JP4494144B2 - Tubular organ treatment tool - Google Patents

Description

  The present invention relates to a tubular organ treatment tool for inserting a stent or the like into a human tubular organ such as a blood vessel, a ureter, a bile duct, and a trachea, and a stent placement method using the same.

  In recent years, for the treatment of tubular organs of the human body such as blood vessels, ureters, bile ducts, and trachea, a covered stent is inserted and placed through the catheter in the affected area. For example, a treatment method is known in which a covered stent is placed in a stenosis portion of a blood vessel to be expanded, or a covered stent is placed in a place where an aneurysm is formed to prevent rupture of the aneurysm.

  As a stent delivery system, Non-Patent Document 1 describes a system provided with a dilator.

Treatment of Thoracic and Abdominal Aortic Aneurysms 2001-Focusing on Stent Grafting-Supervised by Kensuke Eri and Hiroaki Takenaka, Medical Tribune, January 31, 2001 (1st edition, 1st print), 13-15, 40- 53 pages

  When inserting a stent into a tubular organ in the body, the treatment device is provided with a protective device such as a dilator at the distal end of the stent by reducing the diameter of the stent so as not to damage the lumen wall of the tubular organ. Is used. However, when inserted into a bent place, the dilator body, the edge of the distal end portion of the stent or sheath may damage the lumen wall of the tubular organ. Further, there is a possibility that the lumen wall may be damaged when the used sheath is extracted. Further, there has been a report that a sheath or the like damages the skin or blood vessel of the insertion portion.

When releasing the reduced diameter self-expandable stent into the tubular organ, the stent is accommodated in a hard cylindrical cover (sheath) in a reduced diameter state, and then the cylindrical cover is inserted into the tubular organ. The shaped cover is withdrawn to release the stent into the tubular organ. When pulling out the cylindrical cover to release the stent, the pulling out operation requires a large force because the expansion force of the stent becomes friction and resistance is generated, and a large amount of force is applied to the cover and holder (core bar). There is a load. Since the pulling operation requires a large force, it is easily affected by positional deviation due to frictional resistance, and the accuracy of the indwelling position and direction is easily affected. It is also conceivable that the stent itself is distorted or non-uniformly expanded, or the cover attached to the stent is damaged.
It is an object of the present invention to provide a tubular organ that can be inserted into a bent place of a tubular organ in the body without damaging the lumen wall and the introduction portion of the tubular organ, and can easily be placed in a tubular organ such as a stent. It is to provide a treatment tool.

The present invention is a treatment device for a tubular organ having a reduced diameter stent inside the inner layer of the folded cover,
-The folded cover has a folded portion with a structure having at least an inner layer and an outer layer, which is obtained by folding the cylindrical tube at least once.
-The stent in a reduced diameter state is characterized in that the distal end side of the stent is arranged on the folded portion side of the folded cover. (Invention a)

Preferably, the present invention is a treatment device for a tubular organ having a stent with a reduced diameter inside the inner layer of the folded cover,
-The folded cover has a folded portion with a structure having at least an inner layer and an outer layer, which is obtained by folding the cylindrical tube at least once.
-The folded part of the folded cover or the vicinity thereof is tied in a state of unraveling by the string material,
-The stent in a reduced diameter state is characterized in that the distal end side of the stent is arranged on the folded portion side of the folded cover. (Invention B)

Preferably, the present invention is a treatment device for a tubular organ having a stent with a reduced diameter inside the inner layer of the folded cover,
-The folded cover has a folded portion with a structure having at least an inner layer and an outer layer, which is obtained by folding the cylindrical tube at least once.
The cylindrical tube is a tube that connects a flexible tube (A) and a tube (B) that is less flexible than the tube (A),
-The inner layer of the folded cover is the tube (A), and most of the outer layer of the folded cover is the tube (B).
-The stent in a reduced diameter state is characterized in that the distal end side of the stent is arranged on the folded portion side of the folded cover. (Invention C)

Preferably, the present invention is a treatment device for a tubular organ having a stent with a reduced diameter inside the inner layer of the folded cover,
-The folded cover is a structure having at least an inner layer and an outer layer obtained by folding the cylindrical tube at least once, and has a folded portion.
The inner diameter of at least one end of the tubular tube is greater than the inner diameter of the inner layer of the folded cover holding the stent;
-The stent in a reduced diameter state is characterized in that the distal end side of the stent is arranged on the folded portion side of the folded cover. (Invention D)

