JP2000279434A - Intraluminal indwelling object - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an intraluminal indwelling object by which the influence of a length change with the extension of a stent graft on positioning is evaded and the stent graft indwells at a proper position in a proper state under X-rays contrast. SOLUTION: The intraluminal indwelling object 1 is provided with a structure body 2 which is formed to be a tube shape and deformed to have a first outer diameter and the second one being larger than the first one and with keeping means 3a-3f which are extended in the axial direction of the structure body 2, by which the body 2 is kept in a second outer diameter state. Then the means 3a-3f are provided with high X-rays contrast markers which are arranged at positions to be the both end parts of the structure body 2 in a state where the means 3a-3f keep the structure body 2 in the second outer diameter state.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an intraluminal indwelling device which is inserted into and indwelled in a lumen of a living body such as a blood vessel.

[0002]

2. Description of the Related Art Aneurysms usually occur in the lower renal arteries of patients with arteriosclerosis. Aneurysms ultimately result in rupture of the aneurysm and fatal bleeding. Conventionally, as a method of treating this aneurysm, a method of surgically removing the aneurysm and transplanting an artificial blood vessel (a tubular body made of an artificial material) into the portion is performed. However, this surgical treatment has a high mortality rate and a long recovery time after surgery. In addition, the burden on the patient due to the invasion of the surgery is large, and in particular, the elderly, who have chronic diseases, cannot withstand the large burden, and thus may not be applicable in some cases.

Accordingly, instruments and methods for treating an aneurysm by percutaneously placing and implanting a stent graft without performing such a surgical operation have been proposed. The stent graft is expanded in a natural state where no external force is applied, and a radially compressive force is applied to the stent graft to reduce its diameter.
That is, it is transported to a target site in the artery (treatment site where an aneurysm has been formed) in a state where the diameter is regulated by being placed in a tube, where the compressive force is removed and self-expanded, and then placed there. The diameter is reduced in the self-expanding type and in the natural state where no external force is applied, and after being transported to the target site in the artery in this state, the balloon of the separately inserted balloon catheter is inflated to expand the end of the stent graft. A so-called balloon-expansion type in which the metal member installed in the structure is expanded and the expanded state is maintained by plastic deformation of the metal member accompanying the expansion, and the expanded state is maintained by the maintenance means after performing the mechanical expansion. There is a mechanical expand type.

However, self-expanding and balloon-expandable stent grafts have
In any case, the method of inserting the stent graft to the target site in the artery and the method of fixing the stent graft to the target site are complicated, and are more susceptible to blood flow resistance and difficult to position at the target site. There is a disadvantage that the (implantation position) cannot be determined accurately.
Further, even if the stent graft can be placed at an accurate position, since the fixation is unstable, there is a problem that the stent graft is moved by the blood flow afterwards (migration).
Further, in the case of the balloon expand type, since the inflated balloon blocks the blood flow, the burden on the heart is large. Therefore, it may be necessary to supplement the blood flow by performing IABP or the like in some cases, which makes the operation more complicated and places a heavy burden on the patient.

In view of such problems, a mechanical expand type stent graft has been invented. However, in this method, the axial length of the stent graft changes between a contracted state and an expanded state, so that X-ray contrast is increased. There is a problem in that it is difficult to arrange the stent graft at an appropriate position while comparing the length of the expanded state of the stent graft with the size of the aneurysm.

In addition, regardless of the type of the stent graft, when the linear body is bent or bent to form a stent graft, there is a problem that it is difficult to maintain the shape of the stent graft.

[0007]

SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to prevent the influence of the change in length accompanying the expansion of a stent graft on positioning under X-ray imaging, and to maintain the stent graft in an appropriate state. It is an object of the present invention to provide an in-lumen indwelling object which can be indwelled at any position.

[0008] Another object of the present invention is to use a linear body,
It is an object of the present invention to provide an intraluminal indwelling device capable of maintaining the shape of a stent graft when the stent graft is manufactured.

[0009]

What achieves the above object is a tube-shaped structure, which has a first outer diameter and a second outer diameter larger than the first outer diameter. An intraluminal indwelling device having a deformable structure and a maintenance means extending in the axial direction of the structure for maintaining the structure at the second outer diameter, wherein the maintenance means comprises: A high X-ray contrast marker provided at a position to be both ends of the structure in a state where the structure is maintained in the state of the second outer diameter. .

[0010] The structure preferably 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. Further, the maintaining means includes a telescopic guide tube and a rod inserted into the guide tube, and the guide tube is contracted by pulling the rod, whereby the outer diameter of the structure is reduced to the second diameter. It is preferable to be configured to have an outer diameter. Further, the high X-ray contrast markers may be arranged at both ends of the rod or both ends of the guide tube.

An object which achieves the above-mentioned object is a structure formed in a tubular shape, wherein the structure is deformable into a first outer diameter and a second outer diameter larger than the first outer diameter. An intraluminal indwelling device having a body and a retaining means extending in the axial direction of the structure for maintaining the structure at the second outer diameter, wherein the structure comprises a helically wound wire A linear body in which the linear body and the spiral are wound in the opposite direction, and an intersection where these linear bodies intersect,
An intraluminal indwelling device characterized by having a high X-ray contrast marker fixed thereon.

The linear body located at the intersection is
It is preferable that the intersection state is maintained by the high X-ray contrast marker. Further, the maintaining means includes a telescopic guide tube and a rod inserted into the guide tube,
It is preferable that the guide tube is contracted by pulling the rod, whereby the outer diameter of the structure is set to the second outer diameter. Furthermore, the in-lumen indwelling object may include a high X-ray contrast marker disposed at both ends of the rod or at both ends of the guide tube.

