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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
English (en)
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/fr
Publication of WO2014010086A1 publication Critical patent/WO2014010086A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure 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
    • A61F2/0036—Closure 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
    • A61F2/0045—Support slings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482—Needle or suture guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B17/06109—Big needles, either gripped by hand or connectable to a handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0007—Special 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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

Selon la présente invention, un implant (2) comprend : un corps d'implant principal souple (3), dont la forme globale est allongée et qui comprend un premier élément de bande (31) à une extrémité et un second élément de bande (32) à l'autre extrémité ; un moyen de régulation (4) pour réguler la distance dans la direction longitudinale du corps d'implant principal (3) entre le premier élément de bande (31) et le second élément de bande (32) ; et un moyen de libération (5) pour libérer la régulation conférée par le moyen de régulation (4) et permettre au premier élément de bande (31) et au second élément de bande (32) d'être séparés l'un de l'autre vers des directions mutuellement opposées, le moyen de libération (5) étant configuré séparément du moyen de régulation (4).
PCT/JP2012/067992 2012-07-13 2012-07-13 Implant WO2014010086A1 (fr)

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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 (ja) * 2006-06-16 2009-11-19 エーエムエス リサーチ コーポレイション 骨盤の病気を治療する外科用インプラント、ツール、及び方法
JP2009540937A (ja) * 2006-06-22 2009-11-26 エーエムエス リサーチ コーポレイション テンション調節の可能な失禁スリングアセンブリとその用法
JP2010524635A (ja) * 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 動的および調整可能な支持機器
WO2011143572A1 (fr) * 2010-05-13 2011-11-17 Ams Research Corporation Support mécanique implantable

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 (ja) * 2006-06-16 2009-11-19 エーエムエス リサーチ コーポレイション 骨盤の病気を治療する外科用インプラント、ツール、及び方法
JP2009540937A (ja) * 2006-06-22 2009-11-26 エーエムエス リサーチ コーポレイション テンション調節の可能な失禁スリングアセンブリとその用法
JP2010524635A (ja) * 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 動的および調整可能な支持機器
WO2011143572A1 (fr) * 2010-05-13 2011-11-17 Ams Research Corporation Support mécanique implantable

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