JP2004357872A - Balloon catheter inflated in body cavity - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a balloon catheter inflated in body cavity, smoothly and surely inserting a body cavity expansion balloon in a constriction part of a body cavity in a treatment of expanding the constriction part formed in the body cavity or surely preventing the body cavity expansion balloon from being deflected from the constriction part when inflating the body cavity expansion balloon. <P>SOLUTION: The balloon catheter 1 inflated in the body cavity is provided with a shaft body 10 having an inside tubular member 2, a slide tube 3, and a relatively short outside tubular member 4; the body cavity expansion balloon 5 having its one end and the other end liquid-tightly attached to the tip part 31 of the slide tube 3 and the base part 42 of the outside tubular member 4 respectively; and a balloon 6 for being fixed inside the body cavity and provided in the tip part of the shaft body 10. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a catheter for dilatation in a body cavity, which is used in a treatment for dilating a stenosis generated in a body cavity.
[0002]
[Prior art]
For example, in treatments such as percutaneous transvascular coronary angioplasty (PTCA) and percutaneous angioplasty (PTA), a body lumen or body cavity such as a blood vessel, bile duct, esophagus, trachea, urethra, or other organs There is known an in-vivo dilatation catheter used to dilate a stenosis (lesion) that has occurred in a patient with a balloon (for example, see Patent Document 1).
[0003]
However, in the conventional intraluminal dilatation catheter, when the stenosis is expanded by inflating the balloon, the balloon may slip and slip from the stenosis. In this case, the balloon must be once deflated, the balloon positioned at an appropriate position (the position of the stenosis), and then the balloon is expanded again. Further, replacement with another balloon catheter having a different balloon size must be performed. In addition, there is a problem that it takes time and effort, which hinders smooth treatment and increases the burden on the patient. Further, in order to prevent the balloon from deviating from the stenosis, it is conceivable to lower the inflation pressure of the balloon, but in that case, the stenosis cannot be sufficiently expanded, and the desired therapeutic effect cannot be obtained. It may not be expected.
[0004]
[Patent Document 1]
Japanese Patent Publication No. 4-44553
[0005]
[Problems to be solved by the invention]
An object of the present invention is to provide a method for dilating a stenosis generated in a body cavity, to smoothly and reliably insert the dilatation balloon into the stenosis, and to inflate the dilation balloon. An object of the present invention is to provide an intracorporeal dilatation catheter that can reliably prevent the intracorporeal dilatation balloon from being displaced from a stenosis.
[0006]
[Means for Solving the Problems]
The above object is achieved by the present invention described in the following (1) to (12).
[0007]
(1) an inner tubular member;
A slide tube provided outside the inner tubular member and movable in the axial direction with respect to the inner tubular member,
The inner tubular member and the slide tube, which are provided outside the inner tubular member and the slide tube, and whose distal end is liquid-tightly attached to the distal end of the inner tubular member on the distal end side from the distal end of the slide tube. A shaft body comprising a shorter outer tubular member;
An inflatable and deflated in-vivo inflation balloon comprising one end and the other end formed of a membrane member liquid-tightly attached to the distal end of the slide tube and the proximal end of the outer tubular member, respectively;
A member for in-vivo fixation, which is provided at the distal end of the shaft main body and is located on the distal side from the proximal end of the outer tubular member to which the in-vivo dilatation balloon is attached, and is inflatable and deflateable,
An intra-body cavity dilatation catheter, further comprising an operation hub provided at a base end of the shaft main body and configured to move the slide tube in an axial direction with respect to the inner tubular member.
[0008]
(2) A first flow passage through which a working fluid for inflating and deflating the in-vivo dilatation balloon passes is formed between the inner tubular member and the slide tube, and the operation hub is provided with the first flow passage. The catheter for expanding a body cavity according to the above (1), further comprising a first opening communicating with a road.
[0009]
(3) The operation hub according to (1) or (2), wherein the operation hub includes an outer hub provided at a base end of the slide tube, and an inner hub provided at a base end of the inner tubular member. Catheter for intraluminal dilatation.
[0010]
(4) The catheter for expanding a body cavity according to the above (3), wherein the outer hub has a storage portion for storing a part of the inner hub.
[0011]
(5) By moving the slide tube in the axial direction with respect to the inner tubular member, a state in which the in-vivo dilatation balloon is housed inside the outer tubular member, and a state in which the in-vivo dilatation balloon is outside the outer tubular member The intracorporeal dilatation catheter according to any one of the above (1) to (4), which can be in a state of being exposed on the proximal end side of the tubular member.
