WO2014045426A1 - Indwelling device and indwelling device assembled body - Google Patents

Indwelling device and indwelling device assembled body Download PDF

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Publication number
WO2014045426A1
WO2014045426A1 PCT/JP2012/074331 JP2012074331W WO2014045426A1 WO 2014045426 A1 WO2014045426 A1 WO 2014045426A1 JP 2012074331 W JP2012074331 W JP 2012074331W WO 2014045426 A1 WO2014045426 A1 WO 2014045426A1
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WO
WIPO (PCT)
Prior art keywords
stent
graft
stent graft
indwelling device
peripheral wall
Prior art date
Application number
PCT/JP2012/074331
Other languages
French (fr)
Japanese (ja)
Inventor
大内竜也
Original Assignee
テルモ株式会社
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Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to PCT/JP2012/074331 priority Critical patent/WO2014045426A1/en
Publication of WO2014045426A1 publication Critical patent/WO2014045426A1/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
    • 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
    • A61F2002/067—Y-shaped blood vessels modular
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present invention relates to an indwelling device and an indwelling device assembly that are indwelled for treatment of a biological lumen.
  • an abdominal aortic aneurysm occurs due to a weakened arterial wall.
  • an expandable stent graft indwelling device assembly
  • stent graft treatment is performed in which an indwelling and new blood flow path is formed (see, for example, US Pat. No. 6,117,167).
  • the stent graft used for stent graft treatment is placed in the central side of the abdominal aorta, the ipsilateral leg placed in the common iliac artery that delivered the body, and the opposite common iliac artery It is formed in a Y shape with a contralateral leg.
  • the stent graft has, for example, a first stent graft having a body, an ipsilateral leg, and a part of the contralateral leg, and a second stent graft having the other part of the contralateral leg in order to exhibit a Y shape in the blood vessel. It is comprised in the assembly which consists of.
  • first stent graft By delivering the first stent graft from the right common iliac artery and deploying it in the abdominal aorta, and delivering the second stent graft from the left common iliac artery during deployment and inserting it into the first stent graft Connect both members.
  • this type of stent graft may be detached from the first stent graft by receiving shear stress due to blood flow, arterial pressure, pulsation, and the like.
  • the blood flow path constructed by the stent graft is broken, so that blood leaks into the aneurysm and pressurization of the aneurysm cannot be suppressed. Therefore, the stent graft is required to improve the connection force (pullout strength) of the first and second stent grafts.
  • the stent graft disclosed in US Pat. No. 6,117,167 is formed in a tapered shape in which the connecting portion of the first stent graft is reduced in diameter toward the lower end, and the connecting portion of the second stent graft is expanded in diameter toward the upper end.
  • the taper shape is formed.
  • the stent at the connection site of the first stent graft is provided on the outer peripheral surface
  • the stent at the connection site of the second stent graft is provided on the inner peripheral surface.
  • the present invention has been made in connection with a device for connecting and placing two members in a living body lumen, and with a simple configuration, a member to be inserted can be firmly connected. It is an object of the present invention to provide an indwelling device and an indwelling device assembly that can be successfully placed in a lumen and can effectively treat a lesion.
  • the present invention is an indwelling device which is formed in a long cylindrical shape by being surrounded by a flexible peripheral wall and has an internal space extending in the axial direction.
  • the peripheral wall is provided with a skeleton that supports the peripheral wall so that the peripheral wall can be expanded and contracted, and the skeleton has a protruding portion that protrudes inward at a predetermined position of the peripheral wall.
  • the indwelling device can form a narrowed portion in which a predetermined position in the axial direction of the internal space is narrowed inward because the skeleton has a protruding portion that protrudes inward at a predetermined position of the peripheral wall. . Therefore, when the insertion device having a skeleton is inserted into the internal space having the narrow portion, the skeleton is caught in the narrow portion, and the detachment of the insertion device can be suppressed.
  • the narrow portion can also impart a strong frictional force to the outer peripheral surface of the insertion device.
  • the indwelling device is indwelled in the living body lumen while the connection of the insertion device is firmly maintained, the lesioned part can be effectively treated. Further, the protruding portion can be easily provided on the skeleton, and the indwelling device can be easily manufactured.
  • the skeleton is formed in a wave shape that repeatedly extends a peak and a valley along the circumferential direction of the peripheral wall, and the projecting portion is bent obliquely inwardly at the top of the peak. Preferably it is formed.
  • the protrusion can be provided by a simple forming method of bending the skeleton by forming the protrusion by bending the top of the mountain portion obliquely inward.
  • the protruding portion at the peak portion of the skeleton, it is possible to suppress the decrease in the elastic force of the skeleton and to perform the expansion / contraction of the peripheral wall satisfactorily.
  • a plurality of the skeletons are provided along the axial direction of the internal space.
  • the insertion device inserted into the internal space can be hooked along the axial direction. Further, the insertion amount of the insertion device can be adjusted with respect to the axial direction of the internal space, and the insertion device can be firmly connected at the adjustment position.
  • the skeleton is provided on the outer peripheral surface of the peripheral wall, so that the protruding portion pushes the peripheral wall inward to form a raised portion.
  • the skeleton when the skeleton is provided on the outer peripheral surface of the peripheral wall, it is possible to easily form a raised portion that pushes the peripheral wall inwardly by the protruding portion. Since the raised portion increases the contact area with respect to the outer peripheral surface of the insertion device, the frictional force between the members can be further improved.
  • the indwelling device assembly which concerns on this invention is inserted in the said interior space comprised by the indwelling device which has the structure mentioned above, and the said surrounding wall, and is connected to the said indwelling device. And an insertion device.
  • both members can be firmly connected in the living body lumen.
  • the insertion device includes a cylindrical member that is flexible and can contact the peripheral wall, and a ring shape in which a strand extends along a circumferential direction of the cylindrical member and supports the cylindrical member. It preferably includes a skeleton.
  • the strands of the ring-shaped skeleton can be easily or indirectly caught on the protruding portion of the indwelling device, and the connection force between the indwelling device and the insertion device is increased. Can be further improved.
  • FIG. 2A is an enlarged front view of a main part of the first stent graft of FIG. 1
  • FIG. 2B is a perspective view of the first stent of FIG. 1
  • FIG. 2C is a IIC-IIC line of FIG. 2B.
  • FIG. 4A is a first explanatory diagram showing a method for using a stent graft
  • FIG. 4B is a second explanatory diagram showing a method for using a stent graft
  • FIG. 4C is a third explanatory diagram showing a method for using a stent graft.
  • FIG. 5A is a side view of a main part showing a connecting part and a separating part according to a first modification
  • FIG. 5B is a partial side sectional view showing a connecting part according to a second modification
  • FIG. 5D is a partial side cross-sectional view showing a connecting portion according to a third modification
  • FIG. 5D is a main part side view showing a connecting portion according to a fourth modification.
  • FIG. 1 is a schematic explanatory view showing an indwelling state of the indwelling device assembly 10 according to the present embodiment.
  • the indwelling device assembly 10 according to the present embodiment is configured as a stent graft used for the treatment of the abdominal aortic aneurysm 100 (hereinafter, the indwelling device assembly 10 is also referred to as the stent graft 10).
  • the abdominal aortic aneurysm 100 (hereinafter, also simply referred to as the aneurysm 100) is generated in the abdominal aorta 102 below the connection point of the renal artery 104 and above the common iliac artery 106, and is formed in a spindle shape or a sac shape.
  • the stent graft 10 is placed so as to pass through the inside of the aneurysm 100 by an intravascular intervention technique (a technique for delivering the stent graft 10 to the lesioned part through the blood vessel), and a new blood flow path is constructed in the aneurysm 100. Is.
  • FIG. 1 schematically shows a living organ on the patient's side lying on the operating table, and the left / right distinction of the living organ is reversed in the figure.
  • two common iliac arteries 106 connected to the lower part of the abdominal aorta 102 correspond to the right common iliac artery 108 that extends to the left in FIG. 1 and extend to the right in FIG. This corresponds to the left common iliac artery 110.
  • the stent graft 10 is formed as a cylinder, and a flow passage 12 (internal space) through which blood flowing in the abdominal aorta 102 can flow is provided.
  • the stent graft 10 includes a body 14 (main tube portion) extending a predetermined length, an ipsilateral leg 16 (first leg portion) and an opposite leg 18 (second leg portion) that are connected to the body 14.
  • the body 14, the same side and the opposite legs 16, 18 extend in different directions from each other as a starting point.
  • the body 14 With the stent graft 10 placed in the blood vessel, the body 14 is placed in the abdominal aorta 102, the ipsilateral leg 16 is placed from the aneurysm 100 to the right common iliac artery 108, and the contralateral leg 18 is placed from the inside of the aneurysm 100 to the left.
  • the common iliac artery 110 By being arranged over the common iliac artery 110, it exhibits a Y shape as a whole.
  • the flow passage 12 communicates the inside of the body 14, the same side and the opposite legs 16, 18 in the axial direction, and realizes blood flow from the abdominal aorta 102 to the common iliac artery 106.
  • the body 14 of the stent graft 10 is formed relatively thick so as to be in close contact with the blood vessel wall of the abdominal aorta 102 from the inside, and accordingly, the inner diameter of the flow passage 12 is also formed large.
  • the dimensions of the body 14 may be set to an axial length of about 40 to 140 mm and an inner diameter of about 20 to 36 mm.
  • the upper end portion of the body 14 is locked to the healthy part (proxy circle neck 102a) on the upper side of the knob 100. Further, the lower end portion on the opposite side of the upper end portion of the body 14 supports the same leg and the opposite legs 16 and 18 while being swingable within the knob 100.
  • the same side and opposite legs 16, 18 of the stent graft 10 are formed thinner than the body 14, and the inner diameter of the flow passage 12 is also formed smaller.
  • the dimensions of the ipsilateral and contralateral legs 16 and 18 may be set so that the axial length is about 50 to 200 mm and the inner diameter is about 8 to 28 mm.
  • the ipsilateral and contralateral legs 16, 18 extend from the abdominal aorta 102 to the common iliac artery 106. In the indwelling state, the lower regions 16 a and 18 a of the ipsilateral and contralateral legs 16 and 18 are locked to a healthy site (distal neck) of the common iliac artery 106.
  • the opposite leg 18 of the stent graft 10 is configured to be separable up and down at a connection point A in FIG. That is, the stent graft 10 according to this embodiment includes a first stent graft 22 (an indwelling device) having a base end portion (continuous connection portion 20: an extending tube portion) of the body 14, the ipsilateral leg 16, and the opposite leg 18. , An assembly assembled by connection with a second stent graft 26 (insertion device) constituted by the distal portion (separation portion 24) of the contralateral leg 18.
  • the ipsilateral leg 16 is formed as one cylinder (extended cylinder part 17), it is not limited to this, The ipsilateral leg 16 may be comprised detachably. Of course.
  • the first stent graft 22 has a flexible first graft 28 (peripheral wall) that surrounds the flow passage 12, and a first graft 28 that extends along the circumferential direction of the first graft 28 and supports the first graft 28 so that the first graft 28 can expand and contract. And a stent 30 (skeleton).
  • the second stent graft 26 also extends along the circumferential direction of the second graft 32 (tubular member) having flexibility and surrounds the flow passage 12, and can expand and contract the second graft 32.
  • the second stent 34 is supported by the second stent 34.
  • the material constituting the first and second grafts 28 and 32 is not particularly limited, but is a biocompatible woven fabric, nonwoven fabric, porous sheet, or other graft material (having blood impermeability).
  • the material is preferably formed from a material.
  • the material having biocompatibility include artificial materials such as polyester fiber, ePTFE (expanded polytetrafluoroethylene), and polyurethane.
  • the first and second stents 30 and 34 are accommodated in the sheaths 36 and 52 (see FIG. 4B) in a contracted state, and when the first and second stents 30 and 34 are exposed to the outside of the sheaths 36 and 52, the first and second stents 30 and 34 are automatically shifted to an expanded state. For this reason, it is preferable that the first and second stents 30 and 34 are made of a material having sufficient elastic force. Examples of the material constituting the first and second stents 30 and 34 include various materials such as stainless steel, Ni—Ti alloy, Cu—Zn alloy, Ni—Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, and tantalum.
  • first and second stents 30 and 34 examples thereof include metals, relatively high-rigidity polymer materials such as polyamide, polyimide, ultrahigh molecular weight polyethylene, polypropylene, and fluororesin, or combinations of these appropriately.
  • first and second stents 30 and 34 to have X-ray contrast properties, it is possible to satisfactorily perform stent graft treatment under X-ray imaging.
