JP2002102359A - Instrument for expanding biological organ - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an instrument for expanding biological organ, with which a break around the opening part of a sheath or lowering in operability does not occur. SOLUTION: An instrument 1 for expanding biological organ is composed of a main body part 21 of shaft, expanding balloon 3, stent 4, catheter 10 for expansion provided with a guide wire lumen 15 opening one terminal on the top end of the main body part 21 of shaft and opening the other terminal on the intermediate part of the main body part 21 of shaft, and sheath 5 having a side hole 51 for inserting a guide wire, and is produced so that a side hole forming portion 52b of the sheath 5 can become higher rigidity than a top end part 52a of the sheath 5.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a living organ dilator used for improving a stenosis formed in a living organ such as a blood vessel, a bile duct, a trachea, an esophagus, a urethra and other organs. In particular, it is possible to carry a stent for living organ expansion performed after PTCA in a stenotic lesion in endovascular treatment, mainly a stenotic site such as a cardiovascular vessel, to a target living organ site with safe and smooth operability. The present invention relates to a device for expanding a living organ.

[0002]

2. Description of the Related Art Conventionally, there is a living organ dilation method for securing a lumen or body cavity space by placing a stent in a living lumen or a stenosis of a body cavity such as a blood vessel, bile duct, esophagus, trachea, urethra and other organs. Is being done. As the stent used for this purpose, there are a balloon expandable stent and a self-expandable stent depending on the function and the placement method. Balloon expandable stent, the stent itself has no expansion function, in order to indwell the stent at the target site, for example, after inserting the stent attached to the expandable body (balloon) to the target site, expand the balloon, The stent is expanded (plastically deformed) by the expansion force of the balloon, and is fixed in close contact with the inner surface of the target site. Japanese Patent Application Laid-Open No. 6-2350 discloses a device for expanding a living organ in which a balloon expandable stent is placed at a target site.
No. 7 discloses a stent delivery system including a dilatation balloon catheter having a dilatation balloon for dilating a stent and a sheath enclosing the dilatation balloon catheter, that is, a so-called rapid exchange system. This stent delivery system has a guide wire lumen that opens at the distal end and the intermediate portion of the dilatation balloon catheter, and a side hole formed in the sheath intermediate portion. A stent can be operated by inserting a guide wire into the opening formed in the opening.

[0003]

However, in the rapid exchange system having the above-mentioned structure, there is a possibility that the periphery of the sheath side hole is broken due to the guide wire coming into contact with the side hole due to the operation of inserting and removing the guide wire. Further, since the sheath side hole forming portion is more fragile than other portions, there is a possibility that the periphery of the side hole is broken. Also,
At the sheath side hole formation site during the stent placement operation, the torque and the pushing force (in other words, pushability) applied to the rear end side of the living organ dilator may be absorbed, and the operability may be reduced. In view of the above, the present invention has been made to solve the above-mentioned problem, and provides a device for expanding a living organ in which breakage near the sheath opening or deterioration of operability is less likely to occur.

[0004]

Means for achieving the above object is to provide a tubular shaft main body, a foldable and expandable balloon provided at a distal end of the shaft main body, and a folded and expandable balloon. A stent mounted to enclose the balloon, and expanded by expansion of the balloon, one end is opened at the tip of the shaft body,
A living organ dilatation device comprising: a dilatation catheter having a guide wire lumen having the other end opened at an intermediate portion of the shaft main body; and a sheath having a catheter lumen for slidably storing the dilation catheter. is there. The sheath further includes an axially extending side hole for inserting a guidewire into the guidewire lumen provided at a position near the other end side opening of the guidewire lumen of the dilatation catheter, Further, the side hole forming portion of the sheath is a high rigidity portion having higher rigidity than the distal end portion of the sheath.

The dilatation catheter is slidable within the sheath from a state where the distal end of the stent of the dilatation catheter is housed in the sheath to a state where the rear end of the stent is exposed. Preferably, the side hole of the sheath has an axial length equal to or greater than the length of the stent. Also,
The sheath is preferably made of a resin material having higher hardness than the resin material constituting the distal end of the sheath from the distal end of the side hole forming portion to the proximal end of the sheath. The resin material having a high hardness is preferably a resin material having a Shore D hardness of 55 or more. Further, the resin material having high hardness is preferably polyester or polyamide. Also, the distal end of the sheath,
It is preferable to be made of a resin material having a Shore D hardness of 50 or less. Preferably, the resin material forming the distal end of the sheath is polyester or polyamide.

Further, it is preferable that the side hole forming portion has a metal reinforcing member. Preferably, the reinforcing member is a tubular member having a plurality of openings. Preferably, the reinforcing member is a wire-like member. Preferably, the sheath includes an outer sheath layer and an inner sheath layer formed inside the outer sheath layer, and the inner sheath layer is preferably made of a fluororesin material. Further, it is preferable that the inner layer is formed so as to protrude from the distal end of the sheath outer layer. It is preferable that a lock mechanism for fixing the dilatation catheter to the sheath at an arbitrary position is provided. Further, it is preferable that the dilatation catheter includes a stopper that is provided on the distal end side of the stent and that prevents the sheath from moving in the distal direction.

