JP2021100679A - Intracardiac defibrillation catheter - Google Patents

Abstract

To provide a defibrillation catheter that can, by approaching from the inferior vena cava, arrange a first DC electrode group attached to a distal end portion of a tube member inside the coronary sinus and arrange a second DC electrode group inside the right atrium.SOLUTION: The defibrillation catheter is provided with: a first DC electrode group 31G and a second DC electrode group 32G that are attached to a tube member 10; and a first operation wire 71 and a second operation wire 72 for causing the distal end portion of the tube member 10 to bend in both directions. When the rear end of the first operation wire 71 is pulled to the maximum limit in a state in which bending of the tube member 10 is inhibited on the proximal end side of a distal end position of the second DC electrode group 32G, a bend angle (θ1) of the distal end portion of the tube member 10 is greater than 180°.SELECTED DRAWING: Figure 1

Description

The present invention relates to an intracardiac defibrillation catheter that is inserted into the heart chamber to remove atrial fibrillation.

If atrial fibrillation occurs during cardiac catheterization, cardioversion should be performed.
As a catheter for performing such defibrillation in the cardiac cavity, Applicants have an insulating tube member having a multi-lumen structure, a handle connected to the base end of the tube member, and a tip of the tube member. A first DC electrode group consisting of a plurality of ring-shaped electrodes mounted on the region, a second DC electrode group consisting of a plurality of ring-shaped electrodes mounted on a tube member separated from the first DC electrode group toward the proximal end side, and a first A first lead wire group consisting of lead wires connected to each of the electrodes constituting the 1DC electrode group, a second lead wire group consisting of lead wires connected to each of the electrodes constituting the second DC electrode group, and a tube. In order to bend the tip of the member and deflect the tip of the catheter, it must be provided with an operating wire that is eccentric from the central axis of the tube member, extends into the tube member, and has a trailing end that can be pulled. The first lead wire group, the second lead wire group, and the operation wire extend to different lumens of the tube member, and when defibrillation is performed, the first DC electrode group and the first DC electrode group are used. We have proposed an intracardiac defibrillation catheter to which voltages of different polarities are applied to the second DC electrode group (see Patent Document 1).

The tip of the intracardiac defibrillation catheter having such a configuration is inserted into the right atrium from the superior vena cava, and further inserted into the opening of the coronary sinus (coronary sinus ostium) on the posterior inferior wall of the right atrium. As a result, after the first DC electrode group is located in the coronary sinus and the second DC electrode group is located in the right atrium, the first DC electrode group and the second DC electrode group have different polar voltages. Is applied. As a result, the heart causing atrial fibrillation can be provided with sufficient electrical energy necessary for defibrillation.

Recently, a procedure has been performed in which an intracardiac defibrillation catheter is inserted into the right atrium from the inferior vena cava and inserted into the coronary sinus ostium.
Such a procedure (approach from the inferior vena cava) is a conventional procedure in which an intracardiac defibrillation catheter is inserted into the right atrium from the superior vena cava and inserted into the coronary sinus ostium (approach from the superior vena cava). It is less invasive than the above, and is also preferable from the viewpoint of postoperative beauty.

Japanese Unexamined Patent Publication No. 2010-63708

In the inferior vena cava approach, the tip of the defibrillation catheter inserted into the right atrium forms a loop along the side of the right atrium, and then the tip of the defibrillation catheter is placed in the coronary sinus ostium. It is preferable to perform a procedure such as insertion.

However, the inferior vena cava approach is more difficult to insert the tip of the intracardiac defibrillation catheter into the coronary sinus ostium than the superior vena cava approach.

Here, the intracardiac defibrillation catheter disclosed in Patent Document 1 is configured assuming an approach from the superior vena cava, and is a tube member by pulling and operating the rear end of the operation wire. The amount of deflection of the tip portion is small (the deflection angle is at most about 90 °), and depending on the tip portion, a loop having a shape along the side surface of the right atrium cannot be formed. Therefore, even if the effective length of the tube member is extended to a length suitable for the approach from the inferior vena cava, the tip of the defibrillation catheter cannot be guided to the vicinity of the coronary venous sinus ostium.

In such a case, the tip of the tube member after the pulling operation is formed by forming a certain degree of bending shape (pre-shape) at the tip of the tube member before the pulling operation of the rear end of the operation wire. It is conceivable that the part forms the desired loop to guide the tip of the defibrillation catheter near the coronary sinus ostium.

However, even if a loop can be formed in the right atrium by the tip of the tube member, the tip of the defibrillation catheter guided near the coronary sinus ostium is not directed towards the coronary venous ostium (tube). The coronary venous sinus ostium is often located on the opposite side of the flexion direction of the tip portion of the member), and in such a case, the tip portion of the defibrillation catheter cannot be inserted into the coronary venous sinus ostium.

The present invention has been made based on the above circumstances, and an object of the present invention is to insert the tip portion of a tube member into the right atrium from the inferior vena cava and to use the inserted tip portion in the right atrium. It is an object of the present invention to provide an intracardiac defibrillation catheter capable of reliably performing the procedure of inserting the tip portion into the coronary venous sinus ostium after forming a loop with.

