Fine motor

Abstract

The objective is to provide a defibrillator that enables intracardiac pacing using the electrode catheter used during surgery. [Solution] The defibrillator of the present invention is characterized by comprising a power supply equipped with a negative wire and a positive wire, and a connection part that independently and selectively connects a plurality of electrodes provided on an electrode catheter to either the negative wire or the positive wire.

Description

Technical Field

[0001] The present invention relates to a defibrillator.

Background Art

[0002] In cases of EPS (Electrophysiological Study) examination and arrhythmia ablation in a cardiac catheterization laboratory, for the diagnosis and treatment of arrhythmia, an intracardiac defibrillatable electrode catheter (electrode catheter) is placed in the heart cavity and connected to a cardiac catheterization device (polygraph examination device) to measure an intracardiac electrocardiogram, and intracardiac pacing is performed from a stimulator connected via the polygraph examination device. If necessary, low-energy intracardiac defibrillation is performed by synchronous electrical shock synchronized with the QRS wave of the surface electrocardiogram.

[0003] The electrode catheter includes a plurality of electrodes arranged along the longitudinal direction of the catheter body, and these electrodes constitute a plurality of electrode groups.

[0004] When pacing is performed using the electrode catheter, one of the plurality of electrodes is connected to the minus wiring of the stimulator and the other one is connected to the plus wiring via the polygraph examination device, and a low voltage is applied between the two electrodes from the stimulator to continuously apply an electrical pulse to the heart.

[0005] On the other hand, when defibrillation by electrical shock is performed using the electrode catheter, one electrode group of the electrode catheter inserted into the heart cavity is connected to the minus wiring of the defibrillator, and the other one electrode group is connected to the plus wiring, and a pulse for defibrillation by electrical shock is applied between the two electrode groups to perform low-energy electrical defibrillation (compared to the energy required for electrical shock using defibrillation pads or external paddles) (Patent Document 1).

Prior Art Documents

Patent Documents

[0006] Japanese Patent Publication No. 2018-202159 [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] During EPS examinations and arrhythmia ablation treatments, bradycardia may occur due to the effects of electrical shocks or sedatives during the procedure. At the end of the procedure, the electrodes and catheters used during the procedure are removed and preparations are made for the patient to leave the cardiac catheterization laboratory. However, if bradycardia persists and it is determined that it will take time to resolve, temporary bradycardia pacing may be performed using an external pacemaker that can be used in wards or other settings. In that case, a new catheter for temporary pacing must be opened and placed in the cardiac chamber before leaving the laboratory.

[0008] Therefore, the present invention has been made in view of these problems, and aims to provide a defibrillator that enables intracardiac pacing using an electrode catheter used during surgery. [Means for solving the problem]

[0009] The defibrillator of the present invention is characterized by comprising a power supply having a negative wire and a positive wire, and a connection part that independently and selectively connects a plurality of electrodes provided on an electrode catheter to either the negative wire or the positive wire. [Effects of the Invention]

[0010] According to the defibrillator of the present invention, one or more electrodes of the electrode catheter can be connected to the negative wire of the power supply, and one or more other electrodes can be connected to the positive wire of the power supply, and a voltage can be applied between the two electrodes. This makes it possible to perform intracardiac pacing from the defibrillator using the electrode catheter used during surgery. As a result, intracardiac pacing can be performed using a defibrillator equipped with this function installed in the ward, without using a stimulator used in the examination room, thus eliminating the need for an external pacemaker. Furthermore, it is no longer necessary to open the temporary pacing catheter used for connection, thereby reducing the cost of consumables. [Brief explanation of the drawing]

[0011] [Figure 1] This is a schematic diagram illustrating a cardiac medical system equipped with a defibrillator according to an embodiment of the present invention. [Figure 2] This is an example of a connection diagram for the PD switching switch in a cardiac medical system equipped with a defibrillator according to an embodiment of the present invention. [Figure 3] This is another example of a connection diagram for the PD switching switch in a cardiac medical system equipped with a defibrillator according to an embodiment of the present invention. [Figure 4] This flowchart shows the operation of the control unit of the defibrillator in the intracardiac defibrillation mode in an embodiment of the present invention. [Figure 5] This is an example of a connection diagram for the PD switching switch of a cardiac medical system equipped with a defibrillator in an embodiment of the present invention, during impedance measurement, electrocardiogram analysis, and intracardiac pacing. [Figure 6] This is an example of a connection diagram for the PD switching switch of a cardiac medical system equipped with a defibrillator in an embodiment of the present invention during intracardiac defibrillation. [Figure 7] This flowchart shows the operation of the control unit of the defibrillator in the intracardiac pacing mode according to an embodiment of the present invention. [Figure 8] This is another example of a connection diagram for the PD switching switch of a cardiac medical treatment system equipped with a defibrillator in an embodiment of the present invention during intracardiac pacing. [Figure 9] This flowchart shows the operation of the control unit of the defibrillator in AED mode according to an embodiment of the present invention. [Figure 10] This flowchart shows the operation of the control unit of the defibrillator in ICD mode according to an embodiment of the present invention. [Figure 11] This is a schematic diagram of the dial of a defibrillator in an embodiment of the present invention. [Modes for carrying out the invention]

[0012] Embodiments of the present invention will be described below with reference to the drawings.

[0013] First, the outline of a cardiac diagnostic system including a defibrillator in an embodiment of the present invention will be described with reference to FIG. 1. FIG. 1 is a schematic explanatory diagram of a cardiac diagnostic system including a defibrillator in the embodiment.

[0014] The cardiac diagnostic system including a defibrillator in the embodiment includes a defibrillator 1, an electrode catheter 2, and a connection device 3.

