KR101953486B1 - Catheter - Google Patents

Abstract

Provide a catheter with higher functionality. The electrode catheter 1 is provided with the operation part, the shaft 2, and the operation wires PW1 and PW2. The shaft 2 extends and includes the base end region A1, the intermediate region Am, and the front end region A2, which are arranged in order from the side of the operation portion, and are provided with a first passage and a second passage through them. The operation wires PW1 and PW2 are inserted through the first passage or the second passage. The distance between the lumen 4H1 and the central axis CL is closer than the distance between the lumen 5H1 and the central axis CL, and the distance between the lumen 4H2 and the central axis CL is closer than the distance between the lumen 5H2 and the central axis CL. The lumens 6H1 and 6H2 are inclined with respect to the central axis CL so as to be separated from each other by moving from the proximal region A1 to the distal region A2. The shaft 2 has a multi lumen tube 40 in which lumens 4H1 and 4H2 are formed in the proximal region A1.

Description

Catheter {CATHETER}

TECHNICAL FIELD This invention relates to the catheter used, for example for examination (diagnosis), treatment, etc. of arrhythmia.

The catheter is inserted into the body (for example, inside of the heart) through a blood vessel, and is used for examination or treatment of arrhythmia (see Patent Document 1, for example). In such a catheter, generally, the shape near the tip (distal end) inserted into the body changes in one or both directions depending on the operation of the operation unit mounted on the proximal end (proximal end, rear end, and the front side) arranged outside the body. (Deflection, curvature).

Japanese Patent Laid-Open No. 2002-360704

By the way, in the catheter of patent document 1 mentioned above, the single lumen structure which contained one metal pipe (or metal coils, such as a flat coil) in the base end part of the front end side tubular member which has a multi-lumen structure containing several tubes is included. The base end side tubular member which has is provided. Such a metal pipe and a metal coil function as an anti-compressive member which prevents bending, bending and meandering of the proximal end tubular member during operation of the operation unit.

However, such thinning of metal pipes and metal coils is becoming unavoidable due to the weight reduction of the electrode catheter and the improvement of operability. In connection with this, the function as an anti-compression member in a metal pipe or a metal coil is not fully exhibited, and it is feared that meandering of a base end side tubular member, etc. cannot fully be prevented.

The present invention has been made in view of the above problems, and an object thereof is to provide a catheter having a higher function.

The catheter of the present invention is extended to include an operation portion, a proximal region, an intermediate region, and a leading region, which are connected to the operation portion and are arranged in order from the side of the operation portion along a central axis, and further include a proximal region, an intermediate region, and a leading region And a flexible shaft provided with a first passageway and a second passageway passing through all of them in parallel along the central axis, a first wire inserted into the first passageway, and a second wire inserted through the second passageway. . Here, the distance between the first base end region portion passing through the base end region of the first passageway and the central axis is closer than the distance between the first end region portion passing through the tip end region of the first passageway and the central axis, and penetrates through the base end region of the second passageway. The distance between the second base end region portion and the central axis is closer than the distance between the second front end region portion and the central axis passing through the tip region in the second passage. Further, the first intermediate region portion penetrating the intermediate region of the first passage and the second intermediate region portion penetrating the intermediate region of the second passage are inclined with respect to the central axis so as to move away from each other toward the leading region from the proximal region. And the flexible shaft has a multi lumen tube in which the first proximal region portion and the second proximal region portion are formed.

In the catheter of the present invention, the first passages and the second passages, which are independent of each other, are respectively located relatively near the central axis in the proximal end region, and are provided at positions relatively far from the central axis in the distal end region. For this reason, the 1st wire and the 2nd wire inserted through those 1st channel | path and the 2nd channel | path respectively are pulled without contacting each other, and the displacement operation of a flexible shaft in a front end area | region is performed smoothly. On the other hand, in the proximal region, both the first wire and the second wire are located relatively close to the central axis, whereby bending and meandering of the flexible shaft in the proximal region are suppressed.

In addition, the multi lumen tube may further have a first lumen and a second lumen symmetrically arranged with respect to the central axis, and a third lumen and a fourth lumen symmetrically arranged with respect to the central axis. Here, the first lumen and the third lumen are symmetrically arranged with the first plane including the central axis as the symmetry plane, and the second lumen and the fourth lumen are symmetrically arranged with the first plane as the symmetry plane, and the first lumen The lumen and the fourth lumen are arranged symmetrically with the second plane orthogonal to the first plane including the central axis as the symmetry plane, and the second lumen and the third lumen are arranged symmetrically with the second plane as the symmetry plane. do.

According to the catheter of the present invention, the first passage through which the first wire is inserted and the second passage through which the second wire is inserted are located at a position approaching the central axis in the proximal region and from the central axis in the distal region. Since it exists in a spaced position, it is excellent in torque response and bending response.

1: A is a schematic diagram which shows schematic structural example of the catheter which concerns on one Embodiment of this invention.
FIG. 1B is an enlarged schematic view showing the vicinity of the tip of the catheter shown in FIG. 1A.
FIG. 2: is sectional drawing along the central axis which shows the detailed structural example of the vicinity of the intermediate | middle area in the catheter shown to FIG. 1A.
FIG. 3A is a perspective view showing a detailed configuration example in the vicinity of the intermediate region in the catheter shown in FIG. 1A. FIG.
FIG. 3B is another perspective view illustrating a detailed configuration example in the vicinity of the intermediate region in the catheter shown in FIG. 1A.
It is sectional drawing orthogonal to a center axis which shows the detailed structural example of the base end area | region in the catheter shown to FIG. 1A.
4B is a cross-sectional view orthogonal to the central axis, illustrating a detailed configuration example of the tip region in the catheter shown in FIG. 1A.
FIG. 5: A is a top view which shows the cross section which opposes the base end area | region of the guide member in the shaft shown in FIG.
FIG. 5B is a plan view illustrating a cross section of the guide member in the shaft illustrated in FIG. 2 facing the tip region. FIG.

EMBODIMENT OF THE INVENTION Hereinafter, embodiment of this invention is described in detail with reference to drawings.

<Embodiment>

[Schematic Configuration]

1A schematically shows a schematic configuration of an electrode catheter 1 according to an embodiment of the present invention. 1B shows the area IB enclosed by the broken line enlarged in FIG. 1A. The electrode catheter 1 is inserted into the body (for example, inside the heart) through blood vessels, and is used for examination, treatment, or the like of arrhythmia. This electrode catheter 1 is provided with the shaft 2 (catheter shaft) as a catheter main body, and the operation part 3 attached to the base end (proximal end, rear end, and the front side of this shaft 2).

(Shaft (2))

The shaft 2 has a tubular structure (the tubular members 4 and 5 to be described later) showing flexibility, and is intermediate with the proximal end region A1 in the order from the operation part 3 side along its own direction (Z-axis direction). It has the area | region (boundary area) Am and the tip area | region A2. The shaft 2 corresponds to one specific example of the "flexible shaft" of the present invention.

The axial length of the shaft 2 is about 500-1200 mm (for example 1100 mm), and the outer diameter (outer diameter of X-Y cross section) of the shaft 2 is about 0.6-3 mm (for example 2.0 mm). In addition, the lengths of the base end region A1, the tip region A2, and the intermediate region Am in the shaft 2 are about 400 to 1200 mm (for example, 800 mm) and about 100 to 400 mm (for example 150 mm), respectively. About 1 to 100 mm (eg 50 mm).

In the tip region A2 of the shaft 2, as shown in FIG. 1B, a plurality of electrodes (here, three ring-shaped electrodes 21A, 21B, 21C) and one tip electrode 22 are provided. In the vicinity of the distal end of the shaft 2, the ring-shaped electrodes 21A, 21B, 21C and the distal end electrode 22 are disposed at predetermined intervals in this order toward the distal end side. 21A, 21B, and 21C are respectively fixedly arranged on the outer circumferential surface of the shaft 2 (tubular structure), while the tip electrode 22 is fixedly arranged at the uppermost end of the shaft 2. Is electrically connected to a connector provided in the operation unit 3 via a plurality of conductive wires 71A to 71C and 72 (not shown in FIGS. 1A and 1B) described below, which are inserted into the tubular structure of the shaft 2. .

Such ring-shaped electrodes 21A, 21B, 21C and tip electrode 22 are, for example, aluminum (Al), copper (Cu), stainless steel (SUS), gold (Au), platinum (Pt), or the like. It is comprised by the metal material with good electrical conductivity. Moreover, in order to make the contrast with respect to X-rays at the time of use of the electrode catheter 1 favorable, it is preferable that it is comprised by platinum or its alloy. The outer diameters of the ring electrodes 21A, 21B, 21C and the tip electrode 22 are not particularly limited, but are preferably about the same as the outer diameter of the shaft 2 described above.

(Control panel 3)

The operation part 3 corresponds to one specific example of the "operation part" of this invention. The operation part 3 is attached to the base end (end part of base end area | region A1) of the shaft 2, and has the handle 31 (gripping part) and the rotating plate 32 other than the connector mentioned above, for example.

The handle 31 is a part held by the operator (doctor) when the electrode catheter 1 is used. Inside the handle 31, various fine wires (conductors 71A to 71C, 72) and operation wires PW1 and PW2 described later are drawn out from the inside of the shaft 2, respectively.

The rotating plate 32 is a member for performing deflection movement operation (neck operation), which is an operation for deflecting (curving) the vicinity of the tip end of the shaft 2. Specifically, the rotating plate 32 has protrusions 32A and 32B, and for example, as shown by the arrow in FIG. 1A, the pressing plate 32A and 32B is pressed along the rotation direction d1a or the rotation direction d1b. The operation which rotates the 32 in the direction of rotation direction d1a or the rotation direction d1b is attained.

[Detailed Structure of Shaft 2]

(Overall Configuration of Shaft 2)

Next, with reference to FIGS. 2-5B, the detailed structure of the shaft 2 is demonstrated. FIG. 2: is a schematic diagram which shows the structural example of the detailed cross section (Y-Z cross section) of the vicinity of intermediate region Am of the shaft 2 shown in FIG. 1A. 3A and 3B are schematic diagrams showing a detailed perspective configuration example in the vicinity of the intermediate region Am. 4A is a schematic diagram which shows the structural example of the cross section (XY cross section) of the arrow direction along the IVA-IVA line shown in FIG. 1A, and FIG. 4B is a cross section of the arrow direction along the IVB-IVB line shown in FIG. 1A. It is a schematic diagram which shows the structural example of (XY cross section). That is, FIG. 4A is sectional drawing orthogonal to center axis CL which shows the detailed structural example of base end area | region A1, and FIG. 4B is sectional drawing orthogonal to center axis CL which shows the detailed structural example of tip area A2. 5A shows a cross section facing the proximal end region A1 of the guide member 6 (to be described later) provided in the intermediate region Am, and FIG. 5B shows the leading region of the guide member 6 provided in the intermediate region Am. It shows the cross section facing A2.

As shown in FIG. 2, the shaft 2 is intersected by the operation wire PW1 and the operation wire PW2. Specifically, the shaft 2 is provided with two passages (first passage and second passage) that continuously pass all of the base region A1, the intermediate region Am, and the tip region A2 in parallel with the central axis CL. have. The operation wire PW1 is slidably inserted into the "first passage", and the operation wire PW2 is slidably inserted into the "second passage". Here, the "first passage" includes a lumen (pore, through hole) 4H1 penetrating the proximal end region A1, a lumen 6H1 penetrating the intermediate region Am, and a lumen 5H1 penetrating the proximal region A2. It is formed through. The "second passage" is formed by communicating the lumen 4H2 through the proximal end region A1, the lumen 6H2 through the intermediate region Am, and the lumen 5H2 through the proximal region A2. The lumens 4H1, 4H2, 5H1, 5H2 all extend substantially in parallel with the central axis CL. On the other hand, the lumens 6H1 and 6H2 are both inclined and extended with respect to the central axis CL so as to move away from the proximal end region A1 toward the distal end region A2. In addition, the lumens 4H1, 4H2, 5H1, 5H2, 6H1, and 6H2 are the "first proximal region portion", "second proximal region portion", "first proximal region portion" and "second proximal edge" of the present invention, respectively. Region portion ”,“ first intermediate region portion ”, and“ second intermediate region portion ”.

As shown in FIG. 2, the distance between the lumen 4H1 and the central axis CL in the first passage is closer than the distance between the lumen 5H1 and the central axis CL in the first passage. Similarly, the distance between the lumen 4H2 and the central axis CL in the second passage is closer than the distance between the lumen 5H2 and the central axis CL in the second passage. Here, the distance between the lumen 4H1 and the central axis CL is preferably substantially equal to the distance between the lumen 4H2 and the central axis CL. In addition, the distance between the lumen 5H1 and the central axis CL is preferably substantially equal to the distance between the lumen 5H2 and the central axis CL.

(Base area A1)

In the proximal end region A1, the shaft 2 has a structure in which a multi-lumen tube 40 extending in the Z-axis direction is accommodated inside the tubular member 4 having a tubular (hollow shape) as shown in FIG. 4A. have. The multi lumen tube 40 includes a resin such as polyetheretherketone (PEEK) or polytetrafluoroethylene (PTFE). The multi-lumen tube 40 is formed with a plurality of lumens extending along the central axis CL, including the lumens 4H1 and 4H2 disposed to face each other with the central axis CL interposed therebetween. Specifically, in addition to the lumens 4H1 and 4H2, for example, a pair of lumens 41A and 41B that are disposed to face each other with the lumens 4H1 and 4H2 interposed therebetween, and the ones arranged to face each other with the central axis CL interposed therebetween. A pair of lumens 42A and 42B and a pair of lumens 43A and 43B are disposed to face each other with the central axis CL interposed therebetween. In addition, although the lumens 4H1, 4H2, 41A, 41B, 42A, 42B, 43A, 43B all have circular cross sections, for example, their shape and dimensions (inner diameter) are not particularly limited. For example, the inner diameters of the lumens 4H1 and 4H2 are about 0.15 to 0.4 mm, the inner diameters of the lumens 41A and 41B are about 0.1 to 0.7 mm, and the inner diameters of the lumens 42A, 42B, 43A, 43B are 0.2 to It is about 0.7mm. In addition, a pair of lumens 41A and 41B, a pair of lumens 42A and 42B, and a pair of lumens 43A and 43B correspond to one specific example of the "pore pair" of the present invention.

Here, the lumens 41A and lumens 41B in the multi-lumen tube 40 are disposed symmetrically with respect to the central axis CL, and the lumens 42A and lumen 42B are disposed symmetrically with respect to the central axis CL. The lumen 43A and the lumen 43B may be disposed symmetrically with respect to the central axis CL. The lumens 41A, 42A and 43A and the lumens 41B, 43B and 42B may be arranged symmetrically in the Y-axis direction with the XZ plane including the central axis CL as the symmetry plane. The lumens 42A and 43B and the lumens 43A and 42B may be disposed symmetrically in the X-axis direction with the YZ plane including the central axis CL as the symmetry plane.

The operating wires PW1 and PW2 are slidably inserted through the lumens 4H1 and 4H2, respectively. In addition, conducting wires 71A, 72, 71B, and 71C are inserted through the lumens 42A, 42B, 43A, and 43B, respectively. Therefore, in the electrode catheter 1, the number of conductors inserted through the lumen 42A and the lumen 43B, which are symmetrically arranged with the XZ plane including the central axis CL as the symmetry plane, is the same (Fig. 4A). In the example, the number of conductors inserted through the lumen 43A and the lumen 42B, which are arranged symmetrically with the XZ plane including the central axis CL as the symmetry plane, is the same number (in the example of FIG. 4A). One). In the electrode catheter 1, the number of conductors inserted through the lumens 42A and the lumens 43A arranged symmetrically with the YZ plane including the central axis CL as the symmetry plane is the same number (example of FIG. 4A). Is the same number of conductors inserted through the lumen 43B and the lumen 42B arranged symmetrically with the YZ plane including the central axis CL as the symmetry plane (one in the example of FIG. 4A). )to be. Here, for example, the conductor 71A is the ring-shaped electrode 21A described above, the conductor 71B is the ring-shaped electrode 21B described above, and the conductor 71C is the ring-shaped electrode 21C described above, respectively. It is electrically connected. In addition, the conducting wire 72 is electrically connected to the tip electrode 22 described above. The leading ends (distal side of the shaft 2) of these conductive wires 71A to 71C are respectively fixed to the corresponding electrodes using welding or solder not shown, and the base ends (proximal side of the shaft 2) are respectively And it is pulled into the operation part 3 (handle 31).

On the other hand, the tip ends of the operation wires PW1 and PW2 are fixed to the tip side of the shaft 2 (on the inner circumferential surface of the tip electrode 22) by an anchor, solder, or the like, and the proximal end is a rotating plate of the operation unit 3. It is attached to (32). Thereby, the tension | tensile_strength of the operation wires PW1 and PW2 changes according to the rotation operation (operation of the rotating plate 32) of this rotating plate 32, and centers inside the shaft 2 (inside of a tubular structure). Towing operation (slide operation) of the operation wires PW1 and PW2 along the axis CL is enabled. Therefore, when the rotating plate 32 is rotated, the tip portion of the electrode catheter 1 is deflected.

Thus, the operation wires PW1 and PW2 are separately inserted through the lumens 4H1 and 4H2 to thereby move the operation wires PW1 and PW2 in the radial direction of the multi-lumen tube 40 in the XY plane. Movement) is limited. This is because the movement in the XY plane of the operation wire PW1 stays inside the lumen 4H1, and the movement in the XY plane of the operation wire PW2 stays inside the lumen 4H2. As a result, the maximum amount of curvature in the tip region A2 of the electrode catheter 1 generated by moving the operation wires PW1 and PW2 in the radial direction of the multi-lumen tube 40 in the lumens 4H1 and 4H2. The reduction is suppressed. Therefore, the tip curve responsiveness during the bending operation is improved.

In addition, the conducting wires 71A-71C and 72 are each comprised by metal materials, such as copper, for example, and the diameter is about 50-200 micrometers (for example, 100 micrometers). In addition, the operation wires PW1 and PW2 are comprised by the superelastic metal material, such as stainless steel (SUS) and NiTi, for example, and the diameter is about 0.10 mm-about 0.35 mm. Here, the difference between the inner diameter of the lumens 4H1 and 4H2 and the diameter of the operation wires PW1 and PW2 is preferably 0.05 to 0.25 mm, for example. By reducing the diameter difference between the inner diameters of the lumens 4H1 and 4H2 and the wires PW1 and PW2 in this manner, the amount of movement of the wires PW1 and PW2 in the radial direction of the multi-lumen tube 40 can be further reduced. Because it can. As a result, the tip curve responsiveness of the electrode catheter 1 is further improved.

The tubular member 4 corresponds to one specific example of the "first exterior tube" of the present invention. The tubular member 4 has a cylindrical wall portion 4A extending along the direction (Z-axis direction) of the central axis CL of the shaft 2 and a blade 4B embedded therein.

4 A of wall parts are comprised by synthetic resins, such as a polyolefin, a polyamide, a polyether polyamide, and a polyurethane, for example. 4 A of wall parts are about 0.4-1.5 mm (for example, 0.8 mm), Preferably it is 0.6-1.2 mm.

The blade 4B has a braided structure in which a plurality of plate-shaped line members (flat element wires) are intersected and woven together. The thickness of the blade 4B is about 10-200 micrometers (for example, 50 micrometers), for example.

(Tip area A2)

In the tip region A2, the shaft 2 is formed in the tubular member 5 of the tubular (hollow shape) as shown in Fig. 4B, each of which includes a plurality of tubes (here six tubes 51) growing along the central axis CL. To 56)). Here, the tube 51 and the tube 52 are disposed opposite to each other with the central axis CL interposed therebetween, and the tube 53 and the tube 54 are disposed to face each other with the central axis CL interposed therebetween. Reference numeral 56 is disposed to face each other with the central axis CL interposed therebetween. The shaft 2 further has a leaf spring member 57 in the tip region A2.

The tubular member 5 has a multilayer structure in which the inner layer 5A, the intermediate layer 5B, and the outer layer 5C are laminated in this order from the inner circumferential side toward the outer circumferential side. The inner layer 5A, the intermediate layer 5B, and the outer layer 5C are all made of the same material as the wall portion 4A described above, for example. Moreover, it is preferable that the tubular member 5 is comprised so that the flexibility of the front end side may become relatively high and the flexibility of the base end side will become relatively low. This is because the shaft 2 easily bends selectively near the tip. The inner layer 5A is provided so as to cover the tubes 51 to 56 and the leaf spring members 57 in close contact with these. The thickness of 5C of outer layers in the tubular member 5 is about 50-500 micrometers (for example, 200 micrometers), for example. In addition, the tubular member 5 corresponds to the specific example of the "2nd exterior tube" of this invention. In the vicinity of the base end of the tubular member 5, a part of the tubular member 5 is cut toward the base end, and the thickness is thin. The thinned portion near the proximal end of the tubular member 5 is fused with one end of the tubular member 4 extending from the proximal end region A1 to the part of the proximal region A2 via the intermediate region Am.

The leaf spring member 57 is fitted between the tube 51 accommodating the operation wire PW1 and the tube 52 accommodating the operation wire PW2 and extends along the central axis CL, for example. The leaf spring member 57 is, for example, a plate member widened along the XZ plane, and both edges of the end portions in the X-axis direction are formed by the inner layer 5A of the tubular member 5 over the entire length of the Z-axis direction. It is locked. For this reason, the leaf spring member 57 can suppress the distortion of the tubular member 5 which arises, for example when the operation wires PW1 and PW2 are pulled. As a result, the torsional rigidity of the shaft 2 becomes high, and the torque response and the bending response of the shaft 2 can be improved.

The tubes 51 to 56 each extend along the central axis CL of the shaft 2 and each have a hollow structure having one lumen. As shown in FIG. 4B, the operation wire PW1 is slidably inserted into the lumen 5H1 that is inside the tube 51, and the operation wire PW2 slides into the lumen 5H2 that is inside the tube 52. It is possibly penetrated. In addition, the conductor wire 71A is in the lumen 5H3 which is the inside of the tube 53, and the conductor wire 72 is in the lumen 5H4 which is the inside of the tube 54, and in the lumen 5H5 which is the inside of the tube 55. The conducting wire 71C penetrates through the lumen 5H6 which is the conducting wire 71B inside the tube 56.

These tubes 51-56 are each comprised by synthetic resins, such as a polyolefin, a polyamide, a polyether polyamide, and polyurethane, respectively, The thickness of each about 10-200 micrometers (for example, 30 μm). In addition, the inner diameter (diameter of each lumen 5H1-5H6) of each tube 51-56 is about 100-800 micrometers (for example, 500 micrometers).

