WO2019103054A1 - Intravascular indwelling instrument connecting structure and intravascular indwelling system - Google Patents

Intravascular indwelling instrument connecting structure and intravascular indwelling system Download PDF

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Publication number
WO2019103054A1
WO2019103054A1 PCT/JP2018/043045 JP2018043045W WO2019103054A1 WO 2019103054 A1 WO2019103054 A1 WO 2019103054A1 JP 2018043045 W JP2018043045 W JP 2018043045W WO 2019103054 A1 WO2019103054 A1 WO 2019103054A1
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Prior art keywords
indwelling device
intravascular
stent graft
intravascular indwelling
locked
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PCT/JP2018/043045
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French (fr)
Japanese (ja)
Inventor
健太郎 左
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川澄化学工業株式会社
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Publication of WO2019103054A1 publication Critical patent/WO2019103054A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts

Definitions

  • the present invention relates to an intravascular indwelling device connection structure and an intravascular indwelling system.
  • a stent graft in which a skeleton called a stent is disposed on the peripheral surface of an artificial blood vessel is known as an endovascular indwelling device used for treatment of aortic aneurysm and aortic dissection generated in the aorta (for example, patent Reference 1).
  • a plurality of stent grafts may be connected depending on the state of a lesion site.
  • the stent length is selected according to the treatment length (length of lesion site + central and peripheral neck lengths), but one stent graft has a treatment length If it can not cover, it is necessary to connect multiple stent grafts.
  • branch vessels in the stent graft placement area in the aorta it is necessary to connect the branch stent graft to the main vessel stent graft in order to ensure blood flow to the branch vessels.
  • a stent-graft deployed first in a blood vessel is referred to as a "first stent-graft”
  • a stent-graft deployed later is referred to as a "second stent-graft”.
  • a second stent graft having a diameter equal to or larger than the inner diameter of the first stent graft is inserted in a contracted state and expanded at the junction of the first stent graft, and the overlapping portion of the second stent graft and the first stent graft is The close contact connects the second stent graft to the first stent graft. In this case, the expansion force of the second stent graft at the overlapping portion holds the connected state.
  • An object of the present invention is to provide an intravascular indwelling device connection structure and an intravascular indwelling system capable of preventing positional deviation of a stent graft at the time of connecting and indwelling a plurality of stent grafts and maintaining a good connection state.
  • An intravascular indwelling device connection structure for connecting a plurality of intravascular indwelling devices deployed in a blood vessel, comprising:
  • the plurality of intravascular indwelling devices include: a first intravascular indwelling device; and a second intravascular indwelling device intercalated and connected to the first intravascular indwelling device;
  • the first and second intravascular indwelling devices have a tubular shape, and
  • the first intravascular indwelling device has a locking portion projecting in the radial direction of the connecting portion at a connecting portion with the second intravascular indwelling device,
  • the second intravascular indwelling device has a film portion and a locked portion disposed on the outer peripheral surface of the film portion,
  • the to-be-locked portion extends in the circumferential direction while bending so as to have a bending portion in the axial direction of the second intravascular indwelling device, In the state where the second indwelling device is inserted and connected
  • An intravascular placement system comprising an intravascular placement device placed within a blood vessel, comprising:
  • the intravascular indwelling device includes first and second intravascular indwelling devices connected in blood vessels,
  • the first and second intravascular indwelling devices have a tubular shape, and
  • the first intravascular indwelling device has a locking portion projecting in the radial direction of the connecting portion at a connecting portion with the second intravascular indwelling device
  • the second intravascular indwelling device has a film portion and a locked portion disposed on the outer peripheral surface of the film portion,
  • the to-be-locked portion extends in the circumferential direction while bending so as to have a bending portion in the axial direction of the second intravascular indwelling device,
  • the bending portion is the first on the far side in the axial direction with respect to the locking portion.
  • a second bent portion close to the locking
  • FIG. 1 is a view showing a stent graft set according to an embodiment of the present invention.
  • FIGS. 2A and 2B show the stent graft set indwelling in a blood vessel.
  • 3A to 3C show the configuration of the first stent graft.
  • FIG. 4 is a view showing the configuration of a second stent graft.
  • 5A and 5B are diagrams showing the configuration of the connection end of the second stent graft.
  • 6A and 6B are diagrams showing a locked state of the first stent graft and the second stent graft.
  • FIGS. 7A and 7B are diagrams showing the configuration of a stent graft indwelling system (intravascular indwelling system) for indwelling a stent graft into a blood vessel.
  • 8A and 8B show another example of a stent graft set.
  • FIG. 1 is a view showing a stent graft set 1 according to an embodiment of the present invention.
  • 2A and 2B show the stent graft set 1 indwelled in a blood vessel.
  • the stent graft 10 corresponds to the "first intravascular indwelling device” in the present invention
  • the stent graft 20 corresponds to the "second intravascular indwelling device” in the present invention. That is, the blood vessel indwelling device connection structure according to the present invention is applied to the stent graft set 1.
  • the stent graft set 1 is a stent graft 10 for the main blood vessel indwelled in the lesion site of the aorta V1 which is the main blood vessel (for example, Hereinafter, “a first stent graft 10”) and a stent graft 20 for a branched blood vessel deployed in a branched blood vessel V2 branching from an aorta V1 in the vicinity of a lesion site (hereinafter “a second stent graft 20”) And so forth).
  • the outer diameter of the second stent graft 20 in the expanded state is equal to or larger than the inner diameter of the branch 12 of the first stent graft 10.
  • the first stent graft 10 is delivered to the lesion site in a contracted state and expanded into the aorta V1 by expanding (see FIG. 2A).
  • the second stent graft 20 is inserted into the branch portion 12 in a contracted state, positioned so as to overlap a predetermined length, and expanded to be indwelled in the branch blood vessel V2 (see FIG. 2B).
  • the inner peripheral surface of the first stent graft 10 (branch portion 12) and the outer peripheral surface of the second stent graft 20 are in close contact with each other in the overlapping portion, and the first stent graft 10 (branch portion 12) and the second The stent graft 20 is connected.
  • the second stent graft 20 may be transported through the inside of the first stent graft 10 and inserted into the branch 12 or may be transported through the branch blood vessel V2 and inserted into the branch 12. It may be done.
  • FIG. 3A to 3C show the configuration of the first stent graft 10.
  • FIG. 3A is a perspective view of the first stent graft 10.
  • FIG. 3B is a plan view of the first stent graft 10 as viewed from the branch 12 side.
  • FIG. 3C is a cross-sectional view of the branch 12 taken along line AA in FIG. 3B.
  • FIGS. 3A to 3C schematically show the expanded state of the first stent graft 10.
  • the first stent graft 10 has a tubular graft body 11 having openings at both ends, and a branch portion 12 provided on a tube wall of the graft body 11.
  • the graft body 11 has a tubular shape that defines a blood flow path.
  • the graft body 11 has a straight pipe shape
  • the graft body 11 has a curved shape (for example, corresponding to the shape of the aortic arch of the patient) according to the indwelling site It may have a shape or may have a curved shape along the shape of the blood vessel after indwelling.
  • the graft body 11 has a coating 111 and a skeleton 112.
  • the skeleton 112 is sewed and fixed to the circumferential surface of the coating 111 by, for example, a suture thread.
  • the skeleton 112 may be fixed to the film 111 by a method other than suturing, such as adhesion with tape, adhesion or welding.
  • the film part 111 is a graft part which becomes a flow path of blood.
  • the material for forming the film portion 111 include fluorine resins such as PTFE (polytetrafluoroethylene) and polyester resins such as polyethylene terephthalate.
  • the frame portion 112 is a reinforcing member which is fixed to the circumferential surface of the film portion 111 and holds the film portion 111 in a predetermined expanded state.
  • the skeleton 112 is, for example, a self-expanding stent skeleton formed in a tubular shape along the circumferential surface of the coating 111 while the thin metal wires are folded in a zigzag in the axial direction.
  • the skeleton portion 112 is configured to be deformable from a contracted state that is contracted radially inward to an expanded state that is expanded radially outward to define a tubular flow channel.
  • Examples of the material of the metal fine wire forming the skeleton 112 include known metals or metal alloys represented by stainless steel, Ni—Ti alloy, titanium alloy and the like.
  • the graft body 11 has a recess 11 a in which a part of the outer peripheral surface is recessed radially inward.
  • the recess 11 a has a flat bottom, and the branch 12 is disposed substantially at the center of the bottom.
  • the branch portion 12 is formed to project radially outward of the graft body 11 from the tube wall of the graft body 11 (the bottom surface of the recess 11 a).
  • the branch portion 12 has a through hole 12 a communicating with the lumen of the graft body 11.
  • the second stent graft 20 is inserted into and connected to the through hole 12 a of the branch 12. Note that a plurality of branch portions 12 may be provided on the tube wall of the graft body 11.
  • the branch portion 12 preferably has a tapered shape that reduces in diameter toward the opening end of the through hole 12a. Thereby, the adhesion between the first stent graft 10 and the second stent graft 20 can be enhanced.
  • the skeleton portion 112 is not disposed in the branch portion 12.
  • the branch portion 12 is made of the same material as the film portion 111 of the graft body 11 and is integrally formed with the graft body 11. Thereby, for example, the branch part 12 has a flexibility such that the opening direction can be deformed by the blood flow from the main blood vessel V1 to the branch blood vessel V2.
  • the branch portion 12 has the locking portion 13 protruding in the radial direction at the open end of the through hole 12a.
  • the locking portion 13 projecting radially inward will be referred to as the “first locking portion 131”
  • the locking portion 13 projecting radially outward will be referred to as the “second locking portion 132”.
  • the locking portion 13 may be disposed in the vicinity of the distal end of the open end instead of the distal end of the open end, as long as the locking portion 13 overlaps with the second stent graft 20.
  • the locking portion 13 is formed, for example, by attaching an annular member to the open end of the branch portion 12.
  • the annular member is formed of, for example, a high elastic material such as silicone rubber, and is fixed to the open end of the branch 12 by heat welding, ultrasonic welding, pressure bonding, adhesion, suturing or the like.
  • the annular member may be formed of a rubber material other than silicone, or may be formed of a material other than rubber (for example, a metal or the like). Further, a rubber or the like may be used as a main material, and a radiopaque substance such as barium sulfate may be added as an auxiliary material.
  • the locking portion 13 has a function of preventing displacement of the second stent graft 20 when the second stent graft 20 is connected to the first stent graft 10. Specifically, the locking portion 13 regulates the movement of the second stent graft 20 in the axial direction by locking the locked portion 23 (see FIG. 4) of the second stent graft 20.
  • the first locking portion 131 and the second locking portion 132 are provided in the present embodiment, either one may be provided.
  • the locking portion 13 has a function of maintaining the open state of the through hole 12a in a state in which the graft body 11 is expanded, specifically, the opening dimension of the through hole 12a so that the opening of the through hole 12a is not closed. It also has a function of maintaining the above-mentioned predetermined dimension or more. Thereby, the insertability at the time of attaching the 2nd stent graft 20 to branch part 12 improves.
