JP2011098060A - Cutting balloon catheter - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a cutting balloon catheter of a new configuration which exhibits an excellent cutting function with respect to a constricted part. <P>SOLUTION: The cutting balloon catheter includes; a balloon attached to a distal end side of a catheter body; a first pipe body provided on a distal end side of the balloon; a second pipe body provided on a proximal end side of the balloon; an extension wire in which either the first pipe body or the second pipe body is slidable, which is extensively provided on the outer surface of the balloon to be swollen or contracted, and connects the first pipe body and the second pipe body; and a projection member which has a through-hole and has a projection shape on a part of the outer surface. The extension wire is inserted into the projection member. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a cutting balloon catheter for cutting a thrombus that becomes a stenosis site of a blood vessel.

  Conventionally, when a blood clot due to coagulated blood or atheroma has formed on the inner surface of a blood vessel, a method has been known in which a balloon catheter is inserted into the blood vessel constricted by the thrombus and inflated, thereby causing blood vessel formation by expansion pressure. It has been. However, when a hard thrombus such as a calcified gastric lesion is generated, blood vessel formation may not be successful in the above-described embodiment. Therefore, a so-called cutting balloon catheter is known in which a blade is fixed to the surface of the balloon and a thrombus is removed by the balloon expansion pressure (Patent Document 1: Special Table 2008-529740).

  However, in such a cutting balloon catheter, when the hard stenosis site as described above is expanded, the balloon may bulge into an irregular shape (for example, a dogbone shape), and thus the blade may fall off.

  In addition, the cutting balloon catheter may include a mode in which a notch is provided in a part of the blade to increase the flexibility of the blade. However, in such a cutting balloon catheter, the number of notches cannot be increased any more from the viewpoint of fixing the blade and the balloon, that is, from the viewpoint of manufacturing (Patent Document 2: Special Table 2008-519654, Patent Document 3). : Special table 2008-519655).

Special table 2008-529740 Special table 2008-519654 Special table 2008-519655

  The present invention has been made in view of these circumstances, and an object thereof is to provide a cutting balloon catheter having a novel structure capable of exhibiting an excellent cutting function with respect to a stenotic site.

  A feature of the present invention is that a balloon attached to the distal end side of the catheter body, a first tube body provided on the distal end side of the balloon, and a proximal end side of the balloon are provided. The second tube, and the first tube that is slidable in one of the first tube and the second tube, and is extended to the outer surface of the balloon to be inflated or deflated And an extension wire connecting the second tubular body, and a protruding member having a through hole and having a convex shape on a part of the outer surface, the cutting of which the extension wire is inserted into the protruding member Located on the balloon catheter.

  In the cutting balloon catheter having the structure according to the present invention, the protruding member is followed as the balloon is deformed, so that an excellent cutting function can be exerted on the narrowed portion.

  Further, the protruding members are installed in a rosary shape on the extension wire, and the protruding members sandwich the flexible member, so that the cutting balloon catheter of the present invention is flexible in the cutting site composed of a plurality of protruding members and a plurality of flexible members. Can be increased.

The distal end side schematic diagram which shows the cutting balloon catheter as embodiment of this invention. The distal end schematic diagram which shows the cutting balloon catheter as another embodiment of this invention. An example of AA sectional drawing of FIG. An example of the top view of the cutting balloon catheter of FIG.

  Hereinafter, in order to clarify the present invention more specifically, embodiments of the present invention will be described in detail with reference to the drawings.

  In the proximal end side of the cutting balloon catheter referred to in the present invention, for example, a pressure fluid supply / discharge port or a guide wire outlet port is desirably provided. Since the proximal end side is exposed from the human body during the treatment, pressure fluid is supplied or discharged from the supply / discharge port or the outlet port to inflate or deflate the balloon, or the guide wire Operations such as insertion are possible.

  FIG. 1 shows a distal end side of a cutting balloon catheter as an embodiment of the present invention. A balloon is attached to the distal end side of the cutting balloon catheter as an embodiment of the present invention.

  The distal end side of the cutting balloon catheter 1 has a catheter body 2, a balloon 3, a first tube 4, a second tube 5, an expansion wire 6 connecting the first tube 4 and the second tube 5, and an expansion. It is comprised by the protrusion member 7 penetrated by the wire.

  The cutting balloon catheter 1 of the present invention is provided with a long catheter body 2. The catheter body 2 has a thickness that can be inserted into a blood vessel to be inserted and a length that reaches a target treatment site. The catheter body 2 is formed of a soft material that can be bent along the blood vessel. Examples of the material include polyamide, polyvinyl chloride, polyurethane, polyimide, polyethylene, polyethylene elastomer, polypropylene, polytetrafluoroethylene, poly A synthetic resin material such as ether ether ketone and polyvinylidene fluoride, a metal material such as stainless steel and nickel-titanium alloy, and a combination thereof are preferably employed.

