JP6592892B2 - Balloon catheter - Google Patents

Description

  The present invention relates to a balloon catheter.

  The balloon catheter is used by being inserted into a stenosis part, an obstruction part, an adhesion part (hereinafter, also referred to as “stenosis part etc.”) generated in a living body lumen. The balloon catheter is configured by mounting an expandable balloon on a distal portion of a long and flexible tubular body called a catheter shaft or a sheath. By injecting a fluid such as a liquid into the balloon through the lumen of the tubular body, the balloon can be expanded in the living body lumen. For this reason, by inflating the deflated balloon in a state where it is placed in the stenosis part or the like, the stenosis part or the like can be expanded and expanded from the inside.

  The lumen of a living body in which a balloon catheter is used includes a wide range of gastrointestinal tracts such as the intestinal tract, blood vessels, trachea, and oviduct.

  Patent Document 1 describes an example of a balloon catheter. In this balloon catheter, a balloon is made into two layers by an inner layer made of polyester or the like and an outer layer made of polyamide. The double-layered balloon is attached to the distal portion of the catheter shaft and inserted into the living body lumen in a contracted state. Patent Document 1 discloses disposing a stent on the surface of a balloon. By inflating the balloon at the stenosis part or the like of the living body lumen, the stent is expanded along with the balloon and lined to the stenosis part or the like. Thus, the balloon catheter is also used as a stent delivery catheter.

Special table 2009-519778

  A balloon catheter is difficult to insert into a living body lumen due to the bulk of the balloon, as compared with a general catheter without a balloon. For this reason, the balloon catheter is inserted into the living body lumen along the guide wire.

  The procedure using a guide wire is roughly classified into an over-the-wire type and a monorail type. The over-the-wire method is a procedure for inserting a guide wire over the entire length from the proximal end to the distal end of the catheter shaft, and the monorail method is a procedure for inserting the guide wire only into the distal portion of the catheter shaft. Hereinafter, procedures for inserting a balloon catheter into a living body lumen using an over-the-wire type or a monorail type using a guide wire are collectively referred to as a guide wire type.

  In the guide wire type procedure, first, a guide wire is inserted in advance into a living body lumen and is placed in a predetermined position. Next, the guide wire is inserted from the proximal end side into the lumen formed at the full length or the distal portion of the balloon catheter, and the balloon catheter is inserted into the living body lumen while covering the guide wire. When the balloon catheter has been inserted sufficiently deeply, the guide wire is once removed as necessary, the tip bending angle is adjusted, and the balloon catheter is inserted deeper into the living body lumen through the balloon catheter lumen. Thus, by inserting the guide wire and the balloon catheter alternately little by little, the branch of the living body lumen can be selected as desired, and the balloon can reach the stenosis of the subject.

  In order to align the balloon to the formation position of the stenosis part or the like, the guide wire is further advanced before the stenosis part or the like, and the depth position where the balloon is pushed along the guide wire is finely adjusted. At this time, since the stenosis part etc. is formed so as to protrude inward from the tube wall of the living body lumen, the tip of the guide wire that advances along the tube wall collides with the rising part of the stenosis part etc. There is a risk of applying a load.

  In addition, there is a portion that is bent with a large curvature in a biological lumen such as a blood vessel, and it may be difficult to pass the bent portion only by adjusting the bending angle of the tip of the guide wire. That is, depending on the occurrence position of the stenosis or the like, it is difficult to reach and place the balloon with the conventional balloon catheter. Furthermore, even if a guide wire with a bent tip is bent forward with respect to a bent portion bent with a large curvature, the guide wire can be advanced along the bent guide wire in the living body lumen. It is difficult to insert a subsequent balloon. Because the balloon has a larger diameter and higher bending rigidity than the guide wire, if you try to push the balloon along a largely bent guide wire, the balloon will not follow the guide wire but bend. This is because the balloon tries to go straight while reducing the bending of.

  The present invention has been made in view of the above-described problems, and a balloon catheter that can prevent the tip of the guide wire from colliding with a stenosis or the like and applying a large load when performing a guide wire type procedure. Is to provide.

According to the present invention, it is long and flexible, and is provided at the distal portion of the tubular body, which is made of a resin-made tubular body having three or more lumens formed therein with a through hole formed at least partially in length, An expandable balloon that communicates with the first lumen; an operating line that is slidably inserted into the second lumen and has a distal end connected to a distal portion of the tubular body; and a contrast agent or A third lumen through which a guide wire is inserted; and an operating portion body provided on the proximal side of the tubular body and having a liquid injection port for injecting fluid into the balloon through the first lumen. A base end portion of the operation line is connected to the operation portion main body, and by bending the operation portion main body, at least a distal side of the distal portion of the tubular main body is bent than the balloon, The third lumen is Both ends are open to the distal end of the tubular body and the proximal end of the operating portion body, and a plurality of second lumens are arranged at opposing positions across the third lumen, and a plurality of The second lumen and the first lumen are distributed around the third lumen, and an inner reinforcing layer and an outer reinforcing layer formed by braiding or winding a metal wire, respectively, in the wall of the tubular body. Embedded, the outer reinforcing layer is coaxial with the inner reinforcing layer and disposed outside the inner reinforcing layer, the third lumen is formed inside the inner reinforcing layer, the first lumen and the first The second lumen is formed between the inner reinforcing layer and the outer reinforcing layer, and a radiopaque annular marker is provided near each of the proximal end and the distal end of the balloon. ,in front The tubular body is made of a resin outer layer containing the inner reinforcing layer, a resin material of the same kind as the outer layer and having a lower hardness than the outer layer, or a softer resin material than the outer layer, and is the outermost layer of the tubular body. A distal tip formed at the distal end, and the marker on the distal side is mounted further on the distal side than the distal end of the balloon and is embedded in the distal tip The balloon catheter is characterized in that the tip of the operation line is fixed to the distal marker .