[0007]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A living organ dilator according to the present invention will be described with reference to a preferred embodiment shown in the drawings. FIG. 1 is a front view of an embodiment of the living organ dilator according to the present invention, and FIG.
FIG. 3 is an enlarged cross-sectional view of the vicinity of the distal end of the living organ dilating device shown in FIG. 1, FIG. 3 is an enlarged cross-sectional view of a central joining portion of the living organ expanding device shown in FIG. 1, and FIG. A section view,
5 is a sectional view taken along line BB of FIG. 1, and FIG. 6 is a sectional view taken along line CC of FIG.
7, FIG. 7 is a sectional view taken along line DD of FIG. 3, FIG. 8 is an enlarged sectional view of a branch hub of the device for expanding a living organ shown in FIG. 1, and FIG. 9 is a living body shown in FIG. FIG. 10 is an enlarged cross-sectional view of the rear end portion of the dilatation catheter of the organ dilatation device, and FIG. 10 is an explanatory view for explaining another embodiment of the living organ dilation device of the present invention.

The living organ dilator 1 of the present invention comprises a tubular shaft body 21 and a foldable and expandable balloon 3 provided at the tip of the shaft body 21.
And a stent 4 mounted so as to enclose the balloon 3 in a folded state and expanded by expansion of the balloon 3, one end of which is opened at the tip of the shaft body 21,
A dilatation catheter 10 including a guide wire lumen 15 whose other end is opened at an intermediate portion of the shaft body 21.
And a sheath 5 having a catheter lumen 50 for slidably storing the expansion catheter 10. The sheath 5 is connected to the guide wire lumen 15 provided at a position near the other end side opening of the guide wire lumen 15 of the dilatation catheter 10.
And a side hole 51 extending in the axial direction for inserting the sheath 5, the side hole forming portion 52 b of the sheath has a rigidity of the sheath 5.
Is a high-rigidity portion higher than the tip portion 52a.

The device 1 for expanding a living organ of the present invention is of a so-called rapid exchange type, and is provided inside a dilatation catheter 10 as shown in FIGS. And a guide wire lumen 15 opened at the middle part (the other end side opening part 36), and a guide wire insertion side hole 51 formed at the sheath middle part. With such a configuration, the living organ dilator 1 inserts a guide wire into the opening (the other end side opening 36) formed in the catheter middle part through the side hole of the sheath from the middle (middle part) of the sheath. , So that a stent operation can be performed.

As shown in FIG. 1, the living organ dilator 1 includes a shaft main body 21, a stopper 6 provided at the distal end of the shaft main body 21, and a stent expander provided at the distal end of the shaft main body 21. Balloon 3, stent 4 mounted on balloon 3, and shaft body 21
A dilatation catheter 10 comprising a hub 8 attached to a rear end of the catheter, a sheath 5 enclosing the catheter 10,
A branch hub 60 attached to the rear end of the sheath 5.

The dilatation catheter 10 comprises a front end shaft portion 10a and a rear end shaft portion 10b. The front end shaft portion 10a and the rear end shaft portion 10b are connected to each other by a connector 7 as shown in FIGS. Are joined through. The dilatation catheter 10 is slidable within the sheath 5 from a state where the distal end of the stent 4 of the dilatation catheter 10 is stored in the sheath 5 to a state where the rear end of the stent 4 is exposed. The distal shaft portion 10a is
As shown in FIGS. 2 and 3, an inner tube 12 forming a guide wire lumen 15, a balloon 3 provided at a distal end of the inner tube 12, and a stent 4 mounted on the outer periphery of the balloon 3
And a balloon expansion lumen 1 provided between the outer surface of the inner tube 12 and provided on the rear end side of the balloon 3 to cover the inner tube 12.
6 comprising an outer tube 13. The distal shaft portion 10a is slidably housed in the catheter lumen 50 of the sheath 5. The rear end of the distal shaft portion 10b is joined to the distal end of the joining connector 7.

As shown in FIG. 2, the balloon 3 has a distal joint 3a and a rear joint 3b, and the distal joint 3a is fixed at a position slightly rearward from the distal end of the inner tube 12. The rear end side joining portion 3 b is fixed to the front end of the outer tube 13. The balloon 3 communicates with the balloon expansion lumen 16 near the base end. A stopper 6 is fixed to the distal end of the inner tube 12 so as to cover the distal end of the distal end side joining portion 3a of the balloon 3. The stopper 6 is formed in an annular shape from an elastic material, and the outer diameter of the rear end portion is substantially equal to or slightly larger than the inner diameter of the sheath 5. By having the stopper 6 in this manner, the movement of the stent 4 in the distal direction is prevented, and the stent 4 does not fall off the catheter during the stent placement operation. The stopper 6 has a tapered shape whose diameter gradually decreases toward the tip. By forming in this manner, the stopper 6 can have a function of guiding to the stenosis, and the insertion of the stent mounting portion into the stenosis of the living organ can be facilitated.

The inner tube 12 has an outer diameter of 0.3.
5 to 1.0 mm, preferably 0.45 to 0.8 mm, and an inner diameter of 0.2 to 0.9 mm, preferably 0.35 to
0.7 mm. The outer diameter of the outer tube 13 is 0.6 to
1.5 mm, preferably 0.8 to 1.1 mm, inner diameter 0.5 to 1.4 mm, preferably 0.7 to 1.0 m
m. The outer diameter of the sheath 5 is 0.8 to 1.8 m.
m, preferably 1.2 to 1.5 mm, and an inner diameter of 0.1 mm.
It is 5 to 1.5 mm, preferably 1.0 to 1.3 mm. As a material for forming the inner tube 12, the outer tube 13, and the stopper 6, a material having a certain degree of flexibility is preferable. For example, polyamide, polyester, polyolefin (including crosslinked or partially crosslinked products), polyvinyl chloride, polyurethane and the like Thermoplastic resin, silicone rubber,
Latex rubber and the like can be used, and the above-mentioned thermoplastic resins are preferred.

