JP4095197B2 - Intraluminal indwelling - Google Patents

Description

[0001]
[Technical field to which the invention belongs]
The present invention relates to an intraluminal indwelling object that is inserted into an in vivo lumen such as a blood vessel.
[0002]
[Prior art]
Aneurysms usually occur in the lower renal artery in patients with atherosclerosis. An aneurysm eventually results in a rupture of the aneurysm resulting in fatal bleeding. Conventionally, as a method for treating this aneurysm, a method in which the aneurysm is surgically excised and an artificial blood vessel (a tubular body made of an artificial material) is transplanted to that portion.
However, this surgical treatment has a high mortality rate and a long recovery period after surgery. In addition, the burden on the patient due to the surgical invasion is large, and it cannot be applied to the elderly who have a chronic disease in particular.
[0003]
Therefore, there have been proposed instruments and methods for treating aneurysms by placing and grafting a stent graft percutaneously without performing such a surgical operation.
This stent graft is broadly classified as follows: (1) It is expanded in a natural state where no external force is applied, and a compressive force in the radial direction is applied to the stent graft so that the diameter is reduced, that is, the expansion is restricted by being placed in a tube. The so-called self-expanding type that is transferred to the target site in the artery (the treatment site where the aneurysm is formed), self-expands by removing the compression force, and does not apply external force. In a natural state, the diameter is reduced, and after transferring to a target site in the artery in this state, the balloon of the balloon catheter inserted separately is inflated to expand the metal member installed at the end of the stent graft. A so-called balloon expanding type structure in which the expanded state is maintained by plastic deformation of the metal member accompanying expansion, (3) after mechanically expanding, by the maintenance means There is a thing of the mechanical expanded type to maintain Zhang state.
[0004]
These stent grafts are configured by combining a membrane made of a polymer such as polyester or PTFE with a tubular skeleton formed mainly of stainless steel, Ni, Ti or the like.
[0005]
[Problems to be solved by the invention]
However, in any method, since the operation of inserting the stent graft to the target site in the artery and fixing the stent graft to the fixed site is performed under X-ray contrast, the stent graft formed from these materials having low contrast properties is accurate. There is a problem that it is difficult to position and position in an appropriate state.
In order to avoid such a problem, conventionally, a high X-ray contrast marker made of platinum or gold has been attached to one or two places of the skeleton. It was not enough to grasp the general positional relationship.
[0006]
The present invention has been made in view of such problems, and is joined to at least a part of a deformable structure having a first outer diameter and a second outer diameter larger than the first outer diameter. An object of the present invention is to provide an intraluminal indwelling device having a membrane and capable of being placed in an appropriate state at an accurate position under X-ray imaging.
[0007]
[Means for Solving the Problems]
  What achieves the above object is as follows.
(1) It is placed in the aorta and has a contour.Formed into a tubeAndA first outer diameter andTheDeformable to a second outer diameter larger than the first outer diameterThree-dimensionalA structure,A cylindrical shape that encloses the three-dimensional structure in a state where the whole of the three-dimensional structure or an end of the three-dimensional structure is exposed.Intraluminal indwelling having a membraneThe membrane is made of a woven fabric or a knitted fabric, and the in-lumen indwelling device is annularly and meandering along the circumference in the vicinity of each end of the cylindrical membrane. Meandering high X-ray contrast markers sewn on the edge and edge height X-ray contrast markers provided to edge each end of the membrane in order to prevent the ends of the tubular membrane from being unwound And havingIntraluminal indwelling.
[0008]
(2) The linear high X-ray contrast marker is formed of a simple substance or compound of a metal that is an X-ray opaque substance, an alloy containing the metal, or a resin material containing the metal.(1) Intraluminal indwelling object.
(3)The structure includes a linear body wound in a spiral shape, and a linear body in which the linear body and the spiral are wound in opposite directions.The intraluminal indwelling material of (1) or (2).
(4) The structure includes a maintaining means for maintaining the outer diameter of the structure at the second outer diameter, and the maintaining means includes a telescopic guide tube and an outer diameter smaller than the inner diameter of the guide tube. A rod having a diameter and inserted into the guide tube, wherein the structure has the first outer diameter when the guide tube is in an extended state, and the guide tube contracts when the rod is pulled. Accordingly, the in-luminal indwelling product according to any one of (1) to (3), wherein the structure has a diameter that becomes the second outer diameter.
(5) The intraluminal indwelling material according to (4), wherein the guide tube is configured by a coil made of an elastic material.
(6) The intraluminal indwelling product according to any one of (1) to (5), wherein the cylindrical membrane is a bifurcated cylindrical membrane encapsulating the three-dimensional structure.
[0009]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the indwelling object of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.
FIG. 1 is a view showing an embodiment in which the intraluminal indwelling material of the present invention is applied to a stent graft, FIG. 2 is a view in which the membrane in the vicinity of the central portion of the embodiment of FIG. 1 is a perspective view showing the structure of the maintenance means in the stent graft shown in FIG. 1, FIGS. 5 to 8 are partial sectional side views showing the operation of the maintenance means and the outer diameter expanding means, and FIG. It is a perspective view which shows the structure of the one end part of an expansion means. 1 to 9, the upper side is described as “upper” or “upper end”, and the lower side is described as “lower” or “lower end”.
[0010]
  The intraluminal indwelling object 1 of the present invention is a structure formed in a tube shape, and has a first outer diameter and the first outer diameter.DiameterLarger second outsideDiameterThe structure 2 can be deformed and the film 4 bonded to at least a part of the structure 2. And the linear high X-ray contrast marker 11 provided along the substantially circumferential direction is provided in at least one part of the film | membrane 4. As shown in FIG.
[0011]
A stent graft (intraluminal indwelling object) 1 according to the embodiment shown in FIG. 1 is inserted into an aorta and indwelled (implanted), and its structure is formed in a tube shape (three-dimensional structure). 2 and a bifurcated film 4 enclosing the structure 2 in a state where the three ends of the structure 2 are exposed. As shown in FIG. 2, the structure 2 includes a main body tube 21 and two branch tubes 22 and 23 branched from the main body tube 21 into two branches. The outer diameters of the branch tubes 22 and 23 are smaller than the outer diameter of the main body tube 21. Openings 24, 25, and 26 are formed in the upper end of the main body tube 21 and the lower ends of both branch tubes 22, 23, respectively.
