TW201521823A - Intracardiac defibrillation catheter system - Google Patents

Intracardiac defibrillation catheter system Download PDF

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TW201521823A
TW201521823A TW103115279A TW103115279A TW201521823A TW 201521823 A TW201521823 A TW 201521823A TW 103115279 A TW103115279 A TW 103115279A TW 103115279 A TW103115279 A TW 103115279A TW 201521823 A TW201521823 A TW 201521823A
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electrode group
event
power supply
defibrillation
input
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TWI503142B (en
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Yutaka Onodera
Shuichi Horiuchi
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Japan Lifeline Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/395Heart defibrillators for treating atrial fibrillation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/271Arrangements of electrodes with cords, cables or leads, e.g. single leads or patient cord assemblies
    • A61B5/273Connection of cords, cables or leads to electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283Invasive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346Analysis of electrocardiograms
    • A61B5/349Detecting specific parameters of the electrocardiograph cycle
    • A61B5/352Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587Epicardial electrode systems; Endocardial electrodes piercing the pericardium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3918Heart defibrillators characterised by shock pathway, e.g. by electrode configuration

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

An intracardiac defibrillation catheter system used for defibrillation by applying direct voltage synchronously with R waves of an electrocardiogram only when extrasystole and other unusual situations do not occur is provided. The intracardiac defibrillation catheter system is provided with a defibrillation catheter, a power source device, and an electrocardiograph. The power source device is provided with: a DC power source unit (71); an external switch (74) of an energy applying switch 744; and an arithmetic processing unit (75) which controls the DC power source unit. The arithmetic processing unit controls the DC power source unit in the following manner that: events deducing that the electrocardiogram input by the electrocardiograph is an R wave is sensed gradually, and when the polarity of the sensed event (Vn) after the input of the energy applying switch, the polarity of the former sensed event (Vn-1) and the polarity of the antepenultimate event (Vn-2) accord, direct voltage is applied to a number 1 DC electrode group (31G) and a number 2 DC electrode group (32G) synchronously with the event (Vn).

Description

心腔內除顫導管系統Intracardiac defibrillation catheter system

本發明涉及心腔內導管除顫系統,更詳細而言,涉及具備插入到心腔內的除顫導管、對該除顫導管的電極施加直流電壓的電源裝置、以及心電計的導管系統。The present invention relates to an intracardiac catheter defibrillation system, and more particularly to a defibrillation catheter having a heart inserted into a heart chamber, a power supply device for applying a DC voltage to the electrodes of the defibrillation catheter, and a catheter system for the electrocardiograph.

作為去除心房纖顫的除顫器,已知體外式除顫器(以下簡稱AED)。在利用AED的除顫治療中,透過在患者的體表安裝電極片並施加直流電壓,來對患者的體內提供電能。此處,從電極片流到患者的體內的電能通常是150~200J,其中的一部分(通常,幾%~20%左右)流到心臟而用於除顫治療。As a defibrillator for removing atrial fibrillation, an external defibrillator (hereinafter referred to as AED) is known. In the defibrillation treatment using the AED, electric power is supplied to the patient's body by mounting an electrode sheet on the body surface of the patient and applying a DC voltage. Here, the electrical energy flowing from the electrode sheet to the patient's body is usually 150 to 200 J, and a part (usually, several to 20% or so) flows to the heart for defibrillation treatment.

但是,在心臟導管術中容易引起心房纖顫,在該情況下也需要進行電除顫。However, atrial fibrillation is easily caused in cardiac catheterization, and in this case, defibrillation is also required.

然而,透過從體外供給電能的AED,難以對發生纖顫的心臟高效地供給電能(例如10~30J)。However, it is difficult to efficiently supply electric energy (for example, 10 to 30 J) to the heart where fibrillation is generated by the AED that supplies electric energy from outside the body.

即,在從體外供給的電能中流到心臟的比例少的情況(例如幾%左右)下,無法進行充分的除顫治療。That is, in the case where the proportion of electric energy supplied from the outside of the body to the heart is small (for example, about several %), sufficient defibrillation treatment cannot be performed.

另一方面,在從體外供給的電能以高比例流到心臟的情況下,還具有心臟的組織有可能受到損傷的顧慮。On the other hand, in the case where electric energy supplied from outside the body flows to the heart at a high ratio, there is a concern that the tissue of the heart may be damaged.

另外,在利用AED的除顫治療中,在安裝了電極片的體表容易產生燒傷。並且,如上所述,在流到心臟的電能的比例少的情況下,反覆進行電能的供給,從而燒傷的程度變重,對於接受導管術的患者而言成為相當的負擔。Further, in the defibrillation treatment using the AED, burns are likely to occur on the body surface on which the electrode sheets are attached. Further, as described above, when the proportion of electric energy flowing to the heart is small, the supply of electric energy is repeated, and the degree of burns becomes heavier, which is a considerable burden for patients undergoing catheterization.

鑒於這樣的事情,本發明者們提出一種導管除顫系統,該導管除顫系統具備除顫導管,其被插入至心腔內來進行除顫;電源裝置,其對該除顫導管的電極施加直流電壓;以及心電計,其中,除顫導管具備:絕緣性的管部件;第一DC電極組,其由安裝在該管部件的前端區域的多個環狀電極構成;第二DC電極組,其由與第一DC電極組向基端側隔開間隔地安裝在管部件的多個環狀電極構成;第一引線組,其由前端與構成該第一DC電極組的電極分別連接的多個引線構成;以及第二引線組,其由前端與構成該第二DC電極組的電極分別連接的多個引線構成,電源裝置具備:DC電源部;導管連接連接器,其與該除顫導管的第一引線組以及第二引線組的基端側連接;心電計連接連接器,其與該心電計的輸入端子連接;運算處理部,其根據外部開關的輸入來對該DC電源部進行控制,並且具有來自該DC電源部的直流電壓的輸出電路;以及切換部,其由一電路二接點的切換開關構成,公共接點連接導管連接連接器,第一接點連接心電計連接連接器,第二接點連接運算處理部,在透過除顫導管的電極(構成第一DC電極組和/或第二DC電極組的電極)測定心電位時,在切換部選擇第一接點,來自除顫導管的心電位資訊經由電源裝置的導管連接連接器、切換部以及心電計連接連接器被輸入到心電計,在透過除顫導管進行除顫時,透過電源裝置的運算處理部,切換部的接點被切換到第二接點,從DC電源部經由運算處理部的輸出電路、切換部以及導管連接連接器,對除顫導管的第一DC電極組和第二DC電極組施加互不相同極性的電壓(參照下述專利文獻1)。In view of such a matter, the inventors propose a catheter defibrillation system having a defibrillation catheter that is inserted into a cardiac chamber for defibrillation, and a power supply device that applies an electrode to the defibrillation catheter a DC voltage; and an electrocardiograph, wherein the defibrillation catheter comprises: an insulating tube member; a first DC electrode group consisting of a plurality of annular electrodes mounted in a front end region of the tube member; and a second DC electrode group And consisting of a plurality of annular electrodes mounted on the tube member at a distance from the first DC electrode group to the proximal end side; the first lead group being connected to the electrodes constituting the first DC electrode group by a front end a plurality of lead wires; and a second lead wire group comprising a plurality of lead wires respectively connected to the electrodes constituting the second DC electrode group; the power supply device includes: a DC power source portion; a conduit connection connector, and the defibrillation a first lead set of the catheter and a base end side of the second lead set are connected; an electrocardiograph connection connector is connected to the input terminal of the electrocardiograph; and an arithmetic processing unit that supplies the DC power source according to an input of the external switch unit An output circuit having a DC voltage from the DC power supply unit; and a switching portion formed by a switch of a circuit two contacts, the common contact connecting the conduit connection connector, and the first contact connecting the electrocardiograph The connector is connected, and the second contact is connected to the arithmetic processing unit. When the cardiac potential is measured through the electrode of the defibrillation catheter (the electrode constituting the first DC electrode group and/or the second DC electrode group), the first connection is selected in the switching unit. At the point, the cardiac potential information from the defibrillation catheter is input to the electrocardiograph via the catheter connection connector, the switching portion, and the electrocardiographic connection connector of the power supply device, and the operation of the power supply device is performed when defibrillation is performed through the defibrillation catheter. The processing unit switches the contact of the switching unit to the second contact, and the first DC electrode group and the second DC of the defibrillation catheter are connected from the DC power supply unit via the output circuit of the arithmetic processing unit, the switching unit, and the catheter connection connector. Voltages of mutually different polarities are applied to the electrode group (see Patent Document 1 below).

根據專利文獻1所述的除顫導管系統,能夠在心臟導管術中對發生心房纖顫等的心臟可靠地供給除顫所需且充分的電能。另外,也不會在患者的體表產生燒傷且侵襲性也少。According to the defibrillation catheter system described in Patent Document 1, it is possible to reliably supply a sufficient amount of electric energy required for defibrillation to a heart such as atrial fibrillation during cardiac catheterization. In addition, it does not cause burns on the body surface of the patient and has less invasiveness.

另外,在不需要除顫治療時,能夠將構成本發明的除顫導管用作心電位測定用的電極導管。Further, when the defibrillation treatment is not required, the defibrillation catheter constituting the present invention can be used as an electrode catheter for measuring cardiac potential.

在專利文獻1所述的導管系統中,若外部開關亦即能量施加開關被輸入,則透過運算處理部,切換部的接點從第一接點被切換到第二接點,從導管連接連接器經由切換部到達運算處理部的路徑被確保。In the catheter system described in Patent Document 1, when an external switch, that is, an energy application switch is input, the communication processing unit transmits the contact of the switching unit from the first contact to the second contact, and connects from the catheter. The path that the device reaches the arithmetic processing unit via the switching unit is secured.

切換部的接點被切換到第二接點後,從接受了來自運算處理部的控制信號的DC電源部經由運算處理部的輸出電路、切換部以及導管連接連接器,對除顫導管的第一DC電極組和第二DC電極組施加互不相同極性的直流電壓。After the contact of the switching unit is switched to the second contact, the DC power supply unit that has received the control signal from the arithmetic processing unit passes through the output circuit of the arithmetic processing unit, the switching unit, and the catheter connection connector, and the defibrillation catheter is A DC electrode group and a second DC electrode group apply DC voltages of mutually different polarities.

此處,運算處理部進行運算處理並向DC電源部發送控制信號,以便與經由心電圖輸入連接器輸入的心電位波形同步地施加電壓。Here, the arithmetic processing unit performs arithmetic processing and transmits a control signal to the DC power supply unit to apply a voltage in synchronization with the cardiac potential waveform input through the electrocardiogram input connector.

具體而言,以如下的方式對DC電源部發送控制信號,即:在逐次輸入到運算處理部的心電位波形(心電圖)中檢測1個R波(最大峰值),求出其峰值高度,接下來,在從電位差到達了該峰值高度的80%的高度(觸發電平)的時刻起經過一定時間(例如,R波的峰值寬度的1/10左右的極其短的時間)之後開始施加。Specifically, a control signal is transmitted to the DC power supply unit in such a manner that one R wave (maximum peak value) is detected in the cardiac potential waveform (electrocardiogram) sequentially input to the arithmetic processing unit, and the peak height is obtained. The application is started after a certain period of time (for example, an extremely short time of about 1/10 of the peak width of the R wave) from the time when the potential difference reaches a height (trigger level) of 80% of the peak height.

專利文獻1:日本特許專利4545216號公報Patent Document 1: Japanese Patent No. 4545216

為了進行有效地除顫治療,並且不對心室造成壞影響,除顫(電壓的施加)通常與R波同步地進行。In order to perform effective defibrillation treatment without causing a bad influence on the ventricle, defibrillation (application of voltage) is usually performed in synchronization with the R wave.

若與T波同步地進行除顫,則招致重度的心室纖顫的危險性高,因此,必須避免與T波同步。Defibrillation in synchronization with the T wave has a high risk of causing severe ventricular fibrillation, and therefore it is necessary to avoid synchronization with the T wave.

因此,在專利文獻1所述的導管系統中,將能量施加開關輸入之後不久到達觸發電平的峰值識別為R波,使與該峰值同步地對第一電極組以及第二電極組施加電壓。Therefore, in the catheter system described in Patent Document 1, the peak reaching the trigger level shortly after the input of the energy application switch is recognized as an R wave, and a voltage is applied to the first electrode group and the second electrode group in synchronization with the peak.

然而,在欲接受除顫治療的患者的心臟產生期外收縮,或者輸入至運算處理部的心電圖的基準線(基線)擺動的漂移產生的情況下,有時在能量施加開關的輸入之後不久到達了觸發電平的電位差的峰值(被識別為R波的峰值)實際上不是R波的峰值。However, in the case where the heart of the patient who is to receive the defibrillation treatment is contracted outside the contraction, or the drift of the reference line (baseline) swing input to the electrocardiogram of the arithmetic processing unit is generated, it sometimes arrives shortly after the input of the energy application switch. The peak of the potential difference of the trigger level (identified as the peak of the R wave) is actually not the peak of the R wave.

例如,在患者的心臟產生單發性期外收縮的情況下,輸入至運算處理部的心電圖(心電位波形)如圖19所示,R波(圖中,從左數第四個的R波)的極性反轉,並且其下一個T波的峰值有增大的趨勢。For example, when a single-shot extra-systolic contraction occurs in the heart of the patient, the electrocardiogram (cardiac potential waveform) input to the arithmetic processing unit is as shown in FIG. 19, and the R wave (in the figure, the fourth R-wave from the left) The polarity of the ) is reversed, and the peak of the next T wave tends to increase.

而且,如圖中所示,若在產生了期外收縮之後不久輸入了電能施加開關,則認為有將增大而到達了觸發電平的T波誤感測(檢測)為R波,並與該T波同步地施加電壓來實施除顫的情況。Further, as shown in the figure, if the electric energy application switch is input shortly after the occurrence of the extra-systolic contraction, it is considered that the T-wave missensing (detection) which is increased to reach the trigger level is R wave, and The T wave is synchronously applied with a voltage to perform defibrillation.

另外,若心電圖的基準線擺動,則認為有將通常不被感測的波形誤認為R波來感測的情況。例如,透過基準線的上升,存在有不是R波的陽性的波形的高度被高於實際讀取的情況。圖20示出漂移產生而基準線下降,之後基準線上升而回復到原來的基準線的心電圖。但在基準線上升之前輸入了電能施加開關,從而將基準線的上升誤認為R波來感測(檢測),並與此同步地施加電壓實施除顫。Further, when the reference line of the electrocardiogram is swung, it is considered that there is a case where the waveform that is not normally sensed is mistaken for the R wave and sensed. For example, when the rise of the reference line occurs, there is a case where the height of the waveform that is not positive for the R wave is higher than the actual reading. Fig. 20 shows an electrocardiogram in which drift occurs and the reference line is lowered, and then the reference line rises and returns to the original reference line. However, before the reference line rises, the electric energy application switch is input, so that the rise of the reference line is mistaken for the R wave to be sensed (detected), and the voltage is applied in synchronization with the defibrillation.

本發明是基於上述的事情來完成的。The present invention has been completed based on the above matters.

本發明的第一目的在於,提供一種心腔內除顫導管系統,其能夠在接受除顫治療的患者的心臟發生期外收縮時,不對除顫導管的電極施加電壓,而在未發生期外收縮時,與輸入運算處理部的心電圖的R波同步地對除顫導管的電極施加直流電壓來進行除顫。A first object of the present invention is to provide an intracardiac defibrillation catheter system capable of applying a voltage to an electrode of a defibrillation catheter without contracting during a cardiac contraction of a patient undergoing defibrillation therapy. At the time of contraction, a DC voltage is applied to the electrodes of the defibrillation catheter in synchronization with the R wave of the electrocardiogram input to the arithmetic processing unit to perform defibrillation.

本發明的第二目的在於,提供一種心腔內除顫導管系統,其能夠在輸入至運算處理部的心電圖的基準線擺動(漂移)時,不對除顫導管的電極施加電壓,而在基準線穩定時,與該心電圖的R波同步地對除顫導管的電極施加直流電壓來進行除顫。A second object of the present invention is to provide an intracardiac defibrillation catheter system capable of applying a voltage to an electrode of a defibrillation catheter without being applied to a reference line of an electrocardiogram input to the arithmetic processing unit, but at a reference line When it is stable, a DC voltage is applied to the electrodes of the defibrillation catheter in synchronization with the R wave of the electrocardiogram to perform defibrillation.

為了達成上述目的,本發明者們反覆專心研究的結果,發現了在患者的心臟發生了期外收縮時、另外在被輸入至電源裝置的運算處理部的心電圖的基準線擺動時,在該心電圖中逐次感測的事件(被推定為R波的波形)的極性變化;該事件的極性連續三次向相同方向產生時,至少在感測到第三次的事件的時刻,成為未發生期外收縮也未發生漂移的穩定狀態,且第三次的事件(波形)確實是R波的峰值;僅在被推定為R波的事件的極性連續三次以上向相同方向產生時(電能施加開關被輸入後感測到的事件的極性與之前兩次感測到的事件的極性一致時),透過與該事件同步地施加電壓,從而能夠可靠地進行與R波同步的除顫,並基於這些發現完成了本發明。In order to achieve the above-mentioned object, the inventors of the present invention have found that the electrocardiogram is generated when the patient's heart is contracted outside the heart, and when the reference line of the electrocardiogram of the arithmetic processing unit input to the power supply device is swung. The polarity change of the event that is sequentially sensed (the waveform that is presumed to be the R wave); when the polarity of the event is generated in the same direction three times in succession, at least at the time of sensing the event of the third time, it becomes non-occurring There is no steady state of drift, and the third event (waveform) is indeed the peak of the R wave; only when the polarity of the event estimated as the R wave is generated three times or more in the same direction (after the power application switch is input) When the polarity of the sensed event coincides with the polarity of the previous two sensed events, the defibrillation synchronized with the R wave can be reliably performed by applying a voltage in synchronization with the event, and based on these findings, this invention.