  The catheter body 2 is composed of an inner shaft and a distal shaft each having a long tube shape. The inner shaft is inserted into the center hole of the distal shaft, and the distal end side of the inner shaft is It is desirable to project in the axial direction from the distal end side of the distal shaft. Furthermore, it is desirable that a tip end having a substantially cylindrical shape whose diameter is reduced toward the distal end side is attached to the distal end side of the inner shaft.

  The balloon 3 has a substantially bag-like shape, and examples of the material include polyethylene terephthalate, nylon, polyamide, polyethylene, polyethylene elastomer, polypropylene, silicon rubber, and latex rubber. Among them, the material of the balloon 3 is preferably polyethylene terephthalate or nylon from the viewpoint of manufacturing.

  The balloon 3 is desirably arranged so as to surround the distal end side of the inner shaft protruding from the distal shaft. For example, the balloon 3 is arranged such that the proximal end side of the balloon 3 is fixed to the distal end side of the distal shaft, and the inner space of the balloon 3 is communicated with the pressure adjusting lumen. It is desirable that the side be welded to the distal end side of the inner shaft and fixed to the tip. The balloon 3 is not particularly limited in its inflation or deflation method, but a mode of supplying or discharging fluid from the proximal end side of the cutting balloon catheter is desirable.

  The first tube body 4 and the second tube body 5 are provided on the distal end side and the proximal end side of the balloon 3, respectively. As arrangement | positioning of the 1st pipe body 4 and the 2nd pipe body 5, any one should just be arrange | positioned so that sliding is possible. The first tube body 4 and the second tube body 5 are preferably disposed in a manner that the first tube body is the catheter body from the viewpoint that the expansion wire 5 is not easily dropped from the balloon 3 even if it is repeatedly expanded and contracted in the blood vessel. And the second tube body is slidable with the catheter body.

  The method for fixing the first tubular body 4 to the catheter body is not particularly limited, and examples thereof include adhesion or welding. As used herein, the term “adhesion” is preferably fixed by an adhesive. Examples of the adhesive include an epoxy adhesive, an acrylic adhesive, a cyanoacrylate adhesive, a urethane adhesive, and the like.

  Although the method in particular does not limit that the 2nd pipe | tube body 5 is slidable on a catheter main body, For example, since the internal hole of the 2nd pipe | tube body 5 is larger than the diameter of the catheter main body 2, Examples include a mode in which it is rotated at the contact site.

  Examples of the material of the first tube body 4 and the second tube body 5 include resins, metals, alloys, and the like. From the viewpoint of joining with the catheter body, it is particularly preferable to use stainless steel or SUS304.

  The expansion wire 6 is extended to the outer surface of the balloon 3. More specifically, it is desirable that the expansion wire 6 is not fixed to the outer surface of the balloon 3 but has a function of following the expansion or contraction of the balloon 3 by elastic deformation. The material of the extension wire 6 may be a known elastically deformable material such as a nickel-titanium alloy. If the expansion wire 6 is made of a nickel-titanium alloy, it is a superelastic alloy that maintains a predetermined shape. Therefore, the shape when the balloon 3 is deflated can be memorized, and it can be broken even if it is repeatedly expanded or contracted in the blood vessel. It is a difficult form.

  Further, the number of connections of the extension wires 6 is not particularly limited. One or a plurality of expansion wires 6 can be used. From the viewpoint of easily connecting to the first tube 4 and the second tube 5 and extending to the outer surface of the balloon 3, a predetermined wire is provided on the outer periphery of the balloon 3. A configuration in which four are provided at intervals is desirable.

  The expansion wire 6 connects the first tube body 4 and the second tube body 5 as long as the expansion wire 6 is in contact with the first tube body 4 and the second tube body 5. The extension wire 6 is in contact with any one of the two tubular bodies 5 by sliding. For example, the method is not particularly limited, and for example, the expansion wire 6 is fixed to the first tube body 4 and the second tube body 5, or the expansion wire 6 is fixed to the first tube body 4, The second tubular body 5 includes a hole and an expansion wire 6 is inserted through the hole.

  The protruding member 7 has a convex shape having a function of excising a thrombus in a part of the outer surface. Further, the protruding member 7 has a through hole for allowing the extension wire 6 to pass therethrough. The protruding member 7 is inserted into the extension wire 6 through the through hole. The insertion here may be a state in which the extension wire 6 is inserted from one of the through holes of the projecting member 7 and is extracted from the hole on the opposite side of the inserted hole. Moreover, as a raw material of the protrusion member 7, although a metal, an alloy, resin etc. are mentioned, it is desirable to use especially stainless steel and SUS304 from a viewpoint of thrombus cutting.

