WO2020035918A1 - Balloon-type electrode catheter - Google Patents

Balloon-type electrode catheter Download PDF

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Publication number
WO2020035918A1
WO2020035918A1 PCT/JP2018/030365 JP2018030365W WO2020035918A1 WO 2020035918 A1 WO2020035918 A1 WO 2020035918A1 JP 2018030365 W JP2018030365 W JP 2018030365W WO 2020035918 A1 WO2020035918 A1 WO 2020035918A1
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WO
WIPO (PCT)
Prior art keywords
balloon
outer tube
lumen
type electrode
fluid
Prior art date
Application number
PCT/JP2018/030365
Other languages
French (fr)
Japanese (ja)
Inventor
謙二 森
Original Assignee
日本ライフライン株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 日本ライフライン株式会社 filed Critical 日本ライフライン株式会社
Priority to PCT/JP2018/030365 priority Critical patent/WO2020035918A1/en
Priority to JP2020537324A priority patent/JP6894582B2/en
Priority to TW108112794A priority patent/TWI703955B/en
Publication of WO2020035918A1 publication Critical patent/WO2020035918A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor

Definitions

  • the present invention relates to a balloon-type electrode catheter, and more particularly, to a balloon-type electrode catheter which is introduced transvascularly and is used for high-frequency ablation treatment of a vessel or its surrounding tissue.
  • an outer tube catheter shaft
  • a balloon connected to the distal end of the outer tube and an outer tube
  • the inner tube inserted into the lumen of the balloon and the lumen
  • the lumen tube supply lumen
  • the lumen tube inserted through the lumen of the outer tube to supply fluid to the interior of the balloon
  • the interior of the balloon That includes a lumen tube (return lumen) inserted into the lumen of the outer tube to discharge the fluid supplied to the outer tube, and a surface electrode (high-frequency electrode) provided on the outer surface of the balloon.
  • the balloon constituting the balloon-type electrode catheter described in Patent Literature 1 has an expanding portion that expands and contracts and neck portions formed at both ends thereof, and a proximal neck portion is fixed to the outer tube.
  • the distal neck portion is fixed to the inner tube (guide wire lumen).
  • high-frequency current is applied to a surface electrode provided on the outer surface of the balloon to perform high-frequency ablation treatment on a vascular vessel or a lesion tissue around the vessel. It can be carried out. Further, by circulating the fluid supplied from the lumen tube (supply lumen) into the balloon and discharging the fluid from the lumen tube (return lumen), the interior of the balloon can be cooled.
  • a high-frequency current is applied to a surface electrode formed on the outer surface of the balloon.
  • the present inventors have proposed a form of electrical connection by a conductive wire (see Patent Document 2 below).
  • JP-T-2013-532564A JP 2016-185296 A (in particular, FIG. 4)
  • a metal ring is mounted on the neck portion (proximal neck portion) of a balloon fixed to an outer tube (catheter shaft) as described in Patent Literature 2, and power is supplied through the metal ring. Can be considered.
  • an inner tube (a guide wire lumen) through which a guide wire is inserted and a cooling fluid through which a cooling fluid flows are provided in the lumen of the outer tube constituting the balloon-type electrode catheter described in Patent Document 1. Due to the inclusion of the lumen tube (supply lumen and return lumen), its outer diameter is quite large.
  • the outer diameter of the metal ring is determined by an electrode catheter.
  • the outer diameter (shaft diameter or wrapping diameter) that is limited by the sheath or endoscope used when introducing the catheter is greatly exceeded. The metal ring is caught, and it becomes impossible to insert a balloon-type electrode catheter into these lumens.
  • An object of the present invention is to allow transvascular introduction without impairing the penetrability of a sheath or an endoscope used in a lumen, and extensive cauterization of a vascular tissue or a surrounding lesion tissue.
  • An object of the present invention is to provide a balloon-type electrode catheter capable of performing treatment. It is another object of the present invention to provide a balloon-type electrode catheter capable of performing uniform cautery treatment on a vessel or a tissue around the vessel along the circumferential direction of the vessel. Still another object of the present invention is to provide a balloon-type electrode catheter which is excellent in the cooling effect of the inside of the balloon, and further, the cooling effect of the tissue around the surface electrode.
  • the balloon-type electrode catheter of the present invention is a balloon-type electrode catheter that is introduced transvascularly and performs high-frequency ablation treatment of a vessel or surrounding tissue, An outer tube having a central lumen and a plurality of sub-lumens disposed therearound, A current-carrying connector arranged on the proximal end side of the outer tube, An expansion portion that expands and contracts, and a neck connected to the distal end of the outer tube, having a continuous neck at both ends thereof, and having a proximal neck fixed to the distal end of the outer tube.
  • An inner tube having a lumen through which a guide wire can be inserted, being inserted into the central lumen of the outer tube, extending from the opening of the central lumen into the balloon, and extending inside the balloon,
  • a distal tip having a lumen communicating with the lumen of the inner tube, connected to a distal end of the inner tube inside the balloon, and fixed to a distal neck portion and extending outside the balloon;
  • a surface electrode made of a metal thin film formed on the outer surface of the balloon in the expanded portion and the distal neck portion, A metal ring electrically connected to the surface electrode by being mounted on the distal end neck of the balloon so that the inner peripheral surface thereof is in contact with the front end of the surface electrode,
  • the distal end is fixed to the inner peripheral surface of the metal ring, extends to the sublumen of the inside of the balloon and any of the outer tube, the base end is fixed to the connector for electricity,
  • a conducting wire for electrically connecting the surface electrode and the current-carrying connector.
  • the surface electrode formed on the outer surface of the balloon can be electrically connected to the current-carrying connector via the metal ring and the conducting wire.
  • High-frequency current can be reliably supplied. This makes it possible to perform ablation treatment over a wide range of the vascular tissue or the surrounding lesion tissue.
  • the distal neck portion of the balloon to which the metal ring is attached is a neck portion fixed to the distal tip, and has a significantly smaller outer diameter than the proximal neck portion fixed to the outer tube.
  • the outer diameter of the metal ring attached to the distal neck can be smaller than the outer diameter of the outer tube or the proximal neck.
  • the surface electrodes are formed so as to extend along the axial direction of the balloon, and are arranged in a plurality of strips arranged at equal angular intervals along the circumferential direction of the balloon. It is an electrode, and it is preferable that the inner peripheral surface of the metal ring is in contact with the tip of each of the strip electrodes.
  • each of the plurality of strip-shaped electrodes formed at equal angular intervals along the circumferential direction of the balloon is electrically connected to the current-carrying connector via the metal ring and the conductive wire.
  • High-frequency current can be uniformly applied to each of the plurality of band-shaped electrodes, and thereby, the vessel or the surrounding tissue can be passed along the circumferential direction of the vessel.
  • a homogeneous cautery treatment can be performed.
  • the metal ring is coated with an insulating material.
  • the balloon-type electrode catheter having such a configuration, it is possible to prevent the metal ring from becoming hot when energized, and to avoid cauterizing normal tissue around the metal ring.
  • At least one of the sub-lumens included in the outer tube is a fluid-supplying sub-lumen that circulates the fluid in order to supply a fluid to the inside of the balloon, It is preferable that at least one of the sub-lumens of the outer tube is a fluid discharge sub-lumen that allows the fluid to flow in order to discharge the fluid supplied to the inside of the balloon from the inside of the balloon.
  • the distal end portion of the outer tube fixed to the proximal end neck portion of the balloon is included in the expanded portion of the balloon.
  • the opening of the fluid supply sub-lumen is located more distally than the axially intermediate position of the expansion portion,
  • the opening of the fluid discharge sublumen is preferably located at or near the base end of the extension.
  • the fluid supply port to the inside of the balloon and the fluid discharge port from the inside of the balloon are axially displaced from each other. Even after the fluid is filled, the fluid flows from the distal end to the proximal end, and the fluid can flow inside the balloon. Thus, the tissue around the surface electrode can be sufficiently cooled.
  • the number of the sub-lumens for supplying fluid is larger than the number of sub-lumens for discharging fluid.
  • the inside of the balloon can be maintained at a constant pressure (expansion pressure).
  • the outer diameter of the distal end of the outer tube to which the proximal neck of the balloon is fixed is larger than the outer diameter of the proximal end of the outer tube. It is formed small, It is preferable that an outer diameter of the proximal neck portion of the balloon is substantially equal to an outer diameter of the proximal end portion of the outer tube.
  • the outer diameter of the proximal neck portion having the maximum outer diameter is substantially equal to the outer diameter of the proximal end portion of the outer tube.
  • the portion does not hinder the penetration of the sheath or endoscope into the lumen.
  • the outer diameter of the outer tube can be the maximum diameter limited by the sheath or the endoscope, it is necessary to sufficiently secure the diameter of the fluid supply sub-lumen and the fluid discharge sub-lumen of the outer tube.
  • the cooling effect inside the balloon can be further improved.
  • a temperature sensor is disposed on a tube wall of the balloon.
  • the balloon-type electrode catheter of this invention can introduce
  • a wide range of cautery treatments can be performed.
  • the balloon-type electrode catheter of the present invention provided with a surface electrode composed of a plurality of band-shaped electrodes, it is possible to perform a uniform cauterization treatment on a vessel or a tissue around the vessel along the circumferential direction of the vessel. it can.
  • the balloon further includes an outer tube having a fluid supply sub-lumen that opens on the distal side from the axial middle position of the balloon expansion portion, and a fluid discharge sub-lumen that opens at or near the proximal end of the balloon expansion portion.
  • FIG. 2 is a partially broken front view (a front view including a II-II cross section of FIG. 1) of the balloon-type electrode catheter shown in FIG. 1.
  • FIG. 2 is a perspective view showing a distal end portion of the balloon-type electrode catheter shown in FIG. 1.
  • FIG. 2 is a perspective view showing a distal end portion (the distal end side of the balloon) of the balloon-type electrode catheter shown in FIG. 1.
  • FIG. 2 is a perspective view showing a distal end portion (a proximal end side of the balloon) of the balloon-type electrode catheter shown in FIG. 1.
  • FIG. 3 is a partially enlarged view (a detailed view of a VI section) of FIG. 2.
  • FIG. 2 is a partially broken front view (a front view including a II-II cross section of FIG. 1) of the balloon-type electrode catheter shown in FIG. 1.
  • FIG. 2 is a perspective view showing a distal end portion of the balloon-type electrode catheter shown in FIG. 1.
  • FIG. 2 is a perspective view
  • FIG. 7 is a partially enlarged view (a detailed view of a VII section) of FIG. 6. It is the elements on larger scale of FIG. 2 (VIII section detailed drawing). It is IX-IX sectional drawing of FIG. It is the elements on larger scale of FIG. 9 (X part detailed view).
  • FIG. 2 is a sectional view taken along the line XI-XI in FIG. 1.
  • FIG. 2 is a sectional view taken along line XII-XII of FIG. 1.
  • FIG. 13 is a partially enlarged view (a detailed view of an XIII portion) of FIG. 12.
  • FIG. 4 is a sectional view taken along line XIV-XIV of FIG. 1. It is XV-XV sectional drawing of FIG. It is the elements on larger scale of FIG.
  • FIG. 7 is a sectional view taken along line XVII-XVII of FIG. 1. It is the elements on larger scale of FIG. 17 (XVIII part detailed view). It is XIX-XIX sectional drawing of FIG. FIG. 20 is a partially enlarged view (XX section detailed view) of FIG. 19.
  • FIG. 2 is a sectional view taken along line XXI-XXI of FIG. 1. It is the elements on larger scale of FIG. 21 (XXII part detailed figure).
  • FIG. 3 is a sectional view taken along line XXIII-XXIII of FIG. 1.
  • FIG. 4 is a sectional view taken along line XXIV-XXIV of FIG. 1.
  • the balloon-type electrode catheter 100 of this embodiment is a balloon-type electrode catheter that is introduced transvascularly and treats a lesion tissue such as a tumor in or around a vessel by high-frequency ablation.
  • the balloon-type electrode catheter 100 shown in FIGS. 1 to 24 is composed of a circular tubular portion 11 and a semicircular tubular portion 13, and has an outer tube having a central lumen 10L and sublumens 101L to 112L disposed therearound.
  • the metal ring 6 electrically connected to each of the strip electrodes 51 to 54 is provided.
  • the distal end is connected to the inner peripheral surface of the metal ring 60, the inner peripheral surface of the metallic ring 60 extends to the inside of the balloon 30 and the sublumen 112 ⁇ / b> L of the outer tube 10 (the tubular portion 11), and the proximal end thereof is connected to the electrical connector 21.
  • the distal end (temperature measuring section 81) is buried in the tube wall of the expansion section 31 of the balloon 30, and the tube wall of the expansion section 31 and the proximal neck section 35 and the outer tube 10 (the circular tubular section 11).
  • a temperature sensor (thermocouple) 80 extending to the lumen 106L and having a proximal end connected to the electrical connector 21 is provided.
  • 20 is a Y connector connected to the proximal end side of the outer tube 10
  • 22 is a fluid supply connector
  • 23 is a fluid discharge connector
  • 24 is a guide wire connector
  • 26 is a lead protection tube
  • 27 is a fluid supply tube
  • 28 is a fluid discharge tube.
  • the outer tube 10 constituting the balloon-type electrode catheter 100 includes a circular tubular portion 11 and a semicircular tubular portion 13.
  • a part of the proximal end and the distal end of the outer tube 10 is constituted by a circular tubular portion 11, and a distal end (excluding the above-mentioned part) of the outer tube 10 is constituted by a semicircular tubular portion 13.
  • each of the sublumens 101L to 112L is formed by a lumen tube surrounding the same, and these lumen tubes are fixed by a binder resin forming the tubular portion 11.
  • sublumens 101L to 105L are formed inside the semicircular tubular portion 13 of the outer tube 10 continuously from the inside of the tubular portion 11.
  • the lumen tube surrounding each of the sublumens 101L to 105L in the semicircular tubular portion 13 is fixed by a binder resin forming the semicircular tubular portion 13.