[0012]
The structure 2 is mainly composed of a plurality of struts (linear bodies) 27 wound in a spiral shape. The structure 2 of this embodiment includes a plurality of struts 27a spirally wound in the same direction (winded so as to be substantially parallel), and a plurality of struts 27a wound in the opposite direction to the plurality of struts 27a. Struts 27b. For this reason, in the structure 2, a large number of intersections where the struts 27 a and the struts 27 b intersect are formed. The skeleton of the structure 2 is formed by these struts 27 (27a, 27b). In addition, the shape and form of the strut 27 are not limited to a spiral shape, but may be, for example, a ring shape (particularly, a shape in which a plurality of rings are connected) or a net shape.
[0013]
Examples of the constituent material of the strut 27 include stainless steel, Ni—Ti alloy, Cu—Zn alloy, Ni—Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, tantalum, and other metals, polyamide, polyimide, super Examples include relatively high-rigidity polymer materials such as high-molecular-weight polyethylene, polypropylene, and fluorine-based resins, or combinations of these appropriately. Among these, stainless steel or stainless steel is used as a core material. Is preferred. Moreover, the wire diameter of the strut 27 is not particularly limited, but can preferably be about 0.03 to 2 mm. More preferably, it can be about 0.1-1 mm.
[0014]
The outer diameter of the main body tube 21 of the structure 2 is changed by the action of an external force. That is, the main body tube 21 has a first outer diameter in a natural state (a state in which no external force is applied) (hereinafter, this state is referred to as a “reduced diameter state”), but outer diameter expanding means 5a to 5f described later. Is activated, the second outer diameter becomes larger than the first outer diameter (hereinafter, this state is referred to as “expanded diameter state”).
[0015]
In this case, the first outer diameter is such that the stent graft 1 can move within the aorta, and the second outer diameter is such that the body tube 21 portion of the stent graft 1 can sufficiently adhere to the inner wall of the aorta. It is. As the outer diameter of the main body tube 21 (hereinafter referred to as “the outer diameter of the structure 2”) changes, the branch tubes 22 and 23 similarly change in outer diameter.
[0016]
Further, the structure 2 is provided with rod-like maintaining means 3a to 3f extending along the longitudinal direction thereof. The maintaining means has a function of maintaining the outer diameter of the structure 2 at the second outer diameter, and a plurality of the maintaining means are preferably arranged along the circumferential direction of the structure 2.
That is, two maintenance means 3a and 3b that vertically cut the main body tube 21 and the branch tube 22, two maintenance means 3c and 3d that vertically cut the main body tube 21 and the branch tube 23, and a maintenance means that vertically cut the branch tube 22. 3e and maintaining means 3f for longitudinally cutting the branch tube 23. Thereby, in the main body tube 21, four maintenance means 3a-3d are installed at substantially equal intervals along the tube circumferential direction, and in the branch tube 22, the three maintenance means 3a, 3b, 3e are arranged in the tube circumferential direction. In the branch tube 23, the three maintaining means 3c, 3d, and 3f are installed at substantially equal intervals along the circumferential direction of the tube.
[0017]
  The ends of the struts 27 are fixed to the upper end 35 and the lower end 36 of the maintaining means 3a to 3d and the lower end 36 of the maintaining means 3e and 3f. Further, the upper end portions of the maintaining means 3e and 3f are fixed to each other, and an intermediate portion of the strut 27 is fixed in the vicinity thereof. Moreover, the site | part which cross | intersects the strut 27 in the middle of the maintenance means 3a-3f and the cross site | part of struts 27 are also fixed similarly. These are fixed by, for example, bonding with an adhesive, brazing such as soldering, welding, ligation or the like.
[0018]
Here, the fixing of the struts 27 to the intermediate parts of the maintaining means 3a to 3f and the fixing of the crossing portions of the struts 27 are preferably loose fixings in which the crossing angle is variable. Thereby, expansion and contraction of the stent graft 1 can be performed more smoothly. In addition, the strut 27 is fixed to the guide tube 31 with respect to the maintenance means 3a-3f (refer FIG. 3, FIG. 4).
As described above, the maintaining means 3 a to 3 f form a part of the skeleton of the structure 2 together with the strut 27. In particular, the maintaining means 3 a to 3 f serve as pillars extending in the longitudinal direction of the structure 2. Thereby, necessary and sufficient strength and elasticity, particularly uniform strength and elasticity can be ensured without complicating the structure of the structure 2.
[0019]
As shown in FIG. 1, a film 4 is coated on the inner surface and / or the outer surface of the structure 2. Thereby, since the stent graft 1 and the inner surface of the lumen are in close contact with each other, it is possible to prevent positional deviation and angular deviation from the axis of the blood vessel after placement. The membrane 4 is preferably one that expands and contracts with a change in the outer diameter of the structure 2 or one that expands from a folded state. The membrane 4 may be, for example, a fibrous porous membrane such as a woven or knitted fabric, a non-woven fabric, or a paper material, a non-fibrous porous membrane, or a dense membrane such as a polymer sheet.
[0020]
When a fiber material is used as the membrane 4, for example, natural fibers such as cellulose fiber, cotton, linter, kapok, flax, cannabis, ramie, silk, wool, nylon (polyamide), fluororesin fiber, rayon, cupra A chemical fiber such as acetate, vinyl resin fiber, acrylic, polyethylene terephthalate (polyester), polypropylene, or a combination of two or more of the above natural and chemical fibers (such as blended fibers) can be used.
[0021]
Further, when a polymer sheet is used as the film 4, examples of the material include polyesters such as polyethylene, polypropylene, polyurethane, polyethylene terephthalate, and polybutylene terephthalate, polyvinyl chloride, polytetrafluoroethylene, natural rubber, and isoprene. Various rubbers such as rubber, silicone rubber, styrene-butadiene rubber and latex rubber, and various thermoplastic elastomers such as polyamide, polyester and polyurethane can be used.
The film 4 may be a laminate of two or more layers made of the same or different materials.
The outer surface and / or inner surface of the membrane 4 is coated with an anticoagulant such as heparin or urokinase, an anti-thrombotic material such as a block copolymer of urethane and silicone (registered trademark Abcosan), or a hydroxymethacrylate-styrene copolymer. May be.
[0022]
The installation location of the membrane 4 with respect to the structure 2 may be the whole structure 2 or a part thereof, but preferably covers the central portion in the longitudinal direction of the main body tube 21, more preferably substantially the entire inner surface or outer surface of the main body tube 21. It is preferable. Thereby, when the main body tube 21 and the branch tubes 22 and 23 are expanded to have the second outer diameter, a close contact portion between the inner wall of the lumen and the stent graft 1 is increased, and displacement of the placed stent graft 1 is prevented. can do.
