KR20120114401A - Intercardiac defibrillation catheter system - Google Patents

Abstract

A defibrillation catheter 100 and a power supply 700; The defibrillation catheter 100 includes a memory 110 having a first connection information storage section 112 and an event information storage section 113; The power supply device 700 has an output circuit 751 of a DC voltage, a memory 752 for storing a use time limit, and an internal clock 753, and writes and reads the memory 110 of the defibrillation catheter 100. An arithmetic processing unit 75 for controlling the output; The arithmetic processing unit 75 is connected to the first connection information storage unit 112 of the memory 110 of the defibrillation catheter 100 for each event recorded in the event storage unit 113 of the memory 110 of the defibrillation catheter 100. An intracardiac defibrillation catheter system which controls not to execute the next event when it is determined that the elapsed time from the recorded connection time to the time at which the event is executed exceeds the usage limit time.

Description

Intracardiac defibrillation catheter system {INTERCARDIAC DEFIBRILLATION CATHETER SYSTEM}

The present invention relates to an intracardiac defibrillation catheter system, and more particularly, to a catheter system having a defibrillation catheter inserted into the deep cavity and a power supply device for applying a DC voltage to an electrode of the defibrillation catheter.

An external defibrillator (AED) is known as a defibrillator for removing atrial fibrillation (see Patent Document 1, for example).

In defibrillation treatment by AED, electrical energy is applied to the body of the patient by attaching an electrode pad to the body surface of the patient and applying a DC voltage. The electrical energy flowing from the electrode pad into the patient's body is usually 150? 200 J, and a part (usually several%-about 20%) flows into a heart and is used for defibrillation treatment.

See Japanese Unexamined Patent Publication No. 2001-112874

However, atrial fibrillation tends to occur during cardiac catheterization, and even in this case, electrical defibrillation needs to be performed.

However, according to the AED which supplies electric energy from the outside of the body, it is difficult to supply effective electric energy (for example, 10-30 J) to the heart which is causing the fibrillation.

That is, sufficient defibrillation therapy cannot be performed when the ratio of the electrical energy supplied from the outside to the heart is small (for example, about several%).

On the other hand, when the electrical energy supplied from the body flows to the heart at a high rate, the tissues of the heart may be damaged.

Moreover, in defibrillation treatment by AED, an image tends to occur on a body surface on which an electrode pad is attached. As described above, when the ratio of electrical energy flowing to the heart is small, the degree of burn becomes heavy by repeatedly supplying electrical energy, which is a considerable burden for patients undergoing catheterization.

In order to solve such a problem, the present inventors propose a catheter system including a defibrillation catheter inserted into the deep cavity to perform defibrillation, a power supply device for applying a DC voltage to an electrode of the defibrillation catheter, and a catheter system having an electrocardiogram ( Japanese Patent Application No. 2009-70940).

However, defibrillation catheter is a disposable product, the performance is degraded by using for some time.

In addition, when the defibrillation catheter is used for a long time, safety problems such as fatigue of the pull wire, breakdown of the lead wire, and elution of the constituent material into the blood occur.

Therefore, in view of performance and safety, it is desirable to limit the time for which the defibrillation catheter can be used and to prevent the use of the defibrillation catheter beyond this time limit.

In order to ensure that the defibrillation catheter cannot be used for longer than the time limit, the power supply is stored at the time when the power supply device is connected to the defibrillation catheter. The control by the said power supply device can be considered.

However, in such control means, when the power supply device is disconnected from the defibrillation catheter, the connected time is canceled, and by reconnecting the power supply device, the reconnected time becomes the starting point of the usage time limit, and the usage time limit again from that time. It becomes possible to operate.

In this case, the serial number readable by the power supply device is assigned to the defibrillation catheter, the serial device is stored in the power supply device connected to the defibrillation catheter, and the power supply is reconnected to the defibrillation catheter of the stored serial number. It is also conceivable that the time of first connection to the defibrillation catheter is regarded as a starting point, and control is performed so that operation by the defibrillation catheter cannot be performed after the use time limit elapses from that time.

However, even in such control means, when the power supply device connected to the defibrillation catheter is not one unit, for example, when the spare power supply device is reconnected during surgery, the power supply that was first connected to the connected power supply device Since the information of the history (time of connecting the power supply for the first time) that the defibrillation catheter has been operated by the device is not stored, the time of reconnecting becomes the starting point, and the operation time limit operation can be started again from that time. .

The present invention has been made on the basis of the above circumstances, and an object of the present invention is to provide an intracardiac defibrillation catheter system capable of reliably supplying sufficient electric energy necessary for defibrillation to a heart that causes atrial fibrillation during cardiac catheterization. Is to provide.

Another object of the present invention is to provide an intracardiac defibrillation catheter system capable of performing defibrillation treatment without causing burns on the body surface of a patient.

It is still another object of the present invention to provide an intracardiac defibrillation catheter system capable of using (operating) a defibrillation catheter, which is a disposable product, for a limited time in view of its performance and safety.

Still another object of the present invention is to provide an intracardiac defibrillation catheter system capable of using (operating) the defibrillation catheter only for a time when there is no problem in view of its performance or safety even if the same or different power supply is reconnected to the defibrillation catheter. Is to provide.

(1) An intracardiac defibrillation catheter system of the present invention (first invention) is a catheter system including a defibrillation catheter inserted into a deep cavity to perform 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 (first DC electrode group) consisting of a plurality of ring-shaped electrodes attached to the tip region of the tube member,

A second electrode group (second DC electrode group) comprising a plurality of ring-shaped electrodes spaced apart from the first electrode group on the proximal side and attached to the tube member;

A first lead wire group including a plurality of lead wires having a tip connected to each of the electrodes constituting the first DC electrode group;

A second lead wire group including a plurality of lead wires having a tip connected to each of the electrodes constituting the second DC electrode group;

Catheter serial storage unit for storing the serial information of the defibrillation catheter,

A first connection information storage unit for storing the time at which the power supply is first connected to the defibrillation catheter and the serial information of the first connected power supply unit, and

A memory having an event information storage section for storing information related to the event including the defibrillation by the defibrillation catheter together with the time at which the event was performed and the serial information of the connected power supply device;

The power supply unit, the DC power supply unit,

A catheter connecting connector connected to proximal ends 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 to a defibrillation mode, a setting switch of electrical energy, and an application switch of electrical energy;

The DC power supply unit is controlled based on an input of the external switch, and has an output circuit of a DC voltage from the DC power supply unit, and also stores serial information of the power supply device and a time limit for use of the catheter, and stores time. An arithmetic processing unit having an internal clock for confirmation and controlling a write and read output to a memory of said defibrillation catheter;

When defibrillation is performed by the defibrillation catheter, the 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, from the DC power supply unit of the power supply device, Voltages of different polarities are applied to the first DC electrode group and the second DC electrode group of the defibrillation catheter via the output circuit of the calculation processing unit and the catheter connecting connector,

The calculation processing unit of the power supply device,

(a) When the power supply device is first connected to the defibrillation catheter, the time of first connection and the serial information of the power supply device connected for the first time are recorded in the first connection information storage unit in the memory of the defibrillation catheter,

(b) an electric resistance to be applied between the first DC electrode group and the second DC electrode group when defibrillation is performed by the defibrillation catheter; Information of the energy set value, output voltage and output time, and the information are stored in the event storage unit in the memory of the defibrillation catheter together with the time at which the defibrillation was performed and serial information of the connected power supply. Record it,

(c) When defibrillation is not performed after the resistance value between the first DC electrode group and the second DC electrode group of the defibrillation catheter is measured, the measurement of the resistance value is recognized as an event, and the measured resistance value is measured. Recorded in the event storage unit in the memory of the defibrillation catheter together with the time and serial information of the connected power supply device,

(d) When the same or different power supply is reconnected to the defibrillation catheter in which the used power supply is disconnected, this is recognized as an event, and the time of reconnection and the serial information of the reconnected power supply are used for the defibrillation catheter. In the event storage in the memory of

(e) The elapsed time from the connection time recorded in the first connection information storage unit in the memory of the defibrillation catheter to the time when the event was performed for each event recorded in the event storage unit in the memory of the defibrillation catheter. It is determined whether or not the use time limit (use time limit stored in the arithmetic processing unit of the power supply unit) has been exceeded, and when it is determined that the time limit has been exceeded, control is performed so as not to execute the next event by the defibrillation catheter. It is done.

The defibrillation catheter constituting the intracardiac defibrillation catheter system of the present invention is inserted into the deep cavity so that the first DC electrode group is located in the coronary vein and the second DC electrode group is located in the right atrium, and the first lead wire group is provided by the power supply device. And applying a voltage having a different polarity to the first DC electrode group and the second DC electrode group through the second lead wire group (a DC voltage is applied between the first DC electrode group and the second DC electrode group). Thereby, electrical energy is applied directly to the heart causing the fibrillation, thereby performing defibrillation treatment.

Thus, according to the 1st DC electrode group and the 2nd DC electrode group of the defibrillation catheter arrange | positioned in a deep cavity, electric energy is directly provided to the heart | heart which produced the defibrillation,

It is possible to reliably impart sufficient electrical stimulation (electrical shock) to the heart, which is necessary for defibrillation therapy.

In addition, since electrical energy can be directly applied to the heart, no burn is generated in the body surface of the patient.

When the power supply device constituting the intracardiac defibrillation catheter system of the present invention (first invention) connects the power supply device to the defibrillation catheter for the first time, the operation time of the first connection and the serial information of the power supply device connected for the first time, Recorded in the first connection information storage unit in the defibrillation catheter memory, and when the same or different power supply unit is reconnected to the defibrillation catheter, the time of reconnection and serial information of the reconnected power supply unit are stored in the memory of the defibrillation catheter. Record in event storage. Therefore, by reconnecting the power supply, the time recorded in the first connection information storage unit is not rewritten. In addition, the history of reconnecting (exchanging) the power supply unit is recorded in the event storage unit together with serial information of the power supply unit before and after replacement.

When the defibrillation is performed by the defibrillation catheter, the arithmetic processing unit of the power supply unit has a resistance value (internal resistance value) between the first DC electrode group and the second DC electrode group, and between the first DC electrode group and the second DC electrode group. The set value of the electric energy to be applied, the information of the actually applied output voltage and the output time are recorded along with the time at which the defibrillation was performed and the serial information of the power supply device, and recorded in the event storage unit in the memory of the defibrillation catheter. It can be stored as a history of the event (action) of the defibrillation catheter.

If the defibrillation is not performed after the resistance value between the first DC electrode group and the second DC electrode group of the defibrillation catheter is measured, the arithmetic processing unit of the power supply device measures the measured resistance value and the time at which it is connected. In addition to the serial information of the power supply device, since it is recorded in the event storage unit in the memory of the defibrillation catheter, it is also possible to record the data of the intracardiac resistance value when the defibrillation is not performed.

The arithmetic processing unit of the power supply unit is the time at which the event was performed from the connection time recorded in the first connection information storage unit in the memory of the defibrillation catheter for each event recorded in the event storage unit in the defibrillation catheter. It is determined whether the elapsed time until then (the use time of the defibrillation catheter) has exceeded the usage time limit stored in the operation processing unit of the power supply unit, and when it is determined that the elapsed time has been exceeded, the next event by the defibrillation catheter is executed. If the same or different power supply is reconnected to the defibrillation catheter, even if the event is performed by the defibrillation catheter after the usage limit time has elapsed since the time of the first connection of the power supply, the defibrillation catheter Do not fire the following event:

(2) The arithmetic processing unit of the power supply device constituting the intracardiac defibrillation catheter system of the present invention (first invention) periodically refers to the time indicated by the internal clock, and stores the first connection information storage unit of the memory of the defibrillation catheter. After the use time limit (use time limit stored in the arithmetic processing unit of the power supply device) has elapsed from the recorded connection time, it is possible to control not to execute the event by the defibrillation catheter.

