WO2014196249A1 - Catheter having bendable tip - Google Patents

Catheter having bendable tip Download PDF

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Publication number
WO2014196249A1
WO2014196249A1 PCT/JP2014/059107 JP2014059107W WO2014196249A1 WO 2014196249 A1 WO2014196249 A1 WO 2014196249A1 JP 2014059107 W JP2014059107 W JP 2014059107W WO 2014196249 A1 WO2014196249 A1 WO 2014196249A1
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WO
WIPO (PCT)
Prior art keywords
anchor member
catheter
tip electrode
distal end
temperature sensor
Prior art date
Application number
PCT/JP2014/059107
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
Publication of WO2014196249A1 publication Critical patent/WO2014196249A1/en

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    • 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
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00323—Cables or rods
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00821—Temperature measured by a thermocouple
    • 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 tip-deflable catheter, and more specifically, by operating a proximal-side operation unit arranged outside the body, the orientation of the distal end of the catheter inserted into the body cavity can be changed.
  • the present invention relates to a catheter capable of tip deflection operation.
  • the orientation of the distal end of the catheter inserted into the heart (fixed end of the tip electrode) is set to the proximal end of the catheter placed outside the body ( There is a need to change (deflection) the operation unit attached to the rear end or the hand side.
  • the present applicant has a catheter tube, a tip electrode, a leaf spring for swinging, and a pair of operation wires.
  • the distal end of the leaf spring is coupled to the tip electrode, and the distal end of the manipulation wire is connected and fixed to the tip electrode independently of the coupling portion of the distal end of the leaf spring.
  • a catheter capable of tip deflection operation in which a temperature sensor protective tube is connected and fixed to the tip electrode (see Patent Document 1 below).
  • the distal end of the leaf spring is connected and fixed by solder filled in the inner concave portion of the tip electrode, and the distal end of the operation wire is connected to the solder by the solder of the leaf spring. It is connected and fixed independently of the distal end. Further, the temperature sensor protective tube is fixed to the distal end of the leaf spring independently of the connecting portion of the distal end of the leaf spring or by being fixed to the distal end of the leaf spring. Are independently connected and fixed to the tip electrode.
  • the tip electrode constituting the catheter is not only connected to the distal end of the leaf spring but also connected and fixed to the distal end of the operation wire. Therefore, even if the connection between the tip electrode and the distal end of the leaf spring is disconnected, the tip electrode is connected and fixed to the distal end of the operation wire, so that the tip electrode can be effectively prevented from falling off. Can do.
  • the distal end of the manipulation wire is connected to the tip electrode independently of the connecting portion of the distal end of the leaf spring (away from the distal end of the leaf spring). Since the connection wire is fixed, the distal end of the operation wire comes out of the solder filled in the concave portion inside the tip electrode when the operation wire is pulled (the connection with the tip electrode is lost). There is a risk. Therefore, in order to prevent the distal end of the operation wire from coming off from the solder filled in the inner concave portion of the tip electrode, a retaining portion (a large-diameter portion for retaining) is disposed at the distal end of the manipulation wire. ) Or a sleeve-like anchor member made of a material having good wettability with solder (for example, phosphor bronze) is mounted around the distal end of the operation wire.
  • the anchor member attached to each of the distal ends of the pair of operation wires occupies most of the inner recess (internal space) of the tip electrode, and the size of the tip electrode Depending on the (outer diameter of the catheter), the distal end of the temperature sensor protective tube and the lead electrode lead wire cannot be inserted into the inner recess filled with solder and fixed.
  • a first object of the present invention is to provide a distal end of an operation wire, a distal end of a lead wire of a tip electrode, and a temperature sensor protective tube in which a temperature measuring portion of the temperature sensor is inserted and fixed.
  • An object of the present invention is to provide a catheter capable of tip deflection operation which is disposed at an appropriate position of a recess and is fixed to the tip electrode.
  • a second object of the present invention is to provide a bi-directional type thin catheter having a small diameter tip deflection operation.
  • the third object of the present invention is to provide a catheter capable of tip deflection operation which is excellent in flatness of shape change of the tip flexible portion during tip deflection operation.
  • a fourth object of the present invention is to provide a catheter capable of tip deflection operation that is excellent in workability during manufacture.
  • the tip deflection operable catheter of the present invention includes a catheter tube having a tip flexible portion; A tip electrode fixed to the distal end of the catheter tube; An operation wire that is arranged so as to extend along the axial direction inside the catheter tube, and whose proximal end can be pulled; and A lead wire of the tip electrode, which is disposed so as to extend along the axial direction inside the catheter tube, and whose distal end is connected to the tip electrode; A temperature sensor comprising a thermocouple for measuring the temperature inside the tip electrode; An insulating temperature sensor protective tube into which the temperature measuring section of the temperature sensor is inserted and fixed; A columnar anchor member fitted in an inner recess of the tip electrode to fix the distal end of the manipulation wire to the tip electrode; The anchor member is formed with two through-holes extending in the axial direction so as to face each other across the central axis of the anchor member, and two inner holes extending in the axial direction and opening on the proximal end side,
  • the manipulation wire has a proximal
  • the temperature sensor protective tube is inserted and fixed in one inner hole formed in the anchor member, so that the temperature measuring portion of the temperature sensor is disposed inside the tip electrode, and the other formed in the anchor member.
  • the distal end of the conducting wire is inserted and fixed in the inner hole of the lead wire so that the conducting wire is connected to the tip electrode.
  • the anchor member is fitted in the inner concave portion of the distal electrode, and the operation wire is distant from the one end side (proximal end side) inside the catheter tube.
  • the catheter tube extends in the lateral direction, passes through one through hole of the anchor member fitted in the inner recess of the tip electrode, turns back at the distal end of the anchor member, passes through the other through hole of the anchor member, and passes through the other through hole. Since it consists of one wire extending in the proximal direction to the other end (proximal end), the distal end of the operation wire is arranged and fixed at an appropriate position of the inner recess of the tip electrode. be able to.
  • the operation wire is folded at the distal end of the anchor member fitted in the inner recess of the tip electrode and fixed to the tip electrode by passing through two through holes.
  • the distal end of the operation wire does not come off from the inner concave portion of the electrode, and can be firmly fixed to the tip electrode regardless of the type of the constituent material.
  • the two through holes formed in the anchor member are arranged so as to face each other with the central axis of the anchor member interposed therebetween, one end and the other end of the operation wire passed through the two through holes are pulled.
  • the direction of the distal end of the catheter can be changed in both directions, and the shape change flatness at the distal end flexible portion of the catheter is excellent.
  • the temperature sensor protection tube is inserted and fixed in one of the inner holes formed in the anchor member, the temperature sensor protection tube (the temperature sensor of the temperature sensor) is placed at an appropriate position in the inner recess of the tip electrode. It can be placed and secured to the tip electrode.
  • the conducting wire is disposed at an appropriate position in the inner recess of the tip electrode, and is electrically connected to the tip electrode. Can be connected.
  • the arrangement position (occupied space) of the distal end of the operation wire in the inner recess of the tip electrode can be secured by the through hole of the anchor member, and the arrangement position of the distal end of the conductor and the temperature sensor protective tube ( Occupied space) can be ensured by the corresponding inner hole of the anchor member. Then, by efficiently disposing the through hole and the inner hole in the anchor member, the size of the tip electrode is reduced and the diameter of the catheter is reduced (for example, the outer diameter is set to 5 Fr or less). Can do.
  • the distal end of the operation wire, the distal end of the lead wire of the tip electrode, the temperature sensor protective tube (the temperature sensor of the temperature sensor), Is attached to the anchor member to constitute an assembly, and this assembly is attached to the tip electrode (the anchor member is fitted into the inner recess), whereby the workability can be improved.
  • the outer diameter of the catheter tube is 5 Fr or less, and the opening diameter of the inner recess of the distal electrode is 1.3 mm or less. In such a small-diameter catheter, it is effective to employ the structure according to the present invention.
  • the anchor member is preferably made of brass.
  • the temperature sensor protective tube in which the distal end of the operation wire constituting the catheter, the distal end of the lead wire of the tip electrode, and the temperature sensor of the temperature sensor are inserted and fixed Can be disposed at an appropriate position in the inner recess of the tip electrode, and these can be fixed to the tip electrode.
  • a catheter having a small diameter for example, an outer diameter of 5 Fr or less
  • the distal deflection operable catheter of the present invention is excellent in the flatness of the shape change of the distal flexible portion during the distal deflection operation.
  • the distal deflection operable catheter of the present invention is excellent in workability at the time of manufacture.
  • FIG. 3 is a longitudinal sectional view showing a distal end portion of the electrode catheter shown in FIG. 1 (cross-sectional view taken along line III-III in FIG. 2).
  • FIG. 4 is a transverse sectional view (IV-IV sectional view of FIG. 2) showing a distal end portion of the electrode catheter shown in FIG.
  • FIG. 5 is a transverse sectional view (a VV sectional view of FIG. 2) showing a distal end portion of the electrode catheter shown in FIG.
  • the electrode catheter 100 of the present embodiment shown in FIGS. 1 to 5 is used for, for example, diagnosis or treatment of arrhythmia in the heart.
  • the electrode catheter 100 of this embodiment includes a catheter tube 10 having a tip flexible portion 15, a tip electrode 20 having an inner recess 20 ⁇ / b> C fixed to the distal end of the catheter tube 10, and the inside of the catheter tube 10 (lumen 11). And the lumen 12) are arranged so as to extend along the axial direction, and the proximal end of the manipulation wire 30 can be pulled and the catheter tube 10 (lumen 14) extends along the axial direction. And a temperature sensor 50 including a thermocouple for measuring a temperature inside the tip electrode 20, and a temperature measuring unit of the temperature sensor 50.
  • Insulating temperature sensor protective tube 60 into which 50A is inserted, and tip electrode 20 for fixing the distal end of operation wire 30 to tip electrode 20 A cylindrical anchor member 80 fitted in the inner recess 20C, and a connector (handle) 70 attached to the proximal end of the catheter tube 10; the anchor member 80 includes a center of the anchor member 80; Two through holes (through hole 81 and through hole 82) extending in the axial direction so as to face each other across the shaft, and two inner holes (inner hole 83 and inner hole 84) extending in the axial direction and opening at the proximal end side
  • One end and the other end of the operation wire 30 are proximal ends, and the inside (lumen 11) of the catheter tube 10 extends in the distal direction from one end side, and one through-hole 81 of the anchor member 80 is formed.
  • the temperature sensor protective tube 60 is inserted into and fixed to one inner hole 83 formed in the anchor member 80, and the temperature measuring unit 50A of the temperature sensor 50 is connected to the tip electrode 20 by the one end hole 83 formed in the anchor member 80.
  • the distal end of the conducting wire 40 is inserted into and fixed to the other inner hole 84 formed in the anchor member 80, so that the conducting wire 40 is electrically connected to the tip electrode 20. It is connected to the.
  • the electrode catheter 100 of the present embodiment shown in FIGS. 1 to 5 includes a catheter tube 10, a tip electrode 20, an operation wire 30, a lead electrode lead wire 40, a temperature sensor 50, and a temperature sensor protective tube 60.
  • the anchor member 80 and the connector 70 are provided.
