WO2022195644A1 - Intracardiac defibrillation catheter system - Google Patents

Intracardiac defibrillation catheter system Download PDF

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Publication number
WO2022195644A1
WO2022195644A1 PCT/JP2021/010260 JP2021010260W WO2022195644A1 WO 2022195644 A1 WO2022195644 A1 WO 2022195644A1 JP 2021010260 W JP2021010260 W JP 2021010260W WO 2022195644 A1 WO2022195644 A1 WO 2022195644A1
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WO
WIPO (PCT)
Prior art keywords
switch
catheter
electrode group
defibrillation
power supply
Prior art date
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PCT/JP2021/010260
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French (fr)
Japanese (ja)
Inventor
卓也 平尾
Original Assignee
日本ライフライン株式会社
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.)
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Publication date
Application filed by 日本ライフライン株式会社 filed Critical 日本ライフライン株式会社
Priority to JP2023506372A priority Critical patent/JPWO2022195644A1/ja
Priority to PCT/JP2021/010260 priority patent/WO2022195644A1/en
Publication of WO2022195644A1 publication Critical patent/WO2022195644A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators

Definitions

  • the present invention relates to an intracardiac defibrillation catheter system. and a catheter system.
  • the present applicant has proposed a defibrillation catheter inserted into the heart chamber for defibrillation,
  • the defibrillation catheter comprises a power supply for applying a DC voltage to the electrodes of the defibrillation catheter, and an electrocardiograph;
  • the defibrillation catheter comprises a plurality of ring-shaped electrodes attached to the tip region of an insulating tube member.
  • a first lead wire group consisting of a plurality of lead wires whose tips are connected to the electrodes; and a second lead wire group consisting of a plurality of lead wires whose tips are connected to each of the electrodes constituting the second electrode group.
  • the power supply device includes a DC power supply unit, a catheter connection connector connected to the proximal end side of the first lead wire group and the second lead wire group of the defibrillation catheter, and the input terminal of the electrocardiograph.
  • an electrocardiograph connection connector connected to an electrocardiograph, an arithmetic processing unit that controls the DC power supply unit based on the input of an external switch, and has a DC voltage output circuit from the DC power supply unit; a switching unit comprising a changeover switch, wherein the catheter connection connector is connected to a common contact, the electrocardiograph connection connector is connected to a first contact, and the arithmetic processing unit is connected to a second contact;
  • the switching unit selects the first contact, and the cardiac potential information from the defibrillation catheter is , is input to the electrocardiograph via the catheter connection connector, the switching unit, and the electrocardiograph connection connector of the power supply device, and when performing defibrillation with the defibrillation catheter, the The contact of the switching unit is switched to the second contact by the arithmetic processing unit, and the DC power supply unit passes through the output circuit of the
  • the defibrillation catheter that constitutes the catheter system can be used as an electrode catheter for cardiac potential measurement.
  • the mode changeover switch of the power supply in the "electrocardiographic measurement mode"
  • the mode of the power supply is set for a certain period of time (for example for 1 second) to switch to "defibrillation mode”.
  • the impedance between the first and second electrodes of the defibrillation catheter is measured.
  • the applied energy setting switch to set the electrical energy to be applied when performing defibrillation
  • the charge switch the voltage determined based on the measured impedance and the set electrical energy is charged to the DC power supply.
  • the contact of the switching unit is switched from the first contact to the second contact by inputting the energy application switch (thereby changing the mode of the power supply from the "cardiogram measurement mode” to the "defibrillation mode”).
  • switching the first electrode group of the defibrillation catheter and the second electrode are sent from the DC power supply unit that receives the control signal from the arithmetic processing unit via the output circuit of the arithmetic processing unit, the switching unit, and the catheter connection connector.
  • DC voltages of polarities different from each other are applied to the groups.
  • the present applicant avoids applying a voltage to the electrodes of the defibrillation catheter when the baseline of the electrocardiogram input from the electrocardiograph to the processing unit is fluctuating (drift),
  • a defibrillation catheter, a power supply, and an electrocardiograph including a DC power supply and first and second lead groups of the defibrillation catheter a catheter connection connector connected to the proximal end of the group; an electrocardiograph connection connector connected to the input terminal of the electrocardiograph; an external switch including an electrical energy application preparation switch and an application execution switch; It has a DC voltage output circuit from the power supply unit, and is composed of an arithmetic processing unit that controls the DC power supply unit based on the input of the external switch, and a
  • a switching unit having a connector connected thereto, the electrocardiograph connecting connector being connected to a first contact, and the arithmetic processing unit being connected to a second contact; and an electrocardiogram input connector; when the application execution switch is input after the application preparation switch is input, defibrillation is performed by the defibrillation catheter, and when defibrillation is performed, the DC power supply voltages of different polarities are applied from the unit to the first electrode group and the second electrode group of the defibrillation catheter via the output circuit of the arithmetic processing unit and the catheter connector;
  • the arithmetic processing unit sequentially senses events presumed to be R waves from the electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and events ( Vn ) matches at least the polarity of the event sensed one before (V n-1 ) and the polarity of the event sensed two before (V n-2 ), and the applied When an abnormal wave height event occurs between the input of the preparation switch and the
  • the polarities of the three events (V n-2 ), (V n-1 ), and (V n ) match, and the application preparation switch is input, and then the application is executed.
  • this event (V n ) is detected only when the event (V n ) is sensed after a certain waiting time has passed since the occurrence of the abnormal wave height event.
  • the arithmetic processing unit of the power supply controls the DC power supply unit so that the voltage is applied in synchronization with the , avoid applying voltage to the electrodes of the defibrillation catheter, and apply a DC voltage to the electrodes of the defibrillation catheter in synchronization with the R wave of the electrocardiogram when the baseline is stable. defibrillation can be performed.
  • a power supply device that constitutes the intracardiac defibrillation catheter system described in Patent Document 2 includes an energy application preparation switch and an energy application execution switch as external switches for applying energy.
  • the energy application preparation switch When the energy application preparation switch is input, the contact of the switching unit that receives the control signal of the arithmetic processing unit switches from the first contact to the second contact (thereby changing the mode of the power supply from the "electrocardiographic measurement mode” to the "electrocardiographic measurement mode”). defibrillation mode”), and a path is secured from the catheter connector to the arithmetic processing unit via the switching unit.
  • the DC power supply section that receives the control signal from the computation processing section transmits the output circuit of the computation processing section, the switching section, and the catheter connection.
  • DC voltages of different polarities are applied to the first electrode group and the second electrode group of the defibrillation catheter via the connector.
  • the cardiac potential information measured by the constituent electrodes of the first electrode group and the constituent electrodes of the second electrode group immediately before applying the DC voltage is extremely important.
  • the time from inputting the energy application preparation switch to inputting the energy application execution switch usually 8 to 10 seconds
  • the switching unit consisting of a switch with two contacts for one circuit selects the second contact, and the path from the catheter connection connector to the electrocardiograph connection connector via the switching unit is cut off.
  • the constituent electrocardiographs cannot acquire electrocardiographic information measured by the constituent electrodes of the first electrode group and/or the second electrode group.
  • An object of the present invention is to obtain cardiac potential information from the constituent electrodes of the first electrode group and/or the second electrode group until immediately before a DC voltage is applied to the first electrode group and the second electrode group of a defibrillation catheter.
  • the intracardiac defibrillation catheter system of the present invention comprises a defibrillation catheter inserted into a heart chamber for defibrillation, and a power supply for applying a DC voltage to electrodes of the defibrillation catheter.
  • the defibrillation catheter includes an insulating tube member, a first electrode group (first DC electrode group) composed of a plurality of ring-shaped electrodes attached to a tip region of the tube member, a second electrode group (second DC electrode group) comprising a plurality of ring-shaped electrodes mounted on the distal end region of the tube member spaced from the first electrode group toward the proximal end;
  • the power supply device includes a DC power supply section including a capacitor; an external switch as input means; an arithmetic processing unit that controls the DC power supply unit based on the input of the external switch and has a circuit that outputs a DC voltage from the DC power supply unit; a catheter connector electrically connected to each of the first DC electrode group and the second DC electrode group of the defibrillation catheter; an electrocardiograph connection connector connected to an input terminal of the electrocardiograph; a first ON/OFF switch interposed between the catheter connection connector and the electrocardiograph connection connector; a second
  • the first ON/OFF switch and the second ON/OFF switch are independent of each other, unlike a one-circuit, two-contact changeover switch. ” or “OFF”.
  • a path from the catheter connection connector to the arithmetic processing unit via the second ON/OFF switch is secured, and energy can be applied. (preparation for energy application is completed), and electrocardiographic information can be acquired from the constituent electrodes of the first DC electrode group and/or the second DC electrode group of the defibrillation catheter.
  • electrocardiographic information can be acquired from the constituent electrodes of the first DC electrode group and/or the second DC electrode group until the first ON/OFF switch is switched to "OFF".
  • the power supply device includes, as the external switches, an energy application preparation switch for preparing for defibrillation and an energy application preparation switch for applying electrical energy to perform defibrillation.
  • an energy application execution switch for executing the motion
  • the arithmetic processing unit switches the first ON/OFF controlling the ON/OFF switches such that the switches remain “ON” and the second ON/OFF switch switches from “OFF” to “ON”;
  • the energy application execution switch is input after the energy application preparation switch is input, the arithmetic processing unit maintains the second ON/OFF switch in the “ON” state, and the first ON/OFF switch is in the "ON” state.
  • these ON/OFF switches are controlled to switch from “ON” to "OFF”.
  • the defibrillation catheter system having such a configuration, even at the stage where the preparation for energy application has been completed by inputting the energy application preparation switch, the defibrillation catheter continues to operate until the energy application execution switch is input.
  • Cardiac potential information can be obtained from the constituent electrodes of the first DC electrode group and/or the second DC electrode group.
  • the first ON/OFF switch is switched from “ON” to "OFF”, and a path from the catheter connection connector to the electrocardiograph connection connector via the first ON/OFF switch is established. Since it is cut off immediately, no DC voltage is applied to the electrocardiograph.
  • the power supply device includes a main power switch, a mode switch for switching between an electrocardiographic measurement mode and a defibrillation mode, and a defibrillation mode switch.
  • an applied energy setting switch for setting the electric energy to be applied at the time of application; a charging switch for accumulating a voltage determined based on the set electric energy in the DC power supply; the energy application preparation switch; an energy application execution switch;
  • the arithmetic processing unit turns the first ON/OFF switch “ON” and turns the second ON/OFF switch “OFF” when the main power switch is turned on, for a certain period of time after the mode changeover switch is turned on, the first ON/OFF switch is turned “OFF” and the second ON/OFF switch is turned “ON”;
  • By inputting the applied energy setting switch or the charging switch "ON"/"OFF” of the first ON/OFF switch and the second ON/OFF switch are not switched,
  • the energy application preparation switch is input, both the first ON/OFF switch and the second ON/OFF switch are turned “ON”, so that when the energy application execution switch is input, the first ON/OFF switch is turned “OFF” and the second ON/OFF switch is turned “ON”;
  • the initial mode is set to the "electrocardiogram measurement mode" by turning on the main power switch, and the "defibrillation mode” is set for a certain period of time by turning on the mode selector switch. Then, it becomes possible to measure the impedance between the first DC electrode group and the second DC electrode group of the defibrillation catheter, and the "electrocardiographic measurement mode" is maintained when setting the applied electrical energy and charging the DC power supply.
  • the arithmetic processing unit of the power supply device controls the first mode of the defibrillation catheter during the predetermined time after the mode changeover switch is input. It is preferable to control to measure the impedance between one DC electrode group and the second DC electrode group.
  • the arithmetic processing unit of the power supply device combines the measured impedance with the electrical energy set by inputting the applied energy setting switch. It is preferable to control the DC power supply unit to store the voltage determined based on the above.
  • the power supply device preferably includes an electrocardiogram input connector connected to output terminals of the arithmetic processing unit and the electrocardiograph.
  • the electrocardiographic information output from the electrocardiograph can be input to the arithmetic processing unit, and the arithmetic processing unit operates on the basis of the electrocardiographic information to generate the DC power supply. section, a first ON/OFF switch and a second ON/OFF switch.
  • the defibrillation catheter comprises a plurality of electrodes attached to the tube member spaced apart from the first DC electrode group or the second DC electrode group. , comprising a group of potential measurement electrodes electrically connected to the catheter connector,
  • the power supply device is formed with a path that directly connects the catheter connection connector and the electrocardiograph connection connector,
  • the electrocardiographic information measured by the electrodes constituting the potential measuring electrode group is transmitted from the catheter connector of the power supply device via the electrocardiograph connector without passing through the first ON/OFF switch. It is preferably input to an electrocardiograph.
  • An electrocardiograph can acquire a cardiac potential measured by a group of potential measuring electrodes.
  • the electrocardiograph is preferably connected to electrocardiographic measurement means other than the defibrillation catheter.
  • the cardiac potential measuring means is an electrode pad or an electrode catheter.
  • the electrocardiograph can acquire the electrocardiogram measured by the electrocardiogram measuring means.
  • the second Electrocardiographic information can be obtained from constituent electrodes of one electrode group and/or a second electrode group.
  • FIG. 1 is a block diagram illustrating one embodiment of an intracardiac defibrillation catheter system of the present invention
  • FIG. FIG. 2 is an explanatory plan view showing a defibrillation catheter that constitutes the catheter system shown in FIG. 1
  • FIG. 2 is an explanatory plan view (a diagram for explaining dimensions and hardness) showing a defibrillation catheter that constitutes the catheter system shown in FIG. 1
  • FIG. 3 is a transverse sectional view showing the AA section of FIG. 2
  • 3A and 3B are transverse cross-sectional views showing a BB cross section, a CC cross section, and a DD cross section of FIG.
  • FIG. 2 is an explanatory view schematically showing a connection state between a connector of a defibrillation catheter and a catheter connection connector of a power supply device in the catheter system shown in FIG. 1;
  • 2 is a flow chart showing the operation and operation of the power supply in the catheter system shown in FIG. 1;
  • 2 is a block diagram showing the flow of electrocardiographic information in the electrocardiographic measurement mode after the main power switch is turned on in the catheter system shown in FIG. 1;
  • FIG. 2 is a block diagram showing the flow of information related to measured values of impedance between electrode groups and electrocardiographic information in defibrillation mode after input of a mode switch in the catheter system shown in FIG. 1;
  • 2 is a block diagram showing the flow of electrocardiographic information in the electrocardiographic measurement mode after a certain period of time has passed since the mode selector switch was turned on in the catheter system shown in FIG. 1.
  • FIG. 2 is a block diagram showing the flow of electrocardiographic information after an application preparation switch is input in the catheter system shown in FIG. 1;
  • FIG. 2 is a block diagram showing the flow of electrocardiographic information after an application execution switch is input in the catheter system shown in FIG. 1;
  • FIG. FIG. 2 is a block diagram showing a state in which a DC voltage is applied after an application execution switch is input in the catheter system shown in FIG. 1;
  • the intracardiac defibrillation catheter system of this embodiment includes a defibrillation catheter 100 , a power supply device 700 , an electrocardiograph 800 , and electrocardiographic measurement means 900 .
  • the defibrillation catheter 100 constituting the catheter system of the present embodiment includes a multi-lumen tube 10, a handle 20, a first DC electrode group 31G, a second DC electrode group 32G, It has a proximal side potential measuring electrode group 33G, a first lead wire group 41G, a second lead wire group 42G, and a third lead wire group 43G.
  • the multi-lumen tube 10 is formed with four lumens (first lumen 11, second lumen 12, third lumen 13, and fourth lumen 14).
  • 15 is a fluororesin layer that partitions the lumen
  • 16 is an inner (core) portion made of a low-hardness nylon elastomer
  • 17 is an outer (shell) portion made of a high-hardness nylon elastomer.
  • 18 in FIG. 4 is a stainless wire forming a braided braid.
  • the handle 20 that constitutes the defibrillation catheter 100 of this embodiment includes a handle body 21, a knob 22, and a strain relief 24. By rotating the knob 22, the tip of the multi-lumen tube 10 can be deflected (swinged).
  • a first DC electrode group 31G, a second DC electrode group 32G, and a proximal side potential measurement electrode group 33G are attached to the distal end region of the multi-lumen tube 10 .
  • electrode group means a set of a plurality of electrodes that constitute the same pole (have the same polarity) or have the same purpose and are mounted at narrow intervals (for example, 5 mm or less). say the body
  • the first DC electrode group 31G is composed of eight ring-shaped electrodes 31 attached to the tip region of the multi-lumen tube 10 .
  • the electrodes 31 that make up the first DC electrode group 31G are connected to the catheter connector 72 of the power supply device 700 via the lead wires 41 that make up the first lead wire group 41G and a connector that will be described later.
  • the first DC electrode group 31G is positioned, for example, in the coronary vein.
  • the second DC electrode group 32G is composed of eight ring-shaped electrodes 32 attached to the distal end region of the multi-lumen tube 10 at a distance from the attachment position of the first DC electrode group 31G toward the proximal side.
  • the electrodes 32 forming the second DC electrode group 32G are connected to the catheter connector 72 of the power supply device 700 via the lead wires 42 forming the second lead wire group 42G and a connector described later.
  • the second DC electrode group 32G is positioned, for example, in the right atrium.
  • the proximal side potential measuring electrode group 33G is composed of four ring-shaped electrodes 33 attached to the distal end region of the multi-lumen tube 10 spaced proximally from the attachment position of the second DC electrode group 32G.
  • the electrodes 33 forming the proximal side potential measuring electrode group 33G are connected to the catheter connector 72 of the power supply device 700 via the lead wires 43 forming the third lead wire group 43G and a connector described later.
  • the proximal side potential-measuring electrode group 33G is positioned, for example, in the superior vena cava.
  • a distal tip 35 is attached to the distal end of the defibrillation catheter 100 .
  • No lead wire is connected to the distal tip 35, and it is not used as an electrode in this embodiment.
  • the first lead wire group 41G shown in FIGS. 4 and 5 is an assembly of eight lead wires 41 connected to each of the eight electrodes 31 forming the first DC electrode group 31G.
  • Each of the eight electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the power supply device 700 by the first lead wire group 41G.
