WO2014162428A1 - Dispositif d'ancrage à demeure - Google Patents

Dispositif d'ancrage à demeure Download PDF

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Publication number
WO2014162428A1
WO2014162428A1 PCT/JP2013/059893 JP2013059893W WO2014162428A1 WO 2014162428 A1 WO2014162428 A1 WO 2014162428A1 JP 2013059893 W JP2013059893 W JP 2013059893W WO 2014162428 A1 WO2014162428 A1 WO 2014162428A1
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WO
WIPO (PCT)
Prior art keywords
anchor
hole
indwelling
elongated body
implant
Prior art date
Application number
PCT/JP2013/059893
Other languages
English (en)
Japanese (ja)
Inventor
政克 川浦
有浦　茂樹
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/JP2013/059893 priority Critical patent/WO2014162428A1/fr
Publication of WO2014162428A1 publication Critical patent/WO2014162428A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0467—Instruments for cutting sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B17/06109—Big needles, either gripped by hand or connectable to a handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A61B2017/0488—Instruments for applying suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B2017/0608—J-shaped

Definitions

  • the present invention relates to an anchor indwelling device.
  • Urinary incontinence particularly stress urinary incontinence, urine leakage occurs due to abdominal pressure applied during normal exercise, laughing, coughing, sneezing, etc.
  • the cause of this is, for example, that the pelvic floor muscle, which is a muscle that supports the urethra, is loosened due to childbirth and the like.
  • Surgical therapy is effective for the treatment of urinary incontinence.
  • a band-like tissue-supporting indwelling material called a “sling”
  • the sling is placed in the body, and the sling supports the urethra (for example, Patent Document 1).
  • the operator incises the vagina 920 with a scalpel, peels off the space between the urethra 910 and the vagina 920, and uses the puncture needle or the like to remove the peeled portion and the outside. Are communicated with each other through a closing hole. Then, the sling is placed in the puncture hole formed by the puncture needle.
  • a sling what is called a “mini sling” in which a pair of anchors 810 and 820 are provided at both ends of a belt-like main body is known (see, for example, Patent Document 2).
  • one anchor 810 is inserted from the incised site to close one closing hole 931 of the pelvis 930, and the large opening of the closing hole 931 occurs from the edge of the closing hole 931.
  • the film is hooked and fixed to the closing membrane 933 by penetrating through a closing membrane (ligament tissue) 933 which is a ligamentous thin film that closes the portion.
  • the other anchor 820 is inserted from the incised portion and penetrated through the closing membrane 934 that closes the other closing hole 932, thereby being hooked and fixed to the closing membrane 934 to obtain the state shown in FIG.
  • an appropriate tension is applied to the urethra by adjusting the length of the sling between the pair of anchors 810 and 820.
  • the incision is sutured.
  • the placement of the sling 800 is completed. According to such a technique, since the portion to be punctured is shortened, there is an advantage that the burden on the patient is reduced.
  • An object of the present invention is to provide an anchor indwelling device that can indwell an anchor in a living body so that its effect is maintained over time.
  • An anchor indwelling device for fixing a living tissue supporting indwelling object used for pelvic treatment in a living body A long body, An anchor portion removably provided at the distal end of the elongated body, The anchor portion has a guide portion into which the living tissue supporting indwelling material is inserted, and is fixed to a part of the living tissue supporting indwelling material inserted into the guide portion. Ingredients.
  • the biological tissue supporting indwelling object is disposed inside the body so that at least one end is exposed outside the body, The one end of the biological tissue support indwelling object is inserted into the guide part, and the guide part is inserted into the body along the biological support indwelling object, and is fixed to the biological tissue support indwelling object in the body.
  • the anchor indwelling device according to claim 1.
  • the cylindrical elongated body having a first through hole on the inner side, and the anchor portion including the second through hole in which the guide portion communicates with the first through hole,
  • a second instrument comprising a fixing part for fixing the anchor part to the biological tissue supporting indwelling object,
  • the anchor portion is configured to be detached from the elongated body when the elongated body is moved to the proximal end side in a state where the anchor portion is fixed to the biological tissue supporting indwelling object ( The anchor indwelling device according to any one of 1) to (3).