  • reference numeral 75 denotes a knob for performing a swinging operation (catheter tip deflection operation) of the catheter tube 10.
  • 90 is a solder for fixing the anchor member 80 to the tip electrode 20.
  • the catheter tube 10 is a multi-lumen tube having a flexible distal end portion 15 and four lumens (11, 12, 13, 14) formed therein.
  • the “tip flexible portion” refers to a distal end portion of the catheter tube that can be bent (bent) by pulling the operation wire.
  • the catheter tube 10 may be formed of a tube having the same characteristics along the axial direction, but the distal end flexible portion (distal end portion) having relatively high flexibility and the distal end flexible portion It is preferable to have a rear end portion (proximal end portion) that is integrally formed in the axial direction and is relatively more rigid than the tip flexible portion.
  • the constituent material of the catheter tube 10 include synthetic resins such as polyolefin, polyamide, polyether block polyamide, and polyurethane.
  • the outer diameter of the catheter tube 10 is usually 2 Fr (0.65 mm) to 8 Fr (2.7 mm), and is preferably 5 Fr or less from the viewpoint of reducing the diameter.
  • the tip electrode 20 fixed to the distal end of the catheter tube 10 is formed by integrally forming a bullet-shaped tip portion 201 and a cylindrical portion 202 continuous therewith.
  • the cylindrical portion 202 of the tip electrode 20 is inserted into the distal end of the catheter tube 10 and is fixed to the distal end of the catheter tube 10 with an adhesive or the like.
  • the constituent material of the tip electrode 20 include metals having good thermal conductivity such as aluminum, copper, stainless steel, gold, and platinum.
  • the tip electrode 20 is preferably made of platinum or the like in order to provide good contrast properties for X-rays.
  • the outer diameter of the tip electrode 20 is preferably approximately the same as the outer diameter of the catheter tube 10.
  • the inside of the tip electrode 20 is a columnar space (inner recess 20C) for accommodating and fitting an anchor member 80 described later.
  • the opening diameter of the inner recess 20C corresponding to the inner diameter of the tip electrode 20 is 0.1 to 2.4 mm, and preferably 1.3 mm or less.
  • the operation wire 30 constituting the electrode catheter 100 extends along the axial direction inside the catheter tube 10 (lumen 11 and lumen 12).
  • an outward path portion 30 ⁇ / b> A extending in the distal direction from one end side extends to the lumen 11
  • a return path portion 30 ⁇ / b> B that is folded back and extends in the proximal direction extends to the lumen 12.
  • One end and the other end, which are proximal ends of the operation wire 30, are connected to a knob 75 for performing a deflection operation of the catheter tube 10, thereby enabling a pulling operation.
  • the distal end of the operation wire 30 is fixed to the tip electrode 20 by a columnar anchor member 80 fitted in the inner recess 20 ⁇ / b> C of the tip electrode 20.
  • the anchor member 80 has two through-holes (through-hole 81 and through-hole 82) extending in the axial direction so as to face each other across the central axis, and the center of the anchor member 80.
  • Two inner holes (an inner hole 83 and an inner hole 84 that open on the proximal end side) are formed to extend in the axial direction so as to face each other across the shaft.
  • the outer diameter of the anchor member 80 is formed to be slightly smaller than the inner diameter of the inner recess 20C of the tip electrode 20, and the anchor member 80 is inserted into the inner recess 20C of the tip electrode 20, and in a slight gap between the two. Is filled with solder 90. In this way, the anchor member 80 and the inner concave portion 20C of the tip electrode 20 are fitted (by this, the central axes of both of them match), and electrical conductivity and good thermal conductivity are ensured between them. Has been.
  • a metal material having good wettability with respect to the solder 90 is preferable. From this point of view, copper or a copper alloy can be cited as a suitable constituent material of the anchor member 80, and brass (brass) having good thermal conductivity and good wettability with respect to solder is particularly preferable.
  • the solder 90 filled in the inner recess 20C (the gap with the anchor member 80) of the tip electrode 20 is not particularly limited.
  • Pb-free solders such as Sn—Ag—Cu, Sn—Cu, Sn—Ag, Sn—Ag—Cu—Bi and the like can also be used.
  • the operation wire 30 is composed of one wire whose one end and the other end are a proximal end and whose folded portion is a distal end.
  • the operation wire 30 extends in the distal direction from one end side (proximal end side) in the lumen 11 inside the catheter tube 10, and the through hole 81 of the anchor member 80 fitted in the inner recess 20 ⁇ / b> C of the tip electrode 20.
  • the operation wire 30 extending inside the catheter tube 10 passes through the through hole 81 of the anchor member 80, is folded at the distal end surface 80D, and passes through the through hole 82.
  • the distal end of the operation wire 30 can be firmly fixed to the anchor member 80 (and thus the tip electrode 20). Even if the proximal end of the operation wire 30 is pulled, the distal end of the operation wire 30 does not come out of the inner recess 20 ⁇ / b> C of the tip electrode 20.
  • the through hole 81 and the through hole 82 are arranged so as to face each other with the central axis of the anchor member 80 (the central axis of the tip electrode 20) interposed therebetween, the through hole 81 and the through hole 82 are located close to the operation wire 30 passed through these through holes.
  • the direction of the distal end of the electrode catheter 100 can be changed in both directions, and the flatness of the shape change of the tip flexible portion of the electrode catheter 100 can be improved. Is also excellent.
  • the constituent material of the operation wire 30 is not particularly limited, and all the same constituent materials as those of the conventionally known operation wires of the tip deflection operable catheter can be used.
  • a metal material having low wettability to solder for example, (Stainless steel) can be suitably used as the constituent material of the operation wire 30, and even a non-metallic material can be used.
  • the diameter of the operation wire 30 is, for example, 0.05 to 0.5 mm, preferably 0.1 to 0.3 mm. Note that the inner diameters of the through hole 81 and the through hole 82 of the anchor member 80 are slightly larger than the diameter of the operation wire 30, and the inner peripheral surface of the through holes 81 and 82 and the outer peripheral surface of the operation wire 30. A small gap between them is filled with solder 90.
  • the conducting wire 40 constituting the electrode catheter 100 extends inside the catheter tube 10 (lumen 14) and inside the connector 70, and the proximal end of the conducting wire 40 is pulled out from the connector 70 and connected to, for example, a high frequency generator.
  • the distal end of the conducting wire 40 is inserted into an inner hole 84 formed in the anchor member 80, and solder 90 entering the inner hole 84 is used to fix the anchor member 80 to the anchor member 80. It is fixed. Thereby, the conducting wire 40 is electrically connected to the anchor member 80 (and thus the tip electrode 20).
  • the conducting wire 40 a normal resin-coated conducting wire can be used.
  • the diameter of the conductor 40 is, for example, 0.04 to 0.3 mm, and preferably 0.06 to 0.12 mm.
  • the temperature sensor 50 constituting the electrode catheter 100 is for measuring the temperature inside the distal electrode 20, and is an essential component in the ablation catheter.
  • the temperature sensor 50 is made of a thermocouple, and the portions other than the tip region including the temperature measuring unit 50A are covered with an insulating material such as polyimide.
  • a temperature measuring unit 50A of the temperature sensor 50 (a joining portion of dissimilar metals in the thermocouple) is inserted into the temperature sensor protective tube 60 and fixed to the temperature sensor protective tube 60 by an adhesive 65 filled therein. Yes. Further, as shown in FIGS. 3 and 4, the temperature sensor protective tube 60 (at least the portion to which the temperature measuring portion 50 ⁇ / b> A of the temperature sensor 50 is bonded and fixed) is inserted into the inner hole 83 formed in the anchor member 80. The anchor member 80 is fixed to the anchor member 80 by an adhesive filled in the inner hole 83. Thereby, the temperature measuring part 50A of the temperature sensor 50 can be disposed and fixed in the inner recess 20C of the tip electrode 20, and the temperature sensor protection tube 60 ensures insulation between the temperature sensor 50 and the tip electrode 20. can do.
  • Examples of the adhesive 65 for filling the temperature sensor protective tube 60 and fixing the temperature sensor 50 and the adhesive for filling the inner hole 83 of the anchor member 80 and fixing the temperature sensor protective tube 60 include: An epoxy-based thermosetting adhesive can be preferably used.
  • the temperature sensor protective tube 60 an insulating resin tube can be used, and a polyimide tube can be cited as a suitable example.
  • the inner diameter of the temperature sensor protective tube 60 is, for example, 0.1 to 0.5 mm, preferably 0.2 to 0.4 mm.
  • the outer diameter of the temperature sensor protective tube 60 is, for example, 0.2 to 0.6 mm, and preferably 0.3 to 0.5 mm.
  • the inner diameter of the inner hole 83 of the anchor member 80 is slightly larger than the outer diameter of the temperature sensor protective tube 60.
  • the temperature sensor protective tube 60 is fixed to the inner hole 83 of the anchor member 80 by filling a small amount of adhesive into the gap between the inner peripheral surface of the inner hole 83 and the outer peripheral surface of the temperature sensor protective tube 60. can do.
  • the air layer is not formed around the temperature sensor protective tube 60 by filling the adhesive, good thermal conductivity from the tip electrode 20 to the temperature sensor 50 can be ensured.
  • either one end or the other end of the operation wire 30 is pulled in the proximal direction, and the distal flexible portion of the electrode catheter 100 is bent, and the electrode catheter 100 is bent.
  • the distal end of can be deflected in the direction indicated by arrow A or B.
  • the knob 75 shown in FIG. 1 in the A1 direction, one end of the operation wire 30 is pulled in the proximal direction, and the distal end of the electrode catheter 100 is deflected in the direction indicated by the arrow A. Further, by rotating the knob 75 in the B1 direction, the other end of the operation wire 30 is pulled in the proximal direction, and the distal end of the electrode catheter 100 is deflected in the direction indicated by the arrow B. If the connector 70 is rotated around the axis, the direction in the A or B direction with respect to the electrode catheter 100 can be freely set while being inserted into the body cavity.
  • the distal end of the operation wire 30 can be disposed at an appropriate position of the inner recess 20C of the tip electrode 20 and can be firmly fixed to the tip electrode 20. Therefore, when the proximal end of the operation wire 30 is pulled, the distal end of the operation wire 30 does not come out of the inner recess 20 ⁇ / b> C of the tip electrode 20. Further, since the temperature sensor protective tube 60 is inserted and fixed in the inner hole 83 formed in the anchor member 80, the temperature measuring unit 50A of the temperature sensor 50 can be connected to the inner recess 20C of the tip electrode 20 appropriately. The tip electrode 20 can be fixed at the position.
  • the conducting wire 40 is disposed at an appropriate position of the inner recess 20C of the tip electrode 20, and the tip The electrode 20 can be electrically connected.
  • the arrangement position of the distal end of the operation wire 30 can be secured by the through hole 81 and the through hole 82 of the anchor member 80, and the arrangement position of the distal end of the conducting wire 40.
  • the diameter can be increased (for example, the outer diameter is 5 Fr or less).
  • the through hole 81 and the through hole 82 are arranged so as to face each other with the central axis of the anchor member 80 (the central axis of the tip electrode 20 with which the anchor member 80 is fitted) interposed therebetween, By pulling one end or the other end of the operation wire 30 passed through the holes 81 and 82, the direction of the distal end of the electrode catheter 100 can be changed in both directions. The flatness of the shape change in the flexible portion 15 is also excellent.
  • the distal end of the operation wire 30, the distal end of the conducting wire 40, and the temperature sensor protective tube 60 are attached to the anchor member 80 to form an assembly, and this assembly is attached to the tip electrode 20.
  • the anchor member 80 in the assembly into the inner recess 20C of the tip electrode 20, the electrode catheter 100 of this embodiment can be easily manufactured.
  • the inner hole into which the temperature sensor and the conducting wire are inserted and fixed may be a through hole.
  • a ring electrode may be attached to the distal end of the catheter tube.
  • a leaf spring may be disposed at the distal flexible portion of the catheter tube.
  • the outer diameter of the tip electrode may be larger than the outer diameter of the catheter tube.
  • Electrode catheter 10 Catheter tube 11, 12, 13, 14 Lumen 15 Tip flexible part 20 Tip electrode 20C Inner recessed part 201 Tip part 202 Cylindrical part 30 Operation wire 30A Outward part 30B Return part 40 Lead wire 50 Temperature sensor 50A Temperature measurement Portion 60 Temperature sensor protective tube 70 Connector 75 Knob 80 Anchor member 80D Distal end surface 81, 82 Through hole 83, 84 Inner hole 90 Solder