Preferred embodiments of the tubular organ treatment device of the present invention are shown below. A plurality of preferred embodiments can be combined.
1) The stent in a reduced diameter state is disposed between the folded portion of the folded cover and the cover end portion. (Invention I, Invention B, Invention C, Invention D)
2) The inner diameter of at least one end of the tubular tube is larger than the inner diameter of the inner layer of the folded cover in which the stent is placed. (Invention B, Invention C)
3) The folded portion of the folded cover or the vicinity thereof and the outer side of the inner layer of the folded cover on which the reduced-diameter stent is disposed are tied in a state of being broken by a string material. (Invention B, Invention D)
4) The folded portion of the folded cover or the vicinity thereof and the outer side of the inner layer of the folded cover on which the reduced-diameter stent is disposed are connected in the unfolded state by the same string material. (Invention B, Invention D)
5) At least two or more locations outside the inner layer of the folded cover in which the folded portion of the folded cover or the vicinity thereof is tied with a string material in a state of tearing, and a stent having a reduced diameter is arranged using the same string material. It is tied in the state of opening the knot. (Invention B, Invention D) 6) The folded cover is a folded cover that is torn in the length direction from the end of the outer layer. (Invention B, Invention B, Invention D)
7) The tubular tube of the folded cover is at least twice as long as the length of the stent in the reduced diameter state. (Invention I, Invention B, Invention C, Invention D)
8) The folded portion of the folded cover should be provided on the same surface as the distal end portion of the stent or in a portion protruding to the distal end side. (Invention I, Invention B, Invention C, Invention D)
9) Connect a member such as a ring that is harder than the folded cover to the end of the outer layer of the folded cover. (Invention B, Invention B, Invention D)
10) The stent has a reduced diameter by being placed inside the inner layer of the folded cover. (Invention I, Invention B, Invention C, Invention D)
11) The folded cover is a multilayer structure such as a double structure having at least an inner layer and an outer layer, in which the cylindrical tube is folded at least once, and the inner layer and the outer layer are connected by a folded portion. (Invention I, Invention B, Invention C, Invention D)
12) The folded cover is obtained by folding the cylindrical tube at least once, has a folded portion, and has a double structure, a quadruple structure or an eightfold structure having an inner layer and an outer layer, and a combination of these structures. There is. (Invention I, Invention B, Invention C, Invention D)
13) The folded cover is folded while turning so that the inner layer of the folded cover is turned up from the folded portion of the inner layer and the outer layer by pulling the end of the outer layer of the folded cover in the direction opposite to the folded portion. There is. (Invention I, Invention B, Invention C, Invention D)

(Invention I, Invention B, Invention C and Invention D)
1) In the tubular organ treatment device of the present invention, by pulling the end of the outer layer in the direction opposite to the folded portion, the inner layer of the folded cover is pulled out from the folded portion while being turned upside down. Therefore, the pulling-out force of the folded cover is only a frictional resistance between the outer surface of the inner layer of the folded cover and the inner surface of the outer layer, and is not affected by the expansion force of the reduced diameter stent. Even if the stent has a strong expansion force, more reliable release and deployment are possible. This is also effective in terms of positioning accuracy and suppression of stent deformation.
2) The folding cover used in the tubular organ treatment device of the present invention only needs to be strong enough to maintain the diameter-reduced state of the stent, and the inner layer of the folding cover is pulled out while being turned upside down from the folded portion. It is enough if it is soft enough to be able to do, especially softer. Although a conventional cylindrical cover such as a sheath uses a hard one, the present invention is completely opposite.
3) The tubular organ treatment device of the present invention can be manufactured by a simple method using a readily available tube.
The tubular organ treatment device of the present invention uses a flexible tubular tube such as a polyolefin such as polyethylene, a polyfluorinated olefin such as polyester, nylon, and Teflon (registered trademark), thereby returning the tubular organ to a bent place. Can be inserted without damaging the lumen wall of the tubular organ.

(Invention B)
In the present invention (b), the folded-back portion of the folded-back cover or the vicinity thereof can be tied with a string to prevent the cover from falling off or the cover from rotating.
In the present invention (b), by tying the outer side of the inner layer of the cover containing the stent by pulling and tying, it can be easily unwound by pulling the end of the string on the operator's hand side (outside the body). Then, the folding cover can be rotated to easily release, expand, and place the stent.
Further, by simultaneously fixing the reduced-diameter stent and the inner layer cover by pulling and tying, even if the cover is broken, the stent does not expand and is safe.
In the present invention (b), the string is formed at a plurality of positions at appropriate intervals from the distal end side to the proximal end side of the stent at the folded portion or the vicinity thereof and the outside of the inner layer of the folded cover housing the stent. By tying by pulling and tying, even if the indwelling part is bent or curved, it can prevent the string from becoming a chord with respect to the arc when the string is pulled, and the inner lumen can be rubbed and damaged. In addition, the string material can be easily pulled out without imposing a large load on the tubular organ.

(Invention C)
In the present invention (c), by using a cover in which a hard tube used as the outer layer and a soft tube used as the inner layer are connected as the folding cover, the pulling-out force of the folding cover is such that the outer surface of the inner layer of the folded cover and the outer layer Frictional resistance between the inner surfaces is sufficient and is not affected by the expansion force of the reduced diameter stent. Even if the stent has a strong expansion force, more reliable release and deployment are possible.

(Invention D)
In the tubular organ treatment device of the present invention (Invention D), the stent can be easily inserted inside the inner layer of the folded cover. Further, the cover can be easily folded back.

  Embodiments of the present invention will be described below in detail with reference to the drawings. However, the present invention is not limited to these embodiments.

