WO2022185654A1 - Système de pose - Google Patents

Système de pose Download PDF

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Publication number
WO2022185654A1
WO2022185654A1 PCT/JP2021/046031 JP2021046031W WO2022185654A1 WO 2022185654 A1 WO2022185654 A1 WO 2022185654A1 JP 2021046031 W JP2021046031 W JP 2021046031W WO 2022185654 A1 WO2022185654 A1 WO 2022185654A1
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WO
WIPO (PCT)
Prior art keywords
anchor
implant
wire portion
coil
shaft
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Application number
PCT/JP2021/046031
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English (en)
Japanese (ja)
Inventor
ウィッチャー タサタン
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朝日インテック株式会社
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Application filed by 朝日インテック株式会社 filed Critical 朝日インテック株式会社
Publication of WO2022185654A1 publication Critical patent/WO2022185654A1/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
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord

Definitions

  • the technology disclosed in this specification relates to a delivery system that transports and places an implant at a target position in vivo.
  • embolization is performed in which, for example, an embolization coil made of a platinum alloy is stuffed inside the aneurysm to block the inflow of blood into the aneurysm.
  • Embolization uses a delivery system comprising a shaft and an implant containing an embolic coil.
  • the implant placed on the distal end side of the shaft is transported to the location of the cerebral aneurysm, and the implant is detached from the shaft and placed at the location of the cerebral aneurysm.
  • an anchor wire and an operation wire are used as a detachment control mechanism that switches between a regulated state that restricts detachment of the implant from the shaft and a release state that permits detachment of the implant from the shaft.
  • a cylindrical hub is provided at the proximal end of the implant, and in the restrained state, anchor wires and manipulating wires extend from the space in the shaft through the space in the hub to the space in the implant. are arranged as follows.
  • An enlarged diameter portion is provided at the tip of the anchor wire.
  • the inner diameter of the hub is set smaller than the sum of the outer diameter of the operating wire and the outer diameter of the enlarged diameter portion of the anchor wire.
  • the operation wire and the enlarged diameter portion restrict movement of the implant including the hub toward the distal side, and as a result, detachment of the implant from the shaft is restricted.
  • the enlarged diameter portion of the anchor wire can pass through the space in the hub. It becomes a released state in which the implant can be detached from the shaft.
  • the above conventional delivery system does not have a means for controlling the position of the anchor wire, even if the operating wire is pulled toward the proximal end and the implant is released, the anchor wire is actually expanded. It is not possible to control the timing at which the diameter passes through the space in the hub to complete the detachment of the implant. Therefore, in the above-described conventional delivery system, there is a possibility that the position of the implant may be unintentionally shifted after the operation of pulling the operating wire to the proximal side is started. There is a problem that it is difficult to adjust.
  • This specification discloses a technology capable of solving the above-described problems.
  • the delivery system disclosed in the present specification is a delivery system for transporting and indwelling an implant to a target position in vivo, comprising a cylindrical shaft and the implant arranged on the distal end side of the shaft. and a detachment control mechanism that switches between a restriction state that restricts detachment of the implant from the shaft and a release state that permits detachment of the implant from the shaft.
  • the implant includes a cylindrical embolic coil and a cylindrical body joined to the proximal end of the embolic coil.
  • the detachment control mechanism includes an anchor member and an operating member.
  • the anchor member comprises an anchor wire portion, a distal side enlarged diameter portion disposed at the distal end of the anchor wire portion and having an outer diameter larger than the outer diameter of the anchor wire portion, and the anchor wire portion disposed at the proximal end, and a proximal enlarged diameter portion having an outer diameter greater than the outer diameter of the anchor wire portion.
  • An operation member is disposed on the operation wire portion and the operation wire portion, has an outer diameter larger than the outer diameter of the operation wire portion, and is capable of engaging with the proximal side enlarged diameter portion of the anchor member. and an enlarged diameter portion.
  • the inner diameter D3 of the cylindrical body of the implant is smaller than the sum of the outer diameter D1 of the operating wire portion and the outer diameter D2 of the distal side enlarged diameter portion of the anchor member.