[0023]
  In the embodiment shown in FIG. 1, the cylindrical tube 4 is covered on the outer periphery of the main body tube 21 and the branch tubes 22 and 23, and the exposed structure 2 portion has only three end portions. is there.
  Further, linear high X-ray contrast markers 11, 12, and 13 for fixing the stent graft 1 to an accurate position in an appropriate state under X-ray contrast are fixed to the membrane 4.
[0024]
The linear high X-ray contrast markers 11, 12, 13 are preferably fixed to at least a part of the membrane 4, and in particular, as shown in FIG. 1, the three openings 24, 25, 26 of the stent graft 1. It is arranged in an annular shape along the circumference of the vicinity (in other words, near the three end portions of the film). By providing the linear high X-ray contrast marker in this way, it is easy to check the degree of expansion of each opening (end) and the deviation from the axis of the blood vessel under X-ray contrast. Note that the high X-ray contrast marker may be provided not only at the three ends of the film as described above, but also near the center of the film and near the branch part. It becomes easy to confirm the degree of expansion of the portion with the X-ray contrast marker and to confirm the deviation from the axis of the blood vessel.
[0025]
The shape of the linear high X-ray contrast marker 11, 12, 13 may be any shape that does not impair the X-ray contrast properties. The cross-sectional shape of the linear high X-ray contrast markers 11, 12, and 13 is not particularly limited, and may be various shapes such as a circle, a rectangle, and an ellipse, but a circle or an ellipse is preferable. The size of the linear high X-ray contrast marker 11, 12, 13 is 10 to 300 mm, more preferably 30 to 150 mm, and the diameter or line width is about 0.01 mm to 1.0 mm. It is preferably 0.03 mm to 0.5 mm.
[0026]
As a forming material of the linear high X-ray contrast markers 11, 12, and 13, a simple substance or compound of a metal which is an X-ray opaque substance, an alloy containing the X-ray opaque substance, or the X-ray A resin material containing an impermeable substance can be used. In particular, metal wires such as Au, Pt, Ir, Ta, W, Ag, or their alloy wires are suitable.
[0027]
The resin material containing the X-ray opaque material is obtained by adding the above-mentioned X-ray opaque material metal simple substance or compound fine particles to a synthetic resin. Is preferably 1 to 4 μm, and the radiopaque substance content in the synthetic resin is preferably 10 to 80% by weight.
[0028]
The synthetic resin is preferably flexible, and may be an olefin resin such as polyethylene, polypropylene, polybutene, or ethylene-vinyl acetate copolymer, or a polyolefin elastomer, fluorine resin, or soft fluorine. Resin, polyester such as polyethylene terephthalate, polybutylene terephthalate or polyester elastomer, methacrylic resin, polyphenylene oxide, modified polyphenylene ether, polyurethane or polyurethane elastomer, polyamide or polyamide elastomer, polycarbonate, polyacetal, polystyrene, styrene butadiene copolymer, etc. Styrene resin or styrene elastomer, thermoplastic polyimide, polyvinyl chloride And the like can be used. It is also possible to use polymer alloys or polymer blends based on these resins. Furthermore, rubbers such as natural rubber, isoprene rubber and silicon rubber can be used.
[0029]
In addition, the above-described linear high X-ray contrast markers 11, 12, and 13 facilitate following the deformation of the membrane 4 accompanying the expansion of the stent graft 1, in other words, so as not to inhibit the expansion of the membrane 4. It is preferable to arrange in a meandering curved shape as in the embodiment shown in FIG. In this case, the line lengths of the linear high X-ray contrast markers are each longer than the second outer diameters of the main body tube 21 and the branch tubes 22 and 23, respectively. Thereby, the linear high X-ray contrast marker 11, 12, 13 does not prevent expansion of the main body tube and the branch tube. Further, the linear high X-ray contrast markers 11, 12, and 13 are sewn to the film 4 in order to prevent movement.
[0030]
The linear high X-ray markers 11, 12, and 13 are preferably provided at the end of the film 4 and have a function of preventing the end of the film 4 from being broken. Specifically, in this embodiment, in order to prevent fraying of the end of the membrane 4, the vicinity of each end of the membrane is bordered using the high X-ray contrast markers 14, 15, 16 It has become. In particular, as in the embodiment shown in FIG. 1, the ends of the main body tube 21 and the branch tubes 22, 23 or the vicinity thereof are bordered using the linear high X-ray contrast markers 14, 15, 16. This prevents the film 4 from being unwound from the end and improves the X-ray visibility at the end. This is particularly effective when the membrane 4 is a woven or knitted fabric. As the edging method, for example, it is preferable to carry out by a stitch stitch or the like.
[0031]
Further, like the stent graft 50 of the embodiment shown in FIG. 10, the membrane 4 may be fixed to the structure 2 using the linear high X-ray contrast marker 17.
The structure 2 is mainly composed of a plurality of struts (linear bodies) 27 wound in a spiral shape. The structure 2 of this embodiment includes a plurality of struts 27a spirally wound in the same direction (winded so as to be substantially parallel), and a plurality of struts 27a wound in the opposite direction to the plurality of struts 27a. Struts 27b. For this reason, a large number of intersections where the struts 27 a and the struts 27 b intersect are formed in the structure 2. The linear high X-ray contrast marker 17 is provided so that the intersection of the strut 27 a and the strut 27 b is sewn to the membrane 4. Thereby, the twist of the film | membrane 4 with respect to the structure 2 can be prevented, and also X-ray visibility can be improved.
[0032]
Further, like the stent graft 60 of the embodiment shown in FIG. 11, the membrane 4 may be fixed to the structure 2 using the linear high X-ray contrast marker 17. In the stent graft 60 of this embodiment, a plurality of linear high X-ray contrast markers 17 are provided along the strut so that a certain length of the strut 27 is sewn to the membrane. For this reason, the linear high X-ray contrast marker 17 is also arranged in a spiral. Further, also in this embodiment, it is preferable that the linear high X-ray contrast marker 17 is provided so that the intersection between the strut 27a and the strut 27b is sewn to the membrane 4.
The material and size of the linear high X-ray contrast markers 14, 15, 16, and 17 are the same as those of the above-described linear high X-ray contrast markers 11, 12, and 13, and the description will refer to the above-described portions. To do.
Corresponding outer diameter expanding means 5a to 5f are detachably connected (linked) to the lower ends of the maintaining means 3a to 3f, respectively. The outer diameter expanding means 5a to 5f are for making the structure 2 in a reduced diameter state into an expanded state and operating the corresponding maintaining means 3a to 3f.
