JP7652736B2 - DEFIBRILLATION SYSTEM, POWER SUPPLY DEVICE, SWITCHING DEVICE, AND CONNECTION STATE SWITCHING CONTROL METHOD - Google Patents

Description

The present disclosure relates to a defibrillation system, a power supply device, a switching device, and a connection state switching control method.

A defibrillation system (defibrillation catheter system) has been disclosed as one type of medical device for removing atrial fibrillation (performing electrical defibrillation) that occurs during cardiac catheterization (see, for example, Patent Document 1). The defibrillation system includes a defibrillation catheter that is inserted into the cardiac cavity to perform defibrillation, and a power supply device that supplies power to the defibrillation catheter during defibrillation.

WO2019/155941 publication

However, there is a demand for improved convenience when using defibrillation systems, etc. It is desirable to provide a defibrillation system, a power supply device, a switching device, and a connection state switching control method that can improve convenience.

A defibrillation system according to an embodiment of the present disclosure includes a power supply device that supplies power to a defibrillation catheter that performs electrical defibrillation, and a switching unit that switches a connection state between the electrode catheter and a cardiac potential device. The electrode catheter is provided separately from the defibrillation catheter. The cardiac potential device displays the cardiac potential measured using the electrode catheter. The power supply device includes a power supply unit that outputs the power, and a switching control unit that performs switching control on the switching unit so that the electrode catheter and the cardiac potential device are disconnected during the execution of defibrillation.

A power supply device according to an embodiment of the present disclosure includes a power supply unit that supplies power to a defibrillation catheter that performs electrical defibrillation, a switching unit that switches a connection state between an electrode catheter and a cardiac potential device, and a switching control unit that performs switching control on the switching unit so that the electrode catheter and the cardiac potential device are disconnected during a period in which defibrillation is being performed. The electrode catheter is provided separately from the defibrillation catheter. The cardiac potential device displays the cardiac potential measured using the electrode catheter.

A switching device according to an embodiment of the present disclosure is a device provided separately from a power supply device that supplies power to a defibrillation catheter that performs electrical defibrillation, and includes a switching unit that switches a connection state between an electrode catheter and a cardiac potential device. The electrode catheter is provided separately from the defibrillation catheter. The cardiac potential device displays a cardiac potential measured using the electrode catheter. The above connection state switching control is performed so that the electrode catheter and the cardiac potential device are disconnected during the execution of defibrillation.

A connection state switching control method according to one embodiment of the present disclosure is a method for controlling switching of a connection state between an electrode catheter provided separately from a defibrillation catheter that performs electrical defibrillation and a cardiac potential device that displays a cardiac potential measured using the electrode catheter, in which a switching control unit controls switching of the connection state so that the electrode catheter and the cardiac potential device are disconnected during the period in which defibrillation is being performed.

1 is a block diagram illustrating an example of the overall configuration of a defibrillation system according to an embodiment of the present disclosure. FIG. 2 is a schematic diagram illustrating an example of a schematic configuration of the defibrillation catheter illustrated in FIG. 1 . 4 is a flowchart illustrating an example of a defibrillation process according to an embodiment. 3B is a flow chart illustrating an example of a defibrillation process following FIG. 3A. FIG. 3B is a block diagram illustrating an example of an operating state during the impedance measurement illustrated in FIG. 3A. FIG. 3B is a block diagram illustrating an example of an operating state during cardiac potential measurement (before defibrillation is performed) illustrated in FIG. 3A. FIG. 3C is a block diagram illustrating an example of an operating state during the defibrillation period illustrated in FIG. 3B. FIG. 3C is a circuit diagram showing a schematic example of a detailed operating state during the execution of defibrillation shown in FIG. 3B. FIG. 3C is a block diagram illustrating an example of an operating state during cardiac potential measurement (after defibrillation) illustrated in FIG. 3B. FIG. 1 is a block diagram illustrating an example of the overall configuration of a defibrillation system according to a first modified example. FIG. 11 is a block diagram illustrating an example of the overall configuration of a defibrillation system according to a second modified example.

Hereinafter, embodiments of the present disclosure will be described in detail with reference to the drawings. The description will be made in the following order.
1. Embodiment (Example in which the first switching unit is built into the power supply device and the second switching unit is provided externally)
2. Modifications Modification 1 (Example in which both the first switching unit and the second switching unit are built into the power supply device)
Modification 2 (Example in which both the first switching unit and the second switching unit are provided outside the power supply device)
3. Other Modifications

1. Preferred embodiment
[Overall configuration]
1 is a schematic block diagram showing an example of the overall configuration of a defibrillation system 6 according to an embodiment of the present disclosure. The defibrillation system 6 is a system used to remove atrial fibrillation (perform electrical defibrillation) occurring in a patient 9 during, for example, cardiac catheterization. Note that the " connection state switching control method" in the present disclosure is embodied in the defibrillation system of the present disclosure, and will therefore also be described below.

As shown in FIG. 1, the defibrillation system 6 includes a defibrillation catheter 1a, an electrode catheter 1b, a power supply 2, and a switching device 3. When performing defibrillation using the defibrillation system 6, the electrocardiograph 4 and electrocardiogram display device 5 (waveform display device) shown in FIG. 1 are also used as appropriate.

Note that the electrocardiograph 4 and the electrocardiogram display device 5 correspond to a specific example of a "cardiac potential device" in this disclosure.

(A. Defibrillation Catheter 1a)
The defibrillation catheter 1a is an electrode catheter that is inserted into the body (cardiac cavity) of a patient 9 through a blood vessel to perform electrical defibrillation. Fig. 2 shows a schematic configuration example of the defibrillation catheter 1a. The defibrillation catheter 1a has a shaft 11 (catheter shaft) as a catheter body, and a handle 12 attached to the proximal end of the shaft 11.

(Shaft 11)
The shaft 11 is made of a flexible tubular structure (tubular member) and extends along its own axial direction (Z-axis direction). The shaft 11 is made of synthetic resin such as polyolefin, polyamide, polyether polyamide, polyurethane, etc. The shaft 11 has a lumen (pore, through hole) formed therein. Various thin wires (such as conductive wires or operating wires) (not shown) are inserted into the lumen while being electrically insulated from each other.