  • the anchor wire portion of the anchor member is positioned so as to extend from the space in the shaft through the space in the cylindrical body of the implant to the space in the embolization coil
  • the operating member is positioned so as to extend from the space in the shaft through the space in the cylindrical body of the implant to the space in the embolization coil
  • the enlarged diameter portion for operation extends from the space in the shaft
  • the length L1 of the portion of the operation wire portion located on the distal side of the proximal end of the cylindrical body of the implant is located on the distal side of the proximal side enlarged diameter portion of the anchor member in the inner space , less than the distance L2 between the operating enlarged portion and the proximal enlarged portion of the anchor member.
  • the operating member In the restricted state, the operating member is pulled toward the proximal side, and the tip of the operating wire portion moves toward the proximal side of the cylindrical body of the implant, thereby switching to the released state, and the operating member is released.
  • the anchor member By further pulling to the proximal side and engaging the operation enlarged-diameter portion with the proximal-side enlarged-diameter portion of the anchor member, the anchor member is moved to the proximal side as the operation member moves to the proximal side. It is configured to move to the edge side.
  • the distal end portion of the anchor wire portion including the distal end portion of the operation wire portion and the distal end side enlarged diameter portion of the anchor member is positioned on the distal side of the cylindrical body of the implant. Therefore, the distal movement of the implant including the cylindrical body is restricted by the operation wire portion and the distal-side enlarged diameter portion of the anchor member, thereby reliably restricting detachment of the implant from the shaft, and By pulling the operating member proximally, it can be easily switched to a released state that allows the implant to be detached from the shaft.
  • the enlarged diameter portion of the operating member and the enlarged diameter portion of the anchor member are brought into engagement with each other, and the operation member is pulled toward the proximal side of the operating member.
  • the anchor member can be moved proximally along with the movement of . Therefore, according to this delivery system, after the operation member is pulled to the proximal end side to be in the released state, the operation member is pulled further by a predetermined amount, thereby moving the distal side enlarged diameter portion of the anchor member into the space inside the cylindrical body of the implant.
  • the implant is completely detached (a state in which the enlarged diameter portion on the distal end side of the anchor member and the tubular body of the implant are not engaged at all). can. Therefore, according to the present delivery system, it is possible to control the timing at which the detachment of the implant is completed. On the contrary, it is possible to intentionally finely adjust the position of the implant, thereby achieving highly accurate control of the position of the implant.
  • the shaft is an engaging member fixed to the distal end side of the proximal side expanded diameter portion of the anchor member in the space in the shaft, and the shaft is in the regulated state.
  • the anchor member may be configured to have an engaging member that engages with the proximal side enlarged diameter portion of the anchor member to pull the anchor member to the proximal side when pulled to the proximal side.
  • the engaging member of the shaft is engaged with the enlarged diameter portion of the anchor member on the proximal side, whereby the anchor member is also pulled proximally.
  • the implant is pulled proximally as a result, and the entire delivery system can be moved proximally. Therefore, according to this delivery system, it is possible to easily and reliably readjust the position of the delivery system in the restricted state.
  • the technology disclosed in this specification can be implemented in various forms, for example, it can be implemented in the form of a delivery system, an implant delivery and detachment mechanism, an implant delivery and detachment method, and the like. can.
  • Explanatory diagram schematically showing the external configuration of the delivery system according to the present embodiment Explanatory drawing schematically showing the external configuration of the implant of the delivery system shown in FIG.
  • Explanatory drawing schematically showing the external configuration of the shaft of the delivery system shown in FIG. FIG. 2 is an explanatory view schematically showing the external configuration of the anchor member of the delivery system shown in FIG. 1
  • FIG. 2 is an explanatory view schematically showing the external configuration of the operating member of the delivery system shown in FIG. 1
  • Explanatory diagram showing the relationship between the size and position of each member constituting the delivery system shown in FIG. Explanatory drawing showing changes in the state of the delivery system in chronological order when the operation wire portion of the operation member is pulled toward the proximal end.
  • Explanatory drawing showing changes in the state of the delivery system in chronological order when the operation wire portion of the operation member is pulled toward the proximal end Explanatory drawing showing changes in the state of the delivery system in chronological order when the operation wire portion of the operation member is pulled toward the proximal end. Explanatory drawing showing changes in the state of the delivery system in chronological order when the operation wire portion of the operation member is pulled toward the proximal end.
  • FIG. 1 is an explanatory view schematically showing the external configuration of the delivery system according to this embodiment
  • FIGS. 2 to 5 are explanatory views schematically showing the external configuration of each component of the delivery system according to this embodiment. is. In each figure, illustration of a portion of the delivery system and its components is omitted as appropriate.
