TW201938221A - Intracardiac defibrillation catheter - Google Patents

Abstract

Provided is 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. 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 to bend in both directions. When the rear end of the first operation wire is pulled to the maximum limit in a state in which bending of the tube member is inhibited on the proximal end side of a distal end position of the second DC electrode group, a bend angle ([Theta]1) of the distal end portion of the tube member is approximately 270 DEG. When the rear end of the second operation wire is pulled to the maximum limit in a state in which bending of the tube member is inhibited on the proximal end side of the distal end position of the second DC electrode group, a bend angle ([Theta]2) of the distal end portion of the tube member is approximately 90 DEG.

Description

Intracardiac defibrillation catheter

The present invention relates to an intracardiac defibrillation catheter that is inserted into a cardiac cavity and removes atrial fibrillation.

When atrial fibrillation occurs during cardiac catheterization, electrical defibrillation is necessary.
As a catheter for performing such defibrillation in the cardiac cavity, the applicant of the present case proposes an intracardiac defibrillation catheter, which is provided with: an insulating tube member having a multi-lumen structure; and connected to A handle at the base end of the tube member; and a first DC electrode group formed by a plurality of ring-shaped electrodes mounted at the front end region of the tube member; and separated from the first DC electrode group toward the base end side and separated by A second DC electrode group formed by a plurality of ring-shaped electrodes mounted on a tube member; and a first lead group formed by a lead connected to each of the electrodes constituting the first DC electrode group; and A second lead group formed by a lead connected to each of the electrodes constituting the second DC electrode group; and a eccentricity from the central axis of the tube member in order to deflect the front end portion of the tube member to deflect the front end of the catheter. The operating steel wire extending and existing in the pipe member and capable of being stretched at its rear end, the first lead group and the second lead group, and the operating steel wire extending in the pipe member. In a different lumen, during defibrillation, Voltages having mutually different polarities are applied to the first DC electrode group and the second DC electrode group (see Patent Document 1).

The front end portion of the intracardiac defibrillation catheter of this configuration is inserted from the superior great vein into the right atrium and further into the opening of the coronary sinus at the lower wall behind the right atrium (coronary sinus orifice). In order to arrange the position of the first DC electrode group in the coronary sinus and the position of the second DC electrode group in the right atrium, the polarities of the first DC electrode group and the second DC electrode group are different from each other. The voltage. As a result, it is possible to impart a sufficient and sufficient electrical energy to a heart having atrial fibrillation that is necessary for defibrillation.

Recently, manual techniques have been performed to insert an intracardiac defibrillation catheter from the inferior great vein into the right atrium and into the coronary sinus ostium.
This technique (access from the inferior great vein) is compared to the previous technique (from the superior vein) where an intracardiac defibrillation catheter is inserted from the superior vein into the right atrium and into the coronary sinus ostium. From the beginning), its invasiveness is low, and it is also ideal from the viewpoint of aesthetics after surgery.
[Prior technical literature]
[Patent Literature]

[Patent Document 1] Japanese Patent Laid-Open No. 2010-63708

[Problems to be Solved by the Invention]

For access from the inferior great vein, it is desirable to perform the following general techniques: that is, to form the part along the right atrium by the anterior part of the defibrillation catheter inserted into the right atrium. After the lateral loop, the anterior end of the defibrillation catheter is inserted into the coronary sinus ostium.

However, it is difficult to insert the anterior part of the intracardiac defibrillation catheter into the coronary sinus ostium from the entry from the lower great vein compared to the entry from the superior great vein.

Here, the intracardiac defibrillation catheter disclosed in Patent Document 1 is configured as a tube member that is intended to enter from the upper great vein, and is a tube member caused by the operation of stretching the rear end of the steel wire for operation The deflection amount of the front end portion is small (the deflection angle is at most about 90 °), and the front end portion cannot form a circuit along the shape of the side of the right atrium. Therefore, even if the effective length of the tube member is extended to a length suitable for access from the inferior great vein, the anterior end of the defibrillation catheter cannot be guided to the vicinity of the coronary sinus orifice.

In this case, it is conceivable that a certain degree of crooked shape (pre-forming) is formed in advance by the front end portion of the pipe member before the operation of stretching the rear end of the steel wire for operation is performed. A desired circuit is formed by the front end portion of the tube member after the stretching operation is performed, and the front end of the defibrillation catheter is guided to the vicinity of the coronary sinus ostium.

However, it is often the case that the circuit caused by the anterior end of the tubular member is successfully formed in the right atrium, and the anterior end of the defibrillation catheter guided to the coronary sinus orifice does not point to the coronary sinus. (The coronary sinus orifice is located on the opposite side of the bending direction of the anterior end portion of the tube member). In this case, it is impossible to insert the anterior end portion of the defibrillation catheter into the coronary sinus orifice.

The present invention has been made in view of the above-mentioned general state of affairs, and an object of the present invention is to provide a method capable of reliably performing "the anterior end portion of a tubular member is first inserted from the inferior great vein into the right atrium, and The inserted anterior part was used to form a circuit in the right atrium, and the anterior part was inserted into the coronary sinus ostium.