In other words, the arithmetic processing unit of the power supply device may have a timer function to prevent a new event from being executed due to the elapse of the usage time limit.

In the first aspect of the present invention, when the elapsed time from the time of first connection of the power supply device to the defibrillation catheter to the time when an event is performed by the defibrillation catheter exceeds the usage time limit, the defibrillation catheter may use the following description. Because it is controlled to not execute the event, it is necessary to execute a certain event just before the usage time limit has elapsed, and then, if it is the same as a long time elapsed with the power supply connected, Thus, the following events can be executed.

Therefore, by using a timer in the first aspect of the invention, even in such a case, it is possible to prevent the event from being executed after the elapse of the usage time limit.

(3) The intracardiac defibrillation catheter system of the present invention (second invention) is a catheter system including a defibrillation catheter inserted into the deep cavity to perform defibrillation and a power supply device for applying a DC voltage to the electrode of the defibrillation catheter;

The defibrillation catheter includes an insulating tube member,

A first DC electrode group comprising a plurality of ring-shaped electrodes attached to the tip region of the tube member;

A second DC electrode group comprising a plurality of ring-shaped electrodes spaced apart from the first DC electrode group toward the proximal side and attached to the tube member;

A first lead wire group including a plurality of lead wires having a tip connected to each of the electrodes constituting the first DC electrode group;

A second lead wire group including a plurality of lead wires having a tip connected to each of the electrodes constituting the second DC electrode group;

Catheter serial storage unit for storing the serial information of the defibrillation catheter,

A first connection information storage unit for storing the time at which the power supply is first connected to the defibrillation catheter and the serial information of the first connected power supply unit, and

A memory having an event information storage section for storing information related to the event including the defibrillation by the defibrillation catheter together with the time at which the event was performed and the serial information of the connected power supply device;

The power supply unit, the DC power supply unit,

A catheter connecting connector connected to proximal ends 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 to a defibrillation mode, a setting switch of electrical energy, and an application switch of electrical energy;

The DC power supply unit is controlled based on an input of the external switch, and has an output circuit of a DC voltage from the DC power supply unit, and also stores serial information of the power supply device and a time limit for use of the catheter, and stores time. An arithmetic processing unit having an internal clock for confirmation and controlling a write and read output to a memory of said defibrillation catheter;

When defibrillation is performed by the defibrillation catheter, the 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, from the DC power supply unit of the power supply device, Voltages of different polarities are applied to the first DC electrode group and the second DC electrode group of the defibrillation catheter via the output circuit of the calculation processing unit and the catheter connecting connector,

The calculation processing unit of the power supply device,

(a) When the power supply device is first connected to the defibrillation catheter, the time of first connection and the serial information of the power supply device connected for the first time are recorded in the first connection information storage unit in the memory of the defibrillation catheter,

(b) an electric resistance to be applied between the first DC electrode group and the second DC electrode group when defibrillation is performed by the defibrillation catheter; Information of the energy set value, output voltage and output time, and the information are stored in the event storage unit in the memory of the defibrillation catheter together with the time at which the defibrillation was performed and serial information of the connected power supply. Record it,

(c) When defibrillation is not performed after the resistance value between the first DC electrode group and the second DC electrode group of the defibrillation catheter is measured, the measurement of the resistance value is recognized as an event, and the measured resistance value is measured. Recorded in the event storage unit in the memory of the defibrillation catheter together with the time and serial information of the connected power supply device,

(d) When the same or different power supply is reconnected to the defibrillation catheter in which the used power supply is disconnected, this is recognized as an event, and the time of reconnection and the serial information of the reconnected power supply are used for the defibrillation catheter. In the event storage in the memory of

(e) When the new event is to be executed by the defibrillation catheter, the elapsed time from the connection time recorded in the first connection information storage unit in the memory of the defibrillation catheter to the current time indicated by the internal clock, It is determined whether or not the use time limit (use time limit stored in the arithmetic processing unit of the power supply device) has been exceeded, and when it is determined that the time limit is exceeded, control is performed so as not to execute the event.

According to the intracardiac defibrillation catheter system of the present invention (second invention), even if the same or different power supply device is reconnected to the defibrillation catheter, the use restriction from the time recorded in the first connection information storage (the time when the power supply is first connected) After the passage of time, the defibrillation catheter is not used (no new event fired).

(4) An intracardiac defibrillation catheter system of the present invention, comprising an electrocardiograph together with the defibrillation catheter and the power supply device,

The power supply device includes an electrocardiograph connecting connector connected to an input terminal of the electrocardiograph;

It consists of a switching switch of one circuit and two contacts, the catheter connecting connector is connected to a common contact, the electrocardiograph connecting connector is connected to a first contact, and the switching part is connected to the arithmetic processing unit at a second contact. ;

When measuring electrocardiograph by the electrode which comprises the 1st electrode group and / or the 2nd electrode group of the said defibrillation catheter, a 1st contact is selected in the said switch part, and the electrocardiogram information from the said defibrillation catheter, Input to the electrocardiograph via the catheter connector, the switching unit and the electrocardiograph connector of the power supply,

When defibrillation is performed by the defibrillation catheter, the contact point of the switching section is switched to a second contact point by the arithmetic processing section of the power supply device, and from the DC power supply section, the output circuit of the arithmetic processing section, the switching section and the catheter It is preferable that voltages of different polarities are applied to the first electrode group and the second electrode group of the defibrillation catheter via a connecting connector.

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

That is, when defibrillation therapy is not required during cardiac catheterization, the defibrillation catheter constituting the present invention can be used as an electrode catheter for electrocardiogram measurement. As a result, when atrial fibrillation occurs during cardiac catheterization, the effort such as removing the electrode catheter and inserting a catheter for defibrillation can be omitted.

(5) The intracardiac defibrillation catheter system of (4), wherein the defibrillation catheter is a potential measurement electrode group including a plurality of electrodes spaced apart from the first electrode group or the second electrode group and attached to the tube member. and,

Comprising a plurality of lead wires having a tip connected to each of the electrodes constituting the potential measuring electrode group, the proximal end is provided with a lead wire group for potential measurement connected to the catheter connecting connector of the power supply device,

The power supply device is provided with a path for directly connecting the catheter connecting connector and the electrocardiograph connecting connector,

Electrocardiogram information measured by the electrodes constituting the electric potential measuring electrode group is preferably input from the catheter connecting connector of the power supply device to the electrocardiograph via the electrocardiograph connecting connector without passing through the switching unit.

According to such a configuration, the electrocardiograph measures the electrocardiogram measured by the potential measuring electrode group even during defibrillation treatment in which the electrocardiograph cannot acquire the electrocardiogram from the first and second DC electrode groups of the defibrillation catheter. The defibrillation treatment can be performed while the electrocardiograph is monitored (monitored).

(6) It is preferable that electrocardiogram measuring means other than the said defibrillation catheter is connected to the electrocardiograph which comprises the intracardiac defibrillation catheter system of said (4) or (5).

(7) Moreover, it is preferable that this electrocardiograph measuring means is an electrode pad or an electrode catheter.

According to such a configuration, the electrocardiogram measured by the electrocardiograph is measured by the electrocardiograph when the electrocardiogram cannot acquire the electrocardiogram from the first and second DC electrode groups of the defibrillation catheter. And defibrillation therapy can be performed while monitoring (monitoring) the electrocardiogram in the electrocardiograph.

(8) above (4)? The power supply device constituting the intracardiac defibrillation catheter system of (7) 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,

Electrocardiogram information from the electrocardiograph input to the electrocardiogram input connector is preferably input to the calculation processing section and displayed on the electrocardiogram information display section.

According to such a structure, the electrocardiograph information input to the electrocardiogram (the electrocardiograph acquired by the electrode which comprises the 1st DC electrode group of a defibrillation catheter, and / or the 2nd DC electrode group is comprised, and the potential measurement electrode group of a defibrillation catheter is comprised. Part of the electrocardiogram acquired by the electrode to be or the electrocardiograph acquired by the electrocardiogram measuring means other than the defibrillation catheter) is input to the computation processing unit, and the arithmetic processing unit controls the DC power supply unit based on the electrocardiogram information. can do.

In addition, defibrillation therapy (such as input of an external switch) can be performed while monitoring the electrocardiogram information (waveform) input to the computation processing unit on the electrocardiogram information display section.

According to the intracardiac defibrillation catheter system of this invention, the following effects are exhibited.

(1) The heart which caused atrial fibrillation or the like during cardiac catheterization can be surely supplied with sufficient electrical energy necessary for defibrillation. In addition, no burn is generated on the body surface of the patient, and the invasiveness is less.

(2) It is possible to use the defibrillation catheter, a disposable product, for a time when there is no problem in terms of its performance and safety (to trigger an event). This ensures the performance and safety of the defibrillation catheter.

(3) By reconnecting the same or different power supply devices to the defibrillation catheter, the defibrillation catheter can be used only for a time when there is no problem in terms of its performance and safety.

(4) The event history of the defibrillation catheter can be recorded.

(5) By reconnecting the different power supply devices, even if the event by the defibrillation catheter is performed using a plurality of power supply devices, the event history by the defibrillation catheter can be stored in one memory (event information storage). For each defibrillation catheter, event history information can be managed.

1 is a block diagram showing one embodiment of an intracardiac defibrillation catheter system of the present invention.
FIG. 2: is explanatory top view which shows the defibrillation catheter which comprises the catheter system shown in FIG.
FIG. 3 is a plan view for explaining the defibrillation catheter constituting the catheter system shown in FIG. 1 (a diagram for explaining the dimensions and hardness). FIG.
4 is a cross-sectional view showing an AA cross section in FIG. 2.
FIG. 5 is a cross-sectional view showing a BB cross section, a CC cross section, and a DD cross section in FIG. 2.
FIG. 6 is a perspective view showing the internal structure of the handle of the embodiment of the defibrillation catheter shown in FIG. 2. FIG.
FIG. 7 is a partially enlarged view of the inside of the handle (front end side) shown in FIG. 6.
FIG. 8 is a partially enlarged view of the inside of the handle (base end) shown in FIG. 6.
FIG. 9 is an explanatory diagram schematically showing a connection state between a connector of a defibrillation catheter and a catheter connection connector of a power supply device in the catheter system shown in FIG. 1.
FIG. 10 is a block diagram showing the flow of ECG information in the case of measuring the ECG by the defibrillation catheter in the catheter system shown in FIG. 1.
FIG. 11A is a part (steps 1 to 7) of a flowchart showing the operation and operation of the power supply device in the catheter system shown in FIG. 1.
FIG. 11B is a remainder (steps 8 to 16) of a flowchart showing the operation and operation of the power supply device in the catheter system shown in FIG. 1.
FIG. 11C is a remainder (steps 17 to 22) of a flowchart showing the operation and operation of the power supply device in the catheter system shown in FIG. 1.
FIG. 12 is a block diagram showing the flow of information between the operation 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. 13 is a block diagram showing the flow of ECG information in the ECG measurement mode in the catheter system shown in FIG. 1.
FIG. 14 is a block diagram showing the flow of information and electrocardiogram information related to resistance values between electrode groups in the defibrillation mode of the catheter system shown in FIG. 1.
FIG. 15 is a block diagram showing a state when a DC voltage is applied in the defibrillation mode of the catheter system shown in FIG. 1.
FIG. 16 is a potential waveform diagram measured when predetermined electrical energy is applied by the defibrillation catheter constituting the catheter system shown in FIG. 1.
FIG. 17 is a block diagram showing a state in which the information related to defibrillation made by the defibrillation catheter is recorded in the memory of the defibrillation catheter by the arithmetic processing unit of the power supply apparatus in the catheter system shown in FIG. 1.
18 is a block diagram showing another embodiment of the intracardiac defibrillation catheter system of the present invention.
FIG. 19A is a part (steps 1 to 7) of a flowchart showing the operation and operation of the power supply device in the catheter system shown in FIG. 18.
FIG. 19B is a remainder (steps 8 to 16) of a flowchart showing the operation and operation of the power supply device in the catheter system shown in FIG. 18.
FIG. 19C is a remainder (steps 17 to 22) of a flowchart showing the operation and operation of the power supply device in the catheter system shown in FIG. 18.

