JP2010268950A - Tubular treatment implement-indwelling apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a tubular treatment implement-indwelling apparatus which reduces time and effort for exchanging a catheter, eliminates the need for independently preparing a balloon catheter, and does not deteriorate smoothness of the outer surface of the apparatus. <P>SOLUTION: The tubular treatment implement indwelling apparatus 1 is used to indwell at an affected area a stent graft SG expandable in the diameter direction. The tubular treatment implement-indwelling apparatus 1 comprises a tubular first sheath 10, a tubular second sheath 20 formed to be movable within the first sheath 10 in the axial direction of the first sheath, a rod member 30 formed to be movable within the second sheath 20 in the axial direction of the second sheath 20, and a balloon 40 arranged on the second sheath 20. By advancing the second sheath 20 with respect to the first sheath 10, the balloon 40 is exposed to the outside of the first sheath 10. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a tubular treatment instrument placement device for placing a tubular treatment tool expandable in a radial direction in an affected area.

  As a stent placement device used in PTCA (percutaneous coronary angioplasty), a stent placement device in which a balloon is disposed at the distal end portion of a sheath is conventionally known (see, for example, Patent Document 1).

When placing a stent that is not self-expanding, if the stent placement device does not have a balloon, it is necessary to remove the stent placement device and insert the balloon catheter after placing the stent. Is very troublesome. In addition, a balloon catheter must be prepared separately from the stent placement device.
On the other hand, according to the above-described conventional stent placement device, since the balloon is provided, the balloon can be expanded with the stent placement device inserted. As a result, it is possible to save labor for exchanging the catheter. Further, it is not necessary to prepare a balloon catheter separately from the stent placement device.

Special table 2003-530200 gazette

  However, in the conventional stent indwelling device, since the balloon is exposed on the outer surface of the stent indwelling device, it is inferior in terms of the smoothness of the outer surface (outer surface) of the device compared to the stent indwelling device not equipped with the balloon. There's a problem.

This problem is not limited to the stent indwelling apparatus, but may also occur in a tubular therapeutic instrument indwelling apparatus for placing a tubular therapeutic instrument other than a stent in an affected area.
For example, in a stent graft placement device for placing a radially expandable stent graft in an affected area, a balloon catheter is inserted in order to stretch the folds and wrinkles of the stent graft and to ensure close contact with the blood vessel wall. The stent graft may be re-expanded (additional expansion). At this time, when the above-described conventional stent placement device is used as a stent graft placement device, it can be re-expanded with a balloon while the device is inserted, so that it is possible to save time and effort for exchanging the catheter. There is no need to prepare separately. However, since the balloon is exposed on the outer surface of the device, it is inferior in terms of the smoothness of the outer surface of the device as compared with a stent graft indwelling device not provided with a balloon.

  Accordingly, the present invention has been made to solve such a problem, and it is possible to save labor for exchanging the catheter, and it is not necessary to prepare a separate balloon catheter, and further, the apparatus. An object of the present invention is to provide a tubular treatment device indwelling device that does not impair the smoothness of the outer surface.

[1] The tubular treatment device placement device (1) of the present invention is a tubular treatment device placement device (1) for placing a tubular treatment device (SG) expandable in the radial direction in an affected area, and is flexible. A tubular first sheath (10), and a tubular second sheath (flexible) configured to be able to advance and retreat inside the first sheath along the axial direction of the first sheath ( 20), a rod member (30) configured to be able to advance and retreat inside the second sheath along the axial direction of the second sheath, and a balloon (40) disposed in the second sheath. The balloon (40) is configured to be exposed from the inside of the first sheath (10) by advancing the second sheath (20) relative to the first sheath (10). It is characterized by that.