[0015] The defibrillator 1 is a device that gives an electric shock to the heart to return an arrhythmia to a normal rhythm. It can also perform EPS examination, pacing in arrhythmia ablation treatment, and demand bradycardia pacing by giving pacing to the heart.

[0016] The electrode catheter 2 is inserted into the heart cavity, sends an intracardiac potential to the defibrillator 1, and is used for intracardiac defibrillation and intracardiac pacing.

[0017] The connection device 3 interconnects various devices, transmits an intracardiac potential from the electrode catheter 2 to the defibrillator 1, transmits an intracardiac potential from the electrode catheter 2 to a polygraph examination device (not shown), transmits a body surface potential from a pad or paddle (not shown) to the defibrillator 1, and transmits an intracardiac electrocardiogram signal and a body surface electrocardiogram signal from a polygraph examination device (not shown) to the defibrillator 1.

[0018] The defibrillator 1 includes an AC / DC power supply 4, a capacitor 5, a dial 6, a synchronization switch 7 (hereinafter, the switch is abbreviated as "SW"), a charging SW 8, an energization SW 9, a screen 10, and a control unit 11.

[0019] The AC / DC power supply 4 obtains power from an external power source.

[0020] [[ID=二十九]] The capacitor 5 supplies the power obtained by the AC / DC power supply 4 to the electrode catheter 2.

[0021] When operated by the user, dial 6 sets the defibrillator 1 to intracardiac defibrillation mode, intracardiac pacing mode, AED mode, or ICD mode. The specific operation of the defibrillator 1 in each mode will be described later.

[0022] When pressed by the user, the synchronous SW7 switches between synchronous electric shock and electric shock settings.

[0023] When the charging switch 8 is pressed by the user, charging of capacitor 5 begins.

[0024] When the power switch SW9 is pressed by the user, it supplies power from the capacitor 5 to the electrode catheter 2.

[0025] Screen 10 displays the electrocardiogram and user instructions.

[0026] The control unit 11 recognizes user operation of the dial 6, synchronization switch 7, charging switch 8, and power supply switch 9, and receives intracardiac potentials from the electrode catheter 2, or outputs electrical energy from the capacitor 5 to the electrode catheter 2.

[0027] The defibrillator 1 is connected to a negative wire L1 and a positive wire L2. The negative wire L1 and the positive wire L2 are selectively connected to the electrode catheter 2 via a connection device 3.

[0028] Negative wiring L1 is the negative wiring that supplies power to electrode catheter 2.

[0029] The positive wiring L2 is the positive wiring that supplies power to electrode catheter 2.

[0030] Negative wire L1 and positive wire L2 receive intracardiac potentials from electrode catheter 2.

[0031] The control unit 11 of the defibrillator 1 receives not only intracardiac potentials from the electrode catheter 2, but also surface electrocardiogram waveforms from pads or paddles (not shown), surface electrocardiogram waveforms from electrocardiogram electrodes (not shown), and intracardiac electrocardiogram signals or surface electrocardiogram signals from a polygraph (not shown), and can perform electrocardiogram analysis based on these waveforms and signals. Conventional and known analysis methods can be used for electrocardiogram analysis.

[0032] The electrode catheter 2 comprises a first electrode group G1, a second electrode group G2, an EP electrode group G3, a first electrode group wiring L3, a second electrode group wiring L4, and an EP electrode group wiring L5.

[0033] The first electrode group G1 consists of eight electrodes arranged in a line along the longitudinal direction of the catheter body.

[0034] The second electrode group G2 consists of eight electrodes that are positioned closer to the tip of the catheter body than the first electrode group G1.

[0035] The EP electrode group G3 consists of four electrodes positioned closer to the proximal end of the catheter body than the second electrode group G2. However, the arrangement of the EP electrode group G3 is not limited to this; it may also be positioned between the first electrode group G1 and the second electrode group G2, or closer to the tip of the catheter body than the first electrode group G1.

[0036] The number of electrode groups and the number of electrodes in each electrode group are examples only; it is possible to use electrode catheters with different numbers of electrode groups or electrodes as needed.

[0037] The first electrode group wiring L3 connects the first electrode group G1 to the defibrillator 1 via the connection device 3.

[0038] The second electrode group wiring L4 connects the second electrode group G2 to the defibrillator 1 via the connection device 3.

[0039] The EP electrode group wiring L5 connects the EP electrode group G3 to the defibrillator 1 via the connection device 3.

[0040] The connection device 3 is equipped with a PD (Pacing defibrillation) switching SW12.

[0041] The PD switching SW12 selectively connects the first electrode group wiring L3, the second electrode group wiring L4, and the EP electrode group wiring L5 to the negative wiring L1 and the positive wiring L2.

[0042] In this embodiment, the PD switching SW12 is provided on the connection device 3, but the PD switching SW12 may also be provided on the defibrillator 1.

[0043] Next, the connection of the PD switching SW12 will be explained using Figure 2. Figure 2 is an example of a connection diagram of the PD switching SW12 in a cardiac medical system equipped with a defibrillator 1 in an embodiment of the present invention.

[0044] In Figure 2, the PD switching SW12 includes a negative electrode 13, a positive electrode 14, a branching point 15, and an ON / OFF switching SW16.

[0045] The negative electrode 13 is connected to the negative wiring L1.

[0046] The positive electrode 14 is connected to the positive wiring L2.

[0047] Branch point 15 divides the wiring of the first electrode group L3, the second electrode group L4, and the EP electrode group L5 into two separate branches.