≪ First Embodiment >

The intracardiac defibrillation catheter system of the present embodiment includes a defibrillation catheter 100 inserted into the cardiac cavity and performing defibrillation, a power supply device 700 for applying a DC voltage to an electrode of the defibrillation catheter 100, and an electrocardiograph 800 And a catheter system provided with electrocardiograph measuring means 900;

The defibrillation catheter 100 includes a multilumen tube 10,

A first DC electrode group 31G composed of eight ring-shaped electrodes 31 attached to the tip region of the multilumen tube 10,

A second DC electrode group 32G composed of eight ring-shaped electrodes 32 spaced apart from the first DC electrode group 31G toward the proximal side and attached to the multi-lumen tube 10;

A proximal end potential measurement electrode group 33G comprising four ring-shaped electrodes 33 spaced apart from the second DC electrode group 32G toward the proximal side and attached to the multilumen tube 10;

A first lead wire group 41G including eight lead wires 41 having a tip connected to each of the electrodes 31 constituting the first DC electrode group 31G,

A second lead wire group 42G including eight lead wires 42 having a tip connected to each of the electrodes 32 constituting the second DC electrode group 32G,

A third lead wire group 43G composed of four lead wires 43 whose ends are connected to each of the electrodes 33 constituting the base end side potential measurement electrode group 33G,

Catheter serial storage 111 storing the serial information of the defibrillation catheter 100, first connection information storage unit storing the time when the power supply is first connected to the defibrillation catheter 100 and the serial information of the power supply device first connected ( 112 and a memory having an event information storage unit 113 that stores information related to an event including the defibrillation by the defibrillation catheter 100 together with the time at which the event was performed and the serial information of the connected power supply. With 110;

The power supply unit 700 includes a DC power supply unit 71,

A catheter connecting connector 72 connected to the proximal ends 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 electrical energy setting switch 742, a charging switch 743, and an electrical energy application switch 744 for putting the power supply 700 into the defibrillation mode;

In addition to controlling the DC power supply unit 71 based on the input of the external switch 74, it has an output circuit 751 of the DC voltage from the DC power supply unit 71, and further includes serial information of the power supply device 700 and An arithmetic processing unit 75 having a memory 752 in which the time limit for use of the catheter is stored, and an internal clock 753 for determining the time, and controlling the write and read output to the memory 110 of the defibrillation catheter 100. ) Wow,

It consists of a switching switch of one circuit and two contacts, the catheter connecting connector 72 is connected to the common contact, the said electrocardiograph connecting connector 73 is connected to the 1st contact, and the arithmetic processing part 75 is connected to the 2nd contact. A switching section 76 provided;

When measuring electrocardiograph by the electrodes which comprise the 1st DC electrode group 31G and / or the 2nd DC electrode group 32G of the defibrillation catheter 100, the 1st contact is selected by the switching part 76. Electrocardiogram information from the defibrillation catheter 100 is input to the electrocardiograph 800 via the catheter connecting connector 72, the switching unit 76, and the electrocardiograph connecting connector 73 of the power supply device 700,

When defibrillation is performed by the defibrillation catheter 100, after the resistance value (internal resistance value) between the first DC electrode group 31G and the second DC electrode group 32G is measured, the external switch 74 (electrical energy) is measured. Based on the inputs of the setting switch 742, the charging switch 743, and the electrical energy application switch 744, the contact of the switching unit 76 is switched by the arithmetic processing unit 75 of the power supply device 700 to the second contact point. And the defibrillation catheter 100 from the DC power supply unit 71 of the power supply device 700 via the output circuit 751 of the arithmetic processing unit 75, the switching unit 76, and the catheter connection connector 72. Voltages of different polarities are applied to the first DC electrode group 31G and the second DC electrode group 32G of the two electrodes;

The arithmetic processing part 75 of the power supply apparatus 700,

(a) When the power supply device 700 is first connected to the defibrillation catheter 100, the time of first connection and the serial information of the first power supply device 700 connected are stored in the memory 110 of the defibrillation catheter 100. In the first access information storage unit 112,

(b) 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. The set value of the electric energy to be applied between the groups 32G, the information of the actually applied output voltage and the output time are obtained, and these information is obtained by the time at which the defibrillation was performed and the serial information of the connected power supply device 700. Together with the event information storage unit 113 in the memory 110 of the defibrillation catheter 100,

(c) When 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 recorded in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100 together with the measured time and serial information of the connected power supply device 700.

(d) When the same or different power supply 700 is reconnected to the defibrillation catheter 100 with which the power supply being used was disconnected, it is recognized as an event, and the time of the reconnection and the reconnected power supply 700 Serial information is recorded in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100,

(e) The first connection information storage unit 112 in the memory 110 of the defibrillation catheter 100 for each event recorded in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100. When the elapsed time from the connection time recorded in the above time to the time when the event is performed exceeds the usage time limit of the catheter stored in the memory 752 of the power supply device 700, and judges that it has exceeded, It is a system which controls so that defibrillation or resistance measurement as a next event by the said defibrillation catheter 100 may not be performed.

As shown in FIG. 1, the intracardiac defibrillation catheter system of this embodiment is equipped with the defibrillation catheter 100, the power supply apparatus 700, the electrocardiograph 800, and the electrocardiograph measuring means 900. As shown in FIG.

As shown in FIGS. 2-5, the defibrillation catheter 100 which comprises the catheter system of this embodiment is the multi-lumen tube 10, the handle 20, the 1st DC electrode group 31G, The second DC electrode group 32G, the proximal end potential measurement electrode group 33G, the first lead wire group 41G, the second lead wire group 42G, and the third lead wire group 43G are provided. .

As shown in FIG.4 and FIG.5, four lumens (1st lumen 11, 2nd) are included in the multi lumen tube 10 (insulating tube member which has a multi lumen structure) which comprises the defibrillation catheter 100. FIG. The lumen 12, the third lumen 13, and the fourth lumen 14 are formed.

In FIG.4 and FIG.5, 15 is the fluororesin layer which divides a lumen, 16 is an inner (core) part which consists of a low hardness nylon elastomer, 17 is an outer (shell) part which consists of a high hardness nylon elastomer 18 in FIG. 4 is a stainless steel wire which forms a braided blade.

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

The nylon elastomer which comprises the outer part 17 of the multi lumen tube 10 has the thing of the hardness different from the axial direction. Thereby, the multi lumen tube 10 is comprised so that hardness may become step by step toward the base end side from the front end side.

3, the hardness (hardness by the D type hardness meter) of the area indicated by L1 (length 52 mm) is 40, the hardness of the area indicated by L2 (length 108 mm) is 55, L3 The hardness of the region indicated by L5 (length: 500 mm) is 72, and the hardness of the region represented by L4 (having the length of 10 mm) is 68;

The braided blade comprised by the stainless wire 18 is formed only in the area | region represented by L5 in FIG. 3, and is shown between the inner part 16 and the outer part 17 as shown in FIG. .

The outer diameter of the multi lumen tube 10 is, for example, 1.2? 3.3 mm.

The method for producing the multilumen 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 distal end portion of the multi lumen tube 10 can be deflected (swinged).

On the outer circumference (tip region where no braid is formed inside) of the multilumen tube 10, the first DC electrode group 31G, the second DC electrode group 32G, and the proximal end potential measurement electrode group 33G are provided. It is installed. Here, an "electrode group" means the assembly of the some electrode which comprises the same pole (it has the same polarity), or has the same purpose, and was attached by narrow space | interval (for example, 5 mm or less).

In the first DC electrode group, a plurality of electrodes constituting the same pole (-pole or + pole) are mounted at a narrow interval in the tip region of the multilumen tube. Here, although the number of electrodes which comprise a 1st DC electrode group differs also according to the width | variety of an electrode and an arrangement | positioning interval, it is 4? 13 pieces, Preferably it is 8? 10 pieces.

In the present embodiment, the first DC electrode group 31G is composed of eight ring-shaped electrodes 31 attached to the tip region of the multilumen tube 10.

An electrode 31 constituting the first DC electrode group 31G is connected to a catheter 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. It is connected to the connector.

Here, the width (length in the axial direction) of the electrode 31 is 2? It is preferable that it is 5 mm, and if it shows a preferable example, it is 4 mm.

If the width of the electrode 31 is too narrow, the amount of heat generated at the time of voltage application is excessive, which may damage the surrounding tissue. On the other hand, when the width | variety of the electrode 31 is too wide, the flexibility and the flexibility of the part in which the 1st DC electrode group 31G in the multi lumen tube 10 is formed may be impaired.

The mounting interval of the electrodes 31 (distance between adjacent electrodes) is 1? It is preferable that it is 5 mm, and if it shows a preferable example, it is 2 mm.

In use of the defibrillation catheter 100 (when placed in the deep cavity), the first DC electrode group 31G is located, for example, in the coronary vein.

The second DC electrode group is spaced apart from the mounting position of the first DC electrode group of the multi-lumen tube to the proximal side to form a plurality of electrodes that constitute a pole (+ pole or-pole) opposite to the first DC electrode group. It is mounted at narrow intervals. Here, although the number of electrodes which comprise a 2nd DC electrode group differs also according to the width | variety of an electrode, and arrangement | positioning interval, it is 4? 13 pieces, Preferably it is 8? 10 pieces.

In the present embodiment, the second DC electrode group 32G is composed of eight ring-shaped electrodes 32 spaced apart from the mounting position of the first DC electrode group 31G to the proximal side and attached to the multilumen tube 10. It is.

The electrode 32 constituting the second DC electrode group 32G is connected to the catheter 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. It is connected to the connector.

Here, the width (length in the axial direction) of the electrode 32 is 2? It is preferable that it is 5 mm, and if it shows a preferable example, it is 4 mm.

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, when the width | variety of the electrode 32 is too wide, the flexibility and flexibility of the part in which the 2nd DC electrode group 32G in the multi lumen tube 10 is formed may be impaired.

The mounting interval of the electrodes 32 (distance between adjacent electrodes) is 1? It is preferable that it is 5 mm, and if it shows a preferable example, it is 2 mm.

In use of the defibrillation catheter 100 (when placed in the heart cavity), the second DC electrode group 32G is located, for example, in the right atrium.

In the present embodiment, the base end potential measuring electrode group 33G is separated from the mounting position of the second DC electrode group 32G to the base end side by four ring-shaped electrodes 33 attached to the multilumen tube 10. Consists of.

The electrode 33 constituting the base end side potential measurement electrode group 33G is a catheter 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. It is connected to the connecting connector.

Here, the width (length in the axial direction) of the electrode 33 is 0.5? It is preferable that it is 2.0 mm, and if it shows a preferable example, it is 1.2 mm.

When the width of the electrode 33 is too wide, the measurement accuracy of the electrocardiogram is lowered, or it becomes difficult to specify the generation site of the abnormal potential.

The mounting intervals of the electrodes 33 (distances of neighboring electrodes) were 1.0? It is preferable that it is 10.0 mm, and if it shows a preferable example, it is 5 mm.

In the use of the defibrillation catheter 100 (when placed in the deep cavity), the proximal end-side potential measuring electrode group 33G is, for example, located in a relative vein in which an abnormal potential is likely to occur.

The tip chip 35 is attached to the tip of the defibrillation catheter 100.

