JP2012192124A - Intracardiac defibrillation catheter - Google Patents

Abstract

A mounting portion of a first DC electrode group is inserted into a blood vessel such as a coronary sinus, the first DC electrode group is positioned at a predetermined site in the blood vessel, and the mounting portion of the second DC electrode group is placed in the blood vessel. To provide a defibrillation catheter that can be placed so that the second DC electrode group is positioned at a site in front of the blood vessel without being inserted into the blood vessel.
An insulating tube, a handle, a first DC electrode group consisting of a plurality of ring-shaped electrodes mounted on a distal end region of the tube, and a second DC electrode consisting of a plurality of ring-shaped electrodes. A catheter that performs defibrillation in the heart chamber by applying voltages of different polarities to the first DC electrode group 31G and the second DC electrode group 32G. Arc-shaped curved portions 101, 102, and 103 that are alternately bent in opposite directions are formed between the mounting portion 106 of the 1DC electrode group and the mounting portion 105 of the second DC electrode group.
[Selection] Figure 2

Description

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

An external defibrillator (AED) is known as a defibrillator for removing atrial fibrillation (see, for example, Patent Document 1).
In defibrillation treatment by AED, electrical energy is given to the patient's body by attaching an electrode pad to the patient's body surface and applying a DC voltage. Here, the electrical energy flowing from the electrode pad into the patient's body is usually 150 to 200 J, and a part (usually, about several percent to 20%) of the fluid flows to the heart and is used for defibrillation treatment.

Thus, atrial fibrillation is likely to occur during cardiac catheterization, and even in this case, it is necessary to perform cardioversion.
However, depending on the AED that supplies electric energy from outside the body, it is difficult to supply effective electric energy (for example, 10 to 30 J) to the heart that is causing fibrillation.

That is, sufficient defibrillation treatment cannot be performed when the proportion of electrical energy supplied from outside the body is small (for example, about several percent).
On the other hand, when the electrical energy supplied from outside the body flows to the heart at a high rate, the heart tissue may be damaged.
Further, in the defibrillation treatment by AED, burns are likely to occur on the body surface to which the electrode pad is attached. And as mentioned above, when the ratio of the electrical energy flowing through the heart is small, repeated supply of electrical energy increases the degree of burns, which places a heavy burden on the patient undergoing catheterization.

  In order to solve such a problem, the applicant of the present invention is a catheter for defibrillation inserted into a heart chamber, and an insulating tube member having a multi-lumen structure, and a proximal end of the tube member A first DC electrode group composed of a plurality of ring-shaped electrodes attached to a distal end region of the tube member, and attached to the tube member spaced from the first DC electrode group to the proximal end side A second DC electrode group comprising a plurality of ring-shaped electrodes; a first lead wire group comprising lead wires connected to each of the electrodes constituting the first DC electrode group; and each electrode constituting the second DC electrode group A second lead wire group consisting of lead wires connected to each other; the first lead wire group and the second lead wire group extending to different lumens of the tube member, Do fibrillation Kiniwa, said first 1DC electrode group, the said first 2DC electrode group has proposed the intracardiac defibrillation catheter different polarity voltage is applied to each other (see Patent Document 2).

  According to the intracardiac defibrillation catheter having such a configuration, the electrical energy necessary and sufficient for defibrillation can be reliably supplied to the heart that has undergone atrial fibrillation during cardiac catheterization. In addition, the patient's body surface is not burned and is less invasive. Further, it is possible to reliably prevent a short circuit from occurring between the first lead wire group and the second lead wire group when a voltage necessary for intracardiac defibrillation is applied.

JP 2001-112874 A JP 2010-63708 A

  The defibrillation treatment by the intracardiac defibrillation catheter described in Patent Document 2 is performed as follows. That is, the defibrillation catheter is inserted into the right atrium from the superior vena cava, and further inserted into the opening (coronary sinus ostium) of the coronary sinus in the posterior lower wall of the right atrium. Is placed in the coronary sinus and the second DC electrode group G is located in the right atrium, and then voltages having different polarities are applied to the first DC electrode group G and the second DC electrode group. As a result, electrical energy can be directly applied to the heart causing atrial fibrillation.

  Here, in order to perform an effective defibrillation treatment using a defibrillation catheter as described in Patent Document 2, the first DC electrode group inserted into the coronary sinus is placed under the heart (rear side). (At this time, the most proximal electrode constituting the first DC electrode group is located near the coronary sinus ostium), and the second DC electrode group is preferably located in the right atrium. It is desirable to position it along the inner wall (myocardium) (the second DC electrode group is brought into contact with the inner wall of the right atrium).