  • first and second stents 30 and 34 are not limited to the above-described structures, and can adopt various configurations that can support the first and second grafts 28 and 32 in a freely expandable and contractible manner.
  • the first and second stents 30 and 34 may employ not only a structure that shifts from a contracted state to an expanded state by self-expansion, but also a structure that is expanded by an expansion device (such as a balloon).
  • FIG. 2A is an enlarged front view of a main part of the first stent graft 22 shown in FIG. 1
  • FIG. 2B is a perspective view showing the first stent 30 shown in FIG. 1
  • FIG. FIG. 3 is a cross-sectional view taken along the line IIC
  • FIG. 3 is an enlarged cross-sectional view of a main part showing a state where the continuous portion 20 and the separation portion 24 of FIG. 1 are connected.
  • the continuous portion 20 of the first stent graft 22 constitutes the upper portion of the opposite leg 18, and is located on the body 14 at the same height position (continuous portion) as the same side leg 16. It is a series.
  • the extension length of the continuous portion 20 is shorter than the extension length of the ipsilateral leg 16. Therefore, the first stent graft 22 is formed in an outer shape in which one of the Y-shaped parts (the opposite leg 18) is partially missing.
  • An opening 20a communicating with the flow passage 12 is formed at the lower end of the continuous portion 20, so that the second stent graft 26 can be inserted.
  • the separation portion 24 (second stent graft 26) is configured to be expandable while being inserted into the flow passage 12 from the opening 20a.
  • the outer diameter of the separating portion 24 in the expanded state is slightly larger than the inner diameter of the connecting portion 20, and the outer peripheral surface 24 a of the separating portion 24 is in close contact with the inner peripheral surface 20 b of the connecting portion 20 in the expanded state. To do.
  • connecting portion 20 and the separating portion 24 are configured such that the connection force between the first stent 30 and the second stent 34 is increased based on the configuration of the first stent 30 and the second stent 34.
  • the configuration of the continuous portion 20 and the separation portion 24 will be specifically described.
  • the first stent 30 is formed in a wave shape (Z-shaped skeleton) extending along the circumferential direction while swinging up and down, and is formed on the outer peripheral surface of the first graft 28. It is sewn.
  • the second stent 34 that supports the second stent graft 26 is formed in a ring shape (ring-shaped skeleton) in which the strands extend along the circumferential direction, and is sewn to the inner peripheral surface of the second graft 32. ing.
  • the first stent 30 that supports the ipsilateral leg 16 and the connecting portion 20 includes three crests 38 and three troughs 40 along the circumferential direction of the first graft 28, It is comprised by the six trunk
  • FIG. In other words, the first stent 30 is formed in an endless shape that makes a round by repeating the amplitude of the crest 38 and the trough 40 three times.
  • the intervals between the adjacent peak portions 38 or the valley portions 40 are set evenly, and the vertical positions of the peaks 38 and the valley portions 40 (the amplitudes of the peak portions 38 and the valley portions 40) are also set equal. .
  • each peak portion 38 of the first stent 30 (hereinafter referred to as the continuous portion side stent 31) that supports the continuous portion 20 is bent at a predetermined angle from the body portion 42 toward the radially inner side ( That is, a projecting portion 44 that projects obliquely upward is formed.
  • the valley portion 40 and the body portion 42 of the continuous portion side stent 31 are parallel to the axial direction of the continuous portion 20, and only the top portion of the peak portion 38 is bent to form the first graft. It acts to push 28 inward.
  • a narrow portion 48 narrowed inward by the protruding portion 44 is formed in the flow passage 12.
  • a protruding portion 46 is formed on the inner peripheral surface 20b of the connecting portion 20 where the protruding portion 44 overlaps, and the protruding portion 44 pushes the first graft 28 radially inward.
  • Three raised portions 46 are formed at equal intervals along the circumferential direction of the continuous portion 20 corresponding to the wave shape of the continuous portion side stent 31 (see FIG. 2C), and the flow passage 12 is formed by the three raised portions 46.
  • a narrow portion 48 is constructed that partially narrows in the radial direction.
  • the narrow portion 48 has a function of hooking the second stent 34 of the separation portion 24 by narrowing a predetermined position in the axial direction of the flow passage 12 inward. Further, the narrow portion 48 increases the frictional force between the inner peripheral surface 20 b of the connecting portion 20 and the outer peripheral surface 24 a of the separating portion 24, thereby improving the connection force between the connecting portion 20 and the separating portion 24.
  • the narrowed portion 48 partially narrows the circumferential direction of the continuous portion 20 by three raised portions 46 provided at equal intervals (120 ° intervals). Therefore, when cannulation is performed in the connection work, the guide wire 50 (see FIG. 4B) can be advanced so as to avoid the raised portion 46.
  • the number and positions of the raised portions 46 are not particularly limited, but may be formed by two or more raised portions 46, and the adjacent raised portions 46 may be formed at equal intervals.
  • the narrow part 48 can narrow the inner peripheral surface 20b of the connection part 20 equally (it is not biased to one side).
  • the projecting portion 44 projecting obliquely upward facilitates allowing the sheath 36 (see FIG. 4B) containing the second stent graft 26 to advance, while providing a strong resistance force in the direction in which the second stent graft 26 is deployed. Can be granted.
  • the protruding portion 44 of the continuous portion side stent 31 forming the narrowed portion 48 is preferably set appropriately with respect to the protruding amount and the inclination angle in consideration of the insertion connection state of the separating portion 24 with respect to the continuous portion 20. . If the protruding amount of the protruding portion 44 is increased and the inside of the flow passage 12 is significantly narrowed, the sheath 36 and the guide wire 50 are easily caught by the narrowed portion 48 when the separating portion 24 is inserted.
  • a suitable shape of the projecting portion 44 for example, a projecting amount projecting inward by about 10 to 20% with respect to the inner diameter of the flow passage 12 and an inclination angle of about 40 ° to 65 ° may be set. In particular, if the protruding portion 44 has a large protruding amount with respect to the thickness of the strand of the second stent 34, the second stent 34 is easily hooked.
  • the ring-shaped second stent 34 brings the outer peripheral surface 24 a of the separating portion 24 into surface contact with the inner peripheral surface 20 b of the connecting portion 20 by its elastic force.
  • the second stent 34 is provided so as to be orthogonal to the axial direction of the separating portion 24 and pushes the second graft 32 from the inside to the outside, thereby supporting the shape of the outer peripheral surface 24a of the separating portion 24 having relatively high rigidity.
  • a portion 54 is formed.
  • the shape support portion 54 can be connected to the connecting portion 20 and the separation portion 24 by being hooked on the narrow portion 48 (drawing strength).
  • the 2nd stent 34 may be provided in the outer peripheral surface 24a side of the isolation
  • the continuous portion 20 includes three narrow portions 48 by attaching a plurality (three in FIG. 2A) of continuous portion side stents 31 along the axial direction. It is a side-by-side configuration.
  • the attachment interval D1 between the adjacent continuous portion side stents 31 is set to be slightly wider than the amplitudes of the peak portions 38 and the valley portions 40 of the continuous portion side stent 31.
  • the width ⁇ of the thickness of the second stent 34 between the peak portion 38 (projecting portion 44) of the lower continuous portion side stent 31 and the valley portion 40 of the upper continuous portion side stent 31. Is set to be formed.
  • interval D1 of the connection part side stent 31 is set, the kink resistance of the connection part 20 can be improved and the connection with the isolation
  • the attachment interval D1 of the continuous portion side stent 31 is not particularly limited.
  • the peak portion 38 of the lower continuous portion side stent 31 and the valley portion 40 of the upper continuous portion side stent 31 are provided. It may be zero or less.
  • the attachment interval D2 of the second stents 34 arranged in the axial direction of the separation portion 24 is set shorter than the attachment interval D1 of the continuous portion side stent 31.
  • the attachment interval D2 of the second stent 34 is set to half of the attachment interval D1 of the continuous portion side stent 31, the second stent 34 may be hooked on each of the narrow portions 48.
  • the connection force between the continuous portion 20 and the separation portion 24 can be further improved.
  • the stent graft 10 includes the continuous portion 20 and the separation portion by the three narrow portions 48 aligned in the axial direction of the continuous portion 20 or the plurality of shape support portions 54 aligned in the axial direction of the separation portion 24. It becomes possible to adjust the connection position of 24 each other. Therefore, by adjusting the length of the assembled contralateral leg 18, the stent graft 10 can be placed more satisfactorily according to the shape of the abdominal aorta 102 or the left common iliac artery 110, for example. Increased versatility.
  • the stent graft 10 (first and second stent grafts 22 and 26) according to the present embodiment is basically configured as described above.
  • the operation and effect of the stent graft 10 will be described as an intravascular placement operation. This will be explained in relation to
  • the stent graft 10 according to the present embodiment is suitably used for the treatment of an abdominal aortic aneurysm (aneurysm 100) that occurs in the abdominal aorta 102 as described above.
  • an abdominal aortic aneurysm aneurysm 100
  • X-ray imaging of the vicinity of the aneurysm 100 that is a lesioned part of the patient is performed, and the position and shape of the aneurysm 100 are specified.
  • the operator cuts the inguinal portion of the patient's right thigh and inserts the guide wire 58 percutaneously through the cut portion, and then the first delivery device 56 in which the first stent graft 22 is accommodated. Are delivered along the guidewire 58. Then, as shown in FIG. 4A, the sheath 52 of the first delivery device 56 is moved backward to expand (deploy) the first stent graft 22, and the upper end of the body 14 is locked to the proximal neck 102a. A part of the same leg 16 and the connecting portion 20 of the opposite leg 18 are expanded in the knob 100. At this time, the first stent 30 expands the first graft 28 to form a narrow portion 48 that narrows the flow passage 12 by the protruding portion 44 of the continuous portion-side stent 31.
  • the surgeon incises the groin of the left thigh of the patient, delivers the guide wire 50 from the left common iliac artery 110 into the aneurysm 100, and further guides into the flow passage 12 of the first stent graft 22.
  • a cannulation for inserting the wire 50 is performed. In this cannulation, even if the guide wire 50 comes into contact with the raised portion 46 in the continuous portion 20, the guide wire 50 moves smoothly by avoiding it easily in the circumferential direction of the raised portion 46.
  • the second delivery device 60 in which the second stent graft 26 is accommodated is delivered along the guide wire 50 and inserted into the connecting portion 20.
  • the insertion amount of the separation unit 24 with respect to the continuous unit 20 can be adjusted as appropriate under X-ray imaging based on the shape of the left common iliac artery 110 specified in advance.
  • the sheath 36 of the second delivery device 60 is moved backward at the position where the amount of insertion of the separation unit 24 is adjusted to expose the separation unit 24.
  • the second stent 34 of the separating portion 24 expands the second graft 32 radially outward.
  • the first graft 28 is pushed radially inward by the narrowed portion 48, and the inner peripheral surface 20 b of the continuous portion 20 and the outer peripheral surface 24 a of the separating portion 24 act so as to press each other. Therefore, the frictional force of the contact surfaces of the first and second grafts 28 and 32 is increased, and the connection between the first and second stent grafts 22 and 26 is strengthened.
  • the shape support portion 54 of the separation portion 24 is hooked on the upper side of the narrow portion 48, the connection force of the first and second stent grafts 22 and 26 can be further increased.
  • the stent graft 10 When the stent graft 10 is assembled in this manner, for example, as shown in FIG. 4C, blood flows into the flow passage 12 of the opposite leg 18 and pressure from the blood is applied to the separation portion 24 (second stent graft 26), and the communication is performed. An attempt is made to push down the separating portion 24 relative to the installation portion 20. In this case, the shape support portion 54 of the stent graft 10 is positively hooked to the narrow portion 48 provided in the continuous portion 20 due to the downward movement of the separation portion 24.
  • the protruding portion 44 of the first stent 30 is inclined obliquely upward, so that the raised portion 46 has high resistance to the downward movement of the separating portion 24, and the protruding portion is caused by the downward movement of the separating portion 24. It is elastically deformed so that 44 is further bent inward. Therefore, as the separating portion 24 moves downward, the raised portion 46 acts so as to narrow further inward, and the shape support portion 54 is caught by the narrow portion 48. Thereby, the separation
  • the sheaths 52 and 36 of the first and second delivery devices 56 and 60 are further retracted to the same side and the opposite side.
  • the legs 16 and 18 are deployed in the common iliac artery 106.
  • the first and second delivery devices 56, 60 and the guide wires 58, 50 are removed, and the intravascular placement operation of the stent graft 10 is completed.