Abstract

The present invention addresses the problem of providing a bidirectional-type catheter having a bendable tip and a small diameter. A catheter having a bendable tip is provided with: a catheter tube (10); a tip electrode (20); an operation wire (30); a conducting wire (40); a temperature sensor (50); a temperature sensor protection tube (60); and an anchor member (80) for the operation wire. Through holes (81, 82) and internal holes (83, 84) are formed in the anchor member (80). The operation wire (30) comprises one wire that extends within the catheter tube (10) from one edge side thereof in the distal direction, passes through the through hole (81) of the anchor member (80), is bent back at a distal end (80D), passes through the through hole (82), extends within the catheter tube (10) in the proximal direction, and reaches another edge. The temperature sensor protection tube (60) is inserted in the internal hole (83) of the anchor member (80) and secured so that the temperature measurement section of the temperature sensor (50) is arranged within the tip electrode (20). The distal end of the conducting wire (40) is inserted in the through hole (84) of the anchor member (80) and secured so that the conducting wire (40) is connected to the tip electrode (20).

Description

先端偏向操作可能カテーテルTip deflectable catheter
　本発明は先端偏向操作可能カテーテルに関し、更に詳しくは、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カテーテルの遠位端の向きを変化させることができる先端偏向操作可能カテーテルに関する。 The present invention relates to a tip-deflable catheter, and more specifically, by operating a proximal-side operation unit arranged outside the body, the orientation of the distal end of the catheter inserted into the body cavity can be changed. The present invention relates to a catheter capable of tip deflection operation.
　例えば、動脈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では、心臓内に挿入されたカテーテルの遠位端（先端電極の固定端）の向きを、体外に配置されるカテーテルの近位端（後端または手元側）に装着された操作部を操作して変化（偏向）させる必要性が生じる。 For example, in the case of an electrode catheter inserted into the heart through an arterial blood vessel, the orientation of the distal end of the catheter inserted into the heart (fixed end of the tip electrode) is set to the proximal end of the catheter placed outside the body ( There is a need to change (deflection) the operation unit attached to the rear end or the hand side.
　手元側で操作することにより遠位端を偏向させることのできるバイデレクションタイプのカテーテルとして、本出願人は、カテーテルチューブと、先端電極と、首振り用の板バネと、一対の操作用ワイヤとを備え、板バネの遠位端が先端電極に対して連結され、板バネの遠位端の連結部とは独立に、操作用ワイヤの遠位端が先端電極に接続固定され、操作用ワイヤの遠位端の接続固定部とは独立に、温度センサ用保護管が先端電極に接続固定されている先端偏向操作可能カテーテルを提案している（下記特許文献１参照）。 As a bi-direction type catheter capable of deflecting the distal end by operating on the proximal side, the present applicant has a catheter tube, a tip electrode, a leaf spring for swinging, and a pair of operation wires. The distal end of the leaf spring is coupled to the tip electrode, and the distal end of the manipulation wire is connected and fixed to the tip electrode independently of the coupling portion of the distal end of the leaf spring. Independent of the connection fixing portion at the distal end of the wire, there has been proposed a catheter capable of tip deflection operation in which a temperature sensor protective tube is connected and fixed to the tip electrode (see Patent Document 1 below).
　特許文献１に記載されたカテーテルにおいては、先端電極の内側凹部に充填されたハンダにより板バネの遠位端が接続固定され、このハンダに対して、操作用ワイヤの遠位端が板バネの遠位端とは独立に接続固定されている。
　また、温度センサ用保護管は、板バネの遠位端の連結部とは独立に、あるいは、板バネの遠位端に固定されることにより、操作用ワイヤの遠位端の接続固定部とは独立して先端電極に対して接続固定されている。 In the catheter described in Patent Document 1, the distal end of the leaf spring is connected and fixed by solder filled in the inner concave portion of the tip electrode, and the distal end of the operation wire is connected to the solder by the solder of the leaf spring. It is connected and fixed independently of the distal end.
Further, the temperature sensor protective tube is fixed to the distal end of the leaf spring independently of the connecting portion of the distal end of the leaf spring or by being fixed to the distal end of the leaf spring. Are independently connected and fixed to the tip electrode.
　特許文献１に記載されたカテーテルによれば、これを構成する先端電極が、板バネの遠位端に連結してあるのみでなく、操作用ワイヤの遠位端に対しても接続固定されているので、先端電極と板バネの遠位端との連結が外れたとしても、先端電極は、操作用ワイヤの遠位端に接続固定してあるため、先端電極の脱落を有効に防止することができる。 According to the catheter described in Patent Document 1, the tip electrode constituting the catheter is not only connected to the distal end of the leaf spring but also connected and fixed to the distal end of the operation wire. Therefore, even if the connection between the tip electrode and the distal end of the leaf spring is disconnected, the tip electrode is connected and fixed to the distal end of the operation wire, so that the tip electrode can be effectively prevented from falling off. Can do.
特開２００６－６１３５０号公報JP 2006-61350 A
（１）特許文献１に記載されたカテーテルにおいては、板バネの遠位端の連結部とは独立して（板バネの遠位端から離れて）、先端電極に操作用ワイヤの遠位端が接続固定されているため、操作用ワイヤの引張操作を行うときに、先端電極の内側凹部に充填されているハンダから操作用ワイヤの遠位端が抜けてしまう（先端電極との接続がはずれてしまう）おそれがある。
　そこで、先端電極の内側凹部に充填されているハンダから操作用ワイヤの遠位端が抜けてしまうことを防止するために、操作用ワイヤの遠位端に抜け止め部（抜け止め用大径部）を形成したり、操作用ワイヤの遠位端のまわりにハンダとの濡れ性のよい材料（例えばリン青銅）からなるスリーブ状のアンカー部材を装着したりすることが行われている。 (1) In the catheter described in Patent Document 1, the distal end of the manipulation wire is connected to the tip electrode independently of the connecting portion of the distal end of the leaf spring (away from the distal end of the leaf spring). Since the connection wire is fixed, the distal end of the operation wire comes out of the solder filled in the concave portion inside the tip electrode when the operation wire is pulled (the connection with the tip electrode is lost). There is a risk.
Therefore, in order to prevent the distal end of the operation wire from coming off from the solder filled in the inner concave portion of the tip electrode, a retaining portion (a large-diameter portion for retaining) is disposed at the distal end of the manipulation wire. ) Or a sleeve-like anchor member made of a material having good wettability with solder (for example, phosphor bronze) is mounted around the distal end of the operation wire.
　然るに、このような構造を採用すると、一対の操作用ワイヤの遠位端の各々に装着され
たアンカー部材によって先端電極の内側凹部（内部空間）の大部分が占められてしまい、先端電極のサイズ（カテーテルの外径）によっては、ハンダが充填される内側凹部に対して、温度センサ用保護管や先端電極の導線の遠位端を挿入して、固定することができなくなる。 However, when such a structure is employed, the anchor member attached to each of the distal ends of the pair of operation wires occupies most of the inner recess (internal space) of the tip electrode, and the size of the tip electrode Depending on the (outer diameter of the catheter), the distal end of the temperature sensor protective tube and the lead electrode lead wire cannot be inserted into the inner recess filled with solder and fixed.
　近年、アブレーションカテーテルなどの電極カテーテルにおいて、小児の患者にも適用可能となるよう、カテーテルの細径化の要請がある。具体的には、外径が５Ｆｒ（フレンチ）程度のバイデレクションタイプのカテーテルが望まれている。 In recent years, there has been a demand for reducing the diameter of an electrode catheter such as an ablation catheter so that it can be applied to a child patient. Specifically, a bi-direction type catheter having an outer diameter of about 5 Fr (French) is desired.
　しかしながら、特許文献１に記載されたカテーテルによっては、先端電極の内側凹部に対して、板バネの遠位端と、スリーブ状のアンカー部材が装着されている一対（２本）の操作用ワイヤの遠位端と、温度センサ用保護管と、先端電極の導線の遠位端とを挿入してハンダにより固定することができなくなるため、カテーテルの細径化、例えば、外径を５Ｆｒ程度とすることは不可能である。 However, depending on the catheter described in Patent Document 1, the distal end of the leaf spring and the pair of (two) operation wires on which the sleeve-like anchor member is attached to the inner recess of the tip electrode Since the distal end, the temperature sensor protective tube, and the distal end of the tip electrode lead wire cannot be inserted and fixed by soldering, the diameter of the catheter is reduced, for example, the outer diameter is set to about 5 Fr. It is impossible.
（２）特許文献１に記載されたカテーテルにおいて、狭い空間である先端電極の内側凹部に対して、板バネの遠位端と、スリーブ状のアンカー部材が装着されている一対（２本）の操作用ワイヤの遠位端と、温度センサ用保護管と、先端電極の導線の遠位端とを適正な位置に配置することはきわめて困難である。特に一対の操作用ワイヤは、先端電極の中心軸を挟んで対向するように（１８０°間隔で）配置する必要があり、そのように配置されていないカテーテルは、その先端偏向操作時において、先端可撓部分の形状を同一平面上で変化させる（形状変化の平面性を確保する）ことができなくなる。 (2) In the catheter described in Patent Document 1, a pair (two) of a distal end of a leaf spring and a sleeve-like anchor member attached to an inner recess of a tip electrode that is a narrow space It is extremely difficult to place the distal end of the operating wire, the temperature sensor protective tube, and the distal end of the tip electrode lead wire in the proper positions. In particular, the pair of operation wires must be arranged so as to face each other across the central axis of the tip electrode (at an interval of 180 °). It becomes impossible to change the shape of the flexible portion on the same plane (to ensure the flatness of the shape change).
（３）特許文献１に記載されたカテーテルを製造する際に、先端電極の内側凹部に対して、板バネの遠位端と、スリーブ状のアンカー部材が装着されている一対の操作用ワイヤの遠位端と、温度センサ用保護管と、先端電極の導線の遠位端とを別々に挿入してハンダにより固定する作業はきわめて煩雑である。 (3) When manufacturing the catheter described in Patent Document 1, the distal end of the leaf spring and the pair of operation wires on which the sleeve-like anchor member is attached to the inner recess of the tip electrode The operation of inserting the distal end, the temperature sensor protective tube, and the distal end of the tip electrode lead wire separately and fixing them with solder is extremely complicated.
　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。