FIG. 1 shows a schematic cross-sectional view of an example of a treatment device for a tubular organ having a reduced-diameter stent inside the inner layer of the folded cover.
The tubular organ treatment instrument 1 has a stent 3 in a reduced diameter state inside an inner layer 2 a of a folded cover 2.
The folded cover 2 has a double structure in which the cylindrical tube is folded once, has a folded portion 2d, and has an inner layer 2a that is an inner layer from the folded portion 2d and an outer layer 2b that is an outer layer from the folded portion 2d. The inner layer 2a and the outer layer 2b are connected by a folded portion 2d. The length of the inner layer 2a of the cylindrical tube is shorter than the length of the outer layer 2b of the cylindrical tube, and is the end 2c of the inner layer 2a of the folded cover and the end 2e of the outer layer 2b. In FIG. 1, in order to make it easy to understand the inner layer 2a and the outer layer 2b of the folded cover, a gap is provided between the inner layer 2a and the outer layer 2b, but actually there is almost no gap, and the outer surface of the inner layer and the outer layer Most of it touches the inner surface.
The stent 3 is such that the distal end side 3a of the stent is held on the side of the folded portion 2d of the folded cover, the proximal end side 3b of the stent is held on the end portion 2c side of the inner layer of the folded cover, In this state, it is detained or placed inside the inner layer 2a of the tubular tube.
In FIG. 1, reference numeral 4 denotes a holder (core bar).
The tubular organ treatment tool 1 is formed by pulling the end 2e of the outer layer 2b of the folded cover in the direction of the arrow 8 (opposite direction of the folded portion), so that the folded cover disposed on the outer side of the distal end portion 3a of the stent. The inner layer 2a is removed and gradually expanded from the distal end 3a side of the stent.

FIG. 2 is a schematic cross-sectional view of another example of a tubular organ treatment instrument having a reduced diameter stent inside the inner layer of the folded cover.
The tubular organ treatment instrument 11 has a stent 13 in a reduced diameter state inside the inner layer 12 a of the folded cover 12.
The folded cover 12 uses a tubular tube having a diameter at both ends larger than the diameter of the portion where the stent is disposed.
The folded cover 12 is folded twice, and has a folded portion 12d. The folded cover 12 has a double structure of an inner layer 12a that is an inner layer from the folded portion 12d and an outer layer 12b that is an outer layer from the folded portion 12d. The inner layer 12a and the outer layer 12b are connected by a folded portion 12d. The length of the inner layer 12a of the tubular tube is shorter than the length of the outer layer 12b of the tubular tube, and is the end 12c of the inner layer 12a of the folded cover and the end 12e of the outer layer 12b.
In FIG. 2, in order to make the inner layer 12a and the outer layer 12b of the folded cover easy to understand, a gap is provided between the inner layer 12a and the outer layer 12b, but in reality there is almost no gap, and the outer surface of the inner layer and the outer layer Most of it touches the inner surface.
In the stent 13, the entire stent is held in a reduced diameter state or a reduced diameter, while the distal end side 13 a of the stent is on the side of the folded portion 12 d of the folded cover and the proximal end side 13 b of the stent is on the end portion 12 c side of the inner layer of the folded cover. In this state, it is detained or placed inside the inner layer 12a of the tubular tube.
In FIG. 2, reference numeral 14 denotes a holder (core bar).
The tubular organ treatment tool 11 is formed by pulling the end portion 12e of the outer layer 12b of the folded cover in the direction of the arrow 18 (opposite direction of the folded portion), thereby arranging the folded cover disposed outside the distal end portion 13a of the stent. The inner layer 12a is removed and can be gradually expanded from the distal end portion 13a side of the stent.

FIG. 3 shows a schematic cross-sectional view of another example of a tubular organ treatment tool having a stent with a reduced diameter inside the inner layer of the folded cover.
The tubular organ treatment device 21 has a stent 23 in a reduced diameter state inside the inner layer 22 a of the folded cover 22.
The folded cover 22 folds the cylindrical tube once, has a folded portion 22d, and has a double structure of an inner layer 22a that is an inner layer from the folded portion 22d and an outer layer 22b that is an outer layer from the folded portion 22d. The inner layer 22a and the outer layer 22b are connected by a folded portion 22d. The length of the inner layer 22a of the tubular tube is shorter than the length of the outer layer 22b of the tubular tube, and is the end 22c of the inner layer 22a of the folded cover and the end 22e of the outer layer 22b.
The folding cover 22 has a ring 25 connected to an end 22e of the outer layer of the folding cover. The diameter of the ring 25 is approximately the same as the diameter of the outer layer 22b of the folded cover.
In FIG. 3, in order to make it easy to understand the inner layer 22a and the outer layer 22b of the folded cover, a gap is provided between the inner layer 22a and the outer layer 22b, but actually there is almost no gap, and the outer surface of the inner layer and the outer layer Most of it touches the inner surface.
In the stent 23, the distal end side 23a of the stent is held on the side of the folded portion 22d of the folded cover, the proximal end side 23b of the stent is held on the end portion 22c side of the inner layer of the folded cover, In this state, it is detained or placed inside the inner layer 22a of the tubular tube.
In FIG. 3, the code | symbol 24 is a holder (core bar).
The tubular organ treatment device 21 is pulled outside the distal end portion 23a of the stent by pulling the ring 25 connected to the end portion 22e of the outer layer 22b of the folded cover in the direction of the arrow 28 (opposite direction of the folded portion). The inner layer 22a of the folded cover that has been disposed is removed, and can be gradually expanded from the distal end portion 23a side of the stent.
The folded cover 22 can be a cylindrical tube having a diameter at both ends larger than the diameter of the portion where the stent is disposed.