  • the stent graft 10 is not limited to the above-described configuration, and various configurations capable of strengthening the connection force between the first stent graft 22 and the second stent graft 26 can be applied.
  • some examples of other configurations (modifications) of the stent graft according to the present invention will be exemplified.
  • symbol is attached
  • the stent graft 10A according to the first modified example is different from the first embodiment in that the second stent 35 of the separating portion 25 (second stent graft 26a) is formed in a wavy shape (Z-type stent). It differs from the stent graft 10 concerning. Specifically, a plurality of second stents 35 (wavy skeletons) are provided on the inner peripheral surface of the second graft 32, and the same number of peaks as the continuous portion side stent 31 along the circumferential direction of the second graft 32. It has 35a and a trough 35b.
  • a wavy shape support portion 55 is formed on the outer peripheral surface 25 a of the separation portion 25 according to the second stent 35. Further, the interval (amplitude) between the crest 35 a and the trough 35 b of the second stent 35 is formed smaller than the amplitude of the first stent 30.
  • the wavy second stent 35 is provided in the separation portion 25, it can be firmly connected to the continuous portion 20 (first stent graft 22). That is, the narrow portion 48 formed by the protruding portion 44 of the first stent 30 improves the frictional force between the outer peripheral surface 25a of the separating portion 25 and the inner peripheral surface 20b of the connecting portion 20 that are supported in a wavy shape. And since the amplitude of the 2nd stent 35 is formed small, the predetermined site
  • connection force between the first stent graft 22 and the second stent graft 26a can be greatly improved.
  • the second stent grafts 26 and 26a connected to the first stent graft 22 may be in contact with the narrow portion 48 with sufficient frictional force, and the configuration is not particularly limited.
  • the continuous portion side stent 31 is provided on the inner peripheral surface 20b side of the continuous portion 20 (first graft 28). Yes. And the protrusion part 44 which inclines and bends diagonally upwards in the top part of the peak part 38 of the connection part side stent 31 is also sewn on the inner peripheral surface 20b of the 1st graft 28.
  • the narrowed portion 48 a that narrows the inside of the flow passage 12 is formed by the protruding portion 44.
  • the shape support portion 54 of the separation portion 24 inserted into the continuous portion 20 is caught by the narrow portion 48a, and the connection force between the first stent graft 22a and the second stent graft 26 can be greatly improved.
  • the stent graft 10C (first stent graft 22b) according to the third modified example is different from the first stent graft 22a according to the second modified example, and is connected to the continuous surface 20b of the connecting portion 20.
  • the protruding portion 44 of the installation portion side stent 31 is configured to be inclined obliquely upward while being separated from the inner peripheral surface 20b. Therefore, the narrow portion 48 b that narrows the flow passage 12 inward is constituted by the strands of the protruding portion 44 of the continuous portion-side stent 31.
  • the shape support part 54 of the separation part 24 inserted in the continuous arrangement part 20 comes to be directly hooked on the protrusion part 44, and the connection force between the first stent graft 22b and the second stent graft 26 is greatly increased. Can be improved.
  • the projecting portion 44 is not continuously provided on the top portion of the continuous portion-side stent 31a, and the crest portion 38 and the trough portion 40 are provided.
  • the bulging member 62 (protruding part) is provided in the body part 42 between them. The bulging member 62 pushes the first graft 28 inward to form a raised portion 46 a on the inner peripheral surface 20 b of the connecting portion 20.
  • the shape support portion 54 of the separating portion 24 comes to be caught by the narrowed portion 48c, and the first stent graft 22c. And the connection force of the 2nd stent graft 26 can be improved significantly.
  • the narrow portion 48 narrowed inward by the protruding portion 44 of the first stent 30 is formed in the flow path 12,
  • the narrowed portion 48 can apply a strong frictional force to the outer peripheral surface 24a of the separation portion 24.
  • the narrow part 48 is simply comprised by the protrusion part 44 of the connection part side stent 31 which supports the 1st graft 28 so that expansion / contraction is possible, the 1st stent graft 22 can be manufactured easily.
  • the narrow portion 48 is provided by a simple forming method of bending the first stent 30 by forming the protrusion 44 by bending the top of the peak portion 38 of the continuous portion-side stent 31 obliquely inward. Can do. And since the protrusion part 44 is formed in the peak part 38 of the 1st stent 30, the fall of the elastic force of skeleton can be suppressed and the 1st graft 28 can be expanded and contracted favorably.
  • the separation portion 24 inserted into the flow passage 12 can be firmly connected along the axial direction. Therefore, the insertion amount of the separation part 24 can be adjusted with respect to the axial direction of the flow passage 12, and the separation part 24 can be firmly connected at the adjustment position.
  • the inner peripheral surface 20 b of the continuous portion 20 can be brought into surface contact with the outer peripheral surface 24 a of the separation portion 24.
  • the frictional force can be further improved.
  • the present invention has been described with reference to preferred embodiments.
  • the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention.
  • the stent graft 10 can be used not only for the treatment of the abdominal aortic aneurysm 100 but also for various treatments.
  • the shape of the stent graft 10 can be freely designed according to the treatment method and the treatment site.

Abstract

A stent graft (10) which is an indwelling device assembled body is formed by assembling a first stent graft (22) and a second stent graft (26). The first stent graft (22) has a flow channel (12) enclosed by a flexible first graft (28) and extending in the axial direction. The first graft (28) is provided with a first stent (30) that holds the first graft (28) so that the same can be enlarged or reduced. The first stent (30) has a projection section (44) that projects inward at a prescribed position of the first graft (28). Formed in the flow channel (12) is a narrow part (48) that is made narrow in the inward direction due to the projection section (44).

Description

留置デバイス及び留置デバイス組立体Indwelling device and indwelling device assembly
　本発明は、生体管腔の治療のために留置される留置デバイス及び留置デバイス組立体に関する。 The present invention relates to an indwelling device and an indwelling device assembly that are indwelled for treatment of a biological lumen.
　大動脈（生体管腔）のうち横隔膜の下側を下行する腹部大動脈は、動脈壁が弱くなる等の原因により腹部大動脈瘤が発生する。腹部大動脈瘤の治療としては、開腹して腹部大動脈を切除し人工血管に置換する人工血管置換術の他に、拡縮可能なステントグラフト（留置デバイス組立体）をデリバリーデバイスにより血管内を通して治療箇所に送達及び留置し、新たな血流路を形成するステントグラフト治療が実施されている（例えば、米国特許第６１１７１６７号明細書参照）。 In the abdominal aorta descending below the diaphragm of the aorta (biological lumen), an abdominal aortic aneurysm occurs due to a weakened arterial wall. For the treatment of abdominal aortic aneurysms, in addition to the artificial blood vessel replacement method in which the abdominal aorta is excised and replaced with an artificial blood vessel, an expandable stent graft (indwelling device assembly) is delivered to the treatment site through the blood vessel using a delivery device In addition, stent graft treatment is performed in which an indwelling and new blood flow path is formed (see, for example, US Pat. No. 6,117,167).
　ステントグラフト治療に用いられるステントグラフトは、腹部大動脈の中枢側に留置されるボディと、ボディを送達した側の総腸骨動脈に留置される同側レッグと、反対側の総腸骨動脈に留置される対側レッグとを有するＹ字形状に形成される。また、ステントグラフトは、血管内においてＹ字形状を呈するために、例えば、ボディ、同側レッグ、及び対側レッグの一部を有する第１ステントグラフトと、対側レッグの他部を有する第２ステントグラフトとからなる組立体に構成される。術者は、第１ステントグラフトを右総腸骨動脈から送達して腹部大動脈内で展開し、展開中に左総腸骨動脈から第２ステントグラフトを送達して、第１ステントグラフト内に挿入することにより両部材の接続を行う。 The stent graft used for stent graft treatment is placed in the central side of the abdominal aorta, the ipsilateral leg placed in the common iliac artery that delivered the body, and the opposite common iliac artery It is formed in a Y shape with a contralateral leg. In addition, the stent graft has, for example, a first stent graft having a body, an ipsilateral leg, and a part of the contralateral leg, and a second stent graft having the other part of the contralateral leg in order to exhibit a Y shape in the blood vessel. It is comprised in the assembly which consists of. By delivering the first stent graft from the right common iliac artery and deploying it in the abdominal aorta, and delivering the second stent graft from the left common iliac artery during deployment and inserting it into the first stent graft Connect both members.
　ところで、この種のステントグラフトは、血流によるずり応力や動脈圧、拍動等を受けることにより第１ステントグラフトから第２ステントグラフトが離脱するおそれがある。この場合、ステントグラフトにより構築した血流路が壊れることで、血液が瘤内に漏れて瘤の加圧が抑制できなくなる。そのため、ステントグラフトには、第１及び第２ステントグラフトの接続力（引き抜き強度）の向上が求められている。 By the way, this type of stent graft may be detached from the first stent graft by receiving shear stress due to blood flow, arterial pressure, pulsation, and the like. In this case, the blood flow path constructed by the stent graft is broken, so that blood leaks into the aneurysm and pressurization of the aneurysm cannot be suppressed. Therefore, the stent graft is required to improve the connection force (pullout strength) of the first and second stent grafts.
　例えば、米国特許第６１１７１６７号明細書に開示されているステントグラフトは、第１ステントグラフトの接続箇所が下端に向かって縮径したテーパ形状に形成され、第２ステントグラフトの接続箇所が上端に向かって拡径したテーパ形状に形成されている。これにより、両部材の接続状態では、テーパ部分が重ねられるので、その接続力が向上する。 For example, the stent graft disclosed in US Pat. No. 6,117,167 is formed in a tapered shape in which the connecting portion of the first stent graft is reduced in diameter toward the lower end, and the connecting portion of the second stent graft is expanded in diameter toward the upper end. The taper shape is formed. Thereby, in the connection state of both members, since a taper part is piled up, the connection force improves.
　また、米国特許第７２９４１４７号明細書に開示されているステントグラフトは、第１ステントグラフトの接続箇所のステントが外周面に設けられ、第２ステントグラフトの接続箇所のステントが内周面に設けられる。これにより、接続状態では、グラフト同士が接触することになり摩擦抵抗が増加するので、その接続力が向上する。 Also, in the stent graft disclosed in US Pat. No. 7,294,147, the stent at the connection site of the first stent graft is provided on the outer peripheral surface, and the stent at the connection site of the second stent graft is provided on the inner peripheral surface. Thereby, in a connection state, since grafts will contact and frictional resistance will increase, the connection force will improve.
　本発明は、生体管腔内において２つの部材を接続して留置するデバイスに関連してなされたものであり、簡単な構成によって、挿入される部材を強固に接続することができ、これにより生体管腔内に良好に留置され、病変部の治療を効果的に行うことができる留置デバイス及び留置デバイス組立体を提供することを目的とする。 The present invention has been made in connection with a device for connecting and placing two members in a living body lumen, and with a simple configuration, a member to be inserted can be firmly connected. It is an object of the present invention to provide an indwelling device and an indwelling device assembly that can be successfully placed in a lumen and can effectively treat a lesion.
　上記の目的を達成するために、本発明は、可撓性を有する周壁に囲われることで長尺な筒状に形成され、軸方向に延在する内部空間を有する留置デバイスであって、前記周壁には、該周壁を拡縮可能に支持する骨格が設けられ、前記骨格は、前記周壁の所定位置で内側に向かって突出する突出部を有することを特徴とする。 In order to achieve the above object, the present invention is an indwelling device which is formed in a long cylindrical shape by being surrounded by a flexible peripheral wall and has an internal space extending in the axial direction. The peripheral wall is provided with a skeleton that supports the peripheral wall so that the peripheral wall can be expanded and contracted, and the skeleton has a protruding portion that protrudes inward at a predetermined position of the peripheral wall.
　上記によれば、留置デバイスは、骨格が周壁の所定位置で内側に向かって突出する突出部を有することで、内部空間の軸方向の所定位置を内側に狭めた狭隘部を形成することができる。そのため、狭隘部を有する内部空間に対し、骨格を有する挿入デバイスを挿入すると、狭隘部に骨格が引っ掛かることになり、挿入デバイスの離脱を抑止することができる。また、狭隘部は、挿入デバイスの外周面に対し強い摩擦力を付与することもできる。これにより、留置デバイスは、挿入デバイスの接続が強固に維持されて生体管腔内に留置されるため、病変部の治療を効果的に行うことができる。また、突出部は、骨格に簡単に設けることが可能であり、留置デバイスを容易に製造することができる。 According to the above, the indwelling device can form a narrowed portion in which a predetermined position in the axial direction of the internal space is narrowed inward because the skeleton has a protruding portion that protrudes inward at a predetermined position of the peripheral wall. . Therefore, when the insertion device having a skeleton is inserted into the internal space having the narrow portion, the skeleton is caught in the narrow portion, and the detachment of the insertion device can be suppressed. In addition, the narrow portion can also impart a strong frictional force to the outer peripheral surface of the insertion device. Thereby, since the indwelling device is indwelled in the living body lumen while the connection of the insertion device is firmly maintained, the lesioned part can be effectively treated. Further, the protruding portion can be easily provided on the skeleton, and the indwelling device can be easily manufactured.
