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WO2021171540A1 - Système de cathéter de défibrillation - Google Patents

Système de cathéter de défibrillation Download PDF

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Publication number
WO2021171540A1
WO2021171540A1 PCT/JP2020/008250 JP2020008250W WO2021171540A1 WO 2021171540 A1 WO2021171540 A1 WO 2021171540A1 JP 2020008250 W JP2020008250 W JP 2020008250W WO 2021171540 A1 WO2021171540 A1 WO 2021171540A1
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WO
WIPO (PCT)
Prior art keywords
defibrillation catheter
defibrillation
information
unit
determined
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2020/008250
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English (en)
Japanese (ja)
Inventor
小島　康弘
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Japan Lifeline Co Ltd
Original Assignee
Japan Lifeline Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Japan Lifeline Co Ltd filed Critical Japan Lifeline Co Ltd
Priority to PCT/JP2020/008250 priority Critical patent/WO2021171540A1/fr
Priority to JP2022502763A priority patent/JP7307409B2/ja
Publication of WO2021171540A1 publication Critical patent/WO2021171540A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators

Definitions

  • the present invention relates to a defibrillation catheter system comprising a defibrillation catheter and a power supply that supplies power to the defibrillation catheter.
  • a catheter system provided with an electrode catheter is the following defibrillation catheter system (see, for example, Patent Document 1).
  • 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.
  • 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.
  • electrical stimulation for example, electrical energy consisting of DC voltage
  • the defibrillation catheter system described above is generally required to improve convenience when used, for example. It is desirable to provide a defibrillation catheter system that can improve convenience.
  • the defibrillation catheter system provides a defibrillation catheter that is inserted into the patient's heart cavity to perform electrical defibrillation and supplies power to the defibrillation catheter. It is equipped with a power supply device to perform. This power supply device is based on the power supply unit that supplies power, the reading unit that reads out the unique identification information held in the defibrillation catheter, and the identification information read by the reading unit. It has a determination unit for determining the effectiveness of using a defibrillation catheter.
  • the unique identification information held in the defibrillation catheter is read out on the power supply side, and based on the unique identification information. , The effectiveness of the use of the defibrillation catheter is determined. As a result, it becomes possible to easily obtain a determination result as to whether or not the use of the defibrillation catheter is effective by utilizing the unique identification information in the defibrillation catheter. As a result, the use of non-regular defibrillation catheters (eg, degraded or counterfeit products) can be effectively eliminated.
  • non-regular defibrillation catheters eg, degraded or counterfeit products
  • the determination unit determines that the identification information is non-regular information, the use of the defibrillation catheter is invalid. If it is determined that the identification information is legitimate information, the effectiveness of the use of the defibrillation catheter is determined in consideration of the elapsed time from the start of use of the defibrillation catheter. In addition to the determination, if the elapsed time is within the threshold time, it may be determined that the use of the defibrillation catheter is effective.
  • the effectiveness of using the defibrillation catheter is determined in consideration of the elapsed time from the start of use of the defibrillation catheter. Therefore, the effectiveness of use can be judged more effectively. As a result, the convenience is further improved.
  • the determination unit determines that the identification information is legitimate information and the elapsed time exceeds the threshold time
  • the use of the defibrillation catheter is invalid. It may be determined that.
  • the identification information is legitimate information
  • the elapsed time exceeds the threshold time
  • the reading unit further reads out information on the number of times the defibrillation catheter has been used held in the defibrillation catheter, and the determination unit uses the identification information. If it is determined that the information is legitimate and the elapsed time exceeds the threshold time, the information on the number of times the defibrillation catheter has been used read by the reading unit is also taken into consideration. The effectiveness of the use of defibrillation catheters may be determined. In this case, the defibrillation catheter is used in consideration of the information on the number of times the defibrillation catheter has been used even when the elapsed time exceeds the threshold time while the identification information is legitimate information. Since the effectiveness regarding the use of the above is determined, the effectiveness regarding the use can be more effectively determined by adding the information of both the elapsed time and the number of times of use. As a result, the convenience is further improved.
  • the determination unit determines that the use of the defibrillation catheter is effective. However, if the number of times of use exceeds the number of times of use, it may be determined that the use of the defibrillation catheter is invalid. In this case, by considering the balance between the elapsed time and the number of times of use and the threshold time and the number of times of use, the use of a defibrillation catheter that becomes a deteriorated product exceeding the expiration date and the limit of the number of times of use. Can be eliminated more effectively. As a result, the convenience can be further improved.
  • the reading unit further reads out the usage status information of the defibrillation catheter held in the defibrillation catheter.
  • the determination unit determines that the identification information is legitimate information, and the usage status information read by the reading unit indicates that it is not in use, the above exclusion If it is determined that the use of the defibrillation catheter is effective and the usage status information read by the reading unit indicates that the catheter is in use, the defibrillation catheter should be taken into consideration in consideration of the elapsed time. You may want to determine the effectiveness of the use of.
