WO2023026346A1 - Catheter system - Google Patents

Abstract

The purpose of the present invention is to provide a catheter system that is able to quickly and accurately detect a disconnection of a lead wire of an electrode that constitutes a defibrillation catheter. This catheter system comprises a defibrillation catheter (100) and a power source device (700), wherein: the defibrillation catheter comprises a first DC electrode group (31G) made up of a plurality of first electrodes (31) and a second DC electrode group (32G) made up of a plurality of second electrodes (32); the power source device comprises a DC power supply unit (71) and a computation processing unit (75); the computation processing unit comprises an output circuit (751) for direct current voltage and an IMP measuring circuit (752) for measuring the IMP between electrode groups or the IMP between electrodes; and the computation processing unit controls the IMP measuring circuit so as to perform, on all of the first electrodes and the second electrodes, the IMP measuring between one first electrode and one second electrode before defibrillation is performed.

Description

catheter system

TECHNICAL FIELD The present invention relates to a catheter system, and more particularly to an intracardiac defibrillation catheter system comprising a defibrillation catheter inserted into a heart chamber and a power supply device for applying a DC voltage to electrodes of the defibrillation catheter. .

As an intracardiac defibrillation catheter system for performing defibrillation treatment of a heart with atrial fibrillation or the like, the present applicant has proposed a defibrillation catheter inserted into the heart chamber for defibrillation, The defibrillation catheter comprises a power supply for applying a DC voltage to the electrodes of the defibrillation catheter, and an electrocardiograph; the defibrillation catheter comprises a plurality of ring-shaped electrodes attached to the tip region of an insulating tube member. A first electrode group, a second electrode group consisting of a plurality of ring-shaped electrodes attached to the tube member at a distance from the first electrode group toward the proximal end, and electrodes constituting the first electrode group. a first lead wire group consisting of a plurality of lead wires whose tips are connected to the electrodes; and a second lead wire group consisting of a plurality of lead wires whose tips are connected to each of the electrodes constituting the second electrode group. The power supply device includes a DC power supply unit, a catheter connection connector connected to the proximal end side of the first lead wire group and the second lead wire group of the defibrillation catheter, and the input terminal of the electrocardiograph. an electrocardiograph connection connector connected to an electrocardiograph, an arithmetic processing unit that controls the DC power supply unit based on the input of an external switch, and has a DC voltage output circuit from the DC power supply unit; a switching unit comprising a changeover switch, wherein the catheter connection connector is connected to a common contact, the electrocardiograph connection connector is connected to a first contact, and the arithmetic processing unit is connected to a second contact; When the cardiac potential is measured by the electrodes constituting the first electrode group and/or the second electrode group of the defibrillation catheter, the switching unit selects the first contact, and the cardiac potential information from the defibrillation catheter is , is input to the electrocardiograph via the catheter connection connector, the switching unit, and the electrocardiograph connection connector of the power supply device, and when performing defibrillation with the defibrillation catheter, the The contact of the switching unit is switched to the second contact by the arithmetic processing unit, and the DC power supply unit passes through the output circuit of the arithmetic processing unit, the switching unit, and the catheter connection connector to the defibrillation catheter. A catheter system has been proposed in which voltages of different polarities are applied to the first electrode group and the second electrode group (see Patent Document 1 below).

According to this intracardiac defibrillation catheter system, it is possible to reliably supply electrical energy necessary and sufficient for defibrillation to a heart that has atrial fibrillation or the like during cardiac catheterization. Moreover, when defibrillation therapy is not required, the defibrillation catheter that constitutes the catheter system can be used as an electrode catheter for cardiac potential measurement.
In the defibrillation treatment using the intracardiac defibrillation catheter system described in Patent Document 1, by inputting the mode changeover switch of the power supply in the "electrocardiographic measurement mode", the mode of the power supply is set for a certain period of time ( for example for 1 second) to switch to "defibrillation mode". During this time, the impedance between the first and second electrodes of the defibrillation catheter is measured. After that, by inputting the applied energy setting switch to set the electrical energy to be applied when performing defibrillation, and inputting the charge switch, the voltage determined based on the measured impedance and the set electrical energy is charged to the DC power supply. After charging is completed, the contact of the switching unit is switched from the first contact to the second contact by inputting the energy application switch (thereby changing the mode of the power supply from the "cardiogram measurement mode" to the "defibrillation mode"). switching), the first electrode group of the defibrillation catheter and the second electrode are sent from the DC power supply unit that receives the control signal from the arithmetic processing unit via the output circuit of the arithmetic processing unit, the switching unit, and the catheter connection connector. DC voltages of polarities different from each other are applied to the groups.

Japanese Patent No. 4545216

In the defibrillation catheter that constitutes the catheter system of Patent Document 1, some lead wires among the plurality of lead wires that constitute the first lead wire group and the plurality of lead wires that constitute the second lead wire group are broken. It is conceivable that
Depending on the defibrillation catheter with some of the lead wires disconnected, not only will the intended treatment not be possible, but more energy will be applied to electrodes other than the electrode to which the disconnected lead wire is connected (defibrillation). There is a risk that the kinetic energy will concentrate) and damage the patient's intracardiac tissue at the site where the electrode is located.
It is also conceivable that lead wire breakage may occur during defibrillation therapy due to the effects of peak current due to defibrillation, body movement of the patient, and the like.

However, it is extremely difficult to grasp that some lead wires are disconnected. For example, the impedance measured between the first electrode group and the second electrode group increases due to disconnection of some of the lead wires, but the impedance value between the electrode groups varies depending on the patient. Even if an increase in impedance is observed, it cannot be determined immediately that it is due to disconnection.
In addition, electrocardiograms measured by electrodes connected to disconnected lead wires tend to produce noise, but it is not possible to determine whether this noise is due to the disconnection. In particular, noise is likely to occur in an electrocardiogram immediately after defibrillation, and the cause of this noise is often something other than disconnection.

The present invention has been made based on the circumstances as described above.
SUMMARY OF THE INVENTION A first object of the present invention is to provide a defibrillation catheter system capable of quickly and reliably detecting disconnection of a lead wire constituting the defibrillation catheter.
A second object of the present invention is to provide a defibrillation catheter system capable of preventing defibrillation from occurring when a lead wire is broken.
A third object of the present invention is to provide a defibrillation catheter system that can identify a disconnected lead wire (the electrode to which it is connected) and make the operator recognize it.
A fourth object of the present invention is to provide a defibrillation catheter system capable of detecting disconnection of a lead wire during defibrillation therapy.
A fifth object of the present invention is to provide a catheter system capable of quickly and reliably detecting disconnection of a lead wire constituting an electrode catheter.

(1) The intracardiac defibrillation catheter system of the present invention comprises a defibrillation catheter inserted into a heart chamber for defibrillation, and a power supply for applying a DC voltage to electrodes of the defibrillation catheter. A catheter system comprising:
The defibrillation catheter includes an insulating tube member, a first DC electrode group including a plurality of first electrodes attached to a distal region of the tube member, and spaced apart proximally from the first DC electrode group. A second DC electrode group consisting of a plurality of second electrodes attached to the distal end region of the tube member, and a plurality of first leads each having a distal end connected to each of the first electrodes constituting the first DC electrode group. a first lead wire group consisting of wires; and a second lead wire group consisting of a plurality of second lead wires each having a tip end connected to each of the second electrodes constituting the second DC electrode group,
The power supply device includes a DC power supply unit including a capacitor, and an arithmetic processing unit that controls the DC power supply unit based on an external input and has a circuit for outputting a DC voltage from the DC power supply unit,
When performing defibrillation with the defibrillation catheter, the first DC electrode group and the second DC electrode group of the defibrillation catheter are connected from the DC power supply unit via the output circuit of the arithmetic processing unit. voltages of different polarities are applied to
The arithmetic processing unit of the power supply device, prior to performing defibrillation, to all the first electrodes constituting the first DC electrode group and all the second electrodes constituting the second DC electrode group In contrast (repeatedly until all of the first electrodes and the second electrodes are selected), one first electrode selected from the first group of DC electrodes and one selected from the second group of DC electrodes is controlled to measure the impedance between the second electrode of the

(2) In the intracardiac defibrillation catheter system of the present invention, the arithmetic processing unit of the power supply unit includes the first DC electrode group or the first electrodes constituting the same, the second DC electrode group or the Having an impedance measurement circuit capable of measuring the impedance between the constituting second electrode,
The power supply device is connected to a base end of each of the first lead wires or a base end of each of the second lead wires, and connects each of the base ends to the output circuit or the impedance measurement circuit. has a switch group consisting of a plurality of switches that can
The arithmetic processing unit of the power supply device, prior to performing defibrillation, to all the first electrodes constituting the first DC electrode group and all the second electrodes constituting the second DC electrode group In contrast (repeatedly until all of the first electrodes and the second electrodes are selected), one first electrode selected from the first group of DC electrodes and one selected from the second group of DC electrodes It is preferable to control the switch group such that the impedance between the second electrode of is measured by the impedance measurement circuit.

