WO2023176909A1 - 留置装置 - Google Patents

留置装置 Download PDF

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Publication number
WO2023176909A1
WO2023176909A1 PCT/JP2023/010190 JP2023010190W WO2023176909A1 WO 2023176909 A1 WO2023176909 A1 WO 2023176909A1 JP 2023010190 W JP2023010190 W JP 2023010190W WO 2023176909 A1 WO2023176909 A1 WO 2023176909A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
indwelling device
indwelling
distal tip
cylindrical treatment
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2023/010190
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
佳樹 石丸
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sumitomo Bakelite Co Ltd
SB Kawasumi Laboratories Inc
Original Assignee
Sumitomo Bakelite Co Ltd
SB Kawasumi Laboratories Inc
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 Sumitomo Bakelite Co Ltd, SB Kawasumi Laboratories Inc filed Critical Sumitomo Bakelite Co Ltd
Priority to JP2024508239A priority Critical patent/JPWO2023176909A1/ja
Priority to EP23770862.3A priority patent/EP4494601A1/en
Priority to CN202380027983.5A priority patent/CN118946331A/zh
Publication of WO2023176909A1 publication Critical patent/WO2023176909A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/041—Bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0091—Additional features; Implant or prostheses properties not otherwise provided for transparent or translucent

Definitions

  • the present invention relates to an indwelling device for a cylindrical treatment device.
  • Cylindrical treatment devices such as stent grafts have been known for some time to be used to treat aneurysms that occur in blood vessel walls, and various proposals have also been made regarding indwelling devices for transporting and indwelling cylindrical treatment devices to the affected area.
  • indwelling devices for transporting and indwelling cylindrical treatment devices to the affected area.
  • an indwelling device indwells the cylindrical treatment device in the affected area by transporting the cylindrical treatment device in a radially contracted state to the affected area and expanding the cylindrical treatment device in the radial direction at the affected area.
  • the shaft-like member (inner tube) that held the cylindrical treatment device during indwelling is extracted and removed from the inside of the cylindrical treatment device after indwelling.
  • the present invention has been made in view of the above-mentioned situation, and suppresses the step of the shaft member from getting caught on the tubular therapeutic instrument when the tubular therapeutic instrument is placed in a bent part of the living body lumen.
  • the indwelling device that indwells a radially expandable cylindrical treatment device at a bent site within a living body lumen.
  • the indwelling device includes a sheath that can accommodate a cylindrical treatment device, and a long shaft-shaped sheath that can hold the cylindrical treatment device and whose distal end side can move forward and backward in the axial direction inside the sheath.
  • the shaft-like member has a step portion that protrudes in the radial direction of the shaft-like member, and a covering portion that covers the boundary portion between the step portion and the shaft-like member with an inclined surface on the proximal end side of the step portion.
  • the step of the shaft member is prevented from being caught on the cylindrical treatment device, and the shaft member can be pulled out smoothly.
  • FIG. 1 is a diagram showing a configuration example of a stent graft according to the present embodiment, and (b) is a sectional view taken along the line Ib-Ib in FIG. 1(a).
  • (a) is a diagram showing the indwelling state of the stent graft of the present embodiment, and (b) is an enlarged diagram showing the hepatic portal in FIG. 2(a).
  • (a) is an exploded view of the indwelling device 1 of this embodiment
  • (b) is a diagram showing the assembled state of the indwelling device 1 of this embodiment
  • (c) is a diagram showing the state in which the inner tube is inserted into the stent graft.
  • FIG. FIG. 3 is an enlarged view of one side of the inner tube.
  • FIG. 5 is a diagram showing a state in which the stent graft in FIG. 4 is attached.
  • 6 is a sectional view taken along the line VI-VI in FIG. 5.
  • FIG. It is a figure showing the procedure of indwelling a stent graft using an indwelling device. It is a figure showing the procedure of indwelling a stent graft using an indwelling device. It is a figure which shows typically the state when removing an indwelling device from inside a stent graft.
