JP2024079244A - Defibrillation Systems - Google Patents

Abstract

To easily and reliably perform intracardiac defibrillation regardless of the size and shape of a patient's heart.SOLUTION: A defibrillation system has: an RA electrode catheter having an RA electrode detained in the right atrium; a CS electrode catheter having a CS electrode detained in the coronary sinus; and a defibrillator which applies voltage different in potential for intracardiac defibrillation to each of the RA electrode catheter and the CS electrode catheter.SELECTED DRAWING: Figure 2

Description

The present invention relates to a defibrillation system.

During atrial fibrillation ablation treatment, atrial fibrillation, atrial flutter, or atrial tachycardia may occur when atrial fibrillation is induced to identify the site of the cause, or as a spontaneous attack during surgery.

Intracardiac defibrillation is used when atrial fibrillation that occurs during surgery must be stopped by electrical defibrillation by applying electrical energy to an electrode catheter that has been placed in the cardiac chamber beforehand, thereby eliminating the fibrillation. Intracardiac defibrillation has the advantage that less electrical energy is given to the patient than external defibrillation (for example, external defibrillation is about 150-200 J, while intracardiac defibrillation is 30 J or less), which reduces the burden on the patient.

Intracardiac defibrillation is performed using one RA-CS catheter, as shown in the intracardiac defibrillation catheter system of Patent Document 1. The RA-CS catheter has two electrode groups that are placed in the coronary sinus and the right atrium, respectively, with a predetermined distance between them.
The RA-CS catheter 1 is often inserted into the heart from the upper side via the superior vena cava, but can also be inserted into the heart from the lower side via the inferior vena cava as shown in Fig. 1. Whether it is inserted into the heart from the upper or lower side, the RA-CS catheter 1 inserted into the heart 4, as shown in Fig. 1, places the RA electrode 2 and the CS electrode 3 in the right atrium 4a and the coronary sinus 4b of the heart 4, respectively, and applies electrical energy to these electrodes 2 and 3 to perform defibrillation.

JP 2010-220778 A

In conventional intracardiac defibrillation, a single RA-CS catheter 1 is operated to place the electrodes 2 and 3 provided on that single RA-CS catheter 1. For this reason, depending on the size of the patient's heart 4, such as when the heart 4 is too small or too large compared to the standard size, or the shape (including the angle) of the heart 4, it may be difficult to manipulate the electrode catheter 1 to place it in the optimal location of the right atrium 4a and coronary sinus 4b. In this case, it is difficult to respond to cases where atrial fibrillation cannot be stopped even when electricity is applied to each group of electrodes 2 and 3, or when potential acquisition or pacing, etc., is performed in addition to defibrillation.

In particular, when inserting the catheter 1 into the heart cavity from the inferior vena cava as shown in Figure 1, the catheter 1 must be looped around the right atrium 4a to form a ring shape, and the tip of the catheter 1 must then be advanced into the coronary sinus 4b, making it difficult to even place the electrodes 2 and 3. Therefore, when inserting the RA-CS catheter 1 into the relatively large heart 4 from the inferior vena cava and placing the electrodes 2 and 3 in the right atrium 4a and coronary sinus 4b, it is even more difficult to place them in the optimal locations.

The present invention has been made in consideration of these points, and aims to provide a defibrillation system that can easily and reliably perform intracardiac defibrillation regardless of the size or shape of the patient's heart.

One aspect of the defibrillation system according to the present invention comprises:
a first electrode catheter and a second electrode catheter;
and a defibrillator that applies voltages of different potentials independently to each of the first electrode catheter and the second electrode catheter.

The present invention makes it possible to easily and reliably perform intracardiac defibrillation regardless of the size or shape of the patient's heart.

FIG. 1 is a diagram showing a state in which a catheter electrode is placed in a cardiac chamber when performing conventional intracardiac defibrillation. 1 is a schematic diagram showing a configuration of a main part of a defibrillation system according to an embodiment of the present invention; FIG. 1 is a plan view showing an RA electrode catheter constituting a defibrillation system according to an embodiment of the present invention. FIG. 1 is a plan view showing a CS electrode catheter constituting a defibrillation system according to an embodiment of the present invention. 1 is a schematic diagram showing a state in which a catheter of a defibrillation system according to an embodiment of the present invention is placed in a patient's heart cavity via the inferior vena cava. FIG. FIG. 13 is a plan view showing a first modified example of an RA electrode catheter. FIG. 13 is a plan view showing a first modified example of the CS electrode catheter. 8 is a cross-sectional view taken along line AA in FIG. 7.