Preferably, the structure is branched. Further, it is preferable that a plurality of the maintaining means are located. Furthermore, the in-lumen indwelling object may include an outer diameter expanding unit that changes the outer diameter of the structure from the first outer diameter to the second outer diameter. The outer diameter expanding means is provided at an outer tube, a pulling wire inserted into the outer tube, and an end of the outer tube,
And a connecting member forming a connecting portion with the maintaining means.

[0014]

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view showing an intraluminal indwelling device according to the present invention.
FIG. 1 is a view showing an embodiment in which the in-lumen indwelling material of the present invention is applied to a stent graft, and FIGS. 2 and 3 are perspective views showing a configuration of a maintenance means in the stent graft shown in FIG. 1, respectively. 4 to 7 are partial cross-sectional side views showing the operation of the maintaining means and the outer diameter expanding means, respectively, and FIGS.
FIG. 3 is an explanatory view of a maintenance means of the embodiment shown in FIG. Note that the upper side in FIGS. 1 to 8 is described as “upper” or “upper end”, and the lower side is described as “lower” or “lower end”.

The stent graft (intraluminal indwelling object) 1 of the present invention is a tubular structure 2 having a first outer diameter and a second outer diameter larger than the first outer diameter. It has a deformable structure 2 and maintaining means 3a to 3f extending in the axial direction of the structure to maintain the structure at the second outer diameter. And the maintenance means 3a-3f are the maintenance means 3a-3
f has a high X-ray contrast marker provided at a position to be both ends of the structure 2 in a state where the structure 2 is maintained in the state of the second outer diameter.

As shown in FIG. 1, a stent graft (intraluminal indwelling object) 1 (when expanded) of the present invention is inserted and indwelled (implanted) in an aorta, and its contour is formed in a tube shape. Structure (three-dimensional structure) 2 and maintaining means 3a to 3f arranged along the axial direction of the structure 2
And high X-ray contrast markers 136 and 137 (FIG. 1) which are arranged on the maintenance means so as to be both ends of the structure 2 at the time of expansion.
Omitted, see FIG. 8) and the high X-ray contrast marker 136, 1
In addition to the high-contrast markers 37, the high-contrast radiographic markers 101 to 120 are arranged on the structure 2. As shown in FIGS. 4 to 7 described later, in the stent graft 1 of this embodiment, high X-ray contrast markers 136 and 137 are provided at the upper end and the lower end of each rod 32 of the maintaining means 3a to 3f (3c in the drawing). Are located. This structure 2 is composed of a main body tube 21 and two branch tubes 2 bifurcated from the main body tube.
2, 23. Branch tubes 22, 23
Is smaller than the outer diameter of the main body tube 21. Also,
Upper end of main body tube 21 and both branch tubes 22, 2
Openings 24, 25, 26 are formed at the lower end of 3 respectively.

The structure 2 is mainly composed of a plurality of struts (linear bodies) 27 wound spirally. The structure 2 of this embodiment has a plurality of struts 27a spirally wound in the same direction (winded substantially parallel) and a plurality of struts 27a wound in the opposite direction to the plurality of struts 27a. The strut 27b is provided. For this reason,
In the structure 2, the struts 27a and the struts 27b
Are formed. The struts 27 (27a, 27b) form the skeleton of the structure 2. The shape and form of the strut 27 are not limited to a spiral shape, but may be a ring shape (in particular, a shape in which a plurality of rings are connected) or a net shape.

As the constituent material of the strut 27, for example, stainless steel, Ni-Ti alloy, Cu-Zn alloy,
Various metals such as Ni-Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, tantalum, and relatively high-rigidity polymer materials such as polyamide, polyimide, ultra-high-molecular-weight polyethylene, polypropylene, and fluorine-based resin, or Are appropriately combined, and among these, stainless steel or a material having stainless steel as a core material is particularly preferable. Strut 2
The wire diameter of No. 7 is not particularly limited, but is preferably 0.03
About 2 mm. More preferably, 0.
It can be about 1 to 1 mm.

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 body tube 21 is in a natural state (a state in which no external force is applied).
This is the first outer diameter (hereinafter, this state is referred to as “reduced diameter state”), but when the outer diameter expanding means 5a to 5f described later is operated, the second outer diameter larger than the first outer diameter is obtained. (Hereinafter, this state is referred to as “diameter expansion state”). In this case, the first
Has an outer diameter that allows the stent graft 1 to move within the aorta, and a second outer diameter corresponds to the stent graft 1.
Of the main body tube 21 can sufficiently adhere to the inner wall of the aorta. In addition, with the change of the outer diameter of the main body tube 21 (hereinafter, referred to as the “outer diameter of the structure 2”), the branch tubes 22 and 23 also change their outer diameters.

Further, as described above, the structural body 2 is provided with the rod-shaped maintaining means 3a to 3f extending along the axial direction. The maintenance means has a function of maintaining the outer diameter of the structure 2 at the second outer diameter, and it is preferable that a plurality of the maintenance means are arranged along the circumferential direction of the structure 2. That is, as in the embodiment shown in FIG. 1, two maintaining means 3 a and 3 b for vertically traversing the main tube 21 and the branch tube 22, and two maintaining means 3 c and 3 d for traversing the main tube 21 and the branch tube 23 A maintaining means 3e for vertically traversing the branch tube 22 and a maintaining means 3f for traversing the branch tube 23
And Thereby, in the main body tube 21,
The four maintaining means 3a to 3d are installed at substantially equal intervals along the tube circumferential direction. In the branch tube 22, the three maintaining means 3a, 3b, 3e are installed at substantially equal intervals along the tube circumferential direction. In the branch tube 23, three maintaining means 3c, 3d, 3f are installed at substantially equal intervals along the tube circumferential direction.

