JP6632511B2 - Intracardiac defibrillation catheter system - Google Patents

Description

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

  Conventionally, it is possible to reliably and sufficiently supply electrical energy necessary for defibrillation to a heart that has undergone atrial fibrillation or the like during cardiac catheterization, and to perform defibrillation without causing burns on the patient's body surface. As an intracardiac defibrillation catheter system capable of performing dynamic therapy, a defibrillation catheter inserted into the heart chamber to perform defibrillation, and a power supply device for applying a DC voltage to electrodes of the defibrillation catheter And a catheter system including an electrocardiograph, wherein the defibrillation catheter has an insulating tube member, and a first DC electrode group including a plurality of ring-shaped electrodes attached to a distal end region of the tube member. A second DC electrode group consisting of a plurality of ring-shaped electrodes attached to the tube member spaced apart from the first DC electrode group on the base end side, and a plurality of tips each having a distal end connected to each of the electrodes constituting the first DC electrode group. Re A first lead wire group consisting of a plurality of lead wires, and a second lead wire group consisting of a plurality of lead wires each having a tip connected to each of the electrodes constituting the second DC electrode group; Part, a catheter connector connected to the proximal ends of the first lead group and the second lead group of the defibrillation catheter, an electrocardiograph connector connected to the input terminal of the electrocardiograph, and an external The DC power supply is controlled based on the input of the switch. The DC power supply is controlled by an arithmetic processing unit having a circuit for outputting a DC voltage from the DC power supply. The catheter connection connector is connected to a common contact. An electrocardiograph connector is connected to the first contact, and a switching unit is connected to the second contact to an arithmetic processing unit; electrodes of the defibrillation catheter (the first DC electrode group and / or the second DC Electrode group When the cardiac potential is measured by the constituent electrodes), the first contact is selected in the switching unit, and the cardiac potential information from the defibrillation catheter passes through the catheter connector of the power supply device, the switching unit, and the electrocardiograph connector. When the defibrillation is performed by 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 the output circuit of the arithmetic processing unit is switched from the DC power supply unit to the second contact. The present applicant has proposed a catheter system in which voltages of different polarities are applied to a first DC electrode group and a second DC electrode group of a defibrillation catheter via a switching unit and a catheter connector. (See Patent Document 1 below).

In the catheter system described in Patent Literature 1, when an energy application switch, which is an external switch, is input, the contact of the switching unit is switched from the first contact to the second contact by the arithmetic processing unit, and the switching unit is switched from the catheter connector to the switching unit. And a route to the arithmetic processing unit via.
After the contact of the switching unit is switched to the second contact, the defibrillation catheter is supplied from the DC power supply unit that receives the control signal from the processing unit via the output circuit of the processing unit, the switching unit, and the catheter connector. DC voltages having different polarities are applied to the first DC electrode group and the second DC electrode group.
Here, the arithmetic processing unit performs arithmetic processing so that a voltage is applied in synchronization with a cardiac potential waveform input via the electrocardiogram input connector, and sends a control signal to the DC power supply unit.

Defibrillation (application of a voltage) is usually performed in synchronization with the R-wave so that effective defibrillation treatment is performed and the ventricle is not adversely affected.
If defibrillation is performed in synchronization with the T-wave, there is a high risk of causing severe ventricular fibrillation, and therefore synchronization with the T-wave must be avoided.

  Therefore, in the catheter system described in Patent Document 1, one R wave is detected in a cardiac potential waveform (electrocardiogram) sequentially input to the arithmetic processing unit, the wave height is obtained, and immediately after the input of the energy application switch, A peak reaching 80% of the wave height is recognized as an R wave, and a voltage is applied to the first electrode group and the second electrode group in synchronization with the peak.

  However, when extrasystole occurs in the heart of the patient who is to undergo defibrillation treatment, or when a drift occurs in which the baseline (baseline) of the electrocardiogram input to the arithmetic processing unit is generated, the energy is reduced. The peak of the potential difference that has reached the trigger level immediately after the input of the application switch (the peak recognized as an R wave) may not actually be the peak of the R wave.

For example, when a single extrasystole occurs in the patient's heart, the electrocardiogram (cardiac potential waveform) input to the arithmetic processing unit is an R wave (fourth from the left in the figure) as shown in FIG. As the polarity of the (R wave) is inverted, the peak of the next T wave tends to increase.
Then, as shown in the same figure, when the switch for applying the electric energy is input immediately after the extra-systole occurs, the T wave that increases and reaches the trigger level is erroneously recognized as the R wave and sensed (detected). It is conceivable that defibrillation is performed by applying a voltage in synchronization with the T wave.

Further, when the baseline of the electrocardiogram fluctuates, it is conceivable that a waveform that is not normally sensed is erroneously recognized as an R wave and sensed. For example, the height of a positive waveform that is not an R-wave may be read higher than the actual height due to an increase in the baseline. FIG. 24 shows an electrocardiogram in which a baseline has been lowered due to a drift, and then the baseline has been raised and returned to the original level. With this, sensing (detection) is performed by erroneously recognizing the rise of the baseline as an R wave, and in synchronization with this, a voltage is applied to perform defibrillation.

In view of such circumstances, the present inventor has proposed a defibrillation catheter that is inserted into a heart chamber to perform defibrillation, a power supply device that applies a DC voltage to electrodes of the defibrillation catheter, and an electrocardiograph. A defibrillation catheter, wherein the defibrillation catheter has an insulating tube member, a first electrode group including a plurality of ring-shaped electrodes attached to a distal end region of the tube member, and A second electrode group consisting of a plurality of ring-shaped electrodes attached to the tube member spaced apart from the one electrode group on the base end side, and a plurality of electrodes each having a tip connected to each of the electrodes constituting the first electrode group. A first lead wire group consisting of a lead wire, and a second lead wire group consisting of a plurality of lead wires each having a tip connected to each of the electrodes constituting the second electrode group; A DC power source and a defibrillation catheter A catheter connection connector connected to the proximal ends of the lead wire group and the second lead wire group, an external switch including an electric energy application switch, and a DC voltage output circuit from the DC power supply unit; An arithmetic processing unit for controlling the DC power supply unit based on an input of a switch; and an electrocardiogram input connector connected to the arithmetic processing unit and an output terminal of the electrocardiograph; When performing defibrillation, the first electrode group of the defibrillation catheter and the second electrode group from the DC power supply unit via the output circuit of the arithmetic processing unit and the catheter connector. The arithmetic processing unit of the power supply device estimates an R wave from the electrocardiogram input from the electrocardiograph via the electrocardiogram input connector. Sequentially sensing events, the polarity of the electrical energy input after the sensing event of application switch (V _n) is at least polar and 2 of the one previously sensed event (V _n-1) When the polarity of the previously sensed event (V _n−2 ) matches, a voltage is applied to the first electrode group and the second electrode group in synchronization with the event (V _n ). The intracardiac defibrillation catheter system has been proposed in which the DC power supply unit is controlled by performing arithmetic processing (see Patent Document 2 below).

  According to the catheter system described in Patent Literature 2, extrasystole occurs in the heart of a patient who undergoes defibrillation treatment, or the baseline of an electrocardiogram input to an arithmetic processing unit fluctuates (drifts). When this is done, applying a voltage to the electrodes of the defibrillation catheter can be prevented.

Japanese Patent No. 4545216 Japanese Patent No. 5900974

However, even if the polarity of the event (waveform estimated as R wave) sequentially sensed in the electrocardiogram input to the arithmetic processing unit of the power supply device occurs three times in a row in the same direction, drift occurs. It is possible.
FIG. 25 shows an electrocardiogram in which the stable baseline has risen, and then the baseline has fallen and returned to the original level, as indicated by the drifting arrow (SW-ON). When the electric energy application switch is input at the time, the polarity of the event (V ₁ ) sensed immediately after the input is switched to the polarity of the event (V ₀ ) sensed immediately before and the sense immediately before the event (V ₀ ). Since the polarity of the event (V _-1 ) matches the polarity of the event (V _-1 ), defibrillation is performed in synchronization with the event (V _n ) during drift.
Therefore, in order to avoid defibrillation (application of voltage) during drift, it is necessary to reliably detect that drift has occurred.

  According to the catheter system described in Patent Literature 2, defibrillation can be prevented from being performed in synchronization with the T wave, but from the viewpoint of further safety, synchronization is performed when performing defibrillation. There is a need to ensure that the event being attempted is not a T-wave.

  A first object of the present invention is to reliably avoid application of voltage to the electrodes of a defibrillation catheter when the baseline of an electrocardiogram input to an arithmetic processing unit is fluctuating (drift). Intracardiac defibrillation that 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. It is to provide a catheter system.

  A second object of the present invention is to reliably prevent defibrillation from being performed in synchronization with a T wave, and to perform defibrillation in synchronization with an R wave of an electrocardiogram input to an arithmetic processing unit. It is an object of the present invention to provide an intracardiac defibrillation catheter system capable of performing defibrillation by applying a DC voltage to an electrode of a catheter.

(1) An intracardiac defibrillation catheter system according to the first invention of the present invention includes a defibrillation catheter that is inserted into a heart chamber to perform defibrillation, and a DC voltage is applied to electrodes of the defibrillation catheter. A power supply device for applying and a catheter system including an electrocardiograph,
The defibrillation catheter, an insulating tube member,
A first electrode group (first DC electrode group) including a plurality of ring-shaped electrodes mounted on the distal end region of the tube member, and a plurality of ring electrodes mounted on the tube member separated from the first DC electrode group on the base end side. A second electrode group (second DC electrode group) composed of a ring-shaped electrode of
A first lead wire group including a plurality of lead wires each having a tip connected to each of the electrodes constituting the first DC electrode group;
A second lead wire group consisting of a plurality of lead wires each having a tip connected to each of the electrodes constituting the second DC electrode group;
The power supply device includes a DC power supply unit,
A catheter connector connected to the proximal end of the first lead group and the second lead group of the defibrillation catheter;
An external switch including an electric energy application preparation switch and an application execution switch,
An arithmetic processing unit having an output circuit of a DC voltage from the DC power supply unit and controlling the DC power supply unit based on an input of the external switch;
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, the DC power supply unit outputs an output circuit of the arithmetic processing unit. And voltages of different polarities are applied to the first DC electrode group and the second DC electrode group of the defibrillation catheter via the catheter connection connector;
The arithmetic processing unit of the power supply device sequentially senses an event estimated as an R wave from an electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and detects an event sensed after input of the application execution switch. The polarity of (V _n ) coincides at least with the polarity of the event (V _n−1 ) sensed immediately before and the polarity of the event (V _n−2 ) sensed two times before, and When an abnormal wave height event occurs between the input of the application preparation switch and the time of inputting the application execution switch, the abnormal wave height event (an abnormal wave height event that occurs first when a plurality of abnormal wave heights occur) Only when the event (V _n ) is sensed after a certain standby time has elapsed since the occurrence of the event, the event (V _n ) is synchronized with the event (V _n ). The DC power supply unit is controlled by performing arithmetic processing so that a voltage is applied to the first DC electrode group and the second DC electrode group.

(2) The abnormal wave height event in the intracardiac defibrillation catheter system of the present invention (first invention) has a wave height exceeding 120% of the average wave height of two events sensed immediately before the input of the application preparation switch. It is preferably an event.

(3) The waiting time in the intracardiac defibrillation catheter system of the present invention (first invention) is preferably 1000 to 5000 msec.

According to the intracardiac defibrillation catheter system having such a configuration, in the electrocardiogram input to the arithmetic processing unit of the power supply device, three consecutively sensed events (V _n−2 ) and (V _n− ) _If the polarities of ₁ ) and (V _n ) do not match, there is a possibility that the patient's heart is undergoing extrasystole or the baseline of the electrocardiogram has become unstable due to drift or the like. It is determined that the event (V _n ) sensed after the input of ( ₁ ) may not be the peak of the R wave, and no voltage is applied in synchronization with the event (V _n ). When the polarities of the three events (V _n-2 ), (V _n-1 ), and (V _n ) match, it is determined that the third event (V _n ) will be the peak of the R wave. Can be.
In addition, when a drift occurs, an abnormal wave height tends to occur, and this drift phenomenon usually stops in about several seconds, and thereafter, the baseline tends to be stabilized.
Therefore, in addition to the fact that the polarities of the three events (V _n−2 ), (V _n−1 ) and (V _n ) match, from the input of the application preparation switch to the input of the application execution switch When the occurrence of an abnormal wave height event is detected during the period, only when the event (V _n ) is sensed after a lapse of a predetermined standby time from the occurrence of the abnormal wave height event, the event is synchronized with the event (V _n ). A voltage was applied.
Thereby, it is possible to reliably prevent the voltage from being applied to the electrodes of the defibrillation catheter when the drift is occurring, and to synchronize with the R wave of the electrocardiogram when the baseline is stable. Thus, defibrillation can be performed by applying a DC voltage to the electrodes of the defibrillation catheter.