  • the first instrument further includes an operation unit capable of switching between a restricted state for restricting detachment of the anchor portion from the long body and an allowable state for allowing detachment from the long body.
  • the anchor portion has a proximal end portion that is inserted into the first through hole and engages with a distal end portion of the elongated body, When the elongated body is moved to the proximal end side in a state where the anchor portion is fixed to the living tissue supporting indwelling object, the distal end portion of the elongated body is elastically deformed and the engagement is released.
  • the anchor portion is configured to be detached from the elongated body
  • the operation portion has a cylindrical shape and is provided on the outer periphery of the elongated body so as to be slidable. In the restricted state, the operation portion suppresses the deformation by covering a distal end portion of the elongated body, and allows the tolerance.
  • the anchor indwelling device according to (5) wherein the distal end portion of the elongated body is exposed and the deformation is allowed.
  • the first instrument further includes a guiding portion that guides the biological tissue supporting indwelling material to the first through hole through the second through hole.
  • the anchor indwelling device according to any one of the above.
  • the guiding portion is inserted into the first through hole and the second through hole so that the distal end portion and the proximal end portion are exposed from the first instrument, and the living tissue supporting indwelling is placed in the distal end portion.
  • the second instrument may further include a long insertion portion that is inserted into the first through-hole and the fixing portion is detachably provided at a distal end portion thereof.
  • the anchor indwelling device according to any one of 11).
  • Anchor detainer
  • the insertion portion has a third through hole through which the biological tissue supporting indwelling object is inserted.
  • an anchor portion can be fixed to the sling after the sling (living tissue supporting indwelling object) is placed in the living body. Therefore, for example, in the case of the treatment of urinary incontinence described above, the anchor portion can be disposed on the closing membrane without penetrating the closing membrane. As a result, it is possible to maintain the tension applied to the urethra over time without the anchors coming off or loosening from the closure membrane.
  • FIG. 1 is a side view showing a preferred embodiment of the anchor indwelling device of the present invention.
  • FIG. 2 is a cross-sectional view of a shaft included in the anchor placement device shown in FIG. 3 (a) and 3 (b) are cross-sectional views for explaining the movement of the operation portion of the shaft shown in FIG. 4 is a cross-sectional view of an insertion tool provided in the anchor placement device shown in FIG.
  • FIG. 5 is a cross-sectional view showing a distal end portion of the insertion tool shown in FIG.
  • FIGS. 6A and 6B are side views for explaining the movement of the cutting portion of the insertion tool shown in FIG.
  • FIG. 7 is a diagram illustrating an example of an implant.
  • FIG. 8 is a diagram for explaining an operation procedure of the anchor indwelling device shown in FIG. 1.
  • FIG. 9 is a diagram for explaining an operation procedure of the anchor indwelling device shown in FIG. 1.
  • FIG. 10 is a diagram for explaining an operation procedure of the anchor indwelling device shown in FIG. 1.
  • FIG. 11 is a diagram for explaining an operation procedure of the anchor indwelling device shown in FIG. 1.
  • FIG. 12 is a diagram for explaining an operation procedure of the anchor indwelling device shown in FIG. 1.
  • FIG. 13 is a diagram for explaining an operation procedure of the anchor indwelling device shown in FIG. 1.
  • FIG. 14 is a diagram for explaining an operation procedure of the anchor indwelling device shown in FIG. 1.
  • FIG. 15 is a view for explaining an operation procedure of the anchor indwelling device shown in FIG. 1.
  • FIG. 16 is a diagram for explaining an operation procedure of the anchor indwelling device shown in FIG. 1.
  • FIG. 17 is a view for explaining an operation procedure of the anchor indwelling device shown in FIG. 1.
  • FIG. 18 is a view for explaining an operation procedure of the anchor indwelling device shown in FIG. 1.
  • FIG. 19 is a diagram for explaining an operation procedure of the anchor indwelling device shown in FIG. 1.
  • 20 is a view showing a modification of the anchor indwelling device shown in FIG. 1, in which (a) is a side view and (b) is a cross-sectional view taken along the line AA in (a).
  • FIG. 21 is a side view showing an example of an implant cutting tool.
  • 22 (a) and 22 (b) are side views for explaining the movement of the cutting portion of the implant cutting tool shown in FIG.