　この場合、前記骨格は、前記周壁の周方向に沿って山部と谷部を繰り返して延在する波状に形成されており、前記突出部は、前記山部の頂部を斜め内側に曲折して形成されることが好ましい。 In this case, the skeleton is formed in a wave shape that repeatedly extends a peak and a valley along the circumferential direction of the peripheral wall, and the projecting portion is bent obliquely inwardly at the top of the peak. Preferably it is formed.
　このように、突出部が山部の頂部を斜め内側に曲折して形成されることで、骨格を折り曲げるという簡単な形成方法によって突出部を設けることができる。また、骨格の山部に突出部が形成されることで、骨格の弾性力の低下を抑え、周壁の拡縮を良好に行うことができる。 Thus, the protrusion can be provided by a simple forming method of bending the skeleton by forming the protrusion by bending the top of the mountain portion obliquely inward. In addition, by forming the protruding portion at the peak portion of the skeleton, it is possible to suppress the decrease in the elastic force of the skeleton and to perform the expansion / contraction of the peripheral wall satisfactorily.
　また、前記骨格は、前記内部空間の軸方向に沿って複数設けられるとよい。 Further, it is preferable that a plurality of the skeletons are provided along the axial direction of the internal space.
　このように、骨格が内部空間の軸方向に沿って複数設けられることで、突出部が内部空間の軸方向に沿って複数配置される。そのため、内部空間に挿入される挿入デバイスを軸方向に沿って引っ掛けることができる。また、内部空間の軸方向に対し挿入デバイスの挿入量を調整し、その調整位置において挿入デバイスを強固に接続することもできる。 Thus, by providing a plurality of skeletons along the axial direction of the internal space, a plurality of protrusions are arranged along the axial direction of the internal space. Therefore, the insertion device inserted into the internal space can be hooked along the axial direction. Further, the insertion amount of the insertion device can be adjusted with respect to the axial direction of the internal space, and the insertion device can be firmly connected at the adjustment position.
　さらに、前記骨格は、前記周壁の外周面に設けられることで、前記突出部により前記周壁を内側に押し出して***部を形成することが好ましい。 Furthermore, it is preferable that the skeleton is provided on the outer peripheral surface of the peripheral wall, so that the protruding portion pushes the peripheral wall inward to form a raised portion.
　このように、骨格が周壁の外周面に設けられると、突出部により周壁を内側に押し出す***部を簡単に形成することができる。***部は、挿入デバイスの外周面に対して接触面積を増加させるため、部材同士の摩擦力を一層向上することができる。 Thus, when the skeleton is provided on the outer peripheral surface of the peripheral wall, it is possible to easily form a raised portion that pushes the peripheral wall inwardly by the protruding portion. Since the raised portion increases the contact area with respect to the outer peripheral surface of the insertion device, the frictional force between the members can be further improved.
　また、上記の目的を達成するために、本発明に係る留置デバイス組立体は、上述した構成を有する留置デバイスと、前記周壁によって構成される前記内部空間に挿入され、前記留置デバイスに接続される挿入デバイスとを含むことを特徴とする。 Moreover, in order to achieve said objective, the indwelling device assembly which concerns on this invention is inserted in the said interior space comprised by the indwelling device which has the structure mentioned above, and the said surrounding wall, and is connected to the said indwelling device. And an insertion device.
　このように、留置デバイスと挿入デバイスによって構成される留置デバイス組立体によれば、生体管腔内において両部材を強固に接続することができる。 Thus, according to the indwelling device assembly configured by the indwelling device and the insertion device, both members can be firmly connected in the living body lumen.
　また、前記挿入デバイスは、可撓性を有し前記周壁に接触可能な筒状部材と、素線が前記筒状部材の周方向に沿って延在し、前記筒状部材を支持するリング状骨格とを含むことが好ましい。 The insertion device includes a cylindrical member that is flexible and can contact the peripheral wall, and a ring shape in which a strand extends along a circumferential direction of the cylindrical member and supports the cylindrical member. It preferably includes a skeleton.
　このように、挿入デバイス側にリング状骨格が設けられることで、リング状骨格の素線が留置デバイスの突出部に対して間接的又は直接的に引っ掛かり易くなり、留置デバイスと挿入デバイスの接続力をさらに向上することができる。 Thus, by providing the ring-shaped skeleton on the insertion device side, the strands of the ring-shaped skeleton can be easily or indirectly caught on the protruding portion of the indwelling device, and the connection force between the indwelling device and the insertion device is increased. Can be further improved.
本実施形態に係る留置デバイス組立体の留置状態を示す概略説明図である。It is a schematic explanatory drawing which shows the indwelling state of the indwelling device assembly which concerns on this embodiment. 図２Ａは、図１の第１ステントグラフトを拡大して示す要部正面図であり、図２Ｂは、図１の第１ステントを示す斜視図であり、図２Ｃは、図２ＢのＩＩＣ－ＩＩＣ線の断面図である。2A is an enlarged front view of a main part of the first stent graft of FIG. 1, FIG. 2B is a perspective view of the first stent of FIG. 1, and FIG. 2C is a IIC-IIC line of FIG. 2B. FIG. 図１の連設部と分離部を接続した状態を示す要部拡大断面図である。It is a principal part expanded sectional view which shows the state which connected the connection part and isolation | separation part of FIG. 図４Ａは、ステントグラフトの使用方法を示す第１説明図であり、図４Ｂは、ステントグラフトの使用方法を示す第２説明図であり、図４Ｃはステントグラフトの使用方法を示す第３説明図である。FIG. 4A is a first explanatory diagram showing a method for using a stent graft, FIG. 4B is a second explanatory diagram showing a method for using a stent graft, and FIG. 4C is a third explanatory diagram showing a method for using a stent graft. 図５Ａは、第１変形例に係る連設部及び分離部を示す要部側面図であり、図５Ｂは、第２変形例に係る連設部を示す一部側面断面図であり、図５Ｃは、第３変形例に係る連設部を示す一部側面断面図であり、図５Ｄは、第４変形例に係る連設部を示す要部側面図である。FIG. 5A is a side view of a main part showing a connecting part and a separating part according to a first modification, and FIG. 5B is a partial side sectional view showing a connecting part according to a second modification. FIG. 5D is a partial side cross-sectional view showing a connecting portion according to a third modification, and FIG. 5D is a main part side view showing a connecting portion according to a fourth modification.
　以下、本発明に係る留置デバイス及び留置デバイス組立体について、その組立方法及び留置方法との関係で好適な実施の形態を挙げ、添付の図面を参照して詳細に説明する。 Hereinafter, an indwelling device and an indwelling device assembly according to the present invention will be described in detail with reference to the accompanying drawings by giving preferred embodiments in relation to the assembling method and the indwelling method.
　図１は、本実施形態に係る留置デバイス組立体１０の留置状態を示す概略説明図である。本実施形態に係る留置デバイス組立体１０は、腹部大動脈瘤１００の治療に用いられるステントグラフトとして構成されている（以下、留置デバイス組立体１０をステントグラフト１０ともいう）。腹部大動脈瘤１００（以下、単に瘤１００ともいう）は、例えば、腎動脈１０４の接続箇所の下側且つ総腸骨動脈１０６の上側の腹部大動脈１０２に発生し、紡錘状又は嚢状に形成される。ステントグラフト１０は、血管内インターベンション手技（血管内を通してステントグラフト１０を病変部に送達する手技）により、瘤１００の内部を挿通するように留置されて、新たな血流路を瘤１００内に構築するものである。 FIG. 1 is a schematic explanatory view showing an indwelling state of the indwelling device assembly 10 according to the present embodiment. The indwelling device assembly 10 according to the present embodiment is configured as a stent graft used for the treatment of the abdominal aortic aneurysm 100 (hereinafter, the indwelling device assembly 10 is also referred to as the stent graft 10). The abdominal aortic aneurysm 100 (hereinafter, also simply referred to as the aneurysm 100) is generated in the abdominal aorta 102 below the connection point of the renal artery 104 and above the common iliac artery 106, and is formed in a spindle shape or a sac shape. The The stent graft 10 is placed so as to pass through the inside of the aneurysm 100 by an intravascular intervention technique (a technique for delivering the stent graft 10 to the lesioned part through the blood vessel), and a new blood flow path is constructed in the aneurysm 100. Is.
　なお、図１の二点鎖線は、手術台に仰臥した患者側の生体器官を概略的に図示しており、生体器官の左右の区別は図中において逆になる。例えば、腹部大動脈１０２の下部に連なる２本の総腸骨動脈１０６は、図１中の左側に延在しているものが右総腸骨動脈１０８に相当し、図１中の右側に延在しているものが左総腸骨動脈１１０に相当する。 Note that the two-dot chain line in FIG. 1 schematically shows a living organ on the patient's side lying on the operating table, and the left / right distinction of the living organ is reversed in the figure. For example, two common iliac arteries 106 connected to the lower part of the abdominal aorta 102 correspond to the right common iliac artery 108 that extends to the left in FIG. 1 and extend to the right in FIG. This corresponds to the left common iliac artery 110.
　ステントグラフト１０は、筒体として形成され、その内部には腹部大動脈１０２内を流れる血液を流通可能な流通路１２（内部空間）が設けられている。また、ステントグラフト１０は、所定長さ延在するボディ１４（主筒部）と、ボディ１４に連設される同側レッグ１６（第１脚部）及び対側レッグ１８（第２脚部）とを有する。ボディ１４、同側及び対側レッグ１６、１８は、相互の連結部分を基点として互いに異なる方向に延在している。ステントグラフト１０を血管内に留置した状態では、ボディ１４が腹部大動脈１０２に配置され、同側レッグ１６が瘤１００内から右総腸骨動脈１０８にかけて配置され、対側レッグ１８が瘤１００内から左総腸骨動脈１１０にかけて配置されることで、全体的にＹ字形状を呈する。流通路１２は、ボディ１４、同側及び対側レッグ１６、１８の内部をそれぞれ軸方向に連通しており、腹部大動脈１０２から総腸骨動脈１０６への血液の流通を実現している。 The stent graft 10 is formed as a cylinder, and a flow passage 12 (internal space) through which blood flowing in the abdominal aorta 102 can flow is provided. The stent graft 10 includes a body 14 (main tube portion) extending a predetermined length, an ipsilateral leg 16 (first leg portion) and an opposite leg 18 (second leg portion) that are connected to the body 14. Have The body 14, the same side and the opposite legs 16, 18 extend in different directions from each other as a starting point. With the stent graft 10 placed in the blood vessel, the body 14 is placed in the abdominal aorta 102, the ipsilateral leg 16 is placed from the aneurysm 100 to the right common iliac artery 108, and the contralateral leg 18 is placed from the inside of the aneurysm 100 to the left. By being arranged over the common iliac artery 110, it exhibits a Y shape as a whole. The flow passage 12 communicates the inside of the body 14, the same side and the opposite legs 16, 18 in the axial direction, and realizes blood flow from the abdominal aorta 102 to the common iliac artery 106.
　ステントグラフト１０のボディ１４は、腹部大動脈１０２の血管壁に内側から密接されるように比較的太く形成され、これにともない流通路１２の内径も大きく形成されている。例えば、ボディ１４の寸法としては、軸方向の長さが４０～１４０ｍｍ程度、内径が２０～３６ｍｍ程度に設定するとよい。 The body 14 of the stent graft 10 is formed relatively thick so as to be in close contact with the blood vessel wall of the abdominal aorta 102 from the inside, and accordingly, the inner diameter of the flow passage 12 is also formed large. For example, the dimensions of the body 14 may be set to an axial length of about 40 to 140 mm and an inner diameter of about 20 to 36 mm.
　ボディ１４の上端部は、瘤１００の上側の健全部位（プロキシマルネック１０２ａ）に係止される。また、ボディ１４の上端部の反対側にある下端部は、瘤１００内において揺動自在の状態で同側及び対側レッグ１６、１８を支持している。 The upper end portion of the body 14 is locked to the healthy part (proxy circle neck 102a) on the upper side of the knob 100. Further, the lower end portion on the opposite side of the upper end portion of the body 14 supports the same leg and the opposite legs 16 and 18 while being swingable within the knob 100.
