WO2018008250A1 - Electrode catheter - Google Patents

Electrode catheter Download PDF

Info

Publication number
WO2018008250A1
WO2018008250A1 PCT/JP2017/017735 JP2017017735W WO2018008250A1 WO 2018008250 A1 WO2018008250 A1 WO 2018008250A1 JP 2017017735 W JP2017017735 W JP 2017017735W WO 2018008250 A1 WO2018008250 A1 WO 2018008250A1
Authority
WO
WIPO (PCT)
Prior art keywords
pipe
catheter shaft
electrode
electrode assembly
irrigation
Prior art date
Application number
PCT/JP2017/017735
Other languages
French (fr)
Japanese (ja)
Inventor
拓也 桝田
佐々木 卓也
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 WO2018008250A1 publication Critical patent/WO2018008250A1/en

Links

Images

Classifications

    • 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

Definitions

  • the present invention relates to an electrode catheter in which a basket-like electrode assembly is connected to the tip of a catheter shaft.
  • Patent Document 1 listed below Is a catheter shaft (flexible tube) and a plurality of spines (vertebral columns) each having a proximal end fixed to the distal end of the catheter shaft and electrodes attached to the outer periphery thereof.
  • An electrode assembly formed in a basket shape by being joined, and extends in the axial direction inside the catheter shaft, and extends from the tip of the catheter shaft to the inside (center) of the electrode assembly.
  • An operation wire (tube pulling wire) that extends axially within the tell shaft and whose distal end is fixed to the distal end of the catheter shaft and whose proximal end can be pulled, and an operation wire (collection)
  • a control handle connected to the proximal end of each of the body pulling wire and the tube pulling wire), and a branch portion provided between the proximal end of the catheter shaft and the control handle and connected to the water injection tube.
  • An electrode catheter has been introduced in which liquid supplied from a tube is ejected from the distal end of the catheter shaft (the base end of the electrode assembly) through the inside of the catheter shaft.
  • the proximal end of the electrode assembly It is not possible to sufficiently irrigate the portion (joint portion between the proximal ends of a plurality of spines and the vicinity thereof).
  • the distance from the liquid outlet to the vicinity of the proximal end of the spine is Since it becomes longer than the distance before expansion (the vicinity of the proximal end of the spine moves away from the radial direction of the operation wire), it becomes more difficult to irrigate the liquid to the proximal end portion of the electrode assembly. .
  • the present invention has been made based on the above situation.
  • the first object of the present invention is to sufficiently irrigate the tip of the basket-shaped electrode assembly and sufficiently suppress the formation of thrombus at the tip of the electrode assembly. It is to provide an electrode catheter that can be used.
  • the second object of the present invention is to sufficiently irrigate the liquid even to the base end portion of the basket-shaped electrode assembly, and sufficiently suppress the formation of thrombus at the base end portion of the electrode assembly. It is an object of the present invention to provide an electrode catheter that can be used.
  • the third object of the present invention is that the basket-shaped electrode assembly is expanded with respect to the end portions (the base end portion and the front end portion) of the electrode assembly even when the basket-shaped electrode assembly is expanded in the radial direction of the operation wire.
  • An object of the present invention is to provide an electrode catheter capable of sufficiently irrigating a liquid.
  • a fourth object of the present invention is to provide an electrode catheter capable of reducing a difference in irrigation amount between a proximal end portion and a distal end portion of a basket-shaped electrode assembly.
  • the electrode catheter of the present invention includes a catheter shaft, A plurality of spines each having a proximal end fixed to the distal end of the catheter shaft and having at least one ring electrode mounted on the outer periphery thereof are joined to each other at the distal end to form a basket shape.
  • An electrode assembly A conducting wire connected to the ring-shaped electrode; A handle connected to the proximal end of the catheter shaft;
  • the catheter shaft extends movably in the axial direction of the catheter shaft, extends from the distal end of the catheter shaft and extends into the electrode assembly, and the distal end of the distal end of the electrode assembly And a cylindrical pipe whose proximal end is capable of pulling operation,
  • the conductive wire is connected to the ring-shaped electrode by being joined to the inner peripheral surface of the ring-shaped electrode at the tip thereof, and extends inside the spine and the catheter shaft,
  • an irrigation lumen serving as a liquid flow path is formed, and at the outer periphery of the pipe, there are joints between the tips of the plurality of spines and the vicinity thereof (tips of the electrode assembly).
  • a distal side irrigation opening group comprising a plurality of side hole openings formed in the pipe wall of the pipe so as to reach the irrigation lumen, and a joint portion between the proximal ends of the plurality of spines
  • a proximal-side irrigation opening group consisting of a plurality of side-hole openings formed in a pipe wall of the pipe so as to reach the irrigation lumen for irrigation in the vicinity (the proximal end portion of the electrode assembly)
  • each of the plurality of spines is bent to expand the electrode assembly in the radial direction of the pipe, and the formation region of the proximal-side irrigation opening group in the pipe
  • a portion of the irrigation lumen is drawn into the interior of the catheter shaft, and the liquid constituting the irrigation lumen forms a proximal irrigation opening group in the remaining portion of the formation region that is not drawn into the catheter shaft. It is injected from the opening which comprises the opening group for the tip side irrigation.
  • the liquid supplied to the irrigation lumen of the pipe constitutes the distal-side irrigation opening group formed on the outer periphery of the pipe extending inside the electrode assembly. Since the pipe can be sprayed in the radial direction of the pipe toward the joint between the tips of the plurality of spines and the vicinity thereof, the liquid can be sufficiently irrigated to the tip of the electrode assembly. .
  • the liquid supplied to the irrigation lumen of the pipe is supplied to the proximal ends of the plurality of spines from the openings constituting the proximal-side irrigation opening group formed on the outer periphery of the pipe extending inside the electrode assembly. Since the pipe can be sprayed in the radial direction toward the joints and the vicinity thereof, the liquid can be sufficiently irrigated also to the base end of the electrode assembly.
  • the electrode assembly expands in the radial direction of the pipe, and when the vicinity of the proximal end and the vicinity of the distal end of the spine constituting the electrode assembly are moved away from the pipe, A part of the formation region of the end irrigation opening group is drawn into the catheter shaft, and the opening in the undrawn region (the remaining part of the formation region of the proximal irrigation opening group) and the distal irrigation opening group The injection pressure of the liquid from the opening which comprises is raised. This makes it possible to irrigate the liquid also in the vicinity of the proximal end and the distal end of the spine away from the pipe (the proximal end side irrigation opening group and the distal end side irrigation opening group).
  • the ejection pressure of the liquid from the openings constituting the proximal irrigation opening group and the distal irrigation opening group increases. Even when the assembly is expanded, the liquid can be sufficiently irrigated to the end portions (the base end portion and the front end portion) of the electrode assembly.
  • the outer peripheral surface of the pipe is liquid-tightly covered with an inner wall (constituent resin) in at least the distal end region of the catheter shaft.
  • an inner wall constitutituent resin
  • the opening in a part of the formation region of the proximal-side irrigation opening group drawn into the catheter shaft is reliably blocked, and the liquid flows out from the opening. While being able to suppress reliably, it can prevent that a liquid infiltrates into the inside of a catheter shaft from the front end side of a catheter shaft.
  • the total area of the openings constituting the distal irrigation opening group is S61,
  • the formation region of the proximal irrigation opening group that is not drawn into the catheter shaft is S621, and the total area of the non-injectable opening in a part of the formation region of the proximal irrigation opening group drawn into the catheter shaft is S622 , It is preferable that (S61 + S621) / (S61 + S621 + S622) is 0.7 or less.
  • S61 / (S621 + S622 / 2) is preferably 1.2 to 2.0. According to the electrode catheter having such a configuration, when the electrode assembly is in a predetermined expanded state (standard state), the difference in irrigation amount between the proximal end portion and the distal end portion of the electrode assembly is reduced. can do.
  • FIG. 3 is a transverse sectional view (III-III sectional view) of the electrode catheter shown in FIG.
  • FIG. 4 is a transverse sectional view (IV-IV sectional view) of the electrode catheter shown in FIG. 1.
  • FIG. 5 is a cross-sectional view (VV cross-sectional view) of a spine that constitutes the electrode assembly of the electrode catheter shown in FIG. 2. It is a longitudinal cross-sectional view which shows the front-end
  • FIG. 1 It is a perspective view which shows the front-end
  • the electrode catheter 100 of this embodiment shown in FIGS. 1 to 7 has a catheter shaft 10, each proximal end fixed to the distal end of the catheter shaft 10, and twelve ring-shaped electrodes 20 attached to each outer periphery. 10 spines 31 are joined to each other at their distal ends, connected to the electrode assembly 30 formed in a basket shape, the conductive wire 40 connected to the ring electrode 20, and the proximal end of the catheter shaft 10.
  • the handle 50 and the catheter shaft 10 extend movably in the axial direction of the catheter shaft 10, extend from the distal end of the catheter shaft 10, and extend into the electrode assembly 30.
  • a cylindrical pipe 60 fixed to an anchor 33 which is a distal end portion of the assembly 30 and having a proximal end capable of being pulled.
  • the conducting wire 40 is connected to the ring-shaped electrode 20 by being joined to the inner peripheral surface of the ring-shaped electrode 20 at the distal end thereof, and extends inside the spine 31 and the catheter shaft 10.
  • the pipe 60 is formed with an irrigation lumen 60 ⁇ / b> L that serves as a liquid flow path, and on the outer periphery of the pipe 60, there is a joint between the tips of the spine 31 that is the tip of the electrode assembly 30 and the vicinity thereof.
  • each of the plurality of spines 31 bends and the electrode assembly 30 expands in the radial direction of the pipe 60, and the formation region of the proximal end side irrigation opening group 62G in the pipe 60 Is partially pulled into the catheter shaft 10 and the liquid from the irrigation lumen 60L is not drawn into the catheter shaft 10, and the opening 62 and the distal end of the remaining region of the proximal irrigation opening group 62G are formed. It is comprised so that it may inject from the opening 61 which comprises the opening group 61G for side irrigation.
  • reference numeral 70 denotes an electrode connector incorporating a plurality of terminals to which the respective base ends of the conducting wire 40 are connected
  • 71 denotes a single lumen structure including the conducting wire 40 extending from the handle 50 toward the electrode connector 70.
  • 81 is a fixed valve connected to the handle 50
  • 82 is a fixed valve hub for holding the fixed valve 81
  • 83 is a connecting tube for connecting the handle 50 and the fixed valve hub 82
  • 85 is a perfusion connector
  • 86 is a perfusion tube having a lumen that connects the pipe 60 and the perfusion connector 85 and communicates with the irrigation lumen 60 ⁇ / b> L of the pipe 60.
  • a central lumen 11 is formed inside a catheter shaft 10 constituting the electrode catheter 100, and ten sub-lumens 13 having a rectangular cross section around it are equiangularly spaced. Is formed.
  • the length of the catheter shaft 10 is usually 800 to 1300 mm, and is 1100 mm if a suitable example is shown.
  • the outer diameter of the catheter shaft 10 is usually 2.4 to 4.0 mm, and is 2.8 mm as a suitable example.
  • the inner diameter of the catheter shaft 10 (the diameter of the central lumen 11) is usually 0.4 to 1.0 mm, and 0.7 mm if a suitable example is shown.
  • PEBAX polyether block amide
  • the catheter shaft 10 may have the same hardness over its entire length, but preferably has different hardness along the length direction.
  • the catheter shaft 10 changes (decreases) from 72D to 40D in the tip direction. ) Can be preferably used.
  • the catheter shaft 10 may be a blade tube reinforced by braiding.
  • a resin capable of exhibiting a reinforcing effect by being embedded can be exemplified, and a PEEK resin can be exemplified as a suitable resin.
  • An electrode assembly 30 is connected to the distal end of the catheter shaft 10.
  • the electrode assembly 30 constituting the electrode catheter 100 is formed in a basket shape by ten spines 31.
  • the constituent material of the spine 31 the same material as the constituent material of the catheter shaft 10 can be used, and it is preferable to use PEBAX.
  • each proximal end of the spine 31 is fixed to the distal end of the catheter shaft 10.
