WO2018012387A1 - Stent recouvert. - Google Patents

Stent recouvert. Download PDF

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Publication number
WO2018012387A1
WO2018012387A1 PCT/JP2017/024761 JP2017024761W WO2018012387A1 WO 2018012387 A1 WO2018012387 A1 WO 2018012387A1 JP 2017024761 W JP2017024761 W JP 2017024761W WO 2018012387 A1 WO2018012387 A1 WO 2018012387A1
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WO
WIPO (PCT)
Prior art keywords
stent
covered stent
region
cover member
display
Prior art date
Application number
PCT/JP2017/024761
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English (en)
Japanese (ja)
Inventor
淳 住谷
京典 白川
Original Assignee
株式会社パイオラックスメディカルデバイス
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 株式会社パイオラックスメディカルデバイス filed Critical 株式会社パイオラックスメディカルデバイス
Publication of WO2018012387A1 publication Critical patent/WO2018012387A1/fr

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    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents

Definitions

  • the present invention relates to a covered stent placed in the bile duct or pancreatic duct.
  • Patent Document 1 discloses a stent body, a cylindrical cover that covers the side surface of the stent body, and an X-ray contrast medium provided on the cylindrical cover so as not to contact the stent body.
  • a stent for in-vivo placement with a marker for use is described.
  • the stent When placing such a stent in the bile duct or pancreatic duct, first, the stent is housed in a state where the diameter of the stent is reduced on the distal end side of a transporting device including an inner tube and an outer tube.
  • This transporter is inserted through the distal end of an endoscope placed in the duodenum, inserted into the bile duct and pancreatic duct via the nipple while visually confirming the transporter with an endoscope camera, and then under fluoroscopy.
  • the stent is placed in
  • the covered stent when the covered stent is placed in a bile duct or pancreatic duct constricted by a tumor or the like, depending on the form of the tumor or the like, one end of the covered stent may protrude from the nipple toward the duodenum side. .
  • an object of the present invention is to provide a covered stent that can easily grasp the insertion amount of the covered stent into the bile duct and pancreatic duct and can easily adjust the amount of protrusion from the nipple at one end of the covered stent under the view of the endoscope. It is to provide.
  • the present invention is a covered stent placed in a bile duct or pancreatic duct, comprising a stent body and a cover member disposed inside and / or outside the stent body,
  • a display that can recognize the boundary between the end region extending from one end of the main body to the other end of the selected length of 5 to 15 mm and the other region under the endoscope is the cover. It is characterized by being applied to the member.
  • the display that can recognize the boundary between the region reaching the length selected from one end of the stent body between 5 and 15 mm and the other region under the endoscope is the cover. Since it is applied to the member, when the covered stent is placed in the bile duct or pancreatic duct through the endoscope, the amount of the covered stent inserted into the bile duct or pancreatic duct can be grasped by observing the above indication on the cover member. This makes it easier to adjust the amount of protrusion of the covered stent from the nipple when the covered stent is placed in the bile duct or pancreatic duct.
  • FIG. 1 It is a perspective view which shows one Embodiment of the covered stent which concerns on this invention. It is sectional drawing at the time of cut
  • this covered stent is placed in the bile duct V2 or pancreatic duct V3.
  • the covered stent 10 of this embodiment has a plurality of mesh-like openings 25, and has a substantially cylindrical shape with one end 21 side and the other end 23 side opened in the axial direction. And a cover member 30 disposed inside and outside the stent body 20.
  • the stent body 20 in this embodiment is formed by forming a mesh-like opening 25 by, for example, laser processing or etching of a metal cylinder.
  • the mesh-like opening is formed by knitting, assembling, or entanglement of a metal wire.
  • And may be formed in a cylindrical shape with both axial ends open, and is not particularly limited.
  • the material of the stent body 20 is not particularly limited.
  • the stent body 20 has a substantially cylindrical shape with a substantially constant diameter from one end 21 to the other end 23, but one end of the one end 21 side or one end of the other end 23 side, or Further, the engagement force with respect to the bile duct V2 and the pancreatic duct V3 may be increased by forming a trumpet shape in which both end portions are expanded in diameter.
  • the stent body 20 is a self-expanding type that is normally expanded in diameter.
  • the stent body 20 is housed in the distal end of a stent delivery device 5 to be described later, and is transported and indwelled. It is good also as a balloon diameter expansion type which expands the diameter by mounting
  • the cover member 30 in this embodiment includes an inner cover 40 disposed inside the stent body 20 and an outer cover 50 disposed outside the stent body 20. The entire length from one end 21 of the 20 to the other end 23 is covered.