According to the defibrillation catheter system having such a configuration, measurement is performed between one first electrode selected from the first DC electrode group and one second electrode selected from the second DC electrode group. If the measured impedance is less than a predetermined value, it can be determined that the lead wires (first lead wire and second lead wire) connected to these electrodes are not disconnected, and the measured impedance exceeds a predetermined value, it can be determined that at least one of the lead wires connected to these electrodes is broken.
In addition, the impedance measurement is performed for all the first electrodes constituting the first DC electrode group and all the second electrodes constituting the second DC electrode group (impedance measurement is performed until all the constituent electrodes are selected). is repeated), so that all lead wires connected to these electrodes can be checked for disconnection.

(3) In the intracardiac defibrillation catheter system of the present invention, the first DC electrode group is composed of n first electrodes (n is an integer equal to or greater than 2), and the second DC electrode group is composed of n composed of the second electrodes,
The arithmetic processing unit of the power supply device includes a first electrode that is the k-th electrode from the tip of the first DC electrode group (k is any integer from 1 to n) and a first electrode that is the k-th electrode from the tip of the second DC electrode group. It is preferable to control (the switch group) such that the impedance between the two electrodes is measured (by the impedance measuring circuit) n times.

According to the defibrillation catheter system having such a configuration, the k (1, 2, 3 . . . n-2, n-1, n) first electrode from the tip of the first DC electrode group, The impedance between the tip of the 2DC electrode group and the k (1, 2, 3 ... n-2, n-1, n)-th second electrode is measured, and the first DC electrode is measured n times. n first lead wires connected to each of the n first electrodes forming the group and n second lead wires connected to each of the n second electrodes forming the second DC electrode group can be checked for disconnection.
In addition, since the distance between the electrodes whose impedance is measured is substantially the same, it is possible to eliminate the influence (error) on the measured value due to the difference in the distance between the electrodes.

(4) In the intracardiac defibrillation catheter system of the present invention, the arithmetic processing unit of the power supply performs defibrillation only when all of the plurality of measured impedances are equal to or less than a predetermined value. It is preferable to control the DC power supply unit so that

According to the defibrillation catheter system having such a configuration, if the impedance exceeding the predetermined value is measured even once, the application of DC voltage (defibrillation) is not performed. It is possible to reliably avoid the occurrence of tissue damage caused by

(5) In the intracardiac defibrillation catheter system of the present invention, the power supply includes display means, and the arithmetic processing unit of the power supply, when an impedance exceeding a predetermined value is measured, Preferably, the display means is controlled to display the combination of the first electrode and the second electrode for which the impedance is measured.

According to the defibrillation catheter system having such a configuration, it is possible to grasp that at least one of the lead wires connected to the first electrode and the second electrode whose impedance exceeds a predetermined value is broken. can do.

(6) In the intracardiac defibrillation catheter system described in (5) above, the arithmetic processing unit of the power supply device may be configured to detect the first electrode and/or the second electrode that caused the impedance exceeding a predetermined value to be measured. Preferably, an electrode is identified and the display means is controlled to display the electrode.

According to the defibrillation catheter system with such a configuration, it is possible to identify the disconnected lead wire and make the operator recognize it.

Here, the causative electrodes are each of the first electrode and the second electrode for which the impedance exceeding the predetermined value was measured, and each of the second electrode and the first electrode for which the impedance of the predetermined value or less was measured. can be identified by measuring the impedance between
For example, when only the impedance between the third electrode from the tip of the first DC electrode group and the third electrode from the tip of the second DC electrode group exceeds a predetermined value, the third electrode from the tip Measure the impedance between the first electrode and the second second electrode from the tip, and measure the impedance between the second first electrode from the tip and the third second electrode from the tip .

At this time, if the impedance between the third first electrode from the tip and the second electrode second from the tip exceeds a predetermined value, the first electrode connected to the third first electrode from the tip It can be determined that the lead wire is disconnected, and if the impedance between the first electrode second from the tip and the second electrode third from the tip exceeds a predetermined value, three It can be determined that the second lead wire connected to the th second electrode is disconnected.

(7) In the intracardiac defibrillation catheter system of the present invention, after defibrillation is performed, the arithmetic processing unit of the power supply unit repeats all of the first DC electrode groups constituting the first DC electrode group. One first electrode selected from the first DC electrode group and one selected from the second DC electrode group for all the second electrodes constituting one electrode and the second DC electrode group It is preferable to control so that the impedance between the second electrode is measured.

According to the intracardiac defibrillation catheter system having such a configuration, when disconnection occurs after performing defibrillation, it can be recognized, and the defibrillation treatment can be stopped to ensure the safety of the patient. can be secured.

(8) In the intracardiac defibrillation catheter system of (7) above, it is preferable that the arithmetic processing unit of the power supply device controls so that impedance measurement is started immediately after defibrillation is performed. .

According to the intracardiac defibrillation catheter system having such a configuration, by measuring the impedance using the waiting time until the cardiac potential stabilizes after defibrillation is performed, the waiting time can be shortened. It can be used effectively to shorten the time until the next defibrillation.
Here, "immediately start impedance measurement" means, for example, that the operation for performing the next defibrillation (for example, input of the mode switch for setting the defibrillation/impedance measurement mode) does not wait means to start the measurement at

(9) In the intracardiac defibrillation catheter system of the present invention, the arithmetic processing unit of the power supply device further includes that the impedance between the first DC electrode group and the second DC electrode group (between the electrode groups) is It is preferable to control to be measured.

(10) The intracardiac defibrillation catheter system of (2) above, further comprising an electrocardiograph,
The power supply device is a catheter electrically connected to each of the DC power supply unit, an external switch as input means, the arithmetic processing unit, and the first DC electrode group and the second DC electrode group of the defibrillation catheter. a connection connector, an electrocardiograph connection connector connected to an input terminal of the electrocardiograph, and a branch connector connected to the catheter connection connector and to the electrocardiograph connection connector and the arithmetic processing unit. and
When the intracardiac potential is measured by the electrodes (the first electrode and/or the second electrode) constituting the first DC electrode group and/or the second DC electrode group of the defibrillation catheter, from the defibrillation catheter is input to the electrocardiograph via the catheter connection connector, the branch connection and the electrocardiograph connection connector,
When performing defibrillation with the defibrillation catheter, from the DC power supply unit, the first DC of the defibrillation catheter via the output circuit of the arithmetic processing unit, the branch connection unit and the catheter connection connector Voltages of different polarities are applied to the electrode group and the second DC electrode group,
When measuring the impedance between the first DC electrode group and the second DC electrode group or the impedance between the first electrode and the second electrode of the defibrillation catheter, the measured impedance information includes: It is preferable that the signal is input to the arithmetic processing section via the catheter connector, the branch connection section, and the impedance measurement circuit of the arithmetic processing section.

(11) The intracardiac defibrillation catheter system of the present invention comprises a defibrillation catheter inserted into the heart chamber to perform defibrillation, and a power supply for applying a DC voltage to the electrodes of the defibrillation catheter. A catheter system comprising:
The defibrillation catheter includes an insulating tube member, a first DC electrode group including a plurality of first electrodes attached to a distal region of the tube member, and spaced apart proximally from the first DC electrode group. A second DC electrode group consisting of a plurality of second electrodes attached to the distal end region of the tube member, and a plurality of first leads each having a distal end connected to each of the first electrodes constituting the first DC electrode group. a first lead wire group consisting of wires; and a second lead wire group consisting of a plurality of second lead wires each having a tip end connected to each of the second electrodes constituting the second DC electrode group,
The power supply device includes a DC power supply unit having a capacitor and an arithmetic processing unit. The arithmetic processing unit controls the DC power supply unit based on an external input, a voltage output circuit; and an impedance measuring circuit capable of measuring the impedance between the first DC electrode group and the second DC electrode group and the impedance between the electrodes constituting the first DC electrode group or the second DC electrode group. death,
When performing defibrillation with the defibrillation catheter, the first DC electrode group and the second DC electrode group of the defibrillation catheter are connected from the DC power supply unit via the output circuit of the arithmetic processing unit. voltages of different polarities are applied to
The arithmetic processing unit of the power supply device, prior to performing defibrillation, to all the first electrodes constituting the first DC electrode group and all the second electrodes constituting the second DC electrode group whereas (repeatedly until all of the first electrodes and the second electrodes have been selected), the impedance between two electrodes selected from the first DC electrode group and the second DC electrode group is determined by the impedance measurement circuit. It is characterized by controlling to be measured by
According to the intracardiac defibrillation catheter system with such a configuration, not only the impedance between the first electrode and the second electrode, but also the impedance between the same DC electrode group (between the first electrode and the first electrode) and between the second electrode) can also be measured.

(12) In the intracardiac defibrillation catheter system of (11) above, the two electrodes selected from the first DC electrode group and the second DC electrode group are adjacent electrodes (first electrode and/or second electrode).
According to the intracardiac defibrillation catheter system with such a configuration, the distance between the electrodes where the impedance is measured can be minimized, and the effect (error) on the measurement value due to the increased distance between the electrodes ) can be eliminated.

(13) In the intracardiac defibrillation catheter system of (2) or (11) above, part of the arithmetic processing unit including the impedance measurement circuit may be arranged outside the power supply device.