  • FIG. 23 is a view for explaining an operation procedure of the implant cutting tool shown in FIG.
  • FIG. 24 is a view for explaining an operation procedure of the implant cutting tool shown in FIG.
  • FIG. 25 is a view for explaining an operation procedure of the implant cutting tool shown in FIG.
  • FIG. 26 is a side view showing a modified example of the implant cutting tool shown in FIG.
  • FIG. 27 is a view for explaining an operation procedure of the implant cutting tool shown in FIG.
  • FIG. 28 is a side view showing another modification of the implant cutting tool shown in FIG.
  • FIG. 29 is a diagram for explaining the prior art.
  • FIG. 1 is a side view showing a preferred embodiment of the anchor indwelling device of the present invention.
  • FIG. 2 is a cross-sectional view of a shaft included in the anchor placement device shown in FIG. 3 (a) and 3 (b) are cross-sectional views for explaining the movement of the operation portion of the shaft shown in FIG. 4 is a cross-sectional view of an insertion tool provided in the anchor placement device shown in FIG.
  • FIG. 5 is a cross-sectional view showing a distal end portion of the insertion tool shown in FIG.
  • FIGS. 6A and 6B are side views for explaining the movement of the cutting portion of the insertion tool shown in FIG.
  • FIG. 7 is a diagram illustrating an example of an implant.
  • FIG. 8 to 19 are diagrams for explaining the operation procedure of the anchor indwelling device shown in FIG. 20 is a view showing a modification of the anchor indwelling device shown in FIG. 1, in which (a) is a side view and (b) is a cross-sectional view taken along the line AA in (a).
  • the right side in FIG. 1 is referred to as “tip” and the left side is referred to as “base end”.
  • Anchor Indwelling Device 1 shown in FIG. 1 is an apparatus used when, for example, an urinary incontinence treatment for women, that is, an implant (living tissue supporting indwelling material) 9 for urinary incontinence treatment is embedded in a living body. It is.
  • the anchor detainer 1 includes a tubular shaft (first instrument) 2 and an insertion instrument (second instrument) 3 inserted into the shaft 2.
  • first instrument tubular shaft
  • second instrument insertion instrument
  • the shaft 2 includes an elongated body 21, an anchor portion 22 held at the distal end of the elongated body 21, and the anchor portion 22 being detached from the elongated body 21. It has the operation part 23 made into a possible state, the maintenance part 24 which maintains the state of the operation part 23, and the string body (guidance
  • the long body 21 has a cylindrical shape, and has a through hole (first through hole) 211 penetrating both ends. Further, a concave portion 212 that engages with the anchor portion 22 is formed on the inner peripheral surface of the distal end portion of the long body 21. The distal end portion of the long body 21 is configured to be elastically deformed and expanded in diameter by a predetermined stress, and the engagement between the long body 21 and the anchor portion 22 is released by expanding the diameter of the distal end portion. It has come to be. Further, a flange 213 protruding from the outer peripheral surface is formed at the proximal end portion of the long body 21. The flange 213 has a function of preventing the maintenance unit 24 from being detached from the long body 21.
  • the length of the long body 21 is not particularly limited, and varies depending on the treatment to be used, but is preferably about 1 to 10 cm, for example. Thereby, it becomes a size suitable for using especially when the implant for treatment of urinary incontinence is embedded in the living body.
  • the anchor portion 22 is attached to the distal end portion of the long body 21.
  • the anchor portion 22 includes a main body 221 that protrudes toward the distal end side of the long body 21, and a base end portion 222 that is provided on the base end side of the main body 221 and inserted into the through hole 211 of the long body 21.
  • the front end of the main body 221 is rounded, for example, hemispherical or semi-long. Thereby, the resistance at the time of inserting the shaft 2 in a living body can be reduced.
  • the base end portion of the main body 221 has a diameter larger than the outer periphery of the long body 21, and protrudes outward from the outer peripheral surface of the long body 21.
  • a convex portion 223 is formed on the outer periphery of the base end portion 222, and the convex portion 223 engages with the concave portion 212 of the long body 21.
  • the anchor part 22 is hold
  • the anchor portion 22 is formed with a guide portion constituted by a through hole (second through hole) 224 along the axis of the shaft 2, and the through hole 224 is a through hole at the proximal end side opening. 211 communicates.