In the tip region P1 of the shaft 11, as shown in FIG. 2, for example, a plurality of electrodes (tip electrode 110 and ring electrodes 111, 112, 113) are provided. Specifically, one tip electrode 110 and a plurality of ring electrodes 111, 112, 113 are arranged at a predetermined interval in this order from the tip side to the base end side of the shaft 11 along the axial direction (Z-axis direction) of the shaft 11. The ring electrodes 111, 112, 113 are fixedly arranged on the outer circumferential surface of the shaft 11, and the tip electrode 110 is fixedly arranged at the tip end of the shaft 11. As shown in FIG. 2, an electrode group 111G is formed by a plurality of ring electrodes 111 arranged at intervals from each other. Similarly, an electrode group 112G is formed by a plurality of ring electrodes 112 arranged at intervals from each other, and an electrode group 113G is formed by a plurality of ring electrodes 113 arranged at intervals from each other.

The term "electrode group" used here refers to a collection of multiple electrodes that form the same pole (have the same polarity) or have the same purpose and are attached at close intervals (for example, 5 mm or less).

The ring electrodes 111, 112, and 113 are each electrically connected to the handle 12 via multiple conductors (lead wires) inserted into the lumen of the shaft 11. As will be described in detail later, a cardiac potential signal Sc1 measured using the ring electrodes 111, 112, and 113 is output to the power supply 2 via the conductors (see FIG. 1). Meanwhile, in this example, no conductors are connected to the tip electrode 110. However, conductors may also be connected to the tip electrode 110.

The tip electrode 110 and the ring electrodes 111, 112, and 113 are each made of a metal material with good electrical conductivity, such as aluminum (Al), copper (Cu), stainless steel (SUS), gold (Au), platinum (Pt), or various resin materials.

The electrode group 111G is made up of multiple ring-shaped electrodes 111 that form the same pole (negative or positive pole). The number of ring-shaped electrodes 111 that form the electrode group 111G varies depending on the width and spacing of the electrodes, but is, for example, 4 to 13, and preferably 8 to 10. The width (axial length) of the ring-shaped electrodes 111 is preferably, for example, about 2 to 5 mm, and a suitable example is 4 mm. The attachment spacing of the ring-shaped electrodes 111 (the distance between adjacent electrodes) is preferably, for example, about 1 to 5 mm, and a suitable example is 2 mm. When the defibrillation catheter 1a is in use (placed in the cardiac cavity), the electrode group 111G is located, for example, in the coronary vein.

The electrode group 112G is made up of multiple ring-shaped electrodes 112 that constitute the opposite pole (positive or negative pole) to the electrode group 111G. The number of ring-shaped electrodes 112 that constitute the electrode group 112G varies depending on the width and spacing of the electrodes, but is, for example, 4 to 13, and preferably 8 to 10. The width (axial length) of the ring-shaped electrodes 112 is preferably, for example, about 2 to 5 mm, and a suitable example is 4 mm. The attachment spacing of the ring-shaped electrodes 112 (the distance between adjacent electrodes) is preferably, for example, about 1 to 5 mm, and a suitable example is 2 mm. When the defibrillation catheter 1a is in use, the electrode group 112G is located, for example, in the right atrium.

In the example shown in FIG. 2, the electrode group 113G is composed of four ring electrodes 113. The width (axial length) of the ring electrodes 113 is preferably, for example, about 0.5 to 2.0 mm, and a suitable example is 1.2 mm. The attachment interval (the distance between adjacent electrodes) of the ring electrodes 113 is preferably, for example, about 1.0 to 10.0 mm, and a suitable example is 5 mm. When the defibrillation catheter 1a is in use, the electrode group 113G is located, for example, in the superior vena cava, where abnormal electrical potentials are likely to occur.

(Handle 12)
The handle 12 has a handle body 121 (grip portion) and a rotating plate 122 .

The handle body 121 is the part that the operator (doctor) grasps (holds) when using the defibrillation catheter 1a. Inside the handle body 121, the various thin wires (conductors, operating wires, etc.) mentioned above are pulled out from inside the shaft 11 while being electrically insulated from each other.

The rotating plate 122 is a member that is operated when bending the tip of the shaft 11. For example, the rotating plate 122 can be rotated (rotation operation) along the direction indicated by the arrow d1 in FIG. 2.

(B. Electrode Catheter 1b)
The electrode catheter 1b is a catheter used when performing electrical defibrillation using the defibrillation catheter 1a, and is provided separately from the defibrillation catheter 1a.

The electrode catheter 1b, like the defibrillation catheter 1a, has a shaft with an electrode near the tip and a handle attached to the base end of the shaft. As will be described in detail later, a cardiac potential signal Sc2 measured using an electrode on the shaft of the electrode catheter 1b is output via a specified conductor to the switching device 3, which will be described later (see Figure 1).

(C. Power Supply Unit 2)
The power supply device 2 supplies power to the defibrillation catheter 1a. As shown in Fig. 1, the power supply device 2 has an input unit 21, a power supply unit 22, an internal circuit 24, a switching unit 31, a display unit 25, and an audio output unit 26. As will be described in detail later, the power supply device 2 is capable of switching among a plurality of (three) modes, namely, a "cardiac potential measurement mode", an "impedance measurement mode", and a "defibrillation mode".

The "cardiac potential measurement mode" is a mode in which cardiac potential measurement is performed using the defibrillation catheter 1a or electrode catheter 1b described above. The "impedance measurement mode" is a mode in which the measurement process of impedance Z, which will be described later, is performed using the defibrillation catheter 1a. The "defibrillation mode" is a mode in which electrical defibrillation is performed using the defibrillation catheter 1a.

(Input section 21, power supply section 22)
The input unit 21 is a part that outputs various set values or instruction signals (operation signals Sin) for instructing a predetermined operation. The operation signals Sin are output from the input unit 21 to the internal circuit 24 in response to the operation of a button (switch) or the like by an operator (e.g., an engineer) of the power supply device 2. However, various set values may not be input in response to an operation by an operator, but may be preset in the power supply device 2, for example, at the time of product shipment.

The above-mentioned switches include, for example, a mode changeover switch for switching between the above-mentioned multiple types of modes, an applied energy setting switch for setting the electrical energy (DC voltage Vdc) to be applied during defibrillation, a charging switch for charging the power supply unit 22, and an energy application switch (discharge switch) for applying electrical energy to perform defibrillation.