The outer diameter expanding means 5a to 5f are detachably connected (coupled) to the lower ends of the maintaining means 3a to 3f, respectively. Outer diameter expansion means 5a to 5f
Is for bringing the structure 2 in the reduced diameter state into the expanded state and operating the corresponding maintaining means 3a to 3f.

Hereinafter, the structures of the maintaining means 3a to 3f and the outer diameter expanding means 5a to 5f will be described. Since each of the maintaining means 3a to 3f and each of the outer diameter expanding means 5a to 5f have substantially the same configuration, the following description will be given with reference to FIGS.
Based on the above, the maintenance means 3c and the outer diameter expanding means 5c connected thereto will be representatively described.

The holding means 3c is provided with a telescopic guide tube 31.
And a rod 32 having an outer diameter smaller than the inner diameter of the guide tube 31. The rod 32 is inserted into the guide tube 31. The guide tube 31 is formed of a coil (coil spring) made of an elastic material. This guide tube 31
Is extended in a natural state, but can be contracted by the indexing operation of the rod 32.

As described above, the strut 27 is fixed to the guide tube 31. As shown in FIG. 2, 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 diameter of the structure 2 is reduced. Also, as shown in FIG.
When the guide tube 31 contracts due to traction, the guide tube 31
, The distance between the fixing points of the struts 27 in the axial direction is reduced, the struts 27 are expanded in the radial direction, and the structure 2 is in the expanded state.

The contraction rate of the guide tube 31 may be the same over the entire length of the guide tube 31.
May have portions having different shrinkage rates in the longitudinal direction. In this case, the position of the fixing point of the strut 27 with respect to the guide tube 31 and the distance between the fixing points are selected.
The diameter expansion ratio (= second outer diameter / first outer diameter) of the structure 2 can be partially 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 indwelling portion of the lumen can be further improved.

Examples of a method of giving different shrinkage rates to the guide tubes 31 include, for example, a method of connecting a plurality of unit guide tubes having different mechanical characteristics (spring elasticity and the like) in the longitudinal direction to form one guide tube 31; For one guide tube, a method of changing the coil winding conditions (density (number of turns), coil outer diameter, etc.) so as to make the elastic modulus different, or the like can be used.

The rod 32 is made of a wire, and a hook (stopper) 321 for engaging with the upper end of the guide tube 31 is formed at the upper end. The hook 321 is
The guide tube 31 may be fixed to the upper end by the same method as described above.

The lower end of the rod 32 is
Has an engaging portion 322 formed by bending the same into a loop shape. The engaging portion 322 is engaged with the lower end of the guide tube 31 to maintain the contracted state of the guide tube 31 (see FIGS. 6 and 7).

Further, the maintaining means has a high X-ray contrast marker provided at a position which is both ends of the structure in a state where the maintaining means maintains the structure at the second outer diameter. Thereby, it is possible to arrange at an appropriate position while comparing the length of the expanded state of the indwelling object and the size of the aneurysm under X-ray contrast.

As shown in FIGS. 4 to 7, in the stent graft 1 shown in FIG. 1, high X-ray contrast markers 136 and 137 are arranged at the upper end and the lower end of the rod 32 of the maintaining means 3c (FIG. 1). Omitted, see FIG. 8). Maintaining means 3a,
The same applies to 3b and 3d to 3f. The location of the high X-ray contrast markers 136 and 137 is not limited to the upper and lower ends of the rod 32, but may be the hook 321 and the engaging portion 322. In this case, the same effects as described above can be obtained. can get.

Further, like the stent graft 1, a high X-ray contrast marker may be provided at both ends of the rod 32, and the high X-ray contrast markers 101 to 120 may be provided on the strut 27. Thereby, the visibility under X-ray contrast is enhanced, and accurate positioning of the target part in the lumen can be performed.

In the embodiment shown in FIG. 1, high X-ray contrast markers 101 to 120 are arranged on struts 27. Among them, the high X-ray contrast markers 101, 102, 10
The set of 3,104 is provided on the circumference near the upper end of the stent graft 1 and serves as an index indicating the degree of expansion of the upper end opening 24 of the stent graft 1 under X-ray during the index expansion operation.
In addition, high X-ray contrast markers 109, 110, 111, 11
The pair 2 is provided on the circumference near the lower end of the main tube 21 of the stent graft 1 and indicates the degree of expansion of the lower end of the stent graft 1 main tube 21 under X-ray during the index expansion operation, and at the same time, a plurality of expansion means. The angle deviation between the blood vessel axis and the stent graft axis due to the difference in the amount of tension between the stent graft and the like is detected, and serves as an index for correcting the arrangement to an appropriate position. The number of high X-ray contrast markers arranged near the upper end opening 24 and near the lower end described above is not limited to four as in the embodiment shown in FIG. 1, and three or more are arranged so as to form a plane. Preferably.

The high X-ray contrast markers 114, 115,
The set of 116 and the set of 118, 119, 120 are provided on the circumference near the lower ends of the branch tubes 22, 23, respectively, and the lower ends of the branch tubes 25, 26 under X-ray during the traction expansion operation. At the same time as indicating the degree of expansion, an index for detecting a deviation in the angle between the vascular axis and the stent graft axis due to a difference in the amount of pulling of a plurality of expansion means (described later) and correcting the position to an appropriate position. Become. It is preferable that three or more high X-ray contrast markers arranged near the lower ends of the branch tubes 22 and 23 are arranged similarly to the case of the main tube 21.