  • a force acts radially inward on the second stent graft 20 due to the elasticity of the annular member, so that the branch 12 and the second stent graft 20 Adhesion can be improved.
  • the locking portion 13 may not have the function of maintaining the open state of the through hole 12 a or the function of biasing the second stent graft 20.
  • FIG. 4 is a view showing the configuration of the second stent graft 20.
  • FIG. 5A and 5B are views showing an end 20a of the second stent graft 20 to be connected to the first stent graft 10 (hereinafter, referred to as "connection end 20a").
  • FIG. 5A is an enlarged view of the connection end 20a.
  • FIG. 5B is a cross-sectional view of the connection side end 20a.
  • FIGS. 4, 5A and 5B schematically show the expanded state of the second stent graft 20.
  • FIG. 4 and 5A the branch 12 of the first stent graft 10 is indicated by a broken line.
  • the second stent graft 20 has, like the first stent graft 10, a coating 21 and a skeleton 22 and has a tubular shape that defines a blood flow path.
  • the configurations of the coating portion 21 and the skeleton portion 22 are the same as the configurations of the coating portion 111 and the skeleton portion 112 of the first stent graft 10, and thus the detailed description will be omitted.
  • connection end 20a preferably has a tapered shape that increases in diameter toward the open end. Thereby, the adhesion between the first stent graft 10 and the second stent graft 20 can be enhanced.
  • the second stent graft 20 has a locked portion 23 that is locked to the locking portion 13 of the first stent graft 10 at the connection end 20 a.
  • first locked portion 231 the locked portion 23 disposed in the portion overlapping with the branch portion 12
  • second locked portion 232 the locked portion 23 disposed at a portion exposed from the branch portion 12
  • the locked portion 23 is formed of a thin metal wire having a predetermined shape, as with the skeleton 22, and is fixed to the outer peripheral surface of the film portion 21.
  • the first engaged portion 231 extends in the circumferential direction while bending so as to have bending portions 231 a and 231 b in the axial direction of the second stent graft 20.
  • the bending portion 231a on the side farther in the axial direction with respect to the locking portion 13 of the first stent graft 10 is referred to as "first bending portion 231a”.
  • first bending portion 231a the bent portion 231b closer to the axial direction with respect to the locking portion 13 of the first stent graft 10 is referred to as a "second bent portion 231b" .
  • bent portions 231a and 231b in the axial direction means that the portions other than the first bent portion 231a are bent in the axial direction without being separated from the film portion 21 as described later. That is, in a state where a portion other than the first bent portion 231a is separated from the film portion 21, the bent portions 231a and 231b are bent in the direction intersecting the axial direction.
  • the first bent portion 231a is sewn and fixed to the film portion 21 by, for example, a suture thread.
  • the portions other than the first bent portion 231 a of the first engaged portion 231 including the second bent portion 231 b are not fixed to the film portion 21. That is, the first engaged portion 231 is configured such that the second bent portion 231 b is separated from the film portion 21 with the first bent portion 231 a as a fixing point.
  • the second engaged portion 232 has the same configuration as the first engaged portion 231.
  • the attachment form of the second engaged portion 232 to the film portion 21 is opposite to that of the first engaged portion 231.
  • the second engaged portion 232 extends in the circumferential direction while bending so as to have the bent portions 232 a and 232 b in the axial direction of the second stent graft 20.
  • the bending portion 232a on the side far in the axial direction with respect to the locking portion 13 of the first stent graft 10 is referred to as "first bending portion 232a”.
  • first bending portion 232a the bending portion 232b closer to the axial direction with respect to the locking portion 13 of the first stent graft 10
  • second bending portion 232b closer to the axial direction with respect to the locking portion 13 of the first stent graft 10
  • bent portions 232a and 232b in the axial direction means that the portions other than the first bent portion 232a are bent in the axial direction without being separated from the film portion 21 as described later. That is, in a state where a portion other than the first bent portion 232a is separated from the film portion 21, the bent portions 232a and 232b are bent in the direction intersecting the axial direction.
  • the second bent portion 232a is sewn and fixed to the film portion 21 by, for example, a suture thread.
  • the portions other than the first bent portion 232 a of the second engaged portion 232, including the second bent portion 232 b, are not fixed to the film portion 21. That is, the second engaged portion 232 is configured such that the second bent portion 232 b is separated from the film portion 21 with the first bent portion 232 a as a fixing point.
  • FIGS. 7A and 7B are diagrams showing the configuration of a stent graft indwelling system 100 (intravascular indwelling system) for indwelling a stent graft in a blood vessel.
  • the stent graft placement system 100 can be used to place the first stent graft 10 and the second stent graft 20 in a blood vessel.
  • FIG. 7A shows the stent graft indwelling system 100 in a disassembled state.
  • FIG. 7B shows the stent graft indwelling system 100 in an assembled state.
  • the stent graft indwelling system 100 is disposed inside the tubular sheath 101 and the sheath 101, and is configured to be able to advance and retract in the sheath 101 along the axial direction (longitudinal direction) of the sheath 101.
  • An inner rod 102 and a stent graft 103 are provided.
  • the sheath 101 has a tubular sheath body portion 101a and a hub 101b provided on the proximal end side (proximal end side) of the sheath body portion 101a.
  • the hub 101 b is provided with a nut for fixing the inner rod 102 to the sheath 101 or for releasing the fixing.
  • the sheath 101 is formed of a flexible material.
  • a material having flexibility for example, a biocompatible synthetic resin (elastomer) selected from fluorine resin, polyamide resin, polyethylene resin, polyvinyl chloride resin and the like, and other materials for these resins Resin composites, multilayer structures of these synthetic resins, and composites of these synthetic resins and metal wires.
  • the inner rod 102 has a rod-like rod body 102a, a holding portion 102b for holding the stent graft 103 in a contracted state, and a tip 102c provided at the tip (distal end) of the inner rod 102. .
  • the holder 102 b is set to have a diameter smaller than that of the rod body 102 a by, for example, the thickness of the stent graft 103.
  • various materials which have moderate hardness and pliability such as resin (plastic, elastomer) or metal, are mentioned, for example.
  • resin plastic, elastomer
  • tip tip 102c various materials which have moderate hardness and pliability, such as synthetic resin (elastomer) chosen from polyamide system resin, polyurethane system resin, polyvinyl chloride system resin etc., for example It can be mentioned.
  • a lumen for passing a guide wire and a trigger for expanding the stent graft 103 in a contracted state in the affected area for example, a lumen for passing a guide wire and a trigger for expanding the stent graft 103 in a contracted state in the affected area.
  • a lumen or the like for passing a wire is formed along the axial direction of the inner rod 102.
  • connection structure (the intravascular indwelling device connection structure) of the stent graft set 1 includes the first stent graft 10 (the first intravascular indwelling device) and the second stent graft 20 (the second intravascular indwelling device). And intravascular detaining tools).
  • the first stent graft 10 and the second stent graft 20 have a tubular shape.
  • the first stent graft 10 has a locking portion 13 protruding in the radial direction of the branch portion 12 at the branch portion 12 (a connection portion with the second stent graft 20).
  • the second stent graft 20 has a film portion 21 and a locked portion 23 disposed on the outer peripheral surface of the film portion 21.
  • the locked portion 23 extends in the circumferential direction while bending so as to have bending portions 231 a, 231 b, 232 a and 232 b in the axial direction of the second stent graft 20.
  • the bent portions 231a, 231b, 232a, and 232b are axially distant from the locking portion 13 in a state where the second stent graft 20 is inserted into and connected to the branch portion 12 of the first stent graft 10.
  • the first bent portions 231 a and 232 a are fixed to the film portion 21, and the second bent portions 231 b and 232 b can be locked to the locking portion 13.
  • the stent graft indwelling system 100 (intravascular placement system) according to the embodiment includes a stent graft 103 (intravascular placement tool) which is indwelled in a blood vessel.
  • the stent graft 103 includes a first stent graft 10 (first endovascular indwelling device) and a second stent graft 20 (second endovascular indwelling device) connected in a blood vessel.
  • the first stent graft 10 and the second stent graft 20 have a tubular shape.
  • the first stent graft 10 has a locking portion 13 protruding in the radial direction of the branch portion 12 at the branch portion 12 (a connection portion with the second stent graft 20).
  • the second stent graft 20 has a film portion 21 and a locked portion 23 disposed on the outer peripheral surface of the film portion 21.
  • the locked portion 23 extends in the circumferential direction while bending so as to have bending portions 231 a, 231 b, 232 a and 232 b in the axial direction of the second stent graft 20.
  • the bent portions 231a, 231b, 232a, and 232b are axially distant from the locking portion 13 in a state where the second stent graft 20 is inserted into and connected to the branch portion 12 of the first stent graft 10. It has a first bent portion 231 a, 232 a and a second bent portion 231 b, 232 b closer to the locking portion 13 in the axial direction.
  • the first bent portions 231 a and 232 a are fixed to the film portion 21, and the second bent portions 231 b and 232 b can be locked to the locking portion 13.
  • connection structure of the stent graft set 1 and the stent graft indwelling system 100 According to the connection structure of the stent graft set 1 and the stent graft indwelling system 100 according to the present embodiment, the positional deviation of the second stent graft 20 at the time of connecting and indwelling the first stent graft 10 and the second stent graft 20 is prevented. It is possible to maintain a good connection state. Therefore, since the endoleak from the connection part of the 1st stent graft 10 and the 2nd stent graft 20 can be prevented, highly reliable stent graft indwelling is attained.
  • the present invention is not limited to the above-mentioned embodiment, and can be changed in the range which does not deviate from the gist.
  • the branch portion 12 of the first stent graft 10 may have a form in which an opening is provided in the tube wall of the graft body 11.
  • the first locking portion 131 is provided on the inner peripheral edge of the opening, and the opening edge of the graft body 11 becomes the second locking portion 132.
  • the branch portion 12 may be configured as a separate member from the graft body 11 and may be formed by being joined to the graft body 11.
  • the branch 12 may be formed of the same material as the coating 111 of the graft body 11 or may be formed of a different material.
  • first engaged portion 231 and the second engaged portion 232 are provided as the engaged portions 23 .
  • first engaged portions 231 and the second engaged portions 232 are described. Only one of the engaged portions 232 may be provided.
  • first locked portion 231 is provided, the second stent graft 20 can not be inhibited from entering the branch 12, but the advancement of the second stent graft 20 from the branch 12 is inhibited and the branch blood vessel V2 is formed. Position adjustment can be performed.
  • the present invention connects a plurality of stent grafts to the main blood vessels.
  • indwelling that is, as shown in FIGS. 8A and 8B
  • the first stent graft 10 and the second stent graft 20 can be applied to the stent graft set 1 in which both the first stent graft 10 and the second stent graft 20 are indwelled in the main blood vessel.