The lead wire is not connected to this tip chip 35, and is not used as an electrode in this embodiment. However, it can also be used as an electrode by connecting lead wires. The constituent material of the tip chip 35 is not specifically limited, such as metal materials, such as platinum and stainless steel, and various resin materials.

The separation distance d2 between the first DC electrode group 31G (the electrode 31 on the proximal side) and the second DC electrode group 32G (the electrode 32 on the distal side) is 40? It is preferable that it is 100 mm, and if it shows a preferable example, it is 66 mm.

The separation distance d3 of the 2nd DC electrode group 32G (electrode 32 of a base end), and the base end potential measuring electrode group 33G (electrode 33 of a front end side) is 5? It is preferable that it is 50 mm, and if it shows a preferable example, it is 30 mm.

As the electrodes 31, 32, and 33 constituting the first DC electrode group 31G, the second DC electrode group 32G, and the proximal end-side potential measurement electrode group 33G, the contrast to X-rays is good. For this reason, it is preferable that it consists of platinum or a platinum type alloy.

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).

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 circumferential surface of the electrode 31 at the tip portion thereof, and enters the first lumen 11 from side holes formed in the tube wall of the multi-lumen tube 10. The eight lead wires 41 entering the first lumen 11 are extended to the first lumen 11 as the first lead wire group 41G.

The second lead wire group 42G shown in FIGS. 4 and 5 is an aggregate 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 circumferential surface of the electrode 32 at the tip portion thereof, and the second lumens 12 (first lead wire group 41G) are formed from side holes formed in the tube wall of the multi-lumen tube 10. Enters the lumen different from the first lumen 11 that extends. The eight lead wires 42 entering the second lumen 12 are extended to the second lumen 12 as the second lead wire group 42G.

As described above, since 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, both of them are multi-lumen tubes 10. Are completely insulated from each other. Therefore, when a voltage necessary for the defibrillation is applied, the potential difference between the first lead line group 41G (first DC electrode group 31G) and the second lead line group 42G (second DC electrode group 32G) A short circuit can surely be prevented.

The third lead wire group 43G shown in FIG. 4 is an aggregate of four lead wires 43 connected to each of the electrodes 33 constituting the base end side potential measurement electrode group 33G.

Each of the electrodes 33 constituting the base end 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).

Four electrodes 33 which constitute the base end 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 circumferential surface of the electrode 33 at the tip portion thereof and enters the third lumen 13 from the side hole formed in the tube wall of the multilumen tube 10. The four lead wires 43 entering the third lumen 13 are extended to the third lumen 13 as the third lead wire group 43G.

As described above, the third lead wire group 43G extending in the third lumen 13 is completely insulated from and separated from both the first lead wire group 41G and the second lead wire group 42G. For this reason, when the voltage required for defibrillation is applied, the third lead wire group 43G (base end side potential measurement electrode group 33G), the first lead wire group 41G (first DC electrode group 31G), or Short circuit between the second lead wire group 42G (the second DC electrode group 32G) can be reliably prevented.

The lead wire 41, the lead wire 42, and the lead wire 43 are all made of a resin coated wire in which the outer circumferential surface of the metal conductive wire is covered with a resin such as polyimide. Here, the film thickness of the coating resin is 2? It becomes about 30 micrometers.

In FIG.4 and FIG.5, 65 is a full wire.

The pullwire 65 extends to the fourth lumen 14 and extends eccentrically with respect to the central axis of the multilumen tube 10.

The tip portion of the pull wire 65 is fixed to the tip chip 35 by soldering. Moreover, the large diameter part (fall prevention part) for a fall prevention may be formed in the front-end | tip of the pull wire 65. FIG. Thereby, the tip chip 35 and the pull wire 65 are firmly coupled, and it is possible to reliably prevent the tip chip 35 from falling off.

On the other hand, the proximal end of the pull wire 65 is connected to the knob 22 of the handle 20, and the pull wire 65 is pulled out by operating the knob 22, whereby the multilumen tube 10 ) Is deflected.

Although the full wire 65 is comprised from stainless steel and Ni-Ti type superelastic alloy, it does not necessarily need to be comprised with a metal. The pull wire 65 may be made of, for example, a high strength nonconductive wire or the like.

In addition, the mechanism which deflects the front-end | tip part of a multi lumen tube is not limited to this, For example, it may be provided with the leaf spring.

In the fourth lumen 14 of the multi lumen tube 10, only the pull wire 65 is extended, and the lead wire (group) is not extended. As a result, in the deflection operation of the distal end portion of the multi-lumen tube 10, the lead wire can be prevented from being damaged (for example, abrasion) by the pull wire 65 moving in the axial direction.

In the defibrillation catheter 100 in this embodiment, also in the inside of the handle 20, the 1st lead wire group 41G, the 2nd lead wire group 42G, and the 3rd lead wire group 43G are insulation isolation | separation. It is.

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

As shown in FIG. 6, the base end part of the multi lumen tube 10 is inserted in the front end opening of the handle 20, and the multi lumen tube 10 and the handle 20 are connected by this.

6 and 8, a cylindrical connector 50 formed by disposing a plurality of pin terminals 51, 52, and 53 protruding in the distal direction on the distal end surface 50A at a proximal end of the handle 20. Is built in.

6 to 8, the inside of the handle 20 includes three lead wire groups (a first lead wire group 41G, a second lead wire group 42G, and a third lead wire group 43G). Three insulating tubes (the first insulating tube 26, the second insulating tube 27, and the third insulating tube 28) through which each is inserted are extended.

As shown in FIG. 6 and FIG. 7, the tip portion (about 10 mm from the tip) of the first insulating tube 26 is inserted into the first lumen 11 of the multilumen tube 10, thereby providing a first insulating property. The tube 26 is connected to the first lumen 11 in which the first lead wire group 41G extends.

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 so that the connector 50 (the pin terminal is connected). It extends to the vicinity of 50 A of arrange | positioned front end surfaces, and the insertion path which guides the base end part of 41 G of 1st lead wire groups to the vicinity of the connector 50 is formed. Thereby, the 1st lead wire group 41G extended from the multi lumen tube 10 (1st lumen 11) is not kink, but the inside of the handle 20 (inner hole of the 1st insulating tube 26). Can be extended.

The first lead wire group 41G extending from the proximal end opening of the first insulating tube 26 is decomposed into eight lead wires 41 constituting this, and each of these lead wires 41 is connected to the connector 50. It is connected and fixed by soldering to each of the pin terminals arrange | positioned at 50 A of front end surfaces. Here, the area | region in which the pin terminal (pin terminal 51) with which the lead wire 41 which comprises the 1st lead wire group 41G is connected and is arrange | positioned is made into "the 1st terminal group area | region."

The tip portion (about 10 mm from the tip) of the second insulating tube 27 is inserted into the second lumen 12 of the multilumen tube 10, whereby the second insulating tube 27 is the second lead wire group. 42G is connected to the extending second lumen 12.

The second insulative tube 27 connected to the second lumen 12 passes through the inner hole of the second protective tube 62 extending inside the handle 20 and is connected to the connector 50 (a tip end surface where the pin terminal is disposed). It extends to the vicinity of 50A), and the insertion path which guides the base end part of 42 G of 2nd lead wire groups to the vicinity of the connector 50 is formed. Thereby, the 2nd lead wire group 42G extended from the multi lumen tube 10 (2nd lumen 12) is not kink, but the inside of the handle 20 (inner hole of the 2nd insulating tube 27) Can be extended.

The second lead wire group 42G extending from the proximal opening of the second insulating tube 27 is decomposed into eight lead wires 42 constituting this, and each of these lead wires 42 is connected to the connector 50. It is connected and fixed by soldering to each of the pin terminals arrange | positioned at 50 A of front end surfaces. Here, the area | region in which the pin terminal (pin terminal 52) with which the lead wire 42 which comprises the 2nd lead wire group 42G is fixed is arrange | positioned is made into "the 2nd terminal group area | region."

The tip portion (about 10 mm from the tip) of the third insulating tube 28 is inserted into the third lumen 13 of the multilumen tube 10, whereby the third insulating tube 28 is the third lead wire group. 43G is connected to the extending 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 (a front end surface where the pin terminal is disposed). It extends to the vicinity of 50A), and the insertion path which guides the base end part of 43 G of 3rd lead wire groups to the vicinity of the connector 50 is formed. Thereby, the 3rd lead wire group 43G extended from the multi lumen tube 10 (3rd lumen 13) is not kink, but the inside of the handle 20 (inner hole of the 3rd insulating tube 28) Can be extended.

The third lead wire group 43G extending from the proximal end opening of the third insulating tube 28 is decomposed into four lead wires 43 constituting this, and each of these lead wires 43 is connected to the connector 50. It is connected and fixed by soldering to each of the pin terminals arrange | positioned at 50 A of front end surfaces. Here, the area | region in which the pin terminal (pin terminal 53) with which the lead wire 43 which comprises the 3rd lead wire group 43G is connected and is arrange | positioned is made into "the 3rd terminal group area | region."

Here, as a constituent material of the insulating tube (the first insulating tube 26, the second insulating tube 27, and the third insulating tube 28), polyimide resin, polyamide resin, polyamideimide resin, or the like is used. It can be illustrated. Among them, polyimide resins having a high hardness, easily inserting lead wire groups, and enabling thin molding are particularly preferable.

The thickness of the insulating tube is 20? It is preferable that it is 40 micrometers, and if it shows a preferable example, it is 30 micrometers.

Moreover, as a structural material of the protection tube (the 1st protection tube 61 and the 2nd protection tube 62) in which an insulating tube is interpolated, nylon type elastomers, such as "Pebax" (registered trademark of ARKEMA Corporation), can be illustrated. have.

According to the defibrillation catheter 100 in this embodiment which has the above structures, the 1st lead wire group 41G is extended in the 1st insulating tube 26, and the 2nd lead in the 2nd insulating tube 27 is carried out. Since the 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 also in the handle 20. The group 42G and the third lead group 43G can be completely insulated from each other. As a result, when the voltage required 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 group 43G in the handle 20 is performed. (In particular, the short circuit between the group of lead wires extended in the vicinity of the lumen opening) can be reliably prevented.

In addition, inside 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 second protected. The insulating tube is damaged due to the protection of the tube 52, for example, when the constituent members (movable parts) of the knob 22 come into contact with each other during deflection operation of the distal end portion of the multilumen tube 10. Can be prevented.

The defibrillation catheter 100 according to the present embodiment includes the first terminal group region, the second terminal group region, and the third terminal group region in the front end surface 50A of the connector 50 in which the plurality of pin terminals are arranged. And a partition plate 55 which separates the lead wire 41 and the lead wire 42 and the lead wire 43 from each other.

The partition plate 55 which partitions a 1st terminal group area | region, a 2nd terminal group area | region, and a 3rd terminal group area | region is formed by shape | molding insulating resin in the groove shape which has a flat surface on both sides. It does not specifically limit as insulating resin which comprises the partition plate 55, General purpose resins, such as polyethylene, can be used.

The thickness of the partition plate 55 is 0.1? It is 0.5 mm, and if it shows a preferable example, it is 0.2 mm.

The height of the partition plate 55 (distance from the proximal edge to the proximal edge) is that of the distal end surface 50A of the connector 50 and the insulating tube (the first insulating tube 26 and the second insulating tube 27). It is necessary to be higher than the separation distance, and when the separation distance is 7 mm, the height of the partition plate 55 is, for example, 8 mm. In a partition plate having a height of less than 7 mm, the leading edge cannot be positioned at the leading end side of the insulating tube.

According to such a structure, the lead wire 41 (the base end part of the lead wire 41 extended from the base end opening of the 1st insulating tube 26) which comprises 41 G of 1st lead wire groups, and the 2nd 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 42G can be reliably and insulated.