Further, it is preferable that the high X-ray contrast marker is arranged on the structure 2 on a substantially straight line along the longitudinal direction of the main tube 21. Thereby, under X-ray,
It is possible to detect twisting of the main body portion due to a difference in the amount of pulling of a plurality of expansion units (described later) or the like and correct the arrangement to an appropriate arrangement. For example, the high X-ray contrast markers 102, 1
05, 107, 110, 104, 106, 108,
It is preferable that the sets of 112 are arranged at positions facing each other along the axis of the main body tube 21 at an interval of about 180 degrees around the outer circumference (see FIG. 1). in this case,
The number of high X-ray contrast markers arranged in one set is not limited to four as in the embodiment shown in FIG. 1, but may be two or more. This is because a straight line is formed if at least two or more are arranged.

Similarly, the high X-ray contrast markers may be arranged on a substantially straight line along the longitudinal direction of the branch tubes 22 and 23. Thereby, the same effect as the main body portion can be obtained in the branch portion. For example, high X-ray contrast marker 1
A set of 10, 113, 116 and a set of 112, 117, 119 are arranged at positions facing each other with an interval of about 180 degrees on the outer circumference along the axis of the branch tubes 22, 23, respectively. preferable.

The X-ray contrast markers are not limited to those provided at the upper and lower ends of the rod 32 of the maintaining means 3c as in the above-described stent graft 1.
For example, like the stent graft 50 shown in FIG. 9, the high X-ray contrast markers 1 are provided at both ends of the guide tube 31 of the maintaining means 3c.
What arrange | positioned 21-130 may be sufficient. Also in this manner, similarly to the above, it is possible to arrange the in-lumen indwelling device at an appropriate position while comparing the length of the expanded state and the size of the aneurysm under X-ray contrast. Further, with this stent graft 50, it is also possible to grasp the entire length of the indwelling object in the non-expanded state. Further, a high X-ray contrast marker (not shown) may be arranged near the engaging portion 322. This facilitates engagement of the engaging portion 322 with the lower end of the guide tube 31 under X-ray imaging.

High X-ray contrast markers 101 to 130, 13
6, 137 is, for example, a simple substance or a compound of a metal of an X-ray opaque substance such as gold, platinum, iridium, tantalum, tungsten, silver, or an alloy containing the metal, or a resin material containing the metal It is preferable to produce using. The resin material containing the X-ray opaque substance is obtained by adding fine particles of a single metal or a compound of the X-ray opaque substance to a synthetic resin as described above. Is preferably 1 to 4 μm,
The content of the X-ray opaque substance in the synthetic resin is preferably from 20 to 80% by weight.

The above-mentioned synthetic resin is preferably a flexible resin, and is preferably an olefin resin such as polyethylene, polypropylene, polybutene, ethylene-vinyl acetate copolymer or a polyolefin elastomer thereof, or a fluorine resin. Or soft fluororesin,
Polyester or polyester-based elastomer such as polyethylene terephthalate, polybutylene terephthalate, methacrylic resin, polyphenylene oxide,
Modified polyphenylene ether, polyurethane or polyurethane-based elastomer, polyamide or polyamide-based elastomer, styrene-based resin or styrene-based elastomer such as polycarbonate, polyacetal, polystyrene, styrene-butadiene copolymer, 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 silicone rubber can also be used.

High X-ray contrast markers 101 to 130, 13
As for the shape of 6,137, it is preferable to make it into a cylindrical body through which the skeleton of the structure 2 can pass. For example, it is preferable to use a coil, a pipe, or a pipe having a notch in a part of the circumference.

These high X-ray contrast markers 101 to 13
0, 136 and 137 are arranged so that at least a part of the skeleton of the structure 2 passes through the lumen. Above all, high X
In the case of the radiographic markers 121 to 130, the guide tube 31 itself (see FIG. 9) and the wire of the guide tube 31 are arranged to pass through the lumen. Also, the pipe is
It may be formed directly on a part of the structure 2 by plating such as electroplating (including electrolytic casting) or electroless plating.

High X-ray contrast markers 101 to 130, 13
The size of 6,137 depends on the size of the skeleton passing through the lumen. As the size of the high X-ray contrast markers 101 to 120, the diameter is 0.05 to 2 mm, and the length is
0.2 to 10 mm, the thickness is 0.01 to 1 mm,
As the size of the high X-ray contrast markers 121 to 130, the diameter is 0.05 to 2 mm, the length is 0.2 to 10 mm,
The thickness is 0.01 to 2 mm, and the high X-ray contrast marker 1
As for the size of 36,137, the diameter is 0.05-2.
mm, length is 0.2 ~ 10mm, thickness is 0.01 ~
It is preferably 2 mm.

A ring 33 is engaged (coupled) 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 separate from or integrated with the rod 32.

The material of the coil forming the guide tube 31 is the same as the material of the strut 27. The outer diameter of the guide tube 31 is not particularly limited and depends on the outer diameter of the stent graft 1, but is usually 0.2 to 2. It is preferably about 5 mm.
It is more preferably about 4 to 1.2 mm. The guide tube 3
The cross-sectional shape of one coil is not limited to a circle, but may be any shape such as an ellipse, a square (a flat shape), and the like.

The constituent material of the rod 32 may be the same as the constituent material of the strut 27. Further, the wire diameter of the rod 32 is not particularly limited, but is usually preferably about 0.05 to 1.5 mm,
It is more preferably about 0.2 to 0.8 mm.

The constituent material of the ring 33 is the same as the constituent material of the strut 27. Further, the wire diameter of the ring 33 is not particularly limited, but in the case of a separate ring 33, a relatively thin one is preferable in order to obtain sufficient flexibility, and specifically,
It is preferably about 0.03 to 0.3 mm, and 0.08 to 0.3 mm.
About 15 mm is more preferable.