  • the axial end 10 a of the first stent graft 10 is the connection portion
  • the axial end 20 a of the second stent graft 20 is the connection end.
  • FIG. 8A the axial end 10 a of the first stent graft 10 and the axial end 20 a of the second stent graft 20 are schematically shown.
  • the middle stent graft except for both ends becomes the second stent graft for the first placed stent graft, and for the second placed stent graft. Is the first stent graft.
  • the locking portion of the first stent graft may not be an annular shape along the circumferential direction of the open end, and may be intermittently disposed along the circumferential direction of the open end, for example. It may have a shape (eg, a U-shape) in which a portion between the two is missing.
  • the skeletons of the first stent graft and the second stent graft may be formed of a material other than metal (for example, ceramic, resin, etc.). The same applies to the locked portion of the second stent graft. Also, the first and second stent-grafts may be balloon-expandable rather than self-expanding.
  • a stent graft is described as an example of an intravascular indwelling device, but the present invention is also applied to the case of connecting other intravascular indwelling devices such as artificial blood vessels (grafts), for example. can do.
  • grafts artificial blood vessels
  • Stent-graft set 10 First stent-graft (first intravascular placement device) 11: graft body 111: coating portion 112: skeletal portion 12: branching portion 13: locking portion 131: first locking portion 132: second locking portion 20: second stent graft (second intravascular indwelling device) Reference Signs List 21 film portion 22 skeleton portion 23 locked portion 231 first locked portion 232 second locked portion 231a, 232a first bent portion 231b, 232b second bent portion 100 stent graft indwelling system (within blood vessel Detention system)

Abstract

The present invention prevents mispositioning of a stent graft when a plurality of stent grafts are connected and made to indwell. An intravascular indwelling instrument connecting structure (connecting structure of a stent graft set 1), wherein a first intravascular indwelling instrument (first stent graft 10) has, at a connecting section (branch section 12) connecting with a second intravascular indwelling instrument (second stent graft 20), a locking section (13) that protrudes in a radial direction of the connecting section, and the second intravascular indwelling instrument has a lockable section (23) that is positioned on an outer circumferential surface of a film section (21). The lockable section extends in a circumferential direction while bending so as to have bent sections (231a, 231b, 232a, 232b) in an axial direction of the second intravascular indwelling instrument, and the bent sections have first bent sections (231a, 232a) that are on the side farther from the locking section in the axial direction, and second bent sections (231b, 232b) that are on the side closer to the locking section in the axial direction. The first bent sections are fixed to the film section, and the second bent sections can lock to the locking section.

Description

血管内留置具接続構造及び血管内留置システムIntravascular indwelling device connection structure and intravascular indwelling system
　本発明は、血管内留置具接続構造及び血管内留置システムに関する。 The present invention relates to an intravascular indwelling device connection structure and an intravascular indwelling system.
　従来、大動脈に生じた大動脈瘤及び大動脈解離などの治療に用いられる血管内留置具として、人工血管（グラフト）の周面にステントと呼ばれる骨格部を配置したステントグラフトが知られている（例えば、特許文献１参照）。 Conventionally, a stent graft in which a skeleton called a stent is disposed on the peripheral surface of an artificial blood vessel (graft) is known as an endovascular indwelling device used for treatment of aortic aneurysm and aortic dissection generated in the aorta (for example, patent Reference 1).
　ところで、ステントグラフト留置術においては、病変部位の状態によって複数のステントグラフトを接続することがある。例えば、大動脈における病変部位に対してステントグラフトを留置させる場合、治療長（病変部位の長さ＋中枢側及び末梢側のネック長）に応じてステント長が選択されるが、一つのステントグラフトで治療長をカバーできない場合は、複数のステントグラフトを接続する必要がある。また例えば、大動脈におけるステントグラフトの留置領域に分枝血管がある場合、分枝血管への血流を確保するために、主血管用ステントグラフトに分枝血管用ステントグラフトを接続する必要がある。以下において、血管に先に留置されるステントグラフトを「第１のステントグラフト」、後から留置されるステントグラフトを「第２のステントグラフト」と称する。 By the way, in stent graft indwelling, a plurality of stent grafts may be connected depending on the state of a lesion site. For example, when a stent graft is placed at a lesion site in the aorta, the stent length is selected according to the treatment length (length of lesion site + central and peripheral neck lengths), but one stent graft has a treatment length If it can not cover, it is necessary to connect multiple stent grafts. Also, for example, when there are branch vessels in the stent graft placement area in the aorta, it is necessary to connect the branch stent graft to the main vessel stent graft in order to ensure blood flow to the branch vessels. Hereinafter, a stent-graft deployed first in a blood vessel is referred to as a "first stent-graft", and a stent-graft deployed later is referred to as a "second stent-graft".
特表２００９－５４０９３０号公報Japanese Patent Application Publication No. 2009-540930
　通常、第１のステントグラフトの接続部分に、前記接続部分の内径と同等以上の直径を有する第２のステントグラフトを収縮状態で内挿して拡張させ、第２のステントグラフトと第１のステントグラフトの重複部分を密着させることにより、第１のステントグラフトに対して第２のステントグラフトが接続される。この場合、重複部分における第２のステントグラフトの拡張力によって接続状態が保持される。 Usually, a second stent graft having a diameter equal to or larger than the inner diameter of the first stent graft is inserted in a contracted state and expanded at the junction of the first stent graft, and the overlapping portion of the second stent graft and the first stent graft is The close contact connects the second stent graft to the first stent graft. In this case, the expansion force of the second stent graft at the overlapping portion holds the connected state.
　しかしながら、第２のステントグラフトの拡張力だけで接続状態を保持しようとすると、過剰な外力によって軸方向に第２のステントグラフトが位置ずれする虞があり、接続部分からのエンドリークの発生要因となり得る。 However, if it is attempted to maintain the connected state only by the expansion force of the second stent graft, there is a risk that the second stent graft may be displaced in the axial direction due to excessive external force, which may cause an endoleak from the connected portion.
　本発明の目的は、複数のステントグラフトを接続して留置させる際のステントグラフトの位置ずれを防止でき、良好な接続状態を維持できる血管内留置具接続構造及び血管内留置システムを提供することである。 An object of the present invention is to provide an intravascular indwelling device connection structure and an intravascular indwelling system capable of preventing positional deviation of a stent graft at the time of connecting and indwelling a plurality of stent grafts and maintaining a good connection state.
　本発明の一態様に係る血管内留置具接続構造は、
　血管内に留置される複数の血管内留置具を接続する血管内留置具接続構造であって、
　前記複数の血管内留置具は、第１の血管内留置具と、前記第１の血管内留置具に内挿して接続される第２の血管内留置具と、を含み、
　前記第１及び第２の血管内留置具は、管形状を有し、
　前記第１の血管内留置具は、前記第２の血管内留置具との接続部分に、当該接続部分の径方向に突出する係止部を有し、
　前記第２の血管内留置具は、皮膜部と、皮膜部の外周面に配置される被係止部と、を有し、
　前記被係止部は、前記第２の血管内留置具の軸方向に屈曲部を有するように屈曲しながら周方向に延在してなり、
　前記屈曲部は、前記第１の血管内留置具の接続部分に前記第２の血管内留置具が内挿され接続された状態において、前記係止部に対して軸方向に遠い側の第１の屈曲部と、前記係止部に対して軸方向に近い側の第２の屈曲部を有し、
　前記第１の屈曲部は、前記皮膜部に固定され、
　前記第２の屈曲部は、前記係止部に係止可能となっていることを特徴とする。 An intravascular indwelling device connection structure according to an aspect of the present invention is
An intravascular indwelling device connection structure for connecting a plurality of intravascular indwelling devices deployed in a blood vessel, comprising:
The plurality of intravascular indwelling devices include: a first intravascular indwelling device; and a second intravascular indwelling device intercalated and connected to the first intravascular indwelling device;
The first and second intravascular indwelling devices have a tubular shape, and
The first intravascular indwelling device has a locking portion projecting in the radial direction of the connecting portion at a connecting portion with the second intravascular indwelling device,
The second intravascular indwelling device has a film portion and a locked portion disposed on the outer peripheral surface of the film portion,
The to-be-locked portion extends in the circumferential direction while bending so as to have a bending portion in the axial direction of the second intravascular indwelling device,
In the state where the second indwelling device is inserted and connected to the connection portion of the first indwelling device, the bending portion is the first on the far side in the axial direction with respect to the locking portion. A second bent portion close to the locking portion in the axial direction,
The first bent portion is fixed to the film portion,
The second bent portion is characterized in that it can be locked to the locking portion.
　本発明の一態様に係る血管内留置システムは、
　血管内に留置される血管内留置具を備える血管内留置システムであって、
　前記血管内留置具は、血管内にて接続される第１及び第２の血管内留置具を含み、
　前記第１及び第２の血管内留置具は、管形状を有し、
　前記第１の血管内留置具は、前記第２の血管内留置具との接続部分に、当該接続部分の径方向に突出する係止部を有し、
　前記第２の血管内留置具は、皮膜部と、皮膜部の外周面に配置される被係止部と、を有し、
　前記被係止部は、前記第２の血管内留置具の軸方向に屈曲部を有するように屈曲しながら周方向に延在してなり、
　前記屈曲部は、前記第１の血管内留置具の接続部分に前記第２の血管内留置具が内挿され接続された状態において、前記係止部に対して軸方向に遠い側の第１の屈曲部と、前記係止部に対して軸方向に近い側の第２の屈曲部を有し、
　前記第１の屈曲部は、前記皮膜部に固定され、
　前記第２の屈曲部は、前記係止部に係止可能となっていることを特徴とする。 An intravascular placement system according to one aspect of the present invention is
An intravascular placement system comprising an intravascular placement device placed within a blood vessel, comprising:
The intravascular indwelling device includes first and second intravascular indwelling devices connected in blood vessels,
The first and second intravascular indwelling devices have a tubular shape, and
The first intravascular indwelling device has a locking portion projecting in the radial direction of the connecting portion at a connecting portion with the second intravascular indwelling device,
The second intravascular indwelling device has a film portion and a locked portion disposed on the outer peripheral surface of the film portion,
The to-be-locked portion extends in the circumferential direction while bending so as to have a bending portion in the axial direction of the second intravascular indwelling device,
In the state where the second indwelling device is inserted and connected to the connection portion of the first indwelling device, the bending portion is the first on the far side in the axial direction with respect to the locking portion. A second bent portion close to the locking portion in the axial direction,
The first bent portion is fixed to the film portion,
The second bent portion is characterized in that it can be locked to the locking portion.
　本発明によれば、複数のステントグラフトを接続して留置させる際のステントグラフトの位置ずれを防止でき、良好な接続状態を維持することができる。 According to the present invention, it is possible to prevent positional deviation of the stent grafts when connecting and placing a plurality of stent grafts, and maintain a good connection state.