<Inventor's findings leading to the present invention>
When performing intracardiac defibrillation or the like, in order to obtain an intracardiac electrocardiogram, first, a catheter with multiple electrodes (electrode catheter) is inserted into the heart, and each electrode is placed together at a predetermined location within the heart.

The electrode catheters are the above-mentioned RA-CS catheters having RA and CS electrodes placed in the right atrium and coronary sinus, which are the measurement sites within the heart, a catheter having a His electrode placed on the atrioventricular node (also called the "His electrode catheter"), and a catheter having an RV electrode placed in the right ventricle (also called the "RV electrode catheter"). The RA-CS catheter is capable of measuring electrical potentials and defibrillation using the RA and CS electrodes, while the His and RV electrode catheters are capable of measuring electrical potentials using the His and RV electrodes. An intracardiac electrocardiogram is formed by acquiring electrical signals from the heart directly from the electrodes placed at the specified measurement sites and recording them simultaneously in real time.

When each electrode catheter is inserted into the heart, the His electrode catheter and the RV electrode catheter are inserted into the heart through the inferior vena cava, specifically, the groin, and the RA-CS catheter is inserted into the superior vena cava, specifically, subclavian or cervical.

When inserting an RA-CS catheter into the heart via the superior vena cava, it may also be inserted via the neck (the jugular vein of the superior vena cava), which poses a higher risk to life than inserting it via the inferior vena cava, so it is considered to insert an RA-CS catheter via the inferior vena cava.

As mentioned above, skilled technique is required to insert and manipulate the RA-CS catheter through the inferior vena cava and place each electrode so that it sandwiches the heart.

Depending on the size and shape of the heart, the distance between where the RA electrode is placed in the right atrium and where the CS electrode is placed in the coronary sinus will vary.

Therefore, whether the RA-CS catheter is inserted into the heart from either the upper or lower side, it is difficult to optimally place each RA electrode and CS electrode according to the size and shape of the heart by manipulating the RA-CS catheter alone.

In response to this, in addition to skilled operating techniques, it is possible to prepare multiple RA-CS catheters with different spacing between the RA and CS electrodes and change them according to the size and shape of the heart, but this would be time-consuming and costly.

The inventor therefore came up with a configuration in which, rather than using a single RA-CS catheter for defibrillation, electrodes can be easily placed in each of the RA and CS, allowing the electrical energy required for defibrillation to be supplied independently to each.

Conventionally, two electrode groups have been provided in one RA-CS catheter, so the RA-CS catheter itself is considered to have a multi-lumen structure in which the CS electrode group and the RA electrode group are insulated.

In other words, because each lumen in the RA-CS catheter is wired with lead wires or other insulation structures connected to electrodes with different potentials, such as for RA and CS, the increase in the lumen also increases the diameter of the catheter itself, and depending on the size of the heart, it can be difficult to place the RA and CS electrodes. In response to this, the inventors have discovered that defibrillation is performed using separate electrode catheters for the RA and CS, which allows the diameter of each catheter to be reduced.

The following describes in detail the embodiments of the present invention with reference to the drawings.

<1> System Configuration FIG. 2 is a schematic diagram showing the overall configuration of a defibrillation system 100 according to an embodiment.

The defibrillation system 100 is a system that performs intracardiac defibrillation using an RA electrode catheter (first electrode catheter, see Figure 3) 20 having an RA electrode group 24 placed in the right atrium, and a CS electrode catheter (second electrode catheter, see Figure 4) 30 having a CS electrode group 34 placed in the coronary sinus.

The defibrillation system 100 includes a defibrillator 12, a connection device 14, an RA electrode catheter 20, and a CS electrode catheter 30, and further includes a polygraph testing device 40 that functions as an electrocardiograph.

The defibrillator 12, polygraph testing device 40, RA electrode catheter 20, and CS electrode catheter 30 are connected by a connection device 14. Note that the polygraph testing device 40 in this specification may be read as an electrocardiograph or an electrocardiogram testing device.