(14) A catheter system of the present invention is a catheter system comprising an electrode catheter for performing ablation and a power supply device for applying energy to the electrode of the electrode catheter,
The electrode catheter comprises an insulating tube member, an electrode group consisting of a plurality of electrodes attached to a tip region of the tube member, and a plurality of leads each having a tip end connected to each of the electrodes constituting the electrode group. and a lead wire group consisting of wires,
The power supply device includes a power supply unit and an arithmetic processing unit that controls the power supply unit based on an external input. The arithmetic processing unit includes an energy output circuit from the power supply unit and the electrode group. Having an impedance measurement circuit capable of measuring the impedance between the constituting electrodes,
When performing ablation with the electrode catheter, energy is applied from the power supply unit to the electrodes constituting the electrode group via the output circuit of the arithmetic processing unit,
Prior to performing ablation, the arithmetic processing unit of the power supply device measures the impedance between two electrodes selected from the electrode group for all electrodes constituting the electrode group by the impedance measurement circuit. It is characterized by controlling to be measured by

(15) The catheter system of (14) above can be suitably used to perform pulse field ablation (PFA).

According to the catheter system of the present invention, breakage of lead wires can be detected quickly and reliably.

1 is a block diagram illustrating one embodiment of an intracardiac defibrillation catheter system of the present invention; FIG. FIG. 2 is an explanatory plan view showing a defibrillation catheter that constitutes the catheter system shown in FIG. 1; FIG. 2 is an explanatory plan view (a diagram for explaining dimensions and hardness) showing a defibrillation catheter that constitutes the catheter system shown in FIG. 1; FIG. 3 is a transverse sectional view showing the AA section of FIG. 2; 3A and 3B are transverse cross-sectional views showing a BB cross section, a CC cross section, and a DD cross section of FIG. 2; 3 is a perspective view showing the internal structure of the handle of one embodiment of the defibrillation catheter shown in FIG. 2; FIG. FIG. 2 is an explanatory view schematically showing a connection state between a connector of a defibrillation catheter and a catheter connection connector of a power supply device in the catheter system shown in FIG. 1; 2 is a flow chart showing the operation and operation of the power supply in the catheter system shown in FIG. 1; 2 is a block diagram showing the flow of electrocardiographic information in the electrocardiographic measurement mode after the main power switch is turned on in the catheter system shown in FIG. 1; FIG. FIG. 2 is a block diagram showing the flow of information related to measured values of impedance between electrode groups and electrocardiographic information in the defibrillation/impedance measurement mode after input of a mode switch in the catheter system shown in FIG. 1; 2 is a block diagram showing the flow of electrocardiographic information in the electrocardiographic measurement mode after a certain period of time has passed since the mode selector switch was turned on in the catheter system shown in FIG. 1. FIG. 2 is a block diagram showing the flow of electrocardiographic information after an application preparation switch is input in the catheter system shown in FIG. 1; FIG. 2 is a block diagram showing the flow of electrocardiographic information after an application execution switch is input in the catheter system shown in FIG. 1; FIG. FIG. 2 is a block diagram showing a state in which a DC voltage is applied after an application execution switch is input in the catheter system shown in FIG. 1; It is a circuit diagram for switching between impedance measurement and DC voltage application, and shows a state in which the impedance between the first electrode and the second electrode can be measured. It is a circuit diagram for switching between impedance measurement and DC voltage application, and shows a state in which the impedance between the first DC electrode group and the second DC electrode group can be measured. FIG. 4 is a circuit diagram for switching between impedance measurement and DC voltage application, and shows a state in which a DC voltage can be applied to the first DC electrode group and the second DC electrode group. It is a circuit diagram for switching between impedance measurement and DC voltage application, and shows a state in which impedance between adjacent first electrodes can be measured. It is a circuit diagram for switching between impedance measurement and DC voltage application, and shows a state in which impedance between adjacent second electrodes can be measured. It is a circuit diagram for switching between impedance measurement and DC voltage application, and shows a state in which the impedance between the first DC electrode group and the second DC electrode group can be measured. FIG. 4 is a circuit diagram for switching between impedance measurement and DC voltage application, and shows a state in which a DC voltage can be applied to the first DC electrode group and the second DC electrode group.

<First Embodiment>
As shown in FIG. 1 , the intracardiac defibrillation catheter system of this embodiment includes a defibrillation catheter 100 , a power supply device 700 , an electrocardiograph 800 , and electrocardiographic measurement means 900 .
As shown in FIGS. 2 to 6, the defibrillation catheter 100 constituting the catheter system of the present embodiment includes a multi-lumen tube 10, a handle 20, a first DC electrode group 31G, a second DC electrode group 32G, It has a proximal side potential measuring electrode group 33G, a first lead wire group 41G, a second lead wire group 42G, and a third lead wire group 43G.

As shown in FIGS. 4 and 5, the multi-lumen tube 10 is formed with four lumens (first lumen 11, second lumen 12, third lumen 13, and fourth lumen 14).

4 and 5, 15 is a fluororesin layer that partitions the lumen, 16 is an inner (core) portion made of a low-hardness nylon elastomer, and 17 is an outer (shell) portion made of a high-hardness nylon elastomer. 18 in FIG. 4 is a stainless wire forming a braided braid.

The handle 20 that constitutes the defibrillation catheter 100 of this embodiment includes a handle body 21, a knob 22, and a strain relief 24. By rotating the knob 22, the tip of the multi-lumen tube 10 can be deflected (swinged).

A first DC electrode group 31G, a second DC electrode group 32G, and a proximal side potential measurement electrode group 33G are attached to the distal end region of the multi-lumen tube 10 . Here, "electrode group" means a set of a plurality of electrodes that constitute the same pole (have the same polarity) or have the same purpose and are mounted at narrow intervals (for example, 5 mm or less). say the body

The first DC electrode group 31</b>G is composed of eight ring-shaped first electrodes 31 attached to the distal end region of the multi-lumen tube 10 . The first electrodes 31 constituting the first DC electrode group 31G are connected to the catheter connector 72 of the power supply device 700 via the first lead wires 41 constituting the first lead wire group 41G and a connector described later.
When the defibrillation catheter 100 is in use (placed in the heart chamber), the first DC electrode group 31G is positioned, for example, in the coronary sinus (CS).

The second DC electrode group 32G is composed of eight ring-shaped second electrodes 32 attached to the distal end region of the multi-lumen tube 10 at a distance from the attachment position of the first DC electrode group 31G toward the proximal side. The second electrodes 32 constituting the second DC electrode group 32G are connected to the catheter connector 72 of the power supply device 700 via the second lead wires 42 constituting the second lead wire group 42G and a connector described later.
When the defibrillation catheter 100 is in use (placed in the heart chamber), the second DC electrode group 32G is located, for example, in the right atrium (RA).

The proximal-side potential-measuring electrode group 33G is composed of four ring-shaped third electrodes 33 attached to the distal end region of the multi-lumen tube 10 at a distance from the attachment position of the second DC electrode group 32G toward the proximal side. ing. The third electrode 33 constituting the proximal side potential measuring electrode group 33G is connected to the catheter connector 72 of the power supply device 700 via the third lead wire 43 constituting the third lead wire group 43G and a connector described later. ing.
When the defibrillation catheter 100 is used (placed in the heart chamber), the proximal side potential-measuring electrode group 33G is positioned, for example, in the superior vena cava (SVC).

A distal tip 35 is attached to the distal end of the defibrillation catheter 100 .
No lead wire is connected to the distal tip 35, and it is not used as an electrode in this embodiment.

The first lead wire group 41G shown in FIGS. 4 and 5 is an aggregate of eight first lead wires 41 connected to each of the eight first electrodes 31 constituting the first DC electrode group 31G. .
Each of the eight first electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the power supply device 700 by the first lead wire group 41G.

The eight first electrodes 31 forming the first DC electrode group 31G are connected to different first lead wires 41, respectively. Each of the first lead wires 41 is welded to the inner peripheral surface of the first electrode 31 at its distal end portion and enters the first lumen 11 through a side hole formed in the tube wall of the multi-lumen tube 10 . The eight first lead wires 41 entering 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 FIGS. 4 and 5 is an assembly of eight second lead wires 42 connected to each of the eight second electrodes 32 constituting the second DC electrode group 32G. .
Each of the eight second electrodes 32 constituting the second DC electrode group 32G can be electrically connected to the power supply device 700 by the second lead wire group 42G.

The eight second electrodes 32 forming the second DC electrode group 32G are connected to different second lead wires 42, respectively. Each of the second lead wires 42 is welded to the inner peripheral surface of the second electrode 32 at its distal end portion and enters the second lumen 12 through a side hole formed in the tube wall of the multi-lumen tube 10 . The eight second lead wires 42 entering 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, so that both of them can be used in the multi-lumen tube 10. Completely insulated. Therefore, when a voltage required 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 third lead wire group 43G shown in FIG. 4 is an assembly of four third lead wires 43 connected to each of the third electrodes 33 constituting the proximal end potential measuring electrode group 33G.
Each of the third electrodes 33 constituting the proximal side potential measurement electrode group 33G can be electrically connected to the power supply device 700 by the third lead wire group 43G.

