JP7579422B2 - Intracardiac Defibrillation Catheter System - Google Patents

Description

The present invention relates to an intracardiac defibrillation catheter system, and more specifically to a catheter system comprising a defibrillation catheter to be inserted into a cardiac cavity, a power supply device that applies a DC voltage to the electrodes of the defibrillation catheter, and an electrocardiograph.

The applicant has developed an intracardiac defibrillation catheter system for performing defibrillation treatment of a heart suffering from atrial fibrillation or the like, which comprises a defibrillation catheter that is inserted into a cardiac cavity to perform defibrillation, a power supply unit that applies a DC voltage to the electrodes of the defibrillation catheter, and an electrocardiograph; the defibrillation catheter comprises a first electrode group consisting of a plurality of ring-shaped electrodes attached to the distal end region of an insulating tube member, 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 to the proximal end side, a first lead wire group consisting of a plurality of lead wires whose tips are connected to each of the electrodes constituting the first electrode group, 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 unit comprises a DC power supply unit, a catheter connection connector that is connected to the proximal end side of the first lead wire group and the second lead wire group of the defibrillation catheter, an electrocardiograph connection connector that is connected to an input terminal of the electrocardiograph, and controls the DC power supply unit based on the input of an external switch and supplies a DC voltage to the DC power supply unit. and a switching unit consisting of a one-circuit, two-contact changeover switch, with the catheter connection connector connected to a common contact, the electrocardiograph connection connector connected to a first contact, and the arithmetic processing unit connected to a second contact; when a cardiac potential is measured using electrodes constituting a first electrode group and/or a second electrode group of the defibrillation catheter, the first contact is selected in the switching unit, and cardiac potential information from the defibrillation catheter 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 defibrillation is performed using the defibrillation catheter, the contact of the switching unit is switched to the second contact by the arithmetic processing unit of the power supply device, and voltages of mutually opposite polarities are applied from the DC power supply unit to the first electrode group and the second electrode group of the defibrillation catheter via the output circuit of the arithmetic processing unit, the switching unit, and the catheter connection connector (see Patent Document 1 below).

This intracardiac defibrillation catheter system can reliably supply the necessary and sufficient electrical energy for defibrillation to a heart that has developed atrial fibrillation or the like during cardiac catheterization. In addition, when defibrillation treatment is not required, the defibrillation catheter that constitutes the catheter system can be used as an electrode catheter for measuring cardiac potentials.

In defibrillation treatment using the intracardiac defibrillation catheter system described in Patent Document 1, the mode of the power supply device is switched to the "defibrillation mode" for a certain period of time (e.g., 1 second) by inputting the mode change switch of the power supply device in the "cardiac potential measurement mode". During this time, the impedance between the first electrode group and the second electrode group of the defibrillation catheter is measured. Then, the applied energy setting switch is input to set the electrical energy to be applied when performing defibrillation, and the charging switch is input to charge the DC power supply unit with a voltage determined based on the measured impedance and the set electrical energy. After charging is completed, the energy application switch is input to switch the contact of the switching unit from the first contact to the second contact (thereby switching the mode of the power supply device from the "cardiac potential measurement mode" to the "defibrillation mode"), and DC voltages of different polarities are applied to the first electrode group and the second electrode group of the defibrillation catheter from the DC power supply unit that has received a control signal from the arithmetic processing unit via the output circuit of the arithmetic processing unit, the switching unit, and the catheter connection connector.

The applicant has also developed an intracardiac defibrillation catheter system that can prevent a voltage from being applied to the electrodes of a defibrillation catheter when the baseline of an electrocardiogram input from an electrocardiograph to an arithmetic processing unit is fluctuating (drifting), and can perform defibrillation by applying a DC voltage to the electrodes of the defibrillation catheter in synchronization with the R-wave of the electrocardiogram when the baseline is stable. The catheter system includes a defibrillation catheter, a power supply device, and an electrocardiograph; the power supply device has a DC power supply unit, a catheter connection connector connected to the base end side of a first lead group and a second lead group of the defibrillation catheter, an electrocardiograph connection connector connected to an input terminal of the electrocardiograph, an external switch including an electric energy application preparation switch and an application execution switch, and an output circuit for a DC voltage from the DC power supply unit, and an arithmetic processing unit that controls the DC power supply unit based on an input from the external switch. a switching unit including a one-circuit two-contact changeover switch having a common contact to which the catheter connection connector is connected, a first contact to which the electrocardiograph connection connector is connected, and a second contact to which the arithmetic processing unit is connected, and an electrocardiogram input connector connected to the arithmetic processing unit and an output terminal of the electrocardiograph; defibrillation is performed by the defibrillation catheter by inputting the application execution switch after inputting the application preparation switch, and when defibrillation is performed, voltages of different polarities are applied from the DC power supply unit to the first electrode group and the second electrode group of the defibrillation catheter via the output circuit of the arithmetic processing unit and the catheter connection connector; the arithmetic processing unit of the power supply device sequentially senses events estimated to be R waves from the electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and detects an event (V In one embodiment, the present invention provides an intracardiac defibrillation catheter system _that controls the DC power supply unit by performing arithmetic processing so that a voltage is applied to the first electrode group and the second electrode group in synchronization with an abnormal wave height event ( _V n ) only if the polarity of an abnormal wave height event (V _{n -1} ) matches the polarity of the event (V n-2 ) sensed at least one event before that and the polarity of the event sensed two events before that, and if the event (V _n ) is sensed after a certain waiting time has elapsed since the occurrence of the abnormal wave height event (see Patent Document 2 below).