図１は、本発明の一実施の形態に係るステントグラフトセットを示す図である。FIG. 1 is a view showing a stent graft set according to an embodiment of the present invention. 図２Ａ、図２Ｂは、ステントグラフトセットを血管内に留置させた状態を示す図である。FIGS. 2A and 2B show the stent graft set indwelling in a blood vessel. 図３Ａ～図３Ｃは、第１のステントグラフトの構成を示す図である。3A to 3C show the configuration of the first stent graft. 図４は、第２のステントグラフトの構成を示す図である。FIG. 4 is a view showing the configuration of a second stent graft. 図５Ａ、図５Ｂは、第２のステントグラフトの接続側端部の構成を示す図である。5A and 5B are diagrams showing the configuration of the connection end of the second stent graft. 図６Ａ、図６Ｂは、第１のステントグラフトと第２のステントグラフトの係止状態を示す図である。6A and 6B are diagrams showing a locked state of the first stent graft and the second stent graft. 図７Ａ、図７Ｂは、ステントグラフトを血管内に留置させるためのステントグラフト留置システム（血管内留置システム）の構成を示す図である。7A and 7B are diagrams showing the configuration of a stent graft indwelling system (intravascular indwelling system) for indwelling a stent graft into a blood vessel. 図８Ａ、図８Ｂは、ステントグラフトセットの他の一例を示す図である。8A and 8B show another example of a stent graft set.
　以下、本発明の実施の形態を、図面を参照して詳細に説明する。 Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
　図１は、本発明の一実施の形態に係るステントグラフトセット１を示す図である。図２Ａ、図２Ｂは、ステントグラフトセット１を血管内に留置させた状態を示す図である。本実施の形態では、血管内留置具として、ステントグラフト１０、２０を接続して、血管内に留置させる場合について説明する。ステントグラフト１０が、本発明における「第１の血管内留置具」に相当し、ステントグラフト２０が、本発明における「第２の血管内留置具」に相当する。すなわち、ステントグラフトセット１に、本発明に係る血管留置具接続構造が適用されている。 FIG. 1 is a view showing a stent graft set 1 according to an embodiment of the present invention. 2A and 2B show the stent graft set 1 indwelled in a blood vessel. In the present embodiment, as the intravascular indwelling device, a case where stent grafts 10 and 20 are connected and indwelled in a blood vessel will be described. The stent graft 10 corresponds to the "first intravascular indwelling device" in the present invention, and the stent graft 20 corresponds to the "second intravascular indwelling device" in the present invention. That is, the blood vessel indwelling device connection structure according to the present invention is applied to the stent graft set 1.
　図１、図２Ａ及び図２Ｂに示すように、ステントグラフトセット１は、主血管である大動脈Ｖ１の病変部位（例えば、大動脈瘤等が生じている部位）に留置される主血管用のステントグラフト１０（以下、「第１のステントグラフト１０」と称する）と、病変部位の近傍において大動脈Ｖ１から分枝する分枝血管Ｖ２に留置される分枝血管用のステントグラフト２０（以下、「第２のステントグラフト２０」と称する）と、で構成される。第２のステントグラフト２０の拡張状態における外径は、第１のステントグラフト１０の分枝部１２の内径と同等以上である。 As shown in FIG. 1, FIG. 2A and FIG. 2B, the stent graft set 1 is a stent graft 10 for the main blood vessel indwelled in the lesion site of the aorta V1 which is the main blood vessel (for example, Hereinafter, “a first stent graft 10”) and a stent graft 20 for a branched blood vessel deployed in a branched blood vessel V2 branching from an aorta V1 in the vicinity of a lesion site (hereinafter “a second stent graft 20”) And so forth). The outer diameter of the second stent graft 20 in the expanded state is equal to or larger than the inner diameter of the branch 12 of the first stent graft 10.
　ステントグラフトセット１を血管内に留置する場合、まず、第１のステントグラフト１０を収縮状態で病変部位まで移送し、拡張させることにより大動脈Ｖ１に留置する（図２Ａ参照）。その後、第２のステントグラフト２０を収縮状態で分枝部１２に内挿して所定長が重複するように位置決めし、拡張させることにより分枝血管Ｖ２に留置する（図２Ｂ参照）。これにより、重複部分において、第１のステントグラフト１０（分枝部１２）の内周面と第２のステントグラフト２０の外周面が密着し、第１のステントグラフト１０（分枝部１２）と第２のステントグラフト２０が接続される。なお、第２のステントグラフト２０は、第１のステントグラフト１０の内部を通って移送され分枝部１２に内挿されてもよいし、分枝血管Ｖ２を通って移送され分枝部１２に内挿されてもよい。 When the stent graft set 1 is indwelled in a blood vessel, first, the first stent graft 10 is delivered to the lesion site in a contracted state and expanded into the aorta V1 by expanding (see FIG. 2A). Thereafter, the second stent graft 20 is inserted into the branch portion 12 in a contracted state, positioned so as to overlap a predetermined length, and expanded to be indwelled in the branch blood vessel V2 (see FIG. 2B). As a result, the inner peripheral surface of the first stent graft 10 (branch portion 12) and the outer peripheral surface of the second stent graft 20 are in close contact with each other in the overlapping portion, and the first stent graft 10 (branch portion 12) and the second The stent graft 20 is connected. The second stent graft 20 may be transported through the inside of the first stent graft 10 and inserted into the branch 12 or may be transported through the branch blood vessel V2 and inserted into the branch 12. It may be done.
　図３Ａ～図３Ｃは、第１のステントグラフト１０の構成を示す図である。図３Ａは、第１のステントグラフト１０の斜視図である。図３Ｂは、第１のステントグラフト１０を分枝部１２側からみた平面図である。図３Ｃは、図３Ｂにおける分枝部１２のＡ－Ａ断面図である。図３Ａ～図３Ｃでは、第１のステントグラフト１０の拡張状態を模式的に示している。 3A to 3C show the configuration of the first stent graft 10. As shown in FIG. FIG. 3A is a perspective view of the first stent graft 10. FIG. 3B is a plan view of the first stent graft 10 as viewed from the branch 12 side. FIG. 3C is a cross-sectional view of the branch 12 taken along line AA in FIG. 3B. FIGS. 3A to 3C schematically show the expanded state of the first stent graft 10.
　図３Ａ～図３Ｃに示すように、第１のステントグラフト１０は、両端に開口を有する管状のグラフト本体１１と、グラフト本体１１の管壁に設けられた分枝部１２と、を有する。 As shown in FIGS. 3A to 3C, the first stent graft 10 has a tubular graft body 11 having openings at both ends, and a branch portion 12 provided on a tube wall of the graft body 11.
　グラフト本体１１は、血液の流路を画成する管形状を有する。本実施の形態では、グラフト本体１１が直管形状を有している場合を示しているが、グラフト本体１１は、留置部位に応じて湾曲した形状（例えば、患者の大動脈弓の形状に対応した形状）を有していてもよいし、留置後に血管形状に沿った湾曲形状を有することになってもよい。 The graft body 11 has a tubular shape that defines a blood flow path. In the present embodiment, the case where the graft body 11 has a straight pipe shape is shown, but the graft body 11 has a curved shape (for example, corresponding to the shape of the aortic arch of the patient) according to the indwelling site It may have a shape or may have a curved shape along the shape of the blood vessel after indwelling.
　グラフト本体１１は、皮膜部１１１及び骨格部１１２を有する。骨格部１１２は、皮膜部１１１の周面に、例えば、縫合糸により縫い付けて固定される。なお、骨格部１１２は、テープによる貼着、接着又は溶着等、縫合以外の方法で皮膜部１１１に固定されてもよい。 The graft body 11 has a coating 111 and a skeleton 112. The skeleton 112 is sewed and fixed to the circumferential surface of the coating 111 by, for example, a suture thread. The skeleton 112 may be fixed to the film 111 by a method other than suturing, such as adhesion with tape, adhesion or welding.
　皮膜部１１１は、血液の流路となるグラフト部である。皮膜部１１１を形成する材料としては、例えば、ＰＴＦＥ（ポリテトラフルオロエチレン）等のフッ素樹脂、ポリエチレンテレフタレート等のポリエステル樹脂等が挙げられる。 The film part 111 is a graft part which becomes a flow path of blood. Examples of the material for forming the film portion 111 include fluorine resins such as PTFE (polytetrafluoroethylene) and polyester resins such as polyethylene terephthalate.
　骨格部１１２は、皮膜部１１１の周面に固定され、皮膜部１１１を所定の拡張状態で保持する補強部材である。骨格部１１２は、例えば、金属細線が軸方向にジグザグ状に折り返されながら、皮膜部１１１の周面に沿って管状に形成された自己拡張型のステント骨格である。 The frame portion 112 is a reinforcing member which is fixed to the circumferential surface of the film portion 111 and holds the film portion 111 in a predetermined expanded state. The skeleton 112 is, for example, a self-expanding stent skeleton formed in a tubular shape along the circumferential surface of the coating 111 while the thin metal wires are folded in a zigzag in the axial direction.
　骨格部１１２は、径方向内側に収縮した収縮状態から、径方向外側に拡張して管状流路を画成する拡張状態へと変形可能に構成される。骨格部１１２を形成する金属細線の材料としては、例えば、ステンレス鋼、Ｎｉ－Ｔｉ合金、チタン合金等に代表される公知の金属又は金属合金が挙げられる。 The skeleton portion 112 is configured to be deformable from a contracted state that is contracted radially inward to an expanded state that is expanded radially outward to define a tubular flow channel. Examples of the material of the metal fine wire forming the skeleton 112 include known metals or metal alloys represented by stainless steel, Ni—Ti alloy, titanium alloy and the like.
　グラフト本体１１は、拡張状態において、外周面の一部が径方向内側に窪んだ凹部１１ａを有する。凹部１１ａは、平坦な底面を有し、底面の略中央に分枝部１２が配置されている。 In the expanded state, the graft body 11 has a recess 11 a in which a part of the outer peripheral surface is recessed radially inward. The recess 11 a has a flat bottom, and the branch 12 is disposed substantially at the center of the bottom.
　分枝部１２は、グラフト本体１１の管壁（凹部１１ａの底面）からグラフト本体１１の径方向外側に向けて突出して形成される。分枝部１２は、グラフト本体１１の内腔に連通する貫通孔１２ａを有する。分枝部１２の貫通孔１２ａに第２のステントグラフト２０が内挿され、接続される。なお、分枝部１２は、グラフト本体１１の管壁に複数設けられてもよい。 The branch portion 12 is formed to project radially outward of the graft body 11 from the tube wall of the graft body 11 (the bottom surface of the recess 11 a). The branch portion 12 has a through hole 12 a communicating with the lumen of the graft body 11. The second stent graft 20 is inserted into and connected to the through hole 12 a of the branch 12. Note that a plurality of branch portions 12 may be provided on the tube wall of the graft body 11.
　分枝部１２は、貫通孔１２ａの開口端部に向けて縮径するテーパー形状を有することが好ましい。これにより、第１のステントグラフト１０と第２のステントグラフト２０の密着性を高めることができる。 The branch portion 12 preferably has a tapered shape that reduces in diameter toward the opening end of the through hole 12a. Thereby, the adhesion between the first stent graft 10 and the second stent graft 20 can be enhanced.