However, when the first DC electrode group of the defibrillation catheter is positioned at the intrasinus site on the lower side (rear side) of the heart, the second DC electrode group does not move to the right atrial lumen (the inner space separated from the inner wall). It cannot be positioned along the inner wall (myocardium) of the right atrium.
In such a case, if the defibrillation catheter is further pushed into the right atrium in an attempt to bend the tube member of the mounting portion of the second DC electrode group in order to keep the second DC electrode group along the inner wall of the right atrium, the defibrillation is performed. The distal end of the arterial catheter advances in the coronary sinus, and the first DC electrode group positioned at a suitable intrasinusal site moves to the intrasinusal site on the upper side (anterior side) of the heart in the coronary sinus. The electrode group will move in the vicinity of the coronary sinus ostium in the right atrium. As a result, the defibrillation catheter cannot be placed so that the heart is sandwiched from the left and right by the first DC electrode group and the second DC electrode group, and effective defibrillation treatment cannot be performed.

The present invention has been made based on the above situation.
An object of the present invention is to provide a defibrillation catheter having a first DC electrode group and a second DC electrode group by inserting a mounting portion of the first DC electrode group into a blood vessel such as a coronary sinus, A heart that can be placed at a predetermined site in the blood vessel and can be placed so that the second DC electrode group is positioned at a site in front of the blood vessel without inserting the mounting portion of the second DC electrode group into the blood vessel. It is to provide an intraluminal defibrillation catheter.
Another object of the present invention is such that the first DC electrode group is located at the site in the coronary sinus on the lower side (rear side) of the heart, and the second DC electrode group is located along the inner wall of the right atrium. An object of the present invention is to provide an intracardiac defibrillation catheter that can be placed in a cavity.

(1) An intracardiac defibrillation catheter of the present invention includes an insulating tube member, a handle connected to the proximal end of the tube member, and a plurality of ring electrodes attached to a distal end region of the tube member A first electrode group (first DC electrode group) comprising: a second electrode group (first electrode group comprising a plurality of ring-shaped electrodes mounted on the distal end region of the tube member spaced from the first DC electrode group toward the proximal end side 2DC electrode group), and a catheter that performs defibrillation in the heart chamber by applying voltages having different polarities to the first DC electrode group and the second DC electrode group, and the tube member Is characterized in that at least two arc-shaped curved portions that are alternately bent in opposite directions are formed between the mounting portion of the first DC electrode group and the mounting portion of the second DC electrode group.

  According to the defibrillation catheter having the above-described configuration, “at least two arc-shaped curved portions that are alternately bent in opposite directions” are formed between the mounting portion of the first DC electrode group and the mounting portion of the second DC electrode group. "Serves as a stopper, and it is possible to prevent the mounting portion of the second DC electrode group from being inserted into the blood vessel into which the mounting portion of the first DC electrode group has been inserted. Thereby, only the first DC electrode group is located at a predetermined site in the blood vessel, and the second DC electrode group is located at a site before the blood vessel (opening).

(2) In the intracardiac defibrillation catheter of the present invention, the tube member includes a first arcuate curved portion located on a distal end side of the mounting portion of the second DC electrode group, and the first arcuate curved portion. A second arcuate curve portion that is located on the tip end side of the first arcuate curve portion and bends in a direction opposite to the first arcuate curve portion; and a tip end side of the second arcuate curve portion and a mounting portion of the first DC electrode group. It is preferable that a third arcuate curved portion that is located on the base end side and is bent in a direction opposite to the second arcuate curved portion (the same direction as the first arcuate curved portion) is formed.

(3) In this intracardiac defibrillation catheter, the tube length between the first DC electrode group and the second DC electrode group is 40 to 100 mm, and the radius of curvature of the first arcuate curved portion is 10 -50 mm, the central angle is 30-90 °, the radius of curvature of the second arcuate curved portion is 10-50 mm, the central angle is 60-120 °, the radius of curvature of the third arcuate curved portion is 10-50 mm The central angle is preferably 30 to 90 °.