  According to the above invention, the distal portion of the tubular body in the balloon catheter capable of injecting fluid into the balloon through the first lumen is bent by pulling the operation line inserted through the second lumen. be able to. Therefore, when performing a procedure by inserting a guide wire through the third lumen, the advancing direction of the tip of the guide wire is adjusted to a desired direction by performing a bending operation of the catheter before the stenosis or the like. be able to. As a result, the guide wire can be advanced toward the central cavity such as the constriction. Further, since the balloon catheter of the present invention can be bent at the distal portion, it is possible to select and advance the branch of the living body lumen without using a guide wire. For this reason, it is possible to reach and place the balloon catheter at the stenosis or the like without inserting the guide wire through the third lumen, that is, by a non-guide wire type procedure. In this case, a contrast medium can be injected into the third lumen. That is, when a balloon catheter is inserted under radiography such as X-rays, the body tube is checked while confirming the position and bent shape of the balloon. It can be advanced in the cavity.

  According to the balloon catheter of the present invention, it is possible to prevent the distal end of the guide wire from colliding with the stenosis or the like and applying a large load to the tube wall when performing a guide wire type procedure. Further, when the balloon catheter of the present invention is used for a non-guide wire type procedure, it is possible to select and advance the branch of the living body lumen while confirming the position and the bent shape of the balloon by discharging the contrast medium. it can.

Fig.1 (a) is a top view which shows the balloon catheter of 1st embodiment. FIG. 1B is a plan view showing a state where the balloon is bent. FIG. 2 is a sectional view taken along line II-II in FIG. 3 is a cross-sectional view taken along line III-III in FIG. FIG. 4 is a plan view showing the internal structure of the operation unit main body. Fig.5 (a) is a top view which shows the state which the balloon in the balloon catheter of 1st embodiment was expanded. FIG. 5B is a plan view showing a state where the inflated balloon is bent. FIG.5 (c) is a top view which shows the state which deflated the balloon. FIG. 6A is a schematic diagram showing a living body lumen in which a narrowed portion is formed. FIG. 6B is a schematic diagram showing a state in which the balloon catheter is bent at a position on the near side of the stenosis. FIG. 6C is a schematic diagram showing a state where the balloon is inflated and the stenosis portion is expanded. FIG. 7 is a plan view showing the balloon catheter of the second embodiment. 8 is a cross-sectional view taken along line VIII-VIII in FIG. Fig.9 (a) is a top view which shows the balloon catheter of 3rd embodiment. FIG. 9B is a plan view showing how the balloon is bent.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same components are denoted by the same reference numerals, and description thereof will be omitted as appropriate.

<First embodiment>
First, the outline | summary of the balloon catheter 100 of this embodiment is demonstrated. FIG. 1A is a plan view showing the overall configuration of the balloon catheter 100 of the present embodiment, and FIG. 1B shows a state in which the bending operation section 60 of the operation section main body 50 is operated to bend the balloon 80. FIG. FIG. 2 is a sectional view taken along line II-II in FIG. 3 is a longitudinal sectional view of the distal portion of the balloon catheter 100, and is a sectional view taken along line III-III in FIG. FIG. 4 is a plan view showing the internal structure of the operation unit main body 50.

  The balloon catheter 100 of this embodiment includes a tubular main body 10, a balloon 80, operation lines 30a and 30b, and an operation unit main body 50. The tubular body 10 is made of resin, is long and flexible, and three or more lumens are formed at least partially through the inside. The balloon 80 is expandable, is provided at the distal portion DE of the tubular body 10, and communicates with a first lumen (injection lumen) 58. The operation lines 30 a and 30 b are slidably inserted into the second lumen (sublumen) 32, and the distal end portion is connected to the distal portion DE of the tubular body 10. A contrast medium or a guide wire GW is inserted into the third lumen (main lumen) 20. The operation portion main body 50 is provided on the proximal side of the tubular main body 10 and has a liquid injection port 78 for injecting the fluid F into the balloon 80 through a first lumen (liquid injection lumen) 58. The proximal end portions of the operation lines 30a and 30b are connected to the operation portion main body 50 in the balloon catheter 100 of the present embodiment, and at least the balloon in the distal portion DE of the tubular main body 10 by pulling the operation portion main body 50. The distal side of 80 is bent.

  Next, this embodiment will be described in detail. The balloon catheter 100 of this embodiment is an intravascular catheter that is used by inserting the tubular body 10 into a blood vessel, and the distal portion DE of the tubular body 10 is bent in a desired direction by the operation of the operation section body 50. A deflection catheter that can be oriented.

  The operation part main body 50 is provided on the proximal side of the tubular main body 10, and the tubular main body 10 is moved forward, removed, and torque is rotated, liquid is injected into the balloon 80, and the bending operation part 60 is rotated. It is a general term for parts that perform bending operations and the like, and is composed of a plurality of parts.

  The operation unit main body 50 of the present embodiment includes a liquid injection port 78 and a hub connector 52 in addition to the housing 70 and the bending operation unit 60. However, as will be described later in the second embodiment, the liquid injection port 78 and the hub connector 52 may be shared by common parts (see FIG. 7). The hub connector 52 of the present embodiment is disposed at the rear end portion of the housing 70 and is connected to the proximal end portion PE of the tubular main body 10 so as to communicate with each other. A guide wire GW may be inserted into the hub connector 52 as shown, or a syringe (not shown) may be attached to inject a liquid such as a contrast medium or a chemical solution. The hub connector 52 communicates with the third lumen (main lumen) 20 and supplies a guide wire GW, a contrast medium, and the like from the distal end of the tubular body 10 into the living body lumen 110 (see FIG. 6). Can do.