The outer diameter expanding means 5c includes an outer tube 51, an outer tube 5
1 and a connecting member (spacer) 53 provided at the upper end of the outer tube 51 and constituting a connecting portion with the maintaining means 3c. The outer diameter expanding means 5c is detachably connected (coupled) to the maintaining means 3c.
Is done.

The outer tube 51 has an appropriate rigidity, that is, a rigidity enough to withstand a compressive force generated in the axial direction when the guide tube 31 is contracted by pulling the rod 32 and not causing bending or the like. It has flexibility (flexibility) and includes, for example, a resin tube or a close-wound coil made of the same coil material as the guide tube 31.

The outer diameter of the pulling wire 52 is smaller than the inner diameter of the outer tube 51, so that the pulling wire 52 can slide inside the outer tube 51 smoothly. A hook 521 is provided at the upper end 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.
An unillustrated traction operation unit is formed. The towing operation section is operated to pull the towing wire 52 downward.

When the pull wire 52 is pulled downward while the hook 521 is engaged with the ring 33, the rod 32 is pulled downward through the ring 33, the guide tube 31 contracts, and the structure 2 is pulled. The state is expanded. In addition, the pulling wire 5
2 is provided at a predetermined position on the lower end side of the high X-ray contrast marker 5 as a display means for indicating the movement amount (traction amount) of the pulling wire 52.
22, 523 are attached. In the present embodiment, at least two high X-ray contrast markers 522 and 523 that can be distinguished by different colors, shades or shapes under contrast, and the like are provided.

These high X-ray contrast markers 522, 523
Is used for various purposes. For example, as shown in FIG. 4, the engaging portion 322 is in the guide tube 31 and has not yet been engaged with the lower end of the guide tube 31, so that the guide tube 31 can be freely expanded and contracted. As shown in FIG. 5, it can be known that the engagement portion 322 is engaged with the lower end of the guide tube 31 or is in a state immediately before the engagement. High X
The X-ray contrast markers 522 and 523 are provided at positions corresponding to these states, respectively, and the states are recognized by distinguishing the high X-ray contrast markers 522 and 523 that appear and disappear from the lower end opening of the outer tube 51. be able to. In addition,
Another example of the display means is to attach a scale corresponding to the amount of movement of the pulling wire 52 to the pulling wire 52 or its pulling means (a take-up reel or the like).

As the size of the high X-ray contrast markers 522 and 523, the diameter is 0.01 to 2 mm and the length is 0.2.
It is preferably about 20 mm. High X-ray contrast marker 5
It is preferable that the materials and mounting methods of 22, 22 and 523 are the same as those of the high X-ray contrast markers 101 to 120.

As shown in FIG. 4, the connecting member 53 is formed of a flat box-shaped member, and a pair of opposing protrusions 531 project upward from the center of the upper end. Have been. The guide tube 31 is
The lower end of the abutment or fit. An internal space 530 is formed in the upper part of the connecting member 53 to allow the passage of the engaging portion 322 in a state where the maintaining means 3c and the outer diameter expanding means 5c are connected. Notches 532 are formed on both sides of the upper end of the connection member 53.

In a state where the maintaining means 3c and the outer diameter expanding means 5c are connected, the engaging portion 322 enters the internal space 530, and the end 323 passes through the notch 532 and extends outside the guide tube 31. And allows engagement with the lower end of the guide tube 31. In other words, the connecting member 53 allows the maintaining means 3c to start the operation of maintaining the structure in the expanded diameter state while the maintaining means 3c and the outer diameter expanding means 5c remain 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 rectangular, but is not limited to this, and may be, for example, elliptical. The connection member 53 may be fixed to the outer tube 51 simply by fitting, but may be fixed by bonding with an adhesive, fusion, brazing, welding, or the like.

At the lower end of the outer tube 51, a bundling member 54 is provided. The bundling member 54 is provided with the outer diameter expanding means 5.
c, 5d, 5f (maintenance means 3 on branch tube 23)
(corresponding to c, 3d, 3f)
They are bundled together. The bundling member 54 has a larger diameter than the three outer tubes 51. Therefore, the bundling member 54 constitutes a grasping portion that is grasped by the grasping instrument 9 in a blood vessel (aorta), as described later.

The shape of the bundling member 54 is also preferably the same as that of the high X-ray contrast markers 101 to 120, and in particular, is preferably a pipe having a notch in a part of the circumference. Thus, the three outer tubes 51 of the outer diameter expanding means 5c, 5d, and 5f can be detachably bundled. Further, the bundling member 54 is not limited to a tubular member, and may be formed in a string shape or a clip shape. These make it easier and more reliable to capture under X-ray imaging with a snare catheter inserted from the other foot.

The material of the bundling member 54 is preferably the same as that of the high X-ray contrast markers 101 to 120. As the size of the bundling member 54, in the case of a pipe shape, the diameter is
0.5 to 10 mm, the length is preferably 0.1 to 10 mm, and the thickness is preferably 0.05 to 5 mm.

For 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), such a bundle member 54 is not provided. , May or may not be mounted. 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 a body cavity.
Degree is preferable, and about 0.4 to 1.2 mm is more preferable.

The constituent material of the pulling wire 52 may be the same as the constituent material of the strut 27. The wire diameter of the pulling 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.

Examples of the connecting member 53 include a member obtained by deforming a metal tube into a desired shape, and a resin molded body. Examples of the metal material forming 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 may be used. Examples of the resin material forming the connection member 53 include polyester such as ultrahigh molecular weight polyethylene, polypropylene, polyamide, polyimide, polystyrene, polycarbonate, polymethyl methacrylate, ABS resin, polyethylene terephthalate, and polybutylene terephthalate, polysulfone, and polyethersulfone. And polyphenylene sulfide, polyacetal, polyetheretherketone, and polytetrafluoroethylene.