(1)即,本發明的心腔內除顫導管系統是具備被插入至心腔內進行除顫的除顫導管、對該除顫導管的電極施加直流電壓的電源裝置、以及心電計的導管系統,上述除顫導管具備: 絕緣性的管部件; 第一電極組(第一DC電極組),其由安裝在上述管部件的前端區域的多個環狀電極構成; 第二電極組(第二DC電極組),其由多個環狀電極構成,該多個環狀電極被與上述第一DC電極組向基端側隔開間隔地安裝於上述管部件; 第一引線組,其由前端與構成上述第一DC電極組的電極分別連接的多個引線構成;以及 第二引線組,其由前端與構成上述第二DC電極組的電極分別連接的多個引線構成, 上述電源裝置具備: DC電源部; 導管連接連接器,其與上述除顫導管的第一引線組以及第二引線組的基端側連接; 外部開關,其包括電能施加開關; 運算處理部,其具有來自上述DC電源部的直流電壓的輸出電路,並基於上述外部開關的輸入來控制上述DC電源部;以及 心電圖輸入連接器,其與上述運算處理部以及上述心電計的輸出端子連接, 在透過除顫導管進行除顫時,從上述DC電源部經由上述運算處理部的輸出電路以及上述導管連接連接器,對上述除顫導管的上述第一DC電極組和第二DC電極組施加互不相同(±相反的)極性的電壓, 上述電源裝置的運算處理部按如下方式進行運算處理來對上述DC電源部進行控制,即:逐次感測根據經由上述心電圖輸入連接器被從上述心電計輸入的心電圖而被推斷為R波的事件,並在上述電能施加開關的輸入之後(第n次)感測到的事件(Vn)的極性至少與之前一個感測到的事件(Vn-1)的極性以及其之前二個感測到的事件(Vn-2)的極性一致時,與該事件(Vn)同步地對上述第一DC電極組以及上述第二DC電極組施加電壓。(1) That is, the intracardiac defibrillation catheter system of the present invention is a defibrillation catheter having a defibrillation inserted into a cardiac chamber, a power supply device for applying a DC voltage to an electrode of the defibrillation catheter, and an electrocardiograph a catheter system, the defibrillation catheter comprising: an insulating tube member; a first electrode group (first DC electrode group) comprising a plurality of annular electrodes mounted in a front end region of the tube member; and a second electrode group ( a second DC electrode group) comprising a plurality of annular electrodes, the plurality of ring electrodes being attached to the tube member at a distance from the first DC electrode group toward the proximal end side; the first lead group; a front end is formed of a plurality of leads respectively connected to the electrodes constituting the first DC electrode group; and a second lead group is formed by a plurality of leads respectively connected to the electrodes constituting the second DC electrode group, and the power supply device a DC power supply unit; a catheter connection connector connected to a first lead group of the defibrillation catheter and a base end side of the second lead set; an external switch including an electric energy application switch; and an arithmetic processing unit having An output circuit of a DC voltage of the DC power supply unit, and controlling the DC power supply unit based on an input of the external switch; and an electrocardiogram input connector connected to the arithmetic processing unit and an output terminal of the electrocardiograph When the defibrillation catheter performs defibrillation, the first DC electrode group and the second DC electrode group of the defibrillation catheter are different from each other by the DC power supply unit via the output circuit of the arithmetic processing unit and the catheter connection connector ( The voltage of the ± opposite polarity is calculated by the arithmetic processing unit of the power supply device as follows to control the DC power supply unit, that is, the sequential sensing is input from the electrocardiograph according to the input via the electrocardiogram input connector. An electrocardiogram is inferred as an event of an R wave, and the polarity of the event (Vn) sensed after the input of the above-described power application switch (nth time) is at least the polarity of the previous sensed event (Vn-1) And when the polarities of the previous two sensed events (Vn-2) are the same, the first DC electrode group and the second DC electrode group are applied in synchronization with the event (Vn). Voltage.

根據這樣的構成的心腔內除顫導管系統,在被輸入至電源裝置的運算處理部的心電圖中,如果被連續感測到的三個事件(Vn-2)、(Vn-1)、以及(Vn)的極性不一致,則判斷為存在由於患者的心臟發生期外收縮、或者心電圖的基準線漂移等而成為不穩定的可能性,存在事件(Vn)不是R波的峰值的可能性,從而不與該事件(Vn)同步地施加電壓。而且,在三個事件(Vn-2)、(Vn-1)、以及(Vn)的極性一致時,判斷為第三次的事件(Vn)是R波的峰值,與該事件(Vn)同步地施加電壓,從而能夠可靠地進行與R波同步的除顫。According to the intracardiac defibrillation catheter system having such a configuration, in the electrocardiogram input to the arithmetic processing unit of the power supply device, if three events (Vn-2), (Vn-1), and the like are continuously sensed, When the polarity of (Vn) does not match, it is determined that there is a possibility that the patient's heart is contracted outside the heart, or the reference line of the electrocardiogram is drifted, and the event (Vn) is not the peak of the R wave. The voltage is not applied in synchronization with the event (Vn). Further, when the polarities of the three events (Vn-2), (Vn-1), and (Vn) match, it is determined that the third event (Vn) is the peak of the R wave, and is synchronized with the event (Vn). The voltage is applied to the ground so that defibrillation synchronized with the R wave can be reliably performed.

(2)在本發明的心腔內除顫導管系統中,優選上述電源裝置的運算處理部對上述DC電源部進行控制,以便在感測到被推定為R波的事件之後最短50m秒間、最長500m秒間,優選260m秒間,不對上述第一DC電極組以及上述第二DC電極組施加電壓。(2) In the intracardiac defibrillation catheter system of the present invention, it is preferable that the arithmetic processing unit of the power supply device controls the DC power supply unit so as to be the shortest of 50 m seconds after sensing an event estimated to be an R wave. A voltage is not applied to the first DC electrode group and the second DC electrode group between 500 msec, preferably 260 msec.

根據這樣的構成的心腔內除顫導管系統,在感測出被推定為R波的事件之後,最短在50m秒間,不對上述第一DC電極組以及上述第二DC電極組施加電壓,因此在感測出的事件是R波的峰值的情況下,能夠可靠地避免在其下一個T波出現的時刻進行除顫的情況,也就是說,能夠對被推斷為T波的峰值進行遮罩。According to the intracardiac defibrillation catheter system having such a configuration, after the event estimated to be the R wave is sensed, the voltage is not applied to the first DC electrode group and the second DC electrode group at the shortest time of 50 m seconds. When the sensed event is the peak of the R wave, it is possible to reliably avoid the defibrillation at the time when the next T wave appears, that is, the peak estimated to be the T wave can be masked.

(3)在上述(2)的心腔內除顫導管系統中,優選上述電源裝置的運算處理部在感測出被推定為R波的事件之後最短10m秒間、最長150m秒,優選100m秒間,不新感測被推定為R波的事件。(3) In the intracardiac defibrillation catheter system according to the above (2), preferably, the arithmetic processing unit of the power supply device has a shortest time of 10 m seconds and a maximum length of 150 msec, preferably 100 msec, after sensing an event estimated to be an R wave. No new sensing is estimated to be an R wave event.

根據這樣的構成的心腔內除顫導管系統,在感測出被推定為R波的事件之後,最短10m秒間不感測新的事件,所以能夠防止在感測出的事件是R波峰值,接著該峰值向相反方向出現的S波的峰值增大而到達了觸發電平的情況(該狀態在進行除顫時沒有特別問題)下,感測該S波的峰值而事件的極性的連續性受損(相同極性的計數被重置)的情況。According to the intracardiac defibrillation catheter system having such a configuration, after an event estimated to be an R wave is sensed, a new event is not sensed for a minimum of 10 m seconds, so that the sensed event is prevented from being an R wave peak, and then When the peak value of the S wave appearing in the opposite direction increases and reaches the trigger level (the state has no particular problem when defibrillation is performed), the peak of the S wave is sensed and the polarity of the event is affected by the continuity of the event. The case of loss (the count of the same polarity is reset).

(4)在上述(2)或者(3)的心腔內除顫導管系統中,優選上述電源裝置的運算處理部在上述電能施加開關的輸入之後最短10m秒間、最長500m秒間,優選260m秒間,對上述DC電源部進行控制,以便不對上述第一DC電極組以及上述第二電極組施加電壓。(4) In the intracardiac defibrillation catheter system according to (2) or (3) above, preferably, the arithmetic processing unit of the power supply device is between a shortest time of 10 m seconds and a maximum of 500 msec, preferably 260 msec, after the input of the electric energy application switch. The DC power supply unit is controlled so as not to apply a voltage to the first DC electrode group and the second electrode group.

根據這樣構成的心腔內除顫導管系統,由於在電能施加開關的輸入之後,最短10m秒間不對第一DC電極組以及第二DC電極組施加電壓,所以能夠防止將由於施加開關的輸入而產生的雜訊(與其上次以及再上次的事件相同極性的雜訊)錯誤地感測為R波,而與該雜訊同步地進行除顫的情況。 另外,能夠防止由於施加開關的輸入而產生的雜訊(與其上次以及再上次的事件相同極性的雜訊),導致事件的極性的連續性受損(相同極性的計數被重置)的情況。 並且,能夠防止將在施加開關的輸入不久後發生的基準線的變動錯誤地感測為R波,並與其同步地進行除顫的情況。According to the intracardiac defibrillation catheter system thus constructed, since the voltage is not applied to the first DC electrode group and the second DC electrode group for a minimum of 10 m seconds after the input of the electric energy application switch, it is possible to prevent the input due to the input of the application switch. The noise (the noise of the same polarity as the last time and the last time of the previous event) is erroneously sensed as an R wave, and the defibrillation is performed in synchronization with the noise. In addition, it is possible to prevent noise generated by the input of the switch (noise of the same polarity as the last time and the last event), resulting in impaired continuity of the polarity of the event (the count of the same polarity is reset) Happening. Further, it is possible to prevent the fluctuation of the reference line which occurs shortly after the input of the application switch is erroneously sensed as the R wave, and the defibrillation can be performed in synchronization therewith.

根據本發明的心腔內除顫導管系統,能夠在接受除顫治療的患者的心臟發生期外收縮時,不對除顫導管的電極施加電壓,而在未發生期外收縮時,與被輸入至運算處理部的心電圖R波同步地對除顫導管的電極施加直流電壓來進行除顫。According to the intracardiac defibrillation catheter system of the present invention, when a patient undergoing defibrillation treatment is contracted outside the heart, the voltage of the defibrillation catheter is not applied to the electrode of the defibrillation catheter, and when no extravasation occurs, the input is The electrocardiogram R wave of the arithmetic processing unit synchronously applies a DC voltage to the electrodes of the defibrillation catheter to perform defibrillation.

另外,能夠在被輸入至運算處理部的心電圖的基準線擺動(漂移)時,不對除顫導管的電極施加電壓,而在基準線穩定時,與該心電圖的R波同步地對除顫導管的電極施加直流電壓來進行除顫。Further, when the reference line of the electrocardiogram input to the arithmetic processing unit is swung (drifted), a voltage is not applied to the electrode of the defibrillation catheter, and when the reference line is stabilized, the defibrillation catheter is placed in synchronization with the R wave of the electrocardiogram. A DC voltage is applied to the electrodes for defibrillation.

如圖1所示,本實施方式的心腔內除顫導管系統具備除顫導管100、電源裝置700、心電計800、以及心電位測定單元900。As shown in FIG. 1, the intracardiac defibrillation catheter system of the present embodiment includes a defibrillation catheter 100, a power supply device 700, an electrocardiograph 800, and a cardiac potential measuring unit 900.

如圖2至圖5所示,構成本實施方式的除顫導管系統的除顫導管100具備多腔管10、把手20、第一DC電極組31G、第二DC電極組32G、基端側電位測定電極組33G、第一引線組41G、第二引線組42G、以及第三引線組43G。As shown in FIGS. 2 to 5, the defibrillation catheter 100 constituting the defibrillation catheter system of the present embodiment includes a multi-lumen tube 10, a handle 20, a first DC electrode group 31G, a second DC electrode group 32G, and a proximal end side potential. The electrode group 33G, the first lead group 41G, the second lead group 42G, and the third lead group 43G are measured.

如圖4以及圖5所示,在構成除顫導管100的多腔管10(具有多腔結構的絕緣性的管部件)中,形成了四個管腔(第一管腔11、第二管腔12、第三管腔13、第四管腔14)。As shown in FIGS. 4 and 5, in the multi-lumen tube 10 (insulating tube member having a multi-chamber structure) constituting the defibrillation catheter 100, four lumens (the first lumen 11 and the second tube) are formed. The cavity 12, the third lumen 13, and the fourth lumen 14).

在圖4以及圖5中,15是劃分管腔的氟樹脂層,16是由低硬度的尼龍彈性體構成的裡(芯)部,17是由高硬度的尼龍彈性體構成的外(殼)部,圖4中的18是形成編織葉片的不銹鋼線材。In Fig. 4 and Fig. 5, 15 is a fluororesin layer dividing the lumen, 16 is a lining (core) portion made of a low-hardness nylon elastomer, and 17 is an outer shell (shell) made of a high-hardness nylon elastomer. In the section, 18 in Fig. 4 is a stainless steel wire forming a braided blade.

劃分管腔的氟樹脂層15例如由四氟乙烯-全氟烷氧基乙烯基醚共聚物(PFA)、聚四氟乙烯(PTFE)等絕緣性高的材料構成。The fluororesin layer 15 that divides the lumen is made of, for example, a material having high insulating properties such as tetrafluoroethylene-perfluoroalkoxy vinyl ether copolymer (PFA) or polytetrafluoroethylene (PTFE).

構成多腔管10的外部17的尼龍彈性體使用硬度根據軸向而不同的材料。由此,多腔管10構成為從前端側朝向基端側硬度階段性地變高。The nylon elastomer constituting the outer portion 17 of the multi-lumen tube 10 uses a material having a hardness different depending on the axial direction. Thereby, the multi-lumen tube 10 is configured to gradually increase in hardness from the distal end side toward the proximal end side.

若示出優選的一個例子,則在圖3中,L1(長度52mm)所示的區域的硬度(由D型硬度計得到的硬度)是40,L2(長度108mm)所示的區域的硬度是55、L3(長度25.7mm)所示的區域的硬度是63、L4(長度10mm)所示的區域的硬度是68、L5(長度500mm)的硬度是72。When a preferred example is shown, in FIG. 3, the hardness of the region indicated by L1 (length 52 mm) (hardness obtained by the D-type durometer) is 40, and the hardness of the region indicated by L2 (length 108 mm) is 55. The hardness of the region indicated by L3 (length 25.7 mm) is 63, and the hardness of the region indicated by L4 (length 10 mm) is 68, and the hardness of L5 (length 500 mm) is 72.

由不銹鋼線材構成的編織葉片在圖3中僅在L5所示的區域中形成,如圖4所示,設於裡部16和外部17之間。The braided blade composed of a stainless steel wire is formed only in the region shown by L5 in Fig. 3, as shown in Fig. 4, between the inner portion 16 and the outer portion 17.

多腔管10的外徑例如為1.2~3.3mm。The outer diameter of the multi-lumen tube 10 is, for example, 1.2 to 3.3 mm.

作為製造多腔管10的方法沒有特別限定。The method of manufacturing the multi-lumen tube 10 is not particularly limited.

構成本實施方式中的除顫導管100的把手20具備把手主體21、繩栓22、以及應變消除器24。The handle 20 constituting the defibrillation catheter 100 in the present embodiment includes a handle body 21, a stringer 22, and a strain relief 24.

透過對繩栓22進行旋轉操作,能夠使多腔管10的前端部偏轉(搖頭)。By rotating the stringer 22, the distal end portion of the multi-lumen tube 10 can be deflected (shaking).

在多腔管10的外周(內部未形成編織的前端區域),安裝有第一DC電極組31G、第二DC電極組32G以及基端側電位測定電極組33G。此處,所謂“電極組”是指構成相同極(具有相同極性)、或者、以相同目的以窄的間隔(例如5mm以下)安裝的多個電極的集合體。The first DC electrode group 31G, the second DC electrode group 32G, and the proximal end side potential measurement electrode group 33G are attached to the outer circumference of the multi-lumen tube 10 (the front end region where the knitting is not formed). Here, the "electrode group" refers to an aggregate of a plurality of electrodes constituting the same pole (having the same polarity) or being mounted at a narrow interval (for example, 5 mm or less) for the same purpose.

第一DC電極組透過在多腔管的前端區域中,以窄的間隔安裝構成相同極(-極或者+極)的多個電極而形成。此處,構成第一DC電極組的電極的個數還根據電極的寬度、配置間隔而不同,但例如為4~13個,優選為8~10個。The first DC electrode group is formed by mounting a plurality of electrodes constituting the same pole (-pole or + pole) at narrow intervals in the front end region of the multi-lumen tube. Here, the number of electrodes constituting the first DC electrode group differs depending on the width and arrangement interval of the electrodes, but is, for example, 4 to 13, preferably 8 to 10.

在本實施方式中,第一DC電極組31G由安裝於多腔管10的前端區域的八個環狀電極31構成。In the present embodiment, the first DC electrode group 31G is constituted by eight annular electrodes 31 attached to the front end region of the multi-lumen tube 10.

構成第一DC電極組31G的電極31經由引線(構成第一引線組41G的引線41)以及後述的連接器,連接於電源裝置700的導管連接連接器。The electrode 31 constituting the first DC electrode group 31G is connected to the catheter connection connector of the power supply device 700 via a lead wire (a lead wire 41 constituting the first lead wire group 41G) and a connector to be described later.

此處,電極31的寬度(軸向的長度)優選為2~5mm,若示出優選的一個例子為則4mm。Here, the width (length in the axial direction) of the electrode 31 is preferably 2 to 5 mm, and a preferred example is 4 mm.

若電極31的寬度過窄,則電壓施加時的發熱量變得過大,從而可能對周邊組織造成損傷。另一方面,若電極31的寬度過寬,則多腔管10中的設置有第一DC電極組31G的部分的撓性及柔軟性會受損。If the width of the electrode 31 is too narrow, the amount of heat generated when the voltage is applied becomes excessively large, which may cause damage to the surrounding tissue. On the other hand, if the width of the electrode 31 is too wide, the flexibility and flexibility of the portion of the multi-lumen tube 10 in which the first DC electrode group 31G is provided may be impaired.