  • both axial ends of the cover member 30 are aligned with both ends 21 and 23 of the stent body 20 (see FIG. 2), both axial ends of the cover member 30 are connected to both ends of the stent body 20.
  • a predetermined length may be projected outward from 21 and 23 in the axial direction.
  • the end of the stent body 20 may protrude from the end of the cover member 30 by a predetermined length.
  • the cover member 30 may be only one of the inner cover 40 and the outer cover 50.
  • the inner cover 40 covers the inside of the stent body 20 and is embedded up to the middle of the thickness direction
  • the outer cover 50 covers the outside of the stent body 20.
  • the cover is embedded up to a portion that is not embedded in the inner cover 40, and the mesh-shaped opening 25 of the stent body 20 is closed by the covers 40 and 50.
  • the outer cover 50 has an uneven outer peripheral surface, but the inner cover 40 has a flat inner peripheral surface, and cancer cells are formed on the inner peripheral surface. Etc. are difficult to adhere.
  • the cover member 30 includes an end region R1 extending from one end 21 to the other end 23 of the stent body 20 to a length selected between 5 and 15 mm,
  • a display 60 is provided so that a boundary portion R3 with the other region R2 (meaning a region other than the end region R1 in the entire cover member 30) can be recognized under the endoscope.
  • the display 60 is recognizable under the endoscope, as shown in FIG. 8, an image captured by the camera of the endoscope 1 is displayed on an endoscope scope or a display monitor outside the endoscope. It means that it can be recognized visually.
  • the end region R1 extending from one end 21 of the stent body 20 to the other end 23 and having a length selected between 5 and 15 mm is, in other words, 5 to 15 mm from the end 21 of the stent body 20. In other words, it means that the length of the end region R1 is 5 to 15 mm.
  • the length of the end region R1 from the one end 21 to the other end 23 of the stent body 20 needs to be 5 to 15 mm, preferably 8 to 12 mm, and preferably 9 to 11 mm. More preferred.
  • the length of the end region R1 is less than 5 mm, the amount of protrusion from the nipple N is small when the stent is placed in the bile duct V2 or the pancreatic duct V3, and therefore, the end region R1 is easily drawn into the back side of the nipple N (see FIG. 9). ) If the length exceeds 15 mm, the amount of protrusion from the nipple N increases when the stent is placed in the bile duct V2 or the pancreatic duct V3, and one end of the stent easily comes into contact with the inner wall of the duodenum V1 (see FIG. 10). ).
  • an indication 60 is given to the end region R ⁇ b> 1 of the inner cover 40 and the outer cover 50, and other regions of the inner cover 40 and the outer cover 50.
  • R2 has a structure without the display 60.
  • the display 60 is configured such that a portion of the cover member 30 located in the end region R1 is colored with a hue and brightness different from those of the other portions located in the region R2. .
  • the hue means a difference in color appearance such as yellow, black, orange, pink, or the like.
  • Lightness means the brightness of a color. Note that the display 60 applied to the end region R1 may be different only in hue or different in brightness from the other region R2.
  • the end region R1 and the other region R2 are colored, but only the end region R1 is colored, and the other region R2 is not colored, and the material of the cover member itself is not colored. It is good also as a color (for example, white, black, etc.). That is, the “end region” in the present invention is meant to include those that are colored with different brightness and / or hue with respect to the color of the material of the cover member that is not colored in other regions.
  • the display 60 is given by coloring the entire end region R1 with a hue and brightness different from those of the other regions R2, but the display 60 includes the end region R1.
  • it may be a thick striped pattern provided at the boundary between R1 and the other region R2.
  • the display 60 is continuously provided on the entire circumference of the cover member 30 in the circumferential direction.
  • the display 60 may be applied intermittently at equal intervals in the circumferential direction of the cover member 30 or may be applied at a predetermined position in the circumferential direction of the cover member 30, and is not particularly limited.
  • the display 60 is preferably configured such that the portion located in the end region R1 of the cover member 30 is colored with one color selected from yellow, orange, pink, black, and purple. Among these, yellow is more preferable.
  • the portion of the cover member 30 located in the other region R2 is preferably a color different from the color of the display 60, for example, black, purple, or white, and among these, it may be black. More preferred.
  • the display 60 is yellow, the region R2 is black, the display 60 is yellow, and the region R2 Is purple, the display 60 is yellow, the region R2 is white, the display 60 is orange, the region R2 is black, the display 60 is pink, the region R2 is black, the display 60 is black, and the region R2 is white.
