WO2023276469A1 - Indwelling device delivery apparatus - Google Patents

Indwelling device delivery apparatus Download PDF

Info

Publication number
WO2023276469A1
WO2023276469A1 PCT/JP2022/020438 JP2022020438W WO2023276469A1 WO 2023276469 A1 WO2023276469 A1 WO 2023276469A1 JP 2022020438 W JP2022020438 W JP 2022020438W WO 2023276469 A1 WO2023276469 A1 WO 2023276469A1
Authority
WO
WIPO (PCT)
Prior art keywords
hollow shaft
indwelling device
lumen
indwelling
delivery apparatus
Prior art date
Application number
PCT/JP2022/020438
Other languages
French (fr)
Japanese (ja)
Inventor
洋之 相場
知愛 福岡
Original Assignee
朝日インテック株式会社
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 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 WO2023276469A1 publication Critical patent/WO2023276469A1/en

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin

Definitions

  • the present invention relates to an indwelling device delivery device.
  • a known technique is to place a marker in advance near a lesion in the body in order to identify the lesion for resection or other treatment when performing surgery on easily deformable organs such as the lungs.
  • a catheter having a wireless marker such as an IC tag attached to its distal end is fed into the vicinity of a lesion, and a wire is used to push the wireless marker out of the catheter, thereby indwelling it in the patient's body.
  • a wireless device placed outside the patient's body predetermined treatment is performed while specifying the position of the lesion by wireless communication with a wireless marker indwelled during surgery (see, for example, Patent Document 1).
  • the position of the lesion can be accurately specified by the wireless marker, so it can be expected that the lesion will be treated accurately.
  • the catheter is made of a flexible material so that it can be smoothly advanced through curved body cavities such as the trachea. Therefore, when the marker is pushed out by the wire, if the engagement (holding force) of the marker with the catheter is too strong, the catheter itself is stretched without being pushed out, and as a result, there is a possibility that the marker cannot be indwelled in the body. .
  • the present invention has been made based on the circumstances as described above, and its object is to provide an indwelling device delivery apparatus capable of easily indwelling an indwelling device in the body.
  • Some aspects of the disclosure include: (1) an indwelling device; a flexible first hollow shaft having a first lumen therethrough from distal end to proximal end for detachably retaining the deployment device at the distal end of the first lumen; A second hollow shaft that extends from the proximal end of the first hollow shaft toward the proximal direction, penetrates from the distal end to the proximal end, and has a second lumen that communicates with the first lumen.
  • the indwelling device delivery apparatus comprising: An indwelling device delivery device, wherein the tensile stiffness of the second hollow shaft is greater than the tensile stiffness of the first hollow shaft; (2)
  • the second hollow shaft includes a hollow shaft body having the second lumen, and a cylindrical shape that covers the outer circumference of the hollow shaft body and has a tensile rigidity greater than that of the hollow shaft body.
  • the second hollow shaft includes a hollow shaft body having the second lumen, and linear or ribbon-shaped reinforcing members arranged side by side along the longitudinal direction of the hollow shaft body.
  • the reinforcing member has tensile rigidity greater than the tensile rigidity of the hollow shaft main body, and is fixed to the proximal end portion of the first hollow shaft and/or the distal end portion of the hollow shaft main body.
  • connection member having a tensile rigidity greater than that of the hollow shaft body
  • the connecting member is fixed to the first hollow shaft and the hollow shaft main body at a boundary portion between the first hollow shaft and the hollow shaft main body,
  • tensile stiffness means the tensile elastic modulus specified in JIS 7161-1 2014 and the stiffness in the longitudinal direction of the first and second hollow shafts.
  • distal direction means the direction along the longitudinal direction of the first and second hollow shafts, the direction in which the first hollow shaft is positioned relative to the second hollow shaft.
  • Proximal direction means a direction along the longitudinal direction of the first and second hollow shafts, opposite to the distal direction.
  • the present invention can provide an indwelling device delivery apparatus capable of easily indwelling an indwelling device in the body.
  • FIG. 1 is a schematic cross-sectional view showing the entire first embodiment; FIG. It is a schematic sectional drawing which expands and shows a part of 1st Embodiment.
  • FIG. 2B is a schematic cross-sectional view taken along line IIb-IIb of FIG. 2A; It is a schematic diagram showing the use state of the first embodiment. It is a schematic diagram showing the use state of the first embodiment. It is a schematic diagram showing the use state of the first embodiment. It is a schematic sectional drawing which expands and shows a part of 2nd Embodiment.
  • FIG. 4B is a schematic cross-sectional view taken along line IVb-IVb of FIG. 4A; It is a schematic sectional drawing which expands and shows a part of 3rd Embodiment.
  • An indwelling device delivery apparatus of the present disclosure has an indwelling device and a first lumen penetrating from a distal end to a proximal end, and detachably holds the indwelling device at the distal end of the first lumen.
  • first hollow shaft extending from the proximal end of the first hollow shaft toward the proximal direction, penetrating from the distal end to the proximal end and communicating with the first lumen; a second hollow shaft having a second lumen; and an extrusion mechanism for pushing the indwelling device distally from the first hollow shaft through the first and second lumens;
  • the tensile stiffness of the second hollow shaft is configured to be greater than the tensile stiffness of the first hollow shaft.
  • longitudinal direction refers to the direction along the longitudinal axes of the first hollow shaft and the second hollow shaft, unless otherwise specified.
  • the dimensions of the indwelling device delivery device shown in each drawing are dimensions shown to facilitate understanding of the contents of implementation, and do not correspond to actual dimensions.
  • the left side of the drawing shows the distal direction (distal) of the indwelling device delivery device
  • the right side shows the proximal direction (proximal, hand side) of the indwelling device delivery device.
  • FIG. 1 is a schematic diagram showing a first embodiment.
  • the indwelling device delivery apparatus 1 as shown in FIG. 1, schematically includes an indwelling device 11, a first hollow shaft 21, a second hollow shaft 31, a connector 41, a pusher member 51, and a grasping member. 61.
  • the indwelling device 11 is a device to be indwelled inside the body.
  • the placement device 11 can be composed of, for example, a device body 111 and an engaging member 112, as shown in FIG. 2A.
  • Examples of the device main body 111 include a capsule (not shown) containing a drug, a contrast marker (not shown) containing a radiopaque material, and a device installed outside the body that stores various information inside. and a marker (see FIG. 2A) in which an IC tag 111a that performs wireless communication with is covered with a covering member 111b.
  • the material forming the covering member 111b preferably has biocompatibility because the indwelling device 11 is inserted into the body.
  • the material include resin materials such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluorine resin; metal materials such as SUS304;
  • the engaging member 112 is engaged with the body wall or the like to fix the placement device 11 inside the body.
  • the engaging member 112 include a self-expandable coil-shaped member having one end joined to the device main body 111 and the other end being a free end.
  • Such an engaging member 112 is made of, for example, a shape memory alloy such as Ni--Ti, and held in the first lumen 21h in a pre-shrunk state.
  • the engaging member 112 When indwelling the indwelling device 11, after the indwelling device 11 is detached from the first hollow shaft 21, the engaging member 112 self-expands and engages with a body wall or the like, thereby fixing the device main body 111 inside the body. be.
  • the first hollow shaft 21 has a first lumen 21h penetrating from the distal end to the proximal end. It is a flexible member that holds. Specifically, the first hollow shaft 21 can be configured by, for example, an elongated hollow cylinder.
  • the first hollow shaft 21 is made of a soft (flexible) material. Moreover, since the first hollow shaft 21 is inserted into the body cavity, it is preferable that the first hollow shaft 21 has biocompatibility.
  • the material include resin materials such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluorine resin. Among these, fluororesins are preferred, and polytetrafluoroethylene (PTFE) resins are more preferred. Thereby, the slidability of the pusher member 51 (described later) and the like inserted through the first lumen 21h can be enhanced.
  • the second hollow shaft 31 is a member extending from the proximal end of the first hollow shaft 21 toward the proximal direction.
  • the tensile stiffness of the second hollow shaft 31 is formed to be greater than the tensile stiffness of the first hollow shaft 21 .
  • the second hollow shaft 31 can be configured to have, for example, a hollow shaft main body 311 and a reinforcing member 312, as shown in FIGS. 2A and 2B.
  • the hollow shaft main body 311 has a second lumen 311h penetrating from the distal end to the proximal end and communicating with the first lumen 21h.
  • the inner diameter of the second lumen 311h is the same as the inner diameter of the first lumen 21h, and there is no step at the boundary between the first lumen 21h and the second lumen 311h.
  • the inner peripheral surfaces defining these lumens are provided so as to be continuous.
  • the first lumen 21h and the second lumen 311h form a lumen L through which a pushing mechanism such as a pusher member 51, which will be described later, is inserted.
  • the material forming the hollow shaft main body 311 preferably has flexibility and biocompatibility because the hollow shaft main body 311 is inserted into the body cavity.
  • the material include resin materials such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluorine resin. Among these, fluororesins are preferred, and polytetrafluoroethylene (PTFE) resins are more preferred. Thereby, the slidability of the pusher member 51 (described later) and the like inserted through the second lumen 311h can be enhanced.
  • the reinforcing member 312 is a cylindrical member that covers the outer periphery of the hollow shaft body 311 and has tensile rigidity greater than that of the hollow shaft body 311 .
  • the reinforcement member 312 can be arranged, for example, so as to cover the entire outer periphery of the hollow shaft body 311 from the distal end to the proximal end.
  • the reinforcing member 312 may have the same outer diameter as the first hollow shaft 21 so that it can be smoothly inserted into the body cavity without getting stuck.
  • the material forming the reinforcing member 312 preferably has greater tensile rigidity than the hollow shaft main body 311 and biocompatibility because it is inserted into the body cavity.
  • the material include polyimide resin; composite materials such as fibers reinforced only in the tensile direction. Among these, materials having high tensile rigidity, flexibility in the bending direction, and followability are more preferable.
  • the reinforcing member 312 can be fixed to the proximal end of the first hollow shaft and/or the distal end of the hollow shaft body. In this embodiment, the reinforcing member 312 is fixed to both the proximal end of the first hollow shaft 21 and the distal end of the hollow shaft main body 311 at the fixing portion 31a.
  • a method for fixing the reinforcing member 312 to the proximal end portion of the first hollow shaft 21 and the distal end portion of the hollow shaft main body 31 for example, a method of bonding using a biocompatible adhesive or welding by heating. a method of burying part or all of the reinforcing member 312 in the first hollow shaft 21 and the hollow shaft main body 311, or the like.
  • the connector 41 is a member that operates an extrusion mechanism, which will be described later.
  • the connector 41 is provided with a lumen 41h that penetrates from the distal end to the proximal end and communicates with the second lumen 311h.
  • the connector 41 of this embodiment is interposed between an intermediate wall 41b having an opening 41a in the middle of the lumen 41h and an abutting body 512 provided on the intermediate wall 41b and the pusher member 51, and normally and a spring member 41c that biases the contact body 512 in the proximal direction.
  • a screw groove 41d that is screwed into a screw portion 511a of a pusher member 51, which will be described later, is provided at a portion of the connector 41 in the proximal direction from the contact member 512. As shown in FIG.
  • the pusher member 51 is a member that constitutes an extrusion mechanism.
  • the pushing mechanism is a mechanism for pushing the placement device 11 toward the distal direction from the first hollow shaft 21 through the first and second lumens 21h, 311h.
  • the pushing mechanism is inserted through the first and second lumens 21h and 311h, and has a longitudinal shape that pushes out the placement device 11 while the tip is in contact with the proximal end of the placement device 11. It can be configured to have a pusher member 51 .
  • the pusher member 51 is composed of, for example, a solid shaft 511 formed with a screw portion 511a that is screwed into the screw groove 41d of the connector 41, and a contact member 512 fixed halfway along the longitudinal direction of the shaft 511. Can be configured. In this case, the pusher member 51 slidably advances and retreats in the lumen L due to the screw action of the threaded portion 511 a and the thread groove 41 d during rotation, and the distal end of the shaft 511 contacts the proximal end of the placement device 11 . The placement device 11 can be pushed out in the distal direction by pressing while in contact.
  • the material forming the pusher member 51 preferably has a rigidity that allows the placement device 11 to be pushed out and has biocompatibility.
  • the material include metal materials such as stainless steel, Ni--Ti alloys, and cobalt-chromium alloys.
  • the pusher mechanism has the pusher member 51, so that the placement device 11 can be pushed out with a simple configuration, and the placement device 11 can be left in the body more reliably.
  • the gripping member 61 is a member that the operator operates while gripping the indwelling device delivery device 1 .
  • the grasping member 61 is, for example, fixed to the proximal end of the pusher member 51 and is provided so that the pusher member 51 is rotated by rotating the handle 611 .
