WO2009125575A1

WO2009125575A1 - Catheter

Info

Publication number: WO2009125575A1
Application number: PCT/JP2009/001594
Authority: WO
Inventors: 森謙二
Original assignee: 日本ライフライン株式会社
Priority date: 2008-04-11
Filing date: 2009-04-06
Publication date: 2009-10-15
Also published as: JP4362536B2; KR101035748B1; CN101932356B; JP2009254423A; KR20100124355A; CN101932356A; HK1146715A1

Abstract

A catheter is provided with a flexible tubular member (4) having formed therein lumens extending in the axial direction thereof, and also with an operating wire slidably inserted in any one of the lumens and having one end connected to the distal end of the tubular member (4). The lumen through which the operating wire is inserted is formed at a position including the central axis of the tubular member (4). The tubular member (4) is formed by joining together a member (4a₁) mounted on the distal side of the tubular member and having relatively high flexibility and a member (4a₂) mounted on the proximal side of the tubular member and having relatively low flexibility. The distance from the proximal end of the tubular member (4) to a joint surface (80) between the members having different flexibility decreases stepwise or continuously in a specific direction.

Description

catheter

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, conventionally, an operation wire is 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).

JP 2000-288095 A

In the conventional multi-lumen catheter, the operation wire is inserted into the eccentric lumen. For this reason, there is a possibility that an eccentric force is applied to the entire catheter by pulling the operation wire, and the vicinity of the proximal end of the catheter is also curved.

The present invention has been made in view of such problems, and an object of the present invention is to reduce the possibility that the vicinity of the proximal end of the catheter is curved and to bend the vicinity of the distal end in a predetermined curve shape. On offer.

One embodiment of the present invention is a catheter. The catheter is composed of a relatively flexible member disposed on the distal end side and a relatively inflexible member disposed on the proximal end side. A low-flexibility member is joined so that a highly flexible member has a tapered joining surface that narrows from the distal end side toward the proximal end side, and a plurality of lumens are formed along the axial direction. And an operation wire that is slidably inserted into a lumen formed at a position including the central axis of the tubular member among the plurality of lumens, and has one end connected to the vicinity of the distal end of the tubular member And.

According to this aspect, it is possible to reduce the possibility that the vicinity of the proximal end of the catheter is bent and to bend the vicinity of the distal end with a predetermined curve shape.

In the catheter of the above aspect, the joint surface may be a plane inclined with respect to the central axis of the tubular member. The lumen through which the operation wire is inserted may be formed at a position where the central axis thereof coincides with the central axis of the tubular member.

The tubular member includes an inner cylinder member having a plurality of lumens and an outer cylinder member that covers the inner cylinder member, and both the inner cylinder member and the outer cylinder member are joined by a plurality of members having different flexibility. And the position of each joint surface of an inner cylinder member and an outer cylinder member may shift | deviate to the axial direction of a tubular member.

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

According to the present invention, it is possible to reduce the risk of the vicinity of the proximal end of the catheter being curved and to curve the vicinity of the distal end with a predetermined curve shape.

1 is a side view of a catheter according to Embodiment 1. FIG. 1 is a top view of a catheter according to Embodiment 1. FIG. FIG. 3 is a cross-sectional view of the catheter according to Embodiment 1 taken along the line BB in FIG. FIG. 2 is a cross-sectional view taken along the line CC of FIG. 1 in the catheter according to the first embodiment. FIG. 3 is a cross-sectional view taken along the line DD in FIG. 2 in the catheter according to the first embodiment. FIG. 2 is a cross-sectional view taken along the line EE of FIG. 1 in the catheter according to the first embodiment. In the cross-sectional view, only the tubular member is illustrated. 6 is a side view of a catheter according to Embodiment 2. FIG. 6 is a top view of a catheter according to Embodiment 2. FIG. FIG. 8 is a cross-sectional view taken along the line FF in FIG. 7 in the catheter according to the second embodiment. In the cross-sectional view, only the tubular member is illustrated.