Further, it is preferable that the connecting member 53 has high X-ray contrast. Thereby, under X-ray contrast, it is possible to place the intraluminal indwelling device 1 in an appropriate place while confirming the degree of expansion. That is, the rod 3
If the distance between the high X-ray contrast marker at the lower end of 2 and the connecting member 53 is large, the intraluminal indwelling object 1 is in a contracted state, if it is close, it is in an expanded state, and if it is almost overlapped, it is irreversible. It can be seen that the device is in an extended maintenance state.

As a method for imparting high X-ray contrast, when the connecting member is made of the above-mentioned metal, the above-mentioned simple metal or alloy having high X-ray contrast is plated on the connecting member 53. By doing so, when the connection member 53 is made of the above-described resin, it is preferable that the connection be performed by mixing the above-described single metal or alloy having high X-ray contrast property into the resin.

Since the maintaining means 3c and the outer diameter expanding means 5c are structured as described above, the operability is excellent, and the diameter is reduced while fully exhibiting the functions as the maintaining means and the outer diameter expanding means. be able to. This allows
This contributes to reducing the burden on the patient during insertion into the lumen. In addition, the reduction in the diameter makes it possible to apply to a portion where insertion has been difficult in the past, and the range of application to various parts of the living body can be expanded.

The upper ends 35 of the maintaining means 3a to 3d
An end of the strut 27 is fixed to the lower end 36 and the lower end 36 of the holding means 3e, 3f.
The upper end portions 35 of the maintaining means 3e and 3f are fixed to each other via a strut 27, and a part of the strut 27 is fixed near this end. In addition, maintenance means 3
In the same way as in a to 3f, a portion intersecting the strut 27 and an intersecting portion between the struts 27 are also fixed. These fixings can be performed by, for example, bonding with an adhesive, brazing such as soldering, welding, or purple.

Here, the fixing of the struts 27 to the intermediate portions of the maintaining means 3a to 3f and the fixing of the intersections between the struts 27 are preferably loose fixing so that the intersection angle is variable. Thereby, expansion and contraction of the stent graft can be performed more smoothly. In addition, the strut 27 is fixed to the guide tube 31 for the maintaining means 3a to 3f (see FIGS. 2 and 3).

Next, an intraluminal indwelling object (stent graft) according to another embodiment of the present invention will be described. As shown in FIG. 10, the stent graft 60 of this embodiment is a tubular structure 2 having a first outer diameter and a first outer diameter.
A structure deformable to a second outer diameter larger than the outer diameter of
Maintaining means extending in the axial direction of the structure for maintaining the structure at the second outer diameter. The structure 2 includes a spirally wound linear body (strut) 27a, a linear body 27a and a linear body (strut) 27b spirally wound in the opposite direction, and an intersection where the linear bodies intersect. Further, a high X-ray contrast marker 131 is fixed at the intersection. In particular,
In the stent graft 60, fixation at the intersection of the struts 27 is performed using the high X-ray contrast marker 131.

The structure 2 is mainly composed of a plurality of struts (linear bodies) 27 wound spirally. The structure 2 of this embodiment has a plurality of struts 27a spirally wound in the same direction (winded substantially parallel) and a plurality of struts 27a wound in the opposite direction to the plurality of struts 27a. The strut 27b is provided. For this reason,
In the structure 2, the struts 27a and the struts 27b
Are formed. The structure of the structure 2 is the same as that of the stent graft 1 described above.

As shown in FIGS. 10 and 11, the high X-ray contrast marker 131 has a shape in which two intersecting cylindrical bodies are integrated, and the struts 27a, 27b is inserted. This allows
The shape of the structure 2 can be maintained, and the visibility under X-ray contrast can be improved.

The shape of the high X-ray contrast marker is not limited to the above, and may be, for example, a high X-ray contrast marker 134 shown in FIG. This high X
The radiographic marker 134 is shown in FIG. 13 by forming four notches in a plate made of radiopaque metal or the like partially as shown in FIG. 12, and then bending the strut gripper 135. Thus, the struts 27a and 27b are sandwiched. After the strut grip 135 is bent, the opposite ends may be welded or bonded.

As the material of the high X-ray contrast markers 131 and 134, those described for the high X-ray contrast markers 101 to 120 can be suitably used. High X-ray contrast marker 131
As the size of the diameter of each cylindrical body is 0.0
5 to 2 mm, length 0.2 to 20 mm, thickness 0.
It is preferably from 01 to 1 mm. As the size of the high X-ray contrast marker 134 shown in FIG.
0.2 to 20 mm, thickness is 0.01 to 1 mm, length of the strut grip 135 in the longitudinal direction is 0.5 to 5 m
m, the length in the direction opposite to the longitudinal direction is preferably 0.1 to 10 mm.

Further, like the stent graft 80 or the stent graft 90 of the embodiment shown in FIG. 14, even when the high X-ray contrast markers 121 to 130 are provided not only at the intersection of the struts 27 but also at both ends of the guide tube 31. Good. Accordingly, the shape of the structure 2 can be maintained, and the length of the in-lumen indwelling object under X-ray contrast can be arranged at an appropriate position while comparing the length of the expanded state with the size of the aneurysm. Instead of arranging the high X-ray contrast marker on the guide tube 31, the high X-ray contrast marker may be arranged on both ends of the rod 32 or on the hook 321 and the engaging portion 322. In addition, the strut 27 is fixed to the guide tube 31 for the maintaining means 3a to 3f (see FIGS. 2 and 3).