(4) It is preferable that the intracardiac defibrillation catheter system of the present invention (the first invention) has a function of notifying the possibility that drift has occurred during the standby time.
According to the intracardiac defibrillation catheter system having such a configuration, the operator can easily grasp the possibility that the drift has occurred, and can stand by without inputting the application execution switch.

(5) The intracardiac defibrillation catheter system according to the second invention of the present invention includes a defibrillation catheter that is inserted into a heart chamber and performs defibrillation, and a DC voltage is applied to electrodes of the defibrillation catheter. A power supply device for applying and a catheter system including an electrocardiograph,
The defibrillation catheter, an insulating tube member,
A first electrode group (first DC electrode group) including a plurality of ring-shaped electrodes mounted on the distal end region of the tube member, and a plurality of ring electrodes mounted on the tube member separated from the first DC electrode group on the base end side. A second electrode group (second DC electrode group) composed of a ring-shaped electrode of
A first lead wire group including a plurality of lead wires each having a tip connected to each of the electrodes constituting the first DC electrode group;
A second lead wire group consisting of a plurality of lead wires each having a tip connected to each of the electrodes constituting the second DC electrode group;
The power supply device includes a DC power supply unit,
A catheter connector connected to the proximal end of the first lead group and the second lead group of the defibrillation catheter;
An external switch including an electric energy application preparation switch and an application execution switch,
An arithmetic processing unit having an output circuit of a DC voltage from the DC power supply unit and controlling the DC power supply unit based on an input of the external switch;
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, the DC power supply unit outputs an output circuit of the arithmetic processing unit. And voltages of different polarities are applied to the first DC electrode group and the second DC electrode group of the defibrillation catheter via the catheter connection connector;
The arithmetic processing unit of the power supply device sequentially senses an event estimated as an R wave from an electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and detects an event sensed after input of the application execution switch. The polarity of (V _n ) coincides at least with the polarity of the event (V _n−1 ) sensed immediately before and the polarity of the event (V _n−2 ) sensed two times before, and In the waveform of the event (V _n ), after the base line of the electrocardiogram reaches the bottom line shifted by 0.26 V in the polarity direction of the event (V _n ), sensing is performed immediately before the input of the application preparation switch. If the rise time until reaching the trigger level which is 80% of the average wave height of the two events is within 45 ms, the event (V _n ) The DC power supply unit is controlled by performing arithmetic processing so that a voltage is applied to the first electrode group and the second electrode group in synchronization.

According to the intracardiac defibrillation catheter system having such a configuration, in the electrocardiogram input to the arithmetic processing unit of the power supply device, three consecutively sensed events (V _n−2 ) and (V _n− ) _If the polarities of ₁ ) and (V _n ) do not match, there is a possibility that the patient's heart is undergoing extrasystole or the baseline of the electrocardiogram has become unstable due to drift or the like. It is determined that the event (V _n ) sensed after the input of ( ₁ ) may not be the peak of the R wave, and no voltage is applied in synchronization with the event (V _n ). When the polarities of the three events (V _n-2 ), (V _n-1 ), and (V _n ) match, it is determined that the third event (V _n ) will be the peak of the R wave. Can be.

Further, the rise of the waveform of the T wave is gradual, and the rise time from the bottom line to the trigger level is usually longer than 45 ms. Therefore, in the event (V _n ) waveform, if the rise time from when the bottom line is reached to when the trigger level is reached exceeds 45 ms, the event (V _n ) waveform may be a T-wave. Is not recognized as a trigger point, and no voltage is applied in synchronization with the event (V _n ), so that defibrillation in synchronization with the T wave can be reliably avoided. .

(6) In the intracardiac defibrillation catheter system of the present invention, when the polarities of the three events sensed immediately before the input of the application preparation switch are the same, This polarity is stored as “the polarity of the initial event”, and when the polarity of the event (V _n ) does not match the polarity of the initial event, the first electrode group and the first electrode group are synchronized with the event (V _n ). It is preferable that the DC power supply unit is controlled by performing arithmetic processing so that no voltage is applied to the second electrode group.

The polarity of the event may be reversed when the drift occurs, and return to the original polarity when the drift subsides.
Therefore, according to the intracardiac defibrillation catheter system having such a configuration, when the polarity of the event (V _n ) does not match the polarity of the initial event, it is determined that the drift may be continued. By not applying a voltage in synchronization with this event (V _n ), it is possible to more reliably avoid applying a voltage to the electrodes of the defibrillation catheter when a drift occurs. .

(7) In the intracardiac defibrillation catheter system of the present invention, the arithmetic processing unit of the power supply device senses an event presumed to be an R-wave, and then detects the event for at least 50 ms, at most 500 ms, preferably 260 ms. It is preferable to control the DC power supply unit so that no voltage is applied to the first DC electrode group and the second DC electrode group for a second.

  According to the intracardiac defibrillation catheter system having such a configuration, a voltage is applied to the first DC electrode group and the second DC electrode group for at least 50 ms after sensing an event presumed to be an R wave. Therefore, when the event sensed is the peak of the R wave, it is necessary to reliably avoid performing defibrillation at the time when the next T wave appears, that is, the peak estimated to be a T wave. Can be masked.

(8) In the intracardiac defibrillation catheter system of the above (7), the arithmetic processing unit of the power supply device senses an event estimated to be an R-wave, and then at least 10 ms, at most 150 ms, preferably For 100 ms, it is preferable not to newly sense an event presumed to be an R wave.

  According to the intracardiac defibrillation catheter system having such a configuration, a new event is not sensed for at least 10 msec after sensing an event presumed to be an R wave, so that the sensed event is an R wave. If the peak of the S wave appearing in the opposite direction following this peak increases and reaches the trigger level (this state is not particularly problematic in performing defibrillation), this S wave Wave peaks can be sensed to prevent the event polarity continuity from being lost (counts of the same polarity are reset).

(9) In the intracardiac defibrillation catheter system according to the above (7) or (8), after the input of the application execution switch, the arithmetic processing unit of the power supply device may be at least 10 ms, and at most 500 ms, preferably Preferably, the DC power supply unit is controlled such that no voltage is applied to the first DC electrode group and the second DC electrode group for 260 ms.

According to the intracardiac defibrillation catheter system having such a configuration, the voltage is applied to the first DC electrode group and the second DC electrode group for at least 10 msec after the input of the electric energy application execution switch. Since there is no noise, the noise generated by the input of the application execution switch (noise having the same polarity as that of the previous and two previous events) is erroneously recognized as an R wave, and sensing is performed, and defibrillation in synchronization with the noise is prevented. be able to.
Further, it is possible to prevent the continuity of the polarity of the event from being lost (counts having the same polarity are reset) due to noise generated by the input of the application execution switch (noise having a polarity different from that of the previous and / or last event). can do.
Further, it is also possible to prevent the fluctuation of the baseline generated immediately after the input of the application execution switch from being erroneously recognized as the R-wave and sense it, and perform the defibrillation in synchronization with the sensing.

  According to the intracardiac defibrillation catheter system according to the first aspect of the present invention, when the baseline of the electrocardiogram input to the arithmetic processing unit is fluctuating (drift), the voltage is applied to the electrodes of the defibrillation catheter. Defibrillation is performed by applying a DC voltage to the electrode of the defibrillation catheter in synchronization with the R wave of the electrocardiogram when the baseline is stable. be able to.

  According to the intracardiac defibrillation catheter system according to the second aspect of the present invention, defibrillation can be reliably prevented from being performed in synchronization with the T wave, and the electrocardiogram input to the arithmetic processing unit Defibrillation can be performed by applying a DC voltage to the electrodes of the defibrillation catheter in synchronization with the R-wave.

1 is a block diagram showing one embodiment of the intracardiac defibrillation catheter system of the present invention. FIG. 2 is an explanatory plan view showing a fibrillation catheter constituting the catheter system shown in FIG. 1. FIG. 2 is an explanatory plan view (a diagram for describing dimensions and hardness) showing a fibrillation catheter constituting the catheter system shown in FIG. 1. FIG. 3 is a cross-sectional view showing a cross section taken along line AA of FIG. 2. FIG. 3 is a transverse sectional view showing a BB section, a CC section, and a DD section of FIG. 2. FIG. 3 is a perspective view showing an internal structure of a handle of one embodiment of the defibrillation catheter shown in FIG. 2. FIG. 7 is a partially enlarged view of the inside of the handle (front end side) shown in FIG. 6. FIG. 7 is a partially enlarged view of the inside of the handle (the proximal end side) shown in FIG. 6. FIG. 2 is an explanatory diagram schematically showing a connection state of 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 block diagram showing a flow of cardiac potential information when measuring a cardiac potential with a defibrillation catheter in the catheter system shown in FIG. 1. 2 is a flowchart showing the operation and operation of the power supply device when the catheter system shown in FIG. 1 is used as the system according to the first invention. FIG. 2 is a block diagram showing a flow of cardiac potential information in a cardiac potential measurement mode in the catheter system shown in FIG. 1. FIG. 2 is a block diagram showing a flow of information related to a measured value of resistance between electrode groups and cardiac potential information in a defibrillation mode of the catheter system shown in FIG. 1. FIG. 2 is a block diagram showing a state when a DC voltage is applied in the defibrillation mode of the catheter system shown in FIG. 1. FIG. 2 is a potential waveform chart measured when predetermined electrical energy is applied by a defibrillation catheter constituting the catheter system shown in FIG. 1. FIG. 5 is an explanatory diagram showing timings of input of an energy application execution switch and application of a DC voltage in an electrocardiogram input to an arithmetic processing unit of the power supply device. FIG. 4 is an explanatory diagram showing timings of input of an energy execution application switch and application of a DC voltage in an electrocardiogram input to an arithmetic processing unit of the power supply device. FIG. 5 is an explanatory diagram showing timings of input of an energy application execution switch and application of a DC voltage in an electrocardiogram input to an arithmetic processing unit of the power supply device. FIG. 5 is an explanatory diagram showing timings of input of an energy application execution switch and application of a DC voltage in an electrocardiogram input to an arithmetic processing unit of the power supply device. 6 is a flowchart showing the operation and operation of the power supply device when the catheter system shown in FIG. 1 is used as the system according to the second invention. FIG. 4 is an explanatory diagram showing timings of input of an energy application preparation switch, input of an energy application execution switch, and application of a DC voltage in an electrocardiogram input to an arithmetic processing unit of the power supply device. FIG. 3 is an explanatory diagram showing timings of input of an energy application preparation switch, input of an energy application execution switch, and application of a DC voltage when the catheter system shown in FIG. 1 is used as the system according to the first invention. FIG. 8 is an explanatory diagram showing a rising state (time) of an event after an energy application execution switch is input when the catheter system shown in FIG. 1 is used as a system according to the second invention. Explanatory drawing showing the timing between the input of the energy application execution switch and the application of the DC voltage in the electrocardiogram (cardiac potential waveform when a single extrasystole occurs in the patient's heart) input to the arithmetic processing unit of the power supply device. It is. Description showing the timing between the input of the energy application execution switch and the application of the DC voltage in the electrocardiogram (cardiac potential waveform when continuous extrasystole occurs in the patient's heart) input to the arithmetic processing unit of the power supply device FIG. FIG. 7 is an explanatory diagram showing timings of input of an energy application execution switch and application of a DC voltage in an electrocardiogram (cardiac potential waveform) in which a baseline input to an arithmetic processing unit of the power supply device is fluctuating. In an electrocardiogram (cardiac potential waveform when a single extrasystole occurs in a patient's heart) input to an arithmetic processing unit of a power supply device constituting a conventional catheter system, input of an energy application switch and application of a DC voltage FIG. 5 is an explanatory diagram showing the timing of FIG. FIG. 4 is an explanatory diagram showing timings of input of an energy applying switch and application of a DC voltage in an electrocardiogram (cardiac potential waveform) in which a baseline input to an arithmetic processing unit of a power supply device constituting a conventional catheter system fluctuates. is there. FIG. 4 is an explanatory diagram showing timings of input of an energy applying switch and application of a DC voltage in an electrocardiogram (cardiac potential waveform) in which a baseline input to an arithmetic processing unit of a power supply device constituting a conventional catheter system fluctuates. is there.