  • the shape of the gripping member 61 is not particularly limited as long as the effects of the present invention are not impaired, and for example, it can be formed in a shape that is easy for the operator to operate.
  • the placement device 11 includes a device main body 111 in which an IC tag 111a serving as a marker is covered with a covering member 111b, and a self-expandable engaging member 112 provided on the outer periphery of the proximal end portion of the device main body 111. is used to indwell the indwelling device 11 in the vicinity of the lesion in the bronchi of the lung.
  • the indwelling device delivery device 1 is prepared. Specifically, for example, the indwelling device 11 is inserted through the distal opening 21a of the first hollow shaft 21 into the first lumen 21h, and the engagement member 112 is engaged with the inner wall of the first lumen 21h. This holds the placement device 11 at the distal end of the first hollow shaft 21 . Next, while rotating the handle 611 of the gripping member 61 , the pusher member 51 is advanced to bring the distal end of the shaft 511 into contact with the proximal end of the device main body 111 .
  • the indwelling device delivery device 1 inserts into the body. Specifically, for example, the prepared indwelling device delivery apparatus 1 is inserted into the trachea through the oral cavity, and advanced until the tip of the indwelling device 11 reaches the vicinity of the lesion B in the bronchi A (see FIG. 3A). At this time, since the first hollow shaft 21 has flexibility, it advances smoothly along the inner wall W of the curved bronchi A.
  • the placement device 11 is placed in the bronchi A by pushing the placement device 11 forward from the first hollow shaft 21 .
  • the distal end of the shaft 511 presses the detention device 11 and moves the detention device 11 from the opening 21a toward the distal end. (See FIG. 3B).
  • the engaging member 112 of the indwelling device 11 that has been pushed out is released from the first lumen 21h, so that it expands by self-expanding action, and the outer circumference of the engaging member 112 engages the inner wall W of the bronchi A.
  • the indwelling device 11 is fixed in the bronchi A.
  • the indwelling device delivery apparatus 1 with the detached indwelling device 11 is removed from the bronchi A to complete the indwelling of the indwelling device 11 (see FIG. 3C).
  • the position of the indwelling device 11 in the body is specified by wirelessly communicating with the IC tag 111a using a wireless device (not shown) installed outside the body. Using the position of the indwelling device 11 as a clue, the lesion B located in the vicinity thereof can be treated.
  • the indwelling device delivery apparatus 1 has the above-described configuration, and thus has a flexible distal end.
  • the placement device delivery apparatus 1 can suppress the extension of the second hollow shaft 31 due to the pressure of the pusher member 51 when the pusher member 51 (extrusion mechanism) pushes out the placement device 11 .
  • the indwelling device delivery apparatus 1 can smoothly push out the indwelling device 11 from the first hollow shaft 21 and easily indwell the indwelling device 11 in the body.
  • the cylindrical reinforcing member 312 is provided, it is possible to impart high tensile rigidity to the second hollow shaft 31 , and the second hollow shaft 31 can withstand the pressure of the pusher member 51 .
  • the indwelling device 11 can be easily pushed out into the body without the need to move.
  • FIG. 4A and 4B are schematic diagrams showing a second embodiment.
  • the indwelling device delivery apparatus 2 as shown in FIG. 4A, schematically includes an indwelling device 11, a first hollow shaft 21, a second hollow shaft 32, a connector 41 (not shown), and a pusher member 51. and a holding member 61 (not shown).
  • the indwelling device delivery device 2 differs from the first embodiment in that it has a second hollow shaft 32 .
  • the configurations of the placement device 11, the first hollow shaft 21, the connector 41, the pusher member 51, and the gripping member 61 are the same as those of the first embodiment, so the same parts are denoted by the same reference numerals. A detailed description thereof is omitted.
  • the configuration other than the configuration of the second hollow shaft 32 described below and the mode of use of the indwelling device delivery device 2 are the same as those of the first embodiment.
  • the second hollow shaft 32 is a member extending from the proximal end of the first hollow shaft 21 toward the proximal direction.
  • the tensile stiffness of the second hollow shaft 32 is formed to be greater than the tensile stiffness of the first hollow shaft 21 .
  • the second hollow shaft 32 can be configured to have a hollow shaft main body 321 and a reinforcing member 322, for example.
  • the hollow shaft main body 321 has a second lumen 321h penetrating from the distal end to the proximal end and communicating with the first lumen 21h.
  • the reinforcing member 322 is a linear or ribbon-like member arranged side by side along the longitudinal direction of the hollow shaft main body 321 .
  • the reinforcing member 322 has tensile stiffness greater than that of the hollow shaft body 321 .
  • the linear and ribbon-shaped reinforcing members may be arranged, for example, in contact with the outer circumference of the hollow shaft body 321 and along the longitudinal direction.
  • the number of wires or ribbons constituting the reinforcing member 322 may be one or more. Also, wires and ribbons may be mixed.
  • two wires (linear reinforcing member 322) arranged to face each other across the long axis and embedded in the outer peripheral surface side of the hollow shaft main body 321 are exemplified. there is
  • the linear or ribbon-shaped reinforcing members 322 described above may be evenly arranged around the long axis.
  • they are preferably arranged so as to face each other across the long axis of the second hollow shaft, and when three wires are used, they are arranged along the circumferential direction of the second hollow shaft.
  • the wires are spaced 120 degrees apart, and if four wires are used, they are preferably spaced 90 degrees along the circumference of the second hollow shaft.
  • the reinforcing member 322 can be fixed to the proximal end of the first hollow shaft and/or the distal end of the hollow shaft body. In this embodiment, the reinforcing member 322 is fixed (embedded) over the entire length of the hollow shaft body 321 including the proximal end of the first hollow shaft 21 and the distal end of the hollow shaft body 321 .
  • the indwelling device delivery device 2 has the above-described configuration, and thus has a flexible distal end.
  • the indwelling device delivery apparatus 2 can suppress the extension of the second hollow shaft 32 due to the pressure of the pusher member 51 when the pusher member 51 (extrusion mechanism) pushes out the indwelling device 11 .
  • the indwelling device delivery apparatus 2 can smoothly push out the indwelling device 11 from the first hollow shaft 21 and easily indwell the indwelling device 11 in the body.
  • the linear reinforcing member 322 (wire) is provided, it is possible to impart high tensile rigidity to the second hollow shaft 32 , so that the second hollow shaft 32 is attached to the pusher member 51 .
  • the indwelling device 11 can be easily pushed into the body without losing pressure.
  • FIG. 5 is a schematic diagram showing a third embodiment.
  • the indwelling device delivery apparatus 3 generally includes an indwelling device 11, a first hollow shaft 23, a connecting member 73, a second hollow shaft 33, and a connector 41 (not shown). , a pusher member 51, and a gripping member 61 (not shown).
  • the indwelling device delivery apparatus 3 differs from the first embodiment in that it includes a first hollow shaft 23, a connecting member 73, and a second hollow shaft 33. As shown in FIG.
  • the configurations of the placement device 11, the connector 41, the pusher member 51, and the grasping member 61 are the same as those of the first embodiment, so the same parts are denoted by the same reference numerals, and detailed description thereof will be omitted. . Also, the configuration of the first and second hollow shafts other than the configuration of the first and second hollow shafts 23, 33 described below and the mode of use of the indwelling device delivery device 3 are the same as those of the first embodiment. It is the same.
  • the first hollow shaft 23 has a first lumen 23h penetrating from the distal end to the proximal end. It is a member.
  • the first hollow shaft 23 of the present embodiment is provided at its proximal end with a connected portion 23a to which a connecting portion 73a of a connecting member 73, which will be described later, is connected.
  • the connecting member 73 is a member having tensile rigidity greater than that of the hollow shaft main body 331 .
  • the connecting member 73 is fixed to the first hollow shaft 23 and the hollow shaft body 331 at the boundary between the first hollow shaft 23 and the hollow shaft body 331 .
  • the connecting portion 73a provided at the distal end portion of the connecting member 73 is connected so as to be fitted to the connected portion 23a
  • the connecting portion 73b provided at the proximal end portion of the connecting member 73 is connected to the connecting portion 73b, which will be described later. It is connected so as to be fitted to the connecting portion 331b (the first hollow shaft 23 and the hollow shaft main body 331 are arranged so as to be separated from each other with the connecting member 73 interposed therebetween).
  • the connecting member 73 of the present embodiment is a hollow cylindrical member having a lumen 73h penetrating from the distal end to the proximal end and communicating with the first and second lumens 23h and 331h.
  • the inner diameter of the lumen 73h is the same as the inner diameters of the first and second lumens 23h and 331h, and these lumens are continuous (there is no step at the boundary between the lumens). ) may be provided as follows. As a result, the pusher member 51 can be advanced and retracted smoothly.
  • the outer diameter of the connecting member 73 and the outer diameters of the first and second hollow shafts 23 and 33 are the same, and the outer peripheral surfaces thereof are continuous (there is no step at the boundary between the outer peripheral surfaces). may be provided in As a result, the indwelling device delivery device 3 can be smoothly advanced without being caught on the inner wall of the body cavity.
  • the material forming the connecting member 73 preferably has biocompatibility because it is inserted into the body cavity.
  • the material include super engineering plastics such as PEEK (polyetheretherketone) and PSU (polysulfone); composite materials such as graphite fiber; and metal materials such as SUS304.
  • super engineering plastics such as PEEK (polyetheretherketone) and PSU (polysulfone), which are injection-moldable and excellent in rigidity and strength, and composite materials such as graphite fiber are more preferable.
  • connection method include a method of fitting, bonding, or welding the first and second hollow shafts 23 and 33 and the connection member 73 .
  • the second hollow shaft 33 extends from the proximal end of the first hollow shaft 23 toward the proximal direction, penetrates from the distal end to the proximal end, and communicates with the first lumen 23h. is a member having a lumen 331h of .
  • the tensile stiffness of the second hollow shaft 33 is formed to be greater than the tensile stiffness of the first hollow shaft 23 .
  • the second hollow shaft 33 of this embodiment is composed of a hollow shaft main body 331 and a reinforcing member 332 .
  • a connected portion 331b to which the connecting portion 73b of the connecting member 73 described above is connected is provided at the tip portion of the hollow shaft main body 331 .
  • the distal end portion of the reinforcing member 332 is also fixed to the proximal end portion of the first hollow shaft 23 and the distal end portion of the hollow shaft main body 331 together with the connecting member 73 at the fixing portion 33a.
  • the indwelling device delivery apparatus 3 since the indwelling device delivery apparatus 3 has the above-described configuration, the first hollow shaft 23 and the second hollow shaft 33 are connected via the connection member 73 having high tensile rigidity.
  • the member 51 extendrusion mechanism
  • the indwelling device delivery apparatus 3 can smoothly push out the indwelling device 11 from the first hollow shaft 23 and easily indwell the indwelling device 11 in the body.
  • the cylindrical reinforcing members 312, 332 are used as specific means for making the tensile stiffness of the second hollow shafts 31, 32, 33 greater than the tensile stiffness of the first hollow shafts 21, 23. and an indwelling device delivery device 2 having a linear reinforcing member 322 are exemplified.
  • any aspect may be used as long as the effects of the present invention are not impaired.
  • the placement device 11 including the device main body 111 having the IC tag 111a and the self-expandable engaging member 112 has been described.
  • the subject to be indwelled is, for example, an indwelling object such as an indwelling device that does not have an engaging member, a capsule containing a drug, an imaging marker containing a radiopaque material, a cell, or an electronic device.
  • the reinforcing members 312, 322, 332 are fixed to both the proximal ends of the first hollow shafts 21, 23 and the distal ends of the hollow shaft main bodies 311, 321, 331.
  • the delivery devices 1, 2, 3 have been described.
  • the indwelling device delivery apparatus only requires that the tensile stiffness of the second hollow shaft is greater than the tensile stiffness of the first hollow shaft. That is, in an indwelling device delivery device having a reinforcing member, the reinforcing member may be fixed to at least one of the proximal end of the first hollow shaft, the distal end of the hollow shaft main body, and the connecting member. .
  • the push-out mechanism that advances the shaft 511 and pushes out the placement device 11 by the screw action of the threaded portion 511a and the screw groove 41d has been described.
  • the extrusion mechanism may take any form.
  • the pushing mechanism may be, for example, a shaft that does not have a threaded portion and a thread groove as described above and moves linearly forwards and backwards along the longitudinal direction without rotating the shaft.
  • the extrusion mechanism does not have a shaft as described above, and pressurizes while injecting a fluid such as an inert gas or a physiological saline solution into a lumen that is airtight or liquid-tight to move the indwelling device to the tip. It may be a mechanism that pushes out in the direction.
  • the indwelling device delivery device 3 in which the first hollow shaft 23 and the hollow shaft main body 331 are arranged with the connecting member 73 interposed therebetween has been described.
  • it may be an indwelling device delivery device in which the first hollow shaft and the hollow shaft body are in direct contact.
  • the connection member can be arranged, for example, so as to cover the outer periphery of the interface between the first hollow shaft and the hollow shaft main body.