The power supply unit 22 outputs power (the DC voltage Vdc described above) to the electrode groups 111G, 112G (ring electrodes 111, 112) in the defibrillation catheter 1a in accordance with the control of the internal circuit 24. The power supply unit 22 is configured using a predetermined power supply circuit (e.g., a switching regulator, etc.) and a capacitor (capacitive element) for charging electrical energy.

(Internal circuit 24)
The internal circuit 24 is a part that controls the entire power supply device 2 and performs predetermined arithmetic processing, and is configured using, for example, a microcomputer. The internal circuit 24 controls the operations of the power supply unit 22, switching units 31 and 32 (described later), the display unit 25, and the audio output unit 26. As shown in FIG. 1, the internal circuit 24 has an output circuit 241, a storage unit 242, an impedance measurement circuit 243, and a switching control unit 244.

The output circuit 241 outputs the DC voltage Vdc output from the power supply unit 22 to the defibrillation catheter 1a side (electrode groups 111G, 112G) via the switching unit 31 and the output terminal described below. Specifically, the output circuit 241 outputs the DC voltage Vdc so that the electrode groups 111G, 112G have different polarities (when one electrode group is negative, the other electrode group is positive).

The memory unit 242 is a part (memory) that stores various data.

The impedance measurement circuit 243 measures the impedance Z using the defibrillation catheter 1a. Specifically, the impedance measurement circuit 243 measures the impedance Z between the electrode groups 111G and 112G in the defibrillation catheter 1a. The measured value of the impedance Z is input to the impedance measurement circuit 243 via the switching unit 31, which will be described later.

The switching control unit 244 uses the control signal CTL to perform switching control on the switching units 31 and 32 described below. Specifically, the switching control unit 244 performs switching control on the supply paths of the DC voltage Vdc, cardiac potential signal Sc1, and impedance Z described above in the switching unit 31, and performs switching control on the supply path of the cardiac potential signal Sc2 described above in the switching unit 32. Details of the switching control by the switching control unit 244 will be described later (Figures 3A to 8).

(Switching Unit 31)
The switching unit 31 has a relay structure including three contacts 31a to 31c. The contact 31a is electrically connected to the defibrillation catheter 1a via a wire, the contact 31b is electrically connected to the electrocardiograph 4 via a wire, and the contact 31c is electrically connected to the internal circuit 24 via a wire. The switching unit 31 switches the connection state between the defibrillation catheter 1a, the electrocardiograph 4 (and the electrocardiogram display device 5), and the internal circuit 24. Specifically, as will be described in detail later, the connection state is switched in response to a control signal CTL supplied from the switching control unit 244 so that the contact 31a in the switching unit 31 is connected to the contact 31b (electrocardiograph 4 side) or the contact 31c (internal circuit 24 side).

Note that the switching unit 31 corresponds to a specific example of a "first switching unit" in this disclosure, and the contact 31a corresponds to a specific example of a "first contact" in this disclosure.

(Display unit 25, audio output unit 26)
The display unit 25 is a part (monitor) that displays various information and outputs it to the outside.

The audio output unit 26 is a part that outputs various sounds to the outside based on the audio signal Ss (see Figure 1) supplied from the internal circuit 24.

(D. Electrocardiograph 4)
The electrocardiograph 4 records information such as the cardiac potential signal. In the example of Fig. 1, the electrocardiograph 4 inputs and records the cardiac potential signal Sc1 output from the defibrillation catheter 1a via the above-mentioned switching unit 31 and the cardiac potential signal Sc2 output from the electrode catheter 1b via a switching device 3 (switching unit 32) described later. The cardiac potential signals Sc1 and Sc2 are each output from the electrocardiograph 4 to an electrocardiogram display device 5.

(E. Electrocardiogram Display Device 5)
The electrocardiogram display device 5 displays a cardiac potential waveform (electrocardiogram) and the like based on the cardiac potential signal (cardiac potential signal Sc1 or Sc2) output from the electrocardiograph 4. The electrocardiograph 4 and the electrocardiogram display device 5 are sometimes collectively called a polygraph, a vital sign monitor, a cardiac catheter inspection device, or an EP recording system. The cardiac potential waveform and the like displayed on the electrocardiogram display device 5 are monitored at all times by, for example, the operator (doctor) of the defibrillation catheter 1a.

(F. Switching Device 3)
The switching device 3 includes a switching unit 32. That is, in this embodiment, the switching unit 32 described below is provided in the switching device 3 that is provided separately from the power supply device 2.

The switching unit 32 has a relay structure including three contacts 32a to 32c, similar to the switching unit 31 described above. The contact 32a is electrically connected to the electrode catheter 1b via wiring, the contact 32b is electrically connected to the electrocardiograph 4 via wiring, and the contact 31c is not connected to the outside (is cut off from the outside). The switching unit 32 switches the connection state between the electrode catheter 1b (contact 32a) and the electrocardiograph 4 (and the electrocardiogram display device 5). Specifically, as will be described in detail later, the connection state is switched so that the contact 32a in the switching unit 32 is connected to the contact 32b (electrocardiograph 4 side) or the contact 32c in response to a control signal CTL supplied from the switching control unit 244. In other words, the connection state between the electrode catheter 1b and the electrocardiograph 4 (and the electrocardiogram display device 5) is switched so that the contact 32a is connected (contacts 32a and 32b are connected to each other) or cut off (contacts 32a and 32c are connected to each other).

Note that the switching unit 32 corresponds to a specific example of the "switching unit" and "second switching unit" in this disclosure, and the contact 32a corresponds to a specific example of the "second contact" in this disclosure.

[Actions, actions and effects]
(A. Basic Operation)
In the defibrillation system 6, for example, during defibrillation treatment (defibrillation process) during cardiac catheterization, the distal end side of the shaft 11 of the defibrillation catheter 1a is inserted into the body of a patient 9 through a blood vessel (see FIG. 1). At this time, the shape of the vicinity of the distal end region P1 of the shaft 11 inserted into the body of the patient 9 changes in response to the operation of the handle 12 by the operator (doctor) of the defibrillation catheter 1a. Specifically, when the rotating plate 122 is rotated by the operator's finger, for example, along the direction indicated by the arrow d1 in FIG. 2, an operating wire (not shown) within the shaft 11 is pulled toward the base end. As a result, the vicinity of the distal end region P1 of the shaft 11 is curved along the direction indicated by the arrow d2 in FIG. 2.

