WO2014119030A1 - Electrode catheter - Google Patents

Electrode catheter Download PDF

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Publication number
WO2014119030A1
WO2014119030A1 PCT/JP2013/071359 JP2013071359W WO2014119030A1 WO 2014119030 A1 WO2014119030 A1 WO 2014119030A1 JP 2013071359 W JP2013071359 W JP 2013071359W WO 2014119030 A1 WO2014119030 A1 WO 2014119030A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
end portion
distal end
catheter shaft
core wire
Prior art date
Application number
PCT/JP2013/071359
Other languages
French (fr)
Japanese (ja)
Inventor
拓也 桝田
Original Assignee
日本ライフライン株式会社
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 日本ライフライン株式会社 filed Critical 日本ライフライン株式会社
Priority to KR1020157006623A priority Critical patent/KR101778414B1/en
Priority to CN201380050333.9A priority patent/CN104684468B/en
Publication of WO2014119030A1 publication Critical patent/WO2014119030A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6857—Catheters with a distal pigtail shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6876—Blood vessel
    • 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

Definitions

  • the present invention relates to an electrode catheter capable of tip deflection operation.
  • a catheter shaft having a flexible portion at the distal end, a control handle connected to the proximal end side of the catheter shaft, and a distal end side of the catheter shaft
  • an electrode catheter including a catheter tip portion, a plurality of ring electrodes attached to the outer periphery of the catheter tip portion, and an operation wire for bending the flexible portion of the catheter shaft.
  • an electrode catheter for measuring a potential at a site such as a pulmonary vein of the heart an electrode catheter having a catheter tip formed in a loop shape has been proposed (for example, see Patent Document 1). By forming the distal end portion of the catheter in a loop shape, the inner peripheral portion of the blood vessel can be measured simultaneously.
  • FIG. 6 is a perspective view showing the shape of the distal end portion of the catheter constituting the electrode catheter according to Patent Document 1.
  • This catheter distal end portion (mapping assembly) 117 includes a linear proximal end region 138 and a loop shape.
  • the main body region 139 and the straight distal end side region 140 are connected to the distal end side of the catheter shaft 114.
  • a main body region 139 of the catheter tip 117 is formed in a loop shape, and a plurality of ring electrodes (not shown) are attached to the main body region 139.
  • FIG. 7 is a cross-sectional view showing a connection portion between a catheter shaft and a catheter tip portion constituting an electrode catheter according to Patent Document 1.
  • the catheter shaft 114 is a multi-lumen tube having a first lumen 130, a second lumen 132, and a third lumen 134.
  • a plurality of lead wires 150 extend through the first lumen 130 of the catheter shaft 114.
  • the distal ends of the plurality of lead wires 150 are connected to the plurality of ring-shaped electrodes attached to the main body region 139 of the catheter distal end portion 117, respectively.
  • the base end portion of each of the plurality of lead wires 150 is connected to the connector via a control handle.
  • An operation wire 164 extends in the second lumen 132 of the catheter shaft 114.
  • the proximal end portion of the operation wire 164 is anchored to the control handle so that it can be pulled.
  • the distal end portion of the operation wire 164 is anchored to the distal end portion of the catheter shaft 114 via the anchor member 180.
  • the anchor member 180 has a distal end member piece (a cross-shaped member piece) 182 larger than the diameter of the second lumen 132, thereby preventing the distal end portion of the operation wire 164 from moving in the proximal direction. The As a result, the distal end portion (flexible portion) of the catheter shaft 114 can be bent by pulling the proximal end side of the operation wire 164.
  • the distal end region of the second lumen 132 where the distal end portion (anchor member 180) of the operation wire 164 is located is filled with an adhesive (not shown).
  • the distal end portion of the operation wire 164 is bonded and fixed to the catheter shaft 114 (the inner wall of the second lumen 132).
  • a proximal end portion of the core wire 124 constituting the catheter distal end portion 117 extends in the third lumen 134 of the catheter shaft 114.
  • the catheter tip 117 is formed by extending the core wire 124 made of a shape memory alloy inside the insulating tube 128.
  • the distal end region of the third lumen 134 where the proximal end portion of the core wire 124 extends is filled with an adhesive (not shown). Accordingly, the proximal end portion of the core wire 124 is bonded and fixed to the catheter shaft 114 (the inner wall of the third lumen 134).
  • the proximal end portion of the insulating tube 128 constituting the catheter distal end portion 117 is bonded and fixed to the distal end portion of the catheter shaft 114 with an adhesive 190. In this way, the catheter distal end portion 117 (core wire 124 / insulating tube 128) is connected to the distal end side of the catheter shaft 114.
  • the proximal ends of the plurality of lead wires 150, the operation wire 164, and the core wire 124 have different lumens (first lumen 130, second lumen 132) of the catheter shaft 114, respectively.
  • the internal space for extending the lead wire cannot be secured sufficiently, so that the ring-shaped electrode attached to the distal end portion of the catheter is extended to the third lumen 134).
  • such an electrode catheter cannot cope with an increase in the number of electrodes and a reduction in the diameter of the catheter shaft.
  • the length of the core wire 124 that extends to the third lumen 134 (on the inner wall of the third lumen 134) in order to prevent the catheter tip 117 from being detached from the catheter shaft 114. It is necessary to ensure a sufficient adhesive force by sufficiently lengthening the length of the core wire 124 to be bonded. On the other hand, if the core wire 124 extending to the third lumen 134 is lengthened, the operability as a catheter capable of tip deflection operation may be impaired.
  • An electrode catheter of the present invention includes a catheter shaft having a flexible portion having a multi-lumen structure at a distal end portion; A control handle connected to the proximal side of the catheter shaft; A catheter tip connected to the tip side of the catheter shaft, and a core wire made of a shape memory alloy extending inside the insulating tube, and a plurality of ring-shaped electrodes mounted on the outer periphery of the catheter tip; A plurality of leads connected to each of the plurality of ring-shaped electrodes, extending inside the catheter tip and inside the catheter shaft and reaching the inside of the control handle; In order to bend the flexible portion of the catheter shaft, it extends inside the catheter shaft, the distal end portion of the catheter shaft is anchored to the distal end portion of the catheter shaft, and the proximal end portion thereof can be pulled. An operating wire that is moored to the control handle, The base end portion of the core wire and the distal end portion of the operation wire are joined.
  • the proximal end portion of the core wire and the distal end portion of the operation wire are joined, so that the operation wire is not formed in the flexible portion of the multi-lumen structure constituting the catheter shaft. Since it is not necessary to extend the core wire to a different lumen from the extended lumen (both joints can be extended to one lumen), the lumen in which the core wire is extended in a conventional electrode catheter Can be used to extend the lead, thereby ensuring sufficient space within the catheter shaft to extend the plurality of leads.
  • the proximal end portion of the core wire constituting the distal end portion of the catheter and the distal end portion of the operation wire extending inside the catheter shaft are joined, and the proximal end portion of the operation wire is anchored to the control handle.
  • the operation wire exerts an effect of preventing the core wire from coming off, so that it is possible to effectively prevent the catheter tip from being detached from the catheter shaft.
  • the distal end portion of the catheter is formed in a loop shape.
  • a large number (for example, six or more) of ring-shaped electrodes can be attached to the distal end portion of the catheter formed in a loop shape, and it is necessary to extend a large number of lead wires inside the catheter shaft accordingly. Therefore, in such a case, the structure of the present invention is particularly effective.
  • the catheter shaft has a single lumen structure on the distal end side of the flexible portion of the multi-lumen structure, and in the single lumen, the proximal end portion of the core wire and the operation wire It is preferable that the front-end
  • the proximal end portion of the core wire and the operation wire are disposed inside a tubular anchoring member that prevents the distal end portion of the operation wire from moving in the proximal direction. It is preferable that the front-end
  • the electrode catheter of the present invention a sufficient space for extending a plurality of lead wires can be secured inside the catheter shaft. Moreover, even if the core wire extending inside the catheter shaft is shortened, it is possible to effectively prevent the distal end portion of the catheter constituted by the core wire from being detached from the catheter shaft. In addition, since the core wire extending inside the catheter shaft can be shortened, the operability as a catheter capable of tip deflection operation is excellent.
  • FIG. 2 is a longitudinal sectional view (AA sectional view of FIG. 2A) showing a distal end portion of the electrode catheter shown in FIG.
  • FIG. 4 is a partial enlarged cross-sectional view (part B detail view) of FIG. 3.
  • FIG. 5 is a transverse cross-sectional view (CC cross-sectional view of FIG. 4) at the distal end portion of the electrode catheter shown in FIG.
  • An electrode catheter 100 of the present embodiment shown in FIGS. 1 to 5 includes a catheter shaft 10 having a flexible portion 10A having a multi-lumen structure at a distal end portion 11, and a control handle 20 connected to the proximal end side of the catheter shaft 10.
  • the core wire 35 made of a shape memory alloy is connected to the distal end side of the catheter shaft 10 and extends inside the insulating tube 33, and the catheter distal end portion 30 formed in a loop shape is formed on the outer periphery of the catheter distal end portion 30.
  • the nine attached ring electrodes 41, the tip electrode 42 attached to the tip of the catheter tip 30, and each of the tip electrode 42 and the ring electrode 41 are connected to the catheter tip 30 (insulating tube 33). ) And 10 lead wires 5 extending inside the catheter shaft 10 and reaching the inside of the control handle 20 In order to bend the flexible portion 10A of the catheter shaft 10, the distal end portion 61 of the catheter shaft 10 is anchored to the distal end portion 11 of the catheter shaft 10 and the proximal end portion is pulled. The operation wire 60 whose proximal end is anchored to the control handle 20 and the distal end 61 of the operation wire 60 are prevented from moving in the proximal direction so that the distal end 61 can be connected to the catheter shaft.