Hereinafter, embodiments of the present invention will be described 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. 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. A lead wire electrically connected to the tip electrode 10 and the ring-

shaped electrodes

12a, 12b, and 12c extends from the handle 6. 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 tubular member 4 has a hollow structure having a plurality of lumens formed along the axial direction as will be described later. 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.

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, in the lumen formed in the axial direction of the tubular member 4, the lead wires connected to the tip electrode 10 and the

ring electrodes

12a, 12b, and 12c shown in FIGS. 1 and 2 are insulated from each other. Passed in state. 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 the like. The outer diameters of the tip electrode 10 and the ring-

shaped electrodes

12a, 12b, 12c are not particularly limited, but are preferably about the same as the outer diameter of the tubular member 4, and are usually 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. 4 is a cross-sectional view taken along the line CC of FIG. 1 in the catheter according to the first embodiment. 5 is a cross-sectional view of the catheter according to Embodiment 1 taken along the line DD in FIG.

As shown in FIGS. 3 to 5, the tubular member 4 includes an inner cylinder member 4a having a plurality of lumens and an outer cylinder member 4b covering the inner cylinder member 4a. The inner cylinder member 4a has an axial direction. A first lumen 20, a second lumen 22, a third lumen 24, a fourth lumen 26 and a fifth lumen 28 are formed. The first lumen 20 is formed at a position including the central axis 21 of the tubular member 4. Preferably, the first lumen 20 is formed at a position where the central axis thereof coincides with the central axis 21 of the tubular member 4. Around the first lumen 20, a second lumen 22, a third lumen 24, a fourth lumen 26 and a fifth lumen 28 are formed. In the present embodiment, the second lumen 22 and the third lumen 24 are provided at positions facing each other across the central axis 21 of the tubular member 4, and the fourth lumen 26 and the fifth lumen 28 are tubular. The members 4 are provided at positions facing each other across the central axis 21. In addition, as long as the lumen is formed at a position including the central axis 21 of the tubular member 4, the number of lumens formed around the lumen is 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.

The diameter of the inner cylinder member 4a in this embodiment is about 1.85 mm. The diameter of the first lumen 20 is about 0.1R to 0.45R, where R is the diameter of the tubular member 4. The diameters of the second lumen 22, the third lumen 24, the fourth lumen 26, and the fifth lumen 28 are 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 is about 0.45 mm, and the diameters of the second lumen 22, the third lumen 24, the fourth lumen 26, and the fifth lumen 28 are about 0.47 mm. .

The operation wire 40 is slidably inserted into the first lumen 20. A spherical anchor 42 having a diameter larger than that of the operation wire 40 in the first lumen 20 is formed at the distal end of the operation wire 40. 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 end of the operation wire 40 is embedded in the solder 12, and the distal end of the operation wire 40 is fixed to the solder 30 and the tip electrode 10, thereby connecting the distal end of the tubular member 4. Has been. Further, as described above, the proximal end of the operation wire 40 is fixed to the knob 7 of the handle 6. Accordingly, by operating the knob 7 shown in FIGS. 1 and 2, the operation wire 40 is pulled, and the distal end of the catheter 2 can be swung in the direction of arrow A in FIGS. 2, 4 and 6. ing. In this embodiment, since the anchor 42 is provided at the distal end of the operation wire 40, the distal end of the operation wire 40 is difficult to come out of the solder 30. Thereby, the operation reliability of the catheter 2 can be improved.

Further, a conducting wire 50 is inserted through the second lumen 22. The distal end of the conductive wire 50 is embedded in the solder 30. Thereby, the conducting wire 50 and the tip chip electrode 10 are electrically connected via the solder 30.

Conductive wires

60 a, 60 b and 60 c are inserted through the third lumen 24. The distal ends of the conducting

wires

60a, 60b, 60c are fixed to the ring-shaped

electrodes

12a, 12b, 12c by solder (not shown), respectively, and are thereby electrically connected to the ring-shaped

electrodes

12a, 12b, 12c, respectively.