  • the proximal end of the spine 31 and the distal end of the catheter shaft 10 are fixed by fusion of the constituent resins.
  • the central lumen 11 of the catheter shaft 10 is filled with a fusion resin.
  • the fusion resin constituting the distal end region of the catheter shaft 10 covers the outer peripheral surface of the pipe 60 extending to the central lumen 11 of the catheter shaft 10 in a liquid-tight manner, whereby the central lumen 11 extends from the distal end of the catheter shaft 10. It is possible to prevent the liquid from entering the glass.
  • the tips of the spines 31 are joined to each other by being fixed to the anchor 33.
  • the constituent material of the anchor 33 include metals such as stainless steel.
  • a core wire 35 made of a shape memory alloy extends inside the spine 31.
  • the core wire 35 stores the bending shape of the spine 31 as shown in FIG. 2, and is easily deformed (for example, linearly deformed) by applying a force, but returns to the original bending shape when the force is removed.
  • An example of the constituent material of the core wire 35 is a Ni—Ti alloy.
  • ten holes 335 are formed on the outer peripheral surface of the anchor 33 constituting the electrode assembly 30 so as to be spirally arranged. By inserting the tip of 35, the tip of the spine 31 from which the core wire 35 extends is fixed to the anchor 33.
  • the proximal end of the core wire 35 is inserted into the sub-lumen 13 at the distal end portion of the catheter shaft 10 (for example, a portion about 100 mm from the distal end of the shaft).
  • Twelve ring-shaped electrodes 20 are attached to the outer periphery of each of the spines 31 constituting the electrode assembly 30, so that the number of electrodes of the electrode assembly 30 is 120.
  • a metal having good electrical conductivity such as platinum, gold, silver, aluminum, copper, and stainless steel can be used. From the viewpoint of improving the contrast properties for X-rays, platinum, gold, silver, and alloys containing these as main components are preferable.
  • a conductive wire 40 is connected to each of the ring electrodes 20.
  • the conductive wire 40 constituting the electrode catheter 100 is connected to the ring-shaped electrode 20 by being joined to the inner peripheral surface of the ring-shaped electrode 20 at the distal end thereof, and the ring-shaped electrode.
  • the spine 31 enters the inside of the spine 31 from the side hole 315 formed in the tube wall of the spine 31 corresponding to the mounting position of the spine 31, and extends inside the spine 31.
  • the lead wire 40 extending inside the spine 31 enters the inside (central lumen 11) of the catheter shaft 10 and extends inside the catheter shaft 10. .
  • the lead wire 40 at the distal end portion of the catheter shaft 10 extends inside the catheter shaft 10 in a state of being included in each of the polyimide tubes 37 arranged corresponding to each of the spines 31. Exist.
  • the conducting wire 40 extending inside the catheter shaft 10 enters the inside of the handle 50 connected to the proximal end of the catheter shaft 10, and further extends out of the handle 50 so as to pass through the lumen of the conducting wire protection tube 71. It passes through and is inserted into the electrode connector 70.
  • Each of the base end portions of the conducting wire 40 is connected to each of a plurality of terminals built in the electrode connector 70. Via this electrode connector 70, the electrode catheter 100 of this embodiment is connected to a medical measurement device.
  • the pipe 60 constituting the electrode catheter 100 extends inside the catheter shaft 10 (central lumen 11) so as to be movable in the axial direction of the catheter shaft 10 and extends from the distal end of the catheter shaft 10 to the electrode assembly 30. It extends inside.
  • the distal end of the pipe 60 is fixed to the distal end portion of the electrode assembly 30 by being inserted into a hole 337 formed in the proximal end surface of the anchor 33.
  • a pipe 60 extending inside the catheter shaft 10 extends from the proximal end of the catheter shaft 10 to enter the handle 50, and further extends from the handle 50 to connect the connection tube 83 and the fixed valve hub 82. It extends inside.
  • the proximal end of the pipe 60 is connected to the perfusion connector 85 via the perfusion tube 86.
  • Examples of the constituent material of the pipe 60 include metals such as Ni—Ti and stainless steel, but materials other than metals (for example, hard resin) may be used.
  • the outer diameter of the pipe 60 is normally 0.5 to 1.2 mm, and 0.8 mm if a suitable example is shown.
  • the inner diameter of the pipe 60 (the diameter of the irrigation lumen 60L) is usually 0.4 to 1.0 mm, and 0.7 mm if a suitable example is shown.
  • the proximal end of the pipe 60 can be pulled, and the pipe 60 acts as a pulling wire for expanding the electrode assembly 30.
  • the pipe 60 moves to the proximal side inside the catheter shaft 10.
  • the fusion resin filled in the central lumen 11 of the catheter shaft 10 and liquid-tightly covering the outer peripheral surface of the pipe 60 at the fusion portion between the proximal end of the spine 31 and the distal end of the catheter shaft 10 is the pipe 60. It does not impede movement.
  • the pipe 60 can move inside the catheter shaft 10 while sliding with the fusion resin on the outer periphery thereof.
  • FIG. 12 shows a state in which the shape of the electrode assembly 30 is changed by pulling the perfusion connector 85 connected to the proximal end of the pipe 60.
  • FIG. 1A shows a state in which the electrode assembly 30 is most contracted, and is a suitable shape when the electrode catheter 100 is inserted into the sheath.
  • FIG. 3 (3) shows a state in which the electrode assembly 30 is most expanded by the pulling operation, and is a suitable shape when measuring the potential of the atrial septum (left atrial side).
  • FIG. 2B is an intermediate state (standard state), and the bending shape of the spine 31 at this time is stored by the core wire 35.
  • the pipe 60 is formed with an irrigation lumen 60L serving as a liquid flow path.
  • a plurality of sides are formed on the outer periphery of the pipe 60 so as to irrigate the joint between the tips of the spine 31 and the vicinity thereof (the tip of the electrode assembly 30).
  • a distal-side irrigation opening group 61 ⁇ / b> G composed of hole openings 61 is formed.
  • a plurality of pipes 60 are formed on the outer periphery of the pipe 60 for irrigation at the joint between the proximal ends of the spine 31 and the vicinity thereof (the proximal end of the electrode assembly 30).
  • a proximal end irrigation opening group 62 ⁇ / b> G composed of the side hole openings 62 is formed.
  • the diameters of the opening 61 and the opening 62 are, for example, 0.03 to 0.1 mm, and preferably 0.04 to 0.06 mm.
  • the total area of the openings 61 constituting the distal-side irrigation opening group 61G is, for example, 1.5 to 8 mm 2 .
  • the total area of the openings 62 constituting the proximal irrigation opening group 62G is, for example, 3 to 20 mm 2 .
  • a part of the proximal end side irrigation opening group 62 ⁇ / b> G in the pipe 60 is drawn into the catheter shaft 10 by pulling the proximal end (perfusion connector 85) of the pipe 60. It is.
  • the entire formation region of the proximal irrigation opening group 62 G extends from the distal end of the catheter shaft 10. ing.
  • liquid can be ejected from all the openings 62 constituting the proximal end side irrigation opening group 62G and the openings 61 constituting the distal end side irrigation opening group 61G.
  • a part of the formation region of the proximal irrigation opening group 62G (for example, the proximal region in FIG. 11B). 622A) is retracted into the catheter shaft 10.
  • the outer peripheral surface of the pipe 60 extending to the central lumen 11 of the catheter shaft 10 is liquid-tightly covered with the fusion resin constituting the distal end region of the catheter shaft 10.
  • the opening 62 in a part of the formation region of the proximal-side irrigation opening group 62G (the proximal-side region 622A) that is drawn into is blocked by the fusion resin, and the liquid cannot be ejected.
  • the liquid is ejected from the opening 62 in the remaining part of the formation region of the proximal end side irrigation opening group 62G (the distal side region 621A in FIG. 11B) and the opening 61 constituting the distal side irrigation opening group 61G.
  • a part of the formation region of the proximal end irrigation opening group 62G (for example, the proximal end side of the proximal end region 622A in FIG. 11B). About half of the region) is drawn into the catheter shaft 10, and approximately half of the openings 62 in the proximal region 622 ⁇ / b> A are blocked by the fusion resin that forms the distal region of the catheter shaft 10, thereby allowing liquid to flow. It becomes impossible to inject.
  • the opening 62 and the distal-side irrigation opening group 61G in the remaining part of the formation region of the proximal-side irrigation opening group 62G (the distal-side region 621A and the proximal-side region 622A in FIG. 11B).
  • a liquid is ejected from the opening 61 which comprises.
  • the total area of the openings 62 in the distal end region 621A shown in FIG. 11B is S621, the total area of the openings 62 in the proximal region 622A is S622, and the openings 61 constituting the distal irrigation opening group 61G shown in FIG.
  • S61 the total area of the injectable openings 61 and 62 in the state where the electrode assembly 30 is most contracted as shown in FIG. 12A
  • S61 + S621 + S622 the total area of the injectable openings 61 and 62 in the state in which the electrode assembly 30 is most expanded as shown in FIG. 3
  • the injectable openings 61 and 62 are able to be injected as the electrode assembly 30 is expanded.
  • the total area of the fuel is reduced, and the injection pressure increases accordingly. This makes it possible to irrigate the liquid near the proximal end and the distal end of the spine 31 away from the pipe 60 (the proximal end irrigation opening group 62G and the distal irrigation opening group 61G).
  • the ratio [(S61 + S621) / (S61 + S621 + S622)] to the total area (S61 + S621 + S622) of the injectable openings 61 and 62 in the state [the state shown in FIG. 12 (1)] is 0.7 or less It is preferable that
  • the rate of increase of the injection pressure from the openings 61 and 62 accompanying the expansion of the electrode assembly 30 can be increased to some extent. Even when the assembly 30 is expanded and the proximal end portion and the distal end portion thereof are moved away from the pipe 60 (the proximal end side irrigation opening group 62G and the distal end side irrigation opening group 61G), the electrode assembly 30 The liquid can be sufficiently irrigated to the proximal end portion and the distal end portion.
  • the ratio [S61 / (S621 + S622 / 2)] is preferably 1.2 to 2.0.
  • the liquid supplied to the irrigation lumen 60L of the pipe 60 causes the distal-side irrigation opening group 61G formed on the outer periphery of the pipe 60 extending inside the electrode assembly 30. Can be sprayed in the radial direction of the pipe 60 toward the joint portion between the tips of the spine 31 and the vicinity thereof, so that the liquid is sufficiently irrigated with respect to the tip portion of the electrode assembly 30. can do.
  • the liquid supplied to the irrigation lumen 60L of the pipe 60 is supplied from the opening 62 constituting the proximal irrigation opening group 62G formed on the outer periphery of the pipe 60 extending inside the electrode assembly 30 to the spine. Since the pipe 60 can be sprayed in the radial direction toward the joint portion between the proximal ends of 31 and the vicinity thereof, the liquid can be sufficiently irrigated also to the proximal end portion of the electrode assembly 30.
  • the electrode assembly 30 expands in the radial direction of the pipe 60, and the vicinity of the proximal end and the distal end of the spine 31 constituting the electrode assembly 30. Is moved away from the pipe 60, a part of the formation region of the proximal end side irrigation opening group 62 ⁇ / b> G in the pipe 60 is drawn into the catheter shaft 10, and a region that is not retracted (the proximal end irrigation opening group 62 ⁇ / b> G of the proximal end side irrigation opening group 62 ⁇ / b> G).
  • the pipe 60 (the proximal irrigation opening group 62G and the distal irrigation opening group) 61G), it is possible to irrigate the liquid also in the vicinity of the proximal end and the vicinity of the distal end of the spine 31 that is far from 61G).
  • the electrode catheter 100 of the present embodiment As described above, in the electrode catheter 100 of the present embodiment, as the electrode assembly 30 is expanded, from the opening 62 constituting the proximal end side irrigation opening group 62G and the opening 61 constituting the distal end side irrigation opening group 61G. Therefore, even when the electrode assembly 30 is expanded, the liquid is sufficiently irrigated with respect to the end portions (the base end portion and the front end portion) of the electrode assembly 30. Can do.
  • the distal region 621A and The proximal end region 622A extends from the distal end of the catheter shaft 10, and in the most expanded state as shown in FIG. 12 (3), the entire proximal end region 622A or Area parts may be configured to be drawn into the catheter shaft 10.
  • Electrode catheter 10
  • Catheter shaft 11
  • Center lumen 13
  • Sublumen 20
  • Ring-shaped electrode 30
  • Electrode assembly 31
  • Spine 315 Side hole
  • Anchor 335 Hole 337
  • Polyimide tube 40
  • Conductor 50
  • Handle 60
  • Pipe 60L
  • Irrigation lumen 61G
  • Tip side irrigation opening Group 61 opening 62G proximal end irrigation opening group
  • electrode connector 71
  • conductor protection tube 81
  • fixed valve 82
  • fixed valve hub 83 connecting tube 85 perfusion connector 86 perfusion tube