(1) The intracardiac defibrillation catheter of the present invention includes an insulating tube member having flexibility at least at the tip portion and an insulating tube member.
A control handle connected to the base end of the tube member and
A tip fixed to the tip of the tube member and
A first DC electrode group composed of a plurality of ring-shaped electrodes mounted on the tip portion of the tube member, and
A second DC electrode group composed of a plurality of ring-shaped electrodes mounted on the tip portion of the tube member, separated from the first DC electrode group toward the proximal end side.
A first lead wire group composed of a plurality of lead wires connected to each of the electrodes constituting the first DC electrode group, and a first lead wire group.
A second lead wire group composed of a plurality of lead wires connected to each of the electrodes constituting the second DC electrode group, and a second lead wire group.
In order to bend the tip portion of the tube member in the first direction, the tip portion extends eccentrically from the central axis of the tube member into the tube member, and the tip thereof is connected and fixed to the tip tip or the tip of the tube member. And the first operation wire whose rear end can be pulled and operated,
In order to bend the tip portion of the tube member in the second direction opposite to the first direction, the tube member is inserted into the tube member so as to face the first operation wire with the central axis of the tube member interposed therebetween. It is provided with a second operating wire that extends, its tip is connected and fixed to the tip or the tip of the tube member, and its trailing end is pullable.
In the inferior vena cava approach, the tip inserted into the right atrium forms a loop along the side of the right atrium.
A catheter that defibrillates in the heart chamber by applying voltages of different polarities between the first DC electrode group and the second DC electrode group.
When the rear end of the first operation wire is pulled to the maximum in a state where the tube member is suppressed from bending on the proximal end side of the tip position of the second DC electrode group, the tip portion of the tube member is pulled. The bending angle (θ1) of (the tip portion on the tip side of the tip position of the second DC electrode group) is larger than 180 °.

However, the intracardiac defibrillation catheter of the present invention does not include the following (i) to (iii).
(I) The second operating wire is said to have a bending angle (θ1) of 200 to 360 ° and suppresses bending of the tube member on the proximal end side of the tip position of the second electrode group. When the rear end is pulled to the maximum, the bending angle (θ2) of the tip portion of the tube member is 10 to 90 ° .

(Ii) The tip of the catheter when the rear end of the first operation wire is pulled to the maximum while the bending of the tube member is suppressed on the proximal end side of the tip position of the second electrode group. Is oriented toward the mounting region of the second electrode group of the tube member.

(Iii) The tip of the catheter when the rear end of the first operation wire is pulled to the maximum while the bending of the tube member is suppressed on the proximal end side of the tip position of the second electrode group. The distance (D) from the tube member on the proximal end side of the distal end position of the second electrode group is 50 mm or less.

Here, the "deflection angle of the tip portion" is the angle formed by the direction in which the non-flexible base end portion extends and the direction in which the flexed tip portion extends (the direction in which the tip of the tube member points). To say.

According to the intracardiac defibrillation catheter having such a configuration, the deflection angle (θ1) is larger than 180 °, so that the catheter is inserted into the right atrium from the inferior vena cava in the actual procedure by the approach from the inferior vena cava. The tip of the tube member can form a loop shaped along the side of the right atrium, which can guide the tip of the defibrillation catheter to the vicinity of the coronary venous sinus ostium.

Further, in the actual procedure, even if the tip of the defibrillation catheter guided in the vicinity of the coronary sinus opening is not directed toward the coronary sinus opening, the rear end of the second operation wire is pulled to operate the tube. By bending the tip portion of the member in the second direction, the tip of the defibrillation catheter can be directed toward the coronary venous sinus ostium. This allows the tip of the defibrillation catheter to be reliably inserted into the coronary sinus ostium.

(2) In the intracardiac defibrillation catheter of the present invention, the rear end of the first operation wire is suppressed from bending of the tube member on the proximal end side of the tip position of the second electrode group. It is preferable that the bending angle (θ1) from the state in which the tip portion of the tube member is not bent to the state after bending is larger than 180 ° when the tube member is pulled to the maximum.

(3) The intracardiac defibrillation catheter of the present invention includes an insulating tube member having flexibility at least at the tip portion and an insulating tube member.
A control handle connected to the base end of the tube member and
A tip fixed to the tip of the tube member and
A first DC electrode group composed of a plurality of ring-shaped electrodes mounted on the tip portion of the tube member, and
A second DC electrode group composed of a plurality of ring-shaped electrodes mounted on the tip portion of the tube member, separated from the first DC electrode group toward the proximal end side.
A first lead wire group composed of a plurality of lead wires connected to each of the electrodes constituting the first DC electrode group, and a first lead wire group.
A second lead wire group composed of a plurality of lead wires connected to each of the electrodes constituting the second DC electrode group, and a second lead wire group.
In order to bend the tip portion of the tube member, it extends eccentrically from the central axis of the tube member and extends into the tube member, the tip thereof is connected and fixed to the tip tip or the tip of the tube member, and the rear end thereof. Is equipped with a single operating wire that can be pulled and operated.
In the inferior vena cava approach, the tip inserted into the right atrium forms a loop along the side of the right atrium.
A single-direction catheter that defibrillates in the heart chamber by applying voltages of different polarities between the first DC electrode group and the second DC electrode group.
When the rear end of the operation wire is pulled to the maximum in a state where the bending of the tube member is suppressed on the proximal end side of the tip position of the second DC electrode group, the tip portion (the first portion) of the tube member. The bending angle (θ) of the tip portion on the tip side of the tip position of the 2DC electrode group is larger than 180 °.