  • the axial direction Ax of the indwelling device and the cylindrical treatment device is indicated by an arrow as necessary. Further, a direction substantially perpendicular to the axial direction Ax is defined as a radial direction. Note that, in the drawings, one side (distal end side) of the indwelling device and the cylindrical treatment instrument is indicated by symbol F, and the other side (base end side) is indicated by symbol B, as necessary.
  • FIG. 1(a) is a diagram showing a configuration example of the stent graft 10 of this embodiment
  • FIG. 1(b) is a sectional view taken along the line Ib-Ib in FIG. 1(a).
  • FIG. 2(a) is a diagram showing the indwelling state of the stent graft 10 of this embodiment
  • FIG. 2(b) is an enlarged diagram of the hepatic portal HP in FIG. 2(a).
  • the stent graft 10 is an example of a cylindrical treatment device, and is placed in a diseased area such as a stenosis or occlusion in a living body lumen using an indwelling device 1, which will be described later, and is applied to dilate these diseased areas. be done.
  • the stent graft 10 of this embodiment is a covered stent for bile ducts, and is placed in the hepatic portal, which is an example of a living body lumen.
  • the stent graft 10 has a first main body part 11 and second main body parts 12a and 12b branching from one side of the first main body part 11. As shown in FIGS. 2(a) and 2(b), the first main body portion 11 is placed in the common hepatic duct H1, and the second main body portions 12a and 12b are placed in the right hepatic duct H2 and left hepatic duct H3, respectively. .
  • the first main body portion 11 and the second main body portions 12a and 12b are each formed into a cylindrical shape.
  • the second main body parts 12a and 12b have a smaller pipe diameter than the first main body part 11, and are bifurcated from one end of the first main body part 11 and are connected to each other.
  • one side of the first body part 11 communicates with the other side of each of the second body parts 12a, 12b, and the first body part 11 and the second body parts 12a, 12b form a Y-shaped bile flow path. is formed inside.
  • the angle of the crotch portion where the second main body portions 12a, 12b branch is determined according to the shape of the hepatic portal HP in which the stent graft 10 is placed.
  • the second main body parts 12a, 12b when the second main body parts 12a, 12b are aligned and arranged along the axial direction, the second main body parts 12a, 12b are centered on the axis of the first main body part 11. In contrast, the respective axes are arranged with their centers shifted. This makes it easier to compress the second main body parts 12a and 12b in the radial direction, making it easier to store the stent graft 10 in the sheath 20 of the indwelling device 1, which will be described later. In addition, in the following description, when explaining matters common to the second main body parts 12a and 12b, they may be collectively referred to as the second main body part 12.
  • the first main body part 11 and the second main body parts 12a and 12b each have a skeleton part 13 and a coating part 14 fixed to the skeleton part 13.
  • the skeleton portion 13 has a so-called self-expanding configuration in which the shape of the expanded state is memorized, and is expandable and contractible from a contracted state in which it contracts radially inward to an expanded state in which it expands radially outward. Therefore, the stent graft 10 in the indwelling state presses the inner surfaces of the common hepatic duct H1, right hepatic duct H2, and left hepatic duct H3 by the self-expanding force of the skeleton part 13. Further, in the stent graft 10 in the indwelling state, the skeleton portions 13 disposed in the first main body portion 11 and the second main body portions 12a, 12b are deformable in response to an external force applied from the outside.
  • the skeleton portion 13 has a cylindrical shape in which wire rods made of metal wires are woven into a fence shape.
  • the material of the wire of the skeleton portion 13 include known metals or metal alloys, such as Ni--Ti alloy, stainless steel, titanium alloy, and the like.
  • the skeleton portion 13 may be formed of a material other than metal (eg, ceramic, resin, etc.).
  • an alloy material having X-ray contrast property may be used for the wire rod of the skeleton portion 13, or a marker piece (not shown) formed of an alloy material having X-ray contrast property may be appropriately attached to the wire rod. . In these cases, the position of the stent graft 10 can be confirmed from outside the body.
  • the shape of the expanded state can be made to be stored in the skeleton part 13 by applying a predetermined heat treatment after shaping the skeleton part 13 into the shape of the expanded state. can.
  • the configuration of the skeleton section 13 is not limited to the above.