(Middle area Am)

The guide member 6 is provided between the multi lumen tube 40 provided in the base end area A1, and the tubes 51-56 provided in the front end area A2. The guide member 6 is comprised with ceramics, a liquid crystal polymer, etc., for example. 5A and 5B, in addition to lumens 6H1 and 6H2 penetrating the inside thereof, the guide member 6 includes a plurality of grooves (here, four grooves) extending along the central axis CL on the outer circumferential surface thereof. (61 to 64)) are formed. In addition, although the grooves 61-64 all have a substantially elliptical cross-sectional shape, those shapes and dimensions (inner diameter) are not specifically limited.

The groove 61 communicates with the lumen 42A in the cross section on the proximal end side, and communicates with the lumen 5H3 in the cross section on the tip end side, and the conductor wire 71A is inserted therein. The groove 62 communicates with the lumen 42B in the cross section on the proximal end side and communicates with the lumen 5H4 in the cross section on the tip end side, and the conductive wire 72 is inserted therein. The groove 63 communicates with the lumen 43A in the cross section on the proximal end side, and communicates with the lumen 5H5 in the cross section on the tip end side, and the conductive wire 71B is inserted therein. The groove 64 communicates with the lumen 43B in the cross section on the proximal end side, and communicates with the lumen 5H6 in the cross section on the tip end side, and the conductor wire 71C is inserted therein.

[Action, effect]

(A. Basic Behavior)

In the electrode catheter 1, the shaft 2 is inserted into the body (for example, the inside of the heart) through blood vessels when examining or treating arrhythmia for the patient. At this time, the shape near the tip of the shaft 2 inserted into the body changes, for example, in one direction or in both directions depending on the operation of the operation unit 3 (arranged outside the body) by the operator. )do. Specifically, when the projection 32A is pressed by the operator's finger and the rotating plate 32 is rotated in the rotational direction d1a indicated by the arrow of FIG. 1A, for example, the operation wire PW1 in the shaft 2. Is pulled to the proximal side. As a result, the vicinity of the tip of the shaft 2 curves along the direction d2a indicated by the arrow in FIG. 1A.

Here, for example, when used for the inspection of the arrhythmia described above, the electrocardiogram is measured by the electrodes (tip electrode 22 or ring-shaped electrodes 21A, 21B, 21C) of the electrode catheter 1 inserted into the body. Then, based on the information on the electrocardiogram, a test regarding the presence or the degree of abnormal potential at the inspection site is performed.

On the other hand, for example, when used for the treatment of arrhythmias described above, a counter electrode plate (not shown) mounted on the patient's body surface and an electrode (tip electrode 22) of the electrode catheter 1 inserted into the body are included. In, Radio Frequency (RF) energization is made. By such high frequency energization, the site (blood vessel, etc.) to be treated is selectively cauterized (ablation), and percutaneous treatment of arrhythmia is performed.

(B. Effect based on the action of the shaft 2)

Here, in the electrode catheter 1 of the present embodiment, the shaft 2 is formed with a plurality of pores (lumens 5H1 to 5H6) extending along the direction (Z-axis direction) of the central axis CL in the tip region A2. It has a lumen structure. Then, a plurality of thin wires (conductors 71A to 71C, 72) and operation wires PW1 and PW2 are inserted into these six lumens 5H1 to 5H6 and inserted through the shafts. Compared with the case of having a single lumen structure in the region A2, the operability of the electrode catheter 1 is improved (torque transfer characteristics and the like are improved).

In the electrode catheter 1, the shaft 2 has a multi-lumen structure in which a plurality of pores (lumens 4H1, 4H2, 41A, 41B, 42A, 42B, 43A, 43B) are formed even in the proximal end region A1. . Among them, the operation wire PW1 is inserted through the lumen 4H1 and the operation wire PW2 is inserted through the lumen 4H2, so that the operation wire PW1 and the operation wire PW2 are operated when the operation unit 3 is operated. Interference with each other, such as contact or entanglement with each other, is prevented. Further, the operation wire PW1 and the operation wire PW2 can be restricted from moving in the radial direction of the shaft 2. As a result, the operability of the electrode catheter 1 is improved (the front curve responsiveness is improved). Specifically, according to this electrode catheter 1, the operation of the operation part 3 can bend the shaft 2 of the tip region A2 without delay so as to have an intended curved shape. That is, according to this electrode catheter 1, the problem that the shaft 2 of the tip area | region A2 does not bend enough, and does not reach the intended curve shape by operation of the operation part 3, for example can be avoided.