電極31的安裝間隔(相鄰的電極的隔開距離)優選為1~5mm,若示出優選的一個例子則為2mm。The mounting interval of the electrodes 31 (the distance between adjacent electrodes) is preferably 1 to 5 mm, and is 2 mm if a preferred example is shown.

在使用除顫導管100時(配置於心腔內時),第一DC電極組31G位於例如冠狀靜脈內。When the defibrillation catheter 100 is used (when placed in the heart chamber), the first DC electrode group 31G is located, for example, in a coronary vein.

第二DC電極組透過從多腔管的第一DC電極組的安裝位置向基端側隔開間隔,並以窄的間隔安裝構成與第一DC電極組相反極(+極或者-極)的多個電極而形成。此處,構成第二DC電極組的電極的個數也根據電極的寬度、配置間隔而不同,但例如為4~13個,優選為8~10個。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 base end side, and is installed at a narrow interval to form an opposite pole (+ pole or - pole) to the first DC electrode group. Formed by a plurality of electrodes. Here, the number of electrodes constituting the second DC electrode group also differs depending on the width and arrangement interval of the electrodes, but is, for example, 4 to 13, preferably 8 to 10.

在本實施方式中,第二DC電極組32G由從第一DC電極組31G的安裝位置向基端側隔開地安裝於多腔管10的八個環狀電極32構成。In the present embodiment, the second DC electrode group 32G is composed of eight annular electrodes 32 that are attached to the multi-lumen tube 10 from the attachment position of the first DC electrode group 31G to the proximal end side.

構成第二DC電極組32G的電極32經由引線(構成第二引線組的引線42)以及後述的連接器,連接於電源裝置700的導管連接連接器。The electrode 32 constituting the second DC electrode group 32G is connected to the catheter connection connector of the power supply device 700 via a lead wire (a lead wire 42 constituting the second lead group) and a connector to be described later.

此處,電極32的寬度(軸向的長度)優選為2~5mm,。若示出優選的一個例子則為4mm。Here, the width (length in the axial direction) of the electrode 32 is preferably 2 to 5 mm. If a preferred example is shown, it is 4 mm.

若電極32的寬度過窄,則電壓施加時的發熱量變得過大,可能對周邊組織造成損傷。另一方面,若電極32的寬度過寬,則多腔管10中的設置有第二DC電極組32G的部分的撓性及柔軟性會受損。If the width of the electrode 32 is too narrow, the amount of heat generated when the voltage is applied becomes too large, which may damage the surrounding structure. On the other hand, if the width of the electrode 32 is too wide, the flexibility and flexibility of the portion of the multi-lumen tube 10 in which the second DC electrode group 32G is provided may be impaired.

電極32的安裝間隔(相鄰的電極的距離)優選為1~5mm,若示出優選的一個例子則為2mm。The mounting interval of the electrodes 32 (the distance between adjacent electrodes) is preferably 1 to 5 mm, and is 2 mm if a preferred example is shown.

在使用除顫導管100時(配置於心腔內時),第二DC電極組32G位於例如右心房。When the defibrillation catheter 100 is used (when placed in the heart chamber), the second DC electrode group 32G is located, for example, in the right atrium.

在本實施方式中,基端側電位測定電極組33G由從第二DC電極組32G的安裝位置向基端側隔開間隔地安裝於多腔管10的四個環狀電極32構成。In the present embodiment, the proximal end side potential measurement electrode group 33G is composed of four annular electrodes 32 that are attached to the multi-lumen tube 10 at intervals from the attachment position of the second DC electrode group 32G to the proximal end side.

構成基端側電位測定電極組33G的電極33經由引線(構成第三引線組43G的引線43)以及後述的連接器,連接於電源裝置700的導管連接連接器。The electrode 33 constituting the proximal end side potential measurement electrode group 33G is connected to the catheter connection connector of the power supply device 700 via a lead wire (a lead wire 43 constituting the third lead wire group 43G) and a connector to be described later.

此處,電極33的寬度(軸向的長度)優選為0.5~2.0mm,若示出優選的一個例子則為1.2mm。Here, the width (length in the axial direction) of the electrode 33 is preferably 0.5 to 2.0 mm, and is 1.2 mm if a preferred example is shown.

若電極33的寬度過寬,則心電位的測定精度降低,異常電位的產生部位的確定變得困難。When the width of the electrode 33 is too wide, the measurement accuracy of the cardiac potential is lowered, and the location of the abnormal potential is difficult to determine.

電極33的安裝間隔(相鄰的電極的距離)優選為1.0~10.0mm。若示出優選的一個例子則為5mm。The mounting interval of the electrodes 33 (the distance between adjacent electrodes) is preferably 1.0 to 10.0 mm. If a preferred example is shown, it is 5 mm.

在使用除顫導管100時(配置於心腔內時),基端側電位測定電極組33G位於例如容易產生異常電位的上大靜脈。When the defibrillation catheter 100 is used (when placed in the cardiac chamber), the proximal end side potential measuring electrode group 33G is located, for example, in the upper large vein where an abnormal potential is likely to occur.

在除顫導管100的前端安裝有前端晶片35。A front end wafer 35 is attached to the front end of the defibrillation catheter 100.

未對該前端晶片35連接引線,在本實施方式中不用作電極。但是,還可以透過連接引線來用作電極。前端晶片35的構成材料可以是白金、不銹鋼等金屬材料、各種樹脂材料等,沒有特別限定。The lead wire is not connected to the front end wafer 35, and is not used as an electrode in the present embodiment. However, it is also possible to use the lead wire as an electrode. The constituent material of the front end wafer 35 may be a metal material such as platinum or stainless steel, various resin materials, and the like, and is not particularly limited.

第一DC電極組31G(基端側的電極31)和第二DC電極組32G(前端側的電極32)的隔開距離d2優選為40~100mm,若示出優選的一個例子則為66mm。The distance d2 between the first DC electrode group 31G (the electrode on the proximal end side) and the second DC electrode group 32G (the electrode on the distal end side) is preferably 40 to 100 mm, and is 66 mm as a preferred example.

第二DC電極組32G(基端側的電極32)和基端側電位測定電極組33G(前端側的電極33)的隔開距離d3優選為5~50mm,若示出優選的一個例子則為30mm。The distance d3 between the second DC electrode group 32G (the electrode on the proximal end side) and the proximal-side potential measurement electrode group 33G (the electrode on the distal end side) is preferably 5 to 50 mm, and a preferred example is shown. 30mm.

作為構成第一DC電極組31G、第二DC電極組32G以及基端側電位測定電極組33G的電極31、32、33,為了使針對X射線的造影性變得良好,優選由白金或者白金類的合金構成。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 are preferably made of platinum or platinum in order to improve the contrast property against X-rays. Alloy composition.

圖4以及圖5所示的第一引線41G是與構成第一DC電極組(31G)的八個電極(31)分別連接的八根引線41的集合體。The first lead 41G shown in FIGS. 4 and 5 is an aggregate of eight leads 41 connected to the eight electrodes (31) constituting the first DC electrode group (31G).

可以透過第一引線組41G(引線41),使構成第一DC電極組31G的八個電極31分別與電源裝置700電連接。The eight electrodes 31 constituting the first DC electrode group 31G can be electrically connected to the power supply device 700 through the first lead group 41G (lead 41).

構成第一DC電極組31G的八個電極31分別與不同的引線41連接。引線41分別在其前端部分被焊接到電極31的內周面,並且從形成於多腔管10的管壁的側孔進入第一管腔11。進入第一管腔11的八根引線41作為第一引線組41G在第一管腔11中延伸。The eight electrodes 31 constituting the first DC electrode group 31G are respectively connected to different leads 41. The lead wires 41 are respectively welded to the inner peripheral surface of the electrode 31 at the front end portion thereof, and enter the first lumen 11 from the side holes formed in the tube wall of the multi-lumen tube 10. The eight lead wires 41 entering the first lumen 11 extend as the first lead group 41G in the first lumen 11.

圖4以及圖5所示的第二引線組42G是與構成第二DC電極組(32G)的八個電極(32)分別連接的八根引線42的集合體。The second lead group 42G shown in FIGS. 4 and 5 is an aggregate of eight leads 42 connected to the eight electrodes (32) constituting the second DC electrode group (32G).

可以透過第二引線組42G(引線42),使構成第二DC電極組32G的八個電極32分別與電源裝置700電連接。The eight electrodes 32 constituting the second DC electrode group 32G can be electrically connected to the power supply device 700 through the second lead group 42G (lead 42).

構成第二電極組的八個電極32分別與不同的引線42連接。引線42分別在其前端部分被焊接到電極32的內周面,並且從形成於多腔管10的管壁的側孔進入第二管腔12(與第一引線組41G延伸的第一管腔11不同的管腔)。進入第二管腔12的八根引線42作為第二引線組42G在第二管腔12中延伸。The eight electrodes 32 constituting the second electrode group are respectively connected to different leads 42. The lead wires 42 are respectively welded to the inner peripheral surface of the electrode 32 at the front end portion thereof, and enter the second lumen 12 (the first lumen extending from the first lead group 41G) from the side hole formed in the tube wall of the multi-lumen tube 10 11 different lumens). The eight lead wires 42 entering the second lumen 12 extend as a second lead set 42G in the second lumen 12.

如上所述,第一引線組41G在第一管腔11中延伸,第二引線組42G在第二管腔12中延伸,從而兩者在多腔管10內完全被絕緣隔離。因此,在施加了除顫所需的電壓時,能夠可靠地防止第一引線組41G(第一DC電極組31G)和第二引線組42G(第二DC電極組32G)之間的短路。As described above, the first lead set 41G extends in the first lumen 11, and the second lead set 42G extends in the second lumen 12 such that both are completely insulated from each other within the multi-lumen tube 10. Therefore, when a voltage required for defibrillation is applied, a short circuit between the first lead group 41G (first DC electrode group 31G) and the second lead group 42G (second DC electrode group 32G) can be reliably prevented.

圖4所示的第三引線組43G是與構成基端側電位測定電極(33G)的電極(33)分別連接的四根引線43的集合體。The third lead group 43G shown in FIG. 4 is an aggregate of four leads 43 connected to the electrodes (33) constituting the proximal end side potential measuring electrode (33G).

可以透過第三引線組43G(引線43),使構成基端側電位測定電極組33G的電極33分別與電源裝置700電連接。The electrodes 33 constituting the proximal end side potential measurement electrode group 33G can be electrically connected to the power supply device 700 through the third lead group 43G (lead 43).

構成基端側電位測定電極33G的四個電極33分別與不同的引線43連接。引線43分別在其前端部分被焊接到電極33的內周面,並且從形成於多腔管10的管壁的側孔進入第三管腔13。進入第三管腔13的四根引線43作為第三引線組43G在第三管腔中延伸。The four electrodes 33 constituting the proximal end side potential measuring electrode 33G are respectively connected to different lead wires 43. The lead wires 43 are respectively welded to the inner peripheral surface of the electrode 33 at the front end portion thereof, and enter the third lumen 13 from the side holes formed in the tube wall of the multi-lumen tube 10. The four leads 43 entering the third lumen 13 extend as a third lead set 43G in the third lumen.

如上所述,在第三管腔13中延伸的第三引線組43G被與第一引線組41G以及第二引線組42G均完全絕緣隔離。因此,在施加了除顫所需的電壓時,能夠可靠地防止第三引線組43G(基端側電位測定電極組33G)和第一引線組41G(第一DC電極組31G)或者第二引線組42G(第二DC電極組32G)之間的短路。As described above, the third lead group 43G extending in the third lumen 13 is completely insulated from the first lead group 41G and the second lead group 42G. Therefore, when the voltage required for defibrillation is applied, the third lead group 43G (base end side potential measuring electrode group 33G) and the first lead group 41G (first DC electrode group 31G) or the second lead can be reliably prevented. Short circuit between group 42G (second DC electrode group 32G).

引線41、引線42以及引線43均由用聚醯亞胺等樹脂包覆了金屬導線的外周面的樹脂包覆線構成。此處,作為包覆樹脂的膜厚為2~30μm左右。Each of the lead 41, the lead 42 and the lead 43 is composed of a resin-coated wire coated with an outer peripheral surface of a metal wire with a resin such as polyimide. Here, the film thickness of the coating resin is about 2 to 30 μm.

在圖4以及圖5中,65是拉線。In Fig. 4 and Fig. 5, 65 is a pull wire.

拉線65在第四管腔14中延伸,相對多腔管10的中心軸偏心地延伸。The pull wire 65 extends in the fourth lumen 14 and extends eccentrically relative to the central axis of the multi-lumen tube 10.

拉線65的前端部分透過釺焊固定於前端晶片35。另外,也可以在拉線65的前端形成防脫用大徑部(防脫部)。由此,前端晶片35和拉線65牢固結合,能夠可靠地防止前端晶片35的脫落等。The front end portion of the pull wire 65 is fixed to the front end wafer 35 by soldering. Further, a large diameter portion (a retaining portion) for preventing the detachment may be formed at the tip end of the wire 65. Thereby, the front end wafer 35 and the pull wire 65 are firmly coupled, and it is possible to reliably prevent the front end wafer 35 from coming off or the like.

另一方面,拉線65的基端部分與把手20的繩栓22連接,透過操作繩栓22,拉線65被拉伸,由此,多腔管10的前端部偏轉。On the other hand, the base end portion of the wire 65 is connected to the stringer 22 of the handle 20, and the wire rope 65 is stretched by the operation of the stringer 22, whereby the front end portion of the multi-lumen tube 10 is deflected.

拉線65由不銹鋼、Ni-Ti類超彈性合金構成,但無需一定由金屬構成。拉線65也可以例如由高強度的非導電性線等構成。The wire 65 is made of a stainless steel or a Ni-Ti superelastic alloy, but it does not need to be made of a metal. The pull wire 65 may also be composed of, for example, a high-strength non-conductive wire or the like.

此外,使多腔管的前端部偏轉的機構並不侷限於此,例如,也可以是具備板簧而形成的機構。Further, the mechanism for deflecting the distal end portion of the multi-lumen tube is not limited thereto, and may be, for example, a mechanism including a leaf spring.

在多腔管10的第四管腔14中,只有拉線65延伸,沒有引線(組)延伸。由此,在多腔管10的前端部的偏轉操作時,能夠防止由於在軸向上移動的拉線65而導致引線受損傷(例如,擦傷)的情況。In the fourth lumen 14 of the multi-lumen tube 10, only the pull wire 65 extends without lead (set) extension. Thereby, at the time of the yaw operation of the front end portion of the multi-lumen tube 10, it is possible to prevent the lead wire from being damaged (for example, scratched) due to the wire 65 moving in the axial direction.

本實施方式中的除顫導管100,即使在把手20的內部,第一引線組41G、第二引線組42G、第三引線組43也被絕緣隔離。In the defibrillation catheter 100 of the present embodiment, even in the inside of the handle 20, the first lead group 41G, the second lead group 42G, and the third lead group 43 are insulated and insulated.

圖6是表示本實施方式的除顫導管100的把手的內部結構的立體圖,圖7是把手內部(前端側)的局部放大圖,圖8是把手內部(基端側)的局部放大圖。Fig. 6 is a perspective view showing an internal structure of a handle of the defibrillation catheter 100 according to the present embodiment, Fig. 7 is a partially enlarged view of the inside of the handle (front end side), and Fig. 8 is a partially enlarged view of the inside of the handle (base end side).

如圖6所示,多腔管10的基端部被插入至把手20的前端開口,由此,多腔管10與把手20連接。As shown in FIG. 6, the proximal end portion of the multi-lumen tube 10 is inserted into the front end opening of the handle 20, whereby the multi-lumen tube 10 is coupled to the handle 20.

如圖6以及圖8所示,在把手20的基端部中,內置有圓筒狀的連接器50,該圓筒狀的連接器50是在前端面50A配置向前端方向突出的多個針狀端子(51、52、53)而成的。As shown in FIG. 6 and FIG. 8 , a cylindrical connector 50 is disposed in the proximal end portion of the handle 20, and the cylindrical connector 50 has a plurality of needles that protrude toward the distal end surface of the distal end surface 50A. Formed by terminals (51, 52, 53).