  • the eight electrodes 31 forming the first DC electrode group 31G are connected to different lead wires 41, respectively.
  • Each of the lead wires 41 is welded to the inner peripheral surface of the electrode 31 at its distal end portion and enters the first lumen 11 through a side hole formed in the tube wall of the multi-lumen tube 10 .
  • the eight lead wires 41 entering the first lumen 11 extend to the first lumen 11 as a first lead wire group 41G.
  • the second lead wire group 42G shown in FIGS. 4 and 5 is an assembly of eight lead wires 42 connected to each of the eight electrodes 32 that constitute the second DC electrode group 32G.
  • Each of the eight electrodes 32 constituting the second DC electrode group 32G can be electrically connected to the power supply device 700 by the second lead wire group 42G.
  • the eight electrodes 32 forming the second DC electrode group 32G are connected to different lead wires 42, respectively.
  • Each of the lead wires 42 is welded to the inner peripheral surface of the electrode 32 at its distal end portion and enters the second lumen 12 through a side hole formed in the tube wall of the multi-lumen tube 10 .
  • the eight lead wires 42 entering the second lumen 12 extend to the second lumen 12 as a second lead wire group 42G.
  • the first lead wire group 41G extends to the first lumen 11 and the second lead wire group 42G extends to the second lumen 12, so that both of them can be used in the multi-lumen tube 10. Completely insulated. Therefore, when a voltage required for defibrillation is applied, a short circuit between the first lead wire group 41G (first DC electrode group 31G) and the second lead wire group 42G (second DC electrode group 32G) can be reliably prevented.
  • the third lead wire group 43G shown in FIG. 4 is an aggregate of four lead wires 43 connected to each of the electrodes 33 constituting the proximal side potential measuring electrode group 33G.
  • Each of the electrodes 33 constituting the proximal side potential measuring electrode group 33G can be electrically connected to the power supply device 700 by the third lead wire group 43G.
  • the four electrodes 33 that constitute the proximal end potential measuring electrode group 33G are connected to different lead wires 43, respectively.
  • Each of the lead wires 43 is welded to the inner peripheral surface of the electrode 33 at its distal end portion and enters the third lumen 13 through a side hole formed in the tube wall of the multi-lumen tube 10 .
  • the four lead wires 43 entering the third lumen 13 extend to the third lumen 13 as a third lead wire group 43G.
  • the third lead wire group 43G extending to the third lumen 13 is completely insulated and isolated from both the first lead wire group 41G and the second lead wire group 42G. Therefore, when the voltage required for defibrillation is applied, the third lead wire group 43G (proximal side potential measurement electrode group 33G) and the first lead wire group 41G (first DC electrode group 31G) or the first lead wire group 41G (first DC electrode group 31G) A short circuit between the lead wire group 42G (the second DC electrode group 32G) and the lead wire group 42G can be reliably prevented.
  • 65 is a pull wire.
  • the pull wire 65 extends to the fourth lumen 14 and extends eccentrically with respect to the central axis of the multi-lumen tube 10 .
  • the distal end portion of the pull wire 65 is fixed to the distal tip 35 by soldering.
  • the proximal end portion of the pull wire 65 is connected to the knob 22 of the handle 20 , and the pull wire 65 is pulled by operating the knob 22 , thereby deflecting the distal end portion of the multi-lumen tube 10 .
  • the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G are insulated and isolated even inside the handle 20.
  • FIG. 6 is a perspective view showing the internal structure of the handle of the defibrillation catheter 100 according to this embodiment. As shown in FIG. 6, the proximal end of the multi-lumen tube 10 is inserted into the distal opening of the handle 20, whereby the multi-lumen tube 10 and the handle 20 are connected.
  • a cylindrical connector 50 is built in the proximal end of the handle 20 .
  • the distal end of the first insulating tube 26 is inserted into the first lumen 11 of the multi-lumen tube 10, whereby the first insulating tube 26 is inserted into the first lumen 11 through which the first lead wire group 41G extends. Concatenated.
  • the first insulating tube 26 extends to the vicinity of the connector 50 through the inner hole of the first protective tube 61 extending inside the handle 20, and connects the proximal ends of the first lead wire group 41G to the connector 50. form an insertion path for guiding to the vicinity of the A first lead wire group 41G extending from the base end opening of the first insulating tube 26 is separated into eight lead wires 41, and each of these lead wires 41 is connected to a pin arranged on the distal end surface of the connector 50. It is connected and fixed to each of the terminals by soldering.
  • the distal end of the second insulating tube 27 is inserted into the second lumen 12 of the multi-lumen tube 10, whereby the second insulating tube 27 is inserted into the second lumen 12 through which the second lead wire group 42G extends. Concatenated.
  • the second insulating tube 27 extends to the vicinity of the connector 50 through the inner hole of the second protective tube 62 extending inside the handle 20, and connects the proximal ends of the second lead wire group 42G to the connector 50. form an insertion path for guiding to the vicinity of the A second lead wire group 42G extending from the proximal end opening of the second insulating tube 27 is separated into eight lead wires 42, each of which is connected to a pin disposed on the distal end surface of the connector 50. It is connected and fixed to each of the terminals by soldering.
  • the distal end of the third insulating tube 28 is inserted into the third lumen 13 of the multi-lumen tube 10, whereby the third insulating tube 28 is inserted into the third lumen 13 through which the third lead wire group 43G extends. Concatenated.
  • the third insulating tube 28 extends to the vicinity of the connector 50 through the inner hole of the second protective tube 62 extending inside the handle 20, and connects the proximal end of the third lead wire group 43G to the connector 50. form an insertion path for guiding to the vicinity of the A third lead wire group 43G extending from the proximal end opening of the third insulating tube 28 is separated into four lead wires 43, each of which is connected to a pin arranged on the distal end surface of the connector 50. It is connected and fixed to each of the terminals by soldering.
  • the first lead wire group 41G extends inside the first insulating tube 26, and the second lead wire group 41G extends inside the second insulating tube 27.
  • the first lead wire group 41G and the second lead wire group 41G and the second lead wire group 41G can be connected even inside the handle 20.
  • the group 42G and the third lead wire 43G can be completely insulated.
  • a power supply device 700 constituting the catheter system of the present embodiment includes a DC power supply unit 71, a catheter connection connector 72, an electrocardiograph connection connector 73, and an external switch (input means) 74. , an arithmetic processing unit 75 , a first ON/OFF switch 761 , a second ON/OFF switch 762 , and an electrocardiogram input connector 77 .
  • the DC power supply unit 71 has a built-in capacitor.
  • a proximal end of each of the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G of the defibrillation catheter 100 is connected to the catheter connector 72 .
  • the catheter connector 72 is electrically connected to each of the first DC electrode group 31G, the second DC electrode group 32G, and the proximal side potential measurement electrode group 33G.
  • the catheter connector 72 is connected to the connector 50 of the defibrillation catheter 100, and electrically connected to the proximal sides of the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G.
  • pin terminals 51 (actually eight) to which the eight lead wires 41 constituting the first lead wire group are connected and fixed; terminals 721 (actually eight) of the catheter connector 72; pin terminals 52 (actually eight) to which the eight lead wires 42 constituting the second lead wire group are connected and fixed; terminals 722 (actually eight) of the catheter connector 72;
  • the pin terminals 53 (four actually) to which the four lead wires 43 constituting the third lead wire group are connected and fixed are connected to the terminals 723 (four actually) of the catheter connector 72.
  • the terminals 721 and 722 of the catheter connector 72 are connected to the first ON/OFF switch 761, and the terminal 723 is directly connected to the electrocardiograph connector 73 without going through the first ON/OFF switch 761.
  • the electrocardiographic information measured by the first DC electrode group 31G and the second DC electrode group 32G reaches the electrocardiograph connector 73 via the first ON/OFF switch 761, and reaches the proximal side potential measuring electrode group.
  • Electrocardiogram information measured by 33G reaches the electrocardiograph connection connector 73 without passing through the first ON/OFF switch 761 .
  • the electrocardiograph connection connector 73 is connected to an input terminal of the electrocardiograph 800 .
  • the external switch 74 which is input means, includes a main power switch 740 for activating the power supply device 700, a mode selector switch 741 for switching between an electrocardiogram measurement mode and a defibrillation mode, and an electrical energy applied during defibrillation.
  • Applied energy setting switch 742 for setting, charging switch 743 for accumulating voltage determined based on the set electrical energy in the DC power supply, preparation for defibrillation (relay switching) It consists of an energy application preparation switch 744 and an energy application execution switch 745 for applying electrical energy to perform defibrillation. All input signals from these external switches 74 are sent to the arithmetic processing section 75 .
  • Arithmetic processing unit 75 controls DC power supply unit 71 , first ON/OFF switch 761 and second ON/OFF switch 762 based on the input of external switch 74 .
  • the arithmetic processing unit 75 includes an output circuit 751 for outputting the DC voltage from the DC power supply unit 71 to the electrodes of the defibrillation catheter 100 via the second ON/OFF switch 762, and a first DC voltage of the defibrillation catheter 100.
  • the terminal 721 of the catheter connector 72 shown in FIG. A DC voltage can be applied so that the second DC electrode group 32G) of the defibrillation catheter 100 has different polarities (when one electrode group has a negative polarity, the other electrode group has a positive polarity). .
  • the CPU circuit 752 allows the impedance between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 to be measured, and this measurement is used to determine the target voltage to be stored in the DC power supply 71. used for
  • the first ON/OFF switch 761 is connected to the catheter connector 72 and the electrocardiograph connector 73 .
  • the second ON/OFF switch 762 is connected to the catheter connector 72 and the arithmetic processing section 75 .
  • the cardiac potential information from the defibrillation catheter 100 is transferred to the catheter connector 72 and the first ON/OFF switch 761. and the electrocardiograph 800 via the electrocardiograph connection connector 73 (electrocardiogram measurement mode).
  • the first ON/OFF switch 761 is turned “OFF” and the second ON/OFF switch 762 is turned “ON”.
  • the first DC electrode group 31G of the defibrillation catheter 100 is supplied from the DC power supply unit 71 via the output circuit 751 of the arithmetic processing unit 75, the switching unit 754, the second ON/OFF switch 762 and the catheter connector 72. and the second DC electrode group 32G (defibrillation mode).
  • the first ON/OFF switch 761 is turned “OFF” and the second ON/OFF switch 762 is turned “ON”.
  • the switching between “ON” and “OFF” of the first ON/OFF switch 761 and the second ON/OFF switch 762 is performed by the arithmetic processing unit 75 based on the inputs of the mode changeover switch 741 and the energy application preparation switch 744 which are the external switches 74 . controlled.
  • the electrocardiogram input connector 77 is connected to the arithmetic processing unit 75 and to the output terminal of the electrocardiograph 800 . Through this electrocardiogram input connector 77, the electrocardiographic information output from the electrocardiograph 800 (normally, part of the electrocardiographic information input to the electrocardiograph 800) can be input to the arithmetic processing unit 75.
  • the arithmetic processing unit 75 can control the DC power supply unit 71, the first ON/OFF switch 761 and the second ON/OFF switch 762 based on this electrocardiographic information.
  • the electrocardiograph 800 (input terminal) constituting the catheter system of this embodiment is connected to the electrocardiograph connection connector 73 of the power supply device 700, and the defibrillation catheter 100 (first DC electrode group 31G, second DC electrode group 32G) and constituent electrodes of the proximal side potential measuring electrode group 33G) is input to the electrocardiograph 800 from the electrocardiograph connection connector 73 .
  • the electrocardiograph 800 (another input terminal) is also connected to the electrocardiographic measurement means 900 , and the electrocardiographic information measured by the electrocardiographic measurement means 900 is also input to the electrocardiograph 800 .
  • the electrocardiogram measuring means 900 includes an electrode pad attached to the patient's body surface for measuring a 12-lead electrocardiogram, and an electrode catheter attached to the patient's heart (an electrode different from the defibrillation catheter 100). catheter) can be mentioned.
  • the electrocardiograph 800 (output terminal) is connected to the electrocardiogram input connector 77 of the power supply device 700, and receives the electrocardiographic information input to the electrocardiograph 800 (the electrocardiographic information from the defibrillation catheter 100 and the electrocardiographic information from the electrocardiographic measuring means 900). electrocardiographic information from the electrocardiogram input connector 77 to the arithmetic processing unit 75 .
  • the defibrillation catheter 100 of this embodiment can be used as an electrode catheter for cardiac potential measurement when defibrillation treatment is not required.
  • Electrocardiographic potentials measured by the electrodes constituting first DC electrode group 31G and/or second DC electrode group 32G of defibrillation catheter 100 are connected to catheter connector 72, first ON/OFF switch 761 and electrocardiograph connector 73. It is input to the electrocardiograph 800 via.
  • the electrocardiographic potential measured by the electrodes constituting the proximal side potential measuring electrode group 33G of the defibrillation catheter 100 is directly transferred from the catheter connecting connector 72 to the electrocardiograph connecting connector without passing through the first ON/OFF switch 761. 73 to the electrocardiograph 800 .
  • Cardiac potential information (cardiogram waveform) from the defibrillation catheter 100 is displayed on a monitor (not shown) of the electrocardiograph 800 .
  • part of the electrocardiographic information from the defibrillation catheter 100 (for example, the potential difference between the electrodes 31 (first and second electrodes) constituting the first DC electrode group 31G) is transferred from the electrocardiograph 800 to the electrocardiogram It can be input to the arithmetic processing unit 75 via the input connector 77 .
  • the defibrillation catheter 100 can be used as an electrode catheter for cardiac potential measurement (cardiac potential measurement mode).
  • defibrillation treatment can be immediately performed using the defibrillation catheter 100 used as an electrode catheter (defibrillation mode).
  • defibrillation mode the trouble of inserting a new catheter for defibrillation can be saved.
  • the defibrillation catheter 100 Connects the defibrillation catheter 100 to the power supply device 700 (catheter connector 72) and turn on the main power switch 740 of the power supply device 700 (STEP 1).
  • the first DC electrode group 31G of defibrillation catheter 100 is positioned in the coronary sinus (CS)
  • the second DC electrode group 32G is positioned in the right atrium (RA)
  • the proximal potential measuring electrode group 33G is positioned in the superior position. It is located in the vena cava (SVC).
  • the mode (initial mode) of the power supply device 700 when the main power switch 740 is turned on is the "electrocardiogram measurement mode" (STEP 2, FIG. 9).
  • the first ON/OFF switch 761 is in the "ON” state
  • the second ON/OFF switch 762 is in the "OFF” state.
  • electrocardiographic information measured by the constituent electrodes of the first DC electrode group 31G and/or the second DC electrode group 32G is transmitted via the catheter connector 72, the first ON/OFF switch 761, and the electrocardiograph connector 73. It is input to the electrocardiograph 800 .
  • the electrocardiographic information measured by the constituent electrodes of the proximal side potential measuring electrode group 33G is input to the electrocardiograph 800 via the catheter connector 72 and the electrocardiograph connector 73 .
  • the electrocardiogram information input to the electrocardiograph 800 is input to the arithmetic processing unit 75 via the electrocardiogram input connector 77 .
  • the electrocardiographic information (12-lead electrocardiogram) measured by the electrocardiographic measuring means 900 is also input to the electrocardiograph 800, and the electrocardiographic information obtained by the electrocardiographic measuring means 900 is also input to the electrocardiogram input connector. 77 to the arithmetic processing unit 75 .
  • the CPU circuit 752 and the internal resistor 753 are connected via the switching unit 754. At this stage, the resistance value of the internal resistor 753 is measured by the CPU circuit 752, It can be checked (tested) to see if it matches a known resistance value.
  • the mode of the power supply device 700 becomes the "defibrillation mode" (STEP 4, FIG. 10).
  • the first ON/OFF switch 761 is in the "OFF” state
  • the second ON/OFF switch 762 is in the "ON” state.
  • the CPU circuit 752 and the second ON/OFF switch 762 are connected via the switching section 754.
  • the path from the catheter connector 72 to the electrocardiograph connector 73 via the first ON/OFF switch 761 is blocked.
  • the electrocardiographic information from the constituent electrodes of the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 cannot be input to the electrocardiograph 800 (therefore, this electrocardiographic information cannot be sent to the arithmetic processing unit 75). cannot be sent).
  • electrocardiographic information from the constituent electrodes of the proximal side potential measuring electrode group 33 ⁇ /b>G that does not pass through the first ON/OFF switch 761 is input to the electrocardiograph 800 .
  • the CPU circuit 752 of the arithmetic processing unit 75 measures the impedance between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 (STEP 5, FIG. 10).
  • the mode of the power supply device 700 returns to the "electrocardiogram measurement mode" (STEP 6, FIG. 11).
  • the first ON/OFF switch 761 is in the “ON” state
  • the second ON/OFF switch 762 is in the "OFF” state.
  • the output circuit 751 and the internal resistor 753 are connected via the switching unit 754, and at this stage, the DC voltage can be applied to the internal resistor 753. , and it is possible to check (test) whether or not the set electric energy can be applied to the internal resistance 753 .
  • the applied energy setting switch 742 to set the applied energy for defibrillation (STEP 7).
  • the applied energy can be set from 1 J to 30 J in increments of 1 J.
  • the second ON/OFF switch 762 maintains the "ON” state in response to the control signal from the arithmetic processing unit 75, and the first ON/OFF switch turns “ ON” is switched to "OFF", and the path from the catheter connector 72 to the electrocardiograph connector 73 is immediately cut off (STEP 15, FIGS. 13 and 14). As a result, no DC voltage is applied to electrocardiograph 800 .
  • the mode of the power supply device 700 After the application of the voltage from the DC power supply unit 71 is stopped, the mode of the power supply device 700 returns to the "electrocardiogram measurement mode", and the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 Electrocardiographic information from the constituent electrodes is input to the electrocardiograph 800 (STEP 17).
  • Heart rate from the configuration electrodes of the defibrillation catheter 100 (the configuration electrodes of the first DC electrode group 31G, the second DC electrode group 32G, and the proximal side potential measurement electrode group 33G) displayed on the monitor of the electrocardiograph 800
  • Potential information (electrocardiogram)
  • electrocardiographic information from the electrocardiographic measurement means 900 (12 The lead electrocardiogram) is observed, and if it is “normal”, it is terminated, and if it is "not normal (atrial fibrillation has not subsided)", return to STEP 2 (STEP 18).
