WO2021044837A1 - Stent - Google Patents

Stent Download PDF

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Publication number
WO2021044837A1
WO2021044837A1 PCT/JP2020/031073 JP2020031073W WO2021044837A1 WO 2021044837 A1 WO2021044837 A1 WO 2021044837A1 JP 2020031073 W JP2020031073 W JP 2020031073W WO 2021044837 A1 WO2021044837 A1 WO 2021044837A1
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WO
WIPO (PCT)
Prior art keywords
stent
main body
bile
axial direction
shape
Prior art date
Application number
PCT/JP2020/031073
Other languages
English (en)
Japanese (ja)
Inventor
白濱　憲昭
Original Assignee
川澄化学工業株式会社
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 川澄化学工業株式会社 filed Critical 川澄化学工業株式会社
Priority to JP2021543682A priority Critical patent/JPWO2021044837A1/ja
Publication of WO2021044837A1 publication Critical patent/WO2021044837A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis

Definitions

  • the present invention relates to a stent that forms an internal fistula between two luminal organs.
  • EUS endoscopic ultrasonography
  • BD EUS-guided biliary drainage
  • the medical device of Patent Document 1 is configured to allow bile to flow directly from the duodenum to the duodenum, but not to prevent backflow of fluid from the duodenum to the duodenum.
  • An object of the present invention is to provide a stent capable of flowing body fluid from one luminal organ in one direction.
  • the stent according to the present invention A stent that communicates two tract organs and allows body fluid to flow from one of the tract organs to the other.
  • a main body that penetrates each lumen wall of the two luminal organs and can be positioned and placed in the axial direction and in the direction intersecting the axial direction.
  • a stent comprising a valve portion that prevents backflow of fluid in the main body portion.
  • body fluid from one luminal organ can flow in one direction.
  • FIG. 1A and 1B are views showing an example of a stent in use.
  • 2A and 2B are perspective views showing the appearance of the stent.
  • 3A to 3D are views showing an example of a stent placement process.
  • FIG. 4 is a diagram showing a modified example of the stent.
  • FIG. 5 is a diagram showing another example of the use state of the stent.
  • FIG. 1 is a diagram showing an example of a usage state of the stent 1.
  • FIG. 1B is an enlarged view of the drainage site in FIG. 1A, and the flow of bile is indicated by an arrow.
  • 2A and 2B are perspective views showing the appearance of the stent 1 as viewed from different directions.
  • the stent 1 is a communication member used to form an internal fistula that serves as a bile flow path between the bile sac G and the duodenum D, and is a communication member used to form a bile sac wall GW and a duodenum wall. It is placed so as to penetrate the DW.
  • the stent 1 communicates the bile sac G and the duodenum D, and the bile stored in the bile sac G can directly flow into the duodenum D.
  • the stent 1 includes a main body portion 10, a valve portion 20 that prevents backflow of fluid in the main body portion 10, and a lumen wall (luminal cavity) of two luminal organs to be communicated with. It comprises an engaging portion 30 that engages (including the inner surface of a through hole formed in the wall).
  • the engaging portion 30 is provided with a first engaging portion 31 that engages with the bile wall GW and a second engaging portion 32 that engages with the duodenal wall DW when the stent 1 is placed. ing.
  • the main body portion 10 has a circular cross-sectional shape orthogonal to the axial direction, and is formed in a tubular shape having a predetermined length in the axial direction.
  • the outer diameter of the main body 10 is larger than the outer diameters of the through holes GW1 and DW1 (see FIG. 3A and the like) formed in the bile sac wall GW and the duodenal wall DW, and the main body 10 is press-fitted into the through holes GW1 and DW1. It has become like.
  • the length of the main body portion 10 is preferably equal to or less than the sum of the thickness of the bile wall GW and the thickness of the duodenal wall DW to be communicated. As a result, the bile sac wall GW and the duodenal wall DW can be reliably held in close contact with each other.
  • first end 10a one end 10a on the back side of the right hand in FIG. 2A of the main body 10
  • second end 10 the other end 10b on the front left side in FIG. 2A
  • part 10b It is referred to as "part 10b”.
  • the stent 1 is placed so that the first end 10a is on the upstream side and the second end 10b is on the downstream side in the bile flow direction (see FIG. 1B and the like).
  • the main body portion 10 is a so-called covered stent having a skeleton portion 11 and a coating portion 12.
  • the skeleton portion 11 has a structure in which, for example, one or a plurality of metal wires are spirally wound in the axial direction while being bent so that peaks and valleys are alternately formed. Further, for example, the skeleton portion 11 is formed by arranging a plurality of skeletons formed in an annular shape while bending the metal wire rod so that peaks and valleys are alternately formed at predetermined intervals in the axial direction. You may.
  • the skeleton portion 11 is configured to be self-expandable from a contracted state contracted inward to an expanded state expanding outward to define a tubular flow path in a radial direction substantially orthogonal to the axial direction.
  • the material, wire type for example, circular wire such as wire, or square wire obtained by laser cutting