  • the sublumens 101L to 105L disposed inside the tubular portion 11 and the semicircular portion 13 are semicircular tubular portions which are the distal end surfaces of the outer tube 10, respectively. 13 has an opening at the distal end surface 14.
  • Each of the sublumens 101L to 105L is in communication with the fluid supply connector 22 shown in FIGS.
  • the sub-lumens 101L to 105L (five of the twelve sub-lumens formed in the outer tube 10) supply fluid to the inside of the balloon 30 (expansion portion 31).
  • the fluid supplied to the inside of the balloon 30 can be exemplified by physiological saline.
  • the central lumen 10L and the sublumens 106L to 112L formed inside the tubular portion 11 are open at the distal end surface 12 of the tubular portion 11, respectively.
  • the openings of the sub-lumens 106L, 110L, and 112L are sealed by a seal material 90 shown in FIG.
  • Each of the sublumens 107L to 111L communicates with the fluid discharge connector 23 shown in FIG. Accordingly, the sub-lumens 107L to 109L and 111L (four of the twelve sub-lumens formed in the outer tube 10) supply the fluid supplied to the inside of the balloon 30 (expansion portion 31). It serves as a “fluid discharge sublumen” for discharging from inside the balloon 30.
  • the constituent material of the outer tube 10 is not particularly limited, and examples thereof include polyamide-based resins such as polyamide, polyether polyamide, polyether block amide (PEBAX (registered trademark)), and nylon. Of these, PEBAX is preferred.
  • An outer diameter of the outer tube 10 (an outer diameter at a base end to be described later) is usually 1.0 to 3.3 mm, and is 1.45 mm as a preferable example.
  • the diameter of the central lumen 10L of the outer tube 10 is usually 0.35 to 0.95 mm, and 0.85 mm as a preferable example.
  • the diameter of the sublumens 101L to 112L of the outer tube 10 is usually 0.10 to 0.75 mm, and is 0.25 mm as a preferable example.
  • the length of the outer tube 10 is usually 100 to 2200 mm, and is 1800 mm in a preferred example.
  • a Y connector 20 is connected to the base end side of the outer tube 10. As shown in FIG. 23, the lumen tubes surrounding the sub lumens 101L to 105L and the sub lumens 107L to 111L of the outer tube 10 enter the inside of the Y connector 20 from the base end of the outer tube 10.
  • the proximal end of the lumen tube surrounding the sublumens 101L to 105L is connected (bonded) to the single lumen structure fluid supply tube 27 inside the Y connector 20. Fixed by an agent 95).
  • the fluid supply tube 27 extends outside the Y connector 20, and the proximal end of the fluid supply tube 27 is connected to the fluid supply connector 22.
  • the proximal end of the lumen tube surrounding the sublumens 107L to 111L is connected (fixed by an adhesive 95) to the single lumen structure fluid discharge tube 28 inside the Y connector 20.
  • the fluid discharge tube 28 extends outside the Y connector 20, and the proximal end of the fluid discharge tube 28 is connected to the fluid discharge connector 23.
  • the balloon 30 constituting the balloon-type electrode catheter 100 includes an expanding portion 31 that expands and contracts, a distal neck portion 33 continuous with the distal end of the expanding portion 31, and a proximal neck portion 35 continuous with the proximal end of the expanding portion 31. It is composed of
  • the expansion portion 31 of the balloon 30 is a space forming portion that expands when a fluid is supplied to the inside thereof, and contracts when the fluid is discharged from the inside.
  • the expanded portion 31 of the balloon 30 includes a cylindrical portion 311, a distal cone portion 313 extending from the distal end of the cylindrical portion 311 to the proximal end of the distal neck portion 33, A proximal cone portion 315 extends from the proximal end of the portion 311 to the distal end of the proximal neck portion 35.
  • the proximal neck 35 is fixed to the distal end of the outer tube 10 (the distal end constituted by the tubular portion 11), and the distal end of the outer tube 10 (the distal end constituted by the semicircular tubular portion 13).
  • the balloon 30 is connected to the distal end side of the outer tube 10 by including the expansion portion 31 in the outer tube 10.
  • the distal end portion (the circular tubular portion 11 shown in FIG. 19) of the outer tube 10 to which the proximal end neck portion 35 of the balloon 30 is fixed has a surface layer portion cut off.
  • the outer diameter of the outer tube 10 to which the side neck portion 35 is not fixed is smaller than the outer diameter of the proximal end portion (the circular tubular portion 11 shown in FIG. 21).
  • the outer diameter of the proximal neck portion 35 shown in FIG. 19 is substantially equal to the outer diameter of the proximal portion of the outer tube 10 shown in FIG.
  • the outer diameter of the outer tube 10 can be set to the maximum diameter limited by the sheath or the endoscope (there is no need to consider the increase in the outer diameter due to the thickness of the proximal neck portion).
  • the diameter of the sublumens 101L to 112L can be sufficiently ensured, and the cooling effect inside the balloon 30 can be further improved.
  • the distal end surface 14 of the semicircular tubular portion 13 in which the fluid supply sublumen 101L to 105L is open is located closer to the distal end than the axially intermediate position of the expanded portion 31 of the balloon 30. It is located near the tip of the cylindrical portion 311.
  • the fluid flowing through the fluid supply sublumen 101L to 105L is discharged in the distal direction from each of the openings located near the distal end of the cylindrical portion 311. It is possible to reach the vicinity of the distal end of the portion 313), whereby a fluid flow from the distal side to the proximal side can be formed inside the balloon 30 (expansion portion 31).
  • the opening position of the fluid supply sub-lumen is located on the proximal side from the axial middle position of the balloon expansion portion, even if the fluid is discharged from the opening toward the distal end after the balloon expansion, the expansion portion is Cannot reach the vicinity of the distal end of the balloon, and the flow of the fluid from the distal side to the proximal side cannot be formed inside the balloon.
  • the distal end surface 12 of the tubular portion 11 from which the fluid discharge sublumens 107L to 109L and 111L open is located at the base end of the expansion portion 31.
  • the constituent material of the balloon 30 is not particularly limited, and the same material as that of a balloon constituting a conventionally known balloon catheter can be used.
  • polyamide such as polyamide, polyether polyamide, PEBAX and nylon
  • Polyurethane resins such as thermoplastic polyether urethane, polyether polyurethane urea, fluorine polyether urethane urea, polyether polyurethane urea resin, and polyether polyurethane urea amide.
  • the diameter of the balloon 30 is usually 0.7 to 30.0 mm, and is 2.0 mm in a preferred example.
  • the outer diameter of the proximal end neck portion 35 of the balloon 30 is substantially equal to the outer diameter of the proximal end portion of the outer tube 10, and is usually 1.0 to 3.3 mm, or 1.45 mm in a preferred example. It is.
  • the length of the balloon 30 (expansion part 31) is usually 8 to 50 mm, and is 20 mm in a preferred example.
  • the inner tube 41 and the distal end tip 46 constitute an inner shaft.
  • the inner tube 41 constituting the balloon-type electrode catheter 100 has a lumen (guidewire lumen) through which a guidewire can be inserted, and is inserted into the central lumen 10L of the outer tube 10 (circular tubular portion 11), and its distal end is inserted.
  • the central lumen 10L extends into the balloon 30 (expanded portion 31) from the opening.
  • the distal end portion of the inner tube 41 extending into the balloon 30 has a semicircular portion of the outer peripheral surface covered with the semicircular tubular portion 13, and has a proximal-side cone portion 315 of the expanded portion 31.
  • the base end of the inner tube 41 enters the inside of the Y connector 20 from the base end of the outer tube 10 (the opening on the base end side of the central lumen 10L), and The inside of the inner tube 41 extends to the outside of the Y connector 20, and the base end of the inner tube 41 is connected to the guide wire connector 24.
  • the same material as the inner tube constituting the conventionally known balloon catheter can be used.
  • PEEK resin polyetherether which is a crystalline thermoplastic resin having excellent mechanical properties
  • Ketone resins are preferred.
  • the outer diameter of the inner tube 41 is equal to or slightly smaller than the diameter of the central lumen 10L of the outer tube 10 into which the inner tube 41 is inserted, and is usually 0.34 to 0.99 mm, and 0.84 mm as a preferable example. It is said.
  • the inner diameter of the inner tube 41 is usually 0.31 to 0.92 mm, and is 0.68 mm in a preferred example.
  • the distal tip 46 constituting the balloon-type electrode catheter 100 has a lumen (guidewire lumen) communicating with the guidewire lumen of the inner tube 41, and the inner tube inside the distal-side cone portion 313 of the expansion section 31 of the balloon 30. It is connected to the distal end of the balloon 41 and is fixed to the distal side neck portion 33 and extends outside the balloon 30.
  • the tip of the tip 46 is open.
  • the constituent material of the tip 46 is not particularly limited, and examples thereof include polyamide, polyether polyamide, polyamide resins such as PEBAX and nylon, and polyurethane.
  • the inner diameter of the distal end tip 46 is substantially the same as the inner diameter of the inner tube 41, and is usually 0.31 to 0.92 mm, and 0.68 mm as a preferable example.
  • the outer diameter of the distal end tip 46 is usually 0.35 to 2.6 mm, and is 1.0 mm in a preferred example.
  • the outer diameter of the distal end neck portion 33 of the balloon 30 to which the distal end tip 46 is fixed is usually 0.37 to 3.3 mm, and is 1.18 mm as a preferable example.
  • a high-frequency current is applied to the outer surfaces of the balloon 30 (the cylindrical portion 311 and the distal cone portion 313 of the expanded portion 31 and the distal neck portion 33).
  • surface electrodes to be formed strip-shaped electrodes 51 to 54 formed of a metal thin film so as to extend along the axial direction of the balloon 30 are arranged at 90 ° intervals along the circumferential direction of the balloon 30.
  • the thickness of the metal thin film forming the strip electrodes 51 to 54 is preferably 0.5 to 5.0 ⁇ m, and more preferably 1.0 to 2.5 ⁇ m. If the film thickness is too small, the metal thin film may become hot due to Joule heat during the procedure (during high-frequency current application). On the other hand, when the thickness of the thin film is excessively large, the metal thin film does not easily follow the shape change of the balloon due to expansion and contraction, and the expansion and contraction properties of the balloon may be impaired.
  • the method for forming the metal thin film forming the strip electrodes 51 to 54 on the outer surface of the balloon 30 is not particularly limited, and a normal metal thin film forming method such as vapor deposition, sputtering, plating, and printing may be employed. it can.
  • a metal ring 60 is mounted on the distal end neck 33 of the balloon 30.
  • the metal ring 60 constituting the balloon-type electrode catheter 100 is caulked and fixed to the distal-end-side neck portion 33 such that the inner peripheral surface thereof comes into contact with the distal end portion of each of the strip electrodes 51 to 54.
  • Each of the strip electrodes 51 to 54 and the metal ring 60 are electrically connected.
  • the metal ring 60 As a constituent material of the metal ring 60, platinum or a platinum-based alloy can be used. As shown in FIG. 9, the metal ring 60 is insulated and covered with a resin material 65. Thus, it is possible to prevent the metal ring 60 from being heated at the time of energization, and to avoid cauterizing normal tissue around the metal ring 60.
  • the inner diameter of the metal ring 60 attached to the distal side neck 33 is substantially the same as the outer diameter of the distal side neck 33, usually 0.37 to 3.3 mm. .18 mm.
  • the outer diameter of the metal ring 60 attached to the distal neck portion 33 is smaller than the outer diameter of the outer tube 10 and the proximal neck portion 35, and is usually 0.98 to 3.28 mm. For example, it is 1.32 mm.
  • the distal end of the conducting wire 70 is fixed to the inner peripheral surface of the metal ring 60.
  • This conducting wire 70 extends into the tube wall of the distal end tip 46 as shown in FIGS. 9 and 11, and expands the balloon 30 along the inner tube 41 as shown in FIGS. 12, 14 and 15.
  • the base end of the conducting wire 70 is connected to the electric connector 21.
  • the electric connector 21 has both a function as an energizing connector for applying a high-frequency current to each of the strip electrodes 51 to 54 and a function as a thermocouple connector for connecting the temperature sensor 80 to a temperature measuring instrument. .
  • Examples of the constituent material of the conductive wire 70 include copper, silver, gold, platinum, tungsten and alloys of these metals, and it is preferable that an electrically insulating protective coating such as a fluororesin is applied.
  • a temperature sensor 80 composed of a thermocouple is embedded in the tube wall of the balloon 30.
  • the side temperature section 81 (temperature measurement contact) of the temperature sensor 80 is located on the tube wall of the extension section 31.
  • the temperature sensor 80 is connected to the proximal neck 35 of the balloon 30.
  • the sub-lumen 106L of the outer tube 10 enters the sub-lumen 106L and extends to the sub-lumen 106L.
  • It extends from the Y connector 20 through the inside of a wire protection tube 26 that extends and extends from the Y connector 20.
  • the base end of the temperature sensor 80 is connected to the electric connector 21.
  • a wide range of high-frequency ablation treatment can be performed on a lesion in or around a blood vessel by each of the band-shaped electrodes 51 to 54 formed on the outer surface of the balloon 30. it can.
  • the metal ring 60 is mounted on the distal end neck of the balloon 30 so that the inner peripheral surface of the distal end of each of the strip electrodes 51 to 54 comes into contact with the distal end of each of the strip electrodes 51 to 54. Since it is electrically connected to the electrical connector 21 via the metal ring 60 and the conducting wire 70, high-frequency current can be uniformly applied to each of the strip electrodes 51 to 54, and thereby, Alternatively, the lesion tissue around it can be uniformly cauterized along the circumferential direction of the vessel.
  • the outer diameter of the metal ring 60 attached to the distal neck portion 33 of the balloon 30 is smaller than the outer diameter of the outer tube 10 and the proximal neck portion 35, a sheath or an endoscope used at the time of introduction is used. There is no possibility that the metal ring 60 is caught in the opening of the balloon electrode, and the penetrability of the balloon-type electrode catheter 100 into the lumen of the sheath or the endoscope is not impaired.
