WO2023021618A1 - Electrode catheter - Google Patents
Electrode catheter Download PDFInfo
- Publication number
- WO2023021618A1 WO2023021618A1 PCT/JP2021/030207 JP2021030207W WO2023021618A1 WO 2023021618 A1 WO2023021618 A1 WO 2023021618A1 JP 2021030207 W JP2021030207 W JP 2021030207W WO 2023021618 A1 WO2023021618 A1 WO 2023021618A1
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- WIPO (PCT)
- Prior art keywords
- tip
- electrode
- diameter
- catheter shaft
- catheter
- Prior art date
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
Definitions
- the present invention relates to an electrode catheter, and more specifically, a tip electrode made of a porous material is attached to the distal end side of a catheter shaft, and the surface of the tip electrode can be irrigated with a liquid such as physiological saline. It relates to electrode catheters.
- Electrode catheters such as ablation catheters are equipped with an irrigation mechanism in order to cool the tip electrode, which has become hot during cauterization, and to prevent the formation of thrombi on the surface of the tip electrode. .
- an electrode catheter equipped with an irrigation mechanism it consists of a catheter shaft having a central lumen serving as a liquid flow path and a conductive porous material (porous metal) connected to the tip side of this catheter shaft.
- a tip electrode having a tip electrode has been introduced (see Patent Document 1).
- the tip electrode that constitutes the electrode catheter described in Patent Document 1 has a cylindrical portion located on the proximal end side and is fixed while being inserted into the central lumen from the tip opening of the central lumen, thereby forming a catheter shaft.
- a cannonball shape Fig. 3 of the same document
- a cylindrical shape Figs. 4 and 5
- a bulbous shape Fig. 2
- the tip electrode is composed of a porous material (porous metal) that allows liquid to pass through. For this reason, the liquid supplied to the central lumen of the catheter shaft is permeated into the tip electrode from the base end surface of the cylindrical portion inserted in the central lumen, and then exuded to the surface of the tip electrode to perform irrigation. be able to.
- the electrode catheter described in Patent Document 1 has the following problems. (1) At the junction (boundary) between the catheter shaft and the tip electrode, an edge is inevitable due to the step between the outer peripheral surface of the cylindrical portion inserted into the central lumen of the catheter shaft and the outer peripheral surface of the electrode portion that appears externally. is formed. During ablation treatment, when the connection between the catheter shaft and the tip electrode comes into contact with body tissue, the current density at the edge becomes extremely high, causing an abnormal temperature rise around the connection and rapid thrombus formation. There is a risk.
- a tip electrode made of a solid porous material it takes time for a liquid that has permeated the inside of the electrode from the base end surface of the cylindrical portion to move in the axial direction inside the electrode and reach the electrode surface at the tip portion. It takes a rather long time, and because of this, the surface of the tip portion of the tip electrode cannot be sufficiently irrigated.
- An object of the present invention is to prevent abnormal temperature rise around the connecting portion (boundary) between the catheter shaft and the tip electrode during ablation treatment, and to An object of the present invention is to provide an electrode catheter that can evenly irrigate the entire surface of the tip electrode, including the .
- the electrode catheter of the present invention comprises a catheter shaft having a lumen serving as a fluid flow path, and a tip electrode made of a porous material connected to the tip side of the catheter shaft,
- the tip electrode has a proximal portion whose diameter increases in the distal direction from the distal end of the catheter shaft, and a distal portion which continues to the proximal portion and decreases in diameter in the distal direction.
- a wall thickness of the tip electrode surrounding the interior space is characterized by being substantially uniform throughout the proximal portion and the distal portion.
- substantially uniform means that the variation in wall thickness [(maximum wall thickness-minimum wall thickness)/average wall thickness] is within ⁇ 20%.
- the electrode catheter having such a configuration, since the base end portion of the tip electrode is expanded in the distal direction, the boundary between the tip electrode and the catheter shaft is prevented from coming into contact with body tissue during ablation treatment. As a result, it is possible to prevent an abnormal temperature rise from occurring around the boundary.
- the tip electrode is made of a porous material that allows liquid to permeate (move)
- an internal space communicating with the lumen of the catheter shaft is intentionally formed in the tip electrode.
- the substantially uniform wall thickness of the electrode throughout the proximal and distal portions allows for uniform irrigation of the entire surface of the tip electrode, including the distal portion and portions of large outer diameter.
- the catheter shaft has a tip-reduced diameter portion whose diameter is reduced in the distal direction, It is preferable that the base end portion of the tip electrode expands in diameter from the tip of the tip reduced diameter portion, which is the tip of the catheter shaft, toward the tip.
- the diameter of the tip reduced diameter portion is reduced in the distal direction, and the diameter of the proximal end portion of the tip electrode is expanded in the distal direction.
- a constriction is formed by the part. This ensures that the boundary between the tip electrode and the catheter shaft does not come into contact with body tissue during ablation treatment, thereby preventing abnormal temperature rise around the boundary. be able to.
- the distal end portion of the distal end electrode has a partially spherical shape with a diameter equal to the maximum outer diameter of the proximal end portion.
- the angle ( ⁇ ) formed by the tapered distal end portion and the proximal portion of the distal electrode is 160° or less. preferable. As a result, it is possible to more reliably avoid the interface between the tip electrode and the catheter shaft from coming into contact with body tissue during the ablation treatment.
- the value of (t)/(D 30 ) is 0.12 to 0, where (D 30 ) is the maximum outer diameter of the tip electrode and (t) is the wall thickness. .25 is preferred.
- the electrode catheter of the present invention during ablation treatment, it is possible to prevent abnormal temperature rise around the boundary between the tip electrode and the catheter shaft, and to prevent the tip portion and the large outer diameter portion from The entire surface of the tip electrode, including, can be evenly irrigated from the inside.
- FIG. 1 is a front view of an ablation catheter according to one embodiment of the invention
- FIG. FIG. 2 is a detailed view of part II of FIG. 1
- FIG. 2 is a cross-sectional view taken along line III-III in FIG. 1
- FIG. 4 is a sectional view along IV-IV of FIGS. 2 and 3;
- the ablation catheter 100 of this embodiment shown in FIGS. 1 to 4 has a distal flexible portion 102, and a catheter shaft 10 formed with eight lumens 11L to 18L including lumens 11L and 12L serving as fluid flow paths.
- a tip electrode 30 made of a conductive porous material connected to the tip side of the catheter shaft 10, three ring-shaped electrodes 41 to 43 attached to the tip flexible portion 102 of the catheter shaft 10, and the catheter shaft 10 is inserted through the interior of the catheter shaft 10 (lumens 15L and 17L) to flex the distal flexible portion 102 of 10 in a first direction (the direction indicated by arrow A in FIG. 2), and its distal end is connected to the anchor member 20.
- a second operation wire 22 which is inserted through the inside of the catheter shaft 10 (lumens 16L and 18L), whose distal end is connected and fixed to the anchor member 20, and whose proximal end can be pulled and operated, and the lumen 11L of the catheter shaft 10. and 12L, a leaf spring 60 for oscillation arranged inside the tip flexible portion 102 along the axial direction of the catheter shaft 10, and a base of the catheter shaft 10.
- the catheter shaft 10 has a distally tapered portion 101 with a distally tapered diameter, and the tip electrode 30 is located at the distal end.
- a base end portion 32 that expands in diameter from the tip position of the diameter-reduced portion 101 toward the tip, and a hemispherical tip portion 31 that is continuous with the base end portion 32 and has a diameter equal to the maximum outer diameter (D 30 ) of the base end portion 32.
- the tip electrode 30 is a hollow structure with an internal space 36 communicating with the lumens 11L and 12L of the catheter shaft 10, and the wall thickness of the tip electrode 30 surrounding this internal space 36 is equal to the proximal end. It is substantially uniform throughout portion 32 and tip portion 31 .
- the ablation catheter 100 includes a catheter shaft 10, a tip electrode 30, ring electrodes 41 to 43, a first operation wire 21, a second operation wire 22, flow channel forming tubes 51 and 52, and a plate. It comprises a spring 60, a control handle 70 and an injection tube 80 for irrigation fluid.
- a catheter shaft 10 that constitutes an ablation catheter 100 has a distal flexible portion 102 .
- the "flexible tip portion” refers to a portion of the catheter shaft that can be flexed (bent) by pulling the proximal end of the operation wire (first operation wire 21 or second operation wire 22). Refers to the tip.
- the length (L 10 ) of the catheter shaft 10 is usually 600-1500 mm, preferably 900-1200 mm, and a preferred example is 1100 mm.
- the length of the tip flexible portion 102 is generally 25-100 mm, preferably 45-80 mm, and a preferred example is 60 mm.
- the outer diameter (D 10 ) of the catheter shaft 10 is usually 1.0-3.0 mm, preferably 1.6-3.0 mm, and a preferred example is 2.75 mm.
- the catheter shaft 10 has a tip reduced-diameter portion 101 on the tip side of the tip flexible portion 102, the diameter of which is reduced in the tip direction.
- the length (L 101 ) of the reduced diameter portion 101 is usually 1.0 to 5.0 mm, preferably 1.0 to 3.0 mm, and a preferred example is 1.2 mm.
- the outer diameter (D 101 ) at the tip of the tip reduced diameter portion 101 is usually 1.5 to 3.0 mm, preferably 1.6 to 3.0 mm, and a preferred example is 2.75 mm.
- the diameter reduction ratio (D 101 /D 10 ) of the tip reduced diameter portion 101 is usually 0.5 to 0.9, preferably 0.6 to 0.8, and a preferred example is 0.73. be.
- the value of (D 10 -D 101 )/L 101 is usually 0.2 to 0.9, preferably 0.5 to 0.8, and a preferred example is 0.63.
- Catheter shaft 10 (excluding tip reduced diameter portion 101) is a multi-lumen structure. As shown in FIG. 3, the catheter shaft 10 has an inner (core) portion 107 formed by fixing lumen tubes defining lumens 11L to 18L with a binder resin, and an inner portion 107 via a reinforcing braid layer 108. and an outer (shell) portion 109 made of a covering resin.
- the hardness of the binder resin forming the inner portion 107 is, for example, 40D or less, preferably 25D to 35D.
- the resin material forming the inner portion 107 include nylon resin, polyether block polyamide resin, polyurethane resin, and polyolefin resin.
- a lumen tube forming the lumens 11L to 18L is made of resin.
- resin for example, fluorine resin, nylon resin such as nylon 11/nylon 12, polyurethane resin, polyolefin resin, etc. can be used. It is preferable to use a fluororesin from the viewpoint of excellent mobility of a member inserted therein.
- PTFE polytetrafluoroethylene
- PFA tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer
- FEP tetrafluoroethylene-hexafluoropropylene copolymer
- ETFE tetrafluoroethylene-ethylene copolymer
- the outer portion 109 of the catheter shaft 10 is made of a resin material covering the inner portion 107 .
- the hardness of the resin forming the outer portion 109 is, for example, 72D or less, preferably 35D to 72D. It is preferable that the hardness of the outer portion 109 increases stepwise in the proximal direction.
- a thermoplastic polyamide-based elastomer can be mentioned, and a polyether block amide copolymer is preferable.