The four third electrodes 33 constituting the group 33G of proximal-side potential-measuring electrodes are connected to different third lead wires 43, respectively. Each of the third lead wires 43 is welded to the inner peripheral surface of the third electrode 33 at its distal end portion and enters the third lumen 13 through a side hole formed in the tube wall of the multi-lumen tube 10 . The four third lead wires 43 entering the third lumen 13 extend to the third lumen 13 as a third lead wire group 43G.

As described above, the third lead wire group 43G 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. Therefore, when the voltage required for defibrillation is applied, the third lead wire group 43G (proximal side potential measurement electrode group 33G) and the first lead wire group 41G (first DC electrode group 31G) or the first lead wire group 41G (first DC electrode group 31G) A short circuit between the lead wire group 42G (the second DC electrode group 32G) and the lead wire group 42G can be reliably prevented.

4 and 5, 65 is a pull wire.
The pull wire 65 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 65 is fixed to the distal tip 35 by soldering. On the other hand, the proximal end portion of the pull wire 65 is connected to the knob 22 of the handle 20 , and the pull wire 65 is pulled by operating the knob 22 , thereby deflecting the distal end portion of the multi-lumen tube 10 .

In the defibrillation catheter 100 of this embodiment, the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G are insulated and isolated even inside the handle 20.

FIG. 6 is a perspective view showing the internal structure of the handle of the defibrillation catheter 100 according to this embodiment. As shown in FIG. 6, the proximal end of the multi-lumen tube 10 is inserted into the distal opening of the handle 20, whereby the multi-lumen tube 10 and the handle 20 are connected.

A cylindrical connector 50 is built in the proximal end of the handle 20 .
Inside the handle 20, there are three insulating tubes (first insulating tube) through which each of the three lead wire groups (first lead wire group 41G, second lead wire group 42G, third lead wire group 43G) is inserted. An insulating tube 26, a second insulating tube 27 and a third insulating tube 28) extend.

The distal end of the first insulating tube 26 is inserted into the first lumen 11 of the multi-lumen tube 10, whereby the first insulating tube 26 is inserted into the first lumen 11 through which the first lead wire group 41G extends. Concatenated.
The first insulating tube 26 extends to the vicinity of the connector 50 through the inner hole of the first protective tube 61 extending inside the handle 20, and connects the proximal ends of the first lead wire group 41G to the connector 50. form an insertion path for guiding to the vicinity of the
A first lead wire group 41</b>G extending from the proximal end opening of the first insulating tube 26 is separated into eight first lead wires 41 , and each of these first lead wires 41 is attached to the distal end surface of the connector 50 . It is connected and fixed to each of the arranged pin terminals by soldering.

The distal end of the second insulating tube 27 is inserted into the second lumen 12 of the multi-lumen tube 10, whereby the second insulating tube 27 is inserted into the second lumen 12 through which the second lead wire group 42G extends. Concatenated.
The second insulating tube 27 extends to the vicinity of the connector 50 through the inner hole of the second protective tube 62 extending inside the handle 20, and connects the proximal ends of the second lead wire group 42G to the connector 50. form an insertion path for guiding to the vicinity of the
A second lead wire group 42</b>G extending from the proximal end opening of the second insulating tube 27 is separated into eight second lead wires 42 , and each of these second lead wires 42 is attached to the distal end surface of the connector 50 . It is connected and fixed to each of the arranged pin terminals by soldering.

The distal end of the third insulating tube 28 is inserted into the third lumen 13 of the multi-lumen tube 10, whereby the third insulating tube 28 is inserted into the third lumen 13 through which the third lead wire group 43G extends. Concatenated.
The third insulating tube 28 extends to the vicinity of the connector 50 through the inner hole of the second protective tube 62 extending inside the handle 20, and connects the proximal end of the third lead wire group 43G to the connector 50. form an insertion path for guiding to the vicinity of the
A third lead wire group 43</b>G extending from the proximal opening of the third insulating tube 28 is separated into four third lead wires 43 , and each of these third lead wires 43 is attached to the distal end surface of the connector 50 . It is connected and fixed to each of the arranged pin terminals by soldering.

According to the defibrillation catheter 100 of this embodiment having the configuration as described above, the first
A first lead wire group 41G extends in the insulating tube 26, a second lead wire group 42G extends in the second insulating tube 27, and a third lead wire group 43G extends in the third insulating tube 28. , the first lead wire group 41G, the second lead wire group 42G, and the third lead wire 43G can be completely insulated and isolated even inside the handle 20.

As shown in FIG. 1, a power supply device 700 constituting the catheter system of the present embodiment includes a DC power supply unit 71, a catheter connection connector 72, an electrocardiograph connection connector 73, and an external switch (input means) 74. , an arithmetic processing unit 75 , a first ON/OFF switch 761 and a second ON/OFF switch 762 forming a branch connection unit 76 , and an electrocardiogram input connector 77 .

The DC power supply unit 71 has a built-in capacitor.

A proximal end of each of the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G of the defibrillation catheter 100 is connected to the catheter connector 72 .
Thereby, the catheter connector 72 is electrically connected to each of the first DC electrode group 31G, the second DC electrode group 32G, and the proximal side potential measurement electrode group 33G.

The catheter connector 72 is connected to the connector 50 of the defibrillation catheter 100, and electrically connected to the proximal sides of the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G.

As shown in FIG. 7, by connecting the connector 50 of the defibrillation catheter 100 and the catheter connection connector 72 of the power supply device 700 with a connector cable C1,
pin terminals 51 (actually eight) to which the eight first lead wires 41 constituting the first lead wire group are connected and fixed; terminals 721 (actually eight) of the catheter connector 72;
Pin terminals 52 (actually eight) to which eight second lead wires 42 constituting the second lead wire group are connected and fixed, terminals 722 (actually eight) of the catheter connector 72,
The pin terminals 53 (four actually) to which the four third lead wires 43 constituting the third lead wire group are connected and fixed are connected to the terminals 723 (four actually) of the catheter connector 72, respectively. It is

Here, the terminals 721 and 722 of the catheter connector 72 are connected to the first ON/OFF switch 761, and the terminal 723 is directly connected to the electrocardiograph connector 73 without going through the first ON/OFF switch 761. there is
As a result, the electrocardiographic information measured by the first DC electrode group 31G and the second DC electrode group 32G reaches the electrocardiograph connector 73 via the first ON/OFF switch 761, and reaches the proximal side potential measuring electrode group. Electrocardiogram information measured by 33G reaches the electrocardiograph connection connector 73 without passing through the first ON/OFF switch 761 .

The electrocardiograph connection connector 73 is connected to an input terminal of the electrocardiograph 800 .
The external switch 74, which is input means, includes a main power switch 740 for activating the power supply device 700, a mode selector switch 741 for switching between an electrocardiogram measurement mode and a defibrillation/impedance measurement mode, and an input during defibrillation. Applied energy setting switch 742 for setting the electrical energy, charging switch 743 for accumulating the voltage determined based on the set electrical energy in the DC power supply, preparation for defibrillation (relay switching) An energy application preparation switch 744 for performing defibrillation and an energy application execution switch 745 for applying electrical energy to perform defibrillation.
All input signals from these external switches 74 are sent to the arithmetic processing section 75 .

Arithmetic processing unit 75 controls DC power supply unit 71 , first ON/OFF switch 761 and second ON/OFF switch 762 based on the input of external switch 74 .
The arithmetic processing unit 75 includes an output circuit 751 for outputting the DC voltage from the DC power supply unit 71 to the electrodes of the defibrillation catheter 100 via the second ON/OFF switch 762, and a first DC voltage of the defibrillation catheter 100. An IMP measurement circuit 752 for measuring the impedance (IMP) between the electrode group 31G or the first electrode 31 constituting this and the second DC electrode group 32G or the second electrode 32 constituting this, and an operation check ( an internal resistor 753 with a known resistance value used for testing), and a switching unit 754 that switches the connection destination of each of the output circuit 751 and the IMP measurement circuit 752 between the internal resistor 753 and the second ON/OFF switch 762. have.

By the output circuit 751, the terminal 721 of the catheter connector 72 shown in FIG. A DC voltage can be applied so that the second DC electrode group 32G) of the defibrillation catheter 100 has different polarities (when one electrode group has a negative polarity, the other electrode group has a positive polarity). .

The IMP measurement circuit 752 allows the impedance between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 to be measured, and the impedance between the first DC electrode group 31G and the second DC electrode group 32G. The measured impedance (between the electrodes) is used to determine the target voltage to be stored in the DC power supply 71 .

The first ON/OFF switch 761 is connected to the catheter connector 72 and the electrocardiograph connector 73 .
The second ON/OFF switch 762 is connected to the catheter connector 72 and the arithmetic processing section 75 .

By setting the first ON/OFF switch 761 to "ON" and the second ON/OFF switch 762 to "OFF", the cardiac potential information from the defibrillation catheter 100 is transferred to the catheter connector 72 and the first ON/OFF switch 761. and the electrocardiograph 800 via the electrocardiograph connection connector 73 (electrocardiogram measurement mode).