As shown in FIG. 5, a thermocouple 70 as a temperature sensor is inserted into the fourth lumen 26. The thermocouple 70 can sense the temperature near the distal end of the catheter. The fifth lumen 28 is a spare lumen. For example, when a ring-shaped electrode is added, a conductive wire connected to the increased ring-shaped electrode can be inserted into the fifth lumen 28.

FIG. 6 is a cross-sectional view of the tubular member 4 of the catheter according to the first embodiment, taken along the line EE of FIG. In the cross-sectional view, only the tubular member 4 is illustrated.

As shown in FIG. 6, the inner cylindrical member 4a of the tubular member 4 is relatively flexible, which is disposed on the distal end side high member 4a ₁ and the proximal end side of the deployed relatively flexible It is composed of a lower member 4a _2. In the present embodiment, the Shore D hardness of the member 4a ₁ is 35 to 72, and the Shore D hardness of the member 4a ₂ is 63 to 80.

The highly flexible member 4 a ₁ and the low flexible member 4 a ₂ are tapered such that the highly flexible member 4 a ₁ becomes thinner from the distal end side to the proximal end side of the tubular member 4. Are joined so as to have a joining surface 80 of That is, the distance from the proximal end of the tubular member 4 to the joint surface 80 between the

members

4a ₁ and 4a _{2 having} different flexibility is gradually reduced in a certain direction stepwise or continuously. For example, the joint surface 80 is a flat surface inclined with respect to the central axis 21 of the tubular member 4. Specifically, to an end point 80b located at a predetermined distance R1 (for example, a distance of about 4R when the diameter of the tubular member 4 is R) from the start point 80a of the joining surface 80 (hereinafter referred to as a region R1). The joining surface 80 is tapered with respect to the axis of the tubular member 4. Therefore, in the region R1, in sectional view perpendicular to the central axis 21 of the tubular member 4, the proximal end ratio of the cross-sectional area of the high member 4a ₁ of flexibility from the distal end side to total cross-sectional area of the tubular member 4 It is getting smaller toward the side. The region R1 where the joining surface 80 exists is provided in a range of about 20 to 200 mm from the distal end, for example.

Here, since the operation wire 40 is located on the central axis 21 of the tubular member 4, when the operation wire 40 is pulled, a force in the contraction direction is applied to the tubular member 4. At this time, in the region R1, the flexibility of the tubular member 4 is biased in a cross-sectional view orthogonal to the central axis 21 of the tubular member 4, a region having high flexibility on one side and low flexibility on the other side. An area exists. Therefore, when a force in the contraction direction is applied to the tubular member 4, in the region R <b> 1 where the joint surface 80 exists, the tubular member 4 tilts toward the side where the highly flexible region exists (upward in FIG. 6). Power is generated. As a result, the tubular member 4 is curved to the side where the highly flexible region is present in the region R1, and the far end portion of the tubular member 4 is deflected in the direction of arrow A in FIGS. In the region R1, the proportion of highly flexible members gradually increases from the proximal end side to the distal end side of the tubular member 4 in a cross-sectional view orthogonal to the central axis 21 of the tubular member 4, so In R1, it bends gradually. On the other hand, in the region other than the region R1, the flexibility of the tubular member 4 is uniform and uniform, so that a force in the direction in which the tubular member 4 tilts does not occur and a force in the contraction direction parallel to the central axis 21 is applied. Only. Therefore, the tubular member 4 is not curved except in the region R1, and the linearity is maintained.

The curve shape of the tubular member 4 in the region R1 can be freely designed according to the taper angle of the joint surface 80 in the region R1. Moreover, since the joining surface 80 faces a certain direction, the direction in which the tubular member 4 bends is limited to a certain direction.

As shown in FIG. 6, a blade 90 is embedded as a reinforcing member in the outer cylinder member 4b of the tubular member 4 from the proximal end side of the tubular member 4 to a predetermined position. Thereby, the rigidity in the proximal end side of the tubular member 4 can be improved. The blade 90 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 90 may be formed of a non-metallic material, for example, polyparaphenylene terephthalamide fiber, liquid crystal polymer fiber, or glass fiber.