  The housing 70 is a housing that is held by a user with his / her hand. The bending operation unit 60 is fixed to the casing 70 so as to be rotatable. In the present specification, “rotation” and “rotation” are not distinguished. The base end portion PE of the tubular main body 10 is introduced into the housing 70.

  As shown in FIG. 2, the tubular body 10 has five lumens. However, the quantity of lumen is not limited to this. The first lumen (injection lumen) 58 is a lumen for injecting a liquid into the balloon 80. The injection lumen 58 is pulled out separately from the main lumen 20 inside the housing 70, and the proximal end communicates with the injection port 78. The tip of the injection lumen 58 communicates with the inside of the balloon 80.

  The tubular body 10 of this embodiment includes a plurality of second lumens (sublumen) 32. The second lumen (sublumen) 32 is a lumen through which the operation lines 30a and 30b are inserted. The plurality of second lumens (sub-lumen) 32 are distributed around the third lumen (main lumen) 20.

  More specifically, the plurality of second lumens (sub lumens) 32 are arranged at opposing positions with the third lumen (main lumen) 20 in between. The plurality of second lumens (secondary lumens) 32 and the first lumen (injection lumen) 58 are distributed around the third lumen (main lumen) 20.

  The third lumen (main lumen) 20 is a lumen having the largest opening diameter among the five lumens, and both ends open to the distal end of the tubular body 10 and the proximal end of the operation unit body 50. Yes. The proximal side of the third lumen (main lumen) 20 communicates with the hub connector 52, and a contrast medium or a guide wire GW can be inserted.

  The fourth lumen (dummy lumen) 59 is formed with a through hole over substantially the entire length of the tubular body 10, and both the distal end and the proximal end are closed. The two auxiliary lumens 32, the injection lumen 58, and the dummy lumen 59 are formed to have substantially the same diameter. The dummy lumen 59 is arranged around the main lumen 20 coaxially and equidistantly with the sub-lumen 32 and the injection lumen 58, and makes the torsional rigidity of the tubular body 10 isotropic.

  The tubular body 10 includes an inner reinforcing layer 26 formed by winding a reinforcing wire 24 around the main lumen 20, and a resin that is disposed outside the inner reinforcing layer 26 and defines a sub-lumen 32 having a smaller diameter than the main lumen 20. And a resin outer layer 38 that encloses the inner reinforcing layer 26 and the resin tube 28.

  The tubular body 10 has a laminated structure. The tubular body 10 is configured by laminating an inner layer 22, a first outer layer 34, and a second outer layer 36 in order from the inner diameter side with the main lumen 20 as the center. A hydrophilic layer (not shown) is formed on the outer surface of the second outer layer 36. The inner layer 22, the first outer layer 34, and the second outer layer 36 are made of a flexible resin material, and each has an annular shape and a substantially uniform thickness. The first outer layer 34 and the second outer layer 36 may be collectively referred to as an outer layer 38.

  The inner layer 22 is the innermost layer of the tubular body 10 and defines the main lumen 20 by its inner wall surface. The cross-sectional shape of the main lumen 20 is not particularly limited, but is circular in this embodiment. In the case of the main lumen 20 having a circular cross section, the diameter may be uniform over the longitudinal direction of the tubular body 10 or may vary depending on the position in the longitudinal direction. For example, in a part or all of the length region of the tubular main body 10, a taper shape in which the diameter of the main lumen 20 continuously increases from the distal end toward the proximal end may be employed.

  Examples of the material of the inner layer 22 include a fluorine-based thermoplastic polymer material. Specific examples of the fluorine-based thermoplastic polymer material include polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), and perfluoroalkoxy fluororesin (PFA). By configuring the inner layer 22 with such a fluorine-based polymer material, the sliding resistance of the guide wire GW is reduced when the guide wire GW is inserted into the main lumen 20. Moreover, the delivery property when the contrast medium is injected through the main lumen 20 is improved.

  Inside the first outer layer 34 corresponding to the inner layer of the outer layer 38, an inner reinforcing layer 26 and a resin tube 28 are provided in order from the inner diameter side. An outer reinforcing layer 40 is provided inside the second outer layer 36 that is the outer layer of the outer layer 38. The outer reinforcing layer 40 is in contact with the outer surface of the first outer layer 34. The inner reinforcing layer 26 and the outer reinforcing layer 40 are arranged coaxially with the tubular main body 10. The outer reinforcing layer 40 is arranged so as to be separated from the inner reinforcing layer 26 and the resin tube 28 so as to surround the periphery.

  As the material of the outer layer 38, a thermoplastic polymer material can be used. As this thermoplastic polymer material, polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), polyamide elastomer (PAE), polyether block amide (PEBA), etc. Mention may be made of nylon elastomers, polyurethane (PU), ethylene-vinyl acetate resin (EVA), polyvinyl chloride (PVC) or polypropylene (PP).

  The outer layer 38 may be mixed with an inorganic filler. Examples of the inorganic filler include contrast agents such as barium sulfate and bismuth subcarbonate. By mixing a contrast agent in the outer layer 38, the X-ray contrast property of the tubular body 10 in the body cavity can be improved.