According to this intracardiac defibrillation catheter system, the polarity of the three events (V _n-2 ), (V _n-1 ), and (V _n ) are the same, and when an abnormal wave height event is detected between when the application preparation switch is turned on and when the application execution switch is turned on, the calculation processing unit of the power supply device controls the DC power supply unit to apply voltage in synchronization with the event (V _n ) only if the event (V _n ) is sensed a certain waiting time after the occurrence of the abnormal wave height event.This prevents voltage from being applied to the electrodes of the defibrillation catheter when the baseline of the electrocardiogram input from the electrocardiograph to the calculation processing unit is fluctuating (drifting), and when the baseline is stable, defibrillation can be performed by applying a DC voltage to the electrodes of the defibrillation catheter in synchronization with the R wave of the electrocardiogram.

The power supply device constituting the intracardiac defibrillation catheter system described in Patent Document 2 includes an energy application preparation switch and an energy application execution switch as external switches for applying energy. When the energy application preparation switch is input, the contact of the switching unit that receives the control signal from the arithmetic processing unit switches from the first contact to the second contact (thereby switching the mode of the power supply device from the "cardiac potential measurement mode" to the "defibrillation mode"), and a path is secured from the catheter connection connector to the arithmetic processing unit via the switching unit. Then, when the energy application execution switch is input after (or simultaneously with) input of the energy application preparation switch, DC voltages of different polarities are applied from the DC power supply unit that receives the control signal from the arithmetic processing unit to the first electrode group and the second electrode group of the defibrillation catheter via the output circuit of the arithmetic processing unit, the switching unit, and the catheter connection connector.

Patent No. 4545216 Patent No. 6632511

Immediately before applying the DC voltage, cardiac potential information measured by the constituent electrodes of the first electrode group and the constituent electrodes of the second electrode group is extremely important.
However, in the intracardiac defibrillation catheter system described in Patent Document 2, during the period between when the energy application preparation switch is turned on and when the energy application execution switch is turned on (usually 8 to 10 seconds), the switching unit consisting of a one-circuit, two-contact changeover switch selects the second contact, and the path from the catheter connection connector to the electrocardiograph connection connector via the switching unit is blocked, so the electrocardiograph that constitutes the system is unable to acquire cardiac potential information measured by the constituent electrodes of the first electrode group and/or the second electrode group.

The present invention has been made based on the above circumstances. The object of the present invention is to provide an intracardiac defibrillation catheter system that can acquire cardiac potential information from the constituent electrodes of the first electrode group and/or the second electrode group until immediately before a DC voltage is applied to the first electrode group and the second electrode group of the defibrillation catheter.

(1) An intracardiac defibrillation catheter system according to the present invention is a catheter system including a defibrillation catheter that is inserted into a cardiac cavity to perform defibrillation, a power supply device that applies a DC voltage to electrodes of the defibrillation catheter, and an electrocardiograph,
The defibrillation catheter includes an insulating tube member, a first electrode group (first DC electrode group) including a plurality of ring-shaped electrodes attached to a distal end region of the tube member, and
a second electrode group (second DC electrode group) consisting of a plurality of ring-shaped electrodes attached to the distal end region of the tubular member and spaced apart from the proximal end side from the first electrode group;
The power supply device includes a DC power supply unit having a capacitor;
An external switch as an input means;
a processor that controls the DC power supply unit based on an input from the external switch and has an output circuit for outputting a DC voltage from the DC power supply unit;
a catheter connector electrically connected to each of the first DC electrode group and the second DC electrode group of the defibrillation catheter;
an electrocardiograph connector to be connected to an input terminal of the electrocardiograph;
a first ON/OFF switch interposed between the catheter connector and the electrocardiograph connector;
a second ON/OFF switch interposed between the catheter connector and the arithmetic processing unit,
When measuring a cardiac potential using the electrodes constituting the first DC electrode group and/or the second DC electrode group of the defibrillation catheter, the first ON/OFF switch is turned "ON", and cardiac potential information from the defibrillation catheter is input to the electrocardiograph via the catheter connection connector, the first ON/OFF switch, and the electrocardiograph connection connector;
When defibrillation is performed using the defibrillation catheter, the second ON/OFF switch is turned "ON", and voltages of different polarities are applied to the first DC electrode group and the second DC electrode group of the defibrillation catheter from the DC power supply unit via the output circuit of the arithmetic processing unit, the second ON/OFF switch, and the catheter connection connector.

According to a defibrillation catheter system configured in this manner, unlike a one-circuit, two-contact changeover switch, the first ON/OFF switch and the second ON/OFF switch are independent of each other, so it is possible to turn both of them "ON" or "OFF."
By turning both the first ON/OFF switch and the second ON/OFF switch "ON", a path from the catheter connection connector via the second ON/OFF switch to the calculation processing unit is secured, making it possible to apply energy (preparation for energy application is completed), and cardiac potential information can be obtained from the constituent electrodes of the first DC electrode group and/or the second DC electrode group of the defibrillation catheter. This makes it possible to obtain cardiac potential information from the constituent electrodes of the first DC electrode group and/or the second DC electrode group until the first ON/OFF switch is switched "OFF".