  • the distal end of the delivery system and its components is referred to as the "distal end,” the distal end and its vicinity as the “distal end,” and the proximal end as the "proximal end.” In other words, the proximal end and its vicinity are referred to as the "base end”.
  • the delivery system 100 is a system that transports and places the implant 20 to a target position in vivo. More specifically, the delivery system 100 intravascularly delivers the implant 20 including the embolic coil 21 into the cerebral aneurysm, detaches the implant 20 at that position, and leaves the implant 20 in the cerebral aneurysm. It is a medical device that In the delivery system 100, the Z-axis positive direction side is the tip side (distal side) that is inserted into the body, and the Z-axis negative direction side is the base end side (proximal side) that is operated by an operator such as a doctor. be.
  • the delivery system 100 includes a shaft 10, an implant 20, and a detachment control mechanism 50.
  • the detachment control mechanism 50 includes an operating member 30 and an anchor member 40 .
  • 2 shows the external configuration of the implant 20
  • FIG. 3 shows the external configuration of the shaft 10
  • FIG. 4 shows the external configuration of the anchor member 40
  • FIG. 5 shows the external configuration of the operation member 30. As shown in FIG.
  • the shaft 10 is a flexible elongated member. More specifically, the shaft 10 is a hollow tubular member with a space extending from the distal end to the proximal end.
  • the shape of the cross section (XY section) at each position of the shaft 10 can take any shape, but is, for example, substantially annular.
  • the total length of the shaft 10 is, for example, approximately 100 mm to 2000 mm, and the outer diameter of the shaft 10 is, for example, approximately 0.2 mm to 2 mm.
  • the material for forming the shaft 10 is not particularly limited as long as it is flexible enough to easily follow the curvature of a lumen (blood vessel, etc.) in a living body. Examples include stainless steel, nickel-titanium alloy, and the like. or synthetic resins such as polyvinyl chloride resins, urethane resins, polyolefin resins, polyamide resins, and fluorine resins.
  • the shaft 10 includes a proximal side coil body 11, a distal side coil body 12 joined to the distal end portion of the proximal side coil body 11, the proximal side coil body 11, and the distal side coil body 12. and an intermediate coil body 13 arranged in the vicinity of the joint.
  • Each of the coil bodies 11, 12 and 13 is a coil body obtained by spirally winding a wire, and is a hollow cylindrical member in which spaces 14, 15 and 16 extending from the distal end to the proximal end are formed.
  • the inner diameter and outer diameter of the proximal side coil body 11 and the inner diameter and outer diameter of the distal side coil body 12 are substantially the same.
  • the proximal-side coil body 11 and the distal-side coil body 12 are joined together by engaging the distal end portion of the proximal-side coil body 11 and the proximal end portion of the distal-side coil body 12 with each other.
  • the outer diameter of the intermediate coil body 13 is smaller than the inner diameters of the proximal side coil body 11 and the distal side coil body 12 .
  • the intermediate coil body 13 is arranged in spaces 14 and 15 in the proximal coil body 11 and the distal coil body 12, and is joined to the proximal coil body 11 and/or the distal coil body 12 by, for example, brazing.
  • the proximal side coil body 11, the distal side coil body 12, and the intermediate coil body 13 are coaxial with each other.
  • the intermediate coil body 13 is an example of an engaging member in the claims.
  • the implant 20 is a member that is delivered to the target position (the position of the cerebral aneurysm) by the delivery system 100 and is arranged on the distal end side of the shaft 10 .
  • Implant 20 comprises embolic coil 21 , tip 22 and sub-coil 23 .
  • the embolization coil 21 is a coil body obtained by spirally winding a wire, and is a hollow cylindrical member in which a space 25 extending from the distal end to the proximal end is formed.
  • the embolization coil 21 is mainly responsible for embolizing a cerebral aneurysm.
  • the total length of the embolization coil 21 is, for example, about 10 mm to 500 mm, and the inner diameter of the embolization coil 21 is, for example, about 0.4 mm to 2 mm.
  • the distal end portion 22 is a substantially hemispherical member and is joined to the distal end of the embolization coil 21 so as to close the opening at the distal end of the embolization coil 21 .