According to the defibrillation catheter configured as described above, the first arcuate curved portion and the second arcuate curved portion formed between the mounting portion of the first DC electrode group and the mounting portion of the second DC electrode group, With the third arcuate curved portion, the second arcuate curved portion can have a detour shape. With this detour shape, it is possible to prevent the mounting portion of the second DC electrode group from being inserted into the coronary sinus from the opening (coronary sinus ostium) into which the mounting portion of the first DC electrode group is inserted. As a result, after the first DC electrode group reaches the intracoronary sinus site (preferred indwelling site of the first DC electrode group) on the lower side (rear side) of the heart, the defibrillation catheter is further pushed into the right atrium. Even so, the tip of the defibrillation catheter does not advance in the coronary sinus, and the first DC electrode group does not move from a suitable intrasinusal site.
Further, when the defibrillation catheter is further pushed into the right atrium in a state where the insertion of the attachment portion of the second DC electrode group into the coronary sinus is blocked, the tube member at the attachment portion of the second DC electrode group is bent. Thus, the second DC electrode group can be along the inner wall of the right atrium.
As a result, the defibrillation catheter is placed in the cardiac cavity so that the first DC electrode group is located at the site in the coronary sinus on the lower side (back side) of the heart and the second DC electrode group is located along the inner wall of the right atrium. Can be placed in.

(4) In the intracardiac defibrillation catheter, the mounting portion of the first DC electrode group of the tube member is bent in the same direction as the third arcuate curved portion (first arcuate curved portion). It is preferable.
According to such a configuration, the tip of the defibrillation catheter inserted into the right atrium from the superior vena cava can be easily guided to the coronary sinus ostium in the posterior lower wall of the right atrium.

(5) In the defibrillation catheter of the present invention, it is preferable that the shape of the distal end region of the tube member is changed by the operation of the handle.
According to the defibrillation catheter having such a configuration, the distal end can be more easily guided to the target site (for example, the coronary sinus ostium).

(6) The defibrillation catheter of the present invention is preferably placed in the heart chamber so that the first DC electrode group is located in the coronary sinus and the second DC electrode group is located in the right atrium.

(7) The above defibrillation catheter is preferably placed in the heart chamber in order to remove atrial fibrillation that occurs during cardiac catheterization.

According to the defibrillation catheter of the present invention, the mounting portion of the first DC electrode group is inserted into a blood vessel such as a coronary sinus, the first DC electrode group is positioned at a predetermined site in the blood vessel, and the first The second DC electrode group can be placed in a position in front of the blood vessel (opening) without inserting the mounting portion of the 2DC electrode group into the blood vessel.
Further, according to the defibrillation catheter of the present invention, the first DC electrode group is located at the site in the coronary sinus on the lower side (rear side) of the heart, and the second DC electrode group is located along the inner wall of the right atrium. Can be placed in the heart chamber.

It is explanatory drawing which shows one Embodiment of the defibrillation catheter of this invention, (1) is a front view, (2) is a top view [AA arrow line view of (1)]. It is explanatory drawing which shows the front-end | tip area | region of the defibrillation catheter shown in FIG. 1, (1) is a front view, (2) is a top view [BB arrow view of (1)]. It is a cross-sectional view which shows CC cross section of FIG. 1 (1). FIG. 2 is a plan view showing a state where the shape of the distal end region of the tube member is changed by a handle operation in the defibrillation catheter shown in FIG. 1. It is a schematic diagram which shows the state which inserted the defibrillation catheter shown in FIG. 1 in the heart chamber. FIG. 6 is a schematic view showing a state where the defibrillation catheter is further pushed into the right atrium from the state shown in FIG. 5. It is an electric potential waveform diagram measured when predetermined | prescribed electric energy is provided with the defibrillation catheter shown in FIG. It is explanatory drawing (plan view) which shows other embodiment of the defibrillation catheter of this invention.

Hereinafter, an embodiment of the present invention will be described.
The defibrillation catheter 100 of the present embodiment is a catheter that is placed in the heart chamber in order to remove atrial fibrillation that occurs during cardiac catheterization.

  The defibrillation catheter 100 of the present embodiment shown in FIGS. 1 to 3 includes a multi-lumen tube 10, a handle 20 connected to the proximal end thereof, and eight rings attached to the distal end region of the multi-lumen tube 10. The first DC electrode group 31G composed of the electrode electrodes 31 and the second DC electrode group 32G composed of the eight ring electrodes 32 mounted on the distal end region of the multi-lumen tube 10 spaced from the first DC electrode group 31G toward the proximal end side. And four ring electrodes 33 for potential measurement mounted on the tip region of the multi-lumen tube 10 apart from the second DC electrode group 32G and the tip mounted on the tip of the multi-lumen tube 10 A chip 35, and by applying voltages of different polarities to the first DC electrode group 31G and the second DC electrode group 32G in the heart chamber A catheter that performs fibrillation; the multi-lumen tube 10 includes a first arcuate curved portion 101 positioned on the distal end side of the mounting portion 105 of the second DC electrode group, and a distal end side of the first arcuate curved portion 101. A second arcuate curve portion 102 that is positioned and bends in the opposite direction to the first arcuate curve portion 101; and a distal end side of the second arcuate curve portion 102 and a proximal end side of the mounting portion 106 of the first DC electrode group The first DC electrode group 31G is a catheter formed with a third arcuate curved portion 103 that is located in the direction opposite to the second arcuate curved portion 102 (the same direction as the first arcuate curved portion 101). Is located in the coronary sinus and the second DC electrode group 32G is placed in the heart chamber so as to be located in the right atrium.