(2) In the intracardiac defibrillation catheter system of the present invention, the power supply device includes, as the external switch, an energy application preparation switch for preparing to perform defibrillation, and an energy application execution switch for applying electrical energy to perform defibrillation;
when the energy application preparation switch is input while the first ON/OFF switch is "ON" and the second ON/OFF switch is "OFF", the arithmetic processing unit controls these ON/OFF switches so that the first ON/OFF switch maintains the "ON" state and the second ON/OFF switch switches from "OFF" to "ON",
It is preferable that when the energy application execution switch is input after the energy application preparation switch is input, the calculation processing unit controls these ON/OFF switches so that the second ON/OFF switch remains in the "ON" state and the first ON/OFF switch is switched from "ON" to "OFF".

With a defibrillation catheter system configured in this manner, even when preparation for energy application has been completed by inputting the energy application preparation switch, cardiac potential information can be acquired from the constituent electrodes of the first DC electrode group and/or the second DC electrode group of the defibrillation catheter until the energy application execution switch is input.
This makes it possible to confirm that the cardiac potential information at the treatment site is stable before turning on the energy application execution switch (performing defibrillation).

In addition, by inputting the energy application execution switch, the first ON/OFF switch is switched from "ON" to "OFF", and the path from the catheter connection connector via the first ON/OFF switch to the electrocardiograph connection connector is immediately blocked, so that no DC voltage is applied to the electrocardiograph.

(3) In the intracardiac defibrillation catheter system of (2), the power supply device includes a main power switch, a mode changeover switch for switching between a cardiac potential measurement mode and a defibrillation mode, an applied energy setting switch for setting an electric energy to be applied during defibrillation, a charging switch for storing a voltage determined based on the set electric energy in the DC power supply unit, the energy application preparation switch, and the energy application execution switch;
When the main power switch is turned on, the first ON/OFF switch is turned "ON" and the second ON/OFF switch is turned "OFF",
For a certain period of time after the mode changeover switch is turned on, the first ON/OFF switch is turned "OFF" and the second ON/OFF switch is turned "ON",
When the applied energy setting switch or the charging switch is turned on,
The first ON/OFF switch and the second ON/OFF switch do not switch “ON”/“OFF”,
When the energy application preparation switch is turned on, both the first ON/OFF switch and the second ON/OFF switch are turned “ON”,
When the energy application execution switch is turned on, the first ON/OFF switch is turned “OFF” and the second ON/OFF switch is turned “ON”.
It is preferable to control the first ON/OFF switch and the second ON/OFF switch.

With a defibrillation catheter system configured as described above, the initial mode is set to "cardiac potential measurement mode" by turning on the main power switch, and is set to "defibrillation mode" for a certain period of time by turning on the mode change switch, making it possible to measure the impedance between the first DC electrode group and the second DC electrode group of the defibrillation catheter, and the "cardiac potential measurement mode" is maintained when setting the electrical energy to be applied and charging the DC power supply unit, and by turning on the energy application preparation switch, preparation for energy application is completed and cardiac potential information can be obtained from the constituent electrodes of the first DC electrode group and/or second DC electrode group of the defibrillation catheter (the baseline of the electrocardiogram related to the cardiac potential information can be monitored, etc.), and defibrillation can be performed by applying a DC voltage to the first DC electrode group and the second DC electrode group by turning on the energy application execution switch.

(4) In the intracardiac defibrillation catheter system of (3) above, it is preferable that the calculation processing unit of the power supply device is controlled to measure the impedance between the first DC electrode group and the second DC electrode group of the defibrillation catheter at the certain time after the mode change switch is input.

(5) In the intracardiac defibrillation catheter system of (4) above, it is preferable that the calculation processing unit of the power supply device controls the DC power supply unit to accumulate a voltage determined based on the measured impedance and the electrical energy set by inputting the applied energy setting switch.

(6) In the intracardiac defibrillation catheter system of the present invention, it is preferable that the power supply device has an electrocardiogram input connector connected to the calculation processing unit and the output terminal of the electrocardiograph.

With a defibrillation catheter system configured in this manner, cardiac potential information output from the electrocardiograph can be input to a calculation processing unit, and the calculation processing unit can control the DC power supply unit, the first ON/OFF switch, and the second ON/OFF switch based on this cardiac potential information.

(7) In the intracardiac defibrillation catheter system of the present invention, the defibrillation catheter includes a plurality of electrodes attached to the tube member at a distance from the first DC electrode group or the second DC electrode group, and includes a potential measurement electrode group electrically connected to the catheter connection connector;
the power supply device is provided with a path that directly connects the catheter connector and the electrocardiograph connector;
It is preferable that cardiac potential information measured by the electrodes constituting the potential measuring electrode group is input to the electrocardiograph from the catheter connection connector of the power supply device via the electrocardiograph connection connector without passing through the first ON/OFF switch.

