CN109922861B

CN109922861B - Intracardiac defibrillation catheter system

Info

Publication number: CN109922861B
Application number: CN201780067384.0A
Authority: CN
Inventors: 小岛康弘; 堀内修一
Original assignee: Japan Lifeline Co Ltd
Current assignee: Japan Lifeline Co Ltd
Priority date: 2016-11-04
Filing date: 2017-07-18
Publication date: 2023-07-14
Anticipated expiration: 2037-07-18
Also published as: JP2018068981A; CN109922861A; WO2018083842A1; TWI652089B; JP6632511B2; TW201818994A

Abstract

An intracardiac defibrillation catheter system capable of reliably avoiding the application of a voltage to the electrodes of a defibrillation catheter during a baseline swing (drift) of an electrocardiogram. The catheter system of the present invention comprises: defibrillation catheter 100, power supply device 700, and electrocardiograph 800, the power supply device includes: the DC power supply unit 71, the external switch 74 including the energy application preparation switch 744 and the energy application execution switch 745, and the arithmetic processing unit 75 for controlling the DC power supply unit so that, when an abnormal wave height event occurs from the input energy application preparation switch to the input energy application execution switch, the arithmetic processing unit detects an event (V) only after a predetermined standby time has elapsed from the occurrence of the abnormal wave height event _n ) In the case of (2) with the event (V _n ) The DC power supply unit is controlled by applying a DC voltage to the first DC electrode group 31G and the second DC electrode group 32G in synchronization.

Description

Intracardiac defibrillation catheter system

Technical Field

The present invention relates to an intracardiac defibrillation catheter system, and more particularly, to a catheter system including 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.

Background

Conventionally, as an intracardiac defibrillation catheter system capable of reliably supplying sufficient electric energy required for defibrillation to a heart that causes atrial fibrillation or the like in a cardiac catheter operation and performing defibrillation treatment without causing burns on the body surface of a patient, the present applicant has proposed a catheter system including a defibrillation catheter inserted into the heart chamber to perform defibrillation, a power supply device for applying a dc voltage to an electrode of the defibrillation catheter, and an electrocardiograph, the defibrillation catheter including: an insulating hose member; a first DC electrode group composed of a plurality of ring-shaped electrodes mounted on the front end region of the hose member; a second DC electrode group composed of a plurality of ring-shaped electrodes which are separately arranged on the hose component from the first DC electrode group to the base end side; a first lead group composed of a plurality of leads each having a front end connected to an electrode constituting the first DC electrode group; and a second wire group including a plurality of wires each having a tip connected to an electrode constituting the second DC electrode group, the power supply device including: a DC power supply section; a catheter connection connector connected to the proximal end sides of the first and second lead sets of the defibrillation catheter; an electrocardiograph connection connector connected with an input terminal of the electrocardiograph; an arithmetic processing unit that controls the DC power supply unit based on an input of an external switch, and has an output circuit for a direct-current voltage from the DC power supply unit; and a switching unit configured by a single-pole double-throw changeover switch, wherein the common contact is connected to the catheter connection connector, the first contact is connected to the electrocardiograph connection connector, and the second contact is connected to the arithmetic processing unit, wherein the first contact is selected in the switching unit when the cardiac potential is measured by the electrode of the defibrillation catheter (the electrode constituting the first DC electrode group and/or the second DC electrode group), the cardiac potential information from the defibrillation catheter is input to the electrocardiograph via the catheter connection connector, the switching unit, and the electrocardiograph connection connector of the power supply device, and when defibrillation is performed 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 voltages of mutually different polarities are applied from the DC power supply unit to the first DC electrode group and the second DC electrode group of the defibrillation catheter via the output circuit of the arithmetic processing unit, the switching unit, and the catheter connection connector (refer to patent document 1 below).

In the catheter system described in patent document 1, when an energy application switch is input as an external switch, the contact point of the switching unit is switched from the first contact point to the second contact point by the operation processing unit, and a path from the catheter connection connector to the operation processing unit via the switching unit is ensured.

After the contact point of the switching unit is switched to the second contact point, a direct current voltage of different polarities is applied to the first DC electrode group and the second DC electrode group of the defibrillation catheter from the DC power supply unit receiving the control signal from the operation processing unit via the output circuit of the operation processing unit, the switching unit and the catheter connection connector.

Here, the arithmetic processing unit performs arithmetic processing and sends a control signal to the DC power supply unit to apply a voltage in synchronization with the electrocardiographic potential waveform inputted through the electrocardiographic input connector.

Defibrillation (application of voltage) is typically performed in synchronization with the R-wave in order to perform an effective defibrillation treatment and not to give negative effects to the ventricles.

If defibrillation is assumed to be performed in synchronization with the T wave, there is a high risk of serious ventricular fibrillation, and thus synchronization with the T wave must be avoided.

Therefore, in the catheter system described in patent document 1, one R wave is detected from an electrocardiographic waveform (electrocardiogram) sequentially inputted to the operation processing unit, the wave height is obtained, a peak reaching 80% of the wave height is identified as the R wave immediately after the input of the energy application switch, and a voltage is applied to the first electrode group and the second electrode group in synchronization with the peak.

However, when the heart of a patient who is to receive defibrillation therapy contracts outside the period of time or when a drift (drift) of the baseline (Base line) of the electrocardiogram input to the arithmetic processing unit occurs, there is a case where the peak value of the potential difference (the peak value identified as the R wave) that reaches the trigger level immediately after the input of the energy application switch is not actually the peak value of the R wave.

For example, as shown in fig. 23, when a single extra-systole occurs in the heart of the patient, the polarity of the R wave (in the figure, the fourth R wave from the left) input to the arithmetic processing unit is inverted, and the peak value of the T wave next tends to increase.

As shown in the figure, if the power is input to the application switch immediately after the extra-systolic is generated, the T wave that has increased and reached the trigger level is erroneously regarded as the R wave to be sensed (detected), and a voltage is applied in synchronization with the T wave to perform defibrillation.

Further, if the baseline swing of the electrocardiogram is considered, the R wave is erroneously regarded as a waveform that is not normally sensed and sensed. For example, the rise in the baseline may be a higher level than the actual level at which a positive waveform other than the R-wave is read. Fig. 24 shows an electrocardiogram in which a baseline is lowered due to drift, and thereafter, the baseline is raised and restored to the original level, and since an application switch of electric power is input immediately before the baseline is raised, the rise of the baseline is mistaken for an R wave to be sensed (detected), and a voltage is applied in synchronization with the rise of the baseline, thereby performing defibrillation.

In view of such circumstances, the present inventors propose an intracardiac defibrillation catheter system comprising: a defibrillation catheter inserted into a heart chamber to perform defibrillation, a power supply device for applying a dc voltage to an electrode of the defibrillation catheter, and an electrocardiograph, wherein the defibrillation catheter comprises: an insulating hose member; a first electrode group including a plurality of ring-shaped electrodes attached to a distal end region of the hose member; a second electrode group including a plurality of ring-shaped electrodes attached to the hose member so as to be separated from the first electrode group toward a base end side; a first lead group including a plurality of leads each having a distal end connected to an electrode constituting the first electrode group; and a second wire group including a plurality of wires each having a tip connected to an electrode constituting the second electrode group, the power supply device including: a DC power supply section; a catheter connection connector connected to a proximal end side of the first and second lead groups of the defibrillation catheter; an external switch including an application switch of electric energy; an arithmetic processing unit having an output circuit for a direct current voltage from the DC power supply unit, and controlling the DC power supply unit based on an input of the external switch; and an electrocardiogram input connector, which is connected with The operation processing unit and the output terminal of the electrocardiograph are connected, and when defibrillation is performed by the defibrillation catheter, voltages of mutually different polarities are applied from the DC power supply unit to the first electrode group and the second electrode group of the defibrillation catheter via the output circuit of the operation processing unit and the catheter connection connector, the operation processing unit of the power supply device performs operation processing and controls the DC power supply unit to sequentially sense events estimated as R waves from an electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and to sense the detected events (V) after input of the application switch of the electric energy _n ) At least with the polarity of the event (V) _n-1 ) And the first two sensed events (V _n-2 ) When the polarity of (C) is consistent with that of the event (V _n ) And applying a voltage to the first electrode group and the second electrode group simultaneously.

According to the catheter system described in patent document 2, it is possible to prevent a voltage from being applied to the electrodes of the defibrillation catheter when the heart of the patient receiving the defibrillation treatment contracts outside the period of time or when the baseline of the electrocardiogram input to the arithmetic processing unit swings (shifts).

Prior art literature

Patent literature

Patent document 1: japanese patent No. 4545216

Patent document 2: japanese patent No. 5900974

However, it is also possible to consider a case where a drift occurs even if the polarities of events (waveforms estimated as R waves) detected by sequential sensing in an electrocardiogram input to the arithmetic processing unit of the power supply device are generated three times in succession in the same direction.

FIG. 25 shows an electrocardiogram in which the stable baseline rises, then the baseline falls and returns to the original level, and if the power is input to the power switch at the timing indicated by the drift-causing arrow (SW-ON), then the detected event (V) ₁ ) And the polarity of the event (V) ₀ ) Polarity of (2) and its first twoSensing detected events (V _-1 ) So is consistent with the polarity of the event (V) _n ) Defibrillation is performed synchronously.

Therefore, in order to avoid defibrillation (application of voltage) in drift, it is necessary to reliably detect that drift is caused.

According to the catheter system described in patent document 2, although defibrillation can be prevented from being performed in synchronization with the T wave, from the viewpoint of more safety, it is necessary to more reliably make the event synchronized with defibrillation not be the T wave.

Disclosure of Invention

A first object of the present invention is to provide an intracardiac defibrillation catheter system capable of reliably avoiding the application of a voltage to the electrodes of a defibrillation catheter when the baseline of an electrocardiogram input to an arithmetic processing unit is shifted (drifting), and capable of performing 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 stabilized.

A second object of the present invention is to provide an intracardiac defibrillation catheter system capable of reliably avoiding defibrillation in synchronization with T waves and applying a dc voltage to electrodes of a defibrillation catheter in synchronization with R waves of an electrocardiogram input to an arithmetic processing unit to perform defibrillation.

(1) An intracardiac defibrillation catheter system according to the present invention includes: a defibrillation catheter inserted into a heart chamber to perform defibrillation, a power supply device for applying a direct-current voltage to an electrode of the defibrillation catheter, and an electrocardiograph, wherein the defibrillation catheter comprises: an insulating hose member; a first electrode group (first DC electrode group) composed of a plurality of ring-shaped electrodes mounted on the front end region of the hose member; a second electrode group (second DC electrode group) composed of a plurality of ring-shaped electrodes separated from the first DC electrode group toward the base end side and attached to the hose member; a first lead group including a plurality of leads each having a front end connected to an electrode constituting the first DC electrode group; and a second lead group including a plurality of leads each having a tip connected to an electrode constituting the second DC electrode group, the power supply device including: a DC power supply section; a catheter connector connected to the first defibrillation catheter The base end side of the second wire group is connected with the wire group; an external switch including an application preparation switch and an application execution switch of electric energy; an arithmetic processing unit having an output circuit for outputting a direct current voltage from the DC power supply unit, and controlling the DC power supply unit based on an input from the external switch; and an electrocardiogram input connector connected to the operation processing unit and the output terminal of the electrocardiograph, for performing defibrillation through the defibrillation catheter by inputting the application execution switch after input of the application preparation switch, wherein, during defibrillation, voltages of mutually different polarities are applied from the DC power supply unit to the first DC electrode group and the second DC electrode group of the defibrillation catheter via the output circuit of the operation processing unit and the catheter connection connector, the operation processing unit of the power supply device performs operation processing and controls the DC power supply unit to sequentially sense events estimated as R waves based on an electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and to sense the detected events (V _n ) At least with the polarity of the event (V) _n-1 ) And the first two sensed events (V _n-2 ) When an abnormal wave height event occurs in a period from the input of the application preparation switch to the input of the application execution switch, sensing the event (V) only after a predetermined standby time has elapsed from the occurrence of the abnormal wave height event (the abnormal wave height event which is initially generated when a plurality of abnormal wave heights are generated) _n ) In the case of (2) with the event (V _n ) And applying a voltage to the first DC electrode group and the second DC electrode group synchronously.