According to the intracardiac defibrillation catheter having such a configuration, the deflection angle (θ) is larger than 180 °, so that the catheter is inserted into the right atrium from the inferior vena cava in the actual procedure by the approach from the inferior vena cava. The tip of the tube member can form a loop shaped along the side of the right atrium, which can guide the tip of the defibrillation catheter to the vicinity of the coronary venous sinus ostium.

(4) In the intracardiac defibrillation catheter of the above (3), the deflection angle (θ) is preferably 200 to 360 °.

According to the intracardiac defibrillation catheter having such a configuration, the deflection angle (θ) of 200 ° or more causes the inferior vena cava to enter the right atrium in the actual procedure by the approach from the inferior vena cava. The tip portion of the inserted tube member can easily form a loop shaped along the side of the right atrium.
Further, since the bending angle (θ) is 360 ° or less, in an actual procedure, a loop having a suitable size can be formed by the tip portion of the tube member inserted into the right atrium.

(5) In the intracardiac defibrillation catheter according to (3) or (4), the operating wire is in a state in which bending of the tube member is suppressed on the proximal end side of the distal end position of the second electrode group. When the rear end of the tube member is pulled to the maximum, the bending angle (θ) from the state in which the tip portion of the tube member is not bent to the state after bending is preferably larger than 180 °.

According to the intracardiac defibrillation catheter of the present invention, the tip portion of the tube member is inserted into the right atrium from the inferior vena cava, a loop is formed in the right atrium by the inserted tip portion, and then the tip portion is formed. The procedure of inserting the part into the coronary sinus ostium can be performed reliably. As a result, the first DC electrode group attached to the tip of the tube member can be placed in the coronary sinus and the second DC electrode group can be placed in the right atrium by the approach from the inferior vena cava.

It is a top view which shows the defibrillation catheter which concerns on one reference embodiment of this invention. It is a cross-sectional view (II-II cross-sectional view of FIG. 1) of the tube member constituting the defibrillation catheter shown in FIG. It is a cross-sectional view (III-III cross-sectional view of FIG. 1) of the tube member constituting the defibrillation catheter shown in FIG. FIG. 5 is a plan view showing a state in which the tip portion (tip side of the tip position of the second DC electrode group) of the tube member constituting the intracardiac defibrillation catheter shown in FIG. 1 is flexed to the maximum in the first direction. .. FIG. 5 is a plan view showing a state in which the tip portion (tip side of the tip position of the second DC electrode group) of the tube member constituting the intracardiac defibrillation catheter shown in FIG. 1 is flexed to the maximum in the second direction. .. 6 is an X-ray image showing a state in which the defibrillation catheter shown in FIG. 1 is placed in a heart chamber.

The defibrillation catheter 100 of this reference embodiment shown in FIGS. 1 to 5 has a flexible multi-lumen structure tube member 10, a control handle 20 connected to the base end thereof, and a tip of the tube member 10. A first DC electrode group 31G composed of a fixed tip 35 and eight ring-shaped electrodes 31 attached to the tip portion of the tube member 10, and a tube member separated from the first DC electrode group 31G toward the proximal end side. A second DC electrode group 32G composed of eight ring-shaped electrodes 32 mounted on the tip portion of the ten, and two for potential measurement mounted on the tip portion of the tube member 10 on the proximal end side of the first DC electrode group 31G. Ring-shaped electrode 33, two ring-shaped electrodes 34 for potential measurement attached to the tip end portion of the tube member 10 on the proximal end side of the second DC electrode group 32G, and the electrode 31 constituting the first DC electrode group 31G. The first lead wire group 41G consisting of eight lead wires 41 connected to each of the above, and the second lead wire 42 consisting of eight lead wires 42 connected to each of the electrodes 32 constituting the second DC electrode group 32G. Group 42G, two lead wires 43 connected to each of the ring-shaped electrodes 33 for potential measurement, two lead wires 44 connected to each of the ring-shaped electrodes 34 for potential measurement, and a tube member. In order to bend the tip portion of 10 in the first direction, the tip portion extends eccentrically from the central axis of the tube member 10 into the tube member 10, the tip thereof is connected and fixed to the tip tip 35, and the rear end can be pulled. In order to bend a certain first operation wire 71 and the tip portion of the tube member 10 in the second direction, the tube member 10 extends into the tube member 10 so as to face the first operation wire with the central axis of the tube member 10 interposed therebetween. It is provided with a second operation wire 72 whose tip is connected and fixed to the tip tip 35 and whose rear end can be pulled and operated, and is provided between the first DC electrode group 31G and the second DC electrode group 32G. A catheter that defibrillates in the heart cavity by applying voltages of different polarities, and is the first in a state in which bending of the tube member 10 on the proximal end side of the distal end position of the second DC electrode group 32G is suppressed. When the rear end of the operation wire 71 is pulled to the maximum, the bending angle (θ1) of the tip portion of the tube member 10 is approximately 270 °, and the tube member is closer to the base end side than the tip position of the second DC electrode group 32G. When the rear end of the second operation wire 72 is pulled to the maximum while the bending of the 10 is suppressed, the bending angle (θ2) of the tip portion of the tube member 10 is increased. It is approximately 90 °.
In FIGS. 1, 4 and 5, 51 and 52 are electrode connectors, and 61 and 62 are external cords.