  • each of the fluid supply sub-lumens 101L to 105L is opened at the distal end surface 14 of the semicircular tubular portion 13 located near the distal end of the cylindrical portion 311 of the expansion portion 31 of the balloon 30, and the fluid discharge sub-lumen 107L is provided.
  • 109109L and 111L are open at the distal end face 12 of the tubular portion 11 located at the base end of the expansion portion 31 of the balloon 30, so that the balloon 30 can be expanded (after the fluid is filled therein). ), The flow of the fluid from the distal side to the proximal side can be formed inside the balloon 30, and the fluid can flow.
  • the fluid discharged in the distal direction from the openings of the fluid supply sub-lumens 101L to 105L hits the inner wall surface of the distal-side cone portion 313 of the extension portion 31, and thereafter, the cylindrical portion 311 and the base end of the extension portion 31 By flowing in the proximal direction along the inner wall surface of the side cone portion 315, a fluid can be circulated inside the balloon 30 (expansion portion 31).
  • the cases to which the balloon-type electrode catheter 100 of the present embodiment can be applied include tumors and vagus nerves in or around blood vessels, and specifically, bile duct cancer, lung cancer, liver cancer, kidney cancer, adrenal adenoma And renal artery vagus nerve.
  • the present invention is not limited to these embodiments, and various modifications are possible.
  • the position of the distal end surface 14 of the semicircular tubular portion 13 inside the balloon 30 (the opening position of the fluid supply sub-lumens 101L to 105L) is on the distal end side with respect to the axially intermediate position of the expansion portion 31, It does not need to be near the tip of the cylindrical portion 311 of the extension portion 31.
  • the opening of the fluid supply sublumen and / or the fluid discharge sublumen is formed on the outer peripheral surface of the outer tube, and the fluid is discharged / discharged in the radial direction of the outer tube. Good.
  • the opening of the fluid supply sublumen is located at or near the proximal end of the expansion portion of the balloon, and the opening of the fluid discharge sublumen is located more distally than the axial middle position of the expansion portion. It may be.
  • the fluid supply sub-lumen and the fluid discharge sub-lumen may be open at the same axial position.
  • Balloon type electrode catheter 10 Outer tube 10L Central lumen 101L-105L Sublumen (sublumen for fluid supply) 107L to 109L, 111L Sublumen (sublumen for fluid discharge) 106L, 110L, 112L Sublumen 11 Circular section 12 Tip face of tubular section 13 Semicircular section 14 Tip face of semicircular section 20 Y connector 21 Electrical connector 22 Connector for fluid supply 23 Connector for fluid discharge 24 Guide wire Connector 26 Conductive wire protection tube 27 Fluid supply tube 28 Fluid discharge tube 30 Balloon 31 Expansion part 311 Cylindrical part 311 313 Tip cone section 313 315 proximal cone portion 315 33 distal end neck 35 proximal end neck 41 inner tube 46 distal tip 51-54 strip electrode (surface electrode) 60 Metal ring 70 Conductor 80 Temperature sensor (thermocouple) 81 Temperature measurement part of temperature sensor 90 Seal material 95 Adhesive

Abstract

The purpose of the present invention is to provide a balloon-type electrode catheter that can be introduced intravascularly without impairing the ability of a sheath or an endoscope to be inserted into a lumen and that also makes it possible to cauterize lesion tissue over a wide area. This balloon-type electrode catheter comprises: an outer tube (10); an energization connector (21); a balloon (30) that has a neck part (33), (35) at either end of an expanding part (31); an inner tube (41); a distal-end tip (46); strip electrodes (51)–(54) that are formed on an outer surface of the balloon (30); a metal ring (60) that is installed at a distal-end-side neck part (31) such that an inner circumferential surface thereof contacts a distal-end part of each of the strip electrodes (51)–(54); and a conducting wire (70) that electrically connects the energization connector (21) and each of the strip electrodes (51)–(54) as a result of a distal end thereof being fixed to the inner circumferential surface of the metal ring (60) and a base end thereof being fixed to the energization connector (21).

Description

バルーン型電極カテーテルBalloon type electrode catheter
　本発明は、バルーン型電極カテーテルに関し、更に詳しくは、経脈管的に導入され、脈管またはその周囲の組織を高周波焼灼治療するためのバルーン型電極カテーテルに関する。 The present invention relates to a balloon-type electrode catheter, and more particularly, to a balloon-type electrode catheter which is introduced transvascularly and is used for high-frequency ablation treatment of a vessel or its surrounding tissue.
　脈管またはその周囲の組織を高周波焼灼治療するためのバルーン型の電極カテーテル（脈管内アブレーション装置）として、従来、アウターチューブ（カテーテルシャフト）と、アウターチューブの先端に接続されたバルーンと、アウターチューブのルーメンおよびバルーンの内部に挿通されたインナーチューブ（ガイドワイヤ管腔）と、バルーンの内部に流体を供給するためにアウターチューブのルーメンに挿通されたルーメンチューブ（供給管腔）と、バルーンの内部に供給された流体を排出するためにアウターチューブのルーメンに挿通されたルーメンチューブ（帰還管腔）と、バルーンの外表面に設けられた表面電極（高周波電極）とを備えてなるものが紹介されている（下記特許文献１参照）。 Conventionally, an outer tube (catheter shaft), a balloon connected to the distal end of the outer tube, and an outer tube have been used as a balloon-type electrode catheter (intravascular ablation device) for performing high-frequency ablation treatment on a vessel or its surrounding tissue. The inner tube (guide wire lumen) inserted into the lumen of the balloon and the lumen, the lumen tube (supply lumen) inserted through the lumen of the outer tube to supply fluid to the interior of the balloon, and the interior of the balloon That includes a lumen tube (return lumen) inserted into the lumen of the outer tube to discharge the fluid supplied to the outer tube, and a surface electrode (high-frequency electrode) provided on the outer surface of the balloon. (See Patent Document 1 below).
　特許文献１に記載されているバルーン型電極カテーテルを構成するバルーンは、拡張収縮する拡張部と、その両端に形成されたネック部とを有しており、基端側ネック部はアウターチューブに固定され、先端側ネック部はインナーチューブ（ガイドワイヤ管腔）に固定されている。 The balloon constituting the balloon-type electrode catheter described in Patent Literature 1 has an expanding portion that expands and contracts and neck portions formed at both ends thereof, and a proximal neck portion is fixed to the outer tube. The distal neck portion is fixed to the inner tube (guide wire lumen).
　特許文献１に記載されているバルーン型電極カテーテルによれば、バルーンの外表面に設けられた表面電極に高周波電流を通電することにより、脈管またはその周囲の病巣組織に対して高周波焼灼治療を行うことができる。
　また、ルーメンチューブ（供給管腔）からバルーンの内部に供給された流体をバルーンの内部で循環させてルーメンチューブ（帰還管腔）から排出することにより、バルーンの内部を冷却することができる。 According to the balloon-type electrode catheter described in Patent Literature 1, high-frequency current is applied to a surface electrode provided on the outer surface of the balloon to perform high-frequency ablation treatment on a vascular vessel or a lesion tissue around the vessel. It can be carried out.
Further, by circulating the fluid supplied from the lumen tube (supply lumen) into the balloon and discharging the fluid from the lumen tube (return lumen), the interior of the balloon can be cooled.
　一方、肺静脈を電気的に隔離するためのバルーン型電極カテーテルにおいて、バルーンの外表面に形成された表面電極に高周波電流を通電する形態として、カテーテルシャフトの先端部に固定されているバルーンのネック部（通電用のコネクタが位置する側である基端側のネック部）に金属リングを装着し、この金属リングに表面電極を電気的に接続するとともに、この金属リングと通電用のコネクタとを導線により電気的に接続する形態が、本発明者により提案されている（下記特許文献２参照）。 On the other hand, in a balloon-type electrode catheter for electrically isolating a pulmonary vein, a high-frequency current is applied to a surface electrode formed on the outer surface of the balloon. Attach a metal ring to the part (the neck on the proximal end side where the connector for energization is located), electrically connect the surface electrode to this metal ring, and connect the metal ring and the connector for energization. The present inventors have proposed a form of electrical connection by a conductive wire (see Patent Document 2 below).
特表２０１３－５３２５６４号公報JP-T-2013-532564A 特開２０１６－１８５２９６号公報（特に、図４）JP 2016-185296 A (in particular, FIG. 4)
　特許文献１に記載されているような、脈管またはその周囲の組織を高周波焼灼治療するためのバルーン型電極カテーテルにおいて、バルーンの外表面に形成された表面電極に高周波電流を通電する形態として、特許文献２に記載したような形態、すなわち、アウターチューブ（カテーテルシャフト）に固定されているバルーンのネック部（基端側ネック部）に金属リングを装着し、この金属リングを介して通電することが考えられる。 As described in Patent Document 1, in a balloon-type electrode catheter for high-frequency ablation treatment of a vessel or its surrounding tissue, as a form for applying a high-frequency current to a surface electrode formed on the outer surface of the balloon, A metal ring is mounted on the neck portion (proximal neck portion) of a balloon fixed to an outer tube (catheter shaft) as described in Patent Literature 2, and power is supplied through the metal ring. Can be considered.
　然るに、特許文献１に記載されているようなバルーン型電極カテーテルを構成するアウターチューブのルーメンには、ガイドワイヤを挿通させるためのインナーチューブ（ガイドワイヤ管腔）、冷却用流体を流通させるためのルーメンチューブ（供給管腔および帰還管腔）を内包しているために、その外径がかなり大きいものである。 However, an inner tube (a guide wire lumen) through which a guide wire is inserted and a cooling fluid through which a cooling fluid flows are provided in the lumen of the outer tube constituting the balloon-type electrode catheter described in Patent Document 1. Due to the inclusion of the lumen tube (supply lumen and return lumen), its outer diameter is quite large.
　特に、バルーン型電極カテーテルにより腫瘍などの焼灼治療を行う場合には、表面電極の周囲の組織の冷却効果を高めるために、バルーン内部を循環させる流体の流量を大きくする必要があり、このため、冷却用流体を流通させるためのルーメンチューブの大径化が要請され、これに伴って、アウターチューブの外径も更に大きくする必要がある。 In particular, when performing ablation treatment of a tumor or the like with a balloon-type electrode catheter, it is necessary to increase the flow rate of the fluid circulating inside the balloon in order to enhance the cooling effect of the tissue around the surface electrode. It is required to increase the diameter of the lumen tube for flowing the cooling fluid, and accordingly, it is necessary to further increase the outer diameter of the outer tube.
　そして、このような外径の大きなアウターチューブにバルーンの基端側ネック部を固定し、更に、当該基端側ネック部に金属リングを装着する場合において、当該金属リングの外径は、電極カテーテルを導入する際に使用するシースや内視鏡によって制限される外径（シャフト径またはラッピング径）を大きく超えてしまい、バルーン型電極カテーテルの導入時において、使用するシースや内視鏡の開口に当該金属リングが引っ掛かり、これらの内腔にバルーン型電極カテーテルを挿通させることができなくなる。 And when fixing the proximal neck portion of the balloon to the outer tube having such a large outer diameter, and further attaching a metal ring to the proximal neck portion, the outer diameter of the metal ring is determined by an electrode catheter. The outer diameter (shaft diameter or wrapping diameter) that is limited by the sheath or endoscope used when introducing the catheter is greatly exceeded. The metal ring is caught, and it becomes impossible to insert a balloon-type electrode catheter into these lumens.
　本発明は以上のような事情に基いてなされたものである。
　本発明の目的は、使用するシースや内視鏡の内腔への挿通性が損なわれることなく経脈管的に導入することができ、脈管またはその周囲の病巣組織に対して広範囲にわたり焼灼治療を行うことができるバルーン型電極カテーテルを提供することにある。
　本発明の他の目的は、脈管またはその周囲の組織を当該脈管の円周方向に沿って均質な焼灼治療を行うことができるバルーン型電極カテーテルを提供することにある。
　本発明の更に他の目的は、バルーン内部の冷却効果、延いては、表面電極の周囲の組織の冷却効果に優れたバルーン型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 circumstances.
An object of the present invention is to allow transvascular introduction without impairing the penetrability of a sheath or an endoscope used in a lumen, and extensive cauterization of a vascular tissue or a surrounding lesion tissue. An object of the present invention is to provide a balloon-type electrode catheter capable of performing treatment.
It is another object of the present invention to provide a balloon-type electrode catheter capable of performing uniform cautery treatment on a vessel or a tissue around the vessel along the circumferential direction of the vessel.
Still another object of the present invention is to provide a balloon-type electrode catheter which is excellent in the cooling effect of the inside of the balloon, and further, the cooling effect of the tissue around the surface electrode.
