TWI569828B - Electrode catheter - Google Patents

Electrode catheter Download PDF

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Publication number
TWI569828B
TWI569828B TW102131529A TW102131529A TWI569828B TW I569828 B TWI569828 B TW I569828B TW 102131529 A TW102131529 A TW 102131529A TW 102131529 A TW102131529 A TW 102131529A TW I569828 B TWI569828 B TW I569828B
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TW
Taiwan
Prior art keywords
end portion
catheter
catheter shaft
distal end
wire
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TW102131529A
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Chinese (zh)
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TW201431575A (en
Inventor
桝田拓也
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日本來富恩有限公司
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Publication of TWI569828B publication Critical patent/TWI569828B/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283Invasive
    • A61B5/287Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements 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
    • A61B5/6847Arrangements 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
    • A61B5/6852Catheters
    • A61B5/6857Catheters with a distal pigtail shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements 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
    • A61B5/6867Arrangements 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
    • A61B5/6876Blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices

Description

電極導管 Lead

本發明是關於前端偏向操作可能的電極導管。 The present invention relates to electrode conduits that are possible for front end biasing operations.

作為診斷或治療心臟的心律不整所使用的醫療用具來說,已知有具備:在前端部具有可撓部分的導管軸;連接在該導管軸的基端側的控制把手;連接在導管軸的前端側的導管前端部;被裝設在導管前端部的外周的複數個環狀電極;以及使導管軸的可撓部分撓曲用的操作用線材之電極導管。 As a medical tool for diagnosing or treating cardiac arrhythmia, a catheter shaft having a flexible portion at a distal end portion, a control handle connected to a proximal end side of the catheter shaft, and a catheter shaft connected to the catheter shaft are known. a catheter tip end portion on the distal end side; a plurality of annular electrodes attached to the outer periphery of the catheter tip end portion; and an electrode catheter for the operation wire for deflecting the flexible portion of the catheter shaft.

又,以測量心臟的肺靜脈等的部位的電位用的電極導管來說,提案有具備形成圈狀的導管前端部者(例如,參照專利文獻1)。藉由將導管前端部形成圈狀,可同時測量血管的內周部分。 In addition, an electrode catheter for measuring the potential of a part of the pulmonary vein or the like of the heart is proposed to have a catheter-shaped distal end portion (see, for example, Patent Document 1). By forming the front end portion of the catheter into a loop shape, the inner peripheral portion of the blood vessel can be simultaneously measured.

圖6表示構成專利文獻1的電極導管的導管前端部的形狀的立體圖,該導管前端部(測繪組件)117,是由直線狀的基端側區域138;圈狀的本體區域 139;直線狀的前端側區域140所形成,且連接在導管軸114的前端側。 Fig. 6 is a perspective view showing the shape of a distal end portion of a catheter constituting the electrode catheter of Patent Document 1, which is a linear proximal end side region 138; a ring-shaped body region. 139; a linear front end side region 140 is formed and connected to the front end side of the catheter shaft 114.

導管前端部117的本體區域139形成圈狀,在該本體區域139裝設有複數個環狀電極(省略圖示)。 The body region 139 of the catheter tip end portion 117 is formed in a ring shape, and a plurality of ring-shaped electrodes (not shown) are mounted in the body region 139.

圖7表示構成專利文獻1的電極導管的導管軸與導管前端部的連接部分的剖視圖。 Fig. 7 is a cross-sectional view showing a connecting portion of a catheter shaft and a distal end portion of a catheter constituting the electrode catheter of Patent Document 1.

導管軸114,是由具有第1管腔130、第2管腔132、以及第3管腔134的多腔管所形成。 The catheter shaft 114 is formed by a multi-lumen tube having a first lumen 130, a second lumen 132, and a third lumen 134.

在導管軸114的第1管腔130內複數個導線150延伸存在。 A plurality of wires 150 extend in the first lumen 130 of the catheter shaft 114.

複數個導線150的各前端部,是被連接在裝設在導管前端部117的本體區域139的複數個環狀電極的各電極。另一方面,複數個導線150的各基端部是經由控制把手連接在連接器。 Each of the distal end portions of the plurality of wires 150 is connected to each of a plurality of annular electrodes provided in the body region 139 of the catheter tip end portion 117. On the other hand, the respective base ends of the plurality of wires 150 are connected to the connector via a control handle.

在導管軸114的第2管腔132內操作用線材164延伸存在。 The wire 164 is extended in operation in the second lumen 132 of the catheter shaft 114.

操作用線材164的基端部,是被繫留在控制把手而可拉引操作這個。另一方面,操作用線材164的前端部,是經由固定構件180繫留在導管軸114的前端部。 The base end portion of the wire 164 for operation is tied to the control handle and can be pulled. On the other hand, the distal end portion of the operation wire 164 is tied to the distal end portion of the catheter shaft 114 via the fixing member 180.

固定構件180具有比第2管腔132的徑更大的前端構件片(十字形構件片)182,藉此,能抑制操作用線材164的前端部朝向基端方向的移動。此結果,藉由拉引操作操作用線材164的基端側,可使導管軸114的前端部(可撓部分)撓曲。 The fixing member 180 has a distal end member piece (cross member piece) 182 that is larger than the diameter of the second lumen 132, whereby movement of the distal end portion of the operation wire 164 toward the proximal end direction can be suppressed. As a result, the front end portion (flexible portion) of the catheter shaft 114 can be deflected by pulling the proximal end side of the operation wire 164.