[Means to solve the problem]

(1) The intracardiac defibrillation catheter of the present invention is provided with: an insulating tube member having flexibility at least at a front end portion; and a control handle connected to a base end of the tube member; And the tip end are fixed to the front end of the tube member; and the first DC electrode group is formed by a plurality of ring electrodes mounted on the front end portion of the tube member; and the second DC electrode group Is formed by a plurality of ring electrodes separated from the first DC electrode group toward the base end side and mounted on the front end portion of the pipe member; and a first lead group is formed by the first and second electrode groups. A plurality of leads connected to each of the electrodes of the 1DC electrode group; and a second lead group composed of a plurality of leads connected to each of the electrodes constituting the second DC electrode group; and The first operating steel wire extends eccentrically from the central axis of the pipe member to the front end portion of the pipe member and bends the front end of the pipe member toward the first direction. Connected and fixed to the front tip or tube The front end of the member can be stretched at its rear end; and the second operation steel wire is used to bend the front end portion of the pipe member toward the second direction opposite to the first direction, and The central axis of the pipe member is sandwiched between the central axis of the pipe member and the first operation steel wire to exist in the pipe member, and the front end of the pipe member is connected and fixed to the front tip or the front end of the pipe member. And the rear end can be stretched, and defibrillation is performed in the heart cavity by applying voltages of mutually different polarities between the first DC electrode group and the second DC electrode group, and the intracardiac defibrillation is performed. The catheter is characterized in that, after the deflection of the tube member at the base end side is suppressed from the front end position of the second DC electrode group, the rear end of the first operation steel wire is suppressed. When the end is stretched to the maximum, the deflection angle (θ1) of the front end portion of the tube member (front end portion at the front end side more than the front end position of the second DC electrode group) is more than 180 ° Big.

Here, the so-called "deflection angle of the front end part" refers to the direction in which the base end part is not bent and the direction in which the front end part is bent (the direction pointed by the front end of the pipe member). The angle between them.

If an intracardiac defibrillation catheter based on this structure is used, the tortuosity angle (θ1) is larger than 180 °, and it can be borrowed in the actual technique caused by the entry from the inferior great vein. The anterior part of the tubular member inserted into the right atrium from the inferior great vein forms a circuit in a shape along the lateral side of the right atrium, whereby the anterior end of the defibrillation catheter can be guided to the coronary shape. Near the sinus ostium.

Moreover, in actual hand technique, even if the front end of the defibrillation catheter which is guided to the vicinity of the coronary sinus ostium does not point to the coronary sinus ostium, the second end of the steel wire for the second operation can be performed. The stretching operation is performed and the front end portion of the tube member is bent in the second direction, so that the front end of the defibrillation catheter is directed toward the coronary sinus ostium. Thereby, the front end portion of the defibrillation catheter can be surely inserted into the coronary sinus ostium.

(2) In the intracardiac defibrillation catheter of the present invention, it is preferable that the deflection angle (θ1) is 200 to 360 °. When the position is higher than the front end of the second DC electrode group, When the deflection of the pipe member at the base end side is suppressed and the rear end of the steel wire for the second operation is stretched to the maximum extent, the deflection of the front end portion of the pipe member is maximized. The folding angle (θ2) is 10 to 90 °.

If an intracardiac defibrillation catheter based on this structure is used, the tortuosity angle (θ1) is 200 ° or more, and in actual handwork caused by the entry from the inferior great vein, it can be achieved by The inferior great vein is inserted into the anterior end portion of the tubular member in the right atrium to easily form a circuit having a shape along the side of the right atrium.
In addition, since the deflection angle (θ1) is 360 ° or less, in a practical technique, a circuit of an appropriate size can be formed by inserting the anterior end portion of the tube member in the right atrium.

In addition, since the tortuosity angle (θ2) is 10 ° or more, in actual technique, even after the formation of a circuit in the right atrium, the coronary sinus ostium is positioned at the anterior end portion of the tortuosity. The front end of the defibrillation catheter can also be sufficiently directed toward the coronary sinus ostium at the side opposite to the direction (first direction).
In addition, since the deflection angle (θ2) is 90 ° or less, the flatness when the front end portion of the pipe member is bent in the second direction can be sufficiently ensured.

(3) In the intracardiac defibrillation catheter of the present invention, it is preferable that the defibrillation catheter is configured such that the bending of the tube member is closer to the base end side than the front end position of the second DC electrode group. When the rear end of the first operating steel wire is stretched to the maximum extent in a suppressed state, the front end of the catheter is directed to the mounting area of the second DC electrode group of the pipe member.

(4) In the intracardiac defibrillation catheter of the present invention, it is preferable that the defibrillation catheter is configured such that the bending of the tube member at the base end side with respect to the front end position of the second DC electrode group is performed. When the rear end of the first operating steel wire is stretched to the maximum extent in a suppressed state, the front end of the catheter and the tube at the base end side are located closer to the front end than the front end of the second DC electrode group. The separation distance (D) between the components (the part that is not bent) is 50 mm or less.

(5) The intracardiac defibrillation catheter of the present invention is provided with: an insulating tube member having flexibility at least at a front end portion; and a control handle connected to a base end of the tube member; And the tip end are fixed to the front end of the tube member; and the first DC electrode group is formed by a plurality of ring electrodes mounted on the front end portion of the tube member; and the second DC electrode group Is formed by a plurality of ring electrodes separated from the first DC electrode group toward the base end side and mounted on the front end portion of the pipe member; and a first lead group is formed by the first and second electrode groups. A plurality of leads connected to each of the electrodes of the 1DC electrode group; and a second lead group composed of a plurality of leads connected to each of the electrodes constituting the second DC electrode group; and The steel wire for operation is eccentrically extended from the central axis of the pipe member to exist in the pipe member in order to bend the front end portion of the pipe member, and the front end is connected and fixed to the tip of the front end. Head or front end of the aforementioned pipe member And the rear end can perform a tension operation, and defibrillation is performed in the heart cavity by applying voltages of mutually different polarities between the first DC electrode group and the second DC electrode group, and the intracardiac defibrillation catheter It is characterized in that the rear end of the steel wire for operation is made while suppressing the deflection of the tube member at the base end side from the front end position of the second DC electrode group. When maximally stretched, the deflection angle (θ) of the front end portion of the tube member (positioned closer to the front end side than the front end portion of the second DC electrode group) is larger than 180 °.