The balloon 3 is foldable, and can be folded around the inner tube 12 when not expanded. Balloon 3
Has an expandable portion 31 which is a cylindrical portion (preferably a cylindrical portion) having substantially the same diameter so that the stent 4 to be mounted can be expanded. The above-mentioned substantially cylindrical portion does not have to be a perfect cylinder, and may be a polygonal column. And, as described above, the balloon 3 is connected to the distal end side joint 3a.
Is bonded to the inner tube 12 and the rear end side joining portion 3b is fixed to the front end of the outer tube 13 in a liquid-tight manner by an adhesive or heat fusion.
The balloon 3 forms an expansion space 3c between the inner surface of the balloon 3 and the outer surface of the inner tube 12, as shown in FIG. The expansion space communicates with the expansion lumen 16 on the entire periphery at the rear end. As described above, the rear end of the balloon 3 communicates with the expansion lumen having a relatively large volume, so that the injection of the expansion fluid from the expansion lumen 16 into the balloon is ensured.

The material for forming the balloon 3 is preferably a material having a certain degree of flexibility, for example, thermoplastic resins such as polyolefin, polyvinyl chloride, polyamide, polyurethane, polyester, and polyarylene sulfide, silicone rubber, and latex. Rubber or the like can be used. Particularly, the balloon 3 is preferably a stretchable material, and the balloon 3 is preferably biaxially stretched having high strength and expansion force. As the size of the balloon 3, the outer diameter of the cylindrical portion (expandable portion 31) when expanded is
1.5 to 5.0 mm, preferably 2.5 to 4.0 mm, and a length of 5 to 50 mm, preferably 10 to 40 mm
It is. Also, the outer diameter of the distal end side joining portion 3a is 0.5 to
It is 1.5 mm, preferably 0.7-1.0 mm, and the length is 1-5 mm, preferably 1.0-1.3 mm. Further, the outer diameter of the rear end side joining portion 3b is 0.8 to 1.6.
mm, preferably 1.0-1.5 mm and a length of 1
５5 mm, preferably 2-4 mm.

The distal contrast marker 17 is fixed to the shaft main body 21 (in this embodiment, the inner tube 12) on the outer surface at a position near the distal end inside the expandable portion 31 of the balloon 3. . Similarly, the shaft body 21
The rear end contrast marker 18 is fixed to the outer surface of the inner tube 12 (in this embodiment) at a position near the rear end inside the expandable portion 31 of the balloon 3. The contrast marker is
It is preferably formed of an X-ray opaque material (for example, gold, platinum, tungsten, or an alloy thereof, or a silver-palladium alloy). By doing so, the positions of the leading end and the trailing end of the expandable portion 31 of the balloon 3, and further, the positions of the leading end and the trailing end of the stent 4 are set to X.
It can be confirmed by line contrast.

The stent 4 used in the living organ dilator 1 of the present invention is formed in a substantially tubular body, has a diameter for insertion into a living body, and is disposed radially outward from the inside of the tubular body. When the spreading force is applied, in other words, the balloon 3
Is expandable (expandable) when is expanded,
This is a so-called balloon expandable stent. As shown in FIG. 14, for example, as shown in FIG. 14, a substantially elliptical or polygonal component 22 which is long in the axial direction of the stent 4 and whose central portion is closed is substantially equiangular with respect to the central axis of the stent 4. It is arranged on the circumference at intervals and
A connection portion 23 is formed between adjacent portions (side portions) in the circumferential direction of the component.
(23a, 23b, 23c, 23d) connected annular units 24 (24a, 24b, 24c, 24d, 2)
4e, 24f) and a plurality of annular units 2
4 a, 24 b, 24 c, 24 d, 24 e, 24 f are arranged in the axial direction of the stent 4. Further, the connecting portion 23 of one annular unit 4 and the connecting portion 23 of the adjacent annular unit 24 are connected to the connecting portion 25 (25a, 25b, 25c, 25c).
d, 25e) are preferred to be contacted by at least one location. However, the shape of the stent 4 is not limited to such a shape, and a known shape such as a mesh shape can be used.

As a material for forming the stent 4, a material having a certain degree of biocompatibility is preferable. For example, stainless steel, tantalum or a tantalum alloy, platinum or a platinum alloy, gold or a gold alloy, a cobalt-based alloy or the like can be considered. Further, after forming the stent shape, noble metal plating (gold, platinum) may be performed. As stainless steel, SUS316L, which has the highest corrosion resistance, is preferable. The unexpanded diameter of the stent 4 is 0.8 to
About 1.5 mm is preferable, and in particular, 0.9 to 1.2 m
m is more preferred.

As shown in FIGS. 1 and 3, the rear end side shaft portion 10b comprises a shaft tube 32 and a hub 8 fixed to the rear end of the shaft tube 32. And
The rear end side shaft portion 10 b is slidably housed in the catheter lumen 50 of the sheath 5. The front end of the rear end side shaft portion 10b is joined to the rear end of the joining connector 7. As shown in FIGS. 1 and 7, a stiffening member 33 is inserted into the shaft tube 32, and the stiffening member 33 is provided at the rear end of the shaft tube 32.
, And the distal end protrudes from the distal end of the shaft tube 32, penetrates a joining connector 7 described later, and extends into the distal end side shaft. In this embodiment, the stiffener 3
The distal end of 3 extends between the inner tube 12 and the outer tube 13 of the distal shaft, in other words, into the balloon expansion lumen 16.

