようにして支持する器具である。そして、このインプラント2の支持力により、尿道100が圧迫されて、尿失禁を防止することができる。 The implant 2 is a device that pulls the urethra 100 in a direction away from the vagina wall 300 between the vagina 200 or supports the urethra 100 so as not to approach the vagina wall 300. The urethra 100 is pressed by the support force of the implant 2 and urinary incontinence can be prevented.
 図1に示すように、第1の装置17は、穿刺針組立体9と、支持部材10とを備えている。 As shown in FIG. 1, the first device 17 includes a puncture needle assembly 9 and a support member 10.
 穿刺針組立体9は、円弧状に湾曲した管体で構成された外管91と、当該外管91に挿入された内側構造体としてのインプラント2とを備えている。この穿刺針組立体9は、外管91とインプラント2とが組み立てられた組立状態(図1、図6、図7参照)と、当該組立状態から外管91とインプラント2とが分離した分解状態(図8~図10参照)とを取り得る。 The puncture needle assembly 9 includes an outer tube 91 configured by a tube body curved in an arc shape, and an implant 2 as an inner structure inserted into the outer tube 91. The puncture needle assembly 9 includes an assembled state in which the outer tube 91 and the implant 2 are assembled (see FIGS. 1, 6, and 7), and an exploded state in which the outer tube 91 and the implant 2 are separated from the assembled state. (See FIGS. 8 to 10).
 外管91は、その一端が開口した一端開口部911を有し、他端部に把持部912を有している。一端開口部911には、インプラント2が有する針体7が着脱自在に装着される。また、把持部912は、後述するように外管91を生体組織600から引き抜くときに把持される部分となる。 The outer tube 91 has one end opening 911 having one end opened, and a grip 912 at the other end. The needle body 7 of the implant 2 is detachably attached to the one end opening 911. Further, the grip portion 912 is a portion to be gripped when the outer tube 91 is pulled out from the living tissue 600 as will be described later.
 なお、円弧状をなす外管91の中心角度は、135~210度であるのが好ましく、150~180度であるのがより好ましい。 It should be noted that the center angle of the arc-shaped outer tube 91 is preferably 135 to 210 degrees, and more preferably 150 to 180 degrees.
 また、外管91の構成材料としては、特に限定されず、例えば、ステンレス鋼、アルミニウムまたはアルミニウム合金、チタンまたはチタン合金のような金属材料が挙げられる。 Further, the constituent material of the outer tube 91 is not particularly limited, and examples thereof include metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy.
 図1に示すように、インプラント2は、全体形状が長尺状をなすインプラント本体3と、インプラント本体3の先端部に設けられた針体7と、規制手段4と、解除手段5とを有している。これら各部の構成については、支持部材10および第2の装置18の説明の後に説明する。 As shown in FIG. 1, the implant 2 includes an implant body 3 having an elongated overall shape, a needle body 7 provided at the distal end portion of the implant body 3, a regulating means 4, and a releasing means 5. is doing. The configuration of each part will be described after the description of the support member 10 and the second device 18.
 図1に示すように、支持部材10は、支持部101と、支持部101と異なる位置に配置された、すなわち、支持部101と離間して配置された案内部102と、支持部101と案内部102とを連結する連結部103とを有している。 As shown in FIG. 1, the support member 10 is provided with a support portion 101, a guide portion 102 arranged at a position different from the support portion 101, that is, spaced apart from the support portion 101, and the support portion 101 and the guide. It has the connection part 103 which connects the part 102. FIG.
 支持部101は、直方体または立方体のブロック体で構成され、当該ブロック体を貫通する貫通孔104が形成された部材である。貫通孔104は、組立状態の穿刺針組立体9(外管91)が挿通可能であり、当該外管91と同等の曲率で湾曲している。そして、この貫通孔104により、組立状態の穿刺針組立体9は、外管91の円弧の中心Oを中心軸とする軸回りに回動可能に支持される(図6、図7参照)。 The support portion 101 is a member formed of a rectangular parallelepiped or a cubic block body, and a through hole 104 penetrating the block body is formed. The through-hole 104 can be inserted with the puncture needle assembly 9 (outer tube 91) in an assembled state, and is curved with the same curvature as the outer tube 91. The puncture needle assembly 9 in an assembled state is supported by the through-hole 104 so as to be rotatable about an axis having the center O of the arc of the outer tube 91 as a central axis (see FIGS. 6 and 7).
 また、支持部101の図1中の下側の面105は、体表面700に宛がわれる当て部として機能する。なお、支持部101は、ブロック体には限定されず、例えば曲面を含む形状であってもよい。 Further, the lower surface 105 in FIG. 1 of the support portion 101 functions as a contact portion addressed to the body surface 700. In addition, the support part 101 is not limited to a block body, For example, the shape containing a curved surface may be sufficient.
 案内部102は、直方体または立方体のブロック体で構成され、組立状態の穿刺針組立体9が回動した際に、針体7の針先71が向かう方向に位置する部材である。 The guide portion 102 is a member that is configured by a rectangular parallelepiped or a cubic block body and is positioned in a direction in which the needle tip 71 of the needle body 7 is directed when the assembled puncture needle assembly 9 is rotated.
 案内部102の図1中の下側の面106、すなわち、針先71に臨む面は、体表面700に宛がわれる当て部として機能する。なお、案内部102は、ブロック体には限定されず、例えば曲面を含む形状であってもよい。 The lower surface 106 of the guide portion 102 in FIG. 1, that is, the surface facing the needle tip 71 functions as an abutting portion addressed to the body surface 700. In addition, the guide part 102 is not limited to a block body, For example, the shape containing a curved surface may be sufficient.
 また、案内部102の面106には、組立状態の穿刺針組立体9の回動(移動)を規制する機能を有する規制部8が設けられている。この規制部8は、面106に凹没して形成された凹部107で構成されている。凹部107の形状は、針体7の針先71から段差部72までの外形形状と同じかまたは外形形状よりも若干大きい。 Further, the surface 106 of the guide portion 102 is provided with a restriction portion 8 having a function of restricting the rotation (movement) of the assembled puncture needle assembly 9. The restricting portion 8 includes a concave portion 107 formed by being recessed in the surface 106. The shape of the recess 107 is the same as or slightly larger than the outer shape from the needle tip 71 to the stepped portion 72 of the needle body 7.
 連結部103は、長尺体で構成され、その両端部にそれぞれ支持部101と案内部102とを支持している。これにより、支持部101と案内部102とが連結部103を介して連結される。 The connecting portion 103 is formed of a long body, and supports the support portion 101 and the guide portion 102 at both ends thereof. Thereby, the support part 101 and the guide part 102 are connected via the connection part 103.
 図2に示すように、第2の装置18は、尿道100内に挿入される長手形状の尿道挿入部材30と、膣200内に挿入される長手形状の膣挿入部材40と、尿道挿入部材30と膣挿入部材40とを連結する連結部材50とを備えている。 As shown in FIG. 2, the second device 18 includes a longitudinal urethral insertion member 30 inserted into the urethra 100, a longitudinal vagina insertion member 40 inserted into the vagina 200, and the urethral insertion member 30. And a connecting member 50 that connects the vaginal insertion member 40.
 図3に示すように、尿道挿入部材30および膣挿入部材40は、それぞれ、横断面形状が円形の棒状体で構成されている。また、尿道挿入部材30の直径は、膣挿入部材40の直径よりも小さい。 As shown in FIG. 3, the urethral insertion member 30 and the vagina insertion member 40 are each composed of a rod-shaped body having a circular cross-sectional shape. Further, the diameter of the urethral insertion member 30 is smaller than the diameter of the vaginal insertion member 40.
 尿道挿入部材30の先端面301は、丸みを帯びている。これにより、尿道挿入部材30を尿道100内に挿入するときに、先端面301で尿道100内を傷つけるのを確実に防止することができ、よって、挿入時の安全性が高い。 The distal end surface 301 of the urethral insertion member 30 is rounded. Thus, when the urethra insertion member 30 is inserted into the urethra 100, it is possible to reliably prevent the inside of the urethra 100 from being damaged by the distal end surface 301, and thus the safety during insertion is high.
 また、膣挿入部材40の先端面401も丸みを帯びている。これにより膣挿入部材40を膣200内に挿入するときに、先端面401で膣200内を傷つけるのを確実に防止することができ、よって、挿入時の安全性が高い。 Also, the distal end surface 401 of the vaginal insertion member 40 is rounded. Thereby, when inserting the vagina insertion member 40 into the vagina 200, it is possible to reliably prevent the inside of the vagina 200 from being damaged by the distal end surface 401. Therefore, the safety at the time of insertion is high.
 連結部材50は、尿道挿入部材30と膣挿入部材40とを互いに離間させ、かつ、平行な状態で連結する部材である。なお、連結部材50は、尿道挿入部材30と膣挿入部材40との離間距離を調整可能に構成されているのが好ましい。 The connecting member 50 is a member that separates the urethral insertion member 30 and the vagina insertion member 40 from each other and connects them in a parallel state. In addition, it is preferable that the connection member 50 is comprised so that adjustment of the separation distance of the urethral insertion member 30 and the vagina insertion member 40 is possible.
 尿道挿入部材30、膣挿入部材40、連結部材50、支持部101、案内部102、連結部103の構成材料としては、特に限定されず、例えば、ステンレス鋼、アルミニウムまたはアルミニウム合金、チタンまたはチタン合金のような金属材料が挙げられる。また、その他の構成材料としては、例えば、ポリエチレン、ポリプロピレン、エチレン-プロピレン共重合体、エチレン-酢酸ビニル共重合体(EVA)等のポリオレフィン、環状ポリオレフィン、変性ポリオレフィン、ポリ塩化ビニル、ポリ塩化ビニリデン、ポリスチレン、ポリアミド、ポリイミド、ポリアミドイミド、ポリカーボネート、ポリ-(4-メチルペンテン-1)、アイオノマー、アクリル系樹脂、ポリメチルメタクリレート、アクリロニトリル-ブタジエン-スチレン共重合体(ABS樹脂)、その他フッ素系樹脂、スチレン系、ポリオレフィン系、ポリ塩化ビニル系、ポリウレタン系、ポリエステル系、ポリアミド系、ポリブタジエン系、トランスポリイソプレン系、フッ素ゴム系、塩素化ポリエチレン系等の各種熱可塑性エラストマーが挙げられる。 The constituent materials of the urethral insertion member 30, the vaginal insertion member 40, the connection member 50, the support portion 101, the guide portion 102, and the connection portion 103 are not particularly limited. For example, stainless steel, aluminum or aluminum alloy, titanium or titanium alloy Metal materials such as Other constituent materials include, for example, polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer (EVA), cyclic polyolefin, modified polyolefin, polyvinyl chloride, polyvinylidene chloride, Polystyrene, polyamide, polyimide, polyamideimide, polycarbonate, poly- (4-methylpentene-1), ionomer, acrylic resin, polymethyl methacrylate, acrylonitrile-butadiene-styrene copolymer (ABS resin), other fluorine resins, Various thermoplastics such as styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluoro rubber, and chlorinated polyethylene Elastomers.