Abstract

The purpose of the present invention is to provide an electrode catheter wherein even if a basket-shaped electrode assembly is expanded, proximal and distal portions thereof can be sufficiently irrigated with a liquid. This electrode catheter is provided with a catheter shaft (10), an electrode assembly (30), and a pipe (60). The pipe (60) has an irrigation lumen (60L) formed therein, and a distal irrigation opening group (61G) comprising openings (61) for irrigating the distal portion of the electrode assembly (30) and a proximal irrigation opening group (62G) comprising openings (62) for irrigating the proximal portion of the electrode assembly (30) are formed on the outer circumferential surface of the pipe (60). By pulling the pipe (60), the electrode assembly (30) is expanded and a part of the region in which the proximal irrigation opening group (62G) is formed is withdrawn into the catheter shaft (10) so that a liquid is jetted from the irrigation lumen through the openings (62) which are not withdrawn into the catheter shaft (10) and the openings (61) of the distal irrigation opening group (61G).

Description

電極カテーテルElectrode catheter
 本発明は、カテーテルシャフトの先端にバスケット状の電極組立体が接続されてなる電極カテーテルに関する。 The present invention relates to an electrode catheter in which a basket-like electrode assembly is connected to the tip of a catheter shaft.
 従来、心臓の電気生理学的検査において、左心房肺静脈への挿入と電極位置の保持を容易にするとともに末梢血管を詰まらせるリスクのある血栓の生成を抑えた電極カテーテルとして、下記特許文献1には、カテーテルシャフト(可撓性を有するチューブ)と、カテーテルシャフトの先端に各々の基端が固定され、各々の外周に電極が装着されている複数のスパイン(脊柱)が、各々の先端において互いに接合されることによりバスケット状に形成された電極組立体(集合体)と、カテーテルシャフトの内部において軸方向に移動可能に延在し、カテーテルシャフトの先端から延び出して電極組立体の内部(中心)に延在し、その先端が電極組立体の先端に固定され、その基端が引張操作可能な操作用ワイヤ(集合体牽引ワイヤ)と、カテーテルシャフトの内部において軸方向に移動可能に延在し、その先端が、カテーテルシャフトの先端に固定され、その基端が引張操作可能な操作用ワイヤ(チューブ牽引ワイヤ)と、操作用ワイヤ(集合体牽引ワイヤおよびチューブ牽引ワイヤ)の各々の基端と接続された制御ハンドルと、カテーテルシャフトの基端と制御ハンドルの間に設けられ、注水チューブが接続された分岐部とを備えてなり、注水チューブから供給された液体が、カテーテルシャフトの内部をとおってカテーテルシャフトの先端(電極組立体の基端)から先端方向に噴出される電極カテーテルが紹介されている。 Conventionally, in an electrophysiological examination of the heart, as an electrode catheter that facilitates insertion into the left atrial pulmonary vein and maintenance of the electrode position and suppresses the formation of a thrombus that may clog peripheral blood vessels, Patent Document 1 listed below Is a catheter shaft (flexible tube) and a plurality of spines (vertebral columns) each having a proximal end fixed to the distal end of the catheter shaft and electrodes attached to the outer periphery thereof. An electrode assembly (aggregate) formed in a basket shape by being joined, and extends in the axial direction inside the catheter shaft, and extends from the tip of the catheter shaft to the inside (center) of the electrode assembly. ), The distal end of which is fixed to the distal end of the electrode assembly, and the proximal end of which is capable of pulling operation (aggregate pulling wire); An operation wire (tube pulling wire) that extends axially within the tell shaft and whose distal end is fixed to the distal end of the catheter shaft and whose proximal end can be pulled, and an operation wire (collection) A control handle connected to the proximal end of each of the body pulling wire and the tube pulling wire), and a branch portion provided between the proximal end of the catheter shaft and the control handle and connected to the water injection tube. An electrode catheter has been introduced in which liquid supplied from a tube is ejected from the distal end of the catheter shaft (the base end of the electrode assembly) through the inside of the catheter shaft.
特開2013-81526号公報JP 2013-81526 A
 上記特許文献1に記載されているようなバスケット状に形成された電極組立体にあっては、その先端部(複数のスパインの先端どうしの接合部およびその近傍)および基端部(複数のスパインの基端どうしの接合部およびその近傍)において血液が滞留しやすく血栓が生成されやすい。このため、バスケット形状の電極組立体の先端部および基端部に対して十分に灌注する必要がある。 In the electrode assembly formed in a basket shape as described in Patent Document 1, the tip end portion (joint portion between the tip ends of a plurality of spines and the vicinity thereof) and the base end portion (plural spines) The blood tends to stay at the joint between the proximal ends of the two and the vicinity thereof, and a thrombus is easily generated. For this reason, it is necessary to sufficiently irrigate the distal end portion and the proximal end portion of the basket-shaped electrode assembly.
 しかしながら、上記特許文献1に記載された電極カテーテルでは、カテーテルシャフトの先端から噴出される液体を、バスケット形状の電極組立体の先端部(複数のスパインの先端どうしの接合部およびその近傍)まで到達させることは困難であり、このため、電極組立体の先端部に対して十分に灌注することができず、電極組立体の先端部における血栓の形成を十分に抑制することができない。 However, in the electrode catheter described in Patent Document 1, the liquid ejected from the distal end of the catheter shaft reaches the distal end portion of the basket-shaped electrode assembly (the joint portion between the distal ends of a plurality of spines and the vicinity thereof). Therefore, it is difficult to sufficiently irrigate the tip of the electrode assembly, and thrombus formation at the tip of the electrode assembly cannot be sufficiently suppressed.
 また、カテーテルシャフトの先端から先端方向に噴出される液体は、バスケット形状の電極組立体の内部を操作用ワイヤ(集合体牽引ワイヤ)に沿って先端方向に流動するため、電極組立体の基端部(複数のスパインの基端どうしの接合部およびその近傍)に対しても十分に灌注することができない。 In addition, since the liquid ejected from the distal end of the catheter shaft in the distal direction flows in the basket-shaped electrode assembly along the operation wire (aggregate pulling wire) in the distal direction, the proximal end of the electrode assembly It is not possible to sufficiently irrigate the portion (joint portion between the proximal ends of a plurality of spines and the vicinity thereof).
 特に、操作用ワイヤ(集合体牽引ワイヤ)を引張操作してバスケット形状の電極組立体を操作用ワイヤの半径方向に拡張させたときには、液体の噴出口からスパインの基端近傍までの距離が、拡張前における当該距離と比較して長くなる(スパインの基端近傍が操作
用ワイヤの半径方向に遠ざかる)ため、電極組立体の基端部に対して液体を灌注させることが、より困難となる。
In particular, when the basket-shaped electrode assembly is expanded in the radial direction of the manipulation wire by pulling the manipulation wire (the assembly pulling wire), the distance from the liquid outlet to the vicinity of the proximal end of the spine is Since it becomes longer than the distance before expansion (the vicinity of the proximal end of the spine moves away from the radial direction of the operation wire), it becomes more difficult to irrigate the liquid to the proximal end portion of the electrode assembly. .
 なお、電極組立体を拡張させるときに、注水チューブからの液体の供給量を増加させることも考えられるが、操作が煩雑となって現実的でないばかりか、液体の供給量を増加させると、噴出された液体の先端方向への勢いが増して、操作用ワイヤの半径方向に広がらなくなるため、液体の供給量を増加させるだけでは、電極組立体の基端部に対する灌注量を増加させることはできない。 When expanding the electrode assembly, it is conceivable to increase the amount of liquid supplied from the water injection tube, but not only is the operation complicated and impractical, but if the amount of liquid supplied is increased, Since the momentum of the applied liquid increases and does not spread in the radial direction of the operation wire, it is not possible to increase the irrigation amount to the proximal end portion of the electrode assembly only by increasing the supply amount of the liquid. .
 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、バスケット形状の電極組立体の先端部に対して、液体を十分に灌注することが可能で、電極組立体の先端部の血栓の形成を十分に抑制することができる電極カテーテルを提供することにある。
 本発明の第2の目的は、バスケット形状の電極組立体の基端部に対しても、液体を十分に灌注することが可能で、電極組立体の基端部の血栓の形成を十分に抑制することができる電極カテーテルを提供することにある。
 本発明の第3の目的は、バスケット形状の電極組立体を、操作用ワイヤの半径方向に拡張させたときであっても、電極組立体の端部(基端部および先端部)に対して液体を十分に灌注することができる電極カテーテルを提供することにある。
 本発明の第4の目的は、バスケット形状の電極組立体の基端部と先端部との間における灌注量の差を小さくすることができる電極カテーテルを提供することにある。
The present invention has been made based on the above situation.
The first object of the present invention is to sufficiently irrigate the tip of the basket-shaped electrode assembly and sufficiently suppress the formation of thrombus at the tip of the electrode assembly. It is to provide an electrode catheter that can be used.
The second object of the present invention is to sufficiently irrigate the liquid even to the base end portion of the basket-shaped electrode assembly, and sufficiently suppress the formation of thrombus at the base end portion of the electrode assembly. It is an object of the present invention to provide an electrode catheter that can be used.
The third object of the present invention is that the basket-shaped electrode assembly is expanded with respect to the end portions (the base end portion and the front end portion) of the electrode assembly even when the basket-shaped electrode assembly is expanded in the radial direction of the operation wire. An object of the present invention is to provide an electrode catheter capable of sufficiently irrigating a liquid.
A fourth object of the present invention is to provide an electrode catheter capable of reducing a difference in irrigation amount between a proximal end portion and a distal end portion of a basket-shaped electrode assembly.
 本発明の電極カテーテルは、カテーテルシャフトと、
 前記カテーテルシャフトの先端に各々の基端が固定され、少なくとも1個のリング状電極が各々の外周に装着されている複数のスパインが、各々の先端において互いに接合されることによりバスケット状に形成された電極組立体と、
 前記リング状電極に接続された導線と、
 前記カテーテルシャフトの基端に接続されたハンドルと、
 前記カテーテルシャフトの内部において前記カテーテルシャフトの軸方向に移動可能に延在し、前記カテーテルシャフトの先端から延び出して前記電極組立体の内部に延在し、その先端が前記電極組立体の先端部に固定され、その基端が引張操作可能である円筒状のパイプとを備えてなり、
 前記導線は、その先端部において前記リング状電極の内周面に接合されることによって当該リング状電極に接続されているとともに、前記スパインの内部および前記カテーテルシャフトの内部において延在し、
 前記パイプには、液体の流路となる灌注用ルーメンが形成されているとともに、前記パイプの外周には、前記複数のスパインの先端どうしの接合部およびその近傍(前記電極組立体の先端部)に灌注するために前記灌注用ルーメンに至るよう前記パイプの管壁に形成された複数の側孔の開口からなる先端側灌注用開口群と、前記複数のスパインの基端どうしの接合部およびその近傍(前記電極組立体の基端部)に灌注するために前記灌注用ルーメンに至るよう前記パイプの管壁に形成された複数の側孔の開口からなる基端側灌注用開口群とが形成され、
 前記パイプの基端を引張操作することにより、前記複数のスパインの各々が撓んで前記電極組立体が前記パイプの半径方向に拡張するとともに、前記パイプにおける前記基端側灌注用開口群の形成領域の一部が前記カテーテルシャフトの内部に引き込まれ、前記灌注用ルーメンからの液体が、前記カテーテルシャフトの内部に引き込まれていない前記形成領域の残部における基端側灌注用開口群を構成する開口および前記先端側灌注用開口群を構成する開口から噴射されることを特徴とする。
The electrode catheter of the present invention includes a catheter shaft,
A plurality of spines each having a proximal end fixed to the distal end of the catheter shaft and having at least one ring electrode mounted on the outer periphery thereof are joined to each other at the distal end to form a basket shape. An electrode assembly;
A conducting wire connected to the ring-shaped electrode;
A handle connected to the proximal end of the catheter shaft;
The catheter shaft extends movably in the axial direction of the catheter shaft, extends from the distal end of the catheter shaft and extends into the electrode assembly, and the distal end of the distal end of the electrode assembly And a cylindrical pipe whose proximal end is capable of pulling operation,
The conductive wire is connected to the ring-shaped electrode by being joined to the inner peripheral surface of the ring-shaped electrode at the tip thereof, and extends inside the spine and the catheter shaft,
In the pipe, an irrigation lumen serving as a liquid flow path is formed, and at the outer periphery of the pipe, there are joints between the tips of the plurality of spines and the vicinity thereof (tips of the electrode assembly). A distal side irrigation opening group comprising a plurality of side hole openings formed in the pipe wall of the pipe so as to reach the irrigation lumen, and a joint portion between the proximal ends of the plurality of spines, and A proximal-side irrigation opening group consisting of a plurality of side-hole openings formed in a pipe wall of the pipe so as to reach the irrigation lumen for irrigation in the vicinity (the proximal end portion of the electrode assembly) And
By pulling the proximal end of the pipe, each of the plurality of spines is bent to expand the electrode assembly in the radial direction of the pipe, and the formation region of the proximal-side irrigation opening group in the pipe A portion of the irrigation lumen is drawn into the interior of the catheter shaft, and the liquid constituting the irrigation lumen forms a proximal irrigation opening group in the remaining portion of the formation region that is not drawn into the catheter shaft. It is injected from the opening which comprises the opening group for the tip side irrigation.
 このような構成を有する電極カテーテルによれば、パイプの灌注用ルーメンに供給される液体を、電極組立体の内部に延在する当該パイプの外周に形成された先端側灌注用開口群を構成する開口から、複数のスパインの先端どうしの接合部およびその近傍に向けて当該パイプの半径方向に噴射することができるので、電極組立体の先端部に対して当該液体を十分に灌注することができる。 According to the electrode catheter having such a configuration, the liquid supplied to the irrigation lumen of the pipe constitutes the distal-side irrigation opening group formed on the outer periphery of the pipe extending inside the electrode assembly. Since the pipe can be sprayed in the radial direction of the pipe toward the joint between the tips of the plurality of spines and the vicinity thereof, the liquid can be sufficiently irrigated to the tip of the electrode assembly. .
 また、パイプの灌注用ルーメンに供給される液体を、電極組立体の内部に延在する当該パイプの外周に形成された基端側灌注用開口群を構成する開口から、複数のスパインの基端どうしの接合部およびその近傍に向けて当該パイプの半径方向に噴射することができるので、電極組立体の基端部に対しても当該液体を十分に灌注することができる。 Further, the liquid supplied to the irrigation lumen of the pipe is supplied to the proximal ends of the plurality of spines from the openings constituting the proximal-side irrigation opening group formed on the outer periphery of the pipe extending inside the electrode assembly. Since the pipe can be sprayed in the radial direction toward the joints and the vicinity thereof, the liquid can be sufficiently irrigated also to the base end of the electrode assembly.
 また、パイプの基端を引張操作することにより、パイプの半径方向に電極組立体が拡張して、電極組立体を構成するスパインの基端近傍および先端近傍がパイプから遠ざかったときには、パイプにおける基端側灌注用開口群の形成領域の一部がカテーテルシャフトの内部に引き込まれ、引き込まれていない領域(基端側灌注用開口群の形成領域の残部)における開口および先端側灌注用開口群を構成する開口からの液体の噴射圧力が上昇する。これにより、パイプ(基端側灌注用開口群および先端側灌注用開口群)から遠ざかったスパインの基端近傍および先端近傍に対しても当該液体を灌注することが可能になる。
 このように、本発明の電極カテーテルでは、電極組立体の拡張に伴って、基端側灌注用開口群および先端側灌注用開口群を構成する開口からの液体の噴射圧力が上昇するので、電極組立体を拡張させたときであっても、電極組立体の端部(基端部および先端部)に対して液体を十分に灌注することができる。