In addition, in this embodiment, the connection device 14 is separate from the defibrillator 12, but the connection device 14 may be incorporated into the defibrillator 12 as an integral part. In addition, since the defibrillation system 100 of this embodiment can measure the potential at RA and CS using the RA electrode catheter 20 and the CS electrode catheter 30, it may also have the function of an electrocardiogram test device via four electrode catheters by connecting catheters for His and RV electrocardiogram tests. In addition, the defibrillation system 100 may be configured to be able to connect an external paddle as a device for performing external defibrillation.

The defibrillator 12 generates electrical energy for intracardiac defibrillation using the RA electrode catheter 20 and the CS electrode catheter 30, specifically, voltages that are applied independently so that the potential difference is different or the polarity is different.

The defibrillator 12 can be connected to the RA electrode catheter 20 and the CS electrode catheter 30 via the switching unit 16 of the connection device 14. By being connected to the RA electrode catheter 20 and the CS electrode catheter 30, the defibrillator 12 applies the generated electrical energy (voltages with different potential differences) to each of the RA electrode catheter 20 and the CS electrode catheter 30. For example, voltages with different polarities are applied to the RA electrode catheter 20 and the CS electrode catheter 30.

Although not shown, the defibrillator 12 includes a battery, a boost circuit, an arithmetic circuit, a control circuit, an LCD (Liquid Crystal Display), an AC/DC power supply unit that inputs AC power and converts it to DC power, an input/output terminal unit, etc. The defibrillator 12 obtains an electrocardiogram based on the intracardiac potential obtained from the defibrillation electrodes of the RA electrode group 24 and the defibrillation electrodes of the CS electrode group 34, for example, and applies voltages with different potentials for intracardiac defibrillation to the defibrillation electrodes of the CS electrode group 34 and the defibrillation electrodes of the RA electrode group 24.

<2> Configuration of the electrode catheter Fig. 3 is a diagram showing the basic configuration of the RA electrode catheter 20 of this embodiment. Fig. 4 is a plan view showing the CS electrode catheter constituting the defibrillation system according to an embodiment of the present invention. Note that the basic configurations of the RA electrode catheter 20 and the CS electrode catheter 30 shown in Figs. 3 and 4 are the same, but the configurations of the electrode groups provided in each may be different.

<RA electrode catheter 20>
The RA electrode catheter 20 shown in Fig. 3 has a catheter shaft 22, a handle 23, an RA electrode group 24, and a connector 26. Note that the RA electrode catheter 20 shown in Fig. 3 is configured so that the tip of the catheter shaft 22 is bent in the extension direction by operating the handle 23, but it does not have to have a bending function.

The catheter shaft 22 is configured to be able to pass through a blood vessel and be inserted into the cardiac cavity, and the RA electrode group 24 is provided at the tip so as to be exposed and contact the inner wall of the heart.

The catheter shaft 22 is generally designed so that its hardness decreases toward the tip, and is adapted to withstand the forces acting on the proximal side when the catheter is pushed into a blood vessel or cardiac cavity, but there may be some parts where the hardness is greater toward the tip than toward the proximal side.

The RA electrode group 24 is formed in a predetermined section near the tip of the catheter shaft 22 of the RA electrode catheter 20, and is placed in the upper part of the right atrium (i.e., RA) when the RA electrode catheter 20 is placed in the cardiac cavity.

The longitudinal length of the RA electrode group 24 is determined according to the size of the patient's heart. The RA electrode group 24 has multiple electrodes R1 (also called "dual-purpose electrodes") that are used for both potential measurement and defibrillation. These multiple electrodes R1 are arranged at predetermined positions on the catheter shaft 22, aligned at predetermined intervals along the extension direction.

It is preferable that the electrodes R1 are arranged at equal intervals. For example, each electrode R1 may be ring-shaped and have a width of about 1 mm to 2 mm. For example, each electrode R1 may be arranged with a width of 1 mm and a width between each electrode R1 of 1 mm (for example, 16 electrodes arranged at equal intervals in FIG. 3). Alternatively, each electrode R1 may be arranged with a width of about 2 mm and a width between each electrode R1 of 1 mm (for example, 8 electrodes with a width of 2 mm). In this way, the width of electrode R1 and the width between electrodes R1 and R2 may be set in any way as long as it is applicable to both potential measurement and defibrillation.