[0048] The ON / OFF switch 16 is connected to the negative electrode 13 and the positive electrode 14. The ON / OFF switch 16 connected to the negative electrode 13 connects or disconnects one of the wires that branched off at branch point 15 to the negative wire L1 via the negative electrode 13. The ON / OFF switch 16 connected to the positive electrode 14 connects or disconnects the other wire that branched off at branch point 15 to the positive wire L2 via the positive electrode 14.

[0049] Next, another example of the connection of the PD switching SW12 will be explained with reference to Figure 3. Figure 3 is another example of the connection diagram of the PD switching SW12 in a cardiac medical system equipped with a defibrillator 1 in an embodiment of the present invention.

[0050] In Figure 3, the PD switching SW12 is equipped with a plus / minus switching SW17.

[0051] The positive / negative switch SW17 is connected to the wirings of the first electrode group L3, the second electrode group L4, and the EP electrode group L5. A positive / negative switch SW17 connected to the negative wiring L1 connects the wirings of the first electrode group L3, the second electrode group L4, and the EP electrode group L5 to which the positive / negative switch SW17 is connected to the negative wiring L1. A positive / negative switch SW17 connected to the positive wiring L2 connects the wirings of the first electrode group L3, the second electrode group L4, and the EP electrode group L5 to which the positive / negative switch SW17 is connected to the positive wiring L2.

[0052] <1 Intracardiac defibrillation mode> Next, a series of operations of the cardiac medical system, including the operation of the control unit 11 of the defibrillator 1 in intracardiac defibrillation mode, will be explained using Figures 1, 4 to 6. Figure 4 is a flowchart showing the operation of the control unit 11 of the defibrillator 1 in intracardiac defibrillation mode in an embodiment of the present invention. Figure 5 is an example of a connection diagram of the PD switching SW 12 of the cardiac medical system equipped with the defibrillator 1 in an embodiment of the present invention during impedance measurement, electrocardiogram analysis, and intracardiac pacing. Figure 6 is an example of a connection diagram of the PD switching SW 12 of the cardiac medical system equipped with the defibrillator 1 in an embodiment of the present invention during intracardiac defibrillation.

[0053] In step S1 of Figure 4, the control unit 11 determines whether the system has been set to intracardiac defibrillation mode by the user's operation of dial 6. If the system has been set to intracardiac defibrillation mode (Yes in step S1), in step S5, it determines whether the synchronization SW7 is turned OFF.

[0054] If the system is not set to intracardiac defibrillation mode (No in step S1), in step S2, the control unit 11 determines whether it is set to intracardiac pacing mode. The operation when it is set to intracardiac pacing mode (Yes in step S2) will be described later using Figure 7 (flow chart 1).

[0055] If the system is not set to intracardiac pacing mode (No in step S2), in step S3, the control unit 11 determines whether the system is set to AED mode. The operation when the system is set to AED mode (Yes in step S3) will be described later using Figure 9 (flow chart 2).

[0056] If the system is not set to AED mode (No in step S3), in step S4, the control unit 11 determines whether the system is set to ICD mode. The operation when the system is set to ICD mode (Yes in step S4) will be described later using Figure 10 (flowchart 3).

[0057] If the device is not set to ICD mode (No in step S4), determine again whether it has been set to intracardiac defibrillation mode (step S1).

[0058] (1-1 When synchronous SW7 is OFF) The operation when the synchronization SW7 is ON in intracardiac defibrillation mode (Yes in step S5) will be described later. When the synchronization SW7 is OFF in intracardiac defibrillation mode (No in step S5), in step S6, the control unit 11 controls the PD switching SW12 and connects one of the electrodes in a single electrode group to the negative electrode 13 and the other electrode to the positive electrode 14, as shown in Figure 5. (Note that the electrode connection is intended to form a bipolar system by selecting any two pairs of electrodes from one electrode group, connecting one pair to the negative wire L1, and the other pair to the positive wire L2. The number of electrodes connected is not limited to two. That is, it is possible to connect two electrodes to the negative electrode and two electrodes to the positive electrode, or three electrodes to the negative electrode and one electrode to the positive electrode. The same applies when measuring impedance in each mode, acquiring intracardiac electrocardiograms, and pacing.) In this case, in the case of ventricular fibrillation, the first electrode group G1 is placed in the right atrium (RA), and the second electrode group G2 is placed in the right ventricle (RV).

[0059] In step S7, the control unit 11 measures the impedance to determine whether the electrode group is connected to the defibrillator 1 while it is placed in the cardiac chamber.

[0060] In step S8, the control unit 11 determines whether the impedance is within the normal range. If the impedance is outside the normal range (No in step S8), the control unit 11 measures the impedance again (step S7). Specifically, the user correctly connects the electrode catheter 2 to the defibrillator 1 via the connecting device 3 or correctly places the electrode catheter 2 in the cardiac chamber and operates the defibrillator 1 to instruct impedance measurement.

[0061] If the impedance is within the normal range (Yes in step S8), in step S9, the control unit 11 controls the PD switching SW12 to disconnect all electrodes and measures the intracardiac electrocardiogram waveform using a polygraph device (not shown).

[0062] In step S10, the control unit 11 determines whether the user has pressed the charging switch 8. If the charging switch 8 is not pressed (No in step S10), the control unit waits until the charging switch 8 is pressed.

[0063] If the charging switch 8 is pressed (Yes in step S10), in step S11, the control unit 11 starts charging the capacitor 5 from the AC / DC power supply 4.

[0064] In step S12, the control unit 11 determines whether charging of the capacitor 5 is complete. If charging is still in progress (No in step S12), it waits until charging is complete.