When the partition plate 55 is not provided, the lead wire 41 and the lead wire 42 cannot be separated (divided) in an orderly manner, and there is a fear that 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 by the partition plate 55. Since there is no case where the defibrillation catheter 100 is used, even when a voltage necessary for intracardiac defibrillation is applied, the lead wire 41 constituting the first lead wire group 41G (first insulating tube) A proximal end portion of the lead wire 41 extending from the proximal end opening of 26) and a lead wire 42 constituting the second lead wire group 42G (a lead wire extending from the proximal end opening of the second insulating tube 27) There is no short circuit between the proximal end of 42).

In addition, when a defibrillation catheter is manufactured, when an error occurs when connecting and fixing the lead wire to the pin terminal, for example, the lead wire 41 constituting the first lead wire group 41G is placed in the second terminal group region. When connecting to the pin terminal in this case, since the lead wire 41 exceeds the partition board 55, the mistake of a connection can be found easily.

In addition, the lead wire 43 (the pin terminal 53) constituting the third lead wire group 43G is connected to the lead wire 41 by the partition plate 55 together with the lead wire 42 (the pin terminal 52). Although it is isolated from the pin terminal 51, it is not limited to this, The lead wire 42 (pin terminal 52) by the partition board 55 with the lead wire 41 (pin terminal 51). ) May be isolated from.

In the defibrillation catheter 100, the leading edge of the partition plate 55 is located at the leading end side of either the base end of the first insulating tube 26 and the base end of the second insulating tube 27.

Thereby, the lead wire extended from the base end opening of the 1st insulating tube 26 (lead wire 41 which comprises the 1st lead wire group 41G), and the lead wire extended from the base end opening of the 2nd insulating tube 27 are obtained. The partition plate 55 always exists between the lead wires 42 constituting the second lead wire group 42G, so that a short circuit due to the contact between the lead wires 41 and the lead wires 42 can be reliably prevented. have.

As shown in FIG. 8, of the eight lead wires 41 and the 2nd insulating tube 27 extended from the base end opening of the 1st insulating tube 26, and connected and fixed to the pin terminal 51 of the connector 50. As shown in FIG. Eight lead wires 42 extending from the proximal end opening and connected to and fixed to the pin terminals 52 of the connector 50 extend out from the proximal opening of the third insulating tube 28 and are pin terminals 53 of the connector 50. The four lead wires 43 connected to and fixed to each of the N 2) are hardened by resin 58 so that their respective shapes are held and fixed.

The resin 58 which maintains the shape of the lead wire is molded into a cylindrical shape with the same diameter as the connector 50, and the pin terminal, the lead wire, the base end of the insulating tube and the partition plate 55 are embedded in the resin molded body. It is in the state that became.

And according to the structure in which the base end part of an insulating tube is embedded in the inside of a resin molding, the whole area | region of the lead wire (base end part) extends from the base end opening of an insulating tube until it is connected and fixed to a pin terminal, and the resin (58) It can completely cover by and can hold | maintain and fix the shape of a lead wire (base part) completely.

Moreover, it is preferable that the height (distance from a base end surface to a front end surface) of a resin molding is higher than the height of the partition plate 55, and when the height of the partition plate 55 is 8 mm, it is 9 mm, for example. Becomes

Although it does not specifically limit as resin 58 which comprises a resin molded object here, It is preferable to use a thermosetting resin or photocurable resin. Specifically, curable resin of a urethane type, an epoxy type, and a urethane-epoxy clock can be illustrated.

According to the above structure, 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), it is insulative. The lead wire extending from the proximal opening of the tube can be prevented from being kinked or coming into contact with the edge of the pin terminal to cause damage (for example, cracking in the coating resin of the lead wire).

As shown in FIG. 1, the defibrillation catheter 100 constituting the catheter system of the present embodiment includes a catheter serial storage 111, a first connection information storage 112, and an event information storage 113. The memory 110 is provided.

The memory 110 included 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 together with the recorded information.

In the catheter serial memory 111 of the memory 110, serial information of the defibrillation catheter 100 is stored.

As serial information of the defibrillation catheter 100, a manufacture number (serial number), a manufacture date, etc. are mentioned. This serial information is product management information recorded at the time of manufacture of the defibrillation catheter 100 and cannot be rewritten or additionally recorded.

For example, in the structure of the memory 110 shown in Table 1, the serial number 123456 of the defibrillation catheter is recorded in the catheter serial memory 111.

The first connection information storage unit 112 of the memory 110 stores the time (temporary) when the power supply device is first connected to the defibrillation catheter 100 and the serial information of the power supply device first connected.

The time of first connection and the serial information of the first connected power supply are recorded by the arithmetic processing unit of the first connected power supply, and cannot be rewritten once recorded.

The defibrillation catheter 100, which is a disposable product, is degraded by using for some time. For this reason, in the defibrillation catheter 100, the use time limit (this use time limit is memorize | stored in the memory 752 of the power supply apparatus 700) is set from a viewpoint of performance and safety | security, and "the defibrillation catheter ( The time when the power supply device is first connected to 100 " is the starting point of the use limit time of the defibrillation catheter 100.

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

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

As an event stored in the event information storage unit 113,

(1) defibrillation by the defibrillation catheter 100 (application of electrical energy),

(2) measuring the 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 separated, an operation of reconnecting the same or different power supply device to the defibrillation catheter 100 may be mentioned.

When defibrillation is performed by the defibrillation catheter 100, the resistance value (internal resistance value) between the first DC electrode group 31G and the second DC electrode group 32G, and the set value of electrical energy intended to be applied between these electrode groups. The information of the output voltage and the output time actually applied is recorded in the event information storage unit 113 together with the time at which the defibrillation was performed and the serial information of the power supply device connected at that time.

For example, in the structure of the memory 110 shown in Table 1 above, in the event 2 of the event information storage unit 113, defibrillation is used as an event, and the resistance value between the electrode groups (75 Ω) and the energy set value (15). J), output voltage (300 V) and output time (13.5 msec) indicate the time at which defibrillation was performed (10:06:12, 12 December 2009) and the serial number of the power supply connected at that time (10011). ) Is recorded in the event information storage unit 113. The same applies to events 3, 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 in advance of the defibrillation, it can be included in the event of the defibrillation. In this case, the measurement of the resistance value is recognized as a single event, and the measured resistance value is recorded in the event information storage unit 113 together with the measured time and serial information of the connected power supply device.

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 (75 Ω) between the electrode groups is measured at the time of measurement (December 5, 2009). 10:05:00) and the serial number 10011 of the power supply device connected at that time are recorded in the event information storage unit 113.

In addition, in event 6, the resistance value (79 Ω) between the electrode groups, together with the measurement time (10:53:22 seconds on December 5, 2009) and the serial number 10032 of the power supply device connected at that time, It is recorded 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, when it is the first connection, the time and serial information of the power supply device are recorded in the first connection information storage unit 112. However, when the same or different power supply devices are reconnected, the information is recorded in the event information storage unit 113.

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

In the event 8, the time of the third connection (11:30:00 seconds on December 6, 2009) and the serial number 10055 of the power supply device connected again are recorded in the event information storage unit 113.

As shown in FIG. 1, the power supply device 700 constituting the catheter system according to the present embodiment includes a DC power supply 71, a catheter connection connector 72, an electrocardiograph connector 73, and an external switch (input). Means) 74, an arithmetic processing unit 75, a switching unit 76, an electrocardiogram input connector 77, and an electrocardiogram information display unit 78 are provided.

The capacitor | condenser is built in the DC power supply part 71, and an internal capacitor is charged by the input of the external switch 74 (charge switch 743).

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

As shown in FIG. 9, the connector 50 of the defibrillation catheter 100 and the catheter connection connector 72 of the power supply apparatus 700 are connected by the connector cable C1,

Pin terminals 51 (actually eight) to which eight lead wires 41 constituting the first lead wire group are fixed, and terminals 721 (actually eight) of the catheter connecting connector 72;

Pin terminals 52 (actually eight) to which the eight lead wires 42 constituting the second lead wire group are fixed, and terminals 722 (actually eight) of the catheter connection connector 72,

The pin terminal 53 (actually four) which connected and fixed the four lead wires 43 which comprise the 3rd lead wire group, and the terminal 723 (actually four) of the catheter connection connector 72 are connected, respectively. It is.

Here, the terminal 721 and the terminal 722 of the catheter connecting connector 72 are connected to the switching unit 76, and the terminal 723 is connected to the electrocardiograph connecting connector 73 without passing through the switching unit 76. Directly connected to

Thereby, the electrocardiogram information measured by the 1st DC electrode group 31G and the 2nd DC electrode group 32G reaches | attains the electrocardiograph connection connector 73 via the switching part 76, and proximate side potential measurement The electrocardiogram information measured by the electrode group 33G 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.

The external switch 74, which is an input means, includes a mode changeover switch 741 for switching the ECG measurement mode and the defibrillation mode, an electric energy setting switch 742 for setting the electric energy to be applied during defibrillation, and a DC power supply 71. A charging switch 743 for charging the battery, and an electrical energy applying switch (discharge switch) 744 for performing defibrillation by applying electrical energy. The input signals from these external switches 74 are all sent to the calculation 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 ECG information display unit 78 based on the input of the external switch 74.

The calculation processing unit 75 has an output circuit 751 for outputting the 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 1st DC electrode group 31G of the defibrillation catheter 100), and a catheter connection connector ( 72, so that the terminal 722 (finally, the second DC electrode group 32G of the defibrillation catheter 100) has different polarities (when one electrode group is negative, the other electrode group is a + pole). DC voltage can be applied.

The arithmetic processing unit 75 has a memory 752 in which the serial information of the power supply device 700 and the use time limit of the catheter are stored, and an internal clock 753 for determining the time.

As serial information of the power supply apparatus 700 stored in the memory 752, a manufacture number (serial number), a manufacture date, etc. are mentioned. This serial information is product management information recorded at the time of manufacture of the power supply device, and cannot be input again or additionally.

The "time limit for use of the catheter" stored in the memory 752 is set in view of the performance and safety of the defibrillation catheter 100 and cannot be re-entered by the user of the catheter system.

The time limit for use of the catheter is a time longer than the maximum time required for one operation, and it is a time which does not cause a problem in view of the performance and safety of the defibrillation catheter, and can be set to, for example, 24 hours. Of course, it is not limited to this.

As the time determined by the internal clock 753, the time when the power supply device is first connected to the defibrillation catheter 100, and the event by the defibrillation catheter 100 (defibrillation, measurement of resistance value between electrode groups, The time when reconnection was performed is mentioned.

When the arithmetic processing unit 75 connects the power supply device 700 to the defibrillation catheter 100 for the first time, the operation time unit 75 acquires the connected time with reference to the internal clock 753, and stores this time in the memory 752. Together with the serial information of the power supply device 700, the first connection information storage unit 112 in the memory 110 of the defibrillation catheter 100 is recorded.

Here, the detection means for connecting the power supply device 700 to the defibrillation catheter 100 is not particularly limited. For example, a circuit in which a weak current flows when connected is formed, or the power supply device 700 Means for forming a physical switch in the catheter connecting connector 72 of the "

In addition, whether the connection of the power supply device 700 is the "first" connection or reconnection in the defibrillation catheter 100 is the first connection information storage unit in the memory 110 of the defibrillation catheter 100 ( When 112 is referred to the arithmetic processing unit 75 and no information is stored in the first connection information storage unit 112, it is determined that the connection is the "first" connection, and the information is stored in the first connection information storage unit 112. If so, it is determined to be reconnected.