Hereinafter, an embodiment of the present invention will be described.
The intracardiac defibrillation catheter system of the present embodiment can be used as the system according to the first invention and the system according to the second invention.
As shown in FIG. 1, the intracardiac defibrillation catheter system of the present embodiment includes a defibrillation catheter 100, a power supply device 700, an electrocardiograph 800, and an electrocardiogram measuring means 900.

  As shown in FIGS. 2 to 5, the defibrillation catheter 100 constituting the defibrillation catheter system of the present embodiment includes a multi-lumen tube 10, a handle 20, a first DC electrode group 31G, and a second DC electrode group. 32G, a proximal-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 FIGS. 4 and 5, a multi-lumen tube 10 (insulating tube member having a multi-lumen structure) constituting the defibrillation catheter 100 has four lumens (a first lumen 11 and a second lumen 12). , A third lumen 13 and a fourth lumen 14).

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

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

Nylon elastomer constituting the outer portion 17 of the multi-lumen tube 10 has a different hardness depending on the axial direction. Thereby, the multi-lumen tube 10 is configured so that the hardness increases stepwise from the distal end side to the proximal end side.
As a preferred example, in FIG. 3, the hardness of the area indicated by L1 (length 52 mm) (hardness by a D-type hardness meter) is 40, the hardness of the area indicated by L2 (length 108 mm) is 55, and L3 (length). The hardness of the area indicated by L2 (length: 25.7 mm) is 63, the hardness of the area indicated by L4 (length: 10 mm) is 68, and the hardness of the area indicated by L5 (length: 500 mm) is 72.

The braided blade constituted by the stainless steel wire 18 is formed only in a region indicated by L5 in FIG. 3, and is provided between the inner portion 16 and the outer portion 17, as shown in FIG.
The outer diameter of the multi-lumen tube 10 is, for example, 1.2 to 3.3 mm.

  The method for manufacturing the multi-lumen tube 10 is not particularly limited.

The handle 20 of the defibrillation catheter 100 according to the present 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 mounted on the outer periphery of the multi-lumen tube 10 (the distal end region where no braid is formed inside). Here, the “electrode group” refers to a set of a plurality of electrodes that constitute the same pole (having the same polarity) or are attached at a narrow interval (for example, 5 mm or less) for the same purpose. Refers to the body.

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

In the present embodiment, the first DC electrode group 31G includes eight ring-shaped electrodes 31 mounted on the distal end region of the multi-lumen tube 10.
The electrode 31 constituting the first DC electrode group 31G is connected to a catheter connector of the power supply device 700 via a lead wire (lead wire 41 constituting the first lead wire group 41G) and a connector described later.

Here, the width (length in the axial direction) of the electrode 31 is preferably 2 to 5 mm, and 4 mm as a preferable example.
If the width of the electrode 31 is too narrow, the amount of heat generated at the time of voltage application becomes excessive, and there is a possibility that the tissue may be damaged. On the other hand, if the width of the electrode 31 is too wide, the flexibility and flexibility of the portion of the multi-lumen tube 10 where the first DC electrode group 31G is provided may be impaired.

The mounting interval between the electrodes 31 (the distance between adjacent electrodes) is preferably 1 to 5 mm, and is 2 mm as a preferred example.
When using the defibrillation catheter 100 (when placed in the heart chamber), the first DC electrode group 31G is located, for example, in a coronary vein.

  The second DC electrode group is separated from the mounting position of the first DC electrode group of the multi-lumen tube toward the base end, and forms a pole (+ pole or − pole) opposite to the first DC electrode group. The electrodes are mounted at narrow intervals. Here, the number of electrodes constituting the second DC electrode group varies depending on the width and arrangement interval of the electrodes, but is, for example, 4 to 13, preferably 8 to 10.

In the present embodiment, the second DC electrode group 32G is composed of eight ring-shaped electrodes 32 mounted on the multi-lumen tube 10 at a distance from the mounting position of the first DC electrode group 31G to the base end.
The electrode 32 constituting the second DC electrode group 32G is connected to a catheter connector of the power supply device 700 via a lead wire (lead wire 42 constituting the second lead wire group 42G) and a connector described later.

Here, the width (length in the axial direction) of the electrode 32 is preferably 2 to 5 mm, and is 4 mm as a preferable example.
If the width of the electrode 32 is too narrow, the amount of heat generated at the time of voltage application becomes excessive, and there is a possibility that the surrounding tissue may be damaged. On the other hand, if the width of the electrode 32 is too wide, the flexibility and flexibility of the portion of the multi-lumen tube 10 where the second DC electrode group 32G is provided may be impaired.

The mounting interval between the electrodes 32 (the distance between adjacent electrodes) is preferably 1 to 5 mm, and is 2 mm as a preferred example.
When using the defibrillation catheter 100 (when placed in the heart chamber), the second DC electrode group 32G is located, for example, in the right atrium.

In the present embodiment, the base-side potential measurement electrode group 33G is configured by four ring-shaped electrodes 33 mounted on the multi-lumen tube 10 while being separated from the mounting position of the second DC electrode group 32G toward the base side. I have.
The electrode 33 constituting the proximal-side potential measurement electrode group 33G is connected to the catheter connector of the power supply device 700 via a lead wire (lead wire 43 constituting the third lead wire group 43G) and a connector described later. I have.

Here, the width (length in the axial direction) of the electrode 33 is preferably 0.5 to 2.0 mm, and is 1.2 mm as a preferable example.
If the width of the electrode 33 is too wide, the measurement accuracy of the cardiac potential may be reduced, or it may be difficult to specify the site where the abnormal potential has occurred.

The mounting interval between the electrodes 33 (the distance between adjacent electrodes) is preferably 1.0 to 10.0 mm, and is 5 mm as a preferred example.
When using the defibrillation catheter 100 (when placed in the heart chamber), the proximal-side potential measurement electrode group 33G is located, for example, in the superior vena cava where abnormal potential is likely to occur.

A distal tip 35 is attached to the distal end of the defibrillation catheter 100.
No lead wire is connected to the tip 35, and it is not used as an electrode in this embodiment. However, it can be used as an electrode by connecting a lead wire. The constituent material of the tip 35 is not particularly limited, such as a metal material such as platinum and stainless steel, and various resin materials.

  The distance d2 between the first DC electrode group 31G (the electrode 31 on the proximal end side) and the second DC electrode group 32G (the electrode 32 on the distal end side) is preferably 40 to 100 mm, and 66 mm in a preferred example. is there.

  The separation distance d3 between the second DC electrode group 32G (the base electrode 32) and the base potential measurement electrode group 33G (the front electrode 33) is preferably 5 to 50 mm. It is 30 mm.

  The electrodes 31, 32, and 33 constituting the first DC electrode group 31G, the second DC electrode group 32G, and the base-side potential measurement electrode group 33G are made of platinum or platinum-based in order to improve X-ray contrast. It is preferred to be composed of an alloy of

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

  The eight electrodes 31 constituting the first DC electrode group 31G are connected to different lead wires 41, respectively. Each of the lead wires 41 is welded to the inner peripheral surface of the electrode 31 at the distal end thereof, and enters the first lumen 11 from a side hole formed in the tube wall of the multi-lumen tube 10. The eight lead wires 41 that have entered the first lumen 11 extend to the first lumen 11 as a first lead wire group 41G.

The second lead wire group 42G shown in FIGS. 4 and 5 is an aggregate of eight lead wires 42 connected to each of the eight electrodes (32) constituting the second DC electrode group (32G). .
Each of the eight electrodes 32 constituting the second DC electrode group 32G can be electrically connected to the power supply device 700 by the second lead wire group 42G (lead wire 42).

  The eight electrodes 32 constituting the second DC electrode group 32G are connected to different lead wires 42, respectively. Each of the lead wires 42 is welded to the inner peripheral surface of the electrode 32 at the distal end thereof, and the second lumen 12 (the first lead wire group 41G extends from a side hole formed in the tube wall of the multi-lumen tube 10). (A lumen different from the existing first lumen 11). The eight lead wires 42 that have entered the second lumen 12 extend to the second lumen 12 as a second lead wire group 42G.

  As described above, since 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, both of them are in the multi-lumen tube 10. Completely insulated and isolated. Therefore, when a voltage required for defibrillation is applied, a short circuit occurs 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 aggregate of four lead wires 43 connected to each of the electrodes (33) constituting the proximal end potential measurement electrode group (33G).
With the third lead wire group 43G (lead wire 43), each of the electrodes 33 constituting the base-side potential measurement electrode group 33G can be electrically connected to the power supply device 700.

  The four electrodes 33 forming the base-side potential measurement electrode group 33G are connected to different lead wires 43, respectively. Each of the lead wires 43 is welded to the inner peripheral surface of the electrode 33 at the distal end thereof, 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 have entered 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. For this reason, when a voltage necessary for defibrillation is applied, the third lead wire group 43G (the proximal-end potential measuring electrode group 33G) and the first lead wire group 41G (the first DC electrode group 31G) or the A short circuit between the second lead wire group 42G (the second DC electrode group 32G) can be reliably prevented.

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

4 and 5, reference numeral 65 denotes 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 end tip 35 by solder. Further, a large diameter portion (retaining portion) for retaining may be formed at the tip of the pull wire 65. Thereby, the distal tip 35 and the pull wire 65 are firmly connected, and the falling off of the distal tip 35 can be reliably prevented.

On the other hand, the base end 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, whereby the distal end of the multi-lumen tube 10 is deflected.
The pull wire 65 is made of stainless steel or a Ni-Ti superelastic alloy, but need not necessarily be made of metal. The pull wire 65 may be made of, for example, a high-strength non-conductive wire.
The mechanism for deflecting the distal end of the multi-lumen tube is not limited to this, and may include, for example, a plate spring.

  In the fourth lumen 14 of the multi-lumen tube 10, only the pull wire 65 extends, and the lead wire (group) does not extend. Thereby, it is possible to prevent the lead wire from being damaged (for example, abrasion) by the pull wire 65 moving in the axial direction during the deflection operation of the distal end portion of the multi-lumen tube 10.

  In the defibrillation catheter 100 according to the present embodiment, the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G are also insulated and isolated inside the handle 20.

  FIG. 6 is a perspective view showing the internal structure of the handle of the defibrillation catheter 100 according to the present embodiment, FIG. 7 is a partially enlarged view of the inside of the handle (distal side), and FIG. It is a partial enlarged view.

  As shown in FIG. 6, the base end of the multi-lumen tube 10 is inserted into the distal end opening of the handle 20, thereby connecting the multi-lumen tube 10 and the handle 20.

As shown in FIGS. 6 and 8, a cylindrical connector 50 having a plurality of pin terminals (51, 52, 53) protruding in the distal direction disposed on the distal end surface 50 </ b> A is provided at the proximal end of the handle 20. Built-in.
As shown in FIGS. 6 to 8, each of three lead wire groups (first lead wire group 41G, second lead wire group 42G, and third lead wire group 43G) is inserted into handle 20. The three insulated tubes (the first insulated tube 26, the second insulated tube 27, and the third insulated tube 28) are extended.

As shown in FIGS. 6 and 7, the distal end portion (about 10 mm from 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 And the first lead wire group 41G are connected to the first lumen 11 extending therefrom.
The first insulating tube 26 connected to the first lumen 11 passes through the inner hole of the first protection tube 61 extending inside the handle 20 to connect to the connector 50 (the distal end surface 50A on which the pin terminals are disposed). It extends to the vicinity and forms an insertion passage for guiding the base end of the first lead wire group 41G to the vicinity of the connector 50. Thereby, the first lead wire group 41G extending from the multi-lumen tube 10 (first lumen 11) extends inside the handle 20 (the inner hole of the first insulating tube 26) without kinking. Can be.
The first lead wire group 41G extending from the base end opening of the first insulating tube 26 is divided into eight lead wires 41 constituting the first lead wire group 41G. Are fixedly connected to each of the pin terminals by soldering. Here, an area where the pin terminals (pin terminals 51) to which the lead wires 41 constituting the first lead wire group 41G are connected and fixed is arranged is referred to as a "first terminal group area".