 次に、尿失禁治療の際に生体内に埋設して用いられるインプラント2について説明する。 Next, the implant 2 that is embedded and used in the living body for urinary incontinence treatment will be described.
 前述したように、インプラント2は、インプラント本体3と、針体7と、規制手段4と、解除手段5とを有している。 As described above, the implant 2 has the implant body 3, the needle body 7, the restricting means 4, and the releasing means 5.
 図4~図14に示すように、インプラント本体3は、帯状をなす第1の帯状部材(一方の帯状部材)31と、帯状をなす第2の帯状部材(他方の帯状部材)32とで構成されている。 As shown in FIGS. 4 to 14, the implant body 3 is composed of a first belt-like member (one belt-like member) 31 having a belt shape and a second belt-like member (the other belt-like member) 32 having a belt shape. Has been.
 第1の帯状部材31(第1の部分)と第2の帯状部材32(第2の部分)とは、その長手方向に沿って配置され、一端側に第1の帯状部材31が位置し、他端側に第2の帯状部材32が位置している。 The first belt-like member 31 (first portion) and the second belt-like member 32 (second portion) are arranged along the longitudinal direction, and the first belt-like member 31 is located on one end side, The 2nd strip | belt-shaped member 32 is located in the other end side.
 また、インプラント本体3では、第1の帯状部材31の基端部311と第2の帯状部材32の先端部321とが重なり合った状態となっており、その部分が重なり部33となっている。この重なり部33を、規制手段4を構成する縫合糸41が縫合している。 Further, in the implant body 3, the proximal end portion 311 of the first belt-shaped member 31 and the distal end portion 321 of the second belt-shaped member 32 are overlapped, and the portion is an overlapping portion 33. The overlapping portion 33 is stitched with a suture thread 41 constituting the regulating means 4.
 第1の帯状部材31および第2の帯状部材32は、それぞれ、可撓性を有し、その構成材料としては、ポリエチレン、ポリプロピレン等のような生体適合性を有する各種樹脂材料や、その他、生体適合性を有するポリグリコール酸、ポリジオキサノン、ポリ乳酸等のような樹脂材料を用いることができる。そして、このような樹脂材料を繊維状にして、編んだり撚り合わせたりすることにより、第1の帯状部材31や第2の帯状部材32を構成することができる。 Each of the first belt-like member 31 and the second belt-like member 32 has flexibility, and as its constituent material, various resin materials having biocompatibility such as polyethylene and polypropylene, and other biological materials Resin materials such as compatible polyglycolic acid, polydioxanone, polylactic acid and the like can be used. And the 1st strip | belt-shaped member 31 and the 2nd strip | belt-shaped member 32 can be comprised by making such a resin material into a fiber form, and knitting or twisting together.
 また、第1の帯状部材31および第2の帯状部材32は、それぞれ、メッシュ状をなし、その目開きとしては、特に限定されず、例えば、0.1~3.0mmであるのが好ましく、0.2~1.0mmであるのがより好ましい。 Further, each of the first belt-like member 31 and the second belt-like member 32 has a mesh shape, and the opening is not particularly limited, and is preferably 0.1 to 3.0 mm, for example. More preferably, it is 0.2 to 1.0 mm.
 さらに、第1の帯状部材31および第2の帯状部材32の全長は、それぞれ、30~150mmであるのが好ましく、50~100mmであるのがより好ましい。なお、第1の帯状部材31の全長と第2の帯状部材32の全長とは、異なっていてもよいが、同じであるのが好ましい。全長が同じである場合、インプラント本体3では、その長手方向の中央部に重なり部33が位置する。これにより、インプラント本体3の中でも比較的強度が高い重なり部33で尿道100を確実に支えることができる。 Furthermore, the total length of the first strip member 31 and the second strip member 32 is preferably 30 to 150 mm, and more preferably 50 to 100 mm. In addition, although the full length of the 1st strip | belt-shaped member 31 and the full length of the 2nd strip | belt-shaped member 32 may differ, it is preferable that it is the same. When the full length is the same, in the implant main body 3, the overlap part 33 is located in the center part of the longitudinal direction. Thereby, the urethra 100 can be reliably supported by the overlapping part 33 having relatively high strength in the implant body 3.
 第1の帯状部材31および第2の帯状部材32の幅は、それぞれ、3~15mmであるのが好ましく、5~10mmであるのがより好ましい。なお、第1の帯状部材31の全長と第2の帯状部材32の幅とは、異なっていてもよいが、同じであるのが好ましい。 The widths of the first strip member 31 and the second strip member 32 are each preferably 3 to 15 mm, and more preferably 5 to 10 mm. In addition, although the full length of the 1st strip | belt-shaped member 31 and the width | variety of the 2nd strip | belt-shaped member 32 may differ, it is preferable that it is the same.
 第1の帯状部材31および第2の帯状部材32の厚さは、それぞれ、0.1~2.0mmであるのが好ましく、0.2~1.0mmであるのがより好ましい。なお、第1の帯状部材31の全長と第2の帯状部材32の厚さとは、異なっていてもよいが、同じであるのが好ましい。 The thickness of each of the first belt member 31 and the second belt member 32 is preferably 0.1 to 2.0 mm, and more preferably 0.2 to 1.0 mm. In addition, although the full length of the 1st strip | belt-shaped member 31 and the thickness of the 2nd strip | belt-shaped member 32 may differ, it is preferable that it is the same.
 第1の帯状部材31の先端部には、針体7が連結、固定されている。この固定方法としては、特に限定されず、例えば、接着(接着剤や溶媒による接着)による方法、融着(熱融着、高周波融着、超音波融着等)による方法等が挙げられる。 The needle body 7 is connected and fixed to the distal end portion of the first belt-like member 31. The fixing method is not particularly limited, and examples thereof include a method using adhesion (adhesion using an adhesive or a solvent), a method using fusion (thermal fusion, high frequency fusion, ultrasonic fusion, etc.), and the like.
 針体7は、キノコ状をなし、その頂部が、生体組織600を穿刺する、丸みを帯びた非鋭利な針先71となっている。また、針体7の基端部、すなわち、針先71と反対側の部分には、外径が急峻に変化した段差部72が形成されている。 The needle body 7 has a mushroom shape, and a top portion thereof is a rounded non-sharp needle tip 71 that punctures the living tissue 600. Further, a stepped portion 72 whose outer diameter changes sharply is formed at the proximal end portion of the needle body 7, that is, the portion opposite to the needle tip 71.
 針体7構成材料としては、特に限定されず、例えば、外管91と同様の構成材料を用いることができる。 The constituent material of the needle body 7 is not particularly limited, and for example, the same constituent material as that of the outer tube 91 can be used.
 図5~図10に示すように、穿刺装置1では、尿道挿入部材30を尿道100内に挿入し、膣挿入部材40を膣200内に挿入し、支持部101の面105を体表面700に宛がい、さらに、案内部102の面106を体表面700に宛がった状態(以下この状態を「使用状態」と言う)で、穿刺針組立体9を操作することができる。この操作中に、生体組織600は、針体7の針先71より、支持部101側から案内部102側に向かって、穿刺されることとなる(図7参照)。そして、針先71が案内部102に接近していくと、針先71で、生体組織600の一部が案内部102に向かって押圧されて、凹部107に入り込んで硬くなる。このとき、術者は、その手に穿刺針組立体9の生体組織600に対する穿刺抵抗が急峻に増大したことを感じることができ、穿刺針組立体9を押し込む操作を停止することができる。これにより、生体組織600に形成された穿刺孔は、生体組織600を確実に所定の深さに穿刺したもの、すなわち、生体組織600を貫通しないものとなる。このような穿刺は、患者への負担が少なく、患者の安全性も高い。また、針体7が体外に突出するのが防止されるため、針体7で指先を穿刺してしまうことを防止することができ、安全である。 As shown in FIGS. 5 to 10, in the puncture device 1, the urethral insertion member 30 is inserted into the urethra 100, the vaginal insertion member 40 is inserted into the vagina 200, and the surface 105 of the support portion 101 is placed on the body surface 700. Further, the puncture needle assembly 9 can be operated in a state where the surface 106 of the guide portion 102 is directed to the body surface 700 (hereinafter, this state is referred to as “use state”). During this operation, the living tissue 600 is punctured from the needle tip 71 of the needle body 7 toward the guide portion 102 side from the support portion 101 side (see FIG. 7). When the needle tip 71 approaches the guide portion 102, a part of the living tissue 600 is pressed toward the guide portion 102 by the needle tip 71 and enters the concave portion 107 and becomes hard. At this time, the operator can feel that the puncture resistance of the puncture needle assembly 9 to the living tissue 600 has sharply increased in his hand, and can stop the operation of pushing the puncture needle assembly 9. Thereby, the puncture hole formed in the biological tissue 600 is a puncture of the biological tissue 600 to a predetermined depth, that is, a hole that does not penetrate the biological tissue 600. Such puncture has a low burden on the patient and high patient safety. In addition, since the needle body 7 is prevented from protruding outside the body, it is possible to prevent the needle body 7 from puncturing the fingertip, which is safe.
 規制手段4は、第1の帯状部材31と第2の帯状部材32との、インプラント本体3の長手方向の距離を規制するものである。この規制手段4は、縫合糸41で構成されている。 The regulating means 4 regulates the distance in the longitudinal direction of the implant body 3 between the first belt-like member 31 and the second belt-like member 32. This regulating means 4 is constituted by a suture thread 41.