In the catheter 2 of the present embodiment, the operation wire 40 is slidably inserted through the first lumen 20 formed at a position including the central axis 21 of the tubular member 4. Further, the tubular member 4 is formed by joining the relatively flexible member 4a ₁ disposed on the distal end side and the relatively inflexible member 4a ₂ disposed on the proximal end side. The distance between the joint surface 80 and the proximal end of the tubular member 4 is shortened stepwise or continuously in a certain direction. Thereby, when the operation wire 40 is pulled, a force in a direction in which the tubular member 4 tilts in a certain direction is generated in the region R1 where the joining surface 80 exists, and only a force in the expansion / contraction direction is generated in a region other than the region R1. It takes. As a result, the possibility of the vicinity of the proximal end of the catheter 2 being curved can be reduced, and the vicinity of the distal end can be curved with a predetermined curved shape. Thereby, the possibility of damaging the blood vessel into which the catheter 2 is inserted can be reduced.

(Embodiment 2)
FIG. 7 is a side view of the catheter according to the second embodiment. FIG. 8 is a top view of the catheter according to the second embodiment. 9 is a cross-sectional view of the tubular member 4 of the catheter according to the second embodiment, taken along the line FF of FIG. In the cross-sectional view of FIG. 9, only the tubular member 4 is illustrated.

As shown in FIGS. 7 to 9, in the catheter 2 of the second embodiment, not only the inner cylinder member 4a of the tubular member 4 but also the outer cylinder member 4b are formed by joining members having different flexibility. That is, in the inner cylindrical member 4a, a high member 4a ₁ relatively flexible disposed on a distal end side and the lower member 4a ₂ relatively flexible, which is disposed at the proximal end side is joined Yes. Further, the outer tubular member 4b, a high member 4b ₁ with relatively flexible disposed at the distal end side, flexible than member 4b ₁ which is disposed adjacent the proximal end of the member 4b ₁ a member 4b ₂ low, and low member 4b ₃ flexible are joined than member 4b ₂ disposed adjacent to the proximal end side of the member 4b _2. In the present embodiment, the Shore D hardness of the member 4a ₁ is 35 to 72, and the Shore D hardness of the member 4a ₂ is 63 to 80. Further, the Shore D hardness of the member 4b ₁ is 20 to 48, the Shore D hardness of the member 4b ₂ is 35 to 72, and the Shore D hardness of the member 4b ₃ is 63 to 80.

Further, the

members

4a ₁ , 4b ₁ , 4b ₂ having high flexibility with respect to the members adjacent to the proximal end side are tapered such that each of the tubular members 4 becomes thinner from the distal end side toward the proximal end side. The joint surfaces 80, 82, and 84 are provided. That is, the joint surface 80 of the

members

4a ₁ and 4a ₂ having different flexibility, the joint surface 82 of the

members

4b ₁ and 4b _2, and the joint surface 84 of the

members

4b ₂ and 4b ₃ are the proximal ends of the tubular member 4. The distance from is shortened stepwise or continuously in a certain direction. For example, the joining

surfaces

80, 82, 84 are flat surfaces inclined with respect to the central axis 21 of the tubular member 4. Specifically, predetermined distances R1, R2, and R3 from the

respective starting points

80a, 82a, and 84a of the joining

surfaces

80, 82, and 84 (for example, when the diameter of the tubular member 4 is R, about 6R and 4R, respectively). , 6R) to the

end points

80b, 82b, 84b (hereinafter referred to as regions R1, R2, R3, respectively), the joining

surfaces

80, 82, 84 are tapered with respect to the axis of the tubular member 4. It has become. For this reason, in the regions R1, R2, and R3, the proportion of the

members

4a ₁ , 4b ₁ , and 4b ₂ having relatively high flexibility is increased from the proximal end side to the distal end side. Further, the joining

surfaces

80, 82, and 84 are arranged so as to be offset in the axial direction of the tubular member 4, and in this embodiment, the regions R1, R2, and R3 are about 20 to 40 mm, 30 from the distal end, respectively. It is provided in a range of ˜60 mm and 40˜200 mm.