[0033]
Hereinafter, the structures of the maintaining means 3a to 3f and the outer diameter expanding means 5a to 5f will be described. In addition, since each maintenance means 3a-3f and each outer diameter expansion means 5a-5f are respectively substantially the same structure, based on FIGS. 3-8, the maintenance means 3c and the outer diameter connected to this are hereafter described. The expansion means 5c will be described representatively.
The maintaining means 3 c is configured by a telescopic guide tube 31 and a rod 32 having an outer diameter smaller than the inner diameter of the guide tube 31, and the rod 32 is inserted into the guide tube 31.
[0034]
The guide tube 31 is composed of a coil (coil spring) made of an elastic material. The guide tube 31 extends in a natural state, but can be contracted by a pulling operation of the rod 32.
As described above, the strut 27 is fixed to the guide tube 31. As shown in FIG. 3, when the guide tube 31 is in the extended state, the strut 27 fixed to the guide tube 31 is also extended in the axial direction, and the structure 2 is in a reduced diameter state. Also, as shown in FIG. 4, when the guide tube 31 contracts by pulling the rod 32, the axial distance between the fixed points of the strut 27 with respect to the guide tube 31 decreases, and the strut 27 expands in the radial direction. 2 becomes a diameter-expanded state.
[0035]
Note that the contraction rate of the guide tube 31 may be the same over the entire length of the guide tube 31, but the guide tube 31 may have portions having different contraction rates in the longitudinal direction. In this case, the position of the fixed point of the strut 27 with respect to the guide tube 31 and the distance between the fixed points are selected, and the diameter expansion rate (= second outer diameter / first outer diameter) of the structure 2 is partially set. Can be changed. As a result, the shape of the structure 2 in the expanded state can be arbitrarily set, and the followability and adaptability to the placement site of the lumen can be further improved.
As a method of giving different shrinkage rates to the guide tube 31, for example, a method in which a plurality of unit guide tubes having different mechanical characteristics (spring elastic modulus and the like) are connected in the longitudinal direction to form one guide tube 31, For example, a method of changing the elastic modulus by changing coil winding conditions (density (number of turns), coil outer diameter, etc.) with respect to the guide tube.
[0036]
The rod 32 is made of a wire, and a hook (stopper) 321 that engages with the upper end of the guide tube 31 is formed at the upper end thereof. The hook 321 may be fixed to the upper end portion of the guide tube 31 by the same method as described above.
Further, the lower end portion of the rod 32 has an engaging portion 322 formed by bending the rod 32 into a loop shape. The engaging portion 322 engages with the lower end of the guide tube 31 and thereby maintains the contracted state of the guide tube 31 (see FIG. 7).
A ring 33 is engaged (connected) or fixed to the lower end of the rod 32, that is, the loop portion of the engaging portion 322. The ring 33 is a connecting member that connects the rod 32 and the pulling wire 52. The ring 33 may be a separate body or an integrated body with respect to the rod 32.
[0037]
Examples of the coil material forming the guide tube 31 include the same materials as those described as the constituent material of the strut 27. Further, the outer diameter of the guide tube 31 is not particularly limited, and depends on the outer diameter of the stent graft 1, but usually 0.2 to 2 in consideration of the burden and strength of the patient when inserted into the body cavity. About 0.5 mm is preferable, and about 0.4 to 1.2 mm is more preferable.
The cross-sectional shape of the coil of the guide tube 31 is not limited to a circle, and may be any shape such as an ellipse or a quadrangle (flat shape).
[0038]
Examples of the constituent material of the rod 32 include the same materials as those described above as the constituent material of the strut 27. Moreover, although the wire diameter of the rod 32 is not specifically limited, Usually, about 0.05-1.5 mm is preferable and about 0.1-0.8 mm is more preferable.
[0039]
Examples of the constituent material of the ring 33 include the same materials as those described above as the constituent material of the strut 27. In addition, the wire diameter of the ring 33 is not particularly limited, but in the case of the ring 33 as a separate body, a relatively thin one is preferable in order to obtain sufficient flexibility, and specifically, about 0.03 to 0.3 mm. Is preferable, and about 0.08 to 0.15 mm is more preferable.
[0040]
The outer diameter expanding means 5c is installed at the upper end of the outer tube 51, the pulling wire 52 inserted into the outer tube 51, and the outer tube 51, and is a connecting member (spacer) that constitutes a connecting portion with the maintaining means 3c. 53. The outer diameter expanding means 5c is detachably connected (linked) to the maintaining means 3c.
[0041]
The outer tube 51 has moderate rigidity, that is, when the guide tube 31 is contracted by pulling the rod 32, the outer tube 51 resists the compressive force generated in the heel direction and does not cause bending or the like, and has appropriate flexibility. (Flexibility), for example, a resin tube or a densely wound coil made of the same coil material as that of the guide tube 31 may be used.
[0042]
The puller wire 52 has an outer diameter smaller than the inner diameter of the outer tube 51 and can slide smoothly in the outer tube 51. A hook 521 is provided at the upper end portion of the pulling wire 52. The hook 521 is engaged with the ring 33.
Further, the lower end side of the pulling wire 52 protrudes from the lower end opening of the outer tube 51 by a predetermined length, and a pulling operation unit (not shown) is formed at the lower end portion. The traction operation unit is operated to pull the traction wire 52 downward.
When the pulling wire 52 is pulled downward while the hook 521 is engaged with the ring 33, the rod 32 is pulled downward via the ring 33, the guide tube 31 contracts, and the structure 2 is expanded in diameter. It becomes a state.
[0043]
Markers 522 and 523 are attached to predetermined positions on the lower end side of the pulling wire 52 as display means for indicating the moving amount (pulling amount) of the pulling wire 52. In the present embodiment, at least two markers 522 and 523 that can be distinguished by different colors or shapes are attached.
[0044]
These markers 522 and 523 are used for various purposes. For example, as shown in FIG. 5, the engaging portion 322 is in the guide tube 31 and is not yet engaged with the lower end of the guide tube 31, and the guide tube 31 can be freely expanded and contracted. As shown in FIG. 6, it can be known that the engaging portion 322 is engaged with the lower end of the guide tube 31 or is in a state immediately before the engagement. The markers 522 and 523 are attached to positions corresponding to these states, respectively, and the state can be recognized by distinguishing the markers 522 and 523 that appear and disappear from the lower end opening of the outer tube 51.
As another example of the display means, a scale corresponding to the amount of movement of the pulling wire 52 is attached to the pulling wire 52 or its pulling means (take-up reel or the like).