  • the skeleton portion 13 may be formed by spirally winding a thin metal wire bent in a zigzag shape.
  • the skeleton portion 13 may have a structure in which a plurality of ring-shaped skeleton pieces each having a ring-shaped connection of thin metal wires folded back in a zigzag manner are arranged at intervals in the axial direction.
  • the skeleton portion 13 may be formed by laser cutting a thin cylindrical body made of the various metals mentioned above.
  • the coating portion 14 is a tubular flexible membrane that forms the above-mentioned flow path, and is attached to the skeleton portion 13 so as to close the gap in the skeleton portion 13.
  • the coating portion 14 is attached to the outer circumferential surface of the skeleton portion 13, for example, as shown in FIG. 1(b). Thereby, the coating part 14 suppresses an event (ingrowth) in which the cell tissue of the lesion site infiltrates into the skeleton part 13.
  • the coating portion 14 may be attached to the inner peripheral surface of the skeleton portion 13, or may be attached to the outer peripheral surface and the inner peripheral surface of the skeleton portion 13 so as to sandwich the skeleton portion 13 therebetween.
  • the material forming the coating portion 14 examples include silicone resins, fluororesins such as PTFE (polytetrafluoroethylene), and polyester resins such as polyethylene terephthalate. Further, as a method of fixing the coating portion 14 to the skeleton portion 13, for example, formation of a coating by dipping can be mentioned. However, the method of fixing the coating portion 14 may be sewing with thread, adhesion, welding, pasting with tape, or the like.
  • an unillustrated removal assisting part may be connected to the other end of the first main body part 11.
  • the removal auxiliary part has an anchoring part to which a hook provided at the tip of the recovery catheter is attached, and is used when removing the stent graft 10 indwelled at the hepatic portal HP.
  • the above-described engaging portion is formed, for example, by bending a wire.
  • the engaging portion may have a hook shape or a loop shape, for example.
  • FIG. 3(a) is an exploded view of the indwelling device 1 of this embodiment
  • FIG. 3(b) is a diagram showing an assembled state of the indwelling device 1 of this embodiment
  • FIG. 3(c) is a diagram showing a state in which the inner tube 30 is inserted into the stent graft 10.
  • FIG. 4 is an enlarged view of one side of the inner tube 30.
  • FIG. 5 is a diagram showing a state in which the stent graft 10 in FIG. 4 is attached.
  • FIG. 6 is a sectional view taken along the line VI-VI in FIG.
  • the indwelling device 1 includes a tubular sheath 20 and a tubular inner tube 30 disposed inside the sheath 20.
  • the sheath 20 can house the stent graft 10 in a contracted state.
  • the sheath 20 includes a sheath main body 21 and a hub 22 provided at the other end of the sheath main body 21.
  • the hub 22 includes a nut (not shown) for fixing the sheath 20 to the inner tube 30, an operating member (not shown) for operating the deployment wire 41 (described later), and the like.
  • the sheath main body portion 21 is a tube made of a flexible material.
  • the material for the sheath body 21 include biocompatible synthetic resins (elastomers) selected from fluororesins, polyamide resins, polyethylene resins, polyvinyl chloride resins, etc., and other materials in addition to these resins. Examples include resin compounds in which these are mixed, multilayer structures made of these synthetic resins, and composites of these synthetic resins and metal wires.
  • the inner tube 30 is a shaft-like member that is longer and has a smaller diameter than the sheath 20.
  • the inner tube 30 is disposed inside the sheath 20, and is configured such that its distal end side can move forward and backward in the axial direction Ax with respect to the sheath 20.
  • the inner tube 30 has a sheath in order to be inserted into the second main body part 12a placed in the right hepatic duct H2 and the second main body part 12b placed in the left hepatic duct H3.
  • a pair are arranged in 20. Since the configurations of the pair of inner tubes 30 are the same, in the following explanation, the inner tube 30 corresponding to the second body part 12a will be explained, and the duplicate explanation of the inner tube 30 corresponding to the second body part 12b will be omitted. Omitted.
  • the inner tube 30 is a tubular body having a hole communicating from one side to the other side in the axial direction Ax.