 図11に示すように、縫合糸41は、第1の帯状部材31の基端部311と第2の帯状部材32の先端部321とが重なり合った重なり部33を縫合している。これにより、端部同士が連結され、よって、前記距離を確実に規制することができる。そして、この規制により、インプラント2(インプラント本体3)全体としての伸長も規制され、よって、インプラント2は、尿道100を支えても伸長して弛むのが確実に防止され、尿失禁機能を確実に発揮することができる。 As shown in FIG. 11, the suture thread 41 sews the overlapping portion 33 where the base end portion 311 of the first belt-like member 31 and the tip portion 321 of the second belt-like member 32 overlap each other. Thereby, edge parts are connected, Therefore The said distance can be controlled reliably. This restriction also restricts the extension of the implant 2 (implant body 3) as a whole. Therefore, the implant 2 is reliably prevented from extending and sagging even when the urethra 100 is supported, and the urinary incontinence function is ensured. It can be demonstrated.
 図11に示すように、前記距離を規制した状態での縫合糸41は、「なみ縫い」となっている。また、縫合糸41は、その長手方向の途中が折り返された折り返し部411が形成されている。折り返し部411には、縫合糸41の一方の端部412と、他方の端部413とが一括して挿通している。これにより、解除手段5を構成する牽引糸51が引張られるまで、縫合糸41が弛んで解けるのが防止される。 As shown in FIG. 11, the suture thread 41 in a state where the distance is regulated is “sew stitch”. Further, the suture thread 41 is formed with a folded portion 411 that is folded halfway in the longitudinal direction. One end portion 412 and the other end portion 413 of the suture thread 41 are collectively inserted into the folded portion 411. Thereby, the suture thread 41 is prevented from being loosened and unwound until the pulling thread 51 constituting the release means 5 is pulled.
 解除手段5は、縫合糸41(規制手段4)による規制を解除するものである。この解除手段5は、縫合糸41と別体で構成された牽引糸51で構成されている。図1に示すように、牽引糸51は、外管91内では、インプラント2の長手方向に沿って配置される。 The release means 5 releases the restriction by the suture thread 41 (the restriction means 4). The release means 5 is composed of a pulling thread 51 that is formed separately from the suture thread 41. As shown in FIG. 1, the traction thread 51 is disposed along the longitudinal direction of the implant 2 in the outer tube 91.
 図11に示すように、牽引糸51は、その長手方向の途中が折り返された折り返し部511が形成されている。この折り返し部511は、縫合糸41の折り返し部411を挿通して、当該折り返し部411と係合している。これにより、牽引糸51をインプラント本体の長手方向に沿って引張りさえすれば、縫合糸41を折り返し部411側に確実に牽引して、当該縫合糸41による縫合を容易に解くことができる(図11~図14参照)。このように、インプラント2では、解除操作を引張り操作という簡単な操作で行なうことができる。 As shown in FIG. 11, the pulling thread 51 has a folded portion 511 that is folded halfway in the longitudinal direction. The folded portion 511 is inserted through the folded portion 411 of the suture thread 41 and engaged with the folded portion 411. Thus, as long as the pulling thread 51 is pulled along the longitudinal direction of the implant body, the suture 41 can be reliably pulled toward the folded portion 411 and the suture by the suture 41 can be easily released (see FIG. 11 to 14). Thus, in the implant 2, the release operation can be performed by a simple operation called a pulling operation.
 そして、縫合糸41が解かれる、すなわち、縫合糸41による規制が牽引糸51(解除手段5)で解除されると、第1の帯状部材31と第2の帯状部材32とが分離して、互いに反対方向に向かって離間可能な状態となる。なお、この離間状態とする操作は、後述するように、インプラント2に作用する張力が過剰で、尿閉等の合併症が生じた場合に行なわれる。 Then, when the suture thread 41 is released, that is, when the regulation by the suture thread 41 is released by the traction thread 51 (release means 5), the first belt member 31 and the second belt member 32 are separated, It will be in the state which can be spaced apart in the mutually opposite direction. In addition, the operation for setting the separated state is performed when the tension acting on the implant 2 is excessive and complications such as urinary retention occur, as will be described later.
 なお、図1、図4に示すように、牽引糸51の折り返し部511と反対側の部分には、牽引糸41に対する引張り操作を行なうときに把持される把持部512が設けられている。この把持部512は、リング状をなし、第2の帯状部材32側に配置される。 In addition, as shown in FIGS. 1 and 4, a grip portion 512 that is gripped when a pulling operation is performed on the traction thread 41 is provided on a portion of the traction thread 51 on the side opposite to the folded portion 511. The grip portion 512 has a ring shape and is disposed on the second belt-like member 32 side.
 また、縫合糸41および牽引糸51の構成材料としては、特に限定されず、例えば、第1の帯状部材31や第2の帯状部材32と同様の材料を用いることができる。 Further, the constituent materials of the suture thread 41 and the traction thread 51 are not particularly limited, and for example, the same material as that of the first belt-like member 31 and the second belt-like member 32 can be used.
 次に、穿刺装置1(インプラント2)の使用方法の一例について、図5~図10を参照しつつ説明する。ここでは、穿刺装置1を用いて、女性の尿失禁の治療のための、インプラント2を生体内に埋設するまでの手順について説明する。この手順では、穿刺装置1で形成される穿刺孔は、左側の閉鎖孔400から右側の閉鎖孔400に向かって形成された非貫通孔となる。 Next, an example of how to use the puncture device 1 (implant 2) will be described with reference to FIGS. Here, the procedure until the implant 2 is embedded in the living body for the treatment of female urinary incontinence using the puncture device 1 will be described. In this procedure, the puncture hole formed by the puncture device 1 becomes a non-through hole formed from the left closing hole 400 toward the right closing hole 400.
 図5に示すように、穿刺装置1を使用状態とする。すなわち、第1の装置17の支持部材10の、支持部101の面105を体表面700に宛がい、さらに、案内部102の面106を体表面700に宛がった状態とするとともに、第2の装置18の尿道挿入部材30を尿道100内に挿入し、膣挿入部材40を膣200内に挿入した状態とする。なお、使用状態では、支持部101を体表面700の左側の閉鎖孔400の対応する部分(上部)に宛がい、案内部102を体表面700の右側の閉鎖孔400の対応する部分(上部)に宛がう。 As shown in FIG. 5, the puncture device 1 is put into use. That is, the surface 105 of the support portion 101 of the support member 10 of the first device 17 is in contact with the body surface 700, and the surface 106 of the guide portion 102 is in contact with the body surface 700. The urethral insertion member 30 of the second apparatus 18 is inserted into the urethra 100, and the vagina insertion member 40 is inserted into the vagina 200. In use, the support portion 101 is directed to the corresponding portion (upper portion) of the left closing hole 400 of the body surface 700, and the guide portion 102 is corresponding to the corresponding portion (upper portion) of the right closing hole 400 of the body surface 700. Address.
 次に、図6に示すように、組立状態の穿刺針組立体9を針先71側から、支持部101の貫通孔104に挿入する。 Next, as shown in FIG. 6, the assembled puncture needle assembly 9 is inserted into the through hole 104 of the support portion 101 from the needle tip 71 side.
 そして、図7に示すように、穿刺針組立体9をそのまま押し込んで、支持部101側から案内部102側に向かって回動操作する。このとき、針先71が尿道挿入部材30よりも外管91の円弧の中心Oから遠位側(図7中の下側)を通過する、すなわち、針先71が尿道挿入部材30と膣挿入部材40との間を通過するように、穿刺針組立体9と尿道挿入部材30と膣挿入部材40との位置関係が支持部101によって規制される。これにより、穿刺針組立体9で形成される穿刺孔は、尿道100と膣200との間の、生体組織600の非常に薄い層、すなわち、膣壁300を通過したものとなる。 Then, as shown in FIG. 7, the puncture needle assembly 9 is pushed in as it is and rotated from the support portion 101 side toward the guide portion 102 side. At this time, the needle tip 71 passes the distal side (lower side in FIG. 7) from the center O of the arc of the outer tube 91 with respect to the urethra insertion member 30, that is, the needle tip 71 is inserted into the urethra insertion member 30 and the vagina. The positional relationship among the puncture needle assembly 9, the urethral insertion member 30, and the vaginal insertion member 40 is regulated by the support portion 101 so as to pass between the members 40. Thus, the puncture hole formed by the puncture needle assembly 9 passes through a very thin layer of the living tissue 600 between the urethra 100 and the vagina 200, that is, the vaginal wall 300.
 さらに、穿刺針組立体9を回動し続けると、前述したように、針先71で、生体組織600の一部が案内部102に向かって押圧されて、凹部107に入り込むこととなる。このとき、術者は、その手に穿刺針組立体9の生体組織600に対する穿刺抵抗が急峻に増大したことを感じることができる。これにより、針先71が案内部102側で体表面700に露出する前に、穿刺針組立体9の回動操作を停止することができる。このように生体組織600に形成された穿刺孔は、生体組織600を確実に所定の深さに穿刺したものとなる。 Further, when the puncture needle assembly 9 continues to rotate, a part of the living tissue 600 is pressed toward the guide portion 102 by the needle tip 71 and enters the recess 107 as described above. At this time, the surgeon can feel that the puncture resistance of the puncture needle assembly 9 to the living tissue 600 sharply increases in his / her hand. Thereby, before the needle tip 71 is exposed to the body surface 700 on the guide portion 102 side, the turning operation of the puncture needle assembly 9 can be stopped. In this way, the puncture hole formed in the living tissue 600 is obtained by reliably puncturing the living tissue 600 to a predetermined depth.
 次に、図8に示すように、穿刺針組立体9から外管91のみを前記と反対方向に引張り、当該外管91を抜去する。これにより、穿刺針組立体9は、分解状態となり、インプラント2のみが生体組織600に留置される。また、このインプラント2は、針体7の段差部72が生体組織600に係合することにより、生体組織600から不本意に抜け落ちるのが防止されている。 Next, as shown in FIG. 8, only the outer tube 91 is pulled from the puncture needle assembly 9 in the opposite direction, and the outer tube 91 is removed. As a result, the puncture needle assembly 9 is in a disassembled state, and only the implant 2 is placed in the living tissue 600. Further, the implant 2 is prevented from unintentionally falling off the living tissue 600 when the stepped portion 72 of the needle body 7 is engaged with the living tissue 600.
 次に、図9に示すように、支持部材10を体表面700から取り除く。 Next, as shown in FIG. 9, the support member 10 is removed from the body surface 700.