The stiffening member 33 is formed of a shaft tube 32.
Extends from the base end toward the front end side. Further, the rigidity imparting body 33 is fixed to the shaft tube 32 or the hub 8 only at the base end so as not to hinder the bending of the shaft main body 21, and other parts, specifically, the shaft tube 32 It is not fixed to any of the inside excluding the base end, the joint connector 7 portion, and the distal shaft portion (the inner tube 12 and the outer tube 13). Stiffener 3
3 prevents the shaft tube 32 from being extremely bent at the bending portion without significantly reducing the flexibility of the shaft tube 32, thereby preventing the shaft tube 32 from meandering in the blood vessel. The stiffness imparting body 33 is preferably formed of a linear body. The linear body is preferably a metal wire, and an elastic metal such as stainless steel having a wire diameter of 0.05 to 1.5 mm, preferably 0.1 to 1.0 mm, a superelastic alloy, or the like is particularly preferable. Is a high-tensile stainless steel for a spring and a superelastic alloy wire.

The superelastic alloy referred to here is generally called a shape memory alloy and exhibits superelasticity at least at a biological temperature (around 37 ° C.). Particularly preferably, a Ti-Ni alloy of 49-53 atomic% Ni, 38.5-41.5% by weight
Cu-Zn alloy of Zn, Cu-Zn of 1-10 wt% X
-X alloy (X = Be, Si, Sn, Al, Ga), 36
A superelastic alloy such as a Ni-Al alloy of -38 atomic% Al is preferably used. In particular, the above-mentioned Ti-Ni alloy is desirable. Further, a part of the Ti—Ni alloy is reduced to 0.01 to 10.0.
Ti-Ni-X alloy substituted with atomic% X (X = Co, F
e, Mn, Cr, V, Al, Nb, W, B, etc.) or a part of the Ti—Ni alloy
Ti-Ni-X alloy substituted with atomic% X (X = Cu, P
b, Zr), and by selecting the cold working rate and / or the conditions of the final heat treatment, the mechanical properties can be changed as appropriate. In addition, the above Ti-Ni-
By selecting the cold working ratio and / or the conditions of the final heat treatment using the X alloy, the mechanical properties can be changed as appropriate.

The shaft tube 32 has a rigidity-imparting body 33 fixed at the base end, and the rear end of the shaft tube 32 is fixed to the tip end of the hub 8. The outer surface of the boundary between the hub 8 and the shaft tube 32 is covered with a kink preventing tube 3 so as to cover them.
5 is attached. The rear end of the hub 8 serves as a connection portion 34 of a balloon inflation fluid injection device (for example, a syringe). As the shaft tube 32,
The outer diameter is 0.5 to 1.5 mm, preferably 0.6 to 1.3.
mm, and the inner diameter is 0.3 to 1.4 mm, preferably 0.5 to 1.2 mm. As a material for forming the shaft tube 32, a material having a certain degree of flexibility is preferable. For example, polyolefin (eg, polyethylene, polypropylene, ethylene-propylene copolymer,
Thermoplastic resins such as polyvinyl chloride, polyamide elastomer, polyimide, and polyurethane, silicone rubber, latex rubber, and the like can be used, and the above-mentioned thermoplastic resins are preferable.
Further, as a material for forming the shaft tube 32, a stainless steel tube may be used without using the rigidity imparting body 33.

As shown in FIG. 3, the joining connector 7
An inner pipe insertion passage extending in the axial direction from the center of the distal end to the center, and curved from the center to reach the outer surface on the rear end side; A rear end portion of the inner tube 12 protruding from the side surface 7 forms a guide wire introduction slot 36 (the other end side opening 36). The opening of the other end side opening 36 is formed obliquely upward on the base end side in FIG. Note that the direction of the opening is not limited to that of the embodiment, and may be formed directly above FIG. The joint connector 7 is formed with balloon inflation fluid flow paths 37a and 37b extending from the distal end to the proximal end. By this flow passage, the inner pipe 12 and the outer pipe 13
Balloon expansion lumen 16 formed by
The balloon expansion lumen 16 formed in the shaft tube 32 is in communication with the balloon expansion lumen 16. Further, as described above, the joining connector 7 is formed with the stiffening body conduction path penetrating from the distal end to the base end, and the stiffening body 33 penetrates this.

The sheath 5 is formed in a tube shape as shown in FIGS. 1, 2 and 3, and has a catheter lumen 50 inside and a side hole 51 at an intermediate portion. When the distal end of the stent 4 is housed in the catheter lumen 50, the distal end of the stent 4 and the rear end of the stopper 6 are almost in contact with each other. The rear end of the sheath 5 is joined to the front end of the branch hub 60. Catheter lumen 5
Reference numeral 0 denotes a passage for slidably storing the dilatation catheter 10 as shown in FIGS. In other words,
The catheter lumen 50 is a passage through which the dilatation catheter 10 can be inserted. The catheter lumen 50 extends from the distal end of the catheter lumen, that is, the distal end of the sheath.
The tip of the protrudes, the rear end of the catheter lumen,
The proximal end of the dilatation catheter 10 protrudes from the rear end of the sheath.

The side hole 51 is provided with the guide wire lumen 15.
It is provided for inserting the guide wire 100 therein. The guide wire 100 is inserted into the other end side opening 36 through the side hole 51 and is introduced into the guide wire lumen 15. As shown in FIGS. 1 and 3, the side hole 51 is formed as an elliptical opening extending in the axial direction, and the catheter lumen is located at a position near the other end side opening 36 which is the guide wire insertion port of the guide wire lumen 15. It is formed so as to communicate with 50.