The arithmetic processing unit 75 measures the resistance value between the first DC electrode group 31G and the second DC electrode group 32G when defibrillation is performed by the defibrillation catheter 100 (measured in advance when the defibrillation is performed). Intracardiac resistance), the set value of electrical energy (input by the energy setting switch 742) to be applied between the first DC electrode group 31G and the second DC electrode group 32G, the output voltage and the output time (actually Information of the applied voltage and time) is obtained, and the information is stored in the time at which the defibrillation was performed (time by the internal clock 753) and the serial information (memory 752) of the connected power supply device 700. Together with the stored serial information, the data is recorded in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100 (see events 2, 3, 4, and 7 in Table 1 above).

In addition, in the case where 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 determines the resistance value. The event information storage unit 113 in the memory 110 of the defibrillation catheter 100, together with the time when the measurement is recognized as an event and the measured resistance value is measured and the serial information of the connected power supply device 700. (See events 1 and 6 of Table 1 above).

Thereby, the data of the intracardiac resistance value when the defibrillation is not performed can also be recorded.

In addition, after the power supply device used for the event by the defibrillation catheter 100 is disconnected, the arithmetic processing unit 75 reconnects the same or different power supply device 700 to the defibrillation catheter 100 (of memory 110). When the first connection information storage unit 112 is connected to the defibrillation catheter 100 in which time is stored, the defibrillation catheter 100 recognizes the event as an event, and reconnects the time and serial information of the power supply device 700. Is recorded in the event information storage unit 113 in the memory 110 (see events 5 and 8 in Table 1 above).

In this way, a history of reconnecting (exchanging) the power supply device can be recorded.

According to the catheter system of this embodiment, the history of the event by defibrillation catheter 100 (defibrillation, measurement of resistance value between electrode groups, reconnection of a power supply device) can be recorded. In addition, since the information related to these events is stored in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100, rather than on the power supply side, a plurality of events of one defibrillation catheter 100 are stored. Even if the power supply device is used, the information related to these events is not distributed to a plurality of power supply devices.

In the catheter system of the present embodiment, the arithmetic processing unit 75 stores the memory of the defibrillation catheter 100 for each event recorded in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100. The time limit for use of the catheter stored in the memory 752 of the power supply device 700 in the elapsed time from the connection time recorded in the first connection information storage unit 112 in the time until the event was performed. It is determined whether or not the excess is exceeded, and when it is determined that the excess is exceeded, 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 information storage unit (from the connection time (December 5, 10: 00: 00 seconds) recorded in the first connection information storage unit 112) is used. The elapsed time up to the time when the defibrillation of the event 3 stored in the event 3 is performed (December 5, 10:09:25) is 9 minutes and 25 seconds, and is stored in the memory 752 of the power supply 700. When the use time limit of the catheter is set to 24 hours 00 minutes 00 seconds, the elapsed time does not exceed the use time limit of the catheter, so that the following event 4 can be defibrillated.

On the other hand, from the connection time (December 5, 10: 00: 00 second) recorded in the first connection information storage unit 112, the second connection of the power supply device of the event 8 stored in the event information storage unit 113 is repeated. The elapsed time until this time (11:30:00 seconds on December 6) is 25 hours 30 minutes 00 seconds, and the time limit for use of the catheter stored in the memory 752 of the power supply device 700 (24 hours 00 Minute 00 seconds), the following events cannot be executed.

In the present invention, the mode of “not executing an event” by the operation processing unit is not particularly limited. For example, when a defibrillation is to be executed as an event, even if a mode changeover switch is input, the defibrillation mode is switched. Or the control signal for applying a DC voltage is not sent even if an electrical energy application switch is input.

In this case, the defibrillation and the measurement of the resistance value are examples of events that the calculation processing unit does not execute. Although reconnecting the same or different power supply device to the defibrillation catheter in which the power supply device is disconnected is recognized as an event recorded in the event storage unit, the reconnection is an operation of the operator. It is not included in the event that controls it.

According to the catheter system of this embodiment which has such a structure, the defibrillation catheter which is a disposable product can be used only for the time without a problem from the viewpoint of the performance and safety.

In addition, since the connection time recorded in the first connection information storage unit 112 in the memory 110 of the defibrillation catheter 100 is set as a starting point for the use time limit of the defibrillation catheter 100, the same or different power supply. Even when the device is reconnected to the defibrillation catheter 100, when an event is performed after the usage time limit has elapsed from the connection time (the time of first connecting the power supply device) recorded in the first connection information storage unit 112, The next event by the defibrillation catheter 100 is not executed.

The switching unit 76 includes a catheter connecting connector 72 (terminal 721 and a terminal 722) connected to a common contact, an electrocardiograph connecting connector 73 connected to a first contact, and arithmetic to a second contact. It consists of a switching switch of 1 circuit and 2 contacts to which the process part 75 was connected.

In other words, when the first contact is selected, a catheter connecting connector 72 and a path connecting the electrocardiograph connecting connector 73 are secured. When the second contact is selected, the catheter connecting connector 72 and the arithmetic processing unit are selected. The path connecting 75 is secured.

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

The ECG input connector 77 is connected to the arithmetic processing unit 75 and is connected to the output terminal of the electrocardiograph 800.

By the electrocardiogram input connector 77, electrocardiogram information (usually a part of electrocardiograph information input to the electrocardiograph 800) output from the electrocardiograph 800 can be input to the arithmetic processing section 75. In 75, the DC power supply unit 71 and the switching unit 76 can be controlled based on the electrocardiogram information.

The electrocardiograph information display unit 78 is connected to the arithmetic processing unit 75, and the electrocardiogram information display unit 78 has electrocardiogram information (mainly an electrocardiogram waveform) input from the electrocardiogram input connector 77 to the arithmetic processing unit 75. ) Is displayed, and the operator can perform defibrillation therapy (such as input of an external switch) while monitoring the electrocardiogram information (waveform) input to the calculation processing unit 75.

The electrocardiograph 800 (input terminal) constituting the catheter system of the present embodiment is connected to the electrocardiograph connecting connector 73 of the power supply device 700, and the defibrillation catheter 100 (first DC electrode group 31G), Electrocardiograph information measured by the second DC electrode group 32G and the constituent electrodes of the proximal end potential measurement electrode group 33G) is input to the electrocardiograph 800 from the electrocardiograph connector 73.

The electrocardiograph 800 (other input terminals) is also connected to the electrocardiograph measuring means 900, and the electrocardiogram information measured by the electrocardiograph measuring means 900 is also input to the electrocardiograph 800.

Here, the electrocardiogram measuring means 900 includes an electrode pad attached to the surface of the patient's body to measure 12 induced electrocardiograms, and an electrode catheter (an electrode catheter different from the defibrillation catheter 100) mounted in the patient's heart. Can be mentioned.

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

The defibrillation catheter 100 in this embodiment can be used as an electrode catheter for electrocardiograph measurement when defibrillation treatment is not needed.

FIG. 10 shows the flow of ECG information in the case of measuring the ECG by the defibrillation catheter 100 according to the present embodiment when performing cardiac catheterization (for example, radiofrequency therapy).

At this time, the switching unit 76 of the power supply device 700 selects the first contact to which the electrocardiograph connector 73 is connected.

The electrocardiogram measured by the electrodes constituting the first DC electrode group 31G and / or the second DC electrode group 32G of the defibrillation catheter 100 includes the catheter connecting connector 72, the switching unit 76, and It is input to the electrocardiograph 800 via the electrocardiograph connector 73.

Moreover, the electrocardiogram measured by the electrode which comprises the base end side potential measurement electrode group 33G of the defibrillation catheter 100 does not pass through the switch part 76 from the catheter connection connector 72, but directly connects an ECG connector It is input to the electrocardiograph 800 via 73.

Electrocardiogram information (electrocardiograph waveform) from the defibrillation catheter 100 is displayed on a monitor (not shown) of the electrocardiograph 800.

In addition, part of the ECG information from the defibrillation catheter 100 (for example, the potential difference between the electrode 31 (the first pole and the second pole) constituting the first DC electrode group 31G) is determined by the electrocardiograph. From the 800, the ECG input connector 77 and the arithmetic processing unit 75 can be input to and displayed on the ECG information display unit 78.

As described above, when defibrillation therapy is not required during cardiac catheterization, the defibrillation catheter 100 can be used as an electrode catheter for electrocardiogram measurement.

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

Hereinafter, an example of the defibrillation treatment by the intracardiac defibrillation catheter system of this embodiment is demonstrated 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 steps 1 and 9 of FIG. 11A). .

(2) The arithmetic processing unit 75 of the power supply device 700 that detects that the power supply device 700 is connected to the defibrillation catheter 100 is a catheter serial storage unit 111 in the memory of the defibrillation catheter 100. In order to determine whether the connection is the first connection in the defibrillation catheter 100 or reconnecting the same or different power supplies, the serial information in the memory 110 is read and outputted. With reference to the first connection information storage unit 112, it is determined whether or not information is recorded there. If the information is not recorded in the first connection information storage unit 112, the procedure proceeds to step 3, where the information is recorded. If yes, the process proceeds to step 4 (step 2, see FIG. 12).

(3) When no information is recorded in the first connection information storage unit 112, the arithmetic processing unit 75 of the power supply device 700, at the time of connecting the power supply device 700 in step 1 (internal clock) The first connection information storage unit 112 in the memory 110 of the defibrillation catheter 100, and the serial information (the serial information stored in the memory 752) of the power supply device 700. ), And the process proceeds to step 5 (step 3, see FIG. 12).

(4) In the case where information is recorded in the first connection information storage unit 112, the arithmetic processing unit 75 of the power supply apparatus 700 includes the time and power supply apparatus in which the power supply apparatus 700 is connected in step 1. The serial information of 700 is recorded in the event information storage unit 113 in the memory 110 of the defibrillation catheter 100, and the procedure proceeds to step 5 (see steps 4 and 12).

(5) In the X-ray image, the positions 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 potential measurement electrode group 33G) are determined. While confirming, a part of the electrocardiogram information (12 guided electrocardiograms) input to the electrocardiograph 800 is selected from the electrocardiogram measuring means 900 (the electrode pad affixed to the body surface), and the electrocardiogram input connector 77 is selected. To the arithmetic processing unit 75 of the power supply device 700 (step 5). At this time, part of the ECG information input to the calculation processing unit 75 is displayed on the ECG information display unit 78 (see FIG. 13).

Moreover, the catheter connection connector 72, the switch part 76, and the electrocardiograph connection connector 73 from the component electrodes of the 1st DC electrode group 31G of the defibrillation catheter 100 and / or the 2nd DC electrode group 32G. Via the catheter connecting connector 72 and the electrocardiograph connecting connector 73 from the electrocardiogram information input to the electrocardiograph 800 and the constituent electrodes of the proximal end potential measurement electrode group 33G of the defibrillation catheter 100). ECG information input to the ECG 800 is displayed on a monitor (not shown) of the ECG 800.

(6) Next, the mode switching switch 741 which is the external switch 74 is input (step 6). In the initial state, the power supply device 700 in the present embodiment is the "electrocardiograph measurement mode", and the switching unit 76 selects the first contact point, and the switching unit 76 is selected from the catheter connection connector 72. ), A path to the electrocardiograph connector 73 is secured.

(7) When the mode changeover switch 741 is input, the calculation processing unit 75 of the power supply device 700 is recorded in the first connection information storage unit 112 in the memory 110 of the defibrillation catheter 100. Whether the elapsed time from the time at which the data was last recorded to the time recorded in the event information storage section 113 exceeded the usage time limit of the catheter stored in the memory 752 of the arithmetic processing section 75, If it is not exceeded, the process proceeds to step 8, and if it is exceeded, subsequent operations cannot be performed and the operation ends (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 passing via steps 2, 3, 5, 6), the event information storage unit Since information is not recorded in 113, it can proceed to step 8. On the other hand, when the connection of the power supply device 700 in step 1 is again connected in this defibrillation catheter 100 (when passing via steps 2, 4, 5, 6), the event information storage unit ( The time recorded last in 113 is the time when the power supply device 700 recorded in Step 4 is reconnected.