  • the effectiveness regarding the use of the defibrillation catheter is determined in consideration of the above elapsed time, so that the effectiveness regarding the use is determined. , Will be judged more effectively. As a result, the convenience is further improved.
  • the power supply device is determined by the input unit to be operated by the operator, the output unit to output the determination result by the determination unit, and the determination unit to be effective in using the defibrillation catheter.
  • the execution permission unit for enabling the reception of the operation by the operator at the input unit for executing the power supply may be further provided. In this case, the operator (user) can easily grasp the determination result by the determination unit.
  • the reception of the operation at the input unit (the operation for executing the power supply) by the operator is enabled. , The use of non-regular defibrillation catheters can be eliminated more effectively. As a result, the convenience is further improved.
  • encrypted information may be used as the identification information.
  • the identification information since the identification information is encrypted information, the confidentiality (confidentiality) of the identification information is increased, and for example, misuse of the identification information by another person can be easily prevented. Become. As a result, the convenience is further improved.
  • the unique identification information held in the defibrillation catheter is read out on the power supply side, and based on the unique identification information. Since the effectiveness of the defibrillation catheter use has been determined, the use of non-normal defibrillation catheters can be effectively eliminated. Therefore, it is possible to improve the convenience in the defibrillation catheter system.
  • FIG. 1 It is a block diagram which shows typically the whole structure example of the defibrillation catheter 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.
  • FIG. 7 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.
  • FIG. 1 is a schematic block diagram showing an overall configuration example of the defibrillation catheter system 3 according to the 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.
  • 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.
  • 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.
  • 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.
  • a plurality of electrodes are provided in the tip region P1 of such a shaft 11.
  • 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.
  • the electrode group 111G is composed of a plurality of ring-shaped electrodes 111 arranged at intervals from each other.
  • a plurality of ring-shaped electrodes 112 arranged at intervals from each other constitute an electrode group 112G
  • 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.
  • 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.
  • the lead wire is not connected to the tip electrode 110.
  • 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.
  • 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 is preferably, for example, about 1 to 5 mm, and a preferable example is 2 mm.
  • 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 is preferably, for example, about 1 to 5 mm, and a preferable example is 2 mm.
  • 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 is preferably, for example, about 1.0 to 10.0 mm, and a preferable example is 5 mm.
  • 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.
  • 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.
  • the shaft 11 is formed with four lumens L1 to L4 separated from each other.
  • 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.
  • nylon elastomer constituting the outer portion 70 for example, those having different hardness along the axial direction (Z-axis direction) are used.
  • the shaft 11 is configured to gradually increase in hardness from the tip end side to the base end side.
  • 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.
  • a wire 71 is made of, for example, stainless steel, and is a stainless steel wire.
  • 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.
  • the resin layer 73 is a layer that partitions the four lumens L1 to L4, and is made of, for example, a fluororesin.
  • a fluororesin examples 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
  • 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.
  • an operator for example, an engineer or the like
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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).
  • 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).
  • the elapsed time ⁇ t1 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 ⁇ t2 and the elapsed time ⁇ t2 are derived respectively (see FIG. 4).
  • Such a clock unit 243a corresponds to a specific example of the "first clock unit”
  • the clock unit 243b corresponds to a specific example of the "second clock unit”.
  • the date and time information Idt1 corresponds to a specific example of the "first date and time information”
  • the date and time information Idt2 corresponds to a specific example of the "second date and time information”
  • the date and time information Idt3 corresponds to the "third”.
  • the out-licensing unit 244 uses the date and time information Idt2 to obtain the elapsed time ⁇ t1 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. ⁇ t2 and each are derived. The details of such elapsed times ⁇ t1 and ⁇ t2 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.
  • identification information 131 as identification information unique to the defibrillation catheter 1 (information individually assigned to each defibrillation catheter 1) can be mentioned.
  • 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).
  • examples of the above-mentioned various data include usage status information 132 indicating the usage status of the defibrillation catheter 1.
  • use date / time information 133 indicating the date and time of use of the defibrillation catheter 1 can be mentioned.
  • 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).
  • 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.
  • 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.
  • the display unit 25 has a function of displaying the electrocardiographic waveform based on, for example, the electrocardiographic signal Sc1 described later.
