JP5174542B2 - catheter - Google Patents

Description

  The present invention relates to a catheter. More specifically, the present invention relates to a catheter capable of easily changing the direction of the vicinity of the distal end inserted into the body cavity by operating the operation portion on the proximal end side arranged outside the body. .

  In a catheter such as an electrode catheter inserted through a blood vessel and into the heart, the orientation of the distal end (tip) of the catheter inserted into the body is the proximal end (proximal end or proximal side) of the catheter placed outside the body. It is deflected by operating the operation unit mounted on the. In order to smoothly insert the catheter into a desired site such as the inside of the heart, the vicinity of the distal end of the catheter is required to be bendable with a predetermined curve shape.

  In a so-called multi-lumen catheter in which a plurality of lumens are formed along the axial direction, an operation wire is conventionally inserted into the lumen formed at a position shifted from the central axis of the catheter. Then, by pulling the operation wire in the operation part, the direction of the distal end is deflected by curving the vicinity of the distal end of the catheter in the eccentric direction of the lumen, that is, the side displaced from the central axis of the tubular member. (See Patent Document 1).

In such a multi-lumen catheter, conventionally, a plate-like member such as a spring plate has been provided in the catheter in order to obtain flatness at the bending portion when the vicinity of the distal end of the catheter is bent.
JP 2000-288095 A

  However, the conventional multi-lumen catheter that uses a spring plate to obtain flatness in the curved portion near the distal end of the catheter has a problem that the number of parts increases by the amount of the spring plate and the manufacturing cost increases. .

  The present invention has been made in view of these problems, and an object thereof is to provide a technique capable of obtaining flatness in a curved portion near the distal end of a catheter with a smaller number of parts and cost.

One embodiment of the present invention is a catheter. The catheter has a tubular main body and a flat portion protruding in the axial direction from the proximal end side of the main body, and having a flat cross-sectional shape orthogonal to the axis, and is formed on one surface side of the flat portion. A plurality of lumens including a wire lumen are formed along an axial direction, a bendable inner cylinder member, a bendable outer cylinder member covering the inner cylinder member, and a slidably inserted through the wire lumen. An operation wire having an end portion fixed on the distal end side of the flat portion and an operation portion connected to the other end portion of the operation wire and capable of pulling the operation wire. And

  According to this aspect, the flatness in the curved portion of the distal end portion of the catheter can be obtained with a smaller number of parts and cost.

  In the catheter of the above aspect, the other wire lumen formed on the other surface side of the flat portion and the other wire lumen are slidably inserted, and one end portion is on the distal end side of the flat portion. You may further provide the other operation wire fixed.

  Further, the center of gravity of the cross section of the flat portion may substantially coincide with the central axis of the inner cylinder member.

  Moreover, the flat part may have one surface and the other surface tapered.

  Moreover, the flat part may have a flat plate part in which one surface and the other surface are parallel to each other.

  A lumen may be formed in the cross section of the flat plate portion.

  A combination of the above-described elements as appropriate can also be included in the scope of the invention for which patent protection is sought by this patent application.

  According to the present invention, it is possible to obtain flatness in the curved portion near the distal end of the catheter with a smaller number of parts and cost.

  Embodiments of the present invention will be described below with reference to the drawings. In all the drawings, the same constituent elements are denoted by the same reference numerals, and detailed description thereof will be appropriately omitted in the following description.

(Embodiment 1)
The catheter according to Embodiment 1 is an electrode catheter capable of tip deflection operation, and is suitably used for diagnosis or treatment of arrhythmia in the heart, for example.

  FIG. 1 is a side view of a catheter according to the first embodiment, and FIG. 2 is a top view of the catheter according to the first embodiment. As shown in FIGS. 1 and 2, the catheter 2 according to Embodiment 1 has a tip electrode 10 and ring-shaped electrodes 12 a, 12 b, and 12 c at the distal end of the tubular member 4. The tip electrode 10 and the ring-shaped electrodes 12a, 12b, and 12c are fixed to the tubular member 4 using, for example, an adhesive.