In addition, by pulling the proximal end of the pipe, the electrode assembly expands in the radial direction of the pipe, and when the vicinity of the proximal end and the vicinity of the distal end of the spine constituting the electrode assembly are moved away from the pipe, A part of the formation region of the end irrigation opening group is drawn into the catheter shaft, and the opening in the undrawn region (the remaining part of the formation region of the proximal irrigation opening group) and the distal irrigation opening group The injection pressure of the liquid from the opening which comprises is raised. This makes it possible to irrigate the liquid also in the vicinity of the proximal end and the distal end of the spine away from the pipe (the proximal end side irrigation opening group and the distal end side irrigation opening group).
Thus, in the electrode catheter of the present invention, as the electrode assembly is expanded, the ejection pressure of the liquid from the openings constituting the proximal irrigation opening group and the distal irrigation opening group increases. Even when the assembly is expanded, the liquid can be sufficiently irrigated to the end portions (the base end portion and the front end portion) of the electrode assembly.
 本発明の電極カテーテルにおいて、前記パイプの外周面は、前記カテーテルシャフトの少なくとも先端領域における内壁(構成樹脂)により液密に覆われていることが好ましい。
 このような構成を有する電極カテーテルによれば、カテーテルシャフトの内部に引き込まれた基端側灌注用開口群の形成領域の一部における開口が確実に塞がれて当該開口からの液体の流出を確実に抑止できるとともに、カテーテルシャフトの先端側からカテーテルシャフトの内部に液体が浸入することを防止することができる。
In the electrode catheter of the present invention, it is preferable that the outer peripheral surface of the pipe is liquid-tightly covered with an inner wall (constituent resin) in at least the distal end region of the catheter shaft.
According to the electrode catheter having such a configuration, the opening in a part of the formation region of the proximal-side irrigation opening group drawn into the catheter shaft is reliably blocked, and the liquid flows out from the opening. While being able to suppress reliably, it can prevent that a liquid infiltrates into the inside of a catheter shaft from the front end side of a catheter shaft.
 本発明の電極カテーテルにおいて、前記先端側灌注用開口群を構成する開口の総面積をS61とし、
 前記パイプの基端を引張操作して前記電極組立体が前記パイプの半径方向に最も拡張しているときに、前記カテーテルシャフトの内部に引き込まれていない前記基端側灌注用開口群の形成領域の残部における噴射可能な開口の総面積をS621とし、前記カテーテルシャフトの内部に引き込まれた前記基端側灌注用開口群の形成領域の一部における噴射不能な開口の総面積をS622とするとき、
 (S61+S621)/(S61+S621+S622)が0.7以下であることが好ましい。
In the electrode catheter of the present invention, the total area of the openings constituting the distal irrigation opening group is S61,
When the proximal end of the pipe is pulled and the electrode assembly is most expanded in the radial direction of the pipe, the formation region of the proximal irrigation opening group that is not drawn into the catheter shaft When the total area of the injectable opening in the remaining portion is S621, and the total area of the non-injectable opening in a part of the formation region of the proximal irrigation opening group drawn into the catheter shaft is S622 ,
It is preferable that (S61 + S621) / (S61 + S621 + S622) is 0.7 or less.
 また、この電極カテーテルにおいて、S61/(S621+S622/2)が1.2~2.0であることが好ましい。
 このような構成を有する電極カテーテルによれば、電極組立体が所定の拡張状態(標準状態)にあるときに、当該電極組立体の基端部と先端部との間における灌注量の差を少なくすることができる。
In this electrode catheter, S61 / (S621 + S622 / 2) is preferably 1.2 to 2.0.
According to the electrode catheter having such a configuration, when the electrode assembly is in a predetermined expanded state (standard state), the difference in irrigation amount between the proximal end portion and the distal end portion of the electrode assembly is reduced. can do.
本発明の一実施形態に係る電極カテーテルを示す側面図である。It is a side view which shows the electrode catheter which concerns on one Embodiment of this invention. 図1に示した電極カテーテルの先端部分を示す側面図である。It is a side 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横断面図(III-III断面図)である。FIG. 3 is a transverse sectional view (III-III sectional view) of the electrode catheter shown in FIG. 図1に示した電極カテーテルの横断面図(IV-IV断面図)である。FIG. 4 is a transverse sectional view (IV-IV sectional view) of the electrode catheter shown in FIG. 1. 図2に示した電極カテーテルの電極組立体を構成するスパインの横断面図(V-V断面図)である。FIG. 5 is a cross-sectional view (VV cross-sectional view) of a spine that constitutes the electrode assembly of the electrode catheter shown in FIG. 2. 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2に示した電極カテーテルの電極組立体の先端部を示す斜視図である。It is a perspective view which shows the front-end | tip part of the electrode assembly of the electrode catheter shown in FIG. 電極組立体の先端部を構成するアンカーを示す側面図である。It is a side view which shows the anchor which comprises the front-end | tip part of an electrode assembly. 電極組立体の先端部を構成するアンカーを示す斜視図である。It is a perspective view which shows the anchor which comprises the front-end | tip part of an electrode assembly. 図1に示した電極カテーテルを構成するパイプを示す側面図である。It is a side view which shows the pipe which comprises the electrode catheter shown in FIG. 図10に示したパイプにおける先端側灌注用開口群の形成領域を示す側面図(XIA部拡大図)である。It is a side view (XIA part enlarged view) which shows the formation area of the opening group for front end side irrigation in the pipe shown in FIG. 図10に示したパイプにおける基端側灌注用開口群の形成領域を示す側面図(XIB部拡大図)である。It is a side view (XIB part enlarged view) which shows the formation area of the opening group for proximal end irrigation in the pipe shown in FIG. 図10に示したパイプの正面図(XIC部拡大図)である。It is a front view (XIC part enlarged view) of the pipe shown in FIG. 図1に示した電極カテーテルにおいて、パイプの引張操作に伴う電極組立体の形状変化を示す側面図である。In the electrode catheter shown in FIG. 1, it is a side view which shows the shape change of the electrode assembly accompanying the pipe pulling operation.
  図1~図7に示すこの実施形態の電極カテーテル100は、カテーテルシャフト10と、カテーテルシャフト10の先端に各々の基端が固定され、12個のリング状電極20が各々の外周に装着されている10本のスパイン31が、各々の先端において互いに接合されることによりバスケット状に形成された電極組立体30と、リング状電極20に接続された導線40と、カテーテルシャフト10の基端に接続されたハンドル50と、カテーテルシャフト10の内部においてカテーテルシャフト10の軸方向に移動可能に延在し、カテーテルシャフト10の先端から延び出して電極組立体30の内部に延在し、その先端が電極組立体30の先端部であるアンカー33に固定され、その基端が引張操作可能である円筒状のパイプ60とを備えてなり、
 導線40は、その先端部においてリング状電極20の内周面に接合されることによって当該リング状電極20に接続されているとともに、スパイン31の内部およびカテーテルシャフト10の内部において延在し、
 パイプ60には、液体の流路となる灌注用ルーメン60Lが形成されているとともに、パイプ60の外周には、電極組立体30の先端部であるスパイン31の先端どうしの接合部およびその近傍に灌注するために灌注用ルーメン60Lに至るようパイプ60の管壁に形成された複数の側孔の開口61からなる先端側灌注用開口群61Gと、電極組立体30の基端部であるスパイン31の基端どうしの接合部およびその近傍に灌注するために灌注用ルーメン60Lに至るようパイプ60の管壁に形成された複数の側孔の開口62からなる基端側灌注用開口群62Gとが形成され、
 パイプ60の基端を引張操作することにより、複数のスパイン31の各々が撓んで電極組立体30がパイプ60の半径方向に拡張するとともに、パイプ60における基端側灌注用開口群62Gの形成領域の一部がカテーテルシャフト10の内部に引き込まれ、灌注用ルーメン60Lからの液体が、カテーテルシャフト10の内部に引き込まれていない基端側灌注用開口群62Gの形成領域の残部における開口62および先端側灌注用開口群61Gを構成する開口61から噴射されるように構成されている。
The electrode catheter 100 of this embodiment shown in FIGS. 1 to 7 has a catheter shaft 10, each proximal end fixed to the distal end of the catheter shaft 10, and twelve ring-shaped electrodes 20 attached to each outer periphery. 10 spines 31 are joined to each other at their distal ends, connected to the electrode assembly 30 formed in a basket shape, the conductive wire 40 connected to the ring electrode 20, and the proximal end of the catheter shaft 10. The handle 50 and the catheter shaft 10 extend movably in the axial direction of the catheter shaft 10, extend from the distal end of the catheter shaft 10, and extend into the electrode assembly 30. A cylindrical pipe 60 fixed to an anchor 33 which is a distal end portion of the assembly 30 and having a proximal end capable of being pulled. Ri,
The conducting wire 40 is connected to the ring-shaped electrode 20 by being joined to the inner peripheral surface of the ring-shaped electrode 20 at the distal end thereof, and extends inside the spine 31 and the catheter shaft 10.
The pipe 60 is formed with an irrigation lumen 60 </ b> L that serves as a liquid flow path, and on the outer periphery of the pipe 60, there is a joint between the tips of the spine 31 that is the tip of the electrode assembly 30 and the vicinity thereof. A distal side irrigation opening group 61G formed of a plurality of side hole openings 61 formed in the tube wall of the pipe 60 so as to reach the irrigation lumen 60L for irrigation, and a spine 31 which is a proximal end portion of the electrode assembly 30 A proximal end side irrigation opening group 62G comprising a plurality of side hole openings 62 formed in the pipe wall of the pipe 60 so as to reach the irrigation lumen 60L in order to irrigate the joint portion between the proximal ends thereof and the vicinity thereof. Formed,
By pulling the proximal end of the pipe 60, each of the plurality of spines 31 bends and the electrode assembly 30 expands in the radial direction of the pipe 60, and the formation region of the proximal end side irrigation opening group 62G in the pipe 60 Is partially pulled into the catheter shaft 10 and the liquid from the irrigation lumen 60L is not drawn into the catheter shaft 10, and the opening 62 and the distal end of the remaining region of the proximal irrigation opening group 62G are formed. It is comprised so that it may inject from the opening 61 which comprises the opening group 61G for side irrigation.
 図1において、70は、導線40の各々の基端が接続される複数の端子を内蔵する電極コネクタ、71は、電極コネクタ70に向けてハンドル50から延び出た導線40を内包するシングルルーメン構造の導線保護チューブ、81は、ハンドル50に接続された固定バルブ、82は、固定バルブ81を保持する固定バルブハブ、83は、ハンドル50と固定バルブハブ82とを連結する連結チューブ、85は灌流コネクタ、86は、パイプ60と灌流コネクタ85とを連結し、パイプ60の灌注用ルーメン60Lと連通するルーメン
を有する灌流チューブである。
In FIG. 1, reference numeral 70 denotes an electrode connector incorporating a plurality of terminals to which the respective base ends of the conducting wire 40 are connected, and 71 denotes a single lumen structure including the conducting wire 40 extending from the handle 50 toward the electrode connector 70. 81 is a fixed valve connected to the handle 50, 82 is a fixed valve hub for holding the fixed valve 81, 83 is a connecting tube for connecting the handle 50 and the fixed valve hub 82, 85 is a perfusion connector, 86 is a perfusion tube having a lumen that connects the pipe 60 and the perfusion connector 85 and communicates with the irrigation lumen 60 </ b> L of the pipe 60.
 図4に示すように、電極カテーテル100を構成するカテーテルシャフト10の内部には、中央ルーメン11が形成されているとともに、その周囲において断面が矩形状の10個のサブルーメン13が等角度間隔で形成されている。 As shown in FIG. 4, a central lumen 11 is formed inside a catheter shaft 10 constituting the electrode catheter 100, and ten sub-lumens 13 having a rectangular cross section around it are equiangularly spaced. Is formed.
 カテーテルシャフト10の長さとしては、通常800~1300mmとされ、好適な一例を示せば1100mmである。
 カテーテルシャフト10の外径は、通常2.4~4.0mmとされ、好適な一例を示せば2.8mmとされる。
 カテーテルシャフト10の内径(中央ルーメン11の直径)は、通常0.4~1.0mmとされ、好適な一例を示せば0.7mmとされる。
The length of the catheter shaft 10 is usually 800 to 1300 mm, and is 1100 mm if a suitable example is shown.
The outer diameter of the catheter shaft 10 is usually 2.4 to 4.0 mm, and is 2.8 mm as a suitable example.
The inner diameter of the catheter shaft 10 (the diameter of the central lumen 11) is usually 0.4 to 1.0 mm, and 0.7 mm if a suitable example is shown.
 カテーテルシャフト10の構成材料としては、ポリオレフィン、ポリアミド、ポリエーテルポリアミド、ポリウレタン、ナイロン、ポリエーテルブロックアミド(PEBAX)などの合成樹脂を使用することができ、これらのうち、PEBAXを使用することが好ましい。 As a constituent material of the catheter shaft 10, synthetic resins such as polyolefin, polyamide, polyether polyamide, polyurethane, nylon, polyether block amide (PEBAX) can be used, and among these, it is preferable to use PEBAX. .
 カテーテルシャフト10は、その全長にわたり同じ硬度を有してもよいが、長さ方向に沿って硬度が異なっているものが好ましく、例えば、先端方向に向かって72Dから40Dまで傾斜的に変化(低下)しているものを好適に使用することができる。 The catheter shaft 10 may have the same hardness over its entire length, but preferably has different hardness along the length direction. For example, the catheter shaft 10 changes (decreases) from 72D to 40D in the tip direction. ) Can be preferably used.
 また、カテーテルシャフト10は、編組により補強されたブレードチューブであってもよい。ここに、編組の構成材料としては、埋設されることによって補強効果を発揮できる樹脂を挙げることができ、好適な樹脂としてPEEK樹脂を挙げることができる。 Further, the catheter shaft 10 may be a blade tube reinforced by braiding. Here, as a constituent material of the braid, a resin capable of exhibiting a reinforcing effect by being embedded can be exemplified, and a PEEK resin can be exemplified as a suitable resin.
 カテーテルシャフト10の先端には電極組立体30が接続されている。
 電極カテーテル100を構成する電極組立体30は、10本のスパイン31によりバスケット状に形成されてなる。
 スパイン31の構成材料としては、カテーテルシャフト10の構成材料と同様のものを使用することができ、PEBAXを使用することが好ましい。
An electrode assembly 30 is connected to the distal end of the catheter shaft 10.
The electrode assembly 30 constituting the electrode catheter 100 is formed in a basket shape by ten spines 31.
As the constituent material of the spine 31, the same material as the constituent material of the catheter shaft 10 can be used, and it is preferable to use PEBAX.
 図2および図6に示すように、スパイン31の各々の基端はカテーテルシャフト10の先端に固定されている。
 スパイン31の基端と、カテーテルシャフト10の先端とは、構成樹脂の融着によって固定されており、図3および図6に示すように、両者の融着範囲(例えば、5~15mm)においては、カテーテルシャフト10の中央ルーメン11に融着樹脂が充填されている。カテーテルシャフト10の先端領域を構成する融着樹脂は、カテーテルシャフト10の中央ルーメン11に延在するパイプ60の外周面を液密に覆っており、これにより、カテーテルシャフト10の先端から中央ルーメン11に液体が浸入することを防止することができる。
As shown in FIGS. 2 and 6, each proximal end of the spine 31 is fixed to the distal end of the catheter shaft 10.
The proximal end of the spine 31 and the distal end of the catheter shaft 10 are fixed by fusion of the constituent resins. As shown in FIGS. 3 and 6, in the fusion range of both (for example, 5 to 15 mm), The central lumen 11 of the catheter shaft 10 is filled with a fusion resin. The fusion resin constituting the distal end region of the catheter shaft 10 covers the outer peripheral surface of the pipe 60 extending to the central lumen 11 of the catheter shaft 10 in a liquid-tight manner, whereby the central lumen 11 extends from the distal end of the catheter shaft 10. It is possible to prevent the liquid from entering the glass.
 他方、図2および図7に示すように、スパイン31の各々の先端は、アンカー33に固定されることによって互いに接合されている。
 アンカー33の構成材料としては、ステンレスなどの金属を挙げることができる。
On the other hand, as shown in FIGS. 2 and 7, the tips of the spines 31 are joined to each other by being fixed to the anchor 33.
Examples of the constituent material of the anchor 33 include metals such as stainless steel.
 図5および図6に示すように、スパイン31の内部には、形状記憶合金かならなるコアワイヤ35が延在している。
 コアワイヤ35は、図2に示したようなスパイン31の撓み形状を記憶しており、力を加えることによって容易に変形(例えば直線状に変形)するが、力を取り除くと元の撓み
形状に戻る。コアワイヤ35の構成材料としてはNi-Ti合金を挙げることができる。
   