  • the outer diameter of tip 22 is equal to or slightly smaller than the outer diameter of embolic coil 21 .
  • the sub-coil 23 is a coil body in which a wire is spirally wound, and is a hollow cylindrical member in which a space 26 extending from the distal end to the proximal end is formed.
  • the outer diameter of the sub-coil 23 is smaller than the inner diameter of the embolization coil 21 , and the distal end of the sub-coil 23 is inserted into the space 25 at the proximal end of the embolization coil 21 .
  • the distal end of the sub-coil 23 is joined to the proximal end of the embolization coil 21 by, for example, brazing.
  • the embolization coil 21 and the sub-coil 23 are coaxial with each other.
  • the total length of the sub-coil 23 is, for example, approximately 0.5 mm to 100 mm, and the inner diameter of the sub-coil 23 is, for example, approximately 0.2 mm to 1 mm.
  • the sub-coil 23 is an example of a cylinder in the scope of claims.
  • implant 20 As materials for forming the embolic coil 21, the distal end portion 22, and the sub-coil 23 that constitute the implant 20, for example, radiopaque metals such as platinum, gold, tungsten, or alloys of these metals can be used. can. Implant 20 may also include filaments 24 to prevent stretching of embolic coil 21 during delivery.
  • the detachment control mechanism 50 including the operating member 30 and the anchor member 40 has a restricted state that restricts detachment of the implant 20 from the shaft 10 and a release state that permits detachment of the implant 20 from the shaft 10. It is a mechanism to switch between. Note that FIG. 1 shows the configuration of the delivery system 100 in which the detachment control mechanism 50 is in the restricted state.
  • the anchor member 40 has an anchor wire portion 41, an anchor ball 42, and an anchor coil 43.
  • the anchor wire portion 41 is a flexible elongated portion.
  • the anchor ball 42 is arranged at the distal end of the anchor wire portion 41 and is a substantially spherical portion having an outer diameter larger than the outer diameter of the anchor wire portion 41 .
  • the anchor coil 43 is disposed at the proximal end of the anchor wire portion 41, is a coil body formed by spirally winding a wire, and is a hollow cylindrical member in which a space 44 extending from the distal end to the proximal end is formed. is.
  • a proximal end portion of the anchor wire portion 41 is joined to the anchor coil 43 by, for example, brazing while being inserted into a space 44 within the anchor coil 43 .
  • the anchor coil 43 is configured to be engageable with the intermediate coil body 13 of the shaft 10 in the axial direction. That is, the outer diameter of the anchor coil 43 is larger than the inner diameter of the intermediate coil body 13 and the inner diameter of the anchor coil 43 is smaller than the outer diameter of the intermediate coil body 13 .
  • Materials for forming the anchor member 40 include, for example, superelastic alloy materials such as stainless steel and nickel-titanium alloys, or synthetic resins such as polyvinyl chloride resin, urethane resin, polyolefin resin, polyamide resin, and fluorine resin. can be adopted.
  • the anchor ball 42 is an example of the distal side enlarged diameter portion in the claims
  • the anchor coil 43 is an example of the proximal side enlarged diameter portion in the claims.
  • the operating member 30 has an operating wire portion 31 , a distal side operating ball 32 and a proximal side operating ball 33 .
  • the operation wire portion 31 is a flexible elongated portion.
  • the distal end side operation ball 32 is arranged on the operation wire portion 31 and is a substantially spherical portion having an outer diameter larger than the outer diameter of the operation wire portion 31 .
  • the proximal-side operation ball 33 is arranged on the operation wire portion 31 closer to the proximal side than the distal-side operation ball 32 , and is a substantially spherical portion having an outer diameter larger than the outer diameter of the operation wire portion 31 .
  • the proximal side operation ball 33 has a tapered shape with a smaller diameter toward the distal side.
  • the tapered surface of the proximal side operation ball 33 interferes with the anchor coil 43 of the anchor member 40 and acts as a resistance, thereby causing the axis of the operation member 30 to move.
  • Materials for forming the operation member 30 include, for example, superelastic alloy materials such as stainless steel and nickel-titanium alloys, and synthetic resins such as polyvinyl chloride resins, urethane resins, polyolefin resins, polyamide resins, and fluorine resins. can be adopted.
  • the distal end side operation ball 32 is an example of an enlarged diameter operation portion in the scope of claims.