  A handle 6 is attached to the proximal end of the tubular member 4. The handle 6 is equipped with a knob 7 for performing a deflection movement operation (swing operation) of the distal end portion of the tubular member 4. The handle 6 and the knob 7 constitute the “operation unit” of the present invention.

As will be described later, the tubular member 4 has a hollow structure having a plurality of lumens formed along the axial direction. The vicinity of the distal end of the tubular member 4 is relatively flexible, and the vicinity of the proximal end of the tubular member 4 is relatively inflexible. Here, as will be described later, the tubular member 4 includes an inner cylinder member 4a and an outer cylinder member 4b. As shown in FIGS. 1 and 2, the outer cylinder member 4 b is adjacent to the relatively flexible member 4 b ₁ disposed on the distal end side and the proximal end side of the member 4 b _1. forming a member 4b ₂ less flexible than placed member 4b _1, and the lower member 4b ₃ flexible than member 4b ₂ disposed adjacent to the proximal end side of the member 4b ₂ are joined Has been. The Shore D hardness of the member 4b ₁ is 30 to 63, the Shore D hardness of the member 4b ₂ is 45 to 70, and the Shore D hardness of the member 4b ₃ is 55 to 82.

  The main part of the tubular member 4 is made of a synthetic resin such as polyolefin, polyamide, polyether polyamide, or polyurethane. The outer diameter of the tubular member 4 is generally about 0.6 to 3 mm, and the length is about 1150 to 1200 mm. In the present embodiment, the tubular member 4 has a diameter of about 2.4 mm and a length of about 1170 mm. As will be described later, the lumen formed in the axial direction of the tubular member 4 extends from the handle 6 and is electrically connected to the tip electrode 10 and the ring-shaped electrodes 12a, 12b, and 12c shown in FIGS. The conducting wires are passed through in a state of being insulated from each other. An operation wire is passed through the lumen.

  The tip electrode 10 and the plurality of ring-shaped electrodes 12a, 12b, and 12c are made of a metal having good electrical conductivity, such as aluminum, copper, stainless steel, gold, or platinum. In order to provide a good contrast property for X-rays, the tip electrode 10 and the ring electrodes 12a, 12b, 12c are preferably made of platinum or an alloy thereof. The outer diameters of the tip electrode 10 and the ring-shaped electrodes 12a, 12b, and 12c are not particularly limited, but are preferably approximately the same as the outer diameter of the tubular member 4, and are generally about 0.5 to 3 mm.

  3 is a cross-sectional view of the catheter according to Embodiment 1 taken along the line BB of FIG. 1, FIG. 4 is a cross-sectional view of the catheter according to Embodiment 1 taken along the line CC of FIG. 1, and FIG. FIG. 3 is a cross-sectional view of the catheter according to FIG.

  As shown in FIGS. 3 to 5, the tubular member 4 includes an inner cylinder member 4 a formed with a plurality of lumens and an outer cylinder member 4 b covering the inner cylinder member 4 a, and the inner cylinder member 4 a has an axial direction. A first lumen 20, a second lumen 22, a third lumen 24, and a fourth lumen 26 are formed along the line. In the catheter 2 of the present embodiment, the first lumen 20 and the second lumen 22 are provided at positions facing each other across the central axis 21 of the tubular member 4, and the third lumen 24 and the fourth lumen 26 are provided. The tubular members 4 are provided at positions facing each other across the central axis 21.

  The diameter of the inner cylinder member 4a in this embodiment is about 1.85 mm. The diameter of each lumen is about 0.1R to 0.45R, where R is the diameter of the tubular member 4. In the present embodiment, the diameter of the first lumen 20 and the second lumen 22 is about 0.65 mm, and the diameter of the third lumen 24 and the fourth lumen 26 is about 0.47 mm.

  The operation wire 40 is slidably inserted into the first lumen 20, and therefore the first lumen 20 constitutes a wire lumen. Further, another operation wire 42 is slidably inserted into the second lumen 22, and therefore the second lumen 22 constitutes another wire lumen. Spherical anchors 41 and 43 having a diameter larger than that of the operation wires 40 and 42 located in the first lumen 20 and the second lumen 22 are formed at the distal ends of the operation wires 40 and 42. The proximal end of the operation wire 40 is connected to the knob 7 shown in FIGS. 1 and 2.