The distal end portion (about 10 mm from 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 extends the second lead wire group 42G. Connected to the second lumen 12.
The second insulative tube 27 connected to the second lumen 12 passes through the inner hole of the second protective tube 62 extending inside the handle 20 to connect the connector 50 (the distal end surface 50A on which the pin terminals are disposed). It extends to the vicinity, and forms an insertion passage for guiding the base end of the second lead wire group 42G to the vicinity of the connector 50. Thereby, the second lead wire group 42G extending from the multi-lumen tube 10 (second lumen 12) extends inside the handle 20 (the inner hole of the second insulating tube 27) without kinking. Can be.
The second lead wire group 42G extending from the base end opening of the second insulating tube 27 is divided into eight lead wires 42 constituting the second lead wire group 42G, and each of these lead wires 42 is connected to the distal end surface 50A of the connector 50. Are fixedly connected to each of the pin terminals by soldering. Here, an area where the pin terminals (pin terminals 52) to which the lead wires 42 constituting the second lead wire group 42G are connected and fixed is arranged is referred to as a “second terminal group area”.

The distal end portion (about 10 mm from the distal end) of the third insulating tube 28 is inserted into the third lumen 13 of the multi-lumen tube 10, so that the third insulating tube 28 extends the third lead wire group 43G. Connected to the third lumen 13.
The third insulating tube 28 connected to the third lumen 13 passes through an inner hole of the second protective tube 62 extending inside the handle 20 to connect to the connector 50 (the distal end surface 50A on which the pin terminals are disposed). It extends to the vicinity, and forms an insertion passage for guiding the base end of the third lead wire group 43G to the vicinity of the connector 50. Thereby, the third lead wire group 43G extending from the multi-lumen tube 10 (the third lumen 13) extends inside the handle 20 (the inner hole of the third insulating tube 28) without kinking. Can be.
The third lead wire group 43G extending from the base end opening of the third insulating tube 28 is divided into four lead wires 43 constituting the third lead wire group 43, and each of these lead wires 43 is connected to the distal end surface 50A of the connector 50. Are fixedly connected to each of the pin terminals by soldering. Here, an area where the pin terminals (pin terminals 53) to which the lead wires 43 constituting the third lead wire group 43G are connected and fixed is arranged is referred to as a “third terminal group area”.

Here, as a constituent material of the insulating tubes (the first insulating tube 26, the second insulating tube 27, and the third insulating tube 28), a polyimide resin, a polyamide resin, a polyamideimide resin, and the like can be exemplified. . Among these, a polyimide resin having a high hardness, easy to insert a group of lead wires, and capable of forming a thin wall is particularly preferable.
The thickness of the insulating tube is preferably 20 to 40 μm, and is 30 μm as a preferred example.

  Further, as a constituent material of the protective tubes (the first protective tube 61 and the second protective tube 62) into which the insulating tube is inserted, a nylon-based elastomer such as “Pebax” (registered trademark of ARKEMA) is exemplified. be able to.

  According to the defibrillation catheter 100 of the present embodiment having the above-described configuration, the first lead wire group 41G extends inside the first insulating tube 26, and the second lead wire extends inside the second insulating tube 27. Since the wire group 42G extends and the third lead wire group 43G extends in the third insulating tube 28, the first lead wire group 41G and the second lead wire are also provided inside the handle 20. The group 42G and the third lead group 43G can be completely insulated and isolated. As a result, when a voltage required for defibrillation is applied, a short circuit between the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G inside the handle 20 ( In particular, a short circuit between the lead wire groups extending near the lumen opening can be reliably prevented.

  Further, inside the handle 20, the first insulating tube 26 is protected by the first protective tube 61, and the second insulating tube 27 and the third insulating tube 28 are protected by the second protective tube 52. Thereby, for example, it is possible to prevent the insulating tube from being damaged due to the contact and rubbing of the constituent members (movable parts) of the knob 22 during the deflection operation of the distal end portion of the multi-lumen tube 10.

  The defibrillation catheter 100 according to the present embodiment divides the distal end surface 50A of the connector 50 on which a plurality of pin terminals are arranged into a first terminal group region, a second terminal group region, and a third terminal group region, and leads A partition plate 55 is provided to isolate the wire 41 from the lead wire 42 and the lead wire 43.

  The partition plate 55 that separates the first terminal group region from the second terminal group region and the third terminal group region is formed by molding an insulating resin into a gutter shape having flat surfaces on both sides. The insulating resin forming the partition plate 55 is not particularly limited, and a general-purpose resin such as polyethylene can be used.

The thickness of the partition plate 55 is, for example, 0.1 to 0.5 mm, and is 0.2 mm as a preferable example.
The height (distance from the base edge to the distal edge) of the partition plate 55 is higher than the separation distance between the distal end surface 50A of the connector 50 and the insulating tubes (the first insulating tube 26 and the second insulating tube 27). When the separation distance is 7 mm, the height of the partition plate 55 is, for example, 8 mm. In a partition plate having a height of less than 7 mm, the distal end edge cannot be located on the distal side with respect to the base end of the insulating tube.

According to such a configuration, the lead wire 41 (the base end portion of the lead wire 41 extending from the base end opening of the first insulating tube 26) constituting the first lead wire group 41G, and the second lead wire group The lead wire 42 (the base end portion of the lead wire 42 extending from the base end opening of the second insulating tube 27) constituting the 42G can be reliably and orderly isolated.
If the partition plate 55 is not provided, the lead wire 41 and the lead wire 42 cannot be orderly separated (separated), and there is a possibility that these may be mixed.

  Then, the lead wires 41 constituting the first lead wire group 41G and the lead wires 42 constituting the second lead wire group 42G, to which voltages having different polarities are applied, are separated from each other by the partition plate 55 and contact therewith. Therefore, when the defibrillation catheter 100 is used, even if a voltage necessary for intracardiac defibrillation is applied, the lead wire 41 (the first insulating tube) constituting the first lead wire group 41G is used. 26, and a lead wire 42 (a lead wire 42 extending from a base opening of the second insulating tube 27) constituting a second lead wire group 42G. Short-circuit does not occur between them.

  In addition, when an error occurs in connecting and fixing the lead wire to the pin terminal during the manufacture of the defibrillation catheter, for example, the lead wire 41 constituting the first lead wire group 41G is placed in the second terminal group area. When the lead 41 is connected to the pin terminal, the lead 41 straddles the partition wall 55, so that a connection error can be easily found.

  The lead wires 43 (pin terminals 53) constituting the third lead wire group 43G are isolated from the lead wires 41 (pin terminals 51) by the partition plate 55 together with the lead wires 42 (pin terminals 52). The present invention is not limited to this, and may be separated from the lead wires 42 (pin terminals 52) by the partition plate 55 together with the lead wires 41 (pin terminals 51).

In the defibrillation catheter 100, the distal end edge of the partition plate 55 is located more distally than either the proximal end of the first insulating tube 26 or the proximal end of the second insulating tube 27.
As a result, the lead wires (lead wires 41 constituting the first lead wire group 41G) extending from the base opening of the first insulating tube 26 and the leads extending from the base opening of the second insulating tube 27. The partition plate 55 is always present between the wire (the lead wire 42 constituting the second lead wire group 42G), and the short circuit caused by the contact between the lead wire 41 and the lead wire 42 is reliably prevented. Can be.

  As shown in FIG. 8, eight lead wires 41 extending from the proximal opening of the first insulating tube 26 and connected to and fixed to the pin terminals 51 of the connector 50, from the proximal opening of the second insulating tube 27. Eight lead wires 42 that extend and are connected and fixed to the pin terminals 52 of the connector 50, and four leads that extend from the base opening of the third insulating tube 28 and are connected and fixed to the pin terminals 53 of the connector 50. The shape of the wire 43 is held and fixed by solidifying the periphery thereof with a resin 58.

The resin 58 for maintaining the shape of the lead wire is formed into a cylindrical shape having the same diameter as the connector 50. Inside the resin molded body, the pin terminal, the lead wire, the base end of the insulating tube and the partition plate 55 Is embedded.
According to the configuration in which the base end of the insulating tube is embedded in the resin molded body, the lead wire (base) extending from the base end opening of the insulating tube to being connected and fixed to the pin terminal is provided. The entire area of the end portion) can be completely covered with the resin 58, and the shape of the lead wire (base end portion) can be completely held and fixed.
The height (distance from the base end face to the tip end face) of the resin molded body is preferably higher than the height of the partition plate 55. When the height of the partition plate 55 is 8 mm, for example, it is 9 mm.

  Here, the resin 58 constituting the resin molded body is not particularly limited, but it is preferable to use a thermosetting resin or a photocurable resin. Specifically, urethane-based, epoxy-based, and urethane-epoxy-based curable resins can be exemplified.

  According to the above-described configuration, the shape of the lead wire is held and fixed by the resin 58. Therefore, when manufacturing the defibrillation catheter 100 (when mounting the connector 50 inside the handle 20), the insulating tube is used. Can be prevented from kinking or coming into contact with the edge of the pin terminal and causing damage (for example, cracking of the coating resin of the lead wire).

  As shown in FIG. 1, the power supply device 700 constituting the defibrillation catheter system of the present embodiment includes a DC power supply unit 71, a catheter connector 72, an electrocardiograph connector 73, and an external switch (input means). ) 74, an arithmetic processing unit 75, a switching unit 76, an electrocardiogram input connector 77, and display means 78.

  The DC power supply 71 has a built-in capacitor, and the built-in capacitor is charged by the input of the external switch 74 (charging switch 743).

  The catheter connection connector 72 is connected to the connector 50 of the defibrillation catheter 100, and electrically connects the proximal ends of the first lead wire group (41G), the second lead wire group (42G), and the third lead wire group (43G). Connected.

As shown in FIG. 9, the connector 50 of the defibrillation catheter 100 and the catheter connection connector 72 of the power supply device 700 are connected by the connector cable C1,
A pin terminal 51 (actually eight) to which eight lead wires 41 constituting the first lead wire group are connected and fixed; a terminal 721 (actually eight) of the catheter connector 72;
A pin terminal 52 (actually eight) to which eight lead wires 42 constituting the second lead wire group are connected and fixed; a terminal 722 (actually eight) of the catheter connector 72;
The pin terminals 53 (actually four) to which the four lead wires 43 constituting the third lead wire group are connected and fixed, and the terminals 723 (actually four) of the catheter connector 72 are connected to each other. I have.

Here, the terminal 721 and the terminal 722 of the catheter connector 72 are connected to the switching unit 76, and the terminal 723 is directly connected to the electrocardiograph connector 73 without passing through the switching unit 76.
Thus, the cardiac potential information measured by the first DC electrode group 31G and the second DC electrode group 32G reaches the electrocardiograph connector 73 via the switching unit 76, and is measured by the proximal potential measuring electrode group 33G. The obtained cardiac potential information reaches the electrocardiograph connector 73 without passing through the switching unit 76.

The electrocardiograph connector 73 is connected to an input terminal of the electrocardiograph 800.
An external switch 74 as an input means includes 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 electric energy to be applied at the time of defibrillation, and a DC power supply unit. A charge switch 743 for charging the battery 71, an input, an energy application preparation switch 744 for determining the polarity of an initial event, a trigger level, and an abnormal wave height level to be described later and preparing for defibrillation, An energy application execution switch (discharge switch) 745 for applying electric energy to execute defibrillation by inputting after (or simultaneously) inputting the application preparation switch 744 is provided. All the input signals from the external switch 74 are sent to the arithmetic processing unit 75.

By providing the energy application preparation switch 744 in addition to the energy application execution switch 745 as a switch for applying energy, the user can check the state of the electrocardiographic waveform before inputting the energy application execution switch 745. can do.
Thus, when the energy application preparation switch 744 is input and the contact of the switching unit is switched to the second contact, if disturbance of the electrocardiogram waveform (for example, drift or noise) occurs, energy application is performed. Can be avoided.

The arithmetic processing unit 75 controls the DC power supply unit 71, the switching unit 76, and the display unit 78 based on the input of the external switch 74.
The arithmetic processing unit 75 has 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 switching unit 76.

  By this output circuit 751, the terminal 721 of the catheter connector 72 (finally, the first DC electrode group 31G of the defibrillation catheter 100) and the terminal 722 of the catheter connector 72 (finally) shown in FIG. And the second DC electrode group 32G of the defibrillation catheter 100) have different polarities (when one electrode group has a negative polarity, the other electrode group has a positive polarity). it can.