As shown in FIGS. 5 and 6, a core wire 35 made of a shape memory alloy extends inside the spine 31.
The core wire 35 stores the bending shape of the spine 31 as shown in FIG. 2, and is easily deformed (for example, linearly deformed) by applying a force, but returns to the original bending shape when the force is removed. . An example of the constituent material of the core wire 35 is a Ni—Ti alloy.
 図8および図9に示すように、電極組立体30を構成するアンカー33の外周面には、螺旋状に配置されるようにして10個の孔335が形成されており、この孔335にコアワイヤ35の先端が挿入されることにより、このコアワイヤ35が延在するスパイン31の先端がアンカー33に固定される。 As shown in FIGS. 8 and 9, ten holes 335 are formed on the outer peripheral surface of the anchor 33 constituting the electrode assembly 30 so as to be spirally arranged. By inserting the tip of 35, the tip of the spine 31 from which the core wire 35 extends is fixed to the anchor 33.
 また、図3および図6に示すように、コアワイヤ35の基端は、カテーテルシャフト10の先端部分(例えば、シャフト先端から100mm程度の部分)におけるサブルーメン13に挿入されている。 3 and 6, the proximal end of the core wire 35 is inserted into the sub-lumen 13 at the distal end portion of the catheter shaft 10 (for example, a portion about 100 mm from the distal end of the shaft).
 電極組立体30を構成するスパイン31の各々の外周には、12個のリング状電極20が装着されており、これにより、この電極組立体30の電極数は120となる。
 リング状電極20の構成材料としては、例えば白金、金、銀、アルミニウム、銅、ステンレスなど、電気伝導性の良好な金属を使用することができる。なお、X線に対する造影性を良好なものとする観点からは、白金、金、銀およびこれらを主成分とする合金などが好ましい。
Twelve ring-shaped electrodes 20 are attached to the outer periphery of each of the spines 31 constituting the electrode assembly 30, so that the number of electrodes of the electrode assembly 30 is 120.
As a constituent material of the ring-shaped electrode 20, for example, a metal having good electrical conductivity such as platinum, gold, silver, aluminum, copper, and stainless steel can be used. From the viewpoint of improving the contrast properties for X-rays, platinum, gold, silver, and alloys containing these as main components are preferable.
 リング状電極20の各々には導線40が接続されている。
 図5に示すように、電極カテーテル100を構成する導線40は、その先端部においてリング状電極20の内周面に接合されることによって当該リング状電極20に接続されているとともに、リング状電極20の装着位置に対応してスパイン31の管壁に形成されている側孔315から当該スパイン31の内部に進入して、当該スパイン31の内部を延在する。
A conductive wire 40 is connected to each of the ring electrodes 20.
As shown in FIG. 5, the conductive wire 40 constituting the electrode catheter 100 is connected to the ring-shaped electrode 20 by being joined to the inner peripheral surface of the ring-shaped electrode 20 at the distal end thereof, and the ring-shaped electrode. The spine 31 enters the inside of the spine 31 from the side hole 315 formed in the tube wall of the spine 31 corresponding to the mounting position of the spine 31, and extends inside the spine 31.
 図3および図4、図6に示すように、スパイン31の内部に延在している導線40は、カテーテルシャフト10の内部(中央ルーメン11)に進入し、カテーテルシャフト10の内部に延在する。
 なお、図3に示すように、カテーテルシャフト10の先端部分における導線40は、スパイン31の各々に対応して配置されたポリイミドチューブ37の各々に内包された状態で、カテーテルシャフト10の内部において延在している。
As shown in FIG. 3, FIG. 4, and FIG. 6, the lead wire 40 extending inside the spine 31 enters the inside (central lumen 11) of the catheter shaft 10 and extends inside the catheter shaft 10. .
As shown in FIG. 3, the lead wire 40 at the distal end portion of the catheter shaft 10 extends inside the catheter shaft 10 in a state of being included in each of the polyimide tubes 37 arranged corresponding to each of the spines 31. Exist.
 カテーテルシャフト10の内部に延在している導線40は、カテーテルシャフト10の基端に接続されているハンドル50の内部に進入し、更に、ハンドル50から延び出て、導線保護チューブ71のルーメンを通って、電極コネクタ70の内部に挿入されている。導線40の各々の基端部の各々は、電極コネクタ70に内蔵されている複数の端子の各々に接続されている。この電極コネクタ70を介して、本実施形態の電極カテーテル100は、医療計測機器に接続される。 The conducting wire 40 extending inside the catheter shaft 10 enters the inside of the handle 50 connected to the proximal end of the catheter shaft 10, and further extends out of the handle 50 so as to pass through the lumen of the conducting wire protection tube 71. It passes through and is inserted into the electrode connector 70. Each of the base end portions of the conducting wire 40 is connected to each of a plurality of terminals built in the electrode connector 70. Via this electrode connector 70, the electrode catheter 100 of this embodiment is connected to a medical measurement device.
 電極カテーテル100を構成するパイプ60は、カテーテルシャフト10の内部(中央ルーメン11)において、カテーテルシャフト10の軸方向に移動可能に延在し、カテーテルシャフト10の先端から延び出して電極組立体30の内部に延在している。 The pipe 60 constituting the electrode catheter 100 extends inside the catheter shaft 10 (central lumen 11) so as to be movable in the axial direction of the catheter shaft 10 and extends from the distal end of the catheter shaft 10 to the electrode assembly 30. It extends inside.
 パイプ60の先端は、アンカー33の基端面に形成された孔337に挿入されることにより、電極組立体30の先端部に固定されている。 The distal end of the pipe 60 is fixed to the distal end portion of the electrode assembly 30 by being inserted into a hole 337 formed in the proximal end surface of the anchor 33.
 カテーテルシャフト10の内部に延在しているパイプ60は、カテーテルシャフト10の基端から延び出してハンドル50の内部に進入し、さらに、ハンドル50から延び出して、連結チューブ83および固定バルブハブ82の内部に延在している。パイプ60の基
端は、灌流チューブ86を介して灌流コネクタ85に連結されている。
A pipe 60 extending inside the catheter shaft 10 extends from the proximal end of the catheter shaft 10 to enter the handle 50, and further extends from the handle 50 to connect the connection tube 83 and the fixed valve hub 82. It extends inside. The proximal end of the pipe 60 is connected to the perfusion connector 85 via the perfusion tube 86.
 パイプ60の構成材料としては、Ni-Tiやステンレスなどの金属を挙げることができるが、金属以外の材料(例えば硬質樹脂)であってもよい。
 パイプ60の外径は、通常0.5~1.2mmとされ、好適な一例を示せば0.8mmとされる。
 パイプ60の内径(灌注用ルーメン60Lの径)は、通常0.4~1.0mmとされ、好適な一例を示せば0.7mmとされる。
Examples of the constituent material of the pipe 60 include metals such as Ni—Ti and stainless steel, but materials other than metals (for example, hard resin) may be used.
The outer diameter of the pipe 60 is normally 0.5 to 1.2 mm, and 0.8 mm if a suitable example is shown.
The inner diameter of the pipe 60 (the diameter of the irrigation lumen 60L) is usually 0.4 to 1.0 mm, and 0.7 mm if a suitable example is shown.
 パイプ60の基端は引張操作可能であり、パイプ60は、電極組立体30を拡張させるための引張ワイヤとして作用する。
 パイプ60の基端に連結された灌流コネクタ85を引張操作することにより、パイプ60は、カテーテルシャフト10の内部を基端側に移動する。
The proximal end of the pipe 60 can be pulled, and the pipe 60 acts as a pulling wire for expanding the electrode assembly 30.
By pulling the perfusion connector 85 connected to the proximal end of the pipe 60, the pipe 60 moves to the proximal side inside the catheter shaft 10.
 カテーテルシャフト10に対してパイプ60が基端側に移動することにより、カテーテルシャフト10の先端から延び出ていたパイプ60の一部がカテーテルシャフト10の内部に引き込まれ、これに伴って、パイプ60の先端が固定されている電極組立体30の先端部が基端方向に引っ張られ、スパイン31の各々が撓んで、電極組立体30が拡張する。 When the pipe 60 moves to the proximal end side with respect to the catheter shaft 10, a part of the pipe 60 extending from the distal end of the catheter shaft 10 is drawn into the catheter shaft 10. The distal end portion of the electrode assembly 30 to which the distal end of the electrode assembly 30 is fixed is pulled in the proximal direction, and each of the spines 31 is bent to expand the electrode assembly 30.
 なお、スパイン31の基端と、カテーテルシャフト10の先端との融着部分において、カテーテルシャフト10の中央ルーメン11に充填されて、パイプ60の外周面を液密に覆う融着樹脂は、パイプ60の移動を阻害するものではない。パイプ60は、その外周において融着樹脂と摺動しながら、カテーテルシャフト10の内部を移動することができる。 The fusion resin filled in the central lumen 11 of the catheter shaft 10 and liquid-tightly covering the outer peripheral surface of the pipe 60 at the fusion portion between the proximal end of the spine 31 and the distal end of the catheter shaft 10 is the pipe 60. It does not impede movement. The pipe 60 can move inside the catheter shaft 10 while sliding with the fusion resin on the outer periphery thereof.
 図12は、パイプ60の基端に連結されている灌流コネクタ85を引張操作することにより、電極組立体30の形状が変化する状態を示している。
 同図(1)は、電極組立体30が最も収縮している状態であり、電極カテーテル100をシース内に挿入する際に好適な形状である。
 同図(3)は、引張操作によって電極組立体30が最も拡張している状態であり、心房中隔(左房側)の電位を測定する際に好適な形状である。
 同図(2)は、中間状態(標準状態)であって、このときのスパイン31の撓み形状がコアワイヤ35によって記憶されている。
FIG. 12 shows a state in which the shape of the electrode assembly 30 is changed by pulling the perfusion connector 85 connected to the proximal end of the pipe 60.
FIG. 1A shows a state in which the electrode assembly 30 is most contracted, and is a suitable shape when the electrode catheter 100 is inserted into the sheath.
FIG. 3 (3) shows a state in which the electrode assembly 30 is most expanded by the pulling operation, and is a suitable shape when measuring the potential of the atrial septum (left atrial side).
FIG. 2B is an intermediate state (standard state), and the bending shape of the spine 31 at this time is stored by the core wire 35.
 図10および図11Cに示すように、パイプ60には、液体の流路となる灌注用ルーメン60Lが形成されている。
 また、図10および図11Aに示すように、パイプ60の外周には、スパイン31の先端どうしの接合部およびその近傍(電極組立体30の先端部)に灌注するために複数個形成された側孔の開口61からなる先端側灌注用開口群61Gが形成されている。 また、図10および図11Bに示すように、パイプ60の外周には、スパイン31の基端どうしの接合部およびその近傍(電極組立体30の基端部)に灌注するために複数個形成された側孔の開口62からなる基端側灌注用開口群62Gが形成されている。
As shown in FIGS. 10 and 11C, the pipe 60 is formed with an irrigation lumen 60L serving as a liquid flow path.
Also, as shown in FIGS. 10 and 11A, a plurality of sides are formed on the outer periphery of the pipe 60 so as to irrigate the joint between the tips of the spine 31 and the vicinity thereof (the tip of the electrode assembly 30). A distal-side irrigation opening group 61 </ b> G composed of hole openings 61 is formed. Also, as shown in FIGS. 10 and 11B, a plurality of pipes 60 are formed on the outer periphery of the pipe 60 for irrigation at the joint between the proximal ends of the spine 31 and the vicinity thereof (the proximal end of the electrode assembly 30). A proximal end irrigation opening group 62 </ b> G composed of the side hole openings 62 is formed.
 ここに、開口61および開口62の径としては、例えば0.03~0.1mmとされ、好ましくは0.04~0.06mmである。
 先端側灌注用開口群61Gを構成する開口61の総面積としては、例えば1.5~8mmとされる。
 また、基端側灌注用開口群62Gを構成する開口62の総面積としては、例えば3~20mmとされる。
Here, the diameters of the opening 61 and the opening 62 are, for example, 0.03 to 0.1 mm, and preferably 0.04 to 0.06 mm.
The total area of the openings 61 constituting the distal-side irrigation opening group 61G is, for example, 1.5 to 8 mm 2 .
The total area of the openings 62 constituting the proximal irrigation opening group 62G is, for example, 3 to 20 mm 2 .
 本実施形態の電極カテーテル100においては、パイプ60の基端(灌流コネクタ85)の引張操作によって、パイプ60における基端側灌注用開口群62Gの形成領域の一部がカテーテルシャフト10の内部に引き込まれる。 In the electrode catheter 100 of the present embodiment, a part of the proximal end side irrigation opening group 62 </ b> G in the pipe 60 is drawn into the catheter shaft 10 by pulling the proximal end (perfusion connector 85) of the pipe 60. It is.
 ここに、図12(1)に示したような電極組立体30が最も収縮している状態においては、基端側灌注用開口群62Gの形成領域の全部が、カテーテルシャフト10の先端から延び出ている。
 この場合、基端側灌注用開口群62Gを構成するすべての開口62および先端側灌注用開口群61Gを構成する開口61から液体を噴射させることができる。
Here, in the state where the electrode assembly 30 is most contracted as shown in FIG. 12 (1), the entire formation region of the proximal irrigation opening group 62 G extends from the distal end of the catheter shaft 10. ing.
In this case, liquid can be ejected from all the openings 62 constituting the proximal end side irrigation opening group 62G and the openings 61 constituting the distal end side irrigation opening group 61G.
 一方、図12(3)に示したような電極組立体30が最も拡張している状態においては、基端側灌注用開口群62Gの形成領域の一部(例えば、図11Bにおける基端側領域622A)が、カテーテルシャフト10の内部に引き込まれる。
 既述したように、カテーテルシャフト10の中央ルーメン11に延在するパイプ60の外周面は、カテーテルシャフト10の先端領域を構成する融着樹脂により液密に覆われており、カテーテルシャフト10の内部に引き込まれた基端側灌注用開口群62Gの形成領域の一部(基端側領域622A)における開口62は融着樹脂に塞がれて液体を噴射することができなくなる。
 この場合、基端側灌注用開口群62Gの形成領域の残部(図11Bにおける先端側領域621A)における開口62および先端側灌注用開口群61Gを構成する開口61から液体が噴射される。
On the other hand, in the state in which the electrode assembly 30 is most expanded as shown in FIG. 12 (3), a part of the formation region of the proximal irrigation opening group 62G (for example, the proximal region in FIG. 11B). 622A) is retracted into the catheter shaft 10.