In FIG. 4 (1), a stent having a reduced diameter is provided inside the inner layer of the folded cover, and the folded portion and the outer layer of the folded cover on which the stent is disposed are tied with a string material in a tie-down state. The schematic diagram of an example of the treatment tool 31 of the tubular organ which hold | maintains a stent in the diameter-reduced state, and does not fold the outer-layer part of a folding | turning cover is shown.
In FIG. 4 (2), a stent having a reduced diameter is disposed on the inner side of the inner layer of the folded cover, and the outer side of the folded layer and the inner layer of the folded cover at the portion where the stent is disposed is untied with a string material. Schematic diagram of an example of a tubular organ treatment tool 31a holding the stent in a reduced diameter state.
The tubular organ treatment tool 31a is a reduced diameter stent 33 inside the inner layer 32a of the folded cover 32 by using the tubular organ treatment tool 31 which is not folded back of the outer layer portion of the folded cover shown in FIG. It is obtained by completely folding the outer layer portion 32b of the folded cover once in the direction of the arrow 37 from the folded portion 32d.
The folding cover 32 is a cylindrical tube having a diameter at both ends larger than the diameter of the portion where the stent is disposed, and is constituted by an inner layer 32a of the folding cover, a folding portion 32d, and an outer layer 32b of the folding cover. An end 2c of the inner layer 2a and an end 2e of the outer layer 2b.
The stent 33 is such that the distal end side 33a of the stent is held on the side of the folded portion 32d of the folded cover, the proximal end side 33b of the stent is held on the end portion 32c side of the inner layer of the folded cover, In this state, it is detained or placed inside the inner layer 32a of the tubular tube.
In FIG. 4, the code | symbol 34 is a holder (core bar).
The ring 25 shown in FIG. 3 can be connected to the end 32e of the outer layer of the folded cover.

The tubular organ treatment tool 31a includes:
1) Insert the stent 33 with a reduced diameter inside the inner layer 32a of the folded cover,
2) Using the string member 35, the folded portion 32d of the folded cover and the outer layer of the folded cover where the stent is inserted at least one place or a plurality of places are tied by a knotting method (knot ( 35a, 35b, 35c, 35d)), creating a treatment instrument 31 for a tubular organ in which the outer layer portion of the folded cover is not folded,
3) It can be obtained by folding the end 32e of the outer layer 32b of the folded cover in the direction of the arrow 37 to the outside of the inner layer 32a of the folded cover.
When expanding the stent of the tubular organ treatment tool 31a,
1) By pulling the string member 35 in the direction of the arrow 38 (opposite direction of the folded portion), the folded portion 32d of the folded cover and the knot on the outer side of the inner layer of the folded cover where the stent is inserted (35a, 35b, 35c, 35d) are solved in the order of knots (35a → 35b → 35c → 35d),
2) By pulling the end portion 32e of the outer layer 32b of the folded cover in the direction of arrow 38 (opposite direction of the folded portion), the inner layer 32a of the folded cover outside the distal end portion 33a of the stent is removed, and the distal end of the stent It can be gradually expanded from the part 33a side.

FIG. 5 shows a schematic cross-sectional view of another example of a tubular organ treatment instrument having a stent with a reduced diameter inside the inner layer of the folded cover.
The tubular organ treatment device 41 has a stent 43 in a reduced diameter state inside the inner layer 42 a of the folded cover 42.
The cylindrical tube used by the folding cover 42 is a tube in which a flexible tube (A) and a tube (B) that is less flexible than the tube (A) are connected or bonded together. The inner layer 42a is a tube (A), and all or most of the outer layer 42b of the folded cover is a tube (B).
The folded cover 42 folds the cylindrical tube once, has a folded portion 42d, and has a double structure of an inner layer 42a that is an inner layer from the folded portion 42d and an outer layer 42b that is an outer layer from the folded portion 42d. The inner layer 42a and the outer layer 42b are connected by a folded portion 42d. The length of the inner layer 42a of the tubular tube is shorter than the length of the outer layer 42b of the tubular tube, and is an end portion 42c of the inner layer 42a of the folded cover and an end portion 42e of the outer layer 42b.
In FIG. 5, the tube material of the folded portion 42d is a flexible tube (A) or a connection portion between the tube (A) and the tube (B).
In FIG. 5, in order to make it easy to understand the inner layer 42a and the outer layer 42b of the folded cover, a gap is provided between the inner layer 42a and the outer layer 42b.
The outer surface of the inner layer and the inner surface of the outer layer are mostly in contact.
The stent 43 is such that the distal end side 43a of the stent is held on the folded portion 42d side of the folded cover and the proximal end side 43b of the stent is held on the end portion 42c side of the inner layer of the folded cover. In this state, it is detained or placed inside the inner layer 42a of the tubular tube.
In FIG. 5, reference numeral 44 denotes a holder, reference numeral 45 denotes a holder having a lumen through which a guide wire can pass, and reference numeral 46 denotes a tip protector having a lumen through which the guide wire can pass. It is.
The tubular organ treatment device 41 is formed by pulling the end portion 42e of the outer layer 42b of the folded cover in the direction of the arrow 48 (opposite direction of the folded portion), so that the folded cover disposed on the outer side of the distal end portion 43a of the stent. The inner layer 42a is removed and can be gradually expanded from the distal end portion 43a side of the stent.
A cylindrical tube having a large end diameter can be used as the folded cover.