  • both ON/OFF switches are turned “ON” or “OFF”. It is possible. Then, when the energy application preparation switch 744 is input, both the first ON/OFF switch 761 and the second ON/OFF switch 762 are turned “ON", and from the catheter connector 72 via the second ON/OFF switch 762, A path leading to the arithmetic processing unit 75 is secured, energy can be applied, and preparations for energy application are completed. ECG information can be acquired.
  • the first ON/OFF switch 761 is switched to "OFF", so that the DC voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100.
  • Cardiac potential information from the constituent electrodes of the first DC electrode group 31G and/or the second DC electrode group 32G can be obtained until just before is applied to perform defibrillation.
  • the energy application preparation switch 744 is turned on, the patient's condition can be monitored based on the electrocardiographic information of the treatment site, and energy application is executed after confirming that the electrocardiographic information is stable. You can enter a switch (perform defibrillation).
  • the resistance value of the internal resistor 753 is measured by the CPU circuit 752, and the operating state of the impedance measurement system including the CPU circuit 752 is confirmed. can be done.

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Abstract

The present invention aims to provide a catheter system that can obtain electrocardiographic information from a first electrode group and second electrode group in a defibrillation catheter, up to until immediately prior to a DC voltage being applied to these electrode groups. This catheter system comprises: the defibrillation catheter (100), a power supply device (700), and an electrocardiograph (800). The power supply device comprises a DC power supply unit (71), a calculation unit (75), a catheter connector (72), an electrocardiograph connector (73), a first ON/OFF switch (761), and a second ON/OFF switch (762). When electrocardiographic potential is measured using electrodes that constitute the first electrode group and/or the second electrode group in the defibrillation catheter, the first ON/OFF switch turns ON. When defibrillating using the defibrillation catheter, the second ON/OFF switch turns ON.

Description

心腔内除細動カテーテルシステムIntracardiac defibrillation catheter system
 本発明は心腔内除細動カテーテルシステムに関し、更に詳しくは、心腔内に挿入される除細動カテーテルと、この除細動カテーテルの電極に直流電圧を印加する電源装置と、心電計とを備えたカテーテルシステムに関する。 The present invention relates to an intracardiac defibrillation catheter system. and a catheter system.
 心房細動等を起こした心臓の除細動治療を行うための心腔内除細動カテーテルシステムとして、本出願人は、心腔内に挿入されて除細動を行う除細動カテーテルと、この除細動カテーテルの電極に直流電圧を印加する電源装置と、心電計とを備え;前記除細動カテーテルは、絶縁性のチューブ部材の先端領域に装着された複数のリング状電極からなる第1電極群と、前記第1電極群から基端側に離間して前記チューブ部材に装着された複数のリング状電極からなる第2電極群と、前記第1電極群を構成する電極の各々に先端が接続された複数のリード線からなる第1リード線群と、前記第2電極群を構成する電極の各々に先端が接続された複数のリード線からなる第2リード線群とを備えてなり;前記電源装置は、DC電源部と、前記除細動カテーテルの第1リード線群および第2リード線群の基端側に接続されるカテーテル接続コネクタと、前記心電計の入力端子に接続される心電計接続コネクタと、外部スイッチの入力に基いて前記DC電源部を制御するとともに、当該DC電源部からの直流電圧の出力回路を有する演算処理部と、1回路2接点の切替スイッチからなり、共通接点に前記カテーテル接続コネクタが接続され、第1接点に前記心電計接続コネクタが接続され、第2接点に前記演算処理部が接続された切替部とを備えてなり;前記除細動カテーテルの第1電極群および/または第2電極群を構成する電極により心電位を測定するときには、切替部において第1接点が選択され、前記除細動カテーテルからの心電位情報が、前記電源装置の前記カテーテル接続コネクタ、前記切替部および前記心電計接続コネクタを経由して前記心電計に入力され、前記除細動カテーテルにより除細動を行うときには、前記電源装置の前記演算処理部によって前記切替部の接点が第2接点に切り替わり、前記DC電源部から、前記演算処理部の出力回路、前記切替部および前記カテーテル接続コネクタを経由して、前記除細動カテーテルの前記第1電極群と、前記第2電極群とに、互いに異なる極性の電圧が印加されるカテーテルシステムを提案している(下記特許文献1参照)。 As an intracardiac defibrillation catheter system for performing defibrillation treatment of a heart with atrial fibrillation or the like, the present applicant has proposed a defibrillation catheter inserted into the heart chamber for defibrillation, The defibrillation catheter comprises a power supply for applying a DC voltage to the electrodes of the defibrillation catheter, and an electrocardiograph; the defibrillation catheter comprises a plurality of ring-shaped electrodes attached to the tip region of an insulating tube member. A first electrode group, a second electrode group consisting of a plurality of ring-shaped electrodes attached to the tube member at a distance from the first electrode group toward the proximal end, and electrodes constituting the first electrode group. a first lead wire group consisting of a plurality of lead wires whose tips are connected to the electrodes; and a second lead wire group consisting of a plurality of lead wires whose tips are connected to each of the electrodes constituting the second electrode group. The power supply device includes a DC power supply unit, a catheter connection connector connected to the proximal end side of the first lead wire group and the second lead wire group of the defibrillation catheter, and the input terminal of the electrocardiograph. an electrocardiograph connection connector connected to an electrocardiograph, an arithmetic processing unit that controls the DC power supply unit based on the input of an external switch, and has a DC voltage output circuit from the DC power supply unit; a switching unit comprising a changeover switch, wherein the catheter connection connector is connected to a common contact, the electrocardiograph connection connector is connected to a first contact, and the arithmetic processing unit is connected to a second contact; When the cardiac potential is measured by the electrodes constituting the first electrode group and/or the second electrode group of the defibrillation catheter, the switching unit selects the first contact, and the cardiac potential information from the defibrillation catheter is , is input to the electrocardiograph via the catheter connection connector, the switching unit, and the electrocardiograph connection connector of the power supply device, and when performing defibrillation with the defibrillation catheter, the The contact of the switching unit is switched to the second contact by the arithmetic processing unit, and the DC power supply unit passes through the output circuit of the arithmetic processing unit, the switching unit, and the catheter connection connector to the defibrillation catheter. A catheter system has been proposed in which voltages of different polarities are applied to the first electrode group and the second electrode group (see Patent Document 1 below).
 この心腔内除細動カテーテルシステムによれば、心臓カテーテル術中に心房細動等を起こした心臓に対して、除細動に必要かつ十分な電気エネルギーを確実に供給することができる。また、除細動治療を必要としないときには、カテーテルシステムを構成する除細動カテーテルを心電位測定用の電極カテーテルとして用いることができる。 According to this intracardiac defibrillation catheter system, it is possible to reliably supply the necessary and sufficient electrical energy for defibrillation to the heart with atrial fibrillation or the like during cardiac catheterization. Moreover, when defibrillation therapy is not required, the defibrillation catheter that constitutes the catheter system can be used as an electrode catheter for cardiac potential measurement.
 特許文献1に記載された心腔内除細動カテーテルシステムによる除細動治療において、「心電位測定モード」にある電源装置のモード切替スイッチを入力することにより、電源装置のモードが一定時間(例えば1秒間)「除細動モード」に切り替わる。この間に、除細動カテーテルの第1電極群と第2電極群との間のインピーダンスが測定される。その後、印加エネルギー設定スイッチを入力して、除細動を行う際に印加する電気エネルギーを設定し、充電スイッチを入力することにより、測定されたインピーダンスと設定した電気エネルギーに基いて決定される電圧がDC電源部にチャージされる。チャージ完了後、エネルギー印加スイッチを入力することにより、切替部の接点が第1接点から第2接点に切り替わり(これにより、電源装置のモードが「心電位測定モード」から「除細動モード」に切り替わり)、演算処理部からの制御信号を受けたDC電源部から、演算処理部の出力回路、切替部およびカテーテル接続コネクタを経由して、除細動カテーテルの第1電極群と、第2電極群とに、互いに異なる極性の直流電圧が印加される。 In the defibrillation treatment using the intracardiac defibrillation catheter system described in Patent Document 1, by inputting the mode changeover switch of the power supply in the "electrocardiographic measurement mode", the mode of the power supply is set for a certain period of time ( for example for 1 second) to switch to "defibrillation mode". During this time, the impedance between the first and second electrodes of the defibrillation catheter is measured. After that, by inputting the applied energy setting switch to set the electrical energy to be applied when performing defibrillation, and inputting the charge switch, the voltage determined based on the measured impedance and the set electrical energy is charged to the DC power supply. After charging is completed, the contact of the switching unit is switched from the first contact to the second contact by inputting the energy application switch (thereby changing the mode of the power supply from the "cardiogram measurement mode" to the "defibrillation mode"). switching), the first electrode group of the defibrillation catheter and the second electrode are sent from the DC power supply unit that receives the control signal from the arithmetic processing unit via the output circuit of the arithmetic processing unit, the switching unit, and the catheter connection connector. DC voltages of polarities different from each other are applied to the groups.
 また、本出願人は、心電計から演算処理部に入力される心電図のベースラインが動揺(ドリフト)しているときに、除細動カテーテルの電極に電圧が印加されることを回避し、ベースラインが安定しているときに、当該心電図のR波に同期して、除細動カテーテルの電極に直流電圧を印加して除細動を行うことができる心腔内除細動カテーテルシステムとして、除細動カテーテルと、電源装置と、心電計とを備えたカテーテルシステムであって;前記電源装置は、DC電源部と、前記除細動カテーテルの第1リード線群および第2リード線群の基端側に接続されるカテーテル接続コネクタと、前記心電計の入力端子に接続される心電計接続コネクタと、電気エネルギーの印加準備スイッチおよび印加実行スイッチを含む外部スイッチと、前記DC電源部からの直流電圧の出力回路を有し、前記外部スイッチの入力に基いて、前記DC電源部を制御する演算処理部と、1回路2接点の切替スイッチからなり、共通接点に前記カテーテル接続コネクタが接続され、第1接点に前記心電計接続コネクタが接続され、第2接点に前記演算処理部が接続された切替部と、前記演算処理部および前記心電計の出力端子に接続される心電図入力コネクタとを備えてなり;前記印加準備スイッチの入力後に前記印加実行スイッチを入力することにより前記除細動カテーテルによって除細動が行われ、除細動が行われるときには、前記DC電源部から、前記演算処理部の出力回路および前記カテーテル接続コネクタを経由して、前記除細動カテーテルの第1電極群と第2電極群とに、互いに異なる極性の電圧が印加され;前記電源装置の演算処理部は、前記心電図入力コネクタを経由して前記心電計から入力された心電図からR波と推定されるイベントを逐次センシングし、前記印加実行スイッチの入力後にセンシングされたイベント(V)の極性が、少なくとも、その1つ前にセンシングされたイベント(Vn-1 )の極性およびその2つ前にセンシングされたイベント(Vn-2 )の極性と一致し、かつ、前記印加準備スイッチを入力してから前記印加実行スイッチを入力するまでの間に異常波高イベントが発生したときには、前記異常波高イベントの発生から一定の待機時間の経過後に前記イベント(V)がセンシングされている場合に限り、当該イベント(V)に同期して、前記第1電極群および前記第2電極群に電圧が印加されるように演算処理して前記DC電源部を制御する心腔内除細動カテーテルシステムを提案している(下記特許文献2参照)。 In addition, the present applicant avoids applying a voltage to the electrodes of the defibrillation catheter when the baseline of the electrocardiogram input from the electrocardiograph to the processing unit is fluctuating (drift), As an intracardiac defibrillation catheter system capable of performing defibrillation by applying a DC voltage to the electrodes of the defibrillation catheter in synchronization with the R wave of the electrocardiogram when the baseline is stable , a defibrillation catheter, a power supply, and an electrocardiograph; wherein the power supply includes a DC power supply and first and second lead groups of the defibrillation catheter a catheter connection connector connected to the proximal end of the group; an electrocardiograph connection connector connected to the input terminal of the electrocardiograph; an external switch including an electrical energy application preparation switch and an application execution switch; It has a DC voltage output circuit from the power supply unit, and is composed of an arithmetic processing unit that controls the DC power supply unit based on the input of the external switch, and a changeover switch of one circuit and two contacts, and the catheter is connected to the common contact. a switching unit having a connector connected thereto, the electrocardiograph connecting connector being connected to a first contact, and the arithmetic processing unit being connected to a second contact; and an electrocardiogram input connector; when the application execution switch is input after the application preparation switch is input, defibrillation is performed by the defibrillation catheter, and when defibrillation is performed, the DC power supply voltages of different polarities are applied from the unit to the first electrode group and the second electrode group of the defibrillation catheter via the output circuit of the arithmetic processing unit and the catheter connector; The arithmetic processing unit sequentially senses events presumed to be R waves from the electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and events ( Vn ) matches at least the polarity of the event sensed one before (V n-1 ) and the polarity of the event sensed two before (V n-2 ), and the applied When an abnormal wave height event occurs between the input of the preparation switch and the input of the application execution switch, the event (V n ) is sensed after a certain waiting time has passed since the occurrence of the abnormal wave height event. the first electrode group and the second electrode group in synchronism with the event (V n ) only when An intracardiac defibrillation catheter system has been proposed that controls the DC power source by performing arithmetic processing so that a voltage is applied to a group of electrodes (see Patent Document 2 below).
 この心腔内除細動カテーテルシステムによれば、3つのイベント(Vn-2 ),(Vn-1 ),(V)の極性が一致し、印加準備スイッチを入力してから印加実行スイッチを入力するまでの間に異常波高イベントの発生を検知したときには異常波高イベントの発生から一定の待機時間の経過後にイベント(V)がセンシングされている場合に限り、このイベント(V)に同期させて電圧を印加するよう、電源装置の演算処理部がDC電源部を制御するので、心電計から演算処理部に入力される心電図のベースラインが動揺(ドリフト)しているときに、除細動カテーテルの電極に電圧が印加されることを回避し、ベースラインが安定しているときに、当該心電図のR波に同期して、除細動カテーテルの電極に直流電圧を印加して除細動を行うことができる。 According to this intracardiac defibrillation catheter system, the polarities of the three events (V n-2 ), (V n-1 ), and (V n ) match, and the application preparation switch is input, and then the application is executed. When the occurrence of an abnormal wave height event is detected before the switch is input, this event (V n ) is detected only when the event (V n ) is sensed after a certain waiting time has passed since the occurrence of the abnormal wave height event. Since the arithmetic processing unit of the power supply controls the DC power supply unit so that the voltage is applied in synchronization with the , avoid applying voltage to the electrodes of the defibrillation catheter, and apply a DC voltage to the electrodes of the defibrillation catheter in synchronization with the R wave of the electrocardiogram when the baseline is stable. defibrillation can be performed.
 特許文献2に記載の心腔内除細動カテーテルシステムを構成する電源装置は、エネルギーを印加するための外部スイッチとして、エネルギー印加準備スイッチとエネルギー印加実行スイッチとを備えている。エネルギー印加準備スイッチが入力されると、演算処理部の制御信号を受けた切替部の接点が第1接点から第2接点に切り替わり(これにより、電源装置のモードが「心電位測定モード」から「除細動モード」に切り替わり)、カテーテル接続コネクタから切替部を経由して演算処理部に至る経路が確保される。そして、エネルギー印加準備スイッチの入力後(またはこれと同時に)エネルギー印加実行スイッチを入力すると、演算処理部からの制御信号を受けたDC電源部から、演算処理部の出力回路、切替部およびカテーテル接続コネクタを経由して、除細動カテーテルの第1電極群と、第2電極群とに、互いに異なる極性の直流電圧が印加される。 A power supply device that constitutes the intracardiac defibrillation catheter system described in Patent Document 2 includes an energy application preparation switch and an energy application execution switch as external switches for applying energy. When the energy application preparation switch is input, the contact of the switching unit that receives the control signal of the arithmetic processing unit switches from the first contact to the second contact (thereby changing the mode of the power supply from the "electrocardiographic measurement mode" to the "electrocardiographic measurement mode"). defibrillation mode”), and a path is secured from the catheter connector to the arithmetic processing unit via the switching unit. Then, when the energy application execution switch is input after (or at the same time as) the energy application preparation switch is input, the DC power supply section that receives the control signal from the computation processing section transmits the output circuit of the computation processing section, the switching section, and the catheter connection. DC voltages of different polarities are applied to the first electrode group and the second electrode group of the defibrillation catheter via the connector.
特許第4545216号公報Japanese Patent No. 4545216 特許第6632511号公報Japanese Patent No. 6632511
 直流電圧を印加する直前において、第1電極群の構成電極および第2電極群の構成電極により測定される心電位情報はきわめて重要である。
 しかしながら、上記特許文献2に記載された心腔内除細動カテーテルシステムにおいて、エネルギー印加準備スイッチを入力してからエネルギー印加実行スイッチを入力するまでの間(通常8~10数秒間とされる)、1回路2接点の切替スイッチからなる切替部は第2接点を選択していて、当該切替部を経由してカテーテル接続コネクタから心電計接続コネクタに至る経路が遮断されているので、システムを構成する心電計は、第1電極群および/または第2電極群の構成電極によって測定される心電位情報を取得することができない。
The cardiac potential information measured by the constituent electrodes of the first electrode group and the constituent electrodes of the second electrode group immediately before applying the DC voltage is extremely important.
However, in the intracardiac defibrillation catheter system described in Patent Document 2, the time from inputting the energy application preparation switch to inputting the energy application execution switch (usually 8 to 10 seconds) , the switching unit consisting of a switch with two contacts for one circuit selects the second contact, and the path from the catheter connection connector to the electrocardiograph connection connector via the switching unit is cut off. The constituent electrocardiographs cannot acquire electrocardiographic information measured by the constituent electrodes of the first electrode group and/or the second electrode group.