- Lumens 11L and 12L of catheter shaft 10 are lumens that form flow paths for irrigation fluids.
- physiological saline can be exemplified as the "liquid”.
- a channel-forming tube 51 is inserted through the lumen 11L, and a channel-forming tube 52 is inserted through the lumen 12L.
- An irrigation liquid is circulated inside the flow path forming tubes 51 and 52 .
- the sealing performance of the irrigation liquid (the effect of preventing the liquid from leaking out from the lumen) can be improved.
- resin materials such as polyimide, polyetheretherketone (PEEK), and nylon 11, and metal materials such as stainless steel and Ni—Ti superelastic alloys can be used. can.
- Lumens 13L and 14L of the catheter shaft 10 are lumens through which lead wires or the like are inserted. As shown in FIG. 3, the lead wire 35 of the tip electrode 30 and the thermocouple 90 are passed through the lumen 13L, and the lead wires 46-48 of the ring electrodes 41-43 are passed through the lumen 14L.
- the lumens 15L to 18L of the catheter shaft 10 are passages for manipulating wires for deflecting the tip of the catheter shaft 10 by deflecting the tip flexible portion 102 .
- a first operation wire 21 is inserted through the lumen 15L to bend the tip flexible portion 102 of the catheter shaft 10 in the first direction indicated by the arrow A in FIG.
- the first operation wire 21 is inserted through the inside of the catheter shaft 10 (the lumen 15L at the distal flexible portion 102 and the lumen 17L at the proximal end portion of the shaft) so as to be axially movable.
- the tip of the first operation wire 21 is connected and fixed to the anchor member 20 arranged inside the tip flexible portion 102 .
- the proximal end of the first operation wire 21 is connected to the knob 75 of the control handle 70 so that it can be pulled.
- a second operation wire 22 is inserted through the lumen 16L to bend the tip flexible portion 102 of the catheter shaft 10 in the second direction indicated by the arrow B in FIG.
- the second operation wire 22 is axially movably inserted inside the catheter shaft 10 (the lumen 16L at the distal flexible portion 102 and the lumen 18L at the proximal end portion of the shaft).
- the tip of the second operation wire 22 is connected and fixed to the anchor member 20 so as to face the tip of the first operation wire 21 across the central axis of the catheter shaft 10 .
- the proximal end of the second operation wire 22 is connected to the knob 75 of the control handle 70 so that it can be pulled.
- a leaf spring 60 extending in the axial direction of the catheter shaft 10 is arranged inside the distal flexible portion 102 .
- the tip flexible portion 102 is easily bent in a direction (first direction or second direction) perpendicular to the plane of the leaf spring 60 .
- a control handle 70 is attached to the proximal end of the catheter shaft 10 .
- a connector (not shown) having a plurality of terminals is provided in the control handle 70.
- the terminals of the connector have lead wires (not shown in FIG. 3) connected to the tip electrode 30 and the ring electrodes 41 to 43, respectively.
- the proximal ends of the indicated leads 35 and 46-48) are connected, respectively.
- the control handle 70 also has a knob 75 for pulling the proximal end of the first operating wire 21 and the proximal end of the second operating wire 22 when bending the distal flexible portion 102 of the catheter shaft 10 . is attached.
- the injection tube 80 shown in FIG. 1 is connected to the catheter shaft 10 through the inside of the control handle 70.
- the injection tube 80 passes through the inside of the catheter shaft 10 (the flow path inserted through the lumen 11L).
- An irrigation liquid is supplied to the inside of the forming tube 51 and the passage forming tube 52 inserted through the lumen 12L.
- a tip electrode 30 is connected to the tip side of the catheter shaft 10 .
- the tip electrode 30 that constitutes the ablation catheter 100 has a small-diameter cylindrical portion 33 inserted inside the catheter shaft 10 (tip reduced diameter portion 101) and a diameter that expands in the distal direction from the tip position of the tip reduced diameter portion 101. It consists of a base end portion 32 and a hemispherical tip portion 31 that is continuous with the base end portion 32 and has a diameter equal to the maximum outer diameter (D 30 ) of the base end portion 32 .
- proximal portion 32 and distal portion 31 appear as the outer appearance of tip electrode 30, while cylindrical portion 33 is inserted inside catheter shaft 10 so that the distal portion of tip electrode 30 is not deformed. It doesn't show up in appearance.
- the tip diameter reduction portion 101 of the catheter shaft 10 that is reduced in diameter in the distal direction and the proximal end portion 32 of the tip electrode 30 that is expanded in the distal direction provide a connection between the catheter shaft 10 and the tip electrode 30.
- a constriction having a minimum outer diameter equal to the outer diameter of the connecting portion (boundary) is formed.
- the tip electrode 30 has an internal space 36 that communicates with the lumens 11L and 12L of the catheter shaft 10 and stores liquid.
- the tip electrode 30 is made of a conductive porous material. Specific examples of the porous material forming the tip electrode 30 include stainless steel, tungsten, titanium, aluminum, platinum, copper, and gold.
- the irrigation liquid can permeate the porous material. Therefore, the liquid supplied to the internal space 36 by flowing through the lumens 11L and 12L (channel forming tubes 51 and 52) of the catheter shaft 10 moves (permeates) through the wall of the tip electrode 30 surrounding the internal space 36. ) and ooze to the surface of the tip electrode 30, thereby irrigating the tip electrode 30 from the inside.
- a tip electrode constructed of a porous material can also be internally irrigated without creating an internal space.
- the interior space 36 is formed in the tip electrode 30 .
- the wall thickness (t) of the tip electrode 30 surrounding this internal space 36 is uniform throughout the proximal portion 32 and the distal portion 31 .
- the wall thickness (t) of tip electrode 30 is uniform across proximal portion 32 and distal portion 31, thereby irrigating the entire surface of tip electrode 30 (proximal portion 32 and distal portion 31) evenly. can do.
- the maximum outer diameter (D 30 ) of the tip electrode 30 at the tip of the proximal portion 32 (the diameter of the hemisphere that is the shape of the tip portion 31 ) is approximately the same as the outer diameter (D 10 ) of the catheter shaft 10 .
- the outer diameter (D 32 ) at the proximal end of the proximal portion 32 is the same as the outer diameter (D 101 ) at the distal end of the distal reduced diameter portion 101 .
- the length (L 32 ) of the base end portion 32 is usually 2.0 to 4.0 mm, preferably 2.0 to 3.0 mm, preferably 2.7 mm.
- the diameter expansion ratio (D 30 /D 32 ) of the base end portion 32 is usually 1.1 to 2.0, preferably 1.2 to 1.7, and a preferred example is 1.38. be.
- the value of (D 30 -D 32 )/L 32 is usually 0.1 to 1.0, preferably 0.2 to 0.5, and a preferred example is 0.28.
- the outer diameter of the cylindrical portion 33 is a size that can be inserted into the tip reduced diameter portion 101, and is usually 0.5 to 4.0 mm, preferably 0.7 to 3.0 mm. If shown, it is 1.5 mm.
- the angle ( ⁇ ) formed by the reduced-diameter tip portion 101 and the base end portion 32 of the tip electrode 30 is preferably 160° or less, more preferably. is 90-130°.
- this angle ( ⁇ ) is 160° or less, a conspicuous constriction is formed by the tip reduced diameter portion 101 and the proximal end portion 32, and during cauterization treatment, the connecting portion between the catheter shaft 10 and the tip electrode 30 becomes difficult. Contact with body tissue can be reliably avoided.
- the distal reduced diameter portion 101 and/or the proximal end portion 32 are curved surfaces (R are applied), the proximal end of the distal reduced diameter portion 101 and the connection portion can be seen in a longitudinal cross-sectional view of the ablation catheter 100. and the straight line connecting the tip of the base end portion 32 and the connecting portion is defined as ( ⁇ ).
- the ratio [(t)/(D 30 )] of the wall thickness (t) to the maximum outer diameter (D 30 ) of the tip electrode 30 is 0.12 to 0.25. is preferred, and more preferably 0.18 to 0.22. If the value of the ratio [(t)/(D 30 )] is too small (thin), sufficient strength as the tip electrode cannot be ensured. On the other hand, if this value is too large (thick), it may take a long time for the liquid in the internal space to reach the electrode surface, and the electrode surface may not be sufficiently irrigated.
- Ring-shaped electrodes 41 to 43 are attached to the tip flexible portion 102 of the catheter shaft 10 .
- the method for fixing the tip electrode 30 and the ring-shaped electrodes 41 to 43 is not particularly limited, and examples thereof include a method such as adhesion.
- the ring-shaped electrodes 41 to 43 are made of metal with good electrical conductivity, such as aluminum, copper, stainless steel, gold, and platinum. It should be noted that it is preferably made of platinum or the like in order to have good X-ray imaging properties.
- the outer diameter of the ring-shaped electrodes 41 to 43 is not particularly limited, but is preferably approximately the same as the outer diameter of the catheter shaft 10 .
- thermocouple 90 for controlling the ablation temperature is placed (inserted) in the inner space 36 of the tip electrode 30 and the lumen 13L of the catheter shaft 10.
- a measuring junction 95 of thermocouple 90 is located in the tip wall of tip electrode 30 .
- the distal end portion 101 whose diameter is reduced in the distal direction and the proximal end portion 32 whose diameter is expanded in the distal direction form the outside of the connecting portion between the catheter shaft 10 and the tip electrode 30. Since a constriction with a diameter as the minimum outer diameter is formed, it is possible to avoid contact of the connecting portion between the catheter shaft 10 and the tip electrode 30 with body tissue during ablation treatment. Abnormal temperature rise can be prevented.
- the inner space 36 is formed in the tip electrode 30 as a liquid storage space, and the wall thickness (t) of the tip electrode 30 surrounding the inner space 36 is uniform throughout the proximal portion 32 and the distal portion 31. , the entire surface of the tip electrode 30 (proximal portion 32 and distal portion 31) can be rapidly and evenly irrigated from within.
- REFERENCE SIGNS LIST 100 ablation catheter 10 catheter shaft 101 tip reduced diameter portion 102 tip flexible portion 11L, 12L lumen (liquid flow path) 13L, 14L lumen (passage for lead wire) 15L to 18L lumen (passage for pulling wire) 107 inner portion 108 reinforcing braid layer 109 outer portion 20 anchor member 21 first operation wire 22 second operation wire 30 tip electrode 31 tip portion of tip electrode 32 base portion of tip electrode 33 cylindrical portion of tip electrode 35 tip Electrode lead wire 36 Internal space of tip electrode 41-43 Ring-shaped electrode 46-48 Ring-shaped electrode lead wire 51, 52 Channel forming tube 60 Leaf spring 70 Control handle 75 Knob 80 Liquid injection tube 90 Thermocouple 95 Temperature measuring junction
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Abstract
The purpose of the present invention is to provide an electrode catheter capable of preventing an abnormal temperature rise around the connecting portion between a catheter shaft and a tip electrode and capable of uniformly irrigating the entire surface of the tip electrode. An electrode catheter (100) according to the present invention comprises a catheter shaft (10) having lumens (11L, 12L) serving as liquid flow paths, and a tip electrode (30) made of a porous material and connected to the distal end side of the catheter shaft, wherein the catheter shaft has a distal reduced-diameter portion (101) reducing in diameter in the distal end direction, the tip electrode is a hollow structure that has a proximal portion (32) enlarging in diameter from the distal end of the distal reduced-diameter portion in the distal end direction and a distal portion (31) reducing in diameter in the distal end direction and that has an internal space (36) communicating with the lumens of the catheter shaft, and the wall thickness of the tip electrode surrounding this internal space is substantially uniform throughout the proximal portion and the distal portion.