　本発明の第１の目的は、操作用ワイヤの遠位端と、先端電極の導線の遠位端と、温度センサの測温部が挿入固定された温度センサ保護管とが、先端電極の内側凹部の適正な位置に配置されて当該先端電極に固定されてなる先端偏向操作可能カテーテルを提供することにある。
　本発明の第２の目的は、バイデレクションタイプで細径の先端偏向操作可能カテーテルを提供することにある。
　本発明の第３の目的は、先端偏向操作時における先端可撓部分の形状変化の平面性にも優れた先端偏向操作可能カテーテルを提供することにある。
　本発明の第４の目的は、製造時における作業性にも優れた先端偏向操作可能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.
A first object of the present invention is to provide a distal end of an operation wire, a distal end of a lead wire of a tip electrode, and a temperature sensor protective tube in which a temperature measuring portion of the temperature sensor is inserted and fixed. An object of the present invention is to provide a catheter capable of tip deflection operation which is disposed at an appropriate position of a recess and is fixed to the tip electrode.
A second object of the present invention is to provide a bi-directional type thin catheter having a small diameter tip deflection operation.
The third object of the present invention is to provide a catheter capable of tip deflection operation which is excellent in flatness of shape change of the tip flexible portion during tip deflection operation.
A fourth object of the present invention is to provide a catheter capable of tip deflection operation that is excellent in workability during manufacture.
（１）本発明の先端偏向操作可能カテーテルは、先端可撓部分を有するカテーテルチューブと、
　前記カテーテルチューブの遠位端に固定された先端電極と、
　前記カテーテルチューブの内部に軸方向に沿って延在するように配置され、その近位端が引張操作可能な操作用ワイヤと、
　前記カテーテルチューブの内部に軸方向に沿って延在するように配置され、その遠位端が前記先端電極に接続された当該先端電極の導線と、
　前記先端電極の内部の温度を測定するための熱電対からなる温度センサと、
　前記温度センサの測温部が挿入固定されている絶縁性の温度センサ保護管と、
　前記操作用ワイヤの遠位端を前記先端電極に固定するために当該先端電極の内側凹部に嵌合された円柱状のアンカー部材とを備えてなり；
　前記アンカー部材には、当該アンカー部材の中心軸を挟んで対向するよう軸方向に延びる２つの貫通孔と、軸方向に延びて近位端側が開口する２つの内孔とが形成され、
　前記操作用ワイヤは、その一端および他端が近位端となり、前記カテーテルチューブの内部を一端側から遠位方向に延び、前記アンカー部材の一方の貫通孔を通って、当該アンカー部材の遠位端で折り返し、当該アンカー部材の他方の貫通孔を通って、前記カテーテルチューブの内部を近位方向に延びて他端に至る１本のワイヤからなり、
　前記アンカー部材に形成された一方の内孔に前記温度センサ保護管が挿入固定されることにより、前記温度センサの測温部が前記先端電極の内部に配置され、前記アンカー部材に形成された他方の内孔に前記導線の遠位端が挿入固定されることにより、当該導線が前記先端電極に接続されていることを特徴とする。 (1) The tip deflection operable catheter of the present invention includes a catheter tube having a tip flexible portion;
A tip electrode fixed to the distal end of the catheter tube;
An operation wire that is arranged so as to extend along the axial direction inside the catheter tube, and whose proximal end can be pulled; and
A lead wire of the tip electrode, which is disposed so as to extend along the axial direction inside the catheter tube, and whose distal end is connected to the tip electrode;
A temperature sensor comprising a thermocouple for measuring the temperature inside the tip electrode;
An insulating temperature sensor protective tube into which the temperature measuring section of the temperature sensor is inserted and fixed;
A columnar anchor member fitted in an inner recess of the tip electrode to fix the distal end of the manipulation wire to the tip electrode;
The anchor member is formed with two through-holes extending in the axial direction so as to face each other across the central axis of the anchor member, and two inner holes extending in the axial direction and opening on the proximal end side,
The manipulation wire has a proximal end at one end and the other end, extends in the distal direction from the one end side to the inside of the catheter tube, passes through one through hole of the anchor member, and is distal to the anchor member. It consists of a single wire that is folded at the end, passes through the other through-hole of the anchor member, extends proximally inside the catheter tube and reaches the other end,
The temperature sensor protective tube is inserted and fixed in one inner hole formed in the anchor member, so that the temperature measuring portion of the temperature sensor is disposed inside the tip electrode, and the other formed in the anchor member. The distal end of the conducting wire is inserted and fixed in the inner hole of the lead wire so that the conducting wire is connected to the tip electrode.
　このような構成の先端偏向操作可能カテーテルによれば、先端電極の内側凹部にアンカー部材が嵌合されているとともに、操作用ワイヤが、カテーテルチューブの内部を一端側（近位端側）から遠位方向に延び、先端電極の内側凹部に嵌合されたアンカー部材の一方の貫通孔を通って、当該アンカー部材の遠位端で折り返し、当該アンカー部材の他方の貫通孔を通って、カテーテルチューブの内部を近位方向に延びて他端（近位端）に至る１本のワイヤからなるので、当該操作用ワイヤの遠位端を先端電極の内側凹部の適正な位置に配置して固定することができる。 According to the distal deflection operable catheter having such a configuration, the anchor member is fitted in the inner concave portion of the distal electrode, and the operation wire is distant from the one end side (proximal end side) inside the catheter tube. The catheter tube extends in the lateral direction, passes through one through hole of the anchor member fitted in the inner recess of the tip electrode, turns back at the distal end of the anchor member, passes through the other through hole of the anchor member, and passes through the other through hole. Since it consists of one wire extending in the proximal direction to the other end (proximal end), the distal end of the operation wire is arranged and fixed at an appropriate position of the inner recess of the tip electrode. be able to.
　また、操作用ワイヤは、先端電極の内側凹部に嵌合されたアンカー部材の遠位端で折り返され、２つの貫通孔に通されることによって先端電極に固定されているので、引張操作によって先端電極の内側凹部から操作用ワイヤの遠位端が抜けてしまうようなことはなく、構成材料の種類に関わらず、先端電極に対して強固に固定することができる。 The operation wire is folded at the distal end of the anchor member fitted in the inner recess of the tip electrode and fixed to the tip electrode by passing through two through holes. The distal end of the operation wire does not come off from the inner concave portion of the electrode, and can be firmly fixed to the tip electrode regardless of the type of the constituent material.
　また、アンカー部材に形成された２つの貫通孔は、当該アンカー部材の中心軸を挟んで対向するよう配置されているので、２つの貫通孔に通された操作用ワイヤの一端および他端を引張操作することにより、カテーテルの遠位端の向きを両方向に変化させることができ、しかも、カテーテルの先端可撓部分における形状変化の平面性にも優れている。 Further, since the two through holes formed in the anchor member are arranged so as to face each other with the central axis of the anchor member interposed therebetween, one end and the other end of the operation wire passed through the two through holes are pulled. By operating, the direction of the distal end of the catheter can be changed in both directions, and the shape change flatness at the distal end flexible portion of the catheter is excellent.
　また、アンカー部材に形成された一方の内孔に温度センサ保護管が挿入固定されていることにより、温度センサ保護管（温度センサの測温部）を、先端電極の内側凹部の適正な位置に配置して、先端電極に固定することができる。
　また、アンカー部材に形成された他方の内孔に導線の遠位端が挿入固定されていることにより、この導線を、先端電極の内側凹部の適正な位置に配置して、先端電極に対し電気的に接続させることができる。 In addition, since the temperature sensor protection tube is inserted and fixed in one of the inner holes formed in the anchor member, the temperature sensor protection tube (the temperature sensor of the temperature sensor) is placed at an appropriate position in the inner recess of the tip electrode. It can be placed and secured to the tip electrode.
In addition, since the distal end of the conducting wire is inserted and fixed in the other inner hole formed in the anchor member, the conducting wire is disposed at an appropriate position in the inner recess of the tip electrode, and is electrically connected to the tip electrode. Can be connected.
　また、先端電極の内側凹部における操作用ワイヤの遠位端の配置位置（占有スペース）をアンカー部材の貫通孔によって確保することができると共に、導線の遠位端および温度センサ保護管の配置位置（占有スペース）を、アンカー部材の対応する内孔によって確保することができる。そして、アンカー部材における貫通孔および内孔を効率的に配設することにより、先端電極のサイズダウン、延いては、カテーテルの細径化を図ること（例えば、外径を５Ｆｒ以下とすること）ができる。 Further, the arrangement position (occupied space) of the distal end of the operation wire in the inner recess of the tip electrode can be secured by the through hole of the anchor member, and the arrangement position of the distal end of the conductor and the temperature sensor protective tube ( Occupied space) can be ensured by the corresponding inner hole of the anchor member. Then, by efficiently disposing the through hole and the inner hole in the anchor member, the size of the tip electrode is reduced and the diameter of the catheter is reduced (for example, the outer diameter is set to 5 Fr or less). Can do.
　また、このような構成の先端偏向操作可能カテーテルを製造する場合に、操作用ワイヤの遠位端と、先端電極の導線の遠位端と、温度センサ保護管（温度センサの測温部）とをアンカー部材に装着して組立体を構成し、この組立体を先端電極に装着する（内側凹部にアンカー部材を嵌合する）ことにより、作業性の向上を図ることができる。 Further, when manufacturing the tip-deflable manipulatable catheter having such a configuration, the distal end of the operation wire, the distal end of the lead wire of the tip electrode, the temperature sensor protective tube (the temperature sensor of the temperature sensor), Is attached to the anchor member to constitute an assembly, and this assembly is attached to the tip electrode (the anchor member is fitted into the inner recess), whereby the workability can be improved.
（２）本発明の先端偏向操作可能カテーテルにおいて、前記カテーテルチューブの外径が
５Ｆｒ以下であり、前記先端電極の内側凹部の開口径が１．３ｍｍ以下であることが好ましい。このような細径のカテーテルにおいて、本発明に係る構造を採用することは効果的である。 (2) In the distal deflection operable catheter of the present invention, it is preferable that the outer diameter of the catheter tube is 5 Fr or less, and the opening diameter of the inner recess of the distal electrode is 1.3 mm or less. In such a small-diameter catheter, it is effective to employ the structure according to the present invention.
（３）本発明の先端偏向操作可能カテーテルにおいて、前記アンカー部材が黄銅からなることが好ましい。 (3) In the distal deflection operable catheter of the present invention, the anchor member is preferably made of brass.
　本発明の先端偏向操作可能カテーテルによれば、これを構成する操作用ワイヤの遠位端と、先端電極の導線の遠位端と、温度センサの測温部が挿入固定された温度センサ保護管とを、先端電極の内側凹部における適正な位置に配置して、これらを先端電極に固定することができる。
　また、アンカー部材における２つの貫通孔および２つの内孔を効率的に配設することにより、バイデレクションタイプであっても、細径の（例えば、外径が５Ｆｒ以下である）カテーテルを構成することができる。