[0065] If charging of capacitor 5 is complete (Yes in step S12), in step S13, the control unit 11 controls the PD switching SW12 to connect the first electrode group G1 to the negative electrode 13 and the second electrode group G2 to the positive electrode 14, as shown in Figure 6.

[0066] In step S14, the control unit 11 instructs the user to press the power supply switch 9. Specifically, the instruction is displayed on the screen 10 or given by voice.

[0067] In step S15, the control unit 11 determines whether the power supply switch 9 has been pressed. If the power supply switch 9 has not been pressed (No in step S15), the control unit waits until the power supply switch 9 is pressed.

[0068] If the power switch 9 is pressed (Yes in step S15), in step S16, the control unit 11 performs an electric shock by releasing the electrical energy stored in the capacitor 5 to the electrode catheter 2.

[0069] In step S17, the control unit 11 determines whether the operation to terminate has been performed. If the user does not perform the operation to terminate (No in step S17), the control unit 11 disconnects all electrodes (step S9) and determines whether the charging switch has been pressed (step S10).

[0070] If the user initiates an operation to terminate the operation (Yes in step S17), the control unit 11 terminates the operation. In addition, during operation of any mode, including this mode, if the user initiates an operation to terminate the operation or sets another mode using dial 6, the control unit 11 terminates the operation of that mode.

[0071] (1-2 When Synchronization SW7 is ON) If the synchronization switch 7 is pressed by the user and turned ON (Yes in step S5), the operation of the control unit 11 up to the electrode group connection is the same as when the synchronization switch 7 is OFF (steps S6 to S13). In this case, in the case of atrial fibrillation, the first electrode group G1 is placed in the right atrium (RA), and the second electrode group G2 is placed in the coronary sinus (CS). In the case of ventricular tachycardia, the first electrode group G1 is placed in the right atrium (RA), and the second electrode group G2 is placed in the right ventricle (RV).

[0072] In the next step S20 following step S13, the control unit 11 instructs the user to continue pressing the power supply switch 9.

[0073] In step S21, the control unit 11 determines whether the power supply switch 9 is being pressed down. If the power supply switch 9 is not being pressed down (No in step S21), the control unit 11 waits until the power supply switch 9 is pressed down.

[0074] If the power supply switch 9 is held down (Yes in step S21), in step S22, the control unit 11 detects the QRS wave. Specifically, it detects it using a surface electrocardiogram waveform from electrocardiogram electrodes (not shown). If the user releases the power supply switch 9 before the synchronized electric shock is delivered, the control unit 11 instructs the user to continue holding down the power supply switch 9.

[0075] In step S23, the control unit 11 performs a synchronous electric shock. Specifically, it outputs electrical energy from the capacitor 5 to the first electrode group G1 and the second electrode group G2 of the electrode catheter 2 in synchronization with the QRS wave.

[0076] In step S24, the control unit 11 determines whether the operation to terminate has been performed. If the user does not perform the operation to terminate (No in step S24), the control unit 11 disconnects all electrodes (step S9) and determines whether the charging switch has been pressed (step S10).

[0077] If the user initiates an operation to terminate the operation (Yes in step S17), the control unit 11 terminates the operation.

[0078] <2 Intracardiac Pacing Modes> Next, a series of operations of the cardiac medical system, including the operation of the control unit 11 of the defibrillator 1 during intracardiac pacing mode, will be explained using Figures 1, 4, 7, and 8. Figure 7 is a flowchart showing the operation of the control unit 11 of the defibrillator 1 during intracardiac pacing mode in an embodiment of the present invention. Figure 8 is another example of the connection diagram of the PD switching SW12 of the cardiac medical system equipped with the defibrillator 1 during intracardiac pacing in an embodiment of the present invention.

[0079] Regarding the placement of electrode catheters, in atrial fibrillation ablation treatment, the first electrode group G1 is placed in the right atrium (RA) and the second electrode group G2 is placed in the coronary sinus (CS). However, depending on the content of the pacing treatment, EPS examination, and ablation case, the second electrode group G2 may be placed in another location, such as the right ventricle (RV).

[0080] In step S2 of Figure 4, if the user operates dial 6 to set the device to intracardiac pacing mode (Yes in step S2), then in step S100 of Figure 7, the control unit 11 controls the PD switching SW 12 and connects one of the electrodes in a single electrode group to the negative electrode 13 and the other electrode to the positive electrode 14, as shown in Figure 8.

[0081] In step S101, the control unit 11 measures the impedance to determine whether the electrode group is connected to the defibrillator 1 while it is placed in the cardiac chamber.

[0082] In step S102, the control unit 11 determines whether the impedance is within the normal range. If the impedance is outside the normal range (No in step S102), the control unit 11 measures the impedance again (step S101). Specifically, the user correctly connects the electrode catheter 2 to the defibrillator 1 via the connecting device 3 or correctly places the electrode catheter 2 in the cardiac chamber and operates the defibrillator 1 to instruct impedance measurement.

[0083] (2-1 Demand Mode) If the impedance is within the normal range (Yes in step S102), in step S103, the control unit 11 determines whether it is set to demand mode. The user can select either demand mode or fixed mode in the initial settings, and can also switch between the two modes during intracardiac pacing operation. Demand mode is mainly used for bradycardia pacing.

[0084] The operation when the system is not set to demand mode (No in step S103) will be described later. When the system is set to demand mode (Yes in step S103), in step S104, the control unit 11 analyzes the electrocardiogram. Specifically, it inputs the intracardiac potential from the wiring connected to the electrode catheter 2 to generate an intracardiac electrocardiogram waveform, and then analyzes that intracardiac electrocardiogram waveform.