Abstract

The purpose of the present invention is to provide an indwelling device delivery apparatus capable of easily indwelling an indwelling device inside an organism.　An indwelling device delivery apparatus 1 comprises: an indwelling device 11; a flexible first hollow shaft 21 that has a first inner cavity 21h and detachably holds the indwelling device 11 at a tip end part of the first inner cavity 21h; a second hollow shaft 31 that extends from a base end part of the first hollow shaft 21 in the direction toward the base end and has a second inner cavity 311h communicating with the first inner cavity 21h; and a push-out mechanism 51 that pushes out the indwelling device 11 from the first hollow shaft 21 in the direction toward the tip end via the first and second inner cavities 21h and 311h. The indwelling device delivery apparatus 1 is configured such that the tensile stiffness of the second hollow shaft 31 is larger than the tensile stiffness of the first hollow shaft 21.

Description

留置デバイスデリバリー装置Indwelling device delivery device
　本発明は、留置デバイスデリバリー装置に関する。 The present invention relates to an indwelling device delivery device.
　肺などのような変形し易い臓器を手術をする際、切除等の処置を行う病変部を特定するため、マーカを体内の病変部近傍に予め留置する技術が知られている。 A known technique is to place a marker in advance near a lesion in the body in order to identify the lesion for resection or other treatment when performing surgery on easily deformable organs such as the lungs.
　このような技術においては、例えば、ＩＣタグなどの無線マーカを遠位端に装着したカテーテルを病変部近傍に送り込み、ワイヤを用いて無線マーカをカテーテルから押し出すことでこれを患者の体内に留置する。次いで、患者の体外に配置された無線装置を用い、手術の際に留置した無線マーカとの無線通信により病変部の位置を特定しながら、所定の処置を施す（例えば、特許文献１参照）。 In such a technique, for example, a catheter having a wireless marker such as an IC tag attached to its distal end is fed into the vicinity of a lesion, and a wire is used to push the wireless marker out of the catheter, thereby indwelling it in the patient's body. . Next, using a wireless device placed outside the patient's body, predetermined treatment is performed while specifying the position of the lesion by wireless communication with a wireless marker indwelled during surgery (see, for example, Patent Document 1).
　このような技術によれば、たとえ臓器が変形したとしても無線マーカにより病変部の位置を正確に特定することができるため、病変部に対して正確な処置を行うことが期待できる。 According to such technology, even if the organ is deformed, the position of the lesion can be accurately specified by the wireless marker, so it can be expected that the lesion will be treated accurately.
特表２０１３－５４３４０１号公報Japanese translation of PCT publication No. 2013-543401
　しかしながら、カテーテルを用いてマーカを留置するような技術においては、気管などの湾曲した体腔内を円滑に進行できるように、カテーテルが柔軟な材料で形成されている。このため、ワイヤによりマーカを押し出す際、カテーテルへのマーカの係合（保持力）が強すぎるとマーカが押し出されずにカテーテル自体が伸長してしまい、結果的にマーカを体内に留置できない虞がある。 However, in the technique of placing a marker using a catheter, the catheter is made of a flexible material so that it can be smoothly advanced through curved body cavities such as the trachea. Therefore, when the marker is pushed out by the wire, if the engagement (holding force) of the marker with the catheter is too strong, the catheter itself is stretched without being pushed out, and as a result, there is a possibility that the marker cannot be indwelled in the body. .
　本発明は、以上のような事情に基づいてなされたものであり、その目的は、留置デバイスを体内に容易に留置することが可能な留置デバイスデリバリー装置を提供することにある。 The present invention has been made based on the circumstances as described above, and its object is to provide an indwelling device delivery apparatus capable of easily indwelling an indwelling device in the body.
　本開示のいくつかの態様は、
（１）留置デバイスと、
　先端から基端に亘って貫通する第１の内腔を有し、この第１の内腔の先端部にて前記留置デバイスを脱着可能に保持する柔軟な第１の中空シャフトと、
　前記第１の中空シャフトの基端部から基端方向に向かって延設され、先端から基端に亘って貫通しかつ前記第１の内腔に連通する第２の内腔を有する第２の中空シャフトと、
　前記第１および第２の内腔を介し、前記留置デバイスを前記第１の中空シャフトから先端方向に向かって押し出す押出機構と、を備えている留置デバイスデリバリー装置であって、
　前記第２の中空シャフトの引張剛性は、前記第１の中空シャフトの引張剛性よりも大きいことを特徴とする留置デバイスデリバリー装置、
（２）前記第２の中空シャフトは、前記第２の内腔を有する中空シャフト本体と、この中空シャフト本体の外周を覆い、かつ前記中空シャフト本体の引張剛性よりも大きい引張剛性を有する円筒状の補強部材とを備えており、
　前記補強部材は、前記第１の中空シャフトの基端部および／または前記中空シャフト本体の先端部に固定されている前記（１）に記載の留置デバイスデリバリー装置、
（３）前記第２の中空シャフトは、前記第２の内腔を有する中空シャフト本体と、この中空シャフト本体の長軸方向に沿うように並設された線状またはリボン状の補強部材とを備え、
　前記補強部材は、前記中空シャフト本体の引張剛性よりも大きい引張剛性を有し、かつ前記第１の中空シャフトの基端部および／または前記中空シャフト本体の先端部に固定されている前記（１）に記載の留置デバイスデリバリー装置、並びに
（４）前記中空シャフト本体の引張剛性よりも大きい引張剛性を有する接続部材を備え、
　前記接続部材は、前記第１の中空シャフトと前記中空シャフト本体との境界部にて、前記第１の中空シャフトおよび前記中空シャフト本体に固定されており、
　前記補強部材は、前記接続部材に固定されている前記（２）または（３）に記載の留置デバイスデリバリー装置、である。 Some aspects of the disclosure include:
(1) an indwelling device;
a flexible first hollow shaft having a first lumen therethrough from distal end to proximal end for detachably retaining the deployment device at the distal end of the first lumen;
A second hollow shaft that extends from the proximal end of the first hollow shaft toward the proximal direction, penetrates from the distal end to the proximal end, and has a second lumen that communicates with the first lumen. a hollow shaft;
an extrusion mechanism for pushing the indwelling device distally from the first hollow shaft through the first and second lumens, the indwelling device delivery apparatus comprising:
An indwelling device delivery device, wherein the tensile stiffness of the second hollow shaft is greater than the tensile stiffness of the first hollow shaft;
(2) The second hollow shaft includes a hollow shaft body having the second lumen, and a cylindrical shape that covers the outer circumference of the hollow shaft body and has a tensile rigidity greater than that of the hollow shaft body. and a reinforcing member of
The indwelling device delivery device according to (1), wherein the reinforcing member is fixed to the proximal end of the first hollow shaft and/or the distal end of the hollow shaft body;
(3) The second hollow shaft includes a hollow shaft body having the second lumen, and linear or ribbon-shaped reinforcing members arranged side by side along the longitudinal direction of the hollow shaft body. prepared,
The reinforcing member has tensile rigidity greater than the tensile rigidity of the hollow shaft main body, and is fixed to the proximal end portion of the first hollow shaft and/or the distal end portion of the hollow shaft main body. ), and (4) a connection member having a tensile rigidity greater than that of the hollow shaft body,
The connecting member is fixed to the first hollow shaft and the hollow shaft main body at a boundary portion between the first hollow shaft and the hollow shaft main body,
The indwelling device delivery device according to (2) or (3), wherein the reinforcing member is fixed to the connecting member.
　なお、本明細書において、「引張剛性」とは、ＪＩＳ７１６１－１　２０１４に規定の引張弾性率であって、第１および第２の中空シャフトの長軸方向における剛性を意味する。「先端方向」とは、第１および第２の中空シャフトの長軸方向に沿う方向であって、第２の中空シャフトに対して第１の中空シャフトが位置する方向を意味する。「基端方向」とは、第１および第２の中空シャフトの長軸方向に沿う方向であって、先端方向と反対の方向を意味する。 In this specification, the term "tensile stiffness" means the tensile elastic modulus specified in JIS 7161-1 2014 and the stiffness in the longitudinal direction of the first and second hollow shafts. "Distal direction" means the direction along the longitudinal direction of the first and second hollow shafts, the direction in which the first hollow shaft is positioned relative to the second hollow shaft. "Proximal direction" means a direction along the longitudinal direction of the first and second hollow shafts, opposite to the distal direction.
　本発明は、留置デバイスを体内に容易に留置することが可能な留置デバイスデリバリー装置を提供することができる。 The present invention can provide an indwelling device delivery apparatus capable of easily indwelling an indwelling device in the body.
第１の実施形態の全体を示す概略的断面図である。1 is a schematic cross-sectional view showing the entire first embodiment; FIG. 第１の実施形態の一部を拡大して示す概略的断面図である。It is a schematic sectional drawing which expands and shows a part of 1st Embodiment. 図２ＡのＩＩｂ－ＩＩｂ線で切断した概略的断面図である。FIG. 2B is a schematic cross-sectional view taken along line IIb-IIb of FIG. 2A; 第１の実施形態の使用状態を示す概略図である。It is a schematic diagram showing the use state of the first embodiment. 第１の実施形態の使用状態を示す概略図である。It is a schematic diagram showing the use state of the first embodiment. 第１の実施形態の使用状態を示す概略図である。It is a schematic diagram showing the use state of the first embodiment. 第２の実施形態の一部を拡大して示す概略的断面図である。It is a schematic sectional drawing which expands and shows a part of 2nd Embodiment. 図４ＡのＩＶｂ－ＩＶｂ線で切断した概略的断面図である。FIG. 4B is a schematic cross-sectional view taken along line IVb-IVb of FIG. 4A; 第３の実施形態の一部を拡大して示す概略的断面図である。It is a schematic sectional drawing which expands and shows a part of 3rd Embodiment.
　本開示の留置デバイスデリバリー装置は、留置デバイスと、先端から基端に亘って貫通する第１の内腔を有し、この第１の内腔の先端部にて上記留置デバイスを脱着可能に保持する柔軟な第１の中空シャフトと、上記第１の中空シャフトの基端部から基端方向に向かって延設され、先端から基端に亘って貫通しかつ上記第１の内腔に連通する第２の内腔を有する第２の中空シャフトと、上記第１および第２の内腔を介し、上記留置デバイスを上記第１の中空シャフトから先端方向に向かって押し出す押出機構とを備え、上記第２の中空シャフトの引張剛性は、上記第１の中空シャフトの引張剛性よりも大きくなるように構成されている。 An indwelling device delivery apparatus of the present disclosure has an indwelling device and a first lumen penetrating from a distal end to a proximal end, and detachably holds the indwelling device at the distal end of the first lumen. a flexible first hollow shaft extending from the proximal end of the first hollow shaft toward the proximal direction, penetrating from the distal end to the proximal end and communicating with the first lumen; a second hollow shaft having a second lumen; and an extrusion mechanism for pushing the indwelling device distally from the first hollow shaft through the first and second lumens; The tensile stiffness of the second hollow shaft is configured to be greater than the tensile stiffness of the first hollow shaft.
　なお、本明細書において、「長軸方向」とは、特に記載がない限り、第１の中空シャフトおよび第２の中空シャフトの長軸に沿った方向を指す。 In this specification, the term "longitudinal direction" refers to the direction along the longitudinal axes of the first hollow shaft and the second hollow shaft, unless otherwise specified.
　以下、本発明の第１～第３の実施形態について図面を参照して説明するが、本発明は、当該図面に記載の実施形態にのみ限定されるものではない。また、各図面に示した留置デバイスデリバリー装置の寸法は、実施内容の理解を容易にするために示した寸法であり、実際の寸法に対応するものではない。各図において、図示左側が留置デバイスデリバリー装置の先端方向（遠位）、右側が留置デバイスデリバリー装置の基端方向（近位、手元側）をそれぞれ示している。 The first to third embodiments of the present invention will be described below with reference to the drawings, but the present invention is not limited only to the embodiments described in the drawings. In addition, the dimensions of the indwelling device delivery device shown in each drawing are dimensions shown to facilitate understanding of the contents of implementation, and do not correspond to actual dimensions. In each figure, the left side of the drawing shows the distal direction (distal) of the indwelling device delivery device, and the right side shows the proximal direction (proximal, hand side) of the indwelling device delivery device.
［第１の実施形態］
　図１は、第１の実施形態を示す概略図である。留置デバイスデリバリー装置１は、図１に示すように、概略的に、留置デバイス１１と、第１の中空シャフト２１と、第２の中空シャフト３１と、コネクタ４１と、プッシャー部材５１と、把持部材６１とにより構成されている。 [First Embodiment]
FIG. 1 is a schematic diagram showing a first embodiment. The indwelling device delivery apparatus 1, as shown in FIG. 1, schematically includes an indwelling device 11, a first hollow shaft 21, a second hollow shaft 31, a connector 41, a pusher member 51, and a grasping member. 61.
　留置デバイス１１は、体内に留置されるデバイスである。留置デバイス１１は、図２Ａに示すように、例えば、デバイス本体１１１と、係合部材１１２とにより構成することができる。 The indwelling device 11 is a device to be indwelled inside the body. The placement device 11 can be composed of, for example, a device body 111 and an engaging member 112, as shown in FIG. 2A.
　デバイス本体１１１としては、例えば、薬剤が封入されたカプセル（不図示）、放射線不透過性材料を含んだ造影用のマーカ（不図示）、内部に種々の情報を格納し体外に設置された機器との間で無線通信を行うＩＣタグ１１１ａを被覆部材１１１ｂで被覆したマーカ（図２Ａ参照）等が挙げられる。 Examples of the device main body 111 include a capsule (not shown) containing a drug, a contrast marker (not shown) containing a radiopaque material, and a device installed outside the body that stores various information inside. and a marker (see FIG. 2A) in which an IC tag 111a that performs wireless communication with is covered with a covering member 111b.
　被覆部材１１１ｂを構成する材料は、留置デバイス１１が体内に挿入されることから、生体適合性を有していることが好ましい。上記材料としては、例えば、ポリアミド樹脂、ポリオレフィン樹脂、ポリエステル樹脂、ポリウレタン樹脂、シリコーン樹脂、フッ素樹脂などの樹脂材料；ＳＵＳ３０４などの金属材料等が挙げられる。 The material forming the covering member 111b preferably has biocompatibility because the indwelling device 11 is inserted into the body. Examples of the material include resin materials such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluorine resin; metal materials such as SUS304;