  • a tubular anchoring member 70 that is anchored to the distal end portion 11 is provided, and a proximal end portion 352 of the core wire 35 and a distal end portion 61 of the operation wire 60 are joined inside the tubular anchoring member 70.
  • the electrode catheter 100 includes a catheter shaft 10, a control handle 20, a catheter tip 30, nine ring electrodes 41, one tip electrode 42, ten lead wires 50, and an operation wire 60. And a tubular mooring member 70. 4 and 5, a part of the ten lead wires 50 is illustrated.
  • the catheter shaft 10 constituting the electrode catheter 100 of the present embodiment has a flexible portion 10A having a multi-lumen structure at the distal end portion 11 thereof.
  • the “flexible portion” refers to a shaft portion that can be bent (bent) by pulling the operation wire 60.
  • the flexible portion 10A of the catheter shaft 10 includes a multi-lumen tube 111 and a blade tube 15 covering the outer periphery thereof.
  • the multi-lumen tube 111 is formed with four lumens (a first lumen 11L, a second lumen 12L, a third lumen 13L, and a fourth lumen 14L).
  • the constituent material of the multi-lumen tube 111 is not particularly limited, and examples thereof include resins such as polyurethane, nylon, and PEBAX (polyether block amide).
  • resins such as polyurethane, nylon, and PEBAX (polyether block amide).
  • the blade tube 15 covering the outer periphery of the multi-lumen tube 111 include a tube made of a resin such as polyurethane, nylon, and PEBAX, which is braided with a stainless steel wire.
  • the blade tube 15 covering the outer periphery of the multi-lumen tube 111 further extends to the distal end side of the flexible portion 10A (multi-lumen tube 111) to form a single lumen tube.
  • the outer diameter of the catheter shaft 10 is preferably 3.0 mm or less, more preferably 1.2 to 2.4 mm, and a suitable example is 1.7 mm.
  • the control handle 20 constituting the electrode catheter 100 of the present embodiment is connected to the proximal end side of the catheter shaft 10.
  • 21 is a grip and 22 is a knob.
  • the knob 22 By sliding the knob 22 to the proximal end side, the flexible portion 10A of the catheter shaft 10 is bent, and accordingly, the catheter distal end portion 30 is deflected. Therefore, by operating the control handle 20 to rotate and further deflect the catheter tip 30, the catheter tip 30 can be guided to the target site.
  • the catheter distal end 30 constituting the electrode catheter 100 is formed by extending a core wire 35 made of a shape memory alloy into an insulating tube 33.
  • the catheter tip 30 is formed in a substantially circular loop shape. Thereby, the inner peripheral part of the blood vessel can be measured simultaneously.
  • the catheter tip 30 is not a flat circular closed loop, but a spiral loop (in the present invention, the term “circular” includes strictly a spiral shape).
  • the core wire 35 made of a shape memory alloy stores the loop shape of the catheter tip 30 and is easily deformed (for example, linearly deformed) by applying a force, but returns to the loop shape when the force is removed.
  • An example of the constituent material of the core wire 35 is a Ni—Ti alloy.
  • the ratio of Ni to Ti in the Ni—Ti alloy is preferably 54:46 to 57:43.
  • a preferred Ni—Ti alloy is nitinol.
  • the diameter of the core wire 35 is, for example, 0.1 to 1.0 mm, preferably 0.2 to 0.5 mm, and 0.36 mm if a suitable example is shown.
  • the inside of the insulating tube 33 communicates with the inside of the catheter shaft 10.
  • a constituent material of the insulating tube 33 include a bio-acceptable resin material such as polyurethane or PEBAX.
  • ring-shaped electrodes 41 are mounted on the outer peripheral surface of the catheter tip 30. Further, a tip electrode 42 is attached to the tip of the catheter tip 30.
  • the constituent material of the ring-shaped electrode 41 and the tip electrode 42 include conductive materials such as platinum, gold, iridium, or alloys thereof.
  • the number of ring-shaped electrodes 41 attached to the catheter tip 30 is not limited to nine, and the number of ring-shaped electrodes constituting the electrode catheter of the present invention is, for example, 6 to 20 The number is preferably 8, 12.
  • Lead wires 50 are connected to the ring electrode 41 and the tip electrode 42, respectively.
  • the lead wires 50 connected to each of the ring-shaped electrodes 41 enter the inside of the insulating tube 33 through the pores formed in the tube wall of the insulating tube 33.
  • Ten lead wires 50 connected to each of the ring electrode 41 and the tip electrode 42 are provided inside the insulating tube 33 and inside the catheter shaft 10 (second lumen 12L, third lumen 13L, and fourth lumen 14L). It extends and is inserted into the control handle 20.
  • Each proximal end portion of the lead wire 50 is electrically connected to a connector provided at the proximal end of the control handle 20.
  • the operation wire 60 constituting the electrode catheter 100 extends inside the catheter shaft 10 (the first lumen 11L of the multi-lumen tube 111) in order to bend the flexible portion 10A of the catheter shaft 10.
  • the distal end portion 61 of the operation wire 60 is anchored to the distal end portion 11 of the catheter shaft 10 via a tubular anchoring member 70 described later.
  • the proximal end portion of the operation wire 60 is moored inside the control handle 20, thereby enabling a pulling operation on the proximal end side of the operation wire 60.
  • Examples of the constituent material of the operation wire 60 include stainless steel and Ni—Ti alloy.
  • the surface of the operation wire 60 is preferably covered with PTFE “Teflon (registered trademark)” or the like.
  • the diameter of the operation wire 60 is, for example, 0.1 to 0.5 mm, preferably 0.20 to 0.25 mm, and 0.21 mm if a suitable example is shown.
  • the tubular anchoring member 70 constituting the electrode catheter 100 has an outer diameter larger than the diameter of the first lumen 11L, and prevents the distal end portion 61 of the operation wire 60 to be fixed therein from moving in the proximal direction. It is an anchor member for this purpose, and is disposed inside the distal end portion 11 of the catheter shaft 10 (single lumen tube on the distal end side from the multi-lumen tube 111). Inside the tubular mooring member 70, the proximal end portion 352 of the core wire 35 and the distal end portion 61 of the operation wire 60 are joined.
  • the method for joining the proximal end portion 352 of the core wire 35 and the distal end portion 61 of the operation wire 60 is not particularly limited.
  • the proximal end portion 352 of the core wire 35 and the distal end portion of the operation wire 60 are not limited.
  • 61 a method of filling the inside (gap) of the tubular mooring member 70 with a fixing material 80 such as solder, brazing material, or adhesive, a base end portion 352 of the core wire 35, and a tip end portion of the operation wire 60
  • a method of caulking the tubular mooring member 70 inserted with 61 can be exemplified.
  • the proximal end portion 332 of the insulating tube 33 constituting the catheter distal end portion 30 has entered the distal end portion 11 (inside the single lumen tube) of the catheter shaft 10. 90 is fixed to the distal end of the catheter shaft 10.
  • the proximal end portion 352 of the core wire 35 constituting the catheter distal end portion 30 together with the insulating tube 33 enters the distal end portion 11 (inside the single lumen tube) of the catheter shaft 10, and the tubular anchoring member 70 disposed there. Is joined to the distal end portion 61 of the operation wire 60. Thereby, the catheter distal end portion 30 can be firmly connected to the distal end side of the catheter shaft 10. From the viewpoint of ensuring good operability as a catheter capable of deflecting the distal end, the entry length of the core wire 35 (indicated by L 35 in FIG. 4) into the distal end portion 11 of the catheter shaft 10 is 10 mm or less. It is preferable.
  • the operation wire 60 is moved to the base end side by the piston mechanism inside the control handle 20.
  • the distal end portion 61 of the operation wire 60 is prevented from moving in the proximal direction by the tubular anchoring member 70 (anchor member)
  • the flexible portion 10A of the catheter shaft 10 is bent, and as a result, The catheter tip 30 is deflected.
  • the knob 22 is slid to the distal end side and returned to the original position, the catheter distal end portion 30 can be returned to the original orientation.
  • the proximal end portion 352 of the core wire 35 and the distal end portion 61 of the operation wire 60 are joined inside the tubular anchoring member 70, so that the proximal end of the core wire 35 is obtained. It is not necessary to extend the portion 352 to a lumen (second lumen 12L, third lumen 13L, or fourth lumen 14L) other than the first lumen 11L of the multi-lumen tube 111, and all three lumens are connected to the lead wire 50. Can be used to extend. As a result, a sufficient space for extending the ten lead wires 50 can be secured inside the catheter shaft 10.
  • the proximal end of the core wire 35 is extended with respect to the distal end portion 61 of the operation wire 60 that extends inside the catheter shaft 10 (first lumen 11L) and is anchored at the proximal end portion inside the control handle 20.
  • the operation wire 60 can exert the effect of preventing the core wire 35 from being detached by joining the portion 352.
  • the core wire 35 is configured. It is possible to effectively prevent the catheter tip 30 to be detached from the catheter shaft 10.
  • the length of the core wire 35 extending inside the catheter shaft 10 (the entry length L 35 described above) is short, the operability is also excellent.
  • the electrode catheter of this invention is not limited to this, A various change is possible.
  • the proximal end portion of the core wire and the distal end portion of the operation wire may be joined by welding or the like without arranging the tubular anchoring member (anchor member) inside the catheter shaft.
  • the proximal end portion of the core wire and the distal end portion of the operation wire may be joined.
  • the number of lumens in the multi-lumen tube is not four, and for example, 2 to 9 lumens may be formed. Further, it may be of the bi-direction type provided with two operation wires. In this case, the base end portion of the core wire is joined to the distal end portion of one of the operation wires. .
  • Electrode catheter 10 Catheter shaft 10A Flexible part 11 Tip 11L of the catheter shaft First lumen 12L Second lumen 13L Third lumen 14L Fourth lumen 15 Blade tube 20 Control handle 21 Grip 22 Knob 30 Catheter tip 33 Insulating tube 35 Core wire 352 Core wire proximal end 42 Tip electrode 41 Ring electrode 42 Tip electrode 50 Lead wire 60 Operation wire 61 Operation wire tip 70 Tubular anchoring member (anchor member) 80 Adhesive 90 Adhesive