另外,如圖6至圖8所示,被三個引線組(第一引線組41G、第二引線組42G、第三引線組43G)分別插通的三根絕緣性管(第一絕緣性管26、第二絕緣性管27、第三絕緣性管28)在把手20的內部延伸。 【00100】   如圖6以及圖7所示,第一絕緣性管26的前端部(從前端起10mm左右)被插入至多腔管10的第一管腔11中,由此,第一絕緣性管26被連結於第一引線組41G延伸的第一管腔11。 【00101】   被連結於第一管腔11的第一絕緣性管26透過在把手20的內部延伸的第一保護管61的內孔而延伸到連接器50(配置有針狀端子的前端面50A)的附近,形成了將第一引線組41G的基端部引導至連接器50的附近的插通路。由此,從多腔管10(第一管腔11)延出的第一引線組41G能夠不絞結地在把手20的內部(第一絕緣性管26的內孔)延伸。 【00102】   從第一絕緣性管26的基端開口延出的第一引線組41G被拆成構成第一引線組41G的八根引線41,這些引線41分別透過釺焊而被連接固定於配置於連接器50的前端面50A的針狀端子的每一個。此處,將配置有連接固定了構成第一引線組41G的引線41的針狀端子(針狀端子51)的區域作為“第一端子組區域”。 【00103】   第二絕緣性管27的前端部(從前端起10mm左右)被插入至多腔管10的第二管腔12,由此,第二絕緣性管27被連結於第二引線組42G延伸的第二管腔12。 【00104】   被連結於第二管腔12的第二絕緣性管27透過在把手20的內部延伸的第二保護管62的內孔而延伸到連接器50(配置有針狀端子的前端面50A)的附近,形成了將第二引線組42G的基端部引導至連接器50的附近的插通路。由此,從多腔管10(第二管腔12)延出的第二引線組42G能夠不絞結地在把手20的內部(第二絕緣性管27的內孔)延伸。 【00105】   從第二絕緣性管27的基端開口延出的第二引線組42G被拆成構成第二引線組42G的八根引線42,這些引線42分別透過釺焊而被連接固定於配置在連接器50的前端面50A的針狀端子的每一個。此處,將配置有連接固定有構成第二引線組42G的引線42的針狀端子(針狀端子52)的區域作為“第二端子組區域”。 【00106】   第三絕緣性管28的前端部(從前端起10mm左右)被插入至多腔管10的第三管腔13,由此,第三絕緣性管28被連結於第三引線組43G延伸的第三管腔13。 【00107】   被連結於第三管腔13的第三絕緣性管28透過在把手20的內部延伸的第二保護管62的內孔而延伸到連接器50(配置有針狀端子的前端面50A)的附近,形成了將第三引線組43G的基端部引導至連接器50的附近的插通路。由此,從多腔管10(第三管腔13)延出的第三引線組43G能夠不絞結地在把手20的內部(第三絕緣性管28的內孔)延伸。 【00108】   從第三絕緣性管28的基端開口延出的第三引線組43G被拆成構成第三引線組43G的四根引線43,這些引線43分別透過釺焊而被連接固定於配置於連接器50的前端面50A的針狀端子的每一個。此處,將配置有連接固定有構成第三引線組43G的引線43的針狀端子(針狀端子53)的區域作為“第三端子組區域”。 【00109】   此處,作為絕緣性管(第一絕緣性管26、第二絕緣性管27、以及第三絕緣性管28)的構成材料,能夠例示聚醯亞胺樹脂、聚醯胺樹脂、聚醯胺-醯亞胺樹脂等。其中,尤其優選硬度高且容易插通引線組的、能夠實現薄壁成形的聚醯亞胺樹脂。 【00110】   作為絕緣性管的壁厚,優選為20~40μm,若示出優選的一個例子則為30μm。 【00111】   另外,作為內插有絕緣性管的保護管(第一保護管61以及第二保護管62)的構成材料,能夠例示“Pebax”(ARKEMA公司的註冊商標)等的尼龍系彈性體。 【00112】   根據具有上述那樣的構成的本實施方式中的除顫導管100,第一引線組41G在第一絕緣性管26內延伸,第二引線組42G在第二絕緣性管27內延伸,第三引線組43G在第三絕緣性管28內延伸,從而即使在把手20的內部中,也可以使第一引線組41G、第二引線組42G、以及第三引線組43G完全絕緣隔離。其結果,在施加了除顫所需的電壓時,能夠可靠地防止把手20的內部中的第一引線組41G、第二引線組42G、以及第三引線組43G之間的短路(尤其在管腔的開口附近延出的引線組之間的短路)。 【00113】   並且,在把手20的內部中,第一絕緣性管26被第一保護管61保護,第二絕緣性管27以及第三絕緣性管28被第二保護管62保護,從而能夠防止在例如多腔管10的前端部的偏轉操作時,由於繩栓22的構成部件(可動零件)接觸、摩擦而導致絕緣性管受到損傷的情況。 【00114】   本實施方式中的除顫管100具備隔板55,該隔板55將配置有多個針狀端子的連接器50的前端面50A隔開為第一端子組區域、第二端子組區域、以及第三端子組區域,使引線41、引線42以及引線43相互隔離。 【00115】   隔開第一端子組區域、第二端子組區域、以及第三端子組區域的隔板55透過將絕緣性樹脂加工成形為在兩側具有平坦面的導水管狀而成。作為構成隔板55的絕緣性樹脂,沒有特別限定,能夠使用聚乙烯等通用樹脂。 【00116】   隔板55的厚度例如為0.1~0.5mm,若示出優選的一個例子則為0.2mm。 【00117】   隔板55的高度(從基端邊緣到前端邊緣的距離)需要比連接器50的前端面50A與絕緣性管(第一絕緣性管26以及第二絕緣性管27)的相距距離高,在該相距距離是7mm的情況下,隔板55的高度例如為8mm。若使用高度小於7mm的隔板,則無法使其前端邊緣位於比絕緣性管的基端靠近前端側。 【00118】   根據這樣的構成,能夠可靠且整齊地隔離構成第一引線組41G的引線41(從第一絕緣性管26的基端開口延出的引線41的基端部分)和構成第二引線組42G的引線42(從第二絕緣性管27的基端開口延出的引線42的基端部分)。 【00119】   在不具備隔板55的情況下,無法整齊地隔離(分開)引線41和引線42,它們有可能混線。 【00120】   而且,被施加互不相同極性的電壓的、構成第一引線組41G的引線41和構成第二引線組42G的引線42被隔板55相互隔離而不會接觸,所以在使用除顫導管100時,即使施加心腔內除顫所需的電壓,也不會在構成第一引線組41G的引線41(從第一絕緣性管26的基端開口延出的引線41的基端部分)和構成第二引線組42G的引線42(從第二絕緣性管27的基端開口延出的引線42的基端部分)之間產生短路。 【00121】   另外,在製造除顫導管時,在將引線連接固定於針狀端子時產生了錯誤的情況下,例如,在將構成第一引線組42G的引線41連接固定於第二端子組區域中的針狀端子的情況下,該引線41會跨越隔板55,所以能夠容易地發現連接的錯誤。 【00122】   此外,構成第三引線組43G的引線43(針狀端子53)和引線42(針狀端子52)一起被隔板55與41(針狀端子51)隔離,但並不限於此,也可以與引線41(針狀端子51)一起被隔板55與引線42(針狀端子52)隔離。 【00123】   在除顫導管100中,隔板55的前端邊緣位於比第一絕緣性管26的基端以及第二絕緣性管27的基端都靠近前端側。 【00124】   由此,在從第一絕緣性管26的基端開口延出的引線(構成第一引線組41G的引線41)與從第二絕緣性管27的基端開口延出的引線(構成第二引線組42G的引線42)之間,始終存在隔板55,從而能夠可靠地防止由引線41和引線42的接觸引起的短路。 【00125】   如圖8所示,從第一絕緣性管26的基端開口延出而被連接固定於連接器50的針狀端子51的八根引線41、從第二絕緣性管27的基端開口延出而被連接固定於連接器50的針狀端子52的八根引線42、以及從第三絕緣性管28的基端開口延出而被連接固定於連接器50的針狀端子53的四根引線43透過用樹脂58固定它們的周圍而保持固定了各自的形狀。 【00126】   保持引線的形狀的樹脂58成形為與連接器50相同直徑的圓筒狀,成為在該樹脂成形體的內部埋入有針狀端子、引線、絕緣性管的基端部以及隔板55的狀態。 【00127】   而且,根據絕緣性管的基端部被埋入於樹脂成形體的內部的構成,能夠透過樹脂58完全覆蓋從絕緣性管的基端開口延出起到被連接固定於針狀端子為止的引線(基端部分)的全域,能夠完全保持固定引線(基端部分)的形狀。 【00128】   另外,樹脂成形體的高度(從基端面到前端面的距離)優選高於隔板55的高度,在隔板55的高度為8mm的情況下,例如設為9mm。 【00129】   此處,作為構成樹脂成形體的樹脂58,沒有特別限定,但優選使用熱固化性樹脂或者光固化性樹脂。具體而言,能夠例示氨基甲酸乙酯類、環氧樹脂類、氨基甲酸乙酯-環氧樹脂類的固化性樹脂。 【00130】   根據上述那樣的構成,由於透過樹脂58保持固定引線的形狀,所以在製造除顫導管100時(在把手20的內部安裝連接器50時),能夠防止從絕緣性管的基端開口延出的引線絞結、或者與針狀端子的邊緣接觸而損傷(例如,在引線的包覆樹脂產生裂紋)。 【00131】   如圖1所示,構成本實施方式的除顫導管系統的電源裝置700具備DC電源部71、導管連接連接器72、心電計連接連接器73、外部開關(輸入單元)74、運算處理部75、切換部76、心電圖輸入連接器77、以及顯示單元78。 【00132】   DC電源部71中內置有電容器,透過外部開關74(充電開關743)的輸入來對內置電容器進行充電。 【00133】   導管連接連接器72與除顫導管100的連接器50連接,與第一引線組(41G)、第二引線組(42G)以及第三引線組(43G)的基端側電連接。 【00134】   如圖9所示,除顫導管100的連接器50和電源裝置700的導管連接連接器72透過連接器電纜C1連結,從而連接固定了構成第一引線組的八根引線41的針狀端子51(實際上為八個)和導管連接連接器72的端子721(實際上為八個)、連接固定了構成第二引線組的八根引線42的針狀端子52(實際上為八個)和導管連接連接器72的端子722(實際上為八個)、連接固定了構成第三引線組的四根引線43的針狀端子53(實際上為四個)和導管連接連接器72的端子723(實際為四個)分別連接。 【00135】   此處,導管連接連接器72的端子721以及端子722與切換部76連接,端子723不經由切換部76而直接被連接於心電計連接連接器73。 【00136】   由此,透過第一DC電極組31G以及第二DC電極組32G測定出的心電位資訊經由切換部76到達心電計連接連接器73,由基端側電位測定電極組33G測定出的心電位資訊不經由切換部76到達心電計連接連接器73。 【00137】   心電計連接連接器73與心電計800的輸入端子連接。 【00138】   作為輸入單元的外部開關74包括:用於切換心電位測定模式和除顫模式的模式切換開關741、設定除顫時施加的電能的施加能量設定開關742、用於對DC電源部71進行充電的充電開關743、以及用於施加電能來進行除顫的能量施加開關(放電開關)744。來自這些外部開關74的輸入信號全部被送到運算處理部75。 【00139】   運算處理部75基於外部開關74的輸入,來控制DC電源部71、切換部76、以及顯示單元78。 【00140】   該運算處理部75具有輸出電路751,該輸出電路751用於將來自DC電源部71的直流電壓經由切換部76輸出至除顫導管100的電極。 【00141】   透過該輸出電路751來施加直流電壓,以使圖9所示的導管連接連接器72的端子721(最終是除顫導管100的第一DC電極組31G)、和導管連接連接器72的端子722(最終是除顫導管100的第二DC電極組33G)成為互不相同極性(一方的電極組是-極時,另一方的電極組是+極)。 【00142】   切換部76由一電路二接點(Single Pole Double Throw:單刀雙擲)的切換開關構成,該一電路二接點的切換開關的公共接點連接導管連接連接器72(端子721以及端子722)、第一接點連接心電計連接連接器73、第二接點連接運算處理部75。 【00143】   即,在選擇了第一接點時(第一接點與公共接點連接時),連結導管連接連接器72和心電計連接連接器73的路徑被確保,在選擇了第二接點時(第二接點與公共接點連接時),連結導管連接連接器72和運算處理部75的路徑被確保。 【00144】   根據外部開關74(模式切換開關741、能量施加開關744)的輸入,由運算處理部75控制切換部76的切換動作。 【00145】   心電圖輸入連接器77與運算處理部75連接,另外,還與心電計800的輸出端子連接。 【00146】   可以透過該心電圖輸入連接器77,將從心電計800輸出的心電位資訊(通常,被輸入至心電計800的心電位信息的一部分)輸入至運算處理部75,在運算處理部75中,能夠根據該心電位資訊控制DC電源部71以及切換部76。 【00147】   顯示單元78與運算處理部75連接,顯示單元78顯示有從心電圖輸入連接器77輸入至運算處理部75的心電位資訊(主要是心電圖(心電位波形)),操作員能夠一邊監視被輸入至運算處理部75的心電位資訊(心電圖)一邊進行除顫治療(外部開關的輸入等)。 【00148】   構成本實施方式的除顫導管系統的心電計800(輸入端子)與電源裝置700的心電計連接連接器73連接,由除顫導管100(第一DC電極組31G、第二DC電極組32G、以及基端側電位測定電極組33G的構成電極)測定出的心電位資訊從心電計連接連接器73被輸入至心電計800。 【00149】   另外,心電計800(其他輸入端子)還與電位測定單元900連接,由心電位測定單元900測定出的心電位資訊也被輸入至心電計800。 【00150】   此處,作為心電位測定單元900,能夠列舉出為了測定12感應心電圖而在患者的身體表面粘貼的電極片、在患者的心臟內安裝的電極導管(與除顫導管100不同的電極導管)。 【00151】   心電計800(輸出端子)與電源裝置700的心電圖輸入連接器77連接,能夠將輸入到心電計800的心電位資訊(來自除顫導管100的心電位資訊以及來自心電位測定單元900的心電位資訊)的一部分經由心電圖輸入連接器77發送到運算處理部75。 【00152】   本實施方式的除顫導管100在無需進行除顫治療時,能夠用作心電位測定用的電極導管。 【00153】   圖10示出在進行心臟導管術(例如高頻治療)時,透過本實施方式的除顫導管100測定心電位時的心電位資訊的流向。此時,電源裝置700的切換部76選擇了連接有心電計連接連接器73的第一接點。 【00154】   由構成除顫導管100的第一DC電極組31G以及∕或者第二DC電極組32G的電極測定出的心電位經由導管連接連接器72、切換部76以及心電計連接連接器73被輸入至心電計800。 【00155】   另外,由構成除顫導管100的基端側電位測定電極組33G的電極測定出的心電位從導管連接連接器72不透過切換部76而直接經由心電計連接連接器73被輸入至心電計800。 【00156】   來自除顫導管100的心電位資訊(心電圖)被顯示於心電計800的顯示器(省略圖示)。 【00157】   另外,能夠將來自除顫導管100的心電位資訊的一部分(例如,構成第一DC電極組31G的電極31(第一極和第二極)之間的電位差)從心電計800經由心電圖輸入連接器77以及運算處理部75輸入至顯示單元78來進行顯示。 【00158】   如上該,在心臟導管術中不需要除顫治療時,能夠將除顫導管100用作心電位測定用的電極導管。 【00159】   而且,在心臟導管術中發生了心房纖顫時,能夠利用被使用作電極導管的除顫導管100立即進行除顫治療。其結果,在發生了心房纖顫時,能夠省去新插入用於除顫的導管等麻煩。 【00160】   運算處理部75根據經由心電圖輸入連接器77從心電計800發送來的心電位資訊的一部分(心電圖),逐次感測該心電圖的被推定為R波的事件(波形)。 【00161】   被推定為R波的事件的感測例如透過以下的方式進行,即:檢測欲感測的週期(跳動)的前一個週期中的最大峰值的波形和前二個週期中的最大峰值波形,算出這些最大峰值波形的平均高度,檢測電位差到達了該平均高度的80%的高度(觸發電平)的情況。 【00162】   另外,運算處理部75以如下的方式進行運算處理來控制DC電源部71,即:對感測出的事件分別識別其極性(以±符號表示的峰值的方向),在輸入能量施加開關744後,在第n次的週期中感測出的事件(Vn)的極性與之前一個週期中感測出的事件(Vn-1)的極性以及之前二個週期中感測出的事件(Vn-2)的極性一致時,與該事件(Vn)同步地對導管連接連接器72的端子721(第一DC電極組31G)、和導管連接連接器72的端子722(第二DC電極組32G)施加電壓。 【00163】   在圖16A至圖16D所示的心電圖中,被推定為R波而感測出的六個事件中的、從左邊數第三個事件的極性是(-)(其峰值波形朝下),其他的五個事件的極性是(+)(其峰值波形朝上)。 【00164】   如圖16A所示,在感測出從左邊數第二個的事件(V0)後輸入了能量施加開關744的情況下,第三個事件(V1)的極性(-)與前一個週期中感測出的第二個事件(V0)的極性(+)不同,所以不與該事件(V1)同步地施加電壓。 【00165】   另外,第四個事件(V2)的極性(+)與在前一個週期中感測的第三個事件(V1)的極性(-)不同,所以不與該事件(V2)同步地施加電壓。 【00166】   另外,第五個事件(V3)的極性(+)與在前二個週期中感測的第三個事件(V1)的極性(-)不同,所以不與該事件(V3)同步地施加電壓。 【00167】   第六個事件(V4)的極性(+)與在前一個週期中感測出的第五個事件(V3)的極性(+)以及前二個週期中感測的第四個事件(V2)的極性(+)相同,所以與該事件(V4)同步地對第一DC電極組31G以及第二DC電極組32G施加電壓。 【00168】   如圖16B所示,在感測出從左邊數第三個事件(V0)後輸入了能量施加開關744的情況下,第四個事件(V1)的極性(+)與在前一個週期中感測出的第三個事件(V0)的極性(-)不同,所以不與該事件(V1)同步地施加電壓。 【00169】   另外,第五個事件(V2)的極性(+)與在前二個週期中感測出的第三個事件(V0)的極性(-)不同,所以不與該事件(V2)同步地施加電壓。 【00170】   第六個事件(V3)的極性(+)與在前一個週期中感測出的第五個事件(V2)的極性(+)以及在前二個週期中感測出的第四個事件(V1)的極性(+)相同,所以與該事件(V3)同步地對第一DC電極組31G以及第二DC電極組32G施加電壓。 【00171】   如圖16C所示,在感測出從左邊數第四個事件(V0)後輸入了能量施加開關744的情況下,第五個事件(V1)的極性(+)與在前二個週期中感測的第三個事件(V-1)的極性(-)不同,所以不與該事件(V1)同步地施加電壓。 【00172】   第六個事件(V2)的極性(+)與在前一個週期中感測出的第五個事件(V1)的極性(+)以及在前二個週期中感測出的第四個事件(V0)的極性(+)相同,所以與該事件(V2)同步地對第一DC電極組31G以及第二DC電極組32G施加電壓。 【00173】   如圖16D所示,在感測出從左邊數第五個事件(V0)後輸入了能量施加開關744的情況下,第六個事件(V1)的極性(+)與在前一個週期中感測出的第五個事件(V0)的極性(+)以及在前二個週期中感測出的第四個事件(V-1)的極性(+)相同,所以與該事件(V1)同步地對第一DC電極組31G以及第二DC電極組32G施加電壓。 【00174】   如上所述,即使在圖16A至圖16D所示的任意的時間輸入了能量施加開關744的情況下,均與相同極性(+)連續三次時的第三個事件(從左邊數第六個事件)同步地施加電壓。 【00175】   另外,運算處理部75在被輸入的心電圖中感測出被推定為R波的事件後的260m秒間,對DC電源部71進行控制,以便不對第一DC電極組31G以及第二DC電極組32G施加電壓。 【00176】   由此,感測出的事件是R波的峰值的情況下,能夠可靠地避免在其下一個T波出現的時刻進行除顫。也就是說,對被推定為T波的峰值進行遮罩來使其無法除顫。 【00177】   此外,在感測出事件後,作為不施加直流電壓的期間,並不侷限於260m秒,最短為50m秒,最長為500m秒。在該期間比50m秒短的情況下,有時無法對被推定為T波的峰值進行遮罩。另一方面,在該期間比500m秒長的情況下,有時無法感測下個週期(跳動)中的R波。 【00178】   另外,運算處理部75在感測出推定為R波的事件後100m秒間,進行程式設計以便不新感測被推定為R波的事件。 【00179】   由此,接著R波,在與該R波相反的方向(相反的極性)出現的S波的峰值增大而到達了觸發電平的情況(即使在該狀態下進行除顫也沒有特別問題)下,能夠防止透過感測該S波的峰值,導致事件的極性的連續性受損(相同極性的計數被重置)的情況。 【00180】   此外,感測出事件之後,作為不新感測被推定為R波的事件的期間(抑制期間),並不侷限於100m秒,最短為10m秒,最長為150m秒。 【00181】   並且,運算處理部75在能量施加開關744的輸入後260m秒間,控制DC電源部71,以便不對第一DC電極組31G以及第二DC電極組32G施加電壓。 【00182】   由此,能夠防止將由於能量施加開關744的輸入而產生的雜訊(與之前一次以及前二次的事件不同極性的雜訊)錯誤地感測為R波,並與該雜訊同步地進行除顫這樣的情況。 【00183】   另外,能夠防止透過由於能量施加開關744的輸入而產生的雜訊(與之前一次以及/或者前二次的事件不同極性的雜訊)而損害事件的極性的連續性(相同極性的計數被重置)的情況。 【00184】   並且,也能夠防止將能量施加開關744的輸入後產生的基準線的變動錯誤地感測為R波,並與此同步地進行除顫的情況。 【00185】    此外,能量施加開關744的輸入後,作為不施加直流電壓的期間,並不侷限於260m秒間,最短為10m秒間,最長為500m秒間。 【00186】   以下,按照圖11所示的流程圖對本實施方式的心腔內除顫導管系統的除顫治療的一個例子進行說明。 【00187】   (1)首先,透過X射線圖像,確認除顫導管100的電極(第一DC電極組31G、第二DC電極組32G以及基端側電位測定電極組33G的構成電極)的位置,並且選擇從心電位測定單元900(在身體表面粘貼的電極片)輸入到心電計800的心電位資訊(12感應心電圖)的一部分,來從心電圖輸入連接器77輸入到電源裝置700的運算處理部75(圖11A的步驟1)。此時,輸入到運算處理部75的心電位資訊的一部分被顯示於顯示單元78(參照圖12)。另外,從除顫導管100的第一DC電極組31G以及/或者第二DC電極組32G的構成電極經由導管連接連接器72、切換部76、心電計連接連接器73輸入到心電計800的心電位資訊、從除顫導管100的基端側電位測定電極組33G的構成電極經由導管連接連接器72、心電計連接連接器73輸入到心電計800的心電位資訊被顯示於心電計800的顯示器(省略圖示)。 【00188】   (2)接下來,輸入作為外部開關74的模式切換開關741。本實施方式中的電源裝置700在初始狀態下是“心電位測定模式”,切換部76選擇第一接點,從導管連接連接器72經由切換部76到達心電計連接連接器73的路徑被確保。透過模式切換開關741的輸入成為“除顫模式”(步驟2)。 【00189】   (3)如圖13所示,若模式切換開關741被輸入而被切換成除顫模式,則透過運算處理部75的控制信號,切換部76的接點被切換到第二接點,並從導管連接連接器72經由切換部76到達運算處理部75的路徑被確保,從導管連接連接器72經由切換部76到達心電計連接連接器73的路徑被切斷(步驟3)。在切換部76選擇了第二接點時,來自除顫導管100的第一DC電極組31G以及第二DC電極組32G的構成電極的心電位資訊無法輸入到心電計800(因此,也無法將該心電位資訊發送到運算處理部75。)。但是,不經由切換部76的來自基端側電位測定電極組33G的構成電極的心電位資訊被輸入到心電計800。 【00190】   (4)在切換部76的接點被切換到第二接點時,測定除顫導管100的第一DC電極組(31G)與第二電極組(32G)之間的電阻(步驟4)。從導管連接連接器72經由切換部76輸入到運算處理部75的電阻值與輸入到運算處理部75的來自心電位測定單元900的心電位資訊的一部分一起被顯示於顯示單元78(參照圖13)。 【00191】   (5)切換部76的接點被切換到第一接點,從導管連接連接器72經由切換部76到達心電計連接連接器73的路徑恢復(步驟5)。此外,切換部76的接點選擇了第二接點的時間(上述步驟3~步驟5)例如為1秒間。 【00192】   (6)運算處理部75判定在步驟4中測定出的電阻是否超過了一定的值,在未超過的情況下,進入接下來的步驟7(用於施加直流電壓的準備),在超過的情況下,返回步驟1(除顫導管100的電極的位置確認)(步驟6)。 【00193】   此處,在電阻超過了一定的值的情況下,意味著第一DC電極組以及/或者第二電極組沒有可靠地抵接到規定的部位(例如,冠狀靜脈的管壁、右心房的內壁),所以需要返回步驟1,重新調整電極的位置。 【00194】   這樣,由於只有在除顫導管100的第一DC電極組以及第二DC電極組可靠地抵接到規定的部位(例如,冠狀靜脈的管壁、右心房的內壁)時能夠施加電壓,所以能夠進行高效的除顫治療。 【00195】   (7)輸入作為外部開關74的施加能量設定開關742,來設定除顫時的施加能量(圖11B的步驟7)。根據本實施方式中的電源裝置700,能夠從1J到30J,以1J的刻度來設定施加能量。 【00196】   (8)輸入作為外部開關74的充電開關743,對DC電源部71的內置電容器進行能量的充電(步驟8)。 【00197】   (9)在充電完成後,輸入作為外部開關74的能量施加開關744(步驟9)。 【00198】   (10)作為表示後述的步驟12中感測的這次的事件(Vn)是輸入能量施加開關744後第幾次感測的事件的數(n),使“1”產生(步驟10)。 【00199】   (11)運算處理部75以感測前一次的事件(Vn-1)(能量施加開關744的輸入不久前感測到的事件)後100m秒間作為抑制期間,進行待機而不進行新的感測(步驟11)。 【00200】   (12)經過抑制期間後,運算處理部75對事件(Vn)進行感測(步驟12)。 【00201】   (13)運算處理部75判定在步驟12中感測出的事件(Vn)的極性是否與上次(前一個感測出)的事件(Vn-1)的極性一致,在一致的情況下,進入步驟14,在不一致的情況下,在步驟10’中,對上述的數(n)加1並返回步驟11(步驟13)。 【00202】   (14)運算處理部75判定在步驟12中感測出的事件(Vn)的極性是否與再上次(之前二個感測出)的事件(Vn-2)的極性一致,在一致的情況下,進入步驟15,在不一致的情況下,在步驟10’中,對上述的數(n)加1並返回步驟11(步驟14)。 【00203】   (15)運算處理部75判定從感測到上次事件(Vn-1)起到感測事件(Vn)為止的時間是否超過260m秒,在超過的情況下,進入步驟16,在未超過的情況下,在步驟10’中,對上述的數(n)加1並返回步驟11(圖11的步驟15)。 【00204】   (16)運算處理部75判定從輸入能量施加開關744起到感測事件(Vn)為止的時間是否超過260秒,在超過的情況下,進入步驟17,在未超過的情況下,在步驟10’中,對上述的數(n)加1並返回步驟11(步驟16)。 【00205】   (17)透過運算處理部75,切換部76的接點被切換到第二接點,從導管連接連接器72經由切換部76到達運算處理部75的路徑被確保,從導管連接連接器72經由切換部76到達心電計連接連接器73的路徑被切斷(步驟17)。 【00206】   (18)在切換部76的接點被切換到第二接點後,從接受到來自運算處理部75的控制信號的DC電源部71經由運算處理部75的輸出電路751、切換部76以及導管連接連接器72,對除顫導管100的第一DC電極組和第二DC電極組施加互不相同極性的直流電壓(步驟18,參照圖14)。 【00207】   此處,運算處理部75進行運算處理來對DC電源部71發送控制信號,以便與步驟12中感測出的事件(Vn)同步地對第一DC電極組以及第二DC電極組施加直流電壓。 【00208】   具體而言,從感測出事件(Vn)的時刻(下一個R波上升時)起經過一定時間(例如,事件(Vn)的R波的峰值寬度的1/10左右的極短的時間)之後開始施加。 【00209】   圖15是表示透過本實施方式的除顫導管100賦予了規定的電能(例如,設定輸出=10J)時所測定的電位波形的圖。在該圖中,橫軸表示時間,縱軸表示電位。 【00210】   首先,在運算處理部75感測事件(Vn)起經過一定時間(t0)後,以使第一DC電極組31G成為-極、第二DC電極組32G成為+極的方式對兩者之間施加直流電壓,從而被供給電能而測定電位上升(E1是此時的峰值電壓。)。經過一定時間(t1)之後,以使第一DC電極組31G成為+極、第二DC電極組32G成為-極的方式對兩者之間施加反轉了±的直流電壓,從而被供給電能而測定電位上升(E2是此時的峰值電壓。)。 【00211】   此處,從感測事件(Vn)起到開始施加為止的時間(t0)例如為0.01~0.05秒,若示出優選的一個例子則為0.01秒,時間(t=t1+t2)例如為0.006~0.03秒,若示出優選的一個例子則為0.02秒。由此,能夠與作為R波的事件(Vn)同步地施加電壓,能夠進行高效的除顫治療。 【00212】   所測定的峰值電壓(E1)例如為300~600V。 【00213】   (19)從感測事件(Vn)起經過一定時間(t0+t)後,接受來自運算處理部75的控制信號而停止從DC電源部71施加電壓(步驟19)。 【00214】   (20)在電壓的施加停止之後,施加記錄(如圖15所示那樣的施加時的心電位波形)被顯示於顯示單元78(步驟20)。作為顯示時間例如為5秒。 【00215】   (21)切換部76的接點被切換到第一接點,從導管連接連接器72經由切換部76到達心電計連接連接器73的路徑恢復,來自除顫導管100的第一DC電極組31G以及第二DC電極組32G的構成電極的心電位資訊被輸入至心電計800(步驟21)。 【00216】   (22)觀察顯示於心電計800的顯示器的、來自除顫導管100的構成電極(第一DC電極組31G、第二DC電極組32G以及基端側電位測定電極組33G的構成電極)的心電位資訊(心電圖)、以及來自心電位測定單元900的心電位資訊(12感應心電圖),如果是“正常”則結束,在“不正常(心房纖顫未治癒)”的情況下,返回步驟2(步驟22)。 【00217】   根據本實施方式的導管系統,透過除顫導管100的第一DC電極組31G以及第二DC電極組32G能夠對發生纖顫的心臟直接提供電能,並能夠僅對心臟可靠地提供除顫治療所需且充分的電刺激(電衝擊)。 【00218】   而且,由於能夠對心臟直接提供電能,所以也不會在患者的體表產生燒傷。 【00219】   另外,由基端側電位測定電極組33G的構成電極33測定出的心電位資訊從導管連接連接器72不經由切換部76而經由心電計連接連接器73被輸入至心電計800,並且,該心電計800連接有心電位測定單元900,因而即使在心電計800無法獲取來自除顫導管100的第一DC電極組31G以及第二DC電極組32G的心電位的除顫治療時(切換部76被切換到接點2,從導管連接連接器72經由切換部76到達心電計連接連接器73的路徑被切斷時),心電計800也能夠獲取由基端側電位測定電極組33G以及心電位測定單元900測定出的心電位資訊,並且能夠一邊在心電計800中監視(監控)心電位一邊進行除顫治療。 【00220】   並且,由於電源裝置700的運算處理部75按與經由心電圖輸入連接器77輸入的心電位波形同步地施加電壓方式進行運算處理來對於DC電源部71進行控制(從心電位波形中的電位差到達觸發電平起經過一定時間(例如0.01秒)後開始施加),所以能夠對除顫導管100的第一DC電極組31G以及第二DC電極組32G,與心電位波形同步地施加電壓,並購能夠進行高效的除顫治療。 【00221】   並且,運算處理部75在除顫導管100的電極組間的電阻未超過一定的值的情況下,即,僅在第一DC電極組31G以及第二DC電極組32G可靠地抵接到規定的部位(例如,冠狀靜脈的管壁、右心房的內壁)時,進行控制以便能夠進入用於施加直流電壓的準備,因此能夠進行有效的除顫治療。 【00222】   並且,運算處理部75以如下的方式進行運算來對DC電源部71進行控制,即:在經由心電圖輸入連接器77從心電計800輸入的心電圖中,逐次感測被推定為R波的事件,在能量施加開關744的輸入之後,第n次感測到的事件(Vn)的極性與前一次感測出的事件(Vn-1)的極性以及之前二次感測出的事件(Vn-2)的極性一致時,與事件(Vn)同步地對第一DC電極組31G以及第二DC電極組32施加電壓,從而如果連續感測到的三個事件(Vn-2)、(Vn-1)、以及(Vn)的極性不一致,則不與事件(Vn)同步地施加電壓,而僅在三個事件(Vn-2)、(Vn-1)以及(Vn)的極性一致時,與第三次的事件(Vn)同步地施加電壓,因此能夠可靠地進行與R波同步的除顫。 【00223】   圖17A是在患者的心臟發生單發性期外收縮時被輸入到運算處理部75的心電圖(與圖19所示的相同的心電位波形)。在圖17A中,從左邊數第四個的R波(事件(V0))的極性是(-),接著的T波的峰值增大,該T波被感測為事件(V1)。 【00224】   如該圖所示,在感測到事件(V0)後輸入了能量施加開關744的情況下,其不久後感測到的事件(V1)的極性(+)與之前一個感測到的事件(V0)的極性(-)不同,因此不與該事件(V1)同步地施加電壓。由此,能夠避免與峰值增大而被誤認為R波的T波同步地施加電壓。 【00225】   另外,事件(V1)的下一個感測到的事件(V2)是R波的峰值,但其極性(+)與前二個感測到的事件(V0)的極性(-)不同,因此不與該事件(V2)同步地施加電壓。 【00226】   而且,由於事件(V2)的下一個感測到的事件(V3)的極性(+)與前一個感測到的事件(V2)的極性(+)以及前二個感測到的事件(V1)的極性(+)相同,所以與能夠確信為R波的峰值的事件(V3)同步地對第一DC電極組31G以及第二DC電極組32G施加電壓。 【00227】   圖17B是在患者的心臟連續地發生期外收縮時,輸入到運算處理部75的心電圖。 【00228】   如該圖所示,在感測到由於期外收縮而極性反轉成(-)的事件(V0)後輸入了能量施加開關744的情況下,其不久之後感測到的事件(V1)的極性為(+),下一個感測到的事件(V2)的極性為(-),下一個感測出的事件(V3)的極性為(+),下一個感測出的事件(V4)的極性為(-),下一個感測出的事件(V5)的極性為(+),事件的極性交替地變化。因此,這樣地,在連續感測到的三個事件的極性不一致的狀態下,判斷為這些事件的每一個可能不是R波的峰值,從而不與該事件同步地施加電壓。 【00229】   另外,事件(V5)的下一個感測到的事件(V6)的極性(+)是R波的峰值,但其極性(+)與前二個感測到的事件(V4)的極性(-)不同,所以不與該事件(V6)同步地施加電壓。 【00230】   而且,由於事件(V6)的下一個感測到的事件(V7)的極性(+)與事件(V6)的極性(+)以及事件(V5)的極性(+)相同,所以判斷為在事件(V7)的感測時期外收縮可靠地治癒,與能夠確信為R波的峰值的事件(V7)同步地對第一DC電極組31G以及第二DC電極組32G施加電壓。 【00231】   圖18是漂移發生而基準線下降,之後,基準線上升並恢復到原來的電平的心電圖(與圖20所示的相同的心電位波形),基準線的下降以及上升被誤認為R波,分別被感測為事件(V-1)以及事件(V1)。 【00232】   如圖18所示,在基準線上升之前輸入了能量施加開關744的情況下,其不久後感測到的事件(V1)的極性(+)與前一個感測到的事件(V0)的極性(+)相同,但與前二個感測到的事件(V-1)的極性(-)不同,所以不與該事件(V1)同步地施加電壓,由此,能夠避免與被誤認為R波的基準線的上升時同步地施加電壓。 【00233】   而且,由於事件(V1)的下一個感測到的事件(V2)的極性(+)與前一個感測到的事件(V1)的極性(+)以及前二個感測到的事件(V0)的極性(+)相同,所以判斷為在事件(V2)的感測時基準線穩定,與能夠確信為R波的峰值的事件(V2)同步地對第一DC電極組31G以及第二DC電極組32G施加電壓。 【00234】   並且,運算處理部75在感測到被推定為R波的事件後260m秒間,控制DC電源部71,以便不對第一DC電極組31G以及第二DC電極組32G施加直流電壓,所以在感測到的事件是R波的峰值的情況下,能夠可靠地避免在下一個T波出現的時刻進行除顫。 【00235】   並且,運算處理部75在感測到被推定為R波的事件之後的100m秒間進行程式設計,以便不新感測被推定為R波的事件,因此在感測到的事件是R波的峰值,接著該R波在相反方向出現的S波的峰值增大而到達觸發電平這樣的情況下,能夠防止感測該S波的峰值而相同極性的計數被重置的情況。 【00236】   並且,由於運算處理部75在能量施加開關744的輸入之後260m秒間,控制DC電源部71,以便不對第一DC電極組31G以及第二DC電極組32G施加直流電壓,所以能夠防止將由能量施加開關744的輸入而產生的雜訊錯誤地感測為R波,並與該雜訊同步地進行除顫,或者由於該雜訊而相同極性的計數被重置的情況。 【00237】   以上,對本發明的一實施方式進行了說明,但本發明的除顫導管系統並不侷限於此,能夠進行各種的變更。 【00238】   例如,電源裝置的運算處理部也可以按如下的方式進行運算處理來控制DC電源部,即:在能量施加開關的輸入後感測到的事件(Vn)的極性與之前一個感測到的事件(Vn-1)的極性、之前二個感測到的事件(Vn-2)的極性、以及之前三個感測到的事件(Vn-3)的極性一致時(相同極性連續四次時),與第四次的事件(Vn)同步地對第一DC電極組以及第二DC電極組施加電壓。Further, as shown in FIGS. 6 to 8, three insulating tubes (first insulating tubes 26) that are respectively inserted by the three lead groups (the first lead group 41G, the second lead group 42G, and the third lead group 43G) are inserted. The second insulating tube 27 and the third insulating tube 28) extend inside the handle 20. [00100] As shown in FIGS. 6 and 7, the distal end portion of the first insulating tube 26 (about 10 mm from the front end) is inserted into the first lumen 11 of the multi-lumen tube 10, whereby the first insulating tube 26 is coupled to the first lumen 11 extending from the first lead set 41G. [00101] The first insulating tube 26 coupled to the first lumen 11 extends through the inner hole of the first protective tube 61 extending inside the handle 20 to the connector 50 (the front end face 50A of the needle terminal is disposed) In the vicinity of the connector, an insertion passage for guiding the proximal end portion of the first lead group 41G to the vicinity of the connector 50 is formed. Thereby, the first lead group 41G extending from the multi-lumen tube 10 (the first lumen 11) can be extended inside the handle 20 (the inner hole of the first insulating tube 26) without being twisted. [00102] The first lead group 41G extending from the proximal end opening of the first insulating tube 26 is detached into eight lead wires 41 constituting the first lead group 41G, and these leads 41 are connected and fixed by soldering, respectively. Each of the needle terminals of the front end face 50A of the connector 50. Here, a region in which the needle terminals (needle terminals 51) constituting the lead wires 41 of the first lead group 41G are connected is referred to as a "first terminal group region". The front end portion of the second insulating tube 27 (about 10 mm from the front end) is inserted into the second lumen 12 of the multi-lumen tube 10, whereby the second insulating tube 27 is joined to the second lead group 42G. The second lumen 12. [00104] The second insulating tube 27 coupled to the second lumen 12 extends through the inner hole of the second protective tube 62 extending inside the handle 20 to the connector 50 (the front end face 50A of the needle terminal is disposed) In the vicinity of the connector, an insertion passage for guiding the proximal end portion of the second lead group 42G to the vicinity of the connector 50 is formed. Thereby, the second lead group 42G extending from the multi-lumen tube 10 (the second lumen 12) can be extended inside the handle 20 (the inner hole of the second insulating tube 27) without being twisted. [00105] The second lead group 42G extending from the base end opening of the second insulating tube 27 is detached into eight lead wires 42 constituting the second lead group 42G, and these leads 42 are connected and fixed by soldering, respectively. Each of the needle terminals of the front end face 50A of the connector 50. Here, a region in which the needle terminals (needle terminals 52) constituting the lead wires 42 of the second lead group 42G are connected and fixed is referred to as a "second terminal group region". The front end portion of the third insulating tube 28 (about 10 mm from the front end) is inserted into the third lumen 13 of the multi-lumen tube 10, whereby the third insulating tube 28 is joined to the third lead group 43G. The third lumen 13. [00107] The third insulating tube 28 coupled to the third lumen 13 extends through the inner hole of the second protective tube 62 extending inside the handle 20 to the connector 50 (the front end face 50A of the needle terminal is disposed) In the vicinity of the connector, an insertion passage for guiding the proximal end portion of the third lead group 43G to the vicinity of the connector 50 is formed. Thereby, the third lead group 43G extending from the multi-lumen tube 10 (the third lumen 13) can be extended inside the handle 20 (the inner hole of the third insulating tube 28) without being twisted. [00108] The third lead group 43G extending from the base end opening of the third insulating tube 28 is detached into four lead wires 43 constituting the third lead group 43G, and these lead wires 43 are connected and fixed by soldering, respectively. Each of the needle terminals of the front end face 50A of the connector 50. Here, a region in which the needle terminals (needle terminals 53) constituting the lead wires 43 constituting the third lead group 43G are connected is referred to as a "third terminal group region". [00109] 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), a polyimide resin, a polyamide resin, and the like can be exemplified. Polyamine-quinone imine resin and the like. Among them, a polyimide film having a high hardness and easily inserted into a lead group and capable of achieving thin-wall molding is particularly preferable. [00110] The thickness of the insulating tube is preferably 20 to 40 μm, and is preferably 30 μm as a preferred example. [00111] In addition, as a constituent material of the protective tube (the first protective tube 61 and the second protective tube 62) in which the insulating tube is inserted, a nylon-based elastomer such as "Pebax" (registered trademark of ARKEMA) can be exemplified. . According to the defibrillation catheter 100 of the present embodiment having the above-described configuration, the first lead group 41G extends in the first insulating tube 26, and the second lead group 42G extends in the second insulating tube 27. The third lead group 43G extends inside the third insulating tube 28, so that the first lead group 41G, the second lead group 42G, and the third lead group 43G can be completely insulated from each other even in the inside of the handle 20. As a result, when the voltage required for defibrillation is applied, the short circuit between the first lead group 41G, the second lead group 42G, and the third lead group 43G in the inside of the handle 20 can be reliably prevented (especially in the tube A short circuit between the lead sets extending near the opening of the cavity). [00113] Further, in the inside of the handle 20, the first insulating tube 26 is protected by the first protective tube 61, and the second insulating tube 27 and the third insulating tube 28 are protected by the second protective tube 62, thereby being able to prevent For example, at the time of the yaw operation of the distal end portion of the multi-lumen tube 10, the insulating tube is damaged due to contact or friction of constituent members (movable parts) of the cord plug 22. [00114] The defibrillation tube 100 in the present embodiment includes a partition plate 55 that partitions the front end surface 50A of the connector 50 in which a plurality of needle terminals are disposed as a first terminal group region and a second terminal group The region and the third terminal group region separate the lead 41, the lead 42 and the lead 43 from each other. [0015] The separator 55 that partitions the first terminal group region, the second terminal group region, and the third terminal group region is formed by processing an insulating resin into a water-conducting tube having a flat surface on both sides. The insulating resin constituting the separator 55 is not particularly limited, and a general-purpose resin such as polyethylene can be used. [00116] The thickness of the partition 55 is, for example, 0. 