  The first outer layer 34 and the second outer layer 36 are made of the same or different resin materials. Although the boundary surface between the first outer layer 34 and the second outer layer 36 is clearly shown in FIG. 2, the present invention is not limited to this. When the 1st outer layer 34 and the 2nd outer layer 36 are comprised with the same kind of resin material, the interface of both layers may be united naturally. That is, the outer layer 38 of the present embodiment may be formed of a multilayer in which the first outer layer 34 and the second outer layer 36 can be distinguished from each other, or the first outer layer 34 and the second outer layer 36 are integrated. It may be configured as a single layer.

  A hydrophilic layer (not shown) formed on the outer surface of the second outer layer 36 constitutes the outermost layer of the balloon catheter 100. The hydrophilic layer may be formed over the entire length of the tubular body 10 or may be formed only in a partial length region on the tip side including the distal portion DE. The hydrophilic layer can be made of, for example, a maleic anhydride polymer such as polyvinyl alcohol (PVA) or a copolymer thereof, or a hydrophilic resin material such as polyvinyl pyrrolidone.

  An inner reinforcing layer 26 and an outer reinforcing layer 40 in which metal wires are braided or wound are embedded in the wall of the tubular body 10. The outer reinforcing layer 40 is disposed coaxially with the inner reinforcing layer 26 and outside the inner reinforcing layer 26. The third lumen (main lumen) 20 is formed inside the inner reinforcing layer 26, and the first lumen (injection lumen) 58 and the second lumen (sublumen) 32 are connected to the inner reinforcing layer 26. It is formed between the outer reinforcing layer 40.

  The inner reinforcing layer 26 is a protective layer that is provided on the inner diameter side of the tubular body 10 with respect to the operation lines 30 a and 30 b and protects the inner layer 22. The presence of the inner reinforcing layer 26 on the inner diameter side of the operation lines 30 a and 30 b prevents the operation lines 30 a and 30 b from breaking the first outer layer 34 and the inner layer 22 and exposing them to the main lumen 20. The inner reinforcing layer 26 is formed by winding a reinforcing wire 24. The material of the reinforcing wire 24 includes a metal material such as tungsten (W), stainless steel (SUS), nickel titanium alloy, steel, titanium, copper, titanium alloy or copper alloy, as well as the inner layer 22 and the first outer layer 34. Also, a resin material such as polyimide (PI), polyamideimide (PAI) or polyethylene terephthalate (PET) having high shear strength can be used. In the present embodiment, the reinforcing wire 24 is a fine stainless steel wire. The inner reinforcing layer 26 is formed by winding the reinforcing wire 24 in a coil shape or braiding it in a mesh shape. The number of the reinforcing wires 24, the coil pitch, and the number of meshes are not particularly limited. The inner reinforcing layer 26 of the present embodiment is a blade layer obtained by braiding a plurality of reinforcing wires 24 in a mesh shape.

  A resin tube 28 made of a resin material having a lower friction than that of the tubular main body 10 is attached to the inner wall surface of the second lumen (sublumen) 32 through which the operation lines 30a and 30b are inserted.

  The resin tube 28 is a hollow tubular member that defines the secondary lumen 32. The resin tube 28 is embedded in the first outer layer 34. The resin tube 28 can be made of, for example, a thermoplastic polymer material. As the thermoplastic polymer material, polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), tetrafluoroethylene / hexafluoropropylene copolymer (FEP), or the like has a lower friction than the tubular body 10. Resin material is mentioned. The resin tube 28 is made of a material having a higher bending rigidity and tensile elastic modulus than the outer layer 38.

  The operation lines 30a and 30b are loosely inserted into the resin tube 28 so as to be slidable. The distal ends of the operation wires 30a and 30b are fixed to the distal portion DE of the tubular body 10. By pulling the operation lines 30a and 30b to the proximal end side, a tensile force is applied to a position that is eccentric with respect to the axial center of the tubular body 10, so that the tubular body 10 bends. Since the operation lines 30a and 30b of this embodiment are extremely thin and highly flexible, even if the operation lines 30a and 30b are pushed to the distal side, substantially no pushing force is applied to the distal portion DE of the tubular body 10. .

  The operation lines 30a and 30b are fixed to the formation region of the balloon 80 or the distal side of the distal portion DE of the tubular body 10. By pulling the operation wires 30a and 30b, at least the distal side of the distal portion DE of the tubular body 10 is bent more than the balloon 80. The distal ends of the operation lines 30a and 30b may be fixed inside the formation region of the balloon 80, or may be fixed on the distal side of the balloon 80.

  More specifically, the tip portions of the operation lines 30a and 30b of the present embodiment are connected to the vicinity of the distal end of the balloon 80 or further to the distal side of the distal end. Accordingly, by pulling the operation lines 30a and 30b, the tip portion 19 that extends to the distal side of the balloon 80 in the distal portion DE of the tubular body 10 is bent.

  The tip part 19 is a length region formed at the most distal end of the tubular body 10. An inner layer 22 and an inner reinforcing layer 26 are formed to extend inside the tip part 19. By extending the inner reinforcing layer 26 to the inside of the tip part 19, it is possible to suppress the displacement of the tip part 19 in the radial direction. For this reason, when the balloon catheter 100 is bent, the distal tip portion 19 can apply a large force to the guide wire GW and bend it.

  The tip portion 19 may be made of the same resin material as that of the outer layer 38, or may be made of the same kind of resin material as the outer layer 38 and having a low hardness. Alternatively, the tip portion 19 may be made of a softer resin material than the outer layer 38 such as urethane resin or silicone rubber. As a result, the balloon catheter 100 can be inserted without damaging the living body lumen 110 or the narrowed portion 112 (see FIG. 6). For convenience, in FIG. 3, the tip portion 19 and the outer layer 38 are hatched in common.