[0045]
As shown in FIG. 9, the connection member 53 is configured by a flat box-shaped member, and a pair of opposing protrusions 531 are formed to protrude upward at the center of the upper end thereof. . The lower end of the guide tube 31 is in contact with or fitted into the protrusion 531.
Inside the connection member 53, an internal space 530 that allows the engagement portion 322 to pass in a connected state of the maintaining means 3c and the outer diameter expanding means 5c is formed.
[0046]
Further, notches 532 are formed on both sides of the upper end portion of the connection member 53.
With the maintaining means 3c and the outer diameter expanding means 5c connected, the engaging portion 322 enters the internal space 530, and its end 323 passes through the notch 532 and protrudes outward from the guide tube 31, The guide tube 31 can be engaged with the lower end. That is, the connection member 53 allows the maintenance means 3c to start the operation of maintaining the expanded diameter of the structure while the maintaining means 3c and the outer diameter expanding means 5c are connected. Therefore, the operability of the operation for expanding the diameter of the structure 2 and maintaining the expanded state is improved.
In the illustrated configuration, the planar shape of the connection member 53 is a rectangle, but is not limited thereto, and may be an ellipse, for example.
[0047]
The connection member 53 may be fixed to the outer tube 51 simply by being fitted thereto, or may be fixed by bonding with an adhesive, fusion bonding, brazing, welding, or the like.
A bundling member 54 is installed at the lower end of the outer tube 51. The bundling member 54 bundles three outer tubes 51 of the outer diameter expanding means 5c, 5d, 5f (corresponding to the maintaining means 3c, 3d, 3f in the branch tube 23) into one.
The bundle member 54 has a diameter larger than that of the three outer tubes 51. Therefore, the bundling member 54 constitutes a gripping part that is gripped by the gripping device 9 in the blood vessel (aorta), as will be described later.
[0048]
Specific examples of the bundling member 54 include a rubber band (O-ring), a string (thread), a band tube, a metal or resin clip (clamping member), and the like.
Note that such a bundling member 54 is attached to each outer tube 51 of the outer diameter expanding means 5a, 5b, 5e (corresponding to the maintaining means 3a, 3b, 3e on the branch tube 22). It may or may not be mounted.
[0049]
The outer diameter of the outer tube 51 is not particularly limited, and depends on the outer diameter of the stent graft 1, but is usually 0.2 to 2.5 mm in consideration of the burden and strength of the patient when inserted into the body cavity. The degree is preferable, and about 0.4 to 1.2 mm is more preferable.
Examples of the constituent material of the pulling wire 52 include the same materials as those described as the constituent material of the strut 27. The wire diameter of the puller wire 52 is not particularly limited, but is usually preferably about 0.1 to 1.5 mm, more preferably about 0.2 to 0.8 mm.
[0050]
Examples of the connecting member 53 include a metal tube deformed into a desired shape, a resin molded body, and the like. Examples of the metal material constituting the connection member 53 include iron or an iron-based alloy (such as stainless steel), copper or a copper-based alloy, aluminum or an aluminum alloy, titanium or a titanium alloy. Examples of the resin material constituting the connection member 53 include ultra high molecular weight polyethylene, polypropylene, polyamide, polyimide, polystyrene, polycarbonate, polymethyl methacrylate, ABS resin, polyethylene terephthalate, polybutylene terephthalate, and other polyesters, polysulfone, and polyethersulfur. Hong, polyphenylene sulfide, polyacetal, polyether ether ketone, polytetrafluoroethylene and the like can be mentioned.
[0051]
Since the maintaining means 3c and the outer diameter expanding means 5c are structured as described above, the operability is excellent, and the diameter can be reduced while sufficiently functioning as the maintaining means and the outer diameter expanding means. . This contributes to reducing the burden on the patient during insertion into the lumen. Further, by reducing the diameter, it becomes possible even for sites that have been difficult to insert conventionally, and the range of application to various parts of the living body can be expanded.
[0052]
Next, operations (actions) of the maintaining means 3c and the outer diameter expanding means 5c will be described with reference to FIGS.
As shown in FIG. 5, first, in a state where no external force is applied to the maintaining means 3c, the guide tube 31 of the maintaining means 3c is in an extended state, whereby the structure 2 is in a reduced diameter state. At this time, the engaging portion 322 is accommodated in the guide tube 31. Further, the rod 32 and the pulling wire 52 are connected by a ring 33 so that tension can be transmitted.
[0053]
  Next, when the pulling wire 52 is pulled downward while holding the outer tube 51 as shown in FIG.531Contacts or fits to the lower end of the guide tube 31. When the pulling wire 52 is further pulled downward, the rod 32 is pulled, the guide tube 31 contracts, and the structure 2 is in an expanded state. Further, when the guide tube 31 contracts, the engaging portion 322 is exposed from the lower end opening of the guide tube 31 and enters the internal space 530 of the connection member 53. At this time, the end portion 323 of the engaging portion 322 passes through the notch 532 and protrudes outward from the guide tube 31.
[0054]
Next, when the tension of the pulling wire 52 is weakened and the pulling wire 52 is returned slightly upward, the end portion 323 of the engaging portion 322 is engaged with the lower end of the guide tube 31 as shown in FIG. Thereby, the contraction state of the guide tube 31, that is, the diameter expansion state of the structure 2 is maintained.
In addition, the operator can grasp | ascertain the operation | movement until it changes from the diameter-reduced state of the said structure 2 to a diameter-expanded state, and it is maintained, by visually recognizing the positions of the markers 522, 523 grade | etc.,.
[0055]
Next, as shown in FIGS. 7 to 8, the hook wire 521 is removed from the ring 33 by performing operations such as upward movement and rotation of the pull wire 52, and then the pull wire 52 is moved downward again to hook. 521 is accommodated in the internal space 530 of the connection member 53. Thereby, the outer diameter expanding means 5c is separated from the maintaining means 3c.
The operation as described above is performed in the same manner for the maintaining means and the outer diameter expanding means other than the maintaining means 3c and the outer diameter expanding means 5c. The surgeon can perform such an operation easily and smoothly in a short time.
[0056]
Next, the intraluminal indwelling product (stent graft) 70 of the embodiment shown in FIG. 12 will be described.