（１）本発明のバルーン型電極カテーテルは、経脈管的に導入され、脈管またはその周囲の組織を高周波焼灼治療するためのバルーン型の電極カテーテルであって、
　中央ルーメンと、その周囲に複数配置されたサブルーメンとを有するアウターチューブと、
　前記アウターチューブの基端側に配置された通電用コネクタと、
　拡張収縮する拡張部と、その両端に連続するネック部とを有し、基端側ネック部が前記アウターチューブの先端部に固定されることにより、当該アウターチューブの先端側に接続されたバルーンと、
　ガイドワイヤを挿通可能なルーメンを有し、前記アウターチューブの前記中央ルーメンに挿通されて、当該中央ルーメンの開口から前記バルーンの内部に延出し、当該バルーンの内部を延在するインナーチューブと、
　前記インナーチューブの前記ルーメンに連通するルーメンを有し、前記バルーンの内部において前記インナーチューブの先端に接続されるとともに、先端側ネック部に固定されて前記バルーンの外部に延出する先端チップと、
　前記拡張部および前記先端側ネック部における前記バルーンの外表面に形成された金属薄膜からなる表面電極と、
　前記表面電極の先端部にその内周面が接触するように、前記バルーンの前記先端側ネック部に装着されることにより、前記表面電極と電気的に接続された金属リングと、
　前記金属リングの内周面にその先端が固定され、前記バルーンの内部および前記アウターチューブの何れかの前記サブルーメンに延在して、その基端が前記通電用コネクタに固定されることにより、前記表面電極と前記通電用コネクタとを電気的に接続する導線と
　を備えていることを特徴とする。 (1) The balloon-type electrode catheter of the present invention is a balloon-type electrode catheter that is introduced transvascularly and performs high-frequency ablation treatment of a vessel or surrounding tissue,
An outer tube having a central lumen and a plurality of sub-lumens disposed therearound,
A current-carrying connector arranged on the proximal end side of the outer tube,
An expansion portion that expands and contracts, and a neck connected to the distal end of the outer tube, having a continuous neck at both ends thereof, and having a proximal neck fixed to the distal end of the outer tube. ,
An inner tube having a lumen through which a guide wire can be inserted, being inserted into the central lumen of the outer tube, extending from the opening of the central lumen into the balloon, and extending inside the balloon,
A distal tip having a lumen communicating with the lumen of the inner tube, connected to a distal end of the inner tube inside the balloon, and fixed to a distal neck portion and extending outside the balloon;
A surface electrode made of a metal thin film formed on the outer surface of the balloon in the expanded portion and the distal neck portion,
A metal ring electrically connected to the surface electrode by being mounted on the distal end neck of the balloon so that the inner peripheral surface thereof is in contact with the front end of the surface electrode,
The distal end is fixed to the inner peripheral surface of the metal ring, extends to the sublumen of the inside of the balloon and any of the outer tube, the base end is fixed to the connector for electricity, And a conducting wire for electrically connecting the surface electrode and the current-carrying connector.
　このような構成のバルーン型電極カテーテルによれば、バルーンの外表面に形成された表面電極を、金属リングおよび導線を介して通電用コネクタに電気的に接続することができるので、当該表面電極に高周波電流を確実に通電することができる。
　これにより、脈管またはその周囲の病巣組織に対して広範囲にわたり焼灼治療を行うことができる。 According to the balloon-type electrode catheter having such a configuration, the surface electrode formed on the outer surface of the balloon can be electrically connected to the current-carrying connector via the metal ring and the conducting wire. High-frequency current can be reliably supplied.
This makes it possible to perform ablation treatment over a wide range of the vascular tissue or the surrounding lesion tissue.
　また、金属リングが装着されるバルーンの先端側ネック部は、先端チップに固定されるネック部であり、アウターチューブに固定される基端側ネック部と比較して外径が格段に小さいので、先端側ネック部に装着される金属リングの外径を、アウターチューブや基端側ネック部の外径よりも小さくすることができる。
　これにより、バルーン型電極カテーテルの導入時において、使用するシースや内視鏡の開口に当該金属リングが引っ掛かるようなことはなく、シースや内視鏡の内腔へのバルーン型電極カテーテルの挿通性が損なわれることがない。 In addition, the distal neck portion of the balloon to which the metal ring is attached is a neck portion fixed to the distal tip, and has a significantly smaller outer diameter than the proximal neck portion fixed to the outer tube. The outer diameter of the metal ring attached to the distal neck can be smaller than the outer diameter of the outer tube or the proximal neck.
Thereby, when introducing the balloon-type electrode catheter, the metal ring does not catch on the opening of the sheath or the endoscope to be used, and the penetration of the balloon-type electrode catheter into the lumen of the sheath or the endoscope does not occur. Is not impaired.
（２）本発明のバルーン型電極カテーテルにおいて、前記表面電極は、前記バルーンの軸方向に沿って延びるように形成され、当該バルーンの円周方向に沿って等角度間隔に配置された複数の帯状電極であり、前記帯状電極の各々の先端部に前記金属リングの内周面が接触していることが好ましい。 (2) In the balloon-type electrode catheter of the present invention, the surface electrodes are formed so as to extend along the axial direction of the balloon, and are arranged in a plurality of strips arranged at equal angular intervals along the circumferential direction of the balloon. It is an electrode, and it is preferable that the inner peripheral surface of the metal ring is in contact with the tip of each of the strip electrodes.
　このような構成のバルーン型電極カテーテルによれば、バルーンの円周方向に沿って等角度間隔に形成されている複数の帯状電極の各々を、金属リングおよび導線を介して、通電用コネクタに電気的に接続することができるので、複数の帯状電極の各々に対して均等に高周波電流を通電することができ、これにより、脈管またはその周囲の組織を当該脈管の円周方向に沿って均質な焼灼治療を行うことができる。 According to the balloon-type electrode catheter having such a configuration, each of the plurality of strip-shaped electrodes formed at equal angular intervals along the circumferential direction of the balloon is electrically connected to the current-carrying connector via the metal ring and the conductive wire. High-frequency current can be uniformly applied to each of the plurality of band-shaped electrodes, and thereby, the vessel or the surrounding tissue can be passed along the circumferential direction of the vessel. A homogeneous cautery treatment can be performed.
（３）本発明のバルーン型電極カテーテルにおいて、前記金属リングが絶縁被覆されていることが好ましい。 (3) In the balloon-type electrode catheter of the present invention, it is preferable that the metal ring is coated with an insulating material.
　このような構成のバルーン型電極カテーテルによれば、通電時の金属リングが高温になることを防止でき、金属リングの周囲の正常組織が焼灼されるようなことを回避することができる。 According to the balloon-type electrode catheter having such a configuration, it is possible to prevent the metal ring from becoming hot when energized, and to avoid cauterizing normal tissue around the metal ring.
（４）本発明のバルーン型電極カテーテルにおいて、前記アウターチューブの有する前記サブルーメンの少なくとも１本は、前記バルーンの内部に流体を供給するために当該流体を流通させる流体供給用サブルーメンであり、
　前記アウターチューブの有する前記サブルーメンの少なくとも１本は、前記バルーンの内部に供給された流体を当該バルーンの内部から排出するために、当該流体を流通させる流体排出用サブルーメンであることが好ましい。 (4) In the balloon-type electrode catheter of the present invention, at least one of the sub-lumens included in the outer tube is a fluid-supplying sub-lumen that circulates the fluid in order to supply a fluid to the inside of the balloon,
It is preferable that at least one of the sub-lumens of the outer tube is a fluid discharge sub-lumen that allows the fluid to flow in order to discharge the fluid supplied to the inside of the balloon from the inside of the balloon.
（５）上記（４）のバルーン型電極カテーテルにおいて、前記バルーンの前記基端側ネック部に固定された前記アウターチューブの前記先端部を前記バルーンの前記拡張部が内包しており、
　前記流体供給用サブルーメンの開口は、前記拡張部の軸方向の中間位置よりも先端側に位置し、
　前記流体排出用サブルーメンの開口は、前記拡張部の前記基端またはその近傍に位置していることが好ましい。 (5) In the balloon-type electrode catheter according to (4), the distal end portion of the outer tube fixed to the proximal end neck portion of the balloon is included in the expanded portion of the balloon.
The opening of the fluid supply sub-lumen is located more distally than the axially intermediate position of the expansion portion,
The opening of the fluid discharge sublumen is preferably located at or near the base end of the extension.
　このような構成のバルーン型電極カテーテルによれば、バルーンの内部への流体の供給口と、バルーンの内部からの流体の排出口とが互いに軸方向に変位していることにより、バルーンの拡張後（内部に流体が充填された後）であっても、先端側から基端側への流体
の流れが形成されて、バルーンの内部において当該流体を流動させることができるので、バルーンの内部、延いては、表面電極の周囲の組織を十分に冷却することができる。 According to the balloon-type electrode catheter having such a configuration, the fluid supply port to the inside of the balloon and the fluid discharge port from the inside of the balloon are axially displaced from each other. Even after the fluid is filled, the fluid flows from the distal end to the proximal end, and the fluid can flow inside the balloon. Thus, the tissue around the surface electrode can be sufficiently cooled.
（６）上記（４）および（５）のバルーン型電極カテーテルにおいて、前記流体供給用サブルーメンの数が前記流体排出用サブルーメンの数よりも多いことが好ましい。 (6) In the balloon-type electrode catheters of (4) and (5), it is preferable that the number of the sub-lumens for supplying fluid is larger than the number of sub-lumens for discharging fluid.
　上記のような構成のバルーン型電極カテーテルによれば、バルーンの内部を一定の圧力（拡張圧力）に維持することができる。 According to the balloon-type electrode catheter configured as described above, the inside of the balloon can be maintained at a constant pressure (expansion pressure).
（７）本発明のバルーン型電極カテーテルにおいて、前記バルーンの前記基端側ネック部が固定されている前記アウターチューブの前記先端部の外径が、当該アウターチューブの基端部の外径よりも小さく形成されており、
　前記バルーンの前記基端側ネック部の外径と、前記アウターチューブの前記基端部の外径とが実質的に等しいことが好ましい。 (7) In the balloon-type electrode catheter of the present invention, the outer diameter of the distal end of the outer tube to which the proximal neck of the balloon is fixed is larger than the outer diameter of the proximal end of the outer tube. It is formed small,
It is preferable that an outer diameter of the proximal neck portion of the balloon is substantially equal to an outer diameter of the proximal end portion of the outer tube.
　このような構成のバルーン型電極カテーテルによれば、外径が最大となる基端側ネック部の外径がアウターチューブの基端部の外径と実質的に等しくなるので、この基端側ネック部によってシースや内視鏡の内腔への挿通性が妨げられるようなことはない。
　また、アウターチューブの外径をシースや内視鏡によって制限される最大径とすることができるので、当該アウターチューブの有する流体供給用サブルーメンおよび流体排出用サブルーメンの径を十分に確保することができ、バルーンの内部の冷却効果を更に向上させることができる。 According to the balloon-type electrode catheter having such a configuration, the outer diameter of the proximal neck portion having the maximum outer diameter is substantially equal to the outer diameter of the proximal end portion of the outer tube. The portion does not hinder the penetration of the sheath or endoscope into the lumen.
Further, since the outer diameter of the outer tube can be the maximum diameter limited by the sheath or the endoscope, it is necessary to sufficiently secure the diameter of the fluid supply sub-lumen and the fluid discharge sub-lumen of the outer tube. Thus, the cooling effect inside the balloon can be further improved.
（８）本発明のバルーン型電極カテーテルにおいて、前記バルーンの管壁に温度センサが配置されていることが好ましい。 (8) In the balloon-type electrode catheter of the present invention, it is preferable that a temperature sensor is disposed on a tube wall of the balloon.
　本発明のバルーン型電極カテーテルによれば、使用するシースや内視鏡の内腔への挿通性が損なわれることなく経脈管的に導入することができ、脈管またはその周囲の病巣組織に対して広範囲にわたり焼灼治療を行うことができる。
　また、複数の帯状電極からなる表面電極を備えた本発明のバルーン型電極カテーテルによれば、脈管またはその周囲の組織を当該脈管の円周方向に沿って均質な焼灼治療を行うことができる。
　更に、バルーンの拡張部の軸方向の中間位置より先端側で開口する流体供給用サブルーメンと、バルーンの拡張部の基端またはその近傍で開口する流体排出用サブルーメンとを有するアウターチューブを備えた本発明のバルーン型電極カテーテルによれば、従来のバルーン型電極カテーテルと比較して、バルーン内部の冷却効果、延いては表面電極の周囲の組織の冷却効果に優れている。 ADVANTAGE OF THE INVENTION According to the balloon-type electrode catheter of this invention, it can introduce | transduce transvascularly, without impairing the penetrability to the lumen of the sheath used and an endoscope, and introduce | transduces into a vascular or the surrounding focal tissue. On the other hand, a wide range of cautery treatments can be performed.
Further, according to the balloon-type electrode catheter of the present invention provided with a surface electrode composed of a plurality of band-shaped electrodes, it is possible to perform a uniform cauterization treatment on a vessel or a tissue around the vessel along the circumferential direction of the vessel. it can.
The balloon further includes an outer tube having a fluid supply sub-lumen that opens on the distal side from the axial middle position of the balloon expansion portion, and a fluid discharge sub-lumen that opens at or near the proximal end of the balloon expansion portion. According to the balloon-type electrode catheter of the present invention, as compared with the conventional balloon-type electrode catheter, the effect of cooling the inside of the balloon and, in turn, the effect of cooling the tissue around the surface electrode are excellent.
本発明の一実施形態に係るバルーン型電極カテーテルの平面図である。It is a top view of a balloon type electrode catheter concerning one embodiment of the present invention. 図１に示したバルーン型電極カテーテルの部分破断正面図（図１のＩＩ－ＩＩ断面を含む正面図）である。FIG. 2 is a partially broken front view (a front view including a II-II cross section of FIG. 1) of the balloon-type electrode catheter shown in FIG. 1. 図１に示したバルーン型電極カテーテルの先端部分を示す斜視図である。FIG. 2 is a perspective view showing a distal end portion of the balloon-type electrode catheter shown in FIG. 1. 図１に示したバルーン型電極カテーテルの先端部分（バルーンの先端側）を示す斜視図である。FIG. 2 is a perspective view showing a distal end portion (the distal end side of the balloon) of the balloon-type electrode catheter shown in FIG. 1. 図１に示したバルーン型電極カテーテルの先端部分（バルーンの基端側）を示す斜視図である。FIG. 2 is a perspective view showing a distal end portion (a proximal end side of the balloon) of the balloon-type electrode catheter shown in FIG. 1. 図２の部分拡大図（ＶＩ部詳細図）である。FIG. 3 is a partially enlarged view (a detailed view of a VI section) of FIG. 2. 図６の部分拡大図（ＶＩＩ部詳細図）である。FIG. 7 is a partially enlarged view (a detailed view of a VII section) of FIG. 6. 図２の部分拡大図（ＶＩＩＩ部詳細図）である。It is the elements on larger scale of FIG. 2 (VIII section detailed drawing). 図１のＩＸ－ＩＸ断面図である。It is IX-IX sectional drawing of FIG. 図９の部分拡大図（Ｘ部詳細図）である。It is the elements on larger scale of FIG. 9 (X part detailed view). 図１のＸＩ－ＸＩ断面図である。FIG. 2 is a sectional view taken along the line XI-XI in FIG. 1. 図１のＸＩＩ－ＸＩＩ断面図である。FIG. 2 is a sectional view taken along line XII-XII of FIG. 1. 図１２の部分拡大図（ＸＩＩＩ部詳細図）である。FIG. 13 is a partially enlarged view (a detailed view of an XIII portion) of FIG. 12. 図１のＸＩＶ－ＸＩＶ断面図である。FIG. 4 is a sectional view taken along line XIV-XIV of FIG. 1. 図１のＸＶ－ＸＶ断面図である。It is XV-XV sectional drawing of FIG. 図１５の部分拡大図（ＸＶＩ部詳細図）である。It is the elements on larger scale of FIG. 15 (XVI part detailed view). 図１のＸＶＩＩ－ＸＶＩＩ断面図である。FIG. 7 is a sectional view taken along line XVII-XVII of FIG. 1. 図１７の部分拡大図（ＸＶＩＩＩ部詳細図）である。It is the elements on larger scale of FIG. 17 (XVIII part detailed view). 図１のＸＩＸ－ＸＩＸ断面図である。It is XIX-XIX sectional drawing of FIG. 図１９の部分拡大図（ＸＸ部詳細図）である。FIG. 20 is a partially enlarged view (XX section detailed view) of FIG. 19. 図１のＸＸＩ－ＸＸＩ断面図である。FIG. 2 is a sectional view taken along line XXI-XXI of FIG. 1. 図２１の部分拡大図（ＸＸＩＩ部詳細図）である。It is the elements on larger scale of FIG. 21 (XXII part detailed figure). 図１のＸＸＩＩＩ－ＸＸＩＩＩ断面図である。FIG. 3 is a sectional view taken along line XXIII-XXIII of FIG. 1. 図１のＸＸＩＶ－ＸＸＩＶ断面図である。FIG. 4 is a sectional view taken along line XXIV-XXIV of FIG. 1.