The multi-lumen tube 10 (insulating tube member having a multi-lumen structure) constituting the defibrillation catheter 100 includes a straight part including the mounting part 105 of the second DC electrode group G, a first arcuate curved part 101, The second arcuate curved portion 102, the third arcuate curved portion 103, and the mounting portion 106 of the first DC electrode group are connected.
In FIG. 1, a part of the multi-lumen tube 10 (straight portion) in the length direction is omitted and is shown in a short form.

  As shown in FIGS. 1 and 2, in the defibrillation catheter 100 of the present embodiment, the straight portion of the multi-lumen tube 10 (the mounting portion 105 of the second DC electrode group), the first arcuate curved portion 101, the second The arcuate curved portion 102, the third arcuate curved portion 103, and the first DC electrode group mounting portion 106 are formed on substantially the same plane.

  The straight portion of the multi-lumen tube 10 is a straight portion that includes the mounting portion 105 of the second DC electrode group and the mounting portion of the ring-shaped electrode 33 and reaches the base end of the multi-lumen tube 10. The length of the straight line portion is normally 500 to 1100 mm, and is 570 mm if a suitable example is shown.

The first arcuate curved portion 101 of the multi-lumen tube 10 is connected to the tip of the straight portion including the mounting portion 105 of the second DC electrode group, and in the plan view shown in FIG. It extends to.
The radius of curvature of the first arcuate curved portion 101 is preferably 10 to 50 mm, and 20 mm if a suitable example is shown.
The central angle (θ ₁ ) of the first arcuate curved portion 101 is preferably 30 to 90 °, and 55 ° if a suitable example is shown.

The second arcuate curved portion 102 of the multi-lumen tube 10 is connected to the tip of the first arcuate curved portion 101, and is in a direction opposite to the first arcuate curved portion 101 (left in the plan view shown in FIG. 2 (2)). Direction) and extending in the tip direction to form a detour shape.
Here, the “detour shape” refers to a curved shape that detours around an imaginary line that smoothly connects the mounting portion 105 of the second DC electrode group and the mounting portion 106 of the first DC electrode group.

The radius of curvature of the second arcuate curved portion 102 is preferably 10 to 50 mm, and 15 mm if a suitable example is shown.
The central angle (θ ₂ ) of the second arcuate curved portion 102 is preferably 60 to 120 °, and 90 ° if a suitable example is shown.
When the radius of curvature of the second arcuate curved portion 102 is excessively large (the curvature is excessively small) or when the central angle (θ ₂ ) is excessively small, a detour shape suitable as a stopper cannot be formed.

The third arcuate curved portion 103 of the multi-lumen tube 10 is connected to the tip of the second arcuate curved portion 102 and is in the opposite direction to the second arcuate curved portion 102 (right in plan view shown in FIG. 2 (2)). Direction) and extends in the tip direction.
The curvature radius of the third arcuate curved portion 103 is preferably 10 to 50 mm, and 15 mm if a suitable example is shown.
The central angle (θ ₃ ) of the second arcuate curved portion 103 is preferably 30 to 90 °, and 60 ° is a preferable example.

  In the defibrillation catheter 100 of the present embodiment, the tube length (first arc shape) between the first DC electrode group 31G (proximal electrode 31) and the second DC electrode group 32G (distal electrode 32). The distance between the first DC electrode group 31G and the second DC electrode group 32G when the curved portion 101, the second arc-shaped curved portion 102, and the third arc-shaped curved portion 103 are extended and straightened is 40 to 100 mm. It is preferably 50 to 90 mm.

The mounting portion 106 of the first DC electrode group of the multi-lumen tube 10 is connected to the tip of the third arcuate curved portion 103, and is in the same direction as the third arcuate curved portion 103 ( right in plan view shown in FIG. 2 (2)). Direction ) and extends in the direction of the tip.
Thereby, when the defibrillation catheter 100 is inserted into the right atrium from the superior vena cava, the distal end can be easily guided to the coronary sinus ostium in the posterior lower wall of the right atrium.
The mounting portion 106 of the first DC electrode group is formed by, for example, a single arc or a plurality of arcs having different curvatures. In this case, a relaxation curve or a short curve connecting adjacent arcs is used. It may contain a straight line.