For this reason, according to the tubular treatment instrument placement device of the present invention, since the above-described balloon is provided, the tubular treatment device can be expanded (re-expanded) while the device is inserted. As a result, the labor for exchanging the catheter can be saved, and it is not necessary to prepare a separate balloon catheter.
Further, according to the tubular treatment instrument indwelling device of the present invention, since the second sheath in which the balloon is disposed is disposed in the first sheath, the device is used as a blood vessel in a state in which the balloon is accommodated in the first sheath. As a result of being able to insert or move in the blood vessel, the smoothness of the outer surface of the apparatus is not impaired.

  Therefore, the tubular treatment instrument indwelling device of the present invention can save time and effort for exchanging the catheter, and it is not necessary to prepare a separate balloon catheter, and further, the smoothness of the outer surface of the device is impaired. There will be no tubular treatment device placement device.

[2] In the tubular treatment instrument indwelling device (1) according to [1], the second sheath (20) is a tube wall of a portion of the tube wall of the second sheath where the balloon is disposed. Is preferably configured to be thinner than the thickness (t2) of the tube wall where the balloon is not disposed.

  By configuring in this way, the tube diameter (outer diameter) of the tubular treatment instrument indwelling device at the portion where the balloon is disposed is equal to the tube diameter (outer diameter) of the tubular treatment device indwelling device at the portion where the balloon is not disposed. ) Can be suppressed from becoming too thick.

[3] In the tubular treatment instrument indwelling device (1) according to the above [1] or [2], the second sheath of the second sheath has a tube wall closer to the proximal end than the balloon. It is preferable that a hole (28) communicating with the distal end side opening (26) of the sheath is provided.

  With this configuration, when the balloon is inflated, it is closer to the distal side (distant from the user of the tubular treatment device placement device) and the proximal side (viewed from the user of the tubular treatment device placement device) than the balloon. The blood flow can be maintained with the distal side), so that it is possible to prevent the occurrence of an ischemic state due to balloon inflation.

[4] In the tubular treatment instrument indwelling device (1) according to the above [3], the inner diameter (D2) of the second sheath on the proximal side from the portion where the hole is provided is It is preferable that it is narrower than the inner diameter (D1) of the second sheath.

  With this configuration, the blood flowing from the distal end opening of the second sheath moves toward the hole (or the blood flowing from the second sheath hole toward the distal opening) relatively smoothly. It begins to flow.

[5] In the tubular treatment instrument placement device (1) according to any one of the above [1] to [4], the tubular treatment instrument is preferably a stent graft (SG).

  By configuring in this way, the tubular treatment instrument indwelling device of the present invention can save labor for the catheter exchange work, and it is not necessary to prepare a balloon catheter separately. A stent graft placement device that does not impair smoothness.

  In addition, the reference numerals added in parentheses below the wording of each member, etc. described in the claims and in this column (column of means for solving the problems) are the contents described in the claims and this column. It is used for facilitating understanding of the present invention, and does not limit the contents described in the claims and in this section.

The figure shown in order to demonstrate the tubular treatment tool placement apparatus 1 which concerns on embodiment. The figure shown in order to demonstrate the 2nd sheath 20. FIG. The figure shown in order to demonstrate the usage method of the tubular treatment tool placement apparatus 1 which concerns on embodiment.

  Hereinafter, the tubular treatment instrument placement device of the present invention will be described based on the embodiment shown in the drawings.

[Embodiment]
First, the configuration of the tubular treatment instrument placement device 1 according to the embodiment will be described in detail with reference to FIGS. 1 and 2.

Drawing 1 is a figure shown in order to explain tubular treatment instrument placement device 1 concerning an embodiment. Fig. 1 (a) is a view showing each member and stent graft SG constituting the tubular treatment instrument placement device 1, and Fig. 1 (b) is a view showing a state in which each member is assembled and the stent graft SG is further arranged.
FIG. 2 is a view for explaining the second sheath 20. 2A and 2B are an enlarged side view and a side sectional view showing a portion of the second sheath 20 where the balloon 40 is provided, and FIG. 2C shows the inside of the second sheath 20. It is a figure which shows the flow of the flowing blood.
In FIG. 1 and FIG. 2, in order to facilitate understanding of the invention, the size (length, diameter, etc.) and shape of each member and stent graft SG constituting the tubular treatment instrument placement device 1 are as follows. This is schematically shown. In FIG. 2, in order to facilitate understanding of the invention, the diameter of the rod member 30 relative to the diameter of the second sheath 20 is exaggerated to some extent.