 本発明は以上のような事情に基いてなされたものある。本発明の目的は、除細動カテーテルの第1電極群と第2電極群とに直流電圧が印加される直前まで、第1電極群および/または第2電極群の構成電極からの心電位情報を取得することができる心腔内除細動カテーテルシステムを提供することにある。 The present invention has been made based on the above circumstances. An object of the present invention is to obtain cardiac potential information from the constituent electrodes of the first electrode group and/or the second electrode group until immediately before a DC voltage is applied to the first electrode group and the second electrode group of a defibrillation catheter. To provide an intracardiac defibrillation catheter system capable of obtaining
(1)本発明の心腔内除細動カテーテルシステムは、心腔内に挿入されて除細動を行う除細動カテーテルと、この除細動カテーテルの電極に直流電圧を印加する電源装置と、心電計とを備えたカテーテルシステムであって、
 前記除細動カテーテルは、絶縁性のチューブ部材と、前記チューブ部材の先端領域に装着された複数のリング状電極からなる第1電極群(第1DC電極群)と、
 前記第1電極群から基端側に離間して前記チューブ部材の前記先端領域に装着された複数のリング状電極からなる第2電極群(第2DC電極群)とを備えてなり;
 前記電源装置は、コンデンサを備えたDC電源部と、
 入力手段である外部スイッチと、
 前記外部スイッチの入力に基いて前記DC電源部を制御するとともに、当該DC電源部からの直流電圧の出力回路を有する演算処理部と、
 前記除細動カテーテルの第1DC電極群および第2DC電極群のそれぞれに電気的に接続されるカテーテル接続コネクタと、
 前記心電計の入力端子に接続される心電計接続コネクタと、
 前記カテーテル接続コネクタと前記心電計接続コネクタとの間に介在する第1ON/OFFスイッチと、
 前記カテーテル接続コネクタと前記演算処理部との間に介在する第2ON/OFFスイッチとを備えてなり、
 前記除細動カテーテルの第1DC電極群および/または前記第2DC電極群を構成する前記電極により心電位を測定するときには、前記第1ON/OFFスイッチが「ON」となり、前記除細動カテーテルからの心電位情報が、前記カテーテル接続コネクタ、前記第1ON/OFFスイッチおよび前記心電計接続コネクタを経由して前記心電計に入力され、
 前記除細動カテーテルにより除細動を行うときには、前記第2ON/OFFスイッチが「ON」となり、前記DC電源部から、前記演算処理部の出力回路、前記第2ON/OFFスイッチおよび前記カテーテル接続コネクタを経由して、前記除細動カテーテルの前記第1DC電極群と前記第2DC電極群とに互いに異なる極性の電圧が印加されることを特
徴とする。
(1) The intracardiac defibrillation catheter system of the present invention comprises a defibrillation catheter inserted into a heart chamber for defibrillation, and a power supply for applying a DC voltage to electrodes of the defibrillation catheter. , an electrocardiograph, and a catheter system comprising:
The defibrillation catheter includes an insulating tube member, a first electrode group (first DC electrode group) composed of a plurality of ring-shaped electrodes attached to a tip region of the tube member,
a second electrode group (second DC electrode group) comprising a plurality of ring-shaped electrodes mounted on the distal end region of the tube member spaced from the first electrode group toward the proximal end;
The power supply device includes a DC power supply section including a capacitor;
an external switch as input means;
an arithmetic processing unit that controls the DC power supply unit based on the input of the external switch and has a circuit that outputs a DC voltage from the DC power supply unit;
a catheter connector electrically connected to each of the first DC electrode group and the second DC electrode group of the defibrillation catheter;
an electrocardiograph connection connector connected to an input terminal of the electrocardiograph;
a first ON/OFF switch interposed between the catheter connection connector and the electrocardiograph connection connector;
a second ON/OFF switch interposed between the catheter connector and the arithmetic processing unit;
When the cardiac potential is measured by the electrodes constituting the first DC electrode group and/or the second DC electrode group of the defibrillation catheter, the first ON/OFF switch is turned "ON", and the electrocardiogram information is input to the electrocardiograph via the catheter connection connector, the first ON/OFF switch and the electrocardiograph connection connector;
When defibrillation is performed with the defibrillation catheter, the second ON/OFF switch is turned "ON", and the DC power supply unit supplies power to the output circuit of the arithmetic processing unit, the second ON/OFF switch, and the catheter connection connector. voltages of different polarities are applied to the first DC electrode group and the second DC electrode group of the defibrillation catheter via .
 このような構成の除細動カテーテルシステムによれば、1回路2接点の切替スイッチとは異なり、第1ON/OFFスイッチおよび第2ON/OFFスイッチが互いに独立しているので、これらの両方を「ON」にしたり、「OFF」にしたりすることが可能である。
 第1ON/OFFスイッチおよび第2ON/OFFスイッチの両方を「ON」とすることにより、カテーテル接続コネクタから第2ON/OFFスイッチを経由して演算処理部に至る経路が確保されてエネルギーの印加が可能となる(エネルギー印加の準備が完了する)とともに、除細動カテーテルの第1DC電極群および/または第2DC電極群の構成電極からの心電位情報を取得することができる。これにより、第1ON/OFFスイッチを「OFF」に切り替えるまで、第1DC電極群および/または第2DC電極群の構成電極からの心電位情報を取得することができる。
According to the defibrillation catheter system having such a configuration, the first ON/OFF switch and the second ON/OFF switch are independent of each other, unlike a one-circuit, two-contact changeover switch. ” or “OFF”.
By turning ON both the first ON/OFF switch and the second ON/OFF switch, a path from the catheter connection connector to the arithmetic processing unit via the second ON/OFF switch is secured, and energy can be applied. (preparation for energy application is completed), and electrocardiographic information can be acquired from the constituent electrodes of the first DC electrode group and/or the second DC electrode group of the defibrillation catheter. As a result, electrocardiographic information can be acquired from the constituent electrodes of the first DC electrode group and/or the second DC electrode group until the first ON/OFF switch is switched to "OFF".
(2)本発明の心腔内除細動カテーテルシステムにおいて、前記電源装置は、前記外部スイッチとして、除細動を行う準備をするためのエネルギー印加準備スイッチと、電気エネルギーを印加して除細動を実行するためのエネルギー印加実行スイッチとを備えてなり、
 前記第1ON/OFFスイッチが「ON」、前記第2ON/OFFスイッチが「OFF」となっているときに、前記エネルギー印加準備スイッチが入力されると、前記演算処理部は、前記第1ON/OFFスイッチが「ON」の状態を維持し、前記第2ON/OFFスイッチが「OFF」から「ON」に切り替わるように、これらのON/OFFスイッチを制御し、
 前記エネルギー印加準備スイッチの入力後に、前記エネルギー印加実行スイッチが入力されると、前記演算処理部は、前記第2ON/OFFスイッチが「ON」の状態を維持し、前記第1ON/OFFスイッチが「ON」から「OFF」に切り替わるように、これらのON/OFFスイッチを制御することを特徴とすることが好ましい。
(2) In the intracardiac defibrillation catheter system of the present invention, the power supply device includes, as the external switches, an energy application preparation switch for preparing for defibrillation and an energy application preparation switch for applying electrical energy to perform defibrillation. an energy application execution switch for executing the motion,
When the energy application preparation switch is input when the first ON/OFF switch is "ON" and the second ON/OFF switch is "OFF", the arithmetic processing unit switches the first ON/OFF controlling the ON/OFF switches such that the switches remain "ON" and the second ON/OFF switch switches from "OFF" to "ON";
When the energy application execution switch is input after the energy application preparation switch is input, the arithmetic processing unit maintains the second ON/OFF switch in the "ON" state, and the first ON/OFF switch is in the "ON" state. Preferably, these ON/OFF switches are controlled to switch from "ON" to "OFF".
 このような構成の除細動カテーテルシステムによれば、エネルギー印加準備スイッチの入力によりエネルギー印加の準備が完了した段階であっても、エネルギー印加実行スイッチが入力されるまで、除細動カテーテルの第1DC電極群および/または第2DC電極群の構成電極からの心電位情報を取得することができる。
 これにより、治療部位の心電位情報が安定していることを確認してからエネルギー印加実行スイッチを入力(除細動を実行)することができる。
According to the defibrillation catheter system having such a configuration, even at the stage where the preparation for energy application has been completed by inputting the energy application preparation switch, the defibrillation catheter continues to operate until the energy application execution switch is input. Cardiac potential information can be obtained from the constituent electrodes of the first DC electrode group and/or the second DC electrode group.
Thus, it is possible to input the energy application execution switch (execute defibrillation) after confirming that the electrocardiographic information of the treatment site is stable.
 また、エネルギー印加実行スイッチを入力することにより、第1ON/OFFスイッチが「ON」から「OFF」に切り替わり、カテーテル接続コネクタから第1ON/OFFスイッチを経由して心電計接続コネクタに至る経路が直ちに遮断されているので、心電計に直流電圧が印加されることはない。 Further, by inputting the energy application execution switch, the first ON/OFF switch is switched from "ON" to "OFF", and a path from the catheter connection connector to the electrocardiograph connection connector via the first ON/OFF switch is established. Since it is cut off immediately, no DC voltage is applied to the electrocardiograph.
(3)上記(2)の心腔内除細動カテーテルシステムにおいて、前記電源装置は、主電源スイッチと、心電位測定モードと除細動モードを切り替えるためのモード切替スイッチと、除細動の際に印加する電気エネルギーを設定するための印加エネルギー設定スイッチと、設定された電気エネルギーに基いて決定される電圧をDC電源部に蓄積するための充電スイッチと、前記エネルギー印加準備スイッチと、前記エネルギー印加実行スイッチとを備えてなり、
 前記演算処理部は、前記主電源スイッチが入力されたときには、前記第1ON/OFFスイッチが「ON」、前記第2ON/OFFスイッチが「OFF」となり、
 前記モード切替スイッチが入力されてから一定時間、前記第1ON/OFFスイッチが「OFF」、前記第2ON/OFFスイッチが「ON」となり、
 前記印加エネルギー設定スイッチまたは前記充電スイッチが入力されることによって、
前記第1ON/OFFスイッチおよび前記第2ON/OFFスイッチの「ON」/「OFF」は切り替わらず、
 前記エネルギー印加準備スイッチが入力されたときには、前記第1ON/OFFスイッチおよび前記第2ON/OFFスイッチの両方が「ON」となり、
 前記エネルギー印加実行スイッチが入力されたときには、前記第1ON/OFFスイッチが「OFF」、前記第2ON/OFFスイッチが「ON」となるように、
 前記第1ON/OFFスイッチおよび前記第2ON/OFFスイッチを制御することが好ましい。
(3) In the intracardiac defibrillation catheter system of (2) above, the power supply device includes a main power switch, a mode switch for switching between an electrocardiographic measurement mode and a defibrillation mode, and a defibrillation mode switch. an applied energy setting switch for setting the electric energy to be applied at the time of application; a charging switch for accumulating a voltage determined based on the set electric energy in the DC power supply; the energy application preparation switch; an energy application execution switch;
The arithmetic processing unit turns the first ON/OFF switch "ON" and turns the second ON/OFF switch "OFF" when the main power switch is turned on,
for a certain period of time after the mode changeover switch is turned on, the first ON/OFF switch is turned "OFF" and the second ON/OFF switch is turned "ON";
By inputting the applied energy setting switch or the charging switch,
"ON"/"OFF" of the first ON/OFF switch and the second ON/OFF switch are not switched,
When the energy application preparation switch is input, both the first ON/OFF switch and the second ON/OFF switch are turned "ON",
so that when the energy application execution switch is input, the first ON/OFF switch is turned "OFF" and the second ON/OFF switch is turned "ON";
Preferably, said first ON/OFF switch and said second ON/OFF switch are controlled.
 このような構成の除細動カテーテルシステムによれば、主電源スイッチを入力することによる初期モードが「心電位測定モード」となり、モード切替スイッチを入力することで一定時間「除細動モード」となって、除細動カテーテルの第1DC電極群と第2DC電極群との間のインピーダンスの測定が可能となり、印加する電気エネルギーの設定およびDC電源部への充電時には「心電位測定モード」を維持し、エネルギー印加準備スイッチを入力することにより、エネルギー印加の準備が完了するとともに、除細動カテーテルの第1DC電極群および/または第2DC電極群の構成電極からの心電位情報を取得すること(当該心電位情報に係る心電図のベースラインなどを監視すること)ができ、エネルギー印加実行スイッチを入力することにより、第1DC電極群と第2DC電極群とに直流電圧を印加して除細動を実行することができる。 According to the defibrillation catheter system having such a configuration, the initial mode is set to the "electrocardiogram measurement mode" by turning on the main power switch, and the "defibrillation mode" is set for a certain period of time by turning on the mode selector switch. Then, it becomes possible to measure the impedance between the first DC electrode group and the second DC electrode group of the defibrillation catheter, and the "electrocardiographic measurement mode" is maintained when setting the applied electrical energy and charging the DC power supply. Then, by inputting the energy application preparation switch, preparation for energy application is completed, and electrocardiographic information is acquired from the constituent electrodes of the first DC electrode group and/or the second DC electrode group of the defibrillation catheter ( monitoring the electrocardiogram baseline etc. related to the electrocardiographic information), and by inputting the energy application execution switch, defibrillation is performed by applying a DC voltage to the first DC electrode group and the second DC electrode group. can be executed.
(4)上記(3)の心腔内除細動カテーテルシステムにおいて、前記電源装置の前記演算処理部は、前記モード切替スイッチが入力されてから前記一定時間において、前記除細動カテーテルの前記第1DC電極群と前記第2DC電極群との間のインピーダンスを測定するよう制御することが好ましい。 (4) In the intracardiac defibrillation catheter system of (3) above, the arithmetic processing unit of the power supply device controls the first mode of the defibrillation catheter during the predetermined time after the mode changeover switch is input. It is preferable to control to measure the impedance between one DC electrode group and the second DC electrode group.
(5)上記(4)の心腔内除細動カテーテルシステムにおいて、前記電源装置の前記演算処理部は、測定されたインピーダンスと、前記印加エネルギー設定スイッチを入力して設定された電気エネルギーとに基いて決定される電圧を前記DC電源部に蓄積させるよう制御することが好ましい。 (5) In the intracardiac defibrillation catheter system described in (4) above, the arithmetic processing unit of the power supply device combines the measured impedance with the electrical energy set by inputting the applied energy setting switch. It is preferable to control the DC power supply unit to store the voltage determined based on the above.
(6)本発明の心腔内除細動カテーテルシステムにおいて、前記電源装置は、前記演算処理部および前記心電計の出力端子に接続される心電図入力コネクタを備えていることが好ましい。 (6) In the intracardiac defibrillation catheter system of the present invention, the power supply device preferably includes an electrocardiogram input connector connected to output terminals of the arithmetic processing unit and the electrocardiograph.
 このような構成の除細動カテーテルシステムによれば、心電計から出力される心電位情報を演算処理部に入力することができ、演算処理部では、この心電位情報に基いて、DC電源部、第1ON/OFFスイッチおよび第2ON/OFFスイッチを制御することができる。 According to the defibrillation catheter system having such a configuration, the electrocardiographic information output from the electrocardiograph can be input to the arithmetic processing unit, and the arithmetic processing unit operates on the basis of the electrocardiographic information to generate the DC power supply. section, a first ON/OFF switch and a second ON/OFF switch.
(7)本発明の心腔内除細動カテーテルシステムにおいて、前記除細動カテーテルは、前記第1DC電極群または前記第2DC電極群から離間して前記チューブ部材に装着された複数の電極からなり、前記カテーテル接続コネクタと電気的に接続される電位測定電極群を備えてなり、
 前記電源装置には、前記カテーテル接続コネクタと、前記心電計接続コネクタとを直接結ぶ経路が形成され、
 前記電位測定電極群を構成する電極によって測定された心電位情報は、前記電源装置の前記カテーテル接続コネクタから、前記第1ON/OFFスイッチを経ることなく、前記心電計接続コネクタを経由して前記心電計に入力されることが好ましい。
(7) In the intracardiac defibrillation catheter system of the present invention, the defibrillation catheter comprises a plurality of electrodes attached to the tube member spaced apart from the first DC electrode group or the second DC electrode group. , comprising a group of potential measurement electrodes electrically connected to the catheter connector,
The power supply device is formed with a path that directly connects the catheter connection connector and the electrocardiograph connection connector,
The electrocardiographic information measured by the electrodes constituting the potential measuring electrode group is transmitted from the catheter connector of the power supply device via the electrocardiograph connector without passing through the first ON/OFF switch. It is preferably input to an electrocardiograph.
 このような構成によれば、除細動カテーテルの第1DC電極群および前記第2DC電極
群の構成電極からの心電位情報を心電計が取得することのできない除細動治療の際にも、電位測定電極群によって測定された心電位を心電計が取得することができる。
According to such a configuration, even during defibrillation treatment in which the electrocardiograph cannot acquire electrocardiographic information from the constituent electrodes of the first DC electrode group and the second DC electrode group of the defibrillation catheter, An electrocardiograph can acquire a cardiac potential measured by a group of potential measuring electrodes.
(8)本発明の心腔内除細動カテーテルシステムにおいて、前記心電計には、前記除細動カテーテル以外の心電位測定手段が接続されていることが好ましい。 (8) In the intracardiac defibrillation catheter system of the present invention, the electrocardiograph is preferably connected to electrocardiographic measurement means other than the defibrillation catheter.
(9)上記(8)の心腔内除細動カテーテルシステムにおいて、前記心電位測定手段が電極パッドまたは電極カテーテルであることが好ましい。 (9) In the intracardiac defibrillation catheter system of (8) above, it is preferable that the cardiac potential measuring means is an electrode pad or an electrode catheter.
 このような構成によれば、除細動カテーテルの第1DC電極群および前記第2DC電極群の構成電極からの心電位情報を心電計が取得することのできない除細動治療の際にも、当該心電位測定手段によって測定された心電位を心電計が取得することができる。 According to such a configuration, even during defibrillation treatment in which the electrocardiograph cannot acquire electrocardiographic information from the constituent electrodes of the first DC electrode group and the second DC electrode group of the defibrillation catheter, The electrocardiograph can acquire the electrocardiogram measured by the electrocardiogram measuring means.