Description
本発明は、電極カテーテルに関し、更に詳しくは、カテーテルシャフトの先端側に多孔質材料からなる先端電極が装着され、この先端電極の表面に生理食塩水などの液体を灌注(イリゲーション)することのできる電極カテーテルに関する。
The present invention relates to an electrode catheter, and more specifically, a tip electrode made of a porous material is attached to the distal end side of a catheter shaft, and the surface of the tip electrode can be irrigated with a liquid such as physiological saline. It relates to electrode catheters.
アブレーションカテーテルなどの電極カテーテルにおいて、焼灼時に高温となった先端電極を冷却するとともに、先端電極の表面に血栓が形成されることを防止するために、灌注機構を備えているものが使用されている。
Electrode catheters such as ablation catheters are equipped with an irrigation mechanism in order to cool the tip electrode, which has become hot during cauterization, and to prevent the formation of thrombi on the surface of the tip electrode. .
灌注機構を備えた電極カテーテルとして、液体の流路となる中央ルーメン(中央内腔)を有するカテーテルシャフトと、このカテーテルシャフトの先端側に接続された導電性の多孔質材料(多孔性金属)からなる先端電極とを備えているものが紹介されている(特許文献1参照)。
As an electrode catheter equipped with an irrigation mechanism, it consists of a catheter shaft having a central lumen serving as a liquid flow path and a conductive porous material (porous metal) connected to the tip side of this catheter shaft. A tip electrode having a tip electrode has been introduced (see Patent Document 1).
特許文献1に記載された電極カテーテルを構成する先端電極は、基端側に位置する円柱状部分が、中央ルーメンの先端開口から当該中央ルーメンに挿入された状態で固着されることにより、カテーテルシャフトの先端側に接続されている。
先端電極(前記円柱状部分を除いた外観に現れる電極部分)の形状としては、砲弾状(同文献の図3)、円柱状(図4および図5)、球根状(図2)などが開示されている。 The tip electrode that constitutes the electrode catheter described in Patent Document 1 has a cylindrical portion located on the proximal end side and is fixed while being inserted into the central lumen from the tip opening of the central lumen, thereby forming a catheter shaft. connected to the tip of the
Disclosed as the shape of the tip electrode (the electrode portion that appears in the appearance excluding the cylindrical portion) is a cannonball shape (Fig. 3 of the same document), a cylindrical shape (Figs. 4 and 5), a bulbous shape (Fig. 2), and the like. It is
先端電極(前記円柱状部分を除いた外観に現れる電極部分)の形状としては、砲弾状(同文献の図3)、円柱状(図4および図5)、球根状(図2)などが開示されている。 The tip electrode that constitutes the electrode catheter described in Patent Document 1 has a cylindrical portion located on the proximal end side and is fixed while being inserted into the central lumen from the tip opening of the central lumen, thereby forming a catheter shaft. connected to the tip of the
Disclosed as the shape of the tip electrode (the electrode portion that appears in the appearance excluding the cylindrical portion) is a cannonball shape (Fig. 3 of the same document), a cylindrical shape (Figs. 4 and 5), a bulbous shape (Fig. 2), and the like. It is
先端電極は、液体を透過させることのできる多孔質材料(多孔性金属)から構成されている。このため、カテーテルシャフトの中央ルーメンに供給された液体を、中央ルーメンに挿入されている円柱状部分の基端面から先端電極の内部に浸透させ、先端電極の表面に滲み出させることで灌注を行うことができる。
The tip electrode is composed of a porous material (porous metal) that allows liquid to pass through. For this reason, the liquid supplied to the central lumen of the catheter shaft is permeated into the tip electrode from the base end surface of the cylindrical portion inserted in the central lumen, and then exuded to the surface of the tip electrode to perform irrigation. be able to.
上記特許文献1に記載された電極カテーテルには下記のような問題がある。
(1)カテーテルシャフトと先端電極との接続部(境界)において、カテーテルシャフトの中央ルーメンに挿入される円柱状部分の外周面と、外観に現れる電極部分の外周面との段差により不可避的にエッジが形成される。焼灼治療時において、カテーテルシャフトと先端電極との接続部が体内組織に接触すると、エッジにおける電流密度がきわめて高くなり、接続部の周囲で異常な温度上昇が発生し、血栓が急速に形成されるおそれがある。 The electrode catheter described in Patent Document 1 has the following problems.
(1) At the junction (boundary) between the catheter shaft and the tip electrode, an edge is inevitable due to the step between the outer peripheral surface of the cylindrical portion inserted into the central lumen of the catheter shaft and the outer peripheral surface of the electrode portion that appears externally. is formed. During ablation treatment, when the connection between the catheter shaft and the tip electrode comes into contact with body tissue, the current density at the edge becomes extremely high, causing an abnormal temperature rise around the connection and rapid thrombus formation. There is a risk.
(1)カテーテルシャフトと先端電極との接続部(境界)において、カテーテルシャフトの中央ルーメンに挿入される円柱状部分の外周面と、外観に現れる電極部分の外周面との段差により不可避的にエッジが形成される。焼灼治療時において、カテーテルシャフトと先端電極との接続部が体内組織に接触すると、エッジにおける電流密度がきわめて高くなり、接続部の周囲で異常な温度上昇が発生し、血栓が急速に形成されるおそれがある。 The electrode catheter described in Patent Document 1 has the following problems.
(1) At the junction (boundary) between the catheter shaft and the tip electrode, an edge is inevitable due to the step between the outer peripheral surface of the cylindrical portion inserted into the central lumen of the catheter shaft and the outer peripheral surface of the electrode portion that appears externally. is formed. During ablation treatment, when the connection between the catheter shaft and the tip electrode comes into contact with body tissue, the current density at the edge becomes extremely high, causing an abnormal temperature rise around the connection and rapid thrombus formation. There is a risk.
(2)無垢の多孔質材料から構成される先端電極において、円柱状部分の基端面から電極内部に浸透させた液体が電極内部を軸方向に移動して先端部分における電極表面に到達するまでにある程度長い時間を要し、このために、先端電極の先端部分の表面を十分に灌注することができない。
(2) In a tip electrode made of a solid porous material, it takes time for a liquid that has permeated the inside of the electrode from the base end surface of the cylindrical portion to move in the axial direction inside the electrode and reach the electrode surface at the tip portion. It takes a rather long time, and because of this, the surface of the tip portion of the tip electrode cannot be sufficiently irrigated.
(3)軸方向位置によって外径が異なる先端電極では、電極内部に浸透させた液体が電極表面に滲出するまでの時間にバラツキがあり(外径の大きい部分における電極表面に液体が到達するまでの時間は、外径の小さい部分における電極表面に液体が到達するまでの時
間よりも長くなり)、この結果、外径の大きい部分における電極表面を十分に灌注することができない。 (3) With tip electrodes that have different outer diameters depending on the position in the axial direction, there is variation in the time it takes for the liquid that has permeated the inside of the electrode to seep out to the electrode surface. is longer than the time required for the liquid to reach the electrode surface in the portion with the small outer diameter), and as a result, the electrode surface in the portion with the large outer diameter cannot be sufficiently irrigated.
間よりも長くなり)、この結果、外径の大きい部分における電極表面を十分に灌注することができない。 (3) With tip electrodes that have different outer diameters depending on the position in the axial direction, there is variation in the time it takes for the liquid that has permeated the inside of the electrode to seep out to the electrode surface. is longer than the time required for the liquid to reach the electrode surface in the portion with the small outer diameter), and as a result, the electrode surface in the portion with the large outer diameter cannot be sufficiently irrigated.
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、焼灼治療中に、カテーテルシャフトと先端電極との接続部(境界)の周囲で異常な温度上昇が発生することを防止することができるとともに、先端部分や外径の大きな部分を含めて先端電極の表面全体を均等に灌注することができる電極カテーテルを提供することを目的とする。 The present invention has been made based on the circumstances as described above.
An object of the present invention is to prevent abnormal temperature rise around the connecting portion (boundary) between the catheter shaft and the tip electrode during ablation treatment, and to An object of the present invention is to provide an electrode catheter that can evenly irrigate the entire surface of the tip electrode, including the .
本発明の目的は、焼灼治療中に、カテーテルシャフトと先端電極との接続部(境界)の周囲で異常な温度上昇が発生することを防止することができるとともに、先端部分や外径の大きな部分を含めて先端電極の表面全体を均等に灌注することができる電極カテーテルを提供することを目的とする。 The present invention has been made based on the circumstances as described above.
An object of the present invention is to prevent abnormal temperature rise around the connecting portion (boundary) between the catheter shaft and the tip electrode during ablation treatment, and to An object of the present invention is to provide an electrode catheter that can evenly irrigate the entire surface of the tip electrode, including the .
(1)本発明の電極カテーテルは、液体の流路となるルーメンを有するカテーテルシャフトと、前記カテーテルシャフトの先端側に接続された多孔質材料からなる先端電極とを備えてなり、
前記先端電極は、前記カテーテルシャフトの先端から先端方向に拡径する基端部分と、前記基端部分に連続して先端方向に縮径する先端部分とを有し、前記カテーテルシャフトの前記ルーメンに連通する内部空間が形成された中空構造体であり、
前記内部空間を取り囲む前記先端電極の壁厚が前記基端部分および前記先端部分の全体にわたり実質的に均一であることを特徴とする。
ここに、「実質的に均一」とは、例えば、壁厚のバラツキ〔(最大壁厚-最小壁厚)/平均壁厚〕が±20%以内であることをいうものとする。 (1) The electrode catheter of the present invention comprises a catheter shaft having a lumen serving as a fluid flow path, and a tip electrode made of a porous material connected to the tip side of the catheter shaft,
The tip electrode has a proximal portion whose diameter increases in the distal direction from the distal end of the catheter shaft, and a distal portion which continues to the proximal portion and decreases in diameter in the distal direction. A hollow structure in which a communicating internal space is formed,
A wall thickness of the tip electrode surrounding the interior space is characterized by being substantially uniform throughout the proximal portion and the distal portion.
Here, "substantially uniform" means that the variation in wall thickness [(maximum wall thickness-minimum wall thickness)/average wall thickness] is within ±20%.
前記先端電極は、前記カテーテルシャフトの先端から先端方向に拡径する基端部分と、前記基端部分に連続して先端方向に縮径する先端部分とを有し、前記カテーテルシャフトの前記ルーメンに連通する内部空間が形成された中空構造体であり、
前記内部空間を取り囲む前記先端電極の壁厚が前記基端部分および前記先端部分の全体にわたり実質的に均一であることを特徴とする。
ここに、「実質的に均一」とは、例えば、壁厚のバラツキ〔(最大壁厚-最小壁厚)/平均壁厚〕が±20%以内であることをいうものとする。 (1) The electrode catheter of the present invention comprises a catheter shaft having a lumen serving as a fluid flow path, and a tip electrode made of a porous material connected to the tip side of the catheter shaft,
The tip electrode has a proximal portion whose diameter increases in the distal direction from the distal end of the catheter shaft, and a distal portion which continues to the proximal portion and decreases in diameter in the distal direction. A hollow structure in which a communicating internal space is formed,
A wall thickness of the tip electrode surrounding the interior space is characterized by being substantially uniform throughout the proximal portion and the distal portion.