In this embodiment, when the electrode R1 is used for measuring electric potential, a pair of electrode sets R2 appropriately selected in the longitudinal direction is configured as a basic unit. The electrode set R2 in FIG. 3 is configured with adjacent electrodes R1, but this is configured for convenience, and the electrode set R2 may be configured with electrodes R1 spaced apart by one or two or more.

For example, when measuring potentials, if the pair of electrodes R1, R1 in electrode set R2 are used as adjacent electrodes R1, R1 to calculate the bipolar potential (i.e., differential voltage), a bipolar potential with a sharp waveform that reflects only the local potential can be obtained without being affected by the potential over a wide area. This allows for more accurate measurement of the intracardiac potential at each measurement point in the RA.

In addition, in this embodiment, when electrode R1 is used for defibrillation, electrical energy (voltage) is supplied to the RA electrode group 24 so that adjacent electrodes R1, R1 at a predetermined interval have the same potential. The electrical energy supplied to the RA electrode group 24 is a voltage with a different potential difference or polarity from the voltage supplied to the CS electrode group 34.

The material of the catheter shaft 22 and the internal wiring of the electrode R1 within the catheter shaft 22 can be determined by known configurations such as the wiring of the potential measurement electrode and the wiring of the defibrillation electrode, as described in, for example, Patent Document 1. Therefore, detailed explanations of these will be omitted.

The handle 23 has a catheter shaft 22 attached to its tip and a connector 26 at its rear end. The connector 26 is electrically connected to the RA electrode group 24, which electrically connects the RA electrode group 24 to an electrocardiogram examination device such as a polygraph device or an electrocardiograph or a defibrillator to which the connector 26 is connected.

In this way, the RA electrode catheter 20 can be appropriately selected via the connector 26 to which external device (e.g., a polygraph testing device or a defibrillator) the RA electrode catheter 20 will be connected.

In the configuration shown in FIG. 3 above, the RA electrode group 24 includes 16 electrodes R1, but the electrode catheter of the present invention may also have further electrodes for measuring electrical potential.

<CS electrode catheter 30>
The CS electrode catheter 30 shown in FIG. 4 has a catheter shaft 32, a handle 33, a group of CS electrodes 34, and a connector 36.

The catheter shaft 32 is configured to be able to pass through a blood vessel and be inserted into the cardiac cavity, and a group of CS electrodes 34 is provided at the tip so as to be exposed and contact the inner wall of the heart.

The catheter shaft 32 is, for example, a bidirectional catheter shaft, and is configured so that the tip bends in both directions in the extension direction by operating the handle 33 connected to the proximal side (base end side). Note that the configuration of the bidirectional catheter shaft 32 may be the same as a known configuration.

The catheter shaft 32 is generally designed to have a smaller hardness toward the tip, so as to withstand the forces acting on the proximal side when the catheter is pushed into a blood vessel or cardiac cavity, but there may be some parts where the hardness is greater toward the tip than toward the proximal side.

The CS electrode group 34 is formed in a predetermined section near the tip of the catheter shaft 32 of the CS electrode catheter 30, and is placed in the coronary sinus (i.e., CS) when the CS electrode catheter 30 is placed in the cardiac cavity.

The longitudinal length of the CS electrode group 34 is determined according to the size of the patient's heart. The CS electrode group 34 has multiple electrodes C1 that are used for both potential measurement and defibrillation. These multiple electrodes C1 are arranged at predetermined positions in the extension direction of the catheter shaft 32, lined up at predetermined intervals along the extension direction.

Each electrode C1 may be arranged at equal intervals, for example, and each electrode C1 may be ring-shaped with a width of about 1 mm to 2 mm. For example, each electrode C1 may be arranged with a width of 1 mm and a width between each electrode C1 of 1 mm (for example, 16 electrodes are arranged at equal intervals in FIG. 4). Also, each electrode C1 may be arranged with a width of about 2 mm and a width between each electrode C1 of 1 mm (for example, 8 electrodes C1 with a width of 2 mm).

