WO2021171531A1 - Medical device system - Google Patents

Abstract

Provided is a medical device system that can improve convenience. A medical device system (a defibrillation catheter system 3) that comprises: a medical device (a defibrillation catheter 1) that has an electrode; and a power supply device 2 that supplies power to the medical device. The power supply device 2 has a power supply unit 22 that supplies the power, a first clock unit (clock unit 243a) that outputs first date and time information (date and time information Idt1) to which setting changes can be made at any time in response to operations by an operator, and a second clock unit (clock unit 243b) that outputs second date and time information (date and time information Idt2) for which setting changes in response to operations by the operator are restricted.

Description

Medical device system

The present invention relates to a medical device system including a medical device having electrodes and a power supply device for supplying electric power to the medical device.

An example of a medical device system including a medical device having electrodes is the following defibrillation catheter system (see, for example, Patent Document 1). Specifically, for example, a defibrillation catheter system has been developed as one of medical devices for removing atrial fibrillation (performing electrical defibrillation) generated during cardiac catheterization. This defibrillation catheter system comprises a defibrillation catheter that is inserted into the heart cavity to perform defibrillation and a power supply that supplies power to the defibrillation catheter during defibrillation. There is. By using such a defibrillation catheter system, the heart that has undergone atrial fibrillation is directly subjected to electrical stimulation (for example, electrical energy consisting of DC voltage) in the heart chamber, and as a result, the effect is obtained. Defibrillation treatment has come to be realized.

Japanese Unexamined Patent Publication No. 2017-213444

By the way, medical device systems such as the defibrillation catheter system described above are generally required to improve convenience when used, for example. It is desirable to provide a medical device system that can improve convenience.

The medical device system according to the embodiment of the present invention includes a medical device having electrodes and a power supply device that supplies electric power to the medical device. This power supply device has a power supply unit that supplies power, a first clock unit that outputs date and time information that can be changed at any time according to an operation by the operator, and an operation by the operator. It has a second clock unit that outputs a second date and time information, for which setting changes are restricted accordingly.

In the medical device system according to the embodiment of the present invention, the first clock unit that outputs the first date and time information and the second clock unit that outputs the second date and time information are the power supplies, respectively. It is provided in the device. The first date and time information is information whose settings can be changed at any time according to the operation by the operator, while the second date and time information is restricted from changing the settings according to the operation by the operator. Therefore, various processes can be easily realized in this medical device system by using such two types of date and time information (the first and second date and time information).

In the medical device system according to the embodiment of the present invention, it seems that the setting of the second date and time information can be changed according to the operation by the operator only when the power supply device is started for the first time. It may be. In this case, since the above setting change for the second date and time information is allowed only at the first startup of the power supply device, the restriction of the above setting change after the first startup is maintained. At the same time, the tolerance for changing the above settings will be ensured at a minimum. As a result, the second date and time information becomes easy to use, and various processes in this medical device system can be realized more easily, so that the convenience can be further improved. Further, regarding the second date and time information, it may be impossible to change the setting according to the operation by the operator. In this case, since the above setting change for the second date and time information is completely restricted, the process using the restriction of the above setting change for the second date and time information is realized. It will be easier. As a result, the convenience is further improved.

In the medical device system according to the embodiment of the present invention, in the first clock unit, the first date and time information is set in another device (for example, an electrocardiograph) different from the power supply device. It may be possible to set so as to match the third date and time information. In this case, for example, the process using the first date and time information in the power supply device can be executed while synchronizing with the process using the third date and time information in the other device. Will be. As a result, the convenience is further improved.

Further, the power supply device uses the second date and time information to obtain the elapsed time (first elapsed time) of the power supply device from the initial setting of the second date and time information and the use of the medical device. It may further have a derivation unit that derives at least one of the elapsed time from the start (second elapsed time). In this case, the first elapsed time is used to grasp, for example, the maintenance time of the power supply unit itself and its internal parts, and notify the operator (user) of (warning, etc.). It becomes possible to do. Further, by using the second elapsed time, for example, it is possible to grasp the expiration date of the medical device and limit the use of the medical device. As a result, the convenience is further improved.

In the medical device system according to the embodiment of the present invention, the power supply device is based on a reading unit that reads out unique identification information held in the medical device and the identification information read by the reading unit. Further, it may have a determination unit for determining the effectiveness of the use of the medical device. In this case, the determination result of whether or not the use of the medical device is effective can be easily obtained by using the unique identification information in the medical device. As a result, the use of non-genuine medical devices (for example, deteriorated products and counterfeit products) can be effectively eliminated, and convenience can be further improved.

Examples of the medical device include a defibrillation catheter that is inserted into the heart chamber of a patient to perform electrical defibrillation.

According to the medical device system according to the embodiment of the present invention, the first clock unit that outputs the first date and time information and the second clock unit that outputs the second date and time information are respectively. Since it is provided in the power supply device, various processes can be easily realized in this medical device system. Therefore, it is possible to improve the convenience in the medical device system.

It is a block diagram which shows typically the whole structure example of the defibrillation catheter system as the medical device system which concerns on one Embodiment of this invention. It is a schematic diagram which shows the schematic structure example of the defibrillation catheter shown in FIG. It is a schematic diagram which shows the cross-sectional composition example of the shaft along the line II-II shown in FIG. It is a figure for demonstrating two kinds of clock part and date and time information shown in FIG. It is a block diagram which shows an example of various data held in the storage part in the defibrillation catheter shown in FIG. It is a block diagram which shows an example of various data held in the storage part in the power supply apparatus shown in FIG. It is a flow chart which shows the whole processing example of the defibrillation processing which concerns on embodiment. It is a flow chart which shows the detailed processing example in the determination processing of the effectiveness of use shown in FIG. It is a block diagram which shows typically the example of the operation state at the time of the electrocardiographic potential measurement shown in FIG. It is a block diagram which shows typically the example of the operation state at the time of resistance measurement shown in FIG. It is a block diagram which shows typically the example of the operation state at the time of defibrillation execution shown in FIG. 7. It is a flow chart which shows the detailed processing example of the determination processing of the effectiveness of use which concerns on modification 1. FIG.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The explanation will be given in the following order.
1. 1. Embodiment (Example in the case of determination processing that does not consider the information on the number of times the medical device has been used)
2. Modifications 1 to 3 (Example in the case of judgment processing considering the information on the number of times the medical device has been used)
3. 3. Other variants

<1. Embodiment>
[overall structure]
FIG. 1 is a schematic block diagram showing an overall configuration example of a medical device system (defibrillation catheter system 3) according to an embodiment of the present invention. This defibrillation catheter system 3 is a system used, for example, when removing atrial fibrillation (performing electrical defibrillation) that has occurred in a patient (patient 9 in this example) during cardiac catheterization.

As shown in FIG. 1, the defibrillation catheter system 3 includes a defibrillation catheter 1 and a power supply device 2. Further, when defibrillation or the like using the defibrillation catheter system 3 is performed, for example, as shown in FIG. 1, the electrocardiograph 4, the electrocardiogram display device 5 (waveform display device), and the biometric measurement mechanism 6 are used. Is also used as appropriate.

Here, the defibrillation catheter system 3 corresponds to a specific example of the "medical device system" in the present invention. Further, the defibrillation catheter 1 corresponds to a specific example of the "medical device having an electrode" in the present invention.

(A. Defibrillation catheter 1)
The defibrillation catheter 1 is an electrode catheter that is inserted into the body (intracardiac space) of the patient 9 through a blood vessel to perform electrical defibrillation. FIG. 2 schematically shows a schematic configuration example of the defibrillation catheter 1. The defibrillation catheter 1 has a shaft 11 (catheter shaft) as a catheter body, a handle 12 attached to the base end of the shaft 11, and a storage unit 13 that holds (stores) various data described later. Have.

(Shaft 11)
The shaft 11 has a flexible and insulating tubular structure (tubular member, tube member), and has a shape extending along its own axial direction (Z-axis direction). Further, the shaft 11 has a so-called multi-lumen structure in which a plurality of lumens (pores, through holes) are formed therein so as to extend along its own axial direction. Although details will be described later, various thin wires (conductors, operating wires, etc.) are inserted into each lumen in a state of being electrically insulated from each other. The outer diameter of the shaft 11 is, for example, about 1.2 mm to 3.3 mm.

As shown in FIG. 2, for example, a plurality of electrodes (tip electrode 110 and ring-shaped electrodes 111, 112, 113) are provided in the tip region P1 of such a shaft 11. Specifically, one tip electrode 110 and a plurality of ring-shaped electrodes 111, 112, 113 are predetermined in this order from the tip side to the base end side of the shaft 11, respectively, along the axial direction of the shaft 11. Are arranged at intervals of. The ring-shaped electrodes 111, 112, and 113 are fixedly arranged on the outer peripheral surface of the shaft 11, respectively, while the tip electrode 110 is fixedly arranged at the tip of the shaft 11. Further, as shown in FIG. 2, the electrode group 111G is composed of a plurality of ring-shaped electrodes 111 arranged at intervals from each other. Similarly, a plurality of ring-shaped electrodes 112 arranged at intervals from each other constitute an electrode group 112G, and a plurality of ring-shaped electrodes 113 arranged at intervals from each other constitute an electrode group 113G. ..

The "electrode group" referred to here is a plurality of electrodes that form the same pole (have the same polarity) or have the same purpose and are mounted at narrow intervals (for example, 5 mm or less). It means an aggregate of, and the same applies hereinafter. Further, the separation distance between the electrode group 111G (ring-shaped electrode 111 on the proximal end side) and the electrode group 112G (ring-shaped electrode 112 on the distal end side) is preferably, for example, about 40 to 100 mm, which is a preferable example. If shown, it is 66 mm.

The ring-shaped electrodes 111, 112, and 113 are electrically connected to the handle 12 via a plurality of conductors (lead wires) inserted into the lumen of the shaft 11, although details will be described later. On the other hand, in this example, the lead wire is not connected to the tip electrode 110. However, a conducting wire may be connected to the tip electrode 110 as well.

Such tip electrodes 110 and ring-shaped electrodes 111, 112, 113 are electrically conductive, for example, aluminum (Al), copper (Cu), stainless steel (SUS), gold (Au), platinum (Pt), etc., respectively. It is composed of a metal material having good properties or various resin materials. In order to improve the contrast with respect to X-rays when the defibrillation catheter 1 is used, these tip electrodes 110 and ring-shaped electrodes 111, 112, 113 are each made of platinum or an alloy thereof. Is preferable.