6 (1) to 6 (5) are schematic views showing a cross section of an example of a tubular tube used as a folded cover.
The cylindrical tube 51 in FIG. 6 (1) is a cylindrical tube having both ends opened. The cylindrical tube 51 is an example of a cylindrical tube having the same inner diameter.
The cylindrical tube 52 in FIG. 6 (2) is a cylindrical tube having both ends opened, and the inner diameter of one end is larger than the other part. The tubular tube 52 is an example of a tubular tube in which the inner diameter of one end is larger than the inner diameter for placing the stent.
The cylindrical tube 53 in FIG. 6 (3) is a cylindrical tube having both ends opened, and the inner diameter of both ends is larger than the other part. The tubular tube 53 is an example of a tubular tube whose inner diameters at both ends are larger than the inner diameter where the stent is placed.
The cylindrical tube 54 in FIG. 6 (4) is a cylindrical tube that is open at one end and closed at the other end.
The cylindrical tube 55 in FIG. 6 (5) is a cylindrical tube that is open at one end and closed at the other end. The inner diameter of the open end is larger than the other parts.

FIG. 7A and FIG. 7B are schematic views of a cross section of an example of a tubular tube used as a folding cover.
The tubular tube 61 in FIG. 7A is a tubular tube having both ends opened, and is composed of a tube having the same flexibility over the entire length.
The cylindrical tube 62 in FIG. 7 (2) is a cylindrical tube that is open at both ends, and includes a tube (A) having flexibility and a tube (B) that is less flexible than the tube (A). It consists of connected tubes.

FIGS. 8A to 8C are schematic views of cross sections of examples of the outer layer and the inner layer of the folded cover.
The folded cover 71 in FIG. 8 (1) has a double structure of an inner layer 71a and an outer layer 71b folded from a cylindrical tube, has a folded portion 71d, and the length of the inner layer 71a of the cylindrical tube is the length of the cylindrical tube. It is longer than the length of the outer layer 71b, and is an end portion 71c of the inner layer 71a of the folded cover and an end portion 71e of the outer layer 71b.
The folded cover 72 in FIG. 8 (2) has a double structure of an inner layer 72a and an outer layer 72b folded from the tubular tube, and has a folded portion 72d. The length of the inner layer 72a of the tubular tube is the same as that of the tubular tube. The length of the outer layer 72b is substantially the same as the length of the outer layer 72b.
The folded cover 73 in FIG. 8 (3) has a double structure of an inner layer 73a and an outer layer 73b folded from the cylindrical tube, has a folded portion 73d, and the length of the inner layer 73a of the cylindrical tube is the length of the cylindrical tube. It is shorter than the length of the outer layer 73b, and is an end portion 73c of the inner layer 73a of the folded cover and an end portion 73e of the outer layer 73b.

  9 (1) to 9 (3), cross-sectional schematic diagrams of another example of tubular organ treatment tools 81, 82, and 83 each having a reduced-diameter stent inside the inner layers of the folded covers 71, 72, and 73. The figure is shown.

FIGS. 10 (1) and 10 (2) are schematic views of a cross section of an example of the folded cover in which members are connected to the end of the outer layer of the folded cover so that the end of the folded cover can be easily pulled. Indicates.
FIG. 10A shows a folding cover 81 in which a ring 83 is connected to an end portion 72e of the outer layer 72b of the folding cover using the folding cover 72 shown in FIG. 9B.
FIG. 10 (2) shows a folding cover 82 in which a plurality of string members 83 are connected to the end portion 72e of the outer layer 72b of the folding cover using the folding cover 72 shown in FIG. 9 (2).

The cylindrical tube or folded cover shown in FIGS.
1) The shape of the tubular tube shown in FIGS. 6 (1) to (5),
2) Configuration of cylindrical tube shown in FIGS. 7 (1) to (2) 3) Relationship between lengths of outer layer and inner layer of folded cover shown in FIGS. 8 (1) to (3), and 4) FIG. 10 (1). A tubular tube or a folded cover obtained by combining a plurality of members connected to the end portion of the outer layer of the folded cover shown in (2) to (2) can be used.