[0085] In step S105, the control unit 11 determines whether pacing is necessary. Specifically, pacing is determined to be necessary if the heart rate falls below a preset rate. Until the heart rate falls below the preset rate (No in step S105), the electrocardiogram analysis continues (step S104).

[0086] If the heart rate falls below a preset rate and it is determined that pacing is necessary (Yes in step S105), in step S106, the control unit 11 generates a pacing pulse based on a preset pulse duration, output voltage or current, and pacing rate.

[0087] In step S107, the control unit 11 performs pacing by outputting the generated pacing pulse to the electrode catheter 2.

[0088] In step S108, the control unit 11 determines whether the operation to terminate has been performed. If the user does not perform the operation to terminate (No in step S108), the control unit 11 determines whether the system is set to demand mode (step S103).

[0089] If the user initiates an operation to terminate the operation (Yes in step S109), the control unit 11 terminates the operation.

[0090] (2-2 Fixed Mode) In step S103, if the system is not set to demand mode (No in step S103), the control unit 11 determines that the system is set to fixed mode. Fixed mode is mainly used for examinations during anti-tachycardia pacing, EPS, and arrhythmia ablation.

[0091] In step S110, the control unit 11 generates a pacing pulse based on a preset pulse duration, output voltage or current, and pacing rate.

[0092] In step S111, the control unit 11 performs pacing by outputting the generated pacing pulse to the electrode catheter 2.

[0093] In step S112, the control unit 11 determines whether the operation to terminate has been performed. If the user does not perform the operation to terminate (No in step S112), the control unit 11 determines whether the system is set to demand mode (step S103).

[0094] If the user initiates an operation to terminate the operation (Yes in step S112), the control unit 11 terminates the operation.

[0095] <3 AED Mode> Next, a series of operations of the cardiac medical system, including the operation of the control unit 11 of the defibrillator 1 in AED mode, will be explained using Figures 1, 4, 5, 6, and 9. Figure 9 is a flowchart showing the operation of the control unit 11 of the defibrillator 1 in AED mode in an embodiment of the present invention.

[0096] In step S3 of Figure 4, if the AED mode is set by the user's operation of dial 6 (Yes in step S3), then in step S200 of Figure 9, the control unit 11 determines whether it is set to semi-automatic mode. If the synchronization switch 7 was ON when dial 6 was set to AED mode, the synchronization switch 7 is automatically turned OFF.

[0097] (3-1 Semi-automatic mode) The operation when the system is initially set to fully automatic mode (No in step S200) will be described later. If the system is initially set to semi-automatic mode (Yes in step S200), in step S201, the control unit 11 controls the PD switching SW12 and connects one of the electrodes in one electrode group to the negative electrode 13 and the other electrode to the positive electrode 14, as shown in Figure 5. At this time, the first electrode group G1 is located in the right atrium (RA), and the second electrode group G2 is located in the right ventricle (RV). In AED mode, since the electrocardiogram of a ventricular arrhythmia is analyzed, two sets of electrodes are connected in the second electrode group G2 to form a bipolar system (the same applies hereafter in AED mode).

[0098] In step S202, the control unit 11 measures the impedance to determine whether the electrode group is connected to the defibrillator 1 while it is placed in the cardiac chamber.

[0099] In step S203, the control unit 11 determines whether the impedance is within the normal range. If the impedance is outside the normal range (No in step S203), the control unit 11 measures the impedance again (step S202). Specifically, the user correctly connects the electrode catheter 2 to the defibrillator 1 via the connecting device 3 or correctly places the electrode catheter 2 in the cardiac chamber and operates the defibrillator 1 to instruct impedance measurement.

[0100] If the impedance is within the normal range (Yes in step S203), in step S204, the control unit 11 analyzes the electrocardiogram. Specifically, it inputs the intracardiac potential from the wiring connected to the electrode catheter 2 to generate an intracardiac electrocardiogram waveform, and then analyzes that intracardiac electrocardiogram waveform.

[0101] In step S205, the control unit 11 determines whether an electric shock is necessary based on the analysis results. If it is determined that an electric shock is unnecessary (No in step S205), the control unit 11 re-analyzes the electrocardiogram (step S204).

[0102] If it is determined that an electric shock is necessary (Yes in step S205), in step S206, the control unit 11 controls the PD switching SW12 to disconnect all electrodes (in this example, all electrodes are disconnected, but they may be kept connected until the capacitor is fully charged. The same applies hereafter).

[0103] In step S207, the control unit 11 starts charging the capacitor 5 from the AC / DC power supply 4.

[0104] In step S208, the control unit 11 determines whether charging of the capacitor 5 is complete. If charging is still in progress (No in step S208), it waits until charging is complete.

[0105] If charging of capacitor 5 is complete (Yes in step S208), in step S209, the control unit 11 controls the PD switching SW12 to connect the first electrode group G1 to the negative electrode 13 and the second electrode group G2 to the positive electrode 14, as shown in Figure 6.

[0106] In step S210, the control unit 11 instructs the user to press the power switch 9. Specifically, the instruction is displayed on the screen 10 or given by voice.

[0107] In step S211, the control unit 11 determines whether the power supply switch 9 has been pressed. If the power supply switch 9 has not been pressed (No in step S211), the control unit waits until the power supply switch 9 is pressed.

[0108] If the power switch 9 is pressed (Yes in step S211), in step S212, the control unit 11 performs an electric shock by releasing the electrical energy stored in the capacitor 5 to the electrode catheter 2.

[0109] In step S213, the control unit 11 determines whether the operation to terminate has been performed. If the user does not perform the operation to terminate (No in step S213), the control unit 11 controls the PD switching SW12 to connect one of the electrodes from the electrode group to the negative electrode 13 and the other electrode to the positive electrode 14, and analyzes the electrocardiogram (step S204).