[0012]
(6) The method according to any one of (1) to (5) above, wherein the outer peripheral surface of the slide tube and / or the surface that becomes outside when the balloon for in-vivo expansion is inflated is subjected to a treatment for providing lubricity. Catheter for intraluminal dilatation.
[0013]
(7) The above-mentioned (1) to (6), wherein the outer peripheral surface of the slide tube and / or the surface that becomes outside when inflated of the intracorporeal dilatation balloon is provided with a hydrophilic polymer substance exhibiting lubricity when wet. The catheter for dilatation in a body cavity according to any one of the above items.
[0014]
(8) The catheter for expanding a body cavity according to any one of (1) to (7) above, wherein the inner tubular member has a lumen with open distal and proximal ends.
[0015]
(9) The member for fixing in a body cavity is constituted by a balloon for fixing in a body cavity, and the inner tubular member has a second flow path communicating with the balloon for fixing in a body cavity. (1) to (8) above. The catheter for intraluminal dilatation according to any one of the above.
[0016]
(10) The intraluminal dilatation catheter according to (9), wherein the intraluminal fixation balloon has higher extensibility than the intraluminal expansion balloon.
[0017]
(11) The catheter for expanding a body cavity according to any one of (1) to (10), further including a seal member that seals between an inner peripheral surface of the outer hub and an outer peripheral surface of the inner tubular member.
[0018]
(12) In use, the intracorporeal fixation member inserted into the distal end side of the stenosis is expanded to fix the intracavity fixation member in the body cavity, and the slide tube is fixed to the inner tubular member. Any of the above (1) to (11), wherein the in-body cavity dilatation balloon is inserted into the stenosis by moving it in the end direction, and the stenosis is dilated by inflating the in-vivo dilatation balloon. The catheter for in-vivo dilatation according to claim.
[0019]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, a catheter for dilatation in a body cavity of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.
[0020]
FIG. 1 is a longitudinal sectional view of a distal end portion of a catheter for dilatation in a body cavity according to an embodiment of the present invention. FIG. 2 is a cross-sectional view taken along line II-II of FIG. FIG. 3 is a longitudinal sectional view of a proximal end portion of the intraluminal catheter shown in FIG. 1. FIGS. 4 and 5 are views showing the use state of the intraluminal catheter shown in FIGS. 1 to 3, respectively. In the following, for convenience of description, the right side in FIGS. 1, 3, 4 and 5 is referred to as a “proximal end”, and the left side is referred to as a “distal end”. 1, 4 and 5, the member for fixing the body cavity (balloon for fixing the body cavity) is shown in an inflated state.
[0021]
A catheter 1 for dilatation in a body cavity shown in FIG. 1 is used for a treatment for dilating a stenosis (lesion) formed in a blood vessel, and includes an inner tubular member 2, a slide tube 3, and an outer tubular member 4. It comprises a shaft main body 10 provided, a balloon 5 for expanding the body cavity, a balloon 6 for fixing the body cavity as a member for fixing the body cavity, and an operation hub 7. The total length of the intraluminal catheter 1 (the total length of the shaft 10) is not particularly limited, but is usually preferably 300 to 1500 mm, and more preferably 400 to 1450 mm.
[0022]
Hereinafter, the configuration of each unit will be described.
[0023]
The inner tubular member 2 is formed of a tubular member having bendability, pushability and torque transmission in the axial direction. The constituent material of the inner tubular member 2 is not particularly limited. For example, polyamide resins such as nylon 11, nylon 12, and nylon 610 or polyamide elastomers, polyolefins such as polypropylene and polyethylene, and olefin-based elastomers such as polyethylene elastomer and polypropylene elastomer. , Flexible such as polyester such as polyethylene terephthalate, flexible polyvinyl chloride, polyurethane and polyurethane elastomer, fluororesin and fluororesin-based elastomer such as polytetrafluoroethylene, polyimide, ethylene-vinyl acetate copolymer, silicone rubber Polymer materials can be used, and one or more of these materials can be used in combination.
[0024]
The outer diameter of the inner tubular member 2 is not particularly limited, but is usually preferably 0.5 to 2.0 mm, and more preferably 0.65 to 1.5 mm.