With this configuration, even during defibrillation treatment when the electrocardiograph cannot acquire cardiac potential information from the constituent electrodes of the first DC electrode group and the second DC electrode group of the defibrillation catheter, the electrocardiograph can acquire the cardiac potential measured by the potential measurement electrode group.

(8) In the intracardiac defibrillation catheter system of the present invention, it is preferable that a cardiac potential measuring means other than the defibrillation catheter is connected to the electrocardiograph.

(9) In the intracardiac defibrillation catheter system described above in (8), it is preferable that the cardiac potential measuring means is an electrode pad or an electrode catheter.

With this configuration, even during defibrillation treatment when the electrocardiograph cannot acquire cardiac potential information from the constituent electrodes of the first DC electrode group and the second DC electrode group of the defibrillation catheter, the electrocardiograph can acquire the cardiac potential measured by the cardiac potential measuring means.

According to the intracardiac defibrillation catheter system of the present invention, cardiac potential information can be obtained from the constituent electrodes of the first electrode group and/or the second electrode group until immediately before a DC voltage is applied to the first electrode group and the second electrode group of the defibrillation catheter (defibrillation is performed).

FIG. 1 is a block diagram showing one embodiment of an intracardiac defibrillation catheter system of the present invention. FIG. 2 is an explanatory plan view showing a defibrillation catheter constituting the catheter system shown in FIG. 1 . FIG. 2 is an explanatory plan view (for explaining dimensions and hardness) showing a defibrillation catheter constituting the catheter system shown in FIG. 1 . 3 is a cross-sectional view showing the AA section of FIG. 2. 3A and 3B are cross-sectional views showing the sections BB, CC, and DD in FIG. 2. FIG. 3 is a perspective view showing the internal structure of a handle of one embodiment of the defibrillation catheter shown in FIG. 2 is an explanatory diagram showing a schematic 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 . FIG. 2 is a flowchart showing the operation and manipulation of the power supply device in the catheter system shown in FIG. 1 . 2 is a block diagram showing the flow of cardiac potential information in a cardiac potential measurement mode after a 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 relating to measured values of impedance between electrodes and cardiac potential information in the defibrillation mode after a mode change switch is turned on in the catheter system shown in FIG. 1 . 1. FIG. 4 is a block diagram showing the flow of cardiac potential information in a cardiac potential measurement mode after a certain time has elapsed since a mode change switch was turned on in the catheter system shown in FIG. 2 is a block diagram showing the flow of cardiac potential information after an application preparation switch is turned on in the catheter system shown in FIG. 1. FIG. 2 is a block diagram showing the flow of cardiac potential information after an application execution switch is pressed in the catheter system shown in FIG. 1. FIG. 2 is a block diagram showing a state when a DC voltage is applied after an application execution switch is turned on in the catheter system shown in FIG. 1. FIG.

<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 a cardiac potential measuring means 900.

As shown in Figures 2 to 6, the defibrillation catheter 100 constituting the catheter system of this embodiment comprises a multi-lumen tube 10, a handle 20, a first DC electrode group 31G, a second DC electrode group 32G, a base end potential measurement 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 Figures 4 and 5, the multi-lumen tube 10 has four lumens (a first lumen 11, a second lumen 12, a third lumen 13, and a fourth lumen 14).

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

The handle 20 constituting the defibrillation catheter 100 in 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 (swung).

A first DC electrode group 31G, a second DC electrode group 32G, and a base-end potential measurement electrode group 33G are attached to the distal end region of the multi-lumen tube 10. Here, the term "electrode group" refers to a collection of multiple electrodes that are attached at close intervals (e.g., 5 mm or less) and have the same pole (same polarity) or have the same purpose.

The first DC electrode group 31G is composed of eight ring-shaped electrodes 31 attached to the distal end region of the multi-lumen tube 10. The electrodes 31 constituting the first DC electrode group 31G are connected to a catheter-connecting connector 72 of the power supply device 700 via 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 a heart chamber), the first DC electrode group 31G is located, for example, in a coronary vein.

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

The base-side potential measurement electrode group 33G is composed of four ring-shaped electrodes 33 attached to the tip region of the multi-lumen tube 10, spaced proximally from the attachment position of the second DC electrode group 32G. The electrodes 33 constituting the base-side potential measurement electrode group 33G are connected to the catheter connection connector 72 of the power supply device 700 via lead wires 43 constituting the third lead wire group 43G and a connector described later.
When the defibrillation catheter 100 is in use (placed in a cardiac cavity), the base-end potential measuring electrode group 33G is located in, for example, the superior vena cava.

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

The first lead wire group 41G shown in Figs. 4 and 5 is a collection of eight lead wires 41 connected to the eight electrodes 31 constituting the first DC electrode group 31G, respectively.
Each of the eight electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the power supply device 700 via the first lead wire group 41G.

The eight electrodes 31 constituting the first DC electrode group 31G are each connected to a different lead wire 41. Each of the lead wires 41 is welded at its tip to the inner surface of the electrode 31 and enters the first lumen 11 from a side hole formed in the tube wall of the multi-lumen tube 10. The eight lead wires 41 that enter the first lumen 11 extend into the first lumen 11 as the first lead wire group 41G.