  • the base end part of the through-hole 224 is comprised by the taper part 224a which a diameter increases gradually toward base end opening.
  • An operation unit 23 is arranged on the outer periphery of the long body 21.
  • the operation unit 23 has a cylindrical shape, and is provided so as to be slidable in the axial direction with respect to the long body 21.
  • the operation portion 23 is located on the distal end side and abuts on the anchor portion 22, and as shown in FIG. 3A, the operation portion 23 covers the distal end portion of the long body 21, and the proximal portion is located on the flange 213. As shown in FIG. 3 (b), it is possible to move to an allowable state in which the tip of the long body 21 is exposed.
  • the distal end portion of the long body 21 is covered with the operation unit 23, and therefore elastic deformation (expansion) of the distal end portion of the long body 21 is prevented. Therefore, detachment of the anchor portion 22 from the long body 21 is prevented in the restricted state.
  • the distal end portion of the long body 21 is not covered with the operation unit 23, so that the distal end portion of the long body 21 can be elastically deformed (expanded), and the anchor portion 22 can be Can be disengaged from.
  • the operation part 23 is comprised so hard that the elastic deformation of the front-end
  • the structure of the operation part 23 will not be specifically limited if the state which prevents the elastic deformation
  • a maintenance unit 24 is provided on the outer periphery of the long body 21 and between the flange 213 and the operation unit 23.
  • the maintenance part 24 is comprised by the C-shaped clip, for example, and is detachable with respect to the elongate body 21.
  • the maintenance unit 24 has a function of maintaining the operation unit 23 in a restricted state. That is, when the maintenance unit 24 is attached to the long body 21, the operation unit 23 is maintained in a restricted state, and when the maintenance unit 24 is detached from the long body 21, the operation unit 23 moves to an allowable state. It becomes possible.
  • the configuration of the maintenance unit 24 is not particularly limited as long as the operation unit 23 can be selected between a state in which the operation unit 23 is maintained in a restricted state and a state in which the operation unit 23 can move to an allowable state.
  • the string body 25 is inserted through the through holes 211 and 224.
  • the string body 25 has a distal end projecting from the distal end side opening of the through hole 224 and a proximal end projecting from the proximal end side opening of the through hole 211.
  • a holding portion 251 that holds the implant 9 is provided at the distal end portion of the string body 25.
  • the holding part 251 is configured by a ring (loop) 251 formed by the string body 25.
  • Such a string body 25 is used to guide the implant 9 into the through hole 211 as described later.
  • the configuration of the shaft 2 has been described above. It does not specifically limit as a constituent material of the elongate body 21, the anchor part 22, the operation part 23, and the maintenance part 24, For example, various resin materials and various metal materials can be used. Moreover, it does not specifically limit as a constituent material of the string 25, For example, various resin materials, fibers, etc. which have biocompatibility like a polypropylene etc. can be used.
  • the insertion tool 3 includes an insertion portion 31 having a straight rod shape, a fixing portion 32 attached to the distal end portion of the insertion portion 31, and a cylinder provided on the outer periphery of the insertion portion 31. And a cut portion 33 having a shape.
  • the insertion portion 31 has a through-hole (third through-hole) 311 that penetrates the opposite part of the outer peripheral surface.
  • the through-hole 311 extends while being inclined with respect to the axis of the insertion portion 31, and one opening 311 a and the other opening 311 b are arranged so as to be shifted in the axial direction of the insertion portion 31.
  • the implant 9 is inserted into the through hole 311 from the opening 311a located on the distal end side to the opening 311b located on the proximal end side.
  • the length of the insertion portion 31 is not particularly limited, but is preferably longer than the long body 21.
  • the fixing part 32 is provided detachably from the insertion part 31.
  • the fixing portion 32 is fixed to the anchor portion 22 during use of the anchor placement device 1, and thereby the anchor portion 22 can be fixed to the implant 9 as described later.
  • a method for fixing the fixing portion 32 to the anchor portion 22 is not particularly limited. For example, screwing, fitting, adhesion, or the like can be used. In this embodiment, as shown in FIG. 32 is pressed into the through hole 224 from the base end side to be fixed to the anchor portion 22.