　係合部材１１２は、留置デバイス１１が第１の中空シャフト２１から脱着（分離）した後、体壁などに係合して留置デバイス１１を体内に固定する。係合部材１１２としては、例えば、一端がデバイス本体１１１に接合され、他端が自由端である自己拡張可能なコイル状の部材等が挙げられる。このような係合部材１１２は、例えば、Ｎｉ－Ｔｉなどの形状記憶合金で形成され、予め縮小した状態で第１の内腔２１ｈに保持される。留置デバイス１１を留置する際は、留置デバイス１１が第１の中空シャフト２１から脱着した後、係合部材１１２が自己拡張して体壁などに係合することでデバイス本体１１１が体内に固定される。 After the placement device 11 is detached (separated) from the first hollow shaft 21, the engaging member 112 is engaged with the body wall or the like to fix the placement device 11 inside the body. Examples of the engaging member 112 include a self-expandable coil-shaped member having one end joined to the device main body 111 and the other end being a free end. Such an engaging member 112 is made of, for example, a shape memory alloy such as Ni--Ti, and held in the first lumen 21h in a pre-shrunk state. When indwelling the indwelling device 11, after the indwelling device 11 is detached from the first hollow shaft 21, the engaging member 112 self-expands and engages with a body wall or the like, thereby fixing the device main body 111 inside the body. be.
　第１の中空シャフト２１は、先端から基端に亘って貫通する第１の内腔２１ｈを有し、この第１の内腔２１ｈの先端部にて留置デバイス１１を脱着可能（分離可能）に保持する柔軟な部材である。第１の中空シャフト２１は、具体的には、例えば、長尺状の中空円筒で構成することができる。 The first hollow shaft 21 has a first lumen 21h penetrating from the distal end to the proximal end. It is a flexible member that holds. Specifically, the first hollow shaft 21 can be configured by, for example, an elongated hollow cylinder.
　第１の中空シャフト２１は、柔軟性（可撓性）を有する材料で形成されている。また、第１の中空シャフト２１は、体腔内に挿通されることから、生体適合性を有していることが好ましい。上記材料としては、例えば、ポリアミド樹脂、ポリオレフィン樹脂、ポリエステル樹脂、ポリウレタン樹脂、シリコーン樹脂、フッ素樹脂などの樹脂材料等が挙げられる。これら中では、フッ素樹脂が好ましく、ポリテトラフルオロエチレン（ＰＴＦＥ）樹脂がより好ましい。これにより、第１の内腔２１ｈに挿通されるプッシャー部材５１（後述）等の摺動性を高めることができる。 The first hollow shaft 21 is made of a soft (flexible) material. Moreover, since the first hollow shaft 21 is inserted into the body cavity, it is preferable that the first hollow shaft 21 has biocompatibility. Examples of the material include resin materials such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluorine resin. Among these, fluororesins are preferred, and polytetrafluoroethylene (PTFE) resins are more preferred. Thereby, the slidability of the pusher member 51 (described later) and the like inserted through the first lumen 21h can be enhanced.
　第２の中空シャフト３１は、第１の中空シャフト２１の基端部から基端方向に向かって延設された部材である。第２の中空シャフト３１の引張剛性は、第１の中空シャフト２１の引張剛性よりも大きくなるように形成されている。 The second hollow shaft 31 is a member extending from the proximal end of the first hollow shaft 21 toward the proximal direction. The tensile stiffness of the second hollow shaft 31 is formed to be greater than the tensile stiffness of the first hollow shaft 21 .
　第２の中空シャフト３１は、図２Ａ,図２Ｂに示すように、例えば、中空シャフト本体３１１と、補強部材３１２とを有するように構成することができる。 The second hollow shaft 31 can be configured to have, for example, a hollow shaft main body 311 and a reinforcing member 312, as shown in FIGS. 2A and 2B.
　中空シャフト本体３１１は、先端から基端に亘って貫通しかつ第１の内腔２１ｈに連通する第２の内腔３１１ｈを有している。本実施形態では、第２の内腔３１１ｈの内径は第１の内腔２１ｈの内径と同一であり、かつ第１の内腔２１ｈと第２の内腔３１１ｈとの境界部に段差が生じないように、これらの内腔を画定する内周面が連続するように設けられている。なお、上述した第１の内腔２１ｈと第２の内腔３１１ｈとにより、後述するプッシャー部材５１などの押出機構を挿通するためのルーメンＬが形成される。 The hollow shaft main body 311 has a second lumen 311h penetrating from the distal end to the proximal end and communicating with the first lumen 21h. In this embodiment, the inner diameter of the second lumen 311h is the same as the inner diameter of the first lumen 21h, and there is no step at the boundary between the first lumen 21h and the second lumen 311h. As such, the inner peripheral surfaces defining these lumens are provided so as to be continuous. The first lumen 21h and the second lumen 311h form a lumen L through which a pushing mechanism such as a pusher member 51, which will be described later, is inserted.
　中空シャフト本体３１１を形成する材料としては、この中空シャフト本体３１１が体腔内に挿通されることから、可撓性および生体適合性を有していることが好ましい。上記材料としては、例えば、ポリアミド樹脂、ポリオレフィン樹脂、ポリエステル樹脂、ポリウレタン樹脂、シリコーン樹脂、フッ素樹脂などの樹脂材料等が挙げられる。これら中では、フッ素樹脂が好ましく、ポリテトラフルオロエチレン（ＰＴＦＥ）樹脂がより好ましい。これにより、第２の内腔３１１ｈに挿通されるプッシャー部材５１（後述）等の摺動性を高めることができる。 The material forming the hollow shaft main body 311 preferably has flexibility and biocompatibility because the hollow shaft main body 311 is inserted into the body cavity. Examples of the material include resin materials such as polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluorine resin. Among these, fluororesins are preferred, and polytetrafluoroethylene (PTFE) resins are more preferred. Thereby, the slidability of the pusher member 51 (described later) and the like inserted through the second lumen 311h can be enhanced.
　補強部材３１２は、中空シャフト本体３１１の外周を覆い、かつ中空シャフト本体３１１の引張剛性よりも大きい引張剛性を有する円筒状の部材である。補強部材３１２は、例えば、中空シャフト本体３１１の先端から基端に亘ってその外周全体を覆うように配置することができる。補強部材３１２は、体腔内を引っ掛かることなく円滑に挿入できるように、第１の中空シャフト２１の外径と同一の外径を有していてもよい。 The reinforcing member 312 is a cylindrical member that covers the outer periphery of the hollow shaft body 311 and has tensile rigidity greater than that of the hollow shaft body 311 . The reinforcement member 312 can be arranged, for example, so as to cover the entire outer periphery of the hollow shaft body 311 from the distal end to the proximal end. The reinforcing member 312 may have the same outer diameter as the first hollow shaft 21 so that it can be smoothly inserted into the body cavity without getting stuck.
　補強部材３１２を形成する材料としては、中空シャフト本体３１１よりも大きな引張剛性を有すると共に、体腔内に挿通されることから、生体適合性を有していることが好ましい。上記材料としては、例えば、ポリイミド樹脂；引張方向のみ繊維強化されたファイバー類などの複合材料等が挙げられる。これらの中では、大きな引張剛性の他、曲げ方向の柔軟性や追従性を有する材料がより好ましい。 The material forming the reinforcing member 312 preferably has greater tensile rigidity than the hollow shaft main body 311 and biocompatibility because it is inserted into the body cavity. Examples of the material include polyimide resin; composite materials such as fibers reinforced only in the tensile direction. Among these, materials having high tensile rigidity, flexibility in the bending direction, and followability are more preferable.
　補強部材３１２は、第１の中空シャフトの基端部および／または中空シャフト本体の先端部に固定することができる。本実施形態においては、補強部材３１２は、固定部３１ａにおいて、第１の中空シャフト２１の基端部および中空シャフト本体３１１の先端部の両者に固定されている。 The reinforcing member 312 can be fixed to the proximal end of the first hollow shaft and/or the distal end of the hollow shaft body. In this embodiment, the reinforcing member 312 is fixed to both the proximal end of the first hollow shaft 21 and the distal end of the hollow shaft main body 311 at the fixing portion 31a.
　補強部材３１２と、第１の中空シャフト２１の基端部および中空シャフト本体３１１の先端部とを固定する方法としては、例えば、生体適合性を有する接着剤を用いて接着する方法、加熱により溶着する方法、補強部材３１２の一部または全部を第１の中空シャフト２１，中空シャフト本体３１１に埋設する方法等を採用することができる。 As a method for fixing the reinforcing member 312 to the proximal end portion of the first hollow shaft 21 and the distal end portion of the hollow shaft main body 311, for example, a method of bonding using a biocompatible adhesive or welding by heating. a method of burying part or all of the reinforcing member 312 in the first hollow shaft 21 and the hollow shaft main body 311, or the like.
　コネクタ４１は、後述する押出機構を作動させる部材である。コネクタ４１は、先端から基端に亘って貫通し、第２の内腔３１１ｈに連通する内腔４１ｈが設けられている。本実施形態のコネクタ４１は、内腔４１ｈの中途に開口部４１ａを有する中間壁４１ｂと、この中間壁４１ｂとプッシャー部材５１に設けられた当接体５１２との間に介装され、常時は当接体５１２を基端方向に付勢するバネ部材４１ｃとを有している。また、コネクタ４１における当接体５１２よりも基端方向の部位には、後述するプッシャー部材５１のネジ部５１１ａに螺合するネジ溝４１ｄが設けられている。 The connector 41 is a member that operates an extrusion mechanism, which will be described later. The connector 41 is provided with a lumen 41h that penetrates from the distal end to the proximal end and communicates with the second lumen 311h. The connector 41 of this embodiment is interposed between an intermediate wall 41b having an opening 41a in the middle of the lumen 41h and an abutting body 512 provided on the intermediate wall 41b and the pusher member 51, and normally and a spring member 41c that biases the contact body 512 in the proximal direction. Further, a screw groove 41d that is screwed into a screw portion 511a of a pusher member 51, which will be described later, is provided at a portion of the connector 41 in the proximal direction from the contact member 512. As shown in FIG.
　プッシャー部材５１は、押出機構を構成する部材である。押出機構は、第１および第２の内腔２１ｈ，３１１ｈを介し、留置デバイス１１を第１の中空シャフト２１から先端方向に向かって押し出す機構である。押出機構は、本実施形態のように、例えば、第１および第２の内腔２１ｈ，３１１ｈに挿通され、先端部が留置デバイス１１の基端部に当接しながら留置デバイス１１を押し出す長手形状のプッシャー部材５１を有するような構成とすることができる。 The pusher member 51 is a member that constitutes an extrusion mechanism. The pushing mechanism is a mechanism for pushing the placement device 11 toward the distal direction from the first hollow shaft 21 through the first and second lumens 21h, 311h. As in the present embodiment, for example, the pushing mechanism is inserted through the first and second lumens 21h and 311h, and has a longitudinal shape that pushes out the placement device 11 while the tip is in contact with the proximal end of the placement device 11. It can be configured to have a pusher member 51 .
　プッシャー部材５１は、例えば、コネクタ４１のネジ溝４１ｄに螺合するネジ部５１１aが形成された中実のシャフト５１１と、このシャフト５１１の長軸方向における中途に固定された当接体５１２とにより構成することができる。かかる場合、プッシャー部材５１は、ネジ部５１１ａとネジ溝４１ｄとの螺合による回転時のスクリュー作用によりルーメンＬ内を摺動自在に進退し、シャフト５１１の先端が留置デバイス１１の基端に当接しながら押圧することで留置デバイス１１を先端方向に押し出すことができる。 The pusher member 51 is composed of, for example, a solid shaft 511 formed with a screw portion 511a that is screwed into the screw groove 41d of the connector 41, and a contact member 512 fixed halfway along the longitudinal direction of the shaft 511. Can be configured. In this case, the pusher member 51 slidably advances and retreats in the lumen L due to the screw action of the threaded portion 511 a and the thread groove 41 d during rotation, and the distal end of the shaft 511 contacts the proximal end of the placement device 11 . The placement device 11 can be pushed out in the distal direction by pressing while in contact.
　プッシャー部材５１を形成する材料としては、留置デバイス１１を押し出すことが可能な剛性を有すると共に、生体適合性を有していることが好ましい。上記材料としては、例えば、ステンレス鋼，Ｎｉ－Ｔｉ合金、コバルトクロム合金などの金属材料等が挙げられる。 The material forming the pusher member 51 preferably has a rigidity that allows the placement device 11 to be pushed out and has biocompatibility. Examples of the material include metal materials such as stainless steel, Ni--Ti alloys, and cobalt-chromium alloys.
　このように、押出機構がプッシャー部材５１を有することで、簡易な構成で留置デバイス１１を押し出すことができ、留置デバイス１１をより確実に体内に留置することができる。 As described above, the pusher mechanism has the pusher member 51, so that the placement device 11 can be pushed out with a simple configuration, and the placement device 11 can be left in the body more reliably.
　把持部材６１は、オペレータが留置デバイスデリバリー装置１を把持しながら操作する部材である。把持部材６１は、例えば、プッシャー部材５１の基端に固定され、ハンドル６１１の回転操作によりプッシャー部材５１が回転するように設けられている。把持部材６１の形状は、本発明の効果を損なわない限り特に限定されず、例えば、オペレータが操作しやすい形状に形成することができる。 The gripping member 61 is a member that the operator operates while gripping the indwelling device delivery device 1 . The grasping member 61 is, for example, fixed to the proximal end of the pusher member 51 and is provided so that the pusher member 51 is rotated by rotating the handle 611 . The shape of the gripping member 61 is not particularly limited as long as the effects of the present invention are not impaired, and for example, it can be formed in a shape that is easy for the operator to operate.
　次に、留置デバイスデリバリー装置１の使用態様について説明する。ここでは、マーカとなるＩＣタグ１１１ａが被覆部材１１１ｂで被覆されたデバイス本体１１１と、デバイス本体１１１の基端部外周に設けられた自己拡張可能な係合部材１１２とを備えている留置デバイス１１を用い、この留置デバイス１１を、肺の気管支に生じた病変部の近傍に留置する手技について例示する。 Next, the mode of use of the indwelling device delivery device 1 will be explained. Here, the placement device 11 includes a device main body 111 in which an IC tag 111a serving as a marker is covered with a covering member 111b, and a self-expandable engaging member 112 provided on the outer periphery of the proximal end portion of the device main body 111. is used to indwell the indwelling device 11 in the vicinity of the lesion in the bronchi of the lung.