In this way, as long as each electrode C1 is applicable to both potential measurement and defibrillation, the width of the electrode C1 and the width between the electrodes C1 and C1 may be set in any way. For example, multiple electrodes C1 with an electrode width of 2 mm may be arranged so that the width of the electrodes C1 differs on the left and right sides of each electrode C1. In this case, it is preferable that the width of the adjacent electrodes on the left and right sides of each electrode C1 be the same. For example, multiple electrodes C1 are arranged in the catheter shaft 20 so that the width between adjacent electrodes on the tip side of each electrode C1 is 2 mm, and the width between adjacent electrodes on the proximal side is 5 mm. This arrangement is the same as a configuration in which electrodes C1 with a width of 2 mm are arranged 2 mm apart in one direction, with a gap of 5 mm between them.

In this embodiment, when the electrode C1 is used for measuring electric potential, a pair of electrode sets C2 appropriately selected in the longitudinal direction is configured as a basic unit. The electrode set C2 in FIG. 4 is configured with adjacent electrodes C1, but this is configured for convenience, and the electrode set C2 may also be configured with electrodes R1 skipped by one.

For example, when measuring potentials, if the pair of electrodes C1, C1 in electrode set C2 are treated as adjacent electrodes C1, C1 to calculate the bipolar potential (i.e., differential voltage), a bipolar potential with a sharp waveform that reflects only the local potential can be obtained without being affected by the wide-area potential. This allows for more accurate measurement of the intracardiac potential at each measurement point in the CS.

In addition, in this embodiment, when electrode C1 is used for defibrillation, electrical energy is supplied to the CS electrode group 34 so that adjacent electrodes C1, C1 at a predetermined interval have the same potential.

The material of the catheter shaft 32 and the internal wiring of the electrode C1 within the catheter shaft 32 can be determined by known configurations such as the wiring of the potential measurement electrode and the wiring of the defibrillation electrode, as described in, for example, Patent Document 1. Therefore, detailed explanations of these will be omitted.

The handle 33 has a catheter shaft 32 attached to its tip, and a connector 36 attached to its rear end electrically connects the CS electrode group 34 to a polygraph device, an electrocardiogram device such as an electrocardiograph, or a defibrillator to which the connector 36 is connected.

In this way, the CS electrode catheter 30 can be appropriately selected via the connector 36 to which external device (e.g., a polygraph testing device 40 or a defibrillator 12) the CS electrode catheter 30 will be connected.

In the configuration shown in FIG. 1 above, the CS electrode group 34 includes 16 electrodes C1, but the electrode catheter of the present invention may also have additional electrodes for measuring electrical potential.

Figure 5 is a schematic diagram showing the catheter of a defibrillation system according to an embodiment of the present invention placed in a patient's heart cavity via the inferior aorta.

When performing intracardiac defibrillation using the defibrillation system 100, the RA electrode catheter 20 and the CS electrode catheter 30 are inserted into the cardiac cavity through the inferior vena cava.

Then, the RA electrode catheter 20 is inserted into the right atrium 41, and the RA electrode group 24 is placed at a predetermined position on the inner wall surface of the right atrium 41.

Meanwhile, the CS electrode catheter 30 is inserted into the coronary sinus 42, and the CS electrode group 34 is placed in the coronary sinus 42.

When the defibrillator 12 is connected to the RA electrode catheter 20 and the CS electrode catheter 30 via the connection device 14 by the switching unit 16, the defibrillator 12 supplies the generated electrical energy to the RA electrode catheter 20 and the CS electrode catheter 30 in synchronization.

This allows the RA electrode catheter 20 and the CS electrode catheter 30 to be energized synchronously, allowing defibrillation to be performed optimally.

Also, before and after defibrillation, the defibrillation system 100 can be connected to a polygraph examination device 40, which can measure the potentials of the RA electrode group 24 of the RA electrode catheter 20 and the CS electrode group 34 of the CS electrode catheter 30. The defibrillation system 100 also has catheters for HiS and RV electrocardiogram examinations, and places the HiS electrode group and RV electrode group in the HiS and RV, respectively. This allows the defibrillation system 100 to connect the catheters for HiS and RV electrocardiogram examinations to the polygraph examination device 40, along with the RA electrode catheter 20 and the CS electrode catheter 30. The defibrillation system 100 can thus measure an intracardiac electrocardiogram by measuring the potentials at the His and RV as well as the RA and CS.