The dilatation catheter 10 includes a sheath 5
Inside, the distal end of the stent 4 of the dilatation catheter 10 is slidable from a state in which the distal end of the stent 4 is housed in the sheath 5 to a state in which the rear end of the stent 4 is exposed.
Has an axial length equal to or greater than the length of the stent 4. Since the side hole 51 has a certain length in the axial direction as described above, the other end side opening 3
The rear end of the stent 4 can be completely exposed outside the sheath with the 6 (guide wire insertion port) positioned in the side hole 51. Specifically, in a state where the distal end of the stent 4 is housed in the sheath as shown in FIG. 11, the proximal end 36 a of the other end side opening 36 is located more distally than the proximal end of the side hole 51. When the stent 4 is completely exposed from the distal end of the sheath 5 as shown in FIG.
The base end 36a is located closer to the base end than the front end of the side hole 51. In this state, the other end side opening 3
It is preferable that the distal end 36 b of the sixth side is also located closer to the proximal side than the distal end of the side hole 51. For this reason, since the guide wire 100 does not easily come into contact with the side hole 51 during the stent placement operation, the side hole forming portion is hardly damaged.

At the time of insertion into the living body, as shown in FIG. 1, the living organ dilatation instrument 1 has almost all of the stopper 6 of the dilatation catheter exposed from the distal end of the sheath 5 and the stent 4 has no stent 4 at all. The catheter is not exposed, and in this state, the dilatation catheter 10 is fixed by a catheter lock mechanism 63 of a branch hub 60 provided at the rear end of the sheath 5 described later. Therefore, unless the catheter lock mechanism 63 is released, the state of FIG. 1 is maintained, and the dilatation catheter cannot slide in the sheath. The dilatation catheter 10 includes a sheath 5
Inside, when not locked by the catheter lock mechanism 63, the stent 4 of the dilatation catheter 10 can slide from the state in which the distal end of the stent 4 is housed in the sheath 5 to the state in which the rear end of the stent 4 is exposed.

FIGS. 1 to 3 and FIGS. 10 to 12
As shown in (2), it is formed of a sheath outer layer 52 and a sheath inner layer 53 formed inside the sheath outer layer 52.
The sheath outer layer 52 and the sheath inner layer 53 are integrated. As shown in FIGS. 1 and 2, the distal end of the sheath outer layer 52 and the distal end of the sheath inner layer 53 are manufactured so as to be substantially at the same position in the axial direction of the sheath. As shown in FIG. 8, the base ends of the sheath outer layer 52 and the sheath inner layer 53 are joined to the distal end of the branch hub 60 by an adhesive, heat fusion, or the like. In the embodiment, the outer layer and the inner layer are manufactured as a two-layer structure, but may be a three-layer or more multilayer structure.
Further, the sheath may have a single-layer structure.

The inner sheath layer 53 is preferably formed of a fluorine resin material. As the fluorine-based resin material, polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), or the like can be used, and polytetrafluoroethylene is preferable.
By forming the inner layer of the sheath from a fluorine-based resin material, the inner wall of the catheter lumen becomes slippery, and the dilatation catheter slides easily in the catheter lumen. It is preferable that the sheath outer layer 52 is made of a resin having a certain degree of flexibility so that it can easily advance through a bent body lumen. Sheath outer layer 5
As the constituent material 2, thermoplastic resins such as polyamide, polyester, polyolefin (including crosslinked or partially crosslinked products), polyvinyl chloride, and polyurethane can be used, and the above thermoplastic resins are preferable.

The side hole forming portion (peripheral portion of the side hole) of the sheath 5 is a high rigid portion having higher rigidity than the distal end portion of the sheath 5. With this configuration, during the stent placement operation, the torque and the pushing force applied to the rear end side of the device for expanding a living organ in the side hole formation site or the breakage of the side hole formation site (in other words,
The operability due to absorption of pushability is hardly reduced. Specifically, the sheath 5 (sheath outer layer 5) is inserted from the distal end of the side hole forming portion 52b of the sheath 5 (sheath outer layer 52).
It is made of a resin material having higher hardness than the resin material constituting the distal end portion 52a of the sheath 5 (sheath outer layer 52) up to the base end portion 52c of 2).

A resin material having a high hardness has a Shore D hardness of 50.
It is preferable to use the above resin materials.
The hardness is preferably 55 or more. The resin material having high hardness is preferably polyester or polyamide. As the polyester-based resin, polyethylene terephthalate, polybutylene terephthalate, and the like are preferable, and polyethylene terephthalate is preferable. As the polyamide resin, nylon 6, nylon 66, nylon 46, nylon 11, nylon 1
2 and the like are preferred. Further, the distal end portion 52a of the sheath is preferably made of a resin material having a Shore D hardness of 50 or less. Accordingly, the distal end portion of the sheath has flexibility, and can smoothly proceed through the complicated living body lumen. The resin material forming the sheath distal end portion 52a is a polyester elastomer, an olefin-based elastomer (for example, a polyethylene elastomer or a polypropylene elastomer), a polyamide elastomer, or a styrene-based elastomer (for example, styrene-based elastomer).
Flexible resins such as butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer), polyamide elastomers, polyester elastomers, and thermoplastic fluorine-based elastomers are preferred.