  The shape of the multi-lumen tube 10 shown in FIGS. 1 and 2 is a shape when no external force is received. For example, when the multi-lumen tube 10 is passed through a straight lumen, the first circle When the arcuate curve portion 101, the second arcuate curve portion 102, the third arcuate curve portion 103, and the mounting portion 106 of the first DC electrode group are linearly deformed and the multi-lumen tube 10 is passed through a curved lumen. , And deforms according to the curved shape of the lumen.

As shown in FIG. 3, the multi-lumen tube 10 is formed with four lumens (first lumen 11, second lumen 12, third lumen 13, and fourth lumen 14).
In FIG. 3, 15 is a fluororesin layer that defines a lumen, 16 is an inner (core) portion made of a low-hardness nylon elastomer, 17 is an outer (shell) portion made of a high-hardness nylon elastomer, Is a stainless steel wire forming a braided blade.

  The fluororesin layer 15 partitioning the lumen is made of a highly insulating material such as perfluoroalkyl vinyl ether copolymer (PFA) or polytetrafluoroethylene (PTFE).

  The nylon elastomer that forms the outer portion 17 of the multi-lumen tube 10 has a hardness that varies depending on the axial direction. Thereby, the multi-lumen tube 10 is comprised so that hardness may become high in steps toward the base end side from the front end side.

  The braided blade composed of the stainless steel wire 18 is provided between the inner portion 16 and the outer portion 17 in a portion excluding the tip region. The outer diameter of the multi-lumen tube 10 is, for example, 1.2 to 3.3 mm.

The handle 20 constituting the defibrillation catheter 100 of the present embodiment includes a handle body 21, a knob 22, and a strain relief 24.
By rotating the knob 22, the shape of the distal end region of the catheter tube 10 can be changed.

A first DC electrode group 31G and a second DC electrode group 32G are attached to the tip region of the multi-lumen tube 10.
In the present invention, the “electrode group” refers to a plurality of electrodes constituting the same pole (having the same polarity) or having the same purpose and mounted at a narrow interval (for example, 5 mm or less). An aggregate.

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

  In the present embodiment, the first DC electrode group 31G is composed of eight ring-shaped electrodes 31 mounted on the multi-lumen tube 10 (the mounting portion 106 of the first DC electrode group). The electrode 31 constituting the first DC electrode group 31G is connected to a DC power supply via a lead wire (lead wire 41 constituting the first lead wire group 41G shown in FIG. 3) and a connector built in the proximal end portion of the handle 20. It is connected to the terminal of the same pole in the device.

Here, the width of the electrode 31 (length W1 in the axial direction) is preferably 2 to 5 mm, and 4 mm if a suitable example is shown.
If the width of the electrode 31 is too narrow, the amount of heat generated when a voltage is applied may be excessive, which may damage surrounding tissues. On the other hand, if the width of the electrode 31 is too wide, the flexibility / softness of the portion of the multi-lumen tube 10 where the first DC electrode group 31G is mounted may be impaired.

  The mounting interval of the electrodes 31 (the distance between adjacent electrodes) is preferably 1 to 5 mm, and 2 mm if a suitable example is shown.

  The 2nd DC electrode group in the present invention constitutes a pole (+ pole or-pole) opposite to the 1st DC electrode group in the tip region separated from the attachment position of the 1st DC electrode group of the multi-lumen tube to the base end side. A plurality of electrodes are mounted at narrow intervals. Here, the number of electrodes constituting the second DC electrode group varies depending on the width and arrangement interval of the electrodes, but is 4 to 13, for example, and preferably 8 to 10.

In the present embodiment, the second DC electrode group 32G has eight rings mounted on the multi-lumen tube 10 (the mounting portion 105 of the second DC electrode group) spaced from the mounting position of the first DC electrode group 31G toward the base end side. It consists of the electrode 32.
The electrode 32 constituting the second DC electrode group 32G is connected to a DC power source via a lead wire (lead wire 42 constituting the second lead wire group 42G shown in FIG. 3) and a connector built in the proximal end portion of the handle 20. It is connected to a terminal of the same pole in the device (a terminal of a pole opposite to that to which the first DC electrode group 31G is connected).
Thereby, 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: The electrode groups have different polarities (when one electrode group is a negative electrode, the other electrode group is a positive electrode).

Here, the width of the electrode 32 (length W2 in the axial direction) is preferably 2 to 5 mm, and 4 mm if a suitable example is shown.
If the width of the electrode 32 is too narrow, the amount of heat generated at the time of voltage application 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 multi-lumen tube 10 where the second DC electrode group 32G is mounted may be impaired.