Abstract

An electrode catheter which is capable of tip deflection operation and which comprises: a catheter shaft (10) that has a flexible part (10A) on a distal end portion (11); a control handle (20); a catheter distal end portion (30) that is connected to the distal end side of the catheter shaft (10) and has a core wire (35) made of shape memory alloy extending inside an insulating tube (33); multiple ring-shaped electrodes (42); lead wires (50) that are connected to each of the ring-shaped electrodes (42); and an operating wire (60) for deflecting the flexible part of the catheter shaft (10), a base end portion (352) of the core wire (35) and a distal end portion (61) of the operating wire (60) being joined together. According to this electrode catheter, sufficient space can be reserved inside the catheter shaft for extending multiple lead wires.

Description

電極カテーテルElectrode catheter
　本発明は、先端偏向操作可能な電極カテーテルに関する。 The present invention relates to an electrode catheter capable of tip deflection operation.
　心臓の不整脈を診断または治療するために使用する医療用具として、可撓部分を先端部に有するカテーテルシャフトと、このカテーテルシャフトの基端側に接続された制御ハンドルと、カテーテルシャフトの先端側に接続されたカテーテル先端部と、カテーテル先端部の外周に装着された複数のリング状電極と、カテーテルシャフトの可撓部分を撓ませるための操作用ワイヤとを備えてなる電極カテーテルが知られている。 As a medical device used for diagnosing or treating cardiac arrhythmia, a catheter shaft having a flexible portion at the distal end, a control handle connected to the proximal end side of the catheter shaft, and a distal end side of the catheter shaft There is known an electrode catheter including a catheter tip portion, a plurality of ring electrodes attached to the outer periphery of the catheter tip portion, and an operation wire for bending the flexible portion of the catheter shaft.
　また、心臓の肺静脈などの部位における電位を測定するための電極カテーテルとして、ループ状に形成されたカテーテル先端部を備えたものが提案されている（例えば、特許文献１参照）。カテーテル先端部をループ状に形成することにより、血管の内周部分を同時に測定することができる。 Also, as an electrode catheter for measuring a potential at a site such as a pulmonary vein of the heart, an electrode catheter having a catheter tip formed in a loop shape has been proposed (for example, see Patent Document 1). By forming the distal end portion of the catheter in a loop shape, the inner peripheral portion of the blood vessel can be measured simultaneously.
　図６は、特許文献１に係る電極カテーテルを構成するカテーテル先端部の形状を示す斜視図であり、このカテーテル先端部（マッピング組立体）１１７は、直線状の基端側領域１３８と、ループ状の本体領域１３９と、直線状の先端側領域１４０とからなり、カテーテルシャフト１１４の先端側に接続されている。
　カテーテル先端部１１７の本体領域１３９はループ状に形成され、当該本体領域１３９には、複数のリング状電極（図示省略）が装着されている。 FIG. 6 is a perspective view showing the shape of the distal end portion of the catheter constituting the electrode catheter according to Patent Document 1. This catheter distal end portion (mapping assembly) 117 includes a linear proximal end region 138 and a loop shape. The main body region 139 and the straight distal end side region 140 are connected to the distal end side of the catheter shaft 114.
A main body region 139 of the catheter tip 117 is formed in a loop shape, and a plurality of ring electrodes (not shown) are attached to the main body region 139.
　図７は、特許文献１に係る電極カテーテルを構成するカテーテルシャフトとカテーテル先端部との接続部分を示す断面図である。
　カテーテルシャフト１１４は、第１ルーメン１３０と、第２ルーメン１３２と、第３ルーメン１３４とを有するマルチルーメンチューブからなる。 FIG. 7 is a cross-sectional view showing a connection portion between a catheter shaft and a catheter tip portion constituting an electrode catheter according to Patent Document 1.
The catheter shaft 114 is a multi-lumen tube having a first lumen 130, a second lumen 132, and a third lumen 134.
　カテーテルシャフト１１４の第１ルーメン１３０には、複数のリード線１５０が延在している。
　複数のリード線１５０の各々の先端部は、カテーテル先端部１１７の本体領域１３９に装着されている複数のリング状電極の各々に接続されている。他方、複数のリード線１５０の各々の基端部は、制御ハンドルを経て、コネクタに接続されている。 A plurality of lead wires 150 extend through the first lumen 130 of the catheter shaft 114.
The distal ends of the plurality of lead wires 150 are connected to the plurality of ring-shaped electrodes attached to the main body region 139 of the catheter distal end portion 117, respectively. On the other hand, the base end portion of each of the plurality of lead wires 150 is connected to the connector via a control handle.
　カテーテルシャフト１１４の第２ルーメン１３２には、操作用ワイヤ１６４が延在している。
　操作用ワイヤ１６４の基端部は、これを引張操作できるように制御ハンドルに係留されている。他方、操作用ワイヤ１６４の先端部は、アンカー部材１８０を介して、カテーテルシャフト１１４の先端部に係留されている。
　アンカー部材１８０は、第２ルーメン１３２の径より大きな先端部材片（十字形部材片）１８２を有しており、これにより、操作用ワイヤ１６４の先端部が基端方向に移動することが抑止される。この結果、操作用ワイヤ１６４の基端側を引張操作することにより、カテーテルシャフト１１４の先端部（可撓部分）を撓ませることができる。
　操作用ワイヤ１６４の先端部（アンカー部材１８０）が位置する第２ルーメン１３２の先端領域には、接着剤（図示省略）が充填されている。これにより、操作用ワイヤ１６４の先端部が、カテーテルシャフト１１４（第２ルーメン１３２の内壁）に接着固定されている。 An operation wire 164 extends in the second lumen 132 of the catheter shaft 114.
The proximal end portion of the operation wire 164 is anchored to the control handle so that it can be pulled. On the other hand, the distal end portion of the operation wire 164 is anchored to the distal end portion of the catheter shaft 114 via the anchor member 180.
The anchor member 180 has a distal end member piece (a cross-shaped member piece) 182 larger than the diameter of the second lumen 132, thereby preventing the distal end portion of the operation wire 164 from moving in the proximal direction. The As a result, the distal end portion (flexible portion) of the catheter shaft 114 can be bent by pulling the proximal end side of the operation wire 164.
The distal end region of the second lumen 132 where the distal end portion (anchor member 180) of the operation wire 164 is located is filled with an adhesive (not shown). Thus, the distal end portion of the operation wire 164 is bonded and fixed to the catheter shaft 114 (the inner wall of the second lumen 132).
　カテーテルシャフト１１４の第３ルーメン１３４には、カテーテル先端部１１７を構成するコアワイヤ１２４の基端部が延在している。
　カテーテル先端部１１７は、絶縁チューブ１２８の内部に、形状記憶合金よりなる当該コアワイヤ１２４が延在されてなる。 A proximal end portion of the core wire 124 constituting the catheter distal end portion 117 extends in the third lumen 134 of the catheter shaft 114.
The catheter tip 117 is formed by extending the core wire 124 made of a shape memory alloy inside the insulating tube 128.
　コアワイヤ１２４の基端部が延在している第３ルーメン１３４の先端領域には、接着剤（図示省略）が充填されている。これにより、コアワイヤ１２４の基端部が、カテーテルシャフト１１４（第３ルーメン１３４の内壁）に接着固定される。
　また、カテーテル先端部１１７を構成する絶縁チューブ１２８の基端部は、接着剤１９０によりカテーテルシャフト１１４の先端部に接着固定されている。
　このようにして、カテーテル先端部１１７（コアワイヤ１２４・絶縁チューブ１２８）がカテーテルシャフト１１４の先端側に接続されている。 The distal end region of the third lumen 134 where the proximal end portion of the core wire 124 extends is filled with an adhesive (not shown). Accordingly, the proximal end portion of the core wire 124 is bonded and fixed to the catheter shaft 114 (the inner wall of the third lumen 134).
The proximal end portion of the insulating tube 128 constituting the catheter distal end portion 117 is bonded and fixed to the distal end portion of the catheter shaft 114 with an adhesive 190.
In this way, the catheter distal end portion 117 (core wire 124 / insulating tube 128) is connected to the distal end side of the catheter shaft 114.
特開２００３－１１１７４０号公報JP 2003-111740 A
　然るに、特許文献１に記載の電極カテーテルにおいては、複数のリード線１５０、操作用ワイヤ１６４およびコアワイヤ１２４の基端部が、それぞれ、カテーテルシャフト１１４の異なるルーメン（第１ルーメン１３０、第２ルーメン１３２および第３ルーメン１３４）に延在しており、このような構造の電極カテーテルでは、リード線を延在させる内部空間を十分に確保することができないため、カテーテル先端部に装着されるリング状電極の数に応じた本数のリード線を、カテーテルシャフトの内部に延在させることが困難となる。また、このような電極カテーテルによっては、電極数の増加やカテーテルシャフトの小径化にも対応することができない。 However, in the electrode catheter described in Patent Document 1, the proximal ends of the plurality of lead wires 150, the operation wire 164, and the core wire 124 have different lumens (first lumen 130, second lumen 132) of the catheter shaft 114, respectively. In the electrode catheter having such a structure, the internal space for extending the lead wire cannot be secured sufficiently, so that the ring-shaped electrode attached to the distal end portion of the catheter is extended to the third lumen 134). It becomes difficult to extend the number of lead wires corresponding to the number of wires to the inside of the catheter shaft. In addition, such an electrode catheter cannot cope with an increase in the number of electrodes and a reduction in the diameter of the catheter shaft.
　また、特許文献１に記載の電極カテーテルにおいて、カテーテルシャフト１１４からのカテーテル先端部１１７の離脱を防止するために、第３ルーメン１３４に延在させるコアワイヤ１２４の長さ（第３ルーメン１３４の内壁に接着させるコアワイヤ１２４の長さ）を十分に長くして接着力を確保する必要がある。他方、第３ルーメン１３４に延在させるコアワイヤ１２４を長くすると、先端偏向操作可能カテーテルとしての操作性が損なわれることがある。 In the electrode catheter described in Patent Document 1, the length of the core wire 124 that extends to the third lumen 134 (on the inner wall of the third lumen 134) in order to prevent the catheter tip 117 from being detached from the catheter shaft 114. It is necessary to ensure a sufficient adhesive force by sufficiently lengthening the length of the core wire 124 to be bonded. On the other hand, if the core wire 124 extending to the third lumen 134 is lengthened, the operability as a catheter capable of tip deflection operation may be impaired.
　本発明は以上のような事情に基いてなされたものである。
　本発明の目的は、複数のリード線を延在させるための十分な空間をカテーテルシャフトの内部に確保することができる電極カテーテルを提供することにある。