Here, the above-mentioned electrode group 111G is composed of a plurality of ring-shaped electrodes 111 that form the same pole (-pole or + pole). The number of ring-shaped electrodes 111 constituting the electrode group 111G varies depending on the width of the electrodes and the arrangement interval, but is, for example, 4 to 13, preferably 8 to 10. The width (length in the axial direction) of the ring-shaped electrode 111 is preferably, for example, about 2 to 5 mm, and a suitable example is 4 mm. The mounting interval of the ring-shaped electrodes 111 (separation distance between adjacent electrodes) is preferably, for example, about 1 to 5 mm, and a preferable example is 2 mm. When the defibrillation catheter 1 is used (when it is placed in the heart chamber), the electrode group 111G is located in, for example, a coronary vein.

The electrode group 112G is composed of a plurality of ring-shaped electrodes 112 that form poles (+ poles or-poles) opposite to those of the electrode group 111G described above. The number of ring-shaped electrodes 112 constituting the electrode group 112G varies depending on the width of the electrodes and the arrangement interval, but is, for example, 4 to 13, preferably 8 to 10. The width (length in the axial direction) of the ring-shaped electrode 112 is preferably, for example, about 2 to 5 mm, and a suitable example is 4 mm. The mounting interval of the ring-shaped electrodes 112 (separation distance between adjacent electrodes) is preferably, for example, about 1 to 5 mm, and a preferable example is 2 mm. When the defibrillation catheter 1 is used (when it is placed in the heart chamber), the electrode group 112G is located in the right atrium, for example.

In this example, the electrode group 113G is composed of four ring-shaped electrodes 113. The width (length in the axial direction) of the ring-shaped electrode 113 is preferably, for example, about 0.5 to 2.0 mm, and a suitable example is 1.2 mm. The mounting interval of the ring-shaped electrodes 113 (separation distance between adjacent electrodes) is preferably, for example, about 1.0 to 10.0 mm, and a preferable example is 5 mm. When the defibrillation catheter 1 is used (when it is placed in the heart chamber), the electrode group 113G is located in the superior vena cava where an abnormal potential is likely to occur, for example.

FIG. 3 schematically shows a cross-sectional configuration example (XY cross-sectional configuration example) of the shaft 11 along the line II-II in FIG. In this example, as shown in FIG. 3, the shaft 11 has a multi-lumen structure having an outer portion 70 (shell portion), a wire 71, an inner portion 72 (core portion), and a resin layer 73. Specifically, the shaft 11 is formed with four lumens L1 to L4 separated from each other.

As shown in FIG. 3, the outer portion 70 is a tubular member located on the outermost circumference of the shaft 11. The outer portion 70 is made of, for example, a high-hardness nylon elastomer. As the nylon elastomer constituting the outer portion 70, for example, those having different hardness along the axial direction (Z-axis direction) are used. As a result, the shaft 11 is configured to gradually increase in hardness from the tip end side to the base end side.

As shown in FIG. 3, the strands 71 are arranged between the outer portion 70 and the inner portion 72 to form a braided blade. Further, the braided blade is formed only in a part of the shaft 11 along the axial direction, for example. Such a wire 71 is made of, for example, stainless steel, and is a stainless steel wire.

As shown in FIG. 3, the inner portion 72 is a core member located on the inner peripheral side of the outer portion 70 and the wire 71. The inner portion 72 is made of, for example, a low-hardness nylon elastomer. The four lumens L1 to L4 described above are formed in the inner portion 72, respectively.

As shown in FIG. 3, the resin layer 73 is a layer that partitions the four lumens L1 to L4, and is made of, for example, a fluororesin. Examples of this fluororesin include highly insulating materials such as perfluoroalkyl vinyl ether copolymer (PFA) and polytetrafluoroethylene (PTFE).

The lumen L1 (first lumen) is arranged on the positive side of the X-axis in the shaft 11 as shown in FIG. 3 in this example. A conductor group 81G composed of a plurality of conductors 81 is inserted through the lumen L1. Each of these conductors 81 is individually electrically connected to the plurality of ring-shaped electrodes 111 in the electrode group 111G described above. The conducting wire 81 electrically connected to the ring-shaped electrode 111 in this way constitutes a signal line of the electrocardiographic signal Sc0a described later (see FIG. 2).

The lumen L2 (second lumen) is arranged on the negative side of the X-axis in the shaft 11 as shown in FIG. 3 in this example. A conductor group 82G composed of a plurality of conductors 82 is inserted through the lumen L2. Each of these conductors 82 is individually electrically connected to the plurality of ring-shaped electrodes 112 in the electrode group 112G described above. The conducting wire 82 electrically connected to the ring-shaped electrode 112 in this way also constitutes the signal line of the electrocardiographic signal Sc0a described later (see FIG. 2).

The lumen L3 (third lumen) is arranged on the negative side of the Y axis in the shaft 11 as shown in FIG. 3 in this example. A conductor group 83G composed of a plurality of conductors 83 is inserted through the lumen L3. Each of these conductors 83 is individually electrically connected to the plurality of ring-shaped electrodes 113 in the electrode group 113G described above. The conducting wire 83 electrically connected to the ring-shaped electrode 113 in this way constitutes a signal line of the electrocardiographic signal Sc0b described later (see FIG. 2).

The lumen L4 (fourth lumen) is arranged on the positive side of the Y axis in the shaft 11 as shown in FIG. 3 in this example. In this example, one operating wire 80 is inserted through the lumen L4. That is, the operation wire 80 is arranged in an eccentric state with respect to the central axis of the shaft 11. The operation wire 80 is a member for performing a deflection movement operation (swinging operation), which is an operation for deflecting (curving) the vicinity of the tip of the shaft 11, although details will be described later. The tip portion of such an operating wire 80 is fixed to the tip electrode 110 by, for example, soldering. A large-diameter portion (retaining portion) for preventing the retaining wire may be formed at the tip of the operating wire 80. On the other hand, the base end portion of the operation wire 80 is connected to the inside of the handle 12 (rotary plate 122) described later.

The above-mentioned conductors 81, 82, and 83 are each composed of a resin-coated wire in which the outer peripheral surface of the metal conductor is covered with a resin such as polyimide. The operating wire 80 is made of, for example, stainless steel or a Ni (nickel) -Ti (titanium) -based superelastic alloy. However, the operating wire 80 does not necessarily have to be made of metal, and may be made of, for example, a high-strength non-conductive wire.

(Handle 12)
As shown in FIG. 2, the handle 12 is attached to the base end of the shaft 11 and has a handle body 121 (grip portion) and a rotating plate 122.

The handle body 121 is a portion that the operator (doctor) grasps (grasps) when using the defibrillation catheter 1. Inside the handle body 121, various thin wires ( conductor wires 81, 82, 83, operating wires 80, etc.) described above are extended from the inside of the shaft 11 in a state of being electrically insulated from each other.

The rotating plate 122 is a member for performing a deflection movement operation, which is an operation for deflecting the vicinity of the tip of the shaft 11, although details will be described later. Specifically, for example, the operation of rotating the rotating plate 122 along the rotation direction d1 indicated by the broken line arrow in FIG. 2 is possible. By such a rotation operation, the operation wire 80 described above is pulled toward the proximal end side, so that an operation (deflection movement operation) in which the vicinity of the tip of the shaft 11 is deflected is possible.

(Memory unit 13)
As shown in FIG. 2, for example, the storage unit 13 is arranged in the handle 12 (handle main body 121) and is a portion (memory) for holding various data described later. A detailed example of each data stored in the storage unit 13 will be described later (FIG. 5).

(B. Power supply device 2)
The power supply device 2 is a device that supplies electric power to the defibrillation catheter 1 during defibrillation. Specifically, as shown in FIGS. 1 to 3, the power supply device 2 applies the DC voltage Vdc applied at the time of defibrillation to the electrode groups 111G and 112G (11G, 112G) on the shaft 11 of the defibrillation catheter 1. The ring-shaped electrodes 111 and 112) are supplied via the conductor groups 81G and 82G (conductors 81 and 82).

As shown in FIG. 1, the power supply device 2 has an input unit 21, a power supply unit 22, a switching unit 23, an arithmetic processing unit 24 (control unit), a display unit 25, and an audio output unit 26. As shown in FIG. 1, the power supply device 2 also has two (two types) input terminals Tin1 and Tin2 and two (two types) output terminals Tout1 and Tout2. Further, in this power supply device 2, the details will be described later, but the “electrocardiographic potential measurement mode” in which the electrocardiographic potential is measured (see FIG. 9) and the “resistance measurement mode” in which the resistance value R measurement processing described later is performed (FIG. 9). 10) ”and“ defibrillation mode (see FIG. 11) ”where defibrillation is performed can be switched. That is, in the power supply device 2, it is possible to switch between these plurality of types (for example, three types) of modes.

The input unit 21 is a portion for inputting various set values and an input signal Sin (operation input signal) for instructing a predetermined operation, and is configured by using, for example, a predetermined dial, switch, touch panel, or the like. There is. These set values and instructions (input signal Sin) are input in response to an operation by an operator (for example, an engineer or the like) of the power supply device 2. However, some of the set values and the like may not be input according to the operation by the operator, but may be set in the power supply device 2 in advance at the time of shipment of the product or the like. Further, the above-mentioned switch will be described in detail later, but for example, in order to switch between the above-mentioned plurality of types of modes (“electrocardiographic measurement mode”, “resistance measurement mode”, “defibrillation mode”). Mode changeover switch, applied energy setting switch that sets the electrical energy (DC voltage Vdc) applied during defibrillation, charging switch for charging the power supply unit 22, defibrillation is executed by applying electrical energy. Examples thereof include an energy application switch (discharge switch) for performing the operation. The input signal Sin input by the input unit 21 is supplied to the arithmetic processing unit 24 as shown in FIG.

The power supply unit 22 is a portion that outputs the above-mentioned DC voltage Vdc toward the electrode groups 111G and 112G (ring-shaped electrodes 111 and 112) in the defibrillation catheter 1. The power supply operation in such a power supply unit 22 is controlled by the arithmetic processing unit 24 based on, for example, the input signal Sin from the input unit 21. Further, the power supply unit 22 is configured by using a predetermined power supply circuit (for example, a switching regulator or the like), a capacitor (capacitive element) for charging electric energy, or the like.