　ステントグラフト１０の同側及び対側レッグ１６、１８は、ボディ１４に比べて細く形成されており、流通路１２の内径も小さく形成されている。例えば、同側及び対側レッグ１６、１８の寸法としては、軸方向の長さが５０～２００ｍｍ程度、内径が８～２８ｍｍ程度に設定するとよい。同側及び対側レッグ１６、１８は、腹部大動脈１０２から総腸骨動脈１０６に至るように延在している。留置状態では、同側及び対側レッグ１６、１８の下部領域１６ａ、１８ａが、総腸骨動脈１０６の健全部位（ディスタルネック）に係止される。 The same side and opposite legs 16, 18 of the stent graft 10 are formed thinner than the body 14, and the inner diameter of the flow passage 12 is also formed smaller. For example, the dimensions of the ipsilateral and contralateral legs 16 and 18 may be set so that the axial length is about 50 to 200 mm and the inner diameter is about 8 to 28 mm. The ipsilateral and contralateral legs 16, 18 extend from the abdominal aorta 102 to the common iliac artery 106. In the indwelling state, the lower regions 16 a and 18 a of the ipsilateral and contralateral legs 16 and 18 are locked to a healthy site (distal neck) of the common iliac artery 106.
　また、ステントグラフト１０の対側レッグ１８は、図１中の接続箇所Ａにおいて上下に分離自在に構成されている。すなわち、本実施形態に係るステントグラフト１０は、ボディ１４、同側レッグ１６、及び対側レッグ１８の基端部（連設部２０：延在筒部）を有する第１ステントグラフト２２（留置デバイス）と、対側レッグ１８の末梢部（分離部２４）により構成される第２ステントグラフト２６（挿入デバイス）との接続により組み立てられる組立体である。なお、本実施形態において同側レッグ１６は、１つの筒体（延在筒部１７）として形成されているが、これに限定されず、同側レッグ１６が分離自在に構成されてよいことは勿論である。 Further, the opposite leg 18 of the stent graft 10 is configured to be separable up and down at a connection point A in FIG. That is, the stent graft 10 according to this embodiment includes a first stent graft 22 (an indwelling device) having a base end portion (continuous connection portion 20: an extending tube portion) of the body 14, the ipsilateral leg 16, and the opposite leg 18. , An assembly assembled by connection with a second stent graft 26 (insertion device) constituted by the distal portion (separation portion 24) of the contralateral leg 18. In addition, in this embodiment, although the ipsilateral leg 16 is formed as one cylinder (extended cylinder part 17), it is not limited to this, The ipsilateral leg 16 may be comprised detachably. Of course.
　第１ステントグラフト２２は、流通路１２を囲う可撓性を有する第１グラフト２８（周壁）と、第１グラフト２８の周方向に沿って延在し第１グラフト２８を拡縮可能に支持する第１ステント３０（骨格）とにより構成される。同様に、第２ステントグラフト２６も、流通路１２を囲う可撓性を有する第２グラフト３２（筒状部材）と、第２グラフト３２の周方向に沿って延在し第２グラフト３２を拡縮可能に支持する第２ステント３４により構成される。 The first stent graft 22 has a flexible first graft 28 (peripheral wall) that surrounds the flow passage 12, and a first graft 28 that extends along the circumferential direction of the first graft 28 and supports the first graft 28 so that the first graft 28 can expand and contract. And a stent 30 (skeleton). Similarly, the second stent graft 26 also extends along the circumferential direction of the second graft 32 (tubular member) having flexibility and surrounds the flow passage 12, and can expand and contract the second graft 32. The second stent 34 is supported by the second stent 34.
　第１及び第２グラフト２８、３２を構成する材料は、特に限定されるものではないが、生体適合性を有する織布、不織布、多孔質シート、又はその他のグラフト材料（血液不浸透性を有する材料）から形成されることが好ましい。生体適合性を有する材料としては、例えば、ポリエステル繊維、ｅＰＴＦＥ（延伸ポリテトラフルオロエチレン）、ポリウレタン等の人工素材が挙げられる。 The material constituting the first and second grafts 28 and 32 is not particularly limited, but is a biocompatible woven fabric, nonwoven fabric, porous sheet, or other graft material (having blood impermeability). The material is preferably formed from a material. Examples of the material having biocompatibility include artificial materials such as polyester fiber, ePTFE (expanded polytetrafluoroethylene), and polyurethane.
　第１及び第２ステント３０、３４は、収縮状態でシース３６、５２（図４Ｂ参照）内に収容され、シース３６、５２の外側に露出されると、自動的に拡張状態に移行する。このため、第１及び第２ステント３０、３４は、充分な弾性力を有する材料によって構成されることが好ましい。第１及び第２ステント３０、３４を構成する材料としては、例えば、ステンレス鋼、Ｎｉ－Ｔｉ合金、Ｃｕ－Ｚｎ合金、Ｎｉ－Ａｌ合金、タングステン、タングステン合金、チタン、チタン合金、タンタル等の各種金属や、ポリアミド、ポリイミド、超高分子量ポリエチレン、ポリプロピレン、フッ素系樹脂等の比較的高剛性の高分子材料、あるいは、これらを適宜組み合わせたもの等が挙げられる。また、Ｘ線造影性を有するように第１及び第２ステント３０、３４を構成することで、Ｘ線撮影下にステントグラフト治療を良好に実施させることができる。 The first and second stents 30 and 34 are accommodated in the sheaths 36 and 52 (see FIG. 4B) in a contracted state, and when the first and second stents 30 and 34 are exposed to the outside of the sheaths 36 and 52, the first and second stents 30 and 34 are automatically shifted to an expanded state. For this reason, it is preferable that the first and second stents 30 and 34 are made of a material having sufficient elastic force. Examples of the material constituting the first and second stents 30 and 34 include various materials such as stainless steel, Ni—Ti alloy, Cu—Zn alloy, Ni—Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, and tantalum. Examples thereof include metals, relatively high-rigidity polymer materials such as polyamide, polyimide, ultrahigh molecular weight polyethylene, polypropylene, and fluororesin, or combinations of these appropriately. In addition, by configuring the first and second stents 30 and 34 to have X-ray contrast properties, it is possible to satisfactorily perform stent graft treatment under X-ray imaging.
　なお、第１及び第２ステント３０、３４は、上記の構造に限定されるものではなく、第１及び第２グラフト２８、３２を拡縮自在に支持可能な種々の構成を採り得る。例えば、第１及び第２ステント３０、３４は、自己拡張することで収縮状態から拡張状態に移行する構造だけでなく、拡張デバイス（バルーン等）によって拡張する構造を採用してもよい。 It should be noted that the first and second stents 30 and 34 are not limited to the above-described structures, and can adopt various configurations that can support the first and second grafts 28 and 32 in a freely expandable and contractible manner. For example, the first and second stents 30 and 34 may employ not only a structure that shifts from a contracted state to an expanded state by self-expansion, but also a structure that is expanded by an expansion device (such as a balloon).
　図２Ａは、図１の第１ステントグラフト２２を拡大して示す要部正面図であり、図２Ｂは、図１の第１ステント３０を示す斜視図であり、図２Ｃは、図２ＢのＩＩＣ－ＩＩＣ線の断面図であり、図３は、図１の連設部２０と分離部２４を接続した状態を示す要部拡大断面図である。 2A is an enlarged front view of a main part of the first stent graft 22 shown in FIG. 1, FIG. 2B is a perspective view showing the first stent 30 shown in FIG. 1, and FIG. FIG. 3 is a cross-sectional view taken along the line IIC, and FIG. 3 is an enlarged cross-sectional view of a main part showing a state where the continuous portion 20 and the separation portion 24 of FIG. 1 are connected.
　第１ステントグラフト２２の連設部２０は、図１及び図２Ａに示すように、対側レッグ１８の上側部分を構成し、同側レッグ１６と同じ高さ位置（連設箇所）でボディ１４に連なる。連設部２０の延在長さは、同側レッグ１６の延在長さよりも短い。従って、第１ステントグラフト２２は、Ｙ字形状の一方（対側レッグ１８）が部分的に欠けた外形に形成されている。連設部２０の下端部には、流通路１２に連通する開口部２０ａが形成されており、第２ステントグラフト２６を挿入可能としている。 As shown in FIG. 1 and FIG. 2A, the continuous portion 20 of the first stent graft 22 constitutes the upper portion of the opposite leg 18, and is located on the body 14 at the same height position (continuous portion) as the same side leg 16. It is a series. The extension length of the continuous portion 20 is shorter than the extension length of the ipsilateral leg 16. Therefore, the first stent graft 22 is formed in an outer shape in which one of the Y-shaped parts (the opposite leg 18) is partially missing. An opening 20a communicating with the flow passage 12 is formed at the lower end of the continuous portion 20, so that the second stent graft 26 can be inserted.
　分離部２４（第２ステントグラフト２６）は、開口部２０ａから流通路１２に挿入された状態で拡張可能に構成される。分離部２４の拡張状態の外径は、連設部２０の内径よりも若干大きく形成されており、その拡張状態で、分離部２４の外周面２４ａが連設部２０の内周面２０ｂに密接する。 The separation portion 24 (second stent graft 26) is configured to be expandable while being inserted into the flow passage 12 from the opening 20a. The outer diameter of the separating portion 24 in the expanded state is slightly larger than the inner diameter of the connecting portion 20, and the outer peripheral surface 24 a of the separating portion 24 is in close contact with the inner peripheral surface 20 b of the connecting portion 20 in the expanded state. To do.
　また、本実施形態に係る連設部２０及び分離部２４は、第１ステント３０と第２ステント３４の構成に基づき互いの接続力が増すように構成されている。以下、これら連設部２０及び分離部２４の構成について具体的に説明していく。 Further, the connecting portion 20 and the separating portion 24 according to the present embodiment are configured such that the connection force between the first stent 30 and the second stent 34 is increased based on the configuration of the first stent 30 and the second stent 34. Hereinafter, the configuration of the continuous portion 20 and the separation portion 24 will be specifically described.
　図１及び図２Ａ～図２Ｃに示すように、第１ステント３０は、上下に振幅しつつ周方向に沿って延在する波状（Ｚ状骨格）に形成され、第１グラフト２８の外周面に縫い付けられている。一方、第２ステントグラフト２６を支持する第２ステント３４は、素線が周方向に沿って延在するリング状（リング状骨格）に形成されて、第２グラフト３２の内周面に縫い付けられている。 As shown in FIG. 1 and FIGS. 2A to 2C, the first stent 30 is formed in a wave shape (Z-shaped skeleton) extending along the circumferential direction while swinging up and down, and is formed on the outer peripheral surface of the first graft 28. It is sewn. On the other hand, the second stent 34 that supports the second stent graft 26 is formed in a ring shape (ring-shaped skeleton) in which the strands extend along the circumferential direction, and is sewn to the inner peripheral surface of the second graft 32. ing.
　同側レッグ１６及び連設部２０を支持する第１ステント３０は、第１グラフト２８の周方向に沿って３つの山部３８と、３つの谷部４０とを有し、さらに山部３８と谷部４０間を連結する６つの胴体部４２により構成されている。換言すれば、第１ステント３０は、山部３８と谷部４０の振幅を３回繰り返して一周する無端状に形成されている。隣り合う山部３８同士又は谷部４０同士の間隔は均等に設定され、また山部３８と谷部４０の上下の高さ位置（山部３８と谷部４０の振幅）も等しく設定されている。 The first stent 30 that supports the ipsilateral leg 16 and the connecting portion 20 includes three crests 38 and three troughs 40 along the circumferential direction of the first graft 28, It is comprised by the six trunk | drum parts 42 which connect between the valley parts 40. FIG. In other words, the first stent 30 is formed in an endless shape that makes a round by repeating the amplitude of the crest 38 and the trough 40 three times. The intervals between the adjacent peak portions 38 or the valley portions 40 are set evenly, and the vertical positions of the peaks 38 and the valley portions 40 (the amplitudes of the peak portions 38 and the valley portions 40) are also set equal. .