[0025]
As shown in FIG. 2, the inner tubular member 2 has two lumens 21 and 22 extending parallel to each other. Lumen 21 is open at the proximal and distal ends of the inner tubular member, forming a passage through which a guidewire (not shown) can be inserted. The inner diameter of the lumen 21 is not particularly limited, but is usually preferably 0.2 to 1.2 mm, more preferably about 0.3 to 0.95 mm. The lumen 22 is closed near the distal end of the inner tubular member 2. When the outer diameter of the inner tubular member 2 is made relatively large, a double pipe structure having an inner pipe and an outer pipe arranged concentrically (coaxially) with each other may be adopted.
[0026]
The slide tube 3 is formed of a tubular member having bendability in the axial direction. The slide tube 3 is provided outside the inner tubular member 2 and is located concentrically (coaxially) with the inner tubular member 2. The slide tube 3 is movable (slidable) in the axial direction (longitudinal direction) with respect to the inner tubular member 2.
[0027]
The constituent material of the slide tube 3 is not particularly limited. For example, a metal pipe made of stainless steel, titanium, a titanium alloy, or the like, or polyethylene, polypropylene, polyimide, polyamide, PTFE (polytetrafluoroethylene), It is preferably a relatively hard polymer material such as a fluororesin such as ETFE, FEP and PFA.
[0028]
The outer diameter of the slide tube 3 is not particularly limited, but is usually preferably 0.65 to 2.5 mm, and more preferably 0.8 to 2.0 mm.
[0029]
A first flow path 11 through which a fluid can pass is formed between the inner tubular member 2 and the slide tube 3. That is, the outer diameter of the inner tubular member 2 is smaller than the inner diameter of the slide tube 3.
[0030]
An outer tubular member 4 that is shorter than the inner tubular member 2 and the slide tube 3 and has an axial bending property is provided outside the inner tubular member 2 and the slide tube 3. The outer tubular member 4 is located concentrically (coaxially) with the inner tubular member 2 and the slide tube 3. The outer tubular member 4 extends in the distal direction beyond the distal end of the slide tube 3.
[0031]
The inner diameter of the distal end of the outer tubular member 4 is smaller than the inner diameter of the proximal end of the outer tubular member 4. Specifically, the distal end portion of the outer tubular member 4 has a reduced diameter portion 41 whose outer diameter and inner diameter are reduced toward the distal direction, and the outer tubular member on the distal end side with respect to the reduced diameter portion 41. The inner diameter of the distal end of the outer tubular member 4 is smaller than the inner diameter of the proximal end of the outer tubular member 4. The distal end of the outer tubular member 4 (the portion closer to the distal end than the reduced diameter portion 41) is located on the distal end of the slide tube 3 by, for example, bonding with an adhesive or heat fusion. It is mounted liquid-tight at the tip.
[0032]
The constituent material of the outer tubular member 4 is not particularly limited. For example, a polyamide resin such as nylon 11, nylon 12, nylon 610 or the like, a polyamide elastomer, a polyolefin such as polypropylene or polyethylene, an olefin-based elastomer such as a polyethylene elastomer or a polypropylene elastomer. , Flexible such as polyester such as polyethylene terephthalate, flexible polyvinyl chloride, polyurethane and polyurethane elastomer, fluororesin and fluororesin-based elastomer such as polytetrafluoroethylene, polyimide, ethylene-vinyl acetate copolymer, silicone rubber Polymer materials can be used, and one or more of these materials can be used in combination.
[0033]
The outer diameter of the outer tubular member 4 is not particularly limited, but is usually preferably from 1.0 to 3.0 mm, more preferably from 1.2 to 2.2 mm. The axial length of the outer tubular member 4 is not particularly limited, but is preferably 20 to 80 mm, and more preferably 30 to 60 mm. The axial length of the outer tubular member 4 to be attached to the inner tubular member 2 is not particularly limited, but is preferably 8 to 20 mm, and more preferably 12 to 20 mm.
[0034]
The distal end portion of the shaft main body 10 is formed to penetrate the inner tubular member 2 and the outer tubular member 4 attached to each other on the proximal side from the distal end of the lumen 22 closed near the distal end of the inner tubular member 2. It has side holes 12. The side holes 12 can be formed by laser processing, cutting processing, or the like. The hole diameter of the side hole 12 is not particularly limited, but is preferably about 1 to 10 mm, and more preferably about 3 to 6 mm. The lumen 22 communicates with the intra-body cavity fixing balloon 6 through the side hole 12 to form a second flow path through which a fluid can pass into the intra-body cavity fixing balloon 6.