If an intracardiac defibrillation catheter based on such a structure is used, the tortuosity angle (θ) is larger than 180 °, and it can be borrowed in the actual handwork caused by the entry from the inferior great vein. The anterior part of the tubular member inserted into the right atrium from the inferior great vein forms a circuit in a shape along the lateral side of the right atrium, whereby the anterior end of the defibrillation catheter can be guided to the coronary shape. Near the sinus ostium.

(6) In the intracardiac defibrillation catheter described in (5) above, it is preferable that the defibrillation angle (θ) is 200 to 360 °.

If an intracardiac defibrillation catheter based on such a structure is used, the tortuosity angle (θ) is 200 ° or more, and in actual handwork caused by the entry from the inferior great vein, it can be achieved by The inferior great vein is inserted into the anterior end portion of the tubular member in the right atrium to easily form a circuit having a shape along the side of the right atrium.
In addition, since the deflection angle (θ) is 360 ° or less, in a practical technique, a circuit of an appropriate size can be formed by inserting the anterior end portion of a tube member in the right atrium.

[Effect of the invention]

According to the intracardiac defibrillation catheter according to the present invention, it is possible to surely perform "the anterior end portion of the tubular member is inserted from the inferior great vein into the right atrium, and A circuit is formed in the atrium, and then the front part is inserted into the coronary sinus mouth. As a result, the first DC electrode group attached to the front end portion 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 entering from the lower great vein.

The internal defibrillation catheter 100 of this embodiment shown in FIGS. 1 to 5 includes: a flexible tube member 10 having a multi-lumen structure; and a control handle 20 connected to a proximal end thereof. ; And a front tip 35 fixed to the front end of the tube member 10; and a first DC electrode group 31G formed by eight ring electrodes 31 mounted on the front end of the tube member 10; and The first DC electrode group 31G is a second DC electrode group 32G formed by eight ring-shaped electrodes 32 separated at the front end portion of the tube member 10 toward the base end side, and is mounted on the first DC electrode group 31G. The two ring electrodes 33 for potential measurement at the front end portion of the tube member 10 at the base end side; and the front end portion of the tube member 10 mounted at the base end side of the second DC electrode group 32G. A first ring group 41G formed by two ring electrodes 34 for potential measurement; and eight lead wires 41 connected to each of the electrodes 31 constituting the first DC electrode group 31G; and Each of the electrodes 32 constituting the second DC electrode group 32G has a second lead group 42G formed by eight lead wires 42 connected to each other; and a ring-shaped electrode for potential measurement Each of 33 has two leads 43 connected thereto; and each of the ring electrodes 34 for potential measurement has two leads 44 connected thereto; and the front end portion of the tube member 10 faces the first It bends in the direction, eccentrically extends from the central axis of the pipe member 10 and exists in the pipe member 10, and its front end is connected and fixed at the front tip 35, and its rear end can be stretched first. 1 operation steel wire 71; and in order to bend the front end portion of the pipe member 10 toward the second direction, it extends so as to face the first operation steel wire 71 while sandwiching the central axis of the pipe member 10 The second operation steel wire 72 is connected to the front end of the pipe member 10 and fixed to the tip 35 at the front end, and the rear end can be tensioned, and is formed by the first DC electrode group. 31G and the second DC electrode group 32G are applied with voltages of mutually different polarities to perform defibrillation in the heart cavity. When the tube member 10 is closer to the proximal side than the front end position of the second DC electrode group 32G, In the state where the deflection is suppressed, the rear end of the first operating steel wire 71 is maximized. The degree of deflection (θ1) of the front end portion of the tube member 10 is slightly 270 ° when the tube member 10 is stretched. When the tube member 10 is closer to the base end side than the front end position of the second DC electrode group 32G, When the rear end of the second operation steel wire 72 is stretched to the maximum extent while the deflection is suppressed, the deflection angle (θ2) of the front end portion of the pipe member 10 is approximately 90 °.
In FIGS. 1, 4, and 5, reference numerals 51 and 52 denote electrode connectors, and reference numerals 61 and 62 denote external wires.

The defibrillation catheter 100 according to this embodiment includes a tube member 10, a control handle 20, a distal tip 35, a first DC electrode group 31G, a second DC electrode group 32G, and electrodes 33 and 34 for potential measurement. , And the first lead group 41G, and the second lead group 42G, and the leads 43 and 44, and the first operation steel wire 71, the second operation steel wire 72, and the electrode connectors 51 and 52, and external wires 61 and 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 pipe member 10 is, for example, 1.2 to 3.3 mm, and if one of the examples is suitable, it is 2.0 mm.
The effective length of the tube member 10 is determined by deciding the entry from the lower great vein, for example, it is set to 950 to 1020 mm, and if it is one of the examples suitable, it is 950 mm.

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

At the tube member 10 (the lining portion 16), the four lumens 11L to 14L opened at the front end and the base end are divided by a lumen tube 19 made of a fluorine resin, respectively. And formed.
Examples of the fluorine-based resin constituting the lumen tube 19 include a perfluoroalkyl vinyl ether copolymer (PFA), polytetrafluoroethylene (PTFE), and the like.

The hardness of the resin constituting the lining portion 16 is preferably 25D to 40D.
The hardness of the resin constituting the outer lining portion 17 is preferably 35D to 75D, and more preferably 50D to 75D.
Generally, the resin constituting the outer lining portion 17 is one having a different hardness depending on the axial direction. Accordingly, the pipe member 10 is configured to gradually increase the hardness from the front end side toward the base end side.

