JP4672801B1 - Intracardiac defibrillation catheter system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an intracardiac defibrillation catheter system capable of recording an operation history of a defibrillation catheter.
A defibrillation catheter 100 and a power supply device 700 are provided; the defibrillation catheter 100 includes a first DC electrode group 31G, a second DC electrode group 32G, and a memory 110 having an event information storage unit 113. The power supply device 700 controls the DC power supply unit 71, the catheter connection connector 72, and the DC power supply unit 71, and includes a DC voltage output circuit 751 from the DC power supply unit 71. And a calculation processing unit 75 for controlling writing and reading to the memory 110 of the defibrillation catheter 100; Information related to fibrillation is written in the event information storage unit 113 of the memory of the defibrillation catheter 100.
[Selection] Figure 1

Description

  The present invention relates to an intracardiac defibrillation catheter system, and more specifically, includes a defibrillation catheter that is inserted into the heart chamber, and a power supply device that applies a DC voltage to the electrode of the defibrillation catheter. The present invention relates to a catheter system.

An external defibrillator (AED) is known as a defibrillator for removing atrial fibrillation (see, for example, Patent Document 1).
In defibrillation treatment by AED, electrical energy is given to the patient's body by attaching an electrode pad to the patient's body surface and applying a DC voltage. Here, the electrical energy flowing from the electrode pad into the patient's body is usually 150 to 200 J, and a part (usually, about several percent to 20%) of the fluid flows to the heart and is used for defibrillation treatment.

See JP 2001-112874 A

Thus, atrial fibrillation is likely to occur during cardiac catheterization, and even in this case, it is necessary to perform cardioversion.
However, depending on the AED that supplies electric energy from outside the body, it is difficult to supply effective electric energy (for example, 10 to 30 J) to the heart that is causing fibrillation.

That is, sufficient defibrillation treatment cannot be performed when the proportion of electrical energy supplied from outside the body is small (for example, about several percent).
On the other hand, when the electrical energy supplied from outside the body flows to the heart at a high rate, the heart tissue may be damaged.
Further, in the defibrillation treatment by AED, burns are likely to occur on the body surface to which the electrode pad is attached. And as mentioned above, when the ratio of the electrical energy flowing to the heart is small, repeated supply of electrical energy increases the degree of burns, which is a considerable burden for patients undergoing catheterization. .

  In order to solve such a problem, the present inventors have introduced a defibrillation catheter that is inserted into the heart chamber and performs defibrillation, and a power supply device that applies a DC voltage to the electrode of the defibrillation catheter. Have proposed a catheter system including an electrocardiograph (Japanese Patent Application No. 2009-70940).

  Therefore, in the intracardiac defibrillation catheter system configured as described above, it is desirable if the operation history of the defibrillation catheter can be recorded.

  For example, when an abnormality occurs in the defibrillation catheter during use and the desired defibrillation treatment cannot be performed, the history of the operation (under what conditions defibrillation was performed) Is extremely useful information for investigating the cause of abnormalities.

  Also, in the endurance test in the defibrillation catheter development process, the operation history when operating under severe conditions (for example, application of excessive voltage) and causing problems will narrow down the improvements of the defibrillation catheter. Very useful information above.

  Further, it is preferable that the operation history of the defibrillation catheter is left as a part of the treatment record, for example, the output voltage and output time in each defibrillation can be printed and attached to the patient's chart.

As a method of recording the operation history of the defibrillation catheter, a memory for storing the operation history is provided in the power supply device, and an output voltage and an output time each time an operation such as defibrillation is performed by the defibrillation catheter. Such information may be written in the memory of the power supply device.
In this case, the defibrillation catheter needs to be given serial information (serial number) that can be read by the power supply device.

  However, when there is not one power supply device connected to the defibrillation catheter, for example, when the power supply device is reconnected to the spare power supply device during the procedure, the operation history information of the defibrillation catheter includes a plurality of power supply devices. Management of the operation history information becomes very complicated.

The present invention has been made based on the circumstances as described above, and an object of the present invention is to ensure the necessary and sufficient electric energy for defibrillation for the heart that has undergone atrial fibrillation during cardiac catheterization. It is an object of the present invention to provide an intracardiac defibrillation catheter system that can be supplied to a patient.
Another object of the present invention is to provide an intracardiac defibrillation catheter system capable of performing defibrillation treatment without causing burns on the patient's body surface.
Still another object of the present invention is to provide an intracardiac defibrillation catheter system capable of recording the operation history of a defibrillation catheter.
Still another object of the present invention is to reconnect different power supply devices so that even if there is a history of operating the defibrillation catheters by a plurality of power supply devices, the operation history by the defibrillation catheters is stored in one memory. It is an object of the present invention to provide an intracardiac defibrillation catheter system that can be stored in the device and can manage operation history information for each defibrillation catheter.

(1) An intracardiac defibrillation catheter system of the present invention includes a defibrillation catheter that is inserted into the heart chamber and performs defibrillation, and a power supply device that applies a DC voltage to the electrode of the defibrillation catheter. 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 the distal end region of the tube member;
A second electrode group (second DC electrode group) composed of a plurality of ring-shaped electrodes mounted on the tube member apart from the first DC electrode group on the proximal end side;
A first lead wire group comprising a plurality of lead wires each having a tip connected to each of the electrodes constituting the first DC electrode group;
A second lead wire group comprising a plurality of lead wires each having a tip connected to each of the electrodes constituting the second DC electrode group;
The catheter serial storage unit in which the serial information of the defibrillation catheter is stored, and the information related to the event including the defibrillation by the defibrillation catheter, the time at which the event is performed, and the connected power supply device A memory having an event information storage unit for storing serial information;
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;
An external switch including a mode changeover switch for setting the power supply device in a defibrillation mode, an electric energy setting switch, and an electric energy application switch;
The DC power supply unit is controlled based on the input of the external switch, and has a DC voltage output circuit from the DC power supply unit, and further stores serial information of the power supply device to determine the time And an arithmetic processing unit that has an internal clock and controls writing to and reading from the memory of the defibrillation catheter;
When defibrillation is performed by the defibrillation catheter, a resistance value between the first DC electrode group and the second DC electrode group is measured, and then, based on an input of the external switch, the DC of the power supply device is measured. Voltages having different polarities are applied from the power supply unit to the first DC electrode group and the second DC electrode group of the defibrillation catheter via the output circuit of the arithmetic processing unit and the catheter connector.
The arithmetic processing unit of the power supply device, when defibrillation is performed by the defibrillation catheter, a resistance value between the first DC electrode group and the second DC electrode group, the first DC electrode group and the Information on the set value of the electrical energy to be applied between the second DC electrode group, the actually applied output voltage and the output time is acquired, and the information is used for the time and connection of the defibrillation. Along with the serial information of the power supply device, the event information storage unit in the memory of the defibrillation catheter is written.

  The defibrillation catheter constituting the intracardiac defibrillation catheter system of the present invention is inserted into the heart chamber such that the first DC electrode group is located in the coronary vein and the second DC electrode group is located in the right atrium. Then, the power supply device applies voltages having different polarities to the first DC electrode group and the second DC electrode group via the first lead wire group and the second lead wire group (the first DC electrode group and the second DC electrode group). By applying a DC voltage to the group), electrical energy is directly applied to the heart undergoing fibrillation, whereby defibrillation treatment is performed.

As described above, according to the first DC electrode group and the second DC electrode group of the defibrillation catheter disposed in the heart chamber, electrical energy is directly applied to the fibrillated heart. The electrical stimulation (electric shock) necessary and sufficient for treatment can be reliably applied only to the heart.
And since electrical energy can be given directly to the heart, it does not cause burns on the patient's body surface.

  When defibrillation is performed by the defibrillation catheter constituting the intracardiac defibrillation catheter system of the present invention, the arithmetic processing unit of the power supply apparatus (connected to the defibrillation catheter) constituting this system Thus, the resistance value (intracardiac resistance value) between the first DC electrode group and the second DC electrode group, the set value of the electrical energy to be applied between the first DC electrode group and the second DC electrode group, the output voltage ( Event information storage unit in the memory of the defibrillation catheter includes information on the actual applied voltage) and output time (actually applied time) along with the time when this defibrillation was performed and the serial information of the power supply device. And is stored as an event (operation) history of the defibrillation catheter.

According to the intracardiac defibrillation catheter system of the present invention, information related to an event including defibrillation is stored in the event information storage unit in the memory of the defibrillation catheter. Even if an event is performed using a plurality of power supply devices, information relating to the event is not distributed to the plurality of power supply devices. Thereby, event history information can be managed for each defibrillation catheter specified by the serial information.
In addition, regarding the event history information, the defibrillation catheter has only a memory (storage means), and the processing unit of the power supply apparatus is responsible for processing such information. Does not increase in size or its structure.

(2) The arithmetic processing unit of the power supply device constituting the intracardiac defibrillation catheter system of the present invention measures the resistance value between the first DC electrode group and the second DC electrode group of the defibrillation catheter. When the defibrillation is not performed after the detection, the measurement of the resistance value is recognized as an event, and the measured resistance value is measured together with the measured time and the serial information of the connected power supply device. It is preferable to write in the event information storage unit in the catheter memory.
Thereby, it is possible to record the data of the intracardiac resistance value when the defibrillation is not performed.

(3) The arithmetic processing unit of the power supply device constituting the intracardiac defibrillation catheter system of the present invention reconnects the same or different power supply device to the defibrillation catheter from which the power supply device used was removed Sometimes, it is preferable to recognize this as an event, and write the reconnection time and the serial information of the reconnected power supply device in the event information storage unit in the memory of the defibrillation catheter.
As a result, the history of reconnection (replacement) of the power supply device can be recorded together with the serial information of the power supply device before and after the replacement.

(4) A power supply device constituting the intracardiac defibrillation catheter system of the present invention has a memory information display unit or a memory information output unit connected to the calculation processing unit, and the calculation processing unit of the power supply device includes: The information written in the memory of the defibrillation catheter may be read and displayed on the memory information display unit or output to the memory information output unit.
By displaying the information written in the memory, for example, the history of defibrillation written in the event information storage unit on the memory information display unit, this can be confirmed during the procedure. Further, by outputting the information written in the memory to the memory information output unit, it can be left as a part of the treatment record.