(A-1. Defibrillation Treatment)
When the above-mentioned defibrillation treatment is performed, a DC voltage Vdc is supplied as electrical energy for defibrillation from the power supply device 2 (power supply unit 22) to the electrode groups 111G, 112G (ring electrodes 111, 112) of the defibrillation catheter 1a. Specifically, the DC voltage Vdc is output from the output circuit 241 in the power supply device 2 so that the electrode groups 111G, 112G have mutually opposite polarities (when one electrode group is negative, the other electrode group is positive). The DC voltage Vdc, which gives the electrode groups 111G, 112G mutually opposite polarities, is applied as direct electrical energy from the tip region P1 of the defibrillation catheter 1a inserted into the body of the patient 9 to the heart of the patient 9, thereby performing electrical defibrillation treatment.

Defibrillation treatment using the defibrillation system 6 (defibrillation catheter 1a) has the following advantages over, for example, an AED (Automated External Defibrillator), which is a device that supplies electrical energy from outside the patient's body. That is, first, the electrode group 111G, 112G of the defibrillation catheter 1a arranged in the cardiac cavity directly applies electrical energy to the fibrillated heart, thereby reliably supplying the heart with electrical stimulation (electric shock) necessary and sufficient for defibrillation treatment. As a result, it is possible to perform defibrillation treatment more effectively (efficiently) than, for example, when using the AED, etc. described above. In addition, since electrical energy is applied directly to the heart, unlike, for example, when using the AED, etc. described above, burns are not caused on the surface of the patient's body, which makes it possible to reduce the invasiveness of defibrillation treatment to the patient.

(A-2. Cardiac potential measurement process)
On the other hand, when measuring the cardiac potential of the patient 9, the cardiac potential (cardiac potential signals Sc1, Sc2) are measured using the defibrillation catheter 1a or the electrode catheter 1b inserted into the body of the patient 9 (see FIG. 1). The measured cardiac potential signals Sc1, Sc2 are input to the electrocardiograph 4 via the switching units 31, 32, respectively, and then supplied to the electrocardiogram display device 5 (see FIG. 1). Then, a cardiac potential waveform based on the cardiac potential signals Sc1, Sc2 is displayed on the electrocardiogram display device 5, so that the cardiac potential waveform can be appropriately monitored by the operator (engineer, etc.) of the power supply device 2 or the operator (doctor) of the defibrillation catheter 1a.

However, conventional defibrillation systems using a defibrillation catheter and an electrode catheter have the problem that after electrical defibrillation is performed, it is not possible to monitor the cardiac potential measured by the electrode catheter (display the cardiac potential waveform) for a certain period of time (e.g., about 8 seconds). This is because the electrical energy generated from the defibrillation catheter during defibrillation is transmitted through the electrode catheter to the electrocardiograph and electrocardiogram display device. In this way, conventional defibrillation systems have a period of time after defibrillation is performed during which it is not possible to monitor the cardiac potential, which may reduce convenience when using the system.

(B. Details of defibrillation treatment)
In the defibrillation system 6 of the present embodiment, during the above-described defibrillation process, the switching control unit 244 performs the switching control described below. Details of the defibrillation process (defibrillation treatment) including the switching control will be described below with reference to Figs. 3A to 8.

3A and 3B are flow diagrams showing an example of the defibrillation process according to the present embodiment. FIG. 4 is a schematic block diagram showing an example of the operating state during the impedance Z measurement process (see step S15) shown in FIG. 3A. FIG. 5 is a schematic block diagram showing an example of the operating state during the cardiac potential measurement process (before defibrillation is performed: see step S18) shown in FIG. 3A. FIG. 6 is a schematic block diagram showing an example of the operating state during the defibrillation execution period (see steps S23 to S24) shown in FIG. 3B. FIG. 7 is a schematic circuit diagram showing a detailed example of the operating state during the defibrillation execution period (see steps S23 to S24) shown in FIG. 3B. FIG. 8 is a schematic block diagram showing an example of the operating state during the cardiac potential measurement process (after defibrillation is performed: see step S27) shown in FIG. 3B.

3A and 3B, first, the power supply device 2 is turned on (step S11), and the energy to be applied during defibrillation is set (step S12). Specifically, the operator (engineer, etc.) of the power supply device 2 operates the input unit 21 (for example, the aforementioned applied energy setting switch) to supply an operation signal Sin to the internal circuit 24, thereby setting the energy to be applied during defibrillation. Note that the applied energy at this time is set in increments of 1 J (joules) within a range of, for example, 1 J to 30 J.

Then, the operator of the power supply device 2 operates the input unit 21 (for example, operates the mode change switch described above) to supply an operation signal Sin to the internal circuit 24, thereby switching to the "defibrillation mode" for performing defibrillation (step S13). Then, the switching control unit 244 uses the control signal CTL to perform switching control on the switching unit 31 so that the connection destination of the contact 31a in the switching unit 31 is switched from the contact 31b side (the electrocardiograph 4 side) to the contact 31c side (the internal circuit 24 side) (step S14). As a result, the defibrillation catheter 1a is connected to the internal circuit 24, and the defibrillation catheter 1a is disconnected from the electrocardiograph 4 (see FIG. 4).

Next, as shown in FIG. 4, for example, the impedance measurement circuit 243 measures the impedance Z between the electrode groups 111G and 112G in the defibrillation catheter 1a (step S15). That is, the defibrillation system 6 is set to the "resistance measurement mode" described above, and the impedance Z is measured. The measured value of the impedance Z is input from the defibrillation catheter 1a to the impedance measurement circuit 243 via the switching unit 31 (contacts 31a and 31c) (see FIG. 4).

Next, the switching control unit 244 uses the control signal CTL to control the switching unit 31 so that the connection of the contact 31a in the switching unit 31 is switched from the contact 31c side (the internal circuit 24 side) to the contact 31b side (the electrocardiograph 4 side) (step S16). This disconnects the defibrillation catheter 1a from the internal circuit 24 and connects the defibrillation catheter 1a to the electrocardiograph 4 (see FIG. 1).

Next, the internal circuit 24 in the power supply device 2 determines whether the measured value of impedance Z is within a predetermined range defined by predetermined thresholds Zth1 and Zth2 (whether Zth1<Z<Zth2 is satisfied) (step S17).