 本発明の心腔内除細動カテーテルシステムによれば、除細動カテーテルの第1電極群と第2電極群とに直流電圧が印加される(除細動が実行される)直前まで、第1電極群および/または第2電極群の構成電極からの心電位情報を取得することができる。 According to the intracardiac defibrillation catheter system of the present invention, until immediately before the DC voltage is applied to the first electrode group and the second electrode group of the defibrillation catheter (defibrillation is performed), the second Electrocardiographic information can be obtained from constituent electrodes of one electrode group and/or a second electrode group.
本発明の心腔内除細動カテーテルシステムの一実施形態を示すブロック図である。1 is a block diagram illustrating one embodiment of an intracardiac defibrillation catheter system of the present invention; FIG. 図1に示したカテーテルシステムを構成する除細動カテーテルを示す説明用平面図である。FIG. 2 is an explanatory plan view showing a defibrillation catheter that constitutes the catheter system shown in FIG. 1; 図1に示したカテーテルシステムを構成する除細動カテーテルを示す説明用平面図(寸法および硬度を説明するための図)である。FIG. 2 is an explanatory plan view (a diagram for explaining dimensions and hardness) showing a defibrillation catheter that constitutes the catheter system shown in FIG. 1; 図2のA-A断面を示す横断面図である。FIG. 3 is a transverse sectional view showing the AA section of FIG. 2; 図2のB-B断面、C-C断面、D-D断面を示す横断面図である。3A and 3B are transverse cross-sectional views showing a BB cross section, a CC cross section, and a DD cross section of FIG. 2; 図2に示した除細動カテーテルの一実施形態のハンドルの内部構造を示す斜視図である。3 is a perspective view showing the internal structure of the handle of one embodiment of the defibrillation catheter shown in FIG. 2; FIG. 図1に示したカテーテルシステムにおいて、除細動カテーテルのコネクタと、電源装置のカテーテル接続コネクタとの連結状態を模式的に示す説明図である。FIG. 2 is an explanatory view schematically showing a connection state between a connector of a defibrillation catheter and a catheter connection connector of a power supply device in the catheter system shown in FIG. 1; 図1に示したカテーテルシステムにおける電源装置の動作および操作を示すフローチャートである。2 is a flow chart showing the operation and operation of the power supply in the catheter system shown in FIG. 1; 図1に示したカテーテルシステムにおいて、主電源スイッチをONした後の心電位測定モードにおける心電位情報の流れを示すブロック図である。2 is a block diagram showing the flow of electrocardiographic information in the electrocardiographic measurement mode after the main power switch is turned on in the catheter system shown in FIG. 1; FIG. 図1に示したカテーテルシステムにおいて、モード切替スイッチの入力後の除細動モードにおける電極群間のインピーダンスの測定値に係る情報および心電位情報の流れを示すブロック図である。FIG. 2 is a block diagram showing the flow of information related to measured values of impedance between electrode groups and electrocardiographic information in defibrillation mode after input of a mode switch in the catheter system shown in FIG. 1; 図1に示したカテーテルシステムにおいて、モード切替スイッチを入力してから一定時間経過後の心電位測定モードにおける心電位情報の流れを示すブロック図である。2 is a block diagram showing the flow of electrocardiographic information in the electrocardiographic measurement mode after a certain period of time has passed since the mode selector switch was turned on in the catheter system shown in FIG. 1. FIG. 図1に示したカテーテルシステムにおいて、印加準備スイッチの入力後における心電位情報の流れを示すブロック図である。2 is a block diagram showing the flow of electrocardiographic information after an application preparation switch is input in the catheter system shown in FIG. 1; FIG. 図1に示したカテーテルシステムにおいて、印加実行スイッチの入力後における心電位情報の流れを示すブロック図である。2 is a block diagram showing the flow of electrocardiographic information after an application execution switch is input in the catheter system shown in FIG. 1; FIG. 図1に示したカテーテルシステムにおいて、印加実行スイッチの入力後における直流電圧印加時の状態を示すブロック図である。FIG. 2 is a block diagram showing a state in which a DC voltage is applied after an application execution switch is input in the catheter system shown in FIG. 1;
<実施形態>
 図1に示すように、本実施形態の心腔内除細動カテーテルシステムは、除細動カテーテル100と、電源装置700と、心電計800と、心電位測定手段900とを備えている。
<Embodiment>
As shown in FIG. 1 , the intracardiac defibrillation catheter system of this embodiment includes a defibrillation catheter 100 , a power supply device 700 , an electrocardiograph 800 , and electrocardiographic measurement means 900 .
 図2~図6に示すように、本実施形態のカテーテルシステムを構成する除細動カテーテル100は、マルチルーメンチューブ10と、ハンドル20と、第1DC電極群31Gと、第2DC電極群32Gと、基端側電位測定電極群33Gと、第1リード線群41Gと、第2リード線群42Gと、第3リード線群43Gとを備えている。 As shown in FIGS. 2 to 6, the defibrillation catheter 100 constituting the catheter system of the present embodiment includes a multi-lumen tube 10, a handle 20, a first DC electrode group 31G, a second DC electrode group 32G, It has a proximal side potential measuring electrode group 33G, a first lead wire group 41G, a second lead wire group 42G, and a third lead wire group 43G.
 図4および図5に示すように、マルチルーメンチューブ10には、4つのルーメン(第1ルーメン11、第2ルーメン12、第3ルーメン13、第4ルーメン14)が形成されている。 As shown in FIGS. 4 and 5, the multi-lumen tube 10 is formed with four lumens (first lumen 11, second lumen 12, third lumen 13, and fourth lumen 14).
 図4および図5において、15は、ルーメンを区画するフッ素樹脂層、16は、低硬度のナイロンエラストマーからなるインナー(コア)部、17は、高硬度のナイロンエラストマーからなるアウター(シェル)部であり、図4における18は、編組ブレードを形成するステンレス素線である。 4 and 5, 15 is a fluororesin layer that partitions the lumen, 16 is an inner (core) portion made of a low-hardness nylon elastomer, and 17 is an outer (shell) portion made of a high-hardness nylon elastomer. 18 in FIG. 4 is a stainless wire forming a braided braid.
 本実施形態における除細動カテーテル100を構成するハンドル20は、ハンドル本体21と、摘まみ22と、ストレインリリーフ24とを備えている。摘まみ22を回転操作することにより、マルチルーメンチューブ10の先端部を偏向(首振り)させることができる。 The handle 20 that constitutes the defibrillation catheter 100 of this embodiment includes a handle body 21, a knob 22, and a strain relief 24. By rotating the knob 22, the tip of the multi-lumen tube 10 can be deflected (swinged).
 マルチルーメンチューブ10の先端領域には、第1DC電極群31G、第2DC電極群32Gおよび基端側電位測定電極群33Gが装着されている。ここに、「電極群」とは、同一の極を構成し(同一の極性を有し)、または、同一の目的を持って、狭い間隔(例えば5mm以下)で装着された複数の電極の集合体をいう。 A first DC electrode group 31G, a second DC electrode group 32G, and a proximal side potential measurement electrode group 33G are attached to the distal end region of the multi-lumen tube 10 . Here, "electrode group" means a set of a plurality of electrodes that constitute the same pole (have the same polarity) or have the same purpose and are mounted at narrow intervals (for example, 5 mm or less). say the body
 第1DC電極群31Gは、マルチルーメンチューブ10の先端領域に装着された8個のリング状電極31から構成されている。第1DC電極群31Gを構成する電極31は、第1リード線群41Gを構成するリード線41および後述するコネクタを介して、電源装置700のカテーテル接続コネクタ72に接続されている。
 除細動カテーテル100の使用時(心腔内に配置されるとき)において、第1DC電極群31Gは、例えば冠状静脈内に位置する。
The first DC electrode group 31G is composed of eight ring-shaped electrodes 31 attached to the tip region of the multi-lumen tube 10 . The electrodes 31 that make up the first DC electrode group 31G are connected to the catheter connector 72 of the power supply device 700 via the lead wires 41 that make up the first lead wire group 41G and a connector that will be described later.
When the defibrillation catheter 100 is used (placed in the heart chamber), the first DC electrode group 31G is positioned, for example, in the coronary vein.
 第2DC電極群32Gは、第1DC電極群31Gの装着位置から基端側に離間してマルチルーメンチューブ10の先端領域に装着された8個のリング状電極32から構成されている。第2DC電極群32Gを構成する電極32は、第2リード線群42Gを構成するリード線42および後述するコネクタを介して、電源装置700のカテーテル接続コネクタ72に接続されている。
 除細動カテーテル100の使用時(心腔内に配置されるとき)において、第2DC電極群32Gは、例えば右心房に位置する。
The second DC electrode group 32G is composed of eight ring-shaped electrodes 32 attached to the distal end region of the multi-lumen tube 10 at a distance from the attachment position of the first DC electrode group 31G toward the proximal side. The electrodes 32 forming the second DC electrode group 32G are connected to the catheter connector 72 of the power supply device 700 via the lead wires 42 forming the second lead wire group 42G and a connector described later.
When the defibrillation catheter 100 is in use (placed in the heart chamber), the second DC electrode group 32G is positioned, for example, in the right atrium.
 基端側電位測定電極群33Gは、第2DC電極群32Gの装着位置から基端側に離間してマルチルーメンチューブ10の先端領域に装着された4個のリング状電極33から構成されている。基端側電位測定電極群33Gを構成する電極33は、第3リード線群43Gを構成するリード線43および後述するコネクタを介して、電源装置700のカテーテル接続コネクタ72に接続されている。
 除細動カテーテル100の使用時(心腔内に配置されるとき)において、基端側電位測定電極群33Gは、例えば上大静脈に位置する。
The proximal side potential measuring electrode group 33G is composed of four ring-shaped electrodes 33 attached to the distal end region of the multi-lumen tube 10 spaced proximally from the attachment position of the second DC electrode group 32G. The electrodes 33 forming the proximal side potential measuring electrode group 33G are connected to the catheter connector 72 of the power supply device 700 via the lead wires 43 forming the third lead wire group 43G and a connector described later.
When the defibrillation catheter 100 is used (placed in the heart chamber), the proximal side potential-measuring electrode group 33G is positioned, for example, in the superior vena cava.
 除細動カテーテル100の先端には、先端チップ35が装着されている。
 この先端チップ35には、リード線は接続されておらず、本実施形態では電極として使用していない。
A distal tip 35 is attached to the distal end of the defibrillation catheter 100 .
No lead wire is connected to the distal tip 35, and it is not used as an electrode in this embodiment.
 図4および図5に示される第1リード線群41Gは、第1DC電極群31Gを構成する8個の電極31の各々に接続された8本のリード線41の集合体である。
 第1リード線群41Gにより、第1DC電極群31Gを構成する8個の電極31の各々を電源装置700に電気的に接続することができる。
The first lead wire group 41G shown in FIGS. 4 and 5 is an assembly of eight lead wires 41 connected to each of the eight electrodes 31 forming the first DC electrode group 31G.
Each of the eight electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the power supply device 700 by the first lead wire group 41G.
 第1DC電極群31Gを構成する8個の電極31は、それぞれ、異なるリード線41に接続される。リード線41の各々は、その先端部分において電極31の内周面に溶接されるとともに、マルチルーメンチューブ10の管壁に形成された側孔から第1ルーメン11に進入する。第1ルーメン11に進入した8本のリード線41は、第1リード線群41Gとして、第1ルーメン11に延在する。 The eight electrodes 31 forming the first DC electrode group 31G are connected to different lead wires 41, respectively. Each of the lead wires 41 is welded to the inner peripheral surface of the electrode 31 at its distal end portion and enters the first lumen 11 through a side hole formed in the tube wall of the multi-lumen tube 10 . The eight lead wires 41 entering the first lumen 11 extend to the first lumen 11 as a first lead wire group 41G.
 図4および図5に示される第2リード線群42Gは、第2DC電極群32Gを構成する8個の電極32の各々に接続された8本のリード線42の集合体である。
 第2リード線群42Gにより、第2DC電極群32Gを構成する8個の電極32の各々を電源装置700に電気的に接続することができる。
The second lead wire group 42G shown in FIGS. 4 and 5 is an assembly of eight lead wires 42 connected to each of the eight electrodes 32 that constitute the second DC electrode group 32G.
Each of the eight electrodes 32 constituting the second DC electrode group 32G can be electrically connected to the power supply device 700 by the second lead wire group 42G.
 第2DC電極群32Gを構成する8個の電極32は、それぞれ、異なるリード線42に接続される。リード線42の各々は、その先端部分において電極32の内周面に溶接されるとともに、マルチルーメンチューブ10の管壁に形成された側孔から第2ルーメン12に進入する。第2ルーメン12に進入した8本のリード線42は、第2リード線群42Gとして、第2ルーメン12に延在する。 The eight electrodes 32 forming the second DC electrode group 32G are connected to different lead wires 42, respectively. Each of the lead wires 42 is welded to the inner peripheral surface of the electrode 32 at its distal end portion and enters the second lumen 12 through a side hole formed in the tube wall of the multi-lumen tube 10 . The eight lead wires 42 entering the second lumen 12 extend to the second lumen 12 as a second lead wire group 42G.
 上記のように、第1リード線群41Gが第1ルーメン11に延在し、第2リード線群42Gが第2ルーメン12に延在していることにより、両者は、マルチルーメンチューブ10内において完全に絶縁隔離されている。このため、除細動に必要な電圧が印加されたときに、第1リード線群41G(第1DC電極群31G)と、第2リード線群42G(第2DC電極群32G)との間の短絡を確実に防止することができる。 As described above, the first lead wire group 41G extends to the first lumen 11 and the second lead wire group 42G extends to the second lumen 12, so that both of them can be used in the multi-lumen tube 10. Completely insulated. Therefore, when a voltage required for defibrillation is applied, a short circuit between the first lead wire group 41G (first DC electrode group 31G) and the second lead wire group 42G (second DC electrode group 32G) can be reliably prevented.
 図4に示される第3リード線群43Gは、基端側電位測定電極群33Gを構成する電極33の各々に接続された4本のリード線43の集合体である。
 第3リード線群43Gにより、基端側電位測定電極群33Gを構成する電極33の各々を電源装置700に電気的に接続することができる。
The third lead wire group 43G shown in FIG. 4 is an aggregate of four lead wires 43 connected to each of the electrodes 33 constituting the proximal side potential measuring electrode group 33G.
Each of the electrodes 33 constituting the proximal side potential measuring electrode group 33G can be electrically connected to the power supply device 700 by the third lead wire group 43G.
 基端側電位測定電極群33Gを構成する4個の電極33は、それぞれ、異なるリード線43に接続されている。リード線43の各々は、その先端部分において電極33の内周面に溶接されるとともに、マルチルーメンチューブ10の管壁に形成された側孔から第3ルーメン13に進入する。第3ルーメン13に進入した4本のリード線43は、第3リード線群43Gとして、第3ルーメン13に延在する。 The four electrodes 33 that constitute the proximal end potential measuring electrode group 33G are connected to different lead wires 43, respectively. Each of the lead wires 43 is welded to the inner peripheral surface of the electrode 33 at its distal end portion and enters the third lumen 13 through a side hole formed in the tube wall of the multi-lumen tube 10 . The four lead wires 43 entering the third lumen 13 extend to the third lumen 13 as a third lead wire group 43G.
 上記のように、第3ルーメン13に延在している第3リード線群43Gは、第1リード線群41Gおよび第2リード線群42Gの何れからも完全に絶縁隔離されている。このため、除細動に必要な電圧が印加されたときに、第3リード線群43G(基端側電位測定電極群33G)と、第1リード線群41G(第1DC電極群31G)または第2リード線群42G(第2DC電極群32G)との間の短絡を確実に防止することができる。 As described above, the third lead wire group 43G extending to the third lumen 13 is completely insulated and isolated from both the first lead wire group 41G and the second lead wire group 42G. Therefore, when the voltage required for defibrillation is applied, the third lead wire group 43G (proximal side potential measurement electrode group 33G) and the first lead wire group 41G (first DC electrode group 31G) or the first lead wire group 41G (first DC electrode group 31G) A short circuit between the lead wire group 42G (the second DC electrode group 32G) and the lead wire group 42G can be reliably prevented.
 図4および図5において65はプルワイヤである。
 プルワイヤ65は、第4ルーメン14に延在し、マルチルーメンチューブ10の中心軸に対して偏心して延びている。プルワイヤ65の先端部分は、ハンダによって先端チップ35に固定されている。一方、プルワイヤ65の基端部分は、ハンドル20の摘まみ22に接続されており、摘まみ22を操作することによってプルワイヤ65が引っ張られ、これにより、マルチルーメンチューブ10の先端部が偏向する。
4 and 5, 65 is a pull wire.
The pull wire 65 extends to the fourth lumen 14 and extends eccentrically with respect to the central axis of the multi-lumen tube 10 . The distal end portion of the pull wire 65 is fixed to the distal tip 35 by soldering. On the other hand, the proximal end portion of the pull wire 65 is connected to the knob 22 of the handle 20 , and the pull wire 65 is pulled by operating the knob 22 , thereby deflecting the distal end portion of the multi-lumen tube 10 .
 本実施形態における除細動カテーテル100は、ハンドル20の内部においても、第1リード線群41Gと、第2リード線群42Gと、第3リード線群43Gとが絶縁隔離されている。 In the defibrillation catheter 100 of this embodiment, the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G are insulated and isolated even inside the handle 20.
 図6は、本実施形態における除細動カテーテル100のハンドルの内部構造を示す斜視図である。図6に示すように、マルチルーメンチューブ10の基端部は、ハンドル20の先端開口に挿入され、これにより、マルチルーメンチューブ10とハンドル20とが接続されている。 FIG. 6 is a perspective view showing the internal structure of the handle of the defibrillation catheter 100 according to this embodiment. As shown in FIG. 6, the proximal end of the multi-lumen tube 10 is inserted into the distal opening of the handle 20, whereby the multi-lumen tube 10 and the handle 20 are connected.
 ハンドル20の基端部には、円筒状のコネクタ50が内蔵されている。
 ハンドル20の内部には、3つのリード線群(第1リード線群41G、第2リード線群42G、第3リード線群43G)の各々が挿通される3本の絶縁性チューブ(第1絶縁性チューブ26、第2絶縁性チューブ27、第3絶縁性チューブ28)が延在している。
A cylindrical connector 50 is built in the proximal end of the handle 20 .