　本発明の他の目的は、カテーテルシャフトの内部に延在させるコアワイヤを短くしても当該コアワイヤによって構成されるカテーテル先端部がカテーテルシャフトから離脱することを有効に防止することができ、先端偏向操作可能カテーテルとしての操作性も良好な電極カテーテルを提供することにある。 The present invention has been made based on the above situation.
An object of the present invention is to provide an electrode catheter capable of securing a sufficient space for extending a plurality of lead wires inside a catheter shaft.
Another object of the present invention is to effectively prevent the distal end of the catheter constituted by the core wire from detaching from the catheter shaft even if the core wire extending inside the catheter shaft is shortened. An object of the present invention is to provide an electrode catheter having good operability as a possible catheter.
（１）本発明の電極カテーテルは、マルチルーメン構造の可撓部分を先端部に有するカテーテルシャフトと、
　前記カテーテルシャフトの基端側に接続された制御ハンドルと、
　前記カテーテルシャフトの先端側に接続され、絶縁チューブの内部に形状記憶合金よりなるコアワイヤが延在されてなるカテーテル先端部と
　前記カテーテル先端部の外周に装着された複数のリング状電極と、
　前記複数のリング状電極の各々に接続され、前記カテーテル先端部の内部および前記カテーテルシャフトの内部を延在して前記制御ハンドルの内部に至る複数のリード線と、
　前記カテーテルシャフトの可撓部分を撓ませるために、当該カテーテルシャフトの内部に延在し、その先端部が前記カテーテルシャフトの先端部に係留され、その基端部を引張操作できるように当該基端部が前記制御ハンドルに係留されている操作用ワイヤとを備えてなり、
　前記コアワイヤの基端部と、前記操作用ワイヤの先端部とが接合されていることを特徴とする。 (1) An electrode catheter of the present invention includes a catheter shaft having a flexible portion having a multi-lumen structure at a distal end portion;
A control handle connected to the proximal side of the catheter shaft;
A catheter tip connected to the tip side of the catheter shaft, and a core wire made of a shape memory alloy extending inside the insulating tube, and a plurality of ring-shaped electrodes mounted on the outer periphery of the catheter tip;
A plurality of leads connected to each of the plurality of ring-shaped electrodes, extending inside the catheter tip and inside the catheter shaft and reaching the inside of the control handle;
In order to bend the flexible portion of the catheter shaft, it extends inside the catheter shaft, the distal end portion of the catheter shaft is anchored to the distal end portion of the catheter shaft, and the proximal end portion thereof can be pulled. An operating wire that is moored to the control handle,
The base end portion of the core wire and the distal end portion of the operation wire are joined.
　このような構成の電極カテーテルによれば、コアワイヤの基端部と操作用ワイヤの先端部とが接合されていることにより、カテーテルシャフトを構成するマルチルーメン構造の可撓部分において、操作用ワイヤが延在されているルーメンと異なるルーメンにコアワイヤを延在させる必要はない（両者の接合体を１つのルーメンに延在させることができる）ので、従来の電極カテーテルにおいてコアワイヤを延在させていたルーメンを、リード線を延在させるために使用することができ、これにより、複数のリード線を延在させるための十分な空間をカテーテルシャフトの内部に確保することができる。 According to the electrode catheter having such a configuration, the proximal end portion of the core wire and the distal end portion of the operation wire are joined, so that the operation wire is not formed in the flexible portion of the multi-lumen structure constituting the catheter shaft. Since it is not necessary to extend the core wire to a different lumen from the extended lumen (both joints can be extended to one lumen), the lumen in which the core wire is extended in a conventional electrode catheter Can be used to extend the lead, thereby ensuring sufficient space within the catheter shaft to extend the plurality of leads.
　また、カテーテル先端部を構成するコアワイヤの基端部と、カテーテルシャフトの内部に延在する操作用ワイヤの先端部とが接合され、この操作用ワイヤの基端部が制御ハンドルに係留されていることにより、当該操作用ワイヤが、コアワイヤの抜け止め効果を発揮するので、カテーテルシャフトからカテーテル先端部が離脱することを有効に防止することができる。 Further, the proximal end portion of the core wire constituting the distal end portion of the catheter and the distal end portion of the operation wire extending inside the catheter shaft are joined, and the proximal end portion of the operation wire is anchored to the control handle. As a result, the operation wire exerts an effect of preventing the core wire from coming off, so that it is possible to effectively prevent the catheter tip from being detached from the catheter shaft.
（２）本発明の電極カテーテルにおいて、前記カテーテル先端部がループ状に形成されていることが好ましい。
　ループ状に形成されたカテーテル先端部には、多数（例えば６個以上）のリング状電極を装着することができ、これに伴って多数のリード線をカテーテルシャフトの内部に延在させる必要があるので、このような場合において、本発明の構造は特に効果的である。 (2) In the electrode catheter of the present invention, it is preferable that the distal end portion of the catheter is formed in a loop shape.
A large number (for example, six or more) of ring-shaped electrodes can be attached to the distal end portion of the catheter formed in a loop shape, and it is necessary to extend a large number of lead wires inside the catheter shaft accordingly. Therefore, in such a case, the structure of the present invention is particularly effective.
（３）本発明の電極カテーテルにおいて、前記カテーテルシャフトは、マルチルーメン構造の可撓部分の先端側においてシングルルーメン構造を有し、当該シングルルーメンにおいて、前記コアワイヤの基端部と、前記操作用ワイヤの先端部とが接合されていることが好ましい。 (3) In the electrode catheter of the present invention, the catheter shaft has a single lumen structure on the distal end side of the flexible portion of the multi-lumen structure, and in the single lumen, the proximal end portion of the core wire and the operation wire It is preferable that the front-end | tip part of is joined.
（４）上記（３）の電極カテーテルにおいては、前記操作用ワイヤの先端部が基端方向に移動することを抑止する管状係留部材の内部において、前記コアワイヤの基端部と、前記操作用ワイヤの先端部とが接合されていることが好ましい。 (4) In the electrode catheter of (3), the proximal end portion of the core wire and the operation wire are disposed inside a tubular anchoring member that prevents the distal end portion of the operation wire from moving in the proximal direction. It is preferable that the front-end | tip part of is joined.
　本発明の電極カテーテルによれば、複数のリード線を延在させるための十分な空間を、カテーテルシャフトの内部に確保することができる。
　また、カテーテルシャフトの内部に延在するコアワイヤを短くしても、当該コアワイヤにより構成されるカテーテル先端部がカテーテルシャフトから離脱することを有効に防止することができる。
　また、カテーテルシャフトの内部に延在するコアワイヤを短くすることができるので、先端偏向操作可能カテーテルとしての操作性にも優れている。 According to the electrode catheter of the present invention, a sufficient space for extending a plurality of lead wires can be secured inside the catheter shaft.
Moreover, even if the core wire extending inside the catheter shaft is shortened, it is possible to effectively prevent the distal end portion of the catheter constituted by the core wire from being detached from the catheter shaft.
In addition, since the core wire extending inside the catheter shaft can be shortened, the operability as a catheter capable of tip deflection operation is excellent.
本発明の電極カテーテルの一実施形態を示す斜視図である。It is a perspective view which shows one Embodiment of the electrode catheter of this invention. 図１に示した電極カテーテルの先端部を先端側から見た説明図である。It is explanatory drawing which looked at the front-end | tip part of the electrode catheter shown in FIG. 1 from the front end side. 図１に示した電極カテーテルの先端部を示す説明図である。It is explanatory drawing which shows the front-end | tip part of the electrode catheter shown in FIG. 図１に示した電極カテーテルの先端部を示す縦断面図（図２ＡのＡ－Ａ断面図）である。FIG. 2 is a longitudinal sectional view (AA sectional view of FIG. 2A) showing a distal end portion of the electrode catheter shown in FIG. 図３の部分拡大断面図（Ｂ部詳細図）である。FIG. 4 is a partial enlarged cross-sectional view (part B detail view) of FIG. 3. 図１に示した電極カテーテルの先端部における横断面図（図４のＣ－Ｃ断面図）である。FIG. 5 is a transverse cross-sectional view (CC cross-sectional view of FIG. 4) at the distal end portion of the electrode catheter shown in FIG. 従来の電極カテーテルを構成するカテーテル先端部の形状を示す斜視図である。It is a perspective view which shows the shape of the catheter front-end | tip part which comprises the conventional electrode catheter. 従来の電極カテーテルを構成するカテーテルシャフトとカテーテル先端部との接続部分を示す断面図である。It is sectional drawing which shows the connection part of the catheter shaft which comprises the conventional electrode catheter, and a catheter front-end | tip part.
　以下、本発明の電極カテーテルの一実施形態について図面を用いて説明する。
　図１～図５に示す本実施形態の電極カテーテル１００は、マルチルーメン構造の可撓部分１０Ａを先端部１１に有するカテーテルシャフト１０と、カテーテルシャフト１０の基端側に接続された制御ハンドル２０と、カテーテルシャフト１０の先端側に接続され、絶縁チューブ３３の内部に形状記憶合金よりなるコアワイヤ３５が延在されてなり、ループ状に形成されたカテーテル先端部３０と、カテーテル先端部３０の外周に装着された９個のリング状電極４１と、カテーテル先端部３０の先端に装着された先端電極４２と、この先端電極４２およびリング状電極４１の各々に接続され、カテーテル先端部３０（絶縁チューブ３３）の内部およびカテーテルシャフト１０の内部を延在して制御ハンドル２０の内部に至る１０本のリード線５０と、カテーテルシャフト１０の可撓部分１０Ａを撓ませるために、当該カテーテルシャフト１０の内部に延在し、その先端部６１がカテーテルシャフト１０の先端部１１に係留され、その基端部を引張操作できるように当該基端部が制御ハンドル２０に係留されている操作用ワイヤ６０と、操作用ワイヤ６０の先端部６１が基端方向に移動することを抑止することにより当該先端部６１をカテーテルシャフト１０の先端部１１に係留する管状係留部材７０とを備えてなり、コアワイヤ３５の基端部３５２と、操作用ワイヤ６０の先端部６１とが管状係留部材７０の内部において接合されている。 Hereinafter, an embodiment of an electrode catheter of the present invention will be described with reference to the drawings.