  • the fixed portion 32 has a substantially conical shape as a whole, the outer diameter R1 of the distal end thereof is smaller than the inner diameter r1 of the through hole 224, and the outer diameter R2 on the proximal end side is the inner diameter of the proximal end opening of the through hole 224. It is configured to be larger than r2. By setting it as such a shape, the fixing
  • a convex portion is formed on one of the tapered portions 224a and 321 and a concave portion that engages with the convex portion is formed on the other side.
  • the fixing portion 32 may be press-fitted into the through hole 224 and the concave portion and the convex portion may be engaged.
  • a cylindrical cutting portion 33 is disposed on the outer periphery of the insertion portion 31.
  • the insertion part 31 is inserted inside the cutting part 33.
  • the cutting part 33 is provided so as to be slidable in the axial direction with respect to the insertion part 31.
  • an opening 331 is provided at the tip of the cutting part 33, and a blade part 332 is provided in the opening 331.
  • a flange 333 that protrudes to the outer periphery is provided at the base end portion of the cutting portion 33.
  • the cutting part 33 can move from the first state shown in FIG. 6A to the second state shown in FIG. 6B moved to the proximal end side.
  • the opening 311a is located on the tip side with respect to the cutting part 33, and the opening 311b is located in the opening 331. Therefore, both the openings 311a and 311b are exposed from the cutting part 33, and the blade part 332 Is located on the tip side of the opening 311b.
  • the blade portion 332 moves so as to straddle the opening 311 b, 9 is cut.
  • the configuration of the insertion tool 3 has been described above. It does not specifically limit as a constituent material of the insertion part 31, the fixing
  • the implant 9 shown in FIG. 7 is an implantable device for the treatment of female urinary incontinence, that is, a device that supports the urethra, for example, when the urethra is about to move toward the vaginal wall, It is the instrument supported in the direction (ventral side) which leaves
  • this implant 9 for example, a long object having flexibility can be used.
  • the implant 9 has a net shape, and the entire shape thereof has a band shape.
  • the implant 9 is called a “sling”.
  • the implant 9 can be constituted by, for example, a braided body in which a linear body is crossed and knitted in a net shape (lattice shape), that is, a net-like braided body.
  • the linear body include a circular cross-sectional shape, a flat cross-sectional shape, that is, a belt-like (ribbon-like) shape, and the like.
  • One end of the thread 91 is fixed to one end of the implant 9, and one end of the thread 92 is fixed to the other end.
  • the constituent material of the implant 9 is not particularly limited, and various resin materials, fibers, and the like having biocompatibility such as polypropylene can be used. Further, the constituent materials of the yarns 91 and 92 are not particularly limited, and various biomaterials such as polypropylene, fibers, and the like can be used, for example.
  • the implant 9 is not limited to the net-like one as long as the same effect can be exhibited.
  • the vagina 920 is incised with a scalpel, the puncture needle 7 is punctured from the incision portion 921, and is extracted from one buttocks to the body surface S through one closing hole 931 of the pelvis 930. To do.
  • the puncture needle 7 holds the thread 91 of the implant 9, whereby the thread 91 is exposed to the body surface S from the buttocks.
  • the puncture needle 7 is punctured from the incision 921, and is extracted from the other buttocks to the body surface S via the other closing hole 932.
  • the puncture needle 7 holds the thread 92 of the implant 9, whereby the thread 92 is exposed to the body surface S from the buttocks.
  • the threads 91 and 92 are pulled, and the implant 9 is placed between the urethra 910 and the vagina 920 as shown in FIG.
  • the shaft 2 is prepared, and the thread 91 is inserted through the ring 251 of the string body 25.
  • yarn 91 (A part of the implant 9 may be contained in the string body 25. It is the same below.) Is hold
  • the string body 25 is pulled to the proximal end side, the thread 91 is guided into the through hole 211 through the through hole 224, and further guided to the outside from the proximal end opening of the through hole 211. To do.
  • the shaft 2 is inserted into the living body along the thread 91 and the implant 9, and the anchor portion 22 is brought into contact with the closing membrane 933 as shown in FIGS. .
  • the thread 91 is inserted into the through hole 311 from the opening 311a and pulled out from the opening 311b.
  • the insertion tool 3 is inserted into the shaft 2 from the proximal end side in a state where the thread 91 is tensioned, and the fixing portion 32 is pressed against the anchor portion 22 as shown in FIG.