This intraluminal indwelling product (stent graft) 70 is a tube-like structure similar to the stent graft 1 described above, and has a first outer diameter and a second outer diameter larger than the first outer diameter. It is an intraluminal indwelling object having a structure 2 that can be deformed into a shape and a membrane 4 joined to at least a part of the structure. The structure 2 includes a spirally wound linear body 27a, a linear body 27a, and a strut 27b in which the spiral is wound in the opposite direction, and the intraluminal indwelling object 70 fixes the struts 27a and 27b to the membrane. A high X-ray contrast marker 18 is provided.
The structure 2 and the membrane 4 are the same as the stent graft 1 of the embodiment described above, and the above description should be referred to.
[0057]
The high X-ray contrast marker 18 used in the stent graft 70 of this embodiment includes a main body 19 and a leg 20 for sandwiching a strut 27 continuous with the main body 19. Although four legs 20 are provided in FIG. 13, any number may be used as long as the legs 20 can be fixed to the strut 27. The shape of the main body 19 is not limited to a rectangle as in the embodiment shown in FIG. 13, but may be a rectangle such as a square, or a polygon such as a circle, an ellipse, or a pentagon.
[0058]
For fixing the high X-ray contrast marker 18 to the strut 27 and the membrane 4, if necessary, a slit for inserting the leg portion of the marker 18 is provided in the membrane 4, and the high X-ray contrast marker 18 is provided in the membrane 4 from this slit. After the leg 20 is inserted, the leg 20 is bent inward so as to sandwich the strut 27. As a result, the state shown in FIG. 14 is obtained.
As a material of the high X-ray contrast marker 18, a simple substance or a compound of the above-described X-ray opaque substance, a compound, or an alloy containing the metal can be used.
[0059]
  The size of the high X-ray contrast marker 18 needs to be large enough to be visible under X-ray contrast. Specifically, the body 19 has a surface area of 0.05 to 10 mm.²It is preferable that it is a grade. Further, as shown in FIG.)In this case, the length in the longitudinal direction is preferably about 0.3 to 10 mm, and the length in the direction opposite to the longitudinal direction is preferably about 0.1 to 1 mm. Moreover, as a magnitude | size of the leg part 20, length is 0.5-5 mm and width | variety is about 0.1-3 mm suitably.
[0060]
Further, the X-ray contrast marker is not limited to the above-described form. For example, even if the high X-ray contrast marker 37 is formed in a coil shape as in the embodiment shown in FIG. Good.
The high X-ray contrast marker 37 is formed by winding a wire made of a material having a high X-ray contrast property as described above into a coil shape. Moreover, it is preferable that the both ends of the wire which comprises the high X-ray contrast marker 37 are produced so that it may exist on the same side surface of a coil. By producing in this way, both ends of the wire do not protrude from the outer surface of the film 4 during fixing.
[0061]
The high X-ray contrast marker 37 is fixed by bringing the membrane 4 and the strut 27 into close contact, piercing the end of the high X-ray contrast marker 37 into the membrane 4, and then rotating the strut 27 so as to be involved. As a result, the state shown in FIG. 16 is obtained. In this case, it is preferable to fix the coil and the film 4 using an adhesive or the like so that both ends of the wire do not protrude from the outer surface of the film 4.
The material of the high X-ray contrast marker 37 is the same as that of the high X-ray contrast marker 18.
As the size of the high X-ray contrast marker 37, the diameter of the wire is 0.05 to 2 mm, more preferably 0.1 to 1 mm, and the length of the wire is 0.3 to 50 mm, more preferably 1 The diameter of the coil is 0.1 to 3 mm, more preferably 0.2 to 2 mm, and the length is 0.1 to 20 mm, more preferably 0.5 to 10 mm.
[0062]
Further, the high X-ray contrast marker is not limited to the form as described above, and is one that is crimped to the structure 2 by the contraction force of the film 4 against the structure 2 of the film 4; For example, it may be fixed to the maintaining means 3a to 3f or the strut 27 by adhesion or fusion (thermal fusion, ultrasonic fusion, etc.) with an adhesive.
[0063]
Next, an example of a method for inserting and placing (transplanting) the stent graft 1 of the present invention into the lumen will be described.
FIGS. 17 to 21 are diagrams schematically showing a procedure when the stent graft 1 is percutaneously inserted and placed in the aorta, and FIGS. 22 and 23 are perspective views each showing a configuration example of the grasping device. FIG. 24 and FIG. 24 are longitudinal sectional views showing a state in which the stent graft 1 is inserted into the distal end portion of the introduction sheath. 17 and 18, the outer diameter and the like of the distal end portion of the introduction sheath 7 are exaggerated.
[0064]
[1] First, as preparation, the stent graft 1 is inserted into the distal end portion of the introduction sheath 7 as shown in FIG. The introduction sheath 7 is an instrument for introducing the stent graft 1 into the aorta 100 while supporting the stent graft 1, and is composed of a flexible tube.
The stent graft 1 accommodated in the introduction sheath 7 receives a compressive force from the inner peripheral surface of the introduction sheath 7 and has an outer diameter slightly smaller than the first outer diameter (an outer diameter equal to or smaller than the first outer diameter). It has become.
A tube-like pusher 8 is inserted into the introduction sheath 7. The distal end of the pusher 8 is in contact with the lower end of the stent graft 1, and the proximal end portion (hand side) of the pusher 8 projects from the proximal end opening of the introduction sheath 7 (see FIG. 17).
Outer diameter expansion means 5a, 5b, 5e connected to the maintenance means 3a, 3b, 3e on the branch tube 22 of the stent graft 1 accommodated in the introduction sheath 7 pass through the inside of the pusher 8, and It protrudes from the end opening (see FIGS. 17 and 24).
Further, the outer diameter expanding means 5c, 5d, 5f connected to the maintaining means 3c, 3d, 3f on the branch tube 23 pass through the inside of the pusher 8 and are folded in the middle thereof toward the distal end where the stent graft 1 is located. Returning, it passes between the outer surface of the stent graft 1 and the inner surface of the introduction sheath 7 and protrudes from the distal end opening 71 of the introduction sheath 7 by a predetermined length (see FIG. 24). In this case, as described above, the lower end portions of the outer diameter expanding means 5c, 5d, 5f are bundled by the bundle member 54.
[0065]
[2] On the other hand, a gripping device 9 for gripping the bundle member 54 of the outer diameter expanding means 5c, 5d, 5f is prepared. As shown in FIG. 22 and FIG. 23, the gripping instrument 9 includes a flexible tube 91 and a trap wire 92 that is inserted into the tube 91.
  The trap wire 92 is bent into two in the middle, and a loop (ring) 93 is formed at the bent portion. The loop 93 projects from the distal end opening of the tube 91. Further, the end (both ends) of the trap wire 92 opposite to the loop 93 protrudes from the proximal end opening of the tube 91.