Here, if it is determined that the impedance Z is not within the predetermined range (corresponding to Z≦Zth1 or Zth2≦Z) (step S17: N), it means that the electrode group 111G, 112G of the defibrillation catheter 1a is not securely abutted against a predetermined part in the body of the patient 9 (for example, the wall of the coronary vein or the inner wall of the right atrium). Therefore, in this case, the mode transitions to the above-mentioned "cardiac potential measurement mode" (step S18), and the measurement process of the cardiac potential before defibrillation is performed. Specifically, for example, as shown in FIG. 5, the cardiac potential signal Sc1 measured using the defibrillation catheter 1a is supplied from the defibrillation catheter 1a to the electrocardiograph 4 (and the electrocardiogram display device 5) via the switching unit 31 (contacts 31a, 31b). Also, the cardiac potential signal Sc2 measured using the electrode catheter 1b is supplied from the electrode catheter 1b to the electrocardiograph 4 (and the electrocardiogram display device 5) via the switching unit 32 (contacts 32a, 32b). This causes the electrocardiogram display device 5 to display the cardiac potential (cardiac potential waveform) based on the cardiac potential signals Sc1 and Sc2. After that, the process returns to step S12 described above.

On the other hand, if it is determined that the impedance Z is within the predetermined range (Zth1<Z<Zth2 is satisfied) (step S17: Y), this means that the electrode groups 111G, 112G of the defibrillation catheter 1a are securely abutted against predetermined sites in the body of the patient 9, as described above. Therefore, in this case, the capacitor in the power supply unit 22 of the power supply device 2 is then charged with energy (electric charge) for defibrillation (step S19). Specifically, the operator of the power supply device 2 operates the input unit 21 (for example, the aforementioned charging switch), which supplies an operation signal Sin to the internal circuit 24, thereby charging the capacitor in the power supply unit 22 with energy for defibrillation.

Next, after the above-mentioned energy charging to the capacitor is completed, the device transitions to a standby state for defibrillation (step S20). Specifically, the operator of the power supply device 2 operates the input unit 21 (for example, operates the energy application switch described above) to supply an operation signal Sin to the internal circuit 24, thereby transitioning to a standby state for defibrillation.

Then, the switching control unit 244 uses the control signal CTL to control the switching unit 31 so that the connection of the contact 31a in the switching unit 31 is switched from the contact 31b side (the electrocardiograph 4 side) to the contact 31c side (the internal circuit 24 side) (step S21). As a result, the defibrillation catheter 1a is connected to the internal circuit 24, and the defibrillation catheter 1a is disconnected from the electrocardiograph 4 (see FIG. 6).

Then, the switching control unit 244 uses the control signal CTL to perform switching control on the switching unit 32 so that the connection destination of the contact 32a in the switching unit 32 is switched from the contact 32b side (the electrocardiograph 4 side) to the contact 32c side (step S22). As a result, the connection between the electrode catheter 1b (contact 32a) and the electrocardiograph 4 (and the electrocardiogram display device 5) is cut off, resulting in a cut-off state (see FIG. 6).

The order of execution of the above-mentioned step S21 (switching control of the switching unit 31 before defibrillation is performed) and step S22 (switching control of the switching unit 32 before defibrillation is performed) (see reference symbol P21 in FIG. 3B) may be reversed from the example in FIG. 3B, for example. In other words, step S21 (switching control of the switching unit 31 before defibrillation is performed) may be performed after step S22 (switching control of the switching unit 32 before defibrillation is performed).

Next, defibrillation is started at a predetermined trigger timing (step S23), and the defibrillation execution period (the "defibrillation mode" described above: see FIG. 6) is started. During this defibrillation execution period, the contact 31a in the switching unit 31 is connected to the contact 31c side (the internal circuit 24 side), so that the DC voltage Vdc output from the power supply unit 22 in the power supply device 2 is supplied to the defibrillation catheter 1a via the output circuit 241 and the switching unit 31 (contacts 31c, 31a) (see FIG. 6). As a result, the DC voltage Vdc is applied as electrical energy between the electrode groups 111G and 112G in the defibrillation catheter 1a, and defibrillation is performed inside the patient 9. On the other hand, during the defibrillation execution period, as described above, the contact 32a in the switching unit 32 is connected to the contact 32c side, so that the electrode catheter 1b (contact 32a) and the electrocardiograph 4 (and the electrocardiogram display device 5) are disconnected. As a result, the cardiac potential signal Sc2 measured using the electrode catheter 1b is no longer input to the electrocardiograph 4 and the electrocardiogram display device 5 (see Figure 6).

Now, referring to Figure 7, a detailed example of the operating state during the above-mentioned defibrillation execution period will be described. Figure 7(A) shows, in a schematic circuit diagram, an example of the operating state when defibrillation output is provided on the "+" side during the defibrillation execution period. Figure 7(B) shows, in a schematic circuit diagram, an example of the operating state when defibrillation output is provided on the "-" side during the defibrillation execution period.

For ease of explanation, Figs. 7(A) and 7(B) show only a portion of the configuration of the defibrillation system 6 in a partially simplified manner. Specifically, the power supply unit 22 includes the aforementioned capacitor (capacitor C). The switching unit 31 includes a relay RL that connects or disconnects the aforementioned contacts 31a and 31c, and for convenience, the contact 31b on the electrocardiograph 4 side is not shown. The output circuit 241 includes, as some of the components within the circuit, four switches SW1 to SW4, each configured, for example, by a field effect transistor (FET).

Switch SW1 is disposed on the wiring connecting connection points P31 and P32, and switch SW2 is disposed on the wiring connecting connection points P32 and P34. Switch SW3 is inserted on the wiring connecting connection points P31 and P33, and switch SW4 is inserted on the wiring connecting connection points P33 and P34. Connection point P31 is connected to one end of capacitor C via a wiring, and connection point P34 is connected to the other end of capacitor C via a wiring. A defibrillation catheter 1a is disposed on the wiring between connection points P32 and P33 via a relay RL.

Here, in step S20 described above, when the energy application switch is operated to transition to a standby state for defibrillation after energy charging of the capacitor C is completed, the relay RL in the switching unit 31 is turned on. As a result, as shown in Figures 7(A) and 7(B), the internal circuit 241 and the defibrillation catheter 1a are connected (see step S21 described above). Then, the process moves to the defibrillation execution period from step S23 described above to step S24 described below. In this defibrillation execution period, in detail, the processes of steps S31 to S34 described below are performed. In other words, the period during which the processes of steps S31 to S34 described below are performed corresponds to one specific example of the "defibrillation execution period" in this disclosure.

