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WO2009125575A1 - Catheter - Google Patents

Catheter Download PDF

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Publication number
WO2009125575A1
WO2009125575A1 PCT/JP2009/001594 JP2009001594W WO2009125575A1 WO 2009125575 A1 WO2009125575 A1 WO 2009125575A1 JP 2009001594 W JP2009001594 W JP 2009001594W WO 2009125575 A1 WO2009125575 A1 WO 2009125575A1
Authority
WO
WIPO (PCT)
Prior art keywords
tubular member
lumen
catheter
distal end
central axis
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2009/001594
Other languages
French (fr)
Japanese (ja)
Inventor
森謙二
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Japan Lifeline Co Ltd
Original Assignee
Japan Lifeline Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Japan Lifeline Co Ltd filed Critical Japan Lifeline Co Ltd
Priority to CN200980103500.5A priority Critical patent/CN101932356B/en
Priority to HK11100818.7A priority patent/HK1146715B/en
Publication of WO2009125575A1 publication Critical patent/WO2009125575A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0141—Tip steering devices having flexible regions as a result of using materials with different mechanical properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A61M2025/015—Details of the distal fixation of the movable mechanical means

Definitions

  • 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. .
  • 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.
  • the vicinity of the distal end of the catheter is required to be bendable with a predetermined curve shape.
  • 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.
  • 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.
  • 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
  • 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.
  • FIG. 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. 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.
  • 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.
  • 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.
  • 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.
  • FIG. 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.
  • 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.
  • 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.
  • a second lumen 22, a third lumen 24, a fourth lumen 26 and a fifth lumen 28 are formed.
  • 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.
  • 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.
  • the diameter of the first lumen 20 is about 0.45 mm
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the Shore D hardness of the member 4a 1 is 35 to 72
  • 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.
  • the joint surface 80 is a flat surface inclined with respect to the central axis 21 of the tubular member 4.
  • a region R1 a distance of about 4R when the diameter of the tubular member 4 is R
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the inner cylinder member 4a of the tubular member 4 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.
  • 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.
  • the Shore D hardness of the member 4a 1 is 35 to 72
  • the Shore D hardness of the member 4a 2 is 63 to 80.
  • 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
  • the Shore D hardness of the member 4b 3 is 63 to 80.
  • 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.
  • the joining surfaces 80, 82, 84 are flat surfaces inclined with respect to the central axis 21 of the tubular member 4.
  • 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
  • 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.
  • 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.
  • 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.
  • 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
  • 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 inner cylinder member 4a of the tubular member 4 is formed of two types of members having different flexibility.
  • the outer cylinder member 4b is formed of three types of members having different flexibility.
  • the number of members having different flexibility forming the tubular member 4 is not particularly limited, and may be two or more types.
  • 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.
  • the present invention can be used for a catheter.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

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

カテーテルcatheter

　本発明は、カテーテルに関する。より具体的には、本発明は、体外に配置される近位端側の操作部を操作することにより、体腔内に挿入された遠位端近傍の向きを容易に変化させることができるカテーテルに関する。 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. .

　血管を通して心臓の内部まで挿入される電極カテーテルなどのカテーテルでは、体内に挿入されたカテーテルの遠位端（先端）の向きが、体外に配置されるカテーテルの近位端（基端または手元側）に装着された操作部を操作することにより偏向される。カテーテルを心臓の内部などの所望の部位にスムースに挿入するために、カテーテルの遠位端近傍は所定のカーブ形状で湾曲可能であることが求められる。 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.

　複数のルーメンが軸方向に沿って形成された、いわゆるマルチルーメンカテーテルでは、従来、カテーテルの中心軸からずれた位置に形成されたルーメン内に操作用ワイヤを挿通していた。そして、操作部において操作用ワイヤを引っ張ることで、ルーメンの偏芯方向、すなわち管状部材の中心軸からずれた側にカテーテルの遠位端近傍を湾曲させて、遠位端の向きを偏向していた（特許文献１参照）。 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).