　そして、連設部２０を支持する第１ステント３０（以下、連設部側ステント３１という）の各山部３８の頂部には、胴体部４２から径方向内側に向かって所定角度で曲折する（すなわち、斜め上方向に突出する）突出部４４が形成されている。連設部２０の外周面では、連設部側ステント３１の谷部４０及び胴体部４２が連設部２０の軸方向に平行しており、山部３８の頂部のみが曲げられて第１グラフト２８を内側に押し込むように作用する。 Then, the top portion of each peak portion 38 of the first stent 30 (hereinafter referred to as the continuous portion side stent 31) that supports the continuous portion 20 is bent at a predetermined angle from the body portion 42 toward the radially inner side ( That is, a projecting portion 44 that projects obliquely upward is formed. On the outer peripheral surface of the continuous portion 20, the valley portion 40 and the body portion 42 of the continuous portion side stent 31 are parallel to the axial direction of the continuous portion 20, and only the top portion of the peak portion 38 is bent to form the first graft. It acts to push 28 inward.
　そのため、流通路１２には、突出部４４により内側に狭められた狭隘部４８が形成される。具体的には、連設部２０の内周面２０ｂのうち突出部４４が重なる部分に、突出部４４によって第１グラフト２８が径方向内側に押し出される***部４６が形成される。***部４６は、連設部側ステント３１の波状に対応して連設部２０の周方向に沿って等間隔に３つ形成され（図２Ｃ参照）、この３つの***部４６により流通路１２を径方向に部分的に狭める狭隘部４８が構築される。 Therefore, a narrow portion 48 narrowed inward by the protruding portion 44 is formed in the flow passage 12. Specifically, a protruding portion 46 is formed on the inner peripheral surface 20b of the connecting portion 20 where the protruding portion 44 overlaps, and the protruding portion 44 pushes the first graft 28 radially inward. Three raised portions 46 are formed at equal intervals along the circumferential direction of the continuous portion 20 corresponding to the wave shape of the continuous portion side stent 31 (see FIG. 2C), and the flow passage 12 is formed by the three raised portions 46. A narrow portion 48 is constructed that partially narrows in the radial direction.
　狭隘部４８は、流通路１２の軸方向の所定位置を内側に狭くすることで、分離部２４の第２ステント３４を引っ掛ける機能を有する。また、狭隘部４８は、連設部２０の内周面２０ｂと分離部２４の外周面２４ａの摩擦力を増して、連設部２０と分離部２４の接続力を向上させる。 The narrow portion 48 has a function of hooking the second stent 34 of the separation portion 24 by narrowing a predetermined position in the axial direction of the flow passage 12 inward. Further, the narrow portion 48 increases the frictional force between the inner peripheral surface 20 b of the connecting portion 20 and the outer peripheral surface 24 a of the separating portion 24, thereby improving the connection force between the connecting portion 20 and the separating portion 24.
　さらに、狭隘部４８は、均等間隔（１２０°間隔）に設けられた３つの***部４６により連設部２０の周方向を部分的に狭めている。そのため、接続作業においてカニュレーションを行う際に、***部４６を避けるようにガイドワイヤ５０（図４Ｂ参照）を進出させることができる。なお、***部４６の数及び位置は、特に限定されるものではないが、２以上の***部４６によって構成され、隣り合う***部４６同士が互いに均等間隔となる位置に形成されるとよい。このように２以上の***部４６を有すると、狭隘部４８は、連設部２０の内周面２０ｂを均等に（一方に偏らずに）狭めることができる。 Furthermore, the narrowed portion 48 partially narrows the circumferential direction of the continuous portion 20 by three raised portions 46 provided at equal intervals (120 ° intervals). Therefore, when cannulation is performed in the connection work, the guide wire 50 (see FIG. 4B) can be advanced so as to avoid the raised portion 46. The number and positions of the raised portions 46 are not particularly limited, but may be formed by two or more raised portions 46, and the adjacent raised portions 46 may be formed at equal intervals. Thus, when it has two or more raised parts 46, the narrow part 48 can narrow the inner peripheral surface 20b of the connection part 20 equally (it is not biased to one side).
　斜め上方に突出した突出部４４は、第２ステントグラフト２６を収容したシース３６（図４Ｂ参照）の進出移動を許容し易くする一方で、展開後の第２ステントグラフト２６の抜け方向に強い抵抗力を付与することができる。 The projecting portion 44 projecting obliquely upward facilitates allowing the sheath 36 (see FIG. 4B) containing the second stent graft 26 to advance, while providing a strong resistance force in the direction in which the second stent graft 26 is deployed. Can be granted.
　狭隘部４８を形成する連設部側ステント３１の突出部４４は、連設部２０に対する分離部２４の挿入接続の状態を勘案して、その突出量及び傾斜角度を適切に設定することが好ましい。仮に、突出部４４の突出量を多くして流通路１２の内側を大幅に狭くすると、分離部２４の挿入時にシース３６やガイドワイヤ５０が狭隘部４８に引っ掛かり易くなる。突出部４４の好適な形状としては、例えば、流通路１２の内径に対し１０～２０％程度内側に突出した突出量、４０°～６５°程度の傾斜角度に設定するとよい。特に、突出部４４は、第２ステント３４の素線の太さに対してその突出量が多いと、第２ステント３４を引っ掛け易くなる。 The protruding portion 44 of the continuous portion side stent 31 forming the narrowed portion 48 is preferably set appropriately with respect to the protruding amount and the inclination angle in consideration of the insertion connection state of the separating portion 24 with respect to the continuous portion 20. . If the protruding amount of the protruding portion 44 is increased and the inside of the flow passage 12 is significantly narrowed, the sheath 36 and the guide wire 50 are easily caught by the narrowed portion 48 when the separating portion 24 is inserted. As a suitable shape of the projecting portion 44, for example, a projecting amount projecting inward by about 10 to 20% with respect to the inner diameter of the flow passage 12 and an inclination angle of about 40 ° to 65 ° may be set. In particular, if the protruding portion 44 has a large protruding amount with respect to the thickness of the strand of the second stent 34, the second stent 34 is easily hooked.
　一方、リング状の第２ステント３４は、図３に示すように、その弾性力によって分離部２４の外周面２４ａを連設部２０の内周面２０ｂに面接触させる。この第２ステント３４は、分離部２４の軸方向と直交するように設けられて第２グラフト３２を内側から外側に押し出すことで、分離部２４の外周面２４ａに比較的高い剛性を有する形状支持部５４を形成する。この形状支持部５４は、狭隘部４８に引っ掛かることで、連設部２０と分離部２４の接続力（引き抜き強度）を向上させることができる。 On the other hand, as shown in FIG. 3, the ring-shaped second stent 34 brings the outer peripheral surface 24 a of the separating portion 24 into surface contact with the inner peripheral surface 20 b of the connecting portion 20 by its elastic force. The second stent 34 is provided so as to be orthogonal to the axial direction of the separating portion 24 and pushes the second graft 32 from the inside to the outside, thereby supporting the shape of the outer peripheral surface 24a of the separating portion 24 having relatively high rigidity. A portion 54 is formed. The shape support portion 54 can be connected to the connecting portion 20 and the separation portion 24 by being hooked on the narrow portion 48 (drawing strength).
　なお、第２ステント３４は、分離部２４（第２グラフト３２）の外周面２４ａ側に設けられてもよい。この場合、第２ステント３４を容易に取り付けることができるとともに、第２ステント３４を狭隘部４８に直接的に引っ掛けることが可能となる。 In addition, the 2nd stent 34 may be provided in the outer peripheral surface 24a side of the isolation | separation part 24 (2nd graft 32). In this case, the second stent 34 can be easily attached and the second stent 34 can be directly hooked on the narrow portion 48.
　また、図２Ａ及び図３に示すように、連設部２０は、連設部側ステント３１が軸方向に沿って複数（図２Ａ中では３つ）取り付けられることで、狭隘部４８を３つ並設した構成となっている。隣り合う連設部側ステント３１同士の取付間隔Ｄ１は、連設部側ステント３１の山部３８と谷部４０の振幅よりも若干広く設定されている。具体的には、下側の連設部側ステント３１の山部３８（突出部４４）と上側の連設部側ステント３１の谷部４０の間に第２ステント３４の太さ程度の幅αが形成されるように設定されている。このように連設部側ステント３１の取付間隔Ｄ１を設定すると、連設部２０の耐キンク性を高め、分離部２４との接続をより容易に行うことができる。また、形状支持部５４を狭隘部４８の上部に配置し易くなり、両部の引っ掛かりを促進することができる。なお、連設部側ステント３１の取付間隔Ｄ１は、特に限定されるものではなく、例えば、下側の連設部側ステント３１の山部３８と上側の連設部側ステント３１の谷部４０の間がゼロ以下であってもよい。 As shown in FIGS. 2A and 3, the continuous portion 20 includes three narrow portions 48 by attaching a plurality (three in FIG. 2A) of continuous portion side stents 31 along the axial direction. It is a side-by-side configuration. The attachment interval D1 between the adjacent continuous portion side stents 31 is set to be slightly wider than the amplitudes of the peak portions 38 and the valley portions 40 of the continuous portion side stent 31. Specifically, the width α of the thickness of the second stent 34 between the peak portion 38 (projecting portion 44) of the lower continuous portion side stent 31 and the valley portion 40 of the upper continuous portion side stent 31. Is set to be formed. Thus, if the attachment space | interval D1 of the connection part side stent 31 is set, the kink resistance of the connection part 20 can be improved and the connection with the isolation | separation part 24 can be performed more easily. Moreover, it becomes easy to arrange | position the shape support part 54 on the upper part of the narrow part 48, and the catch of both parts can be accelerated | stimulated. The attachment interval D1 of the continuous portion side stent 31 is not particularly limited. For example, the peak portion 38 of the lower continuous portion side stent 31 and the valley portion 40 of the upper continuous portion side stent 31 are provided. It may be zero or less.
　さらに、分離部２４の軸方向に並ぶ第２ステント３４の取付間隔Ｄ２は、連設部側ステント３１の取付間隔Ｄ１に比べて短く設定されることが好ましい。このように第２ステント３４の取付間隔Ｄ２を短くすることで、複数の第２ステント３４によって構成される複数の形状支持部５４のいずれかが３つの狭隘部４８のいずれかに引っ掛かり易くなる。そのため、連設部２０と分離部２４の接続力をより向上することができる。なお、図３に示すように、第２ステント３４の取付間隔Ｄ２を連設部側ステント３１の取付間隔Ｄ１の半分に設定すると、複数の狭隘部４８のそれぞれに第２ステント３４を引っ掛けることもでき、連設部２０と分離部２４の接続力をさらに向上することができる。 Furthermore, it is preferable that the attachment interval D2 of the second stents 34 arranged in the axial direction of the separation portion 24 is set shorter than the attachment interval D1 of the continuous portion side stent 31. As described above, by shortening the attachment interval D2 of the second stent 34, any of the plurality of shape support portions 54 constituted by the plurality of second stents 34 is easily caught on any of the three narrow portions 48. Therefore, the connection force between the continuous portion 20 and the separation portion 24 can be further improved. As shown in FIG. 3, when the attachment interval D2 of the second stent 34 is set to half of the attachment interval D1 of the continuous portion side stent 31, the second stent 34 may be hooked on each of the narrow portions 48. In addition, the connection force between the continuous portion 20 and the separation portion 24 can be further improved.
　そして、本実施形態に係るステントグラフト１０は、連設部２０の軸方向に並ぶ３つの狭隘部４８、又は分離部２４の軸方向に並ぶ複数の形状支持部５４により、連設部２０と分離部２４の互いの接続位置を調節することが可能となる。よって、組立てられた対側レッグ１８の長さを調整することにより、例えば、腹部大動脈１０２や左総腸骨動脈１１０の形状に応じてステントグラフト１０を一層良好に留置することができる等、ステントグラフト１０の汎用性が高まる。 The stent graft 10 according to the present embodiment includes the continuous portion 20 and the separation portion by the three narrow portions 48 aligned in the axial direction of the continuous portion 20 or the plurality of shape support portions 54 aligned in the axial direction of the separation portion 24. It becomes possible to adjust the connection position of 24 each other. Therefore, by adjusting the length of the assembled contralateral leg 18, the stent graft 10 can be placed more satisfactorily according to the shape of the abdominal aorta 102 or the left common iliac artery 110, for example. Increased versatility.