As shown in FIG. 1, the switching unit 23 is a part that performs an operation (switching operation) of switching the supply paths of the DC voltage Vdc, the resistance value R and the electrocardiographic signal Sc0a described later. The switching operation in such a switching unit 23 is controlled by the arithmetic processing unit 24 based on, for example, the input signal Sin from the input unit 21. The details of the switching operation in the switching unit 23 will be described later.

(Calculation processing unit 24)
The arithmetic processing unit 24 is a portion that controls the entire power supply device 2 and performs predetermined arithmetic processing, and includes, for example, a microcomputer and the like. Specifically, the arithmetic processing unit 24 controls the operations of the power supply unit 22, the switching unit 23, the display unit 25, and the audio output unit 26, respectively, based on the input signal Sin from the input unit 21. .. The details of such an operation example in the arithmetic processing unit 24 will be described later.

Further, in the example shown in FIG. 1, the arithmetic processing unit 24 has an output circuit 241, a storage unit 242, a clock unit 243a, 243b, a derivation unit 244, a reading unit 245, a determination unit 246, and an execution permission unit 247. ing.

The output circuit 241 transfers the DC voltage Vdc output from the power supply unit 22 to the electrode groups 111G and 112G (ring-shaped electrodes 111 and 112) of the defibrillation catheter 1 via the switching unit 23 and the output terminal Tout1 described later. It is a circuit for output. Specifically, although the details will be described later, in this output circuit 241, the electrode groups 111G and 112G have different polarities from each other (when one electrode group has a negative electrode, the other electrode group has a positive electrode). In addition, the DC voltage Vdc is output.

The storage unit 242 is a part (memory) that holds various data described later. A detailed example of each data stored in the storage unit 242 will be described later (FIG. 6).

The clock unit 243a outputs the date and time information Idt1, and the clock unit 243b outputs the date and time information Idt2 (see FIG. 1). Each of these clock units 243a and 243b includes, for example, an IC (Integrated Circuit) having an RTC (Real-Time Clock) function. The "date and time information" referred to here means information including "date information" and "time information", and the same applies hereinafter.

FIG. 4 is a diagram for explaining such two types of clock units 243a and 243b and date and time information Idt1 and Idt2. Specifically, in FIG. 4, according to the type of the clock unit in the power supply device 2, the type of date and time information in the power supply device 2, and the operation of the input unit 21 by the operator (user) of the power supply device 2. A table shows whether or not the date and time information settings can be changed and examples of using the date and time information.

As shown in FIG. 4, the date and time information Idt1 in the clock unit 243a can be changed at any time (arbitrarily) according to the operation by the operator. Further, the date and time information Idt1 in the clock unit 243a is, for example, date and time information set in another device different from the power supply device 2 (for example, date and time information Idt3 set in the electrocardiograph 4 described later: It can be set so as to match (see FIG. 1).

On the other hand, as shown in FIG. 4, the date and time information Idt2 in the clock unit 243b is restricted from being changed in setting according to the operation by the operator of the power supply device 2. That is, the date and time information Idt2 is basically set by default at the time of factory shipment (manufacturing), for example. Specifically, regarding the date and time information Idt2, the setting can be changed according to the operation by the operator, for example, only when the power supply device 2 is started for the first time (see FIG. 4). Alternatively, for this date and time information Idt2, for example, it is completely impossible to change the setting according to the operation by the operator (see FIG. 4).

Further, by using such date and time information Idt2, in the out-licensing unit 244 described later, the elapsed time Δt1 from the start of use of the defibrillation catheter 1 and the power supply device 2 from the initial setting of the date and time information Idt2 The elapsed time Δt2 and the elapsed time Δt2 are derived respectively (see FIG. 4).

Such a clock unit 243a corresponds to a specific example of the "first clock unit" in the present invention, and the clock unit 243b corresponds to a specific example of the "second clock unit" in the present invention. ing. Further, the date and time information Idt1 corresponds to a specific example of the "first date and time information" in the present invention, and the date and time information Idt2 corresponds to a specific example of the "second date and time information" in the present invention. Idt3 corresponds to a specific example of the "third date and time information" in the present invention.

As described above, the out-licensing unit 244 uses the date and time information Idt2 to obtain the elapsed time Δt1 from the start of use of the defibrillation catheter 1 and the elapsed time of the power supply device 2 from the initial setting of the date and time information Idt2. Δt2 and each are derived. The details of such elapsed times Δt1 and Δt2 will be described later.

The reading unit 245 reads out information on various data held in the defibrillation catheter 1 (storage unit 13 described above: see FIG. 2). Details of the various data read in this way will be described later (see FIG. 5), and examples thereof include the following.

That is, first, identification information 131 as identification information unique to the defibrillation catheter 1 (information individually assigned to each defibrillation catheter 1) can be mentioned. Here, such identification information 131 is, for example, a serial number composed of a list of at least one type of information given by a specific law, among numbers, alphabets, and alphanumeric characters. The identification information 131 may be, for example, information in which such a serial number is encrypted (encrypted identification information). In addition, examples of the above-mentioned various data include usage status information 132 indicating the usage status of the defibrillation catheter 1. Further, use date / time information 133 indicating the date and time of use of the defibrillation catheter 1 can be mentioned. In addition, information indicating the number of times the defibrillation catheter 1 has been used (information on the number of times used N) can be mentioned.

The determination unit 246 determines the effectiveness of using the defibrillation catheter 1 based on the identification information 131 read by the reading unit 245. That is, the determination unit 246 is adapted to perform a determination process as to whether the use of the defibrillation catheter 1 is effective or ineffective. In other words, when it is determined that the use is effective, it means that the defibrillation catheter 1 is determined to be a genuine product, and when it is determined that the use is invalid, it is excluded. It means that the defibrillation catheter 1 is determined to be a non-genuine product (for example, a deteriorated product or a counterfeit product). Specifically, the determination unit 246 determines the effectiveness of using the defibrillation catheter 1 depending on, for example, whether or not the serial number in the identification information 131 is assigned according to the specific law described above. It is designed to judge. That is, for example, when such a serial number is assigned according to the above-mentioned specific law, the identification information 131 is legitimate information, and it is determined that the use of the defibrillation catheter 1 is effective. .. On the other hand, for example, when such a serial number is not assigned according to the above-mentioned specific law, it is determined that the identification information 131 is non-genuine information and the use of the defibrillation catheter 1 is invalid. NS. By performing such a determination process, it is possible to easily eliminate the use of the non-regular defibrillation catheter 1. A detailed processing example of the determination processing by the determination unit 246 will be described later (FIG. 8).

The execution permission unit 247 is operated by the operator in the input unit 21 (for example, power supply for defibrillation by the power supply unit 22) only when the determination unit 246 determines that the use of the defibrillation catheter 1 is effective. The reception of the operation) for executing the operation) is enabled. That is, if the reception of such an operation remains disabled (if it is not enabled), even if the operator performs an operation on the input unit 21, the power supply for defibrillation is not executed. , Electrical defibrillation by the defibrillation catheter 1 is also prevented. In other words, only when the reception of such an operation is enabled, when the operator performs an operation on the input unit 21, power supply for defibrillation is executed, and electricity by the defibrillation catheter 1 is performed. Defibrillation is being performed. A detailed processing example in such an execution permission unit 247 will be described later (FIG. 8).

The display unit 25 is a part (monitor) that displays various information based on various signals supplied from the arithmetic processing unit 24 and outputs the information to the outside. Specifically, the display unit 25 has a function of displaying the electrocardiographic waveform based on, for example, the electrocardiographic signal Sc1 described later. However, the information to be displayed is not limited to such information on the electrocardiographic potential, and other information may be added and displayed. Specifically, for example, information such as the determination result by the determination unit 246 described above may also be displayed on the display unit 25. By displaying such various information on the display unit 25, the operator of the power supply device 2 (for example, an engineer or the like) removes the power supply device 2 while monitoring, for example, the above-mentioned electrocardiographic waveform and the determination result by the determination unit 246. It is possible to perform defibrillation treatment (input operation to the input unit 21 and the like). In addition, such a display unit 25 is configured by using a display by various methods (for example, a liquid crystal display, a CRT (Cathode Ray Tube) display, an organic EL (Electro Luminescence) display, etc.).

As shown in FIG. 1, the voice output unit 26 is a part that outputs various voices to the outside based on the voice signal Ss supplied from the arithmetic processing unit 24. As an example of such an audio signal Ss, although details will be described later, an audio signal Ss generated according to the determination result by the determination unit 246 described above can be mentioned. It should be noted that such an audio output unit 26 is configured by using, for example, a speaker or the like.

Here, each of the display unit 25 and the audio output unit 26 corresponds to a specific example of the "output unit" in the present invention.

(Input terminals Tin1, Tin2)
As shown in FIG. 1, the input terminal Tin1 is a terminal for inputting the electrocardiographic signal Sc1 output from the electrocardiograph 4 described later. Although details will be described later, this electrocardiographic signal Sc1 is a biological signal obtained by measurement by a biological measurement mechanism 6 (a plurality of electrode pads 61 described later) and supplied to the electrocardiograph 4. The electrocardiographic signal Sc1 obtained by such a biometric measurement mechanism 6 may be directly input to the input terminal Tin without passing through the electrocardiograph 4, and the same applies hereinafter. The electrocardiographic signal Sc1 (for example, an analog signal) input to the input terminal Tin1 in this way is supplied to the arithmetic processing unit 24.

As shown in FIG. 1, the input terminal Tin2 is a terminal for inputting the electrocardiographic signals Sc0a, Sc0b and the resistance value R measured in the defibrillation catheter 1. Here, the electrocardiographic signal Sc0a is a electrocardiographic signal measured in the above-mentioned electrode groups 111G and 112G (ring-shaped electrodes 111 and 112) and transmitted via the above-mentioned conductors 81 and 82 (FIGS. 2 and 2). 3). On the other hand, the electrocardiographic signal Sc0b is an electrocardiographic signal measured in the above-mentioned electrode group 113G (ring-shaped electrode 113) and transmitted via the above-mentioned conductor 83 (see FIGS. 2 and 3). The resistance value R is a resistance value between the electrode groups 111G and 112G. Of the signals input to the input terminal Tin2 in this way, the electrocardiographic signal Sc0a is passed through the switching unit 23 and the output terminal Tout2, which will be described later, in this order, as shown in FIG. It is designed to be supplied to the electric meter 4. On the other hand, as shown in FIG. 1, the electrocardiographic signal Sc0b is supplied to the electrocardiograph 4 only via the output terminal Tout2, which will be described later, without going through the switching unit 23. Further, as shown in FIG. 1, the resistance value R is supplied to the arithmetic processing unit 24 via the switching unit 23.