特開２０００－２８８０９５号公報JP 2000-288095 A

　従来のマルチルーメンカテーテルでは、操作用ワイヤを偏芯したルーメン内に挿通していた。そのため、操作用ワイヤの引っ張りによってカテーテル全体に偏芯方向の力がかかり、カテーテルの近位端近傍も湾曲してしまうおそれがあった。 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.

　本発明はこうした課題に鑑みてなされたものであり、その目的は、カテーテルの近位端近傍が湾曲するおそれを低減するとともに、遠位端近傍を所定のカーブ形状で湾曲させることができる技術の提供にある。 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.

　本発明のある態様は、カテーテルである。当該カテーテルは、遠位端側に配置された相対的に柔軟性の高い部材と近位端側に配置された相対的に柔軟性の低い部材とで構成され、柔軟性の高い部材と柔軟性の低い部材とは柔軟性の高い部材が遠位端側から前記近位端側に向けて細くなるようなテーパ状の接合面を有するように接合され、複数のルーメンが軸方向に沿って形成された管状部材と、複数のルーメンのうち管状部材の中心軸を含む位置に形成されたルーメンにスライド可能に挿通され、一方の端部が管状部材の遠位端近傍に接続された操作用ワイヤと、を備えたことを特徴とする。 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.

　この態様によれば、カテーテルの近位端近傍が湾曲するおそれを低減するとともに、遠位端近傍を所定のカーブ形状で湾曲させることができる。 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.

　上記態様のカテーテルにおいて、接合面は、管状部材の中心軸に対して傾いた平面であってもよい。また、操作用ワイヤの挿通されたルーメンは、その中心軸が管状部材の中心軸と一致する位置に形成されていてもよい。 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.

　また、管状部材は複数のルーメンが形成された内筒部材と、内筒部材を覆う外筒部材とからなり、内筒部材および外筒部材の両方が柔軟性の異なる複数の部材が接合されており、内筒部材および外筒部材のそれぞれの接合面の位置が管状部材の軸方向にずれていてもよい。 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.

　なお、上述した各要素を適宜組み合わせたものも、本件特許出願によって特許による保護を求める発明の範囲に含まれうる。 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.

　本発明によれば、カテーテルの近位端近傍が湾曲するおそれを低減するとともに、遠位端近傍を所定のカーブ形状で湾曲させることができる。 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.

実施形態１に係るカテーテルの側面図である。1 is a side view of a catheter according to Embodiment 1. FIG. 実施形態１に係るカテーテルの上面図である。1 is a top view of a catheter according to Embodiment 1. FIG. 実施形態１に係るカテーテルにおける、図１のＢ－Ｂ線上の断面図である。FIG. 3 is a cross-sectional view of the catheter according to Embodiment 1 taken along the line BB in FIG. 実施形態１に係るカテーテルにおける、図１のＣ－Ｃ線上の断面図である。FIG. 2 is a cross-sectional view taken along the line CC of FIG. 1 in the catheter according to the first embodiment. 実施形態１に係るカテーテルにおける、図２のＤ－Ｄ線上の断面図である。FIG. 3 is a cross-sectional view taken along the line DD in FIG. 2 in the catheter according to the first embodiment. 実施形態１に係るカテーテルにおける、図１のＥ－Ｅ線上の断面図である。当該断面図では、管状部材のみを図示している。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. 実施形態２に係るカテーテルの側面図である。6 is a side view of a catheter according to Embodiment 2. FIG. 実施形態２に係るカテーテルの上面図である。6 is a top view of a catheter according to Embodiment 2. FIG. 実施形態２に係るカテーテルにおける、図７のＦ－Ｆ線上の断面図である。当該断面図では、管状部材のみを図示している。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.

　以下、本発明の実施形態を図面を参照して説明する。なお、すべての図面において、同様の構成要素には同様の符号を付し、以下の説明において詳細な説明を適宜省略する。 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.

　（実施形態１）
　実施形態１に係るカテーテルは、先端偏向操作が可能な電極カテーテルであり、たとえば心臓における不整脈の診断または治療に好適に用いられる。 (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.