[0035]
The intracorporeal dilatation balloon 5 is made of a flexible tubular membrane member. One end of the in-vivo dilatation balloon 5 is liquid-tightly attached to a base end (base end opening) 42 of the outer tubular member 4 by, for example, bonding with an adhesive or heat fusion. The slide tube 3 is liquid-tightly attached to a distal end portion (a distal end opening portion) 31 by, for example, bonding with an adhesive or heat fusion. The intracorporeal dilatation balloon 5 is inflated and deflated by a working fluid (preferably a liquid) fed through the first flow path 11.
[0036]
The intracorporeal dilatation balloon 5 is made of various polymer materials (particularly, thermoplastic resins). In this case, the intracorporeal dilatation balloon 5 has flexibility as a whole, but is preferably made of a material having relatively low extensibility (low elongation). Thereby, when the inflation balloon 5 is inflated, the inflation balloon 5 is prevented from being pushed back from the stenosis portion by receiving a reaction force from the stenosis portion such as a blood vessel. Since the expanding force can be reliably applied, a more reliable therapeutic effect (expanding effect) can be obtained.
[0037]
Examples of a constituent material of the in-vivo dilatation balloon 5 include polyamide resin or polyamide elastomer such as nylon 11, nylon 12, or nylon 610, polyester such as polyethylene terephthalate (PET), natural rubber, polypropylene, polyethylene, and ethylene-propylene. Polymer, polyolefin such as ethylene-vinyl acetate copolymer, soft polyvinyl chloride, polyurethane, polyisoprene, polyimide, polyimide elastomer, polytetrafluoroethylene, silicone, or a polymer blend containing at least one of these, a polymer alloy, etc. Materials. Among these, it is preferable to use the above-mentioned polyethylene terephthalate so that a relatively hardened constricted portion such as a calcified constricted portion can be satisfactorily expanded.
[0038]
The in-vivo inflation balloon 5 is housed inside the outer tubular member 4 (shown in FIG. 1), and is exposed on the proximal end side of the outer tubular member 4 (shown in FIGS. 4 and 5). And can be taken. When the inflation balloon 5 is inflated, the balloon 5 is exposed as shown in FIGS.
[0039]
In the state shown in FIG. 1, the distal end portion 31 of the slide tube 3 is located on the distal end side with respect to the proximal end of the outer tubular member 4. By moving the slide tube 3 in the proximal direction with respect to the inner tubular member 2 and the outer tubular member 4 from this state, the in-vivo dilatation balloon 5 is turned from the inside of the outer tubular member 4 while its front and back are reversed. It is exposed so as to be extended in the end direction, and the state shown in FIG. 4 or 5 is obtained.
[0040]
The size of the in-vivo dilatation balloon 5 is not particularly limited, but usually the diameter when inflated is preferably 0.5 to 3.0 mm, more preferably 1.0 to 2.0 mm. The axial length of the in-vivo dilatation balloon 5 is preferably 10 to 40 mm, more preferably 15 to 30 mm.
[0041]
One or both of the outer peripheral surface of the slide tube 3 and the outer surface (the inner surface in the state shown in FIG. 1) when the in-vivo dilatation balloon 5 is inflated have been subjected to lubrication treatment. Is preferred. Thereby, when the intracorporeal dilatation balloon 5 is moved from the state shown in FIG. 1 to the exposed state shown in FIGS. 4 and 5, the frictional resistance between the outer peripheral surface of the slide tube 3 and the dilatation balloon 5 is reduced. Thus, the in-vivo dilatation balloon 5 can be moved to the exposed state more smoothly and reliably.
[0042]
Examples of the treatment for providing lubricity include a method of providing a hydrophilic polymer substance that exhibits lubricity when wet (water absorption) (forming a coating layer), silicone coating, PTFE coating, and the like. The application of a polymer substance is more preferred. Examples of the hydrophilic polymer include a cellulose-based polymer such as hydroxypropyl cellulose, a polyethylene oxide-based polymer, a maleic anhydride-based polymer, and an ester compound copolymer thereof (eg, methyl vinyl ether-anhydride). Acrylamide polymer such as maleic anhydride copolymer such as maleic acid copolymer), polyacrylamide, dimethylacrylamide-glycidyl methacrylate (DMAA-GMA) block copolymer, water-soluble nylon, polyvinylpyrrolidone compound And the like.