First, in step S31, as shown in FIG. 7(A), switches SW1 and SW4 are set to the on state, and switches SW2 and SW3 are set to the off state. In the initial state, all switches SW1 to SW4 are set to the off state. Then, defibrillation energy E that has been charged in capacitor C circulates from one end of capacitor C to the other end of capacitor C via switch SW1, relay RL, defibrillation catheter 1a, and switch SW4. As a result, defibrillation energy E is supplied from power supply unit 22 to defibrillation catheter 1a, and defibrillation output is performed on the "+" side.

Next, in step S32, switches SW1 and SW4 are each switched from the on state to the off state.

Next, in step S33, switches SW2 and SW3 are each switched from the OFF state to the ON state. Then, as shown in FIG. 7B, defibrillation energy E that was charged in capacitor C circulates from one end of capacitor C to the other end of capacitor C via switch SW3, relay RL, defibrillation catheter 1a, and switch SW2. As a result, defibrillation energy E is supplied from power supply unit 22 to defibrillation catheter 1a in the opposite direction to that in FIG. 7A (the opposite direction within defibrillation catheter 1a), and defibrillation output is performed on the "-" side.

In step S34, switches SW2 and SW3 are each switched from the on state to the off state, and defibrillation is stopped in the following step S24 (the above-mentioned defibrillation execution period ends). Note that in step S26 (switching control of switching unit 31 after defibrillation is executed), which will be described later, relay RL in switching unit 31 is switched from the on state to the off state.

Next, after a predetermined time has elapsed, the internal circuit 24 stops the output of the DC voltage Vdc from the power supply unit 22, thereby stopping defibrillation (step S24), and the above-mentioned defibrillation execution period ends.

Then, the switching control unit 244 uses the control signal CTL to control the switching unit 32 so that the connection destination of the contact 32a in the switching unit 32 is switched from the contact 32c side to the contact 32b side (the electrocardiograph 4 side) (step S25). As a result, the electrode catheter 1b (contact 32a) is connected to the electrocardiograph 4 (and the electrocardiogram display device 5) and a connection state is established (see FIG. 8).

Then, the switching control unit 244 uses the control signal CTL to control the switching unit 31 so that the connection of the contact 31a in the switching unit 31 is switched from the contact 31c side (the internal circuit 24 side) to the contact 31b side (the electrocardiograph 4 side) (step S26). As a result, the defibrillation catheter 1a is disconnected from the internal circuit 24, and the defibrillation catheter 1a is connected to the electrocardiograph 4 (see FIG. 8).

The order of execution of the above-mentioned step S25 (switching control of the switching unit 32 after defibrillation is performed) and step S26 (switching control of the switching unit 31 after defibrillation is performed) (see reference symbol P22 in FIG. 3B) may be reversed from the example in FIG. 3B. That is, step S25 (switching control of the switching unit 32 after defibrillation is performed) may be performed after step S26 (switching control of the switching unit 31 after defibrillation is performed).

Then, the mode transitions to the aforementioned "cardiac potential measurement mode," and the cardiac potential measurement process after defibrillation is performed (step S27). Specifically, for example, as shown in FIG. 8, the cardiac potential signal Sc1 measured using the defibrillation catheter 1a is supplied from the defibrillation catheter 1a to the electrocardiograph 4 (and the electrocardiogram display device 5) via the switching unit 31 (contacts 31a, 31b). Also, the cardiac potential signal Sc2 measured using the electrode catheter 1b is supplied from the electrode catheter 1b to the electrocardiograph 4 (and the electrocardiogram display device 5) via the switching unit 32 (contacts 32a, 32b). As a result, the cardiac potential (cardiac potential waveform) based on the cardiac potential signals Sc1 and Sc2 is displayed on the electrocardiogram display device 5.

After that, the power supply device 2 is turned off (step S28), and the series of defibrillation processes shown in Figures 3A and 3B is completed.

(C. Actions and Effects)
In this embodiment, the connection state between the electrode catheter 1b and the electrocardiograph 4 (and the electrocardiogram display device 5) is switched, and during the period in which defibrillation is performed using the defibrillation catheter 1a, the connection state is switched so that the connection between the electrode catheter 1b and the electrocardiograph 4 (and the electrocardiogram display device 5) is disconnected.

As a result, in this embodiment, unlike the conventional defibrillation system described above, the risk of the electrocardiograph 4 and the electrocardiogram display device 5 being affected by the electrical energy generated from the defibrillation catheter 1a during defibrillation via the electrode catheter 1b is avoided. In other words, in this embodiment, unlike the conventional defibrillation system, it is possible to avoid the occurrence of a period during which the cardiac potential cannot be monitored after defibrillation is performed. As a result, this embodiment makes it possible to improve the convenience of using the defibrillation system 6 (power supply device 2 and switching device 3).

In particular, in this embodiment, the switching unit 32 out of the switching units 31 and 32 is provided in the (external) switching device 3 provided separately from the power supply 2, so that it is possible to obtain the following effects, for example. That is, since the power supply 2 itself can be left in its existing configuration, the above-mentioned switching control can be realized for the entire defibrillation system 6 simply by providing an external switching device 3 separately, and as a result, it is possible to further improve convenience.

2. Modified Examples
Next, modified examples (modifications 1 and 2) of the above embodiment will be described. Note that the same components as those in the embodiment will be given the same reference numerals, and the description will be omitted as appropriate.

[Modification 1]
(composition)
Fig. 9 is a schematic block diagram showing an example of the overall configuration of a defibrillation system 6A according to Modification 1. The defibrillation system 6A of Modification 1 includes a defibrillation catheter 1a, an electrode catheter 1b, and a power supply device 2A. That is, in the defibrillation system 6A, the switching device 3 is not provided (is omitted) and a power supply device 2A is provided instead of the power supply device 2 in the defibrillation system 6 (Fig. 1) of the embodiment, but the other configurations are the same.

The power supply device 2A has an input section 21, a power supply section 22, an internal circuit 24, switching sections 31 and 32, a display section 25, and an audio output section 26. That is, the power supply device 2A further includes a switching section 32 in the power supply device 2 (FIG. 1) of the embodiment, but the other configurations are the same. In other words, the switching section 32 that was provided in the switching device 3 in the defibrillation system 6 (FIG. 1) of the embodiment is provided (built-in) in the power supply device 2A in the defibrillation system 6A of the first modification.