　図１は、実施形態１に係るカテーテルの側面図である。図２は、実施形態１に係るカテーテルの上面図である。図１および図２に示すように、実施形態１に係るカテーテル２は、管状部材４の遠位端部に先端チップ電極１０、およびリング状電極１２ａ、１２ｂ、１２ｃを有する。先端チップ電極１０およびリング状電極１２ａ、１２ｂ、１２ｃは、たとえば接着剤などを用いて管状部材４に固定されている。 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.

　管状部材４の近位端には、ハンドル６が装着されている。ハンドル６からは、先端チップ電極１０、およびリング状電極１２ａ、１２ｂ、１２ｃに電気的に接続される導線が延びている。また、ハンドル６には、管状部材４の先端部の偏向移動操作（首振り操作）を行うための摘み７が装着されている。 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.

　管状部材４は、後述するように軸方向に沿って形成された複数のルーメンを有する中空構造を有する。管状部材４の遠位端近傍は相対的に可撓性が高く、管状部材４の近位端近傍は相対的に可撓性が低い。 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.

　管状部材４の主要部は、たとえばポリオレフィン、ポリアミド、ポリエーテルポリアミド、ポリウレタンなどの合成樹脂で構成される。管状部材４の外径は、一般に０．６～３mm程度であり、長さは約１１５０～１２００ｍｍである。本実施形態では、管状部材４の径は約２．４ｍｍ、長さは約１１７０ｍｍである。後述するように、管状部材４の軸方向に形成されたルーメンには、図１および図２に示す先端チップ電極１０およびリング状電極１２ａ、１２ｂ、１２ｃにそれぞれ接続される導線が互いに絶縁された状態で通されている。またルーメンには操作用ワイヤが通されている。 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.

　先端チップ電極１０および複数のリング状電極１２ａ、１２ｂ、１２ｃは、たとえばアルミニウム、銅、ステンレス、金、白金など、電気伝導性の良好な金属で構成される。なお、Ｘ線に対する造影性を良好に持たせるためには、先端チップ電極１０およびリング状電極１２ａ、１２ｂ、１２ｃは、白金などで構成されることが好ましい。先端チップ電極１０およびリング状電極１２ａ、１２ｂ、１２ｃの外径は、特に限定されないが、管状部材４の外径と同程度であることが好ましく、通常、０．５～３mm程度である。 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.

　図３は、実施形態１に係るカテーテルにおける、図１のＢ－Ｂ線上の断面図である。図４は、実施形態１に係るカテーテルにおける、図１のＣ－Ｃ線上の断面図である。また、図５は、実施形態１に係るカテーテルにおける、図２のＤ－Ｄ線上の断面図である。 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.

　図３～図５に示すように、管状部材４は複数のルーメンが形成された内筒部材４ａと、内筒部材４ａを覆う外筒部材４ｂとからなり、内筒部材４ａには、軸方向に沿って第１のルーメン２０、第２のルーメン２２、第３のルーメン２４、第４のルーメン２６および第５のルーメン２８が形成されている。第１のルーメン２０は、管状部材４の中心軸２１を含む位置に形成されている。好ましくは第１のルーメン２０は、その中心軸が管状部材４の中心軸２１と一致する位置に形成される。第１のルーメン２０の周囲には、第２のルーメン２２、第３のルーメン２４、第４のルーメン２６および第５のルーメン２８が形成されている。本実施形態では、第２のルーメン２２と第３のルーメン２４とが管状部材４の中心軸２１を挟んで互いに対向する位置に設けられ、第４のルーメン２６と第５のルーメン２８とが管状部材４の中心軸２１を挟んで互いに対向する位置に設けられている。なお、管状部材４の中心軸２１を含む位置にルーメンが形成されていれば、その周囲に形成されるルーメンの数は特に限定されない。しかしながら、管状部材４の成型上、管状部材４の中心軸２１に対して対称構造となるようにルーメンが配置されていることが好ましい。 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.