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

(3) The above-mentioned standby time in the intracardiac defibrillation catheter system according to the first aspect of the present invention is preferably between 1000 and 5000 msec.

According to the intracardiac defibrillation catheter system having such a configuration, if three events (V _n-2 )、(V _n-1 ) (V) _n ) If the polarities of the (B) are not uniform, it is determined that there is a possibility that the heart of the patient is contracted due to an extra period or the baseline of the electrocardiogram is unstable due to drift or the like, and the detected event (V) _n ) It is possible not to be the peak of the R wave, but not to be the same as the event (V _n ) The voltages are applied synchronously. Furthermore, in three events (V _n-2 )、(V _n-1 ) (V) _n ) When the polarities of the events (V) are identical, the third event (V _n ) And judging as the peak value of the R wave.

In addition, an abnormal wave height tends to be generated when drift occurs, and this drift phenomenon usually recovers around several seconds, and thereafter, the baseline tends to be stable.

Thus, in the event of a sequence other than three events (V _n-2 )、(V _n-1 ) (V) _n ) In addition to the coincidence of the polarities of (a) and (b), when the occurrence of an abnormal wave height event is detected in the period from the input application preparation switch to the input application execution switch, the event is detected only after a predetermined standby time has elapsed from the occurrence of the abnormal wave height event (V _n ) In the case of (2) with the event (V _n ) The voltages are applied synchronously.

Thus, it is possible to reliably avoid applying a voltage to the electrode of the defibrillation catheter when drift occurs, and to apply a DC voltage to the electrode of the defibrillation catheter in synchronization with the R-wave of the electrocardiogram when the baseline is stable, thereby performing defibrillation.

(4) Preferably, the endocardial defibrillation catheter system of the present invention (first aspect) comprises: and reporting the possibility of drift in the standby time.

According to the intracardiac defibrillation catheter system having such a configuration, the operator can easily grasp the possibility of drift, and can wait without inputting the application execution switch.

(5) An intracardiac defibrillation catheter system according to a second aspect of the present invention comprises: defibrillation by insertion into heart chamberA defibrillation catheter, a power supply device for applying a DC voltage to an electrode of the defibrillation catheter, and an electrocardiograph, wherein the defibrillation catheter comprises: an insulating hose member; a first electrode group (first DC electrode group) composed of a plurality of ring-shaped electrodes mounted on the front end region of the hose member; a second electrode group (second DC electrode group) composed of a plurality of ring-shaped electrodes separately attached to the hose member from the first DC electrode group toward the base end side; a first lead group including a plurality of leads each having a front end connected to an electrode constituting the first DC electrode group; and a second lead group including a plurality of leads each having a tip connected to an electrode constituting the second DC electrode group, the power supply device including: a DC power supply section; a catheter connection connector connected to the proximal end sides of the first and second lead groups of the defibrillation catheter; an external switch including an application preparation switch and an application execution switch of electric energy; an arithmetic processing unit having an output circuit for outputting a direct current voltage from the DC power supply unit, and controlling the DC power supply unit based on an input from the external switch; and an electrocardiogram input connector connected to the operation processing unit and the output terminal of the electrocardiograph, for performing defibrillation through the defibrillation catheter by inputting the application execution switch after input of the application preparation switch, wherein, during defibrillation, voltages of mutually different polarities are applied from the DC power supply unit to the first DC electrode group and the second DC electrode group of the defibrillation catheter via the output circuit of the operation processing unit and the catheter connection connector, the operation processing unit of the power supply device performs operation processing and controls the DC power supply unit to sequentially sense events estimated as R waves based on an electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and to sense the detected events (V _n ) At least with the polarity of the event (V) _n-1 ) And the first two sensed events (V _n-2 ) And, in the event (V) _n ) From the arrival of the baseline of the electrocardiogram to the event (V) _n ) The polarity direction of (2) is shifted by 0.26V until about to beWhen the rise time to the trigger level, which is 80% of the average wave height of the two events detected before the application preparation switch is input, is within 45 msec, the control unit is connected with the event (V _n ) And applying a voltage to the first electrode group and the second electrode group simultaneously.

According to the intracardiac defibrillation catheter system having such a configuration, if three events (V _n-2 )、(V _n-1 ) (V) _n ) If the polarities of the (b) are not uniform, it is determined that there is a possibility that the patient contracts during the heart or the baseline of the electrocardiogram becomes unstable due to drift or the like, and the detected event (V) is sensed after the input of the execution switch is applied _n ) Is not the peak of the R wave, but is not in contact with the event (V _n ) The voltages are applied synchronously.

Furthermore, in three events (V _n-2 )、(V _n-1 ) (V) _n ) If the polarities of (a) are identical, it can be determined that the event (V _n ) Is the peak of the R wave.

The waveform of the T wave rises slowly, and the rise time from the bottom line to the trigger level is generally longer than 45 ms. Thus, in event (V _n ) In the waveform of (2), when the rise time from reaching the bottom line to reaching the trigger level exceeds 45m seconds, there is an event (V _n ) The likelihood of the waveform of (a) being a T-wave and not being identified as a trigger point, is not consistent with the event (V _n ) The voltage is applied synchronously, so defibrillation in synchronization with the T wave can be reliably avoided.

(6) In the intracardiac defibrillation catheter system according to the present invention, it is preferable that the arithmetic processing unit of the power supply device stores the polarity of the three events detected immediately before the input of the application preparation switch as the "polarity of the initial event" when the polarities are identical to each other, and stores the polarity of the three events as the "polarity of the initial event" in the event (V _n ) In the case where the polarity of the initial event is not identical to the polarity of the event (V _n ) And a DC power supply unit for performing an operation process while applying a voltage to the first electrode group and the second electrode group simultaneously and controlling the DC power supply unit.

The polarity of the event is reversed when drift occurs, and the polarity may be returned to the original polarity when drift is recovered.

Thus, according to the endocardial defibrillation catheter system thus configured, in the event (V _n ) If the polarity of (a) does not match the polarity of the initial event, it is determined that there is a possibility that the drift continues, but does not match the event (V _n ) The voltages are applied synchronously, so that the application of voltages to the electrodes of the defibrillation catheter when drift is caused can be more reliably avoided.

(7) In the intracardiac defibrillation catheter system according to the present invention, it is preferable that the operation processing unit of the power supply device controls 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 period of up to 500 ms, preferably up to 260 ms, between 50 ms after the event estimated as the R wave is detected.

According to the intracardiac defibrillation catheter system having such a configuration, since no voltage is applied to the first DC electrode group and the second DC electrode group for a minimum of 50m seconds after the event estimated as the R wave is sensed, defibrillation can be reliably avoided at the time when the next T wave appears, that is, the peak estimated as the T wave is masked when the event sensed as the peak of the R wave is sensed.

(8) In the intracardiac defibrillation catheter system according to (7), it is preferable that the operation processing unit of the power supply device does not re-sense the event estimated as the R wave for a period of 150 ms, preferably 100 ms, between the shortest 10 ms after sensing the event estimated as the R wave.

According to the intracardiac defibrillation catheter system having such a configuration, since a new event is not sensed and detected within a minimum of 10m seconds after an event estimated as an R wave is sensed and detected, when the sensed event is a peak value of the R wave and then the peak value of an S wave whose peak value appears in the opposite direction increases and reaches the trigger level (this state is not particularly a problem when defibrillation is performed), it is possible to prevent the sensing and detecting of the peak value of the S wave and the continuity of the polarity of the event (count reset of the same polarity) from being impaired.

(9) In the intracardiac defibrillation catheter system according to (7) or (8), it is preferable that the operation processing unit of the power supply device controls the DC power supply unit without applying a voltage to the first DC electrode group and the second DC electrode group for a period of up to 500 ms, preferably up to 260 ms, between 10 ms after the input of the application execution switch.

According to the intracardiac defibrillation catheter system having such a configuration, since the voltage is not applied to the first DC electrode group and the second DC electrode group for a minimum of 10m seconds after the input of the power is applied to the execution switch, it is possible to prevent noise (noise of the same polarity as the previous and last event) generated by the input of the execution switch from being erroneously detected as R-waves, and to perform defibrillation in synchronization with the noise.

In addition, it is possible to prevent the continuity of the polarity of the event (count reset of the same polarity) from being impaired by noise (noise of a polarity different from that of the last and last event) generated by the application of the input of the execution switch.

Further, it is also possible to prevent the occurrence of a change in the base line immediately after the input of the application execution switch from being mistaken for the R wave to be sensed and to perform defibrillation in synchronization with the sensing.

Effects of the invention

According to the intracardiac defibrillation catheter system according to the first aspect of the present invention, it is possible to reliably avoid the application of a voltage to the electrodes of the defibrillation catheter during the baseline movement (drift) of the electrocardiogram input to the arithmetic processing unit, and to apply a dc voltage to the electrodes of the defibrillation catheter in synchronization with the R-wave of the electrocardiogram to perform defibrillation when the baseline is stabilized.

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

Drawings

Fig. 1 is a block diagram illustrating one embodiment of an intracardiac defibrillation catheter system of the present invention.

Fig. 2 is a plan view illustrating a micro catheter constituting the catheter system shown in fig. 1.

Fig. 3 is a plan view for explaining a micro catheter (a view for explaining dimensions and hardness) constituting the catheter system shown in fig. 1.

Fig. 4 is a cross-sectional view showing section A-A of fig. 2.

FIG. 5 is a cross-sectional view showing the B-B section, C-C section, and D-D section of FIG. 2.

Fig. 6 is a perspective view showing the 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 (front end side) of the handle shown in fig. 6.

Fig. 8 is a partially enlarged view of the inside (base end side) of the handle shown in fig. 6.

Fig. 9 is an explanatory view 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. 10 is a block diagram showing the flow of cardiac potential information in the case of measuring cardiac potential by a defibrillation catheter in the catheter system shown in fig. 1.

Fig. 11 is a flowchart showing the operation and the operation of the power supply device in the case of using the catheter system shown in fig. 1 as the system according to the first aspect.

Fig. 12 is a block diagram showing the flow of the cardiac potential information in the cardiac potential measurement mode in the catheter system shown in fig. 1.

Fig. 13 is a block diagram showing the flow of information related to the measured value of the resistance between the electrode groups and the cardiac potential information in the defibrillation mode of the catheter system shown in fig. 1.

Fig. 14 is a block diagram showing a state when a direct current voltage is applied in a defibrillation mode of the catheter system shown in fig. 1.

Fig. 15 is a graph of potential waveforms measured when prescribed electrical energy is administered through a defibrillation catheter constituting the catheter system shown in fig. 1.

Fig. 16A is an explanatory diagram showing timings of input of the energy application execution switch and application of the dc voltage in the electrocardiogram input to the arithmetic processing unit of the power supply device.

Fig. 16B is an explanatory diagram showing timings of input of the energy execution switch and application of the dc voltage in the electrocardiogram input to the arithmetic processing unit of the power supply device.

Fig. 16C is an explanatory diagram showing timings of input of the energy application execution switch and application of the dc voltage in the electrocardiogram input to the arithmetic processing unit of the power supply device.

Fig. 16D is an explanatory diagram showing timings of input of the energy application execution switch and application of the dc voltage in the electrocardiogram input to the arithmetic processing unit of the power supply device.

Fig. 17 is a flowchart showing the operation and the operation of the power supply device in the case of using the catheter system shown in fig. 1 as the system according to the second aspect.

Fig. 18 is an explanatory diagram showing timings of input of the energy application preparation switch, input of the energy application execution switch, and application of the dc voltage in the electrocardiogram input to the arithmetic processing unit of the power supply device.

Fig. 19 is an explanatory diagram showing the timings of the input of the energy application preparation switch, the input of the energy application execution switch, and the application of the dc voltage in the case of using the catheter system shown in fig. 1 as the system according to the first aspect.