  As shown in FIG. 4, a recess 12 is formed inside the tip electrode 10. This recess 12 is filled with solder 30. The distal ends of the operation wires 40 and 42 are embedded in the solder 30 and fixed to the solder 30 and the tip electrode 10, thereby being connected to the vicinity of the distal end of the tubular member 4. Further, as described above, the proximal ends of the operation wires 40 and 42 are fixed to the knob 7 of the handle 6. Accordingly, by operating the knob 7 shown in FIGS. 1 and 2, the operation wires 40 and 42 are pulled, and the distal end of the catheter 2 can be swung in the direction of arrow A in FIGS. 2 and 4. Yes.

  Furthermore, in this embodiment, since the anchors 41 and 43 are provided at the distal ends of the operation wires 40 and 42, the distal ends of the operation wires 40 and 42 are difficult to come out of the solder 30. Thereby, the operation reliability of the catheter 2 can be improved. In the present embodiment, the operation wires 40 and 42 are fixed to the tip electrode 10, but the operation wires 40 and 42 are not limited to this, and one end of the operation wires 40 and 42 is an inner cylinder. What is necessary is just to be fixed in the distal end side rather than the flat part which the member 4a mentions later. In this case, the operation wires 40 and 42 can be fixed to the inside of the tip electrode 10, the inner cylinder member 4a, the outer cylinder member 4b, and the like.

  As shown in FIG. 5, a tip tip electrode lead wire 50 is inserted through the third lumen 24. The distal end of the tip tip electrode lead wire 50 is embedded in the solder 30. As a result, the tip tip electrode lead wire 50 and the tip tip electrode 10 are electrically connected via the solder 30. The third lumen 24 is inserted with ring electrode conductors 60a, 60b, and 60c. The distal ends of the ring electrode conductors 60a, 60b, 60c are fixed to the ring electrodes 12a, 12b, 12c by solder (not shown), respectively, and are thereby electrically connected to the ring electrodes 12a, 12b, 12c, respectively. Yes. A thermocouple 70 as a temperature sensor is inserted into the fourth lumen 26. The thermocouple 70 can detect the temperature near the distal end of the catheter 2.

  In this embodiment, the third lumen 24 and the fourth lumen 26 are provided as lumens other than the first lumen 20 and the second lumen 22 through which the operation wires 40 and 42 are inserted, but the operation wires are inserted. The arrangement and number of lumens other than the lumen are not particularly limited. However, it is preferable that the lumen is arranged so as to have a symmetrical structure with respect to the central axis 21 of the tubular member 4 in the molding of the tubular member 4.

Next, the inner cylinder member 4a of the tubular member 4 will be described in detail.
6 is a cross-sectional view taken along the line EE of FIG. 1 in the catheter according to the first embodiment, FIG. 7 is a perspective view seen from the distal end direction of the inner cylinder member 4a, and FIG. 8 is a diagram of the inner cylinder member 4a. FIG. 9 is a top view and a perspective view of the inner cylinder member 4a viewed from the proximal end direction. In FIG. 6, the tip electrode 10 and the operation wires 40 and 42 are not shown.

As shown in FIGS. 6 to 9, the inner cylindrical member 4 a of the tubular member 4 has a relatively flexible member 4 a ₁ arranged on the distal end side and a relatively arranged on the proximal end side. It is comprised with the member 4a ₂ with low flexibility. In this embodiment, the Shore D hardness of the member 4a ₁ is 30 to 63, and the Shore D hardness of the member 4a ₂ is 4a ₁ or more. The length of the inner cylinder member 4a is 20 to 300 mm, and the inner cylinder member 4a extends from the distal end of the tubular member 4 to a range of 15 to 280 mm.

  The inner cylinder member 4a has a tubular main body portion 80 disposed on the distal end side, and a flat shape that protrudes in the axial direction from the proximal end side of the main body portion 80 and has a flat cross-sectional shape orthogonal to the axis of the inner cylinder member 4a. Part 82. A first lumen 20 as a wire lumen is formed on the first surface 84 side which is one surface of the flat portion 82. Further, the second lumen 22 as another wire lumen is formed on the second surface 86 side which is the other surface of the flat portion 82. In the present embodiment, the first surface 84 and the second surface 86 are tapered with respect to the central axis 21 of the tubular member 4.