The switching unit 76 has a catheter connection connector 72 (terminal 721 and terminal 722) connected to the common contact, an electrocardiograph connection connector 73 connected to the first contact, and an arithmetic processing unit 75 connected to the second contact. The circuit is composed of a changeover switch having two contacts (Single Pole Double Throw).
That is, when the first contact is selected (when the first contact is connected to the common contact), a path connecting the catheter connector 72 and the electrocardiograph connector 73 is secured, and the second contact is selected. When this is done (when the second contact is connected to the common contact), a path connecting the catheter connection connector 72 and the arithmetic processing unit 75 is secured.

  The switching operation of the switching unit 76 is controlled by the arithmetic processing unit 75 based on the input of the external switch 74 (the mode switch 741 and the energy application preparation switch 744).

The electrocardiogram input connector 77 is connected to the arithmetic processing unit 75 and to an output terminal of the electrocardiograph 800.
With this electrocardiogram input connector 77, the electrocardiogram information (usually a part of the electrocardiogram information input to the electrocardiograph 800) output from the electrocardiograph 800 can be input to the arithmetic processing unit 75, The unit 75 can control the DC power supply unit 71 and the switching unit 76 based on the cardiac potential information.

  The display unit 78 is connected to the arithmetic processing unit 75, and the display unit 78 displays electrocardiogram information (mainly, electrocardiogram (cardiac potential waveform)) input to the arithmetic processing unit 75 from the electrocardiogram input connector 77. Can perform defibrillation therapy (input of an external switch, etc.) while monitoring cardiac potential information (electrocardiogram) input to the arithmetic processing unit 75.

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

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

  The electrocardiograph 800 (output terminal) is connected to the electrocardiogram input connector 77 of the power supply device 700, and the electrocardiogram information (cardiac potential information and cardiac potential measurement means 900 from the defibrillation catheter 100) input to the electrocardiograph 800. A part of the electrocardiographic information from the ECG) can be sent to the arithmetic processing unit 75 via the electrocardiogram input connector 77.

  The defibrillation catheter 100 according to the present embodiment can be used as an electrode catheter for measuring a cardiac potential when defibrillation treatment is not required.

FIG. 10 shows the flow of cardiac potential information when measuring cardiac potential with the defibrillation catheter 100 according to the present embodiment when performing cardiac catheterization (for example, high-frequency treatment).
At this time, the switching unit 76 of the power supply device 700 has selected the first contact to which the electrocardiograph connector 73 is connected.

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 passes through the catheter connector 72, the switching unit 76, and the electrocardiograph connector 73. It is input to the electrocardiograph 800.
Further, the cardiac potential measured by the electrodes constituting the proximal potential measuring electrode group 33G of the defibrillation catheter 100 passes through the electrocardiograph connector 73 directly from the catheter connector 72 without passing through the switching unit 76. Is input to the electrocardiograph 800.

Cardiac potential information (electrocardiogram) from the defibrillation catheter 100 is displayed on a monitor (not shown) of the electrocardiograph 800.
In addition, a part of the cardiac potential information from the defibrillation catheter 100 (for example, the potential difference between the electrodes 31 (first and second poles) constituting the first DC electrode group 31G) is read from the electrocardiograph 800 to the electrocardiogram. Via the input connector 77 and the arithmetic processing unit 75, it can be input to the display means 78 and displayed.

  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 a cardiac potential.

  When atrial fibrillation occurs during cardiac catheterization, defibrillation treatment can be immediately performed by the defibrillation catheter 100 used as the electrode catheter. As a result, when atrial fibrillation occurs, the trouble such as newly inserting a catheter for defibrillation can be saved.

  The arithmetic processing unit 75 sequentially senses an event (waveform) estimated as an R wave of the electrocardiogram from a part (electrocardiogram) of the electrocardiogram information transmitted from the electrocardiograph 800 via the electrocardiogram input connector 77. are doing.

  Sensing of an event estimated to be an R wave includes, for example, a maximum peak waveform (event) in the cycle immediately before the cycle (pulsation) to be sensed, and a maximum peak waveform (event) in the two cycles before. Is detected, the average peak height of these maximum peak waveforms is calculated, and it is detected that the potential difference reaches 80% of the average peak height.

  The arithmetic processing unit 75 stores the height of 80% of the average wave height of the two events sensed immediately before the input of the energy application preparation switch 744 as the “trigger level”, and also performs the defibrillation according to the present embodiment. When the catheter system is used as the system according to the first invention, the height of 120% of the average wave height is stored as the “abnormal wave height level”.

  In addition, the arithmetic processing unit 75 recognizes the polarity (the direction of the peak represented by the sign of ±) of each of the sensed events, and when the energy application preparation switch 744 is input, the sensing is performed immediately before the input. If the polarities of the three events are the same, the polarities are stored as the “initial event polarities”; otherwise, the input of the energy application preparation switch 744 is canceled.

Further, the arithmetic processing unit 75, after entering the energy applied execution switch 745, the polarity of the n th cycle sensed events in (V _n) is sensed event in that preceding cycle (V _n-1 ), The polarity of the event (V _n−2 ) sensed in the cycle two cycles before, and the polarity of the stored initial event, and are required in the first invention or the second invention, respectively. that when satisfying the later-described condition, in synchronization with the event (V _n), and the terminal 721 of the catheter connector 72 (first 1DC electrode group 31G), the terminal 722 (first 2DC electrode group of the catheter connector 72 32G) to control the DC power supply unit 71 by applying a voltage.

FIGS. 16A to 16D show the timing of the input of the energy application execution switch 745 and the application of the DC voltage in the electrocardiogram input to the arithmetic processing unit 75.
16A to 16D, the arrow (SW2-ON) indicates the input point of the energy application execution switch 745, and the arrow (DC) indicates the point of application of the DC voltage.
In the electrocardiograms shown in FIG. 16A to FIG. 16D, the polarity of the third event from the left among the six events estimated and sensed as the R wave is (−) (its peak waveform is downward), and the other 5 The polarity of one event is (+) (its peak waveform is upward).
Although not shown, the energy application preparation switch 744 is input before the energy application execution switch 745 is input, and the polarity of the initial event stored in the arithmetic processing unit 75 is (+). .

As shown in FIG. 16A, when the energy application execution switch 745 is input after sensing the second event (V ₀ ) from the left, the polarity (−) of the third event (V ₁ ) is Since the polarity (+) of the second event (V ₀ ) sensed in the cycle is different (and different from the polarity (+) of the initial event), it is not possible to apply a voltage in synchronization with this event (V ₁ ). Absent.
Further, the fourth polarity event (V ₂₎ (+), the polarity of the third event that was sensed in the previous cycle (V ₁₎ (-) and differs, in this event (V ₂₎ No voltage is applied synchronously.
The polarity of the fifth event (V ₃₎ (+), the polarity of the third event that was sensed in the two previous cycle (V ₁₎ (-) and differs, in this event (V ₃₎ No voltage is applied synchronously.
The polarity (+) of the sixth event (V ₄ ) is the polarity (+) of the fifth event (V ₃ ) sensed in the previous cycle and the polarity (+) of the fourth event sensed in the second cycle. Since the polarity is the same as the polarity (+) of the event (V ₂ ), a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G in synchronization with the event (V ₄ ).

As shown in FIG. 16B, when the energy application execution switch 745 is input after sensing the third event (V ₀ ) from the left, the polarity (+) of the fourth event (V ₁ ) is Since the polarity (−) of the third event (V ₀ ) sensed in the cycle is different, no voltage is applied in synchronization with this event (V ₁ ).
The polarity of the fifth event (V ₂₎ (+), the polarity of the two previous cycles third event that was sensed in (V ₀₎ (-) and differs, in this event (V ₂₎ No voltage is applied synchronously.
The polarity (+) of the sixth event (V ₃ ) is the polarity (+) of the fifth event (V ₂ ) sensed in the previous cycle and the polarity (+) of the fourth event sensed in the second cycle. Since the polarity is the same as the polarity (+) of the event (V ₁ ), a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G in synchronization with the event (V ₃ ).

As shown in FIG. 16C, when the energy application execution switch 745 is input after sensing the fourth event (V ₀ ) from the left, the polarity (+) of the fifth event (V ₁ ) is Since the polarity is different from the polarity (-) of the third event (V _-1 ) sensed in the cycle, no voltage is applied in synchronization with this event (V ₁ ).
The polarity (+) of the sixth event (V ₂ ) is the polarity (+) of the fifth event (V ₁ ) sensed in the previous cycle and the polarity (+) of the fourth event sensed in the second cycle. Since the polarity is the same as the polarity (+) of the event (V ₀ ), a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G in synchronization with the event (V ₂ ).

As shown in FIG. 16D, when the energy application execution switch 745 is input after sensing the fifth event (V ₀ ) from the left, the polarity (+) of the sixth event (V ₁ ) is This event is the same as the polarity (+) of the fifth event (V ₀ ) sensed in the cycle and the polarity (+) of the fourth event (V ₋₁ ) sensed in the two previous cycles. A voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G in synchronization with (V ₁ ).

  As described above, even when the energy application execution switch 745 is input at any of the timings shown in FIGS. 16A to 16D, the third event (the sixth event from the left) when the same polarity (+) continues three times Event), the voltage is applied.

If the polarity of the event (V _n ) sensed in the n-th cycle after inputting the energy application execution switch 745 does not match the polarity of the stored initial event, the arithmetic processing unit 75 sets the event (V _In synchronization with _n ), the DC power supply unit 71 is controlled by performing arithmetic processing so that no voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G.

FIG. 18 shows the timing of the input of the energy application preparation switch 744, the input of the energy application execution switch 745, and the application of the DC voltage in the electrocardiogram input to the arithmetic processing unit 75.
In the figure, an arrow (SW1-ON) indicates an input time of the energy preparation switch 744, an arrow (SW2-ON) indicates an input time of the energy application execution switch 745, and an arrow (DC) indicates a DC voltage application time. is there.
In the electrocardiogram shown in FIG. 18, the polarity of the first to third and seventh to ninth events from the left among the nine events estimated and sensed as the R wave is (+) (its peak waveform is upward). And the polarities of the fourth to sixth events from the left are (-) (the peak waveform is downward).

As shown in the figure, if you enter the energy applied preparation switch 744 after sensing of the third from the left event (V _-2), 3 single event that is sensed in the input immediately prior (V _-2), (V _{- Since} the polarities of ₃ ) and (V _-4 ) are both (+), this polarity (+) is stored as the polarity of the initial event.

Then, as shown in the figure, when the energy execution switch 745 is input after sensing the fifth event (V ₀ ) from the left, the polarity of the sixth event (V ₁ ) from the left is (−). The polarity (-) of the fifth event (V ₀ ) sensed in the previous cycle matches the polarity (-) of the fourth event (V _-1 ) sensed in the previous cycle. However, since the polarity does not match the polarity (+) of the initial event, no voltage is applied in synchronization with this event (V ₁ ).

The polarity of the seventh event (V ₂ ) from the left is (+), which matches the polarity (+) of the initial event, but the sixth event (V ₁ ) sensed in the immediately preceding cycle Does not coincide with the polarity (−) of the event, no voltage is applied in synchronization with this event (V ₂ ).

The polarity of the eighth event (V ₃ ) from the left is (+), the polarity of the initial event (+), and the polarity (+) of the seventh event (V ₂ ) sensed in the previous cycle. ), But does not match the polarity (−) of the sixth event (V ₁ ) sensed in the previous two cycles, so that the voltage is synchronized with this event (V ₂ ). It is not applied.

The polarity of the ninth event (V ₄ ) from the left is (+), the polarity of the initial event (+), the polarity (+) of the eighth event (V ₃ ) sensed in the previous cycle, Since the polarity coincides with the polarity (+) of the seventh event (V ₂ ) sensed in the two cycles before, the first DC electrode group 31G and the second DC electrode group are synchronized with this event (V ₄ ). A voltage is applied to 32G.

In the case where the defibrillation catheter system of the present embodiment is used as the system according to the first invention, the arithmetic processing unit 75 operates between the time when the energy application preparation switch 744 is input and the time when the energy application execution switch 745 is input. abnormality when the wave height events (event that has reached the abnormal pulse height level) is generated only if an event from the occurrence of the abnormal wave height events after a certain waiting time (V _n) is sensed, the event (V _n) Synchronously, the DC power supply unit performs arithmetic processing so that a voltage is applied to the terminal 721 (first DC electrode group 31G) of the catheter connector 72 and the terminal 722 (second DC electrode group 32G) of the catheter connector 72. 71 is controlled.