  The protruding shape of the protruding member 7 only needs to have a function of cutting a thrombus. For example, an aspect in which a part of the protruding member 7 has an acute angle, or an aspect in which a blade of another material is connected to the protruding member main body. From the viewpoint of manufacturing, a mode in which a part of the protruding member 7 has an acute angle is desirable. Therefore, the projecting shape of the projecting member 7 is preferably, for example, a substantially triangular shape, a substantially quadrangular shape, a substantially pentagonal shape, or a form having a projecting portion on the substantially constricted part side plane. . And if the protrusion member 7 is an aspect which has a convex-shaped point part perpendicular | vertical with respect to the outer surface of a balloon, it will be easy to cut a thrombus. Since it is this aspect, since this invention follows a protrusion member with a deformation | transformation of a balloon, it can exhibit the cutting function outstanding with respect to the constriction site | part.

  FIG. 2 shows an outline of the distal end side of a cutting balloon catheter as a second embodiment of the present invention. As 2nd Embodiment, the protrusion member 7 is installed in the expansion wire 6 in the shape of a bead, and the protrusion members are the aspects which are pinching the flexible member. The protruding members 7 are installed in a rosary shape on the extension wire 6 in a form in which a plurality of protruding members 7 are inserted through the extension wires 6.

  The flexible member 8 is held between the protruding members 7. The protruding members sandwich the flexible member as long as a flexible member is installed between the protruding members 7, and the protruding member 7 and the flexible member 8 may not be connected. As a raw material of the flexible member 8, what is necessary is just to have a softness | flexibility, for example, a metal, an alloy, resin, etc. are mentioned. Further, the flexible member 8 may be an elastic rubber, spring, sponge or the like. Examples of the shape of the flexible member 8 include a cylinder, a substantially triangular tube, and a substantially square tube, but any shape may be used.

  In 2nd Embodiment, the cutting site | part which consists of the some protrusion member 7 and the some flexible member 8 can be formed by pinching | pinching a flexible member between protrusion members 7 mutually. Then, the cutting part has a shape that allows the cutting part to easily follow the balloon 3 when the balloon 3 is inflated or contracted due to the gap formed between the protruding member 7 and the flexible member 8, thereby increasing flexibility. Can do. In addition, it is desirable that the protruding members 7 at both ends of the cutting site are bonded to the extension wire 6 from the viewpoint of clarifying the cutting width. Further, the flexible member 8 preferably has a through-hole and is inserted through the expansion wire 6 from the viewpoint of being stable with the expansion wire 6 even when the balloon 3 is expanded or contracted.

  FIG. 3 shows an example of a cross-sectional view taken along the line AA in FIG. The expansion wire 6 has a convex wire shape, and the expansion wire 6 extends from the outer surface of the balloon 3 with a convex smooth surface. The extension wire 6 having a convex wire shape is not a substantially cylindrical shape but has a smooth plane, for example, a substantially triangular prism shape or a substantially quadrangular prism shape. By having the smooth flat surface, the area in contact with the flat surface of the inflated balloon 3 is widened, so that the expansion wire 6 and the balloon 3 are stably fixed.

  Moreover, it is desirable that the through hole of the protruding member 7 has a convex hole shape. The extension wire 6 and the projection member 7 are fitted by making the through hole of the projection member convex, for example, by forming the extension wire 6 in a substantially triangular prism shape and the inner hole of the projection member in the same shape as a substantially triangular prism shape. Therefore, it becomes easy to easily position the convex pointed portion for excising the thrombus of the protruding member 7.

  FIG. 4 shows an example of the third embodiment as a top view of the cutting balloon catheter of FIG. The third embodiment is an aspect in which the cutting range of the cutting balloon catheter is not reduced even when the flexible member 8 referred to in the present invention does not have a function of cutting a thrombus. As 3rd Embodiment, the convex shape of the protrusion member 7 is mentioned to the upper direction of the narrow part side plane of the flexible member 8 is mentioned. The length of the projecting protruding portions is not limited as long as the cutting range is not narrowed, and the protruding portions may be connected in some manner.

1: cutting balloon catheter, 2: catheter body, 3 balloon, 4: first tube, 5: second tube, 6: expansion wire, 7: protruding member, 8: flexible member

Claims (6)

A balloon attached to the distal end of the catheter body;
A first tube provided on the distal end side of the balloon;
A second tubular body provided on the proximal end side of the balloon;
Either the first tube body or the second tube body is slidable, and the first tube body and the second tube body are in contact with the outer surface of the balloon to be inflated or deflated. An extension wire to connect,
A projecting member having a through hole and having a convex shape on a part of the outer surface,
A cutting balloon catheter in which the expansion wire is inserted into the protruding member.   The cutting balloon catheter according to claim 1, wherein the projecting members are arranged in a bead shape on the expansion wire, and the projecting members sandwich the flexible member.   The cutting balloon catheter according to claim 2, wherein the protruding shape of the protruding member protrudes up to a stenosis site side plane of the flexible member.   The cutting balloon catheter according to any one of claims 1 to 3, wherein the first tube is fixed to the catheter body, and the second tube is slidable with the catheter body.   The cutting balloon catheter according to any one of claims 1 to 4, wherein the dilation wire has a convex wire shape, and the dilation wire extends from the outer surface of the balloon with a convex smooth surface.   The cutting balloon catheter according to claim 5, wherein the through-hole has a convex hole shape.

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