　本実施形態における内筒部材４ａの径は、約１．８５ｍｍである。また、第１のルーメン２０の径は、管状部材４の直径をＲとしたとき、約０．１Ｒ～０．４５Ｒである。また、第２のルーメン２２、第３のルーメン２４、第４のルーメン２６および第５のルーメン２８の径は、管状部材４の直径をＲとしたとき、約０．１Ｒ～０．４５Ｒである。本実施形態では、第１のルーメン２０の径は約０．４５ｍｍ、第２のルーメン２２、第３のルーメン２４、第４のルーメン２６および第５のルーメン２８の径は約０．４７ｍｍである。 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. .

　第１のルーメン２０には、操作用ワイヤ４０がスライド可能に挿通されている。操作用ワイヤ４０の遠位端には、第１のルーメン２０内の操作用ワイヤ４０より径が大きい球形状のアンカー４２が形成されている。操作用ワイヤ４０の近位端は、図１および図２に示す摘み７に接続されている。 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.

　図４に示すように、先端チップ電極１０の内側に凹部１２が形成されている。この凹部１２に、はんだ３０が充填されている。操作用ワイヤ４０の遠位端は、はんだ１２に埋め込まれ、操作用ワイヤ４０の遠位端がはんだ３０および先端チップ電極１０に対して固定されることで管状部材４の遠位端近傍に接続されている。また、上述のように操作用ワイヤ４０の近位端はハンドル６の摘み７に固定されている。これにより、図１および図２に示す摘み７を操作することで操作用ワイヤ４０を引っ張り、カテーテル２の遠位端を図２、図４および図６の矢印Ａ方向に首振り偏向可能になっている。なお、本実施形態では、操作用ワイヤ４０の遠位端にアンカー４２が設けられているため、操作用ワイヤ４０の遠位端がはんだ３０から抜けにくくなっている。これにより、カテーテル２の動作信頼性を向上させることができる。 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.

　また、第２のルーメン２２に導線５０が挿通されている。導線５０の遠位端は、はんだ３０に埋め込まれている。これにより、はんだ３０を介して導線５０と先端チップ電極１０とが電気的に接続される。また、第３のルーメン２４に導線６０ａ、６０ｂ、６０ｃが挿通されている。導線６０ａ、６０ｂ、６０ｃの遠位端は、それぞれ図示しないはんだによりリング状電極１２ａ、１２ｂ、１２ｃに固定され、これによりそれぞれリング状電極１２ａ、１２ｂ、１２ｃに電気的に接続されている。 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.

　図５に示すように、第４のルーメン２６に温度センサとしてとしての熱電対７０が挿通されている。熱電対７０によって、カテーテルの遠位端近傍における温度を検知することができる。また、第５のルーメン２８は予備のルーメンであり、たとえばリング状電極が増設された場合に、増設されたリング状電極に接続される導線を第５のルーメン２８に挿通することができる。 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.

　図６は、実施形態１に係るカテーテルの管状部材４における、図１のＥ－Ｅ線上の断面図である。当該断面図では、管状部材４のみを図示している。 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.

　図６に示すように、管状部材４の内筒部材４ａは、遠位端側に配置された相対的に柔軟性の高い部材４ａ１と近位端側に配置された相対的に柔軟性の低い部材４ａ２とで構成されている。本実施形態では、部材４ａ１のショアＤ硬度が３５～７２であり、部材４ａ２のショアＤ硬度が６３～８０である。 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.

　そして、柔軟性の高い部材４ａ１と柔軟性の低い部材４ａ２とは、柔軟性の高い部材４ａ１が管状部材４の遠位端側から近位端側に向けて細くなるようなテーパ状の接合面８０を有するように接合されている。すなわち、管状部材４の近位端から柔軟性の異なる部材４ａ１、４ａ２同士の接合面８０までの距離が一定方向に段階的あるいは連続的に短くなっている。たとえば、接合面８０は、管状部材４の中心軸２１に対して傾いた平面となっている。具体的には、接合面８０の開始点８０ａから所定の距離Ｒ１（たとえば、管状部材４の直径をＲとしたとき、約４Ｒの距離）に位置する終点８０ｂまで（以下、領域Ｒ１とよぶ）、接合面８０は管状部材４の軸に対して傾いたテーパ状となっている。そのため、領域Ｒ１においては、管状部材４の中心軸２１に直交する断面視で、管状部材４の断面積に占める柔軟性の高い部材４ａ１の断面積の割合が遠位端側から近位端側にかけて小さくなっている。接合面８０の存在する領域Ｒ１は、たとえば遠位端から約２０～２００ｍｍの範囲に設けられる。 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.