(Output terminals Tout1, Tout2)
As shown in FIG. 1, the output terminal Tout1 uses the DC voltage Vdc output from the output circuit 241 described above and supplied via the switching unit 23 to the electrode groups 111G and 112G of the defibrillation catheter 1. It is a terminal for outputting to the ring-shaped electrodes 111,112).

As shown in FIG. 1, the output terminal Tout2 passes through the electrocardiographic signal Sc0b supplied from the defibrillation catheter 1 via the above-mentioned input terminal Tin2, the input terminal Tin2, and the switching unit 23 in this order. This is a terminal for outputting the electrocardiographic signal Sc0a supplied from the defibrillation catheter 1 to the electrocardiograph 4.

(C. Electrocardiograph 4)
The electrocardiograph 4 is a device having a function of recording information such as an electrocardiographic signal (in the example of FIG. 1, electrocardiographic signals Sc0a, Sc0b, Sc1). Specifically, in the example of FIG. 1, the electrocardiograph 4 has the electrocardiographic signals Sc0a and Sc0b output from the above-mentioned output terminal Tout2 of the power supply device 2 and the biometric measurement mechanism 6 (a plurality of electrodes described later) described later. The electrocardiographic signal Sc1 output from the pad 61) is input and recorded.

Further, in the example of FIG. 1, the electrocardiograph 4 also has a function of outputting the input and recorded electrocardiographic signal to the outside. Specifically, although details will be described later, in the example of FIG. 1, the electrocardiograph 4 outputs the above-mentioned electrocardiographic signal Sc1 to the input terminal Tin1 of the power supply device 2. Further, in the example of FIG. 1, the electrocardiograph 4 outputs the above-mentioned electrocardiographic signals Sc1, Sc0a, Sc0b to the electrocardiogram display device 5 described later, respectively.

The date and time information Idt3 described above is set in the electrocardiograph 4 (for example, a clock unit (not shown)) as shown in FIG. 1, for example.

(D. ECG display device 5)
The electrocardiogram display device 5 is a device that displays an electrocardiographic waveform (electrocardiogram) or the like based on the electrocardiographic signals Sc1, Sc0a, Sc0b output from the electrocardiograph 4 described above. The electrocardiograph 4 and the electrocardiogram display device 5 may be collectively referred to as a polygraph, a biological information monitor, a cardiac catheterization test device, or an EP recording system. The electrocardiographic waveform and the like displayed on the electrocardiogram display device 5 in this way are monitored at any time by, for example, an operator (doctor) of the defibrillation catheter 1.

(E. Biological measurement mechanism 6)
The biological measurement mechanism 6 is used in a state of being attached (attached) to the body surface of the patient 9 at the time of defibrillation treatment or the like, and the above-mentioned biological signal (electrocardiographic signal Sc1 or the like) is transmitted from the patient 9. It is a device for measuring. In the example shown in FIG. 1, the biological measurement mechanism 6 is configured by using a plurality of (for example, 4 or 6) electrode pads 61.

Here, as shown in FIG. 1, the above-mentioned electrocardiographic signal Sc1 is measured from a combination of six of the plurality of electrode pads 61 by using a general measurement method. .. The electrocardiographic signal Sc1 obtained from the electrode pad 61 in this way is supplied to the electrocardiograph 4. The electrocardiographic waveform of the electrocardiographic signal Sc1 obtained by the above-mentioned general measurement method (measurement method using a combination of six electrode pads) corresponds to what is called a "12-lead electrocardiogram". ..

[Structure example of various data stored in storage units 13 and 242]
Subsequently, with reference to FIGS. 5 and 6 in addition to FIGS. 1 to 4, a configuration example of various data held in the storage units 13 and 242 described above will be described in detail.

FIG. 5 is a block diagram showing an example of various data held in the storage unit 13 in the defibrillation catheter 1 shown in FIG. FIG. 6 is a block diagram showing an example of various data held in the storage unit 242 in the power supply device 2 shown in FIG. The examples of various data held in these storage units 13 and 242 are not limited to the data shown in FIGS. 5 and 6, and in addition to (or instead of) other data are held. You may do so.

(Memory unit 13)
First, in the example shown in FIG. 5, various data such as the following are held in the storage unit 13 in the defibrillation catheter 1. That is, for example, the above-mentioned identification information 131, the above-mentioned usage status information 132, the above-mentioned use date / time information 133, the above-mentioned information on the number of times N of the defibrillation catheter 1 has been used, and the predetermined defibrillation information IDEF. However, each is retained.

As shown in FIG. 5, the use date / time information 133 includes, for example, the first use start date / time dts of the defibrillation catheter 1 (at the time of the first connection) and the second and subsequent use date / time information of the defibrillation catheter 1 (at the time of the first connection). The start date and time of use (dtn at the time of each connection) is included. Further, the defibrillation information IDE is information that is also used for analysis when a problem occurs, and includes, for example, the following information. That is, for example, the date and time during defibrillation (date and time information Idt1 described above), the number of times defibrillation, the voltage value during defibrillation, the defibrillation time, and the impedance value during defibrillation (resistance value R described above). , And the Joule set value at the time of defibrillation are included as the defibrillation information Idef.

(Memory unit 242)
On the other hand, in the example shown in FIG. 6, various data such as the following are stored in the storage unit 242 in the power supply device 2. That is, for example, the above-mentioned identification information 131, various threshold values (threshold time Δtth1, notification threshold value Δth2, and threshold number Nth) described later, and the above-mentioned defibrillation information IDEF are held, respectively.

[Operation and action / effect]
(A. Basic operation)
In this defibrillation catheter system 3, the tip end side of the shaft 11 of the defibrillation catheter 1 is inserted into the body of the patient 9 through a blood vessel, for example, during defibrillation treatment (defibrillation processing) during cardiac catheterization. (See Fig. 1). At this time, the shape of the shaft 11 inserted into the body of the patient 9 near the tip region P1 is deflected in response to the operation of the handle 12 by the operator (doctor) of the defibrillation catheter 1. Specifically, when the rotating plate 122 is rotated by the operator's finger along, for example, the rotation direction d1 indicated by the arrow in FIG. 2, the operating wire 80 is moved to the proximal end side in the shaft 11. Be pulled. As a result, the vicinity of the tip region P1 of the shaft 11 is curved along, for example, the direction d2 indicated by the arrow in FIG.

(A-1. Defibrillation processing)
Here, when the defibrillation process described above is performed, the defibrillation is performed from the power supply device 2 (power supply unit 22) with respect to the electrode groups 111G and 112G (ring-shaped electrodes 111 and 112) of the defibrillation catheter 1. A DC voltage Vdc is supplied as electrical energy for this purpose. Specifically, the output circuit 241 in the power supply device 2 has different polarities for these electrode groups 111G and 112G (when one electrode group has a negative electrode, the other electrode group has a positive electrode). The DC voltage Vdc is output from. In this way, the DC voltage Vdc in which the electrode groups 111G and 112G have different polarities is directly directed from the tip region P1 of the defibrillation catheter 1 inserted into the body of the patient 9 to the heart of the patient 9. By being applied as electrical energy, defibrillation processing is performed electrically.

In the defibrillation process using such a defibrillation catheter system 3 (defibrillation catheter 1), for example, an AED (Automated External Defibrillator), which is a device that supplies electrical energy from outside the patient's body, is used. Compared with defibrillators), for example, there are the following advantages. That is, first, electrical energy is directly applied to the fibrillated heart by the electrode groups 111G and 112G of the defibrillation catheter 1 arranged in the heart cavity, so that the defibrillation treatment can be performed. Necessary and sufficient electrical stimulation (electric shock) can be reliably supplied only to the heart. As a result, it becomes possible to perform more effective (efficient) defibrillation processing as compared with the case where, for example, the above-mentioned AED or the like is used. In addition, since electrical energy is directly applied to the heart, unlike the case where the above-mentioned AED or the like is used, for example, the body surface of the patient 9 is not burned. It is also possible to reduce the invasiveness to the patient.

(A-2. Electrocardiographic potential measurement processing)
On the other hand, when measuring the electrocardiographic potential of the patient 9, the biometric measurement mechanism 6 (electrode pad 61) attached to the body surface of the patient 9 or the electrode of the defibrillation catheter 1 inserted into the body of the patient 9 The electrocardiographic potential is measured using (ring-shaped electrodes 111, 112, 113) and the like (see FIG. 1). Alternatively, another electrode catheter (inserted into the heart chamber of the patient 9) different from the defibrillation catheter 1 may be used to measure the electrocardiographic potential of the patient 9. Of the electrocardiographic information obtained in this way, the electrocardiographic signal Sc1 is supplied into the power supply device 2 via the above-mentioned electrocardiograph 4 and the input terminal Tin1 of the power supply device 2 (FIG. FIG. 1). Further, among the obtained electrocardiographic potential information, the electrocardiographic potential signals Sc1, Sc0a, Sc0b are supplied to the electrocardiogram display device 5 (see FIG. 1). Then, the electrocardiographic waveform based on these electrocardiographic signals is displayed on the display unit 25 in the power supply device 2 and the electrocardiogram display device 5, so that the operator (engineer or the like) of the power supply device 2 or the defibrillation catheter can be displayed. It will be appropriately monitored by the operator (doctor) of 1.

(B. Details of defibrillation processing)
Next, the details of the defibrillation treatment (defibrillation treatment) described above will be described with reference to FIGS. 7 to 11.

(B-1. Overall processing)
FIG. 7 is a flow chart showing an example of the entire defibrillation process in the defibrillation catheter system 3 of the present embodiment. FIG. 8 is a flow chart showing an example of detailed processing in step S11 (processing for determining the effectiveness of use of the defibrillation catheter 1 described later) shown in FIG. 7. Further, FIGS. 9 to 11 schematically show examples of various operation states described later in a block diagram during the defibrillation process.