11 (1) to 11 (4) schematically show an example of a stent placement method at a treatment site such as an aneurysm using the tubular organ treatment device 21 of the present invention shown in FIG.
A method of placing a stent at a treatment site using the tubular organ treatment tool 21 is as follows.
1) As shown in FIG. 11 (1), the tubular organ treatment tool 21 is inserted into a planned placement site 110 a of the tubular organ 110.
2) As shown in FIG. 11 (2), the ring 25 connected to the end 22e of the outer layer 22b of the folded cover 22 is pulled in the direction of the arrow 28 (the direction opposite to the folded portion).
By pulling the ring 25 in the direction of the arrow 28, the folded cover is pulled out in the direction of the arrow 28, and the inner layer of the folded cover is turned over from the folded portion (22f) of the inner layer and the outer layer from the distal end portion 23a side of the stent 23. The stent having a reduced diameter is gradually expanded from the distal end portion 23a of the stent 23.
Even when the ring 25 is pulled in the direction of the arrow 28, the end 22c of the inner layer of the folded cover is hardly pulled out or not pulled out at all. This is because the frictional resistance between the outer surface of the inner layer of the folded cover and the inner surface of the outer layer is smaller than the frictional resistance between the inner surface of the inner layer of the folded cover and the stent in the reduced diameter state.
3) As shown in FIG. 11 (3), the ring 25 is further pulled in the direction of the arrow 28 (the direction opposite to the folded portion).
By pulling the ring 25, the inner layer of the folded cover is pulled out from the folded portion 22f of the inner layer and the outer layer to the folded portion 22g of the inner layer and the outer layer while being turned over, and the stent 23 having a reduced diameter is turned. Expand from the side.
Even when the ring 25 is pulled in the direction of the arrow 28, the end 22c of the inner layer of the folded cover is hardly pulled out or not pulled out at all.
4) As shown in FIG. 11 (4), when the folded cover covering the outside of the stent is completely removed, the stent 23 is expanded over its entire length and can be placed at the planned placement site 110a of the tubular organ 110. it can.
From FIG. 11 (1) to FIG. 11 (4), by pulling the ring 25 in the direction of the arrow 28, the folded portions of the inner layer and the outer layer of the folded cover are changed from the distal end side to the proximal end side (22d → 22f → In 22g), the inner layer of the folded cover is turned over, and is moved by being pulled out while moving.
1, 2, 4, and 5, the stent can be placed in the tubular organ by using the same method as described above.

The tubular tube used for the folded cover may be any tube that can insert a reduced-diameter stent and that cannot be broken after insertion even if the reduced-diameter stent is accommodated.
In particular, the portion used as the inner layer portion of the folded cover of the tubular tube needs to be excellent in flexibility.
The inner layer portion of the folded cover can be turned over and turned over the folded portions of the inner layer and the outer layer, and is excellent in flexibility.
In the folded cover, it is important that the frictional resistance between the inner surface of the outer layer of the folded cover and the outer surface of the inner layer is smaller than the frictional resistance between the inner surface of the inner layer of the folded cover and the stent in a reduced diameter state.
As the folded cover, a tube in which the inner layer is excellent in flexibility and a tube in which most of the outer layer is harder than the inner layer can be used.

  The folded cover is obtained by folding a cylindrical tube, has a folded portion, a double structure having an inner layer and an outer layer, a quadruple structure or an eightfold structure having an innermost layer and an outermost layer, and a combination of these structures. Things can be used.

  The thickness of the cylindrical tube used for the folded cover is not particularly limited as long as it can be handled, can be inserted into a tubular organ, and has appropriate mechanical properties. The thickness of the single layer is preferably 5 to 1000 μm, more preferably Is 8 to 800 μm, particularly preferably 10 to 500 μm.

The cylindrical tube should just be a cylindrical shape or the shape close | similar to a cylinder, For example, what made cloth, such as a textile fabric, a film or a sheet | seat, and a mesh cylindrical shape or the shape close | similar to a cylinder can be used.
As the cylindrical tube, a cloth such as a woven fabric, a film or a sheet bonded to a cylindrical shape or a shape close to a cylinder by a method such as adhesion or heat fusion, or a sewn one can be used.
The folded cover may be a multi-layered tubular tube made of the same material or different materials.

As the cylindrical tube, one that can be torn in the length direction from the end of the cylindrical tube, preferably from the end of the cylindrical tube (corresponding to the operator's hand side) can be used.
By using a tubular tube that can be torn in the length direction, even a stent having a branched shape consisting of a main trunk and a branch pipe can be used. Even if there is not a sufficient distance at hand, the cover can be pulled back to the end by tearing the cover at hand (the stent can be released at the intended location).
For structures that can be torn, use a material that is anisotropic in strength, such as stretched film or plain weave cloth, with slits at the ends, slits, and axial directions that are easy to tear Alternatively, it may be set in a desired direction.

The material of the cylindrical tube is polyolefin such as polyethylene, polypropylene, ethylene / α-olefin copolymer, polyamide, polyurethane, polyethylene terephthalate, polybutylene terephthalate, polycyclohexane terephthalate, polyester such as polyethylene-2,6-naphthalate, poly Fluorine resins such as fluorinated ethylene and polyfluorinated propylene, and thermoplastic resins such as silicone resin can be used.
In particular, the tube material is chemically stable, highly durable, has little tissue reaction, is flexible, has a low surface frictional resistance, such as polyester such as polyethylene terephthalate, fluorine such as polyfluorinated ethylene or polyfluorinated propylene. Resins, polyethylene, polyolefins such as ethylene / α-olefin copolymer, and the like can be preferably used.