Also, in a state in which the output circuit 751 and the second ON/OFF switch 762 are connected via the switching unit 754, the first ON/OFF switch 761 is turned "OFF" and the second ON/OFF switch 762 is turned "ON". As a result, the first DC electrode group 31G of the defibrillation catheter 100 is supplied from the DC power supply unit 71 via the output circuit 751 of the arithmetic processing unit 75, the switching unit 754, the second ON/OFF switch 762 and the catheter connector 72. and the second DC electrode group 32G (defibrillation/impedance measurement mode).

Also, in a state in which the IMP measurement circuit 752 and the second ON/OFF switch 762 are connected via the switching unit 754, the first ON/OFF switch 761 is turned "OFF" and the second ON/OFF switch 762 is turned "ON". By doing so, the impedance between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 can be measured.

The switching between “ON” and “OFF” of the first ON/OFF switch 761 and the second ON/OFF switch 762 is performed by the arithmetic processing unit 75 based on the inputs of the mode changeover switch 741 and the energy application preparation switch 744 which are the external switches 74 . controlled.

The IMP measurement circuit 752 can measure the impedance between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 (between the electrode groups), and constitutes the first DC electrode group 31G. The impedance between the first electrode 31 and the second electrode 32 constituting the second DC electrode group 32G (interelectrode) can also be measured.

Prior to performing defibrillation, the arithmetic processing unit 75 configures the eight first electrodes 31 (311 to 318 shown in FIGS. 15A to 15C) that configure the first DC electrode group 31G and the second DC electrode group 32G. For the eight second electrodes 32 (321 to 328 shown in FIGS. 15A to 15C) (that is, all constituent electrodes to be measured), one first electrode 31 and one second electrode A switch group to be described later is controlled so that the impedance between the electrodes 32 is measured by the IMP measurement circuit 752 .

15A to 15C show the impedance between each of the first electrodes 311 to 318 constituting the first DC electrode group 31G and each of the second electrodes 321 to 328 constituting the second DC electrode group 32G (interelectrode). Measurement of; Measurement of impedance between the first DC electrode group 31G and the second DC electrode group 32G (between the electrode groups); Application of DC voltage to the first DC electrode group 31G and the second DC electrode group 32G (defibrillation execution) and the circuit configuration for switching between.

In FIGS. 15A to 15C, 789 is a selector switch whose common contact is connected to the ON/OFF switches 781 to 788, whose first contact is connected to the output circuit 751, and whose second contact is connected to the IMP measurement circuit 752. is.
Reference numeral 799 denotes a selector switch having a common contact to which ON/OFF switches 791 to 798 are connected, a first contact to which an output circuit 751 is connected, and a second contact to which an IMP measurement circuit 752 is connected.

781 to 788 are ON/OFF switches provided between each of the first electrodes 311 to 318 and the changeover switch 789 . The ON/OFF switches 781-788 are connected to the proximal end of each of the eight first lead wires having the distal end connected to each of the first electrodes 311-318. can be connected to the output circuit 751 or the IMP measurement circuit 752 via the switch 789 .

791 to 798 are ON/OFF switches provided between each of the second electrodes 321 to 328 and the changeover switch 799 . The ON/OFF switches 791-798 are connected to the proximal end of each of the eight second lead wires whose distal ends are connected to the respective second electrodes 321-328. can be connected to the output circuit 751 or the IMP measurement circuit 752 via the switch 799 .

The ON/OFF switches 781-788 and 791-798 constitute a switch group in this embodiment.
A switch group consisting of ON/OFF switches 781 to 788 and 791 to 798 and selector switches 789 and 799 are arranged inside power supply device 700 .

The ON/OFF switches 781 to 788 and 791 to 798 are switched between “ON” and “OFF”, and the changeover switches 789 and 799 are switched between “first contacts” and “second contacts”, which are controlled by the arithmetic processing unit 75. be done.

In FIG. 15A, the second contacts (IMP measurement circuit 752) are selected in the changeover switches 789 and 799, and only the switch 781 of the ON/OFF switches 781 to 788 is "ON". Of the switches 791-798, only the switch 791 is "ON". This makes it possible to measure the impedance between the first electrode 311 and the second electrode 321 (between the electrodes).

Thus, among the switches 781 to 788, only the switch indicated by 78X (X is an integer of 1 to 8) is turned "ON", and of the switches 791 to 798, 79Y (Y is an integer of 1 to 8) is turned ON. By turning "ON" only the indicated switch, it is possible to measure the impedance between the first electrode indicated by 31X and the second electrode indicated by 32Y.

In the above, X = Y, that is, the k-th (k is any integer from 1 to 8) first electrode 31k from the tip of the first DC electrode group 31G and k from the tip of the second DC electrode group 32G All of the first electrodes 311 to 318 and the second electrodes 321 to 328 can be selected as measurement targets by measuring the impedance between the second electrode 32k and the second electrode 32k eight times.

In FIG. 15B, the second contacts (IMP measurement circuit 752) are selected in the changeover switches 789 and 799, and all of the switches 781 to 788 and switches 791 to 798 are "ON". This makes it possible to measure the impedance between the first DC electrode group 31G and the second DC electrode group 32G (between the electrode groups).

In FIG. 15C, the first contacts (output circuit 751) of the changeover switches 789 and 799 are selected, and all of the switches 781 to 788 and switches 791 to 798 are "ON". This makes it possible to perform defibrillation by applying voltages of different polarities to the first DC electrode group 31G and the second DC electrode group 32G via the output circuit 751 .

The electrocardiogram input connector 77 is connected to the arithmetic processing unit 75 and to the output terminal of the electrocardiograph 800 .
Through this electrocardiogram input connector 77, the electrocardiographic information output from the electrocardiograph 800 (usually, part of the electrocardiographic information input to the electrocardiograph 800) can be input to the arithmetic processing unit 75, and arithmetic processing is performed. The unit 75 can control the DC power supply unit 71, the first ON/OFF switch 761 and the second ON/OFF switch 762 based on this electrocardiographic information.

The electrocardiograph 800 (input terminal) constituting the catheter system of this embodiment is connected to the electrocardiograph connection connector 73 of the power supply device 700, and the defibrillation catheter 100 (first DC electrode group 31G, second DC electrode group 32G) and constituent electrodes of the proximal side potential measuring electrode group 33G) is input to the electrocardiograph 800 from the electrocardiograph connection connector 73 .

The electrocardiograph 800 (another input terminal) is also connected to the electrocardiographic measurement means 900 , and the electrocardiographic information measured by the electrocardiographic measurement means 900 is also input to the electrocardiograph 800 .
Here, the electrocardiogram measuring means 900 includes an electrode pad attached to the patient's body surface for measuring a 12-lead electrocardiogram, and an electrode catheter attached to the patient's heart (an electrode different from the defibrillation catheter 100). catheter) can be mentioned.

The electrocardiograph 800 (output terminal) is connected to the electrocardiogram input connector 77 of the power supply device 700, and receives the electrocardiographic information input to the electrocardiograph 800 (the electrocardiographic information from the defibrillation catheter 100 and the electrocardiographic information from the electrocardiographic measuring means 900). electrocardiographic information from the electrocardiogram input connector 77 to the arithmetic processing unit 75 .

The defibrillation catheter 100 of this embodiment can be used as an electrode catheter for cardiac potential measurement when defibrillation treatment is not required.

Electrocardiographic potentials measured by the electrodes constituting first DC electrode group 31G and/or second DC electrode group 32G of defibrillation catheter 100 are connected to catheter connector 72, first ON/OFF switch 761 and electrocardiograph connector 73. It is input to the electrocardiograph 800 via.
In addition, the electrocardiographic potential measured by the electrodes constituting the proximal side potential measuring electrode group 33G of the defibrillation catheter 100 is directly transferred from the catheter connecting connector 72 to the electrocardiograph connecting connector without passing through the first ON/OFF switch 761. 73 to the electrocardiograph 800 .

Cardiac potential information (cardiogram waveform) from the defibrillation catheter 100 is displayed on a monitor (not shown) of the electrocardiograph 800 .
In addition, part of the electrocardiographic information from the defibrillation catheter 100 (for example, the potential difference between the first electrodes 31 (first and second electrodes) constituting the first DC electrode group 31G) is transferred from the electrocardiograph 800 , the electrocardiogram input connector 77 to the arithmetic processing unit 75 .

As described above, when defibrillation treatment is not required during cardiac catheterization, the defibrillation catheter 100 can be used as an electrode catheter for cardiac potential measurement (cardiac potential measurement mode).
Then, when atrial fibrillation occurs during cardiac catheterization, defibrillation therapy can be immediately performed using the defibrillation catheter 100 used as an electrode catheter (defibrillation/impedance measurement mode). As a result, when atrial fibrillation occurs, the trouble of inserting a new catheter for defibrillation can be saved.

An example of defibrillation treatment by the intracardiac defibrillation catheter system of this embodiment will be described below with reference to the flowchart shown in FIG.

(1) Turn on the main power switch 740 of the power supply device 700 (STEP 1).

(2) Connect the defibrillation catheter 100 to the power supply 700 (catheter connector 72) (STEP 2).
Here, the first DC electrode group 31G of defibrillation catheter 100 is positioned in the coronary sinus (CS), the second DC electrode group 32G is positioned in the right atrium (RA), and the proximal potential measuring electrode group 33G is positioned in the superior position. It is located in the vena cava (SVC).