[0043]
It should be noted that such a process of exhibiting lubricity may be performed on the outer peripheral surface of the outer tubular member 4 or the balloon 6 for fixing the body cavity. Thereby, when inserting the intracorporeal dilatation catheter 1 into a body cavity such as a blood vessel, friction is reduced, the insertion can be performed more smoothly, and operability and safety are improved.
[0044]
At the distal end of the shaft main body 10, an inflatable and contractible in-vivo fixing balloon 6 made of a tubular membrane member is provided. Specifically, as shown in FIG. 1, one end (tip) of the intra-body cavity fixing balloon 6 is attached to the tip of the outer tubular member 4 on the tip side of the reduced diameter portion 41 by, for example, an adhesive. The other end (the base end) of the intra-body cavity fixing balloon 6 is fixed to a portion of the outer tubular member 4 closer to the base end than the reduced diameter portion 41 by, for example, an adhesive. Is fixed in a liquid-tight manner by bonding or heat fusion.
[0045]
The intra-cavity fixation balloon 6 is located on the distal end side of the proximal end of the outer tubular member 10 to which the intra-cavity expansion balloon 5 is attached. The in-body cavity fixing balloon 6 is inflated and contracted by a working fluid (preferably a liquid) fed from the side hole 12 through the lumen 22 as the second flow path.
[0046]
The intra-body cavity fixing balloon 6 is made of various polymer materials (particularly, thermoplastic resin). In this case, it is preferable that the intra-body cavity fixing balloon 6 is made of a material having higher extensibility (higher elongation) than the intra-body cavity expansion balloon 5. This allows the in-vivo fixation balloon 8 to be inflated to a certain degree of freedom according to conditions such as the inner diameter of a body cavity including a blood vessel. Can be reliably fixed (positioned) by the inner wall of the body cavity.
[0047]
Examples of the constituent material of the balloon 6 for fixing into the body cavity include polyolefins such as polyethylene and polypropylene, polyolefin-based elastomers, those subjected to a cross-linking treatment (particularly, those cross-linked by electron beam irradiation), and styrene-ethylene. Materials such as -butylene-styrene (SEBS) block copolymer, soft vinyl chloride resin, silicone rubber, or a polymer blend or polymer alloy containing at least one of these.
[0048]
The size of the balloon 6 for fixing the body cavity is not particularly limited, but usually, the diameter when inflated is preferably 1 to 10 mm, and more preferably 1.5 to 6 mm. In addition, the axial length of the intra-body cavity fixing balloon 6 is not particularly limited, but is preferably 10 to 40 mm, and more preferably 15 to 30 mm.
[0049]
Further, a contrast marker 9 having a contrast property (particularly, X-ray contrast property) is provided at a distal end portion of the shaft main body 10 (outer tubular member 4) located in the intra-body cavity fixing balloon 6. The contrast marker 9 can be composed of, for example, a thin line of gold, silver, platinum, tungsten, or the like, a coil, a ring, or the like. Providing such a contrast marker 9 is preferable because it can be inserted into a living body while confirming the position of the intracorporeal fixation balloon 6 under X-ray fluoroscopy.
[0050]
In the intraluminal dilatation catheter 1, for example, a contrast marker may be provided on the proximal end portion 42 of the outer tubular member 4, the distal end portion 31 of the slide tube 3, and the like. Can be confirmed under X-ray fluoroscopy. Further, these contrast markers may have a contrast property in a contrast method other than X-ray, for example, a CT scan, MRI, or the like, and may be capable of confirming the position.
[0051]
As shown in FIG. 3, an operation hub 7 is provided at a base end of the shaft main body 10. A first opening 712 is provided at the tip of the operation hub 7. The first opening 712 communicates with the first flow path 11.
[0052]
In the present embodiment, the operation hub 7 includes an outer hub 71 and an inner hub 72. The outer hub 71 is installed at the base end (the base end side) of the slide tube 3, and has a cylindrical (cylindrical) body 711 fixed concentrically to the base end of the slide tube 3; 711 has a first opening (first port) 712 protruding in the direction inclined from the vicinity of the tip. The body part 711 also serves as a storage part for storing a part of the inner hub 72.
[0053]
A balloon expansion device (not shown) such as a syringe can be connected to the first opening 712, and a working fluid supplied from the balloon expansion device is supplied into the body cavity via the first flow path 11. The inflation balloon 5 can be inflated and deflated by feeding it into the expansion balloon 5 or extracting the working fluid.