Fig. 20 is an explanatory diagram showing a rising state (time) of an event after the switch input is performed by the energy application in the case of using the catheter system shown in fig. 1 as the system according to the second aspect.

Fig. 21A is an explanatory diagram showing the timing of the input of the energy application execution switch and the application of the dc voltage in an electrocardiogram (cardiac potential waveform when the patient's heart has undergone a single extra-systole) input to the operation processing unit of the power supply device.

Fig. 21B is an explanatory diagram showing the timing of the input of the energy application execution switch and the application of the dc voltage in an electrocardiogram (cardiac potential waveform in the case where the heart of the patient is continuously contracting outside the period) input to the operation processing unit of the power supply device.

Fig. 22 is an explanatory diagram showing timings of input of the energy application execution switch and application of the dc voltage in an electrocardiogram (cardiac potential waveform) of a baseline variation input to the arithmetic processing unit of the power supply device.

Fig. 23 is an explanatory diagram showing timings of input of the energy application switch and application of the dc voltage in an electrocardiogram (cardiac potential waveform when a single extra-systole occurs in the heart of a patient) input to an arithmetic processing unit of a conventional power supply device constituting a catheter system.

Fig. 24 is an explanatory diagram showing timings of input of the energy application switch and application of the dc voltage in an electrocardiogram (cardiac potential waveform) of a baseline variation input to an arithmetic processing unit of a conventional power supply device constituting a catheter system.

Fig. 25 is an explanatory diagram showing timings of input of the energy application switch and application of the dc voltage in an electrocardiogram (cardiac potential waveform) of a baseline variation input to an arithmetic processing unit of a conventional power supply device constituting a catheter system.

Detailed Description

An embodiment of the present invention will be described below.

The intracardiac defibrillation catheter system according to the present embodiment can be used as the system according to the first aspect and the system according to the second aspect.

As shown in fig. 1, the intracardiac defibrillation catheter system according to the present embodiment includes a defibrillation catheter 100, a power supply device 700, an electrocardiograph 800, and an electrocardiograph potential measuring unit 900.

As shown in fig. 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, a second DC electrode group 32G, a base-end-side potential measuring electrode group 33G, a first lead group 41G, a second lead group 42G, and a third lead group 43G.

As shown in fig. 4 and 5, four lumens (a first lumen 11, a second lumen 12, a third lumen 13, and a fourth lumen 14) are formed in a multi-lumen tube 10 (an insulating flexible tube member having a multi-lumen structure) constituting a defibrillation catheter 100.

In fig. 4 and 5, 15 is a fluororesin layer dividing a lumen, 16 is an inner (core) portion made of a nylon elastomer having low hardness, 17 is an outer (shell) portion made of a nylon elastomer having high hardness, and 18 in fig. 4 is a stainless steel bare wire forming a braid.

The lumen-dividing fluororesin layer 15 is made of a material having high insulation such as a perfluoroalkyl vinyl ether copolymer (PFA) or Polytetrafluoroethylene (PTFE).

The nylon elastomer constituting the outer portion 17 of the multi-lumen tube 10 uses an elastomer having different hardness according to the axial direction. Thus, the hardness of the multi-lumen tube 10 is gradually increased from the distal end side toward the proximal end side.

In fig. 3, the hardness (based on D-type durometer) of the region shown by L1 (length 52 mm) is 40, the hardness of the region shown by L2 (length 108 mm) is 55, the hardness of the region shown by L3 (length 25.7 mm) is 63, the hardness of the region shown by L4 (length 10 mm) is 68, and the hardness of the region shown by L5 (length 500 mm) is 72, if a preferred example is shown.

A braid consisting of bare stainless steel wires 18 is formed only in the region shown by L5 in fig. 3, and is provided between the inner portion 16 and the outer portion 17 as shown in fig. 4.

The outer diameter of the multilumen tubing 10 is, for example, 1.2 to 3.3mm.

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

The handle 20 comprising the defibrillation catheter 100 of this embodiment includes a handle body 21, a grip 22, and a strain relief 24.

By rotating the knob 22, the distal end portion of the multi-lumen tube 10 can be deflected (swung).

A first DC electrode group 31G, a second DC electrode group 32G, and a base-end-side potential measurement electrode group 33G are attached to the outer periphery of the multilumen tubing 10 (a distal end region where knitting is not formed inside). Here, the "electrode group" refers to an aggregate of a plurality of electrodes which constitute the same pole (have the same polarity), or which have the same purpose and are mounted at a narrow interval (for example, 5mm or less).

The first DC electrode group is provided with a plurality of electrodes constituting the same pole (-pole or +pole) at a narrow interval in the front end region of the multi-lumen tube. 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 is constituted by eight ring-shaped electrodes 31 mounted on the distal end region of the multi-lumen tube 10.

The electrodes 31 constituting the first DC electrode group 31G are connected to a conduit connection connector of the power supply device 700 via wires (wires 41 constituting the first wire group 41G) and a connector described later.

Here, the width (axial length) of the electrode 31 is preferably 2 to 5mm, and in a preferred example, 4mm.

If the width of the electrode 31 is too small, the amount of heat generated during voltage application may be too large, and damage may be given to surrounding tissues. On the other hand, if the width of the electrode 31 is too large, the flexibility/softness of the portion of the multi-lumen tube 10 where the first DC electrode group 31G is provided may be impaired.

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

In use of defibrillation catheter 100 (when deployed within a heart chamber), first DC electrode set 31G is located, for example, within 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 side, and a plurality of electrodes constituting a pole (+pole or-pole) opposite to the first DC electrode group are mounted at a narrow interval. 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 that are separately attached to the multi-lumen tube 10 from the attachment position of the first DC electrode group 31G toward the base end side.

The electrodes 32 constituting the second DC electrode group 32G are connected to a conduit connection connector of the power supply device 700 via leads (leads 42 constituting the second lead group 42G) and a connector described later.

Here, the width (axial length) of the electrode 32 is preferably 2 to 5mm, and in a preferred example, 4mm.

If the width of the electrode 32 is too small, the amount of heat generated during voltage application may be too large, and damage may be given to surrounding tissues. On the other hand, if the width of the electrode 32 is too large, the flexibility/softness of the portion of the multi-lumen tube 10 where the second DC electrode group 32G is provided may be impaired.

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

In use of defibrillation catheter 100 (when deployed within a heart chamber), second DC electrode set 32G is positioned, for example, in the right atrium.

In the present embodiment, the proximal-side potential measurement electrode group 33G is configured by four ring-shaped electrodes 33 that are attached to the multi-lumen tube 10 so as to be separated from the attachment position of the second DC electrode group 32G toward the proximal side.

The electrodes 33 constituting the base-end-side potential measurement electrode group 33G are connected to a catheter-connected connector of the power supply device 700 via wires (wires 43 constituting the third wire group 43G) and a connector described later.

Here, the width (axial length) of the electrode 33 is preferably 0.5 to 2.0mm, and 1.2mm is a preferable example.

If the width of the electrode 33 is too large, the accuracy of measuring the cardiac potential is lowered, or it becomes difficult to identify the site where the abnormal potential occurs.

The mounting interval (separation distance between adjacent electrodes) of the electrodes 33 is preferably 1.0 to 10.0mm, and 5mm is an example if appropriate.

In use of the defibrillation catheter 100 (when disposed in a heart chamber), the proximal-side potential measurement electrode group 33G is located in, for example, a superior vena cava where abnormal potential is likely to occur.

A front-end chip 35 is mounted on the front end of the defibrillation catheter 100.

The lead is not connected to the front chip 35, and is not used as an electrode in the present embodiment. However, the electrode may be used as an electrode by connecting a lead thereto. The constituent material of the front chip 35 is not particularly limited, and may be a metal material such as platinum or stainless steel, various resin materials, or the like.

The separation distance d2 between the first DC electrode group 31G (electrode 31 on the base end side) and the second DC electrode group 32G (electrode 32 on the tip end side) is preferably 40 to 100mm, and 66mm is a preferable example.

The separation distance d3 between the second DC electrode group 32G (electrode 32 on the base end side) and the base end side potential measurement electrode group 33G (electrode 33 on the tip end side) is preferably 5 to 50mm, and in a preferred example, 30mm.

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 preferably made of platinum or a platinum-based alloy in order to improve the contrast with respect to X-rays.

The first lead group 41G shown in fig. 4 and 5 is an aggregate of eight leads 41 connected to the eight electrodes (31) constituting the first DC electrode group (31G), respectively.

The eight electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the power supply device 700 through the first wire group 41G (wires 41).

Eight electrodes 31 constituting the first DC electrode group 31G are connected to different leads 41, respectively. The lead wires 41 are welded at their leading end portions to the inner peripheral surfaces of the electrodes 31, respectively, and enter the first lumen 11 from side holes formed in the wall of the multi-lumen tube 10. Eight wires 41 entering the first lumen 11 extend within the first lumen 11 as a first wire set 41G.

The second lead group 42G shown in fig. 4 and 5 is an aggregate of eight leads 42 connected to the eight electrodes (32) constituting the second DC electrode group (32G), respectively.

The eight electrodes 32 constituting the second DC electrode group 32G can be electrically connected to the power supply device 700 by the second wire group 42G (wires 42).

The eight electrodes 32 constituting the second DC electrode group 32G are connected to different leads 42, respectively. The wires 42 are welded at their leading end portions to the inner peripheral surfaces of the electrodes 32, respectively, and enter the second lumen 12 (a lumen different from the first lumen 11 in which the first wire group 41G extends) from side holes formed in the wall of the multi-lumen tube 10. Eight wires 42 entering the second lumen 12 extend within the second lumen 12 as a second wire set 42G.

As described above, the first wire set 41G extends in the first lumen 11 and the second wire set 42G extends in the second lumen 12, so that both are completely insulated within the multi-lumen tube 10. Therefore, when a voltage required for defibrillation is applied, a short circuit between the first wire group 41G (the first DC electrode group 31G) and the second wire group 42G (the second DC electrode group 32G) can be reliably prevented.

The third lead group 43G shown in fig. 4 is an aggregate of four leads 43 connected to the electrodes (33) constituting the base end side potential measurement electrode group (33G), respectively.

The electrodes 33 constituting the base-end-side potential measurement electrode group 33G can be electrically connected to the power supply device 700 through the third wire group 43G (the wires 43).

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

As described above, the third wire group 43G extending in the third lumen 13 is completely insulated from any of the first wire group 41G and the second wire group 42G. Therefore, when a voltage required for defibrillation is applied, a short circuit between the third wire group 43G (the base end side potential measurement electrode group 33G) and the first wire group 41G (the first DC electrode group 31G) or the second wire group 42G (the second DC electrode group 32G) can be reliably prevented.

The lead 41, the lead 42, and the lead 43 are each composed of a resin-coated wire in which the outer peripheral surface of the metal lead is coated with a resin such as polyimide. The film thickness of the coating resin is about 2 to 30. Mu.m.

In fig. 4 and 5, 65 is a pull wire.

The pull wire 65 extends within the fourth lumen 14 and extends eccentrically with respect to the central axis of the multi-lumen tube 10.

The front end portion of the wire 65 is fixed to the front end chip 35 by solder. Further, a large diameter portion (a drop-preventing portion) for preventing drop may be formed at the tip of the wire 65. Thus, the front chip 35 and the wire 65 are firmly coupled, and the front chip 35 can be reliably prevented from falling off or the like.

On the other hand, the proximal end portion of the wire 65 is connected to the knob 22 of the handle 20, and the distal end portion of the multi-lumen tube 10 is deflected by pulling the wire 65 by operating the knob 22.

The wire 65 is made of stainless steel or a ni—ti super elastic alloy, but is not necessarily 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 portion of the lumen is not limited to this, and may be a mechanism including a leaf spring, for example.

Only the pull wire 65 extends in the fourth lumen 14 of the multi-lumen tube 10, and no guide wire(s) extend. This can prevent the guide wire from being damaged (e.g., scratched) by the pull wire 65 moving in the axial direction during the deflecting operation of the distal end portion of the multi-lumen tube 10.