  The gripping device 9 grips the outer diameter expanding means 5c, 5d, 5f in the body as follows. With the sufficiently large loop 93 formed (see FIG. 22), the lower end portions of the outer diameter expanding means 5c, 5d, and 5f are inserted into the loop 93, and the trap wire 92 is fixed to the tube 91 with the tube 91 fixed. When pulled in the proximal direction (arrow direction in FIG. 23), the loop 93 contracts and winds around the outer circumference of the outer diameter expanding means 5c, 5d, 5f. As a result, the loop in which the bundling member 54 is reduced93And is gripped (see FIG. 23).
[0066]
[3] When the above preparation is completed, as shown in FIG. 17, the sheath 10 is inserted into the left femoral artery 140 and the sheath 6 is inserted into the right femoral artery 150, for example, by the Seldinger method.
[0067]
[4] Then, the introducer sheath 7 containing the pusher 8 and the stent graft 1 is introduced via the sheath 6, and the grasping device 9 is introduced via the sheath 10. The introducer sheath 7 and the grasping device 9 are advanced in the opposite direction to the blood flow in the right iliac artery 130 and the left iliac artery 120, respectively, and their tips are positioned near the lower end of the aorta 100.
[0068]
[5] Next, the aorta100In the inside, as described above, the grasping device 9 grasps the portion of the bundle member 54 of the outer diameter expanding means 5c, 5d, 5f, and further advances the introduction sheath 7 and the grasping device 9 to the upstream side of the blood flow.
[0069]
[6] Next, the introduction sheath 7 is gradually pulled out while the pusher 8 is fixed. Accordingly, as shown in FIG. 18, the stent graft 1 is pressed by the distal end of the pusher 8 and exposed from the distal end opening 71 of the introduction sheath 7.
When the entire stent graft 1 is pushed out from the introduction sheath 7, the stent graft 1 is in a reduced diameter state (first outer diameter), and is near or slightly upstream from the aneurysm (treatment site) 110 of the aorta 100 (in FIG. 18). (Upward). At this time, since the stent graft 1 is in a reduced diameter state, the stent graft 1 is movable (displaceable) in the aorta 100.
[0070]
[7] In this state, the introduction sheath 7, the pusher 8, and the grasping device 9 are extracted from the body. When extracting the grasping instrument 9, the lower end portions of the outer diameter expanding means 5c, 5d, 5f grasped at the distal end portion of the grasping instrument 9 are also pulled out of the body through the left iliac artery 120 and the sheath 10, and The state shown in FIG.
[0071]
[8] Next, by pulling the outer diameter expanding means 5a, 5b, 5e and the outer diameter expanding means 5c, 5d, 5f outside the body with a predetermined tension, the stent graft 1 is pulled and moved to the downstream side of the blood flow, Perform positioning. That is, as shown in FIG. 20, due to the movement of the stent graft 1, the lower end of the main body tube 21 (the portion where the branch tubes 22 and 23 intersect) abuts the branch portion at the lower end of the aorta 100, and the branch tube 22 of the stent graft 1 and 23 are inserted into the right iliac artery 130 and the left iliac artery 120, respectively, and the main body tube 21 is disposed at a position so as to cover the aneurysm 110 in the aorta 100.
The position of the stent graft 1 can be adjusted to a desired position by slightly changing the tension when pulling the outer diameter expanding means 5a, 5b, 5e and the outer diameter expanding means 5c, 5d, 5f.
[0072]
[9] After the stent graft 1 is positioned as described above, the structure 2 is expanded by operating the pulling wires 52 of the outer diameter expanding means 5a to 5f by the above-described method (second outer diameter). And the expanded state is maintained by the action of the maintaining means 3a to 3f.
  Thereby, as shown in FIG. 21, the stent graft 1 is reliably fixed to an appropriate position. That is, the body tube 21 is in close contact with the inner wall of the aorta 100 upstream and downstream of the aneurysm 110, and the branch tubes 22 and 23 are in close contact with the inner walls of the right iliac artery 130 and the left iliac artery 120, respectively. .
  Most of the blood flow in the aorta 100 (flowing from the upper side to the lower side in FIG. 21) passes through the inside of the stent graft 1, and the right iliac artery130And is diverted to the left iliac artery 120.
[0073]
[10] When the insertion and placement of the stent graft 1 are completed as described above, the outer diameter expanding means 5a to 5f are separated from the maintaining means 3a to 3f by the above-described method, and extracted from the body.
The operations in the steps [2] to [10] are performed under fluoroscopy.
[0074]
[11] Finally, the sheaths 6 and 10 are removed to finish the procedure.
[0075]
In the conventional self-expanding type described above, since the diameter of the self-expanding at the same time as it is pushed into the aorta from the introduction sheath and fixed in close contact with the inner surface of the aorta, the positioning cannot be performed. The indwelling position depends on the position from which it is pushed out of the introducer sheath.
[0076]
On the other hand, in the stent graft 1 of the present invention, as described in the steps [6] to [8], when the stent graft 1 is pushed out from the introduction sheath 7 into the aorta 100, the stent graft 1 is in a reduced diameter state, Since it is movable, its positioning can be performed freely. Accordingly, the placement position of the stent graft 1 can be accurately determined.
[0077]
Further, in the conventional balloon expanding type described above, the blood flow is blocked by the inflation of the balloon in the aorta, so that a heavy burden is placed on the heart, and the stent graft is displaced due to a large blood pressure. In addition, adverse effects such as applying pressure to the aneurysm occur.
[0078]
On the other hand, in the stent graft 1 of the present invention, blood can flow inside the stent graft 1 regardless of the diameter-reduced state or the diameter-enlarged state during the steps [6] to [10]. Do not block the flow. Therefore, the safety is high, the stability of the fixation of the stent graft 1 after the diameter expansion is also high, and it is possible to prevent the positional deviation and the adverse effects caused thereby.
[0079]
As described above, the intraluminal indwelling object according to the present invention has been described with respect to the illustrated embodiment. The diameter expanding means can be replaced with one having any shape and structure that can exhibit the same function.
[0080]
In addition, the shape of the indwelling object may be a simple cylindrical shape without the branch portions such as the branch tubes 22 and 23.
In addition, the intraluminal indwelling material of the present invention is not limited to being indwelled in a blood vessel, and in addition, for example, in various lumens (body cavities) such as bile duct, lymphatic vessel, trachea, digestive tract, urethral tube, vagina and the like. It can be applied to what is inserted and detained.