The sheath 5 is, for example, a sheath distal end 52a.
Is made of a polyamide elastomer having a Shore D hardness of 50 or less, and the periphery 52b of the side hole is made of a polyamide elastomer having a Shore D hardness of 50 or more.
c can be made of a polyamide elastomer having a Shore D hardness of 50 or more. By configuring the sheath as described above, even if the guide wire is inserted into the other end opening 36 through the side hole 51 and the stent placement operation is performed,
The side hole forming portion 52b is not broken or the like, and the torque and the pushing force (in other words, pushability) applied on the rear end side of the living organ dilator are absorbed by the side hole forming portion 52b. There is no danger that the operability will be deteriorated. In the embodiment, the distal end portion 52a of the sheath 5 and the side hole forming portion 52 of the sheath 5 are formed.
b, the base end 52c of the sheath 5 is formed as a separate component, and then joined and integrated to form a sheath. However, the present invention is not limited to this.
b and the base end 52c may be formed as one component, and joined to the distal end 52a to form a sheath. Joining is
It can be performed by heat fusion, an adhesive or the like.

It is preferable that the outer surface of the sheath distal end portion 52a has been subjected to a hydrophilic treatment. The hydrophilic treatment can be performed by coating the outer surface of the sheath with a hydrophilic substance (for example, water-soluble silicone, PVA, PVP, or the like). The outer diameter of the sheath is 0.8 to 1.8 mm, preferably 1.2 to 1.5 m.
m, the inner diameter is 0.8 to 1.5 mm, preferably 1.0 to
1.3 mm, length is 800 to 1600 mm, preferably 1200 to 1400 mm. Sheath side hole 51
The length of the sheath in the axial direction is 5 to 80
mm, preferably 15 to 50 mm, and the length in the direction perpendicular to the axial direction of the sheath is 0.1 to 1.0 mm, preferably 0.35 to 0.7 mm.

As shown in FIG. 10, the side hole forming portion 52b of the sheath 5 may have a metal reinforcing member 54 as in the embodiment of the living organ dilating device shown in FIG. By providing the metal reinforcing member at the side hole forming portion, breakage around the sheath side hole 51 and absorption of torque or the like at the side hole forming portion can be prevented. The metal reinforcing member 54 is preferably a tubular member having a plurality of openings 541 as shown in FIG. The metal reinforcing member is manufactured as a tubular member having substantially the same diameter, and has a plurality of elliptical openings 541 extending along the axial direction of the tubular member. The shape of the opening is not limited to an ellipse, but may be a rectangle or the like. The tubular member is placed in contact with the inner layer 53 on the outer wall of the sheath at the side hole forming portion 52b, and is installed such that one of a plurality of openings of the tubular member overlaps the side hole 51. As a method for embedding the tubular member, a base member-side outer layer is formed in a portion other than the tip portion on a core metal whose surface is coated with an inner layer forming material, and a tubular member is formed on a base end portion of the outer layer non-formed portion. By fitting and attaching, and coating the resin for the side hole formation portion thereon, and further coating the resin for the tip portion formation portion on the tip portion of the outer layer non-formation portion. .

Although not shown, the metal reinforcing member may be made of a wire-like member. In the case of a wire-shaped member, it is preferable to embed a plurality of linear wires in the sheath wall material around the side hole 52b along the axial direction of the sheath. Further, a wire-shaped member is formed into a coil shape or a blade shape, and the wire-shaped member is formed into a side hole 5.
1 may be embedded in the inner wall of the sheath. Moreover, you may form a metal reinforcement member by combining a linear wire and a coiled wire. As the constituent material of the metal reinforcing member, it is preferable to use the same material as that of the rigidity imparting body 33. As the size of the metal reinforcing member of the tubular member,
The length is 10 to 90 mm, preferably 20 to 60 mm, and the inner diameter is 0.9 to 1.6 mm, preferably 1.
1 to 1.4 mm, and the wall material has a thickness of 0.03 to 0.3 mm.
It is 15 mm, preferably 0.05 to 0.10 mm. As the wire diameter of the metal reinforcing member of the wire-shaped member,
0.03 to 0.15 mm, preferably 0.05
０．１0.10 mm.

The outer surface of the sheath is preferably subjected to a hydrophilic treatment. Thus, the inner wall is less likely to be damaged when the sheath moves through the body lumen or body cavity. The hydrophilic treatment can be performed by coating the outer surface of the sheath with a hydrophilic substance (for example, water-soluble silicone, PVA, PVP, or the like). Further, as in the living body organ expanding device 70 of the embodiment shown in FIG. 15, the sheath 5 may be manufactured such that the sheath inner layer 73 protrudes more distally than the sheath outer layer 72. By manufacturing so as to protrude toward the distal end side, the thickness of the sheath can be reduced, and the outer diameter of the distal end portion of the sheath can be reduced. It is preferable that such a sheath inner layer 73 is made of a fluorine-based resin as described above. Preferably, the outer surface of the protruding portion of the sheath inner layer is subjected to a hydrophilic treatment. The length of the distal end protruding portion of the sheath inner layer 73 is 0.5 to 50 mm, preferably 1 to 50 mm.
0 to 40 mm. Also, of the inner layer 73 of the sheath,
It may be made of a fluorine-based resin except for the vicinity of the side hole forming portion.