In addition, the conductive wires 71A to 71C and the conductive wires 72 are inserted through the lumens 42A, 42B, 43A, and 43B in the multi-lumen tube 40, respectively, for example to one lumen 42A. The torque transmission characteristic (torque responsiveness) is improved compared with the case where all of the conductors 71A to 71C and 72 are inserted through. However, when a plurality of conductive wires are inserted into one lumen, a plurality of operation wires are biased (local disaster) within the lumen. As a result, when a rotational force is applied to the proximal end of the shaft 2, the rotational force is not fully transmitted to the distal end side, but is in a state of being pushed (a so-called torque pool occurs), which may hinder a continuous response. In this regard, according to the electrode catheter 1 of the present embodiment, since the plurality of conductive wires are dispersed and inserted through the plurality of lumens, generation of the torque pool described above can be avoided.

Moreover, in the electrode catheter 1, even if the shaft 2 does not have an anti-compression member, such as a metal pipe, in base end area | region A1, the bending and curvature which it does not intend can be fully prevented. This arranges the lumen 4H1 through which the operation wire PW1 is inserted and the lumen 4H2 through which the operation wire PW2 is inserted at a position closer to the central axis CL, and on the other hand, in the tip area A2, This is because the lumen 5H1 through which the wire PW1 is inserted and the lumen 5H2 through which the operation wire PW2 is inserted are arranged at a position near the outer circumferential surface further separated from the central axis CL. Thereby, high operability (torque transmission characteristic and tip curve responsiveness at the time of bending operation) of the electrode catheter 1 can be ensured.

Thus, since the electrode catheter 1 does not have an anticompressive member such as a conventional metal pipe, the thickness of the tubular member 4 can be increased by the space occupied by the anticompressive member. As a result, the torque transmission characteristic can be further improved, and the pushability can be improved. Pressure transfer property means the easiness of pushing when an operator inserts the shaft 2 in a patient's body. The rigidity of the tubular member 4 is increased in this electrode catheter 1 by increasing the thickness of the tubular member 4. Thus, when the leading end region A2 of the shaft 2 is inserted into the blood vessel of the patient and pushed to the leading side while holding the proximal region A1 of the shaft 2 to reach the leading electrode 22 to the inside of the heart, for example. The bending and meandering of the tubular member 4 are unlikely to occur. For this reason, pressure transmission is improved. In particular, when the multi-lumen tube 40 is comprised by resin of comparatively high hardness, such as PEEK, since higher pressure transmission property is obtained, it is preferable.

Moreover, in the electrode catheter 1, the cross-sectional shape of each lumen or groove | channel provided in the inside of the tubular member 4 and 5 and the inside of the guide member 6 was made into substantially circular or elliptical shape. For this reason, the intensity | strength of the shaft 2 can be improved in balance, aiming at weight reduction of the shaft 2. As a result, the shaft 2 can maintain a shape that is firmly stable against external forces from multiple directions.

Moreover, in the electrode catheter 1, the some lumen provided in the multi lumen tube 40 in the base end area | region A1 is arrange | positioned symmetrically with respect to the central axis CL. Specifically, for example, the lumen 41A and the lumen 41B are disposed symmetrically with respect to the central axis CL, the lumen 42A and the lumen 42B are disposed symmetrically with respect to the central axis CL, and the lumen 43A ) And lumen 43B are disposed symmetrically with respect to the central axis CL. Moreover, the lumen 41A, 42A, 43A and lumen 41B, 43B, 42B are arrange | positioned symmetrically in the Y-axis direction using the XZ plane containing central axis CL as a symmetry plane. In addition, the lumens 42A and 43B and the lumens 43A and 42B are symmetrically arranged in the X-axis direction with the YZ plane including the central axis CL as the symmetry plane. By such a structure, the rotational force applied to the base end side of the shaft 2 is more easily transmitted to the front end side, and the torque transmission characteristic can be improved further. In particular, when the lumens 41A and 41B disposed in symmetrical positions with each other have the same diameter, and the lumens 42A, 43A, 42B and 43B disposed in the symmetrical positions with each other have the same diameter, the torque transmission characteristic is improved. It becomes more advantageous at the point of.

In the electrode catheter 1, the number of conductors penetrated into the lumen 42A and the lumen 43B arranged symmetrically with the XZ plane including the central axis CL as the symmetry plane is the same, and similarly the XZ including the central axis CL The number of conductors penetrated into the lumen 43A and the lumen 42B arranged symmetrically with the plane as a symmetry plane is the same. In addition, the number of conductors penetrated into the lumen 42A and the lumen 43A arranged symmetrically with the YZ plane including the central axis CL as the symmetry plane is the same, and the YZ plane including the central axis CL is the symmetry plane. The number of conductors inserted through the lumen 43B and the lumen 42B symmetrically arranged is the same. Thus, in the electrode catheter 1, the lumen through which a conducting wire is inserted is provided in the symmetrical position, and is arrange | positioned so that the number of the conducting wires penetrating into each lumen may become the same. For this reason, in the electrode catheter 1, the generation of torque pools is avoided, and the rotational force applied to the proximal end of the shaft 2 is more easily transmitted to the distal end side, and the torque transmission characteristic can be further improved.