  • a guide wire 40 which will be described later, is inserted into the hole of the inner tube 30 and is disposed at the hepatic portal HP.
  • the material for the inner tube 30 include various materials having appropriate hardness and flexibility, such as resins (plastics, elastomers, etc.) and metals.
  • the stent graft 10 is accommodated in a space formed between the outer periphery of the inner tube 30 and the inner periphery of the sheath body 21.
  • the inner tube 30 corresponding to the second body portion 12a is inserted into the sheath 20 through the first body portion 11 and the second body portion 12a of the stent graft 10.
  • the inner tube 30 corresponding to the second body part 12b is inserted into the first body part 11 and the second body part 12b of the stent graft 10 and disposed within the sheath 20.
  • the deployment wire 41 is an example of a linear member, and is arranged in the sheath 20 so as to extend in the axial direction in parallel with the inner tube 30. The other side of the deployment wire 41 passes through the sheath 20 and is connected to the operating member of the hub 22 . The deployment wire 41 can be pulled out along the axial direction by operating the operating member.
  • the holding member 42 is wound around the outer peripheral surface of the second main body portion 12a in such a manner that it cannot maintain the wound state by itself, and is held so that it cannot fall off by engaging with the deployment wire 41.
  • the holding member 42 is hooked onto the deployment wire 41 and wound around the second main body portion 12a while being folded back. At this time, by appropriately pulling both ends of the holding member 42 to apply tension, the diameter of the second main body portion 12a of the stent graft 10 is reduced.
  • the unfolding wire 41 is formed of a material having predetermined strength and rigidity, and examples thereof include a nickel-titanium alloy and a thin metal wire made of stainless steel. Further, as the material for the holding member 42, for example, a suture thread made of nylon fiber or fluorine fiber, or a string-like member made of resin can be used.
  • a distal tip 31 and a rib 32 are attached to one side of the inner tube 30.
  • the distal tip 31 is a cylindrical member attached to one side (the distal end side) of the inner tube 30.
  • the distal tip 31 has a function of suppressing the inner tube 30 from coming into contact with the living tissue of the patient when the indwelling device 1 is inserted into the body and the stent graft 10 is indwelled.
  • various materials having appropriate hardness and flexibility can be used, such as resins (plastics, elastomers, etc.) and metals.
  • the diameter of the distal tip 31 is larger than that of the inner tube 30, and one side of the distal tip 31 has a tapered shape that tapers gently toward the one side.
  • An annular stepped portion 31 a that projects radially from the inner tube 30 is formed on the other side (base end side) of the distal tip 31 . Further, a hole for inserting the guide wire 40 is formed in the center of the distal tip 31 along the axial direction.
  • the distal tip 31 has a recess 31b formed in a part of its outer periphery to receive the distal end portion of one side of the deployment wire 41.
  • the recess 31b is recessed inward from the outer circumferential surface of the distal tip 31 and has a groove shape extending in the axial direction from the proximal end toward the distal end.
  • the specifications (width in the circumferential direction and depth in the radial direction) of the recess 31b are determined within a range that allows the tip of the deployment wire 41 to be accommodated in the recess 31b.
  • a covering portion 33 is formed by covering the stepped portion 31a and the recessed portion 31b of the distal tip 31 from the outside with a thin film member.
  • the covering portion 33 of the distal tip 31 has the function of making the stepped portion 31a on the proximal end side of the distal tip 31 less likely to be caught by the skeleton portion 13, and the function of retaining the deployment wire 41 within the recess 31b of the distal tip 31.
  • the covering portion 33 is formed from the tip of the recess of the distal tip 31 to the inner tube 30 in the axial direction, and is attached to the outer periphery of the distal tip 31 on one side and attached to the outer periphery of the inner tube 30 on the other side.
  • the covering portion 33 forms a tapered inclined surface 33a from the proximal end of the distal tip 31 to the inner tube 30, and the tapered inclined surface 33a extends between the proximal end of the distal tip 31 and the inner tube 30 in the axial direction. 33a.