  Here, the standby time is usually 1000 to 5000 msec, preferably 2000 to 4000 msec, and 3000 msec (3 sec) as a suitable example.

  If a plurality of abnormal wave heights occur between the time when the energy application preparation switch 744 is input and the time when the energy application execution switch 745 is input, the first abnormal wave height event occurs (strictly speaking, The standby time is calculated from the time when the waveform reaches the abnormal wave height level).

FIG. 19 shows the input of the energy application preparation switch 744, the input of the energy application execution switch 745, and the DC voltage of the electrocardiogram (cardiac potential waveform similar to that shown in FIG. 25) input to the arithmetic processing unit 75. The timing with application is shown.
In the figure, an arrow (SW1-ON) indicates an input time of the energy preparation switch 744, an arrow (SW2-ON) indicates an input time of the energy application execution switch 745, and an arrow (DC) indicates a DC voltage application time. is there.
In the electrocardiogram shown in the figure, the stable baseline rises, and then the baseline falls and returns to the original level.

Event when (V _-5) to enter the energy applied preparation switch 744 at the time indicated by the arrow (SW1-ON) after sensing, three events sensed in the input immediately prior _{(V -5), (V -6} ) Since the polarity of (V _-7 ) and (V _-7 ) are both (+), the polarity (+) is stored in the arithmetic processing unit 75 as the polarity of the initial event.
Also, the height of 80% of the average wave height of the two events (V _-5 ) and (V _-6 ) sensed immediately before the input is the "trigger level" (shown by a solid line TL extending in the time axis direction in the figure). And the height of 120% of the average wave height is stored as an “abnormal wave height level” (indicated by a broken line HL extending in the time axis direction in the figure).

When the energy application execution switch 745 is input at the time point indicated by the arrow (SW2-ON), three abnormal wave heights (V) are input after the energy application preparation switch 744 is input and before the energy application execution switch 745 is input. _-2 ), (V _-1 ) and (V ₀ ) have occurred, and in this case, the event sensed within a certain waiting time from the occurrence of the first abnormal wave height event (V _-2 ) is triggered. No point is recognized and no voltage is applied in synchronization with the event.

Here, since the event (V ₁ ) immediately after the input of the energy application execution switch 745 is sensed during a certain waiting time (WAITING TIME) from the abnormal wave height event (V ₋₂ ), this event (V ₁ ) No voltage is applied in synchronization with.

The event (V ₂ ) in the cycle following the event (V ₁ ) is sensed after the elapse of the standby time. The polarity (+) of this event (V ₂ ) is the polarity (+) of the initial event, the polarity (+) of the event (V ₁ ) sensed in the previous cycle, and the polarity (+) of the event (V ₂ ) in the previous cycle. Since the polarity of the event (V ₀ ) is the same as that of the event (V ₀ ), a voltage is applied in synchronization with the event (V ₂ ).

  Further, the arithmetic processing unit 75 detects the event presumed to be the R wave in the input electrocardiogram, and detects the DC power supply unit 71 so that no voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G for 260 ms. Control.

Thereby, when the event detected is the peak of the R wave, it is possible to reliably avoid performing defibrillation at the time when the next T wave appears, that is, to put a mask on the peak estimated as the T wave. Defibrillation.
Note that the period during which no DC voltage is applied after sensing the event is not limited to 260 ms, but is at least 50 ms and at most 500 ms. If this period is shorter than 50 ms, it may not be possible to mask a peak presumed to be a T wave. On the other hand, if this period is longer than 500 ms, it may not be possible to sense the R wave in the next cycle (beat).

  Further, the arithmetic processing unit 75 is programmed so as not to newly sense an event estimated as an R wave for 100 ms after sensing an event estimated as an R wave.

Thus, in the case where the peak of the S wave appearing in the opposite direction (opposite polarity) to the R wave following the R wave increases and reaches the trigger level (even in this state, defibrillation is performed). This does not pose any particular problem in performing this operation), and the peak of the S wave can be sensed to prevent the continuity of the polarity of the event from being lost (counts having the same polarity are reset).
In addition, after sensing an event, a period (a blanking period) in which an event presumed to be an R wave is not newly sensed is not limited to 100 ms, but is 10 ms at a minimum and 150 ms at a maximum. You.

Further, the arithmetic processing unit 75 controls the DC power supply unit 71 so that no voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G for 260 msec after the input of the energy application execution switch 745.
Thus, noise generated by the input of the energy application execution switch 745 (noise having the same polarity as that of the previous and two previous events) is erroneously recognized as an R wave and sensed, and defibrillation is performed in synchronization with the noise. Such a situation can be prevented.
In addition, noise generated by the input of the energy application execution switch 745 (noise having a polarity different from that of the previous and / or last two-time event) impairs the continuity of the polarity of the event (the count of the same polarity is reset). Can be prevented.
Further, it is also possible to prevent the fluctuation of the baseline generated immediately after the input of the energy application execution switch 745 from being erroneously recognized as the R-wave and sensed, and perform the defibrillation in synchronization with the sensing.
Note that the period during which the DC voltage is not applied after the input of the energy application execution switch 745 is not limited to 260 ms, but is at least 10 ms and at most 500 ms.

  FIG. 11 is a flowchart showing an example of defibrillation treatment when the intracardiac defibrillation catheter system of the present embodiment is used as the system according to the first invention.

(1) First, the positions of the electrodes (the constituent electrodes of the first DC electrode group 31G, the second DC electrode group 32G, and the proximal-side potential measurement electrode group 33G) of the defibrillation catheter 100 are confirmed on the X-ray image, and the heart is checked. A part of the electrocardiogram information (12-lead electrocardiogram) input to the electrocardiograph 800 is selected from the electric potential measurement means 900 (electrode pad attached to the body surface), and the processing of the power supply device 700 is performed from the electrocardiogram input connector 77. The data is input to the unit 75 (Step 1). At this time, part of the cardiac potential information input to the arithmetic processing unit 75 is displayed on the display means 78 (see FIG. 12). In addition, from the constituent electrodes of the first DC electrode group 31G and / or the second DC electrode group 32G of the defibrillation catheter 100 to the electrocardiograph 800 via the catheter connector 72, the switching unit 76, and the electrocardiograph connector 73. The input cardiac potential information and the cardiac input from the constituent electrodes of the proximal potential measuring electrode group 33G of the defibrillation catheter 100 to the electrocardiograph 800 via the catheter connector 72 and the electrocardiograph connector 73. The potential information is displayed on a monitor (not shown) of the electrocardiograph 800.

(2) Next, the mode switch 741 which is the external switch 74 is input. The power supply device 700 according to the present embodiment is in the “cardiac potential measurement mode” in an initial state, the switching unit 76 selects the first contact, and the electrocardiograph connecting connector is connected to the catheter connecting connector 72 via the switching unit 76. A route to 73 is secured.
The mode is switched to the "defibrillation mode" by the input of the mode switch 741 (Step 2).

(3) As shown in FIG. 13, when the mode changeover switch 741 is input and the mode is switched to the defibrillation mode, the contact of the switching unit 76 is switched to the second contact by the control signal of the arithmetic processing unit 75, and the catheter connector 72 Thus, a route from the catheter connector 72 to the electrocardiograph connector 73 via the switch 76 is cut off from the catheter connector 72 (Step 3). When the switching unit 76 selects the second contact, the 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 may not be input to the electrocardiograph 800. No (therefore, this cardiac potential information cannot be sent to the arithmetic processing unit 75). However, the cardiac potential information from the constituent electrodes of the proximal potential measuring electrode group 33G that does not pass through the switching unit 76 is input to the electrocardiograph 800.

(4) When the contact of the switching unit 76 is switched to the second contact, the resistance between the first DC electrode group (31G) and the second DC electrode group (32G) of the defibrillation catheter 100 is measured (Step 4). The resistance value input to the arithmetic processing unit 75 from the catheter connector 72 via the switching unit 76 is displayed together with a part of the cardiac potential information from the cardiac potential measuring unit 900 input to the arithmetic processing unit 75. It is displayed on the means 78 (see FIG. 13).

(5) The contact of the switching unit 76 is switched to the first contact, and the path from the catheter connector 72 to the electrocardiograph connector 73 via the switching unit 76 is restored (Step 5).
The time during which the contact of the switching unit 76 selects the second contact (the above-described Step 3 to Step 5) is, for example, 1 second.

(6) The arithmetic processing unit 75 determines whether or not the resistance measured in Step 4 exceeds a certain value, and if not, proceeds to the next Step 7 (preparation for applying a DC voltage). If it exceeds, the process returns to Step 1 (confirmation of the position of the electrode of the defibrillation catheter 100) (Step 6).
Here, when the resistance exceeds a certain value, the first DC electrode group and / or the second DC electrode group surely hit a predetermined site (for example, a coronary vein tube wall or a right atrium inner wall). Since it is not in contact, it is necessary to return to Step 1 and readjust the position of the electrode.
As described above, the voltage is applied only when the first DC electrode group and the second DC electrode group of the defibrillation catheter 100 are securely brought into contact with a predetermined site (for example, the wall of the coronary vein or the inner wall of the right atrium). Can be applied, so that effective defibrillation treatment can be performed.

(7) The applied energy setting switch 742, which is the external switch 74, is input to set the applied energy at the time of defibrillation (Step 7).
According to the electrode device 700 in the present embodiment, the applied energy can be set from 1 J to 30 J in 1 J steps.

(8) The charge switch 743, which is the external switch 74, is input to charge the internal capacitor of the DC power supply 71 with energy (Step 8).

(9) After the charging is completed, the operator inputs the energy application preparation switch 744 which is the external switch 74 (Step 9).

(10) The arithmetic processing unit 75 determines whether the polarities of the three events sensed immediately before the input of the application preparation switch 744 are the same as each other, and proceeds to Step 12 if they are the same (at this time, The display means 78 displays "Waiting Trigger"). If not the same, the input of the energy application preparation switch 744 is cancelled, and the process returns to Step 9 (Step 10).

(11) The contact of the switching unit 76 is switched to the second contact by the arithmetic processing unit 75, and a route from the catheter connector 72 to the arithmetic processing unit 75 via the switching unit 76 is secured. The path leading to the electrocardiograph connector 73 via the switching unit 76 is interrupted (Step 11).

(12) The arithmetic processing unit 75 stores the polarities of the three events sensed immediately before the input of the application preparation switch 744 as “the polarity of the initial event”, and stores the two events sensed immediately before the input of the application preparation switch 744. Is stored as a "trigger level", and a height of 120% of the average wave height is stored as an "abnormal wave height level" (Step 12).

(13) The operator inputs the energy application execution switch 745 which is the external switch 74 (Step 13).

(14) “1” is set as a number (n) indicating how many times the current event (V _n ) sensed in Step 16 to be described later is sensed after inputting the energy application execution switch 745. generate. (Step 14).

(15) The arithmetic processing unit 75 performs new sensing as a blanking period for 100 msec after sensing the previous event (V _n-1 ) (the event sensed immediately before the input of the energy application execution switch 745). There is no waiting (Step 15).

(16) After the lapse of the blanking period, the arithmetic processing unit 75 senses the event (V _n ) (Step 16).

(17) The arithmetic processing unit 75 determines whether or not the polarity of the event (V _n ) sensed in Step 16 matches the polarity of the initial event stored in Step 12, and if it does, proceeds to Step 18. If they do not match, in Step 14 ', 1 is added to the above number (n), and the process returns to Step 15 (Step 17).

(18) The arithmetic processing unit 75 determines whether or not the polarity of the event (V _n ) sensed in Step 16 matches the polarity of the last event (V _n-1 ) sensed last (immediately before). If it is determined that they match, the process proceeds to Step 19, and if they do not match, in Step 14 ', 1 is added to the above number (n), and the process returns to Step 15 (Step 18).

(19) The arithmetic processing unit 75 determines whether or not the polarity of the event (V _n ) sensed in Step 16 matches the polarity of the event (V _n−2 ) of the previous two times (the last sensed two times). If it is determined that they match, the process proceeds to Step 20, and if they do not match, in Step 14 ', 1 is added to the above number (n), and the process returns to Step 15 (Step 19).