  In this specification, the “tip side” refers to the distal side as viewed from the user of the tubular treatment instrument placement device 1, and refers to the tip tip 36 side in FIG. Further, the “proximal end side” refers to the proximal side as viewed from the user of the tubular treatment instrument placement device 1, and refers to the wire introduction port 34 side in FIG.

  The tubular treatment instrument placement device 1 according to the embodiment is a stent graft placement device for placing a stent graft SG (tubular treatment tool) expandable in a radial direction in an affected area, and includes a tubular first sheath 10 and a first sheath. A tubular second sheath 20 configured to be able to advance and retract along the axial direction of the first sheath 10 (longitudinal direction of the first sheath 10) inside the first sheath 10, and the axis of the second sheath 20 inside the second sheath 20 A rod member 30 configured to be able to advance and retreat along a direction (longitudinal direction of the second sheath 20) and a balloon 40 disposed on the second sheath 20 are provided.

  Both the first and second sheaths 10 and 20 are formed of a flexible material. Examples of flexible materials include biocompatible synthetic resins (elastomers) selected from fluororesins, polyamide resins, polyethylene resins, polyvinyl chloride resins, and other materials mixed with these resins. It is possible to preferably use a resin compound prepared, a multilayer structure in which these synthetic resins are composed of multiple layers, or a composite of these synthetic resins and metal wires.

  As shown in FIG. 1A, a first sheath base portion 12 and a second sheath base portion 22 are provided on the proximal end side of each of the sheaths 10 and 20. The first sheath base 12 is provided with a liquid filling port 14 for filling the first sheath 10 with liquid. The second sheath base portion 22 is provided with a balloon inflation port 23 for supplying inflation fluid for inflating the balloon 40 and a liquid filling port 24 for filling the second sheath 20 with liquid. .

  A cap with a valve (not shown) is attached to the base end side of each sheath base 12, 22, and there is no leakage of blood or the like when the second sheath 20 or the rod member 30 is inserted into each sheath 10, 20. It is configured as follows.

  The second sheath 20 is provided with a balloon inflation lumen (not shown) serving as a flow path for sending the inflation fluid supplied from the balloon inflation port 23 to the balloon 40 along the axial direction of the second sheath 20. It has been.

  As shown in FIG. 2 (b), the second sheath 20 has a tube wall thickness t1 of a portion of the second sheath 20 where the balloon 40 is disposed, where the balloon 40 is not disposed. The tube wall is configured to be thinner than the thickness t2.

Also, two holes 28 are provided in the tube wall of the second sheath 20 on the proximal end side with respect to the balloon 40 (see FIGS. 2A and 2B). As shown in FIG. 2B, the hole 28 penetrates from the outer side to the inner side of the tube wall of the second sheath 20 and communicates with the distal end side opening 26 of the second sheath 20. For this reason, as can be seen from FIG. 2C, the blood flowing from the distal end opening 26 when the balloon 40 is inflated in the second sheath 20 and the rod main body 32 described later. Will flow out of the hole 28 through the space formed between the two. That is, the flow path connecting the distal end side opening 26 and the hole 28 becomes a blood flow path when the balloon 40 is inflated.
Here, the case where blood flows in from the front end side opening portion 26 and flows out from the hole 28 has been described, but the same applies to the case where blood flows in from the hole 28 and flows out from the front end side opening portion 26. .

  As shown in FIG. 2B, the inner diameter D2 of the second sheath 20 on the proximal side from the portion where the hole 28 is provided is narrower than the inner diameter D1 of the second sheath 20 on the distal side from the portion. . More specifically, the inner diameter D1 is set from the distal opening 26 of the second sheath 20 to the proximal edge of the hole 28, and the proximal edge to the proximal edge of the hole 28. Is set to the inner diameter D2.