＜Effects＞
According to the defibrillation system 100, the RA electrode group 24 and the CS electrode group 34 are placed in the right atrium 41 and the coronary sinus 42, respectively, when performing intracardiac defibrillation, and are placed by two different electrode catheters, an RA electrode catheter 20 and a CS electrode catheter 30.

The defibrillation system 100 of this embodiment can easily and reliably perform intracardiac defibrillation regardless of the size or shape of the patient's heart.

In this way, the two different RA electrode catheters 20 and CS electrode catheters 30 supply voltages with different potentials (or polarities) to the right atrium 41 and the coronary sinus 42, respectively. Therefore, unlike a single catheter, there is no need to provide an insulator inside to reliably insulate the wiring of the RA electrode group 24 from the wiring of the CS electrode group 34. This makes it possible to reduce the occurrence of insulation breakdown within a single catheter in the past that has the RA electrode group 24 and the CS electrode group 34. Furthermore, in each of the RA electrode catheters 20 and CS electrode catheters 30, instead of an insulator, the wiring of the lead wires, i.e., the number of electrodes, can be increased without increasing the diameter, improving the accuracy of the measured potential.

Because the RA electrode catheter 20 and the CS electrode catheter 30 are separate, the RA electrode group 24 and the CS electrode group 34 can be placed in the right atrium 41 and the coronary sinus 42 using dedicated catheters, respectively. By inserting both the RA electrode catheter 20 and the CS electrode catheter 30 through the inferior vena cava, the RA electrode group 24 can be easily placed in the right atrium 41 and the CS electrode group 34 in the coronary sinus 42 at the appropriate positions, respectively.

Also, when obtaining an intracardiac electrocardiogram, unlike the conventional method, the RA electrode catheter 20 and the CS electrode catheter 30 can be inserted from the inferior vena cava without inserting a catheter into the cardiac cavity from the superior vena cava, and the RA electrode group 24 and the CS electrode group 34 can be placed in appropriate and suitable positions. This allows the RA electrode catheter 20 and the CS electrode catheter 30 to be inserted from the inferior vena cava together with the His electrode catheter and the RV electrode catheter, and each electrode to be placed in a predetermined position.

The RA electrode group 24 and the CS electrode group 34 are provided in different RA electrode catheters 20 and CS electrode catheters 30, respectively. Therefore, since there is no need to provide wiring with different polarities to each catheter, the space can be used to, for example, make a bidirectional type catheter or a catheter with a lumen.

As described above, according to the defibrillation system 100 of this embodiment, the RA electrode catheter 20 and the CS electrode catheter 30 can be inserted from the inferior vena cava, respectively, and the RA electrode group 24 and the CS electrode group 34 can be placed in the specified position without performing complicated operations. In other words, there is no need to surround the heart with electrode catheters, and intracardiac defibrillation can be performed easily and reliably regardless of the size and shape of the patient's heart. In addition, since the lead wires of each electrode can be arranged without having a high-level insulation mechanism in each of the RA electrode catheter 20 and the CS electrode catheter 30, more electrodes can be provided, that is, a more accurate potential can be measured with multiple electrodes, unlike the conventional method.

<Modification 1>
FIG. 6 is a plan view showing a first modified example of the RA electrode catheter.
An RA electrode catheter 20A shown in FIG. 6 is used in the defibrillation system 100 in place of the RA electrode catheter 20.

The RA electrode catheter 20A differs in structure from the RA electrode catheter 20 in that it does not have a handle.

The RA electrode catheter 20A has a catheter shaft 22A, a connector 28, and an RA electrode group 24A. The connector 26A is connected to the base end of the catheter shaft 22A and is connected to the electrode R1 of the electrode group 24A via a lead wire passing through the catheter shaft 22A.

The location where the RA electrode is placed can be moved linearly to the RA by inserting the RA electrode catheter 20 from the inferior vena cava, and even if there is no function to forcibly bend the tip, the RA electrode catheter 20 itself can be operated to easily place it in the desired position. Therefore, even if an RA electrode catheter 20A that does not have a handle 23 is used, the RA electrode R1 can be placed in the same way as when an RA electrode catheter 20 is used. In addition, it is a cheaper electrode catheter than when an RA electrode catheter 20 is used, and an intracardiac defibrillation system 100 with a simple and inexpensive configuration can be realized.