  • wire diameter cross-sectional area
  • number of folds in the circumferential direction and fold shape (mountain part) of the wire forming the skeleton portion 11.
  • the number and shape of the mountain part) and the wire spacing (spiral pitch (skeleton amount per unit length)) in the axial direction are appropriately selected based on the flexibility of the main body 10 required according to the placement site. Will be done.
  • the flexibility refers to the ease of bending of the main body portion 10, and is particularly defined by the flexural rigidity in the axial direction.
  • the high flexibility of the main body 10 means that the flexural rigidity in the axial direction is moderately low, and the main body portion 10 has a property of following the shape of the indwelling portion or the sheath without kinking in the indwelling portion or the sheath.
  • Examples of the material of the metal wire rod forming the skeleton portion 11 include known metals or metal alloys typified by stainless steel, Ni—Ti alloy (Nitinol), titanium alloy and the like. Further, an alloy material having X-ray contrast property may be used.
  • the skeleton portion 11 may be formed of a material other than the metal material (for example, ceramic or resin). Further, the skeleton portion 11 may be formed by, for example, laser processing (laser cutting) one metal pipe (for example, a pipe made of Ni—Ti alloy). The same applies to the metal wire rod forming the skeleton portion 23 provided in the valve portion 20 described later, and the metal wire rod forming the first engaging portion 31 and the second engaging portion 32.
  • the membrane portion 12 is a membrane body that forms a flow path for bile.
  • the film portion 12 may be arranged on the outer peripheral surface and the inner peripheral surface of the skeleton portion 11 so as to sandwich the skeleton portion 11, or may be arranged on only one of the outer peripheral surface and the inner peripheral surface of the skeleton portion 11. May be good.
  • Examples of the material for forming the film portion 12 include silicone resin, fluororesin such as PTFE (polytetrafluoroethylene), polyester resin such as polyethylene terephthalate, and the like.
  • fluororesin such as PTFE (polytetrafluoroethylene)
  • polyester resin such as polyethylene terephthalate, and the like.
  • the valve portion 20 allows bile from the bile sac G to pass in only one direction and prevents reverse flow from the duodenum D (eg, digestive material flow).
  • the valve portion 20 is connected to the second end portion 10b on the downstream side in the bile flow direction in the main body portion 10 and has a bile outlet 20b.
  • the valve portion 20 is formed by a film body and is integrally formed with the film portion 12 in the same manner as the film portion 12 of the main body portion 10.
  • the valve portion 20 is formed in a tapered shape toward the downstream side in the flow direction of bile (body fluid) in the main body portion 10, for example.
  • the valve portion 20 has a tapered portion 21 connected to the main body portion 10 and a flat portion 22 connected to the tip end side of the tapered portion 21, and the windsock whose outer shape is deformed by fluid pressure. It is formed in a shape.
  • the taper portion 21 has a length in the vertical direction D1 substantially orthogonal to the axial direction and the width direction D2 with almost no change in the length of the width direction D2 orthogonal to the axial direction from the inflow port 20a toward the flat portion 22. Is formed to be short.
  • a skeleton portion 23 in which a metal wire rod folded back in a zigzag shape is spirally extended is arranged along a portion connected with the main body portion 10.
  • the skeleton portion 23 has two mountain portions 23a whose tip end side (flat portion 22 side) projects toward the tip end side.
  • the two mountain portions 23a are provided at positions symmetrical with respect to the axial direction, that is, opposite to the width direction D2.
  • the flat portion 22 is formed so that the lengths in the vertical direction D1 and the width direction D2 are maintained, and the length in the vertical direction D1 (thickness of the flat portion 22) is the length in the width direction D2 (the flat portion 22). It has a flat shape smaller than the width). Further, an outlet 20b is provided at the end of the flat portion 22 on the bile outflow side (tip side). The outlet 20b occludes in a straight line when bile does not pass through. On the other hand, when bile passes through the outlet 20b, the outlet 20b is expanded by the internal pressure of the bile, and has an elliptical shape or a rectangular shape, for example.
  • the shape of the outlet 20b when bile passes is not particularly limited as long as the shape allows bile to pass through.
  • the skeleton portion 23 may be urged so that the tops of the two mountain portions 23a are separated from each other in the width direction D2, for example.
  • the two mountain portions 23a pull the tip side (rear end side of the flat portion 22) of the tapered portion 21 so as to separate in the width direction D2, so that the outlet 20a is opened. It is possible to rapidly shift from the state to the closed state and effectively prevent the inflow of fluid from the duodenum D.
  • the first engaging portion 31 and the second engaging portion 32 project into a first shape along the axial direction of the main body portion 10 and in a direction intersecting (for example, substantially orthogonal to) the axial direction of the main body portion 10. It can be deformed to exhibit a shape.
  • the first engaging portion 31 and the second engaging portion 32 are, for example, axially stretched or folded in a state of being housed in the sheath 101 (see FIG. 3A or the like) of the stent placement device 100. It exhibits a shape and, when released from the stenting device, exhibits a second shape and engages with the lumen wall of the luminal organ (eg, the biliary wall GW and the duodenal wall DW). That is, the first engaging portion 31 and the second engaging portion 32 are configured to be self-deployable.
  • 2A and 2B show a case where the first engaging portion 31 and the second engaging portion 32 have a second shape.
  • the first engaging portion 31 and the second engaging portion 32 are formed of, for example, a shape memory material (for example, Ni—Ti alloy) and are heat-treated in a state of being in the second shape to obtain an overall shape. Will be remembered. As a result, with the release of the stent 1 from the sheath 101 (see FIG. 3A and the like), the first engaging portion 31 and the second engaging portion 32 are surely expanded to exhibit the first shape.
  • a shape memory material for example, Ni—Ti alloy
  • the first engaging portion 31 and the second engaging portion 32 are formed, for example, so that fine metal wires are woven into a mesh shape to exhibit a donut-shaped second shape.
  • the first engaging portion 31 and the second engaging portion 32 may be integrally formed with the skeleton portion 11 by the metal wire rod forming the skeleton portion 11 of the main body portion 10, or may be formed separately from the main body portion 10. May be formed with.
  • the first engaging portion 31 and the second engaging portion 32 are formed separately from the main body portion 10, they are caulked and connected to, for example, the skeleton portion 11.
  • the first engaging portion 31 engaged with the bile wall GW has a first shape so that the first end portion 10a of the main body portion 10 does not protrude from the first engaging portion 31 when exhibiting the second shape. It is preferably connected to the rear end of the end portion 10a.
  • bile overcomes the first end portion 10a on which the film portion 12 is formed and flows into the main body portion 10. This is because the flow of bile may be obstructed. That is, by connecting the first engaging portion 31 to the rear end of the first end portion 10a, bile can smoothly flow into the main body portion 10.
  • the second shapes of the first engaging portion 31 and the second engaging portion 32 can be arbitrarily changed, and may be, for example, a flange shape that is crushed in the axial direction rather than the donut shape.
  • the stent 1 has a removal assisting portion 40 (Lasso) used when removing the indwelling stent 1.
  • the removal assisting portion 40 is provided, for example, at the second end portion 10b (downstream side end portion) of both ends in the axial direction of the main body portion 10 so as to project in the axial direction.
  • the removal assisting portion 40 has an engaging portion 41 to which a hook (snare: collecting member) provided at the tip of the collecting catheter is engaged.
  • the engaging portion 41 is formed, for example, by bending a wire rod, and may have, for example, a hook shape or a loop shape.
  • the same wire as the skeleton portion 11 can be applied to the wire rod forming the extraction assisting portion 40, and the extraction assisting portion 40 may be integrally formed with the skeleton portion 11.
  • 3A to 3D are diagrams showing an example of the placement process of the stent 1.
  • endoscopic ultrasonographic bile drainage here, EUS-GBD
  • EUS-GBD endoscopic ultrasonographic bile drainage
  • endoscopic ultrasonography is introduced orally and delivered through the esophagus and stomach to a predetermined site of duodenum D.
  • the stent 1 is housed in the sheath 101 of the stent indwelling device 100 in a folded state of the first engaging portion 31 and the second engaging portion 32, and is introduced into the body via an ultrasonic endoscope.
  • the tip end 102 is provided on the tip end side of the sheath 101.
  • the tip tip 102 has an incision (not shown) capable of incising the lumen wall of the luminal organ by high-frequency energization so that the sheath 101 can be inserted while incising the duodenal wall DW and the biliary wall GW. You may.
  • the sheath 101 is passed through the through holes DW1 and GW1 of the duodenal wall DW and the biliary wall GW from the tip 102 side of the stent indwelling device 100.
  • the puncture is performed after confirming that there are no blood vessels or the like on the puncture line by ultrasonic endoscopy.
  • the sheath 101 is moved to the proximal side with respect to the stent 1. Along with this, the distal side of the stent 1 begins to deploy. Then, when the sheath 101 is further moved to the proximal side with respect to the stent 1, the first engaging portion 31 of the stent 1 is completely expanded to form the second shape (see FIG. 3B).
  • the first engaging portion 31 of the stent 1 is locked to the bile wall GW.
  • the first engaging portion 31 of the stent 1 is locked to the inner surface of the bile wall GW, so that the bile wall GW is attracted to the duodenal wall DWW side.
  • the outer surface of the bile wall GW and the outer surface of the duodenal wall DWW are in close contact with each other (see FIG. 3C).