  The mounting interval of the electrodes 32 (the distance between adjacent electrodes) is preferably 1 to 5 mm, and 2 mm if a suitable example is shown.

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

In the present embodiment, four ring-shaped electrodes 33 for potential measurement are mounted in a distal end region (straight line portion) spaced from the mounting position of the second DC electrode group of the multi-lumen tube toward the proximal end side.
The electrode 33 is connected to the electrocardiograph via a lead wire (lead wire 43 shown in FIG. 3) and a connector built in the proximal end portion of the handle 20.

Here, the width of the electrode 33 (length W3 in the axial direction) is preferably 0.5 to 2.0 mm, and 1.2 mm if a suitable example is shown.
If the width of the electrode 33 is too wide, the measurement accuracy of the cardiac potential is lowered, or it is difficult to specify the site where the abnormal potential is generated.

A distal tip 35 is attached to the distal end of the intracardiac defibrillation catheter 100.
A lead wire is not connected to the tip chip 35 and is not used as an electrode in this 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 metal materials such as platinum and stainless steel, various resin materials, and the like.

  As the electrode 31 constituting the first DC electrode group 31G, the electrode 32 constituting the second DC electrode group 32G, and the electrode 33 for potential measurement, in order to improve the contrast property for X-rays, It is preferably made of an alloy.

The first lead wire group 41G shown in FIG. 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 portion, and enters the first lumen 11 from a side hole formed in the tube wall of the multi-lumen tube 10. The eight lead wires 41 that have entered the first lumen 11 extend to the first lumen 11 as a first lead wire group 41G.

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.
Each of the eight electrodes 32 constituting the second DC electrode group 32G can be electrically connected to the DC power supply device by the second lead wire group 42G (lead wire 42).

  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 portion thereof, and the second lumen 12 (the first lead wire group 41G extends from the side hole formed in the tube wall of the multi-lumen tube 10. A different lumen from the existing first lumen 11 is entered. The eight lead wires 42 that have entered the second lumen 12 extend to the second lumen 12 as a second lead wire group 42G.

  As described above, the first lead wire group 41G extends to the first lumen 11 and the second lead wire group 42G extends to the second lumen 12. Fully insulated and isolated. Therefore, when a voltage necessary for defibrillation is applied, a short circuit between the first lead wire group 41G (first DC electrode group 31G) and the second lead wire group 42G (second DC electrode group 32G). Can be reliably prevented.

  The four lead wires 43 shown in FIG. 3 are connected to each of the electrodes 33 for potential measurement. Each of the electrodes 33 can be connected to an electrocardiograph by a lead wire 43.

  The four electrodes 33 used for the potential measurement are connected to different lead wires 43, respectively. Each of the lead wires 43 is welded to the inner peripheral surface of the electrode 33 at the tip portion thereof, and enters the third lumen 13 from the side hole formed in the tube wall of the multi-lumen tube 10, and enters the third lumen 13. Extend.

  As described above, the lead wire 43 extending to the third lumen 13 is completely insulated and isolated from both the first lead wire group 41G and the second lead wire group 42G. For this reason, when a voltage necessary for defibrillation is applied, the lead wire 43 (potential measurement electrode 33) and the first lead wire group 41G (first DC electrode group 31G) or the second lead wire group 42G. A short circuit with (second DC electrode group 32G) can be reliably prevented.

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

In FIG. 3, 51 is a pull wire.
The pull wire 51 extends to the fourth lumen 14 and extends eccentrically with respect to the central axis of the multi-lumen tube 10.

The distal end portion of the pull wire 51 is fixed to, for example, the distal tip 35 with solder.
On the other hand, the proximal end portion of the pull wire 51 is connected to the knob 22 of the handle 20, and the pull wire 51 is pulled by operating the knob 22. Thereby, the shape of the tip region of the multi-lumen tube 10 can be changed.
Specifically, when the knob 22 of the handle 20 is rotated clockwise from the state shown in FIG. 1B, the curvature of the mounting portion 106 of the first DC electrode group increases (curvature) as shown in FIG. The radius changes. After the change shown in FIG. 4, the first arcuate curved portion 101, the second arcuate curved portion 102, and the third arcuate curved portion 103 change to some extent, but the second arcuate curved portion The detour shape by 102 is maintained.
Thus, by changing the shape of the distal end region, the distal end of the defibrillation catheter 100 can be more easily guided to the coronary sinus ostium.