　まず、留置デバイスデリバリー装置１を準備する。具体的には、例えば、留置デバイス１１を第１の中空シャフト２１の先端開口部２１ａから第１の内腔２１ｈに挿入し、係合部材１１２を第１の内腔２１ｈの内壁に係合させることで留置デバイス１１を第１の中空シャフト２１の先端部に保持する。次いで、把持部材６１のハンドル６１１を回転しながらプッシャー部材５１を前進させ、シャフト５１１の先端をデバイス本体１１１の基端に当接させる。 First, the indwelling device delivery device 1 is prepared. Specifically, for example, the indwelling device 11 is inserted through the distal opening 21a of the first hollow shaft 21 into the first lumen 21h, and the engagement member 112 is engaged with the inner wall of the first lumen 21h. This holds the placement device 11 at the distal end of the first hollow shaft 21 . Next, while rotating the handle 611 of the gripping member 61 , the pusher member 51 is advanced to bring the distal end of the shaft 511 into contact with the proximal end of the device main body 111 .
　次に、留置デバイスデリバリー装置１を体内に挿入する。具体的には、例えば、準備した留置デバイスデリバリー装置１を口腔を介して気管に挿入し、留置デバイス１１の先端が気管支Ａ内の病変部Ｂ近傍に達するまで押し進める（図３Ａ参照）。このとき、第１の中空シャフト２１は柔軟性を有しているので、湾曲した気管支Ａの内壁Ｗに沿って円滑に前進する。 Next, insert the indwelling device delivery device 1 into the body. Specifically, for example, the prepared indwelling device delivery apparatus 1 is inserted into the trachea through the oral cavity, and advanced until the tip of the indwelling device 11 reaches the vicinity of the lesion B in the bronchi A (see FIG. 3A). At this time, since the first hollow shaft 21 has flexibility, it advances smoothly along the inner wall W of the curved bronchi A.
　次に、第１の中空シャフト２１から留置デバイス１１を先端方向に押し出すことで留置デバイス１１を気管支Ａ内に留置する。具体的には、ハンドル６１１を回転操作し、ネジ部５１１ａのスクリュー作用によりプッシャー部材５１を前進させることで、シャフト５１１の先端により留置デバイス１１を押圧し、留置デバイス１１を開口部２１ａから先端方向に向かって押し出す（図３Ｂ参照）。この際、押し出された留置デバイス１１の係合部材１１２は第１の内腔２１ｈから解放されるため、自己拡張作用により拡張し、係合部材１１２の外周が気管支Ａの内壁Ｗに係合することで留置デバイス１１が気管支Ａ内に固定される。次いで、留置デバイス１１が脱着した留置デバイスデリバリー装置１を気管支Ａ内から抜去することで留置デバイス１１の留置が完了する（図３Ｃ参照）。 Next, the placement device 11 is placed in the bronchi A by pushing the placement device 11 forward from the first hollow shaft 21 . Specifically, by rotating the handle 611 and advancing the pusher member 51 by the screw action of the threaded portion 511a, the distal end of the shaft 511 presses the detention device 11 and moves the detention device 11 from the opening 21a toward the distal end. (See FIG. 3B). At this time, the engaging member 112 of the indwelling device 11 that has been pushed out is released from the first lumen 21h, so that it expands by self-expanding action, and the outer circumference of the engaging member 112 engages the inner wall W of the bronchi A. Thus, the indwelling device 11 is fixed in the bronchi A. Next, the indwelling device delivery apparatus 1 with the detached indwelling device 11 is removed from the bronchi A to complete the indwelling of the indwelling device 11 (see FIG. 3C).
　なお、その後の処置（病変部の切除など）の際は、体外に設置された無線装置（不図示）を用いてＩＣタグ１１１ａと無線通信することで体内における留置デバイス１１の位置が特定され、留置デバイス１１の位置を手掛かりとしてその近傍に位置する病変部Ｂに処置を施すことができる。 In the subsequent treatment (excision of a lesion, etc.), the position of the indwelling device 11 in the body is specified by wirelessly communicating with the IC tag 111a using a wireless device (not shown) installed outside the body. Using the position of the indwelling device 11 as a clue, the lesion B located in the vicinity thereof can be treated.
　以上のように、留置デバイスデリバリー装置１は、上記構成であるので、柔軟な先端部を有する。また、留置デバイスデリバリー装置１は、プッシャー部材５１（押出機構）が留置デバイス１１を押し出す際、第２の中空シャフト３１がプッシャー部材５１の押圧に負けて伸長するのを抑制することができる。その結果、留置デバイスデリバリー装置１は、留置デバイス１１を第１の中空シャフト２１から円滑に押し出すことができ、留置デバイス１１を体内に容易に留置することができる。 As described above, the indwelling device delivery apparatus 1 has the above-described configuration, and thus has a flexible distal end. In addition, the placement device delivery apparatus 1 can suppress the extension of the second hollow shaft 31 due to the pressure of the pusher member 51 when the pusher member 51 (extrusion mechanism) pushes out the placement device 11 . As a result, the indwelling device delivery apparatus 1 can smoothly push out the indwelling device 11 from the first hollow shaft 21 and easily indwell the indwelling device 11 in the body.
　また、本実施形態では、円筒状の補強部材３１２を備えているので、第２の中空シャフト３１に高い引張剛性を付与することができ、第２の中空シャフト３１がプッシャー部材５１の押圧に負けることなく、留置デバイス１１を体内により容易に押し出すことができる。 Further, in the present embodiment, since the cylindrical reinforcing member 312 is provided, it is possible to impart high tensile rigidity to the second hollow shaft 31 , and the second hollow shaft 31 can withstand the pressure of the pusher member 51 . The indwelling device 11 can be easily pushed out into the body without the need to move.
［第２の実施形態］
　図４Ａ，図４Ｂは、第２の実施形態を示す概略図である。留置デバイスデリバリー装置２は、図４Ａに示すように、概略的に、留置デバイス１１と、第１の中空シャフト２１と、第２の中空シャフト３２と、コネクタ４１（不図示）と、プッシャー部材５１と、把持部材６１（不図示）とにより構成されている。留置デバイスデリバリー装置２は、第２の中空シャフト３２を備えている点で、第１の実施形態と異なっている。なお、留置デバイス１１、第１の中空シャフト２１、コネクタ４１、プッシャー部材５１、および把持部材６１の構成は第１の実施形態のものと同様であるため、同一部分には同一符号を付してその詳細な説明は省略する。また、以下に示す第２の中空シャフト３２の構成以外の構成、および留置デバイスデリバリー装置２の使用態様は、第１の実施形態のものと同様である。 [Second embodiment]
4A and 4B are schematic diagrams showing a second embodiment. The indwelling device delivery apparatus 2, as shown in FIG. 4A, schematically includes an indwelling device 11, a first hollow shaft 21, a second hollow shaft 32, a connector 41 (not shown), and a pusher member 51. and a holding member 61 (not shown). The indwelling device delivery device 2 differs from the first embodiment in that it has a second hollow shaft 32 . The configurations of the placement device 11, the first hollow shaft 21, the connector 41, the pusher member 51, and the gripping member 61 are the same as those of the first embodiment, so the same parts are denoted by the same reference numerals. A detailed description thereof is omitted. Also, the configuration other than the configuration of the second hollow shaft 32 described below and the mode of use of the indwelling device delivery device 2 are the same as those of the first embodiment.
　第２の中空シャフト３２は、第１の中空シャフト２１の基端部から基端方向に向かって延設された部材である。第２の中空シャフト３２の引張剛性は、第１の中空シャフト２１の引張剛性よりも大きくなるように形成されている。 The second hollow shaft 32 is a member extending from the proximal end of the first hollow shaft 21 toward the proximal direction. The tensile stiffness of the second hollow shaft 32 is formed to be greater than the tensile stiffness of the first hollow shaft 21 .
　第２の中空シャフト３２は、例えば、中空シャフト本体３２１と、補強部材３２２とを有するように構成することができる。 The second hollow shaft 32 can be configured to have a hollow shaft main body 321 and a reinforcing member 322, for example.
　中空シャフト本体３２１は、先端から基端に亘って貫通しかつ第１の内腔２１ｈに連通する第２の内腔３２１ｈを有している。 The hollow shaft main body 321 has a second lumen 321h penetrating from the distal end to the proximal end and communicating with the first lumen 21h.
　補強部材３２２は、中空シャフト本体３２１の長軸方向に沿うように並設された線状またはリボン状の部材である。補強部材３２２は、中空シャフト本体３２１の引張剛性よりも大きい引張剛性を有している。線状およびリボン状の補強部材は、例えば、中空シャフト本体３２１の外周に接しかつ長軸方向に沿うように配置してもよい。補強部材３２２を構成するワイヤまたはリボンは、１本であってもよく、複数本であってもよい。また、ワイヤとリボンとが混在していてもよい。本実施形態では、補強部材３２２として、長軸を挟んで対向するように配置され、中空シャフト本体３２１の外周面側に埋設された２本のワイヤ（線状の補強部材３２２）が例示されている。 The reinforcing member 322 is a linear or ribbon-like member arranged side by side along the longitudinal direction of the hollow shaft main body 321 . The reinforcing member 322 has tensile stiffness greater than that of the hollow shaft body 321 . The linear and ribbon-shaped reinforcing members may be arranged, for example, in contact with the outer circumference of the hollow shaft body 321 and along the longitudinal direction. The number of wires or ribbons constituting the reinforcing member 322 may be one or more. Also, wires and ribbons may be mixed. In this embodiment, as the reinforcing member 322, two wires (linear reinforcing member 322) arranged to face each other across the long axis and embedded in the outer peripheral surface side of the hollow shaft main body 321 are exemplified. there is
　なお、上述した線状またはリボン状の補強部材３２２は、長軸廻りに均等に配置されていてもよい。例えば、２本のワイヤを用いる場合は第２の中空シャフトの長軸を挟んで対向するように配置するのが好ましく、３本のワイヤを用いる場合は第２の中空シャフトの円周方向に沿って１２０度の間隔で配置するのが好ましく、４本のワイヤを用いる場合は第２の中空シャフトの円周方向に沿って９０度の間隔で配置するのが好ましい。これにより、第２の中空シャフトの長軸廻りに均等な剛性を付与することができ、プッシャー部材５１による押圧の際に第２の中空シャフトの軸芯が特定方向に偏向するのを防止することができる。 Note that the linear or ribbon-shaped reinforcing members 322 described above may be evenly arranged around the long axis. For example, when two wires are used, they are preferably arranged so as to face each other across the long axis of the second hollow shaft, and when three wires are used, they are arranged along the circumferential direction of the second hollow shaft. Preferably, the wires are spaced 120 degrees apart, and if four wires are used, they are preferably spaced 90 degrees along the circumference of the second hollow shaft. As a result, it is possible to impart uniform rigidity around the long axis of the second hollow shaft, thereby preventing deflection of the axial center of the second hollow shaft in a specific direction when the pusher member 51 presses. can be done.
　補強部材３２２は、第１の中空シャフトの基端部および／または中空シャフト本体の先端部に固定することができる。本実施形態においては、補強部材３２２は、第１の中空シャフト２１の基端部、および中空シャフト本体３２１の先端部を含む中空シャフト本体３２１の全長に亘って固定（埋設）されている。 The reinforcing member 322 can be fixed to the proximal end of the first hollow shaft and/or the distal end of the hollow shaft body. In this embodiment, the reinforcing member 322 is fixed (embedded) over the entire length of the hollow shaft body 321 including the proximal end of the first hollow shaft 21 and the distal end of the hollow shaft body 321 .
　以上のように、留置デバイスデリバリー装置２は、上記構成であるので、柔軟な先端部を有する。また、留置デバイスデリバリー装置２は、プッシャー部材５１（押出機構）が留置デバイス１１を押し出す際、第２の中空シャフト３２がプッシャー部材５１の押圧に負けて伸長するのを抑制することができる。その結果、留置デバイスデリバリー装置２は、留置デバイス１１を第１の中空シャフト２１から円滑に押し出すことができ、留置デバイス１１を体内に容易に留置することができる。 As described above, the indwelling device delivery device 2 has the above-described configuration, and thus has a flexible distal end. In addition, the indwelling device delivery apparatus 2 can suppress the extension of the second hollow shaft 32 due to the pressure of the pusher member 51 when the pusher member 51 (extrusion mechanism) pushes out the indwelling device 11 . As a result, the indwelling device delivery apparatus 2 can smoothly push out the indwelling device 11 from the first hollow shaft 21 and easily indwell the indwelling device 11 in the body.
　また、本実施形態では、線状の補強部材３２２（ワイヤ）を備えているので、第２の中空シャフト３２に高い引張剛性を付与することができ、第２の中空シャフト３２がプッシャー部材５１の押圧に負けることなく、留置デバイス１１を体内に容易に押し出すことができる。 Further, in this embodiment, since the linear reinforcing member 322 (wire) is provided, it is possible to impart high tensile rigidity to the second hollow shaft 32 , so that the second hollow shaft 32 is attached to the pusher member 51 . The indwelling device 11 can be easily pushed into the body without losing pressure.
［第３の実施形態］
　図５は、第３の実施形態を示す概略図である。留置デバイスデリバリー装置３は、図５に示すように、概略的に、留置デバイス１１と、第１の中空シャフト２３と、接続部材７３と、第２の中空シャフト３３と、コネクタ４１（不図示）と、プッシャー部材５１と、把持部材６１（不図示）とにより構成されている。留置デバイスデリバリー装置３は、第１の中空シャフト２３、接続部材７３、および第２の中空シャフト３３を備えている点で、第１の実施形態と異なっている。なお、留置デバイス１１、コネクタ４１、プッシャー部材５１、および把持部材６１の構成は第１の実施形態のものと同様であるため、同一部分には同一符号を付してその詳細な説明は省略する。また、以下に示す第１および第２の中空シャフト２３，３３の構成以外の第１および第２の中空シャフトの構成、および留置デバイスデリバリー装置３の使用態様は、第１の実施形態のものと同様である。 [Third Embodiment]
FIG. 5 is a schematic diagram showing a third embodiment. As shown in FIG. 5, the indwelling device delivery apparatus 3 generally includes an indwelling device 11, a first hollow shaft 23, a connecting member 73, a second hollow shaft 33, and a connector 41 (not shown). , a pusher member 51, and a gripping member 61 (not shown). The indwelling device delivery apparatus 3 differs from the first embodiment in that it includes a first hollow shaft 23, a connecting member 73, and a second hollow shaft 33. As shown in FIG. The configurations of the placement device 11, the connector 41, the pusher member 51, and the grasping member 61 are the same as those of the first embodiment, so the same parts are denoted by the same reference numerals, and detailed description thereof will be omitted. . Also, the configuration of the first and second hollow shafts other than the configuration of the first and second hollow shafts 23, 33 described below and the mode of use of the indwelling device delivery device 3 are the same as those of the first embodiment. It is the same.