(3) The mode (initial mode) of the power supply device 700 when the main power switch 740 is turned on is the "electrocardiogram measurement mode" (STEP 3, FIG. 9).
As shown in FIG. 9, the first ON/OFF switch 761 is in the "ON" state, and the second ON/OFF switch 762 is in the "OFF" state.
As a result, electrocardiographic information measured by the constituent electrodes of the first DC electrode group 31G and/or the second DC electrode group 32G is transmitted via the catheter connector 72, the first ON/OFF switch 761, and the electrocardiograph connector 73. It is input to the electrocardiograph 800 . Further, the electrocardiographic information measured by the constituent electrodes of the proximal side potential measuring electrode group 33G is input to the electrocardiograph 800 via the catheter connector 72 and the electrocardiograph connector 73 . The electrocardiogram information input to the electrocardiograph 800 is input to the arithmetic processing unit 75 via the electrocardiogram input connector 77 .
Further, the electrocardiographic information (12-lead electrocardiogram) measured by the electrocardiographic measuring means 900 (electrode pads attached to the body surface) is also input to the electrocardiograph 800, and the electrocardiographic information obtained by the electrocardiographic measuring means 900 is also input to the electrocardiogram input connector. 77 to the arithmetic processing unit 75 .
In the arithmetic processing unit 75 shown in FIG. 9, the IMP measurement circuit 752 and the internal resistance 753 are connected via the switching unit 754. At this stage, the IMP measurement circuit 752 measures the resistance value of the internal resistance 753. can be tested to see if it matches a known resistance value.

(4) Input the mode switch 741 (STEP 4).

(5) When the mode changeover switch 741 is turned on, the mode of the power supply device 700 becomes the "defibrillation/impedance measurement mode" (STEP 5, FIG. 10).
As shown in FIG. 10, the first ON/OFF switch 761 is in the "OFF" state, and the second ON/OFF switch 762 is in the "ON" state.
10, the IMP measurement circuit 752 and the second ON/OFF switch 762 are connected via the switching section 754. The operation processing section 75 shown in FIG.
By turning the first ON/OFF switch 761 to the "OFF" state, the path from the catheter connector 72 to the electrocardiograph connector 73 via the first ON/OFF switch 761 is blocked. The electrocardiographic information from the constituent electrodes of the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 cannot be input to the electrocardiograph 800 (therefore, this electrocardiographic information cannot be sent to the arithmetic processing unit 75). cannot be sent). However, electrocardiographic information from the constituent electrodes of the proximal side potential measuring electrode group 33</b>G that does not pass through the first ON/OFF switch 761 is input to the electrocardiograph 800 .

(6) By the IMP measurement circuit 752 of the arithmetic processing unit 75, each of the first electrodes 311 to 318 constituting the first DC electrode group 31G of the defibrillation catheter 100 and the second electrode 321 constituting the second DC electrode group 32G 328 (between the electrodes) are sequentially measured (STEP 6, FIG. 10, FIG. 15A).

First, as shown in FIG. 15A, the second contacts (IMP measurement circuit 752) of the changeover switches 789 and 799 are selected, only the switch 781 out of the switches 781 to 788 is turned "ON", and the switches 791 to 798 are turned ON. Only the switch 791 is turned "ON". Thereby, the impedance between the first electrode 311 and the second electrode 321 is measured.
Next, by turning the switch 781 "OFF", the switch 782 "ON", the switch 791 "OFF", and the switch 792 "ON", the impedance between the first electrode 312 and the second electrode 322 is changed. to measure.
Next, by turning the switch 782 "OFF", the switch 783 "ON", the switch 792 "OFF", and the switch 793 "ON", the impedance between the first electrode 313 and the second electrode 323 is changed. to measure.
Thereafter, in the same manner, the pair of switches (78X, 79X) to be turned ON are switched to switch between the first electrode 314 and the second electrode 324, between the first electrode 315 and the second electrode 325, and between the first electrode 315 and the second electrode 325. The impedance between the first electrode 316 and the second electrode 326, between the first electrode 317 and the second electrode 327, and between the first electrode 318 and the second electrode 328 is measured.
The time required for the inter-electrode impedance measurement performed eight times as described above is about several seconds.

(7) Judge whether or not all eight impedances measured in STEP6 are equal to or less than a predetermined value, and if all impedances are equal to or less than a predetermined value, proceed to STEP8, where at least one impedance is If it exceeds the predetermined value, the defibrillation treatment is interrupted or stopped, and the process returns to STEP2 (STEP7).
When at least one impedance exceeds a predetermined value, the arithmetic processing unit 75 determines that some of the lead wires are broken, and applies a DC voltage to the first DC electrode group 31G and the second DC electrode group 32G. is not sent to the DC power supply unit 71 for applying the . As a result, even if the operator performs post-defibrillation operations (operations in STEPs 10, 11, 13, and 17, which will be described later), the operations are invalidated.
Here, the "predetermined value" used as a criterion for determining the presence or absence of disconnection is, for example, 500Ω.
The fact that at least one impedance exceeds a predetermined value is displayed on display means (not shown) provided in the power supply device 700 or notified to the operator by an alarm or the like. This allows the operator to interrupt or stop defibrillation therapy, such as for exchanging the defibrillation catheter 100 .

(8) The IMP measurement circuit 752 of the arithmetic processing unit 75 measures the impedance between the first DC electrode group 31G and the second DC electrode group 32G (between the electrode groups) of the defibrillation catheter 100 (STEP 8, FIG. 10 , FIG. 15B).

As shown in FIG. 15B, the second contacts (IMP measurement circuit 752) are selected in the changeover switches 789 and 799, and all of the switches 781 to 788 and switches 791 to 798 are turned "ON". This makes it possible to measure the impedance between the first DC electrode group 31G and the second DC electrode group 32G (between the electrode groups).
The time required to measure the impedance between the electrode groups is approximately one second.

(9) The mode of the power supply device 700 returns to the "electrocardiogram measurement mode" (STEP 9, FIG. 11).
As shown in FIG. 11, the first ON/OFF switch 761 is in the "ON" state, and the second ON/OFF switch 762 is in the "OFF" state.
11, the output circuit 751 and the internal resistor 753 are connected via the switching unit 754, and at this stage, the DC voltage can be applied to the internal resistor 753. , and it is possible to check (test) whether or not the set electric energy can be applied to the internal resistance 753 .

(10) The applied energy setting switch 742 is turned on to set the applied energy for defibrillation (STEP 10).
According to the electrode device 700 of this embodiment, the applied energy can be set from 1 J to 30 J in increments of 1 J.

(11) Turn on the charging switch 743 (STEP 11).

(12) A target voltage determined based on the impedance between the electrode groups measured in STEP8 and the electrical energy set in STEP10 is stored in the DC power supply unit (STEP12).

(13) Input the energy application preparation switch 744 (STEP 13).

(14) When the energy application preparation switch 744 is input, the first ON/OFF switch 761 maintains the "ON" state in response to the control signal from the arithmetic processing unit 75, and the second ON/OFF switch 762 is turned on. It switches from "OFF" to "ON" (STEP 14, FIG. 12).
12, the output circuit 751 and the second ON/OFF switch 762 are connected via the switching section 754. The operation processing section 75 shown in FIG.

(15) Visually confirm an electrocardiogram related to electrocardiographic information from the constituent electrodes of the first DC electrode group 31G and/or the second DC electrode group 32G of the defibrillation catheter 100 (STEP 15). At this time, an electrocardiogram related to the electrocardiographic information from the constituent electrodes of the proximal side potential measuring electrode group 33G and/or the electrocardiographic information obtained by the electrocardiographic measuring means 900 may also be confirmed.

(16) Determine whether or not the drift (baseline fluctuation) associated with mode switching or the like in the electrocardiogram has subsided. If it has subsided, proceed to STEP 17. If not, return to STEP 15 (STEP 16).

(17) Input the energy application execution switch 745 (STEP 17).

(18) When the energy application execution switch 745 is input, the second ON/OFF switch 762 maintains the "ON" state in response to the control signal from the arithmetic processing unit 75, and the first ON/OFF switch 761 is turned on. It is switched from "ON" to "OFF", and the path from the catheter connector 72 to the electrocardiograph connector 73 is immediately cut off (STEP 18, FIG. 13). As a result, the mode of the power supply device 700 becomes the “defibrillation/impedance measurement mode”, and no DC voltage is applied to the electrocardiograph 800 .

(19) Remove from the DC power supply unit 71 that receives the control signal from the arithmetic processing unit 75 via the output circuit 751 and the switching unit 754 of the arithmetic processing unit 75, the second ON/OFF switch 762 and the catheter connection connector 72 DC voltages of different polarities are applied to the first DC electrode group 31G and the second DC electrode group 32G of the fibrillation catheter 100 (STEP 19, FIGS. 14 and 15C).

(20) After the application of the voltage from the DC power supply unit 71 is stopped, the mode of the power supply device 700 returns to the "electrocardiogram measurement mode", and the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 Cardiac potential information from the constituent electrodes is input to the electrocardiograph 800 (STEP 20).