In addition, although description by illustration is abbreviate | omitted, the internal diameter of the 1st sheath 10 is comprised so that it may become more than the outer diameter of the 2nd sheath 20. FIG. Thereby, the second sheath 20 can be disposed inside the first sheath 10.
Further, the inner diameter D2 of the second sheath 20 on the proximal end side from the portion where the hole 28 is provided is configured to be equal to or larger than the outer diameter of the rod main body portion 32 of the rod member 30 described later. Thereby, the rod member 30 can be disposed inside the second sheath 20.

  The rod member 30 is a member for exposing the stent graft SG having a reduced diameter from the distal end of the first sheath 10, and as shown in FIG. 1, the rod main body 32 and the proximal end of the rod main body 32. It has a wire introduction port 34 disposed on the side and a distal end tip 36 disposed on the distal end portion of the rod member 30. As shown in FIG. 1 (a), the stent graft SG in a reduced diameter state is held near the distal end portion of the rod main body portion 32.

  As a material constituting the rod body 32, various materials having appropriate hardness and flexibility such as resin (plastic, elastomer) or metal can be preferably used.

  As a material constituting the tip chip 36, for example, various materials having appropriate hardness and flexibility such as a synthetic resin (elastomer) made of polyamide resin, polyurethane resin, polyvinyl chloride resin, or the like are used. It can be preferably used.

  Although not illustrated, the rod main body 32 and the distal tip 36 are provided with, for example, a guide wire lumen for inserting a guide wire or a trigger wire for expanding a reduced-diameter stent graft SG in the affected area. A trigger wire lumen or the like for insertion is formed along the axial direction of the rod member 30 (longitudinal direction of the rod member 30).

  Although not described in detail, the distal tip 36 is provided with a locking groove (not shown) for locking the trigger wire. A method (mechanism) for expanding a stent graft in a reduced diameter state at an affected area using such a trigger wire and a tip is known, for example, as described in Japanese Patent Application Laid-Open No. 2000-350785 or International Publication No. 2005/99806. The method can be used.

  The balloon 40 is disposed in the vicinity of the distal end portion of the second sheath 20 and is configured to be inflatable by the inflation fluid supplied from the balloon inflation port 23. Although details will be described later, the balloon 40 is configured to be exposed from the inside of the first sheath 10 by causing the second sheath 20 to advance with respect to the first sheath 10.

  As a material constituting the balloon 40, various known materials such as a resin material (elastomer) such as polyethylene and polyethylene terephthalate can be preferably used.

  The stent graft SG as a tubular treatment device loaded in the tubular treatment device placement apparatus 1 is not illustrated, but a self-expanding stent portion in which a thin metal wire is folded back in a zigzag shape and formed into a substantially cylindrical shape, And a graft portion which is sutured and fixed so as to cover the stent portion from the outer periphery. As a material of the metal fine wire constituting the stent portion, for example, a known metal or metal alloy represented by stainless steel, Ni—Ti alloy, titanium alloy, or the like can be preferably used. As a material constituting the graft portion, for example, a fluororesin such as PTFE (polytetrafluoroethylene) or a polyester resin such as polyethylene terephthalate can be preferably used. Graft parts made of these resin materials have relatively high biocompatibility and durability, and are chemically stable.

  In addition, the stent graft that can be used for the tubular treatment instrument placement device 1 according to the embodiment (the tubular treatment tool placement device of the present invention) is not limited to the stent graft made of the above-described configuration / material, May be known stent grafts made of different configurations and materials.

Next, an example of a method of using the tubular treatment instrument placement device 1 will be described with reference to FIG.
Drawing 3 is a figure shown in order to explain the usage method of tubular treatment implement placement device 1 concerning an embodiment. FIG. 3A to FIG. 3J are conceptual diagrams showing stepwise how the stent graft SG is placed in the affected area A and further re-expanded with the balloon 40. In FIG. 3, illustration of the guide wire disposed in the blood vessel is omitted. Moreover, in FIG.3 (f)-FIG.3 (i), in order to understand an invention easily, the stent graft SG is shown with the broken line.