  • FIG. 6 is an explanatory diagram showing the size and positional relationship of each member that constitutes the delivery system 100. As shown in FIG. FIG. 6 shows only a part of the components extracted from the delivery system 100 in which the detachment control mechanism 50 is in the regulated state.
  • the inner diameter D3 of the subcoil 23 of the implant 20 (the diameter of the space 26 within the subcoil 23) is the outer diameter D1 of the operating wire portion 31 of the operating member 30, and the outer diameter D2 of the anchor ball 42 of the anchor member 40 (D1+D2>D3). Therefore, when the operation wire portion 31 is positioned in the space 26 within the subcoil 23 , the anchor ball 42 cannot pass through the space 26 within the subcoil 23 . Note that the inner diameter D3 of the sub-coil 23 is larger than both the outer diameter D1 of the operation wire portion 31 and the outer diameter D2 of the anchor ball 42 .
  • the inner diameter D6 of the anchor coil 43 of the anchor member 40 (the diameter of the space 44 within the anchor coil 43) is smaller than the sum of the outer diameter D4 of 32 (D4+D5>D6). Since such a relationship is established and, as described above, the proximal end portion of the anchor wire portion 41 is inserted and fixed in the space 44 within the anchor coil 43, the space 44 within the anchor coil 43 is The remaining space not occupied by the proximal end portion of the anchor wire portion 41 has a size that the distal end side operation ball 32 cannot pass through. That is, the distal end-side operation ball 32 and the anchor coil 43 are configured to engage with each other in the axial direction.
  • the inner diameter D7 of the intermediate coil body 13 of the shaft 10 (the diameter of the space 16 within the intermediate coil body 13) (D4+D5 ⁇ D7). Therefore, even if the anchor wire portion 41 is positioned in the space 16 within the intermediate coil body 13 , the distal end side operation ball 32 can pass through the space 16 within the intermediate coil body 13 .
  • the length L1 of the portion of the operation wire portion 31 located on the distal side from the proximal end of the subcoil 23 of the implant 20 is It is shorter than the distance L2 between the ball 32 and the anchor coil 43 (L1 ⁇ L2).
  • FIGS. 1 and 6 when the detachment control mechanism 50 is in the restricted state of restricting detachment of the implant 20 from the shaft 10, the anchor wire portion 41 of the anchor member 40 is in the space ( It extends from the space 15) within the distal coil body 12 through the space 26 within the subcoil 23 of the implant 20 to the space 25 within the embolization coil 21 .
  • the anchor ball 42 provided at the distal end of the anchor wire portion 41 is positioned in the space 25 inside the embolization coil 21 .
  • the anchor wire portion 41 extends from the space 15 within the distal coil body 12 to the space 14 within the proximal coil body 11 through the space 16 within the intermediate coil body 13 .
  • the anchor coil 43 provided at the proximal end of the anchor wire portion 41 is located in the space 14 inside the proximal coil body 11 (that is, closer to the proximal side than the intermediate coil body 13).
  • Anchor coil 43 is close to intermediate coil body 13 .
  • the operating wire portion 31 of the operating member 30 is arranged in parallel with the anchor wire portion 41 from the space within the shaft 10 (the space 15 within the distal coil body 12), It is positioned so as to extend through the space 26 within the subcoil 23 of the implant 20 to the space 25 within the embolization coil 21 . That is, the distal end portion of the operation wire portion 31 is located in the space 25 inside the embolization coil 21 . Further, the operation wire portion 31 extends from the space 15 in the distal coil body 12 through the space 16 in the intermediate coil body 13 to the space 14 in the proximal coil body 11, and further from the space 14. It protrudes proximally.
  • the distal side operation ball 32 is located in the space 15 inside the distal side coil body 12 (that is, on the distal side of the anchor coil 43).
  • the proximal side operation ball 33 is positioned closer to the proximal side than the anchor coil 43 in the space 14 inside the proximal side coil body 11 .
  • the distal end portion of the operating wire portion 31 and the distal end portion of the anchor wire portion 41 pass through the space 26 within the sub-coil 23 of the implant 20 and reach the space 25 within the embolization coil 21.
  • An anchor ball 42 provided at the distal end of 41 is positioned in the space 25 within the embolization coil 21 .
  • the inner diameter D3 of the sub-coil 23 is smaller than the sum of the outer diameter D1 of the operation wire portion 31 and the outer diameter D2 of the anchor ball 42 (D1+D2>D3).