(21) heart from the configuration electrodes of the defibrillation catheter 100 (the configuration electrodes of the first DC electrode group 31G, the second DC electrode group 32G, and the proximal side potential measurement electrode group 33G) displayed on the monitor of the electrocardiograph 800; Electrocardiographic information (electrocardiogram) and electrocardiographic information (12-lead electrocardiogram) from the electrocardiographic measurement means 900 are observed, and if "normal", the process ends; if "not normal (atrial fibrillation has not subsided)" Then, return to STEP 4 (STEP 21).

According to the catheter system of this embodiment, by measuring the impedance between the electrodes eight times, 16 lead wires connected to each of the first electrodes 311-318 and the second electrodes 321-328 (the The first lead wire 41 and the second lead wire 42) can be checked for disconnection.

In addition, since the distance between the first electrode 31 and the second electrode 32 selected for impedance measurement is the same in eight measurements, the influence (error ) can be eliminated.
In addition, when at least one impedance exceeds a predetermined value, the application of DC voltage (defibrillation) is not performed, so that the occurrence of tissue damage due to disconnection of the lead wire can be reliably avoided. can be done.

By connecting the IMP measurement circuit 752 and the internal resistance 753 by the switching unit 754, the resistance value of the internal resistance 753 is measured by the IMP measurement circuit 752, and the operating state of the impedance measurement system including the IMP measurement circuit 752 is determined. can be confirmed.

In addition, by connecting the output circuit 751 and the internal resistor 753 by the switching unit 754, by applying electrical energy to the internal resistor 753 by the output circuit 751, the operating state of the DC voltage output system including the output circuit 751 is changed. can be confirmed.

<Second embodiment>
The intracardiac defibrillation catheter system of this embodiment has a first circuit configuration for switching between measurement of inter-electrode impedance, measurement of inter-electrode impedance, and application of DC voltage (execution of defibrillation). Unlike the embodiment, other configurations are the same as those of the first embodiment.

16A-16D show the measurement of the impedance (inter-electrode impedance) between two first electrodes 31 selected from the first DC electrode group 31G; and the two second electrodes 32 selected from the second DC electrode group 32G. Measurement of impedance (impedance between electrodes) between; Measurement of impedance (impedance between electrodes) between first DC electrode group 31G and second DC electrode group 32G; Measurement of impedance between first DC electrode group 31G and second DC electrode group 32G 1 schematically shows a circuit configuration for switching between application of a DC voltage to (execution of defibrillation).

In FIGS. 16A-16D, the same reference numerals are used for the same components as shown in FIGS. 15A-15C.
16A to 16D, reference numeral 7894 denotes a changeover switch having a common contact to which the switch 787 is connected, a first contact to which the changeover switch 789 is connected, and a second contact to which the changeover switch 799 is connected.
7893 is a changeover switch having a common contact to which the switch 785 is connected, a first contact to which the changeover switch 789 is connected, and a second contact to which the changeover switch 7894 is connected.
7892 is a changeover switch having a common contact to which the switch 783 is connected, a first contact to which the changeover switch 789 is connected, and a second contact to which the changeover switch 7893 is connected.
7891 is a changeover switch having a common contact to which the switch 781 is connected, a first contact to which the changeover switch 789 is connected, and a second contact to which the changeover switch 7892 is connected.
7994 is a changeover switch having a common contact to which the switch 797 is connected, a first contact to which the changeover switch 799 is connected, and a second contact to which the changeover switch 789 is connected.
7993 is a changeover switch having a common contact to which the switch 795 is connected, a first contact to which the changeover switch 799 is connected, and a second contact to which the changeover switch 7994 is connected.
7992 is a changeover switch having a common contact to which the switch 793 is connected, a first contact to which the changeover switch 799 is connected, and a second contact to which the changeover switch 7993 is connected.
7991 is a changeover switch having a common contact to which the switch 791 is connected, a first contact to which the changeover switch 799 is connected, and a second contact to which the changeover switch 7992 is connected.
Changeover switches 7891 to 7894 and changeover switches 7991 to 7994 are arranged inside power supply device 700 .

In FIG. 16A, the second contacts (IMP measurement circuit 752) are selected in the changeover switches 789 and 799, and the second contacts are selected in the changeover switches 7891-7894 and 7991-7994.
Also, only the switches 781 and 782 of the ON/OFF switches 781 to 788 are "ON", and all of the ON/OFF switches 791 to 798 are "OFF".
This makes it possible to measure the impedance between the adjacent first electrodes 311 and 312 .

From this state, by turning "OFF" the switches 781 and 782 and turning "ON" only the switches 783 and 784, the impedance between the first electrode 313 and the first electrode 314 can be measured. .
From this state, by turning "OFF" the switches 783 and 784 and turning "ON" only the switches 785 and 786, it is possible to measure the impedance between the adjacent first electrodes 315 and 316. becomes.
From this state, by turning the switches 785 and 786 "OFF" and turning only the switches 787 and 788 "ON", it is possible to measure the impedance between the adjacent first electrodes 317 and 318. becomes.

In FIG. 16B, the second contacts (IMP measurement circuit 752) are selected in the changeover switches 789 and 799, and the second contacts are selected in the changeover switches 7891-7894 and 7991-7994.
All of the ON/OFF switches 781 to 788 are "OFF", and only the switches 791 and 792 of the ON/OFF switches 791 to 798 are "ON".
This makes it possible to measure the impedance between the adjacent second electrodes 321 and 322 .

From this state, by turning the switches 791 and 792 "OFF" and turning only the switches 793 and 794 "ON", it becomes possible to measure the impedance between the second electrodes 323 and 324. .
From this state, by turning "OFF" the switches 793 and 794 and turning "ON" only the switches 795 and 796, it is possible to measure the impedance between the adjacent second electrodes 325 and 326. becomes.
From this state, by turning the switches 795 and 796 "OFF" and turning only the switches 797 and 798 "ON", it is possible to measure the impedance between the adjacent second electrodes 327 and 328. becomes.

In FIG. 16C, the second contacts (IMP measurement circuit 752) are selected in the changeover switches 789 and 799, and the first contacts are selected in the changeover switches 7891-7894 and 7991-7994.
Also, all of the switches 781 to 788 and switches 791 to 798 are "ON". This makes it possible to measure the impedance between the first DC electrode group 31G and the second DC electrode group 32G (between the electrode groups).

In FIG. 16D, the first contacts (output circuit 751) are selected in the changeover switches 789 and 799, and the first contacts are selected in the changeover switches 7891-7894 and 7991-7994.
Also, all of the switches 781 to 788 and switches 791 to 798 are "ON". This makes it possible to perform defibrillation by applying voltages of different polarities to the first DC electrode group 31G and the second DC electrode group 32G via the output circuit 751 .

According to the catheter system of this embodiment, by measuring the impedance between the electrodes eight times (four times for the first electrode 31 and four times for the second electrode), the first electrode 31 (311 to 318) and the 16 lead wires (first lead wire 41 and second lead wire 42) connected to each of the two electrodes 32 (321 to 328) can be checked for disconnection.

In addition, since the distance between the first electrode 31 and the second electrode 32 selected for impedance measurement is the same and shortest in eight measurements, the distance between the electrodes may be different or excessive. It is possible to eliminate the influence (error) on the measured value due to

In this embodiment, the impedance between the same DC electrode groups (between adjacent first electrodes and between adjacent second electrodes) was measured. According to the circuit configuration shown in FIG. ), the impedance between the first electrode 31 and the second electrode 32 can also be measured.

Although the embodiments of the present invention have been described above, the catheter system of the present invention is not limited to these, and various modifications are possible.
For example, the ON/OFF switches 781-788 and 791-798 shown in FIGS. 15A-15C and FIGS. switch may be used.

The catheter system of the present invention is not limited to an intracardiac defibrillation catheter system, but a catheter system comprising an electrode catheter having a plurality of electrodes and a power supply for applying energy to these electrodes. There may be.