  • the tapered inclined surface 33a may be formed by attaching the covering portion 33, or may be formed by processing after the covering portion 33 is attached. Further, when the inner tube 30 is pulled out after the stent graft 10 is indwelled, the covering portion 33 located on the proximal end side advances inside the stent graft 10 before the distal tip 31.
  • the covering portion 33 attached to the distal tip 31 covers the outer periphery of the proximal end of the distal tip 31.
  • the recess 31b of the distal tip 31 is closed at the outer peripheral surface of the distal tip 31 by the thin film member of the covering section 33, and the tip of the deployment wire 41 accommodated in the recess 31b protrudes from the recess 31b to the outer peripheral side. things are suppressed.
  • the covering portion 33 tightens the base end side of the distal tip 31 from the outside in the circumferential direction.
  • the width of the recess 31b that accommodates the deployment wire 41 is narrowed in the circumferential direction, so that the tip of the deployment wire 41 is held between the recesses 31b. Therefore, even when the distal tip 31 is tightened by the covering portion 33, the distal end of the deployment wire 41 becomes difficult to protrude outward from the recess 31b.
  • the material of the covering portion 33 is a known thin film member having elasticity and biocompatibility, and is formed of a material having higher elasticity than the material of the distal tip 31, for example. If the covering part 33 has higher elasticity than the distal tip 31, even if the covering part 33 and the skeleton part 13 come into contact when pulling out the inner tube 30, the force will be dispersed by the elasticity of the covering part 33 and the skeleton part 13 will be Misalignment is less likely to occur. Note that the thickness of the covering portion 33 can be adjusted as appropriate depending on the filling rate within the sheath 20.
  • the thin film material of the covering portion 33 has a light-transmitting property that allows visible light to pass therethrough so that the attachment state of the deployment wire 41 to the recess 31b can be visually confirmed from the outside.
  • the covering portion 33 may be attached to the formation site by, for example, heat-shrinking a tubular thin film material, or may be attached to the formation site by winding a sheet-like thin film material. Note that when forming the covering portion 33 by heat-shrinking the thin film material, clogging of the recess 31b can be suppressed by placing a dummy wire or the like in the recess 31b during processing as necessary.
  • the rib 32 is a protrusion formed on one side of the inner tube 30 in a region where the stent graft 10 is held.
  • the ribs 32 have the function of transmitting a thrust toward one side to the stent graft 10 held by the inner tube 30 when the inner tube 30 is advanced to one side with respect to the sheath 20 .
  • the rib 32 has a cylindrical shape with a larger diameter than the inner tube 30, and is attached to the inner tube 30 at a distance from the distal tip 31 to the other side.
  • FIGS. 3 and 4 show an example in which two ribs 32 are arranged in the region where the stent graft 10 is held, the number of ribs 32 provided on the inner tube 30 is not limited to the above.
  • Each rib 32 is formed with annular stepped portions 32a and 32b that protrude radially from the inner tube 30 on one side and the other side, respectively.
  • the step portion 32b on one side of the rib 32 is an example of a first step, and is exposed to the outside in order to transmit thrust to the stent graft 10 to one side.
  • a covering part 34 is formed by covering the stepped part 32a on the base end side of the rib 32 from the outside with a thin film member.
  • the covering portion 34 of the rib 32 has a function of making the stepped portion 32a on the base end side of the rib 32 less likely to be caught on the skeleton portion 13.
  • the step portion 32a is an example of a second step.
  • the covering portion 34 is formed from the proximal end of the rib 32 to the inner tube 30 in the axial direction, and is attached to the outer periphery of the rib 32 on one side and attached to the outer periphery of the inner tube 30 on the other side.
  • the covering portion 34 forms a tapered inclined surface 34a from the proximal end of the rib 32 to the inner tube 30, and the tapered inclined surface 34a forms the tapered inclined surface 34a between the proximal end of the rib 32 and the inner tube 30 in the axial direction.
  • the tapered inclined surface 34a may be formed by attaching the covering portion 34, or may be formed by processing after the covering portion 34 is attached.
  • the covering portion 34 located on the proximal end side advances inside the stent graft 10 before the ribs 32.
  • the material and attachment method of the covering portion 34 attached to the rib 32 are the same as those of the covering portion 33 of the distal tip 31, so a repeated explanation will be omitted.
