WO2014020738A1 - Implant, et dispositif d'implant - Google Patents

Implant, et dispositif d'implant Download PDF

Info

Publication number
WO2014020738A1
WO2014020738A1 PCT/JP2012/069678 JP2012069678W WO2014020738A1 WO 2014020738 A1 WO2014020738 A1 WO 2014020738A1 JP 2012069678 W JP2012069678 W JP 2012069678W WO 2014020738 A1 WO2014020738 A1 WO 2014020738A1
Authority
WO
WIPO (PCT)
Prior art keywords
main body
implant
guide portion
warp yarns
width
Prior art date
Application number
PCT/JP2012/069678
Other languages
English (en)
Japanese (ja)
Inventor
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/JP2012/069678 priority Critical patent/WO2014020738A1/fr
Publication of WO2014020738A1 publication Critical patent/WO2014020738A1/fr

Links

Images

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

Definitions

  • the present invention relates to an implant and an implant 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 “sling” a tape-like and net-like implant is used, and the sling is placed in the body and the urethra is supported by the sling (
  • Patent Document 1 a tape-like and net-like implant is used, and the sling is placed in the body and the urethra is supported by the sling.
  • the surgeon incises the vagina wall with a scalpel, peels off the space between the urethra and the vagina, and uses the puncture needle to communicate the peeled site and the outside through the pelvic obturator. And a puncture hole is formed.
  • TOT surgery such a puncture hole is used to place a sling directly under the urethra in a living body.
  • the sling may cause urinary obstruction, or it may be called “erosion”, and complications such as the sling breaking through the vagina wall and being exposed in the vagina may occur.
  • the conventional sling cannot weaken the tightening force of the urethra due to the sling or change the position of the sling in the living body, so that the sling is taken out from the living body.
  • the operator again uses a scalpel to incise the entire vaginal wall corresponding to the site where the sling is placed, and peel the sling from the living tissue.
  • An object of the present invention is to provide an implant and an implant device that have a low patient burden and high patient safety when an implant embedded in a living body is peeled from a living tissue.
  • An implant that has flexibility, has a longitudinal shape, and can be embedded in a living body, A plurality of warp yarns extending in the longitudinal direction; and a plurality of weft yarns for main body portions intersecting with the warp yarns; A guide portion provided at at least one end in the longitudinal direction of the main body portion, wherein a part or all of the plurality of warp yarns are extended and assembled, The width of the guide portion is smaller than the width of the main body portion,
  • the implant is characterized in that the guide portion is provided with a density lower than that of the main body portion weft and has a guide portion weft that intersects the warp yarn or does not have the guide portion weft.
  • An implant that has flexibility, has a longitudinal shape, and can be embedded in a living body, A plurality of warp yarns extending in the longitudinal direction; and a plurality of weft yarns for main body portions intersecting with the warp yarns; A guide portion provided at at least one end in the longitudinal direction of the main body portion, wherein a part or all of the plurality of warp yarns are extended and assembled, The width of the guide portion is smaller than the width of the main body portion, An end portion of the guide portion on the main body side is curved in a concave shape.
  • An implant that has flexibility, has a longitudinal shape, and can be embedded in a living body, A plurality of warp yarns extending in the longitudinal direction; and a plurality of weft yarns for main body portions intersecting with the warp yarns; A guide portion provided at at least one end in the longitudinal direction of the main body portion, wherein a part or all of the plurality of warp yarns are extended and assembled, The width of the guide portion is smaller than the width of the main body portion, The implant characterized in that the warp yarns at both ends in the width direction of the main body portion extend to constitute at least a part of the guide portion.
  • the guide portion is a string-like traction portion capable of pulling the main body portion, and is arranged between the traction portion and the main body portion, and has a taper whose width gradually decreases toward the traction portion side.
  • the implant according to any one of the above (1) to (6).
  • the tapered portion is inserted into the tubular body before the main body portion when the main body portion is inserted into the tubular body, and is guided so as to be deformed into a shape for inserting the main body portion into the tubular body.
  • the implant is used to treat urinary incontinence, The implant according to any one of (1) to (10), wherein the main body is capable of supporting the urethra.