(5) The intracardiac defibrillation catheter system of the present invention comprises an electrocardiograph together with the defibrillation catheter and the power supply device,
The power supply device is an electrocardiograph connection connector connected to an input terminal of the electrocardiograph,
A switching unit comprising a switching switch of one circuit and two contacts, 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; Comprising:
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 contact is selected in the switching unit, and the cardiac potential information from the defibrillation catheter is selected. Is input to the electrocardiograph via the catheter connection connector of the power supply device, the switching unit and the electrocardiograph connection connector,
When defibrillation is performed by the defibrillation catheter, the calculation processing unit of the power supply device switches the contact of the switching unit to the second contact, and the DC power supply unit outputs the output circuit of the calculation processing unit, the switching It is preferable that voltages having different polarities are applied to the first electrode group and the second electrode group of the defibrillation catheter via the catheter and the catheter connection connector.

  Since the path from the catheter connector to the electrocardiograph connector is secured by selecting the first contact in the switching unit constituting the power supply device, the first DC electrode group and / or the second DC of the defibrillation catheter is secured. The electrocardiogram can be measured by the electrodes constituting the electrode group, and the obtained electrocardiogram information can be input to the electrocardiograph via the catheter connector, the switching unit, and the electrocardiograph connector.

  That is, when defibrillation treatment is not required during cardiac catheterization, the defibrillation catheter constituting the present invention can be used as an electrode catheter for measuring cardiac potential. As a result, when atrial fibrillation occurs during cardiac catheterization, it is possible to save the trouble of removing the electrode catheter and newly inserting a catheter for defibrillation.

(6) In the intracardiac defibrillation catheter system according to (5), the defibrillation catheter includes a plurality of electrodes mounted on the tube member apart from the first electrode group or the second electrode group. A potential measuring electrode group comprising:
The electrode comprises a plurality of lead wires each having a tip connected to each of the electrodes constituting the potential measuring electrode group, and a proximal end side of the electrode includes a potential measuring lead wire group connected to the catheter connector of the power supply device. And
In the power supply device, a path directly connecting the catheter connector and the electrocardiograph connector is formed,
The electrocardiogram information measured by the electrodes constituting the potential measurement electrode group is transmitted from the catheter connection connector of the power supply device via the electrocardiograph connection connector without passing through the switching unit. Is preferably entered.

  According to such a configuration, even in the case of defibrillation treatment in which the electrocardiograph cannot acquire the cardiac potential from the first DC electrode group and the second DC electrode group of the defibrillation catheter, the potential measurement electrode group The electrocardiograph can acquire the electrocardiogram measured by the above-mentioned method, and the defibrillation treatment can be performed while monitoring the electrocardiogram with the electrocardiograph.

(7) It is preferable that an electrocardiogram measuring means other than the defibrillation catheter is connected to the electrocardiograph constituting the intracardiac defibrillation catheter system of (5) or (6).
(8) Moreover, it is preferable that this cardiac potential measuring means is an electrode pad or an electrode catheter.

  According to such a configuration, even in the case of defibrillation treatment in which the electrocardiograph cannot obtain the electrocardiogram from the first DC electrode group and the second DC electrode group of the defibrillation catheter, the electrocardiogram measurement is performed. An electrocardiograph can acquire the electrocardiogram measured by the means, and defibrillation treatment can be performed while monitoring the electrocardiogram with the electrocardiograph.

(9) The power supply device constituting the intracardiac defibrillation catheter system of (5) to (8) above includes an electrocardiogram input connector connected to the arithmetic processing unit and an output terminal of the electrocardiograph, and the calculation An electrocardiogram information display unit connected to the processing unit,
It is preferable that the electrocardiogram information from the electrocardiograph input to the electrocardiogram input connector is input to the arithmetic processing unit and further displayed on the electrocardiogram information display unit.

According to such a configuration, cardiac potential information input to the electrocardiograph (cardiac potential acquired by the electrodes constituting the first DC electrode group and / or the second DC electrode group of the defibrillation catheter, the defibrillation catheter) A part of the cardiac potential acquired by the electrodes constituting the potential measuring electrode group or the cardiac potential acquired by the cardiac potential measuring means other than the defibrillation catheter) is input to the arithmetic processing unit. The DC power supply unit can be controlled based on this electrocardiographic information.
Further, defibrillation treatment (such as input of an external switch) can be performed while monitoring the electrocardiogram information (waveform) input to the arithmetic processing unit with the electrocardiogram information display unit.

According to the intracardiac defibrillation catheter system of the present invention, electrical energy necessary and sufficient for defibrillation can be reliably supplied to the heart that has undergone atrial fibrillation or the like during cardiac catheterization. In addition, it does not cause burns on the patient's body surface and is less invasive.
According to the intracardiac defibrillation catheter system of the present invention, the event history of a defibrillation catheter can be recorded.
According to the intracardiac defibrillation catheter system of the present invention, this defibrillation catheter can be used even if an event by a defibrillation catheter is performed using a plurality of power supply devices by reconnecting different power supply devices. Can be stored in one memory (event information storage unit), and event history information can be managed for each defibrillation catheter.

1 is a block diagram illustrating one embodiment of an intracardiac defibrillation catheter system of the present invention. FIG. It is a top view for description which shows the fibrillation catheter which comprises the catheter system shown in FIG. FIG. 2 is a plan view for explaining the fibrillation catheter constituting the catheter system shown in FIG. 1 (a diagram for explaining dimensions and hardness). It is a cross-sectional view which shows the AA cross section of FIG. It is a cross-sectional view which shows the BB cross section of FIG. 2, CC cross section, and DD cross section. FIG. 3 is a perspective view showing an internal structure of a handle of the embodiment of the defibrillation catheter shown in FIG. 2. FIG. 7 is a partially enlarged view of the inside (front end side) of the handle shown in FIG. 6. FIG. 7 is a partial enlarged view of the inside (base end side) of the handle shown in FIG. 6. In the catheter system shown in FIG. 1, it is explanatory drawing which shows typically the connection state of the connector of a defibrillation catheter, and the catheter connection connector of a power supply device. FIG. 2 is a block diagram showing a flow of cardiac potential information when the cardiac potential is measured by a defibrillation catheter in the catheter system shown in FIG. 1. It is a part (Step1-Step7) of the flowchart which shows operation | movement and operation of the power supply device in the catheter system shown in FIG. It is the remainder (Step8-Step16) of the flowchart which shows operation | movement and operation of the power supply device in the catheter system shown in FIG. It is the remainder (Step17-Step22) of the flowchart which shows operation | movement and operation of the power supply device in the catheter system shown in FIG. FIG. 2 is a block diagram showing a flow of information between the arithmetic processing unit of the power supply device and the memory of the defibrillation catheter when the power supply device is connected to the defibrillation catheter in the catheter system shown in FIG. 1. FIG. 2 is a block diagram showing a flow of electrocardiographic information in an electrocardiographic measurement mode in the catheter system shown in FIG. 1. FIG. 2 is a block diagram showing a flow of information relating to a resistance value between electrode groups and a cardiac potential information in the defibrillation mode of the catheter system shown in FIG. 1. It is a block diagram which shows the state at the time of DC voltage application in the defibrillation mode of the catheter system shown in FIG. It is an electric potential waveform diagram measured when predetermined | prescribed electric energy is provided with the defibrillation catheter which comprises the catheter system shown in FIG. FIG. 2 is a block diagram showing a state in which information related to defibrillation performed by a defibrillation catheter in the catheter system shown in FIG. 1 is written in the memory of the defibrillation catheter by the arithmetic processing unit of the power supply device. . It is a block diagram which shows other embodiment of the intracardiac defibrillation catheter system of this invention.

<First Embodiment>
The intracardiac defibrillation catheter system of this embodiment includes a defibrillation catheter 100 that is inserted into the heart chamber and performs defibrillation, and a power supply device 700 that applies a DC voltage to the electrodes of the defibrillation catheter 100. A catheter system comprising an electrocardiograph 800 and an electrocardiogram measuring means 900;
The defibrillation catheter 100 includes a multi-lumen tube 10,
A first DC electrode group 31G composed of eight ring-shaped electrodes 31 attached to the tip region of the multi-lumen tube 10,
A second DC electrode group 32G consisting of eight ring-shaped electrodes 32 mounted on the multi-lumen tube 10 and spaced from the first DC electrode group 31G toward the base end side;
A proximal-side potential measurement electrode group 33G composed of four ring-shaped electrodes 33 mounted on the multi-lumen tube 10 and spaced apart from the second DC electrode group 32G toward the proximal end side;
A first lead wire group 41G consisting of eight lead wires 41 having tips connected to the electrodes 31 constituting the first DC electrode group 31G;
A second lead wire group 42G consisting of eight lead wires 42 having tips connected to the electrodes 32 constituting the second DC electrode group 32G;
A third lead wire group 43G consisting of four lead wires 43 whose tips are connected to each of the electrodes 33 constituting the base side potential measurement electrode group 33G;
The catheter serial storage unit 111 in which serial information of the defibrillation catheter 100 is stored, the time when the power supply device is first connected to the defibrillation catheter 100 and the initial connection information for storing the serial information of the power supply device connected first. Memory having storage unit 112 and event information storage unit 113 for storing information related to an event including defibrillation by defibrillation catheter 100 together with the time when the event was performed and serial information of the connected power supply device 110;
The power supply device 700 includes a DC power supply unit 71,
A catheter connection connector 72 connected to the proximal end side 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;
An electrocardiograph connector 73 connected to an input terminal of the electrocardiograph 800;
An external switch 74 including a mode changeover switch 741, an electric energy setting switch 742, a charging switch 743, and an electric energy application switch 744 for setting the power supply device 700 to a defibrillation mode;
The DC power supply unit 71 is controlled based on the input of the external switch 74, and the DC voltage output circuit 751 from the DC power supply unit 71 is provided. Further, the serial information of the power supply device 700 and the catheter use time limit are stored. A memory 752 and an internal clock 753 for determining the time, and an arithmetic processing unit 75 that controls writing and reading of the defibrillation catheter 100 to and from the memory 110;
A switching unit comprising a switching switch of one circuit and two contacts, a catheter connection connector 72 connected to a common contact, the electrocardiograph connection connector 73 connected to a first contact, and an arithmetic processing unit 75 connected to a second contact 76 with;
When the cardiac potential is measured by the electrodes constituting the first DC electrode group 31G and / or the second DC electrode group 32G of the defibrillation catheter 100, the first contact is selected in the switching unit 76, and the heart from the defibrillation catheter 100 is selected. The potential information is input to the electrocardiograph 800 via the catheter connection connector 72, the switching unit 76, and the electrocardiograph connection connector 73 of the power supply device 700,
When defibrillation is performed by the defibrillation catheter 100, after the resistance value (intracardiac resistance value) between the first DC electrode group 31G and the second DC electrode group 32G is measured, the external switch 74 (electric energy setting switch) 742, the charging switch 743, and the electric energy application switch 744), the operation processing unit 75 of the power supply device 700 switches the contact of the switching unit 76 to the second contact, and the calculation is performed from the DC power supply unit 71 of the power supply device 700. Voltages having different polarities are applied to the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 via the output circuit 751, the switching unit 76, and the catheter connection connector 72 of the processing unit 75;
The arithmetic processing unit 75 of the power supply device 700
(1) When the power supply device 700 is first connected to the defibrillation catheter 100, the first connection information in the memory 110 of the defibrillation catheter 100 is obtained from the time when the power supply device 700 was first connected and the serial information of the power supply device 700 connected first. Write to the storage unit 112,
(2) When defibrillation is performed by the defibrillation catheter 100, the resistance value between the first DC electrode group 31G and the second DC electrode group 32G, the first DC electrode group 31G and the second DC electrode group 32G Information on the set value of electric energy to be applied in between, information on the actually applied output voltage and output time is acquired, and these information are used as the time when this defibrillation is performed and the connected power supply device 700. Together with the serial information, the event information storage unit 113 in the memory 110 of the defibrillation catheter 100 is written,
(3) When the defibrillation is not performed after the resistance value between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 is measured, the measurement of the resistance value is recognized as an event. The measured resistance value is written in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100 together with the measured time and the serial information of the connected power supply device 700,
(4) When the same or different power supply device 700 is reconnected to the defibrillation catheter 100 from which the power supply device used has been removed, this is recognized as an event, the time of reconnection and the reconnection Write the serial information of the power supply device 700 to the event information storage unit 113 in the memory 110 of the defibrillation catheter 100,
(5) For each event written in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100, the event is determined from the connection time written in the initial connection information storage unit 112 in the memory 110 of the defibrillation catheter 100. It is determined whether or not the elapsed time up to the time at which the operation is performed exceeds the catheter use time limit stored in the memory 752 of the power supply device 700. This is a system for controlling the next event by the catheter 100 not to be executed.