　本実施形態に係るステントグラフト１０（第１及び第２ステントグラフト２２、２６）は、基本的には以上のように構成されるものであり、以下、その作用及び効果についてステントグラフト１０の血管内留置操作との関係で説明する。 The stent graft 10 (first and second stent grafts 22 and 26) according to the present embodiment is basically configured as described above. Hereinafter, the operation and effect of the stent graft 10 will be described as an intravascular placement operation. This will be explained in relation to
　本実施形態に係るステントグラフト１０は、上述したように、腹部大動脈１０２に発生する腹部大動脈瘤（瘤１００）の治療に好適に使用される。このステントグラフト治療の実施前には、患者の病変部である瘤１００付近のＸ線撮影が行われ、瘤１００の位置や形状が特定される。 The stent graft 10 according to the present embodiment is suitably used for the treatment of an abdominal aortic aneurysm (aneurysm 100) that occurs in the abdominal aorta 102 as described above. Before this stent graft treatment is performed, X-ray imaging of the vicinity of the aneurysm 100 that is a lesioned part of the patient is performed, and the position and shape of the aneurysm 100 are specified.
　ステントグラフト治療においては、術者が患者の右太腿部の鼠径部を切開し、ガイドワイヤ５８を切開部分から経皮的に挿入した後、第１ステントグラフト２２が収容されている第１デリバリーデバイス５６をガイドワイヤ５８に沿って送達する。そして、図４Ａに示すように、第１デリバリーデバイス５６のシース５２を後退移動させて第１ステントグラフト２２を拡張（展開）し、ボディ１４の上端部をプロキシマルネック１０２ａに係止し、ボディ１４、同側レッグ１６の一部、及び対側レッグ１８の連設部２０を、瘤１００内において拡張する。この際、第１ステント３０が第１グラフト２８を拡張させて、連設部側ステント３１の突出部４４により流通路１２を狭める狭隘部４８を形成する。 In the stent graft treatment, the operator cuts the inguinal portion of the patient's right thigh and inserts the guide wire 58 percutaneously through the cut portion, and then the first delivery device 56 in which the first stent graft 22 is accommodated. Are delivered along the guidewire 58. Then, as shown in FIG. 4A, the sheath 52 of the first delivery device 56 is moved backward to expand (deploy) the first stent graft 22, and the upper end of the body 14 is locked to the proximal neck 102a. A part of the same leg 16 and the connecting portion 20 of the opposite leg 18 are expanded in the knob 100. At this time, the first stent 30 expands the first graft 28 to form a narrow portion 48 that narrows the flow passage 12 by the protruding portion 44 of the continuous portion-side stent 31.
　次に、術者は、患者の左太腿部の鼠径部を切開し、ガイドワイヤ５０を左総腸骨動脈１１０から瘤１００内に送達し、さらに第１ステントグラフト２２の流通路１２内にガイドワイヤ５０を挿入するカニュレーションを実施する。このカニュレーションにおいて、ガイドワイヤ５０が連設部２０内の***部４６に接触しても、***部４６の周方向に容易に避けることでスムーズに進出移動する。 Next, the surgeon incises the groin of the left thigh of the patient, delivers the guide wire 50 from the left common iliac artery 110 into the aneurysm 100, and further guides into the flow passage 12 of the first stent graft 22. A cannulation for inserting the wire 50 is performed. In this cannulation, even if the guide wire 50 comes into contact with the raised portion 46 in the continuous portion 20, the guide wire 50 moves smoothly by avoiding it easily in the circumferential direction of the raised portion 46.
　その後、図４Ｂに示すように、第２ステントグラフト２６が収容されている第２デリバリーデバイス６０をガイドワイヤ５０に沿って送達し、連設部２０内に挿入する。連設部２０に対する分離部２４の挿入量は、予め特定した左総腸骨動脈１１０の形状に基づき、Ｘ線撮影下に適宜調整することができる。そして、分離部２４の挿入量が調整された位置で第２デリバリーデバイス６０のシース３６を後退移動して分離部２４を露出する。 Thereafter, as shown in FIG. 4B, the second delivery device 60 in which the second stent graft 26 is accommodated is delivered along the guide wire 50 and inserted into the connecting portion 20. The insertion amount of the separation unit 24 with respect to the continuous unit 20 can be adjusted as appropriate under X-ray imaging based on the shape of the left common iliac artery 110 specified in advance. Then, the sheath 36 of the second delivery device 60 is moved backward at the position where the amount of insertion of the separation unit 24 is adjusted to expose the separation unit 24.
　これにより、図３に示すように、分離部２４の第２ステント３４が第２グラフト３２を径方向外側に拡張する。連設部２０では、狭隘部４８により第１グラフト２８を径方向内側に押し出しており、連設部２０の内周面２０ｂと分離部２４の外周面２４ａが互いを押し付け合うように作用する。そのため、第１及び第２グラフト２８、３２の接触面の摩擦力が増加し、第１及び第２ステントグラフト２２、２６の接続を強固にする。また、分離部２４の形状支持部５４が狭隘部４８の上側に引っ掛かることで、第１及び第２ステントグラフト２２、２６の接続力を一層高めることができる。 Thereby, as shown in FIG. 3, the second stent 34 of the separating portion 24 expands the second graft 32 radially outward. In the continuous portion 20, the first graft 28 is pushed radially inward by the narrowed portion 48, and the inner peripheral surface 20 b of the continuous portion 20 and the outer peripheral surface 24 a of the separating portion 24 act so as to press each other. Therefore, the frictional force of the contact surfaces of the first and second grafts 28 and 32 is increased, and the connection between the first and second stent grafts 22 and 26 is strengthened. Further, since the shape support portion 54 of the separation portion 24 is hooked on the upper side of the narrow portion 48, the connection force of the first and second stent grafts 22 and 26 can be further increased.
　このようにステントグラフト１０を組み立てると、例えば、図４Ｃに示すように、対側レッグ１８の流通路１２に血液が流れて、分離部２４（第２ステントグラフト２６）に血液からの圧力がかかり、連設部２０と相対的に分離部２４を下方向に押し下げようとする。この場合、ステントグラフト１０は、分離部２４の下方向の移動によって、連設部２０に設けられた狭隘部４８に形状支持部５４が積極的に引っ掛かることになる。すなわち、第１ステント３０の突出部４４が斜め上方に傾いていることで、***部４６が分離部２４の下方向の移動に高い抵抗力を持ち、分離部２４の下方向の移動により突出部４４を内側に一層屈曲させるように弾性変形する。そのため、分離部２４の下方向の移動にともない***部４６がより内側に狭まるように作用し、形状支持部５４が狭隘部４８に引っ掛かる。これにより、連設部２０からの分離部２４の離脱が抑止される。 When the stent graft 10 is assembled in this manner, for example, as shown in FIG. 4C, blood flows into the flow passage 12 of the opposite leg 18 and pressure from the blood is applied to the separation portion 24 (second stent graft 26), and the communication is performed. An attempt is made to push down the separating portion 24 relative to the installation portion 20. In this case, the shape support portion 54 of the stent graft 10 is positively hooked to the narrow portion 48 provided in the continuous portion 20 due to the downward movement of the separation portion 24. That is, the protruding portion 44 of the first stent 30 is inclined obliquely upward, so that the raised portion 46 has high resistance to the downward movement of the separating portion 24, and the protruding portion is caused by the downward movement of the separating portion 24. It is elastically deformed so that 44 is further bent inward. Therefore, as the separating portion 24 moves downward, the raised portion 46 acts so as to narrow further inward, and the shape support portion 54 is caught by the narrow portion 48. Thereby, the separation | separation of the separation part 24 from the connection part 20 is suppressed.
　以上のように、第１ステントグラフト２２と第２ステントグラフト２６の接続（組立）がなされると、第１及び第２デリバリーデバイス５６、６０のシース５２、３６をさらに後退移動して同側及び対側レッグ１６、１８を総腸骨動脈１０６に展開する。ステントグラフト１０の展開後は、第１及び第２デリバリーデバイス５６、６０、ガイドワイヤ５８、５０を抜去することで、ステントグラフト１０の血管内留置操作が終了する。 As described above, when the first stent graft 22 and the second stent graft 26 are connected (assembled), the sheaths 52 and 36 of the first and second delivery devices 56 and 60 are further retracted to the same side and the opposite side. The legs 16 and 18 are deployed in the common iliac artery 106. After the deployment of the stent graft 10, the first and second delivery devices 56, 60 and the guide wires 58, 50 are removed, and the intravascular placement operation of the stent graft 10 is completed.
　なお、ステントグラフト１０は、上記の構成に限定されないことは勿論であり、第１ステントグラフト２２と第２ステントグラフト２６の接続力を強固することが可能な種々の構成を適用することができる。以下、本発明に係るステントグラフトの他の構成例（変形例）についていくつか例示していく。なお、以下の説明において、本実施形態に係るステントグラフト１０と同一の構成又は同一の機能を有する構成については、同一の符号を付し、その詳細な説明については省略する。 Of course, the stent graft 10 is not limited to the above-described configuration, and various configurations capable of strengthening the connection force between the first stent graft 22 and the second stent graft 26 can be applied. Hereinafter, some examples of other configurations (modifications) of the stent graft according to the present invention will be exemplified. In addition, in the following description, the same code | symbol is attached | subjected about the structure same as the stent graft 10 concerning this embodiment, or the structure which has the same function, and the detailed description is abbreviate | omitted.
　図５Ａに示すように、第１変形例に係るステントグラフト１０Ａは、分離部２５（第２ステントグラフト２６ａ）の第２ステント３５が、波状（Ｚ型ステント）に形成されている点で、本実施形態に係るステントグラフト１０と異なる。具体的には、第２ステント３５（波状骨格）は、第２グラフト３２の内周面に複数設けられ、且つ第２グラフト３２の周方向に沿って連設部側ステント３１と同数の山部３５ａと谷部３５ｂを有して延在している。そのため、分離部２５の外周面２５ａには第２ステント３５に応じて波状の形状支持部５５が形成される。また、第２ステント３５の山部３５ａと谷部３５ｂの間隔（振幅）は、第１ステント３０の振幅よりも小さく形成されている。 As shown in FIG. 5A, the stent graft 10A according to the first modified example is different from the first embodiment in that the second stent 35 of the separating portion 25 (second stent graft 26a) is formed in a wavy shape (Z-type stent). It differs from the stent graft 10 concerning. Specifically, a plurality of second stents 35 (wavy skeletons) are provided on the inner peripheral surface of the second graft 32, and the same number of peaks as the continuous portion side stent 31 along the circumferential direction of the second graft 32. It has 35a and a trough 35b. Therefore, a wavy shape support portion 55 is formed on the outer peripheral surface 25 a of the separation portion 25 according to the second stent 35. Further, the interval (amplitude) between the crest 35 a and the trough 35 b of the second stent 35 is formed smaller than the amplitude of the first stent 30.
　このように、波状の第２ステント３５を分離部２５に設けた構成でも、連設部２０（第１ステントグラフト２２）に強固に接続することができる。すなわち、第１ステント３０の突出部４４により形成される狭隘部４８は、波状に支持される分離部２５の外周面２５ａと連設部２０の内周面２０ｂとの摩擦力を向上させる。そして、第２ステント３５の振幅が小さく形成されていることで、第１ステント３０の***部４６に対していずれかの形状支持部５５の所定部位（例えば、山部３５ａ）を容易に引っ掛けることができる。よって、第１ステントグラフト２２と第２ステントグラフト２６ａの接続力を大幅に向上することができる。要するに、第１ステントグラフト２２に接続される第２ステントグラフト２６、２６ａは、狭隘部４８に対し充分な摩擦力をもって接触可能であればよく、その構成は特に限定されるものではない。 Thus, even in the configuration in which the wavy second stent 35 is provided in the separation portion 25, it can be firmly connected to the continuous portion 20 (first stent graft 22). That is, the narrow portion 48 formed by the protruding portion 44 of the first stent 30 improves the frictional force between the outer peripheral surface 25a of the separating portion 25 and the inner peripheral surface 20b of the connecting portion 20 that are supported in a wavy shape. And since the amplitude of the 2nd stent 35 is formed small, the predetermined site | part (for example, peak part 35a) of any shape support part 55 is easily hooked with respect to the protruding part 46 of the 1st stent 30. Can do. Therefore, the connection force between the first stent graft 22 and the second stent graft 26a can be greatly improved. In short, the second stent grafts 26 and 26a connected to the first stent graft 22 may be in contact with the narrow portion 48 with sufficient frictional force, and the configuration is not particularly limited.