[0110] If the user initiates an operation to terminate the operation (Yes in step S213), the control unit 11 terminates the operation.

[0111] (3-2 Fully Automatic Mode) If the system is initially set to fully automatic mode (No in step S200), the operation of the control unit 11 up to the electrode group connection is the same as in semi-automatic mode (steps S201 to S209).

[0112] In the next step S220 following step S209, the control unit 11 performs an electric shock by releasing the electrical energy stored in the capacitor 5 to the electrode catheter 2.

[0113] In step S221, the control unit 11 determines whether the operation to terminate has been performed. If the user does not perform the operation to terminate (No in step S221), the control unit 11 controls the PD switching SW12 to connect one of the electrodes from the electrode group to the negative electrode 13 and the other electrode to the positive electrode 14, and analyzes the electrocardiogram (step S204).

[0114] If the user initiates an operation to terminate the operation (Yes in step S221), the control unit 11 terminates the operation.

[0115] <4 ICD Mode> Next, a series of operations of the cardiac medical system, including the operation of the control unit 11 of the defibrillator 1 in ICD mode, will be explained using Figures 1, 4, 5, 6, and 10. Figure 10 is a flowchart showing the operation of the control unit 11 of the defibrillator 1 in ICD mode according to an embodiment of the present invention.

[0116] In step S4 of Figure 4, if the user operates dial 6 to set the device to ICD mode (Yes in step S4), then in step S300 of Figure 10, the control unit 11 controls the PD switching SW12 and connects one of the electrodes in one electrode group to the negative electrode 13 and the other electrode to the positive electrode 14, as shown in Figure 5. At this time, the first electrode group G1 is located in the right atrium (RA), and the second electrode group G2 is located in the right ventricle (RV). In ICD mode, since the electrocardiogram of ventricular arrhythmias is analyzed, two sets of electrodes are connected within the second electrode group G2 to form a bipolar system (the same applies hereafter in ICD mode).

[0117] In step S301, the control unit 11 measures the impedance to determine whether the electrode group is connected to the defibrillator 1 while it is placed in the cardiac chamber.

[0118] In step S302, the control unit 11 determines whether the impedance is within the normal range. If the impedance is outside the normal range (No in step S302), the control unit 11 measures the impedance again (step S301). Specifically, the user correctly connects the electrode catheter 2 to the defibrillator 1 via the connecting device 3 or correctly places the electrode catheter 2 in the cardiac chamber and operates the defibrillator 1 to instruct impedance measurement.

[0119] If the impedance is within the normal range (Yes in step S302), in step S303, the control unit 11 analyzes the electrocardiogram. Specifically, it inputs the intracardiac potential from the wiring connected to the electrode catheter 2 to generate an intracardiac electrocardiogram waveform and analyzes that intracardiac electrocardiogram.

[0120] In step S304, the control unit 11 determines whether it is ventricular tachycardia based on the analysis results. The operation when it is determined not to be ventricular tachycardia (No in step S304) will be described later.

[0121] (4-1 In the case of ventricular tachycardia) If ventricular tachycardia is detected (Yes in step S304), in step S307, the control unit 11 generates a preset pulse duration, output voltage or current, and pacing rate.

[0122] In step S308, the control unit 11 performs anti-tachycardia pacing by outputting the generated pacing pulse to the electrode catheter 2.

[0123] In step S309, the control unit 11 determines whether the ventricular tachycardia has been resolved. If it is determined that the ventricular tachycardia has been resolved (Yes in step S309), the control unit 11 analyzes the electrocardiogram again (step S303).

[0124] If it is determined that ventricular tachycardia is not resolved (No in step S309), in step S310, the control unit 11 controls the PD switching SW12 to disconnect all electrodes.

[0125] In step S311, the control unit 11 starts charging the capacitor 5 from the AC / DC power supply 4.

[0126] In step S312, the control unit 11 determines whether charging of the capacitor 5 is complete. If charging is still in progress (No in step S312), it waits until charging is complete.

[0127] If charging of capacitor 5 is complete (Yes in step S312), in step S313, the control unit 11 controls the PD switching SW12 to connect the first electrode group G1 to the negative electrode 13 and the second electrode group G2 to the positive electrode 14, as shown in Figure 6.

[0128] In step S314, the control unit 11 detects the QRS wave. Specifically, it detects it using a surface electrocardiogram waveform from electrocardiogram electrodes (not shown). If the user releases the power supply switch 9 before the synchronized electric shock is delivered, the control unit 11 instructs the user to continue pressing the power supply switch 9 again.

[0129] In step S315, the control unit 11 performs a synchronous electric shock. Specifically, it outputs electrical energy from the capacitor 5 to the first electrode group G1 and the second electrode group G2 of the electrode catheter 2 in synchronization with the QRS wave.

[0130] In step S316, the control unit 11 controls the PD switching SW12 to connect one of the electrodes in a group to the negative electrode 13 and the other electrode to the positive electrode 14, and then analyzes the electrocardiogram again (step S303).

[0131] If it is determined in step S304 that ventricular tachycardia is not present (No in step S304), then in step S305, the control unit 11 determines whether ventricular fibrillation is present. The operation when it is determined that ventricular fibrillation is not present (No in step S305) will be described later.

[0132] (3-2 In the case of ventricular fibrillation) If ventricular fibrillation is detected (Yes in step S305), in step S320, the PD switching SW12 is controlled to disconnect all electrodes.

[0133] In step S321, the control unit 11 starts charging the capacitor 5 from the AC / DC power supply 4.