　第１の中空シャフト２３は、先端から基端に亘って貫通する第１の内腔２３ｈを有し、この第１の内腔２３ｈの先端部にて留置デバイス１１を脱着可能に保持する柔軟な部材である。本実施形態の第１の中空シャフト２３は、その基端部に、後述する接続部材７３の接続部７３ａが接続する被接続部２３ａが設けられている。 The first hollow shaft 23 has a first lumen 23h penetrating from the distal end to the proximal end. It is a member. The first hollow shaft 23 of the present embodiment is provided at its proximal end with a connected portion 23a to which a connecting portion 73a of a connecting member 73, which will be described later, is connected.
　接続部材７３は、中空シャフト本体３３１の引張剛性よりも大きい引張剛性を有する部材である。接続部材７３は、第１の中空シャフト２３と中空シャフト本体３３１との境界部にて、第１の中空シャフト２３および中空シャフト本体３３１に固定されている。本実施形態では、接続部材７３の先端部に設けられた接続部７３ａが被接続部２３ａに嵌合するように接続され、接続部材７３の基端部に設けられた接続部７３ｂが後述する被接続部３３１ｂに嵌合するように接続されている（第１の中空シャフト２３と中空シャフト本体３３１とは、接続部材７３を挟んで離間するように配置されている）。 The connecting member 73 is a member having tensile rigidity greater than that of the hollow shaft main body 331 . The connecting member 73 is fixed to the first hollow shaft 23 and the hollow shaft body 331 at the boundary between the first hollow shaft 23 and the hollow shaft body 331 . In the present embodiment, the connecting portion 73a provided at the distal end portion of the connecting member 73 is connected so as to be fitted to the connected portion 23a, and the connecting portion 73b provided at the proximal end portion of the connecting member 73 is connected to the connecting portion 73b, which will be described later. It is connected so as to be fitted to the connecting portion 331b (the first hollow shaft 23 and the hollow shaft main body 331 are arranged so as to be separated from each other with the connecting member 73 interposed therebetween).
　本実施形態の接続部材７３は、先端から基端に亘って貫通し、第１および第２の内腔２３ｈ，３３１ｈに連通する内腔７３ｈを有する中空円筒形状の部材で構成されている。上記中空円筒形状の部材は、内腔７３ｈの内径が第１および第２の内腔２３ｈ，３３１ｈの内径と同一であり、かつこれらの内腔が連続する（内腔の境界部に段差がない）ように設けられていてもよい。これにより、プッシャー部材５１を円滑に進退することができる。また、接続部材７３の外径と、第１および第２の中空シャフト２３，３３の外径とは同一であり、かつこれらの外周面が連続する（外周面の境界部に段差がない）ように設けられていてもよい。これにより、留置デバイスデリバリー装置３が体腔内壁に引っ掛かることなく円滑に進行することができる。 The connecting member 73 of the present embodiment is a hollow cylindrical member having a lumen 73h penetrating from the distal end to the proximal end and communicating with the first and second lumens 23h and 331h. In the hollow cylindrical member, the inner diameter of the lumen 73h is the same as the inner diameters of the first and second lumens 23h and 331h, and these lumens are continuous (there is no step at the boundary between the lumens). ) may be provided as follows. As a result, the pusher member 51 can be advanced and retracted smoothly. Further, the outer diameter of the connecting member 73 and the outer diameters of the first and second hollow shafts 23 and 33 are the same, and the outer peripheral surfaces thereof are continuous (there is no step at the boundary between the outer peripheral surfaces). may be provided in As a result, the indwelling device delivery device 3 can be smoothly advanced without being caught on the inner wall of the body cavity.
　接続部材７３を形成する材料としては、体腔内に挿通されることから、生体適合性を有していることが好ましい。上記材料としては、例えば、ＰＥＥＫ（ポリエーテルエーテルケトン）、ＰＳＵ（ポリサルホン）などのスーパーエンジニアリングプラスティック；グラファイトファイバーなどの複合材料；ＳＵＳ３０４などの金属材料等が挙げられる。これらの中では、射出成型が可能でかつ剛性・強度に優れた、ＰＥＥＫ（ポリエーテルエーテルケトン）、ＰＳＵ（ポリサルホン）などのスーパーエンジニアリングプラスティック；グラファイトファイバーなどの複合材料がより好ましい。 The material forming the connecting member 73 preferably has biocompatibility because it is inserted into the body cavity. Examples of the material include super engineering plastics such as PEEK (polyetheretherketone) and PSU (polysulfone); composite materials such as graphite fiber; and metal materials such as SUS304. Among these, super engineering plastics such as PEEK (polyetheretherketone) and PSU (polysulfone), which are injection-moldable and excellent in rigidity and strength, and composite materials such as graphite fiber are more preferable.
　接続部７３ａと被接続部２３ａとの接続方法、および接続部７３ｂと被接続部３３１ｂとの接続方法は、本発明の効果を損なわない（例えば、第１の中空シャフト２３と第２の中空シャフト３３とが長軸方向に伸びず、かつ第１の中空シャフト２３の長軸と第２の中空シャフト３３の長軸とがズレない）限り、特に限定されない。上記接続方法としては、例えば、第１および第２の中空シャフト２３，３３と接続部材７３とを嵌着したり、接着したり、溶着したりする方法等が挙げられる。 The method of connecting the connecting portion 73a and the connected portion 23a and the method of connecting the connecting portion 73b and the connected portion 331b do not impair the effects of the present invention (for example, the first hollow shaft 23 and the second hollow shaft 33 does not extend in the longitudinal direction, and the major axis of the first hollow shaft 23 and the major axis of the second hollow shaft 33 do not deviate. Examples of the connection method include a method of fitting, bonding, or welding the first and second hollow shafts 23 and 33 and the connection member 73 .
　第２の中空シャフト３３は、第１の中空シャフト２３の基端部から基端方向に向かって延設され、先端から基端に亘って貫通しかつ第１の内腔２３ｈに連通する第２の内腔３３１ｈを有する部材である。第２の中空シャフト３３の引張剛性は、第１の中空シャフト２３の引張剛性よりも大きくなるように形成されている。 The second hollow shaft 33 extends from the proximal end of the first hollow shaft 23 toward the proximal direction, penetrates from the distal end to the proximal end, and communicates with the first lumen 23h. is a member having a lumen 331h of . The tensile stiffness of the second hollow shaft 33 is formed to be greater than the tensile stiffness of the first hollow shaft 23 .
　本実施形態の第２の中空シャフト３３は、中空シャフト本体３３１と、補強部材３３２とにより構成されている。中空シャフト本体３３１の先端部には、上述した接続部材７３の接続部７３ｂが接続する被接続部３３１ｂが設けられている。補強部材３３２の先端部は、固定部３３ａにおいて、接続部材７３と共に、第１の中空シャフト２３の基端部および中空シャフト本体３３１の先端部にも固定されている。 The second hollow shaft 33 of this embodiment is composed of a hollow shaft main body 331 and a reinforcing member 332 . A connected portion 331b to which the connecting portion 73b of the connecting member 73 described above is connected is provided at the tip portion of the hollow shaft main body 331 . The distal end portion of the reinforcing member 332 is also fixed to the proximal end portion of the first hollow shaft 23 and the distal end portion of the hollow shaft main body 331 together with the connecting member 73 at the fixing portion 33a.
　以上のように、留置デバイスデリバリー装置３は、上記構成であるので、引張剛性が大きい接続部材７３を介して第１の中空シャフト２３と第２の中空シャフト３３とが接続されている分、プッシャー部材５１（押出機構）が留置デバイス１１を押し出す際、第２の中空シャフト３３がプッシャー部材５１の押圧に負けて伸長するのを抑制することができる。その結果、留置デバイスデリバリー装置３は、留置デバイス１１を第１の中空シャフト２３から円滑に押し出すことができ、留置デバイス１１を体内に容易に留置することができる。 As described above, since the indwelling device delivery apparatus 3 has the above-described configuration, the first hollow shaft 23 and the second hollow shaft 33 are connected via the connection member 73 having high tensile rigidity. When the member 51 (extrusion mechanism) pushes out the placement device 11, it is possible to prevent the second hollow shaft 33 from being pushed by the pusher member 51 and extending. As a result, the indwelling device delivery apparatus 3 can smoothly push out the indwelling device 11 from the first hollow shaft 23 and easily indwell the indwelling device 11 in the body.
　なお、本開示は、上述した実施形態の構成に限定されるものではなく、特許請求の範囲によって示され、特許請求の範囲と均等の意味および範囲内での全ての変更が含まれることが意図される。上述した実施形態の構成のうちの一部を削除したり、他の構成に置換してもよく、上述した実施形態の構成に他の構成を追加等してもよい。 It should be noted that the present disclosure is not limited to the configurations of the above-described embodiments, but is indicated by the scope of the claims, and is intended to include all modifications within the scope and meaning equivalent to the scope of the claims. be done. A part of the configuration of the embodiment described above may be deleted or replaced with another configuration, or another configuration may be added to the configuration of the embodiment described above.
　例えば、上述した実施形態では、第２の中空シャフト３１，３２，３３の引張剛性を第１の中空シャフト２１，２３の引張剛性よりも大きくする具体的手段として、円筒状の補強部材３１２，３３２を有する留置デバイスデリバリー装置１,３、および線状の補強部材３２２を有する留置デバイスデリバリー装置２を例示した。しかしながら、本発明の効果を損なわない限り、第２の中空シャフトの引張剛性が第１の中空シャフトの引張剛性よりも大きければいずれの態様であってもよい。 For example, in the above-described embodiment, the cylindrical reinforcing members 312, 332 are used as specific means for making the tensile stiffness of the second hollow shafts 31, 32, 33 greater than the tensile stiffness of the first hollow shafts 21, 23. and an indwelling device delivery device 2 having a linear reinforcing member 322 are exemplified. However, as long as the tensile rigidity of the second hollow shaft is greater than the tensile rigidity of the first hollow shaft, any aspect may be used as long as the effects of the present invention are not impaired.
　また、上述した実施形態では、ＩＣタグ１１１ａを有するデバイス本体１１１と、自己拡張可能な係合部材１１２とを備えた留置デバイス１１について説明した。しかしながら、留置される対象は、例えば、係合部材を備えていない留置デバイス、薬剤が封入されたカプセル、放射線不透過性材料を含んだ造影用のマーカ、細胞、電子機器などの留置物であってもよい。 Also, in the above-described embodiment, the placement device 11 including the device main body 111 having the IC tag 111a and the self-expandable engaging member 112 has been described. However, the subject to be indwelled is, for example, an indwelling object such as an indwelling device that does not have an engaging member, a capsule containing a drug, an imaging marker containing a radiopaque material, a cell, or an electronic device. may
　また、上述した実施形態では、補強部材３１２，３２２，３３２が、第１の中空シャフト２１，２３の基端部および中空シャフト本体３１１，３２１，３３１の先端部の両者に固定されている留置デバイスデリバリー装置１，２，３について説明した。しかしながら、留置デバイスデリバリー装置は、第２の中空シャフトの引張剛性が第１の中空シャフトの引張剛性よりも大きければよい。すなわち、補強部材を有する留置デバイスデリバリー装置においては、補強部材は、第１の中空シャフトの基端部、中空シャフト本体の先端部、および接続部材のうちの少なくともいずれかに固定されていればよい。 Further, in the above-described embodiment, the reinforcing members 312, 322, 332 are fixed to both the proximal ends of the first hollow shafts 21, 23 and the distal ends of the hollow shaft main bodies 311, 321, 331. The delivery devices 1, 2, 3 have been described. However, the indwelling device delivery apparatus only requires that the tensile stiffness of the second hollow shaft is greater than the tensile stiffness of the first hollow shaft. That is, in an indwelling device delivery device having a reinforcing member, the reinforcing member may be fixed to at least one of the proximal end of the first hollow shaft, the distal end of the hollow shaft main body, and the connecting member. .
　また、上述した実施形態では、ネジ部５１１ａとネジ溝４１ｄとの螺合によるスクリュー作用によりシャフト５１１を前進させて留置デバイス１１を押し出す押出機構について説明した。しかしながら、本発明の効果を損なわない限り、押出機構はいずれの態様であってもよい。押出機構は、例えば、上述したようなネジ部およびネジ溝を有さず、シャフトを回転することなく長軸方向に沿って直線的に進退するシャフトであってもよい。また、押出機構は、上述したようなシャフトを有さず、気密若しくは液密に形成されたルーメン内に、不活性ガスや生理食塩水などの流体を注入しながら加圧することで留置デバイスを先端方向に押し出すような機構であってもよい。 Further, in the above-described embodiment, the push-out mechanism that advances the shaft 511 and pushes out the placement device 11 by the screw action of the threaded portion 511a and the screw groove 41d has been described. However, as long as the effects of the present invention are not impaired, the extrusion mechanism may take any form. The pushing mechanism may be, for example, a shaft that does not have a threaded portion and a thread groove as described above and moves linearly forwards and backwards along the longitudinal direction without rotating the shaft. In addition, the extrusion mechanism does not have a shaft as described above, and pressurizes while injecting a fluid such as an inert gas or a physiological saline solution into a lumen that is airtight or liquid-tight to move the indwelling device to the tip. It may be a mechanism that pushes out in the direction.
　また、上述した実施形態では、接続部材７３を挟んで第１の中空シャフト２３と中空シャフト本体３３１とが離間するように配置された留置デバイスデリバリー装置３について説明した。しかしながら、第１の中空シャフトと中空シャフト本体とが直接接している留置デバイスデリバリー装置であってもよい。かかる場合、接続部材は、例えば、第１の中空シャフトと中空シャフト本体と境界部の外周を覆うように配置することができる。 Further, in the embodiment described above, the indwelling device delivery device 3 in which the first hollow shaft 23 and the hollow shaft main body 331 are arranged with the connecting member 73 interposed therebetween has been described. However, it may be an indwelling device delivery device in which the first hollow shaft and the hollow shaft body are in direct contact. In such a case, the connection member can be arranged, for example, so as to cover the outer periphery of the interface between the first hollow shaft and the hollow shaft main body.
　１，２，３　留置デバイスデリバリー装置
　１１　留置デバイス
　２１，２３　第１の中空シャフト
　２１ｈ，２３ｈ　第１の内腔
　３１，３２，３３　第２の中空シャフト
　３１１,３２１，３３１　中空シャフト本体
　３１１ｈ，３２１ｈ，３３１ｈ　第２の内腔
　３１２，３２２，３３２　補強部材
　５１　プッシャー部材（押出機構）
　７３　接続部材 1, 2, 3 indwelling device delivery device 11 indwelling device 21, 23 first hollow shaft 21h, 23h first lumen 31, 32, 33 second hollow shaft 311, 321, 331 hollow shaft body 311h, 321h, 331h Second lumen 312, 322, 332 Reinforcing member 51 Pusher member (extrusion mechanism)
73 connecting member