Inside the handle 20, there are three insulating tubes (first insulating tube) through which each of the three lead wire groups (first lead wire group 41G, second lead wire group 42G, third lead wire group 43G) is inserted. An insulating tube 26, a second insulating tube 27 and a third insulating tube 28) extend.
 第1絶縁性チューブ26の先端部は、マルチルーメンチューブ10の第1ルーメン11に挿入され、これにより、第1絶縁性チューブ26は、第1リード線群41Gが延在する第1ルーメン11に連結されている。
 第1絶縁性チューブ26は、ハンドル20の内部に延在する第1の保護チューブ61の内孔を通ってコネクタ50の近傍まで延びており、第1リード線群41Gの基端部をコネクタ50の近傍に案内する挿通路を形成している。
 第1絶縁性チューブ26の基端開口から延び出した第1リード線群41Gは、8本のリード線41にばらされ、これらリード線41の各々は、コネクタ50の先端面に配置されたピン端子の各々にハンダにより接続固定されている。
The distal end of the first insulating tube 26 is inserted into the first lumen 11 of the multi-lumen tube 10, whereby the first insulating tube 26 is inserted into the first lumen 11 through which the first lead wire group 41G extends. Concatenated.
The first insulating tube 26 extends to the vicinity of the connector 50 through the inner hole of the first protective tube 61 extending inside the handle 20, and connects the proximal ends of the first lead wire group 41G to the connector 50. form an insertion path for guiding to the vicinity of the
A first lead wire group 41G extending from the base end opening of the first insulating tube 26 is separated into eight lead wires 41, and each of these lead wires 41 is connected to a pin arranged on the distal end surface of the connector 50. It is connected and fixed to each of the terminals by soldering.
 第2絶縁性チューブ27の先端部は、マルチルーメンチューブ10の第2ルーメン12に挿入され、これにより、第2絶縁性チューブ27は、第2リード線群42Gが延在する第2ルーメン12に連結されている。
 第2絶縁性チューブ27は、ハンドル20の内部に延在する第2の保護チューブ62の内孔を通ってコネクタ50の近傍まで延びており、第2リード線群42Gの基端部をコネクタ50の近傍に案内する挿通路を形成している。
 第2絶縁性チューブ27の基端開口から延び出した第2リード線群42Gは、8本のリード線42にばらされ、これらリード線42の各々は、コネクタ50の先端面に配置されたピン端子の各々にハンダにより接続固定されている。
The distal end of the second insulating tube 27 is inserted into the second lumen 12 of the multi-lumen tube 10, whereby the second insulating tube 27 is inserted into the second lumen 12 through which the second lead wire group 42G extends. Concatenated.
The second insulating tube 27 extends to the vicinity of the connector 50 through the inner hole of the second protective tube 62 extending inside the handle 20, and connects the proximal ends of the second lead wire group 42G to the connector 50. form an insertion path for guiding to the vicinity of the
A second lead wire group 42G extending from the proximal end opening of the second insulating tube 27 is separated into eight lead wires 42, each of which is connected to a pin disposed on the distal end surface of the connector 50. It is connected and fixed to each of the terminals by soldering.
 第3絶縁性チューブ28の先端部は、マルチルーメンチューブ10の第3ルーメン13に挿入され、これにより、第3絶縁性チューブ28は、第3リード線群43Gが延在する第3ルーメン13に連結されている。
 第3絶縁性チューブ28は、ハンドル20の内部に延在する第2の保護チューブ62の内孔を通ってコネクタ50の近傍まで延びており、第3リード線群43Gの基端部をコネクタ50の近傍に案内する挿通路を形成している。
 第3絶縁性チューブ28の基端開口から延び出した第3リード線群43Gは、4本のリード線43にばらされ、これらリード線43の各々は、コネクタ50の先端面に配置されたピン端子の各々にハンダにより接続固定されている。
The distal end of the third insulating tube 28 is inserted into the third lumen 13 of the multi-lumen tube 10, whereby the third insulating tube 28 is inserted into the third lumen 13 through which the third lead wire group 43G extends. Concatenated.
The third insulating tube 28 extends to the vicinity of the connector 50 through the inner hole of the second protective tube 62 extending inside the handle 20, and connects the proximal end of the third lead wire group 43G to the connector 50. form an insertion path for guiding to the vicinity of the
A third lead wire group 43G extending from the proximal end opening of the third insulating tube 28 is separated into four lead wires 43, each of which is connected to a pin arranged on the distal end surface of the connector 50. It is connected and fixed to each of the terminals by soldering.
 上記のような構成を有する本実施形態における除細動カテーテル100によれば、第1絶縁性チューブ26内に第1リード線群41Gが延在し、第2絶縁性チューブ27内に第2リード線群42Gが延在し、第3絶縁性チューブ28内に第3リード線群43Gが延在していることで、ハンドル20の内部においても、第1リード線群41Gと、第2リード線群42Gと、第3リード線43Gとを完全に絶縁隔離することができる。 According to the defibrillation catheter 100 of this embodiment having the configuration described above, the first lead wire group 41G extends inside the first insulating tube 26, and the second lead wire group 41G extends inside the second insulating tube 27. By extending the wire group 42G and extending the third lead wire group 43G in the third insulating tube 28, the first lead wire group 41G and the second lead wire group 41G and the second lead wire group 41G can be connected even inside the handle 20. The group 42G and the third lead wire 43G can be completely insulated.
 図1に示したように、本実施形態のカテーテルシステムを構成する電源装置700は、DC電源部71と、カテーテル接続コネクタ72と、心電計接続コネクタ73と、外部スイッチ(入力手段)74と、演算処理部75と、第1ON/OFFスイッチ761と、第2ON/OFFスイッチ762と、心電図入力コネクタ77とを備えている。 As shown in FIG. 1, a power supply device 700 constituting the catheter system of the present embodiment includes a DC power supply unit 71, a catheter connection connector 72, an electrocardiograph connection connector 73, and an external switch (input means) 74. , an arithmetic processing unit 75 , a first ON/OFF switch 761 , a second ON/OFF switch 762 , and an electrocardiogram input connector 77 .
 DC電源部71にはコンデンサが内蔵されている。 The DC power supply unit 71 has a built-in capacitor.
 カテーテル接続コネクタ72には、除細動カテーテル100の第1リード線群41G、第2リード線群42Gおよび第3リード線群43Gの各々の基端が接続されている。
 これにより、カテーテル接続コネクタ72は、第1DC電極群31G、第2DC電極群32Gおよび基端側電位測定電極群33Gのそれぞれに電気的に接続されている。
A proximal end of each of the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G of the defibrillation catheter 100 is connected to the catheter connector 72 .
Thereby, the catheter connector 72 is electrically connected to each of the first DC electrode group 31G, the second DC electrode group 32G, and the proximal side potential measurement electrode group 33G.
 カテーテル接続コネクタ72は、除細動カテーテル100のコネクタ50と接続され、第1リード線群41G、第2リード線群42Gおよび第3リード線群43Gの基端側と電気的に接続される。 The catheter connector 72 is connected to the connector 50 of the defibrillation catheter 100, and electrically connected to the proximal sides of the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G.
 図7に示すように、除細動カテーテル100のコネクタ50と、電源装置700のカテーテル接続コネクタ72とが、コネクタケーブルC1によって連結されることにより、
 第1リード線群を構成する8本のリード線41を接続固定したピン端子51(実際には8個)と、カテーテル接続コネクタ72の端子721(実際には8個)、
 第2リード線群を構成する8本のリード線42を接続固定したピン端子52(実際には8個)と、カテーテル接続コネクタ72の端子722(実際には8個)、
 第3リード線群を構成する4本のリード線43を接続固定したピン端子53(実際には4個)と、カテーテル接続コネクタ72の端子723(実際には4個)が、それぞれ接続されている。
As shown in FIG. 7, by connecting the connector 50 of the defibrillation catheter 100 and the catheter connection connector 72 of the power supply device 700 with a connector cable C1,
pin terminals 51 (actually eight) to which the eight lead wires 41 constituting the first lead wire group are connected and fixed; terminals 721 (actually eight) of the catheter connector 72;
pin terminals 52 (actually eight) to which the eight lead wires 42 constituting the second lead wire group are connected and fixed; terminals 722 (actually eight) of the catheter connector 72;
The pin terminals 53 (four actually) to which the four lead wires 43 constituting the third lead wire group are connected and fixed are connected to the terminals 723 (four actually) of the catheter connector 72. there is
 ここに、カテーテル接続コネクタ72の端子721および端子722は、第1ON/OFFスイッチ761に接続され、端子723は、第1ON/OFFスイッチ761を経ることなく心電計接続コネクタ73に直接接続されている。
 これにより、第1DC電極群31Gおよび第2DC電極群32Gにより測定された心電位情報は、第1ON/OFFスイッチ761を経由して心電計接続コネクタ73に到達し、基端側電位測定電極群33Gにより測定された心電位情報は、第1ON/OFFスイッチ761を経ることなく、心電計接続コネクタ73に到達する。
Here, the terminals 721 and 722 of the catheter connector 72 are connected to the first ON/OFF switch 761, and the terminal 723 is directly connected to the electrocardiograph connector 73 without going through the first ON/OFF switch 761. there is
As a result, the electrocardiographic information measured by the first DC electrode group 31G and the second DC electrode group 32G reaches the electrocardiograph connector 73 via the first ON/OFF switch 761, and reaches the proximal side potential measuring electrode group. Electrocardiogram information measured by 33G reaches the electrocardiograph connection connector 73 without passing through the first ON/OFF switch 761 .
 心電計接続コネクタ73は、心電計800の入力端子に接続されている。
 入力手段である外部スイッチ74は、電源装置700を起動させる主電源スイッチ740、心電位測定モードと除細動モードとを切り替えるためのモード切替スイッチ741、除細動の際に印加する電気エネルギーを設定するための印加エネルギー設定スイッチ742、設定された電気エネルギーに基いて決定される電圧をDC電源部に蓄積するための充電スイッチ743、除細動を行う準備(リレーの切替え)をするためのエネルギー印加準備スイッチ744、電気エネルギーを印加して除細動を実行するためのエネルギー印加実行スイッチ745からなる。
 これら外部スイッチ74からの入力信号はすべて演算処理部75に送られる。
The electrocardiograph connection connector 73 is connected to an input terminal of the electrocardiograph 800 .
The external switch 74, which is input means, includes a main power switch 740 for activating the power supply device 700, a mode selector switch 741 for switching between an electrocardiogram measurement mode and a defibrillation mode, and an electrical energy applied during defibrillation. Applied energy setting switch 742 for setting, charging switch 743 for accumulating voltage determined based on the set electrical energy in the DC power supply, preparation for defibrillation (relay switching) It consists of an energy application preparation switch 744 and an energy application execution switch 745 for applying electrical energy to perform defibrillation.
All input signals from these external switches 74 are sent to the arithmetic processing section 75 .
 演算処理部75は、外部スイッチ74の入力に基づいて、DC電源部71、第1ON/OFFスイッチ761および第2ON/OFFスイッチ762を制御する。
 この演算処理部75は、DC電源部71からの直流電圧を第2ON/OFFスイッチ762を介して除細動カテーテル100の電極に出力するための出力回路751と、除細動カテーテル100の第1DC電極群31Gと第2DC電極群32Gとの間のインピーダンスを測定するためのCPU回路752と、動作確認(テスト)のために使用する抵抗値既知の内部抵抗753と、出力回路751およびCPU回路752の各々の接続先を内部抵抗753と第2ON/OFFスイッチ762との間で切り替える切替部754とを有している。
Arithmetic processing unit 75 controls DC power supply unit 71 , first ON/OFF switch 761 and second ON/OFF switch 762 based on the input of external switch 74 .
The arithmetic processing unit 75 includes an output circuit 751 for outputting the DC voltage from the DC power supply unit 71 to the electrodes of the defibrillation catheter 100 via the second ON/OFF switch 762, and a first DC voltage of the defibrillation catheter 100. A CPU circuit 752 for measuring the impedance between the electrode group 31G and the second DC electrode group 32G, an internal resistor 753 with a known resistance value used for operation confirmation (test), an output circuit 751 and a CPU circuit 752 and a switching unit 754 that switches the connection destination of each of them between the internal resistance 753 and the second ON/OFF switch 762 .
 出力回路751により、図7に示したカテーテル接続コネクタ72の端子721(最終的には、除細動カテーテル100の第1DC電極群31G)と、カテーテル接続コネクタ72の端子722(最終的には、除細動カテーテル100の第2DC電極群32G)とが互いに異なる極性となる(一方の電極群が-極のときには、他方の電極群は+極となる)ように直流電圧を印加することができる。 By the output circuit 751, the terminal 721 of the catheter connector 72 shown in FIG. A DC voltage can be applied so that the second DC electrode group 32G) of the defibrillation catheter 100 has different polarities (when one electrode group has a negative polarity, the other electrode group has a positive polarity). .
 CPU回路752により、除細動カテーテル100の第1DC電極群31Gと第2DC電極群32Gとの間のインピーダンスを測定することができ、この測定値は、DC電源部71に蓄積させる目標電圧の決定に利用される。 The CPU circuit 752 allows the impedance between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 to be measured, and this measurement is used to determine the target voltage to be stored in the DC power supply 71. used for
 第1ON/OFFスイッチ761は、カテーテル接続コネクタ72に接続されるとともに心電計接続コネクタ73に接続されている。
 第2ON/OFFスイッチ762は、カテーテル接続コネクタ72に接続されるとともに演算処理部75に接続されている。
The first ON/OFF switch 761 is connected to the catheter connector 72 and the electrocardiograph connector 73 .
The second ON/OFF switch 762 is connected to the catheter connector 72 and the arithmetic processing section 75 .
 第1ON/OFFスイッチ761を「ON」とし、第2ON/OFFスイッチ762を「OFF」とすることにより、除細動カテーテル100からの心電位情報を、カテーテル接続コネクタ72、第1ON/OFFスイッチ761および心電計接続コネクタ73を経由して心電計800に入力させることができる(心電位測定モード)。 By setting the first ON/OFF switch 761 to "ON" and the second ON/OFF switch 762 to "OFF", the cardiac potential information from the defibrillation catheter 100 is transferred to the catheter connector 72 and the first ON/OFF switch 761. and the electrocardiograph 800 via the electrocardiograph connection connector 73 (electrocardiogram measurement mode).
 また、切替部754を介して出力回路751と第2ON/OFFスイッチ762とが接続されている状態で、第1ON/OFFスイッチ761を「OFF」とし、第2ON/OFFスイッチ762を「ON」とすることにより、DC電源部71から、演算処理部75の出力回路751、切替部754、第2ON/OFFスイッチ762およびカテーテル接続コネクタ72を経由して、除細動カテーテル100の第1DC電極群31Gと第2DC電極群32Gとに互いに異なる極性の電圧を印加することができる(除細動モード)。 Also, in a state in which the output circuit 751 and the second ON/OFF switch 762 are connected via the switching unit 754, the first ON/OFF switch 761 is turned "OFF" and the second ON/OFF switch 762 is turned "ON". As a result, the first DC electrode group 31G of the defibrillation catheter 100 is supplied from the DC power supply unit 71 via the output circuit 751 of the arithmetic processing unit 75, the switching unit 754, the second ON/OFF switch 762 and the catheter connector 72. and the second DC electrode group 32G (defibrillation mode).
 また、切替部754を介してCPU回路752と第2ON/OFFスイッチ762とが接続されている状態で、第1ON/OFFスイッチ761を「OFF」とし、第2ON/OFFスイッチ762を「ON」とすることにより、除細動カテーテル100の第1DC電極群31Gと第2DC電極群32Gとの間のインピーダンスを測定することができる。
 第1ON/OFFスイッチ761および第2ON/OFFスイッチ762の「ON」と「OFF」の切替えは、外部スイッチ74であるモード切替スイッチ741およびエネルギー印加準備スイッチ744の入力に基いて演算処理部75により制御される。
Also, in a state in which the CPU circuit 752 and the second ON/OFF switch 762 are connected via the switching unit 754, the first ON/OFF switch 761 is turned "OFF" and the second ON/OFF switch 762 is turned "ON". By doing so, the impedance between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 can be measured.
The switching between “ON” and “OFF” of the first ON/OFF switch 761 and the second ON/OFF switch 762 is performed by the arithmetic processing unit 75 based on the inputs of the mode changeover switch 741 and the energy application preparation switch 744 which are the external switches 74 . controlled.
 心電図入力コネクタ77は、演算処理部75に接続され、また、心電計800の出力端子に接続される。
 この心電図入力コネクタ77により、心電計800から出力される心電位情報(通常、心電計800に入力された心電位情報の一部)を演算処理部75に入力することができ、
演算処理部75では、この心電位情報に基いて、DC電源部71、第1ON/OFFスイッチ761および第2ON/OFFスイッチ762を制御することができる。
The electrocardiogram input connector 77 is connected to the arithmetic processing unit 75 and to the output terminal of the electrocardiograph 800 .
Through this electrocardiogram input connector 77, the electrocardiographic information output from the electrocardiograph 800 (normally, part of the electrocardiographic information input to the electrocardiograph 800) can be input to the arithmetic processing unit 75.
The arithmetic processing unit 75 can control the DC power supply unit 71, the first ON/OFF switch 761 and the second ON/OFF switch 762 based on this electrocardiographic information.
 本実施形態のカテーテルシステムを構成する心電計800(入力端子)は、電源装置700の心電計接続コネクタ73に接続され、除細動カテーテル100(第1DC電極群31G、第2DC電極群32Gおよび基端側電位測定電極群33Gの構成電極)により測定された心電位情報は、心電計接続コネクタ73から心電計800に入力される。 The electrocardiograph 800 (input terminal) constituting the catheter system of this embodiment is connected to the electrocardiograph connection connector 73 of the power supply device 700, and the defibrillation catheter 100 (first DC electrode group 31G, second DC electrode group 32G) and constituent electrodes of the proximal side potential measuring electrode group 33G) is input to the electrocardiograph 800 from the electrocardiograph connection connector 73 .