在操作用線材164的前端部(固定構件180)位置的第2管腔132的前端區域填充有接著劑(省略圖示)。藉此,操作用線材164的前端部被接著固定在導管軸114(第2管腔132的內壁)。 The front end region of the second lumen 132 at the position of the distal end portion (fixing member 180) of the operation wire 164 is filled with an adhesive (not shown). Thereby, the distal end portion of the operation wire 164 is next fixed to the catheter shaft 114 (the inner wall of the second lumen 132).

在導管軸114的第3管腔134內構成導管前端部117的芯線124的基端部延伸存在。 The base end portion of the core wire 124 constituting the catheter tip end portion 117 in the third lumen 134 of the catheter shaft 114 extends.

導管前端部117,是形成在絕緣管128的內部延在有由形狀記憶合金形成的該芯線124而成。 The catheter tip end portion 117 is formed by extending the core wire 124 formed of a shape memory alloy inside the insulating tube 128.

在芯線124的基端部延伸存在的第3管腔134的前端區域填充有接著劑(省略圖示)。藉此,芯線124的基端部被接著固定在導管軸114(第3管腔134的內壁)。 The front end region of the third lumen 134 extending at the proximal end portion of the core wire 124 is filled with an adhesive (not shown). Thereby, the proximal end portion of the core wire 124 is then fixed to the catheter shaft 114 (the inner wall of the third lumen 134).

又,構成導管前端部117的絕緣管128的基端部,是藉由接著劑190被接著固定在導管軸114的前端部。 Further, the proximal end portion of the insulating tube 128 constituting the catheter distal end portion 117 is fixed to the distal end portion of the catheter shaft 114 by the adhesive 190.

如此,導管前端部117(芯線124、絕緣管128)被連接在導管軸114的前端側。 In this manner, the catheter tip end portion 117 (the core wire 124 and the insulating tube 128) is connected to the distal end side of the catheter shaft 114.

[先行技術文獻] [Advanced technical literature] [專利文獻] [Patent Literature]

[專利文獻1]日本特開2003-111740號公報 [Patent Document 1] Japanese Patent Laid-Open Publication No. 2003-111740

然而,記載於專利文獻1的電極導管中,複 數個導線150、操作用線材164及芯線124的基端部分別延伸在導管軸114的不同的管腔(第1管腔130、第2管腔132及第3管腔134),因為在這樣的構造的電極導管,不能充分確保讓導線延伸的內部空間,所以要讓依照被裝設在導管前端部的環狀電極的數量的條數的導線延伸在導管軸的內部是有困難的。且,藉由這樣的電極導管,也不能對應電極數的增加、導管軸的小徑化。 However, it is described in the electrode catheter of Patent Document 1, The plurality of wires 150, the operating wire 164, and the base end portion of the core wire 124 extend in different lumens (the first lumen 130, the second lumen 132, and the third lumen 134) of the catheter shaft 114, respectively, because The electrode catheter of the configuration does not sufficiently ensure the internal space for extending the wire, so it is difficult to extend the number of wires in accordance with the number of the ring-shaped electrodes installed at the tip end portion of the catheter inside the catheter shaft. Further, with such an electrode lead, the number of electrodes cannot be increased and the diameter of the catheter shaft can be reduced.

又,記載於專利文獻1的電極導管,為了防止導管前端部117自導管軸114的脫離,並須將延伸在第3管腔134的芯線124的長度(被接著在第3管腔134的內壁的芯線124的長度)增至足夠長來確保接著力。另一方面,使延伸在第3管腔134的芯線124增長時,會損害作為前端偏向操作可能導管的操作性。 Further, in the electrode catheter described in Patent Document 1, in order to prevent the catheter tip end portion 117 from being detached from the catheter shaft 114, the length of the core wire 124 extending in the third lumen 134 must be followed (in the third lumen 134). The length of the core wire 124 of the wall is increased to be long enough to ensure the adhesion. On the other hand, when the core wire 124 extending in the third lumen 134 is increased, the operability of the catheter which is a front end biasing operation may be impaired.

本發明是有基於以上這樣的事情所研發者。 The present invention has been developed based on the above matters.

本發明之目的在提供一種,在導管軸的內部可確保讓複數個導線延在用的足夠的空間的電極導管。 SUMMARY OF THE INVENTION It is an object of the present invention to provide an electrode catheter which ensures a sufficient space for a plurality of wires to be extended inside the catheter shaft.

本發明的其他的目的在提供一種,即使讓延伸在導管軸的內部的芯線縮短,也可有效防止由該芯線所構成的導管前端部從導管軸脫離的情況,且作為前端偏向操作可能導管的操作性也良好的電極導管。 Another object of the present invention is to provide a method for effectively preventing the front end portion of the catheter formed of the core wire from being detached from the catheter shaft even if the core wire extending inside the catheter shaft is shortened, and as a front end biasing operation possible catheter An electrode catheter that is also operably good.

(1)本發明的電極導管,其特徵為,具備有:在前端部具有多腔構造的可撓部分的導管軸; 連接在前述導管軸的基端側的控制把手;導管前端部,其係連接在前述導管軸的前端側,且在絕緣管的內部延在有由形狀記憶合金形成的芯線而成;被安裝在前述導管前端部的外周的複數個環狀電極;複數個導線,其係連接在前述複數個環狀電極的各電極,且延伸在前述導管前端部的內部及前述導管軸的內部來到前述控制把手的內部;以及操作用線材,其係為了使前述導管軸的可撓部分撓曲,而延伸在該導管軸的內部,並將其前端部繫留在前述導管軸的前端部,將該基端部繫留在前述控制把手而可拉引操作其基端部,接合有前述芯線的基端部、與前述操作用線材的前端部。 (1) An electrode catheter according to the present invention, comprising: a catheter shaft having a flexible portion having a multi-cavity structure at a distal end portion; a control handle connected to a proximal end side of the catheter shaft; a catheter distal end portion connected to a distal end side of the catheter shaft and extending inside the insulating tube with a core wire formed of a shape memory alloy; a plurality of annular electrodes on an outer circumference of the distal end portion of the catheter; a plurality of wires connected to the respective electrodes of the plurality of annular electrodes, and extending inside the front end portion of the catheter and inside the catheter shaft to the control An inner portion of the handle; and an operating wire for extending the flexible portion of the catheter shaft to extend inside the catheter shaft and to retain a distal end portion thereof at a distal end portion of the catheter shaft The end portion is attached to the control handle to pull the base end portion thereof, and the base end portion of the core wire and the front end portion of the operation wire are joined.