In the defibrillation catheter 100 of the present embodiment, the first wire set 41G, the second wire set 42G, and the third wire set 43G are also insulated 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 (distal end side) of the handle, and fig. 8 is a partially enlarged view of the inside (proximal end side) of the handle.

As shown in fig. 6, the base end portion of the multi-lumen tube 10 is inserted into the front end opening of the handle 20, whereby the multi-lumen tube 10 is connected to the handle 20.

As shown in fig. 6 and 8, a cylindrical connector 50 having a plurality of pin terminals (51, 52, 53) protruding in the distal end direction is disposed in a distal end surface 50A is incorporated in the base end portion of the handle 20.

As shown in fig. 6 to 8, three insulating hoses (first, second, and third insulating

hoses

26, 27, and 28) through which three wire groups (first, second, and

third wire groups

41G, 42G, and 43G) are inserted respectively extend inside the handle 20.

As shown in fig. 6 and 7, the distal end portion (about 10mm from the distal end) of the first insulating tube 26 is inserted into the first lumen 11 of the multi-lumen tube 10, and the first insulating tube 26 is thereby connected to the first lumen 11 extending from the first wire group 41G.

The first insulating tube 26 connected to the first lumen 11 extends to the vicinity of the connector 50 (the distal end surface 50A where the pin terminal is disposed) through the inner hole of the first protection tube 61 extending inside the handle 20, and forms an insertion path for guiding the proximal end portion of the first wire group 41G to the vicinity of the connector 50. Thus, the first wire set 41G extending from the multi-lumen tube 10 (the first lumen 11) can extend inside the handle 20 (the inner hole of the first insulating tube 26) without kinking.

The first wire group 41G extending from the base end opening of the first insulating hose 26 is divided into eight wires 41 constituting the wire group, and these wires 41 are fixed to the respective pin terminals arranged on the front end surface 50A of the connector 50 by solder connection. Here, the area where the pin terminals (pin terminals 51) to which the wires 41 constituting the first wire group 41G are connected and fixed are arranged is referred to as a "first terminal group area".

The distal end portion (about 10mm from the distal end) of the second insulating tube 27 is inserted into the second lumen 12 of the multi-lumen tube 10, and the second insulating tube 27 is thereby connected to the second lumen 12 extending from the second wire group 42G.

The second insulating tube 27 connected to the second lumen 12 passes through the inner hole of the second protection tube 62 extending inside the handle 20 and extends to the vicinity of the connector 50 (the distal end surface 50A where the pin terminal is disposed), and forms an insertion path for guiding the proximal end portion of the second wire group 42G to the vicinity of the connector 50. Thus, the second wire group 42G extending from the multi-lumen tube 10 (the second lumen 12) can extend inside the handle 20 (the inner hole of the second insulating tube 27) without kinking.

The second wire group 42G extending from the base end opening of the second insulating hose 27 is divided into eight wires 42 constituting the wire group, and these wires 42 are fixed to the respective pin terminals arranged on the front end surface 50A of the connector 50 by solder connection. Here, the area where the pin terminals (pin terminals 52) to which the wires 42 constituting the second wire group 42G are connected and fixed are arranged is referred to as a "second terminal group area".

The distal end portion (about 10mm from the distal end) of the third insulating tube 28 is inserted into the third lumen 13 of the multi-lumen tube 10, and the third insulating tube 28 is thereby connected to the third lumen 13 extending from the third wire group 43G.

The third insulating tube 28 connected to the third lumen 13 passes through the inner hole of the second protective tube 62 extending inside the handle 20 and extends to the vicinity of the connector 50 (the distal end surface 50A where the pin terminal is disposed), and forms an insertion path for guiding the proximal end portion of the third wire group 43G to the vicinity of the connector 50. Thus, the third wire group 43G extending from the multi-lumen tube 10 (third lumen 13) can extend inside the handle 20 (inner hole of the third insulating tube 28) without kinking.

The third wire group 43G extending from the base end opening of the third insulating hose 28 is divided into four wires 43 of the wire group, and these wires 43 are fixed to the respective pin terminals arranged on the front end surface 50A of the connector 50 by solder connection. Here, the area where the pin terminals (pin terminals 53) to which the wires 43 constituting the third wire group 43G are connected and fixed are arranged is referred to as a "third terminal group area".

Here, as the constituent materials of the insulating hoses (the first insulating hose 26, the second insulating hose 27, and the third insulating hose 28), polyimide resins, polyamide resins, polyamideimide resins, and the like can be exemplified. Among them, polyimide resins having high hardness, allowing easy insertion of a wire set, and capable of thin-wall molding are particularly preferred.

The thickness of the insulating hose is preferably 20 to 40. Mu.m, and in a preferred example, 30. Mu.m.

As a constituent material of the protective tube (the first protective tube 61 and the second protective tube 62) in which the insulating tube is interposed, nylon-based elastomers such as "Pebax" (registered trademark of arcema) can be exemplified.

According to the defibrillation catheter 100 of the present embodiment having the above-described configuration, since the first wire group 41G extends in the first insulating tube 26, the second wire group 42G extends in the second insulating tube 27, and the third wire group 43G extends in the third insulating tube 28, the first wire group 41G, the second wire group 42G, and the third wire group 43G can be completely insulated from each other even in the handle 20. As a result, when a voltage required for defibrillation is applied, a short circuit between the first wire group 41G, the second wire group 42G, and the third wire group 43G (particularly, a short circuit between wire groups extending near the opening of the lumen) inside the handle 20 can be reliably prevented.

Further, the first insulating tube 26 is protected by the first protection tube 61, and the second insulating tube 27 and the third insulating tube 28 are protected by the second protection tube 52 in the interior of the handle 20, so that, for example, damage to the insulating tubes due to contact/friction of the constituent members (movable members) of the knob 22 during a deflecting operation of the distal end portion of the multilumen tubing 10 can be prevented.

The defibrillation catheter 100 according to the present embodiment includes a partition 55 that partitions the distal end surface 50A of the connector 50 in which the plurality of pin terminals are disposed into a first terminal group region, a second terminal group region, and a third terminal group region, and separates the lead 41, the lead 42, and the lead 43 from each other.

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

The thickness of the spacer 55 is, for example, 0.1 to 0.5mm, and 0.2mm is a preferable example.

The height of the spacer 55 (the distance from the base end edge to the tip end edge) needs to be higher than the separation distance between the tip end surface 50A of the connector 50 and the insulating hoses (the first insulating hose 26 and the second insulating hose 27), and in the case where the separation distance is 7mm, the height of the spacer 55 is 8mm, for example. In the separator having a height of less than 7mm, the distal end edge cannot be positioned on the distal end side of the base end of the insulating hose.

With such a configuration, the wires 41 (the base end portions of the wires 41 extending from the base end openings of the first insulating hoses 26) constituting the first wire group 41G and the wires 42 (the base end portions of the wires 42 extending from the base end openings of the second insulating hoses 27) constituting the second wire group 42G can be reliably and neatly isolated.

If the separator 55 is not provided, the wires 41 and the wires 42 may not be separated (separated) in order, and they may be connected in series.

Further, since the wires 41 constituting the first wire group 41G and the wires 42 constituting the second wire group 42G, which are applied with voltages of mutually different polarities, are isolated from each other by the separator 55, a short circuit does not occur between the wires 41 constituting the first wire group 41G (the base end portion of the wires 41 extending from the base end opening of the first insulating hose 26) and the wires 42 constituting the second wire group 42G (the base end portion of the wires 42 extending from the base end opening of the second insulating hose 27) even when the voltage required for endocardial defibrillation is applied at the time of use of the defibrillation catheter 100.

In addition, in the case where an error occurs in connection and fixation of the lead wire to the pin terminal during the manufacture of the defibrillation catheter, for example, in the case where the lead wire 41 constituting the first lead wire group 41G is connected to the pin terminal in the second terminal group region, the lead wire 41 straddles the partition wall 55, so that an error in connection can be easily found.

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

In the defibrillation catheter 100, the distal end edge of the separator 55 is located on the distal end side from the proximal end of the first insulating tube 26 and the proximal end of the second insulating tube 27.

Accordingly, the separator 55 is always present between the wire (the wire 41 constituting the first wire group 41G) extending from the base end opening of the first insulating hose 26 and the wire (the wire 42 constituting the second wire group 42G) extending from the base end opening of the second insulating hose 27, so that a short circuit caused by contact between the wire 41 and the wire 42 can be reliably prevented.

As shown in fig. 8, the eight wires 41 extending from the proximal end opening of the first insulating hose 26 and connected to the pin terminal 51 fixed to the connector 50, the eight wires 42 extending from the proximal end opening of the second insulating hose 27 and connected to the pin terminal 52 fixed to the connector 50, and the four wires 43 extending from the proximal end opening of the third insulating hose 28 and connected to the pin terminal 53 fixed to the connector 50 are fixed around them by the resin 58, so that the respective shapes are kept fixed.

The resin 58 holding the shape of the wire is formed into a cylindrical shape having the same diameter as the connector 50, and the pin terminal, the wire, the base end portion of the insulating hose, and the separator 55 are embedded in the resin molded body.

Further, according to the structure in which the base end portion of the insulating hose is embedded in the resin molded body, the entire region of the wire (base end portion) extending from the base end opening of the insulating hose to the connection and fixation with the pin terminal can be entirely covered with the resin 58, and the shape of the fixed wire (base end portion) can be entirely maintained.

The height of the resin molded body (the distance from the base end surface to the front end surface) is preferably greater than the height of the separator 55, and when the height of the separator 55 is 8mm, for example, 9mm.

Here, the resin 58 constituting the resin molded body is not particularly limited, but a thermosetting resin or a photocurable resin is preferably used. Specifically, polyurethane-based, epoxy-based, and polyurethane-epoxy-based curable resins can be exemplified.

According to the above-described configuration, since the shape of the fixed wire is maintained by the resin 58, it is possible to prevent the wire extending from the proximal end opening of the insulating hose from kinking or coming into contact with the edge of the pin terminal to be damaged (for example, to generate a crack in the coating resin of the wire) when the defibrillation catheter 100 is manufactured (when the connector 50 is mounted inside the handle 20).

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

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

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

As shown in fig. 9, the connector 50 of the defibrillation catheter 100 is connected to the catheter connection connector 72 of the power supply device 700 by the connector cable C1, whereby the pin terminals 51 (actually eight) to which the eight wires 41 constituting the first wire group are connected to the terminals 721 (actually eight) of the catheter connection connector 72, the pin terminals 52 (actually eight) to which the eight wires 42 constituting the second wire group are connected to the terminals 722 (actually eight) of the catheter connection connector 72, and the pin terminals 53 (actually four) to which the four wires 43 constituting the third wire group are connected to the terminals 723 (actually four) of the catheter connection connector 72.

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 electrocardiograph information measured by the first DC electrode group 31G and the second DC electrode group 32G reaches the electrocardiograph connection connector 73 via the switching portion 76, and the electrocardiograph information measured by the base-end-side potentiometric electrode group 33G reaches the electrocardiograph connection connector 73 without going through the switching portion 76.

The electrocardiograph connection connector 73 is connected to an input terminal of the electrocardiograph 800.

The external switch 74 as input means is constituted by a mode changeover switch 741 for switching the cardiac potential measurement mode and the defibrillation mode, an applied energy setting switch 742 for setting electric energy to be applied at the time of defibrillation, a charging switch 743 for charging the DC power supply portion 71, an energy application preparation switch 744 for determining the polarity of an initial event, a trigger level, an abnormal wave height level, and preparing for defibrillation, which will be described later, and an energy application execution switch (discharge switch) 745 for executing defibrillation by applying electric energy by inputting after (or at the same time as) the input of the energy application preparation switch 744. All of the input signals from the external switches 74 are sent to the arithmetic processing unit 75.

As the switch for applying energy, an energy application preparation switch 744 is included in addition to the energy application execution switch 745, so that the user can confirm the state of the electrocardiographic waveform before inputting the energy application execution switch 745.