The second lead wire group 42G shown in Figs. 4 and 5 is a collection of eight lead wires 42 connected to the eight electrodes 32 constituting the second DC electrode group 32G, respectively.
Each of the eight 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 electrodes 32 constituting the second DC electrode group 32G are each connected to a different lead wire 42. Each of the lead wires 42 is welded at its tip to the inner surface of the electrode 32 and enters the second lumen 12 from a side hole formed in the tube wall of the multi-lumen tube 10. The eight lead wires 42 that enter the second lumen 12 extend into the second lumen 12 as the second lead wire group 42G.

As described above, the first lead wire group 41G extends into the first lumen 11, and the second lead wire group 42G extends into the second lumen 12, so that the two are completely insulated and isolated within the multi-lumen tube 10. Therefore, when the 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 a collection of four lead wires 43 connected to each of the electrodes 33 constituting the proximal potential measurement electrode group 33G.
The third lead wire group 43G can electrically connect each of the electrodes 33 constituting the proximal potential measurement electrode group 33G to the power supply device 700.

The four electrodes 33 constituting the base-end potential measurement electrode group 33G are each connected to a different lead wire 43. Each of the lead wires 43 is welded to the inner circumferential surface of the electrode 33 at its tip portion and enters the third lumen 13 from a side hole formed in the tube wall of the multi-lumen tube 10. The four lead wires 43 that enter the third lumen 13 extend into the third lumen 13 as the third lead wire group 43G.

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

In FIG. 4 and FIG. 5, 65 denotes a pull wire.
The pull wire 65 extends into 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. Meanwhile, the proximal end portion of the pull wire 65 is connected to the knob 22 of the handle 20. By operating the knob 22, the pull wire 65 is pulled, thereby deflecting the distal portion of the multi-lumen tube 10.

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

Figure 6 is a perspective view showing the internal structure of the handle of the defibrillation catheter 100 in this embodiment. As shown in Figure 6, the base end of the multi-lumen tube 10 is inserted into the tip opening of the handle 20, thereby connecting the multi-lumen tube 10 and the handle 20.

A cylindrical connector 50 is built into the proximal end of the handle 20 .
Within the handle 20, three insulating tubes (first insulating tube 26, second insulating tube 27, third insulating tube 28) extend, 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.

The tip 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 connected to the first lumen 11 through which the first lead wire group 41G extends.
The first insulating tube 26 extends through the inner hole of the first protective tube 61 extending inside the handle 20 to the vicinity of the connector 50, forming an insertion passage that guides the base ends of the first lead wire group 41G to the vicinity of the connector 50.
The first lead wire group 41G extending from the base end opening of the first insulating tube 26 is separated into eight lead wires 41, and each of these lead wires 41 is connected and fixed by solder to each of the pin terminals arranged on the tip surface of the connector 50.

The tip 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 connected to the second lumen 12 through which the second lead wire group 42G extends.
The second insulating tube 27 extends through the inner hole of the second protective tube 62 extending inside the handle 20 to the vicinity of the connector 50, forming an insertion passage that guides the base ends of the second lead wire group 42G to the vicinity of the connector 50.
The second lead wire group 42G extending from the base end opening of the second insulating tube 27 is separated into eight lead wires 42, and each of these lead wires 42 is connected and fixed by solder to each of the pin terminals arranged on the tip surface of the connector 50.

The tip 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 connected to the third lumen 13 through which the third lead wire group 43G extends.
The third insulating tube 28 extends through the inner hole of the second protective tube 62 extending inside the handle 20 to the vicinity of the connector 50, forming an insertion passage that guides the base ends of the third lead wire group 43G to the vicinity of the connector 50.
The third lead wire group 43G extending from the base end opening of the third insulating tube 28 is separated into four lead wires 43, and each of these lead wires 43 is connected and fixed by solder to each of the pin terminals arranged on the tip surface of the connector 50.

According to the defibrillation catheter 100 of this embodiment having the above-mentioned configuration, the first lead wire group 41G extends into the first insulating tube 26, the second lead wire group 42G extends into the second insulating tube 27, and the third lead wire group 43G extends into the third insulating tube 28, so that 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, the power supply unit 700 constituting the catheter system of this embodiment includes a DC power supply unit 71, a catheter connection connector 72, an electrocardiogram connection connector 73, an external switch (input means) 74, an arithmetic processing unit 75, a first ON/OFF switch 761, a second ON/OFF switch 762, and an electrocardiogram input connector 77.

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

The proximal ends 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 are connected to the catheter connection connector 72.
As a result, the catheter connection connector 72 is electrically connected to each of the first DC electrode group 31G, the second DC electrode group 32G, and the base-end potential measurement electrode group 33G.

The catheter connection connector 72 is connected to the connector 50 of the defibrillation catheter 100 and is electrically connected to the base end 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, the connector 50 of the defibrillation catheter 100 and the catheter connector 72 of the power supply device 700 are connected by a connector cable C1.
Pin terminals 51 (actually eight terminals) to which eight lead wires 41 constituting the first lead wire group are connected and fixed, and terminals 721 (actually eight terminals) of a catheter connection connector 72,
Pin terminals 52 (actually eight terminals) to which the eight lead wires 42 constituting the second lead wire group are connected and fixed, and terminals 722 (actually eight terminals) of a catheter connection connector 72,
The pin terminals 53 (actually four terminals) to which the four lead wires 43 constituting the third lead wire group are fixedly connected are each connected to the terminals 723 (actually four terminals) of the catheter connection connector 72 .