[0054]
As the working fluid for balloon expansion, a liquid is preferably used, and among the liquids, a liquid having X-ray contrast property is more preferable. For example, an X-ray contrast agent such as an arterial contrast agent is used in physiological saline. A liquid or the like diluted several times can be used.
[0055]
An inner hub 72 is provided at a base end (a base end side) of the inner tubular member 2. The inner hub 72 has a cylindrical (cylindrical) inner hub body 721 concentrically fixed to the base end of the inner tubular member 2, and a second opening formed to project in a direction inclined from the inner hub body 721. (A second port) 722 and a second opening (a third port) 723 formed at the base end of the inner hub body 721. The second opening 722 communicates with the lumen 22, which is a second flow path.
[0056]
The inner hub main body 721 is housed in the body 711 of the outer hub 71, and is movable in the body 711 in the axial direction. A groove (opening) 713 extending in the axial direction is formed in the wall of the body 711, and the second opening 722 of the inner hub 72 passes through the groove 713 and extends outward from the body 711. It protrudes.
[0057]
The surgeon performs an operation of moving (sliding) the outer hub 71 (the trunk portion 711) in the proximal direction (or the distal direction) with respect to the inner hub 72 (the second opening 722), so that the slide tube 3 is moved. Can be moved (slid) in the proximal direction (or the distal direction) with respect to the inner tubular member 2.
[0058]
The proximal end of the inner tubular member 2 is inserted into the inner hub body 721 and is fixed to the inner hub 72 such that the lumen 21 communicates with the third opening 723. Further, as shown in FIG. 3, the lumen 21 of the inner tubular member 2 is closed near the proximal end of the inner tubular member 2. Further, a side hole 23 penetrating the side wall of the inner tubular member 2 is formed on the distal end side of the closed lumen 22 with respect to the base end. The formation of the side holes 23 can be performed by laser processing, cutting processing, or the like. The hole diameter of the side hole 23 is not particularly limited, but is preferably about 1 to 10 mm, and more preferably about 3 to 6 mm.
[0059]
A balloon expansion device (not shown) such as a syringe can be connected to the second opening 722, and the working fluid supplied from the balloon expansion device is the side hole 23 and the second flow path. The balloon 6 for in-vivo fixation can be inflated and contracted by feeding it into the balloon 6 for in-vivo fixation via the lumen 22 or by extracting a working fluid. Further, a guide wire (not shown) can be introduced into the lumen 21 from the third opening 723.
[0060]
A seal member 8 that seals between the inner peripheral surface of the trunk 711 and the outer peripheral surface of the inner tubular member 2 is provided in the trunk 711 of the outer hub 71. This seal member 8 is installed on the base end side of the base of the first opening 712. The provision of the seal member 8 can reliably prevent the working fluid injected from the first opening 712 from leaking to the base end side.
[0061]
Next, an example of a method for using the intraluminal catheter 1 will be described.
[0062]
[1] Prior to use, the intraluminal dilatation catheter 1 is in a state where the intraluminal dilation balloon 5 is in the housed state shown in FIG. 1 and the intraluminal fixation balloon 6 is contracted or folded. A priming liquid is previously injected into the body cavity dilatation catheter 1 from the third opening 723 to fill the lumen 21 with the priming liquid. If there is a possibility that air may remain between the in-vivo expansion balloon 4 housed in the outer tubular member 4 and the outer peripheral surface of the slide tube 3, the outer peripheral surface of the slide tube 3 and the in-vivo expansion may be removed. A priming liquid may be injected between the balloons 5.
[0063]
[2] The intraluminal dilatation catheter 1 is inserted into a guiding catheter (not shown) indwelled in the blood vessel 100 and advanced. At this time, the guidewire (not shown) inserted into the lumen 21 is advanced along the lumen of the guiding catheter while preceding.
[0064]
[3] When the intracorporeal fixation balloon 6 is inserted to the distal end side beyond the stenotic portion 110 in the blood vessel 100, the working fluid is supplied into the intracorporeal fixation balloon 6 from the second opening 722, and The fixing balloon 6 is inflated. Thus, the intra-body cavity fixing balloon 6 can be fixed (positioned) in the blood vessel 100. At this time, the proximal end 42 of the outer tubular member 4 is located near the distal end of the stenosis 110 (see FIGS. 4 and 5).