[0134] In step S322, the control unit 11 determines whether charging of the capacitor 5 is complete. If charging is still in progress (No in step S322), it waits until charging is complete.

[0135] If charging of capacitor 5 is complete (Yes in step S322), in step S323, the control unit 11 controls the PD switching SW12 to connect the first electrode group G1 to the negative electrode 13 and the second electrode group G2 to the positive electrode 14, as shown in Figure 6.

[0136] In step S324, the control unit 11 performs an electric shock by releasing the electrical energy stored in the capacitor 5 to the electrode catheter 2.

[0137] In step S325, the PD switching SW12 is controlled to connect one of the electrodes in a group to the negative electrode 13 and the other electrode to the positive electrode 14, and the electrocardiogram is analyzed again (step S303).

[0138] If it is determined in step S305 that ventricular fibrillation is not present (No in step S305), then in step S306, the control unit 11 determines whether it is bradycardia. If it is determined that it is not bradycardia (No in step S306), the control unit 11 analyzes the electrocardiogram again (step S303).

[0139] (3-3 In case of bradycardia) If bradycardia is detected (Yes in step S306), in step S330, the control unit 11 generates a pacing pulse based on the pulse duration, output voltage or current, and pacing rate.

[0140] In step S331, the control unit 11 performs pacing by outputting the generated pacing pulse to the electrode catheter 2.

[0141] In step S332, the control unit 11 determines whether the operation to terminate has been performed. If the user does not perform the operation to terminate (No in step S332), the control unit 11 analyzes the electrocardiogram again (step S303).

[0142] If the user initiates an operation to terminate the operation (Yes in step S332), the control unit 11 terminates the operation.

[0143] <Setting various modes using dial 6> Next, the setting of various modes using dial 6 will be explained with reference to Figure 12. Figure 12 is a schematic diagram of dial 6 of the defibrillator 1 in an embodiment of the present invention.

[0144] When the user rotates dial 6 clockwise or counterclockwise from the "Off" position, various modes of the defibrillator 1 are set according to the rotation position. When rotated to the "Monitor" position, the control unit 11 of the defibrillator 1 displays a waveform on screen 10 using a surface electrocardiogram or a surface electrocardiogram signal from a polygraph examination device (not shown in the diagram). When rotated to the "Pacing" position, it is set to intracardiac pacing mode. Rotating it further clockwise sets it to intracardiac defibrillation mode, and the output energy can be set according to the rotation position. When rotated to the "AED" position, it is set to AED mode. When rotated to the "ICD" position, it is set to ICD mode.

[0145] While the operation of various modes when electrode catheter 2 is connected and used has been described above, the operation when dial 6 is turned to set various modes when a pad or paddle (not shown) is connected and used will differ from the operation described above.

[0146] As described above, by connecting any one or more electrodes of electrode catheter 2 to the negative wiring L1 of the power supply and any one or more other electrodes to the positive wiring L2 of the power supply, a voltage can be applied between the two electrodes. This makes it possible to perform intracardiac pacing from a defibrillator using the electrode catheter used during surgery. This eliminates the need for an external pacemaker, as intracardiac pacing can be performed using a defibrillator equipped with this function installed in the ward, without using a stimulator used in the examination room. Furthermore, it eliminates the need to open the temporary pacing catheter used for connection, thus reducing the cost of consumables.

[0147] <Other uses of the defibrillator in the embodiments of the present invention> By using the electrocardiogram analysis function provided in the defibrillator 1 in the embodiment of the present invention in combination with intracardiac pacing and intracardiac defibrillation (by using it as ICD mode), the wearable automatic cardioverter-defibrillator (WCD) that patients with implantable cardioverter-defibrillators (ICDs) wore in preparation for the occurrence of life-threatening arrhythmias requiring treatment with electric shock before the device was implanted in their bodies becomes unnecessary.

[0148] <Summary> In summary, the defibrillator in the embodiment of the present invention comprises an AC / DC power supply 4 equipped with a negative wire L1 and a positive wire L2, and a connection part that allows for the independent and selective connection of multiple electrodes on the electrode catheter 2 to either the negative wire L1 or the positive wire L2. Therefore, any one or more electrodes of the electrode catheter 2 can be connected to the negative wire L1 of the power supply, and any other one or more electrodes can be connected to the positive wire L2 of the power supply, and a voltage can be applied between the two electrodes, making intracardiac pacing possible from the defibrillator using the electrode catheter used during surgery. This makes intracardiac pacing possible using a defibrillator equipped with this function installed in the ward, without using a stimulator used in the examination room, thus eliminating the need for an external pacemaker, and also eliminating the need to open the temporary pacing catheter used for connection, thereby reducing the cost of consumables.

[0149] Furthermore, the connection section includes wiring connected to each of the multiple electrodes provided on the electrode catheter 2, a branching point 15 that divides the wiring into two, and an ON / OFF switch 16 that connects one of the branched wires at branching point 15 to the negative wire L1 and the other branched wire at branching point 15 to the positive wire L2. Therefore, the wiring can be simplified by providing the negative electrode 13 and the positive electrode 14 to the PD switch 12, and the risk of wire breakage is reduced.

[0150] Furthermore, the connection section includes wiring connected to the electrode catheter 2, and a plus / minus switch SW17 that switches the connection destination of the wiring to either the negative wire L1 or the positive wire L2. Therefore, compared to the case where an ON / OFF switch SW16 is provided, the number of switches in the PD switch SW12 can be reduced, and the risk of poor contact of the switches is reduced.