根據這樣的構成的電極導管,由於接合有芯線的基端部與操作用線材的前端部,藉此在構成導管軸的多腔構造的可撓部分,不用讓芯線延伸在與延伸有操作用線材的管腔不同的管腔(可讓兩者的結合體延伸在1個管腔),所以在以往的電極導管,可將讓芯線延伸的管腔作為讓導線延伸用來使用,藉此,可在導管軸的內部確保讓複數個導線延伸用的充分的空間。 According to the lead pipe having such a configuration, the base end portion of the core wire and the distal end portion of the operation wire are joined, whereby the flexible portion of the multi-chamber structure constituting the catheter shaft does not have the core wire extended and the operation wire is extended. Different lumens of the lumen (the combination of the two can be extended in one lumen), so in the conventional lead, the lumen extending the core wire can be used as a wire extension for use. A sufficient space for extending a plurality of wires is ensured inside the catheter shaft.

又,由於接合構成導管前端部的芯線的基端部;與延伸在導管軸的內部的操作用線材的前端部,並將該操作用線材的基端部繫留在控制把手,藉此該操作用線材發揮防止芯線脫落的效果,所以可有效防止導管前端部 從導管軸脫離的情況。 Further, the base end portion of the core wire constituting the distal end portion of the catheter is joined to the distal end portion of the operation wire extending inside the catheter shaft, and the proximal end portion of the operation wire is tied to the control handle, whereby the operation is performed. The wire is used to prevent the core wire from falling off, so that the front end portion of the catheter can be effectively prevented. The case of detachment from the catheter shaft.

(2)本發明的電極導管中,前述導管前端部形成圈狀為理想。 (2) In the electrode catheter of the present invention, it is preferable that the tip end portion of the catheter is formed in a ring shape.

由於在形成圈狀的導管前端部可裝設許多個(例如6個以上)的環狀電極,伴隨於此,必須讓許多條導線延伸在導管軸的內部,所以在這樣的情況下,本發明的構造特別有效果。 Since a plurality of (for example, six or more) ring-shaped electrodes can be installed at the tip end portion of the loop-shaped catheter, it is necessary to extend a plurality of wires in the inside of the catheter shaft. Therefore, in this case, the present invention The structure is particularly effective.

(3)本發明的電極導管中,前述導管軸在多腔構造的可撓部分的前端側具有單腔構造,在該單腔接合前述芯線的基端部、與前述操作用線材的前端部為理想。 (3) In the electrode catheter of the present invention, the catheter shaft has a single-cavity structure on a distal end side of the flexible portion of the multi-chamber structure, and the proximal end portion of the core wire and the distal end portion of the operation wire are joined to the single cavity ideal.

(4)上述(3)的電極導管中,在抑制前述操作用線材的前端部朝向基端方向移動的管狀繫留構件的內部,接合前述芯線的基端部、與前述操作用線材的前端部為理想。 (4) In the electrode catheter of the above (3), the base end portion of the core wire and the front end portion of the operation wire are joined to the inside of the tubular mooring member that prevents the distal end portion of the operation wire from moving toward the proximal end direction. Ideal.

根據本發明的電極導管,可在導管軸的內部確保讓複數個導線延伸用的充分的空間。 According to the electrode catheter of the present invention, a sufficient space for extending a plurality of wires can be secured inside the catheter shaft.

又,即使縮短延伸在導管軸的內部的芯線,也可有效防止由該芯線所構成的導管前端部從導管軸脫離的情況。 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 formed of the core wire from being detached from the catheter shaft.

又,由於可縮短延伸在導管軸的內部的芯線,所以作為前端偏向操作可能導管的操作性也優。 Further, since the core wire extending inside the catheter shaft can be shortened, the operability of the catheter as the distal end biasing operation is also excellent.

100‧‧‧電極導管 100‧‧‧ lead

10‧‧‧導管軸 10‧‧‧ catheter shaft

10A‧‧‧可撓部分 10A‧‧‧Flexible part

11‧‧‧導管軸的前端部 11‧‧‧ front end of the catheter shaft

11L‧‧‧第1管腔 11L‧‧‧1st lumen

12L‧‧‧第2管腔 12L‧‧‧2nd lumen

13L‧‧‧第3管腔 13L‧‧‧3rd lumen

14L‧‧‧第4管腔 14L‧‧‧4th lumen

15‧‧‧編織管 15‧‧‧ braided tube

20‧‧‧控制把手 20‧‧‧Control handle

21‧‧‧握把 21‧‧‧ grip

22‧‧‧旋鈕 22‧‧‧ knob

30‧‧‧導管前端部 30‧‧‧ catheter front end

33‧‧‧絕緣管 33‧‧‧Insulation tube

35‧‧‧芯線 35‧‧‧core wire

352‧‧‧芯線的基端部 352‧‧‧ the base end of the core wire

42‧‧‧前端電極 42‧‧‧ front electrode

41‧‧‧環狀電極 41‧‧‧Ring electrode

42‧‧‧前端電極 42‧‧‧ front electrode

50‧‧‧導線 50‧‧‧ wire

60‧‧‧操作用線材 60‧‧‧Operating wire

61‧‧‧操作用線材的前端部 61‧‧‧ Front end of wire for operation

70‧‧‧管狀繫留構件(固定構件) 70‧‧‧Tubular tethered members (fixed members)

80‧‧‧固著材 80‧‧‧ Fixing materials

90‧‧‧接著劑 90‧‧‧Adhesive

[圖1]表示本發明的電極導管的一實施形態的立體圖。 Fig. 1 is a perspective view showing an embodiment of an electrode catheter of the present invention.