  • the guide wires 40 are placed in the right hepatic duct H2 and the left hepatic duct H3, which branch from the common hepatic duct H1, so as to pass through the lesion site 50 where the aneurysm is formed. Then, the guide wire 40 is inserted into the indwelling device 1 from one end of the indwelling device 1 in which the stent graft 10 in a contracted state is housed in the sheath 20 . Thereafter, the indwelling device 1 is introduced into the patient's body, and as shown in FIG. 7(a), the indwelling device 1 with the contracted stent graft 10 accommodated in the sheath 20 is advanced to a position where the common hepatic duct H1 branches. let
  • the pair of inner tubes 30, 30 holding the second body parts 12a, 12b in the contracted state while keeping the sheath 20 at the branching position of the common hepatic duct H1. is advanced to one side (distal side) through the right hepatic duct H2 and left hepatic duct H3, respectively.
  • the thrust force to one side of the inner tubes 30, 30 is transmitted to the second main body part 12 via the stepped part 32b on one side of the rib 32, and the second main body part 12 absorbs the movement of the inner tubes 30, 30. progress to one side in synchronization with
  • the deployment wire 41 is also exposed outside the sheath 20 on one side of the indwelling device 1.
  • the distal end of the deployment wire 41 is retained within the recess 31b of the distal tip 31, the distal end of the deployment wire 41 does not come into contact with the patient's body. Therefore, invasion caused by the tip of the deployment wire 41 coming into contact with the living body lumen is suppressed.
  • the deployment wire 41 is pulled out to the other side on the right hepatic duct H2 side and the left hepatic duct H3 side. Then, the engagement between the holding member 42 and the deployment wire 41 is released, the holding member 42 falls off from the outer periphery of the second main body part 12, and the restriction on expansion of the second main body part 12 in the radial direction is released. As a result, as shown in FIG. 8(a), the second main body portions 12a and 12b self-expand radially outward on the right hepatic duct H2 side and the left hepatic duct H3 side, respectively.
  • the sheath 20 is moved toward the other side so as to be pulled out. Then, as shown in FIG. 8(b), the first main body portion 11 of the stent graft 10 is released from the sheath 20 of the indwelling device 1. The first body portion 11 of the stent graft 10 self-expands radially outward by being released from the sheath 20 to the outside. As a result, the stent graft 10 is placed in the hepatic portal HP, and the lesion site 50 is expanded.
  • FIG. 9 is a diagram schematically showing a state when the indwelling device 1 is removed from the inside of the stent graft 10.
  • the inner tube 30 passes through the first body part 11 and the second body part 12, and the distal tip 31 advances to one side of the second body part 12. Therefore, when the inner tube 30 is pulled out to the other side, the distal tip 31 and the rib 32 attached to the inner tube 30 pass through the insides of the second body part 12 and the first body part 11 in order.
  • a guide wire 40 is inserted into the inner tube 30.
  • the guide wire 40 has a predetermined linearity in order to stably advance the indwelling device 1 within the living body lumen, but the guide wire 40 is bent at the hepatic portal HP, which branches on the left and right sides. . Therefore, the two guide wires 40 at the hepatic portal HP take a trajectory in which the radius of curvature becomes as large as possible due to the action of a restoring force that tends to return them to a straight line when they are pulled out.
  • the guide wire 40 approaches the inner wall of the stent graft 10. Since the inner tube 30 through which the guide wire 40 is inserted also follows the trajectory of the guide wire 40, the distal tip 31 and the rib 32 that protrude in the radial direction from the inner tube 30 are, for example, located at the locations indicated by broken lines in FIG. When pulled out, it passes near the inner wall of the stent graft 10.
  • the distal tip 31 and the rib 32 in this embodiment have covering parts 33, 34 that cover the boundary between the step parts 31a, 32a on the other side (base end side) and the inner tube 30 with tapered inclined surfaces 33a, 34a. They each have When the inner tube 30 is pulled out to the other side, the inclined surface 34a of the covering portion 34 formed on the other side of the rib 32 advances inside the stent graft 10 toward the other side before the rib 32. Similarly, when the inner tube 30 is pulled out to the other side, the inclined surface 33a of the covering portion 33 formed on the other side of the distal tip 31 advances inside the stent graft 10 toward the other side before the distal tip 31.