  • the portion released from the sheath 101 of the main body 10 of the stent 1 is press-fitted into the through holes DW1 and GW1 formed in the duodenal wall DW and the biliary wall GW, and is positioned in the axial and radial directions.
  • the first engaging portion 31 is engaged with the bile wall GW in a state where the first engaging portion 31 of the stent 1 is released and completely expanded to form the second shape without going through the state of FIG. 3B. It may be stopped.
  • the sheath 101 is moved further proximal to the stent 1.
  • the second engaging portion 32 on the proximal side of the stent 1 expands to form a second shape and is locked to the inner surface of the duodenal wall DW ( See Figure 3D).
  • the length of the main body 10 of the stent 1 is set to be equal to or less than the thickness of the duodenal wall DW and the biliary wall GW, both are held in a tightly adhered state.
  • the valve portion 20 is exposed to the duodenum D.
  • the bile sac G and the duodenum D are communicated with each other by the stent 1, and bile flows from the bile sac G through the lumen of the stent 1 into the duodenum D.
  • the stent 1 communicates the biliary sac G and the duodenum D (two luminal organs), and flows bile (body fluid) from the biliary sac G (one luminal organ) to the duodenum D (the other luminal organ).
  • a valve portion 20 for preventing backflow of fluid in the main body portion 10 is provided.
  • the main body 10 can be placed in a state of being positioned in the axial direction and the direction intersecting the axial direction, and the stent 1 can be properly placed to form an internal fistula. Then, the valve portion 20 can prevent the backflow of the fluid in the main body portion 10, and the body fluid (bile) from the bile sac G, which is one of the luminal organs, can flow in one direction.
  • the body fluid bile
  • valve portion 20 is formed of a membrane body, and this membrane body is formed in a tapered shape toward the downstream side in the flow direction of the body fluid in the main body portion 10.
  • the shape of the valve portion 20 physically prevents the inflow of the fluid into the main body portion 10, and the backflow of the fluid in the main body portion 10 can be reliably prevented.
  • valve portion 20 is provided at the second end portion 10b (one end portion in the axial direction) of the main body portion 10 and has an outlet 20b for bile (body fluid) flowing through the main body portion 10.
  • bile body fluid
  • the stent 1 is provided at the tubular main body portion 10 and the first end portion 10a (at least one end portion in the axial direction) of the main body portion 10, and is a first engaging portion that engages with the bile wall GW.
  • a second engaging portion 32 provided at the 31 and the second end portion 10b and engaged with the duodenal wall DW is provided.
  • the stent 1 can also engage with the indwelling valveless stent 2 when the stent 2 having no valve function is already indwelled.
  • the indwelling stent 2 has engaging portions 51 and 52 that engage the bile sac wall GW and the duodenal wall DW
  • the first engaging portion 31 and the second engaging portion 32 of the stent 1 are respectively.
  • the main body 10 of the stent 1 inscribes and adheres to the main body 50 of the stent 2.
  • the main body portion 10 of the stent 1 may include a skeleton portion 11 that exerts a radial dilation force, and includes a coating portion 12. It does not have to be.
  • valve portion 20 has the flat portion 22
  • the valve portion 20 does not have to have the flat portion 22.
  • the valve function is improved when the flat portion 22 is provided on the valve portion 20 as in the embodiment.
  • the valve portion 20 does not have to have the skeleton portion 23.
  • the shape of the valve portion 20 is maintained even without the skeleton portion 23.
  • valve portion 20 may be formed of a member different from the main body portion 10 and may be connected to one end portion (for example, the first end portion 10a) of the main body portion 10.
  • the valve portion 20 may be provided inside the main body portion 10, or may be provided at both one end portion and the inside of the main body portion 10.
  • a structure such as an artificial heart valve that switches between a flow state and a cutoff state by opening and closing the valve body can be applied.
  • the valve portions 20 may be provided at a plurality of locations inside the main body portion 10.
  • the main body portion 10 may be composed of a bare stent having only the skeleton portion 11 without having the coating portion 12.
  • body fluid for example, bile
  • the stent 1 may be configured to include only one of the first engaging portion 31 and the second engaging portion 32 (for example, the first engaging portion 31) (see the stent 1A in FIG. 5). , Both may not be provided (not shown).
  • the main body portion 10 is press-fitted into the through holes DW1 and GW1 of the duodenal wall GW and the biliary wall DW, so that, for example, the skeleton portion 11 is buried in the through holes DW1 and GW1 to function as an engaging portion 30, and is positioned in the axial direction and the radial direction.
  • the stent according to the present invention is not limited to endoscopic ultrasonography bile duct drainage (EUS-GBD), EUS-HGS (EUS-guided hepaticogastrostomy) that connects the stomach and bile duct, and EUS-CDS that connects the duodenum and bile duct. It can be used for general drainage surgery performed under endoscopic ultrasonography such as (EUS-guided choledochoduodenostomy).