　分枝部１２には、骨格部１１２が配置されていない。また、分枝部１２は、グラフト本体１１の皮膜部１１１と同じ材料で、グラフト本体１１と一体的に形成されている。これにより、分枝部１２は、例えば、主血管Ｖ１から分枝血管Ｖ２への血流によって開口する向きが変形可能な程度の柔軟性を有する。 The skeleton portion 112 is not disposed in the branch portion 12. Further, the branch portion 12 is made of the same material as the film portion 111 of the graft body 11 and is integrally formed with the graft body 11. Thereby, for example, the branch part 12 has a flexibility such that the opening direction can be deformed by the blood flow from the main blood vessel V1 to the branch blood vessel V2.
　本実施の形態では、分枝部１２は、貫通孔１２ａの開口端部において、径方向に突出する係止部１３を有する。以下において、径方向内側に突出する係止部１３を「第１の係止部１３１」、径方向外側に突出する係止部１３を「第２の係止部１３２」と称する。なお、係止部１３は、第２のステントグラフト２０との重複部分であれば、開口端部の先端ではなく、先端近傍に配置されてもよい。 In the present embodiment, the branch portion 12 has the locking portion 13 protruding in the radial direction at the open end of the through hole 12a. Hereinafter, the locking portion 13 projecting radially inward will be referred to as the “first locking portion 131”, and the locking portion 13 projecting radially outward will be referred to as the “second locking portion 132”. The locking portion 13 may be disposed in the vicinity of the distal end of the open end instead of the distal end of the open end, as long as the locking portion 13 overlaps with the second stent graft 20.
　係止部１３は、例えば、分枝部１２の開口端部に環状部材を取り付けることにより形成される。環状部材は、例えば、シリコーンゴム等の高弾性材料で形成され、熱溶着、超音波溶着、圧着、接着、縫合等により、分枝部１２の開口端部に固定される。なお、環状部材は、シリコーン以外のゴム材料で形成してもよいし、ゴム以外の材料（例えば、金属等）で形成してもよい。また、ゴム等を主材料とし、副材料として硫酸バリウム等の放射線不透過物質を添加してもよい。 The locking portion 13 is formed, for example, by attaching an annular member to the open end of the branch portion 12. The annular member is formed of, for example, a high elastic material such as silicone rubber, and is fixed to the open end of the branch 12 by heat welding, ultrasonic welding, pressure bonding, adhesion, suturing or the like. The annular member may be formed of a rubber material other than silicone, or may be formed of a material other than rubber (for example, a metal or the like). Further, a rubber or the like may be used as a main material, and a radiopaque substance such as barium sulfate may be added as an auxiliary material.
　係止部１３は、第１のステントグラフト１０に第２のステントグラフト２０を接続したときに、第２のステントグラフト２０の位置ずれを防止する機能を有する。具体的には、係止部１３は、第２のステントグラフト２０の被係止部２３（図４参照）を係止することにより、第２のステントグラフト２０の軸方向への移動を規制する。なお、本実施の形態では、第１の係止部１３１及び第２の係止部１３２を設けているが、何れか一方を設けるようにしてもよい。 The locking portion 13 has a function of preventing displacement of the second stent graft 20 when the second stent graft 20 is connected to the first stent graft 10. Specifically, the locking portion 13 regulates the movement of the second stent graft 20 in the axial direction by locking the locked portion 23 (see FIG. 4) of the second stent graft 20. Although the first locking portion 131 and the second locking portion 132 are provided in the present embodiment, either one may be provided.
　また、係止部１３は、グラフト本体１１を拡張させた状態において、貫通孔１２ａの開口状態を維持する機能、具体的には、貫通孔１２ａの開口が閉じないように貫通孔１２ａの開口寸法を所定の寸法以上に維持する機能も有する。これにより、分枝部１２に第２のステントグラフト２０を取り付ける際の挿入性が向上する。また、第２のステントグラフト２０を拡張させたときに、環状部材の弾性により、第２のステントグラフト２０に対して径方向内側に力が作用するので、分枝部１２と第２のステントグラフト２０との密着性を高めることができる。なお、係止部１３は、貫通孔１２ａの開口状態を維持する機能や、第２のステントグラフト２０に向けて付勢する機能を有していなくてもよい。 In addition, the locking portion 13 has a function of maintaining the open state of the through hole 12a in a state in which the graft body 11 is expanded, specifically, the opening dimension of the through hole 12a so that the opening of the through hole 12a is not closed. It also has a function of maintaining the above-mentioned predetermined dimension or more. Thereby, the insertability at the time of attaching the 2nd stent graft 20 to branch part 12 improves. In addition, when the second stent graft 20 is expanded, a force acts radially inward on the second stent graft 20 due to the elasticity of the annular member, so that the branch 12 and the second stent graft 20 Adhesion can be improved. The locking portion 13 may not have the function of maintaining the open state of the through hole 12 a or the function of biasing the second stent graft 20.
　図４は、第２のステントグラフト２０の構成を示す図である。図５Ａ、図５Ｂは、第２のステントグラフト２０の第１のステントグラフト１０に接続される側の端部２０ａ（以下、「接続側端部２０ａ」と称する）を示す図である。図５Ａは、接続側端部２０ａの拡大図である。図５Ｂは、接続側端部２０ａの断面図である。図４、図５Ａ及び図５Ｂでは、第２のステントグラフト２０の拡張状態を模式的に示している。また、図４及び図５Ａでは、第１のステントグラフト１０の分枝部１２を破線で示している。 FIG. 4 is a view showing the configuration of the second stent graft 20. As shown in FIG. 5A and 5B are views showing an end 20a of the second stent graft 20 to be connected to the first stent graft 10 (hereinafter, referred to as "connection end 20a"). FIG. 5A is an enlarged view of the connection end 20a. FIG. 5B is a cross-sectional view of the connection side end 20a. FIGS. 4, 5A and 5B schematically show the expanded state of the second stent graft 20. FIG. 4 and 5A, the branch 12 of the first stent graft 10 is indicated by a broken line.
　図４に示すように、第２のステントグラフト２０は、第１のステントグラフト１０と同様に、皮膜部２１及び骨格部２２を有し、血液の流路を画成する管形状を有する。皮膜部２１及び骨格部２２の構成は、第１のステントグラフト１０の皮膜部１１１及び骨格部１１２の構成と同様であるので、詳細な説明を省略する。 As shown in FIG. 4, the second stent graft 20 has, like the first stent graft 10, a coating 21 and a skeleton 22 and has a tubular shape that defines a blood flow path. The configurations of the coating portion 21 and the skeleton portion 22 are the same as the configurations of the coating portion 111 and the skeleton portion 112 of the first stent graft 10, and thus the detailed description will be omitted.
　第２のステントグラフト２０において、接続側端部２０ａは、開口端部に向けて拡径するテーパー形状を有することが好ましい。これにより、第１のステントグラフト１０と第２のステントグラフト２０の密着性を高めることができる。 In the second stent graft 20, the connection end 20a preferably has a tapered shape that increases in diameter toward the open end. Thereby, the adhesion between the first stent graft 10 and the second stent graft 20 can be enhanced.
　さらに、第２のステントグラフト２０は、接続側端部２０ａに、第１のステントグラフト１０の係止部１３に係止される被係止部２３を有する。以下において、第１のステントグラフト１０と第２のステントグラフト２０を接続したときに、分枝部１２と重複する部分に配置されている被係止部２３を「第１の被係止部２３１」と称する。また、第１のステントグラフト１０と第２のステントグラフト２０を接続したときに、分枝部１２から露出する部分に配置されている被係止部２３を「第２の被係止部２３２」と称する。 Furthermore, the second stent graft 20 has a locked portion 23 that is locked to the locking portion 13 of the first stent graft 10 at the connection end 20 a. In the following, when the first stent graft 10 and the second stent graft 20 are connected, the locked portion 23 disposed in the portion overlapping with the branch portion 12 is referred to as “first locked portion 231”. It is called. Further, when the first stent graft 10 and the second stent graft 20 are connected, the locked portion 23 disposed at a portion exposed from the branch portion 12 is referred to as a "second locked portion 232". .
　本実施の形態では、被係止部２３は、骨格部２２と同様に、所定形状を有する金属細線で形成され、皮膜部２１の外周面に固定されている。 In the present embodiment, the locked portion 23 is formed of a thin metal wire having a predetermined shape, as with the skeleton 22, and is fixed to the outer peripheral surface of the film portion 21.
　具体的には、第１の被係止部２３１は、第２のステントグラフト２０の軸方向に屈曲部２３１ａ、２３１ｂを有するように屈曲しながら周方向に延在する。第１のステントグラフト１０に第２のステントグラフト２０を接続したときに、第１のステントグラフト１０の係止部１３に対して軸方向に遠い側の屈曲部２３１ａを「第１の屈曲部２３１ａ」と称する。第１のステントグラフト１０に第２のステントグラフト２０を接続したときに、第１のステントグラフト１０の係止部１３に対して軸方向に近い側の屈曲部２３１ｂを「第２の屈曲部２３１ｂ」と称する。 Specifically, the first engaged portion 231 extends in the circumferential direction while bending so as to have bending portions 231 a and 231 b in the axial direction of the second stent graft 20. When the second stent graft 20 is connected to the first stent graft 10, the bending portion 231a on the side farther in the axial direction with respect to the locking portion 13 of the first stent graft 10 is referred to as "first bending portion 231a". . When the second stent graft 20 is connected to the first stent graft 10, the bent portion 231b closer to the axial direction with respect to the locking portion 13 of the first stent graft 10 is referred to as a "second bent portion 231b" .
　なお、軸方向に屈曲部２３１ａ、２３１ｂを有するとは、後述するように、第１の屈曲部２３１ａ以外の部分が皮膜部２１から離間していない状態で軸方向に屈曲していることを言う。すなわち、第１の屈曲部２３１ａ以外の部分が皮膜部２１から離間した状態では、屈曲部２３１ａ、２３１ｂは、軸方向と交わる方向に屈曲した形態をなす。 Note that having the bent portions 231a and 231b in the axial direction means that the portions other than the first bent portion 231a are bent in the axial direction without being separated from the film portion 21 as described later. . That is, in a state where a portion other than the first bent portion 231a is separated from the film portion 21, the bent portions 231a and 231b are bent in the direction intersecting the axial direction.