If one example of the hardness change of the outer lining portion 17 is shown, the resin hardness in the range of 0 mm to 51.5 mm from the front end of the pipe member 10 is 50.5D, and the range of 51.5 mm to 158.5 mm from the front end. The hardness of the resin is 70D, and the hardness from the position of 158.5mm from the front end to the base end is 75D. A braid 18 is embedded in the outer lining portion 17 from the position of 339.5 mm from the front end of the pipe 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 portion 23, and a stress release portion 24. At the rotation operation portion 23, grips 231 and 232 for forming a rotation operation are formed.
Here, the dimensions of the grip 231 and the grip 232 are different, and the grip 231 becomes larger. By making the sizes of the grips different, the operator can recognize which finger is hooked to the grip based on the feeling of the finger without visually inspecting the finger. As a result, it is possible to shorten the skill time.

At the side of the rotation operation portion 23 where the grip 231 is formed, the rear end of a later-mentioned first operation steel wire 71 is connected and fixed, and a finger is hooked on the grip 231 so that the rotation operation portion 23 faces the figure. Rotation in the direction indicated by the arrow A1 of 1 enables the rear end of the first operation steel wire 71 to be stretched.

At the side of the rotary operation portion 23 where the grip 232 is formed, the rear end of a second operation steel wire 72 described later is connected and fixed, and a finger is hooked on the grip 232 so that the rotary operation portion 23 faces the figure. Rotation in the direction indicated by arrow B1 of 1 enables the rear end of the second operation steel wire 72 to be stretched.

In the state shown in FIG. 1 (the natural state in which the front end portion of the pipe member 10 is not bent), the relatively small grip 232 is formed on the rotation axis of the rotation operation portion 23 And closer to the base end side.
Thereby, the amount of rotation capable of rotating the rotation operation portion 23 in the direction shown by the arrow A1 is larger than the amount of rotation capable of rotating in the direction shown by the arrow B1.

A first DC electrode group 31G and a second DC electrode group 32G are mounted on the front end portion of the tube member 10.
In the present invention, the "electrode group" refers to a plurality of electrodes that are formed with the same poles (having the same polarity) or have the same purpose and are mounted at narrow intervals (for example, 5 mm or less). Assembly.

The first DC electrode group is composed of a plurality of electrodes constituting the same pole (-pole or + pole) at a narrow interval at the front end portion of the tube member. Here, although the number of electrodes constituting the first DC electrode group varies depending on the width or arrangement interval of the electrodes, for example, it is set to 4 to 13, and it is more preferably set to 8 to 10.

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

Here, the width (length in the axial direction) of the electrode 31 is preferably 2 to 5 mm, and if it is one of the examples suitable, it is 4 mm.
If the width of the electrode 31 is too narrow, the amount of heat generated when a voltage is applied becomes too large, and there is a risk of causing damage to surrounding tissues. On the other hand, if the width of the electrode 31 is too wide, the flexibility and flexibility of the portion where the first DC electrode group 31G is mounted on the tube member 10 may be impaired.
The mounting interval (separation distance between adjacent electrodes) of the electrodes 31 is preferably 1 to 5 mm, and if one of the examples is suitable, it is 2 mm.
When the intracardiac defibrillation catheter 100 is used (when placed in the cardiac cavity), the 31G series of the first DC electrode group is located in the coronary sinus (CS).

The second DC electrode group is formed at the front end portion of the tube member that is distant from the base end side from the mounting position of the first DC electrode group, and will constitute the opposite pole (+ or-pole) to the first DC electrode group. A plurality of electrodes are formed with narrow intervals. Here, although the number of electrodes constituting the second DC electrode group varies depending on the width or arrangement interval of the electrodes, for example, it is set to 4 to 13, and it is more preferably set to 8 to 10.

In this embodiment, the second DC electrode group 32G is composed of eight ring electrodes 32. The electrode 32 constituting the second DC electrode group 32G is connected to the same electrode in the DC power supply device through a lead (the lead 42 constituting the second lead group 42G shown in FIG. 3) and an electrode connector 52 described later. Terminals (terminals opposite to those connected to the first DC electrode group 31G).

As a result, voltages having mutually different polarities are applied to the first DC electrode group 31G (electrode 31) and the second DC electrode group 32G (electrode 32). The first DC electrode group 31G and the second DC electrode group 32G, It is an electrode group with mutually different polarities (when one electrode group is -pole, the other electrode group is + pole).

Here, the width (length in the axial direction) of the electrode 32 is preferably 2 to 5 mm, and if one of the examples is suitable, it is 4 mm.
If the width of the electrode 32 is too narrow, the amount of heat generated when a voltage is applied becomes excessively large, and there is a risk of causing damage to surrounding tissues. On the other hand, if the width of the electrode 32 is too wide, the flexibility and flexibility of the portion where the second DC electrode group 32G is mounted on the tube member 10 may be impaired.
The mounting interval (separation distance between adjacent electrodes) of the electrodes 32 is preferably 1 to 5 mm, and if one of the examples is suitable, it is 2 mm.
When the intracardiac defibrillation catheter 100 is used (when placed in the cardiac cavity), 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 32G can also be used to measure the potential.

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

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

The electrode 34 mounted on the base end side of the second DC electrode group 32G is connected to the electrocardiogram via a lead (lead 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 if one of the examples is suitable, it is 1.2 mm.
If the width of the electrode 33 or the electrode 34 is too wide, the measurement accuracy of the cardiac potential may be reduced, or it may be difficult to identify the location of the abnormal potential.

At the front end of the tube member 10, a front tip 35 is attached.
The lead is not connected to the tip end 35, and in this embodiment, the tip end 35 is not used as an electrode. However, it can also be used as an electrode by connecting it to a lead. The material of the tip end 35 is not particularly limited as long as it can be made of metal materials such as platinum and stainless steel, and various resin materials.

The separation distance between the first DC electrode group 31G (the electrode 31 on the base end side) and the second DC electrode group 32G (the electrode 32 on the front end side) is preferably 40 to 100 mm, and more preferably 50 to 90 mm. If one of the examples is suitable, it 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 preferably made of platinum or platinum in order to improve the developability with respect to X-rays. Made of alloy.