  • the information to be displayed is not limited to such information on the electrocardiographic potential, and other information may be added and displayed.
  • information such as the determination result by the determination unit 246 described above may also be displayed on the display unit 25.
  • a 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).
  • 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.).
  • 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.
  • 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.
  • 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.
  • the input terminal Tin1 is a terminal for inputting the electrocardiographic signal Sc1 output from the electrocardiograph 4 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • the resistance value R is supplied to the arithmetic processing unit 24 via the switching unit 23.
  • 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).
  • 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.
  • 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.
  • an electrocardiographic signal in the example of FIG. 1, electrocardiographic signals Sc0a, Sc0b, Sc1
  • 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.
  • 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.
  • 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.
  • 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.
  • the biological measurement mechanism 6 is configured by using a plurality of (for example, 4 or 6) electrode pads 61.
  • 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 corresponds to what is called a "12-lead electrocardiogram". ..
  • 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.
  • 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.
  • the defibrillation information IDE is information that is also used for analysis when a problem occurs, and includes, for example, the following information.
  • 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).
  • the Joule set value at the time of defibrillation are included as the defibrillation information Idef.
  • 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.
  • 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.
  • 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.
  • defibrillation processing is performed electrically.
  • 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.
  • AED Automatic External Defibrillator
  • 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.
  • 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.
  • 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.
  • FIGS. 9 to 11 schematically show examples of various operation states described later in a block diagram during the defibrillation process.
  • step S10 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.
  • 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).
  • step S12 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 S13 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).
  • the electrocardiographic signal Sc1 measured by the biometric measurement mechanism 6 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • the electrocardiographic signal Sc1 measured by the biometric measurement mechanism 6 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.
  • 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.
  • 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).
  • the electrode groups 111G and 112G of the defibrillation catheter 1 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).
  • 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.
  • 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.
  • step S17 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.
  • the applied energy is set in 1J increments, for example, in the range of 1J (joule) to 30J.
  • 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).
  • step S20 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. ..
  • 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.
  • 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.
  • the electrocardiographic signal Sc1 measured by the biometric measurement mechanism 6 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.
  • 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.
  • 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.
  • 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). ..
  • 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).
  • the application record recording of the electrocardiographic waveform, etc.
  • the application record is temporarily (for example, 5 seconds) displayed on the display unit 25 of the power supply device 2 (step S22).
  • the application record recording of the electrocardiographic waveform, etc.
  • step S13 the above-mentioned "electrocardiographic potential measurement mode" (see step S13, FIG. 9) is set again.
  • 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).
  • step S24 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.
  • step S300 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).
  • step S302 the process proceeds to step S302, which will be described later.
  • step S300 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.
  • 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 are read out.
  • the determination unit 246 in the power supply device 2 determines whether or not the read identification information 131 is legitimate information (step S303).
  • step S303: N 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.
  • step S303: Y 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). ).
  • 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.
  • step S300 the process returns to step S300 described above, and the confirmation process of the connection of the defibrillation catheter 1 is performed again.
  • step S306 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.
  • step S302 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.
  • step S304 determines whether the content of the usage status information 132 indicates "use prohibited". 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.
  • step S304 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).
  • step S308 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".
  • 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).
  • the execution permission unit 247 activates the reception of the operation for executing the defibrillation described above (step S310).
  • 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.
  • step S307: N 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 ⁇ t1 (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 ⁇ t1 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).