　ここで、操作用ワイヤ４０が管状部材４の中心軸２１に位置するため、操作用ワイヤ４０を引っ張ると、管状部材４には収縮方向の力がかかる。このとき、領域Ｒ１では、管状部材４の中心軸２１に直交する断面視で管状部材４の柔軟性に偏りがあり、一方の側に柔軟性の高い領域が、他方の側に柔軟性の低い領域が存在する。そのため、管状部材４に収縮方向の力がかかると、接合面８０の存在する領域Ｒ１においては、柔軟性の高い領域が存在する側（図６における上方向）に管状部材４が傾倒する方向の力が生じる。その結果、管状部材４は領域Ｒ１において柔軟性の高い領域が存在する側に湾曲し、管状部材４の遠異端部分が図２、図４および図６の矢印Ａ方向に偏向される。領域Ｒ１では管状部材４の中心軸２１に直交する断面視で管状部材４の近位端側から遠位端側にかけて徐々に柔軟性の高い部材の割合が増えていくため、管状部材４は領域Ｒ１において、徐々に湾曲する。一方、領域Ｒ１以外の領域では管状部材４の柔軟性に偏りがなく均一であるため、管状部材４が傾倒する方向の力が生じることはなく、中心軸２１に平行な収縮方向の力がかかるだけである。そのため、管状部材４は領域Ｒ１以外では湾曲せず、直線性が保たれている。 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.

　領域Ｒ１における管状部材４のカーブ形状は、領域Ｒ１における接合面８０のテーパの角度によって自在に設計することができる。また、接合面８０が一定方向を向いているため、管状部材４の曲がる方向が一定方向に制限される。 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.

　図６に示すように、管状部材４の近位端側から所定の位置まで、管状部材４の外筒部材４ｂに補強部材としてブレード９０が埋め込まれている。これにより、管状部材４の近位端側における剛性を高めることができる。ブレード９０は、ステンレス鋼、タングステン、金、チタン、銀、銅、白金、またはイリジウムなどの金属、またはこれらの金属の合金によって形成され得る。また、ブレード９０は、非金属材料、例えば、ポリパラフェニレンテレフタルアミド繊維、液晶ポリマー繊維またはガラス繊維によって形成されてもよい。 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.

　本実施形態のカテーテル２では、管状部材４の中心軸２１を含む位置に形成された第１のルーメン２０に操作用ワイヤ４０をスライド可能に挿通している。また、遠位端側に配置された相対的に柔軟性の高い部材４ａ１と近位端側に配置された相対的に柔軟性の低い部材４ａ２とを接合して管状部材４を形成し、接合面８０を管状部材４の近位端からの距離が一定方向に段階的あるいは連続的に短くなるようにした。これにより、操作用ワイヤ４０を引っ張った際に、接合面８０の存在する領域Ｒ１においては管状部材４が一定の方向に傾倒する方向の力が生じ、領域Ｒ１以外の領域では伸縮方向の力のみがかかる。その結果、カテーテル２の近位端近傍が湾曲するおそれが低減するとともに、遠位端近傍が所定のカーブ形状で湾曲できる。これにより、カテーテル２の挿入された血管などにダメージを与えてしまうおそれを低減できる。 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.

　（実施形態２）
　図７は、実施形態２に係るカテーテルの側面図である。図８は、実施形態２に係るカテーテルの上面図である。図９は、実施形態２に係るカテーテルの管状部材４における、図７のＦ－Ｆ線上の断面図である。図９の断面図では、管状部材４のみを図示している。 (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.