  The flat portion 82 has a width in the direction connecting the first lumen 20 and the second lumen 22 by the first surface 84 and the second surface 86 in a cross-sectional view perpendicular to the axis of the inner cylinder member 4a. It is flattened so as to be smaller than the width in the direction connecting the third lumen 24 and the fourth lumen 26. Therefore, the flat portion 82 is easily bent in the direction connecting the first lumen 20 and the second lumen 22, that is, in the direction of arrow A in FIG. 6, and in other directions, particularly the first lumen 20 and the second lumen 22. It is difficult to bend in a direction orthogonal to the direction of tying. In other words, the first surface 84 and the second surface 86 are arranged in the direction in which the catheter 2 is bent, and the flat portion 82 is flat in the bending direction of the catheter 2. The operation wire 40 is slidably inserted into the first surface 84, and the second lumen 22 is slidably inserted into the second surface 86. As a result, the flat portion 82 extends between the operation wire 40 and the operation wire 42.

  In the above configuration, when the vicinity of the distal end of the catheter 2 is bent by the force generated by pulling the operation wire 40 or the operation wire 42 by the knob 7, the vicinity of the distal end of the catheter 2 is Deformation is regulated. That is, the vicinity of the distal end of the catheter 2 is easily bent in the direction of arrow A in FIG. 6 according to the force generated by the sliding of the operation wires 40 and 42, but is difficult to bend in other directions. As a result, the vicinity of the distal end of the catheter 2 is curved in the same plane, and the flatness in the curved portion near the distal end of the catheter 2 is obtained. Here, it is preferable that the flat portion 82 has a center of gravity of a cross section perpendicular to the central axis of the inner cylinder member 4a substantially coincident with the central axis 21 of the inner cylinder member 4a. Thereby, the planarity in the curved part near the distal end of the catheter 2 can be further enhanced. The main body portion 80 and the flat portion 82 have lengths of 10 to 200 mm and 10 to 100 mm, respectively, and the flat portion 82 is disposed within a range of 10 to 300 mm from the distal end of the catheter 2.

  As shown in FIGS. 6 and 9, coil receiving portions 85 and 87 are formed in the first lumen 20 and the second lumen 22, respectively. One end of each of the closely wound coils 90 and 92 is locked to the coil receiving portions 85 and 87, respectively, and the other end of each of the closely wound coils 90 and 92 extends in the proximal end direction and extends into the outer cylindrical member 4b. Yes. The operation wires 40 and 42 are inserted through the closely wound coils 90 and 92, respectively. In the closely wound coils 90 and 92, since the coil wires have a rectangular shape in cross section and the coil wires are in contact with each other in a plane, the force in the direction in which the tubular member 4 is compressed is generated by the sliding of the operation wires 40 and 42. Can withstand. Therefore, the tightly wound coils 90 and 92 can reduce the bending in the proximal end region of the catheter 2, thereby reducing the possibility of damaging the blood vessel into which the catheter 2 is inserted.

  Further, from the proximal end side of the tubular member 4 to a predetermined position, a blade (not shown) may be embedded in the outer cylinder member 4b as a reinforcing member. Thereby, the rigidity in the proximal end side of the tubular member 4 can be improved. The blade may be formed of a metal such as stainless steel, tungsten, gold, titanium, silver, copper, platinum, or iridium, or an alloy of these metals. The blade may also be formed of a non-metallic material, such as polyparaphenylene terephthalamide fiber, liquid crystal polymer fiber or glass fiber.

  Summarizing the operational effects of the configuration described above, in the catheter 2 of the present embodiment, the tubular member 4 protrudes from the tubular main body 80 and the main body 80 in the axial direction, and a flat portion having a flat cross-sectional shape perpendicular to the axis. The inner cylinder member 4a having 82 is provided. The operation wire 40 is slidably inserted into the first lumen 20 formed on the first surface 84 side of the flat portion 82, and the operation wire 42 is inserted into the second lumen 22 formed on the second surface 86 side. It is slidably inserted. Therefore, flatness is obtained in the curved portion near the distal end of the catheter 2 by the flat portion 82. In addition, since the flatness of the curved portion is obtained by the structure of the inner cylinder member 4a, the distal end of the catheter 2 can be obtained with a smaller number of parts and cost compared to the case where the flatness is obtained using a spring plate or the like. Flatness in the curved portion near the end can be obtained.