Thus, when the input energy application preparation switch 744 switches the contact of the switching unit to the second contact, it is possible to avoid the application of energy when disturbance (such as drift or noise) of the electrocardiographic waveform is generated.

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 includes an output circuit 751 for outputting a direct current voltage from the DC power supply unit 71 to the electrodes of the defibrillation catheter 100 via the switching unit 76.

With this output circuit 751, a direct-current voltage can be applied so that the terminal 721 of the catheter connector 72 (in the end, the first DC electrode group 31G of the defibrillation catheter 100) and the terminal 722 of the catheter connector 72 (in the end, the second DC electrode group 32G of the defibrillation catheter 100) have polarities different from each other (in the case where one electrode group is a positive electrode, the other electrode group is a negative electrode), as shown in fig. 9.

The switching unit 76 is configured by a single-pole double-throw (Single Pole Double Throw) switch in which the catheter connector 72 (the terminal 721 and the terminal 722) is connected to the common contact, the electrocardiograph connector 73 is connected to the first contact, and the arithmetic processing unit 75 is connected to the second contact.

That is, when the first contact is selected (when the first contact is connected to the common contact), the path between the connecting catheter connector 72 and the electrocardiograph connector 73 is ensured, and when the second contact is selected (when the second contact is connected to the common contact), the path between the connecting catheter connector 72 and the arithmetic processing unit 75 is ensured.

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 (mode changeover switch 741/energy application preparation switch 744).

The electrocardiogram input connector 77 is connected to the arithmetic processing unit 75, and is connected to an output terminal of the electrocardiograph 800.

The electrocardiographic input connector 77 allows the electrocardiographic information (typically, part of the electrocardiographic information input to the electrocardiograph 800) output from the electrocardiograph 800 to be input to the arithmetic processing unit 75, and the DC power supply unit 71 and the switching unit 76 can be controlled based on the electrocardiographic information in the arithmetic processing unit 75.

The display unit 78 is connected to the operation processing unit 75, and the display unit 78 displays the electrocardiographic information (mainly, an electrocardiogram (electrocardiographic waveform)) input to the operation processing unit 75 from the electrocardiographic input connector 77, so that the operator can perform defibrillation treatment (input of an external switch, etc.) while monitoring the electrocardiographic information (electrocardiographic) input to the operation 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 electrocardiograph information measured by the defibrillation catheter 100 (the constituent electrodes of the first DC electrode group 31G, the second DC electrode group 32G, and the base-end-side potential measurement electrode group 33G) is input to the electrocardiograph 800 from the electrocardiograph connection connector 73.

The electrocardiograph 800 (other input terminal) is also connected to the electrocardiograph 900, and electrocardiograph information measured by the electrocardiograph 900 is also input to the electrocardiograph 800.

Here, as the electrocardiographic measurement means 900, there can be mentioned an electrode pad attached to the body surface of the patient for measuring a 12-lead electrocardiogram, and an electrode catheter (an electrode catheter different from the defibrillation catheter 100) attached to the heart of the patient.

The electrocardiograph 800 (output terminal) is connected to the electrocardiogram input connector 77 of the power supply device 700, and a part of the electrocardiograph information (electrocardiograph information from the defibrillation catheter 100 and electrocardiograph information from the electrocardiograph measurement unit 900) input to the electrocardiograph 800 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 cardiac potential when defibrillation therapy is not necessary.

Fig. 10 shows the flow of cardiac potential information in the case of measuring cardiac potential by the defibrillation catheter 100 according to the present embodiment when performing cardiac catheterization (e.g., high frequency therapy).

At this time, the switching unit 76 of the power supply device 700 selects the first contact to which the electrocardiograph connection connector 73 is connected.

The electrocardiograph 800 is input with the electrocardiograph potentials measured by the electrodes constituting the first DC electrode group 31G and/or the second DC electrode group 32G of the defibrillation catheter 100 through the catheter connection connector 72, the switching unit 76, and the electrocardiograph connection connector 73.

The electrocardiograph potential measured by the electrodes constituting the base-end-side potential measurement electrode group 33G of the defibrillation catheter 100 is directly input from the catheter connection connector 72 to the electrocardiograph 800 through the electrocardiograph connection connector 73 without passing through the switching portion 76.

The electrocardiographic information (electrocardiogram) from the defibrillation catheter 100 is displayed on a monitor (not shown) of the electrocardiograph 800.

Further, a part of the cardiac potential information (for example, a potential difference between the electrodes 31 (first and second poles) constituting the first DC electrode group 31G) from the defibrillation catheter 100 can be input from the electrocardiograph 800 via the electrocardiogram input connector 77 and the arithmetic processing unit 75 and displayed on the display unit 78.

As described above, when defibrillation therapy is not required in the cardiac catheterization, the defibrillation catheter 100 can be used as an electrode catheter for measuring cardiac potential.

Further, when atrial fibrillation is caused in a cardiac catheterization, defibrillation treatment can be immediately performed by the defibrillation catheter 100 used as an electrode catheter. As a result, when atrial fibrillation is caused, the trouble of newly inserting a catheter for defibrillation or the like can be eliminated.

The arithmetic processing unit 75 sequentially senses and detects an event (waveform) of an R wave estimated as an electrocardiogram based on a part of the electrocardiographic potential information (electrocardiogram) sent from the electrocardiograph 800 via the electrocardiogram input connector 77.

For example, the maximum peak waveform (event) in the previous cycle (pulse) and the maximum peak waveform (event) in the previous two cycles of the cycle (pulse) to be detected by sensing are detected, the average wave height of these maximum peak waveforms is calculated, and the potential difference is detected to a height of 80% of the average height, so that the detection of the event estimated as an R wave is performed.

The arithmetic processing unit 75 stores, as a "trigger level", a height of 80% of the average wave height of two events sensed immediately before the input after the input of the energy application preparation switch 744, and stores, as an "abnormal wave height level", a height of 120% of the average wave height in the case of using the defibrillation catheter system of the present embodiment as the system according to the first aspect.

The arithmetic processing unit 75 recognizes the polarity (direction of peak indicated by ± sign) of each event detected by the sensor, and when the energy application preparation switch 744 is inputted, stores the polarity of the three events detected by the sensor immediately before the input as the "polarity of the initial event" when the polarities are the same, and otherwise, cancels the input of the energy application preparation switch 744.

Then, the arithmetic processing unit 75 senses the detected event (V _n ) And the polarity of the event (V) sensed in the previous cycle _n-1 ) And the polarity of the event (V) sensed during the first two cycles _n-2 ) The polarity of the initial event stored in the storage unit matches the polarity of the initial event (V _n ) Synchronously, the DC power supply unit 71 is controlled to connect and disconnect the conduit by performing arithmetic processingA voltage is applied to the terminal 721 (first DC electrode group 31G) of the connector 72 and the terminal 722 (second DC electrode group 32G) of the conduit-connecting connector 72.

Fig. 16A to 16D show timings 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.

In fig. 16A to 16D, an arrow (SW 2-ON) is an input timing of the energy application execution switch 745, and an arrow (DC) is an application timing of the direct current voltage.

In the electrocardiograph shown in fig. 16A to 16D, it is estimated that of six events detected by the R-wave sensing, the polarity of the third event from the left side is (-) (its peak waveform is downward), and the polarity of the other five events 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, in the case of the second event (V ₀ ) In the case where the energy application execution switch 745 inputs after the sensing detection, the third event (V ₁ ) And the polarity (-) of the second event (V) sensed in the previous cycle ₀ ) Is different from the polarity (+) of the initial event (also different from the polarity (+) of the event), and is not different from the event (V ₁ ) The voltages are applied synchronously.

In addition, the fourth event (V ₂ ) And the polarity (+) of the third event (V) detected in the previous cycle ₁ ) Is different from the polarity (-) of the event (V) ₂ ) The voltages are applied synchronously.

In addition, the fifth event (V ₃ ) And the polarity (+) of the third event (V) sensed in the first two cycles ₁ ) Is different from the polarity (-) of the event (V) ₃ ) The voltages are applied synchronously.

Sixth event (V) ₄ ) And the polarity (+) of the fifth event (V) sensed in the previous cycle ₃ ) Polarity (+) of (2) and sensed during the first two cyclesFourth event (V) ₂ ) Is the same as the polarity (+) of the event (V) ₄ ) Synchronously, a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G.

As shown in fig. 16B, a third event (V ₀ ) Then, in the case where the energy application execution switch 745 inputs, a fourth event (V ₁ ) And the polarity (+) of the third event (V) sensed in the previous cycle ₀ ) Is different from the polarity (-) of the event (V) ₁ ) The voltages are applied synchronously.

In addition, the fifth event (V ₂ ) And the polarity (+) of the third event (V) sensed in the first two cycles ₀ ) Is different from the polarity (-) of the event (V) ₂ ) The voltages are applied synchronously.

Sixth event (V) ₃ ) And the polarity (+) of the fifth event (V) sensed in the previous cycle ₂ ) And sensing the detected fourth event (V) ₁ ) Is the same as the polarity (+) of the event (V) ₃ ) Synchronously, a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G.

As shown in fig. 16C, a fourth event (V ₀ ) Then, in the case where the energy application execution switch 745 inputs, a fifth event (V ₁ ) And the polarity (+) of the third event (V) sensed in the first two cycles _-1 ) Is different from the polarity (-) of the event (V) ₁ ) The voltages are applied synchronously.

Sixth event (V) ₂ ) And the polarity (+) of the fifth event (V) sensed in the previous cycle ₁ ) And sensing the detected fourth event (V) ₀ ) Is the same as the polarity (+) of the event (V) ₂ ) Synchronously, a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G.

As shown in fig. 16D, a fifth event (V ₀ ) After which the switch is actuated upon application of energy745, a sixth event (V ₁ ) And the polarity (+) of the fifth event (V) sensed in the previous cycle ₀ ) And sensing the detected fourth event (V) _-1 ) Is the same as the polarity (+) of the event (V) ₁ ) Synchronously, a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G.

As described above, in any of the timing input energy application execution switches 745 shown in fig. 16A to 16D, the voltage is applied in synchronization with the third event (the sixth event from the left side) when the same polarity (+) is continued three times.

The arithmetic processing unit 75 is configured to sense the detected event (V _n ) In the case where the polarity of the stored initial event is not identical to the polarity of the event (V _n ) The DC power supply unit 71 is controlled by performing arithmetic processing so as to apply voltages to the first DC electrode group 31G and the second DC electrode group 32G in synchronization with each other.

Fig. 18 shows timings of input of the energy application preparation switch 744, input of the energy application execution switch 745, and application of the dc voltage, which are input to the electrocardiogram of the arithmetic processing unit 75.

In the figure, an arrow (SW 1-ON) is an input timing of the energy preparation switch 744, an arrow (SW 2-ON) is an input timing of the energy application execution switch 745, and an arrow (DC) is an application timing of the direct current voltage.

In the electrocardiograph shown in fig. 18, it is estimated that of nine events detected by R-wave sensing, the polarities of the first to third and seventh to ninth events are (+) from the left side (peak waveforms thereof are upward), and the polarities of the fourth to sixth events are (-) (peak waveforms thereof are downward) from the left side.

As shown in the figure, when the sensing detects a third event (V _-2 ) In the case where the energy application preparation switch 744 is then input, three events (V _-2 )、(V _-3 ) (V) _-4 ) The polarity of (a) is (+),the polarity (+) is stored as the polarity of the initial event.

Then, as shown in the figure, a fifth event (V) is detected from the left side at the time of sensing ₀ ) Then, in the case where the energy execution switch 745 inputs, a sixth event (V ₁ ) The polarity of (c) is (-) although the same as the fifth event (V) ₀ ) Is sensed in the first two cycles of the fourth event (V _-1 ) Is identical to the polarity (-) of the initial event, but is not identical to the polarity (+) of the event, and is therefore not identical to the event (V ₁ ) The voltages are applied synchronously.

In addition, from the left side, a seventh event (V ₂ ) Is (+) and is identical to the polarity (+) of the initial event, but is identical to the polarity (+) of the sixth event (V) sensed in the previous period ₁ ) Is not consistent with the polarity (-) of the event (V ₂ ) The voltages are applied synchronously.