  Radiopaque annular markers 14 and 16 are provided in the vicinity of the proximal end and the distal end of the balloon 80, respectively. The tips of the operation lines 30a and 30b are fixed to the distal marker 14. A mode in which the operation lines 30a and 30b are fixed to the marker 14 is not particularly limited, and examples thereof include solder bonding, heat fusion, adhesion with an adhesive, and mechanical hooking (caulking).

  More specifically, as shown in FIG. 3, the distal marker 14 is attached further to the distal side than the distal end of the balloon 80. The marker 14 is embedded in the tip part 19. On the other hand, the proximal end of the balloon 80 is formed at a position overlapping the proximal marker 16. Thereby, the tip part 19 is suitably bent by pulling the operation lines 30a and 30b.

  In the balloon catheter 100 of the present embodiment, not only the distal tip portion 19 but also part or all of the length region of the balloon 80 may be bent by bending the operation lines 30a and 30b. In particular, as will be described later, an easy-bending portion 84 (see FIG. 3) is formed in the balloon 80 to reduce the bending rigidity of the balloon 80 so that the balloon 80 is bent well together with the tip portion 19. Can do. In this case, it is preferable that the average curvature of the tip portion 19 when the operation lines 30 a and 30 b are bent is larger than the average curvature of the balloon 80. Thereby, the direction of the distal end of the tubular body 10, that is, the forward direction of the guide wire GW can be deflected corresponding to the bent portion of the living body lumen 110 that is bent with a large curvature.

  Further, by forming the proximal end of the balloon 80 at a position overlapping the marker 16, discontinuity in the bending rigidity of the tubular body 10 is reduced in the vicinity of the proximal end of the balloon 80. This suppresses the tubular body 10 from being kinked on the proximal side of the balloon 80 when the operation lines 30a and 30b are pulled.

  The markers 14 and 16 are ring-shaped members made of a material that does not transmit radiation such as X-rays, such as platinum and tungsten. By using the positions of the two markers 14 and 16 as indexes, the position of the balloon 80 in the living body lumen 110 (see FIGS. 6A to 6C) is accurately visually recognized under radiation (X-ray) observation. be able to. Thereby, the optimal timing for performing the bending operation of the balloon catheter 100 can be easily determined. By pulling the operation lines 30a and 30b, the length region on the proximal side of the marker 14, that is, the tip part 19 or the tip part 19 and the balloon 80 is bent.

  The operation wires 30a and 30b may be formed of a single wire, but may be a stranded wire formed by twisting a plurality of thin wires. The number of fine wires constituting one stranded wire of the operation wires 30a and 30b is not particularly limited, but is preferably 3 or more. A preferable example of the number of thin wires is seven or three.

  As the operation wires 30a and 30b, low carbon steel (piano wire), stainless steel (SUS), corrosion-resistant coated steel wire, titanium or titanium alloy, or metal wire such as tungsten can be used. In addition, the operation lines 30a and 30b include polyvinylidene fluoride (PVDF), high density polyethylene (HDPE), poly (paraphenylenebenzobisoxazole) (PBO), polyether ether ketone (PEEK), polyphenylene sulfide (PPS). ), A polymer fiber such as polybutylene terephthalate (PBT), polyimide (PI), polytetrafluoroethylene (PTFE), or boron fiber.

  The outer reinforcement layer 40 is a protective layer that is provided on the outer peripheral side of the tubular body 10 with respect to the operation lines 30 a and 30 b and protects the second outer layer 36. Since the outer reinforcing layer 40 exists on the outer peripheral side of the operation lines 30a and 30b, the operation lines 30a and 30b break the second outer layer 36 and the hydrophilic layer (not shown) and are exposed to the outside of the tubular body 10. To prevent.

  The outer reinforcing layer 40 is formed by winding the second reinforcing wire 42 in a coiled or mesh shape. For the second reinforcing wire 42, the above-described materials exemplified as the reinforcing wire 24 of the inner reinforcing layer 26 can be used. The second reinforcing wire 42 and the reinforcing wire 24 may be made of the same material or different materials. In the present embodiment, as the second reinforcing wire 42, a blade layer in which fine wires made of the same material (stainless steel) as the reinforcing wire 24 are braided in a mesh shape is illustrated. The wire diameter and the number of strips of the second reinforcing wire 42 and the reinforcing wire 24 may be the same or different.

<About Balloon 80>
The balloon 80 is a stretchable member made of a soft resin material into a sheet shape. Specific resin materials are not particularly limited, but examples include flexible resin materials such as polyolefin, polyvinyl chloride, polyurethane, polyphenylene sulfide, fluororesin, and polyester, as well as polyurethane elastomer, polyamide elastomer, silicone rubber, and latex rubber. A rubber material can be used.

  The thin film balloon 80 is formed of a single layer or two or more layers of resin sheets. The balloon 80 is formed in a sheet shape formed into a belt shape or the like, and is mounted in a liquid-tight manner in a state of surrounding the distal portion DE of the tubular body 10 in a circular shape. Fixing portions 82 are provided at both ends of the balloon 80 on the distal side and the proximal side, and are fixed to the tubular body 10 in a liquid-tight and circular manner. In the fixing portion 82, the balloon 80 can be fixed to the tubular body 10 optionally using an adhesive and a binding band.

  As shown in FIG. 3, the tip of the injection lumen 58 is bent to the side of the tubular main body 10 (upward in FIG. 3) and opens inside the balloon 80. The balloon 80 is inflated by injecting a liquid (fluid F) such as physiological saline through the injection lumen 58 at a predetermined pressure (see FIG. 5A).