[圖2A]從前端側看的圖1所示的電極導管的前端部的說明圖。 FIG. 2A is an explanatory view of a distal end portion of the electrode catheter shown in FIG. 1 as seen from the distal end side.

[圖2B]表示圖1所示的電極導管的前端部的說明圖。 FIG. 2B is an explanatory view showing a distal end portion of the electrode catheter shown in FIG. 1. FIG.

[圖3]表示圖1所示的電極導管的前端部的縱剖視圖(圖2A的A-A剖視圖)。 Fig. 3 is a longitudinal sectional view showing a distal end portion of the electrode catheter shown in Fig. 1 (a cross-sectional view taken along line A-A in Fig. 2A).

[圖4]為圖3的部分放大剖視圖(B部詳細圖)。 Fig. 4 is a partially enlarged cross-sectional view of Fig. 3 (part B detailed view).

[圖5]為圖1所示的電極導管的前端部的橫剖視圖(圖4A的A-A剖視圖)。 Fig. 5 is a transverse cross-sectional view of the tip end portion of the electrode catheter shown in Fig. 1 (a cross-sectional view taken along line A-A of Fig. 4A).

[圖6]表示構成以往的電極導管的導管前端部的形狀的立體圖。 Fig. 6 is a perspective view showing the shape of a distal end portion of a catheter constituting a conventional electrode catheter.

[圖7]表示構成以往的電極導管的導管軸與導管前端部的連接部分的剖視圖。 Fig. 7 is a cross-sectional view showing a connecting portion between a catheter shaft and a distal end portion of a catheter constituting a conventional electrode catheter.

[實施發明用的形態] [Formation for carrying out the invention]

以下,使用圖面針對本發明的電極導管的一實施形態進行說明。 Hereinafter, an embodiment of the electrode catheter of the present invention will be described with reference to the drawings.

圖1~圖5所示的本實施形態的電極導管100係具備有:在前端部11具有多腔構造的可撓部分10A的導管軸10;連接在導管軸10的接端側的控制把手20;形成圈狀的導管前端部30,其係連接在導管軸10的前端側,且在 絕緣管33的內部延在有由形狀記憶合金形成的芯線35而成;被裝設在導管前端部30的外周的9個環狀電極41;裝設在導管前端部30的前端的前端電極42;10根導線50,其係連接在該前端電極42及環狀電極41的各電極,在導管前端部30(絕緣管33)的內部及導管軸10的內部延伸來到控制把手20的內部;操作用線材60,其係為了使導管軸10的可撓部分10A撓曲,而延伸在該導管軸的內部,並將其前端部61繫留在導管軸10的前端部11,將該基端部繫留在控制把手20而可拉引操作其基端部;以及藉由抑制操作用線材60的前端部61朝向基端方向移動,藉此將該前端部61繫留在導管軸10的前端部11的管狀繫留構件70,且在管狀繫留構件70的內部接合芯線35的基端部352、與操作用線材60的前端部61。 The lead electrode 100 of the present embodiment shown in FIGS. 1 to 5 includes a catheter shaft 10 having a flexible portion 10A having a multi-chamber structure at the distal end portion 11 and a control handle 20 connected to the distal end side of the catheter shaft 10; a loop-shaped duct front end portion 30 that is coupled to the front end side of the catheter shaft 10 and The inside of the insulating tube 33 is formed by a core wire 35 formed of a shape memory alloy; nine annular electrodes 41 mounted on the outer circumference of the catheter tip end portion 30; and a front end electrode 42 attached to the front end of the catheter tip end portion 30. 10 wires 50 connected to the respective electrodes of the front end electrode 42 and the annular electrode 41, extending inside the catheter front end portion 30 (insulating tube 33) and inside the catheter shaft 10 to the inside of the control handle 20; The operation wire 60 extends inside the catheter shaft in order to deflect the flexible portion 10A of the catheter shaft 10, and the distal end portion 61 is retained at the distal end portion 11 of the catheter shaft 10, and the base end The front end portion 61 is held at the front end of the catheter shaft 10 by the control portion 20 being held by the control handle 20 to pull the base end portion thereof; and the distal end portion 61 of the operation wire 60 is prevented from moving toward the proximal end portion. The tubular mooring member 70 of the portion 11 and the base end portion 352 of the core wire 35 and the front end portion 61 of the operation wire 60 are joined inside the tubular mooring member 70.

電極導管100,係具備有:導管軸10、控制把手20、導管前端部30、9個環狀電極41、1個前端電極42、10根導線50、操作用線材60、以及管狀繫留構件70而成。 The lead electrode 100 includes a catheter shaft 10, a control handle 20, a catheter distal end portion 30, nine annular electrodes 41, one distal end electrode 42, ten lead wires 50, an operation wire 60, and a tubular capping member 70. Made.

此外,圖4及圖5中,圖示10根導線50的一部分。 In addition, in FIGS. 4 and 5, a part of ten wires 50 is illustrated.