In addition, from the left side, an eighth event (V ₃ ) And the polarity of the initial event, (+), the seventh event detected in the previous cycle (V ₂ ) Is not coincident with the sixth event (V) ₁ ) And therefore does not coincide with the event (V) ₂ ) The voltages are applied synchronously.

Starting from the left side, the ninth event (V ₄ ) And the polarity of the first event, (+), the eighth event detected in the previous cycle (V ₃ ) The polarity (+) of (c), the seventh event detected sensed in the first two cycles (V ₂ ) Is consistent with the polarity (+) of the event (V) ₄ ) Synchronously, a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G.

In the case of using the defibrillation catheter system of the present embodiment as the system according to the first aspect, the arithmetic processing unit 75 is configured to, when an abnormal wave height event (an event that reaches an abnormal wave height level) occurs in the period from the input energy application preparation switch 744 to the input energy application execution switch 745, perform a pass only from the occurrence of the abnormal wave height event After a prescribed standby time an event is sensed (V _n ) In the case of (2) and event (V) _n ) The DC power supply unit 71 is controlled by performing arithmetic processing so as to apply voltages to the terminal 721 (the first DC electrode group 31G) of the conduit connector 72 and the terminal 722 (the second DC electrode group 32G) of the conduit connector 72 in synchronization with each other.

Here, the standby time is usually 1000 to 5000m seconds, preferably 2000 to 4000m seconds, and 3000m seconds (3 seconds) is a preferable example.

When a plurality of abnormal wave heights occur during a period from the input energy application preparation switch 744 to the input energy application execution switch 745, the standby time is calculated from the time when the first abnormal wave height event occurs (strictly speaking, the time when the waveform thereof reaches the abnormal wave height level).

Fig. 19 shows timings of input of the energy application preparation switch 744, input of the energy application execution switch 745, and application of the dc voltage in the electrocardiogram (the same electrocardiographic waveform as the waveform shown in fig. 25) input to the arithmetic processing unit 75.

In the electrocardiogram shown in this figure, the stable baseline rises, and thereafter, the baseline falls and returns to the original level.

If an event is detected at the time of sensing (V _-5 ) When the energy application preparation switch 744 is input at the timing indicated by the following arrow (SW 1-ON), three events (V) detected immediately before the input are sensed _-5 )、(V _-6 ) (V) _-7 ) Since the polarity (+) is positive, the polarity (+) is stored in the arithmetic processing unit 75 as the polarity of the initial event.

In addition, two events (V _-5 ) (V) _-6 ) As "trigger level" (shown in the figure by a solid line TL extending in the direction of the time axis), and storing the average wave heightThe height of 120% is regarded as "abnormal wave high level" (shown in the drawing as a broken line HL extending in the time axis direction).

When the energy application execution switch 745 is input at the timing indicated by the arrow (SW 2-ON), three abnormal wave heights (V) are generated during the period from the input energy application preparation switch 744 to the input energy application execution switch 745 _-2 )、(V _-1 ) (V) ₀ ) In this case, the method does not take place after the initial abnormal wave height event (V _-2 ) An event sensed and detected during a standby time defined at the start of generation of (a) is identified as a trigger point, and a voltage is not applied in synchronization with the event.

Here, an event (V) immediately after the input energy application execution switch 745 ₁ ) Due to the presence of a slave abnormal wave height event (V _-2 ) Is sensed and detected during a predetermined standby time (WAITING TIME) and is therefore not in contact with the event (V) ₁ ) The voltages are applied synchronously.

Sensing an event after the lapse of the standby time (V ₁ ) Event (V) in the next cycle of (a) ₂ ). In addition, the event (V ₂ ) And the polarity (+) of the initial event, the event detected in the previous cycle (V) ₁ ) Polarity (+) of (c), and sensing the detected event (V) in the first two cycles ₀ ) Is the same as the polarity (+) of the event (V) ₂ ) The voltages are applied synchronously.

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 between 260m seconds after the event estimated as the R wave in the input electrocardiogram is sensed.

In this way, when the event detected by the sensing is the peak of the R wave, defibrillation at the time when the next T wave appears can be reliably avoided, in other words, defibrillation can be prevented from being performed by masking the peak estimated as the T wave.

The period during which the dc voltage is not applied after the event is detected by the sensing is not limited to 260 ms, but may be 50 ms at the shortest and 500 ms at the longest. If the period is shorter than 50 ms, the peak estimated as the T wave may not be masked. On the other hand, if the period is longer than 500 ms, the R wave in the next cycle (pulse) may not be detected.

The arithmetic processing unit 75 is programmed not to re-sense the event estimated as the R wave 100m seconds after sensing the event estimated as the R wave.

This prevents the peak of the S wave from being detected when the peak of the S wave appearing in the opposite direction (opposite polarity) to the R wave increases and reaches the trigger level (even in this state, this will not cause a problem when defibrillation is performed), and the continuity of the polarity of the event is impaired (count reset of the same polarity).

The period (blanking period) during which the event estimated as the R wave is detected after the event is detected by the sensing is not limited to 100 ms, but may be 10 ms at the shortest and 150 ms at the longest.

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 260m seconds after the input of the energy application execution switch 745.

This prevents noise (noise of the same polarity as the last event) generated by the input of the energy application execution switch 745 from being mistakenly perceived as R-wave sensing detection, and defibrillation can be performed in synchronization with the noise.

In addition, noise (noise of a polarity different from that of the last and/or last event) generated by the input of the energy application execution switch 745 can be prevented from impairing the continuity of the polarity of the event (count reset of the same polarity).

Further, it is also possible to prevent the R wave from being erroneously considered as a change in the baseline generated immediately after the input energy is applied to the execution switch 745, and to perform defibrillation in synchronization with the detection.

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 may be 10 ms at the shortest and 500 ms at the longest.

Fig. 11 is a flowchart showing an example of defibrillation therapy in the case of using the intracardiac defibrillation catheter system of the present embodiment as the system according to the first aspect.

(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 base-end-side potential measurement electrode group 33G) of the defibrillation catheter 100 are confirmed by using an X-ray image, and a part of the electrocardiographic information (12-lead electrocardiograph) input from the electrocardiograph 900 (electrode pad attached to the body surface) is selected and input from the electrocardiograph input connector 77 to the arithmetic processing section 75 of the power supply device 700 (step 1). At this time, a part of the cardiac potential information input to the arithmetic processing unit 75 is displayed on the display unit 78 (see fig. 12). The electrocardiograph 800 monitor (not shown) displays electrocardiograph 800 electrocardiograph information input from the constituent electrodes of the first DC electrode group 31G and/or the second DC electrode group 32G of the defibrillation catheter 100 via the catheter connection connector 72, the switching unit 76, and the electrocardiograph connection connector 73, and electrocardiograph information input from the constituent electrodes of the base-end-side-potential measurement electrode group 33G of the defibrillation catheter 100 via the catheter connection connector 72 and the electrocardiograph connection connector 73.

(2) Next, a mode changeover switch 741 as the external switch 74 is input. In the power supply device 700 of the present embodiment, the switching unit 76 selects the first contact point in the initial state, and a path from the catheter connection connector 72 to the electrocardiograph connection connector 73 via the switching unit 76 is ensured.

The input through the mode changeover switch 741 becomes the "defibrillation mode" (step 2).

(3) As shown in fig. 13, when the input mode changeover switch 741 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 operation processing unit 75, so that the path from the catheter connector 72 to the operation processing unit 75 via the switching unit 76 is ensured, and the path from the catheter connector 72 to the electrocardiograph connector 73 via the switching unit 76 is cut off (step 3). When the switching unit 76 selects the second contact, the electrocardiograph 800 cannot be input with the electrocardiograph information from the constituent electrodes of the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 (therefore, the electrocardiograph information cannot be sent to the arithmetic processing unit 75). However, the electrocardiograph 800 is input with the electrocardiograph information from the constituent electrodes of the base-end-side potential measurement electrode group 33G without via the switching portion 76.

(4) Even if 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 from the catheter connector 72 to the arithmetic processing unit 75 via the switching unit 76 is displayed on the display unit 78 (see fig. 13) together with a part of the cardiac potential information from the cardiac potential measurement unit 900 input to the arithmetic processing unit 75.

(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 for selecting the second contact point at the contact point of the switching unit 76 (steps 3 to 5 described above) is, for example, 1 second.

(6) The arithmetic processing unit 75 determines whether or not the resistance measured in step 4 exceeds a predetermined value, and if not, it proceeds to step 7 (preparation for applying a dc voltage), and if so, it returns to step 1 (confirmation of the position of the electrode of the defibrillation catheter 100) (step 6).

Here, when the resistance exceeds a predetermined value, it means that the first DC electrode group and/or the second DC electrode group does not reliably contact a predetermined portion (for example, the wall of the coronary vein or the inner wall of the right atrium), and therefore, it is necessary to return to step 1 and readjust the position of the electrode.

In this way, since the voltage can be applied only when the first DC electrode group and the second DC electrode group of the defibrillation catheter 100 reliably contact a predetermined site (for example, the wall of the coronary vein or the inner wall of the right atrium), effective defibrillation treatment can be performed.

(7) An applied energy setting switch 742 as an external switch 74 is input to set the applied energy at the time of defibrillation (step 7).

According to the power supply device 700 of the present embodiment, the applied energy can be set at 1J to 30J intervals of 1J.

(8) A charge switch 743 as an external switch 74 is input to charge energy into the built-in capacitor of the DC power supply section 71 (step 8).

(9) After the completion of the charging, the operator inputs an energy application preparation switch 744 as the external switch 74 (step 9).

(10) The arithmetic processing unit 75 determines whether or not the polarities of the three events detected by sensing immediately before the input of the application preparation switch 744 are the same as each other, and if they are the same as each other, it proceeds to step 12 (in this case, the character "Waiting Trigger" is displayed on the display unit 78), and if they are not the same, it cancels the input of the energy application preparation switch 744, and returns to step 9 (step 10).

(11) The contact point of the switching unit 76 is switched to the second contact point by the operation processing unit 75, so that a path from the catheter connector 72 to the operation processing unit 75 via the switching unit 76 is ensured, and a path from the catheter connector 72 to the electrocardiograph connector 73 via the switching unit 76 is cut off (step 11).

(12) The arithmetic processing section 75 stores the polarities of the three events detected by sensing immediately before the input of the application preparation switch 744 as the "polarity of the initial event", the height of 80% of the average wave height of the two events detected by sensing immediately before the input of the application preparation switch 744 as the "trigger level", and the height of 120% of the average wave height as the "abnormal wave height level" (step 12).

(13) The operator inputs the energy application execution switch 745 as the external switch 74 (step 13).

(14) As a method for indicating the event (V) detected by the sensing at step 16 described later _n ) The number (n) of events detected from the input energy application execution switch 745 to the first sensing time causes a "1" to be generated. (step 14).

(15) The arithmetic processing unit 75 detects the last event (V _n-1 ) (immediately before input energy is applied to implement switch 745The event detected by sensing) is set as a blanking period, and standby is performed so that no new sensing is performed (step 15).

(16) After the blanking period has elapsed, the arithmetic processing unit 75 senses a detection event (V _n ) (step 16).

(17) The arithmetic processing unit 75 determines whether the event (V _n ) If the polarity of the initial event stored in step 12 matches, the routine proceeds to step 18, and if the polarity does not match, the number (n) is added to 1 in step 14' and the routine returns to step 15 (step 17).

(18) The arithmetic processing unit 75 determines whether the event (V _n ) Whether or not the polarity of (a) is the same as the last (previously sensed) event (V _n-1 ) If the polarities match, the process proceeds to step 19, and if the polarities match, the process proceeds to step 14' by adding 1 to the number (n) and returns to step 15 (step 18).

(19) The arithmetic processing unit 75 determines whether the event (V _n ) If the polarity of the event (Vn-2) of the last time (detected by the previous two sensors) matches, the routine proceeds to step 20, and if the polarity does not match, the routine proceeds to step 14' by adding 1 to the number (n) and returns to step 15 (step 19).