1~0. 5mm, if a preferred example is shown, it is 0. 2mm. [00117] The height of the partition 55 (the distance from the base end edge to the front end edge) needs to be longer than the distance between the front end face 50A of the connector 50 and the insulating tubes (the first insulating tube 26 and the second insulating tube 27). High, in the case where the distance is 7 mm, the height of the partition 55 is, for example, 8 mm. If a separator having a height of less than 7 mm is used, the leading edge cannot be positioned closer to the front end than the base end of the insulating tube. According to such a configuration, the lead 41 constituting the first lead group 41G (the base end portion of the lead 41 extending from the base end opening of the first insulating tube 26) and the second lead can be reliably and neatly separated. A lead 42 of the group 42G (a base end portion of the lead 42 extending from the base end opening of the second insulating tube 27). [00119] Without the spacer 55, the leads 41 and the leads 42 cannot be neatly separated (separated), and they are likely to be mixed. Further, the lead 41 constituting the first lead group 41G and the lead 42 constituting the second lead group 42G to which voltages of mutually different polarities are applied are separated from each other by the spacer 55 without contact, so defibrillation is used. At the time of the catheter 100, even if the voltage required for defibrillation in the cardiac chamber is applied, the lead 41 constituting the first lead group 41G (the base end portion of the lead 41 extending from the proximal end opening of the first insulating tube 26) is not present. A short circuit occurs between the lead 42 constituting the second lead group 42G (the base end portion of the lead 42 extending from the proximal end opening of the second insulating tube 27). Further, in the case of manufacturing a defibrillation catheter, when an error occurs in fixing the lead wire to the pin terminal, for example, the lead wire 41 constituting the first lead wire group 42G is connected and fixed to the second terminal group region. In the case of the needle terminal in the middle, the lead 41 crosses the partition 55, so that the connection error can be easily found. [00122] Further, the lead 43 (needle terminal 53) constituting the third lead group 43G and the lead 42 (needle terminal 52) are separated together by the spacers 55 and 41 (the pin terminal 51), but are not limited thereto. It is also possible to be separated from the lead 42 (needle terminal 52) by the spacer 55 together with the lead 41 (the pin terminal 51). [00123] In the defibrillation catheter 100, the front end edge of the partition plate 55 is located closer to the front end side than the base end of the first insulating tube 26 and the proximal end of the second insulating tube 27. Thereby, the lead wire extending from the base end opening of the first insulating tube 26 (the lead wire 41 constituting the first lead group 41G) and the lead wire extending from the base end opening of the second insulating tube 27 ( The separator 55 is always present between the leads 42) constituting the second lead group 42G, so that the short circuit caused by the contact of the lead 41 and the lead 42 can be reliably prevented. As shown in FIG. 8, the eight lead wires 41 extending from the proximal end opening of the first insulating tube 26 and fixed to the pin terminals 51 of the connector 50, and the base from the second insulating tube 27 The eight lead wires 42 that are extended and connected to the pin terminals 52 of the connector 50 and the pin terminals 53 that are extended from the base end opening of the third insulating tube 28 and are connected and fixed to the connector 50 The four lead wires 43 are fixed to their respective shapes by fixing their circumference with the resin 58. The resin 58 that retains the shape of the lead is formed into a cylindrical shape having the same diameter as the connector 50, and a needle terminal, a lead, a base end portion of the insulating tube, and a spacer are embedded in the resin molded body. The state of 55. Further, according to the configuration in which the base end portion of the insulating tube is embedded in the resin molded body, the resin 58 can be completely covered and extended from the base end opening of the insulating tube to be connected and fixed to the needle terminal. The entire circumference of the lead (base end portion) can completely maintain the shape of the fixed lead (base end portion). Further, the height of the resin molded body (distance from the base end surface to the front end surface) is preferably higher than the height of the separator 55, and when the height of the separator 55 is 8 mm, for example, it is set to 9 mm. Here, the resin 58 constituting the resin molded body is not particularly limited, but a thermosetting resin or a photocurable resin is preferably used. Specifically, a curable resin such as a urethane type, an epoxy resin, or a urethane-epoxy resin can be exemplified. According to the configuration described above, since the transmission resin 58 holds the shape of the fixed lead, when the defibrillation catheter 100 is manufactured (when the connector 50 is mounted inside the handle 20), the opening from the base end of the insulating tube can be prevented. The extended lead is twisted or damaged by contact with the edge of the pin terminal (for example, cracking occurs in the coating resin of the lead). As shown in FIG. 1, the power supply device 700 constituting the defibrillation catheter system of the present embodiment includes a DC power supply unit 71, a catheter connection connector 72, an electrocardiographic connection connector 73, an external switch (input unit) 74, The arithmetic processing unit 75, the switching unit 76, the electrocardiogram input connector 77, and the display unit 78. [00132] A capacitor is built in the DC power supply unit 71, and the built-in capacitor is charged by the input of the external switch 74 (charging switch 743). [00133] The catheter connection connector 72 is connected to the connector 50 of the defibrillation catheter 100, and is electrically connected to the proximal end sides of the first lead set (41G), the second lead set (42G), and the third lead set (43G). [00134] As shown in FIG. 9, the connector 50 of the defibrillation catheter 100 and the catheter connection connector 72 of the power supply device 700 are coupled through the connector cable C1, thereby connecting and fixing the needles of the eight lead wires 41 constituting the first lead group. The terminals 51 (actually eight) and the terminals 721 (actually eight) of the conduit connection connector 72 are connected to the pin terminals 52 of the eight lead wires 42 constituting the second lead group (actually eight) And a terminal 722 (actually eight) of the conduit connection connector 72, a pin terminal 53 (actually four) that connects and fixes the four leads 43 of the third lead group, and a conduit connection connector 72 The terminals 723 (actually four) are connected separately. Here, the terminal 721 and the terminal 722 of the catheter connection connector 72 are connected to the switching unit 76, and the terminal 723 is directly connected to the electrocardiographic connection connector 73 without passing through the switching unit 76. By this, the cardiac potential information measured by the first DC electrode group 31G and the second DC electrode group 32G reaches the electrocardiographic connection connector 73 via the switching unit 76, and is measured by the proximal end side potential measurement electrode group 33G. The cardiac potential information does not reach the electrocardiographic connection connector 73 via the switching portion 76. [00137] The electrocardiographic connection connector 73 is connected to the input terminal of the electrocardiograph 800. [00138] The external switch 74 as an input unit includes a mode changeover switch 741 for switching the cardiac potential measurement mode and the defibrillation mode, an applied energy setting switch 742 for setting electric energy applied during defibrillation, and a pair of DC power supply sections 71. A charging switch 743 for charging and an energy application switch (discharging switch) 744 for applying electric energy for defibrillation are provided. All of the input signals from these external switches 74 are sent to the arithmetic processing unit 75. The arithmetic processing unit 75 controls the DC power supply unit 71, the switching unit 76, and the display unit 78 based on the input of the external switch 74. The arithmetic processing unit 75 has an output circuit 751 for outputting a DC voltage from the DC power supply unit 71 to the electrode of the defibrillation catheter 100 via the switching unit 76. [00141] A DC voltage is applied through the output circuit 751 such that the terminal 721 of the catheter connection connector 72 shown in FIG. 9 (finally the first DC electrode group 31G of the defibrillation catheter 100), and the catheter connection connector 72 The terminal 722 (finally, the second DC electrode group 33G of the defibrillation catheter 100) has different polarities (when one electrode group is a -pole, the other electrode group is a + pole). [00142] The switching unit 76 is composed of a switch of a single pole double throw (Single Pole Double Throw), and the common contact of the switch of the two contacts of the circuit is connected with the conduit connecting connector 72 (terminal 721 and The terminal 722), the first contact are connected to the electrocardiographic connector 73, and the second contact is connected to the arithmetic processing unit 75. [00143] That is, when the first contact is selected (when the first contact is connected to the common contact), the path connecting the conduit connection connector 72 and the electrocardiographic connection connector 73 is ensured, and the second is selected. At the time of the contact (when the second contact is connected to the common contact), the path connecting the conduit connection connector 72 and the arithmetic processing unit 75 is secured. [00144] The arithmetic processing unit 75 controls the switching operation of the switching unit 76 based on the input of the external switch 74 (the mode switching switch 741 and the energy application switch 744). [00145] The electrocardiogram input connector 77 is connected to the arithmetic processing unit 75, and is also connected to the output terminal of the electrocardiograph 800. [00146] The electrocardiogram input connector 77 can be used to input the cardiac potential information (usually a part of the cardiac potential information input to the electrocardiograph 800) output from the electrocardiograph 800 to the arithmetic processing unit 75, and perform arithmetic processing. In the unit 75, the DC power supply unit 71 and the switching unit 76 can be controlled based on the cardiac potential information. The display unit 78 is connected to the arithmetic processing unit 75, and the display unit 78 displays the heart potential information (mainly an electrocardiogram (cardiac potential waveform)) input from the electrocardiogram input connector 77 to the arithmetic processing unit 75, and the operator can monitor Defibrillation therapy (input of an external switch, etc.) is performed while being input to the cardiac potential information (electrocardiogram) of the arithmetic processing unit 75. [00148] The electrocardiograph 800 (input terminal) constituting the defibrillation catheter system of the present embodiment is connected to the electrocardiograph connection connector 73 of the power supply device 700, and is provided by the defibrillation catheter 100 (first DC electrode group 31G, second) The cardiac potential information measured by the DC electrode group 32G and the constituent electrode of the proximal end side potential measurement electrode group 33G is input to the electrocardiograph 800 from the electrocardiographic connection connector 73. [00149] Further, the electrocardiograph 800 (other input terminal) is also connected to the potential measuring unit 900, and the cardiac potential information measured by the cardiac potential measuring unit 900 is also input to the electrocardiograph 800. Here, as the cardiac potential measuring unit 900, an electrode sheet attached to the body surface of the patient for measuring the 12-induction electrocardiogram, and an electrode catheter mounted in the heart of the patient (an electrode different from the defibrillation catheter 100) catheter). [00151] The electrocardiograph 800 (output terminal) is connected to the electrocardiogram input connector 77 of the power supply device 700, and can input the heart potential information (the cardiac potential information from the defibrillation catheter 100 and the cardiac potential measurement) input to the electrocardiograph 800. A part of the cardiac potential information of the unit 900 is transmitted to the arithmetic processing unit 75 via the electrocardiogram input connector 77. [00152] The defibrillation catheter 100 of the present embodiment can be used as an electrode catheter for measuring cardiac potential when the defibrillation treatment is not required. [00153] FIG. 10 shows the flow of cardiac potential information when the cardiac electric potential is measured by the defibrillation catheter 100 of the present embodiment when cardiac catheterization (for example, high-frequency treatment) is performed. At this time, the switching unit 76 of the power supply device 700 selects the first contact to which the electrocardiographic connection connector 73 is connected. [00154] The cardiac potential measured by the first DC electrode group 31G constituting the defibrillation catheter 100 and the electrode of the DC or the second DC electrode group 32G is connected via the catheter connection connector 72, the switching portion 76, and the electrocardiographic connection connector 73. It is input to the electrocardiometer 800. In addition, the cardiac potential measured by the electrode constituting the proximal end side potential measurement electrode group 33G of the defibrillation catheter 100 is directly input from the catheter connection connector 72 through the electrocardiographic connection connector 73 without passing through the switching unit 76. To the electrocardiometer 800. [00156] The cardiac potential information (electrocardiogram) from the defibrillation catheter 100 is displayed on a display (not shown) of the electrocardiograph 800. [00157] In addition, a part of the cardiac potential information from the defibrillation catheter 100 (for example, a potential difference between the electrodes 31 (the first pole and the second pole) constituting the first DC electrode group 31G) can be obtained from the electrocardiograph 800 The display is performed by inputting to the display unit 78 via the electrocardiogram input connector 77 and the arithmetic processing unit 75. As described above, when the defibrillation treatment is not required in cardiac catheterization, the defibrillation catheter 100 can be used as an electrode catheter for measuring cardiac potential. [00159] Moreover, when atrial fibrillation occurs during cardiac catheterization, defibrillation treatment can be performed immediately using the defibrillation catheter 100 used as an electrode catheter. As a result, when atrial fibrillation occurs, it is possible to omit troubles such as newly inserting a catheter for defibrillation. The arithmetic processing unit 75 sequentially senses an event (waveform) of the electrocardiogram estimated to be an R wave based on a part (electrocardiogram) of the heart potential information transmitted from the electrocardiograph 800 via the electrocardiogram input connector 77. [00161] The sensing of the event estimated as the R wave is performed, for example, by detecting the waveform of the maximum peak in the previous period of the period (jitter) to be sensed and the maximum peak in the first two periods. The waveform calculates the average height of these maximum peak waveforms, and detects that the potential difference has reached a height (trigger level) of 80% of the average height. Further, the arithmetic processing unit 75 performs arithmetic processing to control the DC power supply unit 71 such that the polarity of the sensed event (the direction of the peak indicated by the ± symbol) is applied to the input energy, and the input energy is applied. After the switch 744, the polarity of the event (Vn) sensed in the nth cycle is the same as the polarity of the event (Vn-1) sensed in the previous cycle and the event sensed in the previous two cycles ( When the polarity of Vn-2) is the same, the terminal 721 (first DC electrode group 31G) of the conduit connection connector 72 and the terminal 722 of the conduit connection connector 72 (second DC electrode group) are synchronized with the event (Vn). 32G) Apply voltage. [00163] In the electrocardiogram shown in FIGS. 16A to 16D, among the six events sensed as R waves, the polarity of the third event from the left is (-) (the peak waveform thereof faces downward) ), the other five events have a polarity of (+) (the peak waveform is facing up). [00164] As shown in FIG. 16A, in the case where the energy application switch 744 is input after sensing the second event (V0) from the left side, the polarity (-) of the third event (V1) is the same as the previous one. The polarity (+) of the second event (V0) sensed in the cycle is different, so the voltage is not applied in synchronization with the event (V1). [00165] In addition, the polarity (+) of the fourth event (V2) is different from the polarity (-) of the third event (V1) sensed in the previous cycle, so it is not synchronized with the event (V2). Apply voltage. [00166] In addition, the polarity (+) of the fifth event (V3) is different from the polarity (-) of the third event (V1) sensed in the first two cycles, so it is not synchronized with the event (V3). Ground voltage is applied. [00167] The polarity (+) of the sixth event (V4) and the polarity (+) of the fifth event (V3) sensed in the previous cycle and the fourth event sensed in the first two cycles Since the polarity (+) of (V2) is the same, a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G in synchronization with the event (V4). [00168] As shown in FIG. 16B, in the case where the energy application switch 744 is input after sensing the third event (V0) from the left side, the polarity (+) of the fourth event (V1) is the same as the previous one. The polarity (-) of the third event (V0) sensed in the cycle is different, so the voltage is not applied in synchronization with the event (V1). [00169] In addition, the polarity (+) of the fifth event (V2) is different from the polarity (-) of the third event (V0) sensed in the first two cycles, so the event (V2) is not associated with this event. The voltage is applied synchronously. [00170] The polarity (+) of the sixth event (V3) is opposite to the polarity (+) of the fifth event (V2) sensed in the previous cycle and the fourth sensed in the first two cycles The polarity (+) of the events (V1) is the same, so a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G in synchronization with the event (V3). [00171] As shown in FIG. 16C, in the case where the energy application switch 744 is input after sensing the fourth event (V0) from the left side, the polarity (+) of the fifth event (V1) is the same as the first two. The polarity (-) of the third event (V-1) sensed in one cycle is different, so the voltage is not applied in synchronization with the event (V1). [00172] The polarity (+) of the sixth event (V2) is opposite to the polarity (+) of the fifth event (V1) sensed in the previous cycle and the fourth sensed in the first two cycles The polarity (+) of the events (V0) is the same, so a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G in synchronization with the event (V2). [00173] As shown in FIG. 16D, in the case where the energy application switch 744 is input after sensing the fifth event (V0) from the left side, the polarity (+) of the sixth event (V1) is the same as the previous one. The polarity (+) of the fifth event (V0) sensed during the cycle and the polarity (+) of the fourth event (V-1) sensed during the first two cycles are the same, so with the event ( V1) A voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G in synchronization. [00174] As described above, even in the case where the energy application switch 744 is input at any time shown in FIGS. 16A to 16D, the third event is the same as the same polarity (+) three times (from the left side) Six events) apply voltage synchronously. In addition, the arithmetic processing unit 75 controls the DC power supply unit 71 within 260 m seconds after the event estimated to be the R wave is sensed in the input electrocardiogram, so that the first DC electrode group 31G and the second DC are not aligned. The electrode group 32G applies a voltage. [00176] Thus, when the sensed event is the peak of the R wave, it is possible to reliably avoid defibrillation at the time when the next T wave appears. That is, the peak that is estimated to be a T wave is masked so that it cannot be defibrillated. [00177] Further, after sensing the event, the period in which the DC voltage is not applied is not limited to 260 msec, the shortest is 50 msec, and the longest is 500 msec. When the period is shorter than 50 m seconds, the peak estimated to be a T wave may not be masked. On the other hand, when the period is longer than 500 msec, the R wave in the next cycle (jump) may not be sensed. In addition, the arithmetic processing unit 75 performs programming so as not to newly sense an event estimated to be an R wave within 100 m seconds after the event estimated as the R wave is sensed. [00179] Thereby, the R wave, in the opposite direction (the opposite polarity) of the R wave, increases the peak value of the S wave and reaches the trigger level (even if defibrillation is performed in this state) In particular, it is possible to prevent the case where the peak of the S wave is sensed and the continuity of the polarity of the event is impaired (the count of the same polarity is reset). Further, after the event is sensed, the period (inhibition period) of the event estimated as the R wave as the non-new sensing is not limited to 100 msec, the shortest is 10 msec, and the longest is 150 msec. Further, the arithmetic processing unit 75 controls the DC power supply unit 71 260 m seconds after the input of the energy application switch 744 so that voltage is not applied to the first DC electrode group 31G and the second DC electrode group 32G. [00182] Thereby, it is possible to prevent the noise generated by the input of the energy application switch 744 (the noise of a polarity different from the previous and previous two events) from being erroneously sensed as the R wave, and the noise The case of defibrillation is performed synchronously. [00183] In addition, it is possible to prevent the continuity of the polarity of the event (the same polarity) from being transmitted through the noise generated by the input of the energy application switch 