  • the operation wire portion 31 and the anchor ball 42 restrict movement of the sub-coil 23 (implant 20 including the sub-coil 23 ) toward the distal side, thereby restricting detachment of the implant 20 from the shaft 10 . It is also, when the anchor member 40 is pulled proximally in this state, the anchor coil 43 cannot pass through the space 26 in the subcoil 23, so the anchor coil 43 is engaged with the subcoil 23, and the implant 20 including the subcoil 23 is pulled. is pulled proximally together with the anchor member 40 .
  • the operator By gripping and manipulating the shaft 10 of the delivery system 100 with the detachment control mechanism 50 in the regulated state, the operator inserts the delivery system 100 into the blood vessel from the distal side and directs the inside of the blood vessel toward the cerebral aneurysm. move forward. At this time, since the detachment control mechanism 50 is in the regulated state, the implant 20 is prevented from being unintentionally detached while the delivery system 100 is being advanced. Further, as described above, the anchor coil 43 of the anchor member 40 and the intermediate coil body 13 of the shaft 10 are configured to be engageable with each other in the axial direction, and are close to each other in the restricted state. .
  • the anchor member 40 is also pulled proximally due to the engagement of the intermediate coil body 13 of the shaft 10 with the anchor coil 43.
  • the implant 20 is also pulled proximally. will be attracted to That is, the entire delivery system 100 can be moved proximally by pulling the shaft 10 proximally. This allows, for example, readjustment of the position of the delivery system 100 .
  • the operator grips and manipulates the shaft 10 to pack the implant 20 (embolic coil 21) into the cerebral aneurysm.
  • the operator then separates implant 20 from shaft 10 .
  • the operator pulls the operation wire portion 31 of the operation member 30 protruding proximally from the space 14 of the shaft 10 toward the proximal side.
  • FIGS. 7 to 10 are explanatory diagrams chronologically showing changes in the state of the delivery system 100 when the operating wire portion 31 of the operating member 30 is pulled toward the proximal end. Similar to FIG. 6, FIGS. 7 to 10 show only some components of the delivery system 100.
  • FIG. 7 When the operation of pulling the operation wire portion 31 of the operation member 30 to the proximal side is started, as shown in FIG. 7, the distal end portion of the operation wire portion 31 elastically deforms and passes through the space 26 in the sub-coil 23 of the implant 20. .
  • FIG. 8 when the distal end of the operation wire portion 31 has moved to the base end side of the subcoil 23 , the operation wire portion 31 does not exist in the space 26 inside the subcoil 23 .
  • the amount of pulling the operation wire portion 31 (the amount of movement of the operation wire portion 31) is the same as that of the sub-coil 23 in the operation wire portion 31 in the regulated state.
  • the length L1 (see FIG. 6) of the portion located on the distal side from the proximal end of the is the same.
  • the distal side operation ball 32 of the operation member 30 abuts and engages with the anchor coil 43 of the anchor member 40, as shown in FIG.
  • the amount of pulling the operation wire portion 31 is the same as the distance L2 (see FIG. 6) between the distal end side operation ball 32 and the anchor coil 43 in the restricted state. It is in a state of When the operation wire portion 31 is further pulled to the proximal side from this state, as shown in FIG. 10, the anchor member 40 moves to the proximal side as the operation wire portion 31 moves to the proximal side.
  • the anchor ball 42 passes through the space 26 in the subcoil 23 and is positioned on the proximal side of the subcoil 23 . In this state, since the anchor member 40 and the sub-coil 23 are not engaged at all, the movement of the implant 20 is completely unrestricted by the anchor member 40 .
  • the shaft 10 and the detachment control mechanism 50 which are components of the delivery system 100 other than the implant 20, move proximally and are finally removed from the body.
  • the delivery system 100 of the present embodiment is a system for transporting and indwelling the implant 20 to a target position in the living body. 20 , and a detachment control mechanism 50 that switches between a restricted state that restricts detachment of the implant 20 from the shaft 10 and a release state that permits detachment of the implant 20 from the shaft 10 .
  • the implant 20 includes a cylindrical embolic coil 21 and a sub-coil 23 joined to the proximal end of the embolic coil 21 .
  • the detachment control mechanism 50 includes an anchor member 40 and an operating member 30 .