An electrode catheter 100 of the present embodiment shown in FIGS. 1 to 5 includes a catheter shaft 10 having a flexible portion 10A having a multi-lumen structure at a distal end portion 11, and a control handle 20 connected to the proximal end side of the catheter shaft 10. The core wire 35 made of a shape memory alloy is connected to the distal end side of the catheter shaft 10 and extends inside the insulating tube 33, and the catheter distal end portion 30 formed in a loop shape is formed on the outer periphery of the catheter distal end portion 30. The nine attached ring electrodes 41, the tip electrode 42 attached to the tip of the catheter tip 30, and each of the tip electrode 42 and the ring electrode 41 are connected to the catheter tip 30 (insulating tube 33). ) And 10 lead wires 5 extending inside the catheter shaft 10 and reaching the inside of the control handle 20 In order to bend the flexible portion 10A of the catheter shaft 10, the distal end portion 61 of the catheter shaft 10 is anchored to the distal end portion 11 of the catheter shaft 10 and the proximal end portion is pulled. The operation wire 60 whose proximal end is anchored to the control handle 20 and the distal end 61 of the operation wire 60 are prevented from moving in the proximal direction so that the distal end 61 can be connected to the catheter shaft. 10, a tubular anchoring member 70 that is anchored to the distal end portion 11 is provided, and a proximal end portion 352 of the core wire 35 and a distal end portion 61 of the operation wire 60 are joined inside the tubular anchoring member 70.
　電極カテーテル１００は、カテーテルシャフト１０と、制御ハンドル２０と、カテーテル先端部３０と、９個のリング状電極４１と、１個の先端電極４２と、１０本のリード線５０と、操作用ワイヤ６０と、管状係留部材７０とを備えてなる。
　なお、図４および図５においては、１０本のリード線５０の一部を図示している。 The electrode catheter 100 includes a catheter shaft 10, a control handle 20, a catheter tip 30, nine ring electrodes 41, one tip electrode 42, ten lead wires 50, and an operation wire 60. And a tubular mooring member 70.
4 and 5, a part of the ten lead wires 50 is illustrated.
　本実施形態の電極カテーテル１００を構成するカテーテルシャフト１０は、その先端部１１において、マルチルーメン構造の可撓部分１０Ａを有している。ここに「可撓部分」とは、操作用ワイヤ６０を引張操作することにより撓む（曲がる）ことのできるシャフト部分をいう。 The catheter shaft 10 constituting the electrode catheter 100 of the present embodiment has a flexible portion 10A having a multi-lumen structure at the distal end portion 11 thereof. Here, the “flexible portion” refers to a shaft portion that can be bent (bent) by pulling the operation wire 60.
　図４および図５に示すように、カテーテルシャフト１０の可撓部分１０Ａは、マルチルーメンチューブ１１１と、その外周を被覆するブレードチューブ１５とにより構成される。また、図５に示すように、マルチルーメンチューブ１１１には、４つのルーメン（第１ルーメン１１Ｌ、第２ルーメン１２Ｌ、第３ルーメン１３Ｌおよび第４ルーメン１４Ｌ）が形成されている。 4 and 5, the flexible portion 10A of the catheter shaft 10 includes a multi-lumen tube 111 and a blade tube 15 covering the outer periphery thereof. As shown in FIG. 5, the multi-lumen tube 111 is formed with four lumens (a first lumen 11L, a second lumen 12L, a third lumen 13L, and a fourth lumen 14L).
　マルチルーメンチューブ１１１の構成材料としては、特に限定されるものではないが、ポリウレタン、ナイロン、ＰＥＢＡＸ（ポリエーテルブロックアミド）などの樹脂を例示することができる。
　また、マルチルーメンチューブ１１１の外周を被覆するブレードチューブ１５としては
、ポリウレタン、ナイロン、ＰＥＢＡＸなどの樹脂からなるチューブをステンレス素線で編組したものを挙げることができる。
　マルチルーメンチューブ１１１の外周を被覆するブレードチューブ１５は、可撓部分１０Ａ（マルチルーメンチューブ１１１）の先端側に更に延びてシングルルーメンチューブを形成している。 The constituent material of the multi-lumen tube 111 is not particularly limited, and examples thereof include resins such as polyurethane, nylon, and PEBAX (polyether block amide).
Examples of the blade tube 15 covering the outer periphery of the multi-lumen tube 111 include a tube made of a resin such as polyurethane, nylon, and PEBAX, which is braided with a stainless steel wire.
The blade tube 15 covering the outer periphery of the multi-lumen tube 111 further extends to the distal end side of the flexible portion 10A (multi-lumen tube 111) to form a single lumen tube.
　カテーテルシャフト１０の外径としては３．０ｍｍ以下であることが好ましく、更に好ましくは１．２～２．４ｍｍ、好適な一例を示せば１．７ｍｍとされる。 The outer diameter of the catheter shaft 10 is preferably 3.0 mm or less, more preferably 1.2 to 2.4 mm, and a suitable example is 1.7 mm.
　本実施形態の電極カテーテル１００を構成する制御ハンドル２０はカテーテルシャフト１０の基端側に接続されている。図１において、２１はグリップ、２２はノブである。
　ノブ２２を基端側にスライドさせることによって、カテーテルシャフト１０の可撓部分１０Ａが屈曲し、これに伴ってカテーテル先端部３０が偏向する。
　従って、制御ハンドル２０を操作して、カテーテル先端部３０を回転させ、さらに偏向させることによって、カテーテル先端部３０を目的部位に誘導することができる。 The control handle 20 constituting the electrode catheter 100 of the present embodiment is connected to the proximal end side of the catheter shaft 10. In FIG. 1, 21 is a grip and 22 is a knob.
By sliding the knob 22 to the proximal end side, the flexible portion 10A of the catheter shaft 10 is bent, and accordingly, the catheter distal end portion 30 is deflected.
Therefore, by operating the control handle 20 to rotate and further deflect the catheter tip 30, the catheter tip 30 can be guided to the target site.
　電極カテーテル１００を構成するカテーテル先端部３０は、形状記憶合金よりなるコアワイヤ３５が絶縁チューブ３３の内部に延在されてなる。
　カテーテル先端部３０は実質的に円形のループ状に形成されている。これにより、血管の内周部分を同時に測定することができる。なお、カテーテル先端部３０は、平坦な円形の閉じたループでなく、螺旋形のループである（本発明において「円形」というときは、厳密には螺旋形であるものを包含する。）。 The catheter distal end 30 constituting the electrode catheter 100 is formed by extending a core wire 35 made of a shape memory alloy into an insulating tube 33.
The catheter tip 30 is formed in a substantially circular loop shape. Thereby, the inner peripheral part of the blood vessel can be measured simultaneously. The catheter tip 30 is not a flat circular closed loop, but a spiral loop (in the present invention, the term “circular” includes strictly a spiral shape).
　形状記憶合金よりなるコアワイヤ３５は、カテーテル先端部３０のループ形状を記憶しており、力を加えることによって容易に変形（例えば直線状に変形）するが、力を取り除くとループ形状に戻る。
　コアワイヤ３５の構成材料としてはＮｉ－Ｔｉ合金を挙げることができる。Ｎｉ－Ｔｉ合金におけるＮｉとＴｉの比率は５４：４６～５７：４３であることが好ましい。好ましいＮｉ－Ｔｉ合金としてニチノールを挙げることができる。
　コアワイヤ３５の直径としては、例えば０．１～１．０ｍｍとされ、好ましくは０．２～０．５ｍｍ、好適な一例を示せば０．３６ｍｍである。 The core wire 35 made of a shape memory alloy stores the loop shape of the catheter tip 30 and is easily deformed (for example, linearly deformed) by applying a force, but returns to the loop shape when the force is removed.
An example of the constituent material of the core wire 35 is a Ni—Ti alloy. The ratio of Ni to Ti in the Ni—Ti alloy is preferably 54:46 to 57:43. A preferred Ni—Ti alloy is nitinol.
The diameter of the core wire 35 is, for example, 0.1 to 1.0 mm, preferably 0.2 to 0.5 mm, and 0.36 mm if a suitable example is shown.
　絶縁チューブ３３の内部は、カテーテルシャフト１０の内部と連通している。
　絶縁チューブ３３の構成材料としては、ポリウレタンまたはＰＥＢＡＸのような生体許容性の樹脂材料を挙げることができる。 The inside of the insulating tube 33 communicates with the inside of the catheter shaft 10.
Examples of a constituent material of the insulating tube 33 include a bio-acceptable resin material such as polyurethane or PEBAX.
　カテーテル先端部３０には、その外周面に９個のリング状電極４１が装着されている。更に、カテーテル先端部３０の先端には先端電極４２が装着されている。
　リング状電極４１および先端電極４２の構成材料としては、白金、金、イリジウム、またはこれらの合金などの導電性材料を挙げることができる。
　なお、カテーテル先端部３０に装着されるリング状電極４１の数としては、９個に限定されないことは勿論であり、本発明の電極カテーテルを構成するリング状電極の数としては、例えば６～２０個とされ、好ましくは８～１２個とされる。 Nine ring-shaped electrodes 41 are mounted on the outer peripheral surface of the catheter tip 30. Further, a tip electrode 42 is attached to the tip of the catheter tip 30.
Examples of the constituent material of the ring-shaped electrode 41 and the tip electrode 42 include conductive materials such as platinum, gold, iridium, or alloys thereof.
Needless to say, the number of ring-shaped electrodes 41 attached to the catheter tip 30 is not limited to nine, and the number of ring-shaped electrodes constituting the electrode catheter of the present invention is, for example, 6 to 20 The number is preferably 8, 12.
　リング状電極４１および先端電極４２には、それぞれリード線５０が接続されている。リング状電極４１の各々に接続されたリード線５０は、絶縁チューブ３３の管壁に形成された細孔から絶縁チューブ３３の内部に進入する。リング状電極４１および先端電極４２の各々に接続された１０本のリード線５０は、絶縁チューブ３３の内部、カテーテルシャフト１０の内部（第２ルーメン１２Ｌ、第３ルーメン１３Ｌおよび第４ルーメン１４Ｌ）に延在して制御ハンドル２０の内部に挿入される。そして、リード線５０の各々の基端部
は、制御ハンドル２０の基端に設けられたコネクタに電気的に接続されている。 Lead wires 50 are connected to the ring electrode 41 and the tip electrode 42, respectively. The lead wires 50 connected to each of the ring-shaped electrodes 41 enter the inside of the insulating tube 33 through the pores formed in the tube wall of the insulating tube 33. Ten lead wires 50 connected to each of the ring electrode 41 and the tip electrode 42 are provided inside the insulating tube 33 and inside the catheter shaft 10 (second lumen 12L, third lumen 13L, and fourth lumen 14L). It extends and is inserted into the control handle 20. Each proximal end portion of the lead wire 50 is electrically connected to a connector provided at the proximal end of the control handle 20.
　電極カテーテル１００を構成する操作用ワイヤ６０は、カテーテルシャフト１０の可撓部分１０Ａを撓ませるために、カテーテルシャフト１０の内部（マルチルーメンチューブ１１１の第１ルーメン１１Ｌ）に延在している。
　操作用ワイヤ６０の先端部６１は、後述する管状係留部材７０を介して、カテーテルシャフト１０の先端部１１に係留されている。
　一方、操作用ワイヤ６０の基端部は、制御ハンドル２０の内部に係留されており、これにより、操作用ワイヤ６０の基端側の引張操作が可能になっている。 The operation wire 60 constituting the electrode catheter 100 extends inside the catheter shaft 10 (the first lumen 11L of the multi-lumen tube 111) in order to bend the flexible portion 10A of the catheter shaft 10.
The distal end portion 61 of the operation wire 60 is anchored to the distal end portion 11 of the catheter shaft 10 via a tubular anchoring member 70 described later.
On the other hand, the proximal end portion of the operation wire 60 is moored inside the control handle 20, thereby enabling a pulling operation on the proximal end side of the operation wire 60.
　操作用ワイヤ６０の構成材料としては、ステンレスおよびＮｉ－Ｔｉ合金などを挙げることができる。操作用ワイヤ６０の表面はＰＴＦＥ「テフロン（登録商標）」などで被覆されていることが好ましい。
　操作用ワイヤ６０の直径としては、例えば０．１～０．５ｍｍとされ、好ましくは０．２０～０．２５ｍｍ、好適な一例を示せば０．２１ｍｍである。 Examples of the constituent material of the operation wire 60 include stainless steel and Ni—Ti alloy. The surface of the operation wire 60 is preferably covered with PTFE “Teflon (registered trademark)” or the like.