As described above, the outer peripheral surface of the pipe 60 extending to the central lumen 11 of the catheter shaft 10 is liquid-tightly covered with the fusion resin constituting the distal end region of the catheter shaft 10. The opening 62 in a part of the formation region of the proximal-side irrigation opening group 62G (the proximal-side region 622A) that is drawn into is blocked by the fusion resin, and the liquid cannot be ejected.
In this case, the liquid is ejected from the opening 62 in the remaining part of the formation region of the proximal end side irrigation opening group 62G (the distal side region 621A in FIG. 11B) and the opening 61 constituting the distal side irrigation opening group 61G.
 また、図12(2)に示したような中間状態(標準状態)においては、基端側灌注用開口群62Gの形成領域の一部(例えば、図11Bにおける基端側領域622Aの基端側略半分の領域)が、カテーテルシャフト10の内部に引き込まれて、当該基端側領域622Aにおける略半数の開口62は、カテーテルシャフト10の先端領域を構成する融着樹脂に塞がれて液体を噴射することができなくなる。
 この場合、基端側灌注用開口群62Gの形成領域の残部(図11Bにおける先端側領域621Aおよび基端側領域622Aの先端側略半分の領域)における開口62並びに先端側灌注用開口群61Gを構成する開口61から液体が噴射される。
Further, in the intermediate state (standard state) as shown in FIG. 12B, a part of the formation region of the proximal end irrigation opening group 62G (for example, the proximal end side of the proximal end region 622A in FIG. 11B). About half of the region) is drawn into the catheter shaft 10, and approximately half of the openings 62 in the proximal region 622 </ b> A are blocked by the fusion resin that forms the distal region of the catheter shaft 10, thereby allowing liquid to flow. It becomes impossible to inject.
In this case, the opening 62 and the distal-side irrigation opening group 61G in the remaining part of the formation region of the proximal-side irrigation opening group 62G (the distal-side region 621A and the proximal-side region 622A in FIG. 11B). A liquid is ejected from the opening 61 which comprises.
 図11Bに示す先端側領域621Aにおける開口62の総面積をS621とし、基端側領域622Aにおける開口62の総面積をS622とし、図11Aに示す先端側灌注用開口群61Gを構成する開口61の総面積をS61とするとき、図12(1)に示したような電極組立体30が最も収縮している状態における噴射可能な開口61および62の総面積は、S61+S621+S622であり、図12(3)に示したような電極組立体30が最も拡張している状態における噴射可能な開口61および62の総面積は、S61+S621であり、電極組立体30の拡張に伴って噴射可能な開口61および62の総面積が減少し、これに伴い噴射圧力が上昇する。
 これにより、パイプ60(基端側灌注用開口群62Gおよび先端側灌注用開口群61G)から遠ざかったスパイン31の基端近傍および先端近傍に対しても当該液体を灌注することが可能になる。
The total area of the openings 62 in the distal end region 621A shown in FIG. 11B is S621, the total area of the openings 62 in the proximal region 622A is S622, and the openings 61 constituting the distal irrigation opening group 61G shown in FIG. When the total area is S61, the total area of the injectable openings 61 and 62 in the state where the electrode assembly 30 is most contracted as shown in FIG. 12A is S61 + S621 + S622, and FIG. The total area of the injectable openings 61 and 62 in the state in which the electrode assembly 30 is most expanded as shown in FIG. 3 is S61 + S621, and the injectable openings 61 and 62 are able to be injected as the electrode assembly 30 is expanded. The total area of the fuel is reduced, and the injection pressure increases accordingly.
This makes it possible to irrigate the liquid near the proximal end and the distal end of the spine 31 away from the pipe 60 (the proximal end irrigation opening group 62G and the distal irrigation opening group 61G).
 ここに、電極組立体30が最も拡張している状態〔図12(3)に示したような状態〕における噴射可能な開口61および62の総面積(S61+S621)と、電極組立体30が最も収縮している状態〔図12(1)に示したような状態〕における噴射可能な開口61および62の総面積(S61+S621+S622)との比〔(S61+S621)/(S61+S621+S622)〕としては、0.7以下であることが好ましい。 Here, the total area (S61 + S621) of the injectable openings 61 and 62 in the state in which the electrode assembly 30 is most expanded [the state shown in FIG. 12 (3)], and the electrode assembly 30 is most contracted. The ratio [(S61 + S621) / (S61 + S621 + S622)] to the total area (S61 + S621 + S622) of the injectable openings 61 and 62 in the state [the state shown in FIG. 12 (1)] is 0.7 or less It is preferable that
 この比〔(S61+S621)/(S61+S621+S622)〕が0.7以下であることにより、電極組立体30の拡張に伴う開口61および62からの噴射圧力の上昇率をある程度高くすることができるので、電極組立体30を拡張させて、その基端部および先端部がパイプ60(基端側灌注用開口群62Gおよび先端側灌注用開口群61G)から遠ざかった場合であっても、電極組立体30の基端部および先端部に対して液体を十分に灌注することができる。 Since the ratio [(S61 + S621) / (S61 + S621 + S622)] is 0.7 or less, the rate of increase of the injection pressure from the openings 61 and 62 accompanying the expansion of the electrode assembly 30 can be increased to some extent. Even when the assembly 30 is expanded and the proximal end portion and the distal end portion thereof are moved away from the pipe 60 (the proximal end side irrigation opening group 62G and the distal end side irrigation opening group 61G), the electrode assembly 30 The liquid can be sufficiently irrigated to the proximal end portion and the distal end portion.
 また、比〔S61/(S621+S622/2)〕が1.2~2.0であることが好ましい。
 ここに、(S621+S622/2)は、図12(2)に示したような中間状態(標準状態)にあるときの噴射可能な開口62の総面積に略等しく、比〔S61/(S621+S622/2)〕を1.2~2.0とすることにより、中間状態(標準状態)にあるときに、電極組立体30の基端部と先端部との間における灌注量の差を小さくすることができる。
The ratio [S61 / (S621 + S622 / 2)] is preferably 1.2 to 2.0.
Here, (S621 + S622 / 2) is substantially equal to the total area of the injectable opening 62 in the intermediate state (standard state) as shown in FIG. 12 (2), and the ratio [S61 / (S621 + S622 / 2). )] Is set to 1.2 to 2.0 to reduce the difference in irrigation amount between the proximal end portion and the distal end portion of the electrode assembly 30 when in the intermediate state (standard state). it can.
 この比〔S61/(S621+S622/2)〕が1.2未満である場合には、電極組立体30の先端部に対する灌注量が、基端部に対する灌注量と比較して過少となる。
 他方、この比が2.0を超える場合には、電極組立体30の基端部に対する灌注量が、先端部に対する灌注量と比較して過少となる。
When this ratio [S61 / (S621 + S622 / 2)] is less than 1.2, the irrigation amount with respect to the distal end portion of the electrode assembly 30 is too small as compared with the irrigation amount with respect to the proximal end portion.
On the other hand, when this ratio exceeds 2.0, the irrigation amount with respect to the proximal end portion of the electrode assembly 30 is too small compared with the irrigation amount with respect to the distal end portion.
 本実施形態の電極カテーテル100によれば、パイプ60の灌注用ルーメン60Lに供給される液体を、電極組立体30の内部に延在するパイプ60の外周に形成された先端側灌注用開口群61Gを構成する開口61から、スパイン31の先端どうしの接合部およびその近傍に向けてパイプ60の半径方向に噴射することができるので、電極組立体30の先端部に対して当該液体を十分に灌注することができる。 According to the electrode catheter 100 of the present embodiment, the liquid supplied to the irrigation lumen 60L of the pipe 60 causes the distal-side irrigation opening group 61G formed on the outer periphery of the pipe 60 extending inside the electrode assembly 30. Can be sprayed in the radial direction of the pipe 60 toward the joint portion between the tips of the spine 31 and the vicinity thereof, so that the liquid is sufficiently irrigated with respect to the tip portion of the electrode assembly 30. can do.
 また、パイプ60の灌注用ルーメン60Lに供給される液体を、電極組立体30の内部に延在するパイプ60の外周に形成された基端側灌注用開口群62Gを構成する開口62から、スパイン31の基端どうしの接合部およびその近傍に向けてパイプ60の半径方向に噴射することができるので、電極組立体30の基端部に対しても当該液体を十分に灌注することができる。 In addition, the liquid supplied to the irrigation lumen 60L of the pipe 60 is supplied from the opening 62 constituting the proximal irrigation opening group 62G formed on the outer periphery of the pipe 60 extending inside the electrode assembly 30 to the spine. Since the pipe 60 can be sprayed in the radial direction toward the joint portion between the proximal ends of 31 and the vicinity thereof, the liquid can be sufficiently irrigated also to the proximal end portion of the electrode assembly 30.
 また、パイプ60の基端(灌流コネクタ85)を引張操作することによって、パイプ60の半径方向に電極組立体30が拡張して、電極組立体30を構成するスパイン31の基端近傍および先端近傍がパイプ60から遠ざかったときには、パイプ60における基端側灌注用開口群62Gの形成領域の一部がカテーテルシャフト10の内部に引き込まれ、引き込まれていない領域(基端側灌注用開口群62Gの形成領域の残部)における開口62および先端側灌注用開口群61Gを構成する開口61からの液体の噴射圧力が上昇するので、パイプ60(基端側灌注用開口群62Gおよび先端側灌注用開口群61G)から遠ざかったスパイン31の基端近傍および先端近傍に対しても当該液体を灌注することが可能になる。 Further, by pulling the proximal end (perfusion connector 85) of the pipe 60, the electrode assembly 30 expands in the radial direction of the pipe 60, and the vicinity of the proximal end and the distal end of the spine 31 constituting the electrode assembly 30. Is moved away from the pipe 60, a part of the formation region of the proximal end side irrigation opening group 62 </ b> G in the pipe 60 is drawn into the catheter shaft 10, and a region that is not retracted (the proximal end irrigation opening group 62 </ b> G of the proximal end side irrigation opening group 62 </ b> G). Since the ejection pressure of the liquid from the opening 62 constituting the opening 62 and the distal irrigation opening group 61G in the remaining portion of the formation region increases, the pipe 60 (the proximal irrigation opening group 62G and the distal irrigation opening group) 61G), it is possible to irrigate the liquid also in the vicinity of the proximal end and the vicinity of the distal end of the spine 31 that is far from 61G).
 このように、本実施形態の電極カテーテル100では、電極組立体30の拡張に伴って、基端側灌注用開口群62Gを構成する開口62および先端側灌注用開口群61Gを構成する開口61からの液体の噴射圧力がそれぞれ上昇するので、電極組立体30を拡張させたときであっても、電極組立体30の端部(基端部および先端部)に対して液体を十分に灌注することができる。 As described above, in the electrode catheter 100 of the present embodiment, as the electrode assembly 30 is expanded, from the opening 62 constituting the proximal end side irrigation opening group 62G and the opening 61 constituting the distal end side irrigation opening group 61G. Therefore, even when the electrode assembly 30 is expanded, the liquid is sufficiently irrigated with respect to the end portions (the base end portion and the front end portion) of the electrode assembly 30. Can do.
 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、上記の実施形態では、図12(1)に示したような電極組立体30が最も収縮している状態では、先端側領域621Aおよび基端側領域622Aが、カテーテルシャフト10の先端から延び出ており、図12(2)に示したような中間状態では、基端側領域622Aの基端側略半分の領域がカテーテルシャフト10の内部に引き込まれ、図12(3)に示したような電極組立体30が最も拡張している状態では、基端側領域622Aがカテーテルシャフト10の内部に引き込まれたが、図12(2)に示したような中間状態において、先端側領域621Aおよび基端側領域622Aが、カテーテルシャフト10の先端から延び出ており、図12(3)に示したような最も拡張している状態において、基端側領域622Aの全域または一部の領域がカテーテルシャフト10の内部に引き込まれるよう構成されていてもよい。
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, in the above embodiment, when the electrode assembly 30 is most contracted as shown in FIG. 12A, the distal end side region 621A and the proximal end region 622A extend from the distal end of the catheter shaft 10. In the intermediate state as shown in FIG. 12 (2), a substantially half region of the proximal side region 622A is drawn into the catheter shaft 10, and as shown in FIG. 12 (3). In the state where the electrode assembly 30 is most expanded, the proximal region 622A is drawn into the catheter shaft 10, but in the intermediate state as shown in FIG. 12 (2), the distal region 621A and The proximal end region 622A extends from the distal end of the catheter shaft 10, and in the most expanded state as shown in FIG. 12 (3), the entire proximal end region 622A or Area parts may be configured to be drawn into the catheter shaft 10.
 100 電極カテーテル
  10 カテーテルシャフト
  11 中央ルーメン
  13 サブルーメン
  20 リング状電極
  30 電極組立体
  31 スパイン
  315 側孔
  33 アンカー
  335 孔
  337 孔
  37 ポリイミドチューブ
  40 導線
  50 ハンドル
  60 パイプ
  60L 灌注用ルーメン
  61G 先端側灌注用開口群
  61  開口
  62G 基端側灌注用開口群
  62  開口
  621A 先端側領域
  622A 基端側領域
  70 電極コネクタ
  71 導線保護チューブ
  81 固定バルブ
  82 固定バルブハブ
  83 連結チューブ
  85 灌流コネクタ
  86 灌流チューブ
DESCRIPTION OF SYMBOLS 100 Electrode catheter 10 Catheter shaft 11 Center lumen 13 Sublumen 20 Ring-shaped electrode 30 Electrode assembly 31 Spine 315 Side hole 33 Anchor 335 Hole 337 Hole 37 Polyimide tube 40 Conductor 50 Handle 60 Pipe 60L Irrigation lumen 61G Tip side irrigation opening Group 61 opening 62G proximal end irrigation opening group 62 opening 621A distal end side region 622A proximal end side region 70 electrode connector 71 conductor protection tube 81 fixed valve 82 fixed valve hub 83 connecting tube 85 perfusion connector 86 perfusion tube