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

The electrocardiograph connector 73 is connected to an input terminal of the electrocardiograph 800 .
The external switch 74, which is an input means, comprises a main power switch 740 for starting the power supply device 700, a mode changeover switch 741 for switching between a cardiac potential measurement mode and a defibrillation mode, an applied energy setting switch 742 for setting the electrical energy to be applied during defibrillation, a charging switch 743 for storing a voltage determined based on the set electrical energy in the DC power supply section, an energy application preparation switch 744 for preparing to perform defibrillation (switching the relay), and an energy application execution switch 745 for applying electrical energy to perform defibrillation.
All of the input signals from these external switches 74 are sent to an arithmetic processing unit 75 .

The arithmetic processing unit 75 controls the DC power supply unit 71 , the first ON/OFF switch 761 and the second ON/OFF switch 762 based on the input of the external switch 74 .
This calculation processing unit 75 has an output circuit 751 for outputting a DC voltage from the DC power supply unit 71 to the electrodes of the defibrillation catheter 100 via a second ON/OFF switch 762, a CPU circuit 752 for measuring the impedance between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100, an internal resistor 753 with a known resistance value used for operation confirmation (testing), and a switching unit 754 for switching the connection destinations of each of the output circuit 751 and the CPU circuit 752 between the internal resistor 753 and the second ON/OFF switch 762.

The output circuit 751 can apply a DC voltage so that terminal 721 (ultimately, the first DC electrode group 31G of the defibrillation catheter 100) of the catheter connection connector 72 shown in Figure 7 and terminal 722 (ultimately, the second DC electrode group 32G of the defibrillation catheter 100) of the catheter connection connector 72 have opposite polarities (when one electrode group is negative, the other electrode group is positive).

The CPU 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, and this measurement value is used to determine the target voltage to be stored in the DC power supply unit 71.

The first ON/OFF switch 761 is connected to the catheter connection connector 72 and also to the electrocardiograph connection connector 73 .
The second ON/OFF switch 762 is connected to the catheter connection connector 72 and also to the calculation processing unit 75 .

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

In addition, by turning the first ON/OFF switch 761 "OFF" and the second ON/OFF switch 762 "ON" while the output circuit 751 and the second ON/OFF switch 762 are connected via the switching unit 754, voltages of different polarities can be applied from the DC power supply unit 71 to the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 via the output circuit 751, the switching unit 754, the second ON/OFF switch 762 and the catheter connection connector 72 of the arithmetic processing unit 75 (defibrillation mode).

In addition, with the CPU circuit 752 and the second ON/OFF switch 762 connected via the switching unit 754, the impedance between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 can be measured by turning the first ON/OFF switch 761 to “OFF” and the second ON/OFF switch 762 to “ON.”
The switching between “ON” and “OFF” of the first ON/OFF switch 761 and the second ON/OFF switch 762 is controlled by the calculation processing unit 75 based on inputs from a mode changeover switch 741 and an energy application preparation switch 744 which are external switches 74 .

The electrocardiogram input connector 77 is connected to the calculation processing unit 75 and also to an output terminal of the electrocardiograph 800 .
This electrocardiogram input connector 77 allows the electrocardiogram information output from the electrocardiograph 800 (usually a part of the electrocardiogram information input to the electrocardiograph 800) to be input to the calculation processing unit 75.
The arithmetic processing 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 cardiac potential 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 unit 700, and cardiac potential information measured by the defibrillation catheter 100 (electrodes constituting the first DC electrode group 31G, the second DC electrode group 32G and the base-end potential measurement electrode group 33G) is input from the electrocardiograph connection connector 73 to the electrocardiograph 800.

The electrocardiograph 800 (the other input terminal) is also connected to a cardiac potential measuring means 900 , and cardiac potential information measured by the cardiac potential measuring means 900 is also input to the electrocardiograph 800 .
Here, the cardiac potential measuring means 900 can include an electrode pad that is attached to the surface of the patient's body to measure a 12-lead electrocardiogram, and an electrode catheter (an electrode catheter different from the defibrillation catheter 100) that is inserted into the patient's heart.

The electrocardiograph 800 (output terminal) is connected to the electrocardiogram input connector 77 of the power supply unit 700, and a portion of the cardiac potential information input to the electrocardiograph 800 (cardiac potential information from the defibrillation catheter 100 and cardiac potential information from the cardiac potential measuring means 900) can be sent from the electrocardiogram input connector 77 to the calculation processing unit 75.

The defibrillation catheter 100 in this embodiment can be used as an electrode catheter for measuring cardiac potentials when defibrillation treatment is not required.

The cardiac potential measured by the electrodes constituting the first DC electrode group 31G and/or the second DC electrode group 32G of the defibrillation catheter 100 is input to the electrocardiograph 800 via the catheter connection connector 72, the first ON/OFF switch 761, and the electrocardiograph connection connector 73.
In addition, the cardiac potential measured by the electrodes that make up the base-end potential measurement electrode group 33G of the defibrillation catheter 100 is input from the catheter connection connector 72 directly to the electrocardiograph 800 via the electrocardiograph connection connector 73 without passing through the first ON/OFF switch 761.