＜実施形態＞
　この実施形態のバルーン型電極カテーテル１００は、経脈管的に導入され、脈管またはその周囲における腫瘍などの病巣組織を、高周波焼灼により治療するためのバルーン型の電極カテーテルである。 <Embodiment>
The balloon-type electrode catheter 100 of this embodiment is a balloon-type electrode catheter that is introduced transvascularly and treats a lesion tissue such as a tumor in or around a vessel by high-frequency ablation.
　図１～図２４に示すバルーン型電極カテーテル１００は、円管状部分１１と、半円管状部分１３とからなり、中央ルーメン１０Ｌと、その周囲に配置されたサブルーメン１０１Ｌ～１１２Ｌとを有するアウターチューブ１０と；アウターチューブ１０の基端側に配置された電気コネクタ２１と；拡張収縮する拡張部３１と、その両端に連続するネック部（先端側ネック部３３および基端側ネック部３５）とを有し、基端側ネック部３５がアウターチューブ１０の先端部を構成する円管状部分１１に固定され、拡張部３１がアウターチューブ１０の先端部を構成する半円管状部分１３を内包することにより、アウターチューブ１０の先端側に接続されているバルーン３０と；ガイドワイヤルーメンを有し、アウターチューブ１０の中央ルーメン１０Ｌに挿通されて、当該中央ルーメン１０Ｌの開口からバルーン３０の内部に延出し、当該バルーン３０の内部を延在するインナーチューブ４１と；インナーチューブ４１のガイドワイヤルーメンに連通するルーメン（ガイドワイヤルーメン）を有し、バルーン３０の内部においてインナーチューブ４１の先端に接続されるとともに、先端側ネック部３３に固定されてバルーン３０の外部に延出する先端チップ４６と；バルーン３０の拡張部３１および先端側ネック部３３の外表面に形成された金属薄膜による帯状電極５１～５４（表面電極）と；帯状電極５１～５４の各々の先端部にその内周面が接触するようバルーン３０の先端側ネック部３３に装着されることにより、帯状電極５１～５４の各々と電気的に接続された金属リング６０と；金属リング６０の内周面にその先端が接続され、バルーン３０の内部およびアウターチューブ１０（円管状部分１１）のサブルーメン１１２Ｌに延在し、その基端が電気コネクタ２１に接続された導線７０と；バルーン３０の拡張部３１の管壁にその先端（測温部８１）が埋設され、拡張部３１および基端側ネック部３５の管壁並びにアウターチューブ１０（円管状部分１１）のルーメン１０６Ｌに延在し、電気コネクタ２１にその基端が接続された、温度センサ（熱電対）８０とを備えている。 The balloon-type electrode catheter 100 shown in FIGS. 1 to 24 is composed of a circular tubular portion 11 and a semicircular tubular portion 13, and has an outer tube having a central lumen 10L and sublumens 101L to 112L disposed therearound. 10; an electrical connector 21 disposed on the proximal end side of the outer tube 10; an expanding portion 31 that expands and contracts; By having the proximal neck portion 35 fixed to the tubular portion 11 constituting the distal end portion of the outer tube 10 and the extension portion 31 enclosing the semicircular tubular portion 13 constituting the distal end portion of the outer tube 10 A balloon 30 connected to the distal end side of the outer tube 10; a central lumen of the outer tube 10 having a guide wire lumen; 10L, which is inserted into the central lumen 10L, extends into the balloon 30 from the opening of the central lumen 10L, and extends through the inside of the balloon 30; a lumen communicating with the guide wire lumen of the inner tube 41 (guide wire lumen) ), Which is connected to the distal end of the inner tube 41 inside the balloon 30 and is fixed to the distal side neck portion 33 and extends outside the balloon 30; and the expanded portion 31 of the balloon 30; Strip electrodes 51 to 54 (surface electrodes) made of a metal thin film formed on the outer surface of the tip side neck portion 33; and the tip side of the balloon 30 so that the inner peripheral surface of each of the strip electrodes 51 to 54 comes into contact with the tip. By being mounted on the neck portion 33, the metal ring 6 electrically connected to each of the strip electrodes 51 to 54 is provided. The distal end is connected to the inner peripheral surface of the metal ring 60, the inner peripheral surface of the metallic ring 60 extends to the inside of the balloon 30 and the sublumen 112 </ b> L of the outer tube 10 (the tubular portion 11), and the proximal end thereof is connected to the electrical connector 21. The distal end (temperature measuring section 81) is buried in the tube wall of the expansion section 31 of the balloon 30, and the tube wall of the expansion section 31 and the proximal neck section 35 and the outer tube 10 (the circular tubular section 11). A temperature sensor (thermocouple) 80 extending to the lumen 106L and having a proximal end connected to the electrical connector 21 is provided.
　図１および図２において、２０は、アウターチューブ１０の基端側に接続されたＹコネクタ、２２は流体供給用コネクタ、２３は流体排出用コネクタ、２４はガイドワイヤコネ
クタ、２６は導線保護チューブ、２７は流体供給用チューブ、２８は流体排出用チューブである。 1 and 2, 20 is a Y connector connected to the proximal end side of the outer tube 10, 22 is a fluid supply connector, 23 is a fluid discharge connector, 24 is a guide wire connector, 26 is a lead protection tube, 27 is a fluid supply tube, and 28 is a fluid discharge tube.
　図３～図５、図１４、図１５、図１７～図２２に示すように、バルーン型電極カテーテル１００を構成するアウターチューブ１０は、円管状部分１１と半円管状部分１３とからなる。
　アウターチューブ１０の基端部および先端部の一部は円管状部分１１により構成され、アウターチューブ１０の先端部（前記一部を除く）は半円管状部分１３により構成されている。 As shown in FIGS. 3 to 5, 14, 15, and 17 to 22, the outer tube 10 constituting the balloon-type electrode catheter 100 includes a circular tubular portion 11 and a semicircular tubular portion 13.
A part of the proximal end and the distal end of the outer tube 10 is constituted by a circular tubular portion 11, and a distal end (excluding the above-mentioned part) of the outer tube 10 is constituted by a semicircular tubular portion 13.
　図１７、図１９および図２１に示すように、アウターチューブ１０の円管状部分１１の内部には、中央ルーメン１０Ｌと、その周囲に等角度（３０°）間隔に配置された１２本のサブルーメン１０１Ｌ～１１２Ｌとが形成されている。
　円管状部分１１において、サブルーメン１０１Ｌ～１１２Ｌの各々は、これを囲繞するルーメンチューブにより形成され、これらのルーメンチューブは、円管状部分１１を形成するバインダ樹脂により固定されている。 As shown in FIG. 17, FIG. 19 and FIG. 21, inside the tubular portion 11 of the outer tube 10, there are a central lumen 10L and twelve sub-lumens arranged around the same at equal angle (30 °) intervals. 101L to 112L are formed.
In the tubular portion 11, each of the sublumens 101L to 112L is formed by a lumen tube surrounding the same, and these lumen tubes are fixed by a binder resin forming the tubular portion 11.
　図１４および図１５に示すように、アウターチューブ１０の半円管状部分１３の内部には、円管状部分１１の内部から連続して、サブルーメン１０１Ｌ～１０５Ｌが形成されている。
　半円管状部分１３においてサブルーメン１０１Ｌ～１０５Ｌの各々を囲繞するルーメンチューブは、半円管状部分１３を形成するバインダ樹脂により固定されている。 As shown in FIG. 14 and FIG. 15, sublumens 101L to 105L are formed inside the semicircular tubular portion 13 of the outer tube 10 continuously from the inside of the tubular portion 11.
The lumen tube surrounding each of the sublumens 101L to 105L in the semicircular tubular portion 13 is fixed by a binder resin forming the semicircular tubular portion 13.
　図３および図４に示すように、円管状部分１１の内部および半円管状部分１３の内部に配置されているサブルーメン１０１Ｌ～１０５Ｌは、それぞれ、アウターチューブ１０の先端面である半円管状部分１３の先端面１４において開口している。 As shown in FIGS. 3 and 4, the sublumens 101L to 105L disposed inside the tubular portion 11 and the semicircular portion 13 are semicircular tubular portions which are the distal end surfaces of the outer tube 10, respectively. 13 has an opening at the distal end surface 14.
　サブルーメン１０１Ｌ～１０５Ｌの各々は、図１および図２に示した流体供給用コネクタ２２と連通している。
　これにより、サブルーメン１０１Ｌ～１０５Ｌ（アウターチューブ１０に形成されている１２本のサブルーメンのうちの５本のサブルーメン）は、バルーン３０（拡張部３１）の内部に流体を供給するための「流体供給用サブルーメン」となる。
　ここに、バルーン３０の内部に供給される流体としては、生理食塩水を例示することができる。 Each of the sublumens 101L to 105L is in communication with the fluid supply connector 22 shown in FIGS.
As a result, the sub-lumens 101L to 105L (five of the twelve sub-lumens formed in the outer tube 10) supply fluid to the inside of the balloon 30 (expansion portion 31). Fluid supply sublumen ".
Here, the fluid supplied to the inside of the balloon 30 can be exemplified by physiological saline.
　図３および図５に示すように、円管状部分１１の内部に形成されている中央ルーメン１０Ｌおよびサブルーメン１０６Ｌ～１１２Ｌは、それぞれ、円管状部分１１の先端面１２において開口している。
　但し、サブルーメン１０６Ｌ、１１０Ｌおよび１１２Ｌの開口は、図１７に示すシール材９０によって封止されている。 As shown in FIGS. 3 and 5, the central lumen 10L and the sublumens 106L to 112L formed inside the tubular portion 11 are open at the distal end surface 12 of the tubular portion 11, respectively.
However, the openings of the sub-lumens 106L, 110L, and 112L are sealed by a seal material 90 shown in FIG.
　サブルーメン１０７Ｌ～１１１Ｌの各々は、図１に示した流体排出用コネクタ２３と連通している。
　これにより、サブルーメン１０７Ｌ～１０９Ｌおよび１１１Ｌ（アウターチューブ１０に形成されている１２本のサブルーメンのうちの４本のサブルーメン）は、バルーン３０（拡張部３１）の内部に供給された流体をバルーン３０の内部から排出するための「流体排出用サブルーメン」となる。 Each of the sublumens 107L to 111L communicates with the fluid discharge connector 23 shown in FIG.
Accordingly, the sub-lumens 107L to 109L and 111L (four of the twelve sub-lumens formed in the outer tube 10) supply the fluid supplied to the inside of the balloon 30 (expansion portion 31). It serves as a “fluid discharge sublumen” for discharging from inside the balloon 30.
　アウターチューブ１０の構成材料としては、特に限定されるものではないが、例えば、ポリアミド、ポリエーテルポリアミド、ポリエーテルブロックアミド（ＰＥＢＡＸ（登録
商標））およびナイロンなどのポリアミド系樹脂を挙げることができ、これらのうち、ＰＥＢＡＸが好ましい。 The constituent material of the outer tube 10 is not particularly limited, and examples thereof include polyamide-based resins such as polyamide, polyether polyamide, polyether block amide (PEBAX (registered trademark)), and nylon. Of these, PEBAX is preferred.
  アウターチューブ１０の外径（後述する基端部における外径）は、通常１．０～３．３ｍｍとされ、好適な一例を示せば１．４５ｍｍとされる。
  アウターチューブ１０の中央ルーメン１０Ｌの径は、通常０．３５～０．９５ｍｍとされ、好適な一例を示せば０．８５ｍｍとされる。
  アウターチューブ１０のサブルーメン１０１Ｌ～１１２Ｌの径は、通常０．１０～０．７５ｍｍとされ、好適な一例を示せば０．２５ｍｍとされる。
　アウターチューブ１０の長さは、通常１００～２２００ｍｍとされ、好適な一例を示せば１８００ｍｍとされる。 An outer diameter of the outer tube 10 (an outer diameter at a base end to be described later) is usually 1.0 to 3.3 mm, and is 1.45 mm as a preferable example.
The diameter of the central lumen 10L of the outer tube 10 is usually 0.35 to 0.95 mm, and 0.85 mm as a preferable example.
The diameter of the sublumens 101L to 112L of the outer tube 10 is usually 0.10 to 0.75 mm, and is 0.25 mm as a preferable example.
The length of the outer tube 10 is usually 100 to 2200 mm, and is 1800 mm in a preferred example.