744 (the noise of a polarity different from the previous and/or the previous two events). The count is reset). Further, it is possible to prevent the fluctuation of the reference line generated after the input of the energy application switch 744 from being erroneously sensed as the R wave, and to perform defibrillation in synchronization with this. [00185] Further, after the input of the energy application switch 744, the period in which the DC voltage is not applied is not limited to 260 msec, and the shortest is 10 msec, and the longest is 500 msec. [00186] Hereinafter, an example of defibrillation treatment of the intracardiac defibrillation catheter system of the present embodiment will be described with reference to the flowchart shown in FIG. (1) First, the position of the electrodes (the first DC electrode group 31G, the second DC electrode group 32G, and the constituent electrode of the proximal end side potential measurement electrode group 33G) of the defibrillation catheter 100 is confirmed by the X-ray image. And a part of the cardiac potential information (12-induction electrocardiogram) input from the cardiac potential measuring unit 900 (the electrode sheet pasted on the body surface) to the electrocardiograph input connector 77 is input to the power supply device 700. Processing unit 75 (step 1 of FIG. 11A). At this time, a part of the heart potential information input to the arithmetic processing unit 75 is displayed on the display unit 78 (see FIG. 12). Further, the constituent electrodes of the first DC electrode group 31G and/or the second DC electrode group 32G of the defibrillation catheter 100 are input to the electrocardiograph 800 via the catheter connection connector 72, the switching portion 76, and the electrocardiographic connection connector 73. The cardiac potential information and the cardiac potential information input from the constituent electrode of the base end side potential measuring electrode group 33G of the defibrillation catheter 100 to the electrocardiograph 800 via the catheter connection connector 72 and the electrocardiographic connection connector 73 are displayed in the heart. A display (not shown) of the electric meter 800. [00188] (2) Next, the mode switching switch 741 as the external switch 74 is input. The power supply device 700 in the present embodiment is the "cardiac potential measurement mode" in the initial state, the switching unit 76 selects the first contact point, and the path from the catheter connection connector 72 to the electrocardiographic connection connector 73 via the switching portion 76 is make sure. The input through the mode changeover switch 741 becomes the "defibrillation mode" (step 2). (3) As shown in FIG. 13, when the mode switching switch 741 is input and 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 connection connector 72 to the arithmetic processing unit 75 via the switching unit 76 is secured, and the path from the catheter connection connector 72 to the electrocardiographic connection connector 73 via the switching unit 76 is cut off (step 3). When the second contact is selected by the switching unit 76, the cardiac potential information of the constituent electrodes of the first DC electrode group 31G and the second DC electrode group 32G from the defibrillation catheter 100 cannot be input to the electrocardiometer 800 (thus, This cardiac potential information is sent to the arithmetic processing unit 75.). However, the heart potential information of the constituent electrode from the proximal end side potential measuring electrode group 33G that does not pass through the switching portion 76 is input to the electrocardiograph 800. [00190] (4) When the contact of the switching portion 76 is switched to the second contact, the resistance between the first DC electrode group (31G) and the second electrode group (32G) of the defibrillation catheter 100 is measured (step 4). The resistance value input from the catheter connection connector 72 to the arithmetic processing unit 75 via the switching unit 76 is displayed on the display unit 78 together with a part of the cardiac potential information from the cardiac potential measurement unit 900 input to the arithmetic processing unit 75 (refer to FIG. 13). ). [00191] (5) The contact of the switching unit 76 is switched to the first contact, and the path from the catheter connection connector 72 to the electrocardiographic connection connector 73 via the switching unit 76 is restored (step 5). Further, the time at which the contact of the switching unit 76 selects the second contact (steps 3 to 5 described above) is, for example, 1 second. (6) The arithmetic processing unit 75 determines whether or not the resistance measured in step 4 exceeds a certain value, and if it does not exceed, proceeds to the next step 7 (preparation for applying a DC voltage). If it is over, return to step 1 (the position of the electrode of the defibrillation catheter 100 is confirmed) (step 6). [00193] Here, in the case where the resistance exceeds a certain value, it means that the first DC electrode group and/or the second electrode group are not reliably abutted to a predetermined portion (for example, the wall of the coronary vein, right) The inner wall of the atrium), so you need to go back to step 1 and re-adjust the position of the electrodes. [00194] Thus, it is possible to apply only when the first DC electrode group and the second DC electrode group of the defibrillation catheter 100 reliably abut against a prescribed portion (for example, the wall of the coronary vein, the inner wall of the right atrium). The voltage is so efficient for defibrillation treatment. (7) The applied energy setting switch 742 as the external switch 74 is input to set the applied energy at the time of defibrillation (step 7 of FIG. 11B). According to the power supply device 700 of the present embodiment, the applied energy can be set from 1 J to 30 J on a scale of 1 J. (8) The charging switch 743 as the external switch 74 is input, and the built-in capacitor of the DC power supply unit 71 is energized (step 8). [00197] (9) After the charging is completed, the energy application switch 744 as the external switch 74 is input (step 9). (10) The event (Vn) that is sensed in step 12, which will be described later, is the number (n) of events that are sensed a few times after the energy application switch 744 is input, and "1" is generated (step 10). ). (11) The arithmetic processing unit 75 waits for 100 m seconds as the suppression period after sensing the previous event (Vn-1) (the event sensed immediately before the input of the energy application switch 744), and does not perform new operation. Sensing (step 11). (12) After the suppression period elapses, the arithmetic processing unit 75 senses the event (Vn) (step 12). (13) The arithmetic processing unit 75 determines whether or not the polarity of the event (Vn) sensed in step 12 matches the polarity of the last (previously sensed) event (Vn-1), and is consistent. In this case, the process proceeds to step 14, and if there is no match, in step 10', the above number (n) is incremented by one and the process returns to step 11 (step 13). [00202] (14) The arithmetic processing unit 75 determines whether or not the polarity of the event (Vn) sensed in step 12 coincides with the polarity of the event (Vn-2) of the last time (the last two sensed), If they match, the process proceeds to step 15. If there is no match, in step 10', the above number (n) is incremented by one and the process returns to step 11 (step 14). (15) The arithmetic processing unit 75 determines whether or not the time from the sense of the last event (Vn-1) to the sensing event (Vn) exceeds 260 msec, and if it exceeds, the process proceeds to step 16, where If it is not exceeded, in step 10', the above number (n) is incremented by one and the process returns to step 11 (step 15 of Fig. 11). (16) The arithmetic processing unit 75 determines whether the time from the input of the energy application switch 744 to the sensing event (Vn) exceeds 260 seconds, and if it is exceeded, the process proceeds to step 17, and if it is not exceeded, In step 10', 1 is added to the above number (n) and the process returns to step 11 (step 16). (17) The transmission processing unit 75 switches the contact of the switching unit 76 to the second contact, and the path from the catheter connection connector 72 to the arithmetic processing unit 75 via the switching unit 76 is secured, and the connection is made from the catheter. The path of the device 72 to the electrocardiographic connection connector 73 via the switching unit 76 is cut off (step 17). (18) After the contact of the switching unit 76 is switched to the second contact, the DC power supply unit 71 that has received the control signal from the arithmetic processing unit 75 passes through the output circuit 751 of the arithmetic processing unit 75 and the switching unit. 76 and the catheter connection connector 72 apply DC voltages of mutually different polarities to the first DC electrode group and the second DC electrode group of the defibrillation catheter 100 (step 18, see FIG. 14). Here, the arithmetic processing unit 75 performs arithmetic processing to transmit a control signal to the DC power supply unit 71 to pair the first DC electrode group and the second DC electrode group in synchronization with the event (Vn) sensed in step S12. Apply a DC voltage. [00208] Specifically, a very short time elapses from a time when the event (Vn) is sensed (when the next R wave rises) (for example, about 1/10 of the peak width of the R wave of the event (Vn)) After the time) began to apply. [00209] FIG. 15 is a view showing a potential waveform measured when a predetermined electric energy (for example, setting output = 10 J) is applied to the defibrillation catheter 100 according to the present embodiment. In the figure, the horizontal axis represents time and the vertical axis represents potential. First, after the predetermined time (t0) has elapsed since the arithmetic processing unit 75 senses the event (Vn), the first DC electrode group 31G is set to the − pole and the second DC electrode group 32G is set to the + pole. A DC voltage is applied between the two, and electric energy is supplied to measure the potential rise (E1 is the peak voltage at this time). After a certain period of time (t1), a DC voltage in which ± is reversed is applied between the first DC electrode group 31G and the second DC electrode group 32G to become a -pole, and electric energy is supplied thereto. The potential rise is measured (E2 is the peak voltage at this time). [00211] Here, the time (t0) from the sensing event (Vn) to the start of application is, for example, 0. 01~0. 05 seconds, if a preferred example is shown, it is 0. 01 seconds, time (t = t1 + t2) is for example 0. 006~0. 03 seconds, if a preferred example is shown, it is 0. 02 seconds. Thereby, a voltage can be applied in synchronization with an event (Vn) which is an R wave, and efficient defibrillation therapy can be performed. [00212] The measured peak voltage (E1) is, for example, 300 to 600V. (19) After a predetermined time (t0+t) elapses from the sensing event (Vn), the control signal from the arithmetic processing unit 75 is received to stop the application of the voltage from the DC power supply unit 71 (step 19). (20) After the application of the voltage is stopped, the application recording (the heart potential waveform at the time of application as shown in FIG. 15) is displayed on the display unit 78 (step 20). The display time is, for example, 5 seconds. [00215] (21) The contact of the switching portion 76 is switched to the first contact, and the path from the catheter connection connector 72 to the electrocardiographic connection connector 73 via the switching portion 76 is restored, the first from the defibrillation catheter 100 The cardiac potential information of the constituent electrodes of the DC electrode group 31G and the second DC electrode group 32G is input to the electrocardiograph 800 (step 21). (22) Observing the constituent electrodes (the first DC electrode group 31G, the second DC electrode group 32G, and the proximal end side potential measuring electrode group 33G) from the defibrillation catheter 100 displayed on the display of the electrocardiograph 800 The cardiac potential information (electrocardiogram) of the electrode) and the cardiac potential information (12-induction electrocardiogram) from the cardiac potential measuring unit 900 are ended if "normal", in the case of "abnormal (atrial fibrillation is not cured)" Go back to step 2 (step 22). According to the catheter system of the present embodiment, the first DC electrode group 31G and the second DC electrode group 32G that pass through the defibrillation catheter 100 can directly supply electric energy to the fibrillated heart, and can reliably provide only the heart. The electrical stimulation (electric shock) required for the treatment of the tremor. [00218] Moreover, since electric energy can be directly supplied to the heart, burns are not generated on the body surface of the patient. In addition, the cardiac potential information measured by the constituent electrode 33 of the proximal end side potential measurement electrode group 33G is input from the catheter connection connector 72 to the electrocardiograph via the electrocardiographic connection connector 73 without passing through the switching unit 76. 800, and the electrocardiograph 800 is connected to the cardiac potential measuring unit 900, and thus the defibrillation treatment of the cardiac potential of the first DC electrode group 31G and the second DC electrode group 32G from the defibrillation catheter 100 cannot be obtained even if the electrocardiograph 800 cannot acquire. When the switching unit 76 is switched to the contact 2 and the path from the conduit connection connector 72 to the electrocardiographic connection connector 73 via the switching unit 76 is cut, the electrocardiograph 800 can also acquire the potential from the proximal end side. The cardiac potential information measured by the electrode group 33G and the cardiac potential measuring unit 900 is measured, and the defibrillation treatment can be performed while monitoring (monitoring) the cardiac potential in the electrocardiograph 800. Further, the arithmetic processing unit 75 of the power supply device 700 performs arithmetic processing on the voltage application in synchronization with the cardiac potential waveform input through the electrocardiogram input connector 77, and controls the DC power supply unit 71 (from the cardiac potential waveform). The potential difference reaches a trigger level for a certain period of time (for example, 0. Since the application is started after 01 seconds), it is possible to apply a voltage to the first DC electrode group 31G and the second DC electrode group 32G of the defibrillation catheter 100 in synchronization with the cardiac potential waveform, and it is possible to perform efficient defibrillation treatment. Further, when the resistance between the electrode groups of the defibrillation catheter 100 does not exceed a certain value, the arithmetic processing unit 75 reliably abuts only the first DC electrode group 31G and the second DC electrode group 32G. When a predetermined portion (for example, the wall of the coronary vein or the inner wall of the right atrium) is controlled, it is possible to control the preparation for applying a DC voltage, so that effective defibrillation treatment can be performed. Further, the arithmetic processing unit 75 performs calculation to control the DC power supply unit 71 such that the electro-acoustic input from the electrocardiograph 800 via the electrocardiogram input connector 77 is sequentially estimated to be estimated as R. The event of the wave, after the input of the energy application switch 744, the polarity of the nth sensed event (Vn) and the polarity of the previous sensed event (Vn-1) and the previous second sensed event When the polarities of (Vn-2) are the same, voltages are applied to the first DC electrode group 31G and the second DC electrode group 32 in synchronization with the event (Vn), so that if three events (Vn-2) are continuously sensed, When the polarities of (Vn-1) and (Vn) do not match, the voltage is not applied in synchronization with the event (Vn), but only the polarity of the three events (Vn-2), (Vn-1), and (Vn) is the same. At the time, the voltage is applied in synchronization with the third event (Vn), so that defibrillation synchronized with the R wave can be reliably performed. 17A is an electrocardiogram (the same cardiac potential waveform as that shown in FIG. 19) that is input to the arithmetic processing unit 75 when a single contraction of the heart of the patient occurs. In FIG. 17A, the polarity of the fourth R wave (event (V0)) from the left is (-), and the peak of the subsequent T wave is increased, and the T wave is sensed as an event (V1). [00224] As shown in the figure, in the case where the energy application switch 744 is input after the event (V0) is sensed, the polarity (+) of the event (V1) sensed shortly thereafter is sensed from the previous one. The polarity (-) of the event (V0) is different, so the voltage is not applied in synchronization with the event (V1). Thereby, it is possible to avoid the application of a voltage in synchronization with the T wave which is mistaken as the R wave due to the increase in the peak value. [00225] In addition, the next sensed event (V2) of the event (V1) is the peak of the R wave, but its polarity (+) is different from the polarity (-) of the first two sensed events (V0). Therefore, the voltage is not applied in synchronization with the event (V2). [00226] Moreover, due to the polarity (+) of the next sensed event (V3) of the event (V2) and the polarity (+) of the previous sensed event (V2) and the first two sensed Since the polarity (+) of the event (V1) is the same, a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G in synchronization with the event (V3) which can be surely the peak of the R wave. 17B is an electrocardiogram input to the arithmetic processing unit 75 when the contraction of the patient's heart continuously occurs. [00228] As shown in the figure, in the case where the energy application switch 744 is input after the event (V0) in which the polarity is reversed to (-) due to the out-of-phase contraction is sensed, the event sensed shortly thereafter ( The polarity of V1) is (+), the polarity of the next sensed event (V2) is (-), and the polarity of the next sensed event (V3) is (+), the next sensed event The polarity of (V4) is (-), and the polarity of the next sensed event (V5) is (+), and the polarity of the event alternates. Therefore, in this state, in a state where the polarities of the three events that are continuously sensed are inconsistent, it is determined that each of these events may not be the peak of the R wave, and thus the voltage is not applied in synchronization with the event. [00229] In addition, the polarity (+) of the next sensed event (V6) of the event (V5) is the peak of the R wave, but its polarity (+) and the first two sensed events (V4) The polarity (-) is different, so the voltage is not applied in synchronization with the event (V6). [00230] Moreover, since the polarity (+) of the next sensed event (V7) of the event (V6) is the same as the polarity (+) of the event (V6) and the polarity (+) of the event (V5), it is judged In order to reliably heal the contraction outside the sensing period of the event (V7), a voltage is applied to the first DC electrode group 31G and the second DC electrode group 32G in synchronization with the event (V7) which can be surely the peak of the R wave. [00231] FIG. 18 is an electrocardiogram (the same cardiac potential waveform as shown in FIG. 20) in which the reference line is lowered and the reference line is lowered to the original level, and the drop and rise of the reference line are mistaken. The R waves are sensed as events (V-1) and events (V1), respectively. [00232] As shown in FIG. 18, in the case where the energy application switch 744 is input before the reference line rises, the polarity (+) of the event (V1) sensed shortly after it is compared with the previous sensed event (V0) The polarity (+) is the same, but different from the polarity (-) of the first two sensed events (V-1), so the voltage is not applied in synchronization with the event (V1), thereby avoiding The voltage is applied synchronously when the rise of the reference line of the R wave is mistaken. [00233] Moreover, due to the polarity (+) of the next sensed event (V2) of the event (V1) and the polarity (+) of the previous sensed event (V1) and the first two sensed Since the polarity (+) of the event (V0) is the same, it is determined that the reference line is stable at the time of sensing of the event (V2), and the first DC electrode group 31G and the event (V2) which can be surely the peak of the R wave are synchronized. The second DC electrode group 32G applies a voltage. Further, the arithmetic processing unit 75 controls the DC power supply unit 71 to apply DC voltage to the first DC electrode group 31G and the second DC electrode group 32G within 260 m seconds after sensing the event estimated as the R wave, so that the DC voltage is not applied to the first DC electrode group 31G and the second DC electrode group 32G. In the case where the sensed event is the peak of the R wave, it is possible to reliably avoid defibrillation at the time when the next T wave appears. Further, the arithmetic processing unit 75 performs programming for 100 m seconds after sensing the event estimated as the R wave so that the event estimated to be R wave is not newly sensed, and therefore the sensed event is R. When the peak value of the S wave increases in the opposite direction and the peak value of the S wave appears in the opposite direction to reach the trigger level, it is possible to prevent the peak of the S wave from being sensed and the count of the same polarity being reset. Further, since the arithmetic processing unit 75 controls the DC power supply unit 71 within 260 m seconds after the input of the energy application switch 744 so as not to apply a DC voltage to the first DC electrode group 31G and the second DC electrode group 32G, it is possible to prevent The noise generated by the input of the energy application switch 744 is erroneously sensed as an R wave, and defibrillation is performed in synchronization with the noise, or the count of the same polarity is reset due to the noise. [00237] Although an embodiment of the present invention has been described above, the defibrillation catheter system of the present invention is not limited thereto, and various modifications can be made. [00238] For example, the arithmetic processing unit of the power supply device may perform arithmetic processing to control the DC power supply unit, that is, the polarity of the event (Vn) sensed after the input of the energy application switch and the previous sensing. When the polarity of the event (Vn-1), the polarity of the previous two sensed events (Vn-2), and the polarity of the previous three sensed events (Vn-3) are the same (the same polarity is continuous four) The second time), a voltage is applied to the first DC electrode group and the second DC electrode group in synchronization with the fourth event (Vn).