  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 an electrocardiogram measuring means 900.

  As shown in FIGS. 2 to 5, 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, A proximal-side potential measurement electrode group 33G, a first lead wire group 41G, a second lead wire group 42G, and a third lead wire group 43G are provided.

  As shown in FIGS. 4 and 5, the multi-lumen tube 10 (insulating tube member having a multi-lumen structure) constituting the defibrillation catheter 100 has four lumens (first lumen 11 and second lumen 12). , A third lumen 13 and a fourth lumen 14) are formed.

  4 and 5, 15 is a fluororesin layer that divides 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. 4 and 18 in FIG. 4 is a stainless steel wire forming a braided blade.

  The fluororesin layer 15 partitioning the lumen is made of a highly insulating material such as perfluoroalkyl vinyl ether copolymer (PFA) or polytetrafluoroethylene (PTFE).

The nylon elastomer that forms the outer portion 17 of the multi-lumen tube 10 has a hardness that varies depending on the axial direction. Thereby, the multi-lumen tube 10 is comprised so that hardness may become high in steps toward the base end side from the front end side.
As a preferable example, in FIG. 3, the hardness of the region indicated by L1 (length 52 mm) (hardness by a D-type hardness meter) is 40, and the hardness of the region indicated by L2 (length 108 mm) is 55, L3 (long). The hardness of the region shown by 25.7 mm) is 63, the hardness of the region shown by L4 (length 10 mm) is 68, and the hardness of the region shown by L5 (length 500 mm) is 72.

The braided blade composed of the stainless steel wire 18 is formed only in the region indicated by L5 in FIG. 3, and is provided between the inner portion 16 and the outer portion 17 as shown in FIG.
The outer diameter of the multi-lumen tube 10 is, for example, 1.2 to 3.3 mm.

  The method for manufacturing the multi-lumen tube 10 is not particularly limited.

The handle 20 constituting the defibrillation catheter 100 in the present embodiment includes a handle main 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 outer periphery of the multi-lumen tube 10 (a distal end region where no braid is formed). Here, the “electrode group” is a set of a plurality of electrodes that constitute the same pole (having the same polarity) or are mounted at a narrow interval (for example, 5 mm or less) with the same purpose. Refers to the body.

  The first DC electrode group is formed by mounting a plurality of electrodes constituting the same pole (-pole or + pole) at a narrow interval in the tip region of the multi-lumen tube. Here, the number of electrodes constituting the first DC electrode group varies depending on the width and arrangement interval of the electrodes, but is 4 to 13, for example, and preferably 8 to 10.

In the present embodiment, the first DC electrode group 31 </ b> G includes eight ring-shaped electrodes 31 attached to the tip region of the multi-lumen tube 10.
The electrode 31 constituting the first DC electrode group 31G is connected to the catheter connection connector of the power supply device 700 via a lead wire (lead wire 41 constituting the first lead wire group 41G) and a connector described later.

Here, the width (length in the axial direction) of the electrode 31 is preferably 2 to 5 mm, and 4 mm if a suitable example is shown.
If the width of the electrode 31 is too narrow, the amount of heat generated when a voltage is applied may be excessive, which may damage surrounding tissues. On the other hand, if the width of the electrode 31 is too wide, the flexibility and flexibility of the portion of the multi-lumen tube 10 where the first DC electrode group 31G is provided may be impaired.

The mounting interval of the electrodes 31 (the distance between adjacent electrodes) is preferably 1 to 5 mm, and 2 mm if a suitable example is shown.
When the defibrillation catheter 100 is used (when placed in the heart chamber), the first DC electrode group 31G is located, for example, in the coronary vein.

  The second DC electrode group is separated from the mounting position of the first DC electrode group of the multi-lumen tube toward the proximal end side, and forms a plurality of poles (+ pole or −pole) opposite to the first DC electrode group. Electrodes are mounted at narrow intervals. Here, the number of electrodes constituting the second DC electrode group varies depending on the width and arrangement interval of the electrodes, but is 4 to 13, for example, and preferably 8 to 10.

In the present embodiment, the second DC electrode group 32G includes eight ring-shaped electrodes 32 that are mounted on the multi-lumen tube 10 while being spaced apart from the mounting position of the first DC electrode group 31G toward the proximal end side.
The electrodes 32 constituting the second DC electrode group 32G are connected to a catheter connection connector of the power supply device 700 via a lead wire (lead wire 42 constituting the second lead wire group 42G) and a connector described later.

Here, the width (length in the axial direction) of the electrode 32 is preferably 2 to 5 mm, and 4 mm if a suitable example is shown.
If the width of the electrode 32 is too narrow, the amount of heat generated at the time of voltage application becomes excessive, which may damage the surrounding tissue. On the other hand, if the width of the electrode 32 is too wide, the flexibility and flexibility of the portion of the multi-lumen tube 10 where the second DC electrode group 32G is provided may be impaired.

The mounting interval of the electrodes 32 (the distance between adjacent electrodes) is preferably 1 to 5 mm, and 2 mm if a suitable example is shown.
When the defibrillation catheter 100 is used (when placed in the heart chamber), the second DC electrode group 32G is located, for example, in the right atrium.

In the present embodiment, the proximal-side potential measurement electrode group 33G includes four ring-shaped electrodes 33 that are mounted on the multi-lumen tube 10 so as to be spaced apart from the mounting position of the second DC electrode group 32G toward the proximal end side. Yes.
The electrodes 33 constituting the proximal-side potential measuring electrode group 33G are connected to the catheter connection connector of the power supply device 700 via a lead wire (lead wire 43 constituting the third lead wire group 43G) and a connector described later. Yes.

Here, the width (length in the axial direction) of the electrode 33 is preferably 0.5 to 2.0 mm, and 1.2 mm if a suitable example is shown.
If the width of the electrode 33 is too wide, the measurement accuracy of the cardiac potential is lowered, or it is difficult to specify the site where the abnormal potential is generated.

The mounting interval of the electrodes 33 (the distance between adjacent electrodes) is preferably 1.0 to 10.0 mm, and 5 mm if a suitable example is shown.
When the defibrillation catheter 100 is used (when placed in the heart chamber), the proximal-side potential measurement electrode group 33G is located, for example, in the superior vena cava where an abnormal potential is likely to occur.

A distal tip 35 is attached to the distal end of the defibrillation catheter 100.
A lead wire is not connected to the tip chip 35 and is not used as an electrode in this embodiment. However, it can also be used as an electrode by connecting a lead wire. The constituent material of the tip 35 is not particularly limited, such as metal materials such as platinum and stainless steel, various resin materials, and the like.

  The separation distance d2 between the first DC electrode group 31G (base end side electrode 31) and the second DC electrode group 32G (tip end side electrode 32) is preferably 40 to 100 mm, and 66 mm is a preferable example. is there.

  The distance d3 between the second DC electrode group 32G (base end side electrode 32) and the base end side potential measurement electrode group 33G (tip end side electrode 33) is preferably 5 to 50 mm, and a suitable example is shown. 30 mm.

  As the electrodes 31, 32, 33 constituting the first DC electrode group 31G, the second DC electrode group 32G, and the proximal-side potential measurement electrode group 33G, platinum or a platinum-based material is used in order to improve the contrast with respect to X-rays. It is preferable to consist of these alloys.

The first lead wire group 41G shown in FIGS. 4 and 5 is an aggregate of eight lead wires 41 connected to each of the eight electrodes (31) constituting 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 (lead wire 41).

  The eight electrodes 31 constituting 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 the tip portion, and enters the first lumen 11 from a side hole formed in the tube wall of the multi-lumen tube 10. The eight lead wires 41 that have entered 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) constituting 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 (lead wire 42).

  The eight electrodes 32 constituting 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 the tip portion thereof, and the second lumen 12 (the first lead wire group 41G extends from the side hole formed in the tube wall of the multi-lumen tube 10. A different lumen from the existing first lumen 11 is entered. The eight lead wires 42 that have entered the second lumen 12 extend to the second lumen 12 as a second lead wire group 42G.

  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. Fully insulated and isolated. Therefore, when a voltage necessary 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 assembly of four lead wires 43 connected to each of the electrodes (33) constituting the proximal-side potential measurement electrode group (33G).
Each of the electrodes 33 constituting the proximal-side potential measurement electrode group 33G can be electrically connected to the power supply device 700 by the third lead wire group 43G (lead wire 43).

  The four electrodes 33 constituting the proximal-side potential measurement 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 the tip portion thereof, and enters the third lumen 13 from a side hole formed in the tube wall of the multi-lumen tube 10. The four lead wires 43 that have entered the third lumen 13 extend to the third lumen 13 as a third lead wire group 43G.