構成本實施形態的電極導管100的導管軸10,是在其前端部11具有多腔構造的可撓部分10A。於此「可撓部分」是指:藉由拉引操作操作用線材60可撓曲(彎曲)的軸部分。 The catheter shaft 10 constituting the electrode catheter 100 of the present embodiment has a flexible portion 10A having a multi-cavity structure at the distal end portion 11. Here, the "flexible portion" means a shaft portion that can be flexed (bent) by pulling the operation wire 60.

如圖4及圖5所示,導管軸10的可撓部分10A是由多腔管111、與被覆其外周的編織管15所構成。 又,如圖5所示,在多腔管111形成有4個管腔(第1管腔11L、第2管腔12L、第3管腔13L及第4管腔14L)。 As shown in FIGS. 4 and 5, the flexible portion 10A of the catheter shaft 10 is composed of a multi-lumen tube 111 and a braided tube 15 covering the outer circumference thereof. Further, as shown in FIG. 5, four lumens (the first lumen 11L, the second lumen 12L, the third lumen 13L, and the fourth lumen 14L) are formed in the multi-lumen tube 111.

以多腔管111的構成材料來說,雖沒有特別限定,可是可例示聚氨酯、尼龍、PEBAX(聚醯胺嵌段共聚物)等的樹脂。 The constituent material of the multi-lumen tube 111 is not particularly limited, and examples thereof include resins such as polyurethane, nylon, and PEBAX (polyamine block copolymer).

又,以被覆多腔管111的外周的編織管15來說,可舉用不銹鋼線材編織由聚氨酯、尼龍、PEBAX等的樹脂形成的管子。 Further, in the braided tube 15 covering the outer circumference of the multi-lumen tube 111, a tube made of a resin such as polyurethane, nylon or PEBAX may be woven with a stainless steel wire.

被覆多腔管111的外周的編織管15,是在可撓部分10A(多腔管111)的前端側更進一步延伸而形成單腔管。 The braided tube 15 covering the outer circumference of the multi-lumen tube 111 is further extended on the distal end side of the flexible portion 10A (multi-lumen tube 111) to form a single lumen tube.

以導管軸10的外徑來說在3.0mm以下為理想,更理想是1.2~2.4mm,若表示適合的一例則設為1.7mm。 The outer diameter of the catheter shaft 10 is preferably 3.0 mm or less, more preferably 1.2 to 2.4 mm, and is 1.7 mm as an example.

構成本實施形態的電極導管100的控制把手20是連接在導管軸10的基端側。圖1中,21為握把,22為旋鈕。 The control knob 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.

藉由讓旋鈕22朝基端側滑動,使導管軸10的可撓部分10A彎曲,且伴隨於此導管前端部30偏向。 The flexible portion 10A of the catheter shaft 10 is bent by sliding the knob 22 toward the proximal end side, and the catheter distal end portion 30 is biased.

因此,操作控制把手20,使導管前端部30旋轉,進而偏向,可將導管前端部30誘導到目的部位。 Therefore, the control knob 20 is operated to rotate the catheter distal end portion 30, thereby deflecting, and the catheter distal end portion 30 can be induced to the target site.

構成電極導管100的導管前端部30,是形成在絕緣管33的內部延伸有由形狀記憶合金形成的芯線。 The catheter tip end portion 30 constituting the electrode catheter 100 is formed with a core wire formed of a shape memory alloy extending inside the insulating tube 33.

導管前端部30實質上形成圓形的圈狀。藉此,可同時測量血管的內周部分。此外,導管前端部30並不是平坦的圓形封閉的圈,而是螺旋形的圈(本發明中,稱為「圓形」時,嚴格來說是包含螺旋形者。)。 The catheter tip end portion 30 substantially forms a circular ring shape. Thereby, the inner peripheral portion of the blood vessel can be simultaneously measured. Further, the catheter tip end portion 30 is not a flat circular closed ring but a spiral ring (in the present invention, when it is called "circular shape", it is strictly a spiral shape).

由形狀記憶合金形成的芯線35,是記憶導管前端部30的圈形狀,雖藉由施力雖容易變形(例如變形成直線狀),可是除去力時就回復到圈形狀。 The core wire 35 formed of the shape memory alloy has a ring shape of the memory catheter tip end portion 30, and is easily deformed (for example, linearly formed) by the biasing force, but returns to the ring shape when the force is removed.

以芯線35的構成材料來說,可舉Ni-Ti合金。Ni-Ti合金中的Ni與Ti的比率是54:46~57:43為理想。理想的Ni-Ti合金來說可舉鎳鈦合金。 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 ideal from 54:46 to 57:43. An ideal Ni-Ti alloy is a nickel-titanium alloy.

以芯線35的直徑來說,例如設為0.1~1.0mm,理想是設為0.2~0.5mm,若表示理想的一例是0.36mm。 The diameter of the core wire 35 is, for example, 0.1 to 1.0 mm, preferably 0.2 to 0.5 mm, and a preferred example is 0.36 mm.

絕緣管33的內部是與導管軸10的內部連通。 The inside of the insulating tube 33 is in communication with the inside of the catheter shaft 10.

以絕緣管33的構成材料來說可舉聚氨酯或PEBAX這類的生物可忍受性的樹脂材料。 The constituent material of the insulating tube 33 is a bioreducible resin material such as polyurethane or PEBAX.

在導管前端部30,在其外周面裝設有9個環狀電極41。再者,在導管前端部30的前端裝設有前端電極42。 In the catheter tip end portion 30, nine annular electrodes 41 are attached to the outer peripheral surface thereof. Further, a distal end electrode 42 is attached to the distal end of the catheter distal end portion 30.