The first lead group 41G shown in FIGS. 2 and 3 is an assembly of eight leads 41 connected to each of the eight electrodes 31 constituting the first DC electrode group 31G.
Each of the eight electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the DC power supply device by the first lead group 41G (lead 41).

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 its front end, and enters into the second lumen 12L from a side hole formed in the pipe wall of the pipe member 10. Eight lead wires 41 that have entered the second lumen 12L extend as the first lead group 41G in the second lumen 12L and enter the inside of the control handle 20.

The second lead group 42G shown in FIG. 3 is an assembly of eight leads 42 connected to each of the eight electrodes 32 constituting the second DC electrode group 32G.
With the second lead group 42G (lead 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 its front end, and enters into the fourth lumen 14L from a side hole formed at the pipe wall of the pipe member 10. The eight leads 42 entering the fourth lumen 14L extend as a second lead group 42G in the fourth lumen 14L and enter the inside of the control handle 20.

As described above, the first lead group 41G (eight leads 41) is extended to exist in the second lumen 12L, and the second lead group 42G (eight leads 42) is extended to exist in the fourth lumen In 14L, the first lead group 41G and the second lead group 42G can be insulated and isolated within the pipe member 10. This makes it possible to reliably prevent the first lead group 41G (the first DC electrode group 31G) and the second lead group 42G (the second DC electrode group 32G) from being applied when a voltage necessary for intracardiac defibrillation is applied. In the case of a short circuit.

The two leads 43 shown in FIGS. 2 and 3 are connected to two electrodes 33 for potential measurement, respectively.
The two lead wires 43 are fused to the inner peripheral surface of the electrode 33 at the front end of each, and enter into the second lumen 12L from a side hole formed in the pipe wall of the pipe member 10, and The lead 41 constituting the first lead group 41G extends in the second lumen 12L together with the lead 41 constituting the first lead group 41G, and enters the inside of the control handle 20. Each of the electrodes 33 can be connected to the electrocardiogram by the lead 43.

The two leads 44 shown in FIG. 3 are connected to two electrodes 34 for potential measurement, respectively.
The two lead wires 44 are welded to the inner peripheral surface of the electrode 34 at the front end of each, and enter the fourth lumen 14L from a side hole formed in the pipe wall of the pipe member 10, and The lead wire 42 constituting the second lead group 42G extends in the fourth lumen 14L, and enters the inside of the control handle 20. Each of the electrodes 34 can be connected to the electrocardiogram by the lead 44.

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

The electrode connector 51 and the electrode connector 52 are respectively disposed outside the control handle 20, and in these interiors, plural terminals (not shown) are provided.

The external electric wire 61 is used to guide the lead wire 41 and the lead wire 43 from the pipe member 10 (the second lumen 12L) into the inside of the control handle 20 to the electrode connector 51.
The external electric wire 62 is used to guide the lead wire 42 and the lead wire 44 from the pipe member 10 (the fourth lumen 14L) into the inside of the control handle 20 to the electrode connector 52.

The defibrillation catheter 100 according to this embodiment is provided with a first operation steel wire 71 for bending the front end portion of the tube member 10 in a first direction (direction indicated by arrow A in FIG. 1), and The second operation steel wire 72 is bent by bending the front end portion of the pipe member 10 in the second direction (the direction indicated by arrow B in FIG. 1).
Here, the first direction and the second direction are opposite bending directions on the same plane.

The first operating steel wire 71 and the second operating steel wire 72 are made of stainless steel or Ni-Ti based superelastic alloy. However, they are not necessarily made of metal. For example, they can be borrowed. It is composed of a high-strength non-conductive wire or the like.

As shown in FIG. 2 and FIG. 3, the first operation steel wire 71 is inserted through the first lumen 11L of the tube member 10 so as to be movable in the tube axis direction.
The front end of the first operation steel wire 71 is connected and fixed to the front end tip 35 by solder filled in the inner space of the front end tip 35.
The rear end of the first operation steel wire 71 is connected and fixed to the rotation operation portion 23 (the side on which the grip 231 is formed) of the control handle 20 and is capable of performing a tension operation.

By hooking a finger on the grip 231 and rotating the rotation operation portion 23 in the direction shown by the arrow A1 in FIG. 1, the rear end of the first operation steel wire 71 is stretched, so that the front end of the pipe member 10 can be made. The part is bent in the first direction shown by arrow A in FIG. 1.

On the other hand, the second operation steel wire 72 is inserted through the third lumen 13L of the pipe member 10 so as to be movable in the pipe axis direction.
The front end of the second operation steel wire 72 is connected and fixed to the front end tip 35 by solder filled in the inner space of the front end tip 35.
The rear end of the second operation steel wire 72 is connected to and fixed to the rotation operation portion 23 (the side on which the grip 232 is formed) of the control handle 20 and is capable of being stretched.

By hooking a finger on the grip 232 and rotating the rotary operation portion 23 in the direction shown by the arrow B1 in FIG. 1, the rear end of the second operation steel wire 72 is stretched, so that the front end of the pipe member 10 can be made. The part is bent in the second direction shown by arrow B in FIG. 1.

As described above, in the defibrillation catheter 100 according to the present embodiment, the rotation operation portion 23 can be turned from the state shown in FIG. 1 (the natural state in which the front end portion of the tube member 10 is not bent) toward the arrow A1. The amount of rotation rotated in the direction shown is set to be larger than the amount of rotation that can be rotated in the direction shown by arrow B1, so that the rear end of the first operation steel wire 71 can be pulled. The length of the tension (maximum tension length) is longer than the length (maximum tension length) at which the rear end of the second operation steel wire 72 can be stretched.