Here, "substantially uniform" means that the variation in wall thickness [(maximum wall thickness-minimum wall thickness)/average wall thickness] is within ±20%.
このような構成の電極カテーテルによれば、先端電極の基端部分が先端方向に拡径しているので、焼灼治療中に、先端電極とカテーテルシャフトとの境界が体内組織に接触することを回避することができ、この結果、境界の周囲で異常な温度上昇が発生することを防止することができる。
According to the electrode catheter having such a configuration, since the base end portion of the tip electrode is expanded in the distal direction, the boundary between the tip electrode and the catheter shaft is prevented from coming into contact with body tissue during ablation treatment. As a result, it is possible to prevent an abnormal temperature rise from occurring around the boundary.
また、液体の浸透(移動)が可能な多孔質材料からなるものでありながら、先端電極には、カテーテルシャフトのルーメンに連通する内部空間が敢えて形成されており、しかも、この内部空間を取り囲む先端電極の壁厚が基端部分および先端部分の全体にわたり実質的に均一であることにより、先端部分や外径の大きな部分を含めて先端電極の表面全体を均等に灌注することができる。
In addition, although the tip electrode is made of a porous material that allows liquid to permeate (move), an internal space communicating with the lumen of the catheter shaft is intentionally formed in the tip electrode. The substantially uniform wall thickness of the electrode throughout the proximal and distal portions allows for uniform irrigation of the entire surface of the tip electrode, including the distal portion and portions of large outer diameter.
(2)本発明の電極カテーテルにおいて、前記カテーテルシャフトは、先端方向に縮径する先端縮径部を有し、
前記先端電極の前記基端部分は、前記カテーテルシャフトの先端である前記先端縮径部の先端から先端方向に拡径することが好ましい。 (2) In the electrode catheter of the present invention, the catheter shaft has a tip-reduced diameter portion whose diameter is reduced in the distal direction,
It is preferable that the base end portion of the tip electrode expands in diameter from the tip of the tip reduced diameter portion, which is the tip of the catheter shaft, toward the tip.
前記先端電極の前記基端部分は、前記カテーテルシャフトの先端である前記先端縮径部の先端から先端方向に拡径することが好ましい。 (2) In the electrode catheter of the present invention, the catheter shaft has a tip-reduced diameter portion whose diameter is reduced in the distal direction,
It is preferable that the base end portion of the tip electrode expands in diameter from the tip of the tip reduced diameter portion, which is the tip of the catheter shaft, toward the tip.
このような構成の電極カテーテルによれば、先端縮径部が先端方向に縮径し、先端電極の基端部分が先端方向に拡径しているので、先端縮径部と先端電極の基端部分とによって括れが形成される。
これにより、焼灼治療中に、先端電極とカテーテルシャフトとの境界が体内組織に接触することを確実に回避することができ、この結果、境界の周囲で異常な温度上昇が発生することを防止することができる。 According to the electrode catheter having such a configuration, the diameter of the tip reduced diameter portion is reduced in the distal direction, and the diameter of the proximal end portion of the tip electrode is expanded in the distal direction. A constriction is formed by the part.
This ensures that the boundary between the tip electrode and the catheter shaft does not come into contact with body tissue during ablation treatment, thereby preventing abnormal temperature rise around the boundary. be able to.
これにより、焼灼治療中に、先端電極とカテーテルシャフトとの境界が体内組織に接触することを確実に回避することができ、この結果、境界の周囲で異常な温度上昇が発生することを防止することができる。 According to the electrode catheter having such a configuration, the diameter of the tip reduced diameter portion is reduced in the distal direction, and the diameter of the proximal end portion of the tip electrode is expanded in the distal direction. A constriction is formed by the part.
This ensures that the boundary between the tip electrode and the catheter shaft does not come into contact with body tissue during ablation treatment, thereby preventing abnormal temperature rise around the boundary. be able to.
(3)本発明の電極カテーテルにおいて、前記先端電極の前記先端部分は、前記基端部分の最大外径を直径とする部分球状であることが好ましい。
(3) In the electrode catheter of the present invention, it is preferable that the distal end portion of the distal end electrode has a partially spherical shape with a diameter equal to the maximum outer diameter of the proximal end portion.
(4)上記(2)または(3)の電極カテーテルの縦断面視において、前記先端縮径部と、前記先端電極の前記基端部分とのなす角度(α)が160°以下であることが好ましい。
これにより、焼灼治療中に、先端電極とカテーテルシャフトとの境界部分が体内組織に接触することをより確実に回避することができる。 (4) In the longitudinal cross-sectional view of the electrode catheter of (2) or (3) above, the angle (α) formed by the tapered distal end portion and the proximal portion of the distal electrode is 160° or less. preferable.
As a result, it is possible to more reliably avoid the interface between the tip electrode and the catheter shaft from coming into contact with body tissue during the ablation treatment.
これにより、焼灼治療中に、先端電極とカテーテルシャフトとの境界部分が体内組織に接触することをより確実に回避することができる。 (4) In the longitudinal cross-sectional view of the electrode catheter of (2) or (3) above, the angle (α) formed by the tapered distal end portion and the proximal portion of the distal electrode is 160° or less. preferable.
As a result, it is possible to more reliably avoid the interface between the tip electrode and the catheter shaft from coming into contact with body tissue during the ablation treatment.
(5)本発明の電極カテーテルにおいて、前記先端電極の最大外径を(D30)、前記壁厚を(t)とするとき、(t)/(D30)の値が0.12~0.25であることが好ましい。
(5) In the electrode catheter of the present invention, the value of (t)/(D 30 ) is 0.12 to 0, where (D 30 ) is the maximum outer diameter of the tip electrode and (t) is the wall thickness. .25 is preferred.
本発明の電極カテーテルによれば、焼灼治療中に、先端電極とカテーテルシャフトとの境界の周囲で異常な温度上昇が発生することを防止することができるとともに、先端部分や外径の大きな部分を含めて先端電極の表面全体を内部から均等に灌注することができる。
According to the electrode catheter of the present invention, during ablation treatment, it is possible to prevent abnormal temperature rise around the boundary between the tip electrode and the catheter shaft, and to prevent the tip portion and the large outer diameter portion from The entire surface of the tip electrode, including, can be evenly irrigated from the inside.
<実施形態>
以下、本発明の電極カテーテルの一実施形態に係るアブレーションカテーテルについて図面を用いて説明する。このアブレーションカテーテルは、心臓における不整脈の治療に用いられる。 <Embodiment>
Hereinafter, an ablation catheter according to one embodiment of the electrode catheter of the present invention will be described with reference to the drawings. This ablation catheter is used to treat arrhythmia in the heart.
以下、本発明の電極カテーテルの一実施形態に係るアブレーションカテーテルについて図面を用いて説明する。このアブレーションカテーテルは、心臓における不整脈の治療に用いられる。 <Embodiment>
Hereinafter, an ablation catheter according to one embodiment of the electrode catheter of the present invention will be described with reference to the drawings. This ablation catheter is used to treat arrhythmia in the heart.
図1~図4に示す本実施形態のアブレーションカテーテル100は、先端可撓部分102を有し、液体の流路となるルーメン11Lおよび12Lを含む8つのルーメン11L~18Lが形成されたカテーテルシャフト10と、このカテーテルシャフト10の先端側に接続された導電性多孔質材料からなる先端電極30と、カテーテルシャフト10の先端可撓部分102に装着された3つのリング状電極41~43と、カテーテルシャフト10の先端可撓部分102を第1方向(図2において矢印Aで示す方向)に撓ませるために、カテーテルシャフト10の内部(ルーメン15Lおよび17L)に挿通され、その先端がアンカー部材20に接続固定され、その基端を引張操作することができる第1操作用ワイヤ21と、カテーテルシャフト10の先端可撓部分102を第2方向(図2において矢印Bで示す方向)に撓ませるために、カテーテルシャフト10の内部(ルーメン16Lおよび18L)に挿通され、その先端がアンカー部材20に接続固定され、その基端を引張操作することができる第2操作用ワイヤ22と、カテーテルシャフト10のルーメン11Lおよび12Lに挿通された流路形成用チューブ51および52と、カテーテルシャフト10の軸方向に沿って先端可撓部分102の内部に配置された首振り用の板バネ60と、カテーテルシャフト10の基端側に装着された制御ハンドル70と、灌注用液体の注入管80とを備えてなり、カテーテルシャフト10は、先端方向に縮径する先端縮径部101を有し、先端電極30は、先端縮径部101の先端位置から先端方向に拡径する基端部分32と、基端部分32に連続し、基端部分32の最大外径(D30)を直径とする半球状の先端部分31とを有し、先端電極30は、カテーテルシャフト10のルーメン11Lおよび12Lに連通する内部空間36が形成された中空構造体であり、この内部空間36を取り囲む先端電極30の壁厚が、基端部分32および先端部分31の全体にわたり実質的に均一である。
The ablation catheter 100 of this embodiment shown in FIGS. 1 to 4 has a distal flexible portion 102, and a catheter shaft 10 formed with eight lumens 11L to 18L including lumens 11L and 12L serving as fluid flow paths. , a tip electrode 30 made of a conductive porous material connected to the tip side of the catheter shaft 10, three ring-shaped electrodes 41 to 43 attached to the tip flexible portion 102 of the catheter shaft 10, and the catheter shaft 10 is inserted through the interior of the catheter shaft 10 ( lumens 15L and 17L) to flex the distal flexible portion 102 of 10 in a first direction (the direction indicated by arrow A in FIG. 2), and its distal end is connected to the anchor member 20. In order to bend the first operation wire 21 which is fixed and whose proximal end can be pulled and the distal flexible portion 102 of the catheter shaft 10 in the second direction (the direction indicated by the arrow B in FIG. 2), A second operation wire 22 which is inserted through the inside of the catheter shaft 10 ( lumens 16L and 18L), whose distal end is connected and fixed to the anchor member 20, and whose proximal end can be pulled and operated, and the lumen 11L of the catheter shaft 10. and 12L, a leaf spring 60 for oscillation arranged inside the tip flexible portion 102 along the axial direction of the catheter shaft 10, and a base of the catheter shaft 10. Equipped with an end-mounted control handle 70 and an irrigation liquid injection tube 80, the catheter shaft 10 has a distally tapered portion 101 with a distally tapered diameter, and the tip electrode 30 is located at the distal end. A base end portion 32 that expands in diameter from the tip position of the diameter-reduced portion 101 toward the tip, and a hemispherical tip portion 31 that is continuous with the base end portion 32 and has a diameter equal to the maximum outer diameter (D 30 ) of the base end portion 32. The tip electrode 30 is a hollow structure with an internal space 36 communicating with the lumens 11L and 12L of the catheter shaft 10, and the wall thickness of the tip electrode 30 surrounding this internal space 36 is equal to the proximal end. It is substantially uniform throughout portion 32 and tip portion 31 .