[4] After the in-vivo fixation balloon 6 is inflated, the outer hub 71 (the first opening 712) is moved to the proximal side with respect to the inner hub 72 (the second opening 722), and the first hub is moved. A working fluid is supplied from the opening 712 into the in-vivo dilatation balloon 5. As a result, the intracorporeal dilatation balloon 5 protrudes from the proximal end of the outer tubular member 4 and expands while being inserted inside the stenosis 110, as shown in FIG. At this time, in the present invention, since the inner tubular member 2 and the outer tubular member 4 are fixed (positioned) within the blood vessel 100 by the intra-body cavity fixing balloon 5, the intra-body cavity expansion balloon 5 can be more smoothly and reliably. By moving it in the proximal direction, it can be reliably inserted into the stenosis 110.
[0065]
[5] The operation of [4] allows the stenosis portion 110 to be expanded by the inflation balloon 5 being inflated while being inserted into the stenosis portion 110 (see FIG. 5). When the inflation balloon 5 is inflated, the inflation is performed such that the second opening (the inner hub 72) does not move in the proximal direction.
[0066]
In the present invention, when the inflation balloon 5 is inflated, the inflation balloon 5 is fixed to the blood vessel 100 by the inflation fixing balloon 6 via the outer tubular member 4 and the inner tubular member 2 ( Positioning). Therefore, according to the present invention, it is possible to reliably prevent the intra-body cavity dilatation balloon 5 from slipping and displacing from the stenosis part 100, and to reliably expand the stenosis part 110. Further, in the present invention, the in-vivo dilatation balloon 5 not only expands toward the outer periphery but also moves in the proximal direction while sliding on the stenosis 110 (see FIG. 4). Is applied not only in the outer peripheral direction but also in the proximal direction. Therefore, the stenotic portion dilating balloon 5 is securely inserted into the stenotic portion 110, and the stenotic portion dilating balloon 5 is less likely to slip from the stenotic portion 110, so that the stenotic portion 110 can be reliably expanded.
[0067]
[6] When the dilation operation of the stenosis part 110 is completed, the working fluid is extracted from the first opening part 712 and the second opening part 722, respectively, and the intracorporeal expansion balloon 5 and the intracorporeal fixation balloon 6 are contracted. Then, the intracorporeal dilatation balloon 5 is removed from the blood vessel 100. Thus, the dilation treatment of the stenosis is completed.
[0068]
As described above, the illustrated embodiment of the intraluminal dilatation catheter of the present invention has been described.However, the present invention is not limited to this.Each part constituting the intraluminal dilatation catheter exhibits the same function. It can be replaced with any configuration obtained. Further, an arbitrary component may be added.
[0069]
Further, the intraluminal dilatation catheter of the present invention is not limited to one used for percutaneous transvascular tubular angioplasty (PTCA), but may be used for other blood vessels (for example, dialysis shunts, lower limbs, blood vessels such as kidneys). It can be applied to those used for percutaneous angioplasty (PTA) and also for expanding stenosis in a body cavity other than blood vessels (eg, fallopian tubes, bile ducts, pancreatic ducts, etc.). it can.
[0070]
In addition, the member for fixing the body cavity in the present invention is not limited to the member such as the balloon in the above-described embodiment. For example, a member such as a self-expanding filter described in JP-A-6-190049 is used. Is also good.
[0071]
【The invention's effect】
As described above, according to the present invention, in a treatment for expanding a stenosis in a body cavity, a balloon for intrabody cavity expansion can be smoothly and reliably inserted into a stenosis, and a balloon for expansion in a body cavity. When the balloon is inflated, the intracorporeal dilatation balloon can be reliably prevented from being displaced from the stenosis. Therefore, the treatment for expanding the stenosis can be performed simply and reliably.
[0072]
Further, the outer peripheral surface of the slide tube and / or the surface that becomes outside when the balloon for in-vivo dilatation is inflated is subjected to a lubricating treatment (particularly, a hydrophilic polymer substance that exhibits lubricity when wet is used. In this case, the frictional resistance between the outer peripheral surface of the slide tube and the in-vivo inflation balloon is reduced, and the in-vivo inflation balloon can be more smoothly and reliably moved to the exposed state.
[0073]
Further, when the balloon for fixation in the body cavity has higher extensibility than the balloon for expansion in the body cavity, the balloon for fixation in the body cavity can be inflated to a certain degree of free size. Thus, the intra-body cavity fixing balloon 6 can be securely fixed (positioned) by the inner wall of the body cavity.
[0074]
When a seal member for sealing between the inner peripheral surface of the outer hub and the outer peripheral surface of the inner tubular member is further provided, the working fluid injected from the first opening 712 is directed to the proximal end side. Leakage can be reliably prevented.