Claims (4)

  1.  カテーテルシャフトと、
     前記カテーテルシャフトの先端に各々の基端が固定され、少なくとも1個のリング状電極が各々の外周に装着されている複数のスパインが、各々の先端において互いに接合されることによりバスケット状に形成された電極組立体と、
     前記リング状電極に接続された導線と、
     前記カテーテルシャフトの基端に接続されたハンドルと、
     前記カテーテルシャフトの内部において前記カテーテルシャフトの軸方向に移動可能に延在し、前記カテーテルシャフトの先端から延び出して前記電極組立体の内部に延在し、その先端が前記電極組立体の先端部に固定され、その基端が引張操作可能である円筒状のパイプとを備えてなり、
     前記導線は、その先端部において前記リング状電極の内周面に接合されることによって当該リング状電極に接続されているとともに、前記スパインの内部および前記カテーテルシャフトの内部において延在し、
     前記パイプには、液体の流路となる灌注用ルーメンが形成されているとともに、前記パイプの外周には、前記電極組立体の先端部である前記複数のスパインの先端どうしの接合部およびその近傍に灌注するために前記灌注用ルーメンに至るよう前記パイプの管壁に形成された複数の側孔の開口からなる先端側灌注用開口群と、前記電極組立体の基端部である前記複数のスパインの基端どうしの接合部およびその近傍に灌注するために前記灌注用ルーメンに至るよう前記パイプの管壁に形成された複数の側孔の開口からなる基端側灌注用開口群とが形成され、
     前記パイプの基端を引張操作することにより、前記複数のスパインの各々が撓んで前記電極組立体が前記パイプの半径方向に拡張するとともに、前記パイプにおける前記基端側灌注用開口群の形成領域の一部が前記カテーテルシャフトの内部に引き込まれ、前記灌注用ルーメンからの液体が、前記カテーテルシャフトの内部に引き込まれていない前記形成領域の残部における基端側灌注用開口群を構成する開口および前記先端側灌注用開口群を構成する開口から噴射されることを特徴とする電極カテーテル。
    A catheter shaft;
    A plurality of spines each having a proximal end fixed to the distal end of the catheter shaft and having at least one ring electrode mounted on the outer periphery thereof are joined to each other at the distal end to form a basket shape. An electrode assembly;
    A conducting wire connected to the ring-shaped electrode;
    A handle connected to the proximal end of the catheter shaft;
    The catheter shaft extends movably in the axial direction of the catheter shaft, extends from the distal end of the catheter shaft and extends into the electrode assembly, and the distal end of the distal end of the electrode assembly And a cylindrical pipe whose proximal end is capable of pulling operation,
    The conductive wire is connected to the ring-shaped electrode by being joined to the inner peripheral surface of the ring-shaped electrode at the tip thereof, and extends inside the spine and the catheter shaft,
    In the pipe, an irrigation lumen serving as a liquid flow path is formed, and on the outer periphery of the pipe, there are joints between the tips of the plurality of spines, which are the tips of the electrode assembly, and the vicinity thereof. A distal end side irrigation opening group consisting of openings of a plurality of side holes formed in a pipe wall of the pipe so as to reach the irrigation lumen, and the plurality of the plurality of base electrode end portions. A proximal-side irrigation opening group consisting of a plurality of side-hole openings formed in the pipe wall of the pipe so as to reach the irrigation lumen in order to irrigate the joint between the proximal ends of the spine and the vicinity thereof And
    By pulling the proximal end of the pipe, each of the plurality of spines is bent to expand the electrode assembly in the radial direction of the pipe, and the formation region of the proximal-side irrigation opening group in the pipe A portion of the irrigation lumen is drawn into the interior of the catheter shaft, and the liquid constituting the irrigation lumen forms a proximal irrigation opening group in the remaining portion of the formation region that is not drawn into the catheter shaft. An electrode catheter sprayed from an opening constituting the distal irrigation opening group.
  2.  前記パイプの外周面は、前記カテーテルシャフトの少なくとも先端領域における内壁により液密に覆われていることを特徴とする請求項1に記載の電極カテーテル。 2. The electrode catheter according to claim 1, wherein an outer peripheral surface of the pipe is liquid-tightly covered with an inner wall in at least a distal end region of the catheter shaft.
  3.  前記先端側灌注用開口群を構成する開口の総面積をS61とし、
     前記パイプの基端を引張操作して前記電極組立体が前記パイプの半径方向に最も拡張しているときに、前記カテーテルシャフトの内部に引き込まれていない前記基端側灌注用開口群の形成領域の残部における噴射可能な開口の総面積をS621とし、前記カテーテルシャフトの内部に引き込まれた前記基端側灌注用開口群の形成領域の一部における噴射不能な開口の総面積をS622とするとき、
     (S61+S621)/(S61+S621+S622)が0.7以下であることを特徴とする請求項1または2に記載の電極カテーテル。
    The total area of the openings constituting the distal irrigation opening group is S61,
    When the proximal end of the pipe is pulled and the electrode assembly is most expanded in the radial direction of the pipe, the formation region of the proximal irrigation opening group that is not drawn into the catheter shaft When the total area of the injectable opening in the remaining portion is S621, and the total area of the non-injectable opening in a part of the formation region of the proximal irrigation opening group drawn into the catheter shaft is S622 ,
    The electrode catheter according to claim 1 or 2, wherein (S61 + S621) / (S61 + S621 + S622) is 0.7 or less.
  4.  S61/(S621+S622/2)が1.2~2.0であることを特徴とする請求項3に記載の電極カテーテル。 The electrode catheter according to claim 3, wherein S61 / (S621 + S622 / 2) is 1.2 to 2.0.
PCT/JP2017/017735 2016-07-06 2017-05-10 Electrode catheter WO2018008250A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016-133910 2016-07-06
JP2016133910A JP6512611B2 (en) 2016-07-06 2016-07-06 Electrode catheter