  The balloon 80 of the present embodiment is provided with an easy-bending portion 84 for reducing the bending rigidity of the balloon 80 at least in the middle thereof. The easy bending portion 84 of the present embodiment is a half-cut groove formed by cutting a part of the thickness of the balloon 80. The easily bendable portion 84 is formed in a circular shape or a spiral shape with respect to the balloon 80. The easily bendable portion 84 may be formed in the entire distal end direction with respect to the balloon 80, or may be formed only on the distal end side with respect to the intermediate portion. By forming the easy-bending portion 84 in the balloon 80, the distal side of the balloon 80 can be bent with a larger curvature than the proximal side when the operation lines 30a and 30b are pulled. In other words, the tubular body 10 and the balloon 80 can be sufficiently bent with a relatively small traction force.

  In addition, the bendable portion 84 may be a thin-walled portion in which the thickness of the balloon 80 is locally reduced, or the material of the sheet-like balloon 80 has a low rigidity continuously or stepwise toward the distal side. You may form by changing to (low Young's modulus).

  As shown in FIG. 1A, the operation portion main body 50 includes a casing 70 and a bending operation portion 60 that are attached to the proximal end portion PE of the tubular main body 10. The bending operation part 60 has a fixing part 66 (see FIG. 4) at the base end part of the operation lines 30a and 30b, and individually applies a traction force to the plurality of operation lines 30a and 30b by a traction operation.

  As shown in FIG. 4, the base ends of the operation lines 30 a and 30 b are drawn out from the outer layer 38 to the outside side through the side holes of the outer layer 38 inside the housing 70. The operation lines 30 a and 30 b are wound around the bending operation unit 60, drawn out from the slit 64, and entangled with the fixing unit 66. When the bending operation unit 60 is rotated in one direction, the first operation line 30a is tensioned and the second operation line 30b is relaxed. Conversely, when the bending operation unit 60 is rotated in the other direction, the second operation is performed. The line 30b is tensioned and the first operation line 30a is relaxed. The pulled operation lines 30a and 30b bend the distal portion DE of the balloon catheter 100. Thereby, the balloon 80 is bent together with the tubular main body 10. It should be noted that the bending of the balloon catheter 100 includes a mode in which the distal portion DE is bent in a substantially V shape and a mode in which the balloon catheter 100 is bent in a bow shape.

  The operation unit main body 50 includes a holding mechanism 88 that holds the operation lines 30a and 30b in a state where the operation unit is pulled. By operating the holding mechanism 88, the bending operation of the balloon catheter 100 is restricted. Thereby, the shape of the balloon catheter 100 is held in the extended state shown in FIG. 1A or the bent state shown in FIG.

  The holding mechanism 88 is operated by the user's finger operation, and slides and engages with the bending operation unit 60 so as to be able to contact and separate. Thereby, rotation of the bending operation part 60 can be controlled in the bent state of the balloon catheter 100 shown in FIG.

  FIG. 5A is a plan view showing a state where the balloon 80 in the balloon catheter 100 of the present embodiment is inflated. FIG. 5B is a plan view showing how the inflated balloon 80 is bent. FIG. 5C is a plan view showing a state in which the balloon 80 is deflated. FIG. 6A is a schematic diagram showing the living body lumen 110 in which the narrowed portion 112 is formed. FIG. 6B is a schematic view showing a state in which the balloon catheter 100 is bent at a position on the near side of the narrowed portion 112. FIG. 6C is a schematic view showing a state in which the stenosis 112 is expanded by inflating the balloon 80.

  By supplying a liquid (fluid F) such as physiological saline to the liquid injection port 78, the liquid is injected into the balloon 80 through the liquid injection lumen 58 (see FIGS. 2 and 3) of the tubular body 10. As a result, the balloon 80 is inflated as shown in FIG. A contrast agent may be mixed in the liquid. This makes it possible to visually confirm that the balloon 80 has expanded to a desired diameter under radiation (X-ray) observation.

  In the state where the balloon 80 is inflated, the inflated state of the balloon 80 is maintained by closing the liquid injection port 78 to prohibit the entry and exit of the liquid. The balloon 80 is deflated again by opening the liquid injection port 78 and discharging the liquid.

  The balloon catheter 100 of the present embodiment is configured such that the distal portion of the tubular body 10 is operated by rotating the bending operation portion 60 in the initial state in which the balloon 80 is contracted as shown in FIGS. 1 (a) and 1 (b). In addition to being able to bend the DE and the balloon 80, as shown in FIGS. 5 (a) and 5 (b), the bending operation can be performed in the same manner even when the balloon 80 is inflated.

  By operating the holding mechanism 88, the balloon 80 expanded by injecting the fluid F (liquid) is held in a bent state. In other words, the balloon catheter 100 of this embodiment can inflate the balloon 80 in a state where the tubular body 10 and the balloon 80 are bent.

  As shown in FIG. 6A, when the narrowed portion 112 is formed in the bent portion of the living body lumen 110, the guide wire GW does not interfere with the rising portion 114 of the narrowed portion 112, as shown in FIG. When the balloon 80 is advanced to the front of the narrowed portion 112 as shown in FIG. Thereby, the advancing direction of the guide wire GW can be directed toward the central portion of the narrowed portion 112.

  Then, as shown in FIG. 6C, the balloon 80 bent according to the bent shape of the narrowed portion 112 is held by operating the holding mechanism 88, thereby reducing the load on the narrowed portion 112. In this state, the narrowed portion 112 can be expanded by the balloon 80.