In addition, when it returns to step 6 from step 22 mentioned later (through steps 22 and 6), the time last recorded in the event information storage | storage part 113 is the time of electric energy in step 17 mentioned later. It is the time when authorization (defibrillation) was performed.

(8) If it is determined that the elapsed time from the time recorded in the first connection information storage section 112 to the last time recorded in the event information storage section 113 does not exceed the use time limit of the catheter, the calculation is performed. The processing unit 75 switches the mode of the power supply device 700 from the "ECG measurement mode" to the "defibrillation mode" (step 8 of FIG. 11B).

(9) As shown in Fig. 14, when the mode changeover switch 741 is input and the mode is switched 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, The path from the catheter connecting connector 72 to the arithmetic processing unit 75 via the switching unit 76 is secured, and the electrocardiograph connecting connector 73 from the catheter connecting connector 72 via the switching unit 76. The path to is blocked (step 9). When the switching unit 76 selects the second contact point, the electrocardiogram 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 determined by the electrocardiograph ( 800 cannot be entered (thus, this ECG information cannot be sent to the calculation processing unit 75). However, the electrocardiogram information from the constituent electrodes of the base end side potential measurement electrode group 33G which 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 from the catheter connection connector 72 via the switching unit 76 to the arithmetic processing unit 75 is a part of the ECG information from the ECG measurement means 900 input to the arithmetic processing unit 75. In addition, it can display on the electrocardiogram information display part 78 (refer FIG. 14).

(11) The contact point of the switching unit 76 is switched to the first contact point, and the path from the catheter connecting connector 72 to the electrocardiograph connecting connector 73 via the switching unit 76 is returned (step 11). .

In addition, the time (step 9-step 10 mentioned above) that the contact of the switching part 76 selects a 2nd contact becomes 1 second, for example.

(12) The arithmetic processing unit 75 determines whether the resistance value measured in step 10 has exceeded a predetermined value, and if not, proceeds to the next step 13 (preparation for applying a DC voltage), If exceeded, the process returns to step 5 (positioning of the electrodes 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 reliably contact a predetermined part (for example, a tube wall of the coronary vein and an inner wall of the right atrium). Since it means no, it is necessary to return to step 5 and readjust the position of the electrode.

In this manner, the voltage is applied only when the first DC electrode group and the second DC electrode group of the defibrillation catheter 100 firmly contact a predetermined part (for example, the tube wall of the coronary vein and the inner wall of the right atrium). Since it can be applied, 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 1 J to 30 J in 1 J units.

(14) The charging switch 743, which is the external switch 74, is input to charge energy into the built-in capacitor of the DC power supply 71 (step 14).

(15) After the charging is completed, the external switch 74, the electric energy applying switch 744, is input (step 15).

(16) When the electric energy applying switch 744 is input, the contact of the switching unit 76 is switched to the second contact by the arithmetic processing unit 75, and the switching unit 76 is moved from the catheter connection connector 72. The path to the arithmetic processing unit 75 is secured via the path, and the path from the catheter connecting connector 72 to the electrocardiograph connecting 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 of the arithmetic processing unit 75 switches, from the DC power supply unit 71 that receives the control signal from the arithmetic processing unit 75. Via the unit 76 and the catheter connecting connector 72, a DC voltage of different polarities is applied to the first DC electrode group and the second DC electrode group of the defibrillation catheter 100 (step 17 in FIG. 11C). , See FIG. 15).

Here, the arithmetic processing unit 75 synchronizes with the ECG waveform input via the ECG input connector 77, arithmetic processing so that a voltage is applied, and sends a control signal to the DC power supply unit 71.

Specifically, one R wave (maximum peak) is detected in the electrocardiogram waveform (part of the 12 induced electrocardiograms from the electrocardiogram measuring means 900) sequentially input to the calculation processing unit 75, and the peak height thereof. Next, 1/10 of the peak width of the R wave from the time point when the potential difference reaches the height (trigger level) of 80% of the peak height (when the next R wave rises) Application is started after the lapse of a very short time).

FIG. 16: is a figure which shows the potential waveform measured when the predetermined | prescribed electric energy (for example, setting output = 10J) is given by the defibrillation catheter 100 in this embodiment. In the figure, the horizontal axis represents time and the vertical axis represents potential.

First, after a predetermined time t0 has elapsed since the potential difference in the ECG waveform input to the calculation processing unit 75 reaches the trigger level, the first DC electrode group 31G is _negative and the second DC electrode group. by applying a DC voltage from, between the two (32G) so that the + pole, the electrical energy is supplied to the measurement potential is increased (V ₁ is a peak voltage at this time). After a predetermined time t ₁ has elapsed, electrical energy is applied by applying a DC voltage inverted ± to both the first DC electrode group 31G to the + pole and the second DC electrode group 32G to the-pole. Is supplied to increase the measurement potential (V ₂ is the peak voltage at this time).

Here, the time t ₀ from reaching the trigger level to starting the application is, for example, 0.01? 0.05 seconds, it represents the preferred embodiment is 0.01 seconds, a time _{(t = t 1 + t 2} ) , for example, 0.006? When 0.03 second shows a preferable example, it will be 0.02 second.

Thereby, the voltage can be applied in synchronization with the electrocardiogram waveform (the R peak which is the maximum peak) input to the arithmetic processing unit 75, and effective defibrillation treatment can be performed.

The peak voltage V ₁ to be measured is, for example, 300? 600 V.

(18) After a predetermined time (t ₀ + t) has elapsed since the potential difference in the ECG waveform reaches the trigger level, the control signal from the calculation processing section 75 is received and the voltage is applied from the DC power supply section 71. Is stopped (step 18).

(19) After the application of the voltage is stopped, the applied record (electrocardiograph waveform at the time of application as shown in Fig. 16) is displayed on the electrocardiograph information display unit 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 includes a resistance value between the first DC electrode group 31G and the second DC electrode group 32G. The intracardiac resistance measured before the defibrillation), the set value of the electric energy to be applied between the first DC electrode group 31G and the second DC electrode group 32G (the input value by the energy setting switch 742). ), The information of the output voltage (actually applied voltage represented by V ₁ of FIG. 16) and the output time (actually applied time represented by t of FIG. 16) is obtained, and these information is obtained when the defibrillation is performed (internally The event information storage in the memory 110 of the defibrillation catheter 100 together with the time determined by the clock 753 and the serial information of the power supply 700 (serial information stored in the memory 752). Recorded in section 113 (step 20, see FIG. 17).

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

(22) The components of the defibrillation catheter 100 displayed on the monitor of the electrocardiograph 800 (the first DC electrode group 31G, the second DC electrode group 32G, and the proximal end potential measurement electrode group 33G). Electrocardiogram information (electrocardiogram) from the constituent electrode and the electrocardiogram information (12 guided electrocardiogram) from the electrocardiogram measuring means 900 were observed and terminated if it was "normal", and the "non-normal (atrial fibrillation) was terminated. Is not calmed), the process returns to step 6 (step 22).

According to the catheter system of this embodiment, the 1st DC electrode group 31G and the 2nd DC electrode group 32G of the defibrillation catheter 100 can provide electrical energy directly to the heart | fever which produced the defibrillation, In addition, it is necessary to provide defibrillation therapy and also to provide sufficient electrical stimulation (electrical shock) to the heart.

In addition, since electrical energy can be directly applied to the heart, no burn is generated in the body surface of the patient.

In addition, the history of the event (defibrillation, measurement of resistance value between electrode groups, reconnection of the power supply device) by the defibrillation catheter 100 can be recorded.

Thus, for example, when an abnormality occurs in the defibrillation catheter while in use, the event history can be used to determine the cause of the abnormality occurrence.

In addition, since information related to these events is stored in the memory 110 (event information storage unit 113) of the defibrillation catheter 100, the 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 devices. Therefore, the event history information can be managed for each defibrillation catheter 100 specified by the serial information.

In the catheter system of this embodiment, only the memory 100 (memory means) is provided in the defibrillation catheter 100 with respect to the initial connection information and the event history information, and the role of processing the information is the power supply device 700. Since the arithmetic processing unit 75 is in charge of the defibrillation catheter, the defibrillation catheter is not enlarged or its structure is complicated.

In addition, the information recorded in the memory 110 of the defibrillation catheter 100 can be read out by an appropriate information reading output device.

According to the catheter system of this embodiment, the defibrillation catheter which is a disposable product can be used only for the time without a problem from the viewpoint of the performance and safety.

Moreover, since the connection time recorded in the first connection information storage part 112 in the memory 110 of the defibrillation catheter 100 is set as the starting point of the use time limit of the defibrillation catheter 100, the same or different power supply device Even after reconnecting the defibrillation catheter 100 to the defibrillation catheter 100, after the use time limit has elapsed from the connection time (the time of the first connection of the power supply device) recorded in the first connection information storage unit 112, a certain event is generated by the defibrillation catheter 100. Is performed, the following event by the defibrillation catheter 100 is not executed.

The electrocardiograph information measured by the constituent electrodes 33 of the proximal end potential measurement electrode group 33G is connected to the electrocardiograph connector 73 from the catheter connector 72 without passing through the switching unit 76. It is input to the electrocardiograph 800 via the electrocardiograph 800, and since the electrocardiograph measuring means 900 is connected, the first DC electrode group 31G and the second DC of the defibrillation catheter 100 are connected. At the time of defibrillation treatment in which the electrocardiograph 800 cannot acquire the electrocardiograph from the electrode group 32G (the switching section 76 is switched to the second contact point, and the switching section 76 is removed from the catheter connection connector 72). The electrocardiograph 800 acquires the electrocardiograph information measured by the proximal end side potential measurement electrode group 33G and the electrocardiograph measuring means 900 even when the path to the electrocardiograph connecting connector 73 is blocked). And monitor (monitor) the electrocardiogram in the electrocardiograph (800). Fibrillation therapy may be performed.

In addition, the arithmetic processing unit 75 of the power supply device 700 controls the DC power supply unit 71 by performing arithmetic processing so that a voltage is applied by synchronizing with the ECG waveform input via the ECG input connector 77 (simulation Since the application of the potential difference in the potential waveform reaches the trigger level after a predetermined time (for example, 0.01 second) has elapsed), the first DC electrode group 31G and the second DC electrode of the defibrillation catheter 100 are started. For the group 32G, a voltage can be applied in synchronization with the electrocardiogram waveform and effective defibrillation treatment can be performed.

In addition, the arithmetic processing part 75 has the predetermined value when the resistance value between the electrode groups of the defibrillation catheter 100 exceeds a fixed value, ie, the 1st DC electrode group 31G and the 2nd DC electrode group 32G are predetermined | prescribed. The control can proceed in preparation for applying a DC voltage only when it is firmly in contact with the site of the coronary vein (eg, the wall of the coronary vein and the inner wall of the right atrium), thereby enabling effective defibrillation treatment.

In the catheter system of the present embodiment, the arithmetic processing unit 75 of the power supply device 700 periodically refers to the time indicated by the internal clock 753, and provides first connection information of the memory 110 of the defibrillation catheter 100. After the usage time limit stored in the memory 752 has elapsed from the connection time recorded in the storage unit 112, the controller has a function (timer) for controlling the event by the defibrillation catheter 100 not to be executed. You may be.

The defibrillation catheter 100 may be used even if it is the same as if a long time elapsed with the power supply 700 connected after the event was performed by the defibrillation catheter 100 immediately before the use time limit. This can prevent the execution of the "next" event.

≪ Second Embodiment >

18 is a block diagram showing another embodiment of the intracardiac defibrillation catheter system of the present invention. In the same figure, the same code | symbol is used for the component same or corresponding to 1st Embodiment.