<Modification 2>
FIG. 7 is a plan view showing a first modified example of the CS electrode catheter, and FIG. 8 is a cross-sectional view taken along line AA in FIG.
The CS electrode catheter 30A shown in FIG. 7 has a hub 35, a catheter shaft 32, a balloon 50 serving as a movement restricting portion, and an electrode group 34A.

The CS electrode catheter 30A is used, for example, in place of the electrode catheter 30 in the defibrillation system 100. The catheter shaft 32 itself, including the tip portion 32a, is percutaneously inserted into the vein (femoral vein) at the base of the patient's leg, and the electrode group 34A is placed at a predetermined location.

The hub 35 is provided with a connector 38 to which a lead wire is connected, a guidewire port 37 through which a guidewire can be inserted, and a balloon expansion port 39 used to expand the balloon 50.
The guidewire port 37, the connector 38 and the balloon expansion port 39 are respectively connected to a guidewire lumen 370, a lead wire lumen 380 and a balloon expansion lumen 390 provided in the catheter shaft 32.

The catheter shaft 32 is flexible and can be bent freely in accordance with the shape of the site where it is placed, and has a tip hole 31 at the center of the tip. The catheter shaft 32 is a multi-lumen type, and includes a lead wire lumen 380, a guidewire lumen 370, and a balloon expansion lumen 390, each extending along the longitudinal direction of the catheter shaft 32.
In the distal end portion 32a of the catheter shaft 32, an electrode group 34A and a balloon 50 are disposed in this order toward the distal end.

The guidewire lumen 370 is formed in the central portion including the axis of the catheter shaft 32, and a guidewire (not shown) is inserted through it. The guidewire lumen 370 is formed to open to the outside at the tip hole 31, and the inserted wide wire can be led out from the tip hole 31. The catheter shaft 30A is guided and installed at a predetermined position using the guidewire led out from the tip hole 31. Around the guidewire lumen 370, a lead wire lumen 380 and a balloon expansion lumen 390 are arranged at equal intervals in the circumferential direction. The guidewire may be pulled out from the tip hole 31, the guidewire lumen 370, and the guidewire port 37, and used as a drug discharge path for introducing a drug through the guidewire port 37 and discharging it to the outside from the tip hole 31.

Lead wires are wired in the lead wire lumen 380, and the lead wires connect each of the electrodes R1 of the electrode group 34A to the connector 38 of the hub 35. The connector 38 is connected to an external device such as a polygraph test device 40 or a defibrillator 12. When connected to the defibrillator 12, the defibrillator 12 can supply power to the electrode R1 of the electrode group 34A, and when connected to the polygraph test device, the polygraph test device 40 can measure the potential from the electrode R1. Note that in the catheter shaft 32, the lead wires are connected to the electrode R1 through the lead wire lumen 380, but this is not limiting, and the lead wires may be embedded and integrated into the catheter shaft 32 itself.

The balloon expansion lumen 390 connects the balloon 50 to the balloon expansion port 39 of the hub 35, and guides a pressurized fluid such as saline from the balloon expansion port 39 into the balloon 50, allowing the balloon 50 to be freely expanded.

The electrode group 34A has the same basic configuration as the electrode group 34, and has multiple electrodes R1 arranged at a predetermined interval in the longitudinal direction on the surface of the tip portion 32a of the catheter shaft 32. The electrode group 34A may be arranged at any position on the catheter shaft 32. In addition, the number of electrodes R1 and the intervals between them may be set in any manner. Each of the multiple electrodes R1 is formed, for example, with the same width (the length in the extension direction of the catheter shaft 32), and a predetermined interval (which may be the same length as the electrode width) is provided between adjacent electrodes R1. In addition, the electrodes R1 are made of, for example, stainless steel, gold, platinum, or other metals. Electrical energy for defibrillation is supplied (voltage is applied) to the electrode group 34A.

The balloon 50 functions as an example of a movement restricting portion that contacts the inner wall of the body lumen, such as the CS, into which the catheter shaft 32 is inserted, and restricts the movement of the catheter shaft.