 次に、図10に示すように、インプラント2の第2の帯状部材32の長さを、尿道100を図中の下側から支持可能な程度に調節して、第2の帯状部材32の不要な部分を切除し、所定の縫合等を行って、手技を終了する。これにより、インプラント2には、その長手方向に張力が作用することとなり、尿道100を図中の下側から確実に圧迫して、尿失禁を防止することができる。なお、縫合を行なう前に、牽引糸51も生体内に埋設されるよう、その長さを調節しておく。 Next, as shown in FIG. 10, the length of the second band-shaped member 32 of the implant 2 is adjusted to such an extent that the urethra 100 can be supported from the lower side in the figure. This part is excised, and a predetermined suture is performed to complete the procedure. As a result, tension is applied to the implant 2 in the longitudinal direction, and the urethra 100 can be reliably compressed from the lower side in the figure to prevent urinary incontinence. Note that the length of the traction thread 51 is adjusted so as to be embedded in the living body before suturing.
 ところで、インプラント2に作用する張力が過剰であった場合には、排尿困難もしくは尿閉等の合併症が生じることがある。この場合の対処方法(処置)について、図11~図14を参照しつつ説明する。なお、従来は、このような合併症が発生すると、膣200を切開して、尿道100と膣200との間のインプラントを切断する手術が実施されていた。この手術は、インプラント切断に際し膣200を比較的広く切開するため、侵襲が大きく、患者への負担が大きいという問題があった。 Incidentally, if the tension acting on the implant 2 is excessive, complications such as difficulty in urination or urinary retention may occur. A coping method (treatment) in this case will be described with reference to FIGS. Conventionally, when such a complication occurs, an operation for incising the vagina 200 and cutting the implant between the urethra 100 and the vagina 200 has been performed. Since this operation cuts the vagina 200 relatively widely when cutting the implant, there is a problem that the invasion is large and the burden on the patient is large.
 まず、インプラント2は、図11に示す状態となっている。すなわち、インプラント2は、第1の帯状部材31と第2の帯状部材32とが縫合糸41により連結されて、これら帯状部材同士間の距離が規制されている。また、前述したように、縫合糸41は、一方の端部412と他方の端部413とが折り返し部411に一括して挿通している。 First, the implant 2 is in the state shown in FIG. That is, in the implant 2, the first band-shaped member 31 and the second band-shaped member 32 are connected by the suture thread 41, and the distance between these band-shaped members is regulated. Further, as described above, in the suture thread 41, one end portion 412 and the other end portion 413 are collectively inserted into the folded portion 411.
 そして、インプラント2の牽引糸51の把持部512を、例えば触診により探し出す。その後、生体の把持部512が埋設されている部分を切開して、生体から把持部512を取り出す。 Then, the grasping portion 512 of the traction thread 51 of the implant 2 is searched for, for example, by palpation. Thereafter, the part in which the living body holding part 512 is embedded is cut open, and the holding part 512 is taken out from the living body.
 次に、把持部512を把持して、図12に示すように、牽引糸51を図中右側に向かって引張る。これにより、縫合糸41は、折り返し部411側から牽引されて、当該折り返し部411から一方の端部412と他方の端部413とが抜け出、当該縫合糸41での縫合が解かれ始める。 Next, the grip part 512 is gripped, and the pulling thread 51 is pulled toward the right side in the figure as shown in FIG. As a result, the suture thread 41 is pulled from the folded-back portion 411 side, and the one end portion 412 and the other end portion 413 come out of the folded-back portion 411, and the suture with the suture thread 41 starts to be released.
 さらに、図13に示すように、牽引糸51を図中右側に向かって引張り続けると、前記縫合の解除が進んでいく。そして、遂には、図14に示すように、前記縫合が完全に解除される。これにより、第1の帯状部材31と第2の帯状部材32とが分離し、よって、インプラント2に作用していた張力が解除される。この状態では、尿道100に対する圧迫力も解除され、よって、合併症による症状が緩和される。 Further, as shown in FIG. 13, when the pulling thread 51 is continuously pulled toward the right side in the drawing, the release of the suturing proceeds. Finally, as shown in FIG. 14, the suturing is completely released. Thereby, the 1st strip | belt-shaped member 31 and the 2nd strip | belt-shaped member 32 isolate | separate, Therefore, the tension | tensile_strength which acted on the implant 2 is cancelled | released. In this state, the compression force on the urethra 100 is also released, and thus symptoms due to complications are alleviated.
 このように、インプラント2では、第1の帯状部材31と第2の帯状部材32とを分離する、すなわち、生体に留置された当該インプラント2に対して手技を行なうに際して、生体に対しては、牽引糸51を引張り出すためのできる限り小さい切開箇所で済む。このため、その手技を低侵襲で行なうことができ、よって、患者への負担を確実に低減することができる。 Thus, in the implant 2, the first strip member 31 and the second strip member 32 are separated, that is, when performing a procedure on the implant 2 placed in the living body, The smallest possible incision site for pulling out the traction thread 51 is sufficient. For this reason, the procedure can be performed with minimal invasiveness, and the burden on the patient can be reliably reduced.
 <第2実施形態>
 図15は、本発明のインプラントの第2実施形態を示す拡大詳細斜視図、図16~図19は、それぞれ、図15に示すインプラントを分離する手順を説明するための図である。
Second Embodiment
FIG. 15 is an enlarged detailed perspective view showing a second embodiment of the implant of the present invention, and FIGS. 16 to 19 are views for explaining a procedure for separating the implant shown in FIG.
 以下、これらの図を参照して本発明のインプラントの第2実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the second embodiment of the implant of the present invention will be described with reference to these drawings. However, the difference from the above-described embodiment will be mainly described, and description of similar matters will be omitted.
 本実施形態は、解除手段の構成が異なること以外は前記第1実施形態と同様である。 This embodiment is the same as the first embodiment except that the configuration of the release means is different.
 図15~図19に示すように、本実施形態のインプラント2では、解除手段5Aは、牽引糸51の他に、さらに固定手段52を有している。固定手段52は、縫合糸41に対する固定と、その固定の解除とを行なうものである。 15 to 19, in the implant 2 of the present embodiment, the releasing means 5A further includes a fixing means 52 in addition to the traction thread 51. The fixing means 52 performs fixing to the suture thread 41 and releasing the fixing.
 固定手段52は、牽引糸51が挿通するチューブ53と、牽引糸51に対する引張り操作を行なうときに把持される把持部材54とを有している。 The fixing means 52 includes a tube 53 through which the traction thread 51 is inserted and a gripping member 54 that is gripped when a pulling operation is performed on the traction thread 51.
 チューブ53は、インプラント本体3の重なり部33から第2の帯状部材32の基端部付近にまで延在している。 The tube 53 extends from the overlapping portion 33 of the implant body 3 to the vicinity of the proximal end portion of the second belt-like member 32.
 図16~図19に示すように、チューブ53の基端部には、その管壁を貫通する貫通孔で構成された第1の係合部531と第2の係合部532とがそれぞれ形成されている。第1の係合部531と第2の係合部532とは、チューブ53の長手方向に沿って配置されており、第1の係合部531が先端側に位置し、第2の係合部532が基端側に位置している。なお、第2の係合部532のチューブ53の長手方向に沿った長さは、第1の係合部531のチューブ53の長手方向に沿った長さよりも長い。 As shown in FIGS. 16 to 19, a first engagement portion 531 and a second engagement portion 532 each formed of a through hole penetrating the tube wall are formed at the proximal end portion of the tube 53. Has been. The first engaging portion 531 and the second engaging portion 532 are arranged along the longitudinal direction of the tube 53, and the first engaging portion 531 is located on the distal end side, and the second engaging portion The part 532 is located on the proximal end side. Note that the length of the second engagement portion 532 along the longitudinal direction of the tube 53 is longer than the length of the first engagement portion 531 along the longitudinal direction of the tube 53.
 把持部材54は、本体部541と、当該本体部541から突出して形成された弾性片542とで構成されている。 The gripping member 54 includes a main body 541 and an elastic piece 542 formed to protrude from the main body 541.
 本体部541は、小片で構成され、その先端部に牽引糸51の一方の端部513と他方の端部514とがそれぞれ連結されている。これにより、牽引糸51を確実に引張ることができる。 The main body portion 541 is composed of small pieces, and one end portion 513 and the other end portion 514 of the traction thread 51 are connected to the tip portion thereof. Thereby, the pulling thread 51 can be reliably pulled.
 また、本体部541は、その先端部にチューブ53の基端部に内側から嵌合する嵌合部543を有している。そして、図16に示すように、嵌合部543がチューブ53の基端部に嵌合した嵌合状態では、嵌合部543の外周部とチューブ53の基端内周部との間で、縫合糸41の一方の端部412と他方の端部413とを一括して挟持することができる。これにより、縫合糸41に対する固定が行われ、よって、縫合糸41が不本意に引張られて、重なり部33に対する縫合が解かれるのが確実に防止される。 Further, the main body portion 541 has a fitting portion 543 that is fitted to the proximal end portion of the tube 53 from the inside at the distal end portion thereof. Then, as shown in FIG. 16, in the fitting state where the fitting portion 543 is fitted to the proximal end portion of the tube 53, between the outer peripheral portion of the fitting portion 543 and the proximal inner peripheral portion of the tube 53, One end 412 and the other end 413 of the suture thread 41 can be clamped together. Thereby, fixation to the suture thread 41 is performed, and therefore, the suture thread 41 is unintentionally pulled, and it is reliably prevented that the suture with respect to the overlapping portion 33 is released.
 弾性片542は、嵌合部543から先端方向に向かって突出して形成されている。この弾性片542の先端部には、爪544が突出して形成されている。この爪544は、チューブ53の第1の係合部531および第2の係合部532にそれぞれ係合することができる。そして、爪544が第1の係合部531に係合した第1の状態(図15、図16参照)では、前記嵌合状態が維持される。また、爪544が第2の係合部532に係合した第2の状態(図17~図19参照)では、前記嵌合状態が解除されて、これに伴って、縫合糸41に対する固定も解除される。また、第2の状態では、チューブ53を牽引糸51とともに引張ることができる。 The elastic piece 542 is formed to protrude from the fitting portion 543 toward the distal end. A claw 544 protrudes from the tip of the elastic piece 542. The claw 544 can engage with the first engaging portion 531 and the second engaging portion 532 of the tube 53, respectively. And in the 1st state (refer to Drawing 15 and Drawing 16) where claw 544 engaged with the 1st engagement part 531, the above-mentioned fitting state is maintained. Further, in the second state (see FIGS. 17 to 19) in which the claw 544 is engaged with the second engaging portion 532, the fitting state is released, and as a result, the suture thread 41 is also fixed. Canceled. In the second state, the tube 53 can be pulled together with the pulling thread 51.