When the arithmetic processing unit 75a of the power supply device 700a constituting the catheter system of the present embodiment attempts to execute a new event (for example, defibrillation) by the defibrillation catheter 100, the defibrillation catheter 100 Usage restriction in which the elapsed time from the time recorded in the first connection information storage unit 112 of the memory 110 to the present time indicated by the internal clock 753 is stored in the memory 752 of the power supply device 700a. It is determined whether or not the time has been exceeded, and when it is determined that the time is exceeded, control is performed so as not to execute the event.

FIG. 19 is a flowchart showing the operation and operation of the power supply device in the catheter system shown in FIG. 18.

In the defibrillation treatment by the intracardiac defibrillation catheter system of the present embodiment, the catheter system of the first embodiment is changed to step 7 of the flowchart shown in FIG. 11A, except that step 7 is changed to step 7 of the flowchart shown in FIG. 19A. Same as defibrillation treatment.

That is, when the mode changeover switch 741 is input, the arithmetic processing unit 75a of the power supply device 700a is stored in the first connection information storage unit 112 in the memory 110 of the defibrillation catheter 100. Read out the time (the time when the power supply was first connected), and the elapsed time (the time using the defibrillation catheter 100) from this time to the present time indicated by the internal clock 753 is determined by the power supply device 700. It is judged whether or not the usage time limit stored in the memory 752 has been exceeded, and if it is not exceeded, the procedure proceeds to step 8 of FIG. 19B. do.

Thus, after the use time limit has elapsed from the connection time (first time the power supply is connected) recorded in the first connection information storage unit 112, a new event is not executed and the defibrillation catheter 100, which is a disposable product, is not executed. Can be used only for a time when there is no problem in terms of performance and safety.

As mentioned above, although embodiment of this invention was described, this invention is not limited to these embodiment, A various change is possible.

For example, "the next event by the defibrillation catheter 100" which is not executed after the use time limit elapses in the first embodiment, or "defibrillation catheter 100 which is not executed after the use time limit elapses in the second embodiment. The new event by) may be only defibrillation.

100: defibrillation catheter
10: multi lumen tube
11: first lumen
12: second lumen
13: Third lumen
14: fourth 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-shaped electrode
32G: 2nd DC electrode group
32: ring-shaped electrode
33G: Proximal side potential measurement electrode group
33: ring-shaped electrode
35: tip chip
41G: First lead group
41: lead wire
42G: 2nd lead wire group
42: lead wire
43G: Third Lead Wire Group
43: lead wire
50: connector of defibrillation catheter
51, 52, 53: pin terminal
55: partition plate
58: resin
61: the first protective tube
62: second protective tube
65: full wire
110: memory
111: Catheter Serial Memory
112: first access information storage unit
113: event information storage unit
700: power supply
71: DC power supply
72: catheter connection connector
721, 722, 723: terminals
73: electrocardiograph connector
74: external switch (input means)
741: mode changeover switch
742: electrical energy setting switch
743: Charge 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
700a: power unit
75a: operation processing unit
800 electrocardiograph
900: electrocardiogram measuring means

Claims (8)

A catheter system comprising a defibrillation catheter inserted into the deep cavity to perform 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 attached to the tip region of the tube member;
A second electrode group comprising a plurality of ring-shaped electrodes spaced apart from the first electrode group toward the proximal side and attached to the tube member;
A first lead wire group including a plurality of lead wires having a tip connected to each of the electrodes constituting the first electrode group;
A second lead wire group including a plurality of lead wires having a tip connected to each of the electrodes constituting the second electrode group;
Catheter serial storage unit for storing the serial information of the defibrillation catheter,
A first connection information storage unit for storing the time at which the power supply is first connected to the defibrillation catheter and the serial information of the first connected power supply unit, and
A memory having an event information storage section for storing information related to the event including the defibrillation by the defibrillation catheter together with the time at which the event was performed and the serial information of the connected power supply device;
The power supply unit, the DC power supply unit,
A catheter connecting connector connected to proximal ends 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 to a defibrillation mode, a setting switch of electrical energy, and an application switch of electrical energy;
The DC power supply unit is controlled based on an input of the external switch, and has an output circuit of a DC voltage from the DC power supply unit, and also stores serial information of the power supply device and a time limit for use of the catheter, and stores time. An arithmetic processing unit having an internal clock for confirmation and controlling a write and read output to a memory of said defibrillation catheter;
When defibrillation is performed by the defibrillation catheter, the resistance value between the first electrode group and the second electrode group is measured, and then, based on an input of the external switch, from the DC power supply unit of the power supply device, the arithmetic processing unit. Voltages of different polarities are applied to the first electrode group and the second electrode group of the defibrillation catheter via an output circuit of the catheter connection connector,
The calculation processing unit of the power supply device,
(a) When the power supply device is first connected to the defibrillation catheter, the time of first connection and the serial information of the power supply device connected for the first time are recorded in the first connection information storage unit in the memory of the defibrillation catheter,
(b) when defibrillation is performed by the defibrillation catheter, a resistance value between the first electrode group and the second electrode group, a set value of electrical energy to be applied between the first electrode group and the second electrode group, Information of the output voltage and output time is obtained, and the information is recorded in the event storage unit in the memory of the defibrillation catheter together with the time at which the defibrillation was performed and serial information of the connected power supply device,
(c) when defibrillation is not performed after the resistance between the first electrode group and the second electrode group of the defibrillation catheter is measured, the measurement of the resistance value is recognized as an event, and the measured resistance value is measured. And recorded in the event storage unit in the memory of the defibrillation catheter together with the serial information of the connected power supply device.
(d) When the same or different power supply is reconnected to the defibrillation catheter in which the used power supply is disconnected, this is recognized as an event, and the time of reconnection and the serial information of the reconnected power supply are used for the defibrillation catheter. In the event storage in the memory of
(e) The elapsed time from the connection time recorded in the first connection information storage unit in the memory of the defibrillation catheter to the time when the event was performed for each event recorded in the event storage unit in the memory of the defibrillation catheter. The intracardiac defibrillation catheter system, characterized in that it is determined whether or not the time limit for use has been exceeded, and if it is determined that the use time limit is exceeded, the next event by the defibrillation catheter is controlled not to be executed. The method of claim 1,
The arithmetic processing unit of the power supply device periodically refers to the time indicated by the internal clock, and after elapse of the use time limit from the connection time recorded in the first connection information storage unit of the memory of the defibrillation catheter, An intracardiac defibrillation catheter system, characterized by controlling not to execute an event by a defibrillation catheter. A catheter system comprising a defibrillation catheter inserted into the deep cavity to perform 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 attached to the tip region of the tube member;
A second electrode group comprising a plurality of ring-shaped electrodes spaced apart from the first electrode group toward the proximal side and attached to the tube member;
A first lead wire group including a plurality of lead wires having a tip connected to each of the electrodes constituting the first electrode group;
A second lead wire group including a plurality of lead wires having a tip connected to each of the electrodes constituting the second electrode group;
Catheter serial storage unit for storing the serial information of the defibrillation catheter,
A first connection information storage unit for storing the time at which the power supply is first connected to the defibrillation catheter and the serial information of the first connected power supply unit, and
A memory having an event information storage section for storing information related to the event including the defibrillation by the defibrillation catheter together with the time at which the event was performed and the serial information of the connected power supply device;
The power supply unit, the DC power supply unit,
A catheter connecting connector connected to proximal ends 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 to a defibrillation mode, a setting switch of electrical energy, and an application switch of electrical energy;
The DC power supply unit is controlled based on an input of the external switch, and has an output circuit of a DC voltage from the DC power supply unit, and also stores serial information of the power supply device and a time limit for use of the catheter, and stores time. An arithmetic processing unit having an internal clock for confirmation and controlling a write and read output to a memory of said defibrillation catheter;
When defibrillation is performed by the defibrillation catheter, the resistance value between the first electrode group and the second electrode group is measured, and then, based on an input of the external switch, from the DC power supply unit of the power supply device, the arithmetic processing unit. Voltages of different polarities are applied to the first electrode group and the second electrode group of the defibrillation catheter via an output circuit of the catheter connection connector,
The calculation processing unit of the power supply device,
(a) When the power supply device is first connected to the defibrillation catheter, the time of first connection and the serial information of the power supply device connected for the first time are recorded in the first connection information storage unit in the memory of the defibrillation catheter,
(b) when defibrillation is performed by the defibrillation catheter, a resistance value between the first electrode group and the second electrode group, a set value of electrical energy to be applied between the first electrode group and the second electrode group, Information of the output voltage and output time is obtained, and the information is recorded in the event storage unit in the memory of the defibrillation catheter together with the time at which the defibrillation was performed and serial information of the connected power supply device,
(c) when defibrillation is not performed after the resistance between the first electrode group and the second electrode group of the defibrillation catheter is measured, the measurement of the resistance value is recognized as an event, and the measured resistance value is measured. And recorded in the event storage unit in the memory of the defibrillation catheter together with the serial information of the connected power supply device.
(d) When the same or different power supply is reconnected to the defibrillation catheter in which the used power supply is disconnected, this is recognized as an event, and the time of reconnection and the serial information of the reconnected power supply are used for the defibrillation catheter. In the event storage in the memory of
(e) When the new event is to be executed by the defibrillation catheter, the elapsed time from the connection time recorded in the first connection information storage unit in the memory of the defibrillation catheter to the current time indicated by the internal clock, The intracardiac defibrillation catheter system, characterized in that it is determined whether the time limit for use has been exceeded, and if it is determined that the time limit has been exceeded, control not to execute the event. An intracardiac defibrillation catheter system according to any one of claims 1 to 3 having an electrocardiograph,
The power supply device includes an electrocardiograph connecting connector connected to an input terminal of the electrocardiograph;
It consists of a switching switch of one circuit and two contacts, the catheter connecting connector is connected to a common contact, the electrocardiograph connecting connector is connected to a first contact, and the switching part is connected to the arithmetic processing unit at a second contact. ;
When measuring electrocardiograph by the electrode which comprises the 1st electrode group and / or the 2nd electrode group of the said defibrillation catheter, a 1st contact is selected in the said switch part, and the electrocardiogram information from the said defibrillation catheter, Input to the electrocardiograph via the catheter connector, the switching unit and the electrocardiograph connector of the power supply,
When defibrillation is performed by the defibrillation catheter, the contact point of the switching section is switched to a second contact point by the arithmetic processing section of the power supply device, and from the DC power supply section, the output circuit of the arithmetic processing section, the switching section, and the catheter An intracardiac defibrillation catheter system, wherein voltages of different polarities are applied to the first electrode group and the second electrode group of the defibrillation catheter via a connecting connector. The method of claim 4, wherein
The defibrillation catheter may include a potential measurement electrode group including a plurality of electrodes spaced apart from the first electrode group or the second electrode group and attached to the tube member;
Comprising a plurality of lead wires having a tip connected to each of the electrodes constituting the potential measuring electrode group, the proximal end is provided with a lead wire group for potential measurement connected to the catheter connecting connector of the power supply device,
The power supply device is provided with a path for directly connecting the catheter connecting connector and the electrocardiograph connecting connector,
The electrocardiogram information measured by the electrodes constituting the potential measuring electrode group is input from the catheter connecting connector of the power supply device to the electrocardiograph via the electrocardiograph connecting connector without passing through the switching unit. Intracardiac defibrillation catheter system. The method according to claim 4 or 5,
An intracardiac defibrillation catheter system, wherein an electrocardiogram measuring means other than the defibrillation catheter is connected to the electrocardiograph. The method according to claim 6,
The intracardiac defibrillation catheter system according to claim 1, wherein the electrocardiogram measuring means is an electrode pad or an electrode catheter. 8. The method according to any one of claims 4 to 7,
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,
Electrocardiogram information from the electrocardiograph inputted to the electrocardiogram input connector is input to the calculation processing section and displayed on the electrocardiogram information display section.

Images