The diameter of the operation wire 60 is, for example, 0.1 to 0.5 mm, preferably 0.20 to 0.25 mm, and 0.21 mm if a suitable example is shown.
　電極カテーテル１００を構成する管状係留部材７０は、第１ルーメン１１Ｌの径よりも大きな外径を有し、その内部において固定する操作用ワイヤ６０の先端部６１が基端方向に移動することを抑止するためのアンカー部材であり、カテーテルシャフト１０の先端部１１（マルチルーメンチューブ１１１より先端側であるシングルルーメンチューブ）の内部に配置されている。
　この管状係留部材７０の内部において、コアワイヤ３５の基端部３５２と、操作用ワイヤ６０の先端部６１とが接合されている。 The tubular anchoring member 70 constituting the electrode catheter 100 has an outer diameter larger than the diameter of the first lumen 11L, and prevents the distal end portion 61 of the operation wire 60 to be fixed therein from moving in the proximal direction. It is an anchor member for this purpose, and is disposed inside the distal end portion 11 of the catheter shaft 10 (single lumen tube on the distal end side from the multi-lumen tube 111).
Inside the tubular mooring member 70, the proximal end portion 352 of the core wire 35 and the distal end portion 61 of the operation wire 60 are joined.
　コアワイヤ３５の基端部３５２と、操作用ワイヤ６０の先端部６１とを接合する方法としては特に限定されるものでなく、例えば、コアワイヤ３５の基端部３５２と、操作用ワイヤ６０の先端部６１とが挿入された管状係留部材７０の内部（隙間）に、はんだ、ロウ材、接着剤などの固着材８０を充填する方法、コアワイヤ３５の基端部３５２と、操作用ワイヤ６０の先端部６１とが挿入された管状係留部材７０をかしめる方法などを例示することができる。 The method for joining the proximal end portion 352 of the core wire 35 and the distal end portion 61 of the operation wire 60 is not particularly limited. For example, the proximal end portion 352 of the core wire 35 and the distal end portion of the operation wire 60 are not limited. 61, a method of filling the inside (gap) of the tubular mooring member 70 with a fixing material 80 such as solder, brazing material, or adhesive, a base end portion 352 of the core wire 35, and a tip end portion of the operation wire 60 For example, a method of caulking the tubular mooring member 70 inserted with 61 can be exemplified.
　図４に示すように、カテーテル先端部３０を構成する絶縁チューブ３３の基端部３３２は、カテーテルシャフト１０の先端部１１（シングルルーメンチューブの内部）に進入しており、この状態で、接着剤９０によってカテーテルシャフト１０の先端に固定されている。 As shown in FIG. 4, the proximal end portion 332 of the insulating tube 33 constituting the catheter distal end portion 30 has entered the distal end portion 11 (inside the single lumen tube) of the catheter shaft 10. 90 is fixed to the distal end of the catheter shaft 10.
　また、絶縁チューブ３３とともにカテーテル先端部３０を構成するコアワイヤ３５の基端部３５２は、カテーテルシャフト１０の先端部１１（シングルルーメンチューブの内部）に進入し、そこに配置されている管状係留部材７０の内部において、操作用ワイヤ６０の先端部６１と接合されている。
　これにより、カテーテル先端部３０を、カテーテルシャフト１０の先端側に強固に接続させることができる。
　なお、先端偏向操作可能カテーテルとしての良好な操作性を確保する観点から、カテーテルシャフト１０の先端部１１へのコアワイヤ３５の進入長さ（図４においてＬ35で示す）としては、１０ｍｍ以下であることが好ましい。 Further, the proximal end portion 352 of the core wire 35 constituting the catheter distal end portion 30 together with the insulating tube 33 enters the distal end portion 11 (inside the single lumen tube) of the catheter shaft 10, and the tubular anchoring member 70 disposed there. Is joined to the distal end portion 61 of the operation wire 60.
Thereby, the catheter distal end portion 30 can be firmly connected to the distal end side of the catheter shaft 10.
From the viewpoint of ensuring good operability as a catheter capable of deflecting the distal end, the entry length of the core wire 35 (indicated by L 35 in FIG. 4) into the distal end portion 11 of the catheter shaft 10 is 10 mm or less. It is preferable.
　本実施形態の電極カテーテル１００において、制御ハンドル２０のノブ２２を基端側にスライドさせる（引張操作する）ことにより、制御ハンドル２０の内部におけるピストン機構によって操作用ワイヤ６０が基端側に移動するが、操作用ワイヤ６０の先端部６１は、管状係留部材７０（アンカー部材）により、基端方向に移動することが抑止されている
ためにカテーテルシャフト１０の可撓部分１０Ａが撓み、この結果、カテーテル先端部３０が偏向する。また、ノブ２２を先端側にスライドさせて元の位置に戻すと、カテーテル先端部３０を元の向きに戻すことができる。 In the electrode catheter 100 of the present embodiment, by sliding the knob 22 of the control handle 20 to the base end side (pulling operation), the operation wire 60 is moved to the base end side by the piston mechanism inside the control handle 20. However, since the distal end portion 61 of the operation wire 60 is prevented from moving in the proximal direction by the tubular anchoring member 70 (anchor member), the flexible portion 10A of the catheter shaft 10 is bent, and as a result, The catheter tip 30 is deflected. Moreover, when the knob 22 is slid to the distal end side and returned to the original position, the catheter distal end portion 30 can be returned to the original orientation.
　本実施形態の電極カテーテル１００によれば、コアワイヤ３５の基端部３５２と、操作用ワイヤ６０の先端部６１とが、管状係留部材７０の内部において接合されていることにより、コアワイヤ３５の基端部３５２を、マルチルーメンチューブ１１１の第１ルーメン１１Ｌ以外のルーメン（第２ルーメン１２Ｌ、第３ルーメン１３Ｌまたは第４ルーメン１４Ｌ）に延在させる必要がなくなり、これら３つのルーメンをすべてリード線５０を延在させるために使用することができる。これにより、１０本のリード線５０を延在させるための十分な空間をカテーテルシャフト１０の内部に確保することができる。 According to the electrode catheter 100 of the present embodiment, the proximal end portion 352 of the core wire 35 and the distal end portion 61 of the operation wire 60 are joined inside the tubular anchoring member 70, so that the proximal end of the core wire 35 is obtained. It is not necessary to extend the portion 352 to a lumen (second lumen 12L, third lumen 13L, or fourth lumen 14L) other than the first lumen 11L of the multi-lumen tube 111, and all three lumens are connected to the lead wire 50. Can be used to extend. As a result, a sufficient space for extending the ten lead wires 50 can be secured inside the catheter shaft 10.
　また、カテーテルシャフト１０の内部（第１ルーメン１１Ｌ）に延在し、制御ハンドル２０の内部にその基端部が係留されている操作用ワイヤ６０の先端部６１に対して、コアワイヤ３５の基端部３５２が接合されていることにより、当該操作用ワイヤ６０がコアワイヤ３５の抜け止め効果を発揮することができる。この結果、カテーテルシャフト１０の内部に延在しているコアワイヤ３５の長さが短くても（マルチルーメンチューブ１１１のルーメンにコアワイヤ３５の基端部を進入させなくても）、当該コアワイヤ３５によって構成されるカテーテル先端部３０が、カテーテルシャフト１０から離脱することを有効に防止することができる。
　また、カテーテルシャフト１０の内部に延在しているコアワイヤ３５の長さ（上記の進入長さＬ35）が短いことにより、操作性にも優れている。 Further, the proximal end of the core wire 35 is extended with respect to the distal end portion 61 of the operation wire 60 that extends inside the catheter shaft 10 (first lumen 11L) and is anchored at the proximal end portion inside the control handle 20. The operation wire 60 can exert the effect of preventing the core wire 35 from being detached by joining the portion 352. As a result, even if the length of the core wire 35 extending inside the catheter shaft 10 is short (even if the proximal end portion of the core wire 35 does not enter the lumen of the multi-lumen tube 111), the core wire 35 is configured. It is possible to effectively prevent the catheter tip 30 to be detached from the catheter shaft 10.
Further, since the length of the core wire 35 extending inside the catheter shaft 10 (the entry length L 35 described above) is short, the operability is also excellent.
　以上、本発明の一実施形態について説明したが、本発明の電極カテーテルはこれに限定されるものでなく、種々の変更が可能である。
　例えば、カテーテルシャフトの内部に管状係留部材（アンカー部材）を配置しないで、コアワイヤの基端部と、操作用ワイヤの先端部とを溶接などにより接合してもよい。
　また、管状係留部材に代わる治具を用いて、コアワイヤの基端部と操作用ワイヤの先端部とを機械的に接合してもよい。
　また、マルチルーメンチューブの内部において、コアワイヤの基端部と、操作用ワイヤの先端部とを接合してもよい。
　また、マルチルーメンチューブの先端側にシングルルーメン構造を設けなくてもよい。
　また、マルチルーメンチューブにおけるルーメンの数も４つではなく、例えば２～９のルーメンが形成されていてもよい。
　また、２本の操作用ワイヤを備えたバイディレクションタイプのものであってもよく、この場合には、何れか一方の操作用ワイヤの先端部に対して、コアワイヤの基端部が接合される。 As mentioned above, although one Embodiment of this invention was described, the electrode catheter of this invention is not limited to this, A various change is possible.
For example, the proximal end portion of the core wire and the distal end portion of the operation wire may be joined by welding or the like without arranging the tubular anchoring member (anchor member) inside the catheter shaft.
Moreover, you may join mechanically the base end part of a core wire, and the front-end | tip part of the wire for operation using the jig | tool replaced with a tubular mooring member.
Further, inside the multi-lumen tube, the proximal end portion of the core wire and the distal end portion of the operation wire may be joined.
Further, it is not necessary to provide a single lumen structure on the distal end side of the multi-lumen tube.
Further, the number of lumens in the multi-lumen tube is not four, and for example, 2 to 9 lumens may be formed.
Further, it may be of the bi-direction type provided with two operation wires. In this case, the base end portion of the core wire is joined to the distal end portion of one of the operation wires. .
１００　電極カテーテル
１０　　カテーテルシャフト
１０Ａ　可撓部分
１１　　カテーテルシャフトの先端部
１１Ｌ　第１ルーメン
１２Ｌ　第２ルーメン
１３Ｌ　第３ルーメン
１４Ｌ　第４ルーメン
１５　　ブレードチューブ
２０　　制御ハンドル
２１　　グリップ
２２　　ノブ
３０　　カテーテル先端部
３３　　絶縁チューブ
３５　　コアワイヤ
３５２　コアワイヤの基端部
４２　　先端電極
４１　　リング状電極
４２　　先端電極
５０　　リード線
６０　　操作用ワイヤ
６１　　操作用ワイヤの先端部
７０　　管状係留部材（アンカー部材）
８０　　固着材
９０　　接着剤 DESCRIPTION OF SYMBOLS 100 Electrode catheter 10 Catheter shaft 10A Flexible part 11 Tip 11L of the catheter shaft First lumen 12L Second lumen 13L Third lumen 14L Fourth lumen 15 Blade tube 20 Control handle 21 Grip 22 Knob 30 Catheter tip 33 Insulating tube 35 Core wire 352 Core wire proximal end 42 Tip electrode 41 Ring electrode 42 Tip electrode 50 Lead wire 60 Operation wire 61 Operation wire tip 70 Tubular anchoring member (anchor member)
80 Adhesive 90 Adhesive