100‧‧‧除顫導管
10‧‧‧多腔管
11‧‧‧第一管腔
12‧‧‧第二管腔
13‧‧‧第三管腔
14‧‧‧第四管腔
15‧‧‧氟樹脂層
16‧‧‧裡(芯)部
17‧‧‧外(殼)部
18‧‧‧不銹鋼線材
20‧‧‧把手
21‧‧‧把手主體
22‧‧‧繩栓
24‧‧‧應變消除器
26‧‧‧第一絕緣性管
27‧‧‧第二絕緣性管
28‧‧‧第三絕緣性管
31G‧‧‧第一DC電極組
31‧‧‧環狀電極
32G‧‧‧第二DC電極組
32‧‧‧環狀電極
33G‧‧‧基端側電位測定電極組
33‧‧‧環狀電極
35‧‧‧前端晶片
41G‧‧‧第一引線組
41‧‧‧引線
42G‧‧‧第二引線組
42‧‧‧引線
43G‧‧‧第三引線組
43‧‧‧引線
50‧‧‧除顫導管的連接器
51、52、53‧‧‧針狀端子
55‧‧‧隔板
58‧‧‧樹脂
61‧‧‧第一保護管
62‧‧‧第二保護管
65‧‧‧拉線
700‧‧‧電源裝置
71‧‧‧DC電源部
72‧‧‧導管連接連接器
721、722、723‧‧‧端子
73‧‧‧心電計連接連接器
74‧‧‧外部開關(輸入單元)
741‧‧‧模式切換開關
742‧‧‧施加能量設定開關
743‧‧‧充電開關
744‧‧‧能量施加開關(放電開關)
75‧‧‧運算處理部
76‧‧‧切換部
77‧‧‧心電圖輸入連接器
78‧‧‧顯示單元
800‧‧‧心電計
900‧‧‧心電位測定單元
100‧‧‧Defibrillation catheter
10‧‧‧Multi-lumen tube
11‧‧‧First lumen
12‧‧‧Second lumen
13‧‧‧ Third lumen
14‧‧‧four lumen
15‧‧‧Fluorin layer
16‧‧‧Li (core)
17‧‧‧ outside (shell)
18‧‧‧Stainless steel wire
20‧‧‧Hands
21‧‧‧Handle body
22‧‧‧ rope bolt
24‧‧‧ strain relief
26‧‧‧First insulating tube
27‧‧‧Second insulating tube
28‧‧‧ Third insulating tube
31G‧‧‧First DC electrode group
31‧‧‧Ring electrode
32G‧‧‧second DC electrode set
32‧‧‧Ring electrode
33G‧‧‧ base-side potential measuring electrode group
33‧‧‧Ring electrode
35‧‧‧ Front-end wafer
41G‧‧‧First lead set
41‧‧‧ lead
42G‧‧‧second lead set
42‧‧‧ lead
43G‧‧‧third lead set
43‧‧‧ leads
50‧‧‧Defibrillator catheter connector
51, 52, 53‧‧ needle terminals
55‧‧‧Baffle
58‧‧‧Resin
61‧‧‧First protection tube
62‧‧‧Second protective tube
65‧‧‧ Pull wire
700‧‧‧Power supply unit
71‧‧‧DC Power Supply Department
72‧‧‧Tube connector
721, 722, 723‧‧‧ terminals
73‧‧‧Electrometer connection connector
74‧‧‧External switch (input unit)
741‧‧‧ mode switch
742‧‧‧Energy setting switch
743‧‧‧Charge switch
744‧‧‧Energy application switch (discharge switch)
75‧‧‧Operation Processing Department
76‧‧‧Switching Department
77‧‧‧ECG input connector
78‧‧‧Display unit
800‧‧‧electrocardiograph
900‧‧‧cardiac potential measurement unit