以環狀電極41及前端電極42的構成材料來說,可舉白金、金,銥、或該等的合金等的導電性材料。 The constituent material of the ring-shaped electrode 41 and the tip electrode 42 may be a conductive material such as platinum, gold, tantalum, or the like.

此外,以裝設在導管前端部30的環狀電極41的數量來說,當然不限定於9個,以構成本發明的電極導管的環狀電極的數量來說,例如可設成6~20個,理想是設成8 ~12個。 Further, the number of the annular electrodes 41 attached to the distal end portion 30 of the catheter is of course not limited to nine, and the number of the annular electrodes constituting the electrode catheter of the present invention can be, for example, 6 to 20 Ideally set to 8 ~12.

在環狀電極41及前端電極42分別連接有導線50。連接在環狀電極41的各電極的導線50,是從被形成在絕緣管33的管壁的細孔進入絕緣管33的內部。連接在環狀電極41及前端電極42的各電極的10根導線50,是延伸在絕緣管33的內部、導管軸10的內部(第2管腔12L、第3管腔13L及第4管腔14L),且被插入控制把手20內部。而且,導線50的各的基端部,是連接在被設在控制把手20的基端的連接器。 A lead wire 50 is connected to each of the ring-shaped electrode 41 and the tip end electrode 42. The lead wire 50 connected to each electrode of the ring-shaped electrode 41 enters the inside of the insulating tube 33 from a fine hole formed in the tube wall of the insulating tube 33. Ten wires 50 connected to the respective electrodes of the ring-shaped electrode 41 and the tip electrode 42 extend inside the insulating tube 33 and inside the catheter shaft 10 (the second lumen 12L, the third lumen 13L, and the fourth lumen) 14L) and inserted into the inside of the control handle 20. Further, each of the base end portions of the wires 50 is connected to a connector provided at the base end of the control handle 20.

構成電極導管100的操作用線材60為了使導管軸10的可撓部分10A撓曲,而延伸在導管軸10的內部(多腔管111的第1管腔11L)。 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 deflect the flexible portion 10A of the catheter shaft 10.

操作用線材60的前端部61,是經由後述的管狀繫留構件70繫留在導管軸10的前端部11。 The distal end portion 61 of the operation wire 60 is retained in the distal end portion 11 of the catheter shaft 10 via a tubular mooring member 70 to be described later.

另一方面,操作用線材60的基端部繫留在控制把手20的內部,藉此,操作用線材60的基端側的拉引操作成為可能。 On the other hand, the base end portion of the operation wire 60 is retained inside the control handle 20, whereby the pulling operation on the proximal end side of the operation wire 60 is possible.

以芯線60的構成材料來說,可舉不銹鋼及Ni-Ti合金等。操作用線材60的表面是被PTFE「鐵氟龍(登記商標)」等所被覆為理想。 Examples of the constituent material of the core wire 60 include stainless steel and a Ni-Ti alloy. It is preferable that the surface of the wire for operation 60 is covered with PTFE "Teflon (registered trademark)" or the like.

以操作用線材芯60的直徑來說,是例如設為0.1~0.5mm,理想是設為0.20~0.25mm,若表示理想的一例是設為0.21mm。 The diameter of the wire core 60 for operation is, for example, 0.1 to 0.5 mm, preferably 0.20 to 0.25 mm, and is preferably 0.21 mm.

構成電極導管100的管狀繫留構件70具有比 第1管腔11L的徑更大的外徑,是抑制在其內部固定的操作用線材60的前端部61朝基端方向的移動用的固定構件,且被配置在導管軸10前端部11(比多腔管111更位於前端側的單腔管)的內部。 The tubular mooring member 70 constituting the electrode catheter 100 has a ratio The outer diameter of the first lumen 11L having a larger diameter is a fixing member for suppressing the movement of the distal end portion 61 of the operation wire 60 fixed in the proximal direction, and is disposed at the distal end portion 11 of the catheter shaft 10 (ratio The multi-lumen tube 111 is located further inside the single-chamber tube on the front end side.

在該管狀繫留構件70的內部接合有芯線35的基端部352;操作用線材60的前端部61。 A base end portion 352 of the core wire 35 and a front end portion 61 of the operation wire 60 are joined to the inside of the tubular mooring member 70.

接著芯線35的基端部352、與操作用線材60的前端部61的方法來說並沒有特別的限定,例如可例示在插入有芯線35的基端部352、與操作用線材60的前端部61的管狀繫留構件70的內部(間隙)填充焊料、臘材、接著劑等的固著材80的方法;鉚接插入有芯線35的基端部352、與操作用線材60的前端部61的管狀繫留構件70的方法等。 The method of the base end portion 352 of the core wire 35 and the distal end portion 61 of the operation wire 60 is not particularly limited, and for example, the base end portion 352 into which the core wire 35 is inserted and the distal end portion of the operation wire 60 can be exemplified. A method of filling the inside (gap) of the tubular mooring member 70 of 61 with a fixing material 80 such as solder, a wax material, or an adhesive; and riveting and inserting the base end portion 352 of the core wire 35 and the front end portion 61 of the operation wire 60 The method of the tubular tethering member 70 and the like.

如圖4所示,構成導管前端部30的絕緣管33的基端部332進入導管軸10的前端部11(單腔管的內部),在該狀態,藉由接著劑90被固定在導管軸10的前端。 As shown in Fig. 4, the proximal end portion 332 of the insulating tube 33 constituting the catheter distal end portion 30 enters the distal end portion 11 (the inside of the single lumen tube) of the catheter shaft 10, and in this state, the catheter shaft is fixed to the catheter shaft by the adhesive 90. 10 front end.

又,與絕緣管33一起構成導管前端部30的芯線35的基端部352,是進入到導管軸10的前端部11(單腔管的內部),在被配置在這裏的管狀繫留構件70的內部與操作用線材60的前端部61接合。 Further, the base 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 of the single lumen tube) of the catheter shaft 10, and the tubular mooring member 70 disposed therein is disposed. The inside is joined to the front end portion 61 of the operation wire 60.

藉此,可將導管前端部30堅固地連接在導管軸10的前端側。 Thereby, the catheter front end portion 30 can be firmly connected to the distal end side of the catheter shaft 10.

此外,從確保作為前端偏向操作可能導管的良好的操 作性的觀點,以芯線35進入到導管軸10的前端部11的長度(圖4中以L35表示)來說,是在10mm以下為理想。 Further, from the viewpoint of ensuring good operability as a possible front end biasing operation guide, the length of the core wire 35 entering the front end portion 11 of the catheter shaft 10 (indicated by L 35 in Fig. 4) is ideal for 10 mm or less. .

本實施的形態的電極導管100中,使控制把手20的旋鈕22朝基端側滑動(進行拉伸操作),藉此,雖藉由控制把手20的內部的活塞機構使操作用線材60朝基端側移動,可是因為操作用線材60的前端部61,是藉由管狀繫留構件70(固定構件)抑制朝基端方向的移動,所以導管軸10的可撓部分10A撓曲,此結果,導管前端部30偏向。又,使旋鈕22在前端側滑動並回復到原本的位置時,可使導管前端部30回復到本來的朝向。 In the electrode catheter 100 of the present embodiment, the knob 22 of the control handle 20 is slid toward the proximal end side (stretching operation), whereby the operation wire 60 is guided toward the proximal end side by the piston mechanism that controls the inside of the 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 mooring member 70 (fixing member), the flexible portion 10A of the catheter shaft 10 is deflected, and as a result, the catheter distal end portion is moved. 30 biased. Further, when the knob 22 is slid on the distal end side and returned to the original position, the catheter distal end portion 30 can be returned to the original orientation.

根據本實施形態的電極導管100,芯線35的基端部352、與操作用線材60的前端部61在管狀繫留構件70的內部被接合,藉此,不用讓芯線35的基端部352延伸在多腔管111的第1管腔11L以外的管腔(第2管腔12L、第3管腔13L或第4管腔14L),可作為讓全部的導線50延伸在該等的3個管腔來使用。藉此,可在導管軸10的內部確保讓10根導線50延伸用的充分的空間。 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 mooring member 70, whereby the base end portion 352 of the core wire 35 is not extended. In the lumen other than the first lumen 11L of the multi-lumen tube 111 (the second lumen 12L, the third lumen 13L, or the fourth lumen 14L), all of the wires 50 can be extended in the three tubes. Use the cavity. Thereby, a sufficient space for extending the ten wires 50 can be secured inside the catheter shaft 10.

又,相對於延伸在導管軸10的內部(第1管腔11L),並將其基端部繫留在控制把手20的內部的操作用線材60的前端部61,藉由接合有芯線35的基端部352,該操作用線材60可發揮芯線35防止脫落的效果。此結果,即使延伸在導管軸10的內部的芯線35的長度短(即使不讓芯線35的基端部進入多腔管111的管腔), 也可有效防止由該芯線35所構成的導管前端部30從導管軸10脫離的情況。 Further, the front end portion 61 of the operation wire 60 that is extended in the inside of the catheter shaft 10 (the first lumen 11L) and that is tied to the inside of the control handle 20 is joined to the distal end portion 61 of the operation wire 20 by the core wire 35. The base end portion 352 can serve the wire 35 to prevent the core wire 35 from falling off. As a result, even if the length of the core wire 35 extending inside the catheter shaft 10 is short (even if the base end portion of the core wire 35 is not allowed to enter the lumen of the multi-lumen tube 111), It is also possible to effectively prevent the catheter tip end portion 30 composed of the core wire 35 from being detached from the catheter shaft 10.

又,藉由延伸在導管軸10的內部的芯線35的長度(上述的進入長度L35)短,操作性也優。 Further, the length of the core wire 35 (the above-described entry length L 35 ) extending inside the catheter shaft 10 is short, and the operability is also excellent.

以上,雖針對本發明的一實施形態進行說明,可是本發明的電極導管並不限於此,可有各種的變更。 Although the embodiment of the present invention has been described above, the electrode catheter of the present invention is not limited thereto, and various modifications are possible.

例如,在導管軸的內部不配置管狀繫留構件(固定構件),也可藉由熔接等接合芯線的基端部、與操作用線材的前端部。 For example, a tubular retaining member (fixing member) is not disposed inside the catheter shaft, and the proximal end portion of the core wire and the distal end portion of the wire for operation may be joined by welding or the like.

又,也可使用治具取代管狀繫留構件,機械性接合芯線的基端部與操作用線材的前端部。 Further, instead of the tubular mooring member, a jig may be used to mechanically join the base end portion of the core wire and the front end portion of the wire for operation.

又,也可在多腔管的內部接合芯線的基端部、與操作用線材的前端部。 Further, the base end portion of the core wire and the front end portion of the wire for operation may be joined inside the multi-lumen tube.

又,在多腔管的前端側也可不設置單腔構造。 Further, a single-chamber structure may not be provided on the distal end side of the multi-lumen tube.

又,多腔管的管腔的數量也不是4個,也可例如2~9個管腔。 Further, the number of lumens of the multi-lumen tube is not four, and may be, for example, 2 to 9 lumens.

又,也可是具備2根操作用線材的雙向形式者,此時,對任一方的操作用線材的前端部接合有芯線的基端部。 Further, a bidirectional form having two operation wires may be used. In this case, the base end portion of the core wire is joined to the distal end portion of one of the operation wires.