(Action and Effects)
In the first modification, basically, the same effects as those of the embodiment can be obtained by the same action. That is, in the first modification, by performing switching control in the same manner as the embodiment, it is possible to improve the convenience when using the defibrillation system 6A (power supply device 2A).

In particular, in variant 1, both switching units 31 and 32 are provided within power supply device 2A, which makes it possible to obtain the following effects, for example. That is, by consolidating the two switching functions of switching units 31 and 32 within power supply device 2A, an external switching device 3 is no longer necessary, and the wiring between devices is simplified, which makes it possible to simplify the overall configuration of defibrillation system 6A.

[Modification 2]
Fig. 10 is a schematic block diagram showing an example of the overall configuration of a defibrillation system 6B according to Modification 2. The defibrillation system 6B of Modification 2 includes a defibrillation catheter 1a, an electrode catheter 1b, a power supply device 2B, and a switching device 3B. That is, in the defibrillation system 6B, a power supply device 2B is provided instead of the power supply device 2 and a switching device 3B is provided instead of the switching device 3 in the defibrillation system 6 (Fig. 1) of the embodiment, but the other configurations are the same.

The power supply device 2B has an input section 21, a power supply section 22, an internal circuit 24, a display section 25, and an audio output section 26. In other words, the power supply device 2B does not have (is omitted from) the switching section 31 in the power supply device 2 (FIG. 1) of the embodiment, but the other configurations are the same.

Switching device 3B has switching units 31 and 32. That is, switching device 3B is the same as switching device 3 of the embodiment (FIG. 1), except that switching unit 32 is further provided. In other words, switching unit 32, which was provided in power supply device 2 in defibrillation system 6 of the embodiment (FIG. 1), is provided (built-in) in switching device 3B in defibrillation system 6B of modification 2.

(Action and Effects)
In the second modification, basically, the same effect as in the embodiment can be obtained by the same action. That is, in the second modification, by performing switching control in the same manner as in the embodiment, it is possible to improve the convenience when using the defibrillation system 6B (power supply device 2B and switching device 3B).

In particular, in the second modification, both switching units 31 and 32 are provided in the switching device 3B, which makes it possible to obtain the following effects, for example. That is, by consolidating the two switching functions of the switching units 31 and 32 in the switching device 3B, it is possible to simplify (reduc) the configuration of the power supply device 2B.

3. Other Modifications
Although the present disclosure has been described above by giving several embodiments and modified examples, the present disclosure is not limited to these embodiments, and various modifications are possible.

For example, in the above embodiment, the configuration of the defibrillation catheter 1a is specifically described, but not all of the components are necessarily included, and other components may be included. The configuration of the electrodes in the shaft 11 (the arrangement, shape, number, etc. of the ring electrodes and tip electrodes) is not limited to that described in the above embodiment. Furthermore, the configuration of each component in the defibrillation catheter 1a (shape, arrangement, material, number, etc.) is not limited to that described in the above embodiment, and may be other shapes, arrangements, materials, numbers, etc. In addition, the values, ranges, magnitude relationships, etc. of the various parameters described in the above embodiment are not limited to those described in the above embodiment, and may be other values, ranges, magnitude relationships, etc.

In the above embodiment, a defibrillation catheter in which the shape of the shaft 11 near the tip region P1 changes in one direction in response to operation of the handle 12 has been described as an example, but the present disclosure is not limited to this example. That is, the present disclosure can also be applied to a defibrillation catheter in which the shape of the shaft 11 near the tip region P1 changes in both directions in response to operation of the handle 12, in which case multiple operating wires will be used. The present disclosure can also be applied to a defibrillation catheter in which the shape of the shaft 11 near the tip region P1 is fixed, in which case operating wires, rotating plate 122, etc. will not be required.

In the above embodiment, each block configuration of the power supply device and the switching device is specifically described, but it is not necessary to include all of the blocks described in the above embodiment, and other blocks may be included. Furthermore, the defibrillation system as a whole does not necessarily have to include all of the devices described in the above embodiment, and other devices may be included. Specifically, at least one of the defibrillation catheter 1a and the electrode catheter 1b may not be included in the defibrillation system. Also, for example, at least one of the electrocardiograph 4 and the electrocardiogram display device 5 may be included in the defibrillation system. Furthermore, not only one electrode catheter for measuring cardiac potential signals may be provided, but multiple electrode catheters may be provided.

In the above embodiment, the configurations of the switching units 31 and 32 are specifically described, but the present invention is not limited to these examples, and other configurations may be used.

In the above embodiment, the entire defibrillation process, including the switching control process for the switching units 31 and 32, has been specifically described, but the processing methods for the switching control process and the entire defibrillation process are not limited to the methods described in the above embodiment. In other words, the switching control process and the entire defibrillation process may be performed using other methods.

The series of processes described in the above embodiments may be performed by hardware (circuits) or software (programs). When performed by software, the software is composed of a group of programs for causing a computer to execute each function. Each program may be, for example, pre-installed in the computer and used, or may be installed in the computer from a network or recording medium and used.

The various examples described above may also be applied in any combination.

The effects described in this specification are merely examples and are not limiting, and other effects may also be present.