  First, the tubular treatment instrument placement device 1 is advanced along the blood vessel to the position of the affected part A (see FIGS. 3A and 3B). At this time, the outer surface of the apparatus is covered with the first sheath 10.

  Next, in a state where the position of the rod member 30 is fixed at an appropriate position of the affected area A, only the first sheath 10 is pulled (moved toward the proximal end side) to expose the stent graft SG from within the first sheath 10 ( (Refer FIG.3 (c) and FIG.3 (d).). Thereafter, a trigger wire (not shown) is pulled to expand the distal end portion of the stent graft SG (see FIG. 3E). As a result, the stent graft SG can be placed in the affected area A.

  Next, the second sheath 20 is advanced without moving the first sheath 10 to expose the balloon 40 from within the first sheath 10 (see FIGS. 3F and 3G). In addition, about the rod member 30, as shown to FIG.3 (f) and FIG.3 (g), you may advance a little with respect to the 1st sheath 10, and it is not necessary to advance at all.

  Then, the balloon 40 is inflated in a state where the balloon 40 is disposed at an appropriate position (see FIG. 3H). Thereby, the crease | fold and wrinkle of stent graft SG can be extended, or the adhesion | attachment to the blood vessel wall can be ensured.

  When the re-expansion of the stent graft SG is completed, the balloon 40 is deflated (see FIG. 3 (i)), and the tubular treatment device placement device 1 is removed from the blood vessel (see FIG. 3 (j)).

According to the tubular treatment device indwelling apparatus 1 according to the embodiment configured as described above, since the balloon 40 is provided, the stent graft SG can be re-expanded while the apparatus is inserted. As a result, the labor for exchanging the catheter can be saved, and it is not necessary to prepare a separate balloon catheter.
Further, according to the tubular treatment instrument placement device 1 according to the embodiment, since the second sheath 20 in which the balloon 40 is disposed is disposed in the first sheath 10, the balloon 40 is accommodated in the first sheath 10. In this state, the device can be inserted into the blood vessel or moved in the blood vessel, so that the smoothness of the outer surface of the device is not impaired.

  Therefore, the tubular treatment instrument indwelling device 1 according to the embodiment can save time and labor for exchanging the catheter, and does not require a separate balloon catheter, and further impairs the smoothness of the outer surface of the device. This is a tubular treatment device indwelling device (stent graft indwelling device) that never happens.

  In the tubular treatment instrument placement device 1 according to the embodiment, the second sheath 20 has a tube wall thickness t1 of a portion of the tube wall of the second sheath 20 where the balloon 40 is disposed, and the balloon 40 is disposed. It is comprised so that it may become thinner than the thickness t2 of the tube wall of the part which is not. Thereby, the tube diameter (outer diameter) of the tubular treatment instrument placement device 1 in the portion where the balloon 40 is disposed is equal to the tube diameter (outer diameter) of the tubular treatment device placement apparatus 1 in the portion where the balloon 40 is not disposed. It becomes possible to suppress becoming overly thick.

  In the tubular treatment instrument placement device 1 according to the embodiment, a hole 28 communicating with the distal end side opening 26 of the second sheath 20 is formed on the tube wall of the second sheath 20 on the proximal side of the balloon 40 among the tube walls of the second sheath 20. Is provided. Thereby, when the balloon 40 is inflated, the blood flow can be maintained between the distal end side and the proximal end side of the balloon 40, so that an ischemic state caused by the inflation of the balloon 40 can be prevented. It becomes possible.

  In the tubular treatment instrument placement device 1 according to the embodiment, the inner diameter D2 of the second sheath 20 on the proximal side from the portion where the hole 28 is provided is narrower than the inner diameter D1 of the second sheath 20 on the distal side from the portion. . As a result, blood that has flowed from the distal end side opening 26 of the second sheath 20 flows relatively smoothly toward the hole 28.