In the defibrillation process of the present embodiment shown in FIG. 7, when the power supply of the power supply device 2 is turned on (ON), first, the clock units 243a, 243b (date and time information Idt1, Idt2) in the power supply device 2 are used. Confirmation (self-check) of the normality of the function (RTC function) is performed (step S10). When it is confirmed that such a function is abnormal, the function is stopped and a series of processes shown in FIG. 7 is terminated.

Next, the determination unit 246 in the power supply device 2 performs the above-mentioned determination process of the effectiveness of the use of the defibrillation catheter 1 (step S11). A detailed processing example of such use effectiveness determination processing will be described later (FIG. 8).

Subsequently, the positions of the electrodes (ring-shaped electrodes 111, 112, 113) of the defibrillation catheter 1 in the body of the patient 9 are confirmed by using an X-ray image or the like (step S12).

Next, the measurement process of the electrocardiographic potential of the patient 9 is performed, for example, as shown in FIG. 9 (step S13). That is, in this example, by setting the defibrillation catheter system 3 to the "electrocardiographic potential measurement mode", the electrocardiographic potential measurement process is performed as follows. Further, subsequently, the gain setting at the time of the predetermined gain adjustment is performed in response to the operation of the input unit 21 by the operator (engineer or the like) of the power supply device 2 (step S14).

In the "electrocardiographic measurement mode" shown in FIG. 9, first, the electrocardiographic signal Sc1 measured by the biometric measurement mechanism 6 (electrode pad 61) is input to the power supply device 2 by the following route. That is, the electrocardiographic signal Sc1 thus obtained is input to the input terminal Tin1 of the power supply device 2 via the electrocardiograph 4. Then, with respect to the electrocardiographic signal Sc1 input to the power supply device 2, the above-mentioned gain adjustment is performed in the arithmetic processing unit 24, and the electrocardiographic waveform based on the electrocardiographic signal Sc1 after such gain adjustment is displayed on the display unit. It is displayed at 25. Further, the electrocardiographic waveform based on the electrocardiographic signal Sc1 input to the electrocardiograph 4 is displayed on the electrocardiogram display device 5.

At this time, as shown in FIG. 9, the electrocardiographic signal Sc0a measured by the electrode groups 111G and 112G (ring-shaped electrodes 111 and 112) of the defibrillation catheter 1 is the input terminal Tin2 of the power supply device 2. , It is supplied to the electrocardiograph 4 via the switching unit 23 and the output terminal Tout2 in this order. On the other hand, as shown in FIG. 9, the electrocardiographic signal Sc0b measured by the electrode group 113G (ring-shaped electrode 113) of the defibrillation catheter 1 sets the input terminal Tin2 and the output terminal Tout2 of the power supply device 2 in this order. It is supplied to the electrocardiograph 4 via (without passing through the switching unit 23). The electrocardiographic signals Sc0a and Sc0b supplied to the electrocardiograph 4 in this way are output to the electrocardiogram display device 5, respectively, and the electrocardiographic waveforms based on these electrocardiographic signals Sc0a and Sc0b are generated by the electrocardiogram display device 5. It is displayed in.

Subsequently, the input signal Sin is supplied to the arithmetic processing unit 24 by the operation to the input unit 21 (for example, the input operation to the mode changeover switch) by the operator (engineer or the like) of the power supply device 2, thereby defibrillating. The "defibrillation mode" for executing the motion is set (step S15).

Then, for example, as shown in FIG. 10, the measurement process of the resistance value R between the electrode groups 111G and 112G in the defibrillation catheter 1 is performed (step S16). That is, when the defibrillation catheter system 3 is set to the "resistance measurement mode", the resistance value R is measured as follows.

Specifically, first, as shown in FIG. 10, the resistance value R measured by the electrode groups 111G and 112G (ring-shaped electrodes 111 and 112) of the defibrillation catheter 1 is the input terminal of the power supply device 2. It is supplied to the arithmetic processing unit 24 via the Tin 2 and the switching unit 23 in this order. Then, the information of the resistance value R thus obtained is displayed on the display unit 25.

At this time, as shown in FIG. 10, the electrocardiographic signal Sc1 measured by the biometric measurement mechanism 6 (electrode pad 61) continues to pass through the electrocardiograph 4, and the input terminal Tin1 of the power supply device 2 continues. And is input to the electrocardiogram display device 5. Then, the electrocardiographic waveform based on the gain-adjusted electrocardiographic signal Sc1 described above is continuously displayed on the display unit 25, and the electrocardiographic waveform based on the electrocardiographic signal Sc1 is continuously displayed on the electrocardiogram display device 5. Is displayed.

At this time, as shown in FIG. 10, the electrocardiographic signal Sc0b measured by the electrode group 113G (ring-shaped electrode 113) of the defibrillation catheter 1 also continues to be the input terminal Tin2 of the power supply device 2 and It is supplied to the electrocardiograph 4 via the output terminal Tout2 in this order (without passing through the switching unit 23). Then, the electrocardiographic signal Sc0b is output from the electrocardiograph 4 to the electrocardiogram display device 5, and the electrocardiographic waveform based on the electrocardiographic signal Sc0b is displayed on the electrocardiogram display device 5.

Next, the arithmetic processing unit 24 in the power supply device 2 determines whether or not the resistance value R thus obtained is within a predetermined range defined by the predetermined threshold values Rth1 and Rth2 (Rth2> R). > Whether or not Rth1 is satisfied) is determined (step S17). Here, when it is determined that the resistance value R does not fall within the predetermined range (corresponding to R ≧ Rth2 or Rth1 ≧ R) (step S17: N), the electrode groups 111G and 112G of the defibrillation catheter 1 However, it means that the patient 9 is not reliably abutted on a predetermined site in the body (for example, the duct wall of the coronary vein or the inner wall of the right atrium). Therefore, in this case, the process returns to step S12 described above, and the positions of the electrodes (ring-shaped electrodes 111, 112, 113) are confirmed again using an X-ray image or the like. In this way, subsequent defibrillation is performed only when the electrode groups 111G and 112G of the defibrillation catheter 1 are reliably in contact with a predetermined site in the body of the patient 9. Therefore, it is possible to perform effective defibrillation treatment.

On the other hand, when it is determined that the resistance value R is within a predetermined range (Satisfying Rth2> R> Rth1) (step S17: Y), as described above, the electrode group 111G of the defibrillation catheter 1 It means that the 112G is reliably in contact with a predetermined site in the body of the patient 9. Therefore, in this case, the input signal Sin is then supplied to the arithmetic processing unit 24 by an operation (for example, an input operation to the applied energy setting switch) to the input unit 21 by an operator (engineer or the like) of the power supply device 2. By doing so, the applied energy at the time of defibrillation is set (step S18). Specifically, the applied energy is set in 1J increments, for example, in the range of 1J (joule) to 30J.

Subsequently, the input signal Sin is supplied to the arithmetic processing unit 24 by the operation to the input unit 21 (for example, the input operation to the charging switch) by the operator (engineer or the like) of the power supply device 2, so that the power supply unit 22 The capacitor inside is charged with energy (electric charge) for defibrillation (step S19).

Then, after the completion of such energy charging, the execution of defibrillation is started (step S20). Specifically, the input signal Sin is supplied to the arithmetic processing unit 24 by an operation (for example, an input operation to the energy application switch) to the input unit 21 by an operator (engineer or the like) of the power supply device 2. The "defibrillation mode" described below is executed. Even in such a "defibrillation mode", for example, a process for confirming the connection of the defibrillation catheter 1 (step S300 in FIG. 8), which will be described later, may be performed periodically. .. By the way, when it is confirmed that the defibrillation catheter 1 is not connected to the power supply device 2 in the middle of the "defibrillation mode", for example, energy discharge processing is performed in the power supply device 2. , The mode shifts to the above-mentioned "electrocardiographic measurement mode".

In this "defibrillation mode", for example, as shown in FIG. 11, a DC voltage Vdc as electrical energy is applied between the electrode groups 111G and 112G in the defibrillation catheter 1, so that the patient 9 Defibrillation is performed in the body.

Specifically, as shown in FIG. 11, the DC voltage Vdc output from the power supply unit 22 in the power supply device 2 connects the output circuit 241 in the arithmetic processing unit 24, the switching unit 23, and the output terminal Tout1 in this order. Via, it is applied between the electrode groups 111G and 112G in the defibrillation catheter 1. At this time, as described above, in the power supply device 2 so that these electrode groups 111G and 112G have different polarities (when one electrode group has a negative electrode, the other electrode group has a positive pole). The DC voltage Vdc is output from the output circuit 241.

At this time, as shown in FIG. 11, the electrocardiographic signal Sc1 measured by the biometric measurement mechanism 6 (electrode pad 61) continues to pass through the electrocardiograph 4, and the input terminal Tin1 of the power supply device 2 continues. And is input to the electrocardiogram display device 5. Then, the electrocardiographic waveform based on the gain-adjusted electrocardiographic signal Sc1 described above is continuously displayed on the display unit 25, and the electrocardiographic waveform based on the electrocardiographic signal Sc1 is continuously displayed on the electrocardiogram display device 5. Is displayed.

At this time, as shown in FIG. 11, the electrocardiographic signal Sc0b measured by the electrode group 113G (ring-shaped electrode 113) of the defibrillation catheter 1 also continues to be the input terminal Tin2 of the power supply device 2 and It is supplied to the electrocardiograph 4 via the output terminal Tout2 in this order (without passing through the switching unit 23). Then, the electrocardiographic signal Sc0b is output from the electrocardiograph 4 to the electrocardiogram display device 5, and the electrocardiographic waveform based on the electrocardiographic signal Sc0b is displayed on the electrocardiogram display device 5.

At this time, the arithmetic processing unit 24 controls the operation of the power supply unit 22 so that the DC voltage Vdc is applied in synchronization with the electrocardiographic signal Sc1 supplied by the above-mentioned path. In this way, effective defibrillation treatment can be performed by applying the DC voltage Vdc in synchronization with the electrocardiographic waveform (R wave which is the maximum peak) input to the arithmetic processing unit 24. It will be possible.

Next, after the elapse of a predetermined time, the arithmetic processing unit 24 stops the output of the DC voltage Vdc from the power supply unit 22, so that the execution of defibrillation in the patient 9 is stopped (step S21). ..