The pull wire 51 is made of stainless steel or a Ni—Ti superelastic alloy, but is not necessarily made of metal. The pull wire 51 may be composed of, for example, a high-strength non-conductive wire.
Note that the mechanism for deflecting the distal end portion of the multi-lumen tube is not limited to this, and may be a plate spring, for example.

  In the fourth lumen 14 of the multi-lumen tube 10, only the pull wire 51 extends, and the lead wire (group) does not extend. Thereby, it is possible to prevent the lead wire from being damaged (for example, scratched) by the pull wire 51 moving in the axial direction during the deflection operation of the distal end portion of the multi-lumen tube 10.

  In the defibrillation catheter 100 of the present embodiment, the first lead wire group 41G (lead wire 41), the second lead wire group 42G (lead wire 42), and the lead wire 43 are insulated even inside the handle 20. It is preferable that it is isolated.

  The defibrillation catheter 100 of the present embodiment directly applies electrical energy to the heart that is causing fibrillation by applying a DC voltage between the first DC electrode group 31G and the second DC electrode group 32G. It is a catheter for performing defibrillation treatment.

  According to the defibrillation catheter 100 of the present embodiment, the first arcuate curved portion 101 and the second arcuate shape formed between the mounting portion 106 of the first DC electrode group and the mounting portion 105 of the second DC electrode group. By the curved portion 102 and the third arcuate curved portion 103, the second arcuate curved portion 102 can be formed in a detour shape.

  Then, as the detour shape by the second arcuate curved portion 102 acts as a stopper, as shown in FIG. 5, the coronary sinus (from the opening (coronary sinus ostium 84) into which the mounting portion 106 of the first DC electrode group is inserted (see FIG. 5). CS) 83 can prevent the mounting portion 105 of the second DC electrode group from being inserted.

  Thus, after the first DC electrode group 31G reaches the intrasinus site of the coronary sinus 83 on the lower side (rear side) of the heart (a suitable indwelling site of the first DC electrode group), the defibrillation catheter 100 is Even if the catheter is further pushed into the right atrium (RA) 82, the distal end of the defibrillation catheter 100 does not advance in the coronary sinus 83, and the first DC electrode group 31G moves from a suitable intrasinusal site. Absent.

Furthermore, when the defibrillation catheter 100 is pushed in the direction of the arrow p shown in FIG. 5 while the insertion of the mounting portion 105 of the second DC electrode group into the coronary sinus is blocked, as shown in FIG. The mounting part 105 (straight line part) of the second DC electrode group bends in the direction of the inner wall (right inner wall) 85 of the right atrium 82. As a result, the second DC electrode group 32G is made to run along the inner wall 85 of the right atrium 82 ( Can be brought into contact with the myocardium).
In FIGS. 5 and 6 schematically showing how the defibrillation catheter 100 is used in the heart chamber, the mounting portion 106 of the first DC electrode group and the mounting portion 105 of the second DC electrode group are the same. Although illustrated in a plane, they are located on different planes.

As a result, in the defibrillation catheter 100 of the present embodiment, the first DC electrode group 31G is located in the intrasinus site of the coronary sinus 83 on the lower side (rear side) of the heart, and the second DC electrode group 32G is It can be placed in the heart chamber so as to be positioned in the right atrium 82 along the inner wall 85.
As a result, the heart is sandwiched between the first DC electrode group 31G and the second DC electrode group 32G.

  The defibrillation catheter 100 of the present embodiment is suitably used when performing cardiac catheterization in which atrial fibrillation is likely to occur. Particularly preferably, the cardiac catheterization is performed after the intracardiac defibrillation catheter 100 is inserted into the heart chamber of the patient in advance.

  During cardiac catheterization, the electrocardiogram measured by the constituent electrodes of the first DC electrode group 31G and / or the second DC electrode group 32G or the electrode 33 for potential measurement is monitored (monitoring), and when atrial fibrillation occurs The cardiac catheterization is interrupted, and the defibrillation treatment using the defibrillation catheter 100 is performed. Specifically, a DC voltage is applied between the first DC electrode group 31G and the second DC electrode group 32G via the first lead wire group 41G and the second lead wire group 42G to cause fibrillation. Give electrical energy directly to the heart.

Here, the electrical energy supplied to the heart by the intracardiac defibrillation catheter 100 is preferably 10 to 30 J.
If the electrical energy is too low, sufficient defibrillation therapy cannot be performed. On the other hand, when the electrical energy is excessive, there is a risk that the surrounding tissue where the first DC electrode group 31G and the second DC electrode group 32G are located is damaged.