  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 a voltage necessary for defibrillation is applied, the third lead wire group 43G (base end side potential measurement electrode group 33G) and the first lead wire group 41G (first DC electrode group 31G) or the first A short circuit between the two lead wire group 42G (second DC electrode group 32G) can be reliably prevented.

  Each of the lead wire 41, the lead wire 42, and the lead wire 43 is made of a resin-coated wire in which the outer peripheral surface of the metal conducting wire is covered with a resin such as polyimide. Here, the film thickness of the coating resin is about 2 to 30 μm.

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 tip end portion of the pull wire 65 is fixed to the tip tip 35 with solder. Moreover, a large-diameter portion for retaining (a retaining portion) may be formed at the tip of the pull wire 65. Thereby, the tip tip 35 and the pull wire 65 are firmly coupled, and the tip tip 35 can be reliably prevented from falling off.

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, whereby the distal end portion of the multi-lumen tube 10 is deflected.
The pull wire 65 is made of stainless steel or a Ni—Ti superelastic alloy, but is not necessarily made of metal. The pull wire 65 may be formed of, for example, a high-strength non-conductive wire.
Note that the mechanism for deflecting the distal end portion of the multi-lumen tube is not limited to this, and may be a plate spring, for example.

  In the fourth lumen 14 of the multi-lumen tube 10, only the pull wire 65 extends, and the lead wire (group) does not extend. Thereby, it is possible to prevent the lead wire from being damaged (for example, scratched) by the pull wire 65 moving in the axial direction during the deflection operation of the distal end portion of the multi-lumen tube 10.

  In the defibrillation catheter 100 according to the present embodiment, the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G are insulated and isolated also inside the handle 20.

  6 is a perspective view showing the internal structure of the handle of the defibrillation catheter 100 in this embodiment, FIG. 7 is a partially enlarged view of the inside of the handle (front end side), and FIG. 8 is the inside of the handle (base end side). It is a partial enlarged view.

  As shown in FIG. 6, the base end portion of the multi-lumen tube 10 is inserted into the distal end opening of the handle 20, whereby the multi-lumen tube 10 and the handle 20 are connected.

As shown in FIGS. 6 and 8, a cylindrical connector 50 formed by arranging a plurality of pin terminals (51, 52, 53) protruding in the distal direction on the distal end surface 50 </ b> A is provided at the proximal end portion of the handle 20. Built in.
As shown in FIGS. 6 to 8, each of the three lead wire groups (first lead wire group 41G, second lead wire group 42G, and third lead wire group 43G) is inserted into the handle 20. Three insulating tubes (the first insulating tube 26, the second insulating tube 27, and the third insulating tube 28) are extended.

As shown in FIGS. 6 and 7, the distal end portion (about 10 mm from 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 The first lead wire group 41G is connected to the first lumen 11 extending.
The first insulating tube 26 connected to the first lumen 11 passes through the inner hole of the first protective tube 61 extending inside the handle 20 and is connected to the connector 50 (tip surface 50A on which the pin terminal is disposed). It extends to the vicinity and forms an insertion path that guides the proximal end portion of the first lead wire group 41G to the vicinity of the connector 50. Thereby, the first lead wire group 41G extending from the multi-lumen tube 10 (first lumen 11) extends inside the handle 20 (inner hole of the first insulating tube 26) without being kinked. Can do.
The first lead wire group 41G extending from the base end opening of the first insulating tube 26 is divided into eight lead wires 41 constituting the first lead wire group 41G, and each of the lead wires 41 is a front end surface 50A of the connector 50. Are fixedly connected to each of the pin terminals arranged by soldering. Here, a region where the pin terminals (pin terminals 51) to which the lead wires 41 constituting the first lead wire group 41G are connected and fixed is arranged is referred to as a “first terminal group region”.

The distal end portion (about 10 mm from 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 lead wire group 42G extends in the second insulating tube 27. Connected to the second lumen 12.
The second insulating tube 27 connected to the second lumen 12 passes through the inner hole of the second protective tube 62 extending to the inside of the handle 20 and is connected to the connector 50 (tip surface 50A on which the pin terminal is disposed). It extends to the vicinity and forms an insertion path that guides the proximal end portion of the second lead wire group 42G to the vicinity of the connector 50. Accordingly, the second lead wire group 42G extending from the multi-lumen tube 10 (second lumen 12) extends inside the handle 20 (inner hole of the second insulating tube 27) without being kinked. Can do.
The second lead wire group 42G extending from the proximal end opening of the second insulating tube 27 is divided into eight lead wires 42 constituting the second lead wire group 42G, and each of these lead wires 42 is a front end surface 50A of the connector 50. Are fixedly connected to each of the pin terminals arranged by soldering. Here, a region where the pin terminals (pin terminals 52) to which the lead wires 42 constituting the second lead wire group 42G are connected and fixed is disposed is referred to as a “second terminal group region”.

The distal end portion (about 10 mm from 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 lead wire group 43G extends in the third insulating tube 28. Connected to the third lumen 13.
The third insulating tube 28 connected to the third lumen 13 passes through the inner hole of the second protective tube 62 extending inside the handle 20 and is connected to the connector 50 (tip surface 50A on which the pin terminal is disposed). It extends to the vicinity and forms an insertion path for guiding the proximal end portion of the third lead wire group 43G to the vicinity of the connector 50. As a result, the third lead wire group 43G extending from the multi-lumen tube 10 (third lumen 13) extends inside the handle 20 (inner hole of the third insulating tube 28) without kinking. Can do.
The third lead wire group 43G extending from the proximal end opening of the third insulating tube 28 is divided into four lead wires 43 constituting the third lead wire group 43, and each of the lead wires 43 is connected to the distal end surface 50A of the connector 50. Are fixedly connected to each of the pin terminals arranged by soldering. Here, an area where the pin terminals (pin terminals 53) to which the lead wires 43 constituting the third lead wire group 43G are connected and fixed is arranged is referred to as a “third terminal group area”.

Here, examples of the constituent material of the insulating tubes (the first insulating tube 26, the second insulating tube 27, and the third insulating tube 28) include polyimide resin, polyamide resin, and polyamideimide resin. . Of these, a polyimide resin is particularly preferable because of its high hardness, easy insertion of the lead wire group, and capable of thin molding.
The thickness of the insulating tube is preferably 20 to 40 μm, and 30 μm if a suitable example is shown.

  Moreover, as a constituent material of the protective tube (the first protective tube 61 and the second protective tube 62) into which the insulating tube is inserted, nylon elastomer such as “Pebax” (registered trademark of ARKEMA) is exemplified. be able to.

  According to the defibrillation catheter 100 in the present embodiment having the above-described configuration, the first lead wire group 41G extends in the first insulating tube 26, and the second lead in the second insulating tube 27. Since the wire group 42G extends and the third lead wire group 43G extends in the third insulating tube 28, the first lead wire group 41G and the second lead wire are also provided inside the handle 20. The group 42G and the third lead wire 43G can be completely insulated and isolated. As a result, when a voltage necessary for defibrillation is applied, a short circuit between the first lead wire group 41G, the second lead wire group 42G, and the third lead wire 43G inside the handle 20 (particularly, Short circuit between the lead wire groups extending near the opening of the lumen can be reliably prevented.

  Further, in the handle 20, the first insulating tube 26 is protected by the first protective tube 61, and the second insulating tube 27 and the third insulating tube 28 are protected by the second protective tube 52. Thereby, for example, it is possible to prevent the insulating tube from being damaged by contact and rubbing of the constituent members (movable parts) of the knob 22 during the deflection operation of the distal end portion of the multi-lumen tube 10.

  The defibrillation catheter 100 according to the present embodiment partitions the distal end surface 50A of the connector 50 on which a plurality of pin terminals are arranged into a first terminal group region, a second terminal group region, and a third terminal group region, and leads A partition plate 55 that separates the wire 41 from the lead wire 42 and the lead wire 43 is provided.

  The partition plate 55 that partitions the first terminal group region, the second terminal group region, and the third terminal group region is formed by molding an insulating resin into a bowl shape having flat surfaces on both sides. The insulating resin constituting the partition plate 55 is not particularly limited, and a general-purpose resin such as polyethylene can be used.

The thickness of the partition plate 55 is, for example, 0.1 to 0.5 mm, and is 0.2 mm if a suitable example is shown.
The height of the partition plate 55 (distance from the base end edge to the front end edge) is higher than the separation distance between the front end surface 50A of the connector 50 and the insulating tubes (the first insulating tube 26 and the second insulating tube 27). When the separation distance is 7 mm, the height of the partition plate 55 is, for example, 8 mm. In the partition plate having a height of less than 7 mm, the distal end edge cannot be positioned on the distal end side with respect to the proximal end of the insulating tube.

According to such a configuration, the lead wire 41 (the base end portion of the lead wire 41 extending from the base end opening of the first insulating tube 26) constituting the first lead wire group 41G, and the second lead wire group The lead wire 42 (the base end portion of the lead wire 42 extending from the base end opening of the second insulating tube 27) constituting the 42G can be reliably and orderly isolated.
When the partition plate 55 is not provided, the lead wire 41 and the lead 42 cannot be separated (separated) in an orderly manner, and these may be mixed.

  The lead wires 41 constituting the first lead wire group 41G and the lead wires 42 constituting the second lead wire group 42G, to which voltages having different polarities are applied, are separated from each other by the partition plate 55 and are in contact with each other. Therefore, when the defibrillation catheter 100 is used, even if a voltage necessary for defibrillation in the heart chamber is applied, the lead wires 41 (first insulating tube) constituting the first lead wire group 41G are applied. 26 of the lead wire 41 extending from the proximal end opening of the lead wire 26 and the lead wire 42 constituting the second lead wire group 42G (the lead wire 42 extending from the proximal end opening of the second insulating tube 27). A short circuit does not occur between the base end portion and the base end portion.

  Further, when an error occurs when the lead wire is connected and fixed to the pin terminal during manufacture of the defibrillation catheter, for example, the lead wire 41 constituting the first lead wire group 41G is connected to the second terminal group region. When connected to the pin terminal, the lead 41 straddles the partition wall 55, so that a connection error can be easily found.

  The lead wire 43 (pin terminal 53) constituting the third lead wire group 43G is separated from the lead wire 41 (pin terminal 51) by the partition plate 55 together with the lead wire 42 (pin terminal 52). However, the present invention is not limited to this, and may be separated from the lead wire 42 (pin terminal 52) by the partition plate 55 together with the lead wire 41 (pin terminal 51).