Claims (6)

  1. 　マルチルーメン構造の可撓部分を先端部に有するカテーテルシャフトと、
    　前記カテーテルシャフトの基端側に接続された制御ハンドルと、
    　前記カテーテルシャフトの先端側に接続され、絶縁チューブの内部に形状記憶合金よりなるコアワイヤが延在されてなるカテーテル先端部と
    　前記カテーテル先端部の外周に装着された複数のリング状電極と、
    　前記複数のリング状電極の各々に接続され、前記カテーテル先端部の内部および前記カテーテルシャフトの内部を延在して前記制御ハンドルの内部に至る複数のリード線と、
    　前記カテーテルシャフトの可撓部分を撓ませるために、当該カテーテルシャフトの内部に延在し、その先端部が前記カテーテルシャフトの先端部に係留され、その基端部を引張操作できるように当該基端部が前記制御ハンドルに係留されている操作用ワイヤとを備えてなり、
    　前記コアワイヤの基端部と、前記操作用ワイヤの先端部とが接合されていることを特徴とする電極カテーテル。     A catheter shaft having a flexible portion of a multi-lumen structure at the tip,
    A control handle connected to the proximal side of the catheter shaft;
    A catheter tip connected to the tip side of the catheter shaft, and a core wire made of a shape memory alloy extending inside the insulating tube, and a plurality of ring-shaped electrodes mounted on the outer periphery of the catheter tip;
    A plurality of leads connected to each of the plurality of ring-shaped electrodes, extending inside the catheter tip and inside the catheter shaft and reaching the inside of the control handle;
    In order to bend the flexible portion of the catheter shaft, it extends inside the catheter shaft, the distal end portion of the catheter shaft is anchored to the distal end portion of the catheter shaft, and the proximal end portion thereof can be pulled. An operating wire that is moored to the control handle,
    An electrode catheter, wherein a proximal end portion of the core wire and a distal end portion of the operation wire are joined.
  2. 　前記カテーテル先端部がループ状に形成されていることを特徴とする請求項１に記載の電極カテーテル。 2. The electrode catheter according to claim 1, wherein the catheter tip is formed in a loop shape.
  3. 　前記カテーテルシャフトは、マルチルーメン構造の可撓部分の先端側においてシングルルーメン構造を有し、当該シングルルーメンにおいて、前記コアワイヤの基端部と、前記操作用ワイヤの先端部とが接合されていることを特徴とする請求項１または請求項２に記載の電極カテーテル。 The catheter shaft has a single lumen structure on the distal end side of the flexible portion of the multi-lumen structure, and the proximal end portion of the core wire and the distal end portion of the operation wire are joined in the single lumen. The electrode catheter according to claim 1 or 2, wherein
  4. 　前記操作用ワイヤの先端部が基端方向に移動することを抑止する管状係留部材の内部において、前記コアワイヤの基端部と、前記操作用ワイヤの先端部とが接合されていることを特徴とする請求項３に記載の電極カテーテル。 The proximal end portion of the core wire and the distal end portion of the operation wire are joined inside a tubular anchoring member that prevents the distal end portion of the operation wire from moving in the proximal direction. The electrode catheter according to claim 3.
  5. 　前記カテーテルシャフトの先端部への前記コアワイヤの進入長さが１０ｍｍ以下であることを特徴とする請求項１または請求項２に記載の電極カテーテル。 The electrode catheter according to claim 1 or 2, wherein the length of the core wire entering the distal end of the catheter shaft is 10 mm or less.
  6. 　前記カテーテルシャフトの外径が３．０ｍｍ以下であり、前記コアワイヤの直径が０．１～１．０ｍｍであることを特徴とする請求項１または請求項２に記載の電極カテーテル。 3. The electrode catheter according to claim 1, wherein an outer diameter of the catheter shaft is 3.0 mm or less and a diameter of the core wire is 0.1 to 1.0 mm.
PCT/JP2013/071359 2013-01-30 2013-08-07 Electrode catheter WO2014119030A1 (en)