[0151] Furthermore, the electrode catheter 2 comprises a long main body and three or more electrodes arranged longitudinally along the main body. The defibrillator further includes a control unit 11 that controls the PD switching SW 12 to connect one of two adjacent electrodes from the electrode catheter 2 to the negative wiring L1 and the other to the positive wiring L2. As a result, pacing can be output to a specific location within the cardiac chamber, and an electrocardiogram waveform can be acquired from that specific location. Therefore, using the electrode catheter 2 connected to the defibrillator, pacing output equivalent to that achieved using a stimulator is possible.

[0152] Furthermore, the electrode catheter 2 comprises a long main body and multiple electrode groups, each having three or more electrodes arranged along the longitudinal direction of the main body (in the above example, three electrode groups: the first electrode group G1, the second electrode group G2, and the EP electrode group G3). The defibrillator further includes a control unit 11 that controls the PD switching SW12 to select any two pairs of electrodes from one of the electrode groups (for example, from the first electrode group G1 or the second electrode group G2), connect one pair to the negative wiring L1, and connect the other pair to the positive wiring L2. Therefore, it becomes possible to select the optimal electrode depending on the situation when measuring impedance, acquiring intracardiac electrocardiogram patterns, and performing pacing.

[0153] Furthermore, the control unit 11 performs pacing by sending electrical signals using any two selected pairs of electrodes. Therefore, the defibrillator 1 can be equipped with a fixed mode for intracardiac pacing.

[0154] Furthermore, the control unit 11 acquires an electrocardiogram and, based on the determination result, performs demand pacing by sending electrical signals using any two selected sets of electrodes. Therefore, the defibrillator 1 can be equipped with a demand mode for intracardiac pacing. Note that the electrocardiogram may be acquired by acquiring an intracardiac electrocardiogram using any two selected sets of electrodes, or by acquiring a surface electrocardiogram using electrode pads or the like.

[0155] Furthermore, the control unit 11 acquires an electrocardiogram and, based on the determination result, connects all electrodes of one electrode group from the first electrode group G1 or the second electrode group G2 to the negative wiring L1, and all electrodes of the other electrode group to the positive wiring L2, thereby performing defibrillation. Therefore, the defibrillator 1 can be equipped with an AED mode. Moreover, by combining it with demand pacing, the defibrillator 1 can be equipped with an ICD mode. As described above, the electrocardiogram may be acquired by acquiring an intracardiac electrocardiogram using any two selected sets of electrodes, or by acquiring a surface electrocardiogram using electrode pads or the like.

[0156] Although embodiments of the present invention have been specifically described above, the present invention is not limited to these embodiments, and modifications are possible within the scope of the technical idea of ​​the present invention. For example, in this embodiment, electrocardiogram analysis was performed by acquiring intracardiac potentials, but it is also possible to perform the analysis by acquiring surface electrocardiograms that can be input to a control unit from electrode pads or the like (not shown). [Industrial applicability]

[0157] The defibrillator of the present invention can be suitably used for electrocardiogram analysis, intracardiac defibrillation and intracardiac pacing during medical treatment such as EPS and ablation therapy, as well as for bradycardia after treatment and as an ICD substitute for patients who are eligible for an ICD until an ICD is implanted in their body. [Explanation of Symbols]

[0158] 1 Defibrillator 2 Electrode Catheter 3. Connection device 4 AC / DC power supply 5 Capacitors 6 Dials 7 Synchronized SW 8 Charging SW 9 Energizing SW 10 screens 11 Control Unit 12 PD selector switch 13 Negative electrode 14 Positive electrode 15 Branching Point 16 ON / OFF Switch 17. Plus / Minus Switch G1 1st electrode group G2 2nd electrode group G3 EP electrode group L1 Negative Wiring L2 Positive Wiring L3 1st electrode group wiring L4 2nd electrode group wiring L5 EP electrode group wiring

Claims

1. A power supply equipped with negative and positive wiring, The electrode catheter comprises a connection part that allows for the independent and selective connection of multiple electrodes to either the negative or positive wiring, Defibrillator.

2. The aforementioned connection part is Wiring connected to each of the aforementioned multiple electrodes, The branching point where the aforementioned wiring is divided into two, The branched wiring separated at the aforementioned branching point, A switch that connects one of the branched wires to the negative wire, The system includes a switch that connects one of the other branch wirings to the positive wiring, The defibrillator according to claim 1.

3. The aforementioned connection part is Wiring connected to each of the aforementioned multiple electrodes, The system includes a switch that switches the connection destination of the aforementioned wiring to either the negative or positive wiring. The defibrillator according to claim 1.

4. The electrode catheter is The long main body, The main body comprises three or more electrodes arranged in the longitudinal direction, The system further includes a control unit that controls the connection portion so that one of two adjacent electrodes from the plurality of electrodes is connected to the negative wire and the other is connected to the positive wire. A defibrillator according to any one of claims 1 to 3.

5. The electrode catheter is The long main body, The main body is provided with multiple electrode groups, each having three or more electrodes arranged in the longitudinal direction, The system further includes a control unit that selects any two sets of electrodes from one of the electrode groups, connects one set to the negative wiring, and connects the other set to the positive wiring, thereby controlling the connection section. A defibrillator according to any one of claims 1 to 3.

6. The defibrillator according to claim 5, wherein the control unit performs pacing by sending an electrical signal using the two selected pairs of electrodes.

7. The defibrillator according to claim 5, wherein the control unit acquires an electrocardiogram and performs demand pacing by sending an electrical signal using any two selected sets of electrodes based on the determination result.

8. The defibrillator according to claim 5, wherein the control unit acquires an electrocardiogram, and based on the determination result, connects all electrodes of one of the plurality of electrode groups to the negative wiring, and connects all electrodes of the other electrode groups to the positive wiring, thereby performing defibrillation.

Images