　また、本発明の先端偏向操作可能カテーテルは、先端偏向操作時において、先端可撓部分の形状変化の平面性にも優れている。
　また、本発明の先端偏向操作可能カテーテルは、製造時における作業性にも優れている。 According to the tip deflection operable catheter of the present invention, the temperature sensor protective tube in which the distal end of the operation wire constituting the catheter, the distal end of the lead wire of the tip electrode, and the temperature sensor of the temperature sensor are inserted and fixed Can be disposed at an appropriate position in the inner recess of the tip electrode, and these can be fixed to the tip electrode.
In addition, by efficiently arranging two through holes and two inner holes in the anchor member, a catheter having a small diameter (for example, an outer diameter of 5 Fr or less) is configured even in the bi-direction type. can do.
In addition, the distal deflection operable catheter of the present invention is excellent in the flatness of the shape change of the distal flexible portion during the distal deflection operation.
In addition, the distal deflection operable catheter of the present invention is excellent in workability at the time of manufacture.
本発明の先端偏向操作可能カテーテルの一実施形態である電極カテーテルを示す正面図である。It is a front view which shows the electrode catheter which is one Embodiment of the catheter in which the front end deflection | deviation operation of this invention is possible. 図１に示した電極カテーテルの先端部分を示す縦断面図である。It is a longitudinal cross-sectional view 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分を示す縦断面図（図２の III－III 断面図）である。FIG. 3 is a longitudinal sectional view showing a distal end portion of the electrode catheter shown in FIG. 1 (cross-sectional view taken along line III-III in FIG. 2). 図１に示した電極カテーテルの先端部分を示す横断面図（図２のIV－IV断面図）である。FIG. 4 is a transverse sectional view (IV-IV sectional view of FIG. 2) showing a distal end portion of the electrode catheter shown in FIG. 図１に示した電極カテーテルの先端部分を示す横断面図（図２のＶ－Ｖ断面図）である。FIG. 5 is a transverse sectional view (a VV sectional view of FIG. 2) showing a distal end portion of the electrode catheter shown in FIG.
　以下、本発明の先端偏向操作可能カテーテルの一実施形態である電極カテーテルについて説明する。図１乃至図５に示す本実施形態の電極カテーテル１００は、例えば、心臓における不整脈の診断または治療に用いられるものである。 Hereinafter, an electrode catheter which is an embodiment of the catheter capable of tip deflection operation according to the present invention will be described. The electrode catheter 100 of the present embodiment shown in FIGS. 1 to 5 is used for, for example, diagnosis or treatment of arrhythmia in the heart.
　本実施形態の電極カテーテル１００は、先端可撓部分１５を有するカテーテルチューブ１０と、カテーテルチューブ１０の遠位端に固定された内側凹部２０Ｃを有する先端電極２０と、カテーテルチューブ１０の内部（ルーメン１１およびルーメン１２）に軸方向に沿って延在するように配置され、その近位端が引張操作可能な操作用ワイヤ３０と、カテーテルチューブ１０の内部（ルーメン１４）に軸方向に沿って延在するように配置され、その遠位端が先端電極２０に接続された導線４０と、先端電極２０の内部の温度を測定するための熱電対からなる温度センサ５０と、温度センサ５０の測温部５０Ａが挿入されている絶縁性の温度センサ保護管６０と、操作用ワイヤ３０の遠位端を先端電極２０に固定するために当該先端電極２０の内側凹部２０Ｃに嵌合された円柱状のアンカー部材８０と、カテーテルチューブ１０の近位端に装着されたコネクタ（ハンドル）７０とを備えてなり；アンカー部材８０には、当該アンカー部材８０の中心軸を挟んで対向するよう軸方向に延びる２つの貫通孔（貫通孔８１および貫通孔８２）と、軸方向に延びて近位端側が開口する２つの内孔（内孔８３および内孔８４）とが形成され、操作用ワイヤ３０は、その一端および他端が近位端となり、カテーテルチューブ１０の内部（ルーメン１１）を一端側から遠位方向に延び、アンカー部材８０の一方の貫通孔８１を通って、アンカー部材８０の遠位端面８０Ｄで折り返し、アンカー部材８０の他方の貫通孔８２を通って、カテーテルチューブ１０の内部（ルーメン１２）を近位方向に延びて他端に至る１本のワイヤからなり、アンカー部材８０に形成された一方の内孔８３に温度センサ保護管６０が挿入固定されることにより、温度センサ５０の測温部５０Ａが先端電極２０の内部（内側凹部２０Ｃ）に配置され、アンカー部材８０に形成された他方の内孔８４に導線４０の遠位端が挿入固定されることにより、当該導線４０が先端電極２０に対して電気的に接続されている。 The electrode catheter 100 of this embodiment includes a catheter tube 10 having a tip flexible portion 15, a tip electrode 20 having an inner recess 20 </ b> C fixed to the distal end of the catheter tube 10, and the inside of the catheter tube 10 (lumen 11). And the lumen 12) are arranged so as to extend along the axial direction, and the proximal end of the manipulation wire 30 can be pulled and the catheter tube 10 (lumen 14) extends along the axial direction. And a temperature sensor 50 including a thermocouple for measuring a temperature inside the tip electrode 20, and a temperature measuring unit of the temperature sensor 50. Insulating temperature sensor protective tube 60 into which 50A is inserted, and tip electrode 20 for fixing the distal end of operation wire 30 to tip electrode 20 A cylindrical anchor member 80 fitted in the inner recess 20C, and a connector (handle) 70 attached to the proximal end of the catheter tube 10; the anchor member 80 includes a center of the anchor member 80; Two through holes (through hole 81 and through hole 82) extending in the axial direction so as to face each other across the shaft, and two inner holes (inner hole 83 and inner hole 84) extending in the axial direction and opening at the proximal end side One end and the other end of the operation wire 30 are proximal ends, and the inside (lumen 11) of the catheter tube 10 extends in the distal direction from one end side, and one through-hole 81 of the anchor member 80 is formed. Through the distal end face 80D of the anchor member 80 and through the other through-hole 82 of the anchor member 80 to extend the interior of the catheter tube 10 (lumen 12) in the proximal direction. The temperature sensor protective tube 60 is inserted into and fixed to one inner hole 83 formed in the anchor member 80, and the temperature measuring unit 50A of the temperature sensor 50 is connected to the tip electrode 20 by the one end hole 83 formed in the anchor member 80. The distal end of the conducting wire 40 is inserted into and fixed to the other inner hole 84 formed in the anchor member 80, so that the conducting wire 40 is electrically connected to the tip electrode 20. It is connected to the.
　図１乃至図５に示す本実施形態の電極カテーテル１００は、カテーテルチューブ１０と、先端電極２０と、操作用ワイヤ３０と、先端電極の導線４０と、温度センサ５０と、温度センサ保護管６０と、アンカー部材８０と、コネクタ７０と備えている。
　図１において、７５は、カテーテルチューブ１０の首振り操作（カテーテルの先端偏向操作）を行うための摘みである。また、図２乃至図４において、９０は、先端電極２０にアンカー部材８０を固定するためのハンダである。 The electrode catheter 100 of the present embodiment shown in FIGS. 1 to 5 includes a catheter tube 10, a tip electrode 20, an operation wire 30, a lead electrode lead wire 40, a temperature sensor 50, and a temperature sensor protective tube 60. The anchor member 80 and the connector 70 are provided.
In FIG. 1, reference numeral 75 denotes a knob for performing a swinging operation (catheter tip deflection operation) of the catheter tube 10. 2 to 4, 90 is a solder for fixing the anchor member 80 to the tip electrode 20.
　図２、図３および図５に示すように、カテーテルチューブ１０は、先端可撓部分１５を有し、４つのルーメン（１１，１２，１３，１４）が形成されたマルチルーメンチューブである。ここに、「先端可撓部分」とは、操作用ワイヤを引張操作することによって撓む（曲がる）ことのできるカテーテルチューブの先端部分をいう。 As shown in FIGS. 2, 3 and 5, the catheter tube 10 is a multi-lumen tube having a flexible distal end portion 15 and four lumens (11, 12, 13, 14) formed therein. Here, the “tip flexible portion” refers to a distal end portion of the catheter tube that can be bent (bent) by pulling the operation wire.
　カテーテルチューブ１０は、軸方向に沿って同じ特性のチューブで構成されていてもよいが、比較的可撓性に優れた先端可撓部分（遠位端部分）と、先端可撓部分に対して軸方向に一体に形成され、先端可撓部分よりも比較的に剛性のある後端部分（近位端部分）とを有するものであることが好ましい。
　カテーテルチューブ１０の構成材料としては、例えばポリオレフィン、ポリアミド、ポリエーテルブロックポリアミド、ポリウレタンなどの合成樹脂を挙げることができる。 The catheter tube 10 may be formed of a tube having the same characteristics along the axial direction, but the distal end flexible portion (distal end portion) having relatively high flexibility and the distal end flexible portion It is preferable to have a rear end portion (proximal end portion) that is integrally formed in the axial direction and is relatively more rigid than the tip flexible portion.
Examples of the constituent material of the catheter tube 10 include synthetic resins such as polyolefin, polyamide, polyether block polyamide, and polyurethane.
　カテーテルチューブ１０の外径は、通常２Ｆｒ（０．６５ｍｍ）～８Ｆｒ（２．７ｍｍ）とされ、細径化を図る観点から５Ｆｒ以下であることが好ましい。 The outer diameter of the catheter tube 10 is usually 2 Fr (0.65 mm) to 8 Fr (2.7 mm), and is preferably 5 Fr or less from the viewpoint of reducing the diameter.
　カテーテルチューブ１０の遠位端に固定された先端電極２０は、砲弾型の先端部分２０１と、これに連続する円筒状部分２０２とが一体的に成形されてなる。先端電極２０の円筒状部分２０２は、カテーテルチューブ１０の遠位端の内部に挿入され、接着剤等によりカテーテルチューブ１０の遠位端に固着されている。
　先端電極２０の構成材料としては、例えばアルミニウム、銅、ステンレス、金、白金など、熱伝導性の良好な金属を挙げることができる。なお、Ｘ線に対する造影性を良好に持たせるために、先端電極２０は、白金などで構成されることが好ましい。 The tip electrode 20 fixed to the distal end of the catheter tube 10 is formed by integrally forming a bullet-shaped tip portion 201 and a cylindrical portion 202 continuous therewith. The cylindrical portion 202 of the tip electrode 20 is inserted into the distal end of the catheter tube 10 and is fixed to the distal end of the catheter tube 10 with an adhesive or the like.
Examples of the constituent material of the tip electrode 20 include metals having good thermal conductivity such as aluminum, copper, stainless steel, gold, and platinum. Note that the tip electrode 20 is preferably made of platinum or the like in order to provide good contrast properties for X-rays.
　先端電極２０の外径は、カテーテルチューブ１０の外径と同程度であることが好ましい。先端電極２０の内部は、後述するアンカー部材８０を収容して嵌合するための円柱状の空間（内側凹部２０Ｃ）となっている。先端電極２０の内径に相当する内側凹部２０Ｃの開口径は、０．１～２．４ｍｍとされ、１．３ｍｍ以下であることが好ましい。 The outer diameter of the tip electrode 20 is preferably approximately the same as the outer diameter of the catheter tube 10. The inside of the tip electrode 20 is a columnar space (inner recess 20C) for accommodating and fitting an anchor member 80 described later. The opening diameter of the inner recess 20C corresponding to the inner diameter of the tip electrode 20 is 0.1 to 2.4 mm, and preferably 1.3 mm or less.
　電極カテーテル１００を構成する操作用ワイヤ３０は、カテーテルチューブ１０の内部（ルーメン１１およびルーメン１２）において軸方向に沿って延在している。