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un stent pouvant empêcher un reflux et amener un fluide corporel à s'écouler dans une direction à partir d'un organe creux. Le stent (1) permet la communication entre deux organes creux (vésicule biliaire G, duodénum D) et amène un fluide corporel à s'écouler à partir d'un organe creux (vésicule biliaire G) à l'autre organe creux (duodénum D), ledit stent étant pourvu : d'une section de corps principal (10) qui passe à travers les parois de la cavité interne (GW, DW) des deux organes creux et peut être positionnée et placée dans la direction axiale et une direction croisant la direction axiale ; et d'une section de valve (20) destinée à empêcher le fluide dans la section de corps principal de refluer.
PCT/JP2020/031073 2019-09-04 2020-08-18 Stent WO2021044837A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2021543682A JPWO2021044837A1 (fr) 2019-09-04 2020-08-18

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2019161292 2019-09-04
JP2019-161292 2019-09-04

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WO2021044837A1 true WO2021044837A1 (fr) 2021-03-11

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PCT/JP2020/031073 WO2021044837A1 (fr) 2019-09-04 2020-08-18 Stent

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013115141A1 (fr) * 2012-01-30 2013-08-08 川澄化学工業株式会社 Prothèse biliaire
JP2015142790A (ja) * 2008-05-12 2015-08-06 エクスルメナ， インコーポレイテッド 組織層を固定するための組織アンカ
JP2017176666A (ja) * 2016-03-31 2017-10-05 日本ゼオン株式会社 ステントデリバリーシステム

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015142790A (ja) * 2008-05-12 2015-08-06 エクスルメナ， インコーポレイテッド 組織層を固定するための組織アンカ
WO2013115141A1 (fr) * 2012-01-30 2013-08-08 川澄化学工業株式会社 Prothèse biliaire
JP2017176666A (ja) * 2016-03-31 2017-10-05 日本ゼオン株式会社 ステントデリバリーシステム

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