As described above, the maintaining means 3 a to 3 f and the strut 27 together form the skeleton of the structure 2. In particular, the maintaining means 3a to 3f play the role of a main column extending in the axial direction of the structure 2. Thereby, necessary and sufficient strength and elasticity, particularly uniform strength and elasticity, can be secured without complicating the structure of the structure 2.

Further, the inner surface and / or the outer surface of the structure 2 may be coated with a film (not shown). It is preferable that the film expands and contracts with a change in the outer diameter of the structure 2 or expands from a folded state. 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 a positional deviation and an angular deviation from the axis of the blood vessel after placement.

The membrane may be any of a fibrous porous membrane such as a woven or knitted fabric, a nonwoven fabric, and a paper material, a non-fibrous porous membrane, and a dense membrane such as a polymer sheet. Examples of the material (fiber) of the membrane include cellulose fiber, cotton, linter, kapok, flax, hemp, ramie, silk, wool, and other natural fibers, nylon (polyamide), tetron, rayon, cupra, acetate, vinylon, and acrylic. And synthetic fibers such as polyethylene terephthalate (polyester) and polypropylene, or combinations of two or more of these natural and chemical fibers (such as mixed spinning). Other examples of the film material (polymer sheet) include, for example, polyesters such as polyethylene, polypropylene, polyurethane, polyethylene terephthalate, and polybutylene terephthalate, polyvinyl chloride, polytetrafluoroethylene, natural rubber, isoprene rubber, Examples include various rubbers such as silicone rubber, styrene-butadiene rubber, and latex rubber, and various thermoplastic elastomers such as polyamide-based, polyester-based, and polyurethane-based. Further, the film may be a laminate of two or more layers made of the same or different materials. Further, the inner surface of the membrane may be coated with an anticoagulant such as heparin or urokinase, an antithrombotic material such as a block copolymer of urethane and silicone (Abucosan®) or a hydroxyethyl methacrylate-styrene copolymer. .

The location of the membrane with respect to the structure 2 may be the whole or a part of the structure 2, but is preferably a central portion in the longitudinal direction of the main tube 21, more preferably an inner or outer surface of substantially the entire main tube 21. Preferably it is coated. The method of fixing the membrane to the structure 2 is as follows.
There is no particular limitation, and besides being pressed against the structure 2 by the contraction force of the membrane 4, for example, the maintenance means 3 a to 3 f and the strut 27
It can be fixed at a plurality of locations by a method such as adhesion with an adhesive, fusion (thermal fusion, ultrasonic fusion, or the like), suturing, ligating, or the like.

Next, the maintaining means 3c and the outer diameter expanding means 5
The operation (operation) of c will be described with reference to FIGS. As shown in FIG. 4, first, in a state where no external force acts on the maintaining means 3c, the guide tube 31 of the maintaining means 3c is in an extended state, and thereby the structure 2 is in a reduced diameter state. At this time, the engaging portion 322 is housed in the guide tube 31. Also, the rod 32 and the pulling wire 52
Are connected by a ring 33 so that tension can be transmitted.

Next, as shown in FIG. 5, when the pulling wire 52 is pulled downward while holding the outer tube 51, first, the projection 532 of the connecting member 53 abuts or fits on the lower end of the guide tube 31. I do. When the pulling wire 52 is further pulled downward, the rod 32 is pulled, the guide tube 31 is contracted, and the structure 2 is in an expanded state. In addition, the engagement portion 322 is exposed from the lower end opening of the guide tube 31 by the contraction of the guide tube 31,
It enters the internal space 530 of the connection member 53. At this time, the end 323 of the engaging portion 322 passes through the notch 532 and projects outward from the guide tube 31.

Next, when the tension of the pulling wire 52 is weakened and the pulling wire 52 is returned slightly upward, the end 323 of the engaging portion 322 engages with the lower end of the guide tube 31 as shown in FIG. . Thereby, the contracted state of the guide tube 31, that is, the expanded state of the structure 2 is maintained. The operation of the structure 2 from the reduced diameter state to the expanded diameter state until the state is maintained is visually recognized by the surgeon outside the body by visually recognizing the positions of the high X-ray contrast markers 522, 523 and the like. be able to.

Next, as shown in FIGS. 6 and 7, the operation of moving the pulling wire 52 upward, rotating the pulling wire 52, and the like is performed.
3, the hook 521 is removed, and then the pulling wire 52 is moved downward again to store the hook 521 in the internal space 530 of the connecting member 53. As a result, the outer diameter expanding means 5c is separated from the maintaining means 3c. The above-mentioned operation is similarly performed on the maintaining means and the outer diameter expanding means other than the maintaining means 3c and the outer diameter expanding means 5c. The operator can easily and smoothly perform such an operation in a short time.

According to the present invention, when the stent graft is pushed out of the introduction sheath into the aorta, the stent graft can be moved freely in a reduced diameter state and can be positioned freely. With the line contrast marker, the upper end and the lower end in the expanded state can be known in advance. In addition, since the entire length and position of the stent graft converge between the high X-ray contrast markers with the expansion operation, the stent graft can be accurately placed at a desired position.

Although the in-lumen indwelling object of the present invention has been described with reference to the illustrated embodiment, the present invention is not limited to this. The means and the outer diameter expanding means can be replaced with those having any shape and structure capable of exhibiting the same function.

Further, the indwelling object may have a simple cylindrical shape without a branch portion such as the branch tubes 22 and 23. Also, what is placed in the blood vessel is not limited to the stent graft as described above,
For example, a stent for expanding a vascular stenosis may be used. In this case, the equivalent to the film 4 may not be present. Further, the indwelling indwelling object of the present invention is not limited to those to be indwelled in blood vessels, and other, for example, bile ducts, lymph vessels,
The present invention can be applied to those inserted and placed in various lumens (body cavities) such as trachea, digestive tract, urethral tract, and vagina.

[0083]

The intraluminal indwelling object of the present invention is a tube-shaped structure, and is deformable into a first outer diameter and a second outer diameter larger than the first outer diameter. In a lumen having a stable structure and a maintenance means extending in the axial direction of the structure for maintaining the structure at the second outer diameter, wherein the maintenance means is such that In the state where the structure is maintained at the second outer diameter, there are high X-ray contrast markers provided at positions that are both ends of the structure.

Thus, under X-ray contrast, the length of the expanded state of the indwelling object and the size of the aneurysm can be compared with each other and placed at an appropriate position.

The in-lumen indwelling object of the present invention is a tube-shaped structure, and has a first outer diameter and the first outer diameter.
A structure deformable to a second outer diameter larger than the outer diameter of
An intraluminal indwelling device having a retaining means extending in the axial direction of the structure for maintaining the structure in the second outer diameter state, wherein the structure comprises a helically wound linear body; A linear body in which the linear body and the spiral are wound in the opposite direction, and an intersection where the linear bodies intersect;
The line contrast marker is fixed.

Thus, the shape of the structure can be maintained, and the visibility under X-ray contrast can be improved.

[Brief description of the drawings]

FIG. 1 is an overall perspective view showing an embodiment in which an in-lumen indwelling object of the present invention is applied to a stent graft.

FIG. 2 is a perspective view showing a configuration (a structure in a reduced diameter state) of a maintaining means in the in-lumen indwelling device shown in FIG. 1;

FIG. 3 is a perspective view showing a configuration (a structure in an expanded state) of a maintenance means in the in-lumen indwelling device shown in FIG. 1;

FIG. 4 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 in-lumen indwelling object of the present invention.

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 indwelling object according to 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 in-lumen indwelling object of the present invention.

FIG. 7 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 in-lumen indwelling object of the present invention.

FIG. 8 is an explanatory diagram of a means for maintaining the indwelling object shown in FIG. 1;

FIG. 9 is an overall perspective view showing another embodiment of the in-lumen indwelling object of the present invention.

FIG. 10 is an overall perspective view showing another embodiment of the in-lumen indwelling object of the present invention.

FIG. 11 is a usage diagram showing one embodiment of a high X-ray contrast marker as an intersection fixing means.

FIG. 12 is an overall perspective view showing another embodiment of a high X-ray contrast marker as an intersection fixing means.

FIG. 13 is a view showing how to use a high X-ray contrast marker as the intersection fixing means in FIG. 12;

FIG. 14 is an overall perspective view showing another embodiment of the in-lumen indwelling object of the present invention.

[Explanation of symbols]

 1, 50, 60, 70, 80, 90 Stent graft 2 structure 27 strut 3a to 3f maintenance means 31 guide tube 32 rod 51 outer tube 52 traction wire

Claims (14)

[Claims] 1. A structure formed in a tubular shape,
A structure deformable to a first outer diameter, a second outer diameter larger than the first outer diameter, and an axial direction of the structure for maintaining the structure at the second outer diameter In the in-lumen indwelling device having a maintenance means extending to the end portion, the maintenance means is provided at both ends of the structure in a state where the maintenance means maintains the structure at the second outer diameter. An intraluminal indwelling object having a provided high X-ray contrast marker. 2. The intraluminal indwelling according to claim 1, wherein the structure comprises 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. object. 3. The maintenance means includes an extendable guide tube and a rod inserted into the guide tube, and the guide tube is contracted by pulling the rod, thereby reducing the outer diameter of the structure. The intraluminal indwelling device according to claim 1 or 2, wherein the indwelling device is configured to have a second outer diameter. 4. The in-lumen indwelling device according to claim 3, wherein the high X-ray contrast markers are arranged at both ends of the rod. 5. The intraluminal indwelling device according to claim 3, wherein the high X-ray contrast markers are arranged at both ends of the guide tube. 6. A tube-shaped structure, comprising:
A structure deformable to a first outer diameter, a second outer diameter larger than the first outer diameter, and an axial direction of the structure for maintaining the structure at the second outer diameter In the in-lumen indwelling device having a maintenance means extending in a direction, the structure includes a helically wound linear body, a linear body in which the linear body and the spiral are wound in the opposite direction, An intraluminal indwelling device comprising: an intersection where a body intersects; and wherein a high X-ray contrast marker is fixed to the intersection. 7. The intraluminal indwelling device according to claim 6, wherein the linear body located at the intersection is maintained in an intersecting state by the high X-ray contrast marker. 8. The maintenance means includes an extendable guide tube and a rod inserted into the guide tube, and the guide tube is contracted by pulling the rod, thereby reducing the outer diameter of the structure. The intraluminal indwelling device according to claim 6 or 7, wherein the indwelling device is configured to have a second outer diameter. 9. The intraluminal indwelling object includes high X-ray contrast markers arranged at both ends of the rod.
The indwelling device according to [1]. 10. The intraluminal indwelling device according to claim 8, wherein the intraluminal indwelling object includes high X-ray contrast markers arranged at both ends of the guide tube. 11. The intraluminal indwelling device according to claim 1, wherein the structure is branched. 12. The intraluminal indwelling device according to claim 1, wherein a plurality of the maintaining means are arranged. 13. The tube according to claim 1, further comprising an outer diameter expanding means for changing an outer diameter of the structure from the first outer diameter to the second outer diameter. Intraluminal indwelling 14. The outer diameter expanding means includes an outer pipe, a pulling wire inserted into the outer pipe, and a connecting member installed at an end of the outer pipe and forming a connecting part with the maintaining means. The in-lumen indwelling device according to claim 13, which is provided.