  • the region R2 is black, the display 60 is yellow, and the region R2 is purple (which is a complementary color relationship in the hue circle), the end region of the cover member 30
  • the boundary R3 between R1 and the other region R2 is preferable because it is easy to recognize clearly.
  • the display 60 is provided on both the end region R1 of the inner cover 40 and the outer cover 50.
  • the end region R1 of the inner cover 40 is displayed on the end region R1. May not display 60.
  • the display 60 is preferably applied to the end region R1 of the outer cover 50.
  • the display 60 may be applied to the end region R1 of the inner cover 40, and the outer cover 50 may be formed of a transparent material that allows the display 60 applied to the inner cover 40 to be visually recognized.
  • the display 60 may be given to the end region R1 of the cover.
  • the cover member 30, the inner cover 40, and the outer cover 50 are made of, for example, polyurethane, silicone, natural rubber, nylon elastomer, polyether block amide, polyethylene, polyvinyl chloride, vinyl acetate, or polytetra Fluoropolymers such as fluoroethylene (PTFE), perfluoroalkoxy resin (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene-ethylene copolymer (ETFE), polybutadiene, etc. It is preferably formed of olefin rubber, styrene elastomer or the like.
  • X-ray opaque metal powder may be added to the coloring material of the display 60 of the cover member 30 to impart X-ray opacity to the display 60.
  • the colored display 60 in order to give the colored display 60 to the cover member 30, for example, after forming the film-like cover member 30 on the stent body 20, a predetermined color is applied to the end region R1 of the cover member 30.
  • the display 60 is provided, or two heat-shrinkable tubes pre-colored with the display 60 and the color of the other region R2 are used as the cover member 30, and the tubes are arranged inside and outside the stent body 20. Then, after heat shrinking, the heat shrinking tube having the color of the region R2 forming the cover member 30 is disposed on the inside or outside of the stent body 20 and is attached by heat shrinking. This can be performed by applying a predetermined color to the partial region R1 to display 60, or by forming a film using a pre-colored film material.
  • a nipple N is provided below the duodenum V1, and a bile duct V2 and a pancreatic duct V3 branch off from the nipple N and extend.
  • the covered stent 10 is accommodated in a transport tool 5 as shown in FIG. 4 and transported to the bile duct V2 and pancreatic duct V3 via the endoscope 1.
  • the transport tool 5 shown in FIG. 4 includes a cylindrical inner tube 6 into which a guide wire G can be inserted, and a cylindrical outer tube 7 slidably disposed on the outer periphery thereof.
  • a tapered cylindrical head 6a that is engaged with the distal end of the outer tube 7 is connected to the distal end side of the inner tube 6, and further, a predetermined length from the distal end of the inner tube 6 toward the hand side.
  • a stopper 6b is fixed at a remote position.
  • a radiopaque marker 7a is disposed on the distal end side of the outer tube 7, and the position on the distal end side of the outer tube 7 can be grasped under X-ray fluoroscopy.
  • the outer tube 7 is made of a transparent or translucent material so that the display 60 of the accommodated covered stent 10 can be visually recognized. Note that the structure of the carrier is merely an example, and any structure may be used as long as the display 60 of the covered stent 10 can be recognized.
  • the covered stent 10 is reduced in diameter, and is accommodated in a gap between the outer periphery of the inner tube 6 and the inner periphery of the outer tube 7, one end side of which is locked to the stopper 6b, and the other end side is engaged with the head 6a.
  • the covered stent 10 is accommodated in a reduced diameter state on the distal end side of the carrier 5.
  • the covered stent 10 is arranged so that one end side on which the display 60 of the cover member 30 is applied is directed toward the proximal side of the carrier 5 (the side opposite to the traveling direction of the stent carrier 5).
  • a guide wire G (see FIG. 4) is inserted and arranged in the bile duct V2 through the nipple N through the lumen of the endoscope 1 by a known method. Thereafter, the proximal end side of the guide wire G is inserted from the head 6 a side of the distal end of the inner tube 6 of the transport tool 5, and the transport tool 5 is inserted into the lumen of the endoscope 1 through the guide wire G. Let it go. And the conveyance tool 5 inserted from the front end side opening of the endoscope 1 passes through the nipple N and is inserted into the bile duct V2.
  • the carrier 5 is advanced. Specifically, while confirming the distance between the nipple N and the display 60 of the covered stent 10 with an endoscope camera, the transport tool 5 is appropriately advanced or retracted (see FIG. 8) to display the display 60 of the covered stent 10. However, when the distance from the nipple N is an appropriate distance, the movement of the carrier 5 is stopped (see FIG. 5).
  • the reference stop position of the covered stent 10 is used as a reference stop position, and fine adjustment is performed therefrom.
  • the covered stent 10 accommodated in a reduced diameter state is accommodated.