　図７～図９に示すように、実施形態２のカテーテル２では、管状部材４の内筒部材４ａだけでなく外筒部材４ｂについても柔軟性の異なる部材が接合されて形成されている。すなわち、内筒部材４ａでは、遠位端側に配置された相対的に柔軟性の高い部材４ａ１と近位端側に配置された相対的に柔軟性の低い部材４ａ２とが接合されている。また、外筒部材４ｂでは、遠位端側に配置された相対的に柔軟性の高い部材４ｂ１と、部材４ｂ１の近位端側に隣接して配置された部材４ｂ１よりも柔軟性の低い部材４ｂ２と、部材４ｂ２の近位端側に隣接して配置された部材４ｂ２よりも柔軟性の低い部材４ｂ３とが接合されている。本実施形態では、部材４ａ１のショアＤ硬度が３５～７２であり、部材４ａ２のショアＤ硬度が６３～８０である。また、部材４ｂ１のショアＤ硬度が２０～４８であり、部材４ｂ２のショアＤ硬度が３５～７２であり、部材４ｂ３のショアＤ硬度が６３～８０である。 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.

　そして、近位端側に隣接する部材に対して柔軟性の高い部材４ａ１、４ｂ１、４ｂ２がそれぞれ管状部材４の遠位端側から近位端側に向けて細くなるようなテーパ状の接合面８０、８２、８４を有している。すなわち、柔軟性の異なる部材４ａ１と４ａ２との接合面８０、部材４ｂ１と４ｂ２との接合面８２、部材４ｂ２と４ｂ３との接合面８４は、管状部材４の近位端からの距離が一定方向に段階的あるいは連続的に短くなっている。たとえば、接合面８０、８２、８４は、管状部材４の中心軸２１に対して傾いた平面となっている。具体的には、接合面８０、８２、８４のそれぞれの開始点８０ａ、８２ａ、８４ａから所定の距離Ｒ１、Ｒ２、Ｒ３（たとえば、管状部材４の直径をＲとしたとき、それぞれ約６Ｒ、４Ｒ、６Ｒの距離）に位置する終点８０ｂ、８２ｂ、８４ｂまで（以下、それぞれ領域Ｒ１、Ｒ２、Ｒ３とよぶ）、接合面８０、８２、８４は管状部材４の軸に対して傾いたテーパ状となっている。そのため、領域Ｒ１、Ｒ２、Ｒ３においては、それぞれ柔軟性の相対的に高い部材４ａ１、４ｂ１、４ｂ２の割合が近位端側から遠位端側にかけて大きくなっている。また、接合面８０、８２、８４は、管状部材４の軸方向にずれて配置されており、本実施形態においては、領域Ｒ１、Ｒ２、Ｒ３は、それぞれ遠位端から約２０～４０ｍｍ、３０～６０ｍｍ、４０～２００ｍｍの範囲に設けられている。 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.

　実施形態１の場合と同様に、操作用ワイヤ４０を引っ張ると、管状部材４には収縮方向の力がかかる。管状部材４に収縮方向の力がかかると、領域Ｒ１、Ｒ２、Ｒ３では、柔軟性の高い領域が存在する側（図９における上方向）に管状部材４が傾倒する方向の力が生じる。その結果、管状部材４は領域Ｒ１、Ｒ２、Ｒ３において柔軟性の高い領域が存在する側に湾曲し、管状部材４の遠異端部分が図８および図９の矢印Ａ方向に偏向される。領域Ｒ１、Ｒ２、Ｒ３では管状部材４の中心軸２１に直交する断面視で、管状部材４の断面積に占める柔軟性の高い部材の断面積の割合が遠位端側から近位端側にかけて徐々に減っていくため、管状部材４は領域Ｒ１、Ｒ２、Ｒ３において、徐々に湾曲する。一方、領域Ｒ１、Ｒ２、Ｒ３以外の領域では管状部材４の柔軟性に偏りがなく均一であるため、管状部材４が傾倒する方向の力が生じることはなく、中心軸２１に平行な収縮方向の力がかかるだけである。そのため、管状部材４は領域Ｒ１以外では湾曲せず、直線性が保たれている。 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.