Claims (4)

  1. 　留置デバイスと、
    　先端から基端に亘って貫通する第１の内腔を有し、この第１の内腔の先端部にて前記留置デバイスを脱着可能に保持する柔軟な第１の中空シャフトと、
    　前記第１の中空シャフトの基端部から基端方向に向かって延設され、先端から基端に亘って貫通しかつ前記第１の内腔に連通する第２の内腔を有する第２の中空シャフトと、
    　前記第１および第２の内腔を介し、前記留置デバイスを前記第１の中空シャフトから先端方向に向かって押し出す押出機構と、を備えている留置デバイスデリバリー装置であって、
    　前記第２の中空シャフトの引張剛性は、前記第１の中空シャフトの引張剛性よりも大きいことを特徴とする留置デバイスデリバリー装置。     an indwelling device;
    a flexible first hollow shaft having a first lumen therethrough from distal end to proximal end for detachably retaining the deployment device at the distal end of the first lumen;
    A second hollow shaft that extends from the proximal end of the first hollow shaft toward the proximal direction, penetrates from the distal end to the proximal end, and has a second lumen that communicates with the first lumen. a hollow shaft;
    an extrusion mechanism for pushing the indwelling device distally from the first hollow shaft through the first and second lumens, the indwelling device delivery apparatus comprising:
    The indwelling device delivery apparatus, wherein the tensile stiffness of the second hollow shaft is greater than the tensile stiffness of the first hollow shaft.
  2. 　前記第２の中空シャフトは、前記第２の内腔を有する中空シャフト本体と、この中空シャフト本体の外周を覆い、かつ前記中空シャフト本体の引張剛性よりも大きい引張剛性を有する円筒状の補強部材とを備えており、
    　前記補強部材は、前記第１の中空シャフトの基端部および／または前記中空シャフト本体の先端部に固定されている請求項１に記載の留置デバイスデリバリー装置。     The second hollow shaft includes a hollow shaft body having the second lumen, and a cylindrical reinforcing member that covers the outer periphery of the hollow shaft body and has tensile rigidity greater than that of the hollow shaft body. and
    The indwelling device delivery apparatus according to claim 1, wherein the reinforcing member is fixed to the proximal end of the first hollow shaft and/or the distal end of the hollow shaft main body.
  3. 　前記第２の中空シャフトは、前記第２の内腔を有する中空シャフト本体と、この中空シャフト本体の長軸方向に沿うように並設された線状またはリボン状の補強部材とを備え、
    　前記補強部材は、前記中空シャフト本体の引張剛性よりも大きい引張剛性を有し、かつ前記第１の中空シャフトの基端部および／または前記中空シャフト本体の先端部に固定されている請求項１に記載の留置デバイスデリバリー装置。     The second hollow shaft includes a hollow shaft body having the second lumen, and a linear or ribbon-shaped reinforcing member arranged along the longitudinal direction of the hollow shaft body,
    2. The reinforcing member has a tensile rigidity greater than that of the hollow shaft main body, and is fixed to the proximal end of the first hollow shaft and/or the distal end of the hollow shaft main body. The indwelling device delivery apparatus according to .
  4. 　前記中空シャフト本体の引張剛性よりも大きい引張剛性を有する接続部材を備え、
    　前記接続部材は、前記第１の中空シャフトと前記中空シャフト本体との境界部にて、前記第１の中空シャフトおよび前記中空シャフト本体に固定されており、
    　前記補強部材は、前記接続部材に固定されている請求項２または請求項３に記載の留置デバイスデリバリー装置。     a connecting member having a tensile stiffness greater than the tensile stiffness of the hollow shaft body;
    The connecting member is fixed to the first hollow shaft and the hollow shaft main body at a boundary portion between the first hollow shaft and the hollow shaft main body,
    The indwelling device delivery apparatus according to claim 2 or 3, wherein the reinforcing member is fixed to the connecting member.
PCT/JP2022/020438 2021-07-01 2022-05-16 Indwelling device delivery apparatus WO2023276469A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2021110306A JP2023007205A (en) 2021-07-01 2021-07-01 Indwelling device delivery apparatus
JP2021-110306 2021-07-01