(20) The arithmetic processing unit 75 determines that the last event (V _n-1 ) Start to sense detection event (V _n ) If the time period exceeds 260m seconds, the process proceeds to step 21, and if the time period does not exceed the time period, the process proceeds to step 14' by adding 1 to the number (n) and returns to step 15 (step 20).

(21) The arithmetic processing unit 75 determines from the input energy application execution switch 745 to the sensing of the detected event (V _n ) If the time period exceeds 260m seconds, the process proceeds to step 22, and if the time period does not exceed the time period, the process proceeds to step 14' by adding 1 to the number (n) and returns to step 15 (step 21).

(22) The arithmetic processing unit 75 determines whether or not an abnormal wave height event (an event that reaches an abnormal wave height level) has occurred during a period from the input application preparation switch 744 to the input application execution switch 745, and proceeds to step 23 when it has occurred, and proceeds to step 25 when it has not occurred (step 22).

(23) At a predetermined standby time (3 seconds) from the occurrence of the abnormal wave height event, "DRIFT" is displayed on the display unit 78 (step 23).

(24) The arithmetic processing unit 75 determines an event (V _n ) Whether or not the detected event is sensed after a predetermined standby time (3 seconds) has elapsed since the occurrence of the abnormal wave height event (the occurrence of the first abnormal wave height event when a plurality of abnormal wave heights have occurred), if the detected event is sensed after the standby time has elapsed, the process proceeds to step 25, and if the detected event is sensed before the standby time has elapsed, the number (n) is incremented by 1 and the process returns to step 15 in step 14' (step 24).

(25) The arithmetic processing unit 75 detects the event (V _n ) A trigger point is identified and step 26 is entered (step 25).

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

(27) The DC power supply unit 71, which receives the control signal from the arithmetic processing unit 75, applies direct-current voltages of different polarities to the first DC electrode group and the second DC electrode group of the defibrillation catheter 100 via the output circuit 751 of the arithmetic processing unit 75, the switching unit 76, and the catheter-connection connector 72 (step 27, see fig. 14).

Here, the arithmetic processing unit 75 compares the event (V _n ) In synchronization, the first DC electrode group and the second electrode group are subjected to an arithmetic process by applying a DC voltage thereto, and a control signal is sent to the DC power supply unit 71.

Specifically, upon detection of an event (V _n ) When a predetermined time (for example, as an event (V) _n ) An extremely short time of around 1/10 of the peak width of the R wave).

Fig. 15 is a diagram showing a potential waveform measured when predetermined electric energy (for example, a set output=10j) is supplied through the defibrillation catheter 100 according to the present embodiment. In the figure, the horizontal axis represents time and the vertical axis represents potential.

First, when an event (V _n ) Starts to pass a predetermined time (t ₀ ) Then, a direct current voltage is applied between the first DC electrode group 31G and the second DC electrode group 32G so that the first DC electrode group 31G is a positive electrode, and a potential rise is measured from the supplied electric energy (E ₁ Is the peak voltage at this time. ). After a predetermined time (t ₁ ) Then, a reverse ±dc voltage is applied between the first DC electrode group 31G and the second DC electrode group 32G so that the first DC electrode group 31G is a positive electrode and the second DC electrode group 32G is a negative electrode, and electric energy is supplied thereto to measure a potential rise (E ₂ Is the peak voltage at this time. ).

Here, an event (V _n ) Time until application is started (t ₀ ) For example, 0.01 to 0.05 seconds, and 0.01 seconds if a preferable example is shown, time (t=t ₁ +t ₂ ) For example, 0.006 to 0.03 seconds, and 0.02 seconds is a preferable example. This can be used to match the event (V _n ) The voltage is applied synchronously, and effective defibrillation treatment can be performed.

Measured peak voltage (E ₁ ) For example 300 to 600V.

(28) After detecting an event (V _n ) Starts to pass a predetermined time (t ₀ +t), and then, the application of the voltage from the DC power supply unit 71 is stopped by receiving the control signal from the arithmetic processing unit 75 (step 28).

(29) After stopping the application of the voltage, the record of the application (the cardiac potential waveform at the time of application as shown in fig. 15) is displayed on the display unit 78 (step 29). The display time is, for example, 5 seconds.

(30) The contact point of the switching unit 76 is switched to the first contact point, and the electrocardiograph 800 is restored by restoring the route from the catheter connection connector 72 to the electrocardiograph connection connector 73 via the switching unit 76, and the electrocardiograph information from the constituent electrodes of the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 is input (step 30).

(31) The electrocardiographic apparatus (800) is configured to observe the electrocardiographic information (electrocardiogram) from the constituent electrodes of the defibrillation catheter (100) (the constituent electrodes of the first DC electrode group (31G), the second DC electrode group (32G), and the base-end-side potential measurement electrode group (33G)) and the electrocardiographic information (12-lead electrocardiogram) from the electrocardiograph (900), and if "normal", the process is completed, and if "abnormal (atrial fibrillation is not calm)", the process returns to step (31).

In the case of using the defibrillation catheter system of the present embodiment as the system according to the second aspect, the arithmetic processing unit 75 is configured to perform the operation of sensing the detected event (V _n ) And the polarity of the event (V) _n-1 ) And the first two sensed events (V _n-2 ) And, in the event (V) _n ) In the waveform of (2), when the rise time from reaching the bottom line to reaching the trigger level is 45 msec or less, the waveform is associated with the event (V _n ) The DC power supply unit 71 is controlled by performing arithmetic processing so as to apply voltages to the terminal 721 (the first DC electrode group 31G) of the conduit connector 72 and the terminal 722 (the second DC electrode group 32G) of the conduit connector 72 in synchronization with each other.

The "bottom line" refers to an event (V) in which the baseline (voltage=0v) of the electrocardiogram is shifted to the time at which the rise time should be measured _n ) The polarity direction of (2) is shifted by 0.26V.

That is, in event (V _n ) The ground line at the (+) polarity is +0.26V, at event (V _n ) The bottom line at a polarity (-) is-0.26V.

Fig. 20 shows an event (V) after the input of the energy application execution switch 745 in the electrocardiogram input to the arithmetic processing unit 75 ₂ ) A rising state (time).

In the figure, a bottom line is shown by a chain line BL extending in the time axis direction, and a trigger level is shown by a solid line TL extending in the time axis direction.

If the energy application preparation switch 744 is input at the timing indicated by the arrow (SW 1-ON), three events detected are sensed immediately before the input (V _-2 )、(V _-3 ) (V) _-4 ) Since the polarity (+) is the polarity of the initial event, the polarity (+) is stored in the arithmetic processing unit 75.

In addition, two events (V _-2 ) (V) _-3 ) The height of 80% of the average wave height of (c) is taken as "trigger level" (TL).

If the energy application execution switch 745 is input at the timing indicated by the arrow (SW 2-ON), the immediately following event (V) is detected by sensing within 260 ms after the input of the energy application execution switch 745 ₁ ) So is not in contact with the event (V ₁ ) The voltages are applied synchronously.

After a lapse of 260m seconds from the input energy application execution switch 745, an event (V) ₁ ) Event (V) in the next cycle of (a) ₂ )。

In addition, event (V ₂ ) And the polarity (+) of the initial event, the event detected by the previous sensor (V) ₁ ) Polarity (+), and the first two sensed event events (V ₀ ) Polarity (+) of (a) are identical.

However, in this event (V ₂ ) In the waveform of (a), the rise time (t) from reaching the Bottom Line (BL) to reaching the Trigger Level (TL) exceeds 45m seconds, so the event (V) ₂ ) The waveform of (2) is the possibility of a T wave and is not identified as a trigger point, and a voltage is not applied in synchronization with the event (V2).

Fig. 17 is a flowchart showing an example of defibrillation therapy in the case of using the intracardiac defibrillation catheter system according to the present embodiment as the system according to the second aspect.

Steps 1 to 21 of defibrillation therapy in the case of using the system according to the second aspect are the same as steps 1 to 21 of defibrillation therapy in the case of using the system according to the first aspect, except that "abnormal wave high level" is not stored in step 12.

In step 22, the arithmetic processing unit 75 measures the event (V _n ) From reaching the bottom line to the trigger level in the waveform of (2)If the rising time is less than 45 ms, the routine proceeds to step 23, and if the rising time exceeds 45 ms, the routine adds 1 to the number (n) and returns to step 15 in step 14'.

Steps 23 to 29 of defibrillation treatment in the case of use as the system according to the second aspect are the same as steps 25 to 31 of defibrillation treatment in the case of use as the system according to the first aspect.

According to the catheter system of the present embodiment, the electric energy of the heart that causes the defibrillation can be directly supplied through the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100, and only the electric stimulation (electric shock) necessary and sufficient for the defibrillation treatment can be reliably supplied to the heart.

Further, since the heart can be directly supplied with electric energy, burn is not caused on the body surface of the patient.

Further, since the electrocardiograph 800 is connected to the electrocardiograph 800 via the electrocardiograph connection connector 73 without the switching portion 76 from the catheter connection connector 72, and the electrocardiograph 900 is connected to the electrocardiograph 800, even when the electrocardiograph 800 cannot acquire defibrillation therapy of the electrocardiograph from the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 (when the switching portion 76 is switched to the second contact and the path from the catheter connection connector 72 to the electrocardiograph connection connector 73 via the switching portion 76 is cut off), the electrocardiograph 800 can acquire the electrocardiograph information measured by the base side electrocardiograph connection connector 33G and the electrocardiograph 900, and can monitor (monitor) the electrocardiograph 800 and perform defibrillation therapy.

Further, since the operation processing unit 75 of the power supply device 700 performs operation processing so as to apply a voltage in synchronization with the cardiac potential waveform input through the electrocardiogram input connector 77 and controls the DC power supply unit 71 (application is started after a predetermined time (for example, 0.01 seconds) has elapsed since the potential difference in the cardiac potential waveform reaches the trigger level), the voltage can be applied to the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 in synchronization with the cardiac potential waveform, and effective defibrillation therapy can be performed.

The arithmetic processing unit 75 is controlled so that preparation for applying a DC voltage can be performed only when the resistance between the electrode groups of the defibrillation catheter 100 does not exceed a predetermined value, that is, only when the first DC electrode group 31G and the second DC electrode group 32G reliably contact a predetermined portion (for example, the wall of the coronary vein or the inner wall of the right atrium).

The arithmetic processing unit 75 sequentially senses an event estimated as an R wave in the electrocardiogram input from the electrocardiograph 800 via the electrocardiogram input connector 77, and if the event (V _n ) Is not of the same polarity as the event (V) _n-1 ) And the first two sensed events (V _n-2 ) Is consistent with the polarity of the event (V) _n ) The voltages are applied synchronously, so that defibrillation can be avoided when extra systole is caused or when the baseline of an electrocardiogram is unstable.

Fig. 21A is an electrocardiogram (the same cardiac potential waveform as the electrocardiogram shown in fig. 23) input to the arithmetic processing unit 75 when a single extra-systole is generated in the heart of the patient. In fig. 21A, the fourth R wave (event (V) ₀ ) The polarity is (-), the peak of the following T wave increases, this T wave being the event (V) ₁ ) Is sensed.

As shown in the figure, when an event (V ₀ ) After that, in the case where the energy application execution switch 745 is inputted, the detected event (V ₁ ) And the polarity (+) of the event (V) ₀ ) Is different from the polarity (-) of the event (V) ₁ ) The voltages are applied synchronously. This can avoid applying a voltage in synchronization with a T wave which is erroneously regarded as an R wave due to an increase in peak value.

In addition, event (V ₁ ) Is the next sensed event (V ₂ ) Is the peak of the R wave, but its polarity (+) is equal to the first two sensed events (V ₀ ) Is different from the polarity (-), and therefore is not different fromThe event (V) ₂ ) The voltages are applied synchronously.

Also, event (V ₂ ) Is the next sensed event (V ₃ ) And the polarity (+) of the previous sensed event (V ₂ ) Polarity (+) of the first two sensed events (V ₁ ) Is the same as the polarity (+) of the R wave, so that the peak of the R wave is believed to be the same as the event (V ₃ ) Synchronously, a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G.