<Second embodiment>
FIG. 7 is a plan view showing the balloon catheter 100 of the second embodiment. 8 is a cross-sectional view taken along line VIII-VIII in FIG.

  This embodiment is different from the first embodiment in that the third lumen (main lumen) 20 is open at both ends at the distal end of the tubular body 10 and the intermediate portion of the tubular body 10. The third lumen (main lumen) 20 of the present embodiment is a monorail type (rapid exchange type) guide wire lumen.

  Here, the intermediate portion of the tubular body 10 is intended to exclude the distal end and the proximal end of the tubular body 10, specifically, the proximal side of the balloon 80 and the distal side of the operation unit body 50. This is the length region.

  A lateral hole 18 into which the guide wire GW can be inserted is provided in the intermediate portion of the tubular main body 10. The opening of the lateral hole 18 may have a directional component toward the proximal end side of the tubular body 10 in order to easily receive the distal end of the guide wire GW that advances from the proximal end side. The lateral hole 18 is formed at a depth from the outer surface of the tubular body 10 to the inside of the inner reinforcing layer 26 through the outer reinforcing layer 40 and the inner reinforcing layer 26, and the main pipe inside the inner reinforcing layer 26. It communicates with a cavity (third lumen) 20 (see FIG. 8). The main lumen 20 of this embodiment is formed exclusively on the distal side of the lateral hole 18 and opens at the distal end of the tubular body 10, and does not open at the proximal end of the tubular body 10.

  The liquid injection lumen 58 is formed through the inner reinforcing layer 26 from the proximal end to the distal end of the tubular body 10. The liquid injection port 78 of this embodiment is also used as the hub connector 52 of the operation unit main body 50. In other words, the hub connector 52 of the operation unit main body 50 communicates with the balloon 80 through the liquid injection lumen 58.

  As shown in FIG. 8, a plurality of second lumens (sublumen) 32 are arranged on the distal side of the intermediate portion of the tubular body 10, and the first lumen (injection lumen) 58 and the third lumen ( The main lumen) 20 is distributed around the periphery. Thereby, the tubular body 10 and the balloon 80 can be bent by a large moment by pulling the operation lines 30a and 30b inserted through the auxiliary lumen 32 arranged on the outer peripheral side.

  Further, as in the first embodiment, an inner reinforcing layer 26 and an outer reinforcing layer 40 each formed by braiding or winding a metal wire are embedded in the wall of the tubular body 10, and the outer reinforcing layer 40 is coaxial with the inner reinforcing layer 26. It is disposed outside the inner reinforcing layer 26. The first lumen (injection lumen) 58 and the third lumen (main lumen) 20 are formed inside the inner reinforcing layer 26, and the second lumen (sub lumen) 32 is formed between the inner reinforcing layer 26 and the outer side. It is formed between the reinforcing layer 40.

<Third embodiment>
Fig.9 (a) is a top view which shows the balloon catheter 100 of 3rd embodiment, FIG.9 (b) is a top view which shows a mode that the balloon 80 of this embodiment is bent.

  The balloon catheter 100 of the present embodiment is different from the first embodiment in that a folded stent 95 or stent graft is attached to the outer surface of the balloon 80.

  As in this embodiment, by attaching an indwelling device such as a stent 95 or a stent graft to the surface of the balloon 80, the balloon 80 can be used as an expansion device for these indwelling devices. The stent 95 used in this embodiment is a non-self-expanding type, and has a cylindrical shape formed by weaving metal wires in a mesh shape.

  Like the balloon catheter 100 of the present embodiment, the distal end DE of the tubular body 10 can be bent by rotating the bending operation portion 60, so that the balloon 80 and the stent 95 are maintained in a bent state. It can be placed in the constricted portion 112 of the living body lumen 110 or the like.

  The present invention is not limited to the above-described embodiment, and includes various modifications and improvements as long as the object of the present invention is achieved.

  It should be noted that the various components of the balloon catheter 100 of the present invention need not be independent of each other. A plurality of components are formed as one member, a component is formed of a plurality of members, one component is a part of another component, and one component is And a part of other components are allowed to overlap.