　ここに、操作用ワイヤ３０は、一端側から遠位方向に延びる往路部分３０Ａがルーメン１１に延在し、折り返されて近位方向に延びる復路部分３０Ｂがルーメン１２に延在している。 The operation wire 30 constituting the electrode catheter 100 extends along the axial direction inside the catheter tube 10 (lumen 11 and lumen 12).
Here, in the operation wire 30, an outward path portion 30 </ b> A extending in the distal direction from one end side extends to the lumen 11, and a return path portion 30 </ b> B that is folded back and extends in the proximal direction extends to the lumen 12.
　操作用ワイヤ３０の近位端である一端および他端は、カテーテルチューブ１０の偏向操
作を行うための摘み７５に接続され、これにより、引張操作可能となっている。
　一方、操作用ワイヤ３０の遠位端は、先端電極２０の内側凹部２０Ｃに嵌合された円柱状のアンカー部材８０によって先端電極２０に固定されている。 One end and the other end, which are proximal ends of the operation wire 30, are connected to a knob 75 for performing a deflection operation of the catheter tube 10, thereby enabling a pulling operation.
On the other hand, the distal end of the operation wire 30 is fixed to the tip electrode 20 by a columnar anchor member 80 fitted in the inner recess 20 </ b> C of the tip electrode 20.
　図２乃至図４に示すように、アンカー部材８０には、その中心軸を挟んで対向するように軸方向に延びる２つの貫通孔（貫通孔８１および貫通孔８２）と、アンカー部材８０の中心軸を挟んで対向するように軸方向に延びる２つの内孔（近位端側が開口する内孔８３および内孔８４）とが形成されている。 As shown in FIGS. 2 to 4, the anchor member 80 has two through-holes (through-hole 81 and through-hole 82) extending in the axial direction so as to face each other across the central axis, and the center of the anchor member 80. Two inner holes (an inner hole 83 and an inner hole 84 that open on the proximal end side) are formed to extend in the axial direction so as to face each other across the shaft.
　アンカー部材８０の外径は、先端電極２０の内側凹部２０Ｃの内径より僅かに小さく形成されており、アンカー部材８０は、先端電極２０の内側凹部２０Ｃに挿入され、両者の間の僅かな隙間にはハンダ９０が充填されている。このようにして、アンカー部材８０と、先端電極２０の内側凹部２０Ｃとが嵌合され（これにより、両者の中心軸が一致する）、両者の間には導電性および良好な熱伝導性が確保されている。 The outer diameter of the anchor member 80 is formed to be slightly smaller than the inner diameter of the inner recess 20C of the tip electrode 20, and the anchor member 80 is inserted into the inner recess 20C of the tip electrode 20, and in a slight gap between the two. Is filled with solder 90. In this way, the anchor member 80 and the inner concave portion 20C of the tip electrode 20 are fitted (by this, the central axes of both of them match), and electrical conductivity and good thermal conductivity are ensured between them. Has been.
　アンカー部材８０の構成材料としては、ハンダ９０に対する濡れ性の良好な金属材料であることが好ましい。かかる観点から、アンカー部材８０の好適な構成材料として銅または銅合金を挙げることができ、特に、熱伝導性およびハンダに対する濡れ性が良好である黄銅（真鍮）が好ましい。 As a constituent material of the anchor member 80, a metal material having good wettability with respect to the solder 90 is preferable. From this point of view, copper or a copper alloy can be cited as a suitable constituent material of the anchor member 80, and brass (brass) having good thermal conductivity and good wettability with respect to solder is particularly preferable.
　先端電極２０の内側凹部２０Ｃ（アンカー部材８０との隙間）に充填されているハンダ９０のとしては、特に限定されるものでなく、例えばＳｎ－Ｐｂ、Ｓｎ－Ｐｂ－Ａｇ、Ｓｎ－Ｐｂ－Ｃｕを例示することができ、また、ＰｂフリーのハンダであるＳｎ－Ａｇ－Ｃｕ、Ｓｎ－Ｃｕ、Ｓｎ－Ａｇ、Ｓｎ－Ａｇ－Ｃｕ－Ｂｉなどを使用することもできる。 The solder 90 filled in the inner recess 20C (the gap with the anchor member 80) of the tip electrode 20 is not particularly limited. For example, Sn—Pb, Sn—Pb—Ag, Sn—Pb—Cu Further, Pb-free solders such as Sn—Ag—Cu, Sn—Cu, Sn—Ag, Sn—Ag—Cu—Bi and the like can also be used.
　操作用ワイヤ３０は、その一端および他端が近位端、折り返し部分が遠位端となる１本のワイヤにより構成されている。
　操作用ワイヤ３０は、カテーテルチューブ１０の内部であるルーメン１１において一端側（近位端側）から遠位方向に延び、先端電極２０の内側凹部２０Ｃに嵌合されてるアンカー部材８０の貫通孔８１を通って、アンカー部材８０の遠位端面８０Ｄで折り返し、アンカー部材８０の貫通孔８２を通って、カテーテルチューブ１０の内部であるルーメン１２において近位方向に延びて他端（近位端）に至る。 The operation wire 30 is composed of one wire whose one end and the other end are a proximal end and whose folded portion is a distal end.
The operation wire 30 extends in the distal direction from one end side (proximal end side) in the lumen 11 inside the catheter tube 10, and the through hole 81 of the anchor member 80 fitted in the inner recess 20 </ b> C of the tip electrode 20. Through the distal end face 80D of the anchor member 80, through the through-hole 82 of the anchor member 80, and extend proximally in the lumen 12 inside the catheter tube 10 to the other end (proximal end). It reaches.
　上記のように、カテーテルチューブ１０の内部（ルーメン１１）を延在している操作用ワイヤ３０が、アンカー部材８０の貫通孔８１を通って、遠位端面８０Ｄで折り返され、貫通孔８２を通って再びカテーテルチューブ１０の内部（ルーメン１２）を延在することにより、操作用ワイヤ３０の遠位端を、アンカー部材８０（延いては、先端電極２０）に対して強固に固定することができ、操作用ワイヤ３０の近位端を引張操作しても、当該操作用ワイヤ３０の遠位端が、先端電極２０の内側凹部２０Ｃから抜けてしまうようなことはない。 As described above, the operation wire 30 extending inside the catheter tube 10 (the lumen 11) passes through the through hole 81 of the anchor member 80, is folded at the distal end surface 80D, and passes through the through hole 82. By extending the inside of the catheter tube 10 (lumen 12) again, the distal end of the operation wire 30 can be firmly fixed to the anchor member 80 (and thus the tip electrode 20). Even if the proximal end of the operation wire 30 is pulled, the distal end of the operation wire 30 does not come out of the inner recess 20 </ b> C of the tip electrode 20.
　また、貫通孔８１および貫通孔８２はアンカー部材８０の中心軸（先端電極２０の中心軸）を挟んで対向するよう配置されているので、これらの貫通孔に通された操作用ワイヤ３０の近位端（一端および他端）を引張操作することにより、電極カテーテル１００の遠位端の向きを両方向に変化させることができ、しかも、電極カテーテル１００の先端可撓部分の形状変化の平面性にも優れている。 Moreover, since the through hole 81 and the through hole 82 are arranged so as to face each other with the central axis of the anchor member 80 (the central axis of the tip electrode 20) interposed therebetween, the through hole 81 and the through hole 82 are located close to the operation wire 30 passed through these through holes. By pulling the distal end (one end and the other end), the direction of the distal end of the electrode catheter 100 can be changed in both directions, and the flatness of the shape change of the tip flexible portion of the electrode catheter 100 can be improved. Is also excellent.
　操作用ワイヤ３０の構成材料としては特に限定されるものではなく、従来公知の先端偏向操作可能カテーテルの操作用ワイヤの構成材料と同一のものをすべて使用することができる。
　特に、操作用ワイヤ３０の遠位端は、先端電極２０の内側凹部２０Ｃに充填されたハンダ９０によって先端電極に対して直接固定されるものではないため、ハンダに対する濡れ性の低い金属材料（例えばステンレス）であっても操作用ワイヤ３０の構成材料として好適に使用することができ、また、非金属材料であっても使用することができる。 The constituent material of the operation wire 30 is not particularly limited, and all the same constituent materials as those of the conventionally known operation wires of the tip deflection operable catheter can be used.
In particular, since the distal end of the operation wire 30 is not directly fixed to the tip electrode by the solder 90 filled in the inner recess 20C of the tip electrode 20, a metal material having low wettability to solder (for example, (Stainless steel) can be suitably used as the constituent material of the operation wire 30, and even a non-metallic material can be used.
　操作用ワイヤ３０の直径としては、例えば０．０５～０．５ｍｍとされ、好ましくは０．１～０．３ｍｍとされる。
　なお、アンカー部材８０の貫通孔８１および貫通孔８２の内径は、操作用ワイヤ３０の直径よりも僅かに大きく形成されており、貫通孔８１，８２の内周面と操作用ワイヤ３０の外周面との間の僅かな隙間にはハンダ９０が充填されている。 The diameter of the operation wire 30 is, for example, 0.05 to 0.5 mm, preferably 0.1 to 0.3 mm.
Note that the inner diameters of the through hole 81 and the through hole 82 of the anchor member 80 are slightly larger than the diameter of the operation wire 30, and the inner peripheral surface of the through holes 81 and 82 and the outer peripheral surface of the operation wire 30. A small gap between them is filled with solder 90.
　電極カテーテル１００を構成する導線４０は、カテーテルチューブ１０の内部（ルーメン１４）およびコネクタ７０の内部において延在し、導線４０の近位端は、コネクタ７０から引き出され、例えば高周波発生装置に接続される。 The conducting wire 40 constituting the electrode catheter 100 extends inside the catheter tube 10 (lumen 14) and inside the connector 70, and the proximal end of the conducting wire 40 is pulled out from the connector 70 and connected to, for example, a high frequency generator. The
　図３および図４に示すように、導線４０の遠位端はアンカー部材８０に形成された内孔８４に挿入され、この内孔８４に浸入しているハンダ９０によって、アンカー部材８０に対して固定されている。これにより、導線４０は、アンカー部材８０（延いては先端電極２０）に対して電気的に接続されている。
　導線４０としては、通常の樹脂被覆導線を使用することができる。
　導線４０の直径としては、例えば０．０４～０．３ｍｍとされ、好ましくは０．０６～０．１２ｍｍとされる。 As shown in FIGS. 3 and 4, the distal end of the conducting wire 40 is inserted into an inner hole 84 formed in the anchor member 80, and solder 90 entering the inner hole 84 is used to fix the anchor member 80 to the anchor member 80. It is fixed. Thereby, the conducting wire 40 is electrically connected to the anchor member 80 (and thus the tip electrode 20).
As the conducting wire 40, a normal resin-coated conducting wire can be used.
The diameter of the conductor 40 is, for example, 0.04 to 0.3 mm, and preferably 0.06 to 0.12 mm.
　電極カテーテル１００を構成する温度センサ５０は、先端電極２０の内部の温度を測定するためのものであり、アブレーションカテーテルにおいて必須の構成部品である。
　温度センサ５０は熱電対からなり、その測温部５０Ａを含む先端領域以外の部分は、ポリイミドなどにより絶縁被覆されている。 The temperature sensor 50 constituting the electrode catheter 100 is for measuring the temperature inside the distal electrode 20, and is an essential component in the ablation catheter.
The temperature sensor 50 is made of a thermocouple, and the portions other than the tip region including the temperature measuring unit 50A are covered with an insulating material such as polyimide.
　温度センサ５０の測温部５０Ａ（熱電対における異種金属の接合部分）は、温度センサ保護管６０の内部に挿入され、そこに充填された接着剤６５によって当該温度センサ保護管６０に固定されている。
　また、図３および図４に示すように、温度センサ保護管６０（少なくとも、温度センサ５０の測温部５０Ａが接着固定されている部分）は、アンカー部材８０に形成された内孔８３に挿入されており、この内孔８３に充填された接着剤によって、アンカー部材８０に対して固定されている。
　これにより、温度センサ５０の測温部５０Ａを先端電極２０の内側凹部２０Ｃに配置して固定することができるとともに、温度センサ保護管６０によって、温度センサ５０と先端電極２０との絶縁性を確保することができる。 A temperature measuring unit 50A of the temperature sensor 50 (a joining portion of dissimilar metals in the thermocouple) is inserted into the temperature sensor protective tube 60 and fixed to the temperature sensor protective tube 60 by an adhesive 65 filled therein. Yes.