  • the inclined surfaces 33a and 34a of the covering parts 33 and 24 cause the diameter from the outer periphery of the inner tube 30 to the rib 32 and the tip 31 to gradually change in the axial direction. That is, on the other side of the rib 32 and the distal tip 31, the radial change (step) is reduced by the covering portions 33 and 34.
  • the inclined surfaces 33a and 34a of the covering parts 33 and 34 slide on the stepped part 31a on the proximal side of the distal tip 31 and the base of the rib 32. It passes over the stepped portion 32a on the end side and is guided to the outer periphery of the distal tip 31 and the rib 32. Therefore, when pulling out the inner tube 30 to the other side, it is possible to suppress the skeleton part 13 of the stent graft 10 from getting caught on the distal tip 31 or the ribs 32.
  • an indwelling device 1 for indwelling a radially expandable stent graft 10 (cylindrical treatment device) at the hepatic portal HP (a bent site within a living body lumen) includes a sheath 20 capable of accommodating the stent graft 10; , a long inner tube 30 (shaft-shaped member) configured to be able to hold the stent graft 10 and configured to be able to move forward and backward along the axial direction on one side (distal end side) inside the sheath 20.
  • the inner tube 30 includes members (distal tip 31, ribs 32) forming step portions 31a, 32a that protrude in the radial direction of the inner tube 30, and a step portion 31a on the other side (base end side) of the step portions 31a, 32a. , 32a and the inner tube 30 are covered with inclined surfaces 33a, 34a.
  • the inclined surfaces 33a and 34a of the covering parts 33 and 34 allow objects that come into contact with the inner tube 30 to overcome the stepped parts 31a and 32a.
  • the covering parts 33 and 34 prevent the stepped parts 31a and 32a of the inner tube 30 pulled out from the stent graft 10 from coming into contact with the inner wall of the living body lumen.
  • a guide wire 40 disposed within the living body lumen is inserted through the inner tube 30 in the axial direction. Due to the linearity of the guide wire 40, the step portions 31a and 32a approach the inner wall of the stent graft 10 when the inner tube 30 is pulled out, but the covering portions 33 and 34 prevent the skeleton portion 13 from getting caught on the step portions 31a and 32a. It can be suppressed.
  • the covering portions 33 and 34 are formed of thin film members attached to the stepped portions 31a and 32a.
  • the inclined surfaces 33a and 34a that cover the step portions 31a and 32a can be formed with relatively simple processing.
  • the covering parts 33 and 34 have higher elasticity than the members forming the stepped parts 31a and 32a, even if the covering parts 33 and 34 come into contact with the skeleton part 13 when pulling out the inner tube 30, The force is dispersed by the elasticity of the parts 33 and 34, making it more difficult for the skeleton part 13 to become misaligned.
  • one aspect of the present embodiment can provide an indwelling device that can suppress the tip of the linear member from coming into contact with the inner wall of the biological lumen when the cylindrical treatment device is placed in the biological lumen.
  • an indwelling device 1 for indwelling a radially expandable stent graft 10 (cylindrical treatment device) in the hepatic portal HP (living body lumen) includes a sheath 20 capable of accommodating the stent graft 10, and a sheath 20 that can accommodate the stent graft 10.
  • a long inner tube 30 (shaft-shaped member) configured to be movable in the axial direction on one side (distal end side) inside the stent graft 10 and a long inner tube 30 (shaft-shaped member) that extends in the axial direction along the inner tube 30 and contracts the stent graft 10.
  • the distal tip 31 has a recess 31b that is recessed from the surface of the distal tip and receives the end of the deployment wire 41.
  • the end of the deployment wire 41 is accommodated in the recess 31b of the distal tip 31, so that the distal end of the deployment wire 41 exposed outside the sheath 20 does not come into contact with the patient's body. Therefore, invasion caused by the tip of the deployment wire 41 penetrating into the living body lumen can be suppressed.