  • the fixing portion 32 is press-fitted into the through hole 224, and the fixing portion 32 is fixed to the anchor portion 22 in a state where the fixing portion 32 and the anchor portion 22 sandwich the implant 9. As a result, the anchor portion 22 is fixed to the implant 9.
  • the cutting unit 33 is changed from the first state to the second state by hooking a finger on the flange 333 of the cutting unit 33 and sliding the cutting unit 33 toward the proximal end side with respect to the insertion unit 31. As shown in FIG. 4, the tip portion is cut from the opening 311b of the implant 9. Thereby, the excess implant 9 is removed.
  • the insertion tool 3 is pulled out from the shaft 2.
  • the maintenance unit 24 is removed from the long body 21, and the operation unit 23 is slid toward the proximal side with respect to the long body 21 to be in an allowable state.
  • the shaft 2 is pulled out from the living body (that is, the long body 21 is moved to the proximal end side).
  • the distal end portion of the long body 21 is elastically deformed (expanded diameter), and the anchor portion 22 is detached from the long body 21, so that the anchor portion 22 abuts against the closing film 933 as shown in FIG. Indwelling in the living body.
  • the anchor part 22 is placed using the anchor placing tool 1 so as to contact the closing film 934 covering the closing hole 932.
  • the anchor portion 22 is placed in a state where the thread 92 is pulled with a predetermined force and a predetermined tension is applied to the urethra 910.
  • a predetermined procedure such as suturing is performed on the incision 921 to complete the procedure.
  • the anchor portion 22 can be inserted from the left and right buttocks and fixed to the implant 9. Therefore, the anchor part 22 does not penetrate the closing films 933 and 934 with which the anchor part 22 abuts (engages). Therefore, a large gap is not formed in the closing membranes 933 and 934 as in the prior art, and the anchor portion 22 can be reliably engaged with the closing membranes 933 and 934. As a result, the state in which a predetermined tension is applied to the urethra by the implant 9 can be reliably maintained for a long time.
  • the two anchors are placed after the yarns 91 and 92 are both exposed from the buttocks to the body surface S.
  • the present invention is not limited to this.
  • the anchor portion 22 is placed so as to contact the closing membrane 933, and then the thread 92 is exposed to the body surface S from the starboard portion so as to contact the closing membrane 934.
  • the anchor part 22 may be placed.
  • the vagina 920 is incised and the implant 9 is disposed between the urethra 910 and the vagina 920 from the incision portion 921, but the arrangement method of the implant 9 is not limited thereto.
  • a puncture member having a puncture needle 71 curved on an arc may be used.
  • a through-hole 940 is formed in the living body by protruding from the other buttocks.
  • the implant 9 is held at the tip of the puncture needle 71, and the puncture needle 71 is rotated in reverse.
  • the needle tip of the puncture needle 71 enters the body from the left groin portion of the patient, passes through the obstruction hole 931, the urethra 910 and the vagina 920, and the obstruction hole 932 in order, and then exits from the right inguinal portion to the outside of the body.
  • the puncture needle 71 is removed from the body.
  • the thread 92 is pulled to insert the implant 9 into the through hole 940. Thereby, as shown in FIG. 19, installation of the implant 9 is completed.
  • the implant 9 when the implant 9 is indwelled, it can be handled only by a minimally invasive technique such as puncture of the puncture needle 71, and it is not necessary to perform a large invasive incision or the like.
  • the patient safety is also high.
  • the anchor placement device 1 has been described above.
  • the through hole 211 is formed in the long body 21 and the through hole 224 is formed in the anchor portion 22.
  • the configuration of the long body 21 and the anchor portion 22 is not limited thereto.
  • the elongated body 21 may be provided with a groove 211 a and the anchor portion 22 may be provided with a groove 225.
  • the openings of the grooves 211a and 225 communicate with each other.
  • the operation unit 23 is provided with a slit 239 at a position corresponding to the opening of the groove 211a so that the opening of the groove 211a is exposed to the outside.
  • the implant 9 (thread 91) can be introduced into the grooves 211a and 225 through the openings of the grooves 211a and 225, the introduction of the implant 9 is facilitated. Moreover, since it is not necessary to use the string body 25 to introduce the implant 9, the operation is facilitated.