Next, the branch hub 60 will be described with reference to FIG. As shown in FIG. 8, the branch hub 60 includes a branch hub body 61, an injection port 62 for priming provided at the center of the branch hub body 61 so as to branch from the body 61, and a branch hub 60. And a catheter lock mechanism 63 provided at the rear end of the branch hub to limit the movement of the dilatation catheter, and a dilatation catheter lumen 64 provided from the distal end to the proximal end of the branch hub. Also,
The catheter lumen diameter at the rear end 65 of the branch hub 60 is made smaller than the distal end of the hub 8, and the distal end of the hub 8 does not move from near the rear end of the branch hub 60 to the distal end. A sheath rear end is joined to the front end of the branch hub 60. The rear end of the sheath 5 is preferably fixed at a position of 1 to 5 mm from the distal end of the branch hub 60 to the proximal side.

The locking mechanism 63 is composed of an elastic body 631 and an elastic body 6 that hold the base end of the dilatation catheter 10 by compression.
And an operating body 632 for compressing the 31. Lock mechanism 6
With the provision of 3, the dilatation catheter 10 is fixed to the sheath 5 at an arbitrary position. The elastic body 631 is
A lumen 631 a forming a part of the catheter lumen 64 is formed in a concave portion 611 provided at the base end of the branch hub main body 61, and inside the elastic body 631. The inner diameter of the main body recess 611 is made slightly larger than the outer diameter of the elastic body 631,
31 allows the elastic body to expand in the radial direction when compressed by the operating body 632. The lumen 631a of the elastic body 631 is formed in a shape in which two substantially spherical shapes partially overlap each other in the axial direction, and both ends and a central portion are reduced in diameter. The lumen 631a is not limited to the shape of the above-described embodiment, and may have any shape as long as it properly locks the dilatation catheter.

The operating body 632 has an elastic body pressing portion 632a protruding toward the front end at the center and a screwing portion 63 formed on the outer periphery thereof and screwed to the rear end 611a of the concave portion 611.
2b and an operating body 632 formed on the outer periphery of the screw portion 632c.
And a supporting portion 632c for supporting when rotating. A lumen 632d that forms a part of the catheter lumen 64 is formed inside the elastic body pressing portion 632a. The distal end portion of the elastic body pressing portion 632a is housed in the main body recess 611 as shown in FIG. 8, and compresses the elastic body 631 by moving the operating body to the distal end. With the above configuration,
When the operating body 632 is rotated and screwed to the distal end side with respect to the branch hub 60, the distal end of the elastic body pressing portion 632a is
The elastic body 631 is compressed in the axial direction by touching the rear end of the elastic member 31 and further screwing the operating body 632 to the distal end side. Then, the inner diameter of the lumen 631a becomes smaller as it is compressed, and the base end of the dilatation catheter 10 is finally fixed by the elastic body 631. The release of the lock mechanism 63 is performed by a rotation operation reverse to the above.

The branch hub 60 other than the elastic body 631 may be made of polycarbonate, polyolefin (eg, polyethylene, polypropylene, ethylene-propylene copolymer), styrene resin [eg, polystyrene, MS resin (methacrylate-styrene copolymer) ), MBS resin (methacrylate-butylene-styrene copolymer)], polyester and the like. As constituent materials of the elastic body 631, synthetic rubber such as urethane rubber, silicone rubber, butadiene rubber, natural rubber such as latex rubber, olefin-based elastomer (eg, polyethylene elastomer, polypropylene elastomer), polyamide elastomer, styrene-based elastomer (eg, Styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer,
Styrene-ethylenebutylene-styrene copolymer),
Polyurethane, urethane-based elastomer, fluororesin-based elastomer and the like are preferable.

In the embodiment of the present invention, the sheath 5 is directly fixed to the distal end of the branch hub 60. However, the present invention is not limited to this.
The sheath and the branch hub may be joined by screwing it to the tip of the branch hub 60. In a state where the stent 4 is housed in the sheath (the state where the catheter 10 is pulled to the proximal end side), the rear end of the branch hub 60 is 10 to 200 mm, preferably 5 to 200 mm from the distal end of the kink preventing tube 35.
It is fixed at a position of 0 to 100 mm.

Next, the operation of the living organ dilator of the present invention will be described. As shown in FIG. 11, when the distal end of the stent 4 is housed in the sheath 5, the other end side opening 3
The opening base end 36a of the opening 6 is located near the front end side of the base end of the side hole 51. The expansion catheter 10 is fixed by the lock mechanism 63 and its movement is restricted. In this state, after inserting the guide wire 100 into the other end side opening 36 through the side hole 51, the injection port 6
A priming solution such as physiological saline is injected from 2 to prime the inside of the dilatation catheter lumen 50. Since the rear end of the stopper 6 is in contact with the distal end of the sheath 5, the priming liquid does not leak from the distal end of the sheath. Then, the living organ dilatation catheter 10 is inserted into a body cavity via a guiding catheter (not shown) and guided to a target site along the guide wire 100.

After the distal end of the living organ dilatation instrument 1 has reached the vicinity of the target site, the branching hub 60 is held with one hand, the lock mechanism 63 is released, and the dilatation catheter 10 is moved to the distal end side with respect to the sheath 5. To expose the stent 4. In the state where the stent 4 is completely exposed, the opening distal end 36b of the other end side opening 36 is located near the base end side of the distal end of the side hole 51 as shown in FIG. After that, stent 4
Is extended and detained at the target site to end the operation. that's all,
Although the device for expanding a living body organ has been described, the configuration of the device for expanding a living body organ is not limited to the above.