Publications (1)

Publication Number Publication Date
WO2023276469A1 true WO2023276469A1 (en) 2023-01-05

Family

ID=84691106

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2022/020438 WO2023276469A1 (en) 2021-07-01 2022-05-16 Indwelling device delivery apparatus

Country Status (2)

Country Link
JP (1) JP2023007205A (en)
WO (1) WO2023276469A1 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016501638A (en) * 2012-12-21 2016-01-21 クリストファー ルブラン， Distal catheter tip and its formation
WO2020053948A1 (en) * 2018-09-11 2020-03-19 朝日インテック株式会社 Indwelling device

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016501638A (en) * 2012-12-21 2016-01-21 クリストファー ルブラン， Distal catheter tip and its formation
WO2020053948A1 (en) * 2018-09-11 2020-03-19 朝日インテック株式会社 Indwelling device

Also Published As

Publication number Publication date
JP2023007205A (en) 2023-01-18

Similar Documents

Publication Publication Date Title
JP6752840B2 (en) Fast exchange stent delivery system
US9095464B2 (en) Slotted pusher rod for flexible delivery system
US9545299B2 (en) Prosthesis deployment device with translucent distal end
US8465536B2 (en) Prosthesis deployment system
US20130035636A1 (en) Delivery and Deployment Catheter for an Implantable Medical Device
US20150057738A1 (en) Catheter system with movable sleeve
US20080114435A1 (en) Flexible delivery system
AU2005232510A1 (en) Stent graft indwelling device and fixed chip
US20090171434A1 (en) Prosthesis loading delivery and deployment apparatus
WO2013161764A1 (en) Operation member
CN111067588A (en) Catheter tube
JP4780688B2 (en) Medical catheter device
WO2023276469A1 (en) Indwelling device delivery apparatus
JP2011072616A (en) Catheter
JP2010057770A (en) Catheter assembly
CN216221855U (en) Conveying device for valve prosthesis and valve prosthesis system
WO2015141392A1 (en) Catheter and catheter set
CN111372538B (en) Medical device delivery system with flexible coupling
CN107690324B (en) Catheter assembly
JP7463246B2 (en) Endoscopes and medical equipment
CN212066944U (en) Support and imbedding system
JP5142785B2 (en) Pin driving device
JP7293594B2 (en) gastrointestinal stent
US20190321205A1 (en) Handle wheel implant delivery device
JP2023136942A (en) Method for manufacturing medical tubular body inner packaging tube and method for manufacturing medical tubular body carrier device

Legal Events

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

Ref document number: 22832628

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE