JP4138144B2 - Intraluminal indwelling - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an intraluminal indwelling object that is inserted into and placed in a lumen such as a blood vessel, and more particularly to an intraluminal indwelling object that is placed at a lesion site such as an abdominal aortic aneurysm.
[0002]
[Prior art]
Conventionally, when treating an abdominal aortic aneurysm, the aneurysm is surgically removed, and an artificial blood vessel (a tube made of an artificial material) is transplanted to that portion, or another new method called bypass surgery is performed. A treatment method has been adopted in which a blood vessel channel is formed and blood is allowed to flow. However, many patients who develop such symptoms are generally over 65 years of age, and such major surgery increases the risk of complications during and after the operation, and is risky.
[0003]
However, with subsequent improvements, using a catheter with local anesthesia, a cylindrical artificial blood vessel called a stent graft is percutaneously introduced into the blood vessel from the thigh, etc., and delivered to the treatment site. The technique of covering the aneurysm with a graft and treating it with a thrombus has been performed. As a result, the burden on the patient can be greatly reduced.
[0004]
FIG. 8 shows a schematic diagram of the abdominal aorta and an arrangement example of a conventional stent graft. In the abdominal aorta 100, there are common iliac arteries 103, 104 that branch from the right and left renal arteries 101, 102 to the left and right legs. And it is an example in which the aortic aneurysm 105 developed in the vicinity, and the stent graft 90 is arrange | positioned as the treatment.
[0005]
[Problems to be solved by the invention]
However, in such a conventional technique, the site where the stent graft can be placed is limited. This is due to the complex structure of the aorta as shown in FIG. 8, and a large number of aortic aneurysms occur in the vicinity of the renal arteries and in the vicinity of the site having a bifurcation connected to the foot. In this case, the stent graft can be placed at a position that does not reach the renal artery. However, especially when an aneurysm occurs at the site of the renal artery, there is a renal artery, which makes it difficult to fix or block the renal artery. Therefore, it is customary that this treatment cannot be applied.
[0006]
The present invention has been made in view of the above-described problems, and an object of the present invention is to enable a treatment in which a stent graft (intraluminal indwelling object) is positively disposed in an aneurysm near the renal artery.
[0007]
[Means for Solving the Problems]
Order to attain the above object, a graft of cylindrical shape disposed in the body cavity, at least a portion on the side holes of the side wall of the graft is formed, the contrast marker is provided on the side hole portion, the contrast marker Is an in-lumen indwelling object characterized in that the periphery of the side hole portion is edged .
[0008]
Also, what achieves the above object is a stent graft disposed in a body cavity, which has a radially expandable cylindrical stent, and covers at least a part of the cover member, and at least the side wall of the cover member. A side hole is formed in a part, a contrast marker is provided in the side hole portion, and the contrast marker is an intraluminal indwelling object having a periphery around the side hole portion .
[0009]
Further, it is preferable that at least two side holes are provided.
[0010]
The intraluminal indwelling material may have a branching portion.
[0011]
Moreover, it is preferable that the said cover member is formed with flexible resin.
[0012]
Further, it is preferable that the contrast marker is bordered by a gold wire around the side hole portion.
[0013]
Moreover, it is preferable that the nonwoven fabric is further provided around the said side hole part.
[0014]
In addition, it is preferable that at least a skeleton structure is disposed in the side hole portion.
[0015]
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. In this embodiment, the upper side in the figure is described as “upper” or “upper side”, and the lower side is described as “lower” or “lower end”.
[0016]
FIG. 1 is a view showing an embodiment in which the intraluminal indwelling material of the present invention is applied to a stent graft. As shown in FIG. 1, a stent graft 1 of the present invention is inserted and placed in an aorta, and has a structure 2 whose outline is formed in a cylindrical shape or a tube shape.
[0017]
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.
[0018]
Openings 24, 25, and 26 are formed at the upper end of the main body tube 21 and the lower ends of both branch tubes 22, 23, respectively.
[0019]
The structure 2 is mainly composed of a plurality of struts (linear bodies) 27 wound in a spiral shape. In this case, the spiral of one strut 27 and the other strut 27 is wound in opposite directions. These struts 27 form the skeleton of the structure 2.
[0020]
The shape and form of the struts 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), a net shape, or a zigzag structure.
[0021]
Thus, the structure serves as a fixing means for forming the skeleton of the cover member (membrane) 4 or fixing the cover member (membrane) at the arrangement location.
[0022]
This cover member (film) 4 is coated on the inner surface and / or outer surface of the structure.
[0023]
As a feature of the present invention, side holes 30 and 31 are provided in the side wall of the main body 21 of the stent graft. This side hole is preferably provided at a position matching the renal arteries 101 and 102. Basically, the two side holes are formed at opposite positions.
[0024]
However, there are individual differences in the position of the renal artery, and it is known that the arrangement position is not always constant. Therefore, it is necessary to confirm in advance the side hole arrangement position for the subject patient. In addition, it is preferable to set the positions of the side holes in several patterns and select a pattern that matches the patient. Or it is also possible to form a side hole after examining the arrangement position in an individual in advance.
[0025]
As the shape of the stent graft, as long as it is a shape that forms a branch hole as shown in FIG. 1 or a shape that only closes the treatment site and forms a side hole, such as the shape 50 of the main body as shown in FIG. It is not limited to these.
[0026]
In this embodiment, two side holes are provided. However, depending on the arrangement of the renal artery and the treatment site, the stent graft may only be placed on one of the renal arteries and may be placed. One side hole may be formed.
[0027]
Although the size of the side hole depends on the size of the renal artery, an opening having a diameter of about 1 to 20 mm is preferable, and more preferably about 3 to 10 mm.
[0028]
FIG. 3 shows a partially enlarged view of the side hole forming portion. Stitches bordered by gold wires 3 are formed at the edges of the side holes. This serves as a contrast marker for confirming the side hole position, which is a feature of the present application, at the time of contrast. Moreover, fraying of the cover member 4 in the side hole portion is also prevented. This enables accurate positioning while confirming the position of the renal artery and the position of the side hole when placing the stent graft.
[0029]
In this embodiment, the material of this contrast marker is bordered using a gold wire, but is not particularly limited as long as the position of the side hole can be confirmed, and is a material selected from a metal group of silver, platinum, iridium, and palladium. It is preferable that the wire is woven or knitted into the end membrane, the sheet is integrally formed, the powder metal is mixed with the sheet, or the stent corresponding to the side hole opening. The skeleton may be coated, plated, or deposited.
[0030]
Moreover, it is preferable to further attach a flexible resin, fluffy fiber, fluffy fiber, etc. to the side hole edge part, and it is particularly preferable to apply the nonwoven fabric 5. This is effective in improving the close contact of the side hole edge part with the living body and preventing leakage of blood flow.
[0031]
The cover member 4 may be, for example, a fibrous porous membrane such as a woven or knitted fabric, a nonwoven fabric, or a paper material, a non-fibrous porous membrane, or a dense membrane such as a polymer sheet.
[0032]
Examples of the material (fiber) of the cover member 4 include cellulose fibers, cotton, linter, kapok, flax, cannabis, ramie, silk, wool, and other natural fibers, nylon (polyamide), tetron, rayon, cupra, acetate, vinylon. And chemical fibers such as acrylic, polyethylene terephthalate (polyester), and polypropylene, or combinations of two or more of these natural and chemical fibers (such as blends).
[0033]
Other examples of the material (polymer sheet) of the cover member 4 include, for example, polyesters such as polyethylene, polypropylene, polyurethane, polyethylene terephthalate, and polybutylene terephthalate, polyvinyl chloride, polytetrafluoroethylene, natural rubber, and isoprene. Examples thereof include various rubbers such as rubber, silicone rubber, styrene-butadiene rubber and latex rubber, and various thermoplastic elastomers such as polyamide, polyester and polyurethane.
[0034]
The cover member 4 may be a laminate of two or more layers made of the same or different materials.
[0035]
Further, the installation location of the cover member 4 with respect to the structure 2 may be the whole structure 2 or a part thereof, but is preferably a 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. Is preferably coated.
[0036]
In addition, the fixing method of the cover member 4 to the structure 2 is not particularly limited, and the cover member 4 is bonded to the structure 2 by the contraction force of the cover member 4, and is bonded to the strut 27 with an adhesive or fused (thermal fusion, It can be fixed at a plurality of locations by methods such as ultrasonic fusion), suturing, and ligating.
[0037]
Next, examples of the skeleton structure of the stent graft of the present invention will be described in detail.
[0038]
Although the skeletal structure is not particularly limited as described above, the skeletal structure of the stent graft 1 of the present invention is formed in a spiral shape by the struts 27 as shown in FIG.
[0039]
As a constituent material of the strut 27, a material having a certain degree of biocompatibility is preferable. For example, stainless steel, Ni-Ti alloy, superelastic alloy, Cu-Zn alloy, Ni-Al alloy, tungsten, tungsten alloy, titanium, Various metals such as titanium alloy, tantalum or tantalum alloy can be mentioned, and particularly preferred are superelastic alloys and high-strength stainless steel for springs.
[0040]
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 to 1 mm.
[0041]
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 diameter of the main body tube 21 is reduced by an external force, and when the external force is removed, the diameter of the main tube 21 is expanded (natural state).
[0042]
In this case, it is preferable to select a stent graft in which the main body tube 21 is sufficiently close to the inner wall of the aorta and the diameter in the natural state is slightly larger than the blood vessel diameter of the aorta.