　図１および図２に示すように、アウターチューブ１０の基端側には、Ｙコネクタ２０が接続されている。
　図２３に示すように、アウターチューブ１０のサブルーメン１０１Ｌ～１０５Ｌおよびサブルーメン１０７Ｌ～１１１Ｌを囲繞するルーメンチューブは、アウターチューブ１０の基端からＹコネクタ２０の内部に進入している。 As shown in FIGS. 1 and 2, a Y connector 20 is connected to the base end side of the outer tube 10.
As shown in FIG. 23, the lumen tubes surrounding the sub lumens 101L to 105L and the sub lumens 107L to 111L of the outer tube 10 enter the inside of the Y connector 20 from the base end of the outer tube 10.
　図２４に示すように、サブルーメン１０１Ｌ～１０５Ｌ（流体供給用サブルーメン）を囲繞するルーメンチューブの基端部は、Ｙコネクタ２０の内部において、シングルルーメン構造の流体供給用チューブ２７に連結（接着剤９５により固定）されている。
　この流体供給用チューブ２７は、Ｙコネクタ２０の外部に延出し、流体供給用チューブ２７の基端は流体供給用コネクタ２２に連結している。 As shown in FIG. 24, the proximal end of the lumen tube surrounding the sublumens 101L to 105L (fluid supply sublumen) is connected (bonded) to the single lumen structure fluid supply tube 27 inside the Y connector 20. Fixed by an agent 95).
The fluid supply tube 27 extends outside the Y connector 20, and the proximal end of the fluid supply tube 27 is connected to the fluid supply connector 22.
　サブルーメン１０７Ｌ～１１１Ｌを囲繞するルーメンチューブの基端部は、Ｙコネクタ２０の内部において、シングルルーメン構造の流体排出用チューブ２８に連結（接着剤９５により固定）されている。
　この流体排出用チューブ２８は、Ｙコネクタ２０の外部に延出し、流体排出用チューブ２８の基端は流体排出用コネクタ２３に連結している。 The proximal end of the lumen tube surrounding the sublumens 107L to 111L is connected (fixed by an adhesive 95) to the single lumen structure fluid discharge tube 28 inside the Y connector 20.
The fluid discharge tube 28 extends outside the Y connector 20, and the proximal end of the fluid discharge tube 28 is connected to the fluid discharge connector 23.
　バルーン型電極カテーテル１００を構成するバルーン３０は、拡張収縮する拡張部３１と、拡張部３１の先端に連続する先端側ネック部３３と、拡張部３１の基端に連続する基端側ネック部３５とにより構成されている。 The balloon 30 constituting the balloon-type electrode catheter 100 includes an expanding portion 31 that expands and contracts, a distal neck portion 33 continuous with the distal end of the expanding portion 31, and a proximal neck portion 35 continuous with the proximal end of the expanding portion 31. It is composed of
　バルーン３０の拡張部３１は、その内部に流体が供給されることによって拡張し、その内部から流体が排出されることによって収縮する空間形成部分である。
　図１～図５に示すように、バルーン３０の拡張部３１は、円筒状部分３１１と、円筒状部分３１１の先端から先端側ネック部３３の基端に至る先端側コーン部分３１３と、円筒状部分３１１の基端から基端側ネック部３５の先端に至る基端側コーン部分３１５とからなる。 The expansion portion 31 of the balloon 30 is a space forming portion that expands when a fluid is supplied to the inside thereof, and contracts when the fluid is discharged from the inside.
As shown in FIGS. 1 to 5, the expanded portion 31 of the balloon 30 includes a cylindrical portion 311, a distal cone portion 313 extending from the distal end of the cylindrical portion 311 to the proximal end of the distal neck portion 33, A proximal cone portion 315 extends from the proximal end of the portion 311 to the distal end of the proximal neck portion 35.
　アウターチューブ１０の先端部（円管状部分１１によって構成される先端部）に基端側ネック部３５が固定されるとともに、アウターチューブ１０の先端部（半円管状部分１３によって構成される先端部）を拡張部３１が内包していることにより、バルーン３０は、アウターチューブ１０の先端側に接続されている。 The proximal neck 35 is fixed to the distal end of the outer tube 10 (the distal end constituted by the tubular portion 11), and the distal end of the outer tube 10 (the distal end constituted by the semicircular tubular portion 13). The balloon 30 is connected to the distal end side of the outer tube 10 by including the expansion portion 31 in the outer tube 10.
　ここに、バルーン３０の基端側ネック部３５が固定されているアウターチューブ１０の先端部（図１９に示した円管状部分１１）は表層部分が斫られており、その外径は、基端側ネック部３５が固定されていないアウターチューブ１０の基端部（図２１に示した円管状部分１１）の外径より小さくなっている。
　また、図１９に示した基端側ネック部３５の外径は、図２１に示したアウターチューブ１０の基端部の外径と実質的に等しい。 Here, the distal end portion (the circular tubular portion 11 shown in FIG. 19) of the outer tube 10 to which the proximal end neck portion 35 of the balloon 30 is fixed has a surface layer portion cut off. The outer diameter of the outer tube 10 to which the side neck portion 35 is not fixed is smaller than the outer diameter of the proximal end portion (the circular tubular portion 11 shown in FIG. 21).
The outer diameter of the proximal neck portion 35 shown in FIG. 19 is substantially equal to the outer diameter of the proximal portion of the outer tube 10 shown in FIG.
　これにより、バルーン型電極カテーテル１００を導入するために使用するシースや内視鏡の内腔への挿通性が、基端側ネック部３５によって損なわれることを防止することができる。
　また、アウターチューブ１０の外径をシースや内視鏡によって制限される最大径とすることできる（基端側ネック部の厚みによる外径の拡大を考慮する必要がない）ので、アウターチューブ１０のサブルーメン１０１Ｌ～１１２Ｌの径を十分確保することができ、バルーン３０の内部の冷却効果を更に向上させることができる。 Thereby, it is possible to prevent the sheath used to introduce the balloon-type electrode catheter 100 or the endoscope from being impaired by the proximal neck 35 from penetrating the lumen.
In addition, the outer diameter of the outer tube 10 can be set to the maximum diameter limited by the sheath or the endoscope (there is no need to consider the increase in the outer diameter due to the thickness of the proximal neck portion). The diameter of the sublumens 101L to 112L can be sufficiently ensured, and the cooling effect inside the balloon 30 can be further improved.
　図３および図４に示すように、流体供給用サブルーメン１０１Ｌ～１０５Ｌが開口する半円管状部分１３の先端面１４は、バルーン３０の拡張部３１の軸方向の中間位置よりも先端側である円筒状部分３１１の先端近傍に位置している。
　これにより、流体供給用サブルーメン１０１Ｌ～１０５Ｌを流通する流体は、円筒状部分３１１の先端近傍に位置する各々の開口から先端方向に吐出され、吐出された流体は、拡張部３１（先端側コーン部分３１３）の先端近傍に到達することができ、これにより、バルーン３０（拡張部３１）の内部において先端側から基端側への流体の流れを形成することができる。 As shown in FIGS. 3 and 4, the distal end surface 14 of the semicircular tubular portion 13 in which the fluid supply sublumen 101L to 105L is open is located closer to the distal end than the axially intermediate position of the expanded portion 31 of the balloon 30. It is located near the tip of the cylindrical portion 311.
As a result, the fluid flowing through the fluid supply sublumen 101L to 105L is discharged in the distal direction from each of the openings located near the distal end of the cylindrical portion 311. It is possible to reach the vicinity of the distal end of the portion 313), whereby a fluid flow from the distal side to the proximal side can be formed inside the balloon 30 (expansion portion 31).
　流体供給用サブルーメンの開口位置が、バルーンの拡張部の軸方向の中間位置より基端側にある場合には、バルーンの拡張後、当該開口から先端方向に流体を吐出させても、拡張部の先端近傍まで当該流体を到達させることができず、バルーンの内部において先端側から基端側への流体の流れを形成することができない。 When the opening position of the fluid supply sub-lumen is located on the proximal side from the axial middle position of the balloon expansion portion, even if the fluid is discharged from the opening toward the distal end after the balloon expansion, the expansion portion is Cannot reach the vicinity of the distal end of the balloon, and the flow of the fluid from the distal side to the proximal side cannot be formed inside the balloon.
　図３および図５に示すように、流体排出用サブルーメン１０７Ｌ～１０９Ｌおよび１１１Ｌが開口する円管状部分１１の先端面１２は、拡張部３１の基端に位置している。 先端 As shown in FIGS. 3 and 5, the distal end surface 12 of the tubular portion 11 from which the fluid discharge sublumens 107L to 109L and 111L open is located at the base end of the expansion portion 31.
  バルーン３０の構成材料としては、特に限定されるものではなく、従来公知のバルーンカテーテルを構成するバルーンと同一のものを使用することができ、例えば、ポリアミド、ポリエーテルポリアミド、ＰＥＢＡＸおよびナイロンなどのポリアミド系樹脂；熱可塑性ポリエーテルウレタン、ポリエーテルポリウレタンウレア、フッ素ポリエーテルウレタンウレア、ポリエーテルポリウレタンウレア樹脂およびポリエーテルポリウレタンウレアアミドなどのポリウレタン系樹脂を挙げることができる。 The constituent material of the balloon 30 is not particularly limited, and the same material as that of a balloon constituting a conventionally known balloon catheter can be used. For example, polyamide such as polyamide, polyether polyamide, PEBAX and nylon Polyurethane resins such as thermoplastic polyether urethane, polyether polyurethane urea, fluorine polyether urethane urea, polyether polyurethane urea resin, and polyether polyurethane urea amide.
　バルーン３０（拡張部３１）の直径としては、通常０．７～３０．０ｍｍとされ、好適な一例を示せば２．０ｍｍとされる。
　バルーン３０の基端側ネック部３５の外径は、アウターチューブ１０の基端部の外径と実質的に等しく、通常１．０～３．３ｍｍとされ、好適な一例を示せば１．４５ｍｍである。
　バルーン３０（拡張部３１）の長さとしては、通常８～５０ｍｍとされ、好適な一例を示せば２０ｍｍとされる。 The diameter of the balloon 30 (expanded portion 31) is usually 0.7 to 30.0 mm, and is 2.0 mm in a preferred example.
The outer diameter of the proximal end neck portion 35 of the balloon 30 is substantially equal to the outer diameter of the proximal end portion of the outer tube 10, and is usually 1.0 to 3.3 mm, or 1.45 mm in a preferred example. It is.
The length of the balloon 30 (expansion part 31) is usually 8 to 50 mm, and is 20 mm in a preferred example.
　本実施形態のバルーン型電極カテーテル１００においては、インナーチューブ４１と、先端チップ４６とにより、インナーシャフトが構成されている。
　バルーン型電極カテーテル１００を構成するインナーチューブ４１は、ガイドワイヤを挿通可能なルーメン（ガイドワイヤルーメン）を有し、アウターチューブ１０（円管状部分１１）の中央ルーメン１０Ｌに挿通され、その先端部が当該中央ルーメン１０Ｌの開口からバルーン３０（拡張部３１）の内部に延出している。 In the balloon-type electrode catheter 100 according to the present embodiment, the inner tube 41 and the distal end tip 46 constitute an inner shaft.
The inner tube 41 constituting the balloon-type electrode catheter 100 has a lumen (guidewire lumen) through which a guidewire can be inserted, and is inserted into the central lumen 10L of the outer tube 10 (circular tubular portion 11), and its distal end is inserted. The central lumen 10L extends into the balloon 30 (expanded portion 31) from the opening.
　バルーン３０（拡張部３１）の内部に延出したインナーチューブ４１の先端部は、その外周面の半周部分が半円管状部分１３に覆われた状態で、拡張部３１の基端側コーン部分３１５、円筒状部分３１１および先端側コーン部分３１３の内部に延在し、先端側コーン部分３１３の内部において、先端チップ４６に連結されている。 The distal end portion of the inner tube 41 extending into the balloon 30 (expanded portion 31) has a semicircular portion of the outer peripheral surface covered with the semicircular tubular portion 13, and has a proximal-side cone portion 315 of the expanded portion 31. , Extends inside the cylindrical portion 311 and the distal cone portion 313, and is connected to the distal tip 46 inside the distal cone portion 313.
　他方、インナーチューブ４１の基端部は、図２３および図２４に示すように、アウターチューブ１０の基端（中央ルーメン１０Ｌの基端側の開口）からＹコネクタ２０の内部に進入し、Ｙコネクタ２０の内部を延在して、Ｙコネクタ２０の外部に延出しており、インナーチューブ４１の基端は、ガイドワイヤコネクタ２４に連結している。 On the other hand, as shown in FIGS. 23 and 24, the base end of the inner tube 41 enters the inside of the Y connector 20 from the base end of the outer tube 10 (the opening on the base end side of the central lumen 10L), and The inside of the inner tube 41 extends to the outside of the Y connector 20, and the base end of the inner tube 41 is connected to the guide wire connector 24.
　インナーチューブ４１の構成材料としては、従来公知のバルーンカテーテルを構成するインナーチューブと同一のものを使用することができるが、機械的特性に優れた結晶性熱可塑性樹脂であるＰＥＥＫ樹脂（ポリエーテルエーテルケトン樹脂）が好ましい。 As the constituent material of the inner tube 41, the same material as the inner tube constituting the conventionally known balloon catheter can be used. However, PEEK resin (polyetherether) which is a crystalline thermoplastic resin having excellent mechanical properties can be used. Ketone resins) are preferred.
  インナーチューブ４１の外径は、これが挿通されるアウターチューブ１０の中央ルーメン１０Ｌの径と同一であるか僅かに小さく、通常０．３４～０．９９ｍｍとされ、好適な一例を示せば０．８４ｍｍとされる。
  インナーチューブ４１の内径は、通常０．３１～０．９２ｍｍとされ、好適な一例を示せば０．６８ｍｍとされる。 The outer diameter of the inner tube 41 is equal to or slightly smaller than the diameter of the central lumen 10L of the outer tube 10 into which the inner tube 41 is inserted, and is usually 0.34 to 0.99 mm, and 0.84 mm as a preferable example. It is said.