Fig. 21B is an electrocardiogram input to the arithmetic processing unit 75 when the heart of the patient continues to cause extra-systole.

As shown in the figure, when an event (V ₀ ) In the case where the energy application execution switch 745 is inputted thereafter, the detected event (V ₁ ) Is (+) and then the detected event (V ₂ ) Is (-), and then the detected event (V ₃ ) Is (+) and then the detected event (V ₄ ) Is (-), and then the detected event (V ₅ ) The polarity of the event is (+) and the polarity of the event is alternately changed. Therefore, in the state where the polarities of the three detected events are not uniform, as described above, it is determined that there is a possibility that each of these events is not a peak of the R wave, and the voltage is not applied in synchronization with the event.

In addition, although the event (V ₅ ) Is the next sensed event (V ₆ ) The polarity (+) of (a) is the peak of the R wave, but its polarity (+) is equal to the polarity (+) of the first two sensed events (V ₄ ) Is different from the polarity (-) of the event (V) ₆ ) The voltages are applied synchronously.

Also, event (V ₆ ) Is the next sensed event (V ₇ ) Polarity (+) of (2) and event (V) ₆ ) Polarity (+) and event (V) ₅ ) The polarity (+) of (a) is the same, so that it is judged that the event (V ₇ ) The shrinkage reliably subsides outside the sensing period of (c) and is correlated with an event (V) which can be confirmed as the peak of the R wave ₇ ) Synchronously, to the first DC electrodeThe group 31G and the second DC electrode group 32G apply voltages.

FIG. 22 shows an electrocardiogram (the same electrocardiographic waveform as that shown in FIG. 24) in which the baseline is shifted and lowered, and thereafter the baseline is raised and restored to the original level, and the lowering and raising of the baseline are mistaken for R-waves, which are detected as events (V _-1 ) Event (V) ₁ )。

As shown in fig. 22, in the case where the energy application execution switch 745 is input immediately before the baseline is raised, the detected event (V ₁ ) And the polarity (+) of the event (V) ₀ ) Is the same as the polarity (+) of the first two sensed events (V _-1 ) Is different from the polarity (-) of the event (V) ₁ ) By applying the voltages synchronously, it is possible to avoid applying the voltages synchronously with the rise of the baseline of the R wave that is mistaken for.

Also, event (V ₁ ) Is the next sensed event (V ₂ ) And the polarity (+) of the previous sensed event (V ₁ ) Polarity (+) of the first two sensed events (V ₀ ) The polarity (+) of (a) is the same, so that it is judged that the event (V ₂ ) Is stable with respect to the baseline at the time of sensing and is associated with an event (V) which can be confirmed as the peak of the R wave ₂ ) The voltages are applied to the first DC electrode group 31G and the second DC electrode group 32G in synchronization.

Further, since the arithmetic processing unit 75 controls the DC power supply unit 71 without applying a DC voltage to the first DC electrode group 31G and the second DC electrode group 32G between 260m seconds after the event estimated as the R wave is detected by the sensing, it is possible to reliably avoid defibrillation at the time when the next T wave occurs when the event detected by the sensing is the peak of the R wave.

The arithmetic processing unit 75 is programmed not to re-sense the event estimated as the R wave between 100m seconds after the event estimated as the R wave is sensed, so that when the event sensed is the peak value of the R wave and the peak value of the S wave appearing in the opposite direction next increases and reaches the trigger level, it is possible to prevent the sensing of the peak value of the S wave and reset the count of the same polarity.

Further, since the arithmetic processing unit 75 controls the DC power supply unit 71 so as not to apply a direct-current voltage to the first DC electrode group 31G and the second DC electrode group 32G during 260m seconds after the input of the energy application execution switch 745, it is possible to prevent noise generated by the input of the energy application execution switch 745 from being erroneously recognized as R-waves from being sensed and defibrillated in synchronization with the noise, or to reset the count of the same polarity due to the noise.

In the case of using the defibrillation catheter system according to the present embodiment as the system according to the first aspect, when an abnormal wave height event occurs in the period from the input energy application preparation switch 744 to the input energy application execution switch 745, the arithmetic processing unit 75 detects the event (V) only after a predetermined standby time (3 seconds) has elapsed from the initiation of the abnormal wave height event _n ) In the case of (2) and event (V) _n ) Since the DC power supply unit 71 is controlled by applying voltages 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 in synchronization with each other, it is possible to reliably avoid applying a DC voltage to the first DC electrode group 31G and the second DC electrode group 32G when drift occurs, and to defibrillate the first DC electrode group 31G and the second DC electrode group 32G in synchronization with the R wave of the electrocardiogram when drift returns to a steady baseline.

In the case of using the defibrillation catheter system according to the present embodiment as the system according to the second aspect, the arithmetic processing unit 75 calculates the defibrillation catheter system as the defibrillation catheter system based on the first aspect, when the defibrillation catheter system is activated (V _n ) In the waveform of (2), when the rise time from reaching the bottom line to reaching the trigger level is 45 msec or less, the waveform is associated with an event (V _n ) In synchronization, since the DC power supply unit 71 is controlled by performing an arithmetic process so as to apply a voltage to the terminal 721 (the first DC electrode group 31G) of the conduit connector 72 and the terminal 722 (the second DC electrode group 32G) of the conduit connector 72, there is a possibility that an event (V _n ) Is T-wave, and is not in communication with the event (V ₂ ) Synchronous application of electricityPressure, defibrillation in synchronization with the T wave can be reliably avoided.

When the polarities of the three events detected 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 events, and after the input of the energy application execution switch 745, the arithmetic processing unit senses the detected event (V _n ) In the case where the polarity of the (B) is not identical to the polarity of the initial event (V) _n ) In synchronization, since the DC power supply 71 is controlled by performing the arithmetic processing so as to apply the DC voltage to the first DC electrode group 31G and the second DC electrode group 32G, defibrillation can be avoided more reliably when drift occurs.

Description of the reference numerals

100 defibrillation catheter, 10 multilumen tubing, 11 first lumen, 12 second lumen, 13 third lumen, 14 fourth lumen, 15 fluororesin layer, 16 inner (core) section, 17 outer (shell) section, 18 stainless bare wire, 20 handle, 21 handle body, 22 knob, 24 strain relief member, 26 first insulating hose, 27 second insulating hose, 28 third insulating hose, 31G first DC electrode group, 31 ring electrode, 32G second DC electrode group, 32 ring electrode, 33G base end side potentiometric electrode group, 33 ring electrode, 35 front end chip, 41G first lead group, 41 lead, 42G second lead group, 42 lead, 43G third lead group, 43 lead, 50 connector of defibrillation catheter, 51, 52, 53 pin terminal, 55 separator, 58 resin, 61 first protective hose, 62 second protective hose, 65 pull wire, 700 power supply device, 71 DC power supply section, 72 catheter connector 721, 722, 723 terminal, 73 cardioelectric instrument connector 74, 74 external switching mode switching means, 74, 75, electrical input-potential input-to the applied switching means, 75, and 75 to the applied-mode, switching means, the applied potentiometric switching means, and performing the applied-mode, thereby switching means, the applied potentiometric switching means, thereby setting the cardioelectric potential, and the applied units.

Claims

1. An intracardiac defibrillation catheter system, comprising: a defibrillation catheter inserted into a heart chamber to perform defibrillation, a power supply device for applying a DC voltage to an electrode of the defibrillation catheter, and an electrocardiograph, characterized in that,

the defibrillation catheter includes:

an insulating hose member;

a first electrode group including a plurality of ring-shaped electrodes attached to a distal end region of the hose member;

a second electrode group including a plurality of ring-shaped electrodes that are separated from the first electrode group toward a base end side and attached to the hose member;

a first lead group including a plurality of leads each having a front end connected to an electrode constituting the first electrode group; and

a second lead group formed by a plurality of leads each having a front end connected to an electrode constituting the second electrode group,

the power supply device includes:

a DC power supply section;

a catheter connection connector connected to the proximal end sides of the first and second lead sets of the defibrillation catheter;

an external switch including an application preparation switch and an application execution switch of electric energy;

an operation processing unit having an output circuit for a direct current voltage from the DC power supply unit, the operation processing unit controlling the DC power supply unit based on an input of the external switch; and

An electrocardiogram input connector connected to the arithmetic processing unit and an output terminal of the electrocardiograph,

defibrillation is performed by the defibrillation catheter by inputting the application execution switch after the input of the application preparation switch, and voltages of different polarities are applied to the first electrode group and the second electrode group of the defibrillation catheter from the DC power supply unit via the output circuit of the arithmetic processing unit and the catheter connection connector at the time of defibrillation,

the operation processing section of the power supply device performs operation processing and controls the DC power supply section to sequentially sense and detect an event estimated as an R wave based on an electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and to sense the detected event (V _n ) At least with the polarity of the event (V) _n-1 ) And the first two sensed events (V _n-2 ) When an abnormal wave height event occurs in a period from the input of the application preparation switch to the input of the application execution switch, detecting the event (V) by sensing only after a predetermined standby time has elapsed from the occurrence of the abnormal wave height event (V _n ) In the case of (2) with the event (V _n ) And applying voltages to the first electrode group and the second electrode group synchronously.

2. An intracardiac defibrillation catheter system according to claim 1, wherein,

the abnormal wave height event is an event of a wave height exceeding 120% of an average wave height of two events sensed immediately before the input of the application preparation switch.

3. An intracardiac defibrillation catheter system according to claim 1 or 2, wherein,

the standby time is between 1000 and 5000 msec.

4. An intracardiac defibrillation catheter system according to claim 1 or 2, wherein,

the endocardial defibrillation catheter system comprises: reporting the possibility of drift caused at the standby time.

5. An intracardiac defibrillation catheter system, comprising: a defibrillation catheter inserted into a heart chamber to perform defibrillation, a power supply device for applying a DC voltage to an electrode of the defibrillation catheter, and an electrocardiograph, characterized in that,

the defibrillation catheter includes:

an insulating hose member;

the power supply device includes:

a DC power supply section;

The operation processing section of the power supply device performs operation processing and controls the DC power supply section to sequentially sense and detect an event estimated as an R wave based on an electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and to sense the detected event (V _n ) Is at least as polar as the previous oneSensing detected events (V _n-1 ) And the first two sensed events (V _n-2 ) And, upon said event (V _n ) From the arrival of the waveform of the Electrocardiogram (ECG) to the event (V) _n ) The polarity direction of (a) is shifted by 0.26V by a base line, and the rise time of the trigger level, which is 80% of the average wave height of the two events detected immediately before the input of the application preparation switch, is within 45 msec, is equal to or shorter than the time of the event (V _n ) And applying voltages to the first electrode group and the second electrode group synchronously.

6. An intracardiac defibrillation catheter system according to claim 1 or 5, wherein,

the operation processing unit of the power supply device performs an operation process and controls the DC power supply unit to store the polarities of three events detected immediately before the input of the application preparation switch as the polarities of the initial events when the polarities are identical to each other, and to output the voltage signal to the power supply unit when the voltage signal is detected as the voltage signal _n ) In the case where the polarity of the initial event is not identical to the polarity of the event (V _n ) And applying voltages to the first electrode group and the second electrode group synchronously.

7. An intracardiac defibrillation catheter system according to claim 1 or 5, wherein,

the operation processing unit of the power supply device controls the DC power supply unit so that no voltage is applied to the first electrode group and the second electrode group for a period of 500 ms between 50 ms and 500 ms after detecting an event estimated as an R wave.

8. The endocardial defibrillation catheter system of claim 7, wherein,

the operation processing unit of the power supply device does not re-sense the event estimated as the R wave between the shortest 10 msec and the longest 150 msec after sensing the event estimated as the R wave.

9. The endocardial defibrillation catheter system of claim 7, wherein,

the operation processing unit of the power supply device controls the DC power supply unit so that no voltage is applied to the first electrode group and the second electrode group for a period of 500 ms at the shortest period of 10 ms after the input of the application execution switch.