As described above, in the present embodiment, similarly to the front end side, the multi-lumen structure is also adopted on the proximal side, and each of the plurality of operation wires is inserted through the individual lumen. Thereby, the electrode catheter 1 can prevent the interference of several operation wires, and can perform the displacement operation of the shaft 2 smoothly. In addition, since the operation wires PW1 and PW2 penetrate through the position approaching the central axis CL in the base end region A1, the twisting and the like in the base end region A1 of the shaft 2 can be suppressed.

<Variation example>

As mentioned above, although embodiment was described and this invention was demonstrated, this invention is not limited to this embodiment, A various deformation | transformation is possible.

For example, the shape, arrangement position, material, etc. of each member described in the above embodiments are not limited, and may be other shapes, arrangement positions, materials, or the like. In addition, the number of lumens, the number of operation wires, etc. are not limited to the content demonstrated by the said embodiment. In addition, the material of each layer, each member, etc. which were demonstrated in the said embodiment are not limited, It is good also as another material. In the said embodiment, although the structure of the electrode catheter (shaft) was mentioned and demonstrated concretely, it is not necessary to necessarily provide all layers, and you may further provide another layer. Specifically, for example, the leaf spring member 57 of the shaft 2 may not be provided.

In addition, in the said embodiment, although the various conducting wires were each penetrated by each lumen of the shaft 2, you may make it penetrate the thermocouple etc. as a temperature sensor, for example. In this way, the combination of insertion through a plurality of tubes (lumens) and a plurality of thin wires can be arbitrarily set according to a use or the like.

In addition, in the said embodiment, although the structure of the electrode in the tip area A2 of the shaft 2 was demonstrated concretely, the arrangement, shape, number, etc. of a ring-shaped electrode and a tip electrode are not limited to this, for example. .

In addition, the present invention can be applied to any of the electrode catheter (so-called EP catheter) for examination (diagnosis) such as arrhythmia and the electrode catheter (so-called ablation catheter) for treatment such as arrhythmia. In addition, the present invention is not limited to an electrode catheter, and can be applied to an esophageal catheter that performs temperature measurement by inserting the inside of the esophagus close to the heart when performing ablation (ablation) by the ablation catheter, for example.

Claims (2)

Control panel,
It is connected to the operation section, and extends and is arranged including a proximal end region, an intermediate region and a front end region arranged in order from the side of the operation portion along a central axis, and further, all of the proximal region, the intermediate region and the front end region, respectively. A flexible shaft provided with a first passage and a second passage penetrating in parallel along the central axis;
A first wire inserted into the first passage,
A second wire inserted into the second passage;
The distance between the first base end region portion passing through the base end region and the central axis in the first passage is closer than the distance between the first front end region portion passing through the tip region and the central axis in the first passage,
The distance between the second proximal region portion penetrating the proximal region and the central axis in the second passage is closer than the distance between the second proximal region portion penetrating the proximal region and the central axis in the second passage,
The first intermediate region portion penetrating the intermediate region of the first passage and the second intermediate region portion penetrating the intermediate region of the second passage are spaced apart from each other toward the tip region from the proximal region. Inclined about the central axis,
The flexible shaft has a lumen for the first wire through which the first wire is inserted into the first base region, and a second wire with the second base region through which the second wire is inserted. Has a multi-lumen tube formed with a lumen for
In order to reduce the amount of movement of the first and second wires in the radial direction of the multi-lumen tube, the difference between the inner diameter of the lumens for the first and second wires and the diameter of the first and second wires is 0.05 mm to 0.25 mm, Catheter. The method of claim 1,
The multi lumen tube further has a first lumen and a second lumen symmetrically disposed about the central axis, and a third lumen and a fourth lumen symmetrically disposed about the central axis,
The first lumen and the third lumen are disposed symmetrically with the first surface including the central axis as a symmetry plane,
The second lumen and the fourth lumen are arranged symmetrically with the first surface as a symmetry plane,
The first lumen and the fourth lumen are disposed symmetrically with a second plane orthogonal to the first plane including the central axis as a symmetry plane,
And the second lumen and the third lumen are arranged symmetrically with the second surface as a symmetry plane.

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