The cardiac potential information (cardiac potential waveform) from the defibrillation catheter 100 is displayed on a monitor (not shown) of the electrocardiograph 800 .
In addition, a portion of the cardiac potential information from the defibrillation catheter 100 (for example, the potential difference between the electrodes 31 (the first pole and the second pole) that constitute the first DC electrode group 31G) can be input from the electrocardiograph 800 to the calculation processing unit 75 via the electrocardiogram input connector 77.

As described above, when defibrillation treatment is not required during cardiac catheterization, the defibrillation catheter 100 can be used as an electrode catheter for measuring cardiac potentials (cardiac potential measurement mode).

If atrial fibrillation occurs during cardiac catheterization, defibrillation treatment can be performed immediately using the defibrillation catheter 100 that was used as the electrode catheter (defibrillation mode). As a result, it is possible to avoid the trouble of inserting a new catheter for defibrillation when atrial fibrillation occurs.

Below, an example of defibrillation treatment using the intracardiac defibrillation catheter system of this embodiment is described with reference to the flowchart shown in Figure 8.

(1) The defibrillation catheter 100 is connected to the power supply device 700 (catheter connection connector 72), and the main power switch 740 of the power supply device 700 is turned ON (STEP 1).
Here, the first DC electrode group 31G of the 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 base-end potential measurement electrode group 33G is positioned in the superior vena cava (SVC).

(2) When the main power switch 740 is turned on, the mode (initial mode) of the power supply device 700 is the "cardiac potential measuring mode" (STEP 2, 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, cardiac potential information measured by the constituent electrodes of the first DC electrode group 31G and/or the second DC electrode group 32G is input to the electrocardiograph 800 via the catheter connection connector 72, the first ON/OFF switch 761, and the electrocardiograph connection connector 73. Moreover, cardiac potential information measured by the constituent electrodes of the base-end potential measurement electrode group 33G is input to the electrocardiograph 800 via the catheter connection connector 72 and the electrocardiograph connection connector 73. The cardiac potential information input to the electrocardiograph 800 is input to the calculation processing unit 75 via the electrocardiogram input connector 77.
In addition, cardiac potential information (12-lead electrocardiogram) measured by the cardiac potential measuring means 900 (electrode pads attached to the body surface) is also input to the electrocardiograph 800, and the cardiac potential information from the cardiac potential measuring means 900 is also input to the calculation processing unit 75 via the electrocardiogram input connector 77.
In the arithmetic processing unit 75 shown in FIG. 9, the CPU circuit 752 and the internal resistor 753 are connected via the switching unit 754. At this stage, the resistance value of the internal resistor 753 can be measured by the CPU circuit 752 to confirm (test) whether it matches a known resistance value.

(3) Turn on mode change switch 741 (STEP 3).

(4) When the mode change switch 741 is turned on, the power supply device 700 goes into the "defibrillation mode" (STEP 4, 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.
In the arithmetic processing unit 75 shown in FIG. 10, the CPU circuit 752 and the second ON/OFF switch 762 are connected via the switching unit 754 .

When the first ON/OFF switch 761 is turned "OFF", the path from the catheter connection connector 72 via the first ON/OFF switch 761 to the electrocardiograph connection connector 73 is blocked, so that cardiac potential 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 (and therefore this cardiac potential information cannot be sent to the calculation processing unit 75). However, cardiac potential information from the constituent electrodes of the base-end potential measuring electrode group 33G that does not pass through the first ON/OFF switch 761 is input to the electrocardiograph 800.

(5) The CPU 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 of the defibrillation catheter 100 (STEP 5, FIG. 10).

(6) The mode of the power supply device 700 returns to the "cardiac potential measuring mode" (STEP 6, 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.
In addition, in the calculation processing unit 75 shown in FIG. 11, the output circuit 751 and the internal resistance 753 are connected via the switching unit 754. At this stage, it is possible to apply a DC voltage to the internal resistance 753, and it is possible to confirm (test) whether or not the set electrical energy can be applied to the internal resistance 753.

(7) The applied energy setting switch 742 is turned on to set the applied energy during defibrillation (STEP 7).
According to the electrode device 700 of this embodiment, the applied energy can be set from 1 J to 30 J in 1 J increments.

(8) Turn on the charging switch 743 (STEP 8).

(9) A target voltage determined based on the impedance measured in STEP 5 and the electrical energy set in STEP 7 is stored in the DC power supply unit (STEP 9).

(10) Turn on the energy application preparation switch 744 (STEP 10).

(11) When the energy application preparation switch 744 is input, a control signal is received from the calculation processing unit 75, and the first ON/OFF switch maintains the “ON” state and the second ON/OFF switch switches from “OFF” to “ON” (STEP 11, FIG. 12).
In the arithmetic processing unit 75 shown in FIG. 12, the output circuit 751 and the second ON/OFF switch are connected via the switching unit 754 .

(12) Visually check the electrocardiogram related to the cardiac potential 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 12). At this time, the electrocardiogram related to the cardiac potential information from the constituent electrodes of the base-end potential measurement electrode group 33G and/or the cardiac potential information by the cardiac potential measurement means 900 may also be checked.