FIG. 4 shows a state in which the defibrillation catheter 100 according to the present embodiment suppresses the deflection of the tube member 10 closer to the base end side than the front end position of the second DC electrode group 32G. The first operation steel wire 71 is stretched at the rear end to the maximum to make the front end portion of the pipe member 10 bend in the first direction.

As shown in FIG. 4, the deflection angle (θ1) of the front end portion of the tube member 10 located closer to the front end side than the front end position of the second DC electrode group 32G is approximately 270 °.

As such, compared with the defibrillation catheter of the prior art, if the defibrillation catheter 100 according to this embodiment exhibits a large deflection angle (θ1), it is actually caused by the entry from the lower great vein. For example, after inserting the anterior part of the tube member 10 from the inferior great vein into the right atrium until at least a part of the second DC electrode group 32G is positioned in the right atrium, the first operation is performed by using The rear end of the steel wire 71 is stretched, which can easily form a circuit of a general shape along the side of the right atrium by being inserted into the front end portion of the tube member 10 in the right atrium. The anterior end of the defibrillation catheter 100 is guided to the vicinity of the mouth of the coronary sinus.

In the defibrillation catheter of the present invention, the deflection angle (θ1) is larger than 180 °, and more ideally, it is 200-360 °, and more preferably, it is 240-300 °.
If the deflection angle (θ1) is 180 ° or less, in actual technique, the system cannot be inserted from the inferior great vein into the anterior end portion of the tubular member in the right atrium to form along the right side. Shaped circuit on the side of the atrium.
On the other hand, if the deflection angle (θ1) is too large, there may be cases where a proper size circuit cannot be formed by inserting the anterior end portion of the tubular member into the right atrium in actual technique. In some cases, it may be difficult to guide the leading end of the defibrillation catheter to the vicinity of the coronary sinus ostium.

As shown in FIG. 4, the tube member 10 at the front end of the defibrillation catheter 100 and at the base end side (the portion where the deflection is suppressed) is located closer to the front end of the second DC electrode group 32G than each other. Separation.
The front end of the defibrillation catheter 100 is directed to the mounting area of the second DC electrode group 32G of the tube member 10.

As such, a certain separation distance (D) is ensured between the front end of the defibrillation catheter 100 and the tube member 10 at the proximal end side than the front end position of the second DC electrode group 32G, and the defibrillation is maintained. The front end of the catheter 100 is directed to the mounting area of the second DC electrode group 32G of the tube member 10, and it is a tube that can be inserted into the right atrium by the actual technique caused by the entry from the lower great vein. The anterior end of the member 10 forms a circuit of a suitable size that can run along the side of the right atrium.

In the defibrillation catheter of the present invention, the separation distance (D) between the front end of the defibrillation catheter 100 and the tube member 10 at the mounting area of the second DC electrode group 32G is preferably 50 mm or less.

When the front end of the defibrillation catheter is directed to the front end side than the mounting area of the second DC electrode group 32G, in actual hand technique, there will be a front end of a tube member inserted into the right atrium. Some of the formed circuits are not fully sized.

On the other hand, when the front end of the defibrillation catheter is directed toward the proximal end side than the mounting area of the second DC electrode group 32G, or when the separation distance (D) is too large, the actual hand technique In some cases, it may be difficult to form a circuit along the side of the right atrium by inserting the anterior end portion of the tubular member into the right atrium.

FIG. 5 shows a state in which the defibrillation catheter 100 according to the present embodiment suppresses the deflection of the tube member 10 on the proximal end side rather than the front end position of the second DC electrode group 32G. The second operation steel wire 72 is stretched to the rear end as much as possible, and the bent shape when the front end portion of the pipe member 10 is bent toward the second direction is shown.

As shown in FIG. 5, the deflection angle (θ2) of the front end portion of the tube member 10 at the front end side, which is closer to the front end position of the second DC electrode group 32G, is slightly 90 °.

In this way, if the defibrillation catheter 100 according to the present embodiment that can bend the front end portion of the tube member 10 in the second direction is used, it is guided to the vicinity of the coronary sinus orifice in actual handwork. The front end of the defibrillation catheter 100 does not point to the coronary sinus opening. The second end of the second operation steel wire 72 may be stretched and the front end of the tube member 10 may be bent in the second direction. Point the leading end of the defibrillation catheter 100 toward the coronary sinus orifice. As a result, the front end portion of the defibrillation catheter 100 can be reliably and easily inserted into the coronary sinus opening.

In the defibrillation catheter of the present invention, the deflection angle (θ2) is preferably 10 to 90 °.
If the tortuosity angle (θ2) is 10 ° or more, even if the coronary sinus ostium system is located on the opposite side of the torsional direction (first direction) where the anterior end portion of the circuit is formed, The front end of the defibrillation catheter 100 can be sufficiently pointed toward the coronary sinus ostium and inserted.
Further, since the deflection angle (θ2) is 90 ° or less, the flatness when the front end portion of the pipe member 10 is bent in the second direction can be sufficiently ensured.

FIG. 6 is an X-ray image showing a state in which the defibrillation catheter 100 of this embodiment is left in the heart cavity, and includes a first DC electrode group and a second DC electrode formed by eight ring electrodes, respectively. The catheters of the group are defibrillation catheters of this embodiment.
The front end of the defibrillation catheter shown in Figure 6 is inserted into the right atrium from the superior great vein, and a circuit is formed in the right atrium before being inserted into the coronary sinus mouth. The first DC electrode The cluster is arranged in the coronary sinus, and the second DC electrode cluster is arranged in the right atrium.
In FIG. 6, the circuit formed by the front end portion of the tube member including the mounting region of the second DC electrode group 32G is recognized along the side of the right atrium.

Although one embodiment of the present invention has been described above, the defibrillation catheter system of the present invention is not limited to these embodiments, and various modifications can be made.
For example, the defibrillation catheter of the present invention may be a so-called one-way configuration including one operation steel wire.