アブレーションカテーテル100は、カテーテルシャフト10と、先端電極30と、リング状電極41~43と、第1操作用ワイヤ21と、第2操作用ワイヤ22と、流路形成
用チューブ51および52と、板バネ60と、制御ハンドル70と、灌注用液体の注入管80とを備えている。 Theablation catheter 100 includes a catheter shaft 10, a tip electrode 30, ring electrodes 41 to 43, a first operation wire 21, a second operation wire 22, flow channel forming tubes 51 and 52, and a plate. It comprises a spring 60, a control handle 70 and an injection tube 80 for irrigation fluid.
用チューブ51および52と、板バネ60と、制御ハンドル70と、灌注用液体の注入管80とを備えている。 The
アブレーションカテーテル100を構成するカテーテルシャフト10は先端可撓部分102を有している。
ここに、「先端可撓部分」とは、操作用ワイヤ(第1操作用ワイヤ21または第2操作用ワイヤ22)の基端を引張操作することにより撓む(曲がる)ことのできるカテーテルシャフトの先端部分をいう。 Acatheter shaft 10 that constitutes an ablation catheter 100 has a distal flexible portion 102 .
Here, the "flexible tip portion" refers to a portion of the catheter shaft that can be flexed (bent) by pulling the proximal end of the operation wire (first operation wire 21 or second operation wire 22). Refers to the tip.
ここに、「先端可撓部分」とは、操作用ワイヤ(第1操作用ワイヤ21または第2操作用ワイヤ22)の基端を引張操作することにより撓む(曲がる)ことのできるカテーテルシャフトの先端部分をいう。 A
Here, the "flexible tip portion" refers to a portion of the catheter shaft that can be flexed (bent) by pulling the proximal end of the operation wire (
カテーテルシャフト10の長さ(L10)は、通常600~1500mmとされ、好ましくは900~1200mm、好適な一例を示せば1100mmとされる。
先端可撓部分102の長さは、通常25~100mmとされ、好ましくは45~80mm、好適な一例を示せば60mmとされる。
カテーテルシャフト10の外径(D10)は、通常1.0~3.0mmとされ、好ましくは1.6~3.0mm、好適な一例を示せば2.75mmとされる。 The length (L 10 ) of thecatheter shaft 10 is usually 600-1500 mm, preferably 900-1200 mm, and a preferred example is 1100 mm.
The length of the tipflexible portion 102 is generally 25-100 mm, preferably 45-80 mm, and a preferred example is 60 mm.
The outer diameter (D 10 ) of thecatheter shaft 10 is usually 1.0-3.0 mm, preferably 1.6-3.0 mm, and a preferred example is 2.75 mm.
先端可撓部分102の長さは、通常25~100mmとされ、好ましくは45~80mm、好適な一例を示せば60mmとされる。
カテーテルシャフト10の外径(D10)は、通常1.0~3.0mmとされ、好ましくは1.6~3.0mm、好適な一例を示せば2.75mmとされる。 The length (L 10 ) of the
The length of the tip
The outer diameter (D 10 ) of the
カテーテルシャフト10は、先端可撓部分102より先端側において、先端方向に縮径する先端縮径部101を有している。
先端縮径部101の長さ(L101 )は、通常1.0~5.0mmとされ、好ましくは1.0~3.0mm、好適な一例を示せば1.2mmとされる。
先端縮径部101の先端における外径(D101 )は、通常1.5~3.0mmとされ、好ましくは1.6~3.0mm、好適な一例を示せば2.75mmとされる。
先端縮径部101の縮径率(D101 /D10)は、通常0.5~0.9とされ、好ましくは0.6~0.8、好適な一例を示せば0.73とされる。
また、(D10-D101 )/L101 の値は、通常0.2~0.9とされ、好ましくは0.5~0.8、好適な一例を示せば0.63とされる。 Thecatheter shaft 10 has a tip reduced-diameter portion 101 on the tip side of the tip flexible portion 102, the diameter of which is reduced in the tip direction.
The length (L 101 ) of the reduceddiameter portion 101 is usually 1.0 to 5.0 mm, preferably 1.0 to 3.0 mm, and a preferred example is 1.2 mm.
The outer diameter (D 101 ) at the tip of the tip reduceddiameter portion 101 is usually 1.5 to 3.0 mm, preferably 1.6 to 3.0 mm, and a preferred example is 2.75 mm.
The diameter reduction ratio (D 101 /D 10 ) of the tip reduceddiameter portion 101 is usually 0.5 to 0.9, preferably 0.6 to 0.8, and a preferred example is 0.73. be.
The value of (D 10 -D 101 )/L 101 is usually 0.2 to 0.9, preferably 0.5 to 0.8, and a preferred example is 0.63.
先端縮径部101の長さ(L101 )は、通常1.0~5.0mmとされ、好ましくは1.0~3.0mm、好適な一例を示せば1.2mmとされる。
先端縮径部101の先端における外径(D101 )は、通常1.5~3.0mmとされ、好ましくは1.6~3.0mm、好適な一例を示せば2.75mmとされる。
先端縮径部101の縮径率(D101 /D10)は、通常0.5~0.9とされ、好ましくは0.6~0.8、好適な一例を示せば0.73とされる。
また、(D10-D101 )/L101 の値は、通常0.2~0.9とされ、好ましくは0.5~0.8、好適な一例を示せば0.63とされる。 The
The length (L 101 ) of the reduced
The outer diameter (D 101 ) at the tip of the tip reduced
The diameter reduction ratio (D 101 /D 10 ) of the tip reduced
The value of (D 10 -D 101 )/L 101 is usually 0.2 to 0.9, preferably 0.5 to 0.8, and a preferred example is 0.63.
カテーテルシャフト10(先端縮径部101を除く)はマルチルーメン構造体である。
図3に示すように、カテーテルシャフト10は、ルーメン11L~18Lをそれぞれ区画形成するルーメンチューブがバインダ樹脂によって固定されてなるインナー(コア)部107と、補強ブレード層108を介してインナー部107を被覆する樹脂からなるアウター(シェル)部109とからなる。 Catheter shaft 10 (excluding tip reduced diameter portion 101) is a multi-lumen structure.
As shown in FIG. 3, thecatheter shaft 10 has an inner (core) portion 107 formed by fixing lumen tubes defining lumens 11L to 18L with a binder resin, and an inner portion 107 via a reinforcing braid layer 108. and an outer (shell) portion 109 made of a covering resin.
図3に示すように、カテーテルシャフト10は、ルーメン11L~18Lをそれぞれ区画形成するルーメンチューブがバインダ樹脂によって固定されてなるインナー(コア)部107と、補強ブレード層108を介してインナー部107を被覆する樹脂からなるアウター(シェル)部109とからなる。 Catheter shaft 10 (excluding tip reduced diameter portion 101) is a multi-lumen structure.
As shown in FIG. 3, the
インナー部107を構成するバインダ樹脂の硬度としては、例えば40D以下とされ、好ましくは25D~35Dとされる。インナー部107を構成する樹脂材料としては、ナイロン樹脂、ポリエーテルブロックポリアミド樹脂、ポリウレタン樹脂、ポリオレフィン系樹脂などを挙げることができる。
The hardness of the binder resin forming the inner portion 107 is, for example, 40D or less, preferably 25D to 35D. Examples of the resin material forming the inner portion 107 include nylon resin, polyether block polyamide resin, polyurethane resin, and polyolefin resin.
ルーメン11L~18Lを形成するルーメンチューブは、樹脂から構成されている。
ルーメンチューブを構成する樹脂としては、例えば、フッ素樹脂、ナイロン11/ナイロン12などのナイロン樹脂、ポリウレタン樹脂、ポリオレフィン樹脂などを使用することができるが、チューブ内(ルーメン)の潤滑性(操作用ワイヤなどの挿通される部材の移動容易性)に優れている観点からフッ素樹脂からなるものが好ましい。
具体的には、ポリテトラフルオロエチレン(PTFE)、テトラフルオロエチレン-パーフルオロアルキルビニルエーテル共重合体(PFA)、テトラフルオロエチレン-ヘキサフルオロプロピレン共重合体(FEP)、テトラフルオロエチレン-エチレン共重合体(ETFE)などを例示することができる。 A lumen tube forming thelumens 11L to 18L is made of resin.
As the resin constituting the lumen tube, for example, fluorine resin, nylon resin such as nylon 11/nylon 12, polyurethane resin, polyolefin resin, etc. can be used. It is preferable to use a fluororesin from the viewpoint of excellent mobility of a member inserted therein.
Specifically, polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene-ethylene copolymer (ETFE) and the like can be exemplified.
ルーメンチューブを構成する樹脂としては、例えば、フッ素樹脂、ナイロン11/ナイロン12などのナイロン樹脂、ポリウレタン樹脂、ポリオレフィン樹脂などを使用することができるが、チューブ内(ルーメン)の潤滑性(操作用ワイヤなどの挿通される部材の移動容易性)に優れている観点からフッ素樹脂からなるものが好ましい。
具体的には、ポリテトラフルオロエチレン(PTFE)、テトラフルオロエチレン-パーフルオロアルキルビニルエーテル共重合体(PFA)、テトラフルオロエチレン-ヘキサフルオロプロピレン共重合体(FEP)、テトラフルオロエチレン-エチレン共重合体(ETFE)などを例示することができる。 A lumen tube forming the
As the resin constituting the lumen tube, for example, fluorine resin, nylon resin such as nylon 11/nylon 12, polyurethane resin, polyolefin resin, etc. can be used. It is preferable to use a fluororesin from the viewpoint of excellent mobility of a member inserted therein.
Specifically, polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), tetrafluoroethylene-ethylene copolymer (ETFE) and the like can be exemplified.
カテーテルシャフト10のアウター部109は、インナー部107を被覆する樹脂材料からなる。
アウター部109を構成する樹脂の硬度としては、例えば72D以下とされ、好ましくは35D~72Dとされる。
アウター部109の硬度は、基端方向に段階的に高くなっていることが好ましい。
アウター部109を構成する樹脂材料としては、熱可塑性ポリアミド系エラストマーを挙げることができ、ポリエーテルブロックアミド共重合体であることが好ましい。 Theouter portion 109 of the catheter shaft 10 is made of a resin material covering the inner portion 107 .
The hardness of the resin forming theouter portion 109 is, for example, 72D or less, preferably 35D to 72D.
It is preferable that the hardness of theouter portion 109 increases stepwise in the proximal direction.
As the resin material forming theouter portion 109, a thermoplastic polyamide-based elastomer can be mentioned, and a polyether block amide copolymer is preferable.
アウター部109を構成する樹脂の硬度としては、例えば72D以下とされ、好ましくは35D~72Dとされる。
アウター部109の硬度は、基端方向に段階的に高くなっていることが好ましい。
アウター部109を構成する樹脂材料としては、熱可塑性ポリアミド系エラストマーを挙げることができ、ポリエーテルブロックアミド共重合体であることが好ましい。 The
The hardness of the resin forming the
It is preferable that the hardness of the
As the resin material forming the
カテーテルシャフト10のルーメン11Lおよび12Lは、灌注用の液体の流路を形成するルーメンである。ここに、「液体」としては、生理食塩水を例示することができる。
図3に示すように、ルーメン11Lには、流路形成用チューブ51が挿通されており、ルーメン12Lには、流路形成用チューブ52が挿通されている。 Lumens 11L and 12L of catheter shaft 10 are lumens that form flow paths for irrigation fluids. Here, physiological saline can be exemplified as the "liquid".
As shown in FIG. 3, a channel-formingtube 51 is inserted through the lumen 11L, and a channel-forming tube 52 is inserted through the lumen 12L.
図3に示すように、ルーメン11Lには、流路形成用チューブ51が挿通されており、ルーメン12Lには、流路形成用チューブ52が挿通されている。
As shown in FIG. 3, a channel-forming
流路形成用チューブ51および52の内部には、灌注用の液体が流通される。流路形成用チューブ51および52の内部に液体を流通させることにより、灌注用液体のシール性(ルーメンからの液体の漏れ出し防止効果)を向上させることができる。
流路形成用チューブ51および52の構成材料としては、ポリイミド、ポリエーテルエーテルケトン(PEEK)およびナイロン11などの樹脂材料、並びにステンレスおよびNi-Ti系超弾性合金などの金属材料を使用することができる。 An irrigation liquid is circulated inside the flow path forming tubes 51 and 52 . By circulating the liquid inside the flow path forming tubes 51 and 52, the sealing performance of the irrigation liquid (the effect of preventing the liquid from leaking out from the lumen) can be improved.
As materials for forming the flow path forming tubes 51 and 52, resin materials such as polyimide, polyetheretherketone (PEEK), and nylon 11, and metal materials such as stainless steel and Ni—Ti superelastic alloys can be used. can.
流路形成用チューブ51および52の構成材料としては、ポリイミド、ポリエーテルエーテルケトン(PEEK)およびナイロン11などの樹脂材料、並びにステンレスおよびNi-Ti系超弾性合金などの金属材料を使用することができる。 An irrigation liquid is circulated inside the flow
As materials for forming the flow
カテーテルシャフト10のルーメン13Lおよび14Lは、リード線などの挿通路となるルーメンである。
図3に示すように、ルーメン13Lには、先端電極30のリード線35および熱電対90が挿通され、ルーメン14Lには、リング状電極41~43のリード線46~48が挿通されている。 Lumens 13L and 14L of the catheter shaft 10 are lumens through which lead wires or the like are inserted.
As shown in FIG. 3, thelead wire 35 of the tip electrode 30 and the thermocouple 90 are passed through the lumen 13L, and the lead wires 46-48 of the ring electrodes 41-43 are passed through the lumen 14L.
図3に示すように、ルーメン13Lには、先端電極30のリード線35および熱電対90が挿通され、ルーメン14Lには、リング状電極41~43のリード線46~48が挿通されている。
As shown in FIG. 3, the
カテーテルシャフト10のルーメン15L~18Lは、先端可撓部分102を撓ませてカテーテルシャフト10の先端を偏向させるための操作用ワイヤの挿通路である。
図3に示すように、ルーメン15Lには、カテーテルシャフト10の先端可撓部分102を、図2の矢印Aで示す第1方向に撓ませるための第1操作用ワイヤ21が挿通されている。
第1操作用ワイヤ21はカテーテルシャフト10の内部(先端可撓部分102においてはルーメン15L、シャフトの基端部分においてはルーメン17L)に軸方向に移動可能に挿通されている。
第1操作用ワイヤ21の先端は、先端可撓部分102の内部に配置されたアンカー部材20に接続固定されている。第1操作用ワイヤ21の基端は、制御ハンドル70の摘み75に接続されることによって引張操作が可能になっている。 Thelumens 15L to 18L of the catheter shaft 10 are passages for manipulating wires for deflecting the tip of the catheter shaft 10 by deflecting the tip flexible portion 102 .
As shown in FIG. 3, afirst operation wire 21 is inserted through the lumen 15L to bend the tip flexible portion 102 of the catheter shaft 10 in the first direction indicated by the arrow A in FIG.
Thefirst operation wire 21 is inserted through the inside of the catheter shaft 10 (the lumen 15L at the distal flexible portion 102 and the lumen 17L at the proximal end portion of the shaft) so as to be axially movable.
The tip of thefirst operation wire 21 is connected and fixed to the anchor member 20 arranged inside the tip flexible portion 102 . The proximal end of the first operation wire 21 is connected to the knob 75 of the control handle 70 so that it can be pulled.
図3に示すように、ルーメン15Lには、カテーテルシャフト10の先端可撓部分102を、図2の矢印Aで示す第1方向に撓ませるための第1操作用ワイヤ21が挿通されている。
第1操作用ワイヤ21はカテーテルシャフト10の内部(先端可撓部分102においてはルーメン15L、シャフトの基端部分においてはルーメン17L)に軸方向に移動可能に挿通されている。
第1操作用ワイヤ21の先端は、先端可撓部分102の内部に配置されたアンカー部材20に接続固定されている。第1操作用ワイヤ21の基端は、制御ハンドル70の摘み75に接続されることによって引張操作が可能になっている。 The
As shown in FIG. 3, a
The
The tip of the
図3に示すように、ルーメン16Lには、カテーテルシャフト10の先端可撓部分102を、図2の矢印Bで示す第2方向に撓ませるための第2操作用ワイヤ22が挿通されている。
第2操作用ワイヤ22はカテーテルシャフト10の内部(先端可撓部分102においてはルーメン16L、シャフトの基端部分においてはルーメン18L)に軸方向に移動可能に挿通されている。
第2操作用ワイヤ22の先端は、カテーテルシャフト10の中心軸を挟んで第1操作用ワイヤ21の先端と対向するように、アンカー部材20に接続固定されている。第2操作用ワイヤ22の基端は、制御ハンドル70の摘み75に接続されることによって引張操作が可能になっている。 As shown in FIG. 3, asecond operation wire 22 is inserted through the lumen 16L to bend the tip flexible portion 102 of the catheter shaft 10 in the second direction indicated by the arrow B in FIG.
Thesecond operation wire 22 is axially movably inserted inside the catheter shaft 10 (the lumen 16L at the distal flexible portion 102 and the lumen 18L at the proximal end portion of the shaft).
The tip of thesecond operation wire 22 is connected and fixed to the anchor member 20 so as to face the tip of the first operation wire 21 across the central axis of the catheter shaft 10 . The proximal end of the second operation wire 22 is connected to the knob 75 of the control handle 70 so that it can be pulled.
第2操作用ワイヤ22はカテーテルシャフト10の内部(先端可撓部分102においてはルーメン16L、シャフトの基端部分においてはルーメン18L)に軸方向に移動可能に挿通されている。
第2操作用ワイヤ22の先端は、カテーテルシャフト10の中心軸を挟んで第1操作用ワイヤ21の先端と対向するように、アンカー部材20に接続固定されている。第2操作用ワイヤ22の基端は、制御ハンドル70の摘み75に接続されることによって引張操作が可能になっている。 As shown in FIG. 3, a
The
The tip of the
図3に示すように、先端可撓部分102の内部には、カテーテルシャフト10の軸方向に延びる板バネ60が配置されている。板バネ60が配置されていることにより、先端可撓部分102は、板バネ60の平面と垂直方向(第1方向または第2方向)に撓みやすく
なっている。 As shown in FIG. 3, aleaf spring 60 extending in the axial direction of the catheter shaft 10 is arranged inside the distal flexible portion 102 . By arranging the leaf spring 60 , the tip flexible portion 102 is easily bent in a direction (first direction or second direction) perpendicular to the plane of the leaf spring 60 .
なっている。 As shown in FIG. 3, a
カテーテルシャフト10の基端側には制御ハンドル70が装着されている。制御ハンドル70内には、複数の端子を備えたコネクタ(図示省略)が設けられ、コネクタの端子には、先端電極30およびリング状電極41~43の各々に接続されたリード線(図3に示したリード線35およびリード線46~48)の基端がそれぞれ接続されている。
また、制御ハンドル70には、カテーテルシャフト10の先端可撓部分102を曲げるときに、第1操作用ワイヤ21の基端および第2操作用ワイヤ22の基端の引張操作を行うための摘み75が装着してある。 A control handle 70 is attached to the proximal end of thecatheter shaft 10 . A connector (not shown) having a plurality of terminals is provided in the control handle 70. The terminals of the connector have lead wires (not shown in FIG. 3) connected to the tip electrode 30 and the ring electrodes 41 to 43, respectively. The proximal ends of the indicated leads 35 and 46-48) are connected, respectively.
The control handle 70 also has aknob 75 for pulling the proximal end of the first operating wire 21 and the proximal end of the second operating wire 22 when bending the distal flexible portion 102 of the catheter shaft 10 . is attached.
また、制御ハンドル70には、カテーテルシャフト10の先端可撓部分102を曲げるときに、第1操作用ワイヤ21の基端および第2操作用ワイヤ22の基端の引張操作を行うための摘み75が装着してある。 A control handle 70 is attached to the proximal end of the
The control handle 70 also has a
図1に示した注入管80は、制御ハンドル70の内部を通ってカテーテルシャフト10に接続されており、この注入管80を通って、カテーテルシャフト10の内部(ルーメン11Lに挿通されている流路形成用チューブ51およびルーメン12Lに挿通されている流路形成用チューブ52の内部)に灌注用の液体が供給される。
The injection tube 80 shown in FIG. 1 is connected to the catheter shaft 10 through the inside of the control handle 70. The injection tube 80 passes through the inside of the catheter shaft 10 (the flow path inserted through the lumen 11L). An irrigation liquid is supplied to the inside of the forming tube 51 and the passage forming tube 52 inserted through the lumen 12L.
カテーテルシャフト10の先端側には先端電極30が接続されている。
アブレーションカテーテル100を構成する先端電極30は、カテーテルシャフト10(先端縮径部101)の内部に挿入される小径の円筒状部分33と、先端縮径部101の先端位置から先端方向に拡径する基端部分32と、基端部分32に連続し、基端部分32の最大外径(D30)を直径とする半球状の先端部分31とからなる。 Atip electrode 30 is connected to the tip side of the catheter shaft 10 .
Thetip electrode 30 that constitutes the ablation catheter 100 has a small-diameter cylindrical portion 33 inserted inside the catheter shaft 10 (tip reduced diameter portion 101) and a diameter that expands in the distal direction from the tip position of the tip reduced diameter portion 101. It consists of a base end portion 32 and a hemispherical tip portion 31 that is continuous with the base end portion 32 and has a diameter equal to the maximum outer diameter (D 30 ) of the base end portion 32 .
アブレーションカテーテル100を構成する先端電極30は、カテーテルシャフト10(先端縮径部101)の内部に挿入される小径の円筒状部分33と、先端縮径部101の先端位置から先端方向に拡径する基端部分32と、基端部分32に連続し、基端部分32の最大外径(D30)を直径とする半球状の先端部分31とからなる。 A
The
図2および図4に示すように、基端部分32および先端部分31は先端電極30の外観として現れるが、円筒状部分33は、カテーテルシャフト10の内部に挿入されるために、先端電極30の外観として現れない。
As shown in FIGS. 2 and 4, proximal portion 32 and distal portion 31 appear as the outer appearance of tip electrode 30, while cylindrical portion 33 is inserted inside catheter shaft 10 so that the distal portion of tip electrode 30 is not deformed. It doesn't show up in appearance.
図2に示すように、先端方向に縮径するカテーテルシャフト10の先端縮径部101と、先端方向に拡径する先端電極30の基端部分32とにより、カテーテルシャフト10と先端電極30との接続部(境界)の外径を最小外径とする括れが形成されている。
これにより、焼灼治療中に、カテーテルシャフト10と先端電極30との接続部が体内組織に接触することを回避することができ、この結果、接続部の周囲で異常な温度上昇が発生することを防止することができる。 As shown in FIG. 2, the tipdiameter reduction portion 101 of the catheter shaft 10 that is reduced in diameter in the distal direction and the proximal end portion 32 of the tip electrode 30 that is expanded in the distal direction provide a connection between the catheter shaft 10 and the tip electrode 30. A constriction having a minimum outer diameter equal to the outer diameter of the connecting portion (boundary) is formed.
As a result, it is possible to prevent the connecting portion between thecatheter shaft 10 and the tip electrode 30 from coming into contact with body tissue during cauterization treatment, and as a result, abnormal temperature rise around the connecting portion can be prevented. can be prevented.
これにより、焼灼治療中に、カテーテルシャフト10と先端電極30との接続部が体内組織に接触することを回避することができ、この結果、接続部の周囲で異常な温度上昇が発生することを防止することができる。 As shown in FIG. 2, the tip
As a result, it is possible to prevent the connecting portion between the
図4に示すように、先端電極30は、カテーテルシャフト10のルーメン11Lおよび12Lに連通して液体を貯留する内部空間36を有している。
As shown in FIG. 4, the tip electrode 30 has an internal space 36 that communicates with the lumens 11L and 12L of the catheter shaft 10 and stores liquid.
先端電極30は、導電性の多孔質材料からなる。
先端電極30を構成する多孔質材料の具体例としては、ステンレススチール、タングステン、チタン、アルミニウム、プラチナ、銅、金などを挙げることができる。 Thetip electrode 30 is made of a conductive porous material.
Specific examples of the porous material forming thetip electrode 30 include stainless steel, tungsten, titanium, aluminum, platinum, copper, and gold.
先端電極30を構成する多孔質材料の具体例としては、ステンレススチール、タングステン、チタン、アルミニウム、プラチナ、銅、金などを挙げることができる。 The
Specific examples of the porous material forming the
灌注用の液体は多孔質材料を透過することができる。このため、カテーテルシャフト10のルーメン11Lおよび12L(流路形成用チューブ51および52)を流動して内部空間36に供給された液体は、内部空間36を取り囲む先端電極30の壁内を移動(透過)して、先端電極30の表面に滲み出することができ、これにより、先端電極30を内部から灌注することができる。
The irrigation liquid can permeate the porous material. Therefore, the liquid supplied to the internal space 36 by flowing through the lumens 11L and 12L (channel forming tubes 51 and 52) of the catheter shaft 10 moves (permeates) through the wall of the tip electrode 30 surrounding the internal space 36. ) and ooze to the surface of the tip electrode 30, thereby irrigating the tip electrode 30 from the inside.
多孔質材料により構成される先端電極は、内部空間を形成しなくても内部から灌注することも可能である。
しかしながら、この実施形態のアブレーションカテーテル100では、先端電極30に内部空間36を形成している。しかも、この内部空間36を取り囲む先端電極30の壁厚(t)が、基端部分32および先端部分31の全体にわたり均一である。 A tip electrode constructed of a porous material can also be internally irrigated without creating an internal space.
However, in theablation catheter 100 of this embodiment, the interior space 36 is formed in the tip electrode 30 . Moreover, the wall thickness (t) of the tip electrode 30 surrounding this internal space 36 is uniform throughout the proximal portion 32 and the distal portion 31 .
しかしながら、この実施形態のアブレーションカテーテル100では、先端電極30に内部空間36を形成している。しかも、この内部空間36を取り囲む先端電極30の壁厚(t)が、基端部分32および先端部分31の全体にわたり均一である。 A tip electrode constructed of a porous material can also be internally irrigated without creating an internal space.
However, in the
これにより、カテーテルシャフト10からの離間距離(軸方向距離)が長く、先端電極30の中心軸からの離間距離(径方向距離)も長い先端部分31の表面に対しても、液体を短時間で到達させて十分に灌注することができる。また、先端電極30の壁厚(t)が、基端部分32および先端部分31の全体にわたり均一であることにより、先端電極30(基端部分32および先端部分31)の表面全体を均等に灌注することができる。
As a result, even the surface of the tip portion 31, which has a long distance (axial distance) from the catheter shaft 10 and a long distance (radial distance) from the central axis of the tip electrode 30, can be coated with the liquid in a short time. It can be reached and adequately irrigated. In addition, the wall thickness (t) of tip electrode 30 is uniform across proximal portion 32 and distal portion 31, thereby irrigating the entire surface of tip electrode 30 (proximal portion 32 and distal portion 31) evenly. can do.
基端部分32の先端における先端電極30の最大外径(D30)(先端部分31の形状である半球の直径)としては、カテーテルシャフト10の外径(D10)と同程度とされる。
基端部分32の基端における外径(D32)は、先端縮径部101の先端における外径(D101 )と同一である。
基端部分32の長さ(L32)としては、通常2.0~4.0mmとされ、好ましくは2.0~3.0mm、好適な一例を示せば2.7mmとされる。
基端部分32の拡径率(D30/D32)としては、通常1.1~2.0とされ、好ましくは1.2~1.7、好適な一例を示せば1.38とされる。
また、(D30-D32)/L32の値は、通常0.1~1.0とされ、好ましくは0.2~0.5、好適な一例を示せば0.28とされる。
円筒状部分33の外径としては、先端縮径部101の内部に挿入可能なサイズであり、通常0.5~4.0mmとされ、好ましくは0.7~3.0mm、好適な一例を示せば1.5mmとされる。 The maximum outer diameter (D 30 ) of thetip electrode 30 at the tip of the proximal portion 32 (the diameter of the hemisphere that is the shape of the tip portion 31 ) is approximately the same as the outer diameter (D 10 ) of the catheter shaft 10 .
The outer diameter (D 32 ) at the proximal end of theproximal portion 32 is the same as the outer diameter (D 101 ) at the distal end of the distal reduced diameter portion 101 .
The length (L 32 ) of thebase end portion 32 is usually 2.0 to 4.0 mm, preferably 2.0 to 3.0 mm, preferably 2.7 mm.
The diameter expansion ratio (D 30 /D 32 ) of thebase end portion 32 is usually 1.1 to 2.0, preferably 1.2 to 1.7, and a preferred example is 1.38. be.
The value of (D 30 -D 32 )/L 32 is usually 0.1 to 1.0, preferably 0.2 to 0.5, and a preferred example is 0.28.
The outer diameter of thecylindrical portion 33 is a size that can be inserted into the tip reduced diameter portion 101, and is usually 0.5 to 4.0 mm, preferably 0.7 to 3.0 mm. If shown, it is 1.5 mm.
基端部分32の基端における外径(D32)は、先端縮径部101の先端における外径(D101 )と同一である。
基端部分32の長さ(L32)としては、通常2.0~4.0mmとされ、好ましくは2.0~3.0mm、好適な一例を示せば2.7mmとされる。
基端部分32の拡径率(D30/D32)としては、通常1.1~2.0とされ、好ましくは1.2~1.7、好適な一例を示せば1.38とされる。
また、(D30-D32)/L32の値は、通常0.1~1.0とされ、好ましくは0.2~0.5、好適な一例を示せば0.28とされる。
円筒状部分33の外径としては、先端縮径部101の内部に挿入可能なサイズであり、通常0.5~4.0mmとされ、好ましくは0.7~3.0mm、好適な一例を示せば1.5mmとされる。 The maximum outer diameter (D 30 ) of the
The outer diameter (D 32 ) at the proximal end of the
The length (L 32 ) of the
The diameter expansion ratio (D 30 /D 32 ) of the
The value of (D 30 -D 32 )/L 32 is usually 0.1 to 1.0, preferably 0.2 to 0.5, and a preferred example is 0.28.
The outer diameter of the
図4に示したようなアブレーションカテーテル100の縦断面視において、先端縮径部101と、先端電極30の基端部分32とのなす角度(α)は160°以下であることが好ましく、更に好ましくは90~130°とされる。
In a longitudinal cross-sectional view of the ablation catheter 100 as shown in FIG. 4, the angle (α) formed by the reduced-diameter tip portion 101 and the base end portion 32 of the tip electrode 30 is preferably 160° or less, more preferably. is 90-130°.
この角度(α)が160°以下であることにより、先端縮径部101と基端部分32とによる顕著な括れが形成され、焼灼治療中において、カテーテルシャフト10と先端電極30との接続部が体内組織に接触することを確実に回避することができる。
なお、先端縮径部101および/または基端部分32が曲面である(Rがかかっている)場合には、アブレーションカテーテル100の縦断面視において、先端縮径部101の基端と前記接続部を結ぶ直線と、基端部分32の先端と前記接続部を結ぶ直線とのなす角度を(α)とする。 When this angle (α) is 160° or less, a conspicuous constriction is formed by the tip reduceddiameter portion 101 and the proximal end portion 32, and during cauterization treatment, the connecting portion between the catheter shaft 10 and the tip electrode 30 becomes difficult. Contact with body tissue can be reliably avoided.
When the distal reduceddiameter portion 101 and/or the proximal end portion 32 are curved surfaces (R are applied), the proximal end of the distal reduced diameter portion 101 and the connection portion can be seen in a longitudinal cross-sectional view of the ablation catheter 100. and the straight line connecting the tip of the base end portion 32 and the connecting portion is defined as (α).
なお、先端縮径部101および/または基端部分32が曲面である(Rがかかっている)場合には、アブレーションカテーテル100の縦断面視において、先端縮径部101の基端と前記接続部を結ぶ直線と、基端部分32の先端と前記接続部を結ぶ直線とのなす角度を(α)とする。 When this angle (α) is 160° or less, a conspicuous constriction is formed by the tip reduced
When the distal reduced
本実施形態のアブレーションカテーテル100において、先端電極30の最大外径(D30)に対する壁厚(t)の比〔(t)/(D30)〕の値は0.12~0.25であることが好ましく、更に好ましくは0.18~0.22である。
比〔(t)/(D30)〕の値が過小(薄肉)であると、先端電極としての強度を十分に確保することができない。
他方、この値が過大(厚肉)であると、内部空間における液体が電極表面に到達するまでに長い時間を要し、当該電極表面を十分に灌注することができない場合がある。 In theablation catheter 100 of this embodiment, the ratio [(t)/(D 30 )] of the wall thickness (t) to the maximum outer diameter (D 30 ) of the tip electrode 30 is 0.12 to 0.25. is preferred, and more preferably 0.18 to 0.22.