Subsequently, the application record (recording of the electrocardiographic waveform, etc.) at the time of defibrillation is temporarily (for example, 5 seconds) displayed on the display unit 25 of the power supply device 2 (step S22). Specifically, for example, at least a part of the above-mentioned defibrillation information IDEF will be displayed on the display unit 25.

Next, the above-mentioned "electrocardiographic potential measurement mode" (see step S13, FIG. 9) is set again. As a result, the electrocardiographic waveform based on the gain-adjusted electrocardiographic signal Sc1 is displayed again on the display unit 25, and the electrocardiographic waveform based on the electrocardiographic signals Sc1, Sc0a, Sc0b is displayed on the electrocardiogram display device 5. It will be displayed again. That is, the electrocardiographic waveform after the defibrillation described above is executed is displayed (step S23).

Then, the electrocardiographic waveform after such defibrillation is observed, and it is determined whether or not it is normal (step S24). If it is determined that the condition is not normal (atrial fibrillation has not subsided) (step S24: N), the process returns to step S15 described above and proceeds to defibrillation again. On the other hand, when it is determined to be normal (step S24: Y), the series of defibrillation processes shown in FIG. 7 ends.

(B-2. Details of the process for determining the effectiveness of use)
Subsequently, with reference to FIG. 8, a detailed processing example of the above-mentioned detailed processing example of the determination processing of the effectiveness of the use of the defibrillation catheter 1 (step S11 in FIG. 7) will be described. In the stage before such determination processing is performed, the above-mentioned reception of the operation by the operator in the input unit 21 (for example, the operation for executing the power supply for definement by the power supply unit 22) is invalid. It is assumed that it has been converted.

In the determination process of the present embodiment shown in FIG. 8, first, the confirmation process of the connection (connection state) of the defibrillation catheter 1 to the power supply device 2 is performed (step S300). That is, it is determined whether or not the defibrillation catheter 1 is connected to the power supply device 2 (whether it is in a connected state or in a non-connected state). Here, when it is determined that the defibrillation catheter 1 is in the connected state (step S300: Y), the process proceeds to step S302, which will be described later. On the other hand, when it is determined that the defibrillation catheter 1 is in a non-connected state (step S300: N), "Disconnected" is displayed on the display unit 25 (step S301), and the process returns to step S300. It should be noted that such a process of confirming the connection of the defibrillation catheter 1 may be performed periodically thereafter.

Next, in step S302 described above, the reading unit 245 in the power supply device 2 holds various data (for example, the above-mentioned identification information 131, usage status information 132, etc.) in the storage unit 13 in the defibrillation catheter 1. The usage date / time information 133 and the number of times of use N (each information, etc.) are read out. Then, the determination unit 246 in the power supply device 2 determines whether or not the read identification information 131 is legitimate information (step S303).

Here, when it is determined that the identification information 131 is non-regular information, or when it is determined that the above-mentioned reading error of various data has occurred (step S303: N), the process proceeds to step S305 described later. Will proceed. On the other hand, when it is determined that the identification information 131 is legitimate information (step S303: Y), the determination unit 246 then determines the content of the read usage status information 132 (step S304). ).

Here, when it is determined that the content of the usage status information 132 is different from the preset specification (outside the specification), the determination unit 246 determines that the use of the defibrillation catheter 1 is "invalid". Is determined, and "Invalid device connected" is displayed on the display unit 25 (step S305). Then, in this case, the execution permission unit 247 maintains the invalidation of the reception of the operation for executing the defibrillation described above (step S306). Therefore, even if the operator performs an operation on the input unit 21, the power supply for defibrillation is not continuously executed, and the electrical defibrillation by the defibrillation catheter 1 is not executed either.

After that, the process returns to step S300 described above, and the confirmation process of the connection of the defibrillation catheter 1 is performed again. However, in the case of returning from step S306 to step S300 in this way, if it is determined that the defibrillation catheter 1 is in the connected state (step S300: Y), the process does not proceed to step S302 described above. Then, the process returns to step S300. That is, in this case, the data in the storage unit 13 is not read (step S302), and the invalidation of the reception of the operation for executing the defibrillation described above is maintained. This point is the same in the modified example (FIG. 12 of the modified example 1) described later.

On the other hand, if it is determined in step S304 that the content of the usage status information 132 indicates "use prohibited", the process proceeds to step S313 described later.

If it is determined in step S304 that the content of the usage status information 132 indicates "unused" or "in use", the determination unit 246 then determines the content of the usage status information 132. However, it is determined whether or not it indicates "unused" (step S307).

Here, when it is determined that the content of the usage status information 132 indicates "unused" (step S307: Y), the following processes are then performed (step S308). ). That is, first, the date and time information Idt2 at that time is written to the storage unit 13 in the defibrillation catheter 1 (writing to the above-mentioned use date and time information 133) as the above-mentioned (first) use start date and time dts. Further, the update process is performed so that the content of the usage status information 132 in the storage unit 13 is changed from the current "unused" to "used". After that, the determination unit 246 determines that the use of the defibrillation catheter 1 is "effective", and the display unit 25 displays "Valid device connected" (step S309). Next, in this case, the execution permission unit 247 activates the reception of the operation for executing the defibrillation described above (step S310). As a result, when the operator performs an operation on the input unit 21, power supply for defibrillation is executed, and electrical defibrillation by the defibrillation catheter 1 is executed. Then, in this case, the series of processes (process for determining the effectiveness of use) shown in FIG. 8 is completed, and the process proceeds to step S12 in FIG. 7 described above. The connection confirmation process of the defibrillation catheter 1 described above may also be performed at a time point after step S309 described above.

On the other hand, when it is determined that the content of the usage status information 132 described above indicates "in use" (step S307: N), then the out-licensing unit 244 in the power supply device 2 is described as follows. Then, the above-mentioned elapsed time Δt1 (elapsed time from the start of use of the defibrillation catheter 1) is derived (step S311). That is, the derivation unit 244 derives such an elapsed time Δt1 by using the date and time information Idt2 at that time and the read date and time information 133 (use start date and time dts). Specifically, the out-licensing unit 244 derives the elapsed time Δt1 by subtracting the use start date and time dts from the date and time information Idt2 at that time (Δt1 = Idt2-dts).

In this case, for example, when the read use start date and time dts is abnormal information (for example, the read use start date and time dts is in the future than the date and time information Idt2 at that time. If it is the date and time, etc.), the process may proceed to step S305 described above. That is, the use of the defibrillation catheter 1 may be determined to be "invalid" and may be displayed as "Invalid device connected" on the display unit 25.

Subsequently, the determination unit 246 determines whether or not the elapsed time Δt1 thus derived is within the above-mentioned threshold time Δtth1 (whether or not Δt1 ≦ Δtth1 is satisfied) (step S312). .. An example of this threshold time Δth1 is 24 hours (1 day), but the present invention is not limited to this example, and any value can be set.

Here, if it is determined that the elapsed time Δt1 is within the threshold time Δth1 (satisfying Δt1 ≦ Δth1) (step S312: Y), the process proceeds to step S309 described above. That is, even in this case, it is determined that the use of the defibrillation catheter 1 is "effective", and "Valid device connected" is displayed on the display unit 25. Then, after the acceptance of the operation for executing the defibrillation is enabled (step S310), the process proceeds to step S12 of FIG. 7 described above.

On the other hand, when it is determined that the elapsed time Δt1 exceeds the threshold time Δth1 (satisfies Δt1> Δth1) (step S312: N), the following processing is then performed. That is, in the storage unit 13 in the defibrillation catheter 1, the update process is performed so that the content of the usage status information 132 is changed from the current "in use" to "prohibition of use" (step S313). Then, the determination unit 246 determines that the use of the defibrillation catheter 1 is "invalid" when the period expires, and displays "Expiry device connected" on the display unit 25 (step S314). After that, the process proceeds to step S306 described above. That is, after the execution permission unit 247 maintains the invalidation of the reception of the operation for executing the defibrillation, the process returns to step S300 described above, and the confirmation process of the connection of the defibrillation catheter 1 is performed again. It will be.

(B-3. Action / effect)
In this way, in the defibrillation catheter system 3 of the present embodiment, for example, the following actions and effects can be obtained.

(About clocks 243a and 243b)
First, in the present embodiment, the power supply device 2 is provided with a clock unit 243a for outputting the date and time information Idt1 and a clock unit 243b for outputting the date and time information Idt2, respectively. The date and time information Idt1 is information whose settings can be changed at any time according to the operation by the operator, while the date and time information Idt2 is restricted from changing the settings according to the operation by the operator. Therefore, by utilizing these two types of date and time information Idt1 and Idt2, in this catheter system (defibrillation catheter system 3), for example, various processes as described above can be easily realized. Therefore, in the present embodiment, it is possible to improve the convenience of the defibrillation catheter system 3.

Further, in the present embodiment, when the setting of the date and time information Idt2 can be changed according to the operation by the operator only when the power supply device 2 is started for the first time, it is as follows. Become. That is, since the setting change for the date and time information Idt2 is permitted only at the first startup of the power supply device 2, the tolerance of the setting change is maintained while maintaining the restriction of the setting change after the first startup. Will be secured at a minimum. Therefore, such date and time information Idt2 becomes easy to use, and various processes in the defibrillation catheter system 3 can be realized more easily. As a result, it is possible to further improve convenience.

Further, in the present embodiment, when the setting change of the date and time information Idt2 according to the operation by the operator is made impossible at all, it becomes as follows. That is, since the setting change of the date and time information Idt2 is completely restricted, it becomes easy to realize the process using the restriction of the setting change of the date and time information Idt2. As a result, it is possible to further improve convenience.

In addition, in the present embodiment, the date and time information Idt1 in the clock unit 243a is the date and time information set in another device different from the power supply device 2 (for example, the date and time information set in the electrocardiograph 4). When it is possible to set so as to match Idt3), the result is as follows. That is, for example, the process using the date and time information Idt1 in the power supply device 2 can be executed while synchronizing with the process using the date and time information (for example, the date and time information Idt3) in another device. As a result, it is possible to further improve convenience.