The inner diameter of the inner tube 41 is usually 0.31 to 0.92 mm, and is 0.68 mm in a preferred example.
　バルーン型電極カテーテル１００を構成する先端チップ４６は、インナーチューブ４１のガイドワイヤルーメンに連通するルーメン（ガイドワイヤルーメン）を有し、バルーン３０の拡張部３１の先端側コーン部分３１３の内部においてインナーチューブ４１の先端に接続されるとともに、先端側ネック部３３に固定されてバルーン３０の外部に延出している。先端チップ４６の先端は開口している。 The distal tip 46 constituting the balloon-type electrode catheter 100 has a lumen (guidewire lumen) communicating with the guidewire lumen of the inner tube 41, and the inner tube inside the distal-side cone portion 313 of the expansion section 31 of the balloon 30. It is connected to the distal end of the balloon 41 and is fixed to the distal side neck portion 33 and extends outside the balloon 30. The tip of the tip 46 is open.
　先端チップ４６の構成材料としては、特に限定されるものではないが、例えば、ポリアミド、ポリエーテルポリアミド、ＰＥＢＡＸおよびナイロンなどのポリアミド系樹脂、ポリウレタンなどを挙げることができる。 The constituent material of the tip 46 is not particularly limited, and examples thereof include polyamide, polyether polyamide, polyamide resins such as PEBAX and nylon, and polyurethane.
　先端チップ４６の内径は、インナーチューブ４１の内径と実質的に同一であり、通常０．３１～０．９２ｍｍとされ、好適な一例を示せば０．６８ｍｍとされる。
　先端チップ４６の外径は、通常０．３５～２．６ｍｍとされ、好適な一例を示せば１．０ｍｍとされる。
　先端チップ４６が固定されるバルーン３０の先端側ネック部３３の外径は、通常０．３７～３．３ｍｍとされ、好適な一例を示せば１．１８ｍｍである。 The inner diameter of the distal end tip 46 is substantially the same as the inner diameter of the inner tube 41, and is usually 0.31 to 0.92 mm, and 0.68 mm as a preferable example.
The outer diameter of the distal end tip 46 is usually 0.35 to 2.6 mm, and is 1.0 mm in a preferred example.
The outer diameter of the distal end neck portion 33 of the balloon 30 to which the distal end tip 46 is fixed is usually 0.37 to 3.3 mm, and is 1.18 mm as a preferable example.
　図３～図７および図９～図１５に示すように、バルーン３０（拡張部３１の円筒状部分３１１および先端側コーン部分３１３並びに先端側ネック部３３）の外表面には、高周波電流が通電される表面電極として、バルーン３０の軸方向に沿って延びるよう金属薄膜によって形成された帯状電極５１～５４が、バルーン３０の円周方向に沿って９０°間隔で配置されている。 As shown in FIGS. 3 to 7 and FIGS. 9 to 15, a high-frequency current is applied to the outer surfaces of the balloon 30 (the cylindrical portion 311 and the distal cone portion 313 of the expanded portion 31 and the distal neck portion 33). As surface electrodes to be formed, strip-shaped electrodes 51 to 54 formed of a metal thin film so as to extend along the axial direction of the balloon 30 are arranged at 90 ° intervals along the circumferential direction of the balloon 30.
  帯状電極５１～５４を構成する金属薄膜の構成材料としては、金、白金、銀、銅およびこれらの合金、ステンレススチールなどを挙げることができる。
  帯状電極５１～５４を構成する金属薄膜の膜厚としては０．５～５．０μｍであることが好ましく、更に好ましくは１．０～２．５μｍとされる。
  この膜厚が過小である場合には、手技中（高周波通電中）において、ジュール熱により金属薄膜が高温となるおそれがある。
  他方、薄膜の膜厚が過大である場合には、拡張収縮に伴うバルーンの形状変化に当該金
属薄膜が追従しにくくなり、バルーンの拡張・収縮性が損なわれることがある。 As a constituent material of the metal thin film forming the strip electrodes 51 to 54, gold, platinum, silver, copper and alloys thereof, stainless steel and the like can be mentioned.
The thickness of the metal thin film forming the strip electrodes 51 to 54 is preferably 0.5 to 5.0 μm, and more preferably 1.0 to 2.5 μm.
If the film thickness is too small, the metal thin film may become hot due to Joule heat during the procedure (during high-frequency current application).
On the other hand, when the thickness of the thin film is excessively large, the metal thin film does not easily follow the shape change of the balloon due to expansion and contraction, and the expansion and contraction properties of the balloon may be impaired.
　帯状電極５１～５４を構成する金属薄膜をバルーン３０の外表面に形成する方法としては特に限定されるものではなく、蒸着、スパッタリング、メッキ、印刷など、通常の金属薄膜形成方法を採用することができる。 The method for forming the metal thin film forming the strip electrodes 51 to 54 on the outer surface of the balloon 30 is not particularly limited, and a normal metal thin film forming method such as vapor deposition, sputtering, plating, and printing may be employed. it can.
　図３、図４、図６、図９および図１０に示すように、バルーン３０の先端側ネック部３３には金属リング６０が装着されている。
　バルーン型電極カテーテル１００を構成する金属リング６０は、その内周面が帯状電極５１～５４の各々の先端部に接触するようにして、先端側ネック部３３にかしめ固定されており、これにより、帯状電極５１～５４の各々と金属リング６０とが電気的に接続されている。 As shown in FIGS. 3, 4, 6, 9 and 10, a metal ring 60 is mounted on the distal end neck 33 of the balloon 30.
The metal ring 60 constituting the balloon-type electrode catheter 100 is caulked and fixed to the distal-end-side neck portion 33 such that the inner peripheral surface thereof comes into contact with the distal end portion of each of the strip electrodes 51 to 54. Each of the strip electrodes 51 to 54 and the metal ring 60 are electrically connected.
　金属リング６０の構成材料としては、白金または白金系の合金などを挙げることができる。図９に示すように、金属リング６０は、樹脂材料６５によって絶縁被覆されている。これにより、通電時の金属リング６０が高温になることを防止することができ、金属リング６０の周囲の正常組織が焼灼されるようなことを回避することができる。 構成 As a constituent material of the metal ring 60, platinum or a platinum-based alloy can be used. As shown in FIG. 9, the metal ring 60 is insulated and covered with a resin material 65. Thus, it is possible to prevent the metal ring 60 from being heated at the time of energization, and to avoid cauterizing normal tissue around the metal ring 60.
　先端側ネック部３３に装着される金属リング６０の内径は、先端側ネック部３３の外径と実質的に同一であり、通常０．３７～３．３ｍｍとされ、好適な一例を示せば１．１８ｍｍとされる。
　先端側ネック部３３に装着される金属リング６０の外径は、アウターチューブ１０や基端側ネック部３５の外径よりも小さく、通常０．９８～３．２８ｍｍとされ、好適な一例を示せば１．３２ｍｍとされる。 The inner diameter of the metal ring 60 attached to the distal side neck 33 is substantially the same as the outer diameter of the distal side neck 33, usually 0.37 to 3.3 mm. .18 mm.
The outer diameter of the metal ring 60 attached to the distal neck portion 33 is smaller than the outer diameter of the outer tube 10 and the proximal neck portion 35, and is usually 0.98 to 3.28 mm. For example, it is 1.32 mm.
　金属リング６０の内周面には導線７０の先端が固定されている。
　この導線７０は、図９および図１１に示すように、先端チップ４６の管壁内に延在し、図１２、図１４および図１５に示すように、インナーチューブ４１に沿ってバルーン３０の拡張部３１の内部に延在し、図１７、図１９および図２１に示すように、アウターチューブ１０（円管状部分１１）のサブルーメン１１２Ｌに延在し、図２３および図２４に示すように、Ｙコネクタ２０の内部に延在し、Ｙコネクタ２０から延出する導線保護チューブ２６の内部を通ってＹコネクタ２０から延出している。 The distal end of the conducting wire 70 is fixed to the inner peripheral surface of the metal ring 60.
This conducting wire 70 extends into the tube wall of the distal end tip 46 as shown in FIGS. 9 and 11, and expands the balloon 30 along the inner tube 41 as shown in FIGS. 12, 14 and 15. Extending inside the portion 31 and extending to the sublumen 112L of the outer tube 10 (circular tubular portion 11) as shown in FIGS. 17, 19 and 21, and as shown in FIGS. 23 and 24, It extends inside the Y connector 20 and extends from the Y connector 20 through the inside of a conductor protection tube 26 extending from the Y connector 20.
　導線７０の基端は電気コネクタ２１に接続されている。この電気コネクタ２１は、帯状電極５１～５４にの各々に高周波電流を通電する通電用コネクタとしての機能と、温度センサ８０を温度測定器に接続するための熱電対コネクタとの機能を兼ね備えている。 基 The base end of the conducting wire 70 is connected to the electric connector 21. The electric connector 21 has both a function as an energizing connector for applying a high-frequency current to each of the strip electrodes 51 to 54 and a function as a thermocouple connector for connecting the temperature sensor 80 to a temperature measuring instrument. .
　金属リング６０および導線７０を介して、帯状電極５１～５４の各々を、電気コネクタ２１に接続することにより、帯状電極５１～５４の各々に対して均等に高周波電流を通電することができる。 (4) By connecting each of the strip electrodes 51 to 54 to the electrical connector 21 via the metal ring 60 and the conducting wire 70, a high-frequency current can be uniformly applied to each of the strip electrodes 51 to 54.
  導線７０の構成材料としては、例えば、銅、銀、金、白金、タングステンおよびこれら金属の合金を挙げることができ、フッ素樹脂などの電気絶縁性保護被覆が施されていることが好ましい。 (5) Examples of the constituent material of the conductive wire 70 include copper, silver, gold, platinum, tungsten and alloys of these metals, and it is preferable that an electrically insulating protective coating such as a fluororesin is applied.
　図３、図５、図１５～図２０に示すように、バルーン３０の管壁には、熱電対からなる温度センサ８０が埋設配置されている。この温度センサ８０の側温部８１（測温接点）は、拡張部３１の管壁に位置している。 As shown in FIGS. 3, 5, and 15 to 20, a temperature sensor 80 composed of a thermocouple is embedded in the tube wall of the balloon 30. The side temperature section 81 (temperature measurement contact) of the temperature sensor 80 is located on the tube wall of the extension section 31.
　図１９～図２２に示すように、温度センサ８０は、バルーン３０の基端側ネック部３５
の管壁からアウターチューブ１０（円管状部分１１）のサブルーメン１０６Ｌに進入して当該サブルーメン１０６Ｌに延在し、図２３および図２４に示すように、導線７０とともに、Ｙコネクタ２０の内部に延在し、Ｙコネクタ２０から延出する導線保護チューブ２６の内部を通ってＹコネクタ２０から延出している。
　温度センサ８０の基端は電気コネクタ２１に接続されている。 As shown in FIGS. 19 to 22, the temperature sensor 80 is connected to the proximal neck 35 of the balloon 30.
23 and 24, the sub-lumen 106L of the outer tube 10 (circular tubular portion 11) enters the sub-lumen 106L and extends to the sub-lumen 106L. As shown in FIGS. It extends from the Y connector 20 through the inside of a wire protection tube 26 that extends and extends from the Y connector 20.
The base end of the temperature sensor 80 is connected to the electric connector 21.
　本実施形態のバルーン型電極カテーテル１００によれば、バルーン３０の外表面に形成された帯状電極５１～５４の各々により、脈管またはその周囲における病巣に対して広範囲にわたる高周波焼灼治療を行うことができる。 According to the balloon-type electrode catheter 100 of the present embodiment, a wide range of high-frequency ablation treatment can be performed on a lesion in or around a blood vessel by each of the band-shaped electrodes 51 to 54 formed on the outer surface of the balloon 30. it can.
　また、帯状電極５１～５４の各々の先端部にその内周面が接触するように、金属リング６０がバルーン３０の先端側ネック部に装着されていることにより、帯状電極５１～５４の各々が、当該金属リング６０および導線７０を介して電気コネクタ２１に電気的に接続されているので、帯状電極５１～５４の各々に対して均等に高周波電流を通電することができ、これにより、脈管またはその周囲における病巣組織を当該脈管の円周方向に沿って均質に焼灼治療することができる。 The metal ring 60 is mounted on the distal end neck of the balloon 30 so that the inner peripheral surface of the distal end of each of the strip electrodes 51 to 54 comes into contact with the distal end of each of the strip electrodes 51 to 54. Since it is electrically connected to the electrical connector 21 via the metal ring 60 and the conducting wire 70, high-frequency current can be uniformly applied to each of the strip electrodes 51 to 54, and thereby, Alternatively, the lesion tissue around it can be uniformly cauterized along the circumferential direction of the vessel.
　また、バルーン３０の先端側ネック部３３に装着されている金属リング６０の外径は、アウターチューブ１０や基端側ネック部３５の外径よりも小さいので、導入時に使用するシースや内視鏡の開口に金属リング６０が引っ掛かるようなことはなく、シースや内視鏡の内腔へのバルーン型電極カテーテル１００の挿通性が損なわれることがない。 Further, since the outer diameter of the metal ring 60 attached to the distal neck portion 33 of the balloon 30 is smaller than the outer diameter of the outer tube 10 and the proximal neck portion 35, a sheath or an endoscope used at the time of introduction is used. There is no possibility that the metal ring 60 is caught in the opening of the balloon electrode, and the penetrability of the balloon-type electrode catheter 100 into the lumen of the sheath or the endoscope is not impaired.