  • the anchor member 40 includes an anchor wire portion 41, an anchor ball 42 arranged at the distal end of the anchor wire portion 41 and having an outer diameter larger than that of the anchor wire portion 41, and an anchor wire portion 41 arranged at the proximal end of the anchor wire portion 41, and an anchor coil 43 having an outer diameter larger than the outer diameter of the anchor wire portion 41 .
  • the operation member 30 includes an operation wire portion 31 and a distal end side operation ball 32 arranged on the operation wire portion 31 and having an outer diameter larger than that of the operation wire portion 31 and capable of being engaged with the anchor coil 43 . have.
  • the inner diameter D3 of the subcoil 23 of the implant 20 is smaller than the sum of the outer diameter D1 of the operating wire portion 31 and the outer diameter D2 of the anchor ball 42 .
  • the anchor wire portion 41 and the operating wire portion 31 are positioned so as to extend from the space 15 within the shaft 10 through the space 26 within the subcoil 23 of the implant 20 to the space 25 within the embolization coil 21 .
  • the distal end side operation ball 32 is positioned distally of the anchor coil 43 in the space 15 inside the shaft 10 .
  • the length L1 of the portion of the operation wire portion 31 located on the distal side from the proximal end of the subcoil 23 of the implant 20 is shorter than the distance L2 between the distal side operation ball 32 and the anchor coil 43 .
  • the operation member 30 In the restricted state, the operation member 30 is pulled proximally, and the distal end of the operation wire portion 31 moves toward the proximal end of the sub-coil 23 of the implant 20, thereby switching to the released state. Further, the operation member 30 is further pulled toward the proximal side, and the distal side operation ball 32 and the anchor coil 43 are engaged with each other. move to
  • the distal end portion of the operation wire portion 31 and the distal end portion of the anchor wire portion 41 including the anchor ball 42 are positioned on the distal end side of the sub-coil 23 in the regulated state.
  • the distal movement of the implant 20 including the sub-coil 23 is restricted by the operation wire portion 31 and the anchor ball 42, so that the detachment of the implant 20 from the shaft 10 can be reliably restricted, and the operation member 30 can be moved. By pulling proximally, it can be easily switched to a released state that allows removal of the implant 20 from the shaft 10 .
  • the delivery system 100 of the present embodiment by further pulling the operating member 30 toward the proximal side, the distal side operating ball 32 and the anchor coil 43 are engaged with each other, and as the operating member 30 moves toward the proximal side, Anchor member 40 can be moved proximally. Therefore, according to the delivery system 100 of the present embodiment, after the operation member 30 is pulled to the proximal end side to be in the released state, the operation member 30 is further pulled by a predetermined amount to move the anchor ball 42 into the subcoil 23 of the implant 20. space 26 to move to the base end side of the subcoil 23, and the implant 20 is completely detached (a state in which the anchor member 40 and the subcoil 23 are not engaged at all).
  • the delivery system 100 of the present embodiment it is possible to control the timing at which the detachment of the implant 20 is completed. Unintentional displacement of the position can be suppressed, and conversely, the position of the implant 20 can be intentionally finely adjusted, and highly accurate control of the position of the implant 20 can be achieved.
  • the shaft 10 has the intermediate coil body 13 .
  • the intermediate coil body 13 is fixed to the distal end side of the anchor coil 43 in the spaces 14 and 15 inside the shaft 10 .
  • the intermediate coil body 13 engages with the anchor coil 43 to pull the anchor member 40 to the proximal side when the shaft 10 is pulled to the proximal side in the restricted state. Therefore, in the delivery system 100 of the present embodiment, when the shaft 10 is pulled proximally in the restricted state, the anchor member 40 is also pulled proximally by the engagement of the intermediate coil body 13 with the anchor coil 43. Accordingly, the implant 20 is also pulled proximally, and as a result, the entire delivery system 100 can be moved proximally. Therefore, according to the delivery system 100 of this embodiment, it is possible to easily and reliably readjust the position of the delivery system 100 in the restricted state.
  • the configuration of the delivery system 100 in the above embodiment is merely an example, and various modifications are possible.
  • the implant 20 includes the tip portion 22 and the filament 24 in the above embodiment, the implant 20 may not include the tip portion 22 and the filament 24 .