  • 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.
  • the determination unit 246 determines whether or not the elapsed time ⁇ t1 thus derived is within the above-mentioned threshold time ⁇ tth1 (whether or not ⁇ t1 ⁇ ⁇ tth1 is satisfied) (step S312). ..
  • An example of this threshold time ⁇ th1 is 24 hours (1 day), but the present invention is not limited to this example, and any value can be set.
  • 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.
  • step S312: N when it is determined that the elapsed time ⁇ t1 exceeds the threshold time ⁇ th1 (satisfies ⁇ t1> ⁇ th1) (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.
  • 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.
  • 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.
  • non-regular defibrillation catheters eg, degraded products, counterfeit products, etc.
  • a very high DC voltage corresponding to the above-mentioned DC voltage Vdc
  • Vdc DC voltage
  • 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 the present embodiment, it is possible to improve the convenience of the defibrillation catheter system 3.
  • 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.
  • the effectiveness regarding the use of the defibrillation catheter 1 is determined in consideration of the above-mentioned elapsed time ⁇ t1, and the elapsed time ⁇ t1 is within the threshold time ⁇ tth1. In some cases, the use of the defibrillation catheter 1 was determined to be effective, so that the result is as follows.
  • the effectiveness of using the defibrillation catheter 1 is determined in consideration of the elapsed time ⁇ t1 (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.
  • the defibrillation catheter 1 when the above-mentioned identification information 131 is determined to be legitimate information and the above-mentioned elapsed time ⁇ t1 exceeds the threshold time ⁇ th1, 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 ⁇ t1 exceeds the threshold time ⁇ th1, 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.
  • 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.
  • the effectiveness regarding the use of the defibrillation catheter 1 is determined in consideration of the elapsed time ⁇ t1 described above, so that the result is as follows.
  • the defibrillation catheter 1 is used in consideration of the elapsed time ⁇ t1 (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.
  • 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.
  • the encrypted information when 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.
  • 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 this embodiment, it is possible to improve the convenience of the defibrillation catheter system 3 in this respect as well.
  • the setting of the date and time information Idt2 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.
  • 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).
  • 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.
  • the lead-out unit 244 for deriving the elapsed time ⁇ t1 and ⁇ t2 described above is provided in the power supply device 2, so that the result is as follows. That is, by using the elapsed time ⁇ t2 (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.
  • 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).
  • the elapsed time ⁇ t2 exceeds the above-mentioned notification threshold value ⁇ ts2 ( ⁇ t2> ⁇ th2)
  • a notification operation warning operation or the like
  • the elapsed time ⁇ t1 the elapsed time from the start of use of the defibrillation catheter 1
  • 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.
  • 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.
  • the processing of the portion changed from FIG. 8 described in the embodiment steps S401, S402, S408 described later
  • 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.
  • step S408 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”.
  • 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).
  • step S312 when it is determined in step S312 described above that the elapsed time ⁇ t1 described above exceeds the threshold time ⁇ th1 (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.
  • step S401: Y 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.
  • step S311 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 ⁇ t1 elapsed time from the start of use of the defibrillation catheter 1 will be derived.
  • step S312: Y if the elapsed time ⁇ t1 is within the threshold time ⁇ tth1 (step S312: Y), it is determined that the use of the defibrillation catheter 1 is “effective” (step S309). become.
  • 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.
  • step S401: N 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.
  • 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.
  • 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 ⁇ t1 exceeds the threshold time ⁇ tth1, 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.
  • 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 ⁇ t1 and the number of times of use N. As a result, in this modified example, it is possible to further improve the convenience.
  • the convenience can be further improved.
  • step S311 in FIG. 12 the above-mentioned elapsed time ⁇ t1 (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 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.
  • the above-mentioned elapsed time ⁇ t1 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 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 ⁇ t1 is derived.
  • step S312 Y
  • step S309 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).
  • each member described in the above-described embodiment and the like are not limited, and other materials may be used.
  • 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.
  • a leaf spring that can be deformed in the bending direction may be provided as a swinging member inside the shaft 11.
  • the configuration of the electrodes on the shaft 11 is not limited to those mentioned in the above-described embodiment.
  • 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.
  • 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.
  • 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.
  • the biological measurement mechanism 6 is configured by using a plurality of electrode pads (electrode pads 61)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the series of processes described in the above-described embodiment or the like may be performed by hardware (circuit) or software (program).
  • 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.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