 なお、チューブ53および把持部材54の構成材料としては、特に限定されず、例えば、第1の帯状部材31や第2の帯状部材32と同様の材料を用いることができる。 In addition, it does not specifically limit as a constituent material of the tube 53 and the holding member 54, For example, the material similar to the 1st strip | belt-shaped member 31 and the 2nd strip | belt-shaped member 32 can be used.
 図16に示すように、縫合糸41は、折り返し部411を介して一方の端部412側の部分414と、他方の端部413の部分415とが、インプラント本体3の幅方向に互いに接近する方向に向かって重なり部33を縫合している。また、折り返し部411には、一方の端部412および他方の端部413の内の少なくとも一方が挿通している。 As shown in FIG. 16, in the suture thread 41, a part 414 on the one end part 412 side and a part 415 on the other end part 413 approach each other in the width direction of the implant body 3 via the folded part 411. The overlapping portion 33 is stitched in the direction. Further, at least one of the one end 412 and the other end 413 is inserted through the folded portion 411.
 次に、インプラント2に作用する過剰な張力によって尿閉等の合併症が生じた場合に、インプラント2を分離して、当該張力を解除する方法について、図16~図19を参照しつつ説明する。 Next, a method of separating the implant 2 and releasing the tension when complications such as urinary retention occur due to excessive tension acting on the implant 2 will be described with reference to FIGS. .
 まず、インプラント2は、図16に示す状態となっている。すなわち、インプラント2は、第1の帯状部材31と第2の帯状部材32とが縫合糸41により連結されて、これら帯状部材同士間の距離が規制されている。また、解除手段5Aは、第1の状態となっており、これにより、前述したように縫合糸41が不本意に解けるのが防止されている。 First, the implant 2 is in the state shown in FIG. That is, in the implant 2, the first band-shaped member 31 and the second band-shaped member 32 are connected by the suture thread 41, and the distance between these band-shaped members is regulated. Further, the releasing means 5A is in the first state, thereby preventing the suture 41 from being unintentionally unraveled as described above.
 そして、インプラント2の把持部材54を、例えば触診により探し出す。その後、生体の把持部材54が埋設されている部分を切開して、生体から把持部材54を取り出す。 Then, the grasping member 54 of the implant 2 is searched for by palpation, for example. Thereafter, the part in which the living body grasping member 54 is embedded is cut open, and the grasping member 54 is taken out from the living body.
 次に、把持部材54を把持して、その弾性片542の爪544を下方に向かって押圧しつつ、図17に示すように、把持部材54を図中右側に向かって引張る。これにより、解除手段5Aは、第2の状態となり、よって、前述したように縫合糸41に対する固定が解除される。また、これとほぼ同時に、縫合糸41は、折り返し部411側から牽引されて、当該縫合糸41での縫合が解かれ始める。 Next, the gripping member 54 is gripped, and the gripping member 54 is pulled toward the right side in the drawing as shown in FIG. 17 while pressing the claw 544 of the elastic piece 542 downward. As a result, the release means 5A enters the second state, and thus the fixation to the suture thread 41 is released as described above. At substantially the same time, the suture thread 41 is pulled from the folded-back portion 411 side, and the suture with the suture thread 41 starts to be released.
 さらに、図18に示すように、把持部材54を図中右側に向かって引張り続けると、前記縫合の解除が進んでいくとともに、チューブ53も生体から抜去させていく。そして、遂には、図19に示すように、前記縫合が完全に解除される。これにより、第1の帯状部材31と第2の帯状部材32とが分離し、よって、インプラント2に作用していた張力が解除される。この状態では、尿道100に対する圧迫力も解除され、よって、合併症による症状が緩和される。 Further, as shown in FIG. 18, when the gripping member 54 is continuously pulled toward the right side in the figure, the release of the suturing proceeds and the tube 53 is also removed from the living body. Finally, as shown in FIG. 19, the suturing is completely released. Thereby, the 1st strip | belt-shaped member 31 and the 2nd strip | belt-shaped member 32 isolate | separate, Therefore, the tension | tensile_strength which acted on the implant 2 is cancelled | released. In this state, the compression force on the urethra 100 is also released, and thus symptoms due to complications are alleviated.
 このように、本実施形態のインプラント2でも、生体に留置された当該インプラント2に対して手技を行なうに際し、生体に対しては、解除手段5Aを引張り出すためのできる限り小さい切開箇所で済む。このため、その手技を低侵襲で行なうことができ、よって、患者への負担を確実に低減することができる。 As described above, even in the implant 2 of the present embodiment, when performing a procedure on the implant 2 placed in the living body, the smallest possible incision portion for pulling out the releasing means 5A is sufficient for the living body. For this reason, the procedure can be performed with minimal invasiveness, and the burden on the patient can be reliably reduced.
 <第3実施形態>
 図20は、本発明のインプラントの第3実施形態を示す平面図および側面図、図21~図23は、それぞれ、図20に示すインプラントを分離する手順を説明するための図である。
<Third Embodiment>
FIG. 20 is a plan view and a side view showing a third embodiment of the implant of the present invention, and FIGS. 21 to 23 are views for explaining a procedure for separating the implant shown in FIG.
 以下、これらの図を参照して本発明のインプラントの第3実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the third embodiment of the implant of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
 本実施形態は、規制手段および解除手段の構成がそれぞれ異なること以外は前記第1実施形態と同様である。 This embodiment is the same as the first embodiment except that the configurations of the restricting means and the releasing means are different from each other.
 図20~図23に示すように、本実施形態のインプラント2では、規制手段4Bは、第1の帯状部材31の基端部311に装着された第1のコネクタ42と、第2の帯状部材32の先端部321に装着された第2のコネクタ43とで構成されている。第1のコネクタ42と第2のコネクタ43とは、図20、図21に示す接続状態と、図22、図23に示す接続解除状態とを取り得る。 As shown in FIGS. 20 to 23, in the implant 2 of the present embodiment, the restricting means 4B includes a first connector 42 attached to the proximal end portion 311 of the first belt-like member 31, and a second belt-like member. The second connector 43 is attached to the distal end portion 321 of 32. The first connector 42 and the second connector 43 can take the connected state shown in FIGS. 20 and 21 and the disconnected state shown in FIGS. 22 and 23.
 第1のコネクタ42は、平板状をなす本体部420と、本体部420の先端面から突出形成された突部421とで構成されている。 The first connector 42 includes a main body 420 having a flat plate shape, and a protrusion 421 formed to protrude from the front end surface of the main body 420.
 本体部420は、両側面からそれぞれ先端面にわたって貫通して形成された一対の挿通孔424を有している。 The main body 420 has a pair of insertion holes 424 formed so as to penetrate from both side surfaces to the front end surface.
 突部421の先端面422は、丸みを帯びている。また、突部421の突出方向(長手方向)の途中の部分には、その幅が急峻に減少した段差部423が形成されている。 The front end surface 422 of the protrusion 421 is rounded. In addition, a stepped portion 423 whose width is sharply reduced is formed in the middle of the protruding portion 421 in the protruding direction (longitudinal direction).
 第2のコネクタ43は、平板状をなす本体部430と、本体部430から突出形成された一対の挟持片431とで構成されている。 The second connector 43 is constituted by a main body portion 430 having a flat plate shape and a pair of sandwiching pieces 431 formed to protrude from the main body portion 430.
 本体部430の先端面には、凹部432が凹没形成されている。 A recess 432 is formed in the front end surface of the main body 430 so as to be recessed.
 凹部432の内側には、一対の挟持片431が対向配置されている。各挟持片431は、それぞれ、弾性変形可能である。また、図21に示すように、各挟持片431同士で、第1のコネクタ42の突部421を挟持し合うことができる。そして、この挟持状態では、第1の帯状部材31と第2の帯状部材32とが連結される。一方、図22、図23に示すように、各挟持片431がそれぞれ弾性変形して突部421から離間した離間状態では、第1の帯状部材31と第2の帯状部材32との連結が解除され、これら帯状部材同士が分離することができる。 A pair of clamping pieces 431 are disposed opposite to each other inside the recess 432. Each clamping piece 431 is elastically deformable. Further, as shown in FIG. 21, the protruding portions 421 of the first connector 42 can be held between the holding pieces 431. And in this clamping state, the 1st strip | belt-shaped member 31 and the 2nd strip | belt-shaped member 32 are connected. On the other hand, as shown in FIG. 22 and FIG. 23, in the separated state in which each holding piece 431 is elastically deformed and separated from the protrusion 421, the connection between the first belt member 31 and the second belt member 32 is released. Thus, these band-like members can be separated from each other.
 図20、図21に示すように、解除手段5Bは、可撓性を有し、長尺状(帯状)をなす一対の長尺部材55で構成されている。各長尺部材55は、それぞれ、第1のコネクタ42の挿通孔424を挿通し、第2のコネクタ43の凹部432にまで到達している。これにより、各長尺部材55が、接続状態の第1のコネクタ42と第2のコネクタ43とに装着される。そして、この装着状態では、各長尺部材55は、それぞれ、凹部432を画成する内周部と、各挟持片431との間に挿入されて、当該各挟持片431の弾性変形を阻止することができる。これにより、前記挟持状態を維持して、第1の帯状部材31と第2の帯状部材32とが不本意に分離するのを確実に防止することができる。 As shown in FIGS. 20 and 21, the release means 5 </ b> B has a pair of long members 55 that are flexible and have a long shape (band shape). Each long member 55 passes through the insertion hole 424 of the first connector 42 and reaches the recess 432 of the second connector 43. Thereby, each long member 55 is attached to the first connector 42 and the second connector 43 in the connected state. In this mounted state, each long member 55 is inserted between the inner peripheral portion that defines the recess 432 and each holding piece 431 to prevent elastic deformation of each holding piece 431. be able to. Thereby, the said clamping state can be maintained and it can prevent reliably that the 1st strip | belt-shaped member 31 and the 2nd strip | belt-shaped member 32 isolate | separate unintentionally.
 また、各長尺部材55をそれぞれ引張ることにより、図22、図23に示すように、各長尺部材55は、それぞれ、接続状態の第1のコネクタ42と第2のコネクタ43とから抜去される、すなわち、離脱する。そして、この離脱状態では、各挟持片431は、それぞれ、弾性変形することができ、よって、第1のコネクタ42の突部421から離間した離間状態となる。これにより、第1の帯状部材31と第2の帯状部材32とが分離することができる。 Further, by pulling each long member 55, as shown in FIGS. 22 and 23, each long member 55 is removed from the connected first connector 42 and second connector 43, respectively. That is, leave. In this disengaged state, each clamping piece 431 can be elastically deformed, and thus is in a separated state separated from the protrusion 421 of the first connector 42. Thereby, the 1st strip | belt-shaped member 31 and the 2nd strip | belt-shaped member 32 can isolate | separate.