  The flat portion 82 has a first surface 84 and a second surface 86 that are tapered. Therefore, since the flat part 82 can be formed by preparing a tube material having the length of the inner cylinder member 4a and cutting one end of the tube material into a tapered shape, the inner cylinder can be formed by a simple method. The member 4a can be manufactured.

  Furthermore, when obtaining flatness in the curved portion of the catheter 2 using a spring plate, it is difficult to increase the number of lumens or the lumen diameter due to the presence of the spring plate. In the present embodiment, since flatness is obtained without using a spring plate, the number of lumens or the lumen diameter can be increased by the amount of no spring plate. As a result, the number of conducting wires or the like that can be inserted into the tubular member 4 can be increased, and the number of ring-shaped electrodes that can be provided on the catheter 2 can be increased.

(Embodiment 2)
In the catheter 2 according to the second embodiment, the structure of the inner cylinder member 4a is different from that of the first embodiment. Specifically, the flat portion 82 of the inner cylinder member 4a is different from the first embodiment in that the first surface 84 and the second surface 86 have a flat plate portion 88 that is parallel to each other. Hereinafter, this embodiment will be described. The other configurations of the catheter 2 are basically the same as those in the first embodiment. The same components as those in the first embodiment are denoted by the same reference numerals, and the description thereof is omitted as appropriate.

  10 is a perspective view of the inner cylinder member 4a in the catheter according to Embodiment 2 as viewed from the distal end direction, FIG. 11 is a top view of the inner cylinder member 4a, and FIG. 12 is a view of the inner cylinder member 4a. It is the perspective view seen from the distal end direction.

  As shown in FIGS. 10-12, the flat part 82 of the inner cylinder member 4a in this embodiment has the flat plate part 88 in which the 1st surface 84 and the 2nd surface 86 are mutually parallel. Further, the first surface 84 and the second surface 86 are also parallel to the central axis 21 of the tubular member 4. When the operation wire 40 and the operation wire 42 are inserted through the first lumen 20 and the second lumen 22, respectively, the flat plate portion 88 extends between the operation wire 40 and the operation wire 42. It becomes. Of the first surface 84 and the second surface 86, a portion between the distal end side of the main body portion 80 and the proximal end side of the flat plate portion 88 is tapered with respect to the central axis 21 of the tubular member 4. It has become. The third lumen 24 and the fourth lumen 26 are provided in the cross section of the flat plate portion 88.

  Or as the inner cylinder member 4a in this embodiment, the thing of the following aspects may be sufficient. 13 is a perspective view of another aspect of the inner cylinder member 4a in the catheter according to Embodiment 2 as viewed from the distal end direction, FIG. 14 is a top view of the inner cylinder member 4a, and FIG. 15 is the inner cylinder. It is the perspective view seen from the proximal end direction of the member 4a.

  As shown in FIGS. 13 to 15, the flat portion 82 of the inner cylindrical member 4 a has a flat plate portion 88 in which the first surface 84 and the second surface 86 are parallel to each other, as in the above-described aspect. A third lumen 24 and a fourth lumen 26 are provided in the cross section of the portion 88. Of the first surface 84 and the second surface 86, a portion between the distal end side of the main body portion 80 and the proximal end side of the flat plate portion 88 is orthogonal to the central axis 21 of the tubular member 4. ing.

  As described above, in the catheter 2 according to the second embodiment, the flat portion 82 has the flat plate portion 88. Therefore, it becomes more difficult to bend in the direction orthogonal to the direction connecting the first lumen 20 and the second lumen 22. Therefore, it is possible to more surely obtain the flatness in the curved portion near the distal end of the catheter 2. Moreover, since the planarity of the curved portion is obtained by the structure of the inner cylinder member 4a as in the first embodiment, the number of parts and the cost are reduced compared to the case where the planarity is obtained by using a spring plate or the like. Thus, planarity in the curved portion of the distal end portion of the catheter 2 can be obtained.