(13) Determine whether the drift (baseline fluctuation) in the electrocardiogram caused by mode switching, etc. has subsided. If it has subsided, proceed to STEP 14; if it has not subsided, return to STEP 12 (STEP 13).

(14) Turn on the energy application execution switch 745 (STEP 14).

(15) When the energy application execution switch 745 is input, the second ON/OFF switch 762 receives a control signal from the calculation processing unit 75, maintains the "ON" state, and the first ON/OFF switch switches from "ON" to "OFF", immediately blocking the path from the catheter connection connector 72 to the electrocardiograph connection connector 73 (STEP 15, Figures 13 and 14). As a result, no DC voltage is applied to the electrocardiograph 800.

(16) Upon receiving a control signal from the calculation processing unit 75, the DC power supply unit 71 applies DC voltages of different polarities to the first DC electrode group and the second DC electrode group of the defibrillation catheter 100 via the output circuit 751 and switching unit 754 of the calculation processing unit 75, the second ON/OFF switch 762, and the catheter connection connector 72 (STEP 16, Figure 14).

(17) After the application of voltage from the DC power supply unit 71 stops, the mode of the power supply unit 700 returns to the "cardiac potential measurement mode", and cardiac potential information from the constituent electrodes of the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 is input to the electrocardiograph 800 (STEP 17).

(18) Cardiac potential information (electrocardiogram) from the constituent electrodes of the defibrillation catheter 100 (the constituent electrodes of the first DC electrode group 31G, the second DC electrode group 32G, and the proximal potential measurement electrode group 33G) and cardiac potential information from the cardiac potential measurement means 900 (12
If the result is "normal," the process ends; if the result is "not normal (atrial fibrillation has not subsided)," the process returns to STEP 2 (STEP 18).

According to the catheter system of this embodiment, the first ON/OFF switch 761 and the second ON/OFF switch 762 are independent of each other, so it is possible to turn both ON/OFF switches "ON" or "OFF."
Then, when the energy application preparation switch 744 is input, both the first ON/OFF switch 761 and the second ON/OFF switch 762 are turned "ON", a path is secured from the catheter connection connector 72 via the second ON/OFF switch 762 to the calculation processing unit 75, making it possible to apply energy and completing preparation for energy application, and cardiac potential information can be obtained from the constituent electrodes of the first DC electrode group 31G and/or the second DC electrode group 32G of the defibrillation catheter 100.

In addition, when the energy application execution switch 745 is input, the first ON/OFF switch 761 is switched to “OFF,” so that cardiac potential information can be obtained from the constituent electrodes of the first DC electrode group 31G and/or the second DC electrode group 32G until just before a DC voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 and defibrillation is performed.
This makes it possible to monitor the patient's condition based on the cardiac potential information of the treatment area even after the energy application preparation switch 744 is turned on, and the energy application execution switch can be turned on (defibrillation can be performed) after confirming that the cardiac potential information is stable.

In addition, by connecting the CPU circuit 752 and the internal resistance 753 by the switching unit 754, the resistance value of the internal resistance 753 can be measured by the CPU circuit 752, and the operating status of the impedance measurement system including the CPU circuit 752 can be confirmed.

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

LIST OF SYMBOLS 100 Defibrillation catheter 10 Multi-lumen tube 11 First lumen 12 Second lumen 13 Third lumen 14 Fourth lumen 15 Fluororesin layer 16 Inner (core) part 17 Outer (shell) part 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 Ring-shaped electrode 32G Second DC electrode group 32 Ring-shaped electrode 33G Base-end potential measurement electrode group 33 Ring-shaped electrode 35 Distal tip 41G First lead wire group 41 Lead wire 42G Second lead wire group 42 Lead wire 43G Third lead wire group 43 Lead wire 50 Defibrillation 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 unit 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 Charging switch 744 Energy application preparation switch 745 Energy application execution switch (discharge switch)
75 Arithmetic processing unit 751 Output circuit 752 CPU circuit 753 Internal resistance 754 Switching unit 761 First ON/OFF switch 762 Second ON/OFF switch 77 Electrocardiogram input connector 800 Electrocardiograph 900 Cardiac potential measuring means

Claims (1)

A power supply device that applies a DC voltage to an electrode of a defibrillation catheter that is inserted into a cardiac cavity to perform defibrillation,
The power supply device includes a DC power supply unit having a capacitor;
An output circuit for a DC voltage from the DC power supply unit;
a first ON/OFF switch interposed between the defibrillation catheter and an electrocardiograph;
a second ON/OFF switch interposed between the defibrillation catheter and the output circuit;
When measuring a cardiac potential using the electrodes, the first ON/OFF switch is "ON";
When defibrillation is performed by the defibrillation catheter, the second ON/OFF switch is “ON”,
the power supply device includes an energy application preparation switch for preparing to perform defibrillation, and an energy application execution switch for applying electrical energy to perform defibrillation;
After the energy application preparation switch is turned on, the first ON/OFF switch is in the “ON” state until the energy application execution switch is turned on;
A power supply device characterized in that, when the energy application execution switch is turned on, the first ON/OFF switch is turned "OFF."

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