[0081]
【The invention's effect】
  The intraluminal indwelling material of the present invention is a structure formed in a tube shape, and has a first outer diameter and the first outer diameter.DiameterLarger second outsideDiameterIn the intraluminal indwelling object having a deformable structure and a film joined to at least a part of the structure, a line provided on at least a part of the film along a substantially circumferential direction Shaped high X-ray contrast marker.
[0082]
For this reason, this invention can grasp | ascertain the exact position of the indwelling object in a lumen | bore under X-ray contrast, and can perform the insertion to the target site | part in a lumen | bore easily and correctly. Further, since the linear high X-ray contrast marker is arranged along the circumferential direction, confirmation of the indwelling object in the lumen and deviation from the axis of the blood vessel are facilitated under X-ray contrast.
[0083]
  The intraluminal indwelling object of the present invention is a structure formed in a tube shape, and includes a first outer diameter and the first outer diameter.DiameterLarger second outsideDiameterAnd a membrane bonded to at least a part of the structure, wherein the structure includes a spirally wound linear body and the linear body And the linear indwelling object is provided with a linear high X-ray contrast marker provided so as to fix the linear body to the membrane.
[0084]
For this reason, this invention can grasp | ascertain the exact position of the indwelling object in a lumen | bore under X-ray contrast, and can perform the insertion to the target site | part in a lumen | bore easily and correctly.
[Brief description of the drawings]
FIG. 1 is an overall perspective view showing an embodiment in which the intraluminal indwelling material of the present invention is applied to a stent graft.
FIG. 2 is a view in which a film in the vicinity of the central portion of the embodiment shown in FIG. 1 is peeled off.
FIG. 3 is a perspective view showing the configuration of the maintaining means (the structure is in a reduced diameter state) in the intraluminal indwelling product shown in FIG. 1;
4 is a perspective view showing a configuration (a structure is in a diameter-enlarged state) of a maintaining means in the intraluminal indwelling thing shown in FIG. 1. FIG.
FIG. 5 is a partial cross-sectional side view showing the operation of the maintaining means and the outer diameter expanding means in one embodiment of the intraluminal indwelling material of the present invention.
FIG. 6 is a partial cross-sectional side view showing the operation of the maintaining means and the outer diameter expanding means in one embodiment of the intraluminal indwelling material of the present invention.
FIG. 7 is a partial sectional side view showing the operation of the maintaining means and the outer diameter expanding means in one embodiment of the intraluminal indwelling material of the present invention.
FIG. 8 is a partial cross-sectional side view showing the operation of the maintaining means and the outer diameter expanding means in one embodiment of the intraluminal indwelling material of the present invention.
FIG. 9 is a perspective view showing the configuration of one end of the outer diameter expanding means.
FIG. 10 is an overall perspective view showing another embodiment of the intraluminal indwelling material of the present invention.
FIG. 11 is a partial perspective view showing another embodiment of the intraluminal indwelling material of the present invention.
FIG. 12 is an overall perspective view showing another embodiment of the intraluminal indwelling material of the present invention.
FIG. 13 is an overall perspective view showing an example of a high X-ray contrast marker as a membrane fixing means.
FIG. 14 is a usage diagram of the embodiment of the high X-ray contrast marker shown in FIG. 13;
FIG. 15 is an overall perspective view showing another embodiment of a high X-ray contrast marker as a membrane fixing means.
FIG. 16 is a usage diagram of another embodiment of the high X-ray contrast marker shown in FIG. 15;
FIG. 17 is a diagram schematically showing a procedure for inserting and placing the intraluminal indwelling material shown in FIG. 1 into the aorta.
18 is a diagram schematically showing a procedure for inserting and placing the intraluminal indwelling material shown in FIG. 1 into the aorta.
FIG. 19 is a diagram schematically showing a procedure for inserting and placing the intraluminal indwelling material shown in FIG. 1 into the aorta.
FIG. 20 is a diagram schematically showing a procedure for inserting and placing the intraluminal indwelling material shown in FIG. 1 into the aorta.
FIG. 21 is a diagram schematically showing a procedure for inserting and placing the intraluminal indwelling product shown in FIG. 1 into the aorta.
FIG. 22 is a perspective view illustrating a configuration example of a gripping device.
FIG. 23 is a perspective view showing a configuration example (gripping state) of the gripping device.
24 is a longitudinal cross-sectional view showing a state where the intraluminal indwelling product shown in FIG. 1 is inserted into the distal end portion of the introduction sheath. FIG.
[Explanation of symbols]
1 Stent graft
2 structures
21 Body tube
22 Branch tube
23 Branch tube
24-26 opening
27 struts
11, 12, 13 High X-ray contrast marker
14, 15, 16 High X-ray contrast marker
17, 18, 37 High X-ray contrast marker

Claims (6)

Is intended to be placed in the aorta, the contour is formed into a tubular shape, and a first outer diameter and said first outer diameter greater than the second outer diameter and a deformable three-dimensional structure, the tertiary An indwelling object having a tubular membrane encapsulating the three-dimensional structure in a state where the entire original structure or the end of the three-dimensional structure is exposed ,
The membrane is made of a woven fabric or a knitted fabric, and the in-luminal indwelling object is sewn to the membrane so as to meander and meander along the circumference in the vicinity of each end of the cylindrical membrane. A meandering linear high X-ray contrast marker and an edge height X-ray contrast marker provided so as to border each end of the membrane in order to prevent the end of the tubular membrane from being unwound Intraluminal indwelling material characterized by.   The linear high X-ray contrast marker is formed of a single substance or compound of a metal that is an X-ray opaque substance, an alloy containing the metal, or a resin material containing the metal. Intraluminal indwelling. The indwelling object according to claim 1 or 2 , wherein the structure includes a linear body wound in a spiral shape and a linear body in which the linear body and a spiral are wound in opposite directions. The structure has a maintaining means for maintaining the outer diameter of the structure at the second outer diameter, and the maintaining means has a telescopic guide tube and an outer diameter smaller than the inner diameter of the guide tube. A rod inserted into the guide tube, and the structure has the first outer diameter when the guide tube is in an extended state, and the guide tube contracts by pulling the rod, The intraluminal indwelling product according to any one of claims 1 to 3, wherein the structure has a diameter that becomes the second outer diameter. The indwelling object according to claim 4, wherein the guide tube is formed of a coil made of an elastic material. The intraluminal indwelling product according to any one of claims 1 to 5, wherein the cylindrical membrane is a bifurcated cylindrical membrane enclosing the three-dimensional structure.

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