The defibrillation catheter 100 of this reference embodiment includes a tube member 10, a control handle 20, a tip tip 35, a first DC electrode group 31G, a second DC electrode group 32G, and electrodes 33 and 34 for potential measurement. The first lead wire group 41G, the second lead wire group 42G, the lead wires 43 and 44, the first operation wire 71, the second operation wire 72, the electrode connectors 51 and 52, the external cord 61 and It has 62.

The tube member 10 constituting the defibrillation catheter 100 is an insulating tube member having a multi-lumen structure.
The outer diameter of the tube member 10 is, for example, 1.2 to 3.3 mm, and a suitable example is 2.0 mm.
The effective length of the tube member 10 is defined assuming an approach from the inferior vena cava, for example, 950 to 1020 mm, and a suitable example is 950 mm.

As shown in FIGS. 2 and 3, the tube member 10 constituting the defibrillation catheter 100 has an inner portion 16 made of a resin having a relatively low hardness and a relatively high hardness covering the inner portion 16. An outer portion 17 made of resin and a braid 18 embedded in the outer portion 17 at the base end portion of the tube member 10 are provided.
Examples of the resin constituting the inner portion 16 and the outer portion 17 include thermoplastic polyamide-based elastomers such as polyether block amide (PEBAX) and nylon.

The tube member 10 (inner portion 16) is formed by partitioning four lumens 11L to 14L, which are opened at the tip end and the base end, by a lumen tube 19 made of a fluororesin, respectively.
Examples of the fluorine-based resin constituting the lumen tube 19 include perfluoroalkyl vinyl ether copolymer (PFA) and polytetrafluoroethylene (PTFE).

The hardness of the resin constituting the inner portion 16 is preferably 25D to 40D.
The hardness of the resin constituting the outer portion 17 is preferably 35D to 75D, more preferably 50D to 75D.
As the resin constituting the outer portion 17, a resin having a hardness different depending on the axial direction is usually used. As a result, the tube member 10 is configured to gradually increase in hardness from the tip end side to the base end side.

To show an example of the hardness change of the outer portion 17, the resin hardness in the range of 0 mm to 51.5 mm from the tip of the tube member 10 is 50.5D, and the resin hardness in the range of 51.5 mm to 158.5 mm from the tip is 70D. The hardness from the position of 158.5 mm from the tip to the base is 75D. A braid 18 is embedded in the outer portion 17 from the position of 339.5 mm from the tip of the tube member 10 to the base end.

As shown in FIG. 1, the control handle 20 constituting the defibrillation catheter 100 includes a handle body 21, a rotation operation unit 23, and a strain relief 24. The rotation operation unit 23 is formed with knobs 231 and 232 for rotation operation.
Here, the knob 231 and the knob 232 are different in size, and the knob 231 is larger. Due to the different knob sizes, the operator can recognize which knob the finger is on without visually recognizing which knob the finger is on, and as a result, the procedure time can be shortened. ..

The rear end of the first operation wire 71, which will be described later, is connected and fixed to the side of the rotation operation unit 23 on which the knob 231 is formed. By rotating in the direction indicated by A1, the rear end of the first operation wire 71 can be pulled.

The rear end of the second operation wire 72, which will be described later, is connected and fixed to the side of the rotation operation unit 23 on which the knob 232 is formed. By rotating in the direction indicated by B1, the rear end of the second operation wire 72 can be pulled.

In the state shown in FIG. 1 (neutral state in which the tip portion of the tube member 10 is not bent), the relatively small knob 232 is formed on the proximal end side of the rotation axis of the rotation operation unit 23.
As a result, the amount of rotation that allows the rotation operation unit 23 to rotate in the direction indicated by the arrow A1 is larger than the amount of rotation that can rotate in the direction indicated by the arrow B1.

A first DC electrode group 31G and a second DC electrode group 32G are attached to the tip portion of the tube member 10.
In the present invention, the "electrode group" refers to a plurality of electrodes that form the same pole (have the same polarity) or have the same purpose and are mounted at narrow intervals (for example, 5 mm or less). An aggregate.

The first DC electrode group is formed by mounting a plurality of electrodes constituting the same pole (-pole or + pole) at a narrow interval at the tip portion of the tube member. Here, the number of electrodes constituting the first DC electrode group varies depending on the width of the electrodes and the arrangement interval, but is, for example, 4 to 13, preferably 8 to 10.

In this reference embodiment , the first DC electrode group 31G is composed of eight ring-shaped electrodes 31. The electrodes 31 constituting the first DC electrode group 31G are the same in the DC power supply device via the lead wires (lead wires 41 constituting the first lead wire group 41G shown in FIGS. 2 and 3) and the electrode connector 51 described later. It is connected to the terminal of the pole.

Here, the width (length in the axial direction) of the electrode 31 is preferably 2 to 5 mm, and a suitable example is 4 mm.
If the width of the electrode 31 is too narrow, the amount of heat generated when a voltage is applied becomes excessive, which may damage the surrounding tissue. On the other hand, if the width of the electrode 31 is too wide, the flexibility and flexibility of the portion of the tube member 10 to which the first DC electrode group 31G is mounted may be impaired.
The mounting interval of the electrodes 31 (separation distance between adjacent electrodes) is preferably 1 to 5 mm, and a suitable example is 2 mm.
When using the intracardiac defibrillation catheter 100 (when placed in the heart chamber), the first DC electrode group 31G is located within the coronary sinus (CS).