If the value of the ratio [(t)/(D 30 )] is too small (thin), sufficient strength as the tip electrode cannot be ensured.
On the other hand, if this value is too large (thick), it may take a long time for the liquid in the internal space to reach the electrode surface, and the electrode surface may not be sufficiently irrigated.
比〔(t)/(D30)〕の値が過小(薄肉)であると、先端電極としての強度を十分に確保することができない。
他方、この値が過大(厚肉)であると、内部空間における液体が電極表面に到達するまでに長い時間を要し、当該電極表面を十分に灌注することができない場合がある。 In the
If the value of the ratio [(t)/(D 30 )] is too small (thin), sufficient strength as the tip electrode cannot be ensured.
On the other hand, if this value is too large (thick), it may take a long time for the liquid in the internal space to reach the electrode surface, and the electrode surface may not be sufficiently irrigated.
カテーテルシャフト10の先端可撓部分102にはリング状電極41~43が装着されている。先端電極30およびリング状電極41~43の固定方法としては特に限定されるものではなく、例えば接着などの方法を挙げることができる。
リング状電極41~43は、例えばアルミニウム、銅、ステンレス、金、白金など、電気伝導性の良好な金属で構成される。なお、X線に対する造影性を良好に持たせるためには、白金などで構成されることが好ましい。
リング状電極41~43の外径としては特に限定されないが、カテーテルシャフト10の外径と同程度であることが好ましい。 Ring-shapedelectrodes 41 to 43 are attached to the tip flexible portion 102 of the catheter shaft 10 . The method for fixing the tip electrode 30 and the ring-shaped electrodes 41 to 43 is not particularly limited, and examples thereof include a method such as adhesion.
The ring-shapedelectrodes 41 to 43 are made of metal with good electrical conductivity, such as aluminum, copper, stainless steel, gold, and platinum. It should be noted that it is preferably made of platinum or the like in order to have good X-ray imaging properties.
The outer diameter of the ring-shapedelectrodes 41 to 43 is not particularly limited, but is preferably approximately the same as the outer diameter of the catheter shaft 10 .
リング状電極41~43は、例えばアルミニウム、銅、ステンレス、金、白金など、電気伝導性の良好な金属で構成される。なお、X線に対する造影性を良好に持たせるためには、白金などで構成されることが好ましい。
リング状電極41~43の外径としては特に限定されないが、カテーテルシャフト10の外径と同程度であることが好ましい。 Ring-shaped
The ring-shaped
The outer diameter of the ring-shaped
図3および図4に示すように、焼灼温度を制御するための熱電対90が先端電極30の内部空間36およびカテーテルシャフト10のルーメン13Lに配置(挿通)されている。熱電対90の測温接点95は、先端電極30の先端壁内に配置されている。
As shown in FIGS. 3 and 4, a thermocouple 90 for controlling the ablation temperature is placed (inserted) in the inner space 36 of the tip electrode 30 and the lumen 13L of the catheter shaft 10. A measuring junction 95 of thermocouple 90 is located in the tip wall of tip electrode 30 .
本実施形態のアブレーションカテーテル100によれば、先端方向に縮径する先端縮径部101と、先端方向に拡径する基端部分32とにより、カテーテルシャフト10と先端電極30との接続部の外径を最小外径とする括れが形成されるので、焼灼治療中において、カテーテルシャフト10と先端電極30との接続部が体内組織に接触することを回避することができ、当該接続部の周囲で異常な温度上昇が発生することを防止することができる。
According to the ablation catheter 100 of the present embodiment, the distal end portion 101 whose diameter is reduced in the distal direction and the proximal end portion 32 whose diameter is expanded in the distal direction form the outside of the connecting portion between the catheter shaft 10 and the tip electrode 30. Since a constriction with a diameter as the minimum outer diameter is formed, it is possible to avoid contact of the connecting portion between the catheter shaft 10 and the tip electrode 30 with body tissue during ablation treatment. Abnormal temperature rise can be prevented.
また、液体の貯留空間として先端電極30に内部空間36が形成され、当該内部空間36を取り囲む先端電極30の壁厚(t)が、基端部分32および先端部分31の全体において均一であるので、先端電極30(基端部分32および先端部分31)の表面全体を、内部から迅速かつ均等に灌注することができる。
In addition, the inner space 36 is formed in the tip electrode 30 as a liquid storage space, and the wall thickness (t) of the tip electrode 30 surrounding the inner space 36 is uniform throughout the proximal portion 32 and the distal portion 31. , the entire surface of the tip electrode 30 (proximal portion 32 and distal portion 31) can be rapidly and evenly irrigated from within.
100 アブレーションカテーテル
10 カテーテルシャフト
101 先端縮径部
102 先端可撓部分
11L,12L ルーメン(液体の流路)
13L,14L ルーメン(リード線の挿通路)
15L~18L ルーメン(引張ワイヤの挿通路)
107 インナー部
108 補強ブレード層
109 アウター部
20 アンカー部材
21 第1操作用ワイヤ
22 第2操作用ワイヤ
30 先端電極
31 先端電極の先端部分
32 先端電極の基端部分
33 先端電極の円筒状部分
35 先端電極のリード線
36 先端電極の内部空間
41~43 リング状電極
46~48 リング状電極のリード線
51,52 流路形成用チューブ
60 板バネ
70 制御ハンドル
75 摘み
80 液体の注入管
90 熱電対
95 測温接点 REFERENCE SIGNSLIST 100 ablation catheter 10 catheter shaft 101 tip reduced diameter portion 102 tip flexible portion 11L, 12L lumen (liquid flow path)
13L, 14L lumen (passage for lead wire)
15L to 18L lumen (passage for pulling wire)
107inner portion 108 reinforcing braid layer 109 outer portion 20 anchor member 21 first operation wire 22 second operation wire 30 tip electrode 31 tip portion of tip electrode 32 base portion of tip electrode 33 cylindrical portion of tip electrode 35 tip Electrode lead wire 36 Internal space of tip electrode 41-43 Ring-shaped electrode 46-48 Ring-shaped electrode lead wire 51, 52 Channel forming tube 60 Leaf spring 70 Control handle 75 Knob 80 Liquid injection tube 90 Thermocouple 95 Temperature measuring junction
10 カテーテルシャフト
101 先端縮径部
102 先端可撓部分
11L,12L ルーメン(液体の流路)
13L,14L ルーメン(リード線の挿通路)
15L~18L ルーメン(引張ワイヤの挿通路)
107 インナー部
108 補強ブレード層
109 アウター部
20 アンカー部材
21 第1操作用ワイヤ
22 第2操作用ワイヤ
30 先端電極
31 先端電極の先端部分
32 先端電極の基端部分
33 先端電極の円筒状部分
35 先端電極のリード線
36 先端電極の内部空間
41~43 リング状電極
46~48 リング状電極のリード線
51,52 流路形成用チューブ
60 板バネ
70 制御ハンドル
75 摘み
80 液体の注入管
90 熱電対
95 測温接点 REFERENCE SIGNS
13L, 14L lumen (passage for lead wire)
15L to 18L lumen (passage for pulling wire)
107
Claims (5)
- 液体の流路となるルーメンを有するカテーテルシャフトと、前記カテーテルシャフトの先端側に接続された多孔質材料からなる先端電極とを備えてなり、
前記先端電極は、前記カテーテルシャフトの先端から先端方向に拡径する基端部分と、前記基端部分に連続して先端方向に縮径する先端部分とを有し、前記カテーテルシャフトの前記ルーメンに連通する内部空間が形成された中空構造体であり、
前記内部空間を取り囲む前記先端電極の壁厚が前記基端部分および前記先端部分の全体にわたり実質的に均一であることを特徴とする電極カテーテル。 comprising a catheter shaft having a lumen serving as a liquid flow path, and a tip electrode made of a porous material connected to the tip side of the catheter shaft,
The tip electrode has a proximal portion whose diameter increases in the distal direction from the distal end of the catheter shaft, and a distal portion which continues to the proximal portion and decreases in diameter in the distal direction. A hollow structure in which a communicating internal space is formed,
An electrode catheter, wherein a wall thickness of said tip electrode surrounding said interior space is substantially uniform throughout said proximal portion and said distal portion. - 前記カテーテルシャフトは、先端方向に縮径する先端縮径部を有し、
前記先端電極の前記基端部分は、前記先端縮径部の先端から先端方向に拡径することを特徴とする請求項1に記載の電極カテーテル。 The catheter shaft has a tip-reduced-diameter portion whose diameter is reduced in the distal direction,
2. The electrode catheter according to claim 1, wherein the proximal portion of the tip electrode increases in diameter from the tip of the tip reduced diameter portion in the distal direction. - 前記先端電極の前記先端部分は、前記基端部分の最大外径を直径とする部分球状であることを特徴とする請求項1または2に記載の電極カテーテル。 The electrode catheter according to claim 1 or 2, wherein the tip portion of the tip electrode has a partially spherical shape with a diameter equal to the maximum outer diameter of the base end portion.
- 前記電極カテーテルの縦断面視において、前記先端縮径部と、前記先端電極の前記基端部分とのなす角度(α)が160°以下であることを特徴とする請求項2または3に記載の電極カテーテル。 4. The electrode catheter according to claim 2 or 3, wherein an angle (α) formed by the reduced diameter tip portion and the base end portion of the tip electrode is 160° or less in a longitudinal cross-sectional view of the electrode catheter. electrode catheter.
- 前記先端電極の最大外径を(D30)、前記壁厚を(t)とするとき、(t)/(D30)の値が0.12~0.25であることを特徴とする請求項1~4の何れかに記載の電極カテーテル。 Where the maximum outer diameter of the tip electrode is (D 30 ) and the wall thickness is (t), the value of (t)/(D 30 ) is 0.12 to 0.25. Item 5. The electrode catheter according to any one of items 1 to 4.
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Citations (3)
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JP2013502967A (en) * | 2009-08-28 | 2013-01-31 | コーニンクレッカ フィリップス エレクトロニクス エヌ ヴィ | Catheter for open-loop irrigation ablation of tissue |
JP2013252202A (en) * | 2012-06-05 | 2013-12-19 | Japan Lifeline Co Ltd | Electrode catheter |
JP2016127919A (en) * | 2014-12-30 | 2016-07-14 | バイオセンス・ウエブスター・(イスラエル)・リミテッドBiosense Webster (Israel), Ltd. | Catheter with irrigated tip electrode with porous substrate and high density surface micro-electrodes |
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2021
- 2021-08-18 WO PCT/JP2021/030207 patent/WO2023021618A1/en active Application Filing
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2013502967A (en) * | 2009-08-28 | 2013-01-31 | コーニンクレッカ フィリップス エレクトロニクス エヌ ヴィ | Catheter for open-loop irrigation ablation of tissue |
JP2013252202A (en) * | 2012-06-05 | 2013-12-19 | Japan Lifeline Co Ltd | Electrode catheter |
JP2016127919A (en) * | 2014-12-30 | 2016-07-14 | バイオセンス・ウエブスター・(イスラエル)・リミテッドBiosense Webster (Israel), Ltd. | Catheter with irrigated tip electrode with porous substrate and high density surface micro-electrodes |
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