[0044]

According to the present invention, there is provided an instrument for expanding a living organ, comprising: a tubular shaft main body; a foldable and expandable balloon provided at a distal end portion of the shaft main body; and a folded balloon. It is attached so as to be encapsulated,
And a stent that is expanded by expansion of the balloon, an expansion catheter including a guide wire lumen that is open at one end at the distal end of the shaft main body and opens at the other end at an intermediate portion of the shaft main body, A sheath having a catheter lumen for slidably storing the dilatation catheter, wherein the sheath is located near the other end side opening of the guide wire lumen of the dilation instrument. A side hole extending in the axial direction for inserting a guide wire into the guide wire lumen provided in the guide wire lumen, and the side hole forming portion of the sheath has a high rigidity portion having a higher rigidity than the distal end portion of the sheath. Has become. For this reason, in the living body dilatation device of the present invention, the sheath side hole formation of the breakage at the sheath side hole formation site and the torque and the pushing force (in other words, pushability) applied on the rear end side of the living body organ expansion device. There is little decrease in operability due to absorption at the site.

[Brief description of the drawings]

FIG. 1 is a front view of an embodiment of the living organ dilator according to the present invention.

FIG. 2 is an enlarged cross-sectional view of the vicinity of a distal end of the living organ dilator shown in FIG.

FIG. 3 is an enlarged cross-sectional view of a central joining portion of the living organ dilator shown in FIG. 1;

FIG. 4 is a sectional view taken along line AA of FIG. 1;

FIG. 5 is a sectional view taken along line BB of FIG. 1;

FIG. 6 is a sectional view taken along line CC of FIG. 3;

FIG. 7 is a sectional view taken along line DD of FIG. 3;

FIG. 8 is an enlarged sectional view of a branch hub of the living organ dilator shown in FIG. 1;

FIG. 9 is an enlarged cross-sectional view of a rear end portion of a dilatation catheter of the living body organ dilatation device shown in FIG. 1;

FIG. 10 is an explanatory view for explaining another embodiment of the living organ dilator according to the present invention.

FIG. 11 is an explanatory view for explaining an embodiment of the device for expanding a living body organ of the present invention.

FIG. 12 is an explanatory diagram for explaining an embodiment of the device for expanding a living body organ according to the present invention.

FIG. 13 is a perspective view of an embodiment of a reinforcing member installed around a sheath side hole.

FIG. 14 is a perspective view showing an embodiment of a stent used for the living organ dilator according to the present invention.

FIG. 15 is an explanatory view for explaining another embodiment of the living organ dilator according to the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Living organ expansion device 3 Balloon 4 Stent 5 Sheath 6 Stopper 7 Joining part 8 Hub 10 Expansion catheter 10a Tip side shaft part 10b Back end side shaft part 15 Guide wire lumen 21 Shaft main body part 50 Catheter lumen 52 Outer layer 52b Side hole Forming part 53 Inner layer 54 Metal reinforcing member 60 Branch hub

Claims (14)

[Claims] 1. A tubular shaft main body, a foldable and expandable balloon provided at a distal end of the shaft main body, and mounted so as to cover the balloon in a folded state, and An expansion catheter including a stent that is expanded by expanding a balloon, a guide wire lumen that is open at one end at the distal end of the shaft main body, and has the other end open at an intermediate portion of the shaft main body; A sheath having a catheter lumen that slidably accommodates a catheter for use in a living body, comprising: a sheath having a catheter lumen, wherein the sheath is located at a position near the other end side opening of the guidewire lumen of the dilatation catheter. An axially extending side hole for inserting a guide wire through the provided guide wire lumen; Wherein the side hole forming portion is a high rigidity portion having higher rigidity than the distal end portion of the sheath. 2. The dilatation catheter is slidable within the sheath from a state where the distal end of the stent of the dilatation catheter is housed in the sheath to a state where the rear end of the stent is exposed. The living organ dilator according to claim 1, wherein the side hole of the sheath has an axial length equal to or longer than the length of the stent. 3. The sheath is made of a resin material having a higher hardness than a resin material constituting a distal end portion of the sheath from a distal end portion of the side hole forming portion of the sheath to a base end portion of the sheath. The device for expanding a living body organ according to claim 1. 4. The living organ dilator according to claim 3, wherein the resin material having a high hardness is a resin material having a Shore D hardness of 55 or more. 5. The device for expanding a living organ according to claim 3, wherein the resin material having high hardness is polyester or polyamide. 6. A sheath having a Shore D hardness of 5
The living organ dilating device according to any one of claims 1 to 5, wherein the device is made of a resin material of 0 or less. 7. The living organ dilator according to claim 1, wherein the resin material constituting the distal end of the sheath is polyester or polyamide. 8. The living organ dilating device according to claim 1, wherein the side hole forming portion has a metal reinforcing member. 9. The device for expanding a living body organ according to claim 8, wherein the reinforcing member is a tubular member having a plurality of openings. 10. The living organ dilator according to claim 8, wherein the reinforcing member is a wire-shaped member. 11. The sheath according to claim 1, wherein the sheath comprises an outer sheath layer and an inner sheath layer formed inside the outer sheath layer, and the inner sheath layer is made of a fluororesin material. A living organ dilator. 12. The living organ dilator according to claim 11, wherein the inner layer is formed so as to protrude from a distal end of the sheath outer layer. 13. The living organ dilating device according to claim 1, further comprising a lock mechanism for fixing the dilatation catheter at an arbitrary position with respect to the sheath. 14. The dilatation catheter according to claim 1, further comprising a stopper provided on a distal end side of the stent, for preventing movement of the sheath in a distal direction.
The device for expanding a living body organ according to any one of the above.