Further, as shown in FIGS. 3 and 4, the temperature sensor protective tube 60 (at least the portion to which the temperature measuring portion 50 </ b> A of the temperature sensor 50 is bonded and fixed) is inserted into the inner hole 83 formed in the anchor member 80. The anchor member 80 is fixed to the anchor member 80 by an adhesive filled in the inner hole 83.
Thereby, the temperature measuring part 50A of the temperature sensor 50 can be disposed and fixed in the inner recess 20C of the tip electrode 20, and the temperature sensor protection tube 60 ensures insulation between the temperature sensor 50 and the tip electrode 20. can do.
　温度センサ保護管６０の内部に充填されて温度センサ５０を固定するための接着剤６５およびアンカー部材８０の内孔８３に充填されて温度センサ保護管６０を固定するための接着剤としては、例えば、エポキシ系などの熱硬化性接着剤を好適に用いることができる。 Examples of the adhesive 65 for filling the temperature sensor protective tube 60 and fixing the temperature sensor 50 and the adhesive for filling the inner hole 83 of the anchor member 80 and fixing the temperature sensor protective tube 60 include: An epoxy-based thermosetting adhesive can be preferably used.
　温度センサ保護管６０としては、絶縁性の樹脂チューブを使用することができ、好適な一例としてポリイミドチューブを挙げることができる。
　温度センサ保護管６０の内径は、例えば０．１～０．５ｍｍとされ、好ましくは０．２～０．４ｍｍとされる。
　また、温度センサ保護管６０の外径としては、例えば０．２～０．６ｍｍとされ、好ましくは０．３～０．５ｍｍとされる。 As the temperature sensor protective tube 60, an insulating resin tube can be used, and a polyimide tube can be cited as a suitable example.
The inner diameter of the temperature sensor protective tube 60 is, for example, 0.1 to 0.5 mm, preferably 0.2 to 0.4 mm.
The outer diameter of the temperature sensor protective tube 60 is, for example, 0.2 to 0.6 mm, and preferably 0.3 to 0.5 mm.
　なお、アンカー部材８０の内孔８３の内径は、温度センサ保護管６０の外径よりも僅かに大きく形成されている。これにより、内孔８３の内周面と温度センサ保護管６０の外周面との間の隙間に少量の接着剤を充填することによって、アンカー部材８０の内孔８３に温度センサ保護管６０を固定することができる。
　また、接着剤の充填によって、温度センサ保護管６０の周囲に空気層が形成されることがないので、先端電極２０から温度センサ５０への良好な熱伝導性を確保することができる。 The inner diameter of the inner hole 83 of the anchor member 80 is slightly larger than the outer diameter of the temperature sensor protective tube 60. Thus, the temperature sensor protective tube 60 is fixed to the inner hole 83 of the anchor member 80 by filling a small amount of adhesive into the gap between the inner peripheral surface of the inner hole 83 and the outer peripheral surface of the temperature sensor protective tube 60. can do.
In addition, since the air layer is not formed around the temperature sensor protective tube 60 by filling the adhesive, good thermal conductivity from the tip electrode 20 to the temperature sensor 50 can be ensured.
　電極カテーテル１００において、コネクタ７０の摘み７５を操作することにより、操作用ワイヤ３０の一端または他端の何れかが近位方向に引っ張られ、電極カテーテル１００の先端可撓部分が撓み、電極カテーテル１００の遠位端は、矢印ＡまたはＢで示す方向に偏向が可能になる。 By operating the knob 75 of the connector 70 in the electrode catheter 100, either one end or the other end of the operation wire 30 is pulled in the proximal direction, and the distal flexible portion of the electrode catheter 100 is bent, and the electrode catheter 100 is bent. The distal end of can be deflected in the direction indicated by arrow A or B.
　例えば、図１に示す摘み７５をＡ１方向に回転させることにより、操作用ワイヤ３０の一端が近位方向に引っ張られて、電極カテーテル１００の遠位端が、矢印Ａで示す方向に偏向する。また、摘み７５をＢ１方向に回転させることにより、操作用ワイヤ３０の他端が近位方向に引っ張られて、電極カテーテル１００の遠位端が、矢印Ｂで示す方向に偏向する。なお、コネクタ７０を軸回りに回転させれば、体腔内に挿入された状態で、電極カテーテル１００に対するＡまたはＢ方向の向きを自由に設定することができる。 For example, by rotating the knob 75 shown in FIG. 1 in the A1 direction, one end of the operation wire 30 is pulled in the proximal direction, and the distal end of the electrode catheter 100 is deflected in the direction indicated by the arrow A. Further, by rotating the knob 75 in the B1 direction, the other end of the operation wire 30 is pulled in the proximal direction, and the distal end of the electrode catheter 100 is deflected in the direction indicated by the arrow B. If the connector 70 is rotated around the axis, the direction in the A or B direction with respect to the electrode catheter 100 can be freely set while being inserted into the body cavity.
　本実施形態の電極カテーテル１００によれば、操作用ワイヤ３０の遠位端を、先端電極２０の内側凹部２０Ｃの適正な位置に配置して当該先端電極２０に強固に固定することができる。従って、操作用ワイヤ３０の近位端を引張操作したときに、当該操作用ワイヤ３０の遠位端が先端電極２０の内側凹部２０Ｃから抜けてしまうようなことはない。
　また、アンカー部材８０に形成された内孔８３に、温度センサ保護管６０が挿入されて固定されていることにより、温度センサ５０の測温部５０Ａを、先端電極２０の内側凹部２０Ｃの適正な位置に配置して当該先端電極２０に固定することができる。
　また、アンカー部材８０に形成された内孔８４に導線４０の遠位端が挿入固定されていることにより、この導線４０を、先端電極２０の内側凹部２０Ｃの適正な位置に配置して、先端電極２０に対し電気的に接続させることができる。 According to the electrode catheter 100 of the present embodiment, the distal end of the operation wire 30 can be disposed at an appropriate position of the inner recess 20C of the tip electrode 20 and can be firmly fixed to the tip electrode 20. Therefore, when the proximal end of the operation wire 30 is pulled, the distal end of the operation wire 30 does not come out of the inner recess 20 </ b> C of the tip electrode 20.
Further, since the temperature sensor protective tube 60 is inserted and fixed in the inner hole 83 formed in the anchor member 80, the temperature measuring unit 50A of the temperature sensor 50 can be connected to the inner recess 20C of the tip electrode 20 appropriately. The tip electrode 20 can be fixed at the position.
Further, since the distal end of the conducting wire 40 is inserted and fixed in the inner hole 84 formed in the anchor member 80, the conducting wire 40 is disposed at an appropriate position of the inner recess 20C of the tip electrode 20, and the tip The electrode 20 can be electrically connected.
　また、先端電極２０の内側凹部２０Ｃにおいて、操作用ワイヤ３０の遠位端の配置位置をアンカー部材８０の貫通孔８１および貫通孔８２によって確保することができ、導線４０の遠位端の配置位置をアンカー部材８０の内孔８４によって確保することができ、温度センサ保護管６０の配置位置をアンカー部材８０の内孔８３によって確保することができる。そして、アンカー部材８０における貫通孔８１，８２および内孔８３，８４を効率的に配設することにより、先端電極２０のサイズダウン、延いては、バイデレクションタイプの先端偏向操作可能カテーテルの細径化を図ること（例えば、外径を５Ｆｒ以下とすること）ができる。 Further, in the inner recess 20 </ b> C of the tip electrode 20, the arrangement position of the distal end of the operation wire 30 can be secured by the through hole 81 and the through hole 82 of the anchor member 80, and the arrangement position of the distal end of the conducting wire 40. Can be secured by the inner hole 84 of the anchor member 80, and the arrangement position of the temperature sensor protective tube 60 can be secured by the inner hole 83 of the anchor member 80. Further, by efficiently arranging the through holes 81 and 82 and the inner holes 83 and 84 in the anchor member 80, the size of the tip electrode 20 is reduced, and further, the narrowing of the bi-direction type tip deflectable manipulating catheter is possible. The diameter can be increased (for example, the outer diameter is 5 Fr or less).
　また、貫通孔８１および貫通孔８２は、アンカー部材８０の中心軸（当該アンカー部材８０が嵌合している先端電極２０の中心軸）を挟んで対向するよう配置されているので、これらの貫通孔８１，８２に通されている操作用ワイヤ３０の一端または他端を引張操作することにより、電極カテーテル１００の遠位端の向きを両方向に変化させることができ、しかも、その際の先端可撓部分１５における形状変化の平面性にも優れている。 Moreover, since the through hole 81 and the through hole 82 are arranged so as to face each other with the central axis of the anchor member 80 (the central axis of the tip electrode 20 with which the anchor member 80 is fitted) interposed therebetween, By pulling one end or the other end of the operation wire 30 passed through the holes 81 and 82, the direction of the distal end of the electrode catheter 100 can be changed in both directions. The flatness of the shape change in the flexible portion 15 is also excellent.
　また、操作用ワイヤ３０の遠位端と、導線４０の遠位端と、温度センサ保護管６０とをアンカー部材８０に装着して組立体を構成し、この組立体を先端電極２０に装着すること（組立体におけるアンカー部材８０を先端電極２０の内側凹部２０Ｃに嵌合する）ことに
より、本実施形態の電極カテーテル１００を容易に製造することができる。 The distal end of the operation wire 30, the distal end of the conducting wire 40, and the temperature sensor protective tube 60 are attached to the anchor member 80 to form an assembly, and this assembly is attached to the tip electrode 20. By fitting the anchor member 80 in the assembly into the inner recess 20C of the tip electrode 20, the electrode catheter 100 of this embodiment can be easily manufactured.
　以上、本発明の一実施形態について説明したが、本発明はこれらに限定されるものではなく、種々の変更が可能である。
　例えば、温度センサおよび導線が挿入固定される内孔は貫通孔であってもよい。
　また、カテーテルチューブの遠位端にリング状電極が装着されていてもよい。
　また、カテーテルチューブの先端可撓部分に板バネが配置されていてもよい。
　また、先端電極の外径が、カテーテルチューブの外径より大きくてもよい。 As mentioned above, although one Embodiment of this invention was described, this invention is not limited to these, A various change is possible.
For example, the inner hole into which the temperature sensor and the conducting wire are inserted and fixed may be a through hole.
A ring electrode may be attached to the distal end of the catheter tube.
In addition, a leaf spring may be disposed at the distal flexible portion of the catheter tube.
Further, the outer diameter of the tip electrode may be larger than the outer diameter of the catheter tube.
　１００　電極カテーテル
　１０　　カテーテルチューブ
　１１，１２，１３，１４　ルーメン
　１５　　先端可撓部分
　２０　　先端電極
　２０Ｃ　内側凹部
　２０１　先端部分
　２０２　円筒状部分
　３０　　操作用ワイヤ
　３０Ａ　往路部分
　３０Ｂ　復路部分
　４０　　導線
　５０　　温度センサ
　５０Ａ　測温部
　６０　　温度センサ保護管
　７０　　コネクタ
　７５　　摘み
　８０　　アンカー部材
　８０Ｄ　遠位端面
　８１，８２　貫通孔
　８３，８４　内孔
　９０　　ハンダ DESCRIPTION OF SYMBOLS 100 Electrode catheter 10 Catheter tube 11, 12, 13, 14 Lumen 15 Tip flexible part 20 Tip electrode 20C Inner recessed part 201 Tip part 202 Cylindrical part 30 Operation wire 30A Outward part 30B Return part 40 Lead wire 50 Temperature sensor 50A Temperature measurement Portion 60 Temperature sensor protective tube 70 Connector 75 Knob 80 Anchor member 80D Distal end surface 81, 82 Through hole 83, 84 Inner hole 90 Solder