In the second DC electrode group, a plurality of electrodes forming poles (+ poles or-poles) opposite to those of the first DC electrode group are formed at the tip portion of the tube member separated from the mounting position of the first DC electrode group toward the proximal end side. It is installed at narrow intervals. Here, the number of electrodes constituting the second DC electrode group varies depending on the width of the electrodes and the arrangement interval, but is, for example, 4 to 13, preferably 8 to 10.

In this reference embodiment , the second DC electrode group 32G is composed of eight ring-shaped electrodes 32. The electrodes 32 constituting the second DC electrode group 32G are via lead wires (lead wires 42 constituting the second lead wire group 42G shown in FIG. 3) and a connector 52 described later, and terminals of the same pole in the DC power supply device ( It is connected to the terminal of the pole opposite to the one to which the first DC electrode group 31G is connected).

As a result, voltages having different polarities are applied to the first DC electrode group 31G (electrode 31) and the second DC electrode group 32G (electrode 32), and the first DC electrode group 31G and the second DC electrode group 32G are separated from each other. The electrodes have different polarities (when one electrode group has a negative electrode, the other electrode group has a positive electrode).

Here, the width (length in the axial direction) of the electrode 32 is preferably 2 to 5 mm, and a suitable example is 4 mm.
If the width of the electrode 32 is too narrow, the amount of heat generated when a voltage is applied becomes excessive, which may damage the surrounding tissue. On the other hand, if the width of the electrode 32 is too wide, the flexibility and flexibility of the portion of the tube member 10 to which the second DC electrode group 32G is mounted may be impaired.
The mounting interval of the electrodes 32 (separation distance between adjacent electrodes) is preferably 1 to 5 mm, and a suitable example is 2 mm.
When using the intracardiac defibrillation catheter 100 (when placed in the heart chamber), the second DC electrode group 32G is located in the right atrium (RA).

The electrodes constituting the first DC electrode group 31G and the second DC electrode group can also be used for measuring the potential.

Two electrodes 33 are mounted on the base end side of the first DC electrode group 31G for potential measurement, and two electrodes 34 are mounted on the base end side of the second DC electrode group 32G for potential measurement.

The electrode 33 mounted on the proximal end side of the first DC electrode group 31G is connected to the electrocardiograph via a lead wire (lead wire 43 shown in FIGS. 2 and 3) and a connector 51 described later.

The electrode 34 mounted on the proximal end side of the second DC electrode group 32G is connected to the electrocardiograph via a lead wire (lead wire 44 shown in FIG. 3) and a connector 52 described later.

Here, the width (length in the axial direction) of the electrode 33 and the electrode 34 is preferably 0.5 to 2.0 mm, and a suitable example is 1.2 mm.
If the width of the electrode 33 or the electrode 34 is too wide, the measurement accuracy of the electrocardiographic potential may be lowered, or it may be difficult to identify the site where the abnormal potential is generated.

A tip tip 35 is attached to the tip of the tube member 10.
No lead wire is connected to the tip 35, and the tip 35 is not used as an electrode in this reference embodiment. However, it can also be used as an electrode by connecting a lead wire. The constituent material of the tip 35 is not particularly limited, such as a metal material such as platinum and stainless steel, and various resin materials.

The distance between the first DC electrode group 31G (electrode 31 on the proximal end side) and the second DC electrode group 32G (electrode 32 on the distal end side) is preferably 40 to 100 mm, more preferably 50 to 90 mm. An example is 70 mm.

The electrodes 31 constituting the first DC electrode group 31G, the electrodes 32 constituting the second DC electrode group 32G, and the electrodes 33 and 34 for potential measurement are platinum or platinum in order to improve the contrastability with respect to X-rays. It is preferably made of a system alloy.

The first lead wire group 41G shown in FIGS. 2 and 3 is an aggregate of eight lead wires 41 connected to each of the eight electrodes 31 constituting the first DC electrode group 31G.
With the first lead wire group 41G (lead wire 41), each of the eight electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the DC power supply device.

The eight electrodes 31 constituting the first DC electrode group 31G are connected to different lead wires 41, respectively. Each of the lead wires 41 is welded to the inner peripheral surface of the electrode 31 at the tip thereof, and enters the second lumen 12L from the side hole formed in the tube wall of the tube member 10. The eight lead wires 41 that have entered the second lumen 12L extend into the second lumen 12L as the first lead wire group 41G and enter the inside of the control handle 20.

The second lead wire group 42G shown in FIG. 3 is an aggregate of eight lead wires 42 connected to each of the eight electrodes 32 constituting the second DC electrode group 32G.
With the second lead wire group 42G (lead wire 42), each of the eight electrodes 32 constituting the second DC electrode group 32G can be electrically connected to the DC power supply device.

The eight electrodes 32 constituting the second DC electrode group 32G are connected to different lead wires 42, respectively. Each of the lead wires 42 is welded to the inner peripheral surface of the electrode 32 at the tip thereof, and enters the fourth lumen 14L from the side hole formed in the tube wall of the tube member 10. The eight lead wires 42 that have entered the fourth lumen 14L extend into the fourth lumen 14L as the second lead wire group 42G and enter the inside of the control handle 20.