　また、流体供給用サブルーメン１０１Ｌ～１０５Ｌの各々が、バルーン３０の拡張部３１の円筒状部分３１１の先端近傍に位置する半円管状部分１３の先端面１４において開口し、流体排出用サブルーメン１０７Ｌ～１０９Ｌおよび１１１Ｌの各々が、バルーン３０の拡張部３１の基端に位置する円管状部分１１の先端面１２において開口していることにより、バルーン３０の拡張後（内部に流体が充填された後）であっても、バルーン３０の内部において、先端側から基端側への流体の流れを形成することができ、当該流体を流動させることができる。 Further, each of the fluid supply sub-lumens 101L to 105L is opened at the distal end surface 14 of the semicircular tubular portion 13 located near the distal end of the cylindrical portion 311 of the expansion portion 31 of the balloon 30, and the fluid discharge sub-lumen 107L is provided. １０９109L and 111L are open at the distal end face 12 of the tubular portion 11 located at the base end of the expansion portion 31 of the balloon 30, so that the balloon 30 can be expanded (after the fluid is filled therein). ), The flow of the fluid from the distal side to the proximal side can be formed inside the balloon 30, and the fluid can flow.
　特に、流体供給用サブルーメン１０１Ｌ～１０５Ｌの開口から、先端方向に吐出される流体が、拡張部３１の先端側コーン部分３１３の内壁面に当たり、その後、拡張部３１の円筒状部分３１１および基端側コーン部分３１５の内壁面に沿って基端方向に流れることにより、バルーン３０（拡張部３１）の内部において流体を循環させることができる。 In particular, the fluid discharged in the distal direction from the openings of the fluid supply sub-lumens 101L to 105L hits the inner wall surface of the distal-side cone portion 313 of the extension portion 31, and thereafter, the cylindrical portion 311 and the base end of the extension portion 31 By flowing in the proximal direction along the inner wall surface of the side cone portion 315, a fluid can be circulated inside the balloon 30 (expansion portion 31).
　この結果、バルーン３０の内部を、拡張部３１の全域にわたり効率よく冷却することができ、これにより、帯状電極５１～５４の周囲の組織が十分に冷却され、当該組織が線維化されることを確実に防止することができる。 As a result, it is possible to efficiently cool the inside of the balloon 30 over the entire area of the expansion section 31, and thereby to sufficiently cool the tissues around the band-shaped electrodes 51 to 54 and convert the tissues to fibrosis. It can be reliably prevented.
　また、アウターチューブ１０に配置された流体供給用サブルーメン１０１Ｌ～１０５Ｌは５本であり、流体排出用サブルーメン１０７Ｌ～１０９Ｌおよび１１１Ｌは４本であるので、バルーン３０の内部を一定の圧力（拡張圧力）に維持することができる。 Further, since five sub-lumens 101L to 105L for fluid supply and four sub-lumens 107L to 109L and 111L for fluid discharge arranged in the outer tube 10, the inside of the balloon 30 is maintained at a constant pressure (expansion). Pressure).
　本実施形態のバルーン型電極カテーテル１００が適用可能な症例としては、脈管またはその周囲における腫瘍や迷走神経などであり、具体的には、胆管ガン、肺ガン、肝ガン、腎臓ガン、副腎腺腫、腎動脈迷走神経などを挙げることができる。 The cases to which the balloon-type electrode catheter 100 of the present embodiment can be applied include tumors and vagus nerves in or around blood vessels, and specifically, bile duct cancer, lung cancer, liver cancer, kidney cancer, adrenal adenoma And renal artery vagus nerve.
　以上、本発明の実施形態について説明したが、本発明はこれらの実施形態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、バルーン３０の内部における半円管状部分１３の先端面１４の位置（流体供給
用サブルーメン１０１Ｌ～１０５Ｌの開口位置）は、拡張部３１の軸方向の中間位置よりも先端側であれば、拡張部３１の円筒状部分３１１の先端近傍でなくてもよい。 Although the embodiments of the present invention have been described above, the present invention is not limited to these embodiments, and various modifications are possible.
For example, if the position of the distal end surface 14 of the semicircular tubular portion 13 inside the balloon 30 (the opening position of the fluid supply sub-lumens 101L to 105L) is on the distal end side with respect to the axially intermediate position of the expansion portion 31, It does not need to be near the tip of the cylindrical portion 311 of the extension portion 31.
　また、本発明のバルーン型電極カテーテルにおいて、流体供給用サブルーメンおよび／または流体排出用サブルーメンの開口をアウターチューブの外周面に形成し、流体をアウターチューブの半径方向に吐出／排出してもよい。 In the balloon-type electrode catheter of the present invention, the opening of the fluid supply sublumen and / or the fluid discharge sublumen is formed on the outer peripheral surface of the outer tube, and the fluid is discharged / discharged in the radial direction of the outer tube. Good.
　また、流体供給用サブルーメンの開口が、バルーンの拡張部の基端またはその近傍に位置し、流体排出用サブルーメンの開口が、拡張部の軸方向の中間位置よりも先端側に位置するようにしてもよい。 In addition, the opening of the fluid supply sublumen is located at or near the proximal end of the expansion portion of the balloon, and the opening of the fluid discharge sublumen is located more distally than the axial middle position of the expansion portion. It may be.
　また、流体供給用サブルーメンおよび流体排出用サブルーメンが互いに同じ軸方向位置に開口していてもよい。 The fluid supply sub-lumen and the fluid discharge sub-lumen may be open at the same axial position.
１００　バルーン型電極カテーテル
　１０　アウターチューブ
　１０Ｌ　中央ルーメン
　１０１Ｌ～１０５Ｌ　　　　　　サブルーメン（流体供給用サブルーメン）
　１０７Ｌ～１０９Ｌ，１１１Ｌ　サブルーメン（流体排出用サブルーメン）
　１０６Ｌ，１１０Ｌ，１１２Ｌ　サブルーメン
　１１　円管状部分
　１２　円管状部分の先端面
　１３　半円管状部分
　１４　半円管状部分の先端面
　２０　Ｙコネクタ
　２１　電気コネクタ
　２２　流体供給用コネクタ
　２３　流体排出用コネクタ
　２４　ガイドワイヤコネクタ
　２６　導線保護チューブ
　２７　流体供給用チューブ
　２８　流体排出用チューブ
　３０　バルーン
　３１　拡張部
　３１１　円筒状部分３１１
　３１３　先端側コーン部分３１３
　３１５　基端側コーン部分３１５
　３３　先端側ネック部
　３５　基端側ネック部
　４１　インナーチューブ
　４６　先端チップ
　５１～５４　帯状電極（表面電極）
　６０　金属リング
　７０　導線
　８０　温度センサ（熱電対）
　８１　温度センサの測温部
　９０　シール材
　９５　接着剤 100 Balloon type electrode catheter 10 Outer tube 10L Central lumen 101L-105L Sublumen (sublumen for fluid supply)
107L to 109L, 111L Sublumen (sublumen for fluid discharge)
106L, 110L, 112L Sublumen 11 Circular section 12 Tip face of tubular section 13 Semicircular section 14 Tip face of semicircular section 20 Y connector 21 Electrical connector 22 Connector for fluid supply 23 Connector for fluid discharge 24 Guide wire Connector 26 Conductive wire protection tube 27 Fluid supply tube 28 Fluid discharge tube 30 Balloon 31 Expansion part 311 Cylindrical part 311
313 Tip cone section 313
315 proximal cone portion 315
33 distal end neck 35 proximal end neck 41 inner tube 46 distal tip 51-54 strip electrode (surface electrode)
60 Metal ring 70 Conductor 80 Temperature sensor (thermocouple)
81 Temperature measurement part of temperature sensor 90 Seal material 95 Adhesive

Claims (8)

  1. 　経脈管的に導入され、脈管またはその周囲の組織を高周波焼灼治療するためのバルーン型の電極カテーテルであって、
    　中央ルーメンと、その周囲に複数配置されたサブルーメンとを有するアウターチューブと、
    　前記アウターチューブの基端側に配置された通電用コネクタと、
    　拡張収縮する拡張部と、その両端に連続するネック部とを有し、基端側ネック部が前記アウターチューブの先端部に固定されることにより、当該アウターチューブの先端側に接続されたバルーンと、
    　ガイドワイヤを挿通可能なルーメンを有し、前記アウターチューブの前記中央ルーメンに挿通されて、当該中央ルーメンの開口から前記バルーンの内部に延出し、当該バルーンの内部を延在するインナーチューブと、
    　前記インナーチューブの前記ルーメンに連通するルーメンを有し、前記バルーンの内部において前記インナーチューブの先端に接続されるとともに、先端側ネック部に固定されて前記バルーンの外部に延出する先端チップと、
    　前記拡張部および前記先端側ネック部における前記バルーンの外表面に形成された金属薄膜からなる表面電極と、
    　前記表面電極の先端部にその内周面が接触するように、前記バルーンの前記先端側ネック部に装着されることにより、前記表面電極と電気的に接続された金属リングと、
    　前記金属リングの内周面にその先端が固定され、前記バルーンの内部および前記アウターチューブの何れかの前記サブルーメンに延在して、その基端が前記通電用コネクタに固定されることにより、前記表面電極と前記通電用コネクタとを電気的に接続する導線と
    　を備えていることを特徴とするバルーン型電極カテーテル。     A balloon-type electrode catheter to be introduced transvascularly and to perform high-frequency ablation treatment on the blood vessel or surrounding tissue,
    An outer tube having a central lumen and a plurality of sub-lumens disposed therearound,
    A current-carrying connector arranged on the proximal end side of the outer tube,
    An expansion portion that expands and contracts, and a neck connected to the distal end of the outer tube, having a continuous neck at both ends thereof, and having a proximal neck fixed to the distal end of the outer tube. ,
    An inner tube having a lumen through which a guide wire can be inserted, being inserted into the central lumen of the outer tube, extending from the opening of the central lumen into the balloon, and extending inside the balloon,
    A distal tip having a lumen communicating with the lumen of the inner tube, connected to a distal end of the inner tube inside the balloon, and fixed to a distal neck portion and extending outside the balloon;
    A surface electrode made of a metal thin film formed on the outer surface of the balloon in the expanded portion and the distal neck portion,
    A metal ring electrically connected to the surface electrode by being mounted on the distal end neck of the balloon so that the inner peripheral surface thereof is in contact with the front end of the surface electrode,
    The distal end is fixed to the inner peripheral surface of the metal ring, and extends to the inside of the balloon and the sub-lumen of any of the outer tubes, and the base end is fixed to the energizing connector, A balloon-type electrode catheter, comprising: a lead wire for electrically connecting the surface electrode and the current-carrying connector.
  2. 　前記表面電極は、前記バルーンの軸方向に沿って延びるように形成され、当該バルーンの円周方向に沿って等角度間隔に配置された複数の帯状電極であり、前記帯状電極の各々の先端部に前記金属リングの内周面が接触していることを特徴とする請求項１に記載のバルーン型電極カテーテル。 The surface electrodes are formed to extend along the axial direction of the balloon, and are a plurality of strip electrodes arranged at equal angular intervals along the circumferential direction of the balloon. 2. The balloon-type electrode catheter according to claim 1, wherein an inner peripheral surface of the metal ring is in contact with the metal ring.
  3. 　前記金属リングが絶縁被覆されていることを特徴とする請求項１または２に記載のバルーン型電極カテーテル。 (3) The balloon-type electrode catheter according to (1) or (2), wherein the metal ring is coated with an insulating material.
  4. 　前記アウターチューブの有する前記サブルーメンの少なくとも１本は、前記バルーンの内部に流体を供給するために当該流体を流通させる流体供給用サブルーメンであり、
    　前記アウターチューブの有する前記サブルーメンの少なくとも１本は、前記バルーンの内部に供給された流体を当該バルーンの内部から排出するために、当該流体を流通させる流体排出用サブルーメンであることを特徴とする請求項１～３の何れかに記載のバルーン型電極カテーテル。     At least one of the sublumens having the outer tube is a fluid supply sublumen that circulates the fluid in order to supply a fluid to the inside of the balloon,
    At least one of the sub-lumens that the outer tube has is a fluid-discharging sub-lumen that allows the fluid to flow in order to discharge the fluid supplied to the inside of the balloon from the inside of the balloon. The balloon-type electrode catheter according to any one of claims 1 to 3.
  5. 　前記バルーンの前記基端側ネック部に固定された前記アウターチューブの前記先端部を前記バルーンの前記拡張部が内包しており、
    　前記流体供給用サブルーメンの開口は、前記拡張部の軸方向の中間位置よりも先端側に位置し、
    　前記流体排出用サブルーメンの開口は、前記拡張部の前記基端またはその近傍に位置していることを特徴とする請求項４に記載のバルーン型電極カテーテル。     The distal end portion of the outer tube fixed to the proximal neck portion of the balloon is included in the expanded portion of the balloon,
    The opening of the fluid supply sub-lumen is located more distally than the axially intermediate position of the expansion portion,
    The balloon-type electrode catheter according to claim 4, wherein an opening of the fluid discharge sublumen is located at or near the proximal end of the expansion section.
  6. 　前記流体供給用サブルーメンの数が前記流体排出用サブルーメンの数よりも多いことを特徴とする請求項４または５に記載のバルーン型電極カテーテル。 6. The balloon-type electrode catheter according to claim 4, wherein the number of the sub-lumens for supplying fluid is larger than the number of sub-lumens for discharging fluid. 7.
  7. 　前記バルーンの前記基端側ネック部が固定されている前記アウターチューブの前記先端部の外径が、当該アウターチューブの基端部の外径よりも小さく形成されており、
    　前記バルーンの前記基端側ネック部の外径と、前記アウターチューブの前記基端部の外径とが実質的に等しいことを特徴とする請求項１～６の何れかに記載のバルーン型電極カテーテル。     The outer diameter of the distal end portion of the outer tube to which the proximal neck portion of the balloon is fixed is formed smaller than the outer diameter of the proximal end portion of the outer tube,
    The balloon-type electrode according to any one of claims 1 to 6, wherein an outer diameter of the proximal end portion of the balloon and an outer diameter of the proximal end portion of the outer tube are substantially equal. catheter.
  8. 　前記バルーンの管壁に温度センサが配置されていることを特徴とする請求項１～６の何れかに記載の電極カテーテル。 (7) The electrode catheter according to any one of (1) to (6), wherein a temperature sensor is arranged on a tube wall of the balloon.
PCT/JP2018/030365 2018-08-15 2018-08-15 Balloon-type electrode catheter WO2020035918A1 (en)

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