Claims (3)

  1. 　先端可撓部分を有するカテーテルチューブと、
    　前記カテーテルチューブの遠位端に固定された先端電極と、
    　前記カテーテルチューブの内部に軸方向に沿って延在するように配置され、その近位端が引張操作可能な操作用ワイヤと、
    　前記カテーテルチューブの内部に軸方向に沿って延在するように配置され、その遠位端が前記先端電極に接続された当該先端電極の導線と、
    　前記先端電極の内部の温度を測定するための熱電対からなる温度センサと、
    　前記温度センサの測温部が挿入固定されている絶縁性の温度センサ保護管と、
    　前記操作用ワイヤの遠位端を前記先端電極に固定するために当該先端電極の内側凹部に嵌合された円柱状のアンカー部材とを備えてなり；
    　前記アンカー部材には、当該アンカー部材の中心軸を挟んで対向するよう軸方向に延びる２つの貫通孔と、軸方向に延びて近位端側が開口する２つの内孔とが形成され、
    　前記操作用ワイヤは、その一端および他端が近位端となり、前記カテーテルチューブの内部を一端側から遠位方向に延び、前記アンカー部材の一方の貫通孔を通って、当該アンカー部材の遠位端で折り返し、当該アンカー部材の他方の貫通孔を通って、前記カテーテルチューブの内部を近位方向に延びて他端に至る１本のワイヤからなり、
    　前記アンカー部材に形成された一方の内孔に前記温度センサ保護管が挿入固定されることにより、前記温度センサの測温部が前記先端電極の内部に配置され、前記アンカー部材に形成された他方の内孔に前記導線の遠位端が挿入固定されることにより、当該導線が前記先端電極に接続されていることを特徴とする先端偏向操作可能カテーテル。     A catheter tube having a tip flexible portion;
    A tip electrode fixed to the distal end of the catheter tube;
    An operation wire that is arranged so as to extend along the axial direction inside the catheter tube, and whose proximal end can be pulled; and
    A lead wire of the tip electrode, which is disposed so as to extend along the axial direction inside the catheter tube, and whose distal end is connected to the tip electrode;
    A temperature sensor comprising a thermocouple for measuring the temperature inside the tip electrode;
    An insulating temperature sensor protective tube into which the temperature measuring section of the temperature sensor is inserted and fixed;
    A columnar anchor member fitted in an inner recess of the tip electrode to fix the distal end of the manipulation wire to the tip electrode;
    The anchor member is formed with two through-holes extending in the axial direction so as to face each other across the central axis of the anchor member, and two inner holes extending in the axial direction and opening on the proximal end side,
    The manipulation wire has a proximal end at one end and the other end, extends in the distal direction from the one end side to the inside of the catheter tube, passes through one through hole of the anchor member, and is distal to the anchor member. It consists of a single wire that is folded at the end, passes through the other through-hole of the anchor member, extends proximally inside the catheter tube and reaches the other end,
    The temperature sensor protective tube is inserted and fixed in one inner hole formed in the anchor member, so that the temperature measuring portion of the temperature sensor is disposed inside the tip electrode, and the other formed in the anchor member. The distal end deflectable maneuverable catheter characterized in that the distal end of the conducting wire is inserted and fixed in the inner hole of the lead wire so that the conducting wire is connected to the tip electrode.
  2. 　前記カテーテルチューブの外径が５Ｆｒ以下であり、
    　前記先端電極の内側凹部の開口径が１．３ｍｍ以下であることを特徴とする請求項１に記載の先端偏向操作可能カテーテル。     The outer diameter of the catheter tube is 5 Fr or less,
    2. The catheter according to claim 1, wherein an opening diameter of an inner concave portion of the tip electrode is 1.3 mm or less.
  3. 　前記アンカー部材が黄銅からなることを特徴とする請求項１または請求項２に記載の先端偏向操作可能カテーテル。 The catheter according to claim 1 or 2, wherein the anchor member is made of brass.
PCT/JP2014/059107 2013-06-06 2014-03-28 Catheter having bendable tip WO2014196249A1 (en)

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CN113316447A (en) * 2019-01-21 2021-08-27 株式会社Jms Tube core device

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JP5969635B2 (en) 2015-01-15 2016-08-17 日本ライフライン株式会社 catheter
JP6456315B2 (en) * 2016-02-16 2019-01-23 日本ライフライン株式会社 Electrode catheter

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JPH05154091A (en) * 1991-12-09 1993-06-22 Olympus Optical Co Ltd Flexible pipe apparatus
JP2009291495A (en) * 2008-06-06 2009-12-17 Japan Lifeline Co Ltd Catheter
US20120190927A1 (en) * 2009-08-10 2012-07-26 EPFlex Feinwektechnik GmbH Medical Catheter Instrument

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JPH05154091A (en) * 1991-12-09 1993-06-22 Olympus Optical Co Ltd Flexible pipe apparatus
JP2009291495A (en) * 2008-06-06 2009-12-17 Japan Lifeline Co Ltd Catheter
US20120190927A1 (en) * 2009-08-10 2012-07-26 EPFlex Feinwektechnik GmbH Medical Catheter Instrument

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113316447A (en) * 2019-01-21 2021-08-27 株式会社Jms Tube core device

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