L'invention concerne un système de cathéter de défibrillation présentant une commodité améliorée. Un système de cathéter de défibrillation 3 comprend un cathéter de défibrillation 1 et un dispositif d'alimentation électrique 2 qui fournit du courant au cathéter de défibrillation 1. Le dispositif d'alimentation électrique 2 comprend une unité d'alimentation électrique 22 qui fournit du courant comme indiqué ci-dessus, une unité de lecture 245 qui lit des informations d'identification unique 131 conservées dans le cathéter de défibrillation 1, et une unité de détermination 246 qui détermine la validité d'utilisation du cathéter de défibrillation 1 sur la base des informations d'identification 131 lues par l'unité de lecture 245.
PCT/JP2020/008250 2020-02-28 2020-02-28 Système de cathéter de défibrillation Ceased WO2021171540A1 (fr)

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PCT/JP2020/008250 WO2021171540A1 (fr) 2020-02-28 2020-02-28 Système de cathéter de défibrillation
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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005520650A (ja) * 2002-03-21 2005-07-14 ケビン アール． オートン， 電解質医薬を用いるヘルスケアサービスの準備および送達
JP2007524456A (ja) * 2003-06-23 2007-08-30 カーディアック・ペースメーカーズ・インコーポレーテッド 埋め込み可能な医療装置のための安全な遠隔測定
JP4672802B1 (ja) * 2010-03-25 2011-04-20 日本ライフライン株式会社 心腔内除細動カテーテルシステム
JP2016128052A (ja) * 2012-02-15 2016-07-14 日立マクセル株式会社 肌状態測定分析情報管理システム、肌状態測定分析情報管理方法、スキンケア装置およびスキンケア装置の制御方法

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3222320B1 (fr) 2012-12-17 2020-05-27 Koninklijke Philips N.V. Auto-test adaptatif et analyse de contrainte de dispositifs médicaux

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005520650A (ja) * 2002-03-21 2005-07-14 ケビン アール． オートン， 電解質医薬を用いるヘルスケアサービスの準備および送達
JP2007524456A (ja) * 2003-06-23 2007-08-30 カーディアック・ペースメーカーズ・インコーポレーテッド 埋め込み可能な医療装置のための安全な遠隔測定
JP4672802B1 (ja) * 2010-03-25 2011-04-20 日本ライフライン株式会社 心腔内除細動カテーテルシステム
JP2016128052A (ja) * 2012-02-15 2016-07-14 日立マクセル株式会社 肌状態測定分析情報管理システム、肌状態測定分析情報管理方法、スキンケア装置およびスキンケア装置の制御方法

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