In the defibrillation catheter 100, the distal end edge of the partition plate 55 is located on the distal end side with respect to both the proximal end of the first insulating tube 26 and the proximal end of the second insulating tube 27.
Thereby, the lead wire (lead wire 41 constituting the first lead wire group 41G) extending from the base end opening of the first insulating tube 26 and the lead extending from the base end opening of the second insulating tube 27 are provided. Between the wires (the lead wires 42 constituting the second lead wire group 42G), the partition plate 55 is always present, and the short circuit due to the contact between the lead wires 41 and the lead wires 42 is surely prevented. Can do.

  As shown in FIG. 8, eight lead wires 41 extending from the base end opening of the first insulating tube 26 and connected and fixed to the pin terminal 51 of the connector 50, and from the base end opening of the second insulating tube 27 are connected. Eight lead wires 42 extending and fixedly connected to the pin terminal 52 of the connector 50, and four leads extending from the proximal end opening of the third insulating tube 28 and fixedly connected to the pin terminal 53 of the connector 50 The shape of the wire 43 is held and fixed by the periphery of the wire 43 being hardened by the resin 58.

The resin 58 that retains the shape of the lead wire is formed into a cylindrical shape having the same diameter as the connector 50, and the pin terminal, the lead wire, the base end portion of the insulating tube, and the partition plate 55 are formed inside the resin molded body. Is embedded.
According to the configuration in which the proximal end portion of the insulating tube is embedded in the resin molded body, the lead wire (base) from the base end opening of the insulating tube until it is connected and fixed to the pin terminal. The entire region of the end portion can be completely covered with the resin 58, and the shape of the lead wire (base end portion) can be completely held and fixed.
Further, the height of the resin molded body (distance from the base end surface to the front end surface) is preferably higher than the height of the partition plate 55, and is 9 mm, for example, when the height of the partition plate 55 is 8 mm.

  Although it does not specifically limit as resin 58 which comprises a resin molding here, It is preferable to use a thermosetting resin or a photocurable resin. Specifically, urethane-based, epoxy-based, and urethane-epoxy-based curable resins can be exemplified.

  According to the above configuration, since the shape of the lead wire is held and fixed by the resin 58, when the defibrillation catheter 100 is manufactured (when the connector 50 is mounted inside the handle 20), an insulating tube is used. It is possible to prevent the lead wire extending from the base end opening from being kinked or coming into contact with the edge of the pin terminal and causing damage (for example, generation of cracks in the coating resin of the lead wire).

As shown in FIG. 1, the defibrillation catheter 100 constituting the catheter system of this embodiment includes a memory 110 having a catheter serial storage unit 111, an initial connection information storage unit 112, and an event information storage unit 113. I have.
The memory 110 provided in the defibrillation catheter 100 is composed of, for example, a memory chip stored inside the handle 20.

  Table 1 below shows an example of the memory structure of the defibrillation catheter 100 with written information.

Serial information of the defibrillation catheter 100 is stored in the catheter serial storage unit 111 of the memory 110.
As serial information of the defibrillation catheter 100, a manufacturing number (serial number), a manufacturing date, etc. can be mentioned. This serial information is information on product management written at the time of manufacture of the defibrillation catheter 100, and cannot be rewritten or added.
For example, in the structure of the memory 110 shown in Table 1, the deserialization catheter serial number (123456) is written in the catheter serial storage unit 111.

The first connection information storage unit 112 of the memory 110 stores the time (date and time) when the power supply device is first connected to the defibrillation catheter 100 and the serial information of the power supply device connected first.
The first connection time and the serial information of the first connected power supply device are written by the arithmetic processing unit of the first connected power supply device, and cannot be rewritten once written.
The performance of the defibrillation catheter 100, which is a disposable product, deteriorates when used for a certain period of time. For this reason, the defibrillation catheter 100 is set with a use time limit (this use time limit is stored in the memory 752 of the power supply device 700) from the viewpoint of performance and safety. The “time when the power supply device is first connected to the catheter 100” is a starting point of the use time limit of the defibrillation catheter 100.

  In the structure of the memory 110 shown in Table 1 above, the first connection information storage unit 112 is written with the time when the power supply device was first connected (December 5, 2009, 10:00:00). A serial number (10011) is written as serial information of the connected power supply device.

  Information related to an event (operation) including defibrillation by the defibrillation catheter 100 was connected to the event information storage unit 113 of the memory 110 and the time (date and time) when the event was performed, and at that time It is stored together with the power supply serial information.

As an event stored in the event information storage unit 113,
(1) Defibrillation (application of electrical energy) by the defibrillation catheter 100,
(2) measurement of a resistance value between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100,
(3) After the power supply device used for the event by the defibrillation catheter 100 is removed, an operation of reconnecting the same or different power supply device to the defibrillation catheter 100 can be exemplified.

  When defibrillation is performed by the defibrillation catheter 100, the resistance value (intracardiac resistance value) between the first DC electrode group 31G and the second DC electrode group 32G is attempted to be applied between these electrode groups. The information on the set value of electric energy, the actually applied output voltage and the output time is stored in the event information storage unit 113 together with the time when this defibrillation is performed and the serial information of the power supply device connected at that time. Written.

  For example, in the structure of the memory 110 shown in Table 1 above, the event 2 of the event information storage unit 113 has a defibrillation as an event, a resistance value (75Ω) between the electrode groups, an energy set value (15J), an output The voltage (300 V) and output time (13.5 msec) are written in the event information storage unit 113 together with the time when defibrillation is performed and the serial number of the power supply device connected at that time (event 3) The same applies to 4 and 7.)

  Since the measurement of the resistance value between the first DC electrode group 31G and the second DC electrode group 32G is usually performed prior to defibrillation, it can be included in the defibrillation event. When the movement is not performed, the measurement of the resistance value is recognized as a single event, and the measured resistance value is measured together with the measured time and the serial information of the connected power supply device, and the event information storage unit 113. Is written to.

For example, in the structure of the memory 110 shown in Table 1 above, in the event 1 of the event information storage unit 113, the resistance value (75Ω) between the electrode groups has a measurement time (December 5, 2009 10:05:00 Second) and the serial number (10011) of the power supply device connected at that time are written in the event information storage unit 113.
In event 6, the resistance value (79Ω) between the electrode groups is measured at the measurement time (December 5, 2009 10:53:22) and the serial number (10032) of the power supply device connected at that time. At the same time, it is written in the event information storage unit 113.

  In the catheter system of this embodiment, when the power supply device is connected to the defibrillation catheter 100, if it is the first connection, the time and serial information of this power supply device are written in the initial connection information storage unit 112. However, when the same or different power supply devices are reconnected, the information is written in the event information storage unit 113.

  For example, in the structure of the memory 110 shown in Table 1, the event 5 in the event information storage unit 113 includes the reconnection time (December 5, 2009, 10:40:08) and the reconnected power supply device. The serial number (10032) is written in the event information storage unit 113.

  As shown in FIG. 1, the 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, an external switch (input means) 74, and the like. , An arithmetic processing unit 75, a switching unit 76, an electrocardiogram input connector 77, and an electrocardiogram information display unit 78.

  The DC power supply unit 71 has a built-in capacitor, and the built-in capacitor is charged by the input of the external switch 74 (charge switch 743).

  The catheter connector 72 is connected to the connector 50 of the defibrillation catheter 100, and is electrically connected to the proximal end side of the first lead wire group (41G), the second lead wire group (42G), and the third lead wire group (43G). Connected.

As shown in FIG. 9, the connector 50 of the defibrillation catheter 100 and the catheter connection connector 72 of the power supply device 700 are connected by the connector cable C1,
Pin terminals 51 (actually 8) that connect and fix the eight lead wires 41 constituting the first lead wire group, and terminals 721 (actually 8) of the catheter connector 72,
Pin terminals 52 (actually 8) that connect and fix the eight lead wires 42 constituting the second lead wire group, and terminals 722 (actually 8) of the catheter connector 72,
Pin terminals 53 (actually four) to which the four lead wires 43 constituting the third lead wire group are connected and fixed, and terminals 723 (actually four) of the catheter connector 72 are connected to each other. Yes.

Here, the terminal 721 and the terminal 722 of the catheter connection connector 72 are connected to the switching unit 76, and the terminal 723 is directly connected to the electrocardiograph connection connector 73 without passing through the switching unit 76.
As a result, the cardiac potential information measured by the first DC electrode group 31G and the second DC electrode group 32G reaches the electrocardiograph connection connector 73 via the switching unit 76, and is measured by the proximal-side potential measurement electrode group 33G. The electrocardiogram information thus reached reaches the electrocardiograph connector 73 without passing through the switching unit 76.

The electrocardiograph connector 73 is connected to the input terminal of the electrocardiograph 800.
An external switch 74 serving as input means includes a mode switch 741 for switching between a cardiac potential measurement mode and a defibrillation mode, an electrical energy setting switch 742 for setting electrical energy applied during defibrillation, and a DC power supply unit A charge switch 743 for charging 71 and an electric energy application switch (discharge switch) 744 for defibrillation by applying electric energy. All input signals from these external switches 74 are sent to the arithmetic processing unit 75.

The arithmetic processing unit 75 of the power supply device controls the DC power supply unit 71, the switching unit 76, and the electrocardiogram information display unit 78 based on the input of the external switch 74.
The arithmetic processing unit 75 has an output circuit 751 for outputting a DC voltage from the DC power supply unit 71 to the electrode of the defibrillation catheter 100 via the switching unit 76.

  By this output circuit 751, the terminal 721 of the catheter connection connector 72 shown in FIG. 9 (finally, the first DC electrode group 31G of the defibrillation catheter 100) and the terminal 722 of the catheter connection connector 72 (finally, The DC voltage may be applied so that the second DC electrode group 32G of the defibrillation catheter 100 has a different polarity from each other (when one electrode group is a negative electrode, the other electrode group is a positive electrode). it can.

  The arithmetic processing unit 75 includes a memory 752 that stores serial information of the power supply device 700 and a catheter use time limit, and an internal clock 753 for determining the time.

The serial information of the power supply device 700 stored in the memory 752 can include a manufacturing number (serial number), a manufacturing date, and the like. This serial information is information on product management written at the time of manufacturing the power supply device, and cannot be rewritten or added.
The catheter use time limit stored in the memory 752 is set from the viewpoint of the performance and safety of the defibrillation catheter 100 and cannot be rewritten by the user of the catheter system.
The time limit for using the catheter is longer than the maximum time required for one procedure, and is a time that does not cause a problem from the viewpoint of the performance and safety of the defibrillation catheter. For example, it is set to 24 hours. Of course, the present invention is not limited to this.

  The time determined by the internal clock 753 includes the time when the power supply device is first connected to the defibrillation catheter 100, and the event (defibrillation, measurement of resistance value between electrode groups, power supply device) by the defibrillation catheter 100. The time at which the reconnection is performed can be given.