  Further, since the third lumen 24 and the fourth lumen 26 are formed in the cross section of the flat plate portion 88, the number of lumens can be increased while obtaining the flatness of the curved portion of the catheter 2.

  The present invention is not limited to the above-described embodiments, and various modifications such as design changes can be added based on the knowledge of those skilled in the art, and the embodiments to which such modifications are added are also possible. It can be included in the scope of the present invention.

  For example, in each of the above-described embodiments, the configuration in which the distal end portion of the catheter 2 is bent in two directions using the two operation wires 40 and 42 is shown, but the single operation wire is used. Even if the distal end portion of the catheter 2 is curved in one direction, the same effect can be obtained by applying the present invention.

  Further, in each of the above-described embodiments, the inner cylinder member 4a is formed by two types of members having different flexibility, and the outer cylinder member 4b is formed by three types of members having different flexibility. However, the number of members having different flexibility forming the tubular member 4 is not particularly limited. Further, the flexibility of each member is not particularly limited as long as the distal end side is relatively flexible and the proximal end side is relatively low flexibility. In addition, it becomes possible to bend the tubular member 4 more freely, so that there are many kinds of members used for the tubular member 4. FIG.

1 is a side view of a catheter according to Embodiment 1. FIG. It is a top view of a catheter. It is sectional drawing on the BB line of FIG. 1 in a catheter. It is sectional drawing on the CC line of FIG. 1 in a catheter. It is sectional drawing on the DD line of FIG. 2 in a catheter. It is sectional drawing on the EE line of FIG. 1 in the tubular member of a catheter. It is the perspective view seen from the distal end direction of the inner cylinder member. It is a top view of an inner cylinder member. It is the perspective view seen from the proximal end direction of the inner cylinder member. It is the perspective view which looked at one mode of the inner cylinder member in the catheter concerning Embodiment 2 from the distal end direction. It is a top view of an inner cylinder member. It is the perspective view seen from the proximal end direction of the inner cylinder member. It is the perspective view which looked at the other aspect of the inner cylinder member from the distal end direction. It is a top view of an inner cylinder member. It is the perspective view seen from the proximal end direction of the inner cylinder member.

Explanation of symbols

  2 catheter, 4 tubular member, 4a inner cylinder member, 4b outer cylinder member, 6 handle, 7 knob, 10 tip electrode, 12a, 12b, 12c ring electrode, 20 first lumen, 21 central axis, 22 second lumen , 24 3rd lumen, 26 4th lumen, 40, 42 operation wire, 50 tip electrode electrode conductor, 60a, 60b, 60c ring electrode conductor, 80 body part, 82 flat part, 84 first surface, 86 first surface Two surfaces, 85, 87 Coil receiving part, 88 Flat plate part, 90, 92 Closely wound coil.

Claims (6)

For a wire formed on the one surface side of the flat portion having a tubular main body portion and a flat portion protruding in the axial direction from the proximal end side of the main body portion and having a flat cross-sectional shape orthogonal to the axis A bendable inner cylindrical member in which a plurality of lumens including a lumen are formed along an axial direction;
A bendable outer cylinder member covering the inner cylinder member;
An operation wire that is slidably inserted into the wire lumen and one end of which is fixed on the distal end side of the flat portion, and
An operation unit connected to the other end of the operation wire and capable of pulling the operation wire;
A catheter comprising: Other wire lumens formed on the other surface side of the flat part,
Another operation wire that is slidably inserted into the other wire lumen and one end of which is fixed on the distal end side of the flat portion;
The catheter according to claim 1, further comprising:   The catheter according to claim 1 or 2, wherein a center of gravity of the cross section of the flat portion substantially coincides with a central axis of the inner cylinder member.   The catheter according to any one of claims 1 to 3, wherein the flat portion has a tapered shape on the one surface and the other surface.   The catheter according to any one of claims 1 to 3, wherein the flat portion has a flat plate portion in which the one surface and the other surface are parallel to each other.   The catheter according to claim 5, wherein a lumen is formed in a cross section of the flat plate portion.

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