　第１の屈曲部２３１ａは、皮膜部２１に、例えば、縫合糸により縫い付けて固定される。一方、第２の屈曲部２３１ｂを含めて、第１の被係止部２３１の第１の屈曲部２３１ａ以外の部分は、皮膜部２１に固定されていない。すなわち、第１の被係止部２３１は、第１の屈曲部２３１ａを固定点として、第２の屈曲部２３１ｂが皮膜部２１から離間するように構成されている。第１のステントグラフト１０と第２のステントグラフト２０を接続した状態において、第２のステントグラフト２０に対して過剰な外力が作用し、第２のステントグラフト２０が分枝部１２から進出する方向に移動しようとしても、第１の被係止部２３１の第２の屈曲部２３１ｂが第１のステントグラフト１０の第１の係止部１３１に引っ掛かるので、位置ずれを許容範囲内に抑制することができる（図６Ａ参照）。 The first bent portion 231a is sewn and fixed to the film portion 21 by, for example, a suture thread. On the other hand, the portions other than the first bent portion 231 a of the first engaged portion 231 including the second bent portion 231 b are not fixed to the film portion 21. That is, the first engaged portion 231 is configured such that the second bent portion 231 b is separated from the film portion 21 with the first bent portion 231 a as a fixing point. In a state in which the first stent graft 10 and the second stent graft 20 are connected, an excessive external force acts on the second stent graft 20 so that the second stent graft 20 moves in the direction of advancing from the branch 12 Also, since the second bent portion 231b of the first engaged portion 231 is hooked on the first engaging portion 131 of the first stent graft 10, the positional deviation can be suppressed within the allowable range (FIG. 6A). reference).
　第２の被係止部２３２は、第１の被係止部２３１と同様の構成を有する。第２の被係止部２３２は、皮膜部２１に対する取付け形態が、第１の被係止部２３１と逆になっている。 The second engaged portion 232 has the same configuration as the first engaged portion 231. The attachment form of the second engaged portion 232 to the film portion 21 is opposite to that of the first engaged portion 231.
　すなわち、第２の被係止部２３２は、第２のステントグラフト２０の軸方向に屈曲部２３２ａ、２３２ｂを有するように屈曲しながら周方向に延在する。第１のステントグラフト１０に第２のステントグラフト２０を接続したときに、第１のステントグラフト１０の係止部１３に対して軸方向に遠い側の屈曲部２３２ａを「第１の屈曲部２３２ａ」と称する。第１のステントグラフト１０に第２のステントグラフト２０を接続したときに、第１のステントグラフト１０の係止部１３に対して軸方向に近い側の屈曲部２３２ｂを「第２の屈曲部２３２ｂ」と称する。 That is, the second engaged portion 232 extends in the circumferential direction while bending so as to have the bent portions 232 a and 232 b in the axial direction of the second stent graft 20. When the second stent graft 20 is connected to the first stent graft 10, the bending portion 232a on the side far in the axial direction with respect to the locking portion 13 of the first stent graft 10 is referred to as "first bending portion 232a". . When the second stent graft 20 is connected to the first stent graft 10, the bending portion 232b closer to the axial direction with respect to the locking portion 13 of the first stent graft 10 is referred to as a "second bending portion 232b". .
　なお、軸方向に屈曲部２３２ａ、２３２ｂを有するとは、後述するように、第１の屈曲部２３２ａ以外の部分が皮膜部２１から離間していない状態で軸方向に屈曲していることを言う。すなわち、第１の屈曲部２３２ａ以外の部分が皮膜部２１から離間した状態では、屈曲部２３２ａ、２３２ｂは、軸方向と交わる方向に屈曲した形態をなす。 Note that having the bent portions 232a and 232b in the axial direction means that the portions other than the first bent portion 232a are bent in the axial direction without being separated from the film portion 21 as described later. . That is, in a state where a portion other than the first bent portion 232a is separated from the film portion 21, the bent portions 232a and 232b are bent in the direction intersecting the axial direction.
　第２の屈曲部２３２ａは、皮膜部２１に、例えば、縫合糸により縫い付けて固定される。一方、第２の屈曲部２３２ｂを含めて、第２の被係止部２３２の第１の屈曲部２３２ａ以外の部分は、皮膜部２１に固定されていない。すなわち、第２の被係止部２３２は、第１の屈曲部２３２ａを固定点として、第２の屈曲部２３２ｂが皮膜部２１から離間するように構成されている。第１のステントグラフト１０と第２のステントグラフト２０を接続した状態において、第２のステントグラフト２０に対して過剰な外力が作用し、第２のステントグラフト２０が分枝部１２に進入する方向に移動しようとしても、第２の被係止部２３２の第２の屈曲部２３２ｂが第１のステントグラフト１０の第１の係止部１３１又は第２の係止部１３２に引っ掛かるので、位置ずれを許容範囲内に抑制することができる（図６Ｂ参照）。 The second bent portion 232a is sewn and fixed to the film portion 21 by, for example, a suture thread. On the other hand, the portions other than the first bent portion 232 a of the second engaged portion 232, including the second bent portion 232 b, are not fixed to the film portion 21. That is, the second engaged portion 232 is configured such that the second bent portion 232 b is separated from the film portion 21 with the first bent portion 232 a as a fixing point. In a state in which the first stent graft 10 and the second stent graft 20 are connected, an excessive external force acts on the second stent graft 20 so that the second stent graft 20 moves in a direction in which the second stent graft 20 enters the branch 12 Also, since the second bent portion 232b of the second locked portion 232 is hooked on the first locking portion 131 or the second locking portion 132 of the first stent graft 10, the positional deviation is within the allowable range. It can be suppressed (see FIG. 6B).
　上述したように、第１のステントグラフト１０の分枝部１２に対して、第２のステントグラフト２０を軸方向に移動させると、第１の被係止部２３１又は第２の被係止部２３２が係止部１３によって係止されるので、第２のステントグラフト２０が軸方向にずれて留置されても、拡張状態のまま摺動移動させる（引っ張ってずらす）ことにより、容易に位置調整を行うことができる。 As described above, when the second stent graft 20 is moved in the axial direction with respect to the branch portion 12 of the first stent graft 10, the first engaged portion 231 or the second engaged portion 232 Since the second stent graft 20 is locked in the axial direction because it is locked by the locking portion 13, position adjustment is easily performed by sliding movement (pulling and shifting) in the expanded state. Can.
　図７Ａ、図７Ｂは、ステントグラフトを血管内に留置させるためのステントグラフト留置システム１００（血管内留置システム）の構成を示す図である。ステントグラフト留置システム１００を用いて、第１のステントグラフト１０及び第２のステントグラフト２０を血管内に留置させることができる。図７Ａは、ステントグラフト留置システム１００を解体した状態を示す。図７Ｂは、ステントグラフト留置システム１００を組み立てた状態を示す。 FIGS. 7A and 7B are diagrams showing the configuration of a stent graft indwelling system 100 (intravascular indwelling system) for indwelling a stent graft in a blood vessel. The stent graft placement system 100 can be used to place the first stent graft 10 and the second stent graft 20 in a blood vessel. FIG. 7A shows the stent graft indwelling system 100 in a disassembled state. FIG. 7B shows the stent graft indwelling system 100 in an assembled state.
　図７Ａ、図７Ｂに示すように、ステントグラフト留置システム１００は、管状のシース１０１、シース１０１の内側に配置されシース１０１の軸方向（長手方向）に沿ってシース１０１内を進退可能に構成されたインナーロッド１０２、及びステントグラフト１０３（第１のステントグラフト１０、第２のステントグラフト２０）を備える。 As shown in FIGS. 7A and 7B, the stent graft indwelling system 100 is disposed inside the tubular sheath 101 and the sheath 101, and is configured to be able to advance and retract in the sheath 101 along the axial direction (longitudinal direction) of the sheath 101. An inner rod 102 and a stent graft 103 (a first stent graft 10, a second stent graft 20) are provided.
　シース１０１は、管状のシース本体部１０１ａと、シース本体部１０１ａの基端側（近位端側）に設けられたハブ１０１ｂと、を有する。図示による説明は省略するが、ハブ１０１ｂには、インナーロッド１０２をシース１０１に対して固定し、又はその固定を解除するためのナットが設けられている。 The sheath 101 has a tubular sheath body portion 101a and a hub 101b provided on the proximal end side (proximal end side) of the sheath body portion 101a. Although description by illustration is omitted, the hub 101 b is provided with a nut for fixing the inner rod 102 to the sheath 101 or for releasing the fixing.
　シース１０１は、可撓性を有する材料で形成される。可撓性を有する材料としては、例えば、フッ素樹脂、ポリアミド系樹脂、ポリエチレン系樹脂、及びポリ塩化ビニル系樹脂等から選択される生体適合性を有する合成樹脂（エラストマー）、これら樹脂に他の材料が混合された樹脂コンパウンド、これらの合成樹脂による多層構造体、並びに、これら合成樹脂と金属線との複合体などが挙げられる。 The sheath 101 is formed of a flexible material. As a material having flexibility, for example, a biocompatible synthetic resin (elastomer) selected from fluorine resin, polyamide resin, polyethylene resin, polyvinyl chloride resin and the like, and other materials for these resins Resin composites, multilayer structures of these synthetic resins, and composites of these synthetic resins and metal wires.
　インナーロッド１０２は、棒状のロッド本体部１０２ａと、収縮状態にあるステントグラフト１０３を保持する保持部１０２ｂと、インナーロッド１０２の先端部（遠位端部）に設けられた先端チップ１０２ｃと、を有する。保持部１０２ｂは、例えば、ステントグラフト１０３の厚さ分だけロッド本体部１０２ａよりも直径が小さく設定されている。 The inner rod 102 has a rod-like rod body 102a, a holding portion 102b for holding the stent graft 103 in a contracted state, and a tip 102c provided at the tip (distal end) of the inner rod 102. . The holder 102 b is set to have a diameter smaller than that of the rod body 102 a by, for example, the thickness of the stent graft 103.
　ロッド本体部１０２ａ及び保持部１０２ｂを構成する材料としては、例えば、樹脂（プラスチック、エラストマー）又は金属等、適度な硬度及び柔軟性を有する種々の材料が挙げられる。先端チップ１０２ｃを構成する材料として、例えば、ポリアミド系樹脂、ポリウレタン系樹脂、及びポリ塩化ビニル系樹脂等から選択される合成樹脂（エラストマー）等の、適度な硬度及び柔軟性を有する種々の材料が挙げられる。 As a material which comprises rod main-body part 102a and attaching part 102b, various materials which have moderate hardness and pliability, such as resin (plastic, elastomer) or metal, are mentioned, for example. As a material which constitutes tip tip 102c, various materials which have moderate hardness and pliability, such as synthetic resin (elastomer) chosen from polyamide system resin, polyurethane system resin, polyvinyl chloride system resin etc., for example It can be mentioned.
　なお、図示による説明は省略するが、ロッド本体部１０２ａ、保持部１０２ｂ及び先端チップ１０２ｃには、例えば、ガイドワイヤーを通すためのルーメンや、収縮状態にあるステントグラフト１０３を患部で拡張させるためのトリガーワイヤーを通すためのルーメン等が、インナーロッド１０２の軸方向に沿って形成されている。 Although illustration by illustration is omitted, for the rod main body 102a, the holding part 102b and the distal end tip 102c, for example, a lumen for passing a guide wire and a trigger for expanding the stent graft 103 in a contracted state in the affected area. A lumen or the like for passing a wire is formed along the axial direction of the inner rod 102.