  When the power supply device 700 is first connected to the defibrillation catheter 100, the arithmetic processing unit 75 obtains the connected time with reference to the internal clock 753, and this time is stored in the memory 752. Are written in the first connection information storage unit 112 in the memory 110 of the defibrillation catheter 100.

  Here, the means for detecting that the power supply device 700 is connected to the defibrillation catheter 100 is not particularly limited. For example, a circuit in which a weak current flows when the power supply device 700 is connected or a power supply device 700 is provided. And a means for providing a physical switch to the catheter connector 72.

  Whether the connection of the power supply device 700 is the “first” connection or reconnection in the defibrillation catheter 100 is calculated by the first connection information storage unit 112 in the memory 110 of the defibrillation catheter 100. When the processing unit 75 refers to and the information is not stored in the first connection information storage unit 112, it is determined that the connection is the “first” connection, and when the information is stored in the first connection information storage unit 112, Judge that it is a reconnection.

  When the defibrillation is performed by the defibrillation catheter 100, the arithmetic processing unit 75 has a resistance value between the first DC electrode group 31G and the second DC electrode group 32G (prior to the defibrillation. Measured intracardiac resistance value), set value of electric energy to be applied between the first DC electrode group 31G and the second DC electrode group 32G (input value by the energy setting switch 742), output voltage and output time (actual Information on the voltage and time applied to the power supply device, and this information is stored in the memory 752 in the time when this defibrillation is performed (time by the internal clock 753) and the power supply device 700 connected thereto. Together with the stored serial information), the event information is stored in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100 (events 2, 3, 4, 7 in Table 1 above). Irradiation).

When the defibrillation is not performed after the resistance value between the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 is measured, the arithmetic processing unit 75 measures the resistance value. And the measured resistance value is written in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100 together with the time at which it was measured and the serial information of the connected power supply device 700 (see the above table). 1 event 1 and 6).
Thereby, it is possible to record the data of the intracardiac resistance value when the defibrillation is not performed.

Further, after the power supply device used for the event by the defibrillation catheter 100 is removed, the arithmetic processing unit 75 reconnects the same or different power supply device 700 to the defibrillation catheter 100 (initial connection information in the memory 110). (When connected to the defibrillation catheter 100 whose time is stored in the storage unit 112), this is recognized as an event, and the reconnection time and the serial information of the power supply device 700 are stored in the memory 110 of the defibrillation catheter 100. Write to the event information storage unit 113 (see event 5 in Table 1 above).
As a result, a history of reconnection (exchange) of the power supply device can be recorded.

  According to the catheter system of the present embodiment, it is possible to record the history of events (defibrillation, measurement of resistance value between electrode groups, reconnection of power supply device) by the defibrillation catheter 100. In addition, since information related to these events is stored not in the power supply device side but in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100, an event of one defibrillation catheter 100 is stored in a plurality of power supply devices. Even if it is performed using the above, the information related to these events is not distributed to a plurality of power supply apparatuses.

  In the catheter system of the present embodiment, the arithmetic processing unit 75 performs the initial connection information storage unit in the memory 110 of the defibrillation catheter 100 for each event written in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100. It is determined whether or not the elapsed time from the connection time written in 112 to the time when the event is performed exceeds the catheter use time limit stored in the memory 752 of the power supply device 700. If it is determined, control is performed so that the next event by the defibrillation catheter 100 is not executed.

  For example, in the structure of the memory 110 shown in Table 1 above, the event 3 stored in the event information storage unit 113 is excluded from the connection time (10:00:00) written in the initial connection information storage unit 112. The elapsed time until the time of fibrillation (10:09:25) is 9 minutes 25 seconds, and the catheter use limit time stored in the memory 752 of the power supply device 700 is set to 24 hours 00 minutes 00, for example. If it is set to second, since the elapsed time does not exceed the catheter use time limit, defibrillation of the next event 4 can be performed.

According to the catheter system of this embodiment having such a configuration, a defibrillation catheter that is a disposable product can be used only during a time when there is no problem in terms of performance and safety.
In addition, the connection time (time when the power supply device is first connected) written in the initial connection information storage unit 112 in the memory 110 of the defibrillation catheter 100 is used as a starting point for the use restriction time of the defibrillation catheter 100. Therefore, even if the event is performed by reconnecting the same or different power supply devices, after the use time limit has elapsed from the connection time written in the initial connection information storage unit 112, the event by the defibrillation catheter 100 is transmitted. There is no execution.

The switching unit 76 has a common contact to which the catheter connection connector 72 (terminal 721 and terminal 722) is connected, an electrocardiograph connection connector 73 is connected to the first contact, and an arithmetic processing unit 75 is connected to the second contact. It consists of a switch with two circuit contacts.
That is, when the first contact is selected, a path connecting the catheter connection connector 72 and the electrocardiograph connection connector 73 is secured, and when the second contact is selected, the catheter connection connector 72 and the arithmetic processing unit 75 are connected. A connecting route is secured.

  The switching operation of the switching unit 76 is controlled by the arithmetic processing unit 75 based on the input of the external switch 74 (mode switching switch 741 and electrical energy application switch 744).

The electrocardiogram input connector 77 is connected to the arithmetic processing unit 75 and also connected to the output terminal of the electrocardiograph 800.
With this electrocardiogram input connector 77, the electrocardiogram information output from the electrocardiograph 800 (usually part of the electrocardiogram information input to the electrocardiograph 800) can be input to the arithmetic processing unit 75. The unit 75 can control the DC power supply unit 71 and the switching unit 76 based on the cardiac potential information.

  The cardiac potential information display unit 78 is connected to the arithmetic processing unit 75, and the cardiac potential information display unit 78 displays the cardiac potential information (mainly the cardiac potential waveform) input from the electrocardiogram input connector 77 to the arithmetic processing unit 75. Then, the operator can perform defibrillation treatment (such as input of an external switch) while monitoring the electrocardiogram information (waveform) input to the arithmetic processing unit 75.

  The electrocardiograph 800 (input terminal) constituting the catheter system of the present embodiment is connected to the electrocardiograph connector 73 of the power supply device 700, and the defibrillation catheter 100 (first DC electrode group 31G, second DC electrode group 32G). Electrocardiographic potential information measured by the configuration electrode of the proximal-side potential measuring electrode group 33G) is input to the electrocardiograph 800 from the electrocardiograph connector 73.

The electrocardiograph 800 (other input terminal) is also connected to the electrocardiogram measuring unit 900, and the electrocardiogram information measured by the electrocardiogram measuring unit 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 (an electrode different from the defibrillation catheter 100) mounted in the patient's heart. Catheter).

  The electrocardiograph 800 (output terminal) is connected to the electrocardiogram input connector 77 of the power supply device 700, and the electrocardiogram information (cardiac potential information from the defibrillation catheter 100 and the electrocardiogram measuring means 900) input to the electrocardiograph 800. A part of the electrocardiogram information) from the electrocardiogram input connector 77 to the arithmetic processing unit 75.

  The defibrillation catheter 100 in the present embodiment can be used as an electrode catheter for measuring cardiac potential when defibrillation treatment is not required.

FIG. 10 shows the flow of cardiac potential information when cardiac potential is measured by the defibrillation catheter 100 according to the present embodiment when performing cardiac catheterization (for example, high frequency therapy).
At this time, the switching unit 76 of the power supply device 700 selects the first contact to which the electrocardiograph connection connector 73 is connected.

The cardiac potential measured by the electrodes constituting the first DC electrode group 31G and / or the second DC electrode group 32G of the defibrillation catheter 100 passes through the catheter connection connector 72, the switching unit 76, and the electrocardiograph connection connector 73. Input to the electrocardiograph 800.
In addition, the cardiac potential measured by the electrodes constituting the proximal-side potential measurement electrode group 33G of the defibrillation catheter 100 passes directly from the catheter connection connector 72 through the electrocardiograph connection connector 73 without passing through the switching unit 76. And input to the electrocardiograph 800.

Cardiac potential information (cardiac potential waveform) from the defibrillation catheter 100 is displayed on a monitor (not shown) of the electrocardiograph 800.
Further, a part of the cardiac potential information from the defibrillation catheter 100 (for example, the potential difference between the electrodes 31 (first pole and second pole) constituting the first DC electrode group 31G) is transferred from the electrocardiograph 800 to the electrocardiogram. Via the input connector 77 and the arithmetic processing unit 75, it can be input to the electrocardiogram information display unit 78 and displayed.

  As described above, when defibrillation treatment is not required during cardiac catheterization, the defibrillation catheter 100 can be used as an electrode catheter for measuring cardiac potential.

  When atrial fibrillation occurs during cardiac catheterization, defibrillation treatment can be performed immediately by the defibrillation catheter 100 used as an electrode catheter. As a result, when atrial fibrillation occurs, the trouble of newly inserting a catheter for defibrillation can be saved.

  Hereinafter, an example of the defibrillation treatment by the intracardiac defibrillation catheter system of the present embodiment will be described along the flowchart shown in FIG.

(1) First, the power supply device 700 is connected to the defibrillation catheter 100. Specifically, the connector 50 of the defibrillation catheter 100 and the catheter connection connector 72 of the power supply device 700 are connected by the connector cable C1 (see Step 1 in FIG. 11A and FIG. 9).

(2) Upon detecting that the power supply device 700 is connected to the defibrillation catheter 100, the arithmetic processing unit 75 of the power supply device 700 reads serial information from the catheter serial storage unit 111 in the memory of the defibrillation catheter 100. In order to determine whether this connection is the first connection in the defibrillation catheter 100 or the reconnection of the same or different power supply device, the initial connection information storage unit 112 in the memory 110 is referred to. Then, it is determined whether or not information is written therein. If no information is written in the initial connection information storage unit 112, the process proceeds to Step 3, and if information is written, the process proceeds to Step 4 (Step 2, (See FIG. 12).

(3) When information is not written in the initial connection information storage unit 112, the arithmetic processing unit 75 of the power supply device 700 causes the time when the power supply device 700 is connected at Step 1 (time by the internal clock 753) and the power supply device 700. Serial information (serial information stored in the memory 752) is written in the initial connection information storage unit 112 in the memory 110 of the defibrillation catheter 100, and the process proceeds to Step 5 (Step 3, see FIG. 12).

(4) When information is written in the initial connection information storage unit 112, the arithmetic processing unit 75 of the power supply device 700 delimits the time when the power supply device 700 was connected in Step 1 and the serial information of the power supply device 700. Write to the event information storage unit 113 in the memory 110 of the kinetic catheter 100 and proceed to Step 5 (Step 4, see FIG. 12).