　本実施形態のカテーテル２では、実施形態１のカテーテル２の構成に加えて、外筒部材４ｂが柔軟性の異なる複数の部材４ｂ１、４ｂ２、４ｂ３が接合されてなる。そして内筒部材４ａおよび外筒部材４ｂのそれぞれの接合面８０、８２、８４の位置が管状部材４の軸方向にずれている。そのため、操作用ワイヤ４０を引っ張った際に、領域Ｒ１、Ｒ２、Ｒ３において管状部材４が一定の方向に傾倒する方向の力が生じる。その結果、遠位端近傍をより自由なカーブ形状で湾曲させることができるようになり、カテーテル２の操作性がさらに向上する。 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.

　本発明は、上述の各実施形態に限定されるものではなく、当業者の知識に基づいて各種の設計変更等の変形を加えることも可能であり、そのような変形が加えられた実施形態も本発明の範囲に含まれうるものである。 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.

　上述の実施形態１および実施形態２では、２種類の柔軟性の異なる部材により管状部材４の内筒部材４ａを形成した。また、実施形態２では、３種類の柔軟性の異なる部材により外筒部材４ｂを形成した。しかしながら、管状部材４を形成する柔軟性の異なる部材の数は特に限定されず、２種類以上であればよい。また、各部材の柔軟性についても、遠位端側が相対的に柔軟性が高く、近位端側が相対的に柔軟性が低ければ、各部材の柔軟性の程度については特に限定されない。なお、管状部材４に用いる部材の種類が多いほど、管状部材４をより自由に曲げることが可能となる。 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.

　本発明は、カテーテルに利用できる。 The present invention can be used for a catheter.

　２　カテーテル、　４　管状部材、　４ａ　内筒部材、　４ｂ　外筒部材、　６　ハンドル、　７　摘み、　１０　先端チップ電極、　１２ａ、１２ｂ、１２ｃ　リング状電極、　２０　第１のルーメン、　２２　第２のルーメン、　２４　第３のルーメン、　２６　第４のルーメン、　２８　第５のルーメン、　３０　はんだ、　４０　操作用ワイヤ、　５０、６０ａ、６０ｂ、６０ｃ　導線、　９０　ブレード。 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 (4)

　遠位端側に配置された相対的に柔軟性の高い部材と近位端側に配置された相対的に柔軟性の低い部材とで構成され、前記柔軟性の高い部材と前記柔軟性の低い部材とは前記柔軟性の高い部材が前記遠位端側から前記近位端側に向けて細くなるようなテーパ状の接合面を有するように接合され、複数のルーメンが軸方向に沿って形成された管状部材と、
　前記複数のルーメンのうち前記管状部材の中心軸を含む位置に形成されたルーメンにスライド可能に挿通され、一方の端部が前記管状部材の遠位端近傍に接続された操作用ワイヤと、
を備えたことを特徴とするカテーテル。 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: 　前記接合面は、管状部材の中心軸に対して傾いた平面であることを特徴とする請求項１に記載のカテーテル。 The catheter according to claim 1, wherein the joint surface is a plane inclined with respect to a central axis of the tubular member. 　前記操作用ワイヤの挿通されたルーメンは、その中心軸が前記管状部材の中心軸と一致する位置に形成されていることを特徴とする請求項１または２に記載のカテーテル。 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. 　管状部材は前記複数のルーメンが形成された内筒部材と、前記内筒部材を覆う外筒部材とからなり、
　前記内筒部材および外筒部材の両方が柔軟性の異なる複数の部材が接合されており、
　前記内筒部材および外筒部材のそれぞれの接合面の位置が前記管状部材の軸方向にずれていることを特徴とする請求項１ないし３のいずれか１項に記載のカテーテル。 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.
PCT/JP2009/001594 2008-04-11 2009-04-06 Catheter Ceased WO2009125575A1 (en)

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