WO2022195644A1 - Système de cathéter de défibrillation cardiaque - Google Patents

Système de cathéter de défibrillation cardiaque 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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WIPO (PCT)
Prior art keywords
switch
catheter
electrode group
defibrillation
power supply
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PCT/JP2021/010260
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English (en)
Japanese (ja)
Inventor
卓也 平尾
Original Assignee
日本ライフライン株式会社
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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 PCT/JP2021/010260 priority Critical patent/WO2022195644A1/fr
Priority to JP2023506372A priority patent/JP7579422B2/ja
Publication of WO2022195644A1 publication Critical patent/WO2022195644A1/fr

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

Definitions

  • the present invention relates to 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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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

La présente invention vise à proposer un système de cathéter qui peut obtenir des informations électrocardiographiques à partir d'un premier groupe d'électrodes et d'un second groupe d'électrodes dans un cathéter de défibrillation, jusqu'à immédiatement avant l'application d'une tension continue à ces groupes d'électrodes. Le système de cathéter de la présente invention comprend : le cathéter de défibrillation (100), un dispositif d'alimentation électrique (700) et un électrocardiographe (800). Le dispositif d'alimentation électrique comprend une unité d'alimentation en courant continu (71), une unité de calcul (75), un connecteur de cathéter (72), un connecteur d'électrocardiographe (73), un premier commutateur marche/arrêt (761) et un second commutateur marche/arrêt (762). Lorsque le potentiel électrocardiographique est mesuré à l'aide d'électrodes qui constituent le premier groupe d'électrodes et/ou le second groupe d'électrodes dans le cathéter de défibrillation, le premier commutateur marche/arrêt devient passant. Lors d'une défibrillation à l'aide du cathéter de défibrillation, le second commutateur marche/arrêt devient passant.
PCT/JP2021/010260 2021-03-13 2021-03-13 Système de cathéter de défibrillation cardiaque WO2022195644A1 (fr)

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PCT/JP2021/010260 WO2022195644A1 (fr) 2021-03-13 2021-03-13 Système de cathéter de défibrillation cardiaque
JP2023506372A JP7579422B2 (ja) 2021-03-13 2021-03-13 心腔内除細動カテーテルシステム

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4545216B1 (ja) * 2009-03-23 2010-09-15 日本ライフライン株式会社 心腔内除細動カテーテルシステム
JP2017176351A (ja) * 2016-03-29 2017-10-05 フクダ電子株式会社 除細動器
JP2018122091A (ja) * 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 電子スイッチボックス

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4545216B1 (ja) * 2009-03-23 2010-09-15 日本ライフライン株式会社 心腔内除細動カテーテルシステム
JP2017176351A (ja) * 2016-03-29 2017-10-05 フクダ電子株式会社 除細動器
JP2018122091A (ja) * 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 電子スイッチボックス

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