The balloon 50 can be expanded so that it protrudes radially outward (radially) from the surface of the catheter shaft 32 by injecting pressurized fluid from the balloon expansion port 39 through the balloon expansion lumen 390, and is provided so as to be freely expandable and contractable. In FIG. 7, the balloon 50 is shown in a state before expansion by solid lines, and in a state after expansion by imaginary lines.

The balloon 50 functions as an anchor, for example, by contacting the inner wall of the CS into which the CS electrode catheter 30A is inserted, and restricts the longitudinal movement of the catheter shaft 32 (corresponding to the portion in which the balloon 50 is disposed) within the CS.

In the intracardiac defibrillation system 100 of this embodiment, when defibrillation is performed using the CS electrode catheter 30A installed in the CS and RA, and the RA electrode catheters 20, 20A, the balloon 50 can be used as an anchor. This restricts the longitudinal movement of the CS electrode catheter 30A (catheter shaft 32), and thus restricts the movement of the electrode group 34A.

The balloon 50 may be configured to expand when inflated and to abut against the inner wall of the CS over its entire circumference. In this case, the balloon 50 can be sandwiched between the inside of the CS into which the catheter shaft 32 is inserted, dividing the inside where the electrode group 34A is located and the inside of the distal end of the balloon 50.

If the CS electrode catheter 30 is configured as a catheter with a guidewire lumen, like the CS electrode catheter 30A, a guidewire can be inserted into the lumen of the CS electrode catheter 30. This allows the guidewire to guide the CS electrode catheter 30 into the heart so that the CS electrode group 34 is placed at a predetermined position in the coronary sinus 42, and to place it at a desired position in the coronary sinus 42. The RA electrode catheter 20 may be configured as a catheter with a wide wire lumen, and for example, the configuration of the CS electrode catheter 30A may be adapted to the RA electrode catheter 20.

Note that the electrodes R1 and C1 in the RA electrode catheters 20 and 20A and the CS electrode catheters 30 and 30A are configured to serve both as an electrode for potential measurement and an electrode for defibrillation, but they may also be configured with dedicated electrodes or groups of electrodes arranged alternately as appropriate.

The above describes an embodiment of the present invention. Note that the above description is an example of a preferred embodiment of the present invention, and the scope of the present invention is not limited to this. In other words, the description of the configuration of the device and the shape of each part is one example, and it is clear that various modifications and additions to these examples are possible within the scope of the present invention.

The defibrillation system of the present invention has the effect of easily and reliably performing intracardiac defibrillation regardless of the size or shape of the patient's heart, and is useful as a system used for intracardiac defibrillation.

12 Defibrillator 14 Connection device 16 Switching unit 20, 20A RA electrode catheter (first electrode catheter)
22, 32 Catheter shaft 23, 33 Handle 24 RA electrode group 26, 26A, 36, 36A Connector 30, 30A CS electrode catheter (second electrode catheter)
31 Tip hole 34 CS electrode group 35 Hub 40 Polygraph examination device (physiological examination device)
100 Intracardiac defibrillation system C1, R1 Electrode C2, R2 Electrode set

Claims (7)

a first electrode catheter and a second electrode catheter;
a defibrillator that applies voltages having different potentials independently to the first electrode catheter and the second electrode catheter,
having
Defibrillation system. the first electrode catheter is an RA electrode catheter having an RA electrode placed in the right atrium,
The second electrode catheter is a CS electrode catheter having a CS electrode placed in the coronary sinus.
2. The defibrillation system of claim 1. a physiological examination device capable of measuring the potential of each of the electrodes of the first electrode catheter and the second electrode catheter;
having
2. The defibrillation system of claim 1. a switching unit that can freely switch a connection state between the first electrode catheter and the second electrode catheter and the defibrillator to a connection state between the first electrode catheter and the second electrode catheter and the physiological testing device;
4. The defibrillation system of claim 3. At least one of the first electrode catheter and the second electrode catheter is a bidirectional catheter.
3. The defibrillation system of claim 2. At least one of the first electrode catheter and the second electrode catheter has a lumen through which a wire is inserted.
3. The defibrillation system of claim 2. At least one of the first electrode catheter and the second electrode catheter has a movement restricting portion that abuts against an inner wall of the body lumen and restricts movement of the catheter shaft.
2. The defibrillation system of claim 1.

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