  • the recess 31b has a groove shape extending in the axial direction from the other side (base end side) of the distal tip 31, and the distal tip 31 covers the recess 31b from the outer peripheral side, and the end of the deployment wire 41 is inserted into the recess 31b. It further has a covering part 33 that is fastened inside. Therefore, the recess 31b is closed by the covering portion 33 at the position of the outer circumferential surface of the distal tip 31, and the tip of the deployment wire 41 accommodated in the recess 31b can be prevented from protruding outward from the recess 31b.
  • the end portion of the unfolded wire 41 is held between the recesses 31b tightened in the circumferential direction by the covering portion 33. Therefore, by tightening the covering portion 33, the holding force of the deploying wire 41 in the recess 31b of the distal tip 31 is improved, and it is possible to suppress the distal end of the deploying wire 41 from detaching from the recess 31b toward the outer circumference.
  • the covering portion 33 is formed of a material having translucency
  • the attachment state of the deployment wire 41 to the recess 31b can be visually confirmed from the outside. Therefore, the attachment state of the deployment wire 41 can be confirmed without performing, for example, X-ray imaging, thereby saving labor in quality confirmation work.
  • an example of the configuration of an indwelling device for indwelling a stent graft placed at the hepatic hilum has been described, but the indwelling device of the present invention is not limited to the above embodiment.
  • the covering portion of the above embodiment may be provided on the stepped portion of the shaft member.
  • a recess for receiving the end of the deployment wire may be provided in the distal tip, as in the above embodiment.
  • a recess may be formed on the inner peripheral side between the distal tip 31 and the inner tube 30, and the distal end of the deployment wire 41 may be inserted and held in the recess. In this case, it becomes possible to hold the distal end portion of the deployable wire 41 in the recessed portion without requiring the covering portion 33.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Prostheses (AREA)
PCT/JP2023/010190 2022-03-17 2023-03-15 留置装置 Ceased WO2023176909A1 (ja)

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JP2024508239A JPWO2023176909A1 (https=) 2022-03-17 2023-03-15
EP23770862.3A EP4494601A1 (en) 2022-03-17 2023-03-15 Deployment device
CN202380027983.5A CN118946331A (zh) 2022-03-17 2023-03-15 留置装置

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008504899A (ja) 2004-07-02 2008-02-21 クック・インコーポレイテッド バルーン／自己拡張ステントグラフト
WO2011036850A1 (ja) * 2009-09-25 2011-03-31 株式会社 京都医療設計 医療用のカテーテル装置
JP2016511042A (ja) 2013-02-21 2016-04-14 メドトロニック ヴァスキュラー インコーポレイテッド 漸進的な展開及び再位置決めのための細長いケーブルを備えたチップキャプチャ機構を有するステントグラフト送達システム
JP2018051322A (ja) * 2012-03-02 2018-04-05 ダブリュ．エル．ゴア アンド アソシエイツ，インコーポレイティドＷ．Ｌ． Ｇｏｒｅ ＆ Ａｓｓｏｃｉａｔｅｓ， Ｉｎｃｏｒｐｏｒａｔｅｄ 改良型生体適合性表面及び当該表面を組み込むデバイス

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008504899A (ja) 2004-07-02 2008-02-21 クック・インコーポレイテッド バルーン／自己拡張ステントグラフト
WO2011036850A1 (ja) * 2009-09-25 2011-03-31 株式会社 京都医療設計 医療用のカテーテル装置
JP2018051322A (ja) * 2012-03-02 2018-04-05 ダブリュ．エル．ゴア アンド アソシエイツ，インコーポレイティドＷ．Ｌ． Ｇｏｒｅ ＆ Ａｓｓｏｃｉａｔｅｓ， Ｉｎｃｏｒｐｏｒａｔｅｄ 改良型生体適合性表面及び当該表面を組み込むデバイス
JP2016511042A (ja) 2013-02-21 2016-04-14 メドトロニック ヴァスキュラー インコーポレイテッド 漸進的な展開及び再位置決めのための細長いケーブルを備えたチップキャプチャ機構を有するステントグラフト送達システム

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