　図５Ｂに示すように、第２変形例に係るステントグラフト１０Ｂ（第１ステントグラフト２２ａ）は、連設部側ステント３１が連設部２０（第１グラフト２８）の内周面２０ｂ側に設けられている。そして、連設部側ステント３１の山部３８の頂部において斜め上方に傾斜して曲折する突出部４４も第１グラフト２８の内周面２０ｂに縫い付けられている。このように構成しても、突出部４４により流通路１２の内側を狭める狭隘部４８ａが形成される。その結果、連設部２０に挿入された分離部２４の形状支持部５４が狭隘部４８ａに引っ掛かるようになり、第１ステントグラフト２２ａと第２ステントグラフト２６の接続力を大幅に向上することができる。 As shown in FIG. 5B, in the stent graft 10B (first stent graft 22a) according to the second modification, the continuous portion side stent 31 is provided on the inner peripheral surface 20b side of the continuous portion 20 (first graft 28). Yes. And the protrusion part 44 which inclines and bends diagonally upwards in the top part of the peak part 38 of the connection part side stent 31 is also sewn on the inner peripheral surface 20b of the 1st graft 28. FIG. Even in this configuration, the narrowed portion 48 a that narrows the inside of the flow passage 12 is formed by the protruding portion 44. As a result, the shape support portion 54 of the separation portion 24 inserted into the continuous portion 20 is caught by the narrow portion 48a, and the connection force between the first stent graft 22a and the second stent graft 26 can be greatly improved.
　図５Ｃに示すように、第３変形例に係るステントグラフト１０Ｃ（第１ステントグラフト２２ｂ）は、第２変形例に係る第１ステントグラフト２２ａと異なり、連設部２０の内周面２０ｂに設けられた連設部側ステント３１の突出部４４が、内周面２０ｂから離間して斜め上方に傾斜した構成となっている。従って、流通路１２を内側に狭める狭隘部４８ｂは、連設部側ステント３１の突出部４４の素線によって構成されている。このように構成しても、連設部２０に挿入された分離部２４の形状支持部５４が直に突出部４４に引っ掛かるようになり、第１ステントグラフト２２ｂと第２ステントグラフト２６の接続力を大幅に向上することができる。 As shown in FIG. 5C, the stent graft 10C (first stent graft 22b) according to the third modified example is different from the first stent graft 22a according to the second modified example, and is connected to the continuous surface 20b of the connecting portion 20. The protruding portion 44 of the installation portion side stent 31 is configured to be inclined obliquely upward while being separated from the inner peripheral surface 20b. Therefore, the narrow portion 48 b that narrows the flow passage 12 inward is constituted by the strands of the protruding portion 44 of the continuous portion-side stent 31. Even if comprised in this way, the shape support part 54 of the separation part 24 inserted in the continuous arrangement part 20 comes to be directly hooked on the protrusion part 44, and the connection force between the first stent graft 22b and the second stent graft 26 is greatly increased. Can be improved.
　図５Ｄに示すように、第４変形例に係るステントグラフト１０Ｄ（第１ステントグラフト２２ｃ）は、連設部側ステント３１ａの頂部に突出部４４が連設されておらず、山部３８と谷部４０間の胴体部４２に膨出部材６２（突出部）を設けた構成となっている。膨出部材６２は、第１グラフト２８を内側に押し出すことで、連設部２０の内周面２０ｂに***部４６ａを形成する。そのため、連設部２０には***部４６ａによって流通路１２を内側に狭める狭隘部４８ｃが形成されるので、分離部２４の形状支持部５４が狭隘部４８ｃに引っ掛かるようになり、第１ステントグラフト２２ｃと第２ステントグラフト２６の接続力を大幅に向上することができる。 As shown in FIG. 5D, in the stent graft 10D (first stent graft 22c) according to the fourth modified example, the projecting portion 44 is not continuously provided on the top portion of the continuous portion-side stent 31a, and the crest portion 38 and the trough portion 40 are provided. The bulging member 62 (protruding part) is provided in the body part 42 between them. The bulging member 62 pushes the first graft 28 inward to form a raised portion 46 a on the inner peripheral surface 20 b of the connecting portion 20. Therefore, since the narrowed portion 48c that narrows the flow passage 12 inward is formed by the raised portion 46a in the continuous portion 20, the shape support portion 54 of the separating portion 24 comes to be caught by the narrowed portion 48c, and the first stent graft 22c. And the connection force of the 2nd stent graft 26 can be improved significantly.
　以上のように、本発明に係るステントグラフト１０（第１ステントグラフト２２）によれば、第１ステント３０が有する突出部４４により内側に狭められた狭隘部４８が流通路１２に形成されることで、連設部２０の流通路１２に分離部２４（第２ステントグラフト２６）を挿入すると、狭隘部４８により分離部２４の外周面２４ａに対し強い摩擦力を付与することができる。これにより、第１ステントグラフト２２と第２ステントグラフト２６の接続が強固に維持されて血管内に留置されるため、瘤１００の治療を効果的に行うことができる。また、狭隘部４８は、第１グラフト２８を拡縮可能に支持する連設部側ステント３１の突出部４４により簡単に構成されるので、第１ステントグラフト２２を容易に製造することができる。 As described above, according to the stent graft 10 (first stent graft 22) according to the present invention, the narrow portion 48 narrowed inward by the protruding portion 44 of the first stent 30 is formed in the flow path 12, When the separation portion 24 (second stent graft 26) is inserted into the flow passage 12 of the continuous portion 20, the narrowed portion 48 can apply a strong frictional force to the outer peripheral surface 24a of the separation portion 24. Thereby, since the connection between the first stent graft 22 and the second stent graft 26 is firmly maintained and placed in the blood vessel, the aneurysm 100 can be effectively treated. Moreover, since the narrow part 48 is simply comprised by the protrusion part 44 of the connection part side stent 31 which supports the 1st graft 28 so that expansion / contraction is possible, the 1st stent graft 22 can be manufactured easily.
　また、突出部４４が連設部側ステント３１の山部３８の頂部を斜め内側に曲折して形成されることで、第１ステント３０を折り曲げるという簡単な形成方法によって、狭隘部４８を設けることができる。そして、第１ステント３０の山部３８に突出部４４が形成されることで、骨格の弾性力の低下を抑えることができ、第１グラフト２８の拡縮を良好に行うことができる。 Further, the narrow portion 48 is provided by a simple forming method of bending the first stent 30 by forming the protrusion 44 by bending the top of the peak portion 38 of the continuous portion-side stent 31 obliquely inward. Can do. And since the protrusion part 44 is formed in the peak part 38 of the 1st stent 30, the fall of the elastic force of skeleton can be suppressed and the 1st graft 28 can be expanded and contracted favorably.
　さらに、狭隘部４８が流通路１２の軸方向に沿って複数設けられることで、流通路１２に挿入される分離部２４を軸方向に沿って強固に接続することができる。従って、流通路１２の軸方向に対し分離部２４の挿入量を調整し、その調整位置において分離部２４を強固に接続することができる。 Furthermore, by providing a plurality of narrow portions 48 along the axial direction of the flow passage 12, the separation portion 24 inserted into the flow passage 12 can be firmly connected along the axial direction. Therefore, the insertion amount of the separation part 24 can be adjusted with respect to the axial direction of the flow passage 12, and the separation part 24 can be firmly connected at the adjustment position.
　またさらに、第１ステント３０が連設部２０の外周面に設けられることで、連設部２０の内周面２０ｂを分離部２４の外周面２４ａに面接触させることができるので、部材同士の摩擦力を一層向上することができる。 Furthermore, since the first stent 30 is provided on the outer peripheral surface of the continuous portion 20, the inner peripheral surface 20 b of the continuous portion 20 can be brought into surface contact with the outer peripheral surface 24 a of the separation portion 24. The frictional force can be further improved.
　上記において、本発明について好適な実施形態を挙げて説明したが、本発明は上記の実施形態に限定されるものではなく、本発明の要旨を逸脱しない範囲において、種々の改変が可能なことは言うまでもない。例えば、ステントグラフト１０は、腹部大動脈瘤１００の治療に用いられるだけでなく種々の治療に適用可能である。ステントグラフト１０の形状は、治療方法や治療箇所に応じて自由に設計することができることは勿論である。 In the above description, the present invention has been described with reference to preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention. Needless to say. For example, the stent graft 10 can be used not only for the treatment of the abdominal aortic aneurysm 100 but also for various treatments. Of course, the shape of the stent graft 10 can be freely designed according to the treatment method and the treatment site.

Claims (6)

  1. 　可撓性を有する周壁（２８）に囲われることで長尺な筒状に形成され、軸方向に延在する内部空間（１２）を有する留置デバイス（２２、２２ａ～２２ｃ）であって、
    　前記周壁（２８）には、該周壁（２８）を拡縮可能に支持する骨格（３１、３１ａ）が設けられ、
    　前記骨格（３１、３１ａ）は、前記周壁（２８）の所定位置で内側に向かって突出する突出部（４４、６２）を有する
    　ことを特徴とする留置デバイス（２２、２２ａ～２２ｃ）。     An indwelling device (22, 22a to 22c) having an inner space (12) formed in a long cylindrical shape by being surrounded by a flexible peripheral wall (28) and extending in the axial direction,
    The peripheral wall (28) is provided with a skeleton (31, 31a) that supports the peripheral wall (28) so as to be able to expand and contract,
    The indwelling device (22, 22a to 22c), wherein the skeleton (31, 31a) has a protruding portion (44, 62) protruding inward at a predetermined position of the peripheral wall (28).
  2. 　請求項１記載の留置デバイス（２２、２２ａ、２２ｂ）において、
    　前記骨格（３１）は、前記周壁（２８）の周方向に沿って山部（３８）と谷部（４０）を繰り返して延在する波状に形成されており、
    　前記突出部（４４）は、前記山部（３８）の頂部を斜め内側に曲折して形成される
    　ことを特徴とする留置デバイス（２２、２２ａ、２２ｂ）。     Indwelling device (22, 22a, 22b) according to claim 1,
    The skeleton (31) is formed in a corrugated shape that repeatedly repeats a peak (38) and a valley (40) along the circumferential direction of the peripheral wall (28),
    The protruding part (44) is formed by bending the top part of the peak part (38) diagonally inward. (22, 22a, 22b).
  3. 　請求項１記載の留置デバイス（２２、２２ａ～２２ｃ）において、
    　前記骨格（３１、３１ａ）は、前記内部空間（１２）の軸方向に沿って複数設けられる
    　ことを特徴とする留置デバイス（２２、２２ａ～２２ｃ）。     Indwelling device (22, 22a-22c) according to claim 1,
    The indwelling device (22, 22a to 22c), wherein a plurality of the skeletons (31, 31a) are provided along the axial direction of the internal space (12).
  4. 　請求項１記載の留置デバイス（２２、２２ｃ）において、
    　前記骨格（３１、３１ａ）は、前記周壁（２８）の外周面に設けられることで、前記突出部（４４、６２）により前記周壁（２８）を内側に押し出して***部（４６、４６ａ）を形成する
    　ことを特徴とする留置デバイス（２２、２２ｃ）。     Indwelling device (22, 22c) according to claim 1,
    The skeleton (31, 31a) is provided on the outer peripheral surface of the peripheral wall (28), so that the protruding portion (44, 62) pushes the peripheral wall (28) inward to form a raised portion (46, 46a). An indwelling device (22, 22c) characterized by forming.
  5. 　請求項１～４のいずれか１項に記載の留置デバイス（２２、２２ａ～２２ｃ）と、
    　前記周壁（２８）によって構成される前記内部空間（１２）に挿入され、前記留置デバイス（２２、２２ａ～２２ｃ）に接続される挿入デバイス（２６、２６ａ）とを含む
    　ことを特徴とする留置デバイス組立体（１０、１０Ａ～１０Ｄ）。     The indwelling device (22, 22a-22c) according to any one of claims 1 to 4,
    An insertion device (26, 26a) inserted into the internal space (12) constituted by the peripheral wall (28) and connected to the placement device (22, 22a to 22c). Assembly (10, 10A-10D).
  6. 　請求項５記載の留置デバイス組立体（１０、１０Ｂ～１０Ｄ）において、
    　前記挿入デバイス（２６）は、可撓性を有し前記周壁（２８）に接触可能な筒状部材（３２）と、
    　素線が前記筒状部材（３２）の周方向に沿って延在し、前記筒状部材（３２）を支持するリング状骨格（３４）とを含む
    　ことを特徴とする留置デバイス組立体（１０、１０Ｂ～１０Ｄ）。     Indwelling device assembly (10, 10B-10D) according to claim 5,
    The insertion device (26) has a cylindrical member (32) that is flexible and can contact the peripheral wall (28);
    An indwelling device assembly (10) characterized in that a strand extends along the circumferential direction of the tubular member (32) and includes a ring-shaped skeleton (34) that supports the tubular member (32). 10B-10D).
PCT/JP2012/074331 2012-09-24 2012-09-24 Indwelling device and indwelling device assembled body WO2014045426A1 (en)

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