FIG. 7 is a diagram showing a potential waveform measured when predetermined electrical energy (for example, set output = 10 J) is applied by the intracardiac defibrillation catheter 100 of the present embodiment. In the figure, the horizontal axis represents time and the vertical axis represents potential.
First, a DC voltage is applied between the first DC electrode group 31G and the second DC electrode group 32G so that the first and second DC electrode groups 31G and 32G have a positive pole, whereby electric energy is supplied and the measurement potential rises (V ₁ is This is the peak voltage at this time.) After a certain time (t ₁ ) elapses, a DC voltage obtained by inverting ± is applied between the two so that the first DC electrode group 31G becomes a positive electrode and the second DC electrode group 32G becomes a negative electrode. When supplied, the measurement potential rises (V ₂ is the peak voltage at this time).
Here, the time (t ₁ ) is, for example, 1.5 to 10.0 seconds, and the measured peak voltage (V ₁ ) is, for example, 300 to 500V.

As mentioned above, although one Embodiment of this invention was described, the intracardiac defibrillation catheter of this invention is not limited to these, A various change is possible.
For example, between the first arc-shaped curved portion and the second arc-shaped curved portion, between the second arc-shaped curved portion and the third arc-shaped curved portion, the third arc-shaped curved portion and the mounting portion of the first DC electrode group In addition, a connecting curve portion (relaxation curve) may be formed between the first arc-shaped curve portion, the second arc-shaped curve portion, the second curve-shaped curve portion, as shown in FIGS. The curvature radius and the size of the central angle in the three arcuate curved portions can be changed as appropriate.

DESCRIPTION OF SYMBOLS 100 Intracardiac defibrillation catheter 10 Multi-lumen tube 101 1st circular arc-shaped curve part 102 2nd circular arc-shaped curve part 103 3rd circular arc-shaped curve part 105 Attachment part 106 of 2nd DC electrode group Attachment part 11 of 1st DC electrode group First lumen 12 Second lumen 13 Third lumen 14 Fourth lumen 15 Fluororesin layer 16 Inner (core) portion 17 Outer (shell) portion 18 Stainless steel wire 20 Handle 21 Handle body 22 Knob 24 Strain relief 31G First DC electrode group 31 Ring electrode 32G Second DC electrode group 32 Ring electrode 33 Ring electrode 35 Tip chip 41G First lead wire group 41 Lead wire 42G Second lead wire group 42 Lead wire 43 Lead wire 51 Pull wire

Claims (7)

An insulating tube member, a handle connected to the proximal end of the tube member, a first electrode group comprising a plurality of ring-shaped electrodes attached to a distal end region of the tube member, and a base from the first electrode group And a second electrode group composed of a plurality of ring-shaped electrodes mounted on the distal end region of the tube member and spaced apart on the end side, the first electrode group and the second electrode group having different polarities A catheter that performs defibrillation in the heart chamber by applying a voltage,
The tube member is formed with at least two arcuate curved portions that are alternately bent in opposite directions between the mounting portion of the first electrode group and the mounting portion of the second electrode group. An intracardiac defibrillation catheter.   The tube member includes a first arcuate curved portion located on a distal end side of the mounting portion of the second electrode group, a distal end side of the first arcuate curved portion, and the first arcuate curved portion, Is a second arcuate curved portion that is bent in the opposite direction, and is located on the distal end side of the mounting portion of the first electrode group on the distal end side of the second arcuate curved portion, 2. The intracardiac defibrillation catheter according to claim 1, wherein a third arcuate curved portion that is bent in the opposite direction is formed. 3. The tube length between the first electrode group and the second electrode group is 40 to 100 mm,
The radius of curvature of the first arcuate curved portion is 10 to 50 mm, its central angle is 30 to 90 °,
The radius of curvature of the second arcuate curved portion is 10 to 50 mm, its central angle is 60 to 120 °,
3. The intracardiac defibrillation catheter according to claim 2, wherein the third arcuate curved portion has a radius of curvature of 10 to 50 mm and a central angle of 30 to 90 °.   The intracardiac defibrillation catheter according to claim 3, wherein a mounting portion of the first electrode group of the tube member is bent in the same direction as the third arcuate curved portion.   The intracardiac defibrillation catheter according to any one of claims 1 to 4, wherein a shape of a distal end region of the tube member is changed by operation of the handle.   6. The device according to claim 1, wherein the first electrode group is placed in a coronary sinus and the second electrode group is placed in a heart chamber so as to be located in the right atrium. The described intracardiac defibrillation catheter.   The intracardiac defibrillation catheter according to claim 6, wherein the catheter is placed in the heart chamber to remove atrial fibrillation that occurs during cardiac catheterization.

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