　このように、本実施の形態に係るステントグラフトセット１の接続構造（血管内留置具接続構造）は、第１のステントグラフト１０（第１の血管内留置具）と、第２のステントグラフト２０（第２の血管内留置具）と、を接続する。第１のステントグラフト１０及び第２のステントグラフト２０は、管形状を有する。第１のステントグラフト１０は、分枝部１２（第２のステントグラフト２０との接続部分）に、当該分枝部１２の径方向に突出する係止部１３を有する。第２のステントグラフト２０は、皮膜部２１と、皮膜部２１の外周面に配置される被係止部２３と、を有する。被係止部２３は、第２のステントグラフト２０の軸方向に屈曲部２３１ａ、２３１ｂ、２３２ａ、２３２ｂを有するように屈曲しながら周方向に延在する。屈曲部２３１ａ、２３１ｂ、２３２ａ、２３２ｂは、第１のステントグラフト１０の分枝部１２に第２のステントグラフト２０が内挿され接続された状態において、係止部１３に対して軸方向に遠い側の第１の屈曲部２３１ａ、２３２ａと、係止部１３に対して軸方向に近い側の第２の屈曲部２３１ｂ、２３２ｂを有する。第１の屈曲部２３１ａ、２３２ａは、皮膜部２１に固定され、第２の屈曲部２３１ｂ、２３２ｂは、係止部１３に係止可能となっている。 As described above, the connection structure (the intravascular indwelling device connection structure) of the stent graft set 1 according to the present embodiment includes the first stent graft 10 (the first intravascular indwelling device) and the second stent graft 20 (the second intravascular indwelling device). And intravascular detaining tools). The first stent graft 10 and the second stent graft 20 have a tubular shape. The first stent graft 10 has a locking portion 13 protruding in the radial direction of the branch portion 12 at the branch portion 12 (a connection portion with the second stent graft 20). The second stent graft 20 has a film portion 21 and a locked portion 23 disposed on the outer peripheral surface of the film portion 21. The locked portion 23 extends in the circumferential direction while bending so as to have bending portions 231 a, 231 b, 232 a and 232 b in the axial direction of the second stent graft 20. The bent portions 231a, 231b, 232a, and 232b are axially distant from the locking portion 13 in a state where the second stent graft 20 is inserted into and connected to the branch portion 12 of the first stent graft 10. It has a first bent portion 231 a, 232 a and a second bent portion 231 b, 232 b closer to the locking portion 13 in the axial direction. The first bent portions 231 a and 232 a are fixed to the film portion 21, and the second bent portions 231 b and 232 b can be locked to the locking portion 13.
　また、実施の形態に係るステントグラフト留置システム１００（血管内留置システム）は、血管内に留置されるステントグラフト１０３（血管内留置具）を備える。ステントグラフト１０３は、血管内にて接続される第１のステントグラフト１０（第１の血管内留置具）及び第２のステントグラフト２０（第２の血管内留置具）を含む。第１のステントグラフト１０及び第２のステントグラフト２０は、管形状を有する。第１のステントグラフト１０は、分枝部１２（第２のステントグラフト２０との接続部分）に、当該分枝部１２の径方向に突出する係止部１３を有する。第２のステントグラフト２０は、皮膜部２１と、皮膜部２１の外周面に配置される被係止部２３と、を有する。被係止部２３は、第２のステントグラフト２０の軸方向に屈曲部２３１ａ、２３１ｂ、２３２ａ、２３２ｂを有するように屈曲しながら周方向に延在する。屈曲部２３１ａ、２３１ｂ、２３２ａ、２３２ｂは、第１のステントグラフト１０の分枝部１２に第２のステントグラフト２０が内挿され接続された状態において、係止部１３に対して軸方向に遠い側の第１の屈曲部２３１ａ、２３２ａと、係止部１３に対して軸方向に近い側の第２の屈曲部２３１ｂ、２３２ｂを有する。第１の屈曲部２３１ａ、２３２ａは、皮膜部２１に固定され、第２の屈曲部２３１ｂ、２３２ｂは、係止部１３に係止可能となっている。 Moreover, the stent graft indwelling system 100 (intravascular placement system) according to the embodiment includes a stent graft 103 (intravascular placement tool) which is indwelled in a blood vessel. The stent graft 103 includes a first stent graft 10 (first endovascular indwelling device) and a second stent graft 20 (second endovascular indwelling device) connected in a blood vessel. The first stent graft 10 and the second stent graft 20 have a tubular shape. The first stent graft 10 has a locking portion 13 protruding in the radial direction of the branch portion 12 at the branch portion 12 (a connection portion with the second stent graft 20). The second stent graft 20 has a film portion 21 and a locked portion 23 disposed on the outer peripheral surface of the film portion 21. The locked portion 23 extends in the circumferential direction while bending so as to have bending portions 231 a, 231 b, 232 a and 232 b in the axial direction of the second stent graft 20. The bent portions 231a, 231b, 232a, and 232b are axially distant from the locking portion 13 in a state where the second stent graft 20 is inserted into and connected to the branch portion 12 of the first stent graft 10. It has a first bent portion 231 a, 232 a and a second bent portion 231 b, 232 b closer to the locking portion 13 in the axial direction. The first bent portions 231 a and 232 a are fixed to the film portion 21, and the second bent portions 231 b and 232 b can be locked to the locking portion 13.
　本実施の形態に係るステントグラフトセット１の接続構造及びステントグラフト留置システム１００によれば、第１のステントグラフト１０及び第２のステントグラフト２０を接続して留置させる際の第２のステントグラフト２０の位置ずれを防止でき、良好な接続状態を維持することができる。したがって、第１のステントグラフト１０と第２のステントグラフト２０との接続部分からのエンドリークを防止できるので、信頼性の高いステントグラフト留置術が可能となる。 According to the connection structure of the stent graft set 1 and the stent graft indwelling system 100 according to the present embodiment, the positional deviation of the second stent graft 20 at the time of connecting and indwelling the first stent graft 10 and the second stent graft 20 is prevented. It is possible to maintain a good connection state. Therefore, since the endoleak from the connection part of the 1st stent graft 10 and the 2nd stent graft 20 can be prevented, highly reliable stent graft indwelling is attained.
　以上、本発明者によってなされた発明を実施の形態に基づいて具体的に説明したが、本発明は上記実施の形態に限定されるものではなく、その要旨を逸脱しない範囲で変更可能である。 As mentioned above, although the invention made by the present inventor was concretely explained based on an embodiment, the present invention is not limited to the above-mentioned embodiment, and can be changed in the range which does not deviate from the gist.
　例えば、第１のステントグラフト１０の分枝部１２は、グラフト本体１１の管壁に開口を設けた形態であってもよい。この場合、開口の内周縁に第１の係止部１３１が設けられ、グラフト本体１１の開口縁部が第２の係止部１３２となる。また、分枝部１２は、グラフト本体１１とは別部材で構成され、グラフト本体１１に接合して形成されてもよい。この場合、分枝部１２は、グラフト本体１１の皮膜部１１１と同じ材料で形成されてもよいし、異なる材料で形成されてもよい。 For example, the branch portion 12 of the first stent graft 10 may have a form in which an opening is provided in the tube wall of the graft body 11. In this case, the first locking portion 131 is provided on the inner peripheral edge of the opening, and the opening edge of the graft body 11 becomes the second locking portion 132. Further, the branch portion 12 may be configured as a separate member from the graft body 11 and may be formed by being joined to the graft body 11. In this case, the branch 12 may be formed of the same material as the coating 111 of the graft body 11 or may be formed of a different material.
　実施の形態では、被係止部２３として、第１の被係止部２３１と第２の被係止部２３２を設けた例について説明したが、第１の被係止部２３１及び第２の被係止部２３２の何れか一方だけを設けるようにしてもよい。第１の被係止部２３１だけを設けた場合、第２のステントグラフト２０の分枝部１２への進入を抑制することはできないが、分枝部１２からの進出の抑制及び分枝血管Ｖ２内での位置調整を行うことができる。一方、第２の被係止部２３２だけを設けた場合、第２のステントグラフト２０の分枝部１２からの進出を抑制することはできないが、分枝部１２への進入の抑制及び分枝血管Ｖ２内での位置調整を行うことができる。 In the embodiment, an example in which the first engaged portion 231 and the second engaged portion 232 are provided as the engaged portions 23 has been described. However, the first engaged portions 231 and the second engaged portions 232 are described. Only one of the engaged portions 232 may be provided. When only the first locked portion 231 is provided, the second stent graft 20 can not be inhibited from entering the branch 12, but the advancement of the second stent graft 20 from the branch 12 is inhibited and the branch blood vessel V2 is formed. Position adjustment can be performed. On the other hand, when only the second engaged portion 232 is provided, the advancement of the second stent graft 20 from the branch 12 can not be suppressed, but the entry into the branch 12 is suppressed and the branch blood vessel Position adjustment in V2 can be performed.
　また例えば、実施の形態では、主血管用の第１のステントグラフト１０に分枝血管用の第２のステントグラフト２０を接続する場合について説明したが、本発明は、主血管に、複数のステントグラフトを連結して留置する場合、すなわち、図８Ａ、図８Ｂに示すように、第１のステントグラフト１０と第２のステントグラフト２０を両方とも主血管に留置するステントグラフトセット１にも適用できる。この場合、第１のステントグラフト１０の軸方向端部１０ａが接続部分となり、第２のステントグラフト２０の軸方向端部２０ａが接続側端部となる。なお、図８Ａにおいては、第１のステントグラフト１０の軸方向端部１０ａ及び第２のステントグラフト２０の軸方向端部２０ａを模式的に表している。
　また、主血管に、３以上のステントグラフトを連結して留置する場合、両端を除く中間のステントグラフトは、先に留置されるステントグラフトに対しては第２のステントグラフトとなり、後に留置されるステントグラフトに対しては第１のステントグラフトとなる。 Also, for example, although in the embodiment, the case of connecting the second stent graft 20 for branching blood vessels to the first stent graft 10 for main blood vessels has been described, the present invention connects a plurality of stent grafts to the main blood vessels. In the case of indwelling, that is, as shown in FIGS. 8A and 8B, the first stent graft 10 and the second stent graft 20 can be applied to the stent graft set 1 in which both the first stent graft 10 and the second stent graft 20 are indwelled in the main blood vessel. In this case, the axial end 10 a of the first stent graft 10 is the connection portion, and the axial end 20 a of the second stent graft 20 is the connection end. In FIG. 8A, the axial end 10 a of the first stent graft 10 and the axial end 20 a of the second stent graft 20 are schematically shown.
When three or more stent grafts are placed in connection with the main blood vessel, the middle stent graft except for both ends becomes the second stent graft for the first placed stent graft, and for the second placed stent graft. Is the first stent graft.