  • An implant device comprising: a tube body into which the implant can be inserted.
  • the main body of the implant when the implant embedded in the living body is peeled from the living tissue, the main body of the implant can be easily and less invasively inserted into the tubular body by the guide portion, and the tubular body is used as the implant. By moving along, the implant can be detached from the living tissue by the tube. For this reason, there is little burden on a patient and patient safety is high. Then, after the implant is peeled from the living tissue, the implant can be taken out from the living body, and the position of the implant can be adjusted.
  • FIG. 1 is a plan view showing an embodiment of the implant device of the present invention.
  • FIG. 2 is a plan view of the implant of the implant device shown in FIG.
  • FIG. 3 is a plan view showing a state where a tube is inserted into the implant partway in the implant device shown in FIG. 1.
  • FIG. 4 is a view for explaining an operation procedure of the implant device shown in FIG. 1.
  • FIG. 5 is a view for explaining an operation procedure of the implant device shown in FIG. 1.
  • FIG. 1 is a plan view showing an embodiment of the implant device of the present invention.
  • FIG. 2 is a plan view of the implant of the implant device shown in FIG.
  • FIG. 3 is a plan view showing a state where a tube is inserted into the implant partway in the implant device shown in FIG. 1.
  • 4 and 5 are diagrams for explaining an operation procedure of the implant device shown in FIG. In FIG. 4 and FIG. 5, the oblique lines in the living body are omitted for easy viewing.
  • an implant device 10 is a device used for treating female urinary incontinence.
  • an implant device 10 includes an implant 1 that is flexible, has a longitudinal shape, and can be embedded in a living body, and a sheath (tubular body) 5 into which the implant 1 can be inserted. ing.
  • the sheath 5 is used by inserting the implant 1 when peeling the implant 1 embedded in the living body from the living tissue.
  • the implant 1 is an instrument that can be implanted in a living body for the treatment of female urinary incontinence. That is, the implant 1 is an instrument that is embedded in a living body and supports the urethra (biological tissue), for example, an instrument that supports the urethra so that it does not move when the urethra tries to move toward the vaginal wall.
  • the implant 1 is inserted into the sheath 5 when the implant 1 embedded in the living body is peeled from the living tissue.
  • the implant 1 has a main body portion 2 and a pair of guide portions 3 provided at both ends in the longitudinal direction of the main body portion 2.
  • the overall shape of the main body 2 is a band (plate), that is, a rectangle.
  • the main body 2 has a plurality of warps 41 extending in the longitudinal direction and a plurality of wefts (wefts for main body) intersecting with the warps 41 and has a net shape.
  • the warp yarn 41 and the weft yarn 42 are orthogonal to each other. Needless to say, the angle formed by the warp yarn 41 and the weft yarn 42 is not limited to 90 °.
  • Such a main body 2 can be constituted by a braided body in which a warp yarn 41 and a weft yarn 42 are crossed, that is, a braided body.
  • the end portion of the weft thread 42 is fixed to the warp thread 41 at the end portion of the main body 2 in the width direction (vertical direction in FIG. 2).
  • Examples of the warp yarn 41 and the weft yarn 42 include, for example, a circular cross section, a flat cross section, that is, a belt (ribbon).
  • warp yarn 41 and the weft yarn 42 are not limited to being knitted but may be integrally formed, for example.
  • the dimensions of the main body 2 are not particularly limited and are appropriately set according to various conditions.
  • the length in the longitudinal direction is preferably about 10 to 600 mm, more preferably about 30 to 300 mm.
  • the length of the main body 2 in the vertical direction in FIGS. 1 and 2, that is, the width W1 in the direction perpendicular to the longitudinal direction of the main body 2 is about 2 to 30 mm. Preferably, it is about 5 to 15 mm.
  • the ratio of the mesh portion of the main body 2, that is, the opening is not particularly limited, and is appropriately set according to various conditions, but is preferably about 20 to 95%, and preferably 50 to 90 More preferably, it is about%. Thereby, when accommodating in the sheath 5, supporting a urethra more reliably, it can deform
  • Each guide part 3 is provided at both ends in the longitudinal direction of the main body part 2, and a plurality of warp threads 41 are extended and assembled. That is, the warp yarn 41 constituting the main body portion 2 and the warp yarn 41 constituting the guide portion 3 are continuous. Moreover, in this embodiment, all the warp threads 41 of the main body portion 2 are extended to constitute the guide portions 3. That is, the number of warp yarns 41 in the main body portion 2 is equal to the number of warp yarns 41 in the guide portion 3.