  • the opening of the groove 211a is made narrower than the internal space, and the hooking portion 214 for hooking the thread 91 is provided, thereby preventing the thread 91 introduced into the groove 211a from being detached. Thus, the movement of the shaft 2 along the yarn 91 can be performed smoothly.
  • FIG. 21 is a side view showing an example of an implant cutting tool.
  • 22 (a) and 22 (b) are side views for explaining the movement of the cutting portion of the implant cutting tool shown in FIG.
  • FIG. 22 is a side view for explaining the movement of the cutting part of the implant cutting part shown in FIG. 23 to 25 are diagrams for explaining the operation procedure of the implant cutting tool shown in FIG.
  • FIG. 26 is a side view showing a modified example of the implant cutting tool shown in FIG.
  • FIG. 27 is a view for explaining an operation procedure of the implant cutting tool shown in FIG.
  • FIG. 28 is a side view showing another modification of the implant cutting tool shown in FIG.
  • the right side in FIG. 21 is referred to as “tip”, and the left side is referred to as “base end”.
  • the implant cutting tool 4 is an instrument used for cutting the implant 9 in vivo. As shown in FIG. 21, the implant cutting tool 4 has a long main body 41 having a through-hole 411 and a cutting portion 42 that is formed in a cylindrical shape and is slidably provided on the outer periphery of the main body 41. Yes.
  • the tip of the main body 41 is rounded. Further, the opening 411 a on the distal end side of the through hole 411 is located at the distal end of the main body 41, and the opening 411 b on the proximal end side is located on the side surface of the main body 41.
  • the implant 9 is inserted into the through hole 411.
  • the length of the through hole 411 is not particularly limited, but is preferably about 1 to 3 cm.
  • An opening 421 is provided at the tip of the cutting part 42, and a blade part 422 is provided in the opening 421. Further, a flange 423 that protrudes to the outer periphery is provided at the proximal end portion of the cutting portion 42.
  • the cutting part 42 can move from the first state shown in FIG. 22A to the second state shown in FIG. 22B moved to the base end side. In the first state, the opening 411b of the through hole 411 is exposed from the cutting part 42, and the blade part 422 is located on the tip side of the opening 411b. Therefore, when the cutting portion 42 is changed from the first state to the second state in a state where the implant 9 is inserted through the through-hole 411, the portion of the implant 9 drawn out from the opening 411b can be cut.
  • Such an implant cutting tool 4 is used as follows. First, as shown in FIG. 23, the implant 9 is placed in the living body. The method for arranging the implant is the same as that described above. Next, after the cut portion is set to the first state, the thread 91 is inserted into the through hole 411 from the opening 411a of the through hole 411 and pulled out from the opening 411b. Next, the thread 91 is stretched, and the implant cutting tool 4 is inserted into the living body along the thread 91 and the implant 9, and the distal end portion is brought into contact with the closing membrane 933 as shown in FIG. Next, the portion of the implant 9 protruding from the opening 411b is cut by sliding the cutting portion 42 to the proximal end side. Then, as shown in FIG. 25, the implant cutting tool 4 is pulled out from the living body. According to such an implant cutting tool 4, an extra portion of the implant 9 can be easily cut in vivo.
  • the implant cutting tool 4 does not place an anchor portion, unlike the anchor placement tool 1 described above.
  • the implant 9 including the threads 91 and 92
  • surrounding biological tissues such as the closing membranes 933 and 934 and muscle tissue
  • an anchor effect can be exerted and necessary tension is applied to the urethra 910. Can do.
  • a positioning marker 424 that determines the insertion depth of the implant cutting tool 4 into the living body may be provided in the cutting part 42.
  • the positioning marker 424 is configured by a flange. By having such a positioning marker 424, as shown in FIG. 27, when the implant cutting tool 4 is inserted into a living body, the positioning marker 424 comes into contact with the body surface S, and thus further insertion is restricted. Therefore, the insertion depth of the implant cutting tool 4 can be accurately controlled.
  • the cutting part 42 may be omitted. That is, as shown in FIG. 28, the implant cutting tool 4 may be composed of only the main body 41. In this case, for example, a portion exposed from the body surface of the implant 9 may be cut with a cutting tool such as a scissors.