  As mentioned above, although the tubular treatment tool indwelling apparatus of this invention was demonstrated based on said embodiment, this invention is not limited to said embodiment, In the range which does not deviate from the summary, it implements in a various aspect. For example, the following modifications are possible.

(1) In the above embodiment, the case where the number of the holes 28 provided in the tube wall of the second sheath 20 is two has been described as an example, but the present invention is not limited to this, and one Or three or more may be sufficient. Further, the position / arrangement of the holes may be any position / arrangement as long as they are on the proximal end side with respect to the balloon 40.

(2) In the above embodiment, the case where the hole 28 penetrates from the outside to the inside of the tube wall of the second sheath 20 has been described as an example, but the present invention is not limited to this. For example, holes that do not penetrate to the inside of the second sheath 20 are provided on the tube wall outer surfaces of the balloon 40 on the proximal end side and the distal end side of the tube wall of the second sheath, respectively. A lumen that connects the provided hole and the hole provided on the distal end side of the balloon 40 may be provided inside the tube wall of the second sheath. Also in this case, when the balloon 40 is inflated, the blood flow can be maintained between the distal end side and the proximal end side of the balloon 40, so that an ischemic state caused by the inflation of the balloon 40 is prevented. Is possible.

(3) In the above embodiment, the stent graft indwelling device for indwelling the stent graft in the affected part has been described as an example, but the present invention is not limited to this. The present invention can also be applied to a tubular treatment device indwelling device (for example, a stent indwelling device for placing a stent in an affected part) for placing a tubular treatment tool other than a stent graft in the affected part.

DESCRIPTION OF SYMBOLS 1 Tubular treatment device indwelling apparatus 10 1st sheath 12 1st sheath base parts 14 and 24 Liquid filling port 20 2nd sheath 22 2nd sheath base part 23 Balloon expansion | swelling port 26 (2nd sheath) front end side opening part 28 Hole 30 Rod member 32 Rod body portion 34 Wire introduction port 36 Tip tip 40 Balloon A Affected part BV Blood vessel D1 Inner diameter D2 of the second sheath on the distal end side from the portion where the hole is provided The inner diameter of the second sheath on the proximal end side from the portion where the hole is provided t1 Thickness of the tube wall of the second sheath tube wall where the balloon is disposed t2 Thickness of the tube wall portion of the second sheath where the balloon is not disposed SG Stent graft

Claims (5)

A tubular treatment device placement device (1) for placing a radially expandable tubular treatment device (SG) in an affected area,
A flexible, tubular first sheath (10);
A tubular second sheath (20) having flexibility and configured to be able to advance and retreat inside the first sheath along the axial direction of the first sheath;
A rod member (30) configured to be capable of advancing and retracting along the axial direction of the second sheath inside the second sheath;
A balloon (40) disposed on the second sheath,
The balloon (40) is configured to be exposed from the inside of the first sheath (10) by advancing the second sheath (20) relative to the first sheath (10). A tubular therapeutic device indwelling device (1) characterized by the above. The tubular treatment instrument placement device according to claim 1,
In the second sheath (20), the thickness (t1) of the portion of the tube wall of the second sheath where the balloon is disposed is equal to the thickness of the portion of the tube wall where the balloon is not disposed. The tubular treatment device placement device (1), which is configured to be thinner than (t2). The tubular treatment device indwelling device according to claim 1 or 2,
Of the tube wall of the second sheath, a tube wall closer to the proximal end than the balloon is provided with a hole (28) communicating with the distal end side opening (26) of the second sheath. Tubular treatment device placement device (1). The tubular treatment device indwelling device according to claim 3,
An inner diameter (D2) of the second sheath on the proximal side from the portion where the hole is provided is narrower than an inner diameter (D1) of the second sheath on the distal side from the portion. Device (1). In the tubular treatment device placement device according to any one of claims 1 to 4,
The tubular treatment device placement device (1), wherein the tubular treatment device is a stent graft (SG).

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