  • the main body 2 and the guide portion at both ends in the width direction of the implant 1 Therefore, when the implant 1 is inserted into the sheath 5, the implant 1 can be inserted smoothly.
  • each guide part 3 does not have a weft. Thereby, it becomes difficult to form unevenness in the guide portion 3, and when the implant 1 is inserted into the sheath 5, the implant 1 can be smoothly inserted.
  • each guide part 3 since the structure of each guide part 3 is the same, below, the one guide part 3 is demonstrated typically.
  • the guide portion 3 includes a string-like traction portion 32 capable of pulling the main body portion 2 and a taper portion 31 disposed between the traction portion 32 and the main body portion 2.
  • the length of the guide portion 3 in the vertical direction in FIGS. 1 and 2, that is, the width W 2 that is the length in the direction perpendicular to the longitudinal direction of the guide portion 3 is smaller than the width W 1 of the main body portion 2. Is set.
  • the taper portion 31 is a function of guiding the main body portion 2 to be deformed into a shape to be inserted into the sheath 5 before the main body portion 2 and inserted into the sheath 5 when the main body portion 2 is inserted into the sheath 5. I am doing.
  • the width W2 of the taper portion 31 is gradually reduced toward the traction portion 32 side. Note that the inclination angle ⁇ of the taper portion 31 may be constant or may vary.
  • the inclination angle ⁇ of the taper portion 31 is not particularly limited and is appropriately set according to various conditions, but is preferably about 2 to 80 °, and preferably about 20 to 45 °. More preferred. Thereby, the taper part 31 can be inserted into the sheath 5 more smoothly.
  • the end portion of the guide portion 3 on the main body portion 2 side that is, the tapered portion 31 is curved in a concave shape so that both end portions in the width direction are located on the front side with respect to the paper surface of FIG. ing.
  • the end portion of the main body portion 2 on the guide portion 3 side is similarly curved in a concave shape due to the curvature of the tapered portion 31.
  • the towing unit 32 is a twisted warp yarn 41.
  • the traction unit 32 is formed by twisting each warp yarn 41 into three parts and knitting each, that is, a braid. Thereby, the intensity
  • each warp thread 41 of the traction unit 32 is not limited to braiding, and for example, it may be two or four or more. Moreover, each warp thread 41 of the traction part 32 does not need to be knitted.
  • the diameter is preferably about 0.1 to 3 mm, more preferably about 0.2 to 2 mm. .
  • the width is preferably about 0.5 to 10 mm, and more preferably about 2 to 5 mm.
  • the thickness is preferably about 0.1 to 5 mm, more preferably about 1 to 3 mm.
  • constituent material of the implant 1, that is, the constituent material of the warp yarn 41 and the weft yarn 42 is not particularly limited, and for example, various resin materials having biocompatibility such as polypropylene, fibers, and the like can be used.
  • the sheath 5 has flexibility.
  • the dimension of the sheath 5 is not particularly limited and is appropriately set according to various conditions such as the dimension of the implant 1, but the inner diameter (diameter) is preferably about 1 to 10 mm. More preferably, it is about 5 mm.
  • the outer diameter (diameter) is preferably about 1 to 15 mm, and more preferably about 2.5 to 5.5 mm.
  • the constituent material of the sheath 5 is not particularly limited.
  • resins polytetrafluoroethylene and the like
  • various other elastomers for example, polyamide-based and polyester-based thermoplastic elastomers
  • FIGS. 4 and 5 an example of a method for using the implant device 10 will be described with reference to FIGS. 4 and 5.
  • a procedure for taking out the implant 1 embedded in the living body for the treatment of female urinary incontinence will be described.
  • the implant 1 is embedded in a patient's living body.
  • the main body portion 2 of the implant 1 is disposed so as to be located immediately below the urethra, that is, between the urethra and the vagina.
  • the traction part 32 of each guide part 3 is inserted through the closing holes of the left and right pelvises, and the end part of each traction part 32 opposite to the main body part 2 is rounded or bent. In the state, it is disposed in the living body in the vicinity of the left and right buttocks.
  • the implant 1 When the implant 1 is taken out from the living body, as shown in FIG. 4 (b), the body surface in the vicinity of one of the buttocks is slightly incised, and the end of the pulling portion 32 of the one guide portion 3 from the incision hole. Remove the part. Then, as shown in FIG. 4C, the traction portion 32 is inserted into the sheath 5, and the end portion of the traction portion 32 is pulled out from the opening at the end portion of the sheath 5.