The tubular tube is preferably an embossed tube.
As a method for obtaining an embossed cylindrical tube, a known tube or film can be used which can be embossed or molded using a molding machine, such as T-die molding, inflation molding, calendar molding. After forming a tube or film by a molding method such as the above, it may be molded using an embossing machine equipped with an embossing roll, or the molten resin such as T-die molding or calendar molding is cooled with a roll. As the solidifying molding method, a method capable of simultaneously performing tube molding or film molding and embossing can be used by using an embossing roll made of metal or the like on a chill roll (cooling roll) and pressing it with a backup roll.
The embossed shape may be any of a lattice pattern, a crest (pear texture) pattern, a trapezoidal pattern, a silk pattern, and an uneven shape.
In particular, the embossed shape is preferably a translucent satin pattern.

The cylindrical tube is formed by forming a thermoplastic resin into a cylindrical shape by extrusion molding, blow molding or the like, a knitted fabric of thermoplastic resin fibers formed into a cylindrical shape, or a thermoplastic resin nonwoven fabric formed into a cylindrical shape A cylindrical resin sheet, a porous resin sheet, or the like can be used. Furthermore, as the knitted fabric, known knitted fabrics and woven fabrics such as plain weave and twill weave can be used.
As a method of processing into a cylindrical shape, a known method such as heat fusion or stitching can be used.
The tubular tube is preferably a seamless tubular structure, but may have a seam.
The tubular tube is preferably a knitted fabric of thermoplastic resin fibers formed into a cylindrical shape, and a plain woven fabric of thermoplastic resin fibers formed into a cylindrical shape, because of excellent strength, porosity, and productivity. .

The inner diameter of the inner layer of the folded cover is a diameter that allows the stent to be inserted and accommodated in a reduced diameter state, and is smaller than the outer diameter when the stent is placed.
The length of the inner layer of the folded cover is a length that can accommodate the entire stent, and is preferably longer than the length of the stent.

  As the cylindrical tube, a tube in which a flexible tube (A) and a tube (B) that is less flexible than the tube (A) are connected by a method such as stitching, fusion, or adhesion is used. it can.

  The string material used for the unraveling knot is a material that does not affect the human body, and has any mechanical characteristics that can hold the diameter-reduced stent accommodated in the folded back cover. Even string material can be used.

The material of the string material is polyolefin such as polyethylene, polypropylene, ethylene / α-olefin copolymer, polyamide, polyurethane, polyethylene terephthalate, polybutylene terephthalate, polycyclohexane terephthalate, polyester such as polyethylene-2,6-naphthalate, and polyfluoride. Fluorine resins such as fluorinated ethylene and polyfluorinated propylene, thermoplastic resins such as silicone resin, and natural materials such as silk and cotton yarn can be used.
In particular, the material of the string material is chemically stable and highly durable, has little tissue reaction, is flexible, has a certain degree of strength, such as polyester such as polyethylene terephthalate, fluororesin such as polyfluorinated ethylene and polyfluorinated propylene, Polyolefins such as polyethylene, ethylene / α-olefin copolymer, polyamide and the like can be preferably used.

  A stent having any structure can be used as long as it is a self-expanding stent that can be reduced in diameter and retained. Processing cylindrical structures made of zigzag wire, knitted fabrics of one or more wires, woven fabrics or braids, cylindrical structures made of a combination of these, or metal cylindrical structures by laser processing, etc. The cylindrical structure etc. which were made can be used.

Examples of the material of the wire rod and metal cylindrical structure used for the stent include stainless steel, tantalum, titanium, platinum, gold, tungsten, Ni-Ti, Cu-Al-Ni, Cu-Zn-Al, etc. A metal wire such as a shape memory alloy can be used. It is also possible to use a metal surface that is coated with gold, platinum or the like by means such as plating.
As a material for the wire rod and metal cylindrical structure used for the stent, a shape memory alloy to which a shape memory effect by heat treatment or superelasticity is imparted can be preferably used.
Although the thickness of the wire used for a stent is not specifically limited, For example, in the case of a blood vessel stent etc., 0.08-1 mm is preferable.
Although the thickness of the metal cylindrical structure used for the stent is not particularly limited, for example, in the case of a blood vessel stent or the like, 0.08 to 1 mm is preferable.
The material of the wire used for the stent and the metallic cylindrical structure may be a hollow pipe. Further, the inside thereof may be filled with a metal that is difficult to transmit radiation, such as gold or platinum.

  A stent having a stent cover on a part or all of the inner surface and / or outer surface can be used.

The stent cover is made of a thermoplastic resin formed into a cylindrical shape by extrusion molding, blow molding or the like, a woven fabric of thermoplastic resin fibers formed into a cylindrical shape, or a thermoplastic resin nonwoven fabric formed into a cylindrical shape A cylindrical resin sheet, a porous resin sheet, or the like can be used. Furthermore, as the knitted fabric, known knitted fabrics and woven fabrics such as plain weave and twill weave can be used.
The cover for the stent can also be used with a crimped or other crease.
The stent cover is preferably a seamless tubular structure.

  As the stent cover, a knitted fabric of thermoplastic resin fibers formed in a cylindrical shape, and a plain woven fabric of thermoplastic resin fibers formed in a cylindrical shape are preferable because of excellent strength, porosity, and productivity. .

  The stent cover can be connected to part or all of the stent. Examples of the method of connecting the cylindrical cover to the stent include a method of sewing, a method of using an adhesive, and a method of fusing with a thermoplastic resin.