The above embodiment includes the following technical idea.
(1) A long and flexible resin-made tubular body in which three or more lumens are formed at least partially through-holes, and a distal portion of the tubular body. An expandable balloon that communicates with the lumen; an operation line that is slidably inserted into the second lumen; a distal end portion connected to a distal portion of the tubular body; and a contrast agent or a guide wire. The third lumen to be inserted, and an operation portion body provided on the proximal side of the tubular body and having a liquid injection port for injecting fluid into the balloon through the first lumen, A base end portion of the operation line is connected to the operation portion main body, and by pulling the operation portion main body, at least a distal side of the distal portion of the tubular main body is bent from the balloon. Balloon catheter Le.
(2) The balloon catheter according to (1), wherein the distal end portion of the operation line is connected to the vicinity of the distal end of the balloon or further to the distal side than the distal end.
(3) The balloon catheter according to (1) or (2), wherein an easy-bending portion for reducing the bending rigidity of the balloon is provided at least in an intermediate portion of the balloon.
(4) The operation portion main body has a holding mechanism that holds the operation line in a state of being pulled, and by operating the holding mechanism, the balloon inflated by injecting the fluid is in a bent state. The balloon catheter according to any one of (1) to (3), which is held.
(5) The third lumen according to any one of (1) to (4), wherein both ends of the lumen are open to a distal end of the tubular body and a proximal end of the operation unit body. Balloon catheter.
(6) The balloon catheter according to (5), wherein a plurality of second lumens are provided, and the plurality of second lumens are distributed around the third lumen.
(7) A plurality of second lumens are arranged at opposing positions with the third lumen interposed therebetween, and a plurality of the second lumen and the first lumen are distributed around the third lumen. The balloon catheter according to (5) or (6) above.
(8) An inner reinforcing layer and an outer reinforcing layer, each of which is braided or wound with a metal wire, are embedded in the wall of the tubular body, and the outer reinforcing layer is disposed coaxially with the inner reinforcing layer and outside the inner reinforcing layer. The third lumen is formed inside the inner reinforcing layer, and the first lumen and the second lumen are formed between the inner reinforcing layer and the outer reinforcing layer. The balloon catheter according to any one of (5) to (7).
(9) The balloon catheter according to any one of (1) to (4), wherein both ends of the third lumen are open at a distal end of the tubular body and an intermediate portion of the tubular body. .
(10) In the above (9), the plurality of second lumens are distributed around the first lumen and the third lumen on the distal side of the intermediate portion of the tubular body. The balloon catheter described.
(11) An inner reinforcing layer and an outer reinforcing layer, each of which is braided or wound with a metal wire, are embedded in the wall of the tubular body, and the outer reinforcing layer is coaxial with the inner reinforcing layer and disposed outside the inner reinforcing layer. The first lumen and the third lumen are formed inside the inner reinforcing layer, and the second lumen is formed between the inner reinforcing layer and the outer reinforcing layer. The balloon catheter according to (9) or (10).
(12) The balloon catheter according to any one of (1) to (11), wherein a folded stent or stent graft is attached to the outer surface of the balloon.
(13) From the above (1) to (12), a resin tube made of a resin material having a lower friction than the tubular main body is attached to the inner wall surface of the second lumen through which the operation line is inserted. The balloon catheter according to any one of the above.
(14) Radiopaque annular markers are respectively provided in the vicinity of the proximal end and the distal end of the balloon, and the tip of the operation line is fixed to the distal marker. The balloon catheter according to any one of (1) to (13) above.

DESCRIPTION OF SYMBOLS 10 Tubular main body 14 * 16 Marker 18 Side hole 19 Tip tip part 20 Main lumen 22 Inner layer 24 Reinforcement wire 26 Inner reinforcement layer 28 Resin pipe 30a, 30b Operation line 32 Secondary lumen 34 First outer layer 36 Second outer layer 38 Outer layer 40 Outer Reinforcing layer 42 Second reinforcing wire 50 Operation part main body 52 Hub connector 58 Injection lumen 59 Dummy lumen 60 Bending operation part 64 Slit 66 Fixing part 70 Housing 78 Injection port 80 Balloon 82 Adhering part 84 Easy bending part 88 Holding mechanism 95 Stent 100 Balloon catheter 110 Living body lumen 112 Stenosis part 114 Standing part DE Distal part F Fluid GW Guide wire PE Base end part

Claims (7)

A resin-made tubular main body that is long and flexible, and has three or more lumens formed therein at least partially through-holes;
An expandable balloon provided at a distal portion of the tubular body and in communication with the first lumen;
An operation line that is slidably inserted into the second lumen and has a tip connected to a distal portion of the tubular body;
A third lumen through which a contrast agent or guidewire is inserted;
An operation part body provided on the proximal side of the tubular body and having a liquid injection port for injecting fluid into the balloon through the first lumen;
A proximal end portion of the operation line is connected to the operation portion main body, and by bending the operation portion main body, at least a distal side of the distal portion of the tubular main body is bent from the balloon,
The third lumen is open at both ends to the distal end of the tubular body and the proximal end of the operating portion body;
A plurality of second lumens are arranged at opposite positions across the third lumen, and a plurality of second lumens and the first lumen are distributed around the third lumen. ,
An inner reinforcing layer and an outer reinforcing layer, each of which is braided or wound with a metal wire, are embedded in the wall of the tubular body, and the outer reinforcing layer is disposed coaxially with the inner reinforcing layer and outside the inner reinforcing layer. ,
A third lumen is formed inside the inner reinforcing layer;
The first lumen and the second lumen are formed between the inner reinforcing layer and the outer reinforcing layer ;
Radiopaque annular markers are respectively provided in the vicinity of the proximal end and the distal end of the balloon,
The tubular body is made of a resin outer layer including the inner reinforcing layer, a resin material of the same kind as the outer layer and having a hardness lower than that of the outer layer, or a resin material softer than the outer layer. A tip portion formed at the most distal end,
The distal marker is mounted further to the distal side than the distal end of the balloon and is embedded in the tip part, and the tip of the operation line is connected to the distal marker. A balloon catheter characterized by being fixed to .   The balloon catheter according to claim 1, wherein the tip portion of the operation line is connected to the vicinity of the distal end of the balloon or further to the distal side than the distal end.   The balloon catheter according to claim 1 or 2, wherein an easy-bending portion for reducing the bending rigidity of the balloon is provided at least in an intermediate portion of the balloon. The operation unit body has a holding mechanism that holds the operation line in a state of being pulled.
The balloon catheter according to any one of claims 1 to 3, wherein the balloon inflated by injecting the fluid is held in a bent state by operating the holding mechanism.   The balloon catheter according to any one of claims 1 to 4, further comprising a plurality of second lumens, wherein the plurality of second lumens are distributed around the third lumen.   The balloon catheter according to any one of claims 1 to 5, wherein a folded stent or stent graft is attached to an outer surface of the balloon.   The resin pipe made of a resin material having a lower friction than the tubular main body is attached to the inner wall surface of the second lumen through which the operation line is inserted. The balloon catheter described.

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