As described above, the first lead group 41G (8 lead wires 41) extends to the second lumen 12L, and the second lead group 42G (8 lead wires 42) extends to the 4th lumen 14L. By being present, the first lead wire group 41G and the second lead wire group 42G can be isolated and isolated in the tube member. As a result, when the voltage required for intracardiac defibrillation is applied, between the first lead wire group 41G (first DC electrode group 31G) and the second lead wire group 42G (second DC electrode group 32G). It is possible to surely prevent a short circuit from occurring.

The two lead wires 43 shown in FIGS. 2 and 3 are each connected to two electrodes 33 for potential measurement.
The two lead wires 43 are welded to the inner peripheral surface of the electrode 33 at their respective tips, and enter the second lumen 12L from the side hole formed in the tube wall of the tube member 10, and the first lead wire group. Together with the lead wire 41 constituting the 41G, it extends to the second lumen 12L and enters the inside of the control handle 20. Each of the electrodes 33 can be connected to the electrocardiograph by the lead wire 43.

The two lead wires 44 shown in FIG. 3 are each connected to two electrodes 34 for potential measurement.
The two lead wires 44 are welded to the inner peripheral surface of the electrode 34 at their respective tips, and enter the fourth lumen 14L from the side hole formed in the tube wall of the tube member 10, and the second lead wire group. Together with the lead wire 42 constituting the 42G, it extends to the fourth lumen 14L and enters the inside of the control handle 20. Each of the electrodes 34 can be connected to the electrocardiograph by the lead wire 44.

The lead wire 41, the lead wire 42, the lead wire 43, and the lead wire 44 are all made of a resin-coated wire in which the outer peripheral surface of the metal conductor wire is coated with a resin such as polyimide. Here, the film thickness of the coating resin is about 2 to 30 μm.

The electrode connector 51 and the electrode connector 52 are respectively arranged outside the control handle 20, and a plurality of terminals (not shown) are provided inside them.

The external cord 61 is for guiding the lead wire 41 and the lead wire 43 that have entered the inside of the control handle 20 from the tube member 10 (second lumen 12L) to the electrode connector 51.
The external cord 62 is for guiding the lead wire 42 and the lead wire 44 that have entered the inside of the control handle 20 from the tube member 10 (fourth lumen 14L) to the electrode connector 52.

In the defibrillation catheter 100 of the present reference embodiment , the first operation wire 71 for bending the tip portion of the tube member 10 in the first direction (the direction indicated by the arrow A in FIG. 1) and the tip portion of the tube member 10 Is provided with a second operation wire 72 for bending the wire in the second direction (direction indicated by the arrow B in FIG. 1).
Here, the first direction and the second direction are bending directions opposite to each other on the same plane.

The first operating wire 71 and the second operating wire 72 are made of stainless steel or a Ni—Ti superelastic alloy, but they do not necessarily have to be made of metal. For example, a high-strength non-conductive wire. It may be composed of such as.

As shown in FIGS. 2 and 3, the first operating wire 71 is movably inserted in the first lumen 11L of the tube member 10 in the pipe axial direction.
The tip of the first operation wire 71 is connected and fixed to the tip tip 35 by solder filled in the internal space of the tip tip 35.
The rear end of the first operation wire 71 is connected and fixed to the rotation operation unit 23 (the side on which the knob 231 is formed) of the control handle 20, and can be pulled.

By putting a finger on the knob 231 and rotating the rotation operation unit 23 in the direction indicated by the arrow A1 in FIG. 1, the rear end of the first operation wire 71 is pulled and the tip end portion of the tube member 10 is moved to the tip portion of FIG. It can be bent in the first direction indicated by the arrow A.

On the other hand, the second operation wire 72 is movably inserted in the third lumen 13L of the tube member 10 in the pipe axial direction.
The tip of the second operation wire 72 is connected and fixed to the tip tip 35 by solder filled in the internal space of the tip tip 35.
The rear end of the second operation wire 72 is connected and fixed to the rotation operation portion 23 (the side on which the knob 232 is formed) of the control handle 20, and can be pulled.

By putting a finger on the knob 232 and rotating the rotation operation unit 23 in the direction indicated by the arrow B1 in FIG. 1, the rear end of the second operation wire 72 is pulled, and the tip end portion of the tube member 10 is in FIG. It can be bent in the second direction indicated by the arrow B.

As described above, in the defibrillation catheter 100 of the present reference embodiment , the direction in which the rotation operation unit 23 is indicated by the arrow A1 from the state shown in FIG. 1 (the neutral state in which the tip portion of the tube member 10 is not bent) is shown. The amount of rotation that can be rotated is set to be larger than the amount of rotation that can be rotated in the direction indicated by the arrow B1, whereby the length at which the rear end of the first operation wire 71 can be pulled (maximum pulling length). Is longer than the length (maximum pulling length) at which the rear end of the second operation wire 72 can be pulled.

FIG. 4 shows the rear end of the first operation wire 71 in the defibrillation catheter 100 of the present reference embodiment in a state where the tube member 10 is suppressed from bending on the proximal end side of the tip position of the second DC electrode group 32G. Shows the bending shape when the tip portion of the tube member 10 is bent in the first direction by pulling the tube member 10 to the maximum.