Reference Signs List 100 defibrillation catheter 10 multi-lumen tube 11 first lumen 12 second lumen 13 third lumen 14 fourth lumen 15 fluorine resin layer 16 inner (core) portion 17 outer (shell) portion 18 stainless steel wire 20 handle 21 handle body 22 knob 24 strain relief 26 first insulating tube 27 second insulating tube 28 third insulating tube 31G first DC electrode group 31 (311 to 318) first electrode 32G second DC electrode group 32 (321 to 328) 2 electrodes 33G proximal side potential measurement electrode group 33 third electrode 35 distal tip 41G first lead wire group 41 first lead wire 42G second lead wire group 42 second lead wire 43G third lead wire group 43 lead wire 50 except Fibrillation catheter connector 51, 52, 53 Pin terminal 61 First protective tube 62 Second protective tube 65 Pull wire 700 Power supply device 71 DC power supply 72 Catheter connection connector 721, 722, 723 Terminal 73 Electrocardiograph connection connector 74 External switch (input means)
740 Main power switch 741 Mode changeover switch 742 Applied energy setting switch 743 Charge switch 744 Energy application preparation switch 745 Energy application execution switch (discharge switch)
75 arithmetic processing unit 751 output circuit 752 IMP measurement circuit 753 internal resistance 754 switching unit 761 first ON/OFF switch 762 second ON/OFF switch 77 electrocardiogram input connector 781 to 788 ON/OFF switch 789 changeover switch 791 to 798 ON/OFF switch 799 change-over switch 7891-7894 change-over switch 7991-7994 change-over switch 800 electrocardiograph 900 electrocardiogram measuring means

Claims (15)

1. A catheter system comprising a defibrillation catheter inserted into a heart chamber for defibrillation and a power supply device for applying a DC voltage to electrodes of the defibrillation catheter,
   The defibrillation catheter includes an insulating tube member, a first DC electrode group including a plurality of first electrodes attached to a distal region of the tube member, and spaced apart proximally from the first DC electrode group. A second DC electrode group consisting of a plurality of second electrodes attached to the distal end region of the tube member, and a plurality of first leads each having a distal end connected to each of the first electrodes constituting the first DC electrode group. a first lead wire group consisting of wires; and a second lead wire group consisting of a plurality of second lead wires each having a tip end connected to each of the second electrodes constituting the second DC electrode group,
   The power supply device includes a DC power supply unit including a capacitor, and an arithmetic processing unit that controls the DC power supply unit based on an external input and has a circuit for outputting a DC voltage from the DC power supply unit,
   When performing defibrillation with the defibrillation catheter, the first DC electrode group and the second DC electrode group of the defibrillation catheter are connected from the DC power supply unit via the output circuit of the arithmetic processing unit. voltages of different polarities are applied to
   The arithmetic processing unit of the power supply device, prior to performing defibrillation, to all the first electrodes constituting the first DC electrode group and all the second electrodes constituting the second DC electrode group On the other hand, control is performed so that the impedance between one first electrode selected from the first DC electrode group and one second electrode selected from the second DC electrode group is measured. An intracardiac defibrillation catheter system characterized by:
2. The arithmetic processing unit of the power supply device is an impedance capable of measuring an impedance between the first DC electrode group or the first electrode constituting the same and the second DC electrode group or the second electrode constituting the second DC electrode group. having a measuring circuit,
   The power supply device is connected to a base end of each of the first lead wires or a base end of each of the second lead wires, and connects each of the base ends to the output circuit or the impedance measurement circuit. has a switch group consisting of a plurality of switches that can
   The arithmetic processing unit of the power supply device, prior to performing defibrillation, to all the first electrodes constituting the first DC electrode group and all the second electrodes constituting the second DC electrode group On the other hand, the impedance between one first electrode selected from the first DC electrode group and one second electrode selected from the second DC electrode group is measured by the impedance measurement circuit. 2. The intracardiac defibrillation catheter system of claim 1, wherein the switch group is controlled so as to.
3. The first DC electrode group is composed of n (n is an integer equal to or greater than 2) of the first electrodes, and the second DC electrode group is composed of n of the second electrodes,
   The arithmetic processing unit of the power supply device includes a first electrode that is the k-th electrode from the tip of the first DC electrode group (k is any integer from 1 to n) and a first electrode that is the k-th electrode from the tip of the second DC electrode group. 3. The intracardiac defibrillation catheter system according to claim 1, wherein the impedance between the two electrodes is controlled to be measured n times.
4. The arithmetic processing unit of the power supply device controls the DC power supply unit so that defibrillation can be performed only when all of the plurality of measured impedances are equal to or less than a predetermined value. The intracardiac defibrillation catheter system according to any one of items 1 to 3.
5. The power supply device comprises display means,
   When an impedance exceeding a predetermined value is measured, the arithmetic processing unit of the power supply device controls the display means to display the combination of the first electrode and the second electrode for which the impedance is measured. The intracardiac defibrillation catheter system according to any one of claims 1 to 3, characterized by:
6. The arithmetic processing unit of the power supply device specifies the first electrode and/or the second electrode that caused the impedance exceeding a predetermined value to be measured, and controls the display means to display the electrode. The intracardiac defibrillation catheter system of claim 5, wherein:
7. After the defibrillation is performed, the arithmetic processing unit of the power supply device again performs all the first electrodes constituting the first DC electrode group and all the second electrodes constituting the second DC electrode group The electrodes are controlled such that the impedance between one first electrode selected from the first DC electrode group and one second electrode selected from the second DC electrode group is measured. The intracardiac defibrillation catheter system according to any one of claims 1 to 6, characterized in that:
8. 3. The arithmetic processing unit of the power supply device performs control so that the measurement of the impedance between the first electrode and the second electrode is started immediately after defibrillation is performed. 8. The intracardiac defibrillation catheter system according to 7.
9. 9. The power supply device according to any one of claims 1 to 8, wherein said arithmetic processing unit of said power supply device further controls such that an impedance between said first DC electrode group and said second DC electrode group is measured. intracardiac defibrillation catheter system.
10. An intracardiac defibrillation catheter system further comprising an electrocardiograph,
    The power supply device is a catheter electrically connected to each of the DC power supply unit, an external switch as input means, the arithmetic processing unit, and the first DC electrode group and the second DC electrode group of the defibrillation catheter. a connection connector, an electrocardiograph connection connector connected to an input terminal of the electrocardiograph, and a branch connector connected to the catheter connection connector and to the electrocardiograph connection connector and the arithmetic processing unit. and
    When the intracardiac potential is measured by the electrodes constituting the first DC electrode group and/or the second DC electrode group of the defibrillation catheter, the cardiac potential information from the defibrillation catheter is transferred to the catheter connector, input to the electrocardiograph via the branch connection and the electrocardiograph connection connector,
    When performing defibrillation with the defibrillation catheter, from the DC power supply unit, the first DC of the defibrillation catheter via the output circuit of the arithmetic processing unit, the branch connection unit and the catheter connection connector Voltages of different polarities are applied to the electrode group and the second DC electrode group,
    When measuring the impedance between the first DC electrode group and the second DC electrode group or the impedance between the first electrode and the second electrode of the defibrillation catheter, the measured impedance information includes: 3. The intracardiac defibrillation catheter system according to claim 2, wherein the signal is input to the arithmetic processing unit via the catheter connection connector, the branch connection portion, and the impedance measurement circuit of the arithmetic processing unit. .
11. A catheter system comprising a defibrillation catheter inserted into a heart chamber for defibrillation and a power supply device for applying a DC voltage to electrodes of the defibrillation catheter,
    The defibrillation catheter includes an insulating tube member, a first DC electrode group including a plurality of first electrodes attached to a distal region of the tube member, and spaced apart proximally from the first DC electrode group. A second DC electrode group consisting of a plurality of second electrodes attached to the distal end region of the tube member, and a plurality of first leads each having a distal end connected to each of the first electrodes constituting the first DC electrode group. a first lead wire group consisting of wires; and a second lead wire group consisting of a plurality of second lead wires each having a tip end connected to each of the second electrodes constituting the second DC electrode group,
    The power supply device includes a DC power supply unit having a capacitor and an arithmetic processing unit. The arithmetic processing unit controls the DC power supply unit based on an external input, a voltage output circuit; and an impedance measuring circuit capable of measuring the impedance between the first DC electrode group and the second DC electrode group and the impedance between the electrodes constituting the first DC electrode group or the second DC electrode group. death,
    When performing defibrillation with the defibrillation catheter, the first DC electrode group and the second DC electrode group of the defibrillation catheter are connected from the DC power supply unit via the output circuit of the arithmetic processing unit. voltages of different polarities are applied to
    The arithmetic processing unit of the power supply device, prior to performing defibrillation, to all the first electrodes constituting the first DC electrode group and all the second electrodes constituting the second DC electrode group In contrast, the intracardiac defibrillation is characterized in that the impedance between two electrodes selected from the first DC electrode group and the second DC electrode group is controlled to be measured by the impedance measurement circuit. catheter system.
12. The intracardiac defibrillation catheter system according to claim 11, wherein the two electrodes selected from the first DC electrode group and the second DC electrode group are adjacent electrodes.
13. The intracardiac defibrillation catheter system according to claim 2 or 11, characterized in that part of said arithmetic processing unit including said impedance measurement circuit is arranged outside said power supply device.
14. A catheter system comprising an electrode catheter for performing ablation and a power supply for applying energy to electrodes of the electrode catheter,
    The electrode catheter comprises an insulating tube member, an electrode group consisting of a plurality of electrodes attached to a tip region of the tube member, and a plurality of leads each having a tip end connected to each of the electrodes constituting the electrode group. and a lead wire group consisting of wires,
    The power supply device includes a power supply unit and an arithmetic processing unit that controls the power supply unit based on an external input. The arithmetic processing unit includes an energy output circuit from the power supply unit and the electrode group. Having an impedance measurement circuit capable of measuring the impedance between the constituting electrodes,
    When performing ablation with the electrode catheter, energy is applied from the power supply unit to the electrodes constituting the electrode group via the output circuit of the arithmetic processing unit,
    Prior to performing ablation, the arithmetic processing unit of the power supply device measures the impedance between two electrodes selected from the electrode group for all electrodes constituting the electrode group by the impedance measurement circuit. A catheter system characterized by controlling to be measured by.
15. 15. The catheter system of claim 14 for performing pulsed field ablation.
    

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