  • the other end side of the tube is released from the gap between the outer tube 7 and the head portion 6a of the inner tube 6 and gradually increases in diameter, and the outer tube 7 is further slid toward the hand side.
  • one end of the covered stent 10 can be placed in a state protruding from the teat N toward the duodenum V1 by a predetermined length.
  • the end region R1 reaching a length selected between 5 and 15 mm from the one end 21 to the other end 23 of the stent body 20 and the other region R2 Since the display 60 capable of recognizing the boundary portion R3 under the endoscope is provided on the cover member 30, when the covered stent 10 is placed in the bile duct V2 or pancreatic duct V3 through the endoscope, By performing while viewing the display 60 (see FIG. 8), it is possible to grasp the insertion amount of the covered stent 10 into the bile duct V2 or pancreatic duct V3, and the covered stent when the covered stent 10 is placed in the bile duct V2 or pancreatic duct V3. It becomes easy to adjust the protrusion amount from the teat N of the one end part of 10.
  • a covered stent that does not have an indication 60 that can be recognized under the endoscope on the cover member 30 such as the covered stent 10 for example, under the X-ray fluoroscopy using the marker 7 a of the carrier 5. Then, after fixing the distal end position of the transport device 5, the covered stent is indwelled, or by estimating the amount of protrusion from the nipple N at one end of the covered stent by the camera of the endoscope 1, Although it is conceivable to place a covered stent, it is difficult to adjust the protruding amount of one end of the covered stent from the nipple N. As a result, as shown in FIG.
  • one end of the covered stent is placed in a state of being retracted into the back of the nipple N, or as shown in FIG. 10, one end of the covered stent is placed in the duodenum V1.
  • One end portion of the covered stent 10 comes close to the inner wall.
  • this covered stent 10 As described above, it is easy to adjust the protruding amount of one end portion of the covered stent 10 from the nipple N. Therefore, one end portion of the covered stent 10 is connected to the nipple N It can be indwelled with an appropriate amount of protrusion that is not pulled into the back of the nipple and that does not protrude too much from the nipple N.
  • the display 60 is colored with a hue (may be different brightness and / or hue) in the portion located in the end region R1 of the cover member 30 from the other region R2. Therefore, the boundary portion R3 between the two can be recognized more clearly under the endoscope, and the amount of protrusion of the covered stent 10 from the nipple N can be adjusted more easily. it can.
  • the display 60 is configured such that the portion located in the end region R1 of the cover member 30 is colored with one color selected from yellow, orange, pink, black, and purple. Therefore, even if the light of the endoscope 1 is irradiated to the covered stent 10, it becomes difficult to halate, and it is easy to visually recognize the portion located in the end region R1 of the cover member 30 with the camera of the endoscope 1. it can.
  • the display 60 is continuously provided on the entire circumference of the cover member 30, the display of the cover member 30 is displayed by the camera of the endoscope 1.
  • the display 60 can be easily viewed regardless of the position of the camera of the endoscope 1.
  • FIG. 11 (a) shows another embodiment of the covered stent according to the present invention. Note that substantially the same parts as those of the above-described embodiment are denoted by the same reference numerals, and description thereof is omitted.
  • the covered stent 10A of this embodiment has a structure in which end regions R1 and other regions R2 are alternately provided from one end 21 to the other end 23 of the stent body 20 (not shown) of the cover member 30.
  • the display 60 colored with brightness and / or hue different from the region R ⁇ b> 2 is applied to both ends and the center in the axial direction of the cover member 30.
  • the indications 60 are provided on both ends of the cover member 30 in the axial direction, it is not necessary to pay attention to the orientation of the covered stent 10A when the covered stent 10A is accommodated in the transporting tool 5. In addition, since there are a plurality of displays 60, it becomes easier to grasp the insertion state of the covered stent 10A during insertion.
  • FIG. 11B shows still another embodiment of the covered stent according to the present invention. Note that substantially the same parts as those of the above-described embodiment are denoted by the same reference numerals, and description thereof is omitted.
  • the end region R1 of the cover member 30 reaching a length selected between 5 to 15 mm from one end 21 of the stent body 20 (not shown), and the other region R2 are: The same brightness and / or hue, and the boundary R3 between the end region R1 and the other region R2 itself is colored with a different brightness and / or hue from the end region R1 and the other region R2.
  • the band-shaped display 60 is applied.
  • the display 60 becomes invisible, so that it is possible to adjust the amount of protrusion of the covered stent 10A by confirming that the display 60 appears again after being pulled back. .