[Brief description of the drawings]
FIG. 1 is a longitudinal sectional view of a distal end portion of a catheter for dilatation in a body cavity according to an embodiment of the present invention.
FIG. 2 is a cross-sectional view taken along line II-II of FIG.
FIG. 3 is a longitudinal sectional view of a proximal end portion of the intraluminal catheter shown in FIG. 1;
FIG. 4 is a view showing a use state of the intraluminal catheter shown in FIGS. 1 to 3;
FIG. 5 is a diagram showing a use state of the intraluminal catheter shown in FIGS. 1 to 3;
[Explanation of symbols]
1 catheter for dilatation in body cavity
10 Shaft body
11 1st channel
2 Inner tubular member
21 lumens
22 lumens (second flow path)
3 slide tube
4 Outer tubular member
5 Balloon for body cavity expansion
6 balloon for fixation in body cavity
7 Operation hub
71 Outer hub
712 first opening
72 Inside Hub
722 second opening
8 Seal members

Claims (12)

An inner tubular member;
A slide tube provided outside the inner tubular member and movable in the axial direction with respect to the inner tubular member,
The inner tubular member and the slide tube, which are provided outside the inner tubular member and the slide tube, and whose distal end is liquid-tightly attached to the distal end of the inner tubular member on the distal end side from the distal end of the slide tube. A shaft body comprising a shorter outer tubular member;
An inflatable and deflated in-vivo inflation balloon comprising one end and the other end formed of a membrane member liquid-tightly attached to the distal end of the slide tube and the proximal end of the outer tubular member, respectively;
A member for in-vivo fixation, which is provided at the distal end of the shaft main body and is located on the distal side from the proximal end of the outer tubular member to which the in-vivo dilatation balloon is attached, and is inflatable and deflateable,
An intra-body cavity dilatation catheter, further comprising an operation hub provided at a base end of the shaft main body and configured to move the slide tube in an axial direction with respect to the inner tubular member. A first channel through which a working fluid for inflating and deflating the in-vivo dilatation balloon passes is formed between the inner tubular member and the slide tube, and the operation hub communicates with the first channel. 2. The intraluminal dilatation catheter according to claim 1, further comprising a first opening. The catheter according to claim 1, wherein the operation hub includes an outer hub provided at a proximal end of the slide tube and an inner hub provided at a proximal end of the inner tubular member. The catheter for expanding a body cavity according to claim 3, wherein the outer hub has a storage portion that stores a part of the inner hub. By moving the slide tube in the axial direction with respect to the inner tubular member, the state in which the in-vivo dilatation balloon is housed inside the outer tubular member, and the in-vivo dilatation balloon is in the outer tubular member. The catheter for dilatation in a body cavity according to any one of claims 1 to 4, wherein the catheter can be in a state of being exposed on a proximal end side. The catheter for in-vivo dilatation according to any one of claims 1 to 5, wherein the outer peripheral surface of the slide tube and / or a surface that becomes outside when the in-vivo dilatation balloon is inflated are subjected to lubrication. The hydrophilic polymer substance which exhibits lubricity when wet is applied to an outer peripheral surface of the slide tube and / or a surface which becomes outer when the balloon for in-body cavity expansion is inflated. Catheter for intraluminal dilatation. The catheter according to any one of claims 1 to 7, wherein the inner tubular member has a lumen with open distal and proximal ends. 9. The device according to claim 1, wherein the member for fixing the body cavity is formed of a balloon for fixing the body cavity, and the inner tubular member has a second flow path communicating with the balloon for fixing the body cavity. 10. Catheter for intraluminal dilatation. 10. The intraluminal dilatation catheter according to claim 9, wherein the intraluminal fixation balloon has higher extensibility than the intraluminal dilatation balloon. The catheter for expanding a body cavity according to any one of claims 1 to 10, further comprising a seal member for sealing between an inner peripheral surface of the outer hub and an outer peripheral surface of the inner tubular member. At the time of use, the member for body cavity fixation inserted in the distal side from the stenosis part is fixed in the body cavity by expanding the member for body cavity fixation, and the slide tube is moved in the proximal direction with respect to the inner tubular member. The in-vivo dilatation balloon according to any one of claims 1 to 11, wherein the in-vivo dilatation balloon is inserted into the stenosis portion by being moved, and the stenosis portion is dilated by inflating the in-vivo dilation balloon. catheter.

Images