(5) The position of the electrodes of the defibrillation catheter 100 (constituting electrodes of the first DC electrode group 31G, the second DC electrode group 32G, and the proximal end side potential measurement electrode group 33G) is confirmed on the X-ray image, and the cardiac potential measurement is performed. A part of the electrocardiogram information (12-lead electrocardiogram) input to the electrocardiograph 800 is selected from the means 900 (electrode pad affixed to the body surface), and the arithmetic processing unit 75 of the power supply 700 is selected from the electrocardiogram input connector 77. (Step 5). At this time, a part of the electrocardiogram information input to the arithmetic processing unit 75 is displayed on the electrocardiogram information display unit 78 (see FIG. 13).
In addition, from the constituent electrodes of the first DC electrode group 31G and / or the second DC electrode group 32G of the defibrillation catheter 100 to the electrocardiograph 800 via the catheter connection connector 72, the switching unit 76, and the electrocardiograph connection connector 73. The inputted cardiac potential information and the heart inputted from the constituent electrodes of the proximal side potential measurement electrode group 33G of the defibrillation catheter 100 to the electrocardiograph 800 via the catheter connector 72 and the electrocardiograph connector 73. The potential information is displayed on a monitor (not shown) of the electrocardiograph 800.

(6) Next, the mode changeover switch 741, which is the external switch 74, is input (Step 6). The power supply device 700 in the present embodiment is in the “cardiac potential measurement mode” in the initial state, the switching unit 76 selects the first contact, and the electrocardiograph connection connector from the catheter connection connector 72 via the switching unit 76. A route to 73 is secured.

(7) When the mode changeover switch 741 is input, the arithmetic processing unit 75 of the power supply device 700 starts from the time written in the initial connection information storage unit 112 in the memory 110 of the defibrillation catheter 100, and the event information storage unit It is determined whether or not the elapsed time up to the time of the last writing in 113 exceeds the catheter use time limit stored in the memory 752 of the arithmetic processing unit 75. If not, the process proceeds to Step 8. If it exceeds, the subsequent operation cannot be performed and “end” is performed (Step 7).

Here, when the connection of the power supply device 700 in Step 1 is the first connection in this defibrillation catheter 100 (when going through Steps 2, 3, 5, 6), information is stored in the event information storage unit 113. Since it has not been written, it is possible to proceed to Step 8. On the other hand, when the connection of the power supply device 700 in Step 1 is a connection again in this defibrillation catheter 100 (when going through Steps 2, 4, 5, and 6), the event information storage unit 113 is finally written. The time is the time when the power supply device 700 written in Step 4 is reconnected.
In addition, when returning from Step 22 described later to Step 6 (when going through Steps 22 and 6), the time last written in the event information storage unit 113 is the application of electric energy (defibrillation) in Step 17 described later. ).

(8) When it is determined that the elapsed time from the time written in the first connection information storage unit 112 to the time last written in the event information storage unit 113 does not exceed the catheter use time limit, The arithmetic processing unit 75 switches the mode of the power supply device 700 from the “cardiac potential measurement mode” to the “defibrillation mode” (Step 8 in FIG. 11B).

(9) As shown in FIG. 14, when the mode changeover switch 741 is input to switch to the defibrillation mode, the contact of the switching unit 76 is switched to the second contact by the control signal of the arithmetic processing unit 75, and the catheter connection connector 72. Thus, a route from the catheter connection connector 72 to the electrocardiograph connection connector 73 via the switching unit 76 is blocked (Step 9). When the switching unit 76 selects the second contact point, 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 is input to the electrocardiograph 800. (Therefore, this electrocardiographic information cannot be sent to the arithmetic processing unit 75). However, the electrocardiographic information from the constituent electrodes of the proximal-side potential measurement electrode group 33G that does not pass through the switching unit 76 is input to the electrocardiograph 800.

(10) When the contact point of the switching unit 76 is switched to the second contact point, the resistance value between the first DC electrode group (31G) and the second DC electrode group (32G) of the defibrillation catheter 100 is measured (Step 10). . The resistance value input to the arithmetic processing unit 75 from the catheter connection connector 72 via the switching unit 76 is combined with a part of the cardiac potential information from the cardiac potential measuring means 900 input to the arithmetic processing unit 75. It can be displayed on the potential information display section 78 (see FIG. 14).

(11) The contact point of the switching unit 76 is switched to the first contact point, and the path from the catheter connection connector 72 to the electrocardiograph connection connector 73 via the switching unit 76 is restored (Step 11). Note that the time during which the contact of the switching unit 76 selects the second contact (Step 9 to Step 10 above) is, for example, 1 second.

(12) The arithmetic processing unit 75 determines whether or not the resistance value measured in Step 10 exceeds a certain value, and if not, in the next Step 13 (preparation for applying a DC voltage). If it has exceeded, the process returns to Step 5 (confirmation of the electrode position of the defibrillation catheter 100) (Step 12).
Here, when the resistance value exceeds a certain value, the first DC electrode group and / or the second DC electrode group is surely placed at a predetermined site (for example, a coronary vein tube wall, an inner wall of the right atrium). Since it means that the contact has not been made, it is necessary to return to Step 5 and readjust the position of the electrode.
Thus, the voltage is applied only when the first DC electrode group and the second DC electrode group of the defibrillation catheter 100 are reliably brought into contact with a predetermined part (for example, the coronary vein tube wall or the right atrial inner wall). Therefore, an effective defibrillation treatment can be performed.

(13) The electric energy setting switch 742 which is the external switch 74 is input to set the applied energy at the time of defibrillation (Step 13).
According to the power supply device 700 in the present embodiment, the applied energy can be set from 1J to 30J in increments of 1J.

(14) The charge switch 743 which is the external switch 74 is input, and the built-in capacitor of the DC power supply unit 71 is charged with energy (Step 14).

(15) After the charging is completed, the electric energy application switch 744 that is the external switch 74 is input (Step 15).

(16) When the electric energy application switch 744 is input, the operation processing unit 75 switches the contact of the switching unit 76 to the second contact, and the catheter connection connector 72 reaches the operation processing unit 75 via the switching unit 76. A path is secured, and the path from the catheter connection connector 72 to the electrocardiograph connection connector 73 via the switching unit 76 is blocked (Step 16).

(17) After the contact point of the switching unit 76 is switched to the second contact point, the output circuit 751, the switching unit 76, and the catheter connection connector of the calculation processing unit 75 are received from the DC power supply unit 71 that has received the control signal from the calculation processing unit 75. Direct current voltages having different polarities are applied to the first DC electrode group and the second DC electrode group of the defibrillation catheter 100 via 72 (see Step 17 in FIG. 11C and FIG. 15).

Here, the arithmetic processing unit 75 performs arithmetic processing so that a voltage is applied in synchronization with the electrocardiographic waveform input via the electrocardiogram input connector 77, and sends a control signal to the DC power supply unit 71.
Specifically, one R wave (maximum peak) is detected in the electrocardiogram waveform (a part of the 12-lead electrocardiogram from the electrocardiogram measurement means 900) sequentially input to the arithmetic processing unit 75, and the peak height is detected. Next, a certain time (for example, 1/10 of the peak width of the R wave) from when the potential difference reaches the height (trigger level) of 80% of the peak height (when the next R wave rises) is obtained. The application is started after a very short time).

FIG. 16 is a diagram illustrating a potential waveform measured when predetermined electrical energy (for example, set output = 10 J) is applied by the defibrillation catheter 100 in the present embodiment. In the figure, the horizontal axis represents time and the vertical axis represents potential.
First, after a lapse of a certain time (t ₀ ) after the potential difference in the electrocardiographic waveform input to the arithmetic processing unit 75 reaches the trigger level, the first DC electrode group 31G is negative, and the second DC electrode group 32G is positive. Thus, by applying a DC voltage between the two, electric energy is supplied and the measured potential rises (V ₁ is the peak voltage at this time). After a certain time (t ₁ ) elapses, electric energy is supplied by applying a DC voltage that is inverted between ± so that the first DC electrode group 31G becomes a positive pole and the second DC electrode group 32G becomes a negative pole. As a result, the measurement potential rises (V ₂ is the peak voltage at this time).

Here, the time (t ₀ ) from the time when the trigger level is reached until the start of application is, for example, 0.01 to 0.05 seconds, 0.01 seconds if a suitable example is shown, and the time (t = t ₁ + t ₂ ) is, for example, 0.006 to 0.03 seconds, and 0.02 seconds if a suitable example is shown.
Thereby, a voltage can be applied synchronizing with the cardiac potential waveform (R wave which is the maximum peak) input to the arithmetic processing unit 75, and effective defibrillation treatment can be performed.
The measured peak voltage (V ₁ ) is, for example, 300 to 600V.

(18) After a certain time (t ₀ + t) has elapsed after the potential difference in the cardiac potential waveform reaches the trigger level, application of a voltage from the DC power supply unit 71 is stopped in response to a control signal from the arithmetic processing unit 75. (Step 18).

(19) After the application of voltage is stopped, the applied record (cardiac potential waveform at the time of application as shown in FIG. 16) is displayed on the cardiac potential information display section 78 (Step 19). The display time is, for example, 5 seconds.

(20) When the defibrillation is performed by the defibrillation catheter 100, the arithmetic processing unit 75 of the power supply device 700 has a resistance value (defibrillation) between the first DC electrode group 31G and the second DC electrode group 32G. The intracardiac resistance value measured in advance when performing the measurement), the set value of electric energy to be applied between the first DC electrode group 31G and the second DC electrode group 32G (input value by the energy setting switch 742), Information on the output voltage (actually applied voltage indicated by V ₁ in FIG. 16) and output time (actually applied time indicated by t in FIG. 16) is obtained, and this information is obtained by this defibrillation. In the memory 110 of the defibrillation catheter 100 together with the time when the movement is performed (time determined by the internal clock 753) and the serial information of the power supply device 700 (serial information stored in the memory 752). Write to kick event information storage unit 113 (Step 20, see FIG. 17).

(21) The contact point of the switching unit 76 is switched to the first contact point, the path from the catheter connection connector 72 to the electrocardiograph connection connector 73 via the switching unit 76 is restored, and the first DC electrode of the defibrillation catheter 100 is restored. The electrocardiographic information from the constituent electrodes of the group 31G and the second DC electrode group 32G is input to the electrocardiograph 800 (Step 21, see FIG. 13).

(22) The heart from the constituent electrodes of the defibrillation catheter 100 (the constituent electrodes of the first DC electrode group 31G, the second DC electrode group 32G, and the proximal potential measuring electrode group 33G) displayed on the monitor of the electrocardiograph 800 When the potential information (electrocardiogram) and the cardiac potential information (12-lead electrocardiogram) from the electrocardiogram measuring means 900 are observed. Then, return to Step 6 (Step 22).