 また、心電計800(他の入力端子)は心電位測定手段900にも接続され、心電位測定手段900により測定された心電位情報も心電計800に入力される。
 ここに、心電位測定手段900としては、12誘導心電図を測定するために患者の体表面に貼付される電極パッド、患者の心臓内に装着される電極カテーテル(除細動カテーテル100とは異なる電極カテーテル)を挙げることができる。
The electrocardiograph 800 (another input terminal) is also connected to the electrocardiographic measurement means 900 , and the electrocardiographic information measured by the electrocardiographic measurement means 900 is also input to the electrocardiograph 800 .
Here, the electrocardiogram measuring means 900 includes an electrode pad attached to the patient's body surface for measuring a 12-lead electrocardiogram, and an electrode catheter attached to the patient's heart (an electrode different from the defibrillation catheter 100). catheter) can be mentioned.
 心電計800(出力端子)は、電源装置700の心電図入力コネクタ77に接続され、心電計800に入力された心電位情報(除細動カテーテル100からの心電位情報および心電位測定手段900からの心電位情報)の一部を、心電図入力コネクタ77から演算処理部75に送ることができる。 The electrocardiograph 800 (output terminal) is connected to the electrocardiogram input connector 77 of the power supply device 700, and receives the electrocardiographic information input to the electrocardiograph 800 (the electrocardiographic information from the defibrillation catheter 100 and the electrocardiographic information from the electrocardiographic measuring means 900). electrocardiographic information from the electrocardiogram input connector 77 to the arithmetic processing unit 75 .
 本実施形態における除細動カテーテル100は、除細動治療を必要としないときには、心電位測定用の電極カテーテルとして用いることができる。 The defibrillation catheter 100 of this embodiment can be used as an electrode catheter for cardiac potential measurement when defibrillation treatment is not required.
 除細動カテーテル100の第1DC電極群31Gおよび/または第2DC電極群32Gを構成する電極によって測定された心電位は、カテーテル接続コネクタ72、第1ON/OFFスイッチ761および心電計接続コネクタ73を経由して心電計800に入力される。
 また、除細動カテーテル100の基端側電位測定電極群33Gを構成する電極によって測定された心電位は、カテーテル接続コネクタ72から、第1ON/OFFスイッチ761を通ることなく直接心電計接続コネクタ73を経由して心電計800に入力される。
Electrocardiographic potentials measured by the electrodes constituting first DC electrode group 31G and/or second DC electrode group 32G of defibrillation catheter 100 are connected to catheter connector 72, first ON/OFF switch 761 and electrocardiograph connector 73. It is input to the electrocardiograph 800 via.
In addition, the electrocardiographic potential measured by the electrodes constituting the proximal side potential measuring electrode group 33G of the defibrillation catheter 100 is directly transferred from the catheter connecting connector 72 to the electrocardiograph connecting connector without passing through the first ON/OFF switch 761. 73 to the electrocardiograph 800 .
 除細動カテーテル100からの心電位情報(心電位波形)は、心電計800のモニタ(図示省略)に表示される。
 また、除細動カテーテル100からの心電位情報の一部(例えば、第1DC電極群31Gを構成する電極31(第1極と第2極)間の電位差)を、心電計800から、心電図入力コネクタ77を経由して演算処理部75に入力することができる。
Cardiac potential information (cardiogram waveform) from the defibrillation catheter 100 is displayed on a monitor (not shown) of the electrocardiograph 800 .
In addition, part of the electrocardiographic information from the defibrillation catheter 100 (for example, the potential difference between the electrodes 31 (first and second electrodes) constituting the first DC electrode group 31G) is transferred from the electrocardiograph 800 to the electrocardiogram It can be input to the arithmetic processing unit 75 via the input connector 77 .
 上記のように、心臓カテーテル術中において除細動治療を必要としないときには、除細動カテーテル100を心電位測定用の電極カテーテルとして用いることができる(心電位測定モード)。 As described above, when defibrillation treatment is not required during cardiac catheterization, the defibrillation catheter 100 can be used as an electrode catheter for cardiac potential measurement (cardiac potential measurement mode).
 そして、心臓カテーテル術中において心房細動が起こったときには、電極カテーテルとして使用していた除細動カテーテル100によって直ちに除細動治療を行うことができる(除細動モード)。この結果、心房細動が起きたときに、除細動のためのカテーテルを新に挿入するなどの手間を省くことができる。 Then, when atrial fibrillation occurs during cardiac catheterization, defibrillation treatment can be immediately performed using the defibrillation catheter 100 used as an electrode catheter (defibrillation mode). As a result, when atrial fibrillation occurs, the trouble of inserting a new catheter for defibrillation can be saved.
 以下、本実施形態の心腔内除細動カテーテルシステムによる除細動治療の一例について、図8に示すフローチャートに沿って説明する。 An example of defibrillation treatment by the intracardiac defibrillation catheter system of this embodiment will be described below with reference to the flowchart shown in FIG.
(1)除細動カテーテル100を電源装置700(カテーテル接続コネクタ72)に接続して、当該電源装置700の主電源スイッチ740をONにする(STEP1)。
 ここに、除細動カテーテル100の第1DC電極群31Gは冠状静脈洞(CS)に位置させ、第2DC電極群32Gは右心房(RA)に位置させ、基端側電位測定電極群33Gは上大静脈(SVC)に位置させている。
(1) Connect the defibrillation catheter 100 to the power supply device 700 (catheter connector 72) and turn on the main power switch 740 of the power supply device 700 (STEP 1).
Here, the first DC electrode group 31G of defibrillation catheter 100 is positioned in the coronary sinus (CS), the second DC electrode group 32G is positioned in the right atrium (RA), and the proximal potential measuring electrode group 33G is positioned in the superior position. It is located in the vena cava (SVC).
(2)主電源スイッチ740をONにしたときの電源装置700のモード(初期モード)は「心電位測定モード」である(STEP2、図9)。
 図9に示すように、第1ON/OFFスイッチ761が「ON」の状態であり、第2ON/OFFスイッチ762が「OFF」の状態である。
 これにより、第1DC電極群31Gおよび/または第2DC電極群32Gの構成電極により測定された心電位情報は、カテーテル接続コネクタ72、第1ON/OFFスイッチ761、心電計接続コネクタ73を経由して心電計800に入力される。また、基端側電位測定電極群33Gの構成電極によって測定された心電位情報は、カテーテル接続コネクタ72、心電計接続コネクタ73を経由して心電計800に入力される。心電計800に入力されたこれらの心電位情報は、心電図入力コネクタ77を経由して演算処理部75に入力される。
 また、心電位測定手段900(体表面に貼付した電極パッド)によって測定された心電位情報(12誘導心電図)も心電計800に入力され、心電位測定手段900による心電位情報も心電図入力コネクタ77を経由して演算処理部75に入力される。
 図9に示した演算処理部75において、切替部754を介して、CPU回路752と内部抵抗753とが接続されており、この段階では、CPU回路752によって内部抵抗753の抵抗値を測定し、既知の抵抗値に合致しているか否かを確認(テスト)することができる。
(2) The mode (initial mode) of the power supply device 700 when the main power switch 740 is turned on is the "electrocardiogram measurement mode" (STEP 2, FIG. 9).
As shown in FIG. 9, the first ON/OFF switch 761 is in the "ON" state, and the second ON/OFF switch 762 is in the "OFF" state.
As a result, electrocardiographic information measured by the constituent electrodes of the first DC electrode group 31G and/or the second DC electrode group 32G is transmitted via the catheter connector 72, the first ON/OFF switch 761, and the electrocardiograph connector 73. It is input to the electrocardiograph 800 . Further, the electrocardiographic information measured by the constituent electrodes of the proximal side potential measuring electrode group 33G is input to the electrocardiograph 800 via the catheter connector 72 and the electrocardiograph connector 73 . The electrocardiogram information input to the electrocardiograph 800 is input to the arithmetic processing unit 75 via the electrocardiogram input connector 77 .
Further, the electrocardiographic information (12-lead electrocardiogram) measured by the electrocardiographic measuring means 900 (electrode pads attached to the body surface) is also input to the electrocardiograph 800, and the electrocardiographic information obtained by the electrocardiographic measuring means 900 is also input to the electrocardiogram input connector. 77 to the arithmetic processing unit 75 .
In the arithmetic processing unit 75 shown in FIG. 9, the CPU circuit 752 and the internal resistor 753 are connected via the switching unit 754. At this stage, the resistance value of the internal resistor 753 is measured by the CPU circuit 752, It can be checked (tested) to see if it matches a known resistance value.
(3)モード切替スイッチ741を入力する(STEP3)。 (3) Input the mode switch 741 (STEP 3).
(4)モード切替スイッチ741が入力されたことにより、電源装置700のモードが「除細動モード」となる(STEP4、図10)。
 図10に示すように、第1ON/OFFスイッチ761が「OFF」の状態となり、第2ON/OFFスイッチ762が「ON」の状態となる。
 また、図10に示した演算処理部75では、切替部754を介して、CPU回路752と第2ON/OFFスイッチ762とが接続されている。
(4) When the mode switch 741 is turned on, the mode of the power supply device 700 becomes the "defibrillation mode" (STEP 4, FIG. 10).
As shown in FIG. 10, the first ON/OFF switch 761 is in the "OFF" state, and the second ON/OFF switch 762 is in the "ON" state.
10, the CPU circuit 752 and the second ON/OFF switch 762 are connected via the switching section 754. The processing section 75 shown in FIG.
 なお、第1ON/OFFスイッチ761が「OFF」の状態になることにより、カテーテル接続コネクタ72から、第1ON/OFFスイッチ761を経由して心電計接続コネクタ73に至る経路が遮断されるので、除細動カテーテル100の第1DC電極群31Gおよび第2DC電極群32Gの構成電極からの心電位情報は、心電計800に入力することはできない(従って、この心電位情報を演算処理部75に送ることもできない。)。但し、第1ON/OFFスイッチ761を経由しない基端側電位測定電極群33Gの構成電極からの心電位情報は心電計800に入力される。 By turning the first ON/OFF switch 761 to the "OFF" state, the path from the catheter connector 72 to the electrocardiograph connector 73 via the first ON/OFF switch 761 is blocked. The electrocardiographic information from the constituent electrodes of the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 cannot be input to the electrocardiograph 800 (therefore, this electrocardiographic information cannot be sent to the arithmetic processing unit 75). cannot be sent). However, electrocardiographic information from the constituent electrodes of the proximal side potential measuring electrode group 33</b>G that does not pass through the first ON/OFF switch 761 is input to the electrocardiograph 800 .
(5)演算処理部75のCPU回路752により、除細動カテーテル100の第1DC電極群31Gと第2DC電極群32Gとの間のインピーダンスが測定される(STEP5、図10)。 (5) The CPU circuit 752 of the arithmetic processing unit 75 measures the impedance between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 (STEP 5, FIG. 10).
(6)電源装置700のモードが「心電位測定モード」に戻る(STEP6、図11)。
 図11に示すように、第1ON/OFFスイッチ761が「ON」の状態となり、第2ON/OFFスイッチ762が「OFF」の状態となる。
 また、図11に示した演算処理部75では、切替部754を介して、出力回路751と内部抵抗753とが接続されており、この段階では、内部抵抗753に直流電圧を印加することが可能であり、設定したとおりの電気エネルギーを内部抵抗753に印加すること
ができるか否かを確認(テスト)することができる。
(6) The mode of the power supply device 700 returns to the "electrocardiogram measurement mode" (STEP 6, FIG. 11).
As shown in FIG. 11, the first ON/OFF switch 761 is in the "ON" state, and the second ON/OFF switch 762 is in the "OFF" state.
11, the output circuit 751 and the internal resistor 753 are connected via the switching unit 754, and at this stage, the DC voltage can be applied to the internal resistor 753. , and it is possible to check (test) whether or not the set electric energy can be applied to the internal resistance 753 .
(7)印加エネルギー設定スイッチ742を入力して、除細動の際の印加エネルギーを設定する(STEP7)。
 本実施形態における電極装置700によれば、印加エネルギーは1Jから30Jまで、1J刻みで設定することができる。
(7) Input the applied energy setting switch 742 to set the applied energy for defibrillation (STEP 7).
According to the electrode device 700 of this embodiment, the applied energy can be set from 1 J to 30 J in increments of 1 J.
(8)充電スイッチ743を入力する(STEP8)。 (8) Turn on the charging switch 743 (STEP 8).
(9)STEP5で測定されたインピーダンスと、STEP7で設定された電気エネルギーとに基づいて決定された目標電圧がDC電源部に蓄積される(STEP9)。 (9) The target voltage determined based on the impedance measured in STEP5 and the electrical energy set in STEP7 is accumulated in the DC power supply (STEP9).
(10)エネルギー印加準備スイッチ744を入力する(STEP10)。 (10) Input the energy application preparation switch 744 (STEP 10).
(11)エネルギー印加準備スイッチ744が入力されたことにより、演算処理部75からの制御信号を受けて、第1ON/OFFスイッチが「ON」の状態を維持し、第2ON/OFFスイッチが「OFF」から「ON」に切り替わる(STEP11、図12)。
 また、図12に示した演算処理部75では、切替部754を介して、出力回路751と第2ON/OFFスイッチとが接続されている。
(11) When the energy application preparation switch 744 is input, the control signal from the arithmetic processing unit 75 is received, the first ON/OFF switch maintains the "ON" state, and the second ON/OFF switch is turned "OFF." ” to “ON” (STEP 11, FIG. 12).
12, the output circuit 751 and the second ON/OFF switch are connected via the switching section 754. The operation processing section 75 shown in FIG.
(12)除細動カテーテル100の第1DC電極群31Gおよび/または第2DC電極群32Gの構成電極からの心電位情報に係る心電図を目視により確認する(STEP12)。このとき、基端側電位測定電極群33Gの構成電極からの心電位情報および/または心電位測定手段900による心電位情報に係る心電図を併せて確認してもよい。 (12) Visually confirm an electrocardiogram related to electrocardiographic information from the constituent electrodes of the first DC electrode group 31G and/or the second DC electrode group 32G of the defibrillation catheter 100 (STEP 12). At this time, an electrocardiogram related to the electrocardiographic information from the constituent electrodes of the proximal side potential measuring electrode group 33G and/or the electrocardiographic information obtained by the electrocardiographic measuring means 900 may also be confirmed.
(13)心電図においてモード切替え等に伴うドリフト(ベースラインの動揺)が収まっているか否かを判断し、収まっている場合にはSTEP14に進み、収まっていな場合にはSTEP12に戻る(STEP13)。 (13) Determine whether or not the drift (baseline fluctuation) associated with mode switching or the like in the electrocardiogram has subsided. If it has subsided, proceed to STEP 14. If not, return to STEP 12 (STEP 13).
(14)エネルギー印加実行スイッチ745を入力する(STEP14)。 (14) Input the energy application execution switch 745 (STEP 14).
(15)エネルギー印加実行スイッチ745が入力されたことにより、演算処理部75からの制御信号を受けて、第2ON/OFFスイッチ762が「ON」の状態を維持し、第1ON/OFFスイッチが「ON」から「OFF」に切り替わり、カテーテル接続コネクタ72から心電計接続コネクタ73に至る経路が直ちに遮断される(STEP15、図13および図14)。これにより、心電計800に直流電圧が印加されることはない。 (15) By inputting the energy application execution switch 745, the second ON/OFF switch 762 maintains the "ON" state in response to the control signal from the arithmetic processing unit 75, and the first ON/OFF switch turns " ON" is switched to "OFF", and the path from the catheter connector 72 to the electrocardiograph connector 73 is immediately cut off (STEP 15, FIGS. 13 and 14). As a result, no DC voltage is applied to electrocardiograph 800 .
(16)演算処理部75からの制御信号を受けたDC電源部71から、演算処理部75の出力回路751および切替部754、第2ON/OFFスイッチ762並びにカテーテル接続コネクタ72を経由して、除細動カテーテル100の第1DC電極群と、第2DC電極群とに、互いに異なる極性の直流電圧が印加される(STEP16、図14)。 (16) Remove from the DC power supply unit 71 that receives the control signal from the arithmetic processing unit 75 via the output circuit 751 and the switching unit 754 of the arithmetic processing unit 75, the second ON/OFF switch 762 and the catheter connection connector 72 DC voltages of different polarities are applied to the first DC electrode group and the second DC electrode group of the fibrillation catheter 100 (STEP 16, FIG. 14).
(17)DC電源部71からの電圧の印加が停止した後、電源装置700のモードが「心電位測定モード」に戻り、除細動カテーテル100の第1DC電極群31Gおよび第2DC電極群32Gの構成電極からの心電位情報が、心電計800に入力される(STEP17)。 (17) After the application of the voltage from the DC power supply unit 71 is stopped, the mode of the power supply device 700 returns to the "electrocardiogram measurement mode", and the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 Electrocardiographic information from the constituent electrodes is input to the electrocardiograph 800 (STEP 17).
(18)心電計800のモニタに表示される、除細動カテーテル100の構成電極(第1DC電極群31G、第2DC電極群32Gおよび基端側電位測定電極群33Gの構成電極)からの心電位情報(心電図)、並びに、心電位測定手段900からの心電位情報(12
誘導心電図)を観察し、「正常」であれば終了とし、「正常でない(心房細動が治まっていない)」場合には、STEP2に戻る(STEP18)。
(18) Heart rate from the configuration electrodes of the defibrillation catheter 100 (the configuration electrodes of the first DC electrode group 31G, the second DC electrode group 32G, and the proximal side potential measurement electrode group 33G) displayed on the monitor of the electrocardiograph 800 Potential information (electrocardiogram), and electrocardiographic information from the electrocardiographic measurement means 900 (12
The lead electrocardiogram) is observed, and if it is "normal", it is terminated, and if it is "not normal (atrial fibrillation has not subsided)", return to STEP 2 (STEP 18).