　また、第１のステントグラフトの係止部は、開口端部の周方向に沿う円環形状でなくてもよく、例えば、開口端部の周方向に沿って断続的に配置されてもよいし、間の一部が欠けた形状（例えば、Ｕ字形状）であってもよい。 In addition, the locking portion of the first stent graft may not be an annular shape along the circumferential direction of the open end, and may be intermittently disposed along the circumferential direction of the open end, for example. It may have a shape (eg, a U-shape) in which a portion between the two is missing.
　また、第１のステントグラフト及び第２のステントグラフトの骨格部は、金属以外の材料（例えば、セラミックや樹脂等）で形成されてもよい。第２のステントグラフトの被係止部についても同様である。また、第１のステントグラフト及び第２のステントグラフトは、自己拡張型ではなく、バルーン拡張型であってもよい。 The skeletons of the first stent graft and the second stent graft may be formed of a material other than metal (for example, ceramic, resin, etc.). The same applies to the locked portion of the second stent graft. Also, the first and second stent-grafts may be balloon-expandable rather than self-expanding.
　さらに、実施の形態では、血管内留置具として、ステントグラフトを例に挙げて説明したが、例えば、人工血管（グラフト）などの、他の血管内留置具を接続する場合にも、本発明を適用することができる。 Furthermore, in the embodiment, a stent graft is described as an example of an intravascular indwelling device, but the present invention is also applied to the case of connecting other intravascular indwelling devices such as artificial blood vessels (grafts), for example. can do.
　今回開示された実施の形態はすべての点で例示であって制限的なものではないと考えられるべきである。本発明の範囲は上記した説明ではなくて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すべての変更が含まれることが意図される。 It should be understood that the embodiments disclosed herein are illustrative and non-restrictive in every respect. The scope of the present invention is indicated not by the above description but by the claims, and is intended to include all the modifications within the meaning and scope equivalent to the claims.
　２０１７年１１月２２日出願の特願２０１７－２２４９００の日本出願に含まれる明細書、図面および要約書の開示内容は、すべて本願に援用される。 The disclosures of the specification, drawings and abstract included in the Japanese application of Japanese Patent Application No. 2017-224900 filed on Nov. 22, 2017 are all incorporated herein by reference.
　１　ステントグラフトセット
　１０　第１のステントグラフト（第１の血管内留置具）
　１１　グラフト本体
　１１１　皮膜部
　１１２　骨格部
　１２　分枝部
　１３　係止部
　１３１　第１の係止部
　１３２　第２の係止部
　２０　第２のステントグラフト（第２の血管内留置具）
　２１　皮膜部
　２２　骨格部
　２３　被係止部
　２３１　第１の被係止部
　２３２　第２の被係止部
　２３１ａ、２３２ａ　第１の屈曲部
　２３１ｂ、２３２ｂ　第２の屈曲部
　１００　ステントグラフト留置システム（血管内留置システム） 1 Stent-graft set 10 First stent-graft (first intravascular placement device)
11: graft body 111: coating portion 112: skeletal portion 12: branching portion 13: locking portion 131: first locking portion 132: second locking portion 20: second stent graft (second intravascular indwelling device)
Reference Signs List 21 film portion 22 skeleton portion 23 locked portion 231 first locked portion 232 second locked portion 231a, 232a first bent portion 231b, 232b second bent portion 100 stent graft indwelling system (within blood vessel Detention system)

Claims (8)

  1. 　血管内に留置される複数の血管内留置具を接続する血管内留置具接続構造であって、
    　前記複数の血管内留置具は、第１の血管内留置具と、前記第１の血管内留置具に内挿して接続される第２の血管内留置具と、を含み、
    　前記第１及び第２の血管内留置具は、管形状を有し、
    　前記第１の血管内留置具は、前記第２の血管内留置具との接続部分に、当該接続部分の径方向に突出する係止部を有し、
    　前記第２の血管内留置具は、皮膜部と、皮膜部の外周面に配置される被係止部と、を有し、
    　前記被係止部は、前記第２の血管内留置具の軸方向に屈曲部を有するように屈曲しながら周方向に延在してなり、
    　前記屈曲部は、前記第１の血管内留置具の接続部分に前記第２の血管内留置具が内挿され接続された状態において、前記係止部に対して軸方向に遠い側の第１の屈曲部と、前記係止部に対して軸方向に近い側の第２の屈曲部を有し、
    　前記第１の屈曲部は、前記皮膜部に固定され、
    　前記第２の屈曲部は、前記係止部に係止可能となっている
    　ことを特徴とする血管内留置具接続構造。     An intravascular indwelling device connection structure for connecting a plurality of intravascular indwelling devices deployed in a blood vessel, comprising:
    The plurality of intravascular indwelling devices include: a first intravascular indwelling device; and a second intravascular indwelling device intercalated and connected to the first intravascular indwelling device;
    The first and second intravascular indwelling devices have a tubular shape, and
    The first intravascular indwelling device has a locking portion projecting in the radial direction of the connecting portion at a connecting portion with the second intravascular indwelling device,
    The second intravascular indwelling device has a film portion and a locked portion disposed on the outer peripheral surface of the film portion,
    The to-be-locked portion extends in the circumferential direction while bending so as to have a bending portion in the axial direction of the second intravascular indwelling device,
    In the state where the second indwelling device is inserted and connected to the connection portion of the first indwelling device, the bending portion is the first on the far side in the axial direction with respect to the locking portion. A second bent portion close to the locking portion in the axial direction,
    The first bent portion is fixed to the film portion,
    The intra-vessel indwelling device connecting structure according to claim 1, wherein the second bent portion is capable of being locked to the locking portion.
  2. 　前記被係止部は、前記第１の屈曲部を固定点として、前記第２の屈曲部が前記皮膜部から離間するように構成されていることを特徴とする請求項１に記載の血管内留置具接続構造。 The blood vessel according to claim 1, wherein the portion to be locked is configured such that the second bent portion is separated from the film portion with the first bent portion as a fixing point. Indwelling device connection structure.
  3. 　前記係止部は、前記第１の血管内留置具の径方向内側に突出する第１の係止部を有することを特徴とする請求項１又は２に記載の血管内留置具接続構造。 The intravascular indwelling device connection structure according to claim 1 or 2, wherein the locking portion has a first locking portion protruding radially inward of the first intravascular indwelling device.
  4. 　前記被係止部は、前記第１の血管内留置具と前記第２の血管内留置具とが接続された状態において、前記皮膜部の前記第１の血管内留置具との重複部分に配置される第１の被係止部を有することを特徴とする請求項３に記載の血管内留置具接続構造。 The to-be-locked portion is disposed at an overlapping portion of the film portion with the first intravascular indwelling device in a state where the first intravascular indwelling device and the second intravascular indwelling device are connected. The intravascular indwelling device connection structure according to claim 3, characterized in that the first engaged portion is provided.
  5. 　前記被係止部は、前記第１の血管内留置具と前記第２の血管内留置具とが接続された状態において、前記皮膜部の前記第１の血管内留置具からの露出部分に配置される第２の被係止部を有することを特徴とする請求項１から４のいずれか一項に記載の血管内留置具接続構造。 The to-be-locked portion is disposed at the exposed portion of the film portion from the first intravascular indwelling device in a state where the first intravascular indwelling device and the second intravascular indwelling device are connected. The intravascular indwelling device connection structure according to any one of claims 1 to 4, further comprising a second locked portion.
  6. 　前記第１の血管内留置具は、血液の流路を画成する管状のグラフト本体と、前記グラフト本体の管壁に配置される分枝部と、を有し、
    　前記接続部分は、前記分枝部の開口端部であることを特徴とする請求項１から５のいずれか一項に記載の血管内留置具接続構造。     The first intravascular indwelling device has a tubular graft body defining a blood flow path, and a branch portion disposed on a tube wall of the graft body,
    The intravascular indwelling device connection structure according to any one of claims 1 to 5, wherein the connection portion is an open end of the branch portion.
  7. 　前記第１の血管内留置具は、血液の流路を画成する管状のグラフト本体を有し、
    　前記接続部分は、前記グラフト本体の開口端部であることを特徴とする請求項１から６のいずれか一項に記載の血管内留置具接続構造。     The first intravascular indwelling device comprises a tubular graft body defining a blood flow path,
    The intravascular indwelling device connection structure according to any one of claims 1 to 6, wherein the connection portion is an open end of the graft body.
  8. 　血管内に留置される血管内留置具を備える血管内留置システムであって、
    　前記血管内留置具は、血管内にて接続される第１及び第２の血管内留置具を含み、
    　前記第１及び第２の血管内留置具は、管形状を有し、
    　前記第１の血管内留置具は、前記第２の血管内留置具との接続部分に、当該接続部分の径方向に突出する係止部を有し、
    　前記第２の血管内留置具は、皮膜部と、皮膜部の外周面に配置される被係止部と、を有し、
    　前記被係止部は、前記第２の血管内留置具の軸方向に屈曲部を有するように屈曲しながら周方向に延在してなり、
    　前記屈曲部は、前記第１の血管内留置具の接続部分に前記第２の血管内留置具が内挿され接続された状態において、前記係止部に対して軸方向に遠い側の第１の屈曲部と、前記係止部に対して軸方向に近い側の第２の屈曲部を有し、
    　前記第１の屈曲部は、前記皮膜部に固定され、
    　前記第２の屈曲部は、前記係止部に係止可能となっている
    　ことを特徴とする血管内留置システム。     An intravascular placement system comprising an intravascular placement device placed within a blood vessel, comprising:
    The intravascular indwelling device includes first and second intravascular indwelling devices connected in blood vessels,
    The first and second intravascular indwelling devices have a tubular shape, and
    The first intravascular indwelling device has a locking portion projecting in the radial direction of the connecting portion at a connecting portion with the second intravascular indwelling device,
    The second intravascular indwelling device has a film portion and a locked portion disposed on the outer peripheral surface of the film portion,
    The to-be-locked portion extends in the circumferential direction while bending so as to have a bending portion in the axial direction of the second intravascular indwelling device,
    In the state where the second indwelling device is inserted and connected to the connection portion of the first indwelling device, the bending portion is the first on the far side in the axial direction with respect to the locking portion. A second bent portion close to the locking portion in the axial direction,
    The first bent portion is fixed to the film portion,
    The intravascular indwelling system according to claim 1, wherein the second bent portion is capable of being locked to the locking portion.
PCT/JP2018/043045 2017-11-22 2018-11-21 Intravascular indwelling instrument connecting structure and intravascular indwelling system WO2019103054A1 (en)

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US20050149166A1 (en) * 2003-11-08 2005-07-07 Schaeffer Darin G. Branch vessel prosthesis with anchoring device and method
JP2010535578A (en) * 2007-08-08 2010-11-25 ゴア エンタープライズ ホールディングス，インコーポレイティド Intraluminal prosthetic conduit system and coupling method
JP2012521267A (en) * 2009-03-23 2012-09-13 メドトロニック ヴァスキュラー インコーポレイテッド Branch vessel prosthesis with roll-up seal assembly
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