[0043]
Similarly, the branch tubes 22 and 23 can be selected in accordance with the blood vessel diameter.
[0044]
Next, FIG. 4 shows a modified example 60 of the skeleton structure. In this configuration, a zigzag stent 28 is arranged at the end of the cover member (gufft) 4. The graft itself may be formed of the above-described materials. It has a structure having a fixing means in the stent graft arrangement at the end.
[0045]
In FIG. 4, the skeleton structure is further arranged at the side hole edge portion. Further, it is also preferable to further attach a flexible resin, fluffy fibers, fluffy fibers, etc. around the side hole portion, and it is particularly preferable to form the nonwoven fabric 5. These are effective in improving the adhesion between the periphery of the side hole portion and the living body and preventing leakage of blood flow.
[0046]
FIG. 5 further shows a modified example 70 of the stent graft. In FIG. 4, the skeletal structures are arranged in several places. However, as shown in FIG. 5, a zigzag stent may be formed in a ring shape and fixed to the membrane to have a skeleton structure as a whole.
[0047]
In FIG. 5, the skeleton structure of the stent is also present in the side hole opening, and the contrast marker 301 is provided on the skeleton structure corresponding to the opening by gold plating.
[0048]
In this embodiment, a self-expanding stent is shown, but the present invention can also be implemented in a balloon expandable stent. However, the self-expanding type is more preferable from the viewpoint of simplicity of operation.
[0049]
Next, the arrangement of the stent graft 1 of the present invention in the lumen is shown in FIG. In this way, the stent graft 1 is disposed so as to cover the site of the aneurysm 105 relating to the renal arteries 101 and 102. Since the side holes 30 and 31 are arranged so as to match the renal artery and the stent graft can be fixed at the normal site (upper side of the renal artery), even in the treatment of aneurysms involving the renal artery, which is currently difficult, A minimally invasive stent graft treatment can be performed.
[0050]
In this embodiment, a skeleton structure called a stent graft has been described in detail with a cover member or a cover member having an end fixing means. However, as shown in FIG. It is needless to say that even the formation of 31 is within the scope of the present invention.
[0051]
【The invention's effect】
As described above, in the intraluminal indwelling device of the present invention, a side hole is formed in the side wall in order to allow blood flow to the renal artery, and a contrast marker is provided in the side hole for accurate position confirmation and arrangement. As a result, it is possible to actively use a minimally invasive intraluminal indwelling product (stent graft) even at a treatment site for the renal artery, which is currently difficult.
[0052]
Further, since the side holes are bordered with gold wires, it is effective in preventing fraying of the film material.
[0053]
Furthermore, adhesion with a living body can be further improved by providing fibers such as nonwoven fabric around the side hole portion.
[Brief description of the drawings]
FIG. 1 shows a stent graft of the present invention.
FIG. 2 illustrates another shape stent graft of the present invention.
FIG. 3 is a partially enlarged view of a side hole forming portion of the present invention.
FIG. 4 illustrates another skeletal structure stent graft of the present invention.
FIG. 5 illustrates another skeletal stent graft of the present invention.
FIG. 6 is a view showing a stent graft of the present invention placed in a lumen.
FIG. 7 is a diagram showing another embodiment of the present invention.
FIG. 8 shows the placement of a stent graft within a conventional lumen.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Stent graft 2 Structure 21 Main body tube 22, 23 Branch tube 24-26 Opening 27 Strut 28 Strut (zigzag line)
3, 301 Contrast marker 4 Membrane 5 Non-woven fabric 100 Aorta 101 Left renal artery 102 Right renal artery 103 Left iliac artery 104 Right iliac artery 105 Aortic aneurysm

Claims (8)

A cylindrical graft disposed in a body cavity, wherein a side hole is formed in at least a part of a side wall of the graft, a contrast marker is provided in the side hole part, and the contrast marker has a periphery around the side hole part. Intraluminal indwelling, characterized in that it is edged . A stent graft disposed in a body cavity, having a radially expandable cylindrical stent, having a cover member covering at least a portion, and a side hole formed in at least a portion of the side wall of the cover member, An intraluminal indwelling object, wherein a contrast marker is provided in a side hole portion, and the contrast marker is edged around the side hole portion . The intraluminal indwelling object according to claim 1, wherein at least two side holes are provided. The intraluminal indwelling product according to claim 1, wherein the intraluminal indwelling product has a branch portion. The intraluminal indwelling object according to claim 2, wherein the cover member is made of a flexible resin. 6. The intraluminal indwelling object according to claim 1, wherein the contrast marker is bordered by a gold wire around the side hole portion. The intraluminal indwelling article according to claim 1, wherein a nonwoven fabric is further provided around the side hole portion. The indwelling object in a lumen according to any one of claims 2 to 7, wherein at least a skeleton structure is disposed in the side hole portion.

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