The material for the stent cover is polyolefin such as polyethylene, polypropylene, ethylene / α-olefin copolymer, polyamide, polyurethane, polyethylene terephthalate, polybutylene terephthalate, polycyclohexane terephthalate, polyester such as polyethylene-2,6-naphthalate, poly Fluorine resins such as fluorinated ethylene and polyfluorinated propylene, and thermoplastic resins such as silicone, polylactic acid, polyglycolic acid, and polyurethane can be used.
In particular, the material of the stent cover is preferably a chemically stable and highly durable polyester resin such as polyethylene terephthalate, or a fluororesin such as polyfluorinated ethylene or polyfluorinated propylene.
The stent cover may be fixed to the stent at one or more portions.

The ring connected to the end of the outer layer of the folded cover may be made of a hard or slightly hard resin, a metal, or a combination thereof. The ring is preferably made of a homogeneous material such as a folded cover.
As a method for connecting the ring to the folded cover, known methods such as adhesion, fusion, pinching, sewing, and pinning can be used.

  Cylindrical covers and stent covers, fibers that make up cylindrical covers and stent covers, and wire and metal tubular structures that make up stents are biocompatible with heparin, collagen, acetylsalicylic acid, gelatin, etc. What is coated with a certain material can be used.

  A radiopaque material may be wound around an appropriate place of the stent, for example, at both ends of the stent and the cylindrical cover, and at the leading end and the leading end of the reduced diameter holding portion. As the X-ray opaque material, for example, gold, platinum, iridium, tantalum, tungsten, silver, or an alloy containing them is preferably used. The radiopaque material can be fixed to the stent by means of soldering, brazing, welding, adhesion, caulking, or the like. Moreover, as long as it does not fall off, it may be entangled as a ring or a coil through the stent wire.

The tubular organ treatment device of the present invention is a tubular organ treatment device for inserting a stent into a human tubular organ such as a blood vessel, a ureter, a bile duct, or a trachea.
The tubular organ treatment instrument of the present invention can be used by being inserted into a catheter or sheath.
The tubular organ treatment device of the present invention can be used for treatment of stenosis or damage of a lumen such as an aneurysm or stenosis.

It is a schematic diagram which shows an example of the treatment tool of a tubular organ. It is a schematic diagram which shows another example of the treatment tool of a tubular organ. It is a schematic diagram which shows another example of the treatment tool of a tubular organ. It is a schematic diagram which shows another example of the treatment tool of a tubular organ. It is a schematic diagram which shows an example of the treatment tool of the tubular organ before folding a cylindrical cover. It is a schematic diagram which shows an example of a cylindrical cover. It is a schematic diagram which shows an example of a cylindrical cover. It is a schematic diagram which shows an example of a folding back cover. It is a schematic diagram which shows an example of the treatment tool of the tubular organ using the folding | turning cover of FIG. It is a schematic diagram which shows another example of a return cover. It is a schematic diagram which shows the indwelling method of the stent using the treatment tool of the tubular organ shown in FIG.

Explanation of symbols

1, 11, 21, 31a, 41: therapeutic device for tubular organ,
2, 12, 22, 32, 42, 71, 72, 73, 81, 82: folding cover,
3, 13, 23, 33, 43: stent,
35: String material,
25, 83: Ring.

Claims (7)

A treatment device for a tubular organ having a stent with a reduced diameter inside the inner layer of the folded cover,
-The folded cover has a folded portion with a structure having at least an inner layer and an outer layer, which is obtained by folding the cylindrical tube at least once.
・ The stent in the reduced diameter state is arranged with the distal end side of the stent on the folded portion side of the folded cover , and the stent in the reduced diameter state is disposed between the folded portion of the folded cover and the end portion of the inner layer of the folded cover. A tubular organ treatment device characterized by comprising: The tubular organ treatment device according to claim 1, wherein an inner diameter of at least one end of the tubular tube is larger than an inner diameter of an inner layer of the folded cover in which the stent is placed. The therapeutic device for a tubular organ according to claim 1 or 2 , wherein the folded portion of the folded cover or the vicinity thereof is tied by a string member in a broken and knotted state. 2. The folded portion of the folded cover or the vicinity thereof and the outer side of the inner layer of the folded cover on which the reduced-diameter stent is disposed are tied in a state of being broken by a string material. Or the treatment tool of the tubular organ of 2 . The tubular organ treatment device according to any one of claims 1 to 4 , wherein the folded cover is a folded cover that is torn in the length direction from an end of the outer layer. The cylindrical tube is a tube connecting a flexible tube (A) and a tube (B) that is less flexible than the tube (A),
The tubular organ treatment device according to claim 1, wherein the inner layer of the folded cover is a tube (A), and all or most of the outer layer of the folded cover is a tube (B). A treatment device for a tubular organ having a stent with a reduced diameter inside the inner layer of the folded cover,
-The folded cover has a folded portion with a structure having at least an inner layer and an outer layer, which is obtained by folding the cylindrical tube at least once.
The cylindrical tube is a tube connecting a flexible tube (A) and a tube (B) less flexible than the tube (A),
The inner layer of the folded cover is the tube (A), and all or most of the outer layer of the folded cover is the tube (B).
-The reduced-diameter stent is a tubular organ treatment device, wherein the distal end side of the stent is disposed on the folded-back portion side of the folded cover.

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