  • the implant 20 includes the sub-coil 23 which is a hollow cylindrical body, but the implant 20 may include a member other than the coil-shaped member as a hollow cylindrical body.
  • the shaft 10 is composed of the proximal side coil body 11, the distal side coil body 12 and the intermediate coil body 13.
  • the proximal side coil body 11, the distal side coil body 12, and the intermediate coil body 13 may be replaced with a cylindrical body other than the coil body.
  • the proximal side coil body 11, the distal side coil body 12, and the intermediate coil body 13 may be an integral member.
  • the anchor ball 42 is provided at the distal end of the anchor wire portion 41 in the above embodiment, the distal end of the anchor wire portion 41 may be provided with an enlarged diameter portion having a shape other than a ball shape.
  • the anchor coil 43 is provided at the proximal end of the anchor wire portion 41 in the above-described embodiment, the proximal end of the anchor wire portion 41 may be provided with an enlarged diameter portion other than the coil body.
  • distal end side operation ball 32 is provided on the operation wire portion 31 in the above embodiment, an enlarged diameter portion having a shape other than a ball shape may be provided on the operation wire portion 31 .
  • proximal side operation ball 33 is provided on the operation wire portion 31 , but the proximal side operation ball 33 may not be provided on the operation wire portion 31 .

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

Abstract

Le but de la présente invention est d'empêcher de manière fiable la libération involontaire d'un implant, de faciliter une commutation à un état permettant la libération de l'implant, et de contrôler avec une grande précision la position de l'implant. Un système de pose est pourvu d'une tige, d'un implant comprenant une bobine embolique et un cylindre, et d'un mécanisme de contrôle de libération comprenant un élément d'ancrage et un élément d'actionnement. L'élément d'ancrage comporte une partie de fil d'ancrage, une partie de diamètre étendu côté extrémité distale et une partie de diamètre étendu côté extrémité de base. L'élément d'actionnement a une partie de fil d'actionnement et une partie de diamètre étendu d'actionnement. Le diamètre intérieur du cylindre est inférieur à la somme du diamètre extérieur de la partie de fil d'actionnement et du diamètre extérieur de la partie de diamètre étendu côté extrémité distale. Dans un état restreint, la partie de fil d'ancrage et la partie de fil d'actionnement passent à travers l'espace à l'intérieur du cylindre de l'implant et s'étendent dans la bobine embolique, la partie de diamètre étendu d'actionnement est située sur le côté d'extrémité distale de la partie de diamètre étendu côté extrémité de base, et la longueur de la partie de la partie de fil d'actionnement située sur le côté d'extrémité distale de l'extrémité de base du cylindre de l'implant est inférieure à la distance entre la partie de diamètre étendu d'actionnement et la partie de diamètre étendu côté extrémité de base de l'élément d'ancrage.
PCT/JP2021/046031 2021-03-01 2021-12-14 Système de pose WO2022185654A1 (fr)

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JP2021031389A JP2022132760A (ja) 2021-03-01 2021-03-01 デリバリシステム
JP2021-031389 2021-03-01

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11244388A (ja) * 1997-12-19 1999-09-14 B Braun Celsa Sa 人体内部通路内に内植器官を位置決めするためのアセンブリ
WO2007070792A2 (fr) * 2005-12-13 2007-06-21 Cordis Development Corporation Manche d'actionneur a utiliser avec des systemes de deploiement de dispositif medical
JP2016036738A (ja) * 2014-08-08 2016-03-22 デピュイ・シンセス・プロダクツ・インコーポレイテッド 格納式の機械式放出機構を有する塞栓コイル送達システム
WO2021010222A1 (fr) * 2019-07-18 2021-01-21 朝日インテック株式会社 Dispositif de type implant

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11244388A (ja) * 1997-12-19 1999-09-14 B Braun Celsa Sa 人体内部通路内に内植器官を位置決めするためのアセンブリ
WO2007070792A2 (fr) * 2005-12-13 2007-06-21 Cordis Development Corporation Manche d'actionneur a utiliser avec des systemes de deploiement de dispositif medical
JP2016036738A (ja) * 2014-08-08 2016-03-22 デピュイ・シンセス・プロダクツ・インコーポレイテッド 格納式の機械式放出機構を有する塞栓コイル送達システム
WO2021010222A1 (fr) * 2019-07-18 2021-01-21 朝日インテック株式会社 Dispositif de type implant

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