 次に、インプラント2に作用する過剰な張力によって尿閉等の合併症が生じた場合に、インプラント2を分離して、当該張力を解除する方法について、図21~図23を参照しつつ説明する。 Next, when a complication such as urinary retention occurs due to excessive tension acting on the implant 2, a method of separating the implant 2 and releasing the tension will be described with reference to FIGS. .
 まず、インプラント2は、図21に示す状態となっている。すなわち、インプラント2は、第1の帯状部材31と第2の帯状部材32とが、接続状態の第1のコネクタ42と第2のコネクタ43とを介して連結されて、これら帯状部材同士間の距離が規制されている。また、各長尺部材55は、それぞれ、装着状態となっており、前述したように、各挟持片431の弾性変形を阻止して、第1のコネクタ42と第2のコネクタ43とが接続解除状態となるのを防止している。 First, the implant 2 is in the state shown in FIG. That is, in the implant 2, the first belt-like member 31 and the second belt-like member 32 are connected via the first connector 42 and the second connector 43 in the connected state, and the band-like members are connected to each other. The distance is regulated. Further, each of the long members 55 is in a mounted state, and as described above, the elastic deformation of each sandwiching piece 431 is prevented, and the first connector 42 and the second connector 43 are disconnected. It is prevented from becoming a state.
 そして、インプラント2の各長尺部材55を、例えば触診により探し出す。 Then, each long member 55 of the implant 2 is searched for by palpation, for example.
 次に、各長尺部材55を把持して、図22に示すように、当該各長尺部材55を引張って、接続状態の第1のコネクタ42と第2のコネクタ43とから抜去する。これにより、前述したように、各挟持片431は、それぞれ、弾性変形することができ、よって、図23に示すように、第1の帯状部材31と第2の帯状部材32とが分離することができる。この分離により、インプラント2に作用していた張力が解除されて、尿道100に対する圧迫力も解除され、よって、合併症による症状が緩和される。 Next, each long member 55 is grasped, and each long member 55 is pulled and removed from the connected first connector 42 and second connector 43 as shown in FIG. As a result, as described above, each sandwiching piece 431 can be elastically deformed. Therefore, as shown in FIG. 23, the first strip member 31 and the second strip member 32 are separated. Can do. By this separation, the tension acting on the implant 2 is released, and the compression force on the urethra 100 is also released, thereby alleviating symptoms due to complications.
 このように、本実施形態のインプラント2でも、生体に留置された当該インプラント2に対して手技を行なうに際し、生体に対しては、各長尺部材55を引張り出すためのできる限り小さい切開箇所で済む。このため、その手技を低侵襲で行なうことができ、よって、患者への負担を確実に低減することができる。 As described above, even in the implant 2 according to the present embodiment, when performing a procedure on the implant 2 placed in the living body, the living body can be cut as small as possible in order to pull out the long members 55. That's it. For this reason, the procedure can be performed with minimal invasiveness, and the burden on the patient can be reliably reduced.
 なお、第1のコネクタ42、第2のコネクタ43および長尺部材55の構成材料としては、特に限定されず、例えば、第1の帯状部材31や第2の帯状部材32と同様の材料を用いることができる。 In addition, it does not specifically limit as a constituent material of the 1st connector 42, the 2nd connector 43, and the elongate member 55, For example, the material similar to the 1st strip | belt-shaped member 31 and the 2nd strip | belt-shaped member 32 is used. be able to.
 また、各長尺部材55は、それぞれ、本実施形態では接続状態の第1のコネクタ42と第2のコネクタ43とに装着されているが、これに限定されず、例えば、第1のコネクタ42から挿通孔424が省略され、その分だけ幅が小さい場合には、第2のコネクタ43にのみ装着されてもよい。 In addition, in the present embodiment, each of the long members 55 is attached to the first connector 42 and the second connector 43 that are in a connected state, but the present invention is not limited to this. For example, the first connector 42 is provided. If the insertion hole 424 is omitted from the above and the width is reduced by that amount, the insertion hole 424 may be attached only to the second connector 43.
 また、長尺部材55は、本実施形態では2本であるが、1本であってもよい。 In addition, the number of the long members 55 is two in this embodiment, but may be one.
 <第4実施形態>
 図24は、本発明のインプラントの第4実施形態を示す平面図、図25は、図24に示すインプラントの長さが調整された状態を示す平面図である。
<Fourth embodiment>
FIG. 24 is a plan view showing a fourth embodiment of the implant of the present invention, and FIG. 25 is a plan view showing a state in which the length of the implant shown in FIG. 24 is adjusted.
 以下、これらの図を参照して本発明のインプラントの第4実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the fourth embodiment of the implant of the present invention will be described with reference to these drawings. However, the difference from the above-described embodiment will be mainly described, and description of similar matters will be omitted.
 本実施形態は、インプラント本体の構成が異なること以外は前記第1実施形態と同様である。 This embodiment is the same as the first embodiment except that the configuration of the implant body is different.
 図24、図25に示すように、本実施形態のインプラント2では、インプラント本体3Cは、帯状をなす少なくとも3本(図中には7本が図示されている)の帯状部材34a、34b、34c、34d、34e、34f、34gを有している。これらの帯状部材34a~34gは、その長手方向に沿って間隔を置いて配置されている。 As shown in FIGS. 24 and 25, in the implant 2 of this embodiment, the implant body 3C has at least three belt-shaped members 34a, 34b, 34c (seven are shown in the figure) forming a belt-like shape. , 34d, 34e, 34f, and 34g. These belt-like members 34a to 34g are arranged at intervals along the longitudinal direction thereof.
 また、インプラント本体3Cは、隣接する第1の組の帯状部材34a、34bの端部同士の間に架設された一対の連結糸35aと、隣接する第2の組の帯状部材34b、34cの端部同士の間に架設された一対の連結糸35bと、隣接する第3の組の帯状部材34c、34dの端部同士の間に架設された一対の連結糸35cと、隣接する第4の組の帯状部材34d、34eの端部同士の間に架設された一対の連結糸35dと、隣接する第5の組の帯状部材34e、34fの端部同士の間に架設された一対の連結糸35eとを有している。連結糸35a~35eは、それぞれ、可撓性を有し、規制手段4Cによる規制が行われている間、撓んでいる。なお、連結糸35a~35eの長さは、同じであってもよいし、異なっていてもよい。 The implant body 3C includes a pair of connecting threads 35a installed between the ends of the adjacent first set of band-shaped members 34a and 34b and the ends of the adjacent second set of band-shaped members 34b and 34c. A pair of connecting yarns 35b laid between the parts, a pair of connecting yarns 35c laid between the ends of the adjacent third set of strip members 34c, 34d, and an adjacent fourth set A pair of connecting yarns 35d laid between the ends of the belt- like members 34d, 34e and a pair of connecting yarns 35e laid between the ends of the adjacent fifth set of belt- like members 34e, 34f. And have. Each of the connecting yarns 35a to 35e has flexibility and is bent while being regulated by the regulating means 4C. Note that the lengths of the connecting yarns 35a to 35e may be the same or different.
 図24に示すように、規制手段4Cは、第1の組の帯状部材34a、34bの端部同士を連結解除可能に連結する一対の連結糸44aと、第2の組の帯状部材34b、34cの端部同士を連結解除可能に連結する一対の連結糸44bと、第3の組の帯状部材34c、34dの端部同士を連結解除可能に連結する連結糸44cと、第4の組の帯状部材34d、34eの端部同士を連結解除可能に連結する一対の連結糸44dと、第5の組の帯状部材34e、34fの端部同士を連結解除可能に連結する一対の連結糸44eとを有している。 As shown in FIG. 24, the regulating means 4C includes a pair of connecting threads 44a for connecting the ends of the first set of band- like members 34a, 34b so as to be disengaged, and a second set of band- like members 34b, 34c. A pair of connecting yarns 44b that connect the ends of the belts in a releasable manner, a connecting yarn 44c that connects the ends of the strip members 34c, 34d in the third set so as to be unlinkable, and a fourth set of strips A pair of connecting yarns 44d that connect the ends of the members 34d and 34e so as to be able to be released, and a pair of connecting yarns 44e that connect the ends of the fifth set of band- like members 34e and 34f so that the ends can be released. Have.
 図24に示すように、解除手段5Cは、各連結糸44aと別体で構成された牽引糸56aと、各連結糸44bと別体で構成された牽引糸56bと、連結糸44cと別体で構成された牽引糸56cと、各連結糸44dと別体で構成された牽引糸56dと、各連結糸44eと別体で構成された牽引糸56eとを有している。なお、牽引糸56a、56bは、それぞれ、図中の左側に向かって延在し、牽引糸56c~56eは、それぞれ、図中の右側に向かって延在している。 As shown in FIG. 24, the release means 5C includes a traction thread 56a configured separately from each connection thread 44a, a traction thread 56b configured separately from each connection thread 44b, and a connection thread 44c. The traction thread 56c is configured as follows, the traction thread 56d is configured separately from each connection thread 44d, and the traction thread 56e is configured separately from each connection thread 44e. The traction yarns 56a and 56b each extend toward the left side in the figure, and the traction yarns 56c to 56e each extend toward the right side in the figure.
 そして、図25に示すように、例えば、連結糸44cによる連結を解除したい場合には、牽引糸56cを引張ることにより、連結糸44cもその方向に引張られて、当該連結糸44cによる連結が解除される。これにより、帯状部材34cと帯状部材34dとが離間して、その離間距離が増大する。これにより、インプラント2に作用する張力を減少させることができ、よって、尿道100に対する圧迫力も抑制される。この結果、合併症による症状が緩和される。 As shown in FIG. 25, for example, when it is desired to release the connection by the connection thread 44c, the connection thread 44c is also pulled in that direction by pulling the pulling thread 56c, and the connection by the connection thread 44c is released. Is done. Thereby, the strip | belt-shaped member 34c and the strip | belt-shaped member 34d separate, and the separation distance increases. Thereby, the tension | tensile_strength which acts on the implant 2 can be decreased, and the compression force with respect to the urethra 100 is also suppressed. As a result, symptoms due to complications are alleviated.