  • the anchor indwelling device of the present invention is an anchor indwelling device for fixing a living tissue supporting indwelling material used for pelvic treatment in a living body, and is detachable from a long body and a distal end portion of the long body.
  • An anchor portion provided on the living body tissue, the anchor portion having a guide portion into which the living tissue supporting indwelling material is inserted, and a part of the living tissue supporting indwelling material inserted into the guide portion It is characterized by being fixed. Therefore, for example, after the implant is placed in the living body, the anchor portion can be fixed to the implant.
  • the anchor portion can be used as the closing membrane without penetrating the closing membrane. Can be arranged. As a result, it is possible to maintain the tension applied to the urethra over time without the anchors coming off or loosening from the closure membrane. Therefore, the anchor indwelling device of the present invention has industrial applicability.

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

Abstract

L'invention concerne un dispositif d'ancrage (1) à demeure pour la fixation, dans le corps, d'un objet à demeure supportant des tissus biologiques, utilisé dans un traitement intrapelvien, pourvu d'un corps allongé (21) et d'une unité d'ancrage (22) qui est située de manière amovible sur la pointe du corps allongé (21). L'unité d'ancrage (22) présente une unité de guidage (trou traversant (224)), dans laquelle l'objet à demeure supportant des tissus biologiques est inséré, et est fixée sur une partie de l'objet à demeure supportant des tissus biologiques inséré dans le trou traversant (224). L'objet à demeure supportant des tissus biologiques est disposé dans le corps de manière telle qu'au moins une extrémité correspondante est apparente à l'extérieur du corps et le trou traversant (224) est inséré dans le corps le long de l'objet à demeure supportant des tissus biologiques et est fixé, à l'intérieur du corps, à l'objet à demeure supportant des tissus biologiques.
PCT/JP2013/059893 2013-04-01 2013-04-01 Dispositif d'ancrage à demeure WO2014162428A1 (fr)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107049600A (zh) * 2017-05-26 2017-08-18 西安医学院第二附属医院 一种耳鼓膜治疗装置
DE102018103977A1 (de) * 2018-02-22 2019-08-22 Rz-Medizintechnik Gmbh Fixiervorrichtung zum Fixieren eines Ligaturbands sowie Vorrichtung zum Einführen und Fixieren eines Ligaturbands in einer Fixiervorrichtung
EP3711708A1 (fr) * 2019-03-18 2020-09-23 Marian Devonec Dispositif combinant suspension et mise en tension réajustable, réversible et amovible pour le traitement de l'incontinence urinaire

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
JP2011235122A (ja) * 2005-04-06 2011-11-24 Boston Scientific Ltd 尿道下の支持のためのシステム、装置および方法
JP2012510863A (ja) * 2008-12-05 2012-05-17 ボストン サイエンティフィック サイムド，インコーポレイテッド メッシュ担体の送達のための挿入デバイスおよび方法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011235122A (ja) * 2005-04-06 2011-11-24 Boston Scientific Ltd 尿道下の支持のためのシステム、装置および方法
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
JP2012510863A (ja) * 2008-12-05 2012-05-17 ボストン サイエンティフィック サイムド，インコーポレイテッド メッシュ担体の送達のための挿入デバイスおよび方法

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107049600A (zh) * 2017-05-26 2017-08-18 西安医学院第二附属医院 一种耳鼓膜治疗装置
CN107049600B (zh) * 2017-05-26 2023-09-22 西安医学院第二附属医院 一种耳鼓膜治疗装置
DE102018103977A1 (de) * 2018-02-22 2019-08-22 Rz-Medizintechnik Gmbh Fixiervorrichtung zum Fixieren eines Ligaturbands sowie Vorrichtung zum Einführen und Fixieren eines Ligaturbands in einer Fixiervorrichtung
EP3711708A1 (fr) * 2019-03-18 2020-09-23 Marian Devonec Dispositif combinant suspension et mise en tension réajustable, réversible et amovible pour le traitement de l'incontinence urinaire
FR3093912A1 (fr) * 2019-03-18 2020-09-25 Marian Devonec Dispositif combinant suspension et mise en tension reajustable, reversible et amovible pour le traitement de l’incontinence urinaire

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