As in the first embodiment, when the operation wire 40 is pulled, a force in the contraction direction is applied to the tubular member 4. When a force in the contraction direction is applied to the tubular member 4, in the regions R1, R2, and R3, a force in a direction in which the tubular member 4 tilts is generated on the side where the highly flexible region exists (upward in FIG. 9). As a result, the tubular member 4 is curved to the side where the highly flexible region exists in the regions R1, R2, and R3, and the far end portion of the tubular member 4 is deflected in the direction of arrow A in FIGS. In the regions R1, R2, and R3, the ratio of the cross-sectional area of the highly flexible member occupying the cross-sectional area of the tubular member 4 from the distal end side to the proximal end side in a cross-sectional view orthogonal to the central axis 21 of the tubular member 4 Since it gradually decreases, the tubular member 4 is gradually curved in the regions R1, R2, and R3. On the other hand, since the flexibility of the tubular member 4 is uniform and uniform in the regions other than the regions R1, R2, and R3, a force in the direction in which the tubular member 4 tilts does not occur, and the contraction direction parallel to the central axis 21 It only takes the power of. Therefore, the tubular member 4 is not curved except in the region R1, and the linearity is maintained.

In the catheter 2 of the present embodiment, in addition to the configuration of the catheter 2 of the first embodiment, a plurality of

members

4b ₁ , 4b ₂ , 4b ₃ having different outer cylinder members 4b are joined. And the position of each

joint surface

80,82,84 of the inner cylinder member 4a and the outer cylinder member 4b has shifted | deviated to the axial direction of the tubular member 4. FIG. Therefore, when the operation wire 40 is pulled, a force in a direction in which the tubular member 4 tilts in a certain direction is generated in the regions R1, R2, and R3. As a result, the vicinity of the distal end can be curved with a more free curve shape, and the operability of the catheter 2 is further improved.

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.

In the first and second embodiments described above, the inner cylinder member 4a of the tubular member 4 is formed of two types of members having different flexibility. In the second embodiment, the outer cylinder member 4b is formed of three types of members having different flexibility. However, the number of members having different flexibility forming the tubular member 4 is not particularly limited, and may be two or more types. 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.

The present invention can be used for a catheter.

2 Catheter, 4 Tubular member, 4a Inner tube member, 4b Outer tube member, 6 Handle, 7 Pick, 10 Tip tip electrode, 12a, 12b, 12c Ring electrode, 20 First lumen, 22 Second lumen, 24 3rd lumen, 26, 4th lumen, 28, 5th lumen, 30 solder, 40 operation wire, 50, 60a, 60b, 60c conductor, 90 blade.

Claims

It is composed of a relatively flexible member disposed on the distal end side and a relatively inflexible member disposed on the proximal end side, and the highly flexible member and the low flexibility member The member is joined so that the highly flexible member has a tapered joining surface that becomes narrower from the distal end side toward the proximal end side, and a plurality of lumens are formed along the axial direction. A tubular member,
An operation wire that is slidably inserted into a lumen formed at a position including the central axis of the tubular member among the plurality of lumens, and has one end connected to the vicinity of the distal end of the tubular member;
A catheter comprising:
The catheter according to claim 1, wherein the joint surface is a plane inclined with respect to a central axis of the tubular member.
The catheter according to claim 1 or 2, wherein the lumen through which the operation wire is inserted is formed at a position where a central axis thereof coincides with a central axis of the tubular member.
The tubular member consists of an inner cylinder member in which the plurality of lumens are formed, and an outer cylinder member that covers the inner cylinder member,
A plurality of members having different flexibility are joined to both the inner cylinder member and the outer cylinder member,
The catheter according to any one of claims 1 to 3, wherein a position of each joint surface of the inner cylinder member and the outer cylinder member is shifted in an axial direction of the tubular member.