 なお、帯状部材34cと帯状部材34dとの間には、一対の連結糸35cが架設されているため、帯状部材34cと帯状部材34dとの離間距離の連結糸35c分以上の増大が規制される。 In addition, since a pair of connecting thread | sled 35c is constructed between the strip | belt-shaped member 34c and the strip | belt-shaped member 34d, increase of the separation distance of the strip | belt-shaped member 34c and the strip-shaped member 34d more than the connecting thread 35c is controlled. .
 また、連結糸44a、44b、44d、44eによる連結をそれぞれ解除したい場合には、牽引糸56a、56b、56d、56eをそれぞれ独立して、その解除を所望のタイミングで行なうことができる。 Further, when it is desired to release the connection by the connecting threads 44a, 44b, 44d, 44e, the traction threads 56a, 56b, 56d, 56e can be released independently at a desired timing.
 連結糸35a~35e、連結糸44a~44e、牽引糸56a~56eの構成材料としては、第1の帯状部材31や第2の帯状部材32と同様の材料を用いることができる。 As the constituent materials of the connecting yarns 35a to 35e, the connecting yarns 44a to 44e, and the pulling yarns 56a to 56e, the same materials as those of the first belt member 31 and the second belt member 32 can be used.
 <第5実施形態>
 図26は、本発明のインプラントの第5実施形態を示す側面図、図27は、図26に示すインプラントの長さが調整された状態を示す側面図である。
<Fifth Embodiment>
FIG. 26 is a side view showing a fifth embodiment of the implant of the present invention, and FIG. 27 is a side view showing a state in which the length of the implant shown in FIG. 26 is adjusted.
 以下、これらの図を参照して本発明のインプラントの第5実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the fifth embodiment of the implant of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
 本実施形態は、インプラント本体の構成が異なること以外は前記第1実施形態と同様である。 This embodiment is the same as the first embodiment except that the configuration of the implant body is different.
 図26、図27に示すように、本実施形態のインプラント2では、インプラント本体3Dは、帯状をなす1本の帯状部材36で構成されている。 As shown in FIGS. 26 and 27, in the implant 2 of the present embodiment, the implant body 3D is composed of a single band-shaped member 36 having a band shape.
 また、図26に示すように、インプラント本体3Dは、その長手方向の途中が伸縮自在に変形する変形部361を有している。 Further, as shown in FIG. 26, the implant main body 3D has a deforming portion 361 that deforms in a stretchable manner in the middle in the longitudinal direction.
 変形部361は、図26に示す収縮状態では、互いに反対方向に折り曲げられた2つの折り曲げ部362を形成することにより、折り畳まれている。また、変形部361は、図27に示す伸長状態では、各折り曲げ部362が前記と反対方向に広がることにより、展開している。 In the contracted state shown in FIG. 26, the deformed portion 361 is folded by forming two bent portions 362 that are bent in opposite directions. Further, in the extended state shown in FIG. 27, the deforming part 361 is unfolded by spreading each bent part 362 in the opposite direction.
 規制手段4である縫合糸41は、変形部361の収縮状態を維持するよう、当該変形部361を縫合している。これにより、インプラント本体3Dは、その一端部と他端部との距離、すなわち、インプラント本体3Dの全長が規制される。この規制により、インプラント2は、尿道100を支えても伸長して弛むのが確実に防止され、尿失禁機能を確実に発揮することができる。 The suture thread 41 that is the restricting means 4 stitches the deformable portion 361 so as to maintain the contracted state of the deformable portion 361. Thereby, the implant main body 3D regulates the distance between its one end and the other end, that is, the total length of the implant main body 3D. By this regulation, the implant 2 can be reliably prevented from expanding and sagging even when the urethra 100 is supported, and the urinary incontinence function can be reliably exhibited.
 また、解除手段5である牽引糸51を引張ることにより前記規制が解除された際、変形部361が収縮状態から伸長状態となる。これにより、縫合糸41の縫合が解かれて、インプラント本体3Dの全長が伸長する。この伸長により、インプラント2に作用する張力が減少し、よって、尿道100に対する圧迫力も抑制される。この結果、合併症による症状が緩和される。 Further, when the restriction is released by pulling the pulling thread 51 which is the releasing means 5, the deforming portion 361 is changed from the contracted state to the extended state. Thereby, the suture of the suture thread 41 is released, and the entire length of the implant body 3D is extended. By this extension, the tension acting on the implant 2 is reduced, and thus the pressing force on the urethra 100 is also suppressed. As a result, symptoms due to complications are alleviated.
 なお、変形部361の形成数は、本実施形態では1つであるが、これに限定されず、例えば、2以上であってもよい。 In addition, although the number of deformation | transformation parts 361 formed is one in this embodiment, it is not limited to this, For example, two or more may be sufficient.
 以上、本発明のインプラントを図示の実施形態について説明したが、本発明は、これに限定されるものではなく、インプラントを構成する各部は、同様の機能を発揮し得る任意の構成のものと置換することができる。また、任意の構成物が付加されていてもよい。 As mentioned above, although the illustrated embodiment of the implant of the present invention has been described, the present invention is not limited to this, and each part constituting the implant is replaced with an arbitrary structure that can exhibit the same function. can do. Moreover, arbitrary components may be added.
 また、本発明のインプラントは、前記各実施形態のうちの、任意の2以上の構成(特徴)を組み合わせたものであってもよい。 Further, the implant of the present invention may be a combination of any two or more configurations (features) of the above embodiments.
 また、本発明のインプラントは、女性の尿失禁の治療に用いられるのに限定されず、男性の尿失禁の治療にも用いることもできる。 Also, the implant of the present invention is not limited to use in the treatment of female urinary incontinence, but can also be used in the treatment of male urinary incontinence.
 また、穿刺装置は、第1の装置と第2の装置とが互いに接近離間可能に連結されていてもよい。 Further, in the puncture device, the first device and the second device may be connected so as to be close to each other.
 また、牽引糸の把持部には、例えば超音波やX線造影下で、当該把持部の位置を確認し得るマーカが付されていてもよい。 In addition, a marker that can confirm the position of the gripping part may be attached to the gripping part of the traction thread, for example, under ultrasound or X-ray contrast.
 また、前記第4実施形態では、規制手段を構成する連結糸と、解除手段を構成する牽引糸とは、連続した1本の線状体で構成することもできる。 In the fourth embodiment, the connecting thread constituting the restricting means and the pulling thread constituting the releasing means can be constituted by a single continuous linear body.
 本発明のインプラントは、長尺状をなし、その一端側の第1の部分と他端側の第2の部分とを有し、可撓性を有するインプラント本体と、前記第1の部分と前記第2の部分との前記インプラント本体の距離を規制する規制手段と、前記規制手段と別体で構成され、該規制手段による規制を解除して、前記第1の部分と前記第2の部分とが互いに離間可能な状態とする解除手段とを備える。 The implant of the present invention has an elongated shape, and has a first part on one end side and a second part on the other end side, and has a flexible implant body, the first part, A restricting means for restricting the distance of the implant body from the second part; and a separate member from the restricting means, the restriction by the restricting means being released, and the first part and the second part Is provided with release means for separating each other from each other.
 さて、生体に留置されたインプラントのインプラント本体には、その長手方向に沿って張力が作用している。そして、この張力が過剰であった場合には、インプラント本体に対して手技を行なって、当該張力を解除することがある。この場合、規制手段によるインプラント本体の第1の部分と第2の部分との長手方向の距離の規制を解除すれば、前記張力を解除する。そこで、本発明によれば、この解除操作を行なう際には、生体に対しては、解除手段を操作し得る程度で、できる限り小さい切開箇所で済む。このため、手技を低侵襲で行なうことができ、よって、患者への負担を確実に低減することができる。 Now, tension is acting along the longitudinal direction of the implant body of the implant placed in the living body. If this tension is excessive, a procedure may be performed on the implant body to release the tension. In this case, if the restriction of the distance in the longitudinal direction between the first part and the second part of the implant body by the restricting means is released, the tension is released. Therefore, according to the present invention, when performing this release operation, the incision site as small as possible is sufficient for the living body to the extent that the release means can be operated. For this reason, the procedure can be performed with minimal invasiveness, and thus the burden on the patient can be reliably reduced.
 従って、本発明のインプラントは、産業上の利用可能性を有する。 Therefore, the implant of the present invention has industrial applicability.