Further, in the present embodiment, the lead-out unit 244 for deriving the elapsed time Δt1 and Δt2 described above is provided in the power supply device 2, so that the result is as follows. That is, by using the elapsed time Δt2 (the elapsed time of the power supply device 2 from the initial setting of the date and time information Idt2), for example, the maintenance time of the power supply device 2 itself and its internal parts (for example, a battery) can be grasped. For example, the display unit 25, the voice output unit 26, and the like can be used to give a notification (warning, etc.) to the operator (user). Specifically, when the elapsed time Δt2 exceeds the above-mentioned notification threshold value Δts2 (Δt2> Δth2), such a notification operation (warning operation or the like) may be performed. Further, by using the elapsed time Δt1 (the elapsed time from the start of use of the defibrillation catheter 1), for example, the expiration date of the defibrillation catheter 1 can be grasped, and the defibrillation catheter 1 can be used. It is possible to limit it. As a result, it is possible to further improve convenience.

(Regarding the process of determining the effectiveness of use)
Further, in the present embodiment, the unique identification information 131 held in the defibrillation catheter 1 is read out on the power supply device 2 side, and the defibrillation catheter is based on the unique identification information 131. Since the effectiveness regarding the use of 1 is judged, it becomes as follows. That is, by utilizing the unique identification information 131 in the defibrillation catheter 1, it becomes possible to easily obtain a determination result as to whether or not the use of the defibrillation catheter 1 is effective. Specifically, first, defibrillation catheters generally apply electrical energy directly to the fibrillated heart, so non-regular defibrillation catheters (eg, degraded products, counterfeit products, etc.) ) May not provide effective defibrillation treatment. Specifically, in the case of electrical defibrillation processing using a defibrillation catheter, a very high DC voltage (corresponding to the above-mentioned DC voltage Vdc) is generally applied. Therefore, for example, the above When a non-regular defibrillation catheter such as a deteriorated product or a counterfeit product is used, it may be difficult to realize an effective defibrillation treatment. On the other hand, in the present embodiment, as described above, it becomes possible to easily obtain a determination result as to whether or not the use of the defibrillation catheter 1 is effective, and thus such an irregularity. The use of the defibrillation catheter 1 can be effectively eliminated. Therefore, in this embodiment, it is possible to improve the convenience of the defibrillation catheter system 3 in this respect as well.

Further, in the present embodiment, when the determination unit 246 determines that the above-mentioned identification information 131 is non-regular information, it determines that the use of the defibrillation catheter 1 is invalid, and the identification information. When 131 is determined to be legitimate information, the effectiveness regarding the use of the defibrillation catheter 1 is determined in consideration of the above-mentioned elapsed time Δt1, and the elapsed time Δt1 is within the threshold time Δtth1. In some cases, the use of the defibrillation catheter 1 was determined to be effective, so that the result is as follows. That is, even when the identification information 131 is legitimate information, the effectiveness of using the defibrillation catheter 1 is determined in consideration of the elapsed time Δt1 (the elapsed time from the start of use of the defibrillation catheter 1). Therefore, the effectiveness of use can be judged more effectively. As a result, it is possible to further improve convenience.

In addition, in the present embodiment, when the above-mentioned identification information 131 is determined to be legitimate information and the above-mentioned elapsed time Δt1 exceeds the threshold time Δth1, the defibrillation catheter 1 is used. Is determined to be invalid, so it becomes as follows. That is, even if the identification information 131 is legitimate information, if the elapsed time Δt1 exceeds the threshold time Δth1, it is determined that the use of the defibrillation catheter 1 is invalid, and therefore the expiration date is exceeded. It becomes possible to effectively eliminate the use of the defibrillation catheter 1 which is a deteriorated product. As a result, the convenience can be further improved.

Further, in the present embodiment, the usage status information 132 of the defibrillation catheter 1 held in the defibrillation catheter 1 is read out, and the above-mentioned identification information 131 is legitimate information. If it is determined that there is, and the read usage status information 132 indicates that it is not in use, it is determined that the use of the defibrillation catheter 1 is effective, and the read usage status information is read. When 132 indicates that the catheter is in use, the effectiveness regarding the use of the defibrillation catheter 1 is determined in consideration of the elapsed time Δt1 described above, so that the result is as follows. That is, even when such usage status information 132 indicates that the catheter is in use, the defibrillation catheter 1 is used in consideration of the elapsed time Δt1 (the elapsed time from the start of use of the defibrillation catheter 1). Since the effectiveness regarding the use is determined, the effectiveness regarding the use can be determined more effectively. As a result, it is possible to further improve convenience.

Further, in the present embodiment, it is effective to use the input unit 21 described above, the output unit (display unit 25 and voice output unit 26) that outputs the determination result by the determination unit 246, and the defibrillation catheter 1. Only when it is determined, the power supply device 2 is provided with an execution permission unit 247 that enables the reception of the operation by the operator (the operation for executing the power supply by the power supply unit 22) at the input unit 21. Since I made it so, it becomes as follows. That is, the operator (user) can easily grasp the determination result by the determination unit 246. Further, since the acceptance of the above-mentioned operation by the operator is valid only when it is determined that the use of the defibrillation catheter 1 is effective, the use of the non-regular defibrillation catheter 1 is further promoted. You will be able to eliminate it effectively. As a result, it is possible to further improve convenience.

In addition, in the present embodiment, when the encrypted information is used as the identification information 131 described above, the result is as follows. That is, since the above-mentioned identification information 131 is encrypted information, the confidentiality (confidentiality) of the identification information 131 is increased, and for example, misuse of the identification information 131 by another person can be easily prevented. become. As a result, it is possible to further improve convenience.

<2. Modification example>
Subsequently, modification examples (modification examples 1 to 3) of the above-described embodiment will be described. Each of these modifications 1 to 3 corresponds to the modifications related to the process of determining the effectiveness of the use of the defibrillation catheter 1 (see FIG. 8) described in the embodiment. Specifically, in the determination process described in the embodiment, the determination process is performed when the information on the number of times N of the defibrillation catheter 1 is used is not taken into consideration. However, the determination process of the modified examples 1 to 3 described below is performed. Each of these is a determination process when the information of the number of times of use N is taken into consideration. In the following, the same components as those in the embodiment are designated by the same reference numerals, and the description thereof will be omitted as appropriate.

[Modification 1]
(Judgment processing of effectiveness of use)
FIG. 12 is a flow chart showing a detailed processing example of the processing for determining the effectiveness of the use of the defibrillation catheter 1 according to the modified example 1. In FIG. 12, the processing of the portion changed from FIG. 8 described in the embodiment (steps S401, S402, S408 described later) and the processing of the portion related to the processing of the modified portion are extracted. Since the processing of other parts is the same as the processing shown in FIG. 8, the illustration is omitted.

In the determination process of the present modification shown in FIG. 12, first, as a premise, the process of step S408 described below is performed instead of step S308 in the determination process of the embodiment shown in FIG. That is, in the same manner as in step S308, the date and time information Idt2 at that time is written to the storage unit 13 as the (first) use start date and time dts, and the content of the usage status information 132 in the storage unit 13 is changed. The update process is performed so that the current "unused" is changed to "in use". In addition, in this step S408, the renewal process is performed so that the value of the number of times N of the defibrillation catheter 1 used in the storage unit 13 becomes "+1" (increases by one).

Further, in the determination process of this modification, when it is determined in step S312 described above that the elapsed time Δt1 described above exceeds the threshold time Δth1 (step S312: N), then the following process is performed. Is done. That is, in this modification, unlike the embodiment (FIG. 8), the content of the usage status information 132 is not immediately changed from "in use" to "prohibited to use". Specifically, in this case, the determination unit 246 then determines whether or not the number of uses N read in step S302 is within the above-mentioned threshold number Nth (whether or not N ≦ Nth is satisfied). The determination is made (step S401). An example of the threshold number Nth is 5 times, but the present invention is not limited to this example, and any value can be set.

Here, when it is determined that the number of uses N is within the threshold number Nth (satisfying N ≦ Nth) (step S401: Y), the following processes are then performed (step S402). .. That is, first, the renewal process is performed so that the value of the number of times of use N in the storage unit 13 of the defibrillation catheter 1 becomes "+1". Further, the date and time information Idt2 at that time overwrites the storage unit 13 (overwrites the above-mentioned use date and time information 133) as the above-mentioned (first) use start date and time dts.

By overwriting the use start date and time dts in this way, when the defibrillation catheter 1 is connected next time, the above-mentioned progress is made by using the use start date and time dts after the overwriting in step S311. The time Δt1 (elapsed time from the start of use of the defibrillation catheter 1) will be derived. As a result, in the subsequent step S312, if the elapsed time Δt1 is within the threshold time Δtth1 (step S312: Y), it is determined that the use of the defibrillation catheter 1 is “effective” (step S309). become.

After the above-mentioned step S402, the process proceeds to the above-mentioned step S309. That is, it is determined that the use of the defibrillation catheter 1 is "effective", and "Valid device connected" is displayed on the display unit 25. Then, after the acceptance of the operation for executing defibrillation is enabled (step S310), the series of processes shown in FIG. 12 (determination process of effectiveness of use) is completed, and the step of FIG. 7 described above is completed. It will proceed to S12.

On the other hand, if it is determined that the number of uses N exceeds the threshold number Nth (satisfies N> Nth) (step S401: N), the process proceeds to step S313 described above. That is, in the storage unit 13 in the defibrillation catheter 1, the update process is performed so that the content of the usage status information 132 is changed from the current "in use" to "prohibition of use". After that, the process proceeds to step S314 described above. That is, the use of the defibrillation catheter 1 is determined to be "invalid" by the expiration of the period, and "Expiry device connected" is displayed on the display unit 25. Then, the execution permission unit 247 maintains the invalidation of the reception of the operation for executing the defibrillation (step S306 described above), and then returns to the step S300 described above to confirm the connection of the defibrillation catheter 1. The process will be performed again.

(Action / effect)
In this way, in this modification, in addition to (or instead of) the actions and effects described in the above-described embodiment, for example, the following actions and effects can be obtained.