 本実施形態のカテーテルシステムによれば、第1ON/OFFスイッチ761および第2ON/OFFスイッチ762が互いに独立しているので、両方のON/OFFスイッチを「ON」にしたり、「OFF」にしたりすることが可能である。
 そして、エネルギー印加準備スイッチ744が入力されることにより、第1ON/OFFスイッチ761および第2ON/OFFスイッチ762の両方が「ON」となり、カテーテル接続コネクタ72から第2ON/OFFスイッチ762を経由して演算処理部75に至る経路が確保されてエネルギーの印加が可能となりエネルギー印加の準備が完了するとともに、除細動カテーテル100の第1DC電極群31Gおよび/または第2DC電極群32Gの構成電極からの心電位情報を取得することができる。
According to the catheter system of this embodiment, since the first ON/OFF switch 761 and the second ON/OFF switch 762 are independent of each other, both ON/OFF switches are turned "ON" or "OFF". It is possible.
Then, when the energy application preparation switch 744 is input, both the first ON/OFF switch 761 and the second ON/OFF switch 762 are turned "ON", and from the catheter connector 72 via the second ON/OFF switch 762, A path leading to the arithmetic processing unit 75 is secured, energy can be applied, and preparations for energy application are completed. ECG information can be acquired.
 また、エネルギー印加実行スイッチ745が入力されることにより、第1ON/OFFスイッチ761が「OFF」に切り替えられるので、除細動カテーテル100の第1DC電極群31Gと第2DC電極群32Gとに直流電圧が印加されて除細動が実行される直前まで、第1DC電極群31Gおよび/または第2DC電極群32Gの構成電極からの心電位情報を取得することができる。
 これにより、エネルギー印加準備スイッチ744の入力後においても、治療部位の心電位情報に基づく患者の状態を監視することができ、当該心電位情報が安定していることを確認してからエネルギー印加実行スイッチを入力(除細動を実行)することができる。
Also, by inputting the energy application execution switch 745, the first ON/OFF switch 761 is switched to "OFF", so that the DC voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100. Cardiac potential information from the constituent electrodes of the first DC electrode group 31G and/or the second DC electrode group 32G can be obtained until just before is applied to perform defibrillation.
As a result, even after the energy application preparation switch 744 is turned on, the patient's condition can be monitored based on the electrocardiographic information of the treatment site, and energy application is executed after confirming that the electrocardiographic information is stable. You can enter a switch (perform defibrillation).
 また、切替部754によりCPU回路752と内部抵抗753とを接続することにより、CPU回路752によって内部抵抗753の抵抗値を測定し、CPU回路752を含むインピーダンスの測定系統の動作状態を確認することができる。 Further, by connecting the CPU circuit 752 and the internal resistor 753 by the switching unit 754, the resistance value of the internal resistor 753 is measured by the CPU circuit 752, and the operating state of the impedance measurement system including the CPU circuit 752 is confirmed. can be done.
 また、切替部754により出力回路751と内部抵抗753とが接続することにより、出力回路751によって内部抵抗753に電気エネルギーを印加することにより、出力回路751を含む直流電圧の出力系統の動作状態を確認することができる。 In addition, by connecting the output circuit 751 and the internal resistor 753 by the switching unit 754, by applying electrical energy to the internal resistor 753 by the output circuit 751, the operating state of the DC voltage output system including the output circuit 751 is changed. can be confirmed.
 100 除細動カテーテル
 10  マルチルーメンチューブ
 11  第1ルーメン
 12  第2ルーメン
 13  第3ルーメン
 14  第4ルーメン
 15  フッ素樹脂層
 16  インナー(コア)部
 17  アウター(シェル)部
 18  ステンレス素線
 20  ハンドル
 21  ハンドル本体
 22  摘まみ
 24  ストレインリリーフ
 26  第1絶縁性チューブ
 27  第2絶縁性チューブ
 28  第3絶縁性チューブ
 31G 第1DC電極群
 31  リング状電極
 32G 第2DC電極群
 32  リング状電極
 33G 基端側電位測定電極群
 33  リング状電極
 35  先端チップ
 41G 第1リード線群
 41  リード線
 42G 第2リード線群
 42  リード線
 43G 第3リード線群
 43  リード線
 50  除細動カテーテルのコネクタ
 51,52,53 ピン端子
 61  第1の保護チューブ
 62  第2の保護チューブ
 65  プルワイヤ
 700 電源装置
 71  DC電源部
 72  カテーテル接続コネクタ
 721,722,723  端子
 73  心電計接続コネクタ
 74  外部スイッチ(入力手段)
 740 主電源スイッチ
 741 モード切替スイッチ
 742 印加エネルギー設定スイッチ
 743 充電スイッチ
 744 エネルギー印加準備スイッチ
 745 エネルギー印加実行スイッチ(放電スイッチ)
 75  演算処理部
 751 出力回路
 752 CPU回路
 753 内部抵抗
 754 切替部
 761 第1ON/OFFスイッチ
 762 第2ON/OFFスイッチ
 77  心電図入力コネクタ
 800 心電計
 900 心電位測定手段
Reference Signs List 100 defibrillation catheter 10 multi-lumen tube 11 first lumen 12 second lumen 13 third lumen 14 fourth lumen 15 fluorine resin layer 16 inner (core) portion 17 outer (shell) portion 18 stainless steel wire 20 handle 21 handle body 22 knob 24 strain relief 26 first insulating tube 27 second insulating tube 28 third insulating tube 31G first DC electrode group 31 ring electrode 32G second DC electrode group 32 ring electrode 33G proximal side potential measurement electrode group 33 ring electrode 35 distal tip 41G first lead wire group 41 lead wire 42G second lead wire group 42 lead wire 43G third lead wire group 43 lead wire 50 defibrillation catheter connector 51, 52, 53 pin terminal 61 second First protective tube 62 Second protective tube 65 Pull wire 700 Power supply device 71 DC power supply unit 72 Catheter connection connector 721, 722, 723 Terminal 73 Electrocardiograph connection connector 74 External switch (input means)
740 Main power switch 741 Mode changeover switch 742 Applied energy setting switch 743 Charge switch 744 Energy application preparation switch 745 Energy application execution switch (discharge switch)
75 arithmetic processing unit 751 output circuit 752 CPU circuit 753 internal resistance 754 switching unit 761 first ON/OFF switch 762 second ON/OFF switch 77 electrocardiogram input connector 800 electrocardiograph 900 electrocardiogram measuring means

Claims (9)

  1.  心腔内に挿入されて除細動を行う除細動カテーテルと、この除細動カテーテルの電極に直流電圧を印加する電源装置と、心電計とを備えたカテーテルシステムであって、
     前記除細動カテーテルは、絶縁性のチューブ部材と、前記チューブ部材の先端領域に装着された複数のリング状電極からなる第1電極群と、
     前記第1電極群から基端側に離間して前記チューブ部材の前記先端領域に装着された複数のリング状電極からなる第2電極群とを備えてなり;
     前記電源装置は、コンデンサを備えたDC電源部と、
     入力手段である外部スイッチと、
     前記外部スイッチの入力に基いて前記DC電源部を制御するとともに、当該DC電源部からの直流電圧の出力回路を有する演算処理部と、
     前記除細動カテーテルの第1電極群および第2電極群のそれぞれに電気的に接続されるカテーテル接続コネクタと、
     前記心電計の入力端子に接続される心電計接続コネクタと、
     前記カテーテル接続コネクタと前記心電計接続コネクタとの間に介在する第1ON/OFFスイッチと、
     前記カテーテル接続コネクタと前記演算処理部との間に介在する第2ON/OFFスイッチとを備えてなり、
     前記除細動カテーテルの第1電極群および/または前記第2電極群を構成する前記電極により心電位を測定するときには、前記第1ON/OFFスイッチが「ON」となり、前記除細動カテーテルからの心電位情報が、前記カテーテル接続コネクタ、前記第1ON/OFFスイッチおよび前記心電計接続コネクタを経由して前記心電計に入力され、
     前記除細動カテーテルにより除細動を行うときには、前記第2ON/OFFスイッチが「ON」となり、前記DC電源部から、前記演算処理部の出力回路、前記第2ON/OFFスイッチおよび前記カテーテル接続コネクタを経由して、前記除細動カテーテルの前記第1電極群と前記第2電極群とに、互いに異なる極性の電圧が印加されることを特徴とする心腔内除細動カテーテルシステム。
    A catheter system comprising a defibrillation catheter inserted into a heart chamber for defibrillation, a power supply for applying a DC voltage to electrodes of the defibrillation catheter, and an electrocardiograph,
    The defibrillation catheter includes an insulating tube member, a first electrode group including a plurality of ring-shaped electrodes attached to a distal end region of the tube member,
    a second electrode group consisting of a plurality of ring-shaped electrodes attached to the distal end region of the tube member spaced proximally from the first electrode group;
    The power supply device includes a DC power supply section including a capacitor;
    an external switch as input means;
    an arithmetic processing unit that controls the DC power supply unit based on the input of the external switch and has a circuit that outputs a DC voltage from the DC power supply unit;
    a catheter connector electrically connected to each of the first electrode group and the second electrode group of the defibrillation catheter;
    an electrocardiograph connection connector connected to an input terminal of the electrocardiograph;
    a first ON/OFF switch interposed between the catheter connection connector and the electrocardiograph connection connector;
    a second ON/OFF switch interposed between the catheter connector and the arithmetic processing unit;
    When the cardiac potential is measured by the electrodes constituting the first electrode group and/or the second electrode group of the defibrillation catheter, the first ON/OFF switch is turned "ON", and the electrocardiogram information is input to the electrocardiograph via the catheter connection connector, the first ON/OFF switch and the electrocardiograph connection connector;
    When defibrillation is performed with the defibrillation catheter, the second ON/OFF switch is turned "ON", and the DC power supply unit supplies power to the output circuit of the arithmetic processing unit, the second ON/OFF switch, and the catheter connection connector. an intracardiac defibrillation catheter system, wherein voltages of different polarities are applied to the first electrode group and the second electrode group of the defibrillation catheter via .
  2.  前記電源装置は、前記外部スイッチとして、除細動を行う準備をするためのエネルギー印加準備スイッチと、電気エネルギーを印加して除細動を実行するためのエネルギー印加実行スイッチとを備えてなり、
     前記第1ON/OFFスイッチが「ON」、前記第2ON/OFFスイッチが「OFF」となっているときに、前記エネルギー印加準備スイッチが入力されると、前記演算処理部は、前記第1ON/OFFスイッチが「ON」の状態を維持し、前記第2ON/OFFスイッチが「OFF」から「ON」に切り替わるように、これらを制御し、
     前記エネルギー印加準備スイッチの入力後に、前記エネルギー印加実行スイッチが入力されると、前記演算処理部は、前記第2ON/OFFスイッチが「ON」の状態を維持し、前記第1ON/OFFスイッチが「ON」から「OFF」に切り替わるように、これらを制御することを特徴とする請求項1に記載の心腔内除細動カテーテルシステム。
    The power supply device comprises, as the external switches, an energy application preparation switch for preparing for defibrillation and an energy application execution switch for applying electrical energy to perform defibrillation,
    When the energy application preparation switch is input when the first ON/OFF switch is "ON" and the second ON/OFF switch is "OFF", the arithmetic processing unit switches the first ON/OFF controlling the second ON/OFF switch so that the switch remains "ON" and the second ON/OFF switch switches from "OFF" to "ON";
    When the energy application execution switch is input after the energy application preparation switch is input, the arithmetic processing unit maintains the second ON/OFF switch in the "ON" state, and the first ON/OFF switch is in the "ON" state. 2. The intracardiac defibrillation catheter system according to claim 1, wherein these are controlled so as to switch from "ON" to "OFF".
  3.  前記電源装置は、主電源スイッチと、心電位測定モードと除細動モードを切り替えるためのモード切替スイッチと、除細動の際に印加する電気エネルギーを設定するための印加エネルギー設定スイッチと、設定された電気エネルギーに基いて決定される電圧をDC電源部に蓄積するための充電スイッチと、前記エネルギー印加準備スイッチと、前記エネルギー印加実行スイッチとを備えてなり、
     前記演算処理部は、前記主電源スイッチが入力されたときには、前記第1ON/OFFスイッチが「ON」、前記第2ON/OFFスイッチが「OFF」となり、
     前記モード切替スイッチが入力されてから一定時間、前記第1ON/OFFスイッチが「OFF」、前記第2ON/OFFスイッチが「ON」となり、
     前記印加エネルギー設定スイッチまたは前記充電スイッチが入力されることによって、前記第1ON/OFFスイッチおよび前記第2ON/OFFスイッチの「ON」/「OFF」は切り替わらず、
     前記エネルギー印加準備スイッチが入力されたときには、前記第1ON/OFFスイッチおよび前記第2ON/OFFスイッチの両方が「ON」となり、
     前記エネルギー印加実行スイッチが入力されたときには、前記第1ON/OFFスイッチが「OFF」、前記第2ON/OFFスイッチが「ON」となるように、
     前記第1ON/OFFスイッチおよび前記第2ON/OFFスイッチを制御することを特徴とする請求項2に記載の心腔内除細動カテーテルシステム。
    The power supply device includes a main power switch, a mode switch for switching between an electrocardiographic measurement mode and a defibrillation mode, an applied energy setting switch for setting the electrical energy to be applied during defibrillation, and a setting switch. a charging switch for accumulating a voltage determined based on the obtained electrical energy in the DC power supply, the energy application preparation switch, and the energy application execution switch,
    The arithmetic processing unit turns the first ON/OFF switch "ON" and turns the second ON/OFF switch "OFF" when the main power switch is turned on,
    for a certain period of time after the mode changeover switch is turned on, the first ON/OFF switch is turned "OFF" and the second ON/OFF switch is turned "ON";
    "ON"/"OFF" of the first ON/OFF switch and the second ON/OFF switch are not switched by inputting the applied energy setting switch or the charging switch,
    When the energy application preparation switch is input, both the first ON/OFF switch and the second ON/OFF switch are turned "ON",
    so that when the energy application execution switch is input, the first ON/OFF switch is turned "OFF" and the second ON/OFF switch is turned "ON";
    3. The intracardiac defibrillation catheter system of claim 2, wherein the first ON/OFF switch and the second ON/OFF switch are controlled.
  4.  前記電源装置の前記演算処理部は、前記モード切替スイッチが入力されてから前記一定時間において、前記除細動カテーテルの前記第1電極群と前記第2電極群との間のインピーダンスを測定するよう制御することを特徴とする請求項3に記載の心腔内除細動カテーテルシステム。 The arithmetic processing unit of the power supply device measures the impedance between the first electrode group and the second electrode group of the defibrillation catheter during the predetermined time after the mode switching switch is input. 4. The intracardiac defibrillation catheter system of claim 3, which controls.
  5.  前記電源装置の前記演算処理部は、測定されたインピーダンスと、前記印加エネルギー設定スイッチを入力して設定された電気エネルギーとに基いて決定される電圧を前記DC電源部に蓄積させるよう制御することを特徴とする請求項4に記載の心腔内除細動カテーテルシステム。 The arithmetic processing unit of the power supply device controls the DC power supply unit to accumulate a voltage determined based on the measured impedance and the electrical energy set by inputting the applied energy setting switch. 5. The intracardiac defibrillation catheter system of claim 4, wherein:
  6.  前記電源装置は、前記演算処理部および前記心電計の出力端子に接続される心電図入力コネクタを備えていることを特徴とする請求項1~5の何れかに記載の心腔内除細動カテーテルシステム。 The intracardiac defibrillation device according to any one of claims 1 to 5, wherein the power supply device includes an electrocardiogram input connector connected to output terminals of the arithmetic processing unit and the electrocardiograph. catheter system.
  7.  前記除細動カテーテルは、前記第1電極群または前記第2電極群から離間して前記チューブ部材に装着された複数の電極からなり、前記カテーテル接続コネクタと電気的に接続される電位測定電極群を備えてなり、
     前記電源装置には、前記カテーテル接続コネクタと、前記心電計接続コネクタとを直接結ぶ経路が形成され、
     前記電位測定電極群を構成する電極によって測定された心電位情報は、前記電源装置の前記カテーテル接続コネクタから、前記第1ON/OFFスイッチを経ることなく、前記心電計接続コネクタを経由して前記心電計に入力されることを特徴とする請求項1~6の何れかに記載の心腔内除細動カテーテルシステム。
    The defibrillation catheter comprises a plurality of electrodes attached to the tube member spaced apart from the first electrode group or the second electrode group, and a potential measurement electrode group electrically connected to the catheter connector. and
    The power supply device is formed with a path that directly connects the catheter connection connector and the electrocardiograph connection connector,
    The electrocardiographic information measured by the electrodes constituting the potential measuring electrode group is transmitted from the catheter connector of the power supply device via the electrocardiograph connector without passing through the first ON/OFF switch. The intracardiac defibrillation catheter system according to any one of claims 1 to 6, which is input to an electrocardiograph.
  8.  前記心電計には、前記除細動カテーテル以外の心電位測定手段が接続されていることを特徴とする請求項1~7の何れかに記載の心腔内除細動カテーテルシステム。 The intracardiac defibrillation catheter system according to any one of claims 1 to 7, wherein electrocardiographic measurement means other than the defibrillation catheter is connected to the electrocardiograph.
  9.  前記心電位測定手段が電極パッドまたは電極カテーテルであることを特徴とする請求項8に記載の心腔内除細動カテーテルシステム。 The intracardiac defibrillation catheter system according to claim 8, wherein the cardiac potential measurement means is an electrode pad or an electrode catheter.
PCT/JP2021/010260 2021-03-13 2021-03-13 Intracardiac defibrillation catheter system WO2022195644A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4545216B1 (en) * 2009-03-23 2010-09-15 日本ライフライン株式会社 Intracardiac defibrillation catheter system
JP2017176351A (en) * 2016-03-29 2017-10-05 フクダ電子株式会社 Defibrillator
JP2018122091A (en) * 2017-02-03 2018-08-09 セント・ジュード・メディカル,カーディオロジー・ディヴィジョン,インコーポレイテッド Electronic switchbox

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4545216B1 (en) * 2009-03-23 2010-09-15 日本ライフライン株式会社 Intracardiac defibrillation catheter system
JP2017176351A (en) * 2016-03-29 2017-10-05 フクダ電子株式会社 Defibrillator
JP2018122091A (en) * 2017-02-03 2018-08-09 セント・ジュード・メディカル,カーディオロジー・ディヴィジョン,インコーポレイテッド Electronic switchbox

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