 1      穿刺装置
 2      インプラント(生体内留置器具)
 3、3C、3D インプラント本体
 31     第1の帯状部材(一方の帯状部材)
 311    基端部
 32     第2の帯状部材(他方の帯状部材)
 321    先端部
 33     重なり部
 34a、34b、34c、34d、34e、34f、34g 帯状部材
 35a、35b、35c、35d、35e、35f 連結糸
 36     帯状部材
 361    変形部
 362    折り曲げ部
 4、4B、4C 規制手段
 41     縫合糸
 411    折り返し部
 412    一方の端部
 413    他方の端部
 414、415 部分
 42     第1のコネクタ
 420    本体部
 421    突部
 422    先端面
 423    段差部
 424    挿通孔
 43     第2のコネクタ
 430    本体部
 431    挟持片
 432    凹部
 44a、44b、44c、44d、44e 連結糸
 5、5A、5B、5C 解除手段
 51     牽引糸
 511    折り返し部
 512    把持部
 513    一方の端部
 514    他方の端部
 52     固定手段
 53     チューブ
 531    第1の係合部
 532    第2の係合部
 54     把持部材
 541    本体部
 542    弾性片
 543    嵌合部
 544    爪
 55     長尺部材
 56a、56b、56c、56d、56e 牽引糸
 7      針体
 71     針先
 72     段差部
 8      規制部
 9      穿刺針組立体
 91     外管
 911    一端開口部
 912    把持部
 10     支持部材
 101    支持部
 102    案内部
 103    連結部
 104    貫通孔
 105、106 面
 107    凹部
 17     第1の装置
 18     第2の装置
 30     尿道挿入部材
 301    先端面
 40     膣挿入部材
 401    先端面
 50     連結部材
 100    尿道
 200    膣
 300    膣壁
 400    閉鎖孔
 600    生体組織
 700    体表面
 O       中心
1 Puncture device 2 Implant (In-vivo indwelling device)
3, 3C, 3D Implant body 31 First strip member (one strip member)
311 Base end portion 32 Second strip member (the other strip member)
321 Tip 33 Overlapping part 34a, 34b, 34c, 34d, 34e, 34f, 34g Band-shaped member 35a, 35b, 35c, 35d, 35e, 35f Connecting thread 36 Band-shaped member 361 Deformation part 362 Bending part 4, 4B, 4C Restricting means 41 Suture 411 Folding portion 412 One end portion 413 The other end portion 414, 415 portion 42 First connector 420 Body portion 421 Projection portion 422 Tip surface 423 Stepped portion 424 Insertion hole 43 Second connector 430 Body portion 431 Nipping Piece 432 Concave part 44a, 44b, 44c, 44d, 44e Connecting thread 5, 5A, 5B, 5C Release means 51 Traction thread 511 Folded part 512 Grip part 513 One end part 514 Other end part 52 Fixing means 53 Chu 531 First engaging portion 532 Second engaging portion 54 Holding member 541 Main body portion 542 Elastic piece 543 Fitting portion 544 Claw 55 Long member 56a, 56b, 56c, 56d, 56e Traction thread 7 Needle body 71 Needle Point 72 Step part 8 Restriction part 9 Puncture needle assembly 91 Outer tube 911 One end opening part 912 Gripping part 10 Support member 101 Support part 102 Guide part 103 Connecting part 104 Through hole 105, 106 Surface 107 Concave part 17 First device 18 First apparatus 18 2 device 30 urethral insertion member 301 distal end surface 40 vaginal insertion member 401 distal end surface 50 connecting member 100 urethra 200 vagina 300 vaginal wall 400 closed hole 600 biological tissue 700 body surface O center

Claims (14)

  1.  長尺状をなし、その一端側の第1の部分と他端側の第2の部分とを有し、可撓性を有するインプラント本体と、
     前記第1の部分と前記第2の部分との前記インプラント本体の距離を規制する規制手段と、
     前記規制手段と別体で構成され、該規制手段による規制を解除して、前記第1の部分と前記第2の部分とが互いに離間可能な状態とする解除手段とを備えることを特徴とするインプラント。
    An implant body having a long shape, having a first portion on one end side and a second portion on the other end side, and having flexibility;
    Regulating means for regulating the distance of the implant body between the first part and the second part;
    It is constituted separately from the restricting means, and comprises a releasing means for releasing the restriction by the restricting means so that the first part and the second part can be separated from each other. Implant.
  2.  前記インプラント本体は、帯状をなし、その長手方向に沿って配置された少なくとも2枚の帯状部材で構成され、該2本の帯状部材のうちの一方の帯状部材が前記第1の部分となり、他方の帯状部材が前記第2の部分となっており、
     前記解除手段により前記規制が解除された際、前記一方の帯状部材と前記他方の帯状部材とが分離する請求項1に記載のインプラント。
    The implant main body has a belt-like shape, and is composed of at least two belt-like members arranged along the longitudinal direction. One of the two belt-like members serves as the first portion, and the other The band-shaped member is the second part,
    The implant according to claim 1, wherein when the restriction is released by the releasing means, the one band-like member and the other band-like member are separated.
  3.  前記規制手段は、前記一方の帯状部材の端部と前記他方の帯状部材の端部とを連結するよう構成されている請求項2に記載のインプラント。 The implant according to claim 2, wherein the restricting means is configured to connect an end of the one band-shaped member and an end of the other band-shaped member.
  4.  前記規制手段は、前記一方の帯状部材の端部と前記他方の帯状部材の端部とを重ねた状態で縫合する縫合糸で構成されている請求項2または3に記載のインプラント。 The implant according to claim 2 or 3, wherein the restricting means is constituted by a suture thread that is sutured in a state where an end portion of the one belt-like member and an end portion of the other belt-like member are overlapped.
  5.  前記縫合糸には、その長手方向の途中が折り返された折り返し部が形成されており、
     前記解除手段は、前記折り返し部に係合し、前記縫合糸を牽引して該縫合糸による縫合を解く牽引糸を有する請求項4に記載のインプラント。
    The suture has a folded portion that is folded in the middle in the longitudinal direction,
    The implant according to claim 4, wherein the release means includes a pulling thread that engages with the folded portion and pulls the suture to release the suture by the suture.
  6.  前記解除手段は、前記縫合糸に対する固定と、該固定の解除とを行なう固定手段を有する請求項5に記載のインプラント。 The implant according to claim 5, wherein the releasing means includes fixing means for fixing the suture and releasing the fixation.
  7.  前記規制手段は、前記一方の帯状部材の端部に装着され、突出形成された突部を有する第1のコネクタと、前記他方の帯状部材の端部に装着され、前記突部を挟持する、弾性変形可能な一対の挟持片を有する第2のコネクタとで構成され、
     前記一対の挟持片により前記突部を挟持した挟持状態では、前記一方の帯状部材と前記他方の帯状部材とが連結され、
     前記一対の挟持片が弾性変形して前記突部から離間した離間状態では、前記一方の帯状部材と前記他方の帯状部材との連結が解除される請求項2または3に記載のインプラント。
    The restricting means is attached to an end portion of the one belt-like member, and has a first connector having a protruding protrusion, and is attached to an end portion of the other belt-like member, and sandwiches the protrusion. A second connector having a pair of elastically deformable clamping pieces;
    In the sandwiched state in which the protrusion is sandwiched by the pair of sandwiching pieces, the one strip member and the other strip member are connected,
    The implant according to claim 2 or 3, wherein in a separated state in which the pair of sandwiching pieces are elastically deformed and separated from the protrusion, the connection between the one belt-like member and the other belt-like member is released.
  8.  前記解除手段は、前記第1のコネクタおよび前記第2のコネクタのうちの少なくとも前記第2のコネクタに着脱自在に装着され、その装着状態で前記一対の挟持片の弾性変形を阻止する部材で構成され、
     前記第2のコネクタに装着された装着状態では、前記一対の挟持片の弾性変形を阻止して、前記挟持状態を維持し、
     前記第2のコネクタから離脱した離脱状態では、前記一対の挟持片の弾性変形により、離間状態となる請求項7に記載のインプラント。
    The release means is a member that is detachably attached to at least the second connector of the first connector and the second connector, and is configured to prevent elastic deformation of the pair of holding pieces in the attached state. And
    In the attached state attached to the second connector, the elastic deformation of the pair of holding pieces is prevented, and the holding state is maintained.
    The implant according to claim 7, wherein in the detached state separated from the second connector, the implant is separated by elastic deformation of the pair of sandwiching pieces.
  9.  前記インプラント本体は、帯状をなし、その長手方向に沿って配置された少なくとも3本の帯状部材を有し、
     前記規制手段は、隣接する各組の前記帯状部材の端部同士を連結解除可能に連結し、該各組の連結がそれぞれ前記解除手段により独立して解除され得る請求項1に記載のインプラント。
    The implant body has a belt-like shape and has at least three belt-like members arranged along the longitudinal direction thereof,
    2. The implant according to claim 1, wherein the restricting means connects the ends of the adjacent band-like members of each set so as to be disengaged, and the connection of each set can be independently released by the releasing means.
  10.  前記インプラント本体は、隣接する各組の前記帯状部材の端部同士の間に架設され、前記規制手段による規制が行われている間、撓んでいる連結糸を有する請求項7に記載のインプラント。 The implant according to claim 7, wherein the implant body includes a connecting thread that is laid between ends of the adjacent band-shaped members and is bent while being regulated by the regulating means.
  11.  前記インプラント本体は、帯状をなし、その長手方向の途中が伸縮自在に変形する少なくとも1つの変形部を有する1本の帯状部材で構成され、
     前記規制手段は、前記変形部の収縮状態を維持するよう構成されており、
     前記解除手段により前記規制が解除された際、前記変形部が前記収縮状態から伸長状態となり、前記インプラント本体の全長が伸長する請求項1に記載のインプラント。
    The implant body is formed of a single belt-like member having a belt-like shape and having at least one deformable portion that deforms in a stretchable manner in the middle of its longitudinal direction.
    The restricting means is configured to maintain a contracted state of the deforming portion,
    The implant according to claim 1, wherein when the restriction is released by the releasing means, the deforming portion is changed from the contracted state to an extended state, and the entire length of the implant body is extended.
  12.  前記変形部は、前記収縮状態では、折り畳まれており、前記伸長状態では、展開する請求項11に記載のインプラント。 The implant according to claim 11, wherein the deformed portion is folded in the contracted state and expanded in the extended state.
  13.  前記解除手段による解除操作は、前記インプラント本体の長手方向に沿って行なわれる請求項1ないし12のいずれか1項に記載のインプラント。 The implant according to any one of claims 1 to 12, wherein the release operation by the release means is performed along a longitudinal direction of the implant body.
  14.  尿失禁の治療に用いられる請求項1ないし13のいずれか1項に記載のインプラント。 The implant according to any one of claims 1 to 13, which is used for treatment of urinary incontinence.
PCT/JP2012/067992 2012-07-13 2012-07-13 Implant WO2014010086A1 (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030065402A1 (en) * 2001-10-03 2003-04-03 Ameican Medical Systems Implantable article
JP2009539558A (en) * 2006-06-16 2009-11-19 エーエムエス リサーチ コーポレイション Surgical implants, tools, and methods for treating pelvic disease
JP2009540937A (en) * 2006-06-22 2009-11-26 エーエムエス リサーチ コーポレイション Tension adjustable incontinence sling assembly and its usage
JP2010524635A (en) * 2007-04-28 2010-07-22 ザ ボード オブ トラスティーズ オブ ザ リーランド スタンフォード ジュニア ユニバーシティ Dynamic and adjustable support equipment
WO2011143572A1 (en) * 2010-05-13 2011-11-17 Ams Research Corporation Implantable mechanical support

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030065402A1 (en) * 2001-10-03 2003-04-03 Ameican Medical Systems Implantable article
JP2009539558A (en) * 2006-06-16 2009-11-19 エーエムエス リサーチ コーポレイション Surgical implants, tools, and methods for treating pelvic disease
JP2009540937A (en) * 2006-06-22 2009-11-26 エーエムエス リサーチ コーポレイション Tension adjustable incontinence sling assembly and its usage
JP2010524635A (en) * 2007-04-28 2010-07-22 ザ ボード オブ トラスティーズ オブ ザ リーランド スタンフォード ジュニア ユニバーシティ Dynamic and adjustable support equipment
WO2011143572A1 (en) * 2010-05-13 2011-11-17 Ams Research Corporation Implantable mechanical support

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