The present disclosure may also have the following configurations.
(1)
a power supply device that supplies power to a defibrillation catheter that performs electrical defibrillation;
a switching unit for switching a connection state between the electrode catheter and the cardiac potential device,
the electrode catheter is provided separately from the defibrillation catheter;
The cardiac potential device displays the cardiac potential measured using the defibrillation catheter or the electrode catheter,
The power supply device is
A power supply unit that outputs the power;
a switching control unit that performs switching control on the switching unit so that the electrode catheter and the cardiac potential device are disconnected during the execution of the defibrillation.
(2)
The power supply device comprises:
An internal circuit including the switching control unit;
a first switching unit that switches a first contact electrically connected to the defibrillation catheter so that the first contact is connected to the cardiac potential device side or the internal circuit side,
a second switching unit as the switching unit switches a connection state between a second contact electrically connected to the electrode catheter and the cardiac potential device;
The switching control unit, during the execution period of the defibrillation,
The first contact is connected to the internal circuit to supply the power to the defibrillation catheter;
so that the second contact is disconnected from the cardiac potential device.
The defibrillation system according to (1) above, further comprising: a first switching unit and a second switching unit.
(3)
After the execution period of the defibrillation, the switching control unit
The first contact is connected to the cardiac potential device,
A connection is made between the second contact and the cardiac potential device.
The defibrillation system according to (2) above, further comprising: a first switching unit and a second switching unit.
(4)
a power supply unit that supplies power to a defibrillation catheter that performs electrical defibrillation;
A switching unit for switching a connection state between the electrode catheter and the cardiac potential device;
a switching control unit that performs switching control on the switching unit so that the electrode catheter and the cardiac potential device are disconnected during the execution of the defibrillation,
the electrode catheter is provided separately from the defibrillation catheter;
In the cardiac potential device, the cardiac potential measured using the defibrillation catheter or the electrode catheter is displayed. Power supply device.
(5)
An internal circuit including the switching control unit is provided,
The switching unit is
a first switching unit that switches a first contact electrically connected to the defibrillation catheter so that the first contact is connected to the cardiac potential device side or the internal circuit side;
a second switching unit that switches a connection state between the second contact electrically connected to the electrode catheter and the cardiac potential device,
The switching control unit, before the execution period of the defibrillation,
The first contact is connected to the internal circuit to supply the power to the defibrillation catheter;
so that the second contact is disconnected from the cardiac potential device.
The power supply device according to (4) above, which performs switching control for the first switching unit and the second switching unit.
(6)
A power supply device that supplies power to a defibrillation catheter that performs electrical defibrillation is provided separately from the power supply device,
a switching unit for switching a connection state between the electrode catheter and the cardiac potential device;
the electrode catheter is provided separately from the defibrillation catheter;
The cardiac potential device displays the cardiac potential measured using the defibrillation catheter or the electrode catheter,
A switching device that performs switching control of the connection state so that the electrode catheter and the cardiac potential device are disconnected during the execution of the defibrillation.
(7)
1. A method for controlling a defibrillation system that performs electrical defibrillation using a defibrillation catheter, comprising:
an electrode catheter is provided separately from the defibrillation catheter, and a cardiac potential measured using the defibrillation catheter or the electrode catheter is displayed in a cardiac potential device;
a control circuit for controlling a connection state between the electrode catheter and the cardiac potential device so that the connection between the electrode catheter and the cardiac potential device is cut off during the execution of the defibrillation.

1a... defibrillation catheter, 1b... electrode catheter, 11... shaft, 110... tip electrode, 111, 112, 113... ring-shaped electrode, 111G, 112G, 113G... electrode group, 12... handle, 121... handle body, 122... rotating plate, 2, 2A, 2B... power supply device, 21... input unit, 22... power supply unit, 24... internal circuit, 241... output circuit, 242... memory unit, 243... impedance measurement circuit, 244... switching control unit, 25... display unit, 26... audio output unit, 3, 3B ...switching device, 31, 32...switching section, 31a-31c, 32a-32c...contacts, 4...electrocardiograph, 5...electrocardiogram display device, 6, 6A, 6B...defibrillation system, 9...patient, Vdc...DC voltage, Z...impedance, Zth1, Zth2...threshold, CTL...control signal, Sc1, Sc2...cardiac potential signal, Sin...operation signal, Ss...audio signal, P1...tip region, P31-P34...connection points, SW1-SW4...switches, RL...relay, C...capacitor, E...defibrillation energy.

Claims (7)

a power supply device that supplies power to a defibrillation catheter that performs electrical defibrillation;
a switching unit for switching a connection state between the electrode catheter and the cardiac potential device,
the electrode catheter is provided separately from the defibrillation catheter;
The cardiac potential device displays the cardiac potential measured using the electrode catheter,
The power supply device is
A power supply unit that outputs the power;
a switching control unit that performs switching control on the switching unit so that the electrode catheter and the cardiac potential device are disconnected during the execution of the defibrillation. The power supply device comprises:
An internal circuit including the switching control unit;
a first switching unit that switches a first contact electrically connected to the defibrillation catheter so that the first contact is connected to the cardiac potential device side or the internal circuit side,
a second switching unit as the switching unit switches a connection state between a second contact electrically connected to the electrode catheter and the cardiac potential device;
The switching control unit, during the execution period of the defibrillation,
The first contact is connected to the internal circuit to supply the power to the defibrillation catheter;
so that the second contact is disconnected from the cardiac potential device.
The defibrillation system according to claim 1 , further comprising: a first switching unit and a second switching unit that perform switching control. After the execution period of the defibrillation, the switching control unit
The first contact is connected to the cardiac potential device,
A connection is made between the second contact and the cardiac potential device.
The defibrillation system according to claim 2 , further comprising: a first switching unit and a second switching unit that perform switching control. a power supply unit that supplies power to a defibrillation catheter that performs electrical defibrillation;
A switching unit for switching a connection state between the electrode catheter and the cardiac potential device;
a switching control unit that performs switching control on the switching unit so that the electrode catheter and the cardiac potential device are disconnected during the execution of the defibrillation,
the electrode catheter is provided separately from the defibrillation catheter;
In the cardiac potential device , the cardiac potential measured using the electrode catheter is displayed. Power supply device. An internal circuit including the switching control unit ;
a first switching unit that switches a first contact electrically connected to the defibrillation catheter so that the first contact is connected to the cardiac potential device side or the internal circuit side;
Further comprising:
a second switching unit as the switching unit switches a connection state between a second contact electrically connected to the electrode catheter and the cardiac potential device ;
The switching control unit, during the execution period of the defibrillation,
The first contact is connected to the internal circuit to supply the power to the defibrillation catheter;
so that the second contact is disconnected from the cardiac potential device.
The power supply device according to claim 4 , further comprising: a first switching unit and a second switching unit that perform switching control. A power supply device that supplies power to a defibrillation catheter that performs electrical defibrillation is provided separately from the power supply device,
a switching unit for switching a connection state between the electrode catheter and the cardiac potential device;
the electrode catheter is provided separately from the defibrillation catheter;
The cardiac potential device displays the cardiac potential measured using the electrode catheter,
A switching device that performs switching control of the connection state so that the electrode catheter and the cardiac potential device are disconnected during the execution of the defibrillation. A method for controlling switching of a connection state between an electrode catheter provided separately from a defibrillation catheter that performs electrical defibrillation, and a cardiac potential device that displays a cardiac potential measured using the electrode catheter, comprising:
a switching control unit that performs switching control of the connection state so that the electrode catheter and the cardiac potential device are disconnected during the execution period of the defibrillation .
A method for controlling switching of connection states .