As such a unidirectional defibrillation catheter, the defibrillation catheter 200 shown in FIG. 7 and FIG. 8 is provided with: a tube member 10 having a flexible multi-lumen structure; and a base end connected thereto. Control knob 25; and front tip 35 fixed to the front end of the tube member 10; and a first DC electrode group formed by eight ring-shaped electrodes 31 mounted on the front end of the tube member 10. 31G; and a second DC electrode group 32G formed by eight ring electrodes 32 separated from the first DC electrode group 31G toward the base end side and mounted on the front end portion of the pipe member 10; and mounted on Two ring electrodes 33 for potential measurement at the front end portion of the tube member 10 at the base end side of the first DC electrode group 31G; and the tube member 10 mounted at the base end side of the second DC electrode group 32G Two ring-shaped electrodes 34 for potential measurement at the front end portion; and eight lead wires connected to each of the electrodes 31 constituting the first DC electrode group 31G and extending in the tube member 10 The first lead group inside (the second lumen); and the eight lead wires connected to each of the electrodes 32 constituting the second DC electrode group 32G. The second lead group formed and extended to exist inside the tube member 10 (the fourth lumen); and connected to each of the ring electrodes 33 for potential measurement and extended to exist inside the tube member 10 (the 2 lumen); 2 leads connected to each of the ring electrodes 34 for potential measurement and extending inside the tube member 10 (the fourth lumen); and The front end portion of the tube member 10 is bent to extend eccentrically from the central axis of the tube member 10 and exists inside the tube member 10 (the first lumen), and the front end thereof is connected and fixed at the front tip 35 And the rear end can be operated with a steel wire for operation, and is constructed by applying voltages of mutually different polarities between the first DC electrode group 31G and the second DC electrode group 32G to perform the operation in the heart cavity. Defibrillation, when the bending of the tube member 10 at the base end side is restrained from the front end position of the second DC electrode group 32G, the rear end of the steel wire for operation is stretched to the maximum extent At this time, the deflection angle (θ) of the front end portion of the pipe member 10 is approximately 270 °.

FIG. 7 shows the defibrillation catheter 200 in a state where the front end portion of the tube member 10 is not bent.
FIG. 8 shows a state in which the rear end of the steel wire for operation is pulled to the maximum when the deflection of the pipe member 10 at the base end side from the front end position of the second DC electrode group 32G is suppressed. The defibrillation catheter 200 when the front end portion of the tube member 10 is flexed is shown in tension.
In FIG. 7 and FIG. 8, portions indicated by the same component symbols as those in FIGS. 1 to 5 have the same configuration as the above-described embodiment described with reference to these drawings.

The control handle 25 constituting the defibrillation catheter 200 is provided with a handle main body 26 with a built-in connector, a rotation operation portion 27, and a stress release portion 29. At the rotation operation portion 27, a grip 28 for forming a rotation operation is formed.
By hooking a finger on the grip 28 and rotating the rotary operation portion 27 in the direction shown by the arrow A1 in FIG. 7, the rear end of the operation steel wire is stretched, so that the front end portion of the pipe member 10 can be directed toward the figure. 7. Fold in the direction shown by arrow A.

In the defibrillation catheter 200, the electrodes 31 constituting the first DC electrode group 31G are connected to the DC power supply device through the leads constituting the first lead group and the connector built in the base end portion of the handle 25. At the terminals of the same pole.
The electrodes 32 constituting the second DC electrode group 32G are connected to terminals of the same pole in the DC power supply device via the leads constituting the second lead group and the connector built in the base end portion of the handle 25. (The terminal of the opposite pole to that of the first DC electrode group 31G).
The electrode 33 and the electrode 34 for potential measurement are connected to the electrocardiogram via a lead wire and a connector built into the base end portion of the handle 25.

As shown in FIG. 8, the deflection angle (θ) of the front end portion of the tube member 10 at the front end side more than the front end position of the second DC electrode group 32G is approximately 270 °.

In this way, compared to the defibrillation catheter of the prior art, if the defibrillation catheter 200 exhibits a large deflection angle (θ), in the actual hand technique caused by the entry from the lower great vein, For example, after inserting the anterior end portion of the tube member 10 into the right atrium from the inferior great vein until at least a part of the second DC electrode group 32G is positioned in the right atrium, the rear end of the operating steel wire is pulled Zhang is able to easily form a circuit with a general shape along the side of the right atrium by being inserted into the anterior end portion of the tube member 10 in the right atrium, so that the anterior end of the defibrillation catheter 200 can be guided. Lead to the coronary sinus mouth.

In the unidirectional defibrillation catheter of the present invention, the deflection angle (θ) is larger than 180 °, and more ideally, it is 200-360 °, and more preferably, it is 240-300 °.
If the deflection angle (θ) is 180 ° or less, in actual technique, the system cannot be inserted from the inferior great vein into the anterior end portion of the tubular member in the right atrium to form a line along the right side. Shaped circuit on the side of the atrium.
On the other hand, if the deflection angle (θ) is too large, there may be cases where a proper size circuit cannot be formed by inserting the anterior end portion of the tubular member into the right atrium in actual technique. In some cases, it may be difficult to guide the leading end of the defibrillation catheter to the vicinity of the coronary sinus ostium.

100‧‧‧ Defibrillation Catheter

10‧‧‧ tube member

11L ～ 14L‧‧‧ Lumen

16‧‧‧lining

17‧‧‧ Outer lining

18‧‧‧Packing

19‧‧‧ lumen tube

20‧‧‧Control handle

21‧‧‧handle body

23‧‧‧Rotary operation section

231, 232‧‧‧

24‧‧‧ Stress Relief Section

31 ～ 34‧‧‧ ring electrode

31G‧‧‧1DC electrode group

32G‧‧‧2DC electrode group

35‧‧‧ tip

41 ～ 44‧‧‧Leader

51, 52‧‧‧ electrode connector

61, 62‧‧‧ External wires

71‧‧‧The first operation steel wire

72‧‧‧ 2nd operation steel wire

200‧‧‧ Defibrillation Catheter

25‧‧‧Control handle

26‧‧‧handle body

27‧‧‧Rotary operation section

28‧‧‧ Grip

29‧‧‧ Stress release section

[FIG. 1] A plan view showing a defibrillation catheter according to one embodiment of the present invention.