As shown in FIG. 4, the bending angle (θ1) of the tip portion of the tube member 10 on the tip side of the tip position of the second DC electrode group 32G is approximately 270 °.

As described above, according to the defibrillation catheter 100 of the present reference embodiment showing a large deflection angle (θ1) as compared with the conventional defibrillation catheter, in an actual procedure by the approach from the inferior vena cava, for example, By inserting the tip of the tube member 10 into the right atrium from the inferior vena cava until at least part of the second DC electrode group 32G is located in the right atrium, the rear end of the first operating wire 71 is pulled. , The tip of the tube member 10 inserted into the right atrium can easily form a loop shaped along the side of the right atrium, which allows the tip of the defibrillation catheter 100 to be placed in the coronary sinus ostium. You can guide to the vicinity.

In the defibrillation catheter of the present invention, the deflection angle (θ1) is larger than 180 °, preferably 200 to 360 °, and more preferably 240 to 300 °.
When this deflection angle (θ1) is 180 ° or less, in an actual procedure, the tip portion of the tube member inserted into the right atrium from the inferior vena cava forms a loop shaped along the side surface of the right atrium. Can't.
On the other hand, if this deflection angle (θ1) is excessive, it may not be possible to form a loop of a suitable size due to the tip of the tube member inserted into the right atrium in the actual procedure, resulting in defibrillation. It may be difficult to guide the tip of the dynamic catheter near the coronary sinus ostium.

As shown in FIG. 4, the tip of the defibrillation catheter 100 and the tube member 10 on the proximal end side (the portion where bending is suppressed) with respect to the distal end position of the second DC electrode group 32G are separated from each other.
The tip of the defibrillation catheter 100 points to the mounting region of the second DC electrode group 32G of the tube member 10.

As described above, a constant separation distance (D) is secured between the tip of the defibrillation catheter 100 and the tube member 10 on the proximal end side of the tip position of the second DC electrode group 32G, and defibrillation is performed. Since the tip of the dynamic catheter 100 points to the mounting area of the second DC electrode group 32G of the tube member 10, the tube member 10 inserted into the right atrium in the actual procedure by the approach from the inferior vena cava The tip can form a loop of suitable size that can be along the side of the right atrium.

In the defibrillation catheter of the present invention, the separation distance (D) between the tip of the defibrillation catheter 100 and the tube member 10 in the mounting region of the second DC electrode group is preferably 50 mm or less.

When the tip of the defibrillation catheter points toward the tip side of the mounting area of the 2nd DC electrode group 32G, in the actual procedure, a loop formed by the tip portion of the tube member inserted into the right atrium. May not have a sufficient size.

On the other hand, if the tip of the defibrillation catheter points toward the proximal end side of the mounting area of the 2nd DC electrode group 32G or if the separation distance (D) is excessive, in the actual procedure, in the right atrium. The tip of the tube member inserted into may make it difficult to form a loop shaped along the side of the right atrium.

FIG. 5 shows the rear end of the second operation wire 72 in the defibrillation catheter 100 of the present reference embodiment in a state where the tube member 10 is suppressed from bending on the proximal end side of the tip position of the second DC electrode group 32G. Shows the bending shape when the tip portion of the tube member 10 is bent in the second direction by pulling the tube member 10 to the maximum.

As shown in FIG. 5, the bending angle (θ2) of the tip portion of the tube member 10 on the tip side of the tip position of the second DC electrode group 32G is approximately 90 °.

As described above, according to the defibrillation catheter 100 of the present reference embodiment capable of bending the tip portion of the tube member 10 in the second direction, the defibrillation guided to the vicinity of the coronary venous sinus ostium in the actual procedure. Even if the tip of the catheter 100 is not oriented toward the coronary sinus ostium, defibrillation is performed by pulling the rear end of the second operation wire 72 and bending the tip portion of the tube member 10 in the second direction. The tip of the catheter 100 can be directed towards the coronary sinus ostium. As a result, the tip portion of the defibrillation catheter 100 can be reliably and easily inserted into the coronary venous sinus ostium.

In the defibrillation catheter of the present invention, the deflection angle (θ2) is preferably 10 to 90 °.
If the deflection angle (θ2) is 10 ° or more, even if the coronary venous sinus ostium is located on the opposite side of the flexion direction (first direction) of the tip portion forming the loop in the actual procedure, the coronary shape The tip of the defibrillation catheter 100 can be sufficiently oriented and inserted into the venous sinus opening.
Further, when the bending angle (θ2) is 90 ° or less, it is possible to sufficiently secure the flatness when the tip portion of the tube member 10 is bent in the second direction.

FIG. 6 is an X-ray image showing a state in which the defibrillation catheter 100 of this reference embodiment is placed in the heart chamber, and includes a first DC electrode group and a second DC electrode group consisting of eight ring-shaped electrodes, respectively. The catheter used is the defibrillation catheter of this reference embodiment.
The tip of the defibrillation catheter shown in FIG. 6 was inserted into the right atrium from the inferior vena cava, formed a loop in the right atrium, and then inserted into the coronary sinus ostium. Is located in the coronary sinus and the second DC electrode group is located in the right atrium.
Further, in FIG. 6, a loop formed along the side surface of the right atrium is recognized by the tip portion of the tube member including the mounting region of the second DC electrode group.