(20) The arithmetic processing unit 75 determines whether the time from sensing the previous event (V _n-1 ) to sensing the event (V _n ) has exceeded 260 ms, and If yes, the process proceeds to Step 21, and if not, in Step 14 ', 1 is added to the above number (n), and the process returns to Step 15 (Step 20).

(21) The arithmetic processing unit 75 determines whether or not the time from input of the energy application execution switch 745 to sensing of the event (V _n ) exceeds 260 msec. The process proceeds to Step 22, and if not exceeded, 1 is added to the above number (n) in Step 14 ', and the process returns to Step 15 (Step 21).

(22) The arithmetic processing unit 75 determines whether or not an abnormal crest event (an event that has reached the abnormal crest level) has occurred between the time when the application preparation switch 744 was input and the time when the application execution switch 745 was input. If it has occurred, the process proceeds to Step 23, and if it has not occurred, the process proceeds to Step 25 (Step 22).

(23) “DRIFT” is displayed on the display means 78 for a certain standby time (3 seconds) from the occurrence of the abnormal wave height event (Step 23).

(24) The arithmetic processing unit 75 senses the event (V _n ) after a lapse of a certain standby time (3 seconds) from the occurrence of the abnormal peak event (the first abnormal peak event occurs when a plurality of abnormal peaks occur). It is determined whether or not it has been sensed. If it is sensed after the lapse of time, the process proceeds to Step 25. If it is sensed before the lapse of time, 1 is added to the above number (n) in Step 14 '. It returns to Step15 (Step24).

(25) The arithmetic processing unit 75 recognizes the event (V _n ) sensed in Step 16 as a trigger point, and proceeds to Step 26 (Step 25).

(26) The switch of the output circuit 751 of the arithmetic processing unit 75 is turned ON, and the process proceeds to Step 27 (Step 26).

(27) The first DC of the defibrillation catheter 100 from the DC power supply unit 71 that has received the control signal from the arithmetic processing unit 75 via the output circuit 751, the switching unit 76, and the catheter connector 72 of the arithmetic processing unit 75. DC voltages having polarities different from each other are applied to the electrode group and the second DC electrode group (Step 27, see FIG. 14).

Here, the arithmetic processing unit 75 performs an arithmetic process so that a DC voltage is applied to the first DC electrode group and the second electrode group in synchronization with the event (V _n ) sensed in Step 12 and performs the DC power supply unit 71 To the control signal.
Specifically, the event (V _n) a predetermined time from the point of sensing (when the next R-wave is rising) (e.g., an event (V _n) at a 1/10 of a very short time of the peak width of the R-wave The application is started after elapse.

FIG. 15 is a diagram showing a potential waveform measured when predetermined electrical energy (for example, setting output = 10 J) is applied by the defibrillation catheter 100 according to the present embodiment. In the figure, the horizontal axis represents time, and the vertical axis represents potential.
First, after a lapse of a predetermined time (t ₀ ) after the arithmetic processing unit 75 senses an event (V _n ), the first DC electrode group 31G is set to a negative pole and the second DC electrode group 32G is set to a positive pole. by applying a DC voltage in the electrical energy is supplied the measured potential rises (E ₁ is the peak voltage at this time.). After a lapse of a fixed time (t ₁ ), a DC voltage with inverted ± is applied between the first DC electrode group 31G and the second DC electrode group 32G such that the first DC electrode group 31G has a positive pole and the second DC electrode group 32G has a negative pole, thereby supplying electric energy. it is the measured potential rises (E ₂ is the peak voltage at this time.).

Here, the time (t ₀ ) from the sensing of the event (V _n ) to the start of application is, for example, 0.01 to 0.05 seconds, and 0.01 second in a preferred example. (T = t ₁ + t ₂ ) is, for example, 0.006 to 0.03 seconds, and 0.02 seconds as a preferable example. As a result, the voltage can be applied in synchronization with the event (V _n ), which is an R wave, and effective defibrillation treatment can be performed.
The measured peak voltage (E ₁₎ is, for example, 300～600V.

(28) After a certain time (t ₀ + t) has elapsed after sensing the event (V _n ), the application of the voltage from the DC power supply unit 71 is stopped in response to the control signal from the arithmetic processing unit 75 (Step 28). .

(29) After the application of the voltage is stopped, the applied recording (the cardiac potential waveform at the time of application as shown in FIG. 15) is displayed on the display means 78 (Step 29). The display time is, for example, 5 seconds.

(30) The contact of the switching unit 76 is switched to the first contact, and the path from the catheter connector 72 to the electrocardiograph connector 73 via the switching unit 76 is restored, and the first DC electrode of the defibrillation catheter 100 is returned. Cardiac potential information from the constituent electrodes of the group 31G and the second DC electrode group 32G is input to the electrocardiograph 800 (Step 30).

(31) Heart 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) displayed on the monitor of the electrocardiograph 800. The potential information (electrocardiogram) and the electrocardiogram information (12-lead electrocardiogram) from the electrocardiogram measuring means 900 are observed. If "normal", the process is terminated, and if "normal (atrial fibrillation has not subsided)" Returns to Step 2 (Step 31).

When the defibrillation catheter system of the present embodiment is used as the system according to the second invention, the arithmetic processing unit 75 determines that the polarity of the event (V _n ) sensed after the input of the energy application execution switch 745 is 1 The bottom line in the waveform of the event (V _n ) matches the polarity of the event (V _n-1 ) sensed immediately before and the polarity of the event (V _n-2 ) sensed immediately before the event, and When the rise time from when the signal reaches the trigger level to when the signal reaches the trigger level is within 45 ms, the terminal 721 (the first DC electrode group 31G) of the catheter connector 72 is synchronized with the event (V _n ). The DC power supply unit 71 is controlled by performing arithmetic processing so that a voltage is applied to the terminal 722 (the second DC electrode group 32G) of the catheter connector 72. .

Here, the “bottom line” refers to a voltage level obtained by shifting the baseline (voltage = 0 V) of the electrocardiogram by 0.26 V in the polarity direction of the event (V _n ) whose rise time is to be measured.
That is, bottom line when the polarity of the event (V _n) is (+) is + 0.26 V, the polarity of the event (V _n) is - bottom line is -0.26V when a () .

FIG. 20 shows a rising state (time) of an event (event (V ₂ )) after the input of the energy application execution switch 745 in the electrocardiogram input to the arithmetic processing unit 75.
In the figure, the bottom line is indicated by a dashed line BL extending in the time axis direction, and the trigger level is indicated by a solid line TL extending in the time axis direction.

When the energy application preparation switch 744 is input at the time indicated by the arrow (SW1-ON), the polarities of the three events (V _-2 ), (V _-3 ) and (V _-4 ) sensed immediately before the input are all changed. Since it is (+), the polarity (+) is stored in the arithmetic processing unit 75 as the polarity of the initial event.
Also, the height of 80% of the average wave height of the two events (V _-2 ) and (V _-3 ) sensed immediately before the input is stored as the "trigger level" (TL).

When the energy application execution switch 745 is input at the time point indicated by the arrow (SW2-ON), the event (V ₁ ) immediately after the input is performed within 260 msec after the input of the energy application execution switch 745. No voltage is applied in synchronization with (V ₁ ).

The event (V ₂ ) in the next cycle of the event (V ₁ ) is sensed 260 ms after the input of the energy application execution switch 745.
The polarity (+) of the event (V ₂ ) is the polarity (+) of the initial event, the polarity (+) of the event event (V ₁ ) sensed immediately before, and the event event sensed two times before. It matches the polarity (+) of (V ₀ ).
However, in the waveform of the event (V _2), since the rise time from reaching the bottom line (BL) until it reaches the trigger level (TL) (t) is over 45m seconds, event (V ₂ ) Is not recognized as a trigger point because the waveform may be a T wave, and no voltage is applied in synchronization with this event (V ₂ ).

  FIG. 17 is a flowchart showing an example of defibrillation treatment when the intracardiac defibrillation catheter system of the present embodiment is used as the system according to the second invention.

  Defibrillation in the case of use as a system according to the first invention, except that Steps 1 to 21 of defibrillation treatment in the case of use as a system according to the second invention, except that “abnormal peak level” is not stored in Step 12. This is the same as Steps 1 to 21 of the treatment.

As Step 22, the arithmetic processing unit 75 measures the rising time from when the bottom line is reached to when the trigger level is reached in the waveform of the event (V _n ) sensed in Step 16, and this time is within 45 ms. In this case, the process proceeds to Step 23, and if this time exceeds 45 ms, in Step 14 ', 1 is added to the number (n), and the process returns to Step 15.

  Steps 23 to 29 of the defibrillation treatment when used as the system according to the second invention are the same as Steps 25 to 31 of the defibrillation treatment when used as the system according to the first invention.

According to the catheter system of the present embodiment, the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 can directly apply electric energy to the fibrillated heart. Electrical stimulation (electric shock) necessary and sufficient for fibrillation treatment can be reliably given only to the heart.
In addition, since electric energy can be directly applied to the heart, there is no possibility of causing a burn on the body surface of the patient.

  In addition, the cardiac potential information measured by the constituent electrodes 33 of the proximal-side potential measuring electrode group 33G is transmitted from the catheter connector 72 to the electrocardiograph via the electrocardiograph connector 73 without passing through the switching section 76. The electrocardiograph 800 is further connected to the electrocardiograph 800, and the electrocardiograph 800 is connected to the electrocardiograph 800, so that the electrocardiogram from the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 is measured. During defibrillation treatment that cannot be obtained by the electrometer 800 (the switching unit 76 is switched to the second contact point, and the path from the catheter connector 72 to the electrocardiograph connector 73 via the switching unit 76 is cut off. ), The electrocardiograph 800 can acquire the cardiac potential information measured by the proximal potential measuring electrode group 33G and the cardiac potential measuring means 900. It is possible to perform defibrillation therapy while monitoring (monitoring) the cardiac potential at 800.

  Further, the arithmetic processing unit 75 of the power supply device 700 controls the DC power supply unit 71 by performing arithmetic processing so that a voltage is applied in synchronization with a cardiac potential waveform input via the electrocardiogram input connector 77 ( The application is started after a certain period of time (for example, 0.01 seconds) has elapsed after the potential difference in the cardiac potential waveform reaches the trigger level), so that the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 are The voltage can be applied in synchronization with the cardiac potential waveform, and effective defibrillation treatment can be performed.

  Further, the arithmetic processing unit 75 determines that the resistance between the electrode groups of the defibrillation catheter 100 does not exceed a certain value, that is, the first DC electrode group 31G and the second DC electrode group 32G Perform effective defibrillation treatment because it controls so that it can proceed to preparation for applying DC voltage only when it is securely in contact with the vessel wall of the coronary vein and the inner wall of the right atrium. Can be.

Further, the arithmetic processing unit 75 sequentially senses an event presumed to be an R wave in the electrocardiogram input from the electrocardiograph 800 via the electrocardiogram input connector 77, and performs the n-th time after the input of the energy application execution switch 745. the polarity of the sensed event (V _n) is consistent with the polarity of the polarity and two previously sensed event that the one previously sensed event _{(V n-1) (V} n-2) Otherwise, no voltage is applied in synchronization with the event (V _n ), thus avoiding defibrillation when extrasystoles are occurring or the ECG baseline is not stable. can do.

FIG. 21A is an electrocardiogram (a cardiac potential waveform similar to that shown in FIG. 23) input to the arithmetic processing unit 75 when a single extrasystole occurs in the patient's heart. In FIG. 21A, the polarity of the fourth R wave [event (V ₀ )] from the left is (−), and the peak of the T wave following this increases, and this T wave is sensed as the event (V ₁ ). Have been.
As shown in the drawing, events (V ₀₎ after the sensing, when you enter the energized execution switch 745, the polarity (+) of the sensed event immediately (V ₁₎ is one before that Is different from the polarity (−) of the event (V ₀ ) sensed in the above, no voltage is applied in synchronization with this event (V ₁ ). Thus, it is possible to prevent the voltage from being applied in synchronization with the T-wave that has been mistaken for the R-wave due to the increased peak.
The event (V ₂ ) sensed next to the event (V ₁ ) is the peak of the R-wave, and its polarity (+) is the polarity (+) of the event (V ₀ ) sensed two immediately before. Since this is different from −), no voltage is applied in synchronization with this event (V ₂ ).
The next sensed event (V ₃₎ of the event (V ₂₎ polarity (+) was sensing the polarity (+) and two previous one previously sensed event (V ₂₎ Since the polarity (+) of the event (V ₁ ) is the same as that of the event (V ₁ ), a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G in synchronization with the event (V ₃ ) at which the peak of the R wave can be convinced. .