[FIG. 2] A cross-sectional view of a tube member constituting the defibrillation catheter shown in FIG. 1 (II-II cross-sectional view of FIG. 1).

[FIG. 3] A cross-sectional view of a tube member constituting the defibrillation catheter shown in FIG. 1 (III-III cross-sectional view of FIG. 1).

[Fig. 4] It is the maximum that the front end portion of the tube member constituting the intracardiac defibrillation catheter shown in Fig. 1 (on the front end side more than the front end position of the second DC electrode group) is directed toward the first direction. The state of the limit is shown as a plan view.

[Fig. 5] It is to maximize the front end portion of the tube member constituting the intracardiac defibrillation catheter shown in Fig. 1 (on the front end side more than the front end position of the second DC electrode group) toward the second direction. The state of the limit is shown as a plan view.

[Fig. 6] It is an X-ray portrait showing a state where the defibrillation catheter shown in Fig. 1 is left in the heart cavity.

7 is a plan view showing a defibrillation catheter according to another embodiment of the present invention.

[Fig. 8] It is the maximum bending of the front end portion of the tube member constituting the intracardiac defibrillation catheter shown in Fig. 7 (on the front end side than the front end position of the second DC electrode group). The floor plan for the status display.

Claims (6)

An intracardiac defibrillation catheter, comprising: Insulating pipe members are flexible at least at the front end; and The control handle is connected to the base end of the aforementioned pipe member; and The front tip is fixed at the front end of the aforementioned pipe member; and The first electrode group is formed of a plurality of ring-shaped electrodes mounted on the front end portion of the tube member; and The second electrode group is formed by a plurality of ring electrodes separated from the first electrode group toward the base end side and mounted on the front end portion of the tube member; and The first lead group is formed of a plurality of leads connected to each of the electrodes constituting the first electrode group; and The second lead group is formed of a plurality of leads connected to each of the electrodes constituting the second electrode group; and The first operating steel wire extends eccentrically from the central axis of the pipe member to the front end portion of the pipe member and bends the front end of the pipe member toward the first direction. The connection is fixed at the front end pointed end or the front end of the tube member, and the rear end can be stretched; and The second operation steel wire is configured to bend the front end portion of the pipe member toward the second direction opposite to the first direction, and sandwich the central axis of the pipe member with the first operation steel. The wires extend opposite to each other and exist in the tube member, and the front end is connected and fixed at the front tip or the front end of the tube member, and the rear end can be stretched. Defibrillation is performed in the heart cavity by applying voltages having mutually different polarities between the first electrode group and the second electrode group, The intracardiac defibrillation catheter is characterized by: When the deflection of the pipe member at the base end side is further suppressed than the front end position of the second electrode group, the rear end of the steel wire for the first operation is maximized. When stretched, the deflection angle (θ1) of the front end portion of the tube member is larger than 180 °. The intracardiac defibrillation catheter as described in the first patent application scope, wherein, The bending angle (θ1) is 200-360 °, When the deflection of the pipe member at the base end side is suppressed from the front end position of the second electrode group, the rear end of the steel wire for the second operation is maximized. When tensioned, the deflection angle (θ2) of the front end portion of the tube member is 10 to 90 °. The intracardiac defibrillation catheter described in item 1 or item 2 of the patent application scope, wherein, When the deflection of the pipe member at the base end side is further suppressed than the front end position of the second electrode group, the rear end of the steel wire for the first operation is maximized. When stretched, the front end of the catheter points toward the mounting area of the second electrode group of the tube member. The intracardiac defibrillation catheter as described in any one of claims 1 to 3, wherein, When the deflection of the pipe member at the base end side is further suppressed than the front end position of the second electrode group, the rear end of the steel wire for the first operation is maximized. At the time of tensioning, the separation distance (D) between the front end of the catheter and the tube member at the base end side more than the front end position of the second electrode group is 50 mm or less. An intracardiac defibrillation catheter, comprising: Insulating pipe members are flexible at least at the front end; and The control handle is connected to the base end of the aforementioned pipe member; and The front tip is fixed at the front end of the aforementioned pipe member; and The first electrode group is formed of a plurality of ring-shaped electrodes mounted on the front end portion of the tube member; and The second electrode group is formed by a plurality of ring electrodes separated from the first electrode group toward the base end side and mounted on the front end portion of the tube member; and The first lead group is formed of a plurality of leads connected to each of the electrodes constituting the first electrode group; and The second lead group is formed of a plurality of leads connected to each of the electrodes constituting the second electrode group; and The steel wire for operation is eccentrically extended from the central axis of the pipe member to exist in the pipe member in order to bend the front end portion of the pipe member, and the front end is connected and fixed to the tip of the front end. The front end of the head or the aforementioned pipe member, and the rear end thereof can be stretched, Defibrillation is performed in the heart cavity by applying voltages having mutually different polarities between the first electrode group and the second electrode group, The intracardiac defibrillation catheter is characterized by: When the deflection of the pipe member at the base end side is suppressed from the front end position of the second electrode group, the rear end of the steel wire for operation is stretched to the maximum extent At this time, the deflection angle (θ) of the front end portion of the pipe member is larger than 180 °. The intracardiac defibrillation catheter according to item 5 of the patent application scope, wherein: The bending angle (θ) is 200 to 360 °.