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (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)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un stent recouvert avec lequel la longueur d'insertion du stent, recouvert dans le canal biliaire ou le canal pancréatique, peut être facilement mesurée par confirmation visuelle à l'aide d'un endoscope, et la quantité de projection d'une extrémité du stent, recouvert à partir d'une papille, peut être facilement ajustée. L'endoprothèse couverte (10) est destinée à être placée dans le canal biliaire, ou dans le canal pancréatique, et comprend un stent et un revêtement à l'intérieur et à l'extérieur du stent. La couverture est pourvu d'un indicateur qui permet de reconnaître une frontière avec un endoscope, une telle frontière se situant entre l'extrémité R1, qui s'étend d'une extrémité du corps principal d'endoprothèse (20) vers l'autre extrémité sur une longueur choisie entre 5 et 15 mm, et une région R2 au-delà de la région terminale R1.
PCT/JP2017/024761 2016-07-12 2017-07-06 Stent recouvert. WO2018012387A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016137886 2016-07-12
JP2016-137886 2016-07-12

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Publication Number Publication Date
WO2018012387A1 true WO2018012387A1 (fr) 2018-01-18

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PCT/JP2017/024761 WO2018012387A1 (fr) 2016-07-12 2017-07-06 Stent recouvert.

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021159393A (ja) * 2020-03-31 2021-10-11 日本ゼオン株式会社 管腔臓器間バイパス用ステント

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11511352A (ja) * 1995-08-24 1999-10-05 インプラ・インコーポレーテッド カバーした内腔内ステント及びその組み立て方法
WO2002035984A2 (fr) * 2000-10-31 2002-05-10 Prodesco, Inc. Greffons resistant au dechirement et a la formation de fuites
JP2007533400A (ja) * 2004-04-21 2007-11-22 ウィルソン−クック・メディカル・インコーポレーテッド 複数の医療装置を導入するためのシステム及び方法
WO2011118081A1 (fr) * 2010-03-26 2011-09-29 オリンパスメディカルシステムズ株式会社 Endoprothèse médicale
JP2015036043A (ja) * 2013-08-12 2015-02-23 シルックス株式会社 チューブステント搬送装置

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11511352A (ja) * 1995-08-24 1999-10-05 インプラ・インコーポレーテッド カバーした内腔内ステント及びその組み立て方法
WO2002035984A2 (fr) * 2000-10-31 2002-05-10 Prodesco, Inc. Greffons resistant au dechirement et a la formation de fuites
JP2007533400A (ja) * 2004-04-21 2007-11-22 ウィルソン−クック・メディカル・インコーポレーテッド 複数の医療装置を導入するためのシステム及び方法
WO2011118081A1 (fr) * 2010-03-26 2011-09-29 オリンパスメディカルシステムズ株式会社 Endoprothèse médicale
JP2015036043A (ja) * 2013-08-12 2015-02-23 シルックス株式会社 チューブステント搬送装置

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021159393A (ja) * 2020-03-31 2021-10-11 日本ゼオン株式会社 管腔臓器間バイパス用ステント
JP7439619B2 (ja) 2020-03-31 2024-02-28 日本ゼオン株式会社 管腔臓器間バイパス用ステント

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