Publications (1)

Publication Number Publication Date
WO2018008250A1 true WO2018008250A1 (en) 2018-01-11

Family

ID=60912057

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2017/017735 WO2018008250A1 (en) 2016-07-06 2017-05-10 Electrode catheter

Country Status (2)

Country Link
JP (1) JP6512611B2 (en)
WO (1) WO2018008250A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023199062A1 (en) * 2022-04-14 2023-10-19 Imperial College Innovations Limited Multi-electrode catheters

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013081526A (en) * 2011-10-06 2013-05-09 Hirakawa Hewtech Corp Electrode catheter
JP2013192948A (en) * 2012-03-21 2013-09-30 Biosense Webster (Israel) Ltd Flower catheter for mapping and ablating venous and other tubular locations

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013081526A (en) * 2011-10-06 2013-05-09 Hirakawa Hewtech Corp Electrode catheter
JP2013192948A (en) * 2012-03-21 2013-09-30 Biosense Webster (Israel) Ltd Flower catheter for mapping and ablating venous and other tubular locations

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023199062A1 (en) * 2022-04-14 2023-10-19 Imperial College Innovations Limited Multi-electrode catheters

Also Published As

Publication number Publication date
JP2018000713A (en) 2018-01-11
JP6512611B2 (en) 2019-05-15

Similar Documents

Publication Publication Date Title
US6210407B1 (en) Bi-directional electrode catheter
US6120476A (en) Irrigated tip catheter
US20120271232A1 (en) Catheter
JPH10503694A (en) Reinforced monorail balloon catheter
JP5164283B2 (en) Balloon catheter
JP2006334399A (en) Steerable catheter equipped with distal tip orientation sheath
JP6282209B2 (en) Chemical ablation device and chemical ablation system
US11628009B2 (en) EP catheter with trained support member, and related methods
JP5631475B1 (en) Balloon catheter
KR20130132531A (en) Electrode catheter
JP2007503920A (en) Device for providing deflectable medical therapy having a common lumen profile
US11717648B2 (en) Puller wire t-bar for medical catheter
US20180256861A1 (en) Guidewires with Variable Rigidity
US20110319922A1 (en) Balloon catheter
WO2018008250A1 (en) Electrode catheter
WO2017056623A1 (en) Balloon catether and chemical ablation device
JP5618421B2 (en) Balloon catheter
JP5579681B2 (en) Electrode catheter
EP2896424A1 (en) Multi-lumen catheters for small body vessel applications
JP5729778B2 (en) Electrode catheter

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 17823858

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 17823858

Country of ref document: EP

Kind code of ref document: A1