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KR1020157006623A KR101778414B1 (en) 2013-01-30 2013-08-07 Electrode catheter
CN201380050333.9A CN104684468B (en) 2013-01-30 2013-08-07 Electrode catheter

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JP2013-016235 2013-01-30

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004275767A (en) * 2003-03-12 2004-10-07 Biosense Webster Inc Catheter with contractable mapping assembly
JP2008520278A (en) * 2004-11-15 2008-06-19 バイオセンス・ウェブスター・インコーポレイテッド Flexible linear mapping catheter with stabilizing tip
JP2008245767A (en) * 2007-03-29 2008-10-16 Japan Lifeline Co Ltd Electrode catheter

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6711428B2 (en) * 2000-01-27 2004-03-23 Biosense Webster, Inc. Catheter having mapping assembly
US7366557B2 (en) * 2003-11-07 2008-04-29 Biosense Webster, Inc. Flower catheter
US8747351B2 (en) * 2009-08-28 2014-06-10 Biosense Webster, Inc. Catheter with multi-functional control handle having linear mechanism

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004275767A (en) * 2003-03-12 2004-10-07 Biosense Webster Inc Catheter with contractable mapping assembly
JP2008520278A (en) * 2004-11-15 2008-06-19 バイオセンス・ウェブスター・インコーポレイテッド Flexible linear mapping catheter with stabilizing tip
JP2008245767A (en) * 2007-03-29 2008-10-16 Japan Lifeline Co Ltd Electrode catheter

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KR20150111902A (en) 2015-10-06
TW201431575A (en) 2014-08-16
JP2014147410A (en) 2014-08-21
TWI569828B (en) 2017-02-11
KR101778414B1 (en) 2017-09-13
JP5729778B2 (en) 2015-06-03
CN104684468A (en) 2015-06-03

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