According to the catheter system of the present embodiment, the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 can directly apply electrical energy to the heart that has caused fibrillation. The electrical stimulation (electric shock) necessary and sufficient for fibrillation treatment can be reliably applied only to the heart.
And since electrical energy can be given directly to the heart, it does not cause burns on the patient's body surface.

In addition, a history of events (defibrillation, measurement of resistance value between electrode groups, reconnection of power supply device) by the defibrillation catheter 100 can be recorded.
In addition, since information related to these events is stored in the memory 110 (event information storage unit 113) of the defibrillation catheter 100, an event of one defibrillation catheter 100 is performed using a plurality of power supply devices. Even so, the information related to these events is not distributed to a plurality of power supply apparatuses. Therefore, event history information can be managed for each defibrillation catheter 100 specified by the serial information.
Thereby, for example, when an abnormality occurs in the defibrillation catheter during use, the event history can be used for investigating the cause of the occurrence of the abnormality.
Information written in the memory 110 of the defibrillation catheter 100 can be read out by an appropriate information reading device.

Furthermore, a defibrillation catheter that is a disposable product can be used only for a limited use time set from the viewpoint of its performance and safety, and for a defibrillation catheter that has passed the limited use time, Defibrillation (application of electrical energy) by the defibrillation catheter is not performed. Thereby, the performance and safety of the defibrillation catheter can be ensured.
In addition, the connection time (time when the power supply device is first connected) written in the initial connection information storage unit 112 in the memory 110 of the defibrillation catheter 100 is used as a starting point for the use restriction time of the defibrillation catheter 100. Therefore, even if the event is performed by reconnecting the same or different power supply devices, the event by the defibrillation catheter 100 is executed after the use time limit has elapsed from the connection time written in the initial connection information storage unit 112. I will not let you.

  Further, the electrocardiogram information measured by the constituent electrodes 33 of the proximal-side potential measurement electrode group 33G is transmitted from the catheter connector 72 to the electrocardiograph via the electrocardiograph connector 73 without passing through the switching unit 76. Since the electrocardiograph 800 is connected to the electrocardiogram measuring means 900, the electrocardiograms from the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 are detected by the heart. During defibrillation treatment that cannot be acquired by the electrometer 800 (the switching unit 76 switches to the second contact, and the path from the catheter connection connector 72 to the electrocardiograph connection connector 73 via the switching unit 76 is blocked. The electrocardiograph 800 can acquire the electrocardiogram information measured by the proximal-side potential measurement electrode group 33G and the electrocardiogram measurement means 900 even when the electrocardiogram 800 is It is possible to perform defibrillation therapy while monitoring (monitoring) the cardiac potential at 800.

  Further, the arithmetic processing unit 75 of the power supply device 700 controls the DC power source 71 by performing arithmetic processing so that a voltage is applied in synchronization with the electrocardiographic waveform input via the electrocardiogram input connector 77 ( Application is started after a lapse of a certain time (for example, 0.01 seconds) after the potential difference in the cardiac potential waveform reaches the trigger level), so that the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 are The voltage can be applied in synchronization with the cardiac potential waveform, and an effective defibrillation treatment can be performed.

  Further, when the resistance value between the electrode groups of the defibrillation catheter 100 does not exceed a certain value, the arithmetic processing unit 75, that is, the first DC electrode group 31G and the second DC electrode group 32G have a predetermined part (for example, Only when it is securely abutted against the coronary vein wall, the inner wall of the right atrium), it is controlled so that it can proceed to preparation for applying a DC voltage, so effective defibrillation treatment is performed. be able to.

<Second Embodiment>
FIG. 18 is a block diagram showing another embodiment of the intracardiac defibrillation catheter system of the present invention.
In addition to the configuration of the power supply device 700 according to the first embodiment, the power supply device 701 of the present embodiment is provided with a memory information display unit or a memory information output unit 79 connected to the arithmetic processing unit 75.
The arithmetic processing unit 75 constituting the power supply device 701 of the present embodiment reads information written in the memory 110 of the defibrillation catheter 100 and displays it on the memory information display unit or outputs it to the memory information output unit. Can be made.
By displaying the information written in the memory 110, for example, the history of defibrillation written in the event information storage unit 113 on the memory information display unit, this can be confirmed during the procedure.
In addition, the information written in the memory 110 is output to the memory information output unit, and this is left as a part of the treatment record. Specifically, the output voltage and output time in each defibrillation are printed. Can be attached to the patient's chart.

DESCRIPTION OF SYMBOLS 100 Defibrillation catheter 10 Multi-lumen tube 11 1st lumen 12 2nd lumen 13 3rd lumen 14 4th lumen 15 Fluororesin layer 16 Inner (core) part 17 Outer (shell) part 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-shaped electrode 35 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 55 septum Board 58 Resin 61 No. Protective tube 62 second protective tube 65 pull wire 110 memory 111 catheter serial storage unit 112 initial connection information storage unit 113 event information storage unit 700 power supply device 71 DC power supply unit 72 catheter connection connector 721, 722, 723 terminal 73 electrocardiograph Connector 74 External switch (input means)
741 Mode changeover switch 742 Electric energy setting switch 743 Charging switch 744 Electric energy application switch (discharge switch)
75 arithmetic processing unit 751 output circuit 752 memory 753 internal clock 76 switching unit 78 electrocardiogram information display unit 800 electrocardiograph 900 electrocardiogram measuring means

Claims (9)

A catheter system comprising a defibrillation catheter inserted into a heart chamber for defibrillation and a power supply device for applying a DC voltage to an electrode of the defibrillation catheter;
The defibrillation catheter includes an insulating tube member;
A first electrode group composed of a plurality of ring-shaped electrodes mounted on the distal end region of the tube member; and a plurality of ring-shaped electrodes mounted on the tube member spaced from the first electrode group toward the base end side. A second electrode group;
A first lead wire group comprising a plurality of lead wires each having a tip connected to each of the electrodes constituting the first electrode group;
A second lead wire group comprising a plurality of lead wires each having a tip connected to each of the electrodes constituting the second electrode group;
The catheter serial storage unit in which the serial information of the defibrillation catheter is stored, and the information related to the event including the defibrillation by the defibrillation catheter, the time at which the event is performed, and the connected power supply device A memory having an event information storage unit for storing serial information;
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;
An external switch including a mode changeover switch for setting the power supply device in a defibrillation mode, an electric energy setting switch, and an electric energy application switch;
The DC power supply unit is controlled based on the input of the external switch, and has a DC voltage output circuit from the DC power supply unit, and further stores serial information of the power supply device to determine the time And an arithmetic processing unit that has an internal clock and controls writing to and reading from the memory of the defibrillation catheter;
When defibrillation is performed by the defibrillation catheter, after the resistance value between the first electrode group and the second electrode group is measured, the DC of the power supply device is determined based on the input of the external switch. Voltages having different polarities are applied from the power supply 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 of the power supply device, when defibrillation is performed by the defibrillation catheter, a resistance value between the first electrode group and the second electrode group, the first electrode group and the Information on the set value, output voltage, and output time of the electrical energy to be applied between the second electrode group is acquired, and these information are used as the time when this defibrillation is performed and the connected power supply device. The intracardiac defibrillation catheter system is written in the event information storage unit in the memory of the defibrillation catheter together with the serial information.   When the defibrillation is not performed after the resistance value between the first electrode group and the second electrode group of the defibrillation catheter is measured, the arithmetic processing unit of the power supply device determines the resistance value. The measurement is recognized as an event, and the measured resistance value is written in the event information storage unit in the memory of the defibrillation catheter together with the measured time and serial information of the connected power supply device. The intracardiac defibrillation catheter system according to Item 1.   The arithmetic processing unit of the power supply device recognizes this as an event when the same or different power supply device is reconnected to the defibrillation catheter from which the power supply device used has been removed, and the reconnection time and The intracardiac defibrillation catheter system according to claim 1 or 2, wherein serial information of the reconnected power supply device is written in an event information storage unit in a memory of the defibrillation catheter. The power supply device has a memory information display unit or a memory information output unit connected to the arithmetic processing unit,
The arithmetic processing unit of the power supply device reads information written in a memory of the defibrillation catheter, displays the information on the memory information display unit, or outputs the information to the memory information output unit. The intracardiac defibrillation catheter system according to any one of claims 1 to 3. The intracardiac defibrillation catheter system of claim 1, comprising an electrocardiograph,
The power supply device is an electrocardiograph connection connector connected to an input terminal of the electrocardiograph,
A switching unit comprising a switching switch of one circuit and two contacts, 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; Comprising:
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 contact is selected in the switching unit, and the cardiac potential information from the defibrillation catheter is selected. Is input to the electrocardiograph via the catheter connection connector of the power supply device, the switching unit and the electrocardiograph connection connector,
When defibrillation is performed by the defibrillation catheter, the calculation processing unit of the power supply device switches the contact of the switching unit to the second contact, and the DC power supply unit outputs the output circuit of the calculation processing unit, the switching A voltage having different polarities is applied to the first electrode group and the second electrode group of the defibrillation catheter via the catheter and the catheter connector. Fibrillation catheter system. The defibrillation catheter includes a potential measurement electrode group composed of a plurality of electrodes mounted on the tube member apart from the first electrode group or the second electrode group;
The electrode comprises a plurality of lead wires each having a tip connected to each of the electrodes constituting the potential measuring electrode group, and a proximal end side of the electrode includes a potential measuring lead wire group connected to the catheter connector of the power supply device. And
In the power supply device, a path directly connecting the catheter connector and the electrocardiograph connector is formed,
The electrocardiogram information measured by the electrodes constituting the potential measurement electrode group is transmitted from the catheter connection connector of the power supply device via the electrocardiograph connection connector without passing through the switching unit. The intracardiac defibrillation catheter system according to claim 5, wherein   The intracardiac defibrillation catheter system according to claim 5 or 6, wherein electrocardiogram measuring means other than the defibrillation catheter is connected to the electrocardiograph.   The intracardiac defibrillation catheter system according to claim 7, wherein the electrocardiographic potential measuring means is an electrode pad or an electrode catheter. The power supply device includes an electrocardiogram input connector connected to the arithmetic processing unit and an output terminal of the electrocardiograph, and an electrocardiogram information display unit connected to the arithmetic processing unit,
6. The electrocardiogram information from the electrocardiograph input to the electrocardiogram input connector is input to the arithmetic processing unit and further displayed on the electrocardiogram information display unit. 9. The intracardiac defibrillation catheter system according to any one of 8 above.

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