That is, first, in this modification, the information on the number of times N of the defibrillation catheter 1 used in the defibrillation catheter 1 is read out, and the identification information 131 is regular information. If it is determined that there is, and the above-mentioned elapsed time Δt1 exceeds the threshold time Δtth1, the defibrillation catheter 1 is taken into consideration in consideration of the information of the number of times N of the defibrillation catheter 1 that has been read out. Since the validity of the use of is judged, it becomes as follows. That is, even when the above-mentioned identification information 131 is legitimate information and the elapsed time Δt1 (elapsed time from the start of use of the defibrillation catheter 1) exceeds the threshold time Δts1, the defibrillation catheter 1 is used. Taking into account the information on the number of times N, the effectiveness of the defibrillation catheter 1 for use will be determined. Therefore, the effectiveness regarding the use of the defibrillation catheter 1 can be more effectively determined by adding the information of both the elapsed time Δt1 and the number of times of use N. As a result, in this modified example, it is possible to further improve the convenience.

Further, in this modification, when the above-mentioned elapsed time Δt1 exceeds the threshold time Δts1 and the above-mentioned number of uses N is within the threshold number Nth, it is considered that the use of the defibrillation catheter 1 is effective. When the determination is made and the number of uses N exceeds the threshold number Nth, it is determined that the use of the defibrillation catheter 1 is invalid, so that the result is as follows. That is, the use of the defibrillation catheter 1 which is a deteriorated product exceeding the expiration date and the limit of the number of times of use by considering the balance between the elapsed time Δt1 and the number of times of use N and the threshold time Δtth1 and the number of times of use Nth. Can be eliminated more effectively. As a result, in this modified example, the convenience can be further improved.

[Modifications 2 and 3]
Subsequently, the modifications 2 and 3 corresponding to the determination process in which only a part of the modification process 1 (determination process shown in FIG. 12) is changed will be described. In these modified examples 2 and 3, basically, the same actions and effects as those in the above-mentioned modified example 1 can be obtained.

First, in the determination process of the second modification, in step S311 in FIG. 12, the above-mentioned elapsed time Δt1 (defibrillation catheter 1) is used instead of the above-mentioned (first) use start date and time dts. Elapsed time from the start of use) is derived. That is, in this modification 2, instead of the above-mentioned use start date and time dts, the "latest" in the storage unit 13 of the above-mentioned second and subsequent use start date and time dts (at the time of each connection) (see FIG. 5). The above-mentioned elapsed time Δt1 is derived by using the information of “use start date and time dtn” (Δt1 = Idt2-dtn). Specifically, for example, when each information (information on the start date and time of use) of "dts, dt1, dt2, dt3, dt4" is held in the storage unit 13, among these pieces of information, The elapsed time Δt1 is derived by using the information of the latest use start date and time “dt4” (use start date and time at the time of the fourth connection). In other words, in this modification 2, the information having the largest value of "n" (number of connections) among the use start date and time dtn held in the storage unit 13 is used.

The above-mentioned use start date and time dtn is set as follows at the time when the value of the number of times N (see FIG. 5) of the defibrillation catheter 1 used is increased by 1 (becomes "+1"). It is designed to be written in the storage unit 13. That is, the date and time information Idt2 at such a time point is written to the storage unit 13 (writing to the above-mentioned use date and time information 133) as the use start date and time dtn. This point is the same in the modified example 3 described below.

On the other hand, in the determination process of the modification example 3, in step S311 in FIG. 12, the above-mentioned elapsed time Δt1 is derived by using the following information instead of the (first) use start date and time dts. That is, in this modification 3, instead of the use start date and time dts, the “number of times the defibrillation catheter 1 is used N (FIG. The elapsed time Δt1 is derived by using the information of the "use start date and time dtn" corresponding to (see 5) (Δt1 = Idt2-dtn). Specifically, for example, when the number of times of use N read from the storage unit 13 is the information indicating the fourth time, the information of "dt4" which is the start date and time of use corresponding to the number of times of use N is used. Using this, the elapsed time Δt1 is derived.

In such modifications 2 and 3, if the elapsed time Δt1 based on the above-mentioned use start date and time dtn is within the threshold time Δth1 in step S312 after the above-mentioned step S311 (step S312: Y). It becomes as follows. That is, the use of the defibrillation catheter 1 is determined to be "effective" (step S309), and the acceptance of the operation for performing the defibrillation is activated (step S310).

<3. Other variants>
Although the present invention has been described above with reference to some embodiments and modifications, the present invention is not limited to these embodiments and the like, and various modifications are possible.

For example, the material and the like of each member described in the above-described embodiment and the like are not limited, and other materials may be used. Further, in the above-described embodiment and the like, the configuration of the defibrillation catheter 1 has been specifically described, but it is not always necessary to include all the members, and other members may be further provided. Specifically, for example, a leaf spring that can be deformed in the bending direction may be provided as a swinging member inside the shaft 11. Further, the configuration of the electrodes on the shaft 11 (arrangement, shape, number, etc. of the ring-shaped electrode and the tip electrode) is not limited to those mentioned in the above-described embodiment. Further, the configuration (shape, arrangement, material, number, etc.) of each member in the defibrillation catheter 1 is not limited to that described in the above embodiment, but may be other shapes, arrangements, materials, numbers, etc. There may be. In addition, the values, ranges, magnitude relationships, etc. of the various parameters described in the above-described embodiment are not limited to those described in the above-described embodiments, but are other values, ranges, magnitude relationships, etc. May be good.

Further, in the above-described embodiment and the like, a defibrillation catheter of a type in which the shape of the shaft 11 in the vicinity of the tip region P1 changes in one direction in response to an operation with the handle 12 has been described as an example. Is not limited. That is, the present invention can be applied to, for example, a type of defibrillation catheter in which the shape of the shaft 11 near the tip region P1 changes in both directions in response to an operation with the handle 12. A plurality of operating wires will be used. The present invention can also be applied to a type of defibrillation catheter in which the shape of the shaft 11 near the tip region P1 is fixed. In this case, an operation wire, a rotating plate 122, etc. Is no longer needed. That is, the handle is composed of only the handle body 121.

Further, in the above-described embodiment and the like, an example in which the biological measurement mechanism 6 is configured by using a plurality of electrode pads (electrode pads 61) has been described, but the present invention is not limited to this example. That is, for example, another electrode catheter (inserted into the heart chamber of the patient 9) different from the defibrillation catheter 1 may be used as the biometric measurement mechanism.

In addition, in the above-described embodiment and the like, the block configuration of the power supply device 2 has been specifically described, but it is not always necessary to include all the blocks described in the above-described embodiment and the like, and other blocks are provided. Further may be provided. Further, the switching operation of the supply path by the switching unit 23 in the power supply device 2 is not limited to the switching operation described in the above-described embodiment and the like, and may be a switching operation using another method. Further, the defibrillation catheter system 3 as a whole may further include other devices in addition to the devices described in the above-described embodiments and the like. Specifically, for example, in some cases, the electrocardiograph 4 and the biometric measurement mechanism 6 (electrode pad 61) may be included in the defibrillation catheter system.

Further, the method for restricting the setting change of the date and time information Idt2 according to the operation by the operator is not limited to the method described in the above-described embodiment or the like, and other methods are used to restrict such setting change. You may try to do it. Further, the usage method of the date and time information Idt1 and Idt2 is not limited to the example of the usage method described in the above-described embodiment and the like (see FIG. 4), and other usage methods may be applied. In addition, in the above-described embodiment and the like, the case where both of the above-mentioned elapsed times Δt1 and Δt2 are derived by the out-licensing unit 244 has been described as an example, but the present invention is not limited to this example, and for example, the progress of these. Only one of the times Δt1 and Δt2 may be derived by the out-licensing unit 244.

Further, in the above-described embodiment and the like, the method of the determination process regarding the effectiveness of the use of the defibrillation catheter 1 in the determination unit 246 has been specifically described and described, but the method is not limited to this example and is not limited to other methods. May be used to perform a determination process relating to the effectiveness of the use of the defibrillation catheter 1. In addition, the types of various data read by the reading unit 245 and the types of various data held in the storage units 13 and 242 are not limited to those described in the above-described embodiment and the like, and other types are also used. It may be the data of. Further, as the process in which the execution is permitted by the execution permission unit 247 (the reception of the operation in the input unit 21 is enabled), the power is supplied from the power supply unit 22 as described in the above embodiment or the like. It is not limited to the processing (for defibrillation execution). That is, for example, both the process for executing such defibrillation and the process for predetermined potential measurement (electrocardiographic measurement, etc.) may be permitted to be executed by the execution permission unit 247.

In addition, in the above-described embodiment and the like, as an example of the "medical device having an electrode" in the present invention, an electrode catheter (defibrillation catheter 1) that is inserted into the heart chamber of the patient 9 to perform electrical defibrillation. ), But it is not limited to this example. That is, other types of "medical devices having electrodes" (for example, ablation devices such as electrode catheters and electrode needles used for ablation of affected areas) are incorporated into the "medical device system" of the present invention. It may be applied.

Further, the series of processes described in the above-described embodiment or the like may be performed by hardware (circuit) or software (program). When it is done by software, the software is composed of a group of programs for executing each function by a computer. Each program may be used by being preliminarily incorporated in the computer, for example, or may be installed and used in the computer from a network or a recording medium.

Furthermore, the various examples described so far may be applied in any combination.

Claims (7)

1. Medical devices with electrodes and
   It is equipped with a power supply device that supplies power to the medical device.
   The power supply unit
   The power supply unit that supplies power and
   A first clock unit that outputs the first date and time information, which can be changed at any time according to the operation by the operator, and
   A medical device system having a second clock unit that outputs second date and time information, for which setting changes according to the operation by the operator are restricted.
2. The medical device system according to claim 1, wherein the setting of the second date and time information can be changed according to the operation by the operator only when the power supply device is started for the first time.
3. The medical device system according to claim 1, wherein the second date and time information cannot be changed at all according to the operation by the operator.
4. A claim that the first clock unit can be set so that the first date and time information matches the third date and time information set in another device different from the power supply device. The medical device system according to any one of claims 1 to 3.
5. The power supply unit
   Using the second date and time information, at least one of the elapsed time of the power supply device from the initial setting of the second date and time information and the elapsed time from the start of use of the medical device can be obtained. The medical device system according to any one of claims 1 to 4, further comprising a derivation unit to be derived.
6. The power supply unit
   A reading unit that reads out unique identification information held in the medical device,
   A determination unit that determines the effectiveness of using the medical device based on the identification information read by the reading unit, and a determination unit.
   The medical device system according to any one of claims 1 to 5, further comprising.
7. The medical device system according to any one of claims 1 to 6, wherein the medical device is a defibrillation catheter that is inserted into a patient's heart cavity to perform electrical defibrillation.

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