Although one reference embodiment of the present invention has been described above, the defibrillation catheter of the present invention is not limited to these, and various modifications can be made.
For example, the defibrillation catheter of the present invention may be a so-called single direction type provided with one operating wire.

100 Defibrillation catheter 10 Tube member 11L-14L Lumen 16 Inner part 17 Outer part 18 Braided 19 Lumen tube 20 Control handle 21 Handle body 23 Rotation operation part 231,232 Knob 24 Strain relief 31-34 Ring electrode 31G 1st DC electrode Group 32G 2nd DC electrode group 35 Tip tip 41-44 Lead wire 51, 52 Electrode connector 61, 62 External cord 71 1st operation wire 72 2nd operation wire

Claims (5)

With an insulating tube member that has flexibility at least at the tip,
A control handle connected to the base end of the tube member and
A tip fixed to the tip of the tube member and
A first electrode group composed of a plurality of ring-shaped electrodes mounted on the tip portion of the tube member, and
A second electrode group composed of a plurality of ring-shaped electrodes mounted on the tip portion of the tube member, separated from the first electrode group toward the proximal end side.
A first lead wire group composed of a plurality of lead wires connected to each of the electrodes constituting the first electrode group, and a first lead wire group.
A second lead wire group composed of a plurality of lead wires connected to each of the electrodes constituting the second electrode group, and a second lead wire group.
In order to bend the tip portion of the tube member in the first direction, the tip portion extends eccentrically from the central axis of the tube member into the tube member, and the tip thereof is connected and fixed to the tip tip or the tip of the tube member. And the first operation wire whose rear end can be pulled and operated,
In order to bend the tip portion of the tube member in the second direction opposite to the first direction, the tube member is inserted into the tube member so as to face the first operation wire with the central axis of the tube member interposed therebetween. It is provided with a second operating wire that extends, its tip is connected and fixed to the tip or the tip of the tube member, and its trailing end is pullable.
In the inferior vena cava approach, the tip inserted into the right atrium forms a loop along the side of the right atrium.
A catheter that defibrillates in the heart chamber by applying voltages of different polarities between the first electrode group and the second electrode group.
When the rear end of the first operation wire is pulled to the maximum in a state where the bending of the tube member is suppressed on the proximal end side of the tip position of the second electrode group, the tip portion of the tube member is pulled. The deflection angle (θ1) of the intracardiac defibrillation catheter is larger than 180 ° [ However, (i) the deflection angle (θ1) is 200 to 360 °, and the tip of the second electrode group is When the rear end of the second operation wire is pulled to the maximum in a state where the bending of the tube member is suppressed on the base end side of the position, the bending angle (θ2) of the tip portion of the tube member is increased. 10 to 90 °; (ii) The rear end of the first operation wire is pulled to the maximum while suppressing the bending of the tube member on the proximal end side of the tip position of the second electrode group. When the tip of the catheter points to the mounting region of the second electrode group of the tube member; (iii), the bending of the tube member on the proximal end side of the tip position of the second electrode group. When the rear end of the first operation wire is pulled to the maximum in the restrained state, the separation distance between the tip of the catheter and the tube member on the proximal end side of the tip position of the second electrode group. Excludes those with (D) of 50 mm or less. ]. When the rear end of the first operation wire is pulled to the maximum in a state where bending of the tube member is suppressed on the proximal end side of the tip position of the second electrode group, the tip portion of the tube member is pulled. The intracardiac defibrillation catheter according to claim 1, wherein the bending angle (θ1) from the state in which the catheter is not bent to the state after bending is larger than 180 °. With an insulating tube member that has flexibility at least at the tip,
A control handle connected to the base end of the tube member and
A tip fixed to the tip of the tube member and
A first electrode group composed of a plurality of ring-shaped electrodes mounted on the tip portion of the tube member, and
A second electrode group composed of a plurality of ring-shaped electrodes mounted on the tip portion of the tube member, separated from the first electrode group toward the proximal end side.
A first lead wire group composed of a plurality of lead wires connected to each of the electrodes constituting the first electrode group, and a first lead wire group.
A second lead wire group composed of a plurality of lead wires connected to each of the electrodes constituting the second electrode group, and a second lead wire group.
In order to bend the tip portion of the tube member, it extends eccentrically from the central axis of the tube member and extends into the tube member, the tip thereof is connected and fixed to the tip tip or the tip of the tube member, and the rear end thereof. Is equipped with a single operating wire that can be pulled and operated.
In the inferior vena cava approach, the tip inserted into the right atrium forms a loop along the side of the right atrium.
A single-direction catheter that defibrillates in the heart chamber by applying voltages of different polarities between the first electrode group and the second electrode group.
When the rear end of the operation wire is pulled to the maximum in a state where the bending of the tube member is suppressed on the proximal end side of the tip position of the second electrode group, the bending of the tip portion of the tube member is suppressed. An intracardiac defibrillation catheter characterized by an angle (θ) greater than 180 °. The intracardiac defibrillation catheter according to claim 3, wherein the deflection angle (θ) is 200 to 360 °. While suppressing the deflection of the tube member at the proximal end side than the distal end position of the second electrode group, when pulled maximize the rear end of the operating wire, the leading end portion of the tube member Deflection The intracardiac defibrillation catheter according to claim 3 or 4, wherein the bending angle (θ) from the non-deflated state to the flexed state is larger than 180 °.

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