FIG. 21B is an electrocardiogram input to the arithmetic processing unit 75 when extrasystole occurs continuously in the patient's heart.
As shown in the figure, when the energy application execution switch 745 is input after sensing the event (V ₀ ) in which the polarity is inverted (−) due to the extra systole, the event ( The polarity of V ₁ ) is (+), the polarity of the next sensed event (V ₂ ) is (−), the polarity of the next sensed event (V ₃ ) is (+), and then the sense is The polarity of the detected event (V ₄ ) is (−), and the polarity of the next sensed event (V ₅ ) is (+), and the polarity of the event is alternately changed. Accordingly, in a state where the polarities of three events sensed consecutively do not match, it is determined that each of these events may not be the peak of the R wave, and the event is synchronized with the event. No voltage is applied.
The polarity (+) of the event (V ₆ ) sensed next to the event (V ₅ ) is the peak of the R wave, and the polarity (+) of the event (V ₆ ) sensed two events before the event (V 5) _Since the polarity is different from the polarity (−) of ₄ ), no voltage is applied in synchronization with this event (V ₆ ).
The polarity (+) of the event (V ₇ ) sensed next to the event (V ₆ ) is the same as the polarity (+) of the event (V ₆ ) and the polarity (+) of the event (V ₅ ). Therefore, during the event (V ₇ ) sensing, it is determined that the extraordinary contraction has surely subsided, and the first DC electrode group 31G and the second DC electrode are synchronized in synchronization with the event (V ₇ ) at which the peak of the R wave can be confident. A voltage is applied to the group 32G.

FIG. 22 is an electrocardiogram (a cardiac potential waveform similar to that shown in FIG. 24) in which a baseline has been lowered due to a drift, and then the baseline has been raised and returned to the original level. The descent and the ascent are misidentified as R-waves and are sensed as event (V _-1 ) and event (V ₁ ), respectively.
As shown in FIG. 22, when the energy application execution switch 745 is input immediately before the baseline rises, the polarity (+) of the event (V ₁ ) sensed immediately thereafter is sensed immediately before that. event (V ₀₎ is the same as the polarity (+) of the two previously sensed event polarity (V _-1) (-) for different and, in synchronization with the event (V ₁₎ No voltage is applied, thereby preventing the voltage from being applied in synchronization with the rise of the baseline that is mistaken for the R-wave.
Then, the event (V ₁₎ following the polarity of the sensed event (V ₂₎ of the (+) was sensing the polarity (+) and two previous one previously sensed event (V ₁₎ Since the polarity is the same as the polarity (+) of the event (V ₀ ), it is determined that the baseline is stable when the event (V ₂ ) is sensed, and is synchronized with the event (V ₂ ) in which the peak of the R wave can be convinced Then, a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G.

  Further, the arithmetic processing unit 75 controls the DC power supply unit 71 so that no DC voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G for 260 msec after sensing the event estimated as the R wave. In addition, when the sensed event is the peak of the R wave, it is possible to reliably prevent the defibrillation from being performed when the next T wave appears.

  Further, the arithmetic processing unit 75 is programmed so as not to newly sense an event estimated as an R wave for 100 ms after sensing an event estimated as an R wave. This is a peak, and when the peak of the S wave appearing in the opposite direction subsequently increases and reaches the trigger level, the peak of the S wave is sensed to prevent the count of the same polarity from being reset. can do.

  Further, the arithmetic processing unit 75 controls the DC power supply unit 71 so that no DC voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G for 260 msec after the input of the energy application execution switch 745. The noise generated by the input of the execution switch 745 is sensed as an R wave and sensed, and defibrillation is performed in synchronization with the noise, and the noise is prevented from resetting the count of the same polarity. it can.

Further, when the defibrillation catheter system of the present embodiment is used as the system according to the first invention, an abnormal wave height event occurs between the time when the energy application preparation switch 744 is input and the time when the energy application execution switch 745 is input. when that occurred, the processing unit 75 only if the elapsed after an event of the first abnormal crest events predetermined standby time from the occurrence of (3 sec) (V _n) is sensed, synchronization to an event (V _n) Then, the DC power supply unit 71 performs arithmetic processing so that a voltage is applied to the terminal 721 (the first DC electrode group 31G) of the catheter connector 72 and the terminal 722 (the second DC electrode group 32G) of the catheter connector 72. Therefore, when drift occurs, the first DC electrode group 31G and the second DC electrode group 32G are directly Voltage application can be reliably avoided, and when the drift has subsided and the baseline is stable, the first DC electrode group 31G and the second DC electrode group 32G are synchronized with the R wave of the electrocardiogram. Defibrillation can be performed by applying a voltage.

Further, when the defibrillation catheter system of the present embodiment is used as the system according to the second invention, the arithmetic processing unit 75 reaches the trigger level after reaching the bottom line in the waveform of the event (V _n ). If the rise time before the connection is within 45 ms, the terminal 721 (first DC electrode group 31G) of the catheter connector 72 and the terminal 722 (second DC electrode) of the catheter connector 72 are synchronized with the event (V _n ). Since the DC power supply unit 71 is controlled by performing arithmetic processing so that a voltage is applied to the electrode group 32G), if the rising time exceeds 45 ms, the waveform of the event (V _n ) is a T wave. as there is a possibility, since it is not possible to apply a voltage in synchronization with the event (V _2), the defibrillation is performed in synchronization with the T wave It can be reliably avoided.

Further, when the polarities of the three events sensed immediately before the input of the application preparation switch 744 are the same as each other, the arithmetic processing unit 75 stores the polarities as the polarities of the initial event. polarity event sensed after the input (V _n) is does not match the polarity of the initial event in synchronization with the event (V _n), a DC voltage to the 1DC electrode group 31G and the 2DC electrode group 32G Is controlled so that DC power is not applied, so that defibrillation can be more reliably avoided when drift occurs.

DESCRIPTION OF SYMBOLS 100 Defibrillation catheter 10 Multi-lumen tube 11 1st lumen 12 2nd lumen 13 3rd lumen 14 4th lumen 15 Fluororesin layer 16 Inner (core) part 17 Outer (shell) part 18 Stainless 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-side potential measuring electrode group 33 Ring-shaped electrode 35 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 Connector for defibrillation catheter 51, 52, 53 Pin terminal 55 Partition wall Board 58 resin 61 1 protection tube 62 second protection 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)
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 section 751 output circuit 76 switching section 77 electrocardiogram input connector 78 display means 800 electrocardiograph 900 electrocardiogram measuring means

Claims (9)

A defibrillation catheter that is inserted into the heart chamber to perform defibrillation, a power supply that applies a DC voltage to the electrodes of the defibrillation catheter, and a catheter system including an electrocardiograph,
The defibrillation catheter, an insulating tube member,
A first electrode group including a plurality of ring-shaped electrodes mounted on a distal end region of the tube member; and a plurality of ring-shaped electrodes mounted on the tube member separated from the first electrode group on a proximal end side. A second electrode group;
A first lead group consisting of a plurality of lead wires each having a tip connected to each of the electrodes constituting the first electrode group;
A second lead group comprising a plurality of lead wires each having a tip connected to each of the electrodes constituting the second electrode group;
The power supply device includes a DC power supply unit,
A catheter connector connected to the proximal end of the first lead group and the second lead group of the defibrillation catheter;
An external switch including an electric energy application preparation switch and an application execution switch,
An arithmetic processing unit having an output circuit of a DC voltage from the DC power supply unit and controlling the DC power supply unit based on an input of the external switch;
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, the DC power supply unit outputs an output circuit of the arithmetic processing unit. And voltages of mutually different polarities are applied to the first electrode group and the second electrode group of the defibrillation catheter via the catheter connector.
The arithmetic processing unit of the power supply device sequentially senses an event estimated as an R wave from an electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and detects an event sensed after input of the application execution switch. The polarity of (V _n ) coincides at least with the polarity of the event (V _n−1 ) sensed immediately before and the polarity of the event (V _n−2 ) sensed two times before, and When an abnormal wave height event occurs between the time when the application preparation switch is input and the time when the application execution switch is input, the event (V _n ) is generated after a predetermined standby time has elapsed after the occurrence of the abnormal wave height event. Only when sensing is performed, arithmetic processing is performed so that a voltage is applied to the first electrode group and the second electrode group in synchronization with the event (V _n ). An intracardiac defibrillation catheter system, wherein the DC power supply is controlled.   The intracardiac defibrillation according to claim 1, wherein the abnormal wave height event is a wave height event exceeding 120% of an average wave height of two events sensed immediately before input of the application preparation switch. Catheter system.   3. The intracardiac defibrillation catheter system according to claim 1, wherein the waiting time is 1000 to 5000 msec. 4.   The intracardiac defibrillation catheter system according to any one of claims 1 to 3, further comprising a function of notifying a possibility that a drift has occurred during the standby time. A defibrillation catheter that is inserted into the heart chamber to perform defibrillation, a power supply that applies a DC voltage to the electrodes of the defibrillation catheter, and a catheter system including an electrocardiograph,
The defibrillation catheter, an insulating tube member,
A first electrode group including a plurality of ring-shaped electrodes mounted on a distal end region of the tube member; and a plurality of ring-shaped electrodes mounted on the tube member separated from the first electrode group on a proximal end side. A second electrode group;
A first lead group consisting of a plurality of lead wires each having a tip connected to each of the electrodes constituting the first electrode group;
A second lead group comprising a plurality of lead wires each having a tip connected to each of the electrodes constituting the second electrode group;
The power supply device includes a DC power supply unit,
A catheter connector connected to the proximal end of the first lead group and the second lead group of the defibrillation catheter;
An external switch including an electric energy application preparation switch and an application execution switch,
An arithmetic processing unit having an output circuit of a DC voltage from the DC power supply unit and controlling the DC power supply unit based on an input of the external switch;
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 input of the application preparation switch, and when defibrillation is performed, the DC power supply unit outputs an output circuit of the arithmetic processing unit. And voltages of mutually different polarities are applied to the first electrode group and the second electrode group of the defibrillation catheter via the catheter connector.
The arithmetic processing unit of the power supply device sequentially senses an event estimated as an R wave from an electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and detects an event sensed after input of the application execution switch. The polarity of (V _n ) matches at least the polarity of the event (V _n-1 ) sensed immediately before and the polarity of the event (V _n-2 ) sensed two times before, and In the waveform of the event (V _n ), after the baseline of the electrocardiogram reaches the bottom line shifted by 0.26 V in the polarity direction of the event (V _n ), it is sensed immediately before the input of the application preparation switch. If the rise time until reaching the trigger level which is 80% of the average wave height of the two events is within 45 ms, the event (V _n ) The intracardiac defibrillation catheter system, wherein the DC power supply unit is controlled by performing arithmetic processing so that a voltage is applied to the first electrode group and the second electrode group in synchronization. If the polarities of the three events sensed immediately before the input of the application preparation switch are the same as each other, the arithmetic processing unit of the power supply device stores the polarities as the initial event polarities, and stores the event (V _n ) Does not match the polarity of the initial event, an arithmetic processing is performed so that no voltage is applied to the first electrode group and the second electrode group in synchronization with the event (V _n ). The intracardiac defibrillation catheter system according to any one of claims 1 to 5, wherein the power supply unit is controlled.   The arithmetic processing unit of the power supply device, after sensing the event presumed to be an R-wave, so that no voltage is applied to the first electrode group and the second electrode group for at least 50 msec and at most 500 msec. The intracardiac defibrillation catheter system according to any one of claims 1 to 6, wherein the DC power supply unit is controlled.   The arithmetic processing unit of the power supply device, after sensing an event estimated as an R wave, does not newly sense an event estimated as an R wave for at least 10 ms and at most 150 ms for at least. Item 8. The intracardiac defibrillation catheter system according to Item 7.   The arithmetic processing unit of the power supply device is configured to operate the DC power supply unit so that no voltage is applied to the first electrode group and the second electrode group for at least 10 ms and at most 500 ms after the input of the application execution switch. The intracardiac defibrillation catheter system according to claim 7 or 8, wherein

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