30‧‧‧導管前端部 30‧‧‧ catheter front end

35‧‧‧芯線 35‧‧‧core wire

352‧‧‧基端部 352‧‧‧ base end

70‧‧‧管狀繫留構件(固定構件) 70‧‧‧Tubular tethered members (fixed members)

80‧‧‧固著材 80‧‧‧ Fixing materials

61‧‧‧前端部 61‧‧‧ front end

11L‧‧‧第1管腔 11L‧‧‧1st lumen

60‧‧‧操作用線材 60‧‧‧Operating wire

111‧‧‧多腔管 111‧‧‧Multi-lumen tube

33‧‧‧絕緣管 33‧‧‧Insulation tube

90‧‧‧接著劑 90‧‧‧Adhesive

332‧‧‧基端部 332‧‧‧ base end

11‧‧‧導管軸的前端部 11‧‧‧ front end of the catheter shaft

10‧‧‧導管軸 10‧‧‧ catheter shaft

50‧‧‧導線 50‧‧‧ wire

15‧‧‧編織管 15‧‧‧ braided tube

13L‧‧‧第3管腔 13L‧‧‧3rd lumen

L35‧‧‧長度 L35‧‧‧ length

10A‧‧‧可撓部分 10A‧‧‧Flexible part

Claims (6)

一種電極導管,其特徵為,具備有:在前端部具有多腔構造的可撓部分的導管軸;連接在前述導管軸的基端側的控制把手;導管前端部,其係連接在前述導管軸的前端側,且包含有絕緣管、和延伸於前述絕緣管的內部並由形狀記憶合金形成的芯線;被安裝在前述導管前端部的外周的複數個環狀電極;複數個導線,其係連接在前述複數個環狀電極的各電極,且延伸在前述導管前端部的內部及前述導管軸的內部來到前述控制把手的內部;以及操作用線材,其係為了使前述導管軸的可撓部分撓曲,而延在於該導管軸的內部,並將其前端部繫留在前述導管軸的前端部,將該基端部繫留在前述控制把手而可拉引操作其基端部,接合有前述芯線的基端部、與前述操作用線材的前端部。 An electrode catheter comprising: a catheter shaft having a flexible portion having a multi-chamber structure at a distal end portion; a control handle connected to a proximal end side of the catheter shaft; and a catheter distal end portion connected to the catheter shaft The front end side includes an insulating tube, and a core wire extending from the inside of the insulating tube and formed of a shape memory alloy; a plurality of annular electrodes mounted on an outer circumference of the front end portion of the catheter; and a plurality of wires connected In each of the plurality of annular electrodes, extending inside the front end portion of the conduit and inside the catheter shaft to the inside of the control handle; and an operating wire for making the flexible portion of the catheter shaft Flexing, extending in the inside of the catheter shaft, and retaining the front end portion of the catheter shaft at the front end portion, and the base end portion is tied to the control handle to pull the base end portion thereof, and the joint is engaged The base end portion of the core wire and the front end portion of the operation wire. 如申請專利範圍第1項記載的電極導管,其中,前述導管前端部形成圈狀。 The electrode catheter according to claim 1, wherein the catheter tip end portion is formed in a ring shape. 如申請專利範圍第1項或第2項記載的電極導管,其中,前述導管軸在多腔構造的可撓部分的前端側具有單腔構造,在該單腔接合前述芯線的基端部、與前述操作用線材的前端部。 The electrode catheter according to the first or second aspect of the invention, wherein the catheter shaft has a single-chamber structure on a distal end side of the flexible portion of the multi-chamber structure, and the base end portion of the core wire is joined to the single cavity, The front end portion of the wire for the aforementioned operation. 如申請專利範圍第3項記載的電極導管,其中, 在抑制前述操作用線材的前端部朝向基端方向移動的管狀繫留構件的內部,接合前述芯線的基端部、與前述操作用線材的前端部。 An electrode catheter according to claim 3, wherein The base end portion of the core wire and the front end portion of the operation wire are joined to the inside of the tubular mooring member that prevents the distal end portion of the operation wire from moving toward the proximal direction. 如申請專利範圍第1項或第2項記載的電極導管,其中,前述芯線往前述導管軸的前端部進入長度在10mm以下。 The electrode catheter according to claim 1 or 2, wherein the core wire has a length of 10 mm or less at a distal end portion of the catheter shaft. 如申請專利範圍第1項或第2項記載的電極導管,其中,前述導管軸的外徑在3.0mm以下,前述芯線的直徑在0.1~1.0mm。 The electrode catheter according to the first or second aspect of the invention, wherein the outer diameter of the catheter shaft is 3.0 mm or less, and the diameter of the core wire is 0.1 to 1.0 mm.
TW102131529A 2013-01-30 2013-09-02 Electrode catheter TWI569828B (en)

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CN101626723A (en) * 2007-03-29 2010-01-13 日本生命线株式会社 Electrode catheter

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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
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Publication number Priority date Publication date Assignee Title
US20040181137A1 (en) * 2003-03-12 2004-09-16 Rodriguez Cynthia D. Catheter with contractable mapping assembly
US20060106295A1 (en) * 2004-11-15 2006-05-18 Pierre Jais Soft linear mapping catheter with stabilizing tip
CN101626723A (en) * 2007-03-29 2010-01-13 日本生命线株式会社 Electrode catheter

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JP5729778B2 (en) 2015-06-03
TW201431575A (en) 2014-08-16
KR20150111902A (en) 2015-10-06
KR101778414B1 (en) 2017-09-13
JP2014147410A (en) 2014-08-21
CN104684468A (en) 2015-06-03
WO2014119030A1 (en) 2014-08-07

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