  • the sheath 5 is inserted into the living body while pulling the pulling portion 32 to the opposite side of the main body portion 2, and the main body portion along the pulling portion 32. Push it to the 2nd side. Thereby, the implant 1 is inserted into the sheath 5, and the implant 1 is peeled from the living tissue by the sheath 5.
  • the tapered portion 31 is inserted into the sheath 5 following the pulling portion 32 of the guide portion 3.
  • the tapered portion 31 is curved in a concave shape, the tapered portion 31 is smoothly inserted into the sheath 5 and further curved, that is, curled and folded (see FIG. 3).
  • the main body portion 2 is inserted into the sheath 5.
  • the main body 2 is bent by the bending of the taper portion 31, and thereby smoothly inserted into the sheath 5 and further bent in the sheath 5, that is, curled and folded (see FIG. 3).
  • the subsequent portion of the main body 2 is similarly bent by the bending of the main body 2 on the near side, so that it is smoothly inserted into the sheath 5 and further bent in the sheath 5, that is, rounded. Folded. Thereafter, such an operation is continuously repeated, and the entire main body 2 is inserted into the sheath 5.
  • the entire main body 2 is peeled from the living tissue.
  • the guide portion 3 does not need to be actively peeled off by the sheath 5.
  • the pulling portion 32 is pulled, the sheath 5 and the implant 1 are extracted from the living body, a predetermined treatment is performed, and the procedure is finished.
  • the tension of the implant 1 may be adjusted while the implant 1 is embedded in the living body. In this case, after the entire body 2 of the implant 1 is peeled from the living tissue by the sheath 5, the tension of the implant 1 is adjusted. In adjusting the tension of the implant, for example, when urine obstruction is caused by the implant 1, the sheath 5 is used to move the main body 2 away from the urethra to reduce the tension of the implant 1. .
  • the implant device 10 when the implant 1 embedded in the living body is peeled from the living tissue, the surface of the living body in the vicinity of the end portion of the pulling portion 32 of the implant 1 is cut small. It can be handled only by an invasive technique, and it is not necessary to make a large incision in the vaginal wall.
  • the main body 2 of the implant 1 when the main body 2 of the implant 1 is inserted into the sheath 5, the main body 2 can be inserted into the sheath 5 easily and smoothly by the tapered portion 31.
  • the taper portion 31 does not have a weft, a step or the like hardly occurs in the taper portion 31, and the taper portion 31 can be inserted into the sheath 5 easily and smoothly.
  • the tapered portion 31 is curved in a concave shape, the main body portion 2 can be smoothly inserted into the sheath 5 by this.
  • the main body 2 and the tapered portion are formed at both ends in the width direction of the implant 1.
  • the boundary part with 31 becomes smooth, and, thereby, the main-body part 2 can be smoothly inserted into the sheath 5.
  • the implant and the implant device of the present invention have been described based on the illustrated embodiment.
  • the present invention is not limited to this, and the configuration of each part is an arbitrary configuration having the same function. Can be replaced.
  • any other component may be added to the present invention.
  • a hard tube may be used as the tube.
  • the guide portion 3 may be configured by extending a part of the plurality of warp threads 41 constituting the main body portion 2 and collecting them. That is, the number of warp threads 41 in the guide part 3 may be smaller than the number of warp threads 41 in the main body part 2.
  • the guide portion 3 may be provided with a lower density than the weft yarn 42 in the main body portion 2 and may have a weft yarn (weft yarn for guide portion) that intersects the warp yarn 41.
  • the guide portion 3 may be provided only at one end portion in the longitudinal direction of the main body portion 2.
  • the contour shape of the main body 2 is not limited to a rectangle, and examples thereof include other polygons such as a pentagon, a circle, an ellipse, and the like.
  • the implant and the implant device of the present invention when the implant and the implant device of the present invention are applied to the treatment of urinary incontinence in women, the application of the implant and the implant device particularly in the TOT operation has been described.
  • the pubic urethra ligament is assumed to be a ligament that passes through both sides of the pubic bone and under the urethra, and is applied to implants and implant devices used in TVT surgery that reinforces the U shape using an implant. May be.
  • the use of the implant and implant device of the present invention is not limited thereto. Other applications include, for example, implants and implant devices for the treatment of male urinary incontinence.

Landscapes

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

Abstract

L'implant (1) de l'invention est flexible et de forme allongée, et peut être introduit à l'intérieur d'un corps vivant. Cet implant (1) possède : une partie corps principal (2) de forme plate et qui possède une pluralité de fils de chaîne (41) se prolongeant dans une direction longitudinale, et une pluralité de fils de trame (42) croisant les fils de chaîne (41) ; et une paire de parties guide (3) agencées aux deux parties extrémité de la partie corps principal (2) dans la direction de sa longueur. Chaque partie guide (3) est équipée : d'une partie traction (32) en forme de corde permettant de tirer la partie corps principal (2) ; et d'une partie évasée (31) disposée entre la partie traction (32) et la partie corps principal (2). Chaque partie guide (3) est configurée par extension et réunion de l'ensemble des fils de chaîne (41). En outre la largeur (W2) de chaque partie guide (3), est plus petite que la largeur (W1) de la partie corps principal (2). Enfin, aucune des parties guide (3) ne possède de fils de trame.
PCT/JP2012/069678 2012-08-02 2012-08-02 Implant, et dispositif d'implant WO2014020738A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/JP2012/069678 WO2014020738A1 (fr) 2012-08-02 2012-08-02 Implant, et dispositif d'implant

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2012/069678 WO2014020738A1 (fr) 2012-08-02 2012-08-02 Implant, et dispositif d'implant

Publications (1)

Publication Number Publication Date
WO2014020738A1 true WO2014020738A1 (fr) 2014-02-06

Family

ID=50027466

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2012/069678 WO2014020738A1 (fr) 2012-08-02 2012-08-02 Implant, et dispositif d'implant

Country Status (1)

Country Link
WO (1) WO2014020738A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6575897B1 (en) * 1998-11-10 2003-06-10 Sofradim Production Suspension device for treating prolapse and urinary incontinence
JP2006055330A (ja) * 2004-08-19 2006-03-02 Cathex Co Ltd ステント及びステントグラフト
US20080207989A1 (en) * 2005-08-29 2008-08-28 Ams Research Corporation System For Positioning Support Mesh in a Patient
JP2008535577A (ja) * 2005-04-06 2008-09-04 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 尿道下の支持のためのシステム、装置および方法
US20110263930A1 (en) * 2010-04-21 2011-10-27 David Elliot Rapp Device and method for vaginal sacrocolpopexy

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6575897B1 (en) * 1998-11-10 2003-06-10 Sofradim Production Suspension device for treating prolapse and urinary incontinence
JP2006055330A (ja) * 2004-08-19 2006-03-02 Cathex Co Ltd ステント及びステントグラフト
JP2008535577A (ja) * 2005-04-06 2008-09-04 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 尿道下の支持のためのシステム、装置および方法
US20080207989A1 (en) * 2005-08-29 2008-08-28 Ams Research Corporation System For Positioning Support Mesh in a Patient
US20110263930A1 (en) * 2010-04-21 2011-10-27 David Elliot Rapp Device and method for vaginal sacrocolpopexy

Similar Documents

Publication Publication Date Title
EP1804715B1 (fr) Système pour la pose d'implants chirurgicaux
KR101354189B1 (ko) 외과 임플란트 및 관련 방법들과 장치
JP6051226B2 (ja) 穿刺装置
US10258374B2 (en) Puncture apparatus
JP6130355B2 (ja) 穿刺装置
US10143468B2 (en) Medical tube and medical tube assembly
RU2540167C2 (ru) Вспомогательное центрирующее устройство для имплантируемой петли
JP5972895B2 (ja) 固定器具
WO2014020738A1 (fr) Implant, et dispositif d'implant
US10238380B2 (en) Medical tube, medical tube assembly, and intrapelvic treatment kit
WO2014162425A1 (fr) Dispositif médical
AU2014265110B2 (en) Surgical implants and related methods and systems
US9370412B2 (en) Bodily implants and methods for delivery and placement of bodily implants into a patients body
US20140207247A1 (en) Implant and implant apparatus
US20160015385A1 (en) Puncture apparatus
WO2014162423A1 (fr) Dispositif médical
US20170000596A1 (en) Puncture member
US20160193024A1 (en) Medical tube assembly and puncture apparatus
US20160175081A1 (en) Medical tube, medical device set, and method of placing implant indwelling
US20160008119A1 (en) Tube assembly
WO2014162431A1 (fr) Tube médical et ensemble de tube médical
JP2013070813A (ja) ガイド装置およびインプラント装置
JP2015116347A (ja) 挿入具および挿入具の挿入方法

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 12882328

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 12882328

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: JP