圖1是表示本發明的心腔內除顫導管系統的一實施方式的方塊圖。 圖2是表示構成圖1所示的導管系統的纖顫導管的說明用俯視圖。 圖3是表示構成圖1所示的導管系統的纖顫導管的說明用俯視圖(用於說明尺寸以及硬度的圖)。 圖4是表示圖2的A-A剖面的橫剖視圖。 圖5是表示圖2的B-B剖面、C-C剖面、D-D剖面的橫剖視圖。 圖6是表示圖2所示的除顫導管的一實施方式的把手的內部構造的立體圖。 圖7是圖6所示的把手內部(前端側)的局部放大圖。 圖8是圖6所示的把手內部(基端側)的局部放大圖。 圖9是在圖1所示的導管系統中,示意性地表示除顫導管的連接器和電源裝置的導管連接連接器的連結狀態的說明圖。 圖10是在圖1所示的導管系統中,表示透過除顫導管測定心電圖的情況的心電位資訊的流向的方塊圖。 圖11A是表示圖1所示的導管系統中的電源裝置的動作以及操作的流程圖的一部分(步驟1~步驟6)。 圖11B是表示圖1所示的導管系統中的電源裝置的動作以及操作的流程圖的一部分(步驟7~步驟14)。 圖11C是表示圖1所示的導管系統中的電源裝置的動作以及操作的流程圖的一部分(步驟15~步驟22)。 圖12是在圖1所示的導管系統中,表示心電位測定模式下的心電位資訊的流向的方塊圖。 圖13是在圖1所示的導管系統的除顫模式下,表示電極組間的電阻的測定值相關的資訊以及心電位資訊的流向的方塊圖。 圖14是表示在圖1所示的導管系統的除顫模式下直流電壓施加時的狀態的方塊圖。 圖15是透過構成圖1所示的導管系統的除顫導管賦予了規定的電能時測定的電位波形圖。 圖16A是在輸入電源裝置的運算處理部的心電圖中,表示能量施加開關的輸入(SW-ON)和直流電壓(DC)的施加時間的說明圖。 圖16B是在輸入至電源裝置的運算處理部的心電圖中,表示能量施加開關的輸入和直流電壓的施加時間的說明圖。 圖16C是在輸入至電源裝置的運算處理部的心電圖中,表示能量施加開關的輸入和直流電壓的施加時間的說明圖。 圖16D是在輸入至電源裝置的運算處理部的心電圖中,表示能量施加開關的輸入和直流電壓的施加時間的說明圖。 圖17A是在輸入至電源裝置的運算處理部的心電圖(在患者的心臟發生單發性期外收縮的情況的心電位波形)中,表示能量施加開關的輸入和直流電壓的施加時間的說明圖。 圖17B是在輸入電源裝置的運算處理部的心電圖(在患者的心臟發生連續的期外收縮的情況的心電位波形)中,表示輸入能量施加開關和施加直流電壓的時間的說明圖。 圖18是在輸入電源裝置的運算處理部的基準線變動的心電圖(心電位波形)中,表示輸入能量施加開關和施加直流電壓的時間的說明圖。 圖19是在輸入構成以往的導管系統的電源裝置的運算處理部的心電圖(在患者的心臟發生單發性期外收縮的情況的心電位波形)中,表示輸入能量施加開關和施加直流電壓的時間的說明圖。 圖20是在輸入構成以往的導管系統的電源裝置的運算處理部的基準線變動的心電圖(心電位波形)中,表示輸入能量施加開關和施加直流電壓的時間的說明圖。1 is a block diagram showing an embodiment of an intracardiac defibrillation catheter system of the present invention. Fig. 2 is a plan view showing the configuration of a fibrillation catheter constituting the catheter system shown in Fig. 1; Fig. 3 is a plan view (for illustration of dimensions and hardness) showing a fibrillation catheter constituting the catheter system shown in Fig. 1; Fig. 4 is a transverse cross-sectional view showing a cross section taken along line A-A of Fig. 2; Fig. 5 is a transverse cross-sectional view showing a B-B cross section, a C-C cross section, and a D-D cross section of Fig. 2; Fig. 6 is a perspective view showing an internal structure of a handle of an embodiment of the defibrillation catheter shown in Fig. 2; Fig. 7 is a partial enlarged view of the inside (front end side) of the handle shown in Fig. 6. Fig. 8 is a partial enlarged view of the inside (base end side) of the handle shown in Fig. 6. Fig. 9 is an explanatory view schematically showing a connection state of 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 cardiac potential information in the case where the electrocardiogram is measured through the defibrillation catheter in the catheter system shown in Fig. 1; Fig. 11A is a part (steps 1 to 6) showing a flowchart of the operation and operation of the power supply device in the catheter system shown in Fig. 1; Fig. 11B is a part (step 7 to step 14) showing a flowchart of the operation and operation of the power supply device in the catheter system shown in Fig. 1; Fig. 11C is a part (steps 15 to 22) showing a flowchart of 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 cardiac potential information in the cardiac potential measurement mode in the catheter system shown in Fig. 1; Fig. 13 is a block diagram showing information relating to measured values of electrical resistance between electrode groups and flow of cardiac potential information in the defibrillation mode of the catheter system shown in Fig. 1. Fig. 14 is a block diagram showing a state in which a DC voltage is applied in the defibrillation mode of the catheter system shown in Fig. 1. Fig. 15 is a waveform diagram of potentials measured when a predetermined amount of electric energy is applied to a defibrillation catheter constituting the catheter system shown in Fig. 1; FIG. 16A is an explanatory diagram showing an application time (SW-ON) and a DC voltage (DC) of an energy application switch in an electrocardiogram of an arithmetic processing unit of an input power supply device. FIG. 16B is an explanatory diagram showing an input of the energy application switch and an application time of the DC voltage in the electrocardiogram input to the arithmetic processing unit of the power supply device. 16C is an explanatory diagram showing an input of the energy application switch and an application time of the DC voltage in the electrocardiogram input to the arithmetic processing unit of the power supply device. 16D is an explanatory diagram showing an input of the energy application switch and an application time of the DC voltage in the electrocardiogram input to the arithmetic processing unit of the power supply device. FIG. 17A is an explanatory diagram showing an input of an energy application switch and an application time of a DC voltage in an electrocardiogram (a cardiac potential waveform in a case where a single episode contraction occurs in a heart of a patient) input to an arithmetic processing unit of a power supply device. . 17B is an explanatory diagram showing the time during which the energy application switch and the DC voltage are applied, in the electrocardiogram of the arithmetic processing unit of the input power supply device (the cardiac potential waveform in the case where the patient's heart is continuously contracted outside the heart). FIG. 18 is an explanatory diagram showing an input energy application switch and a time when a DC voltage is applied in an electrocardiogram (cardiac potential waveform) in which a reference line of the arithmetic processing unit of the input power supply device changes. 19 is an electrocardiogram (cardiac waveform in a case where a single-shot extra-systolic contraction occurs in a heart of a patient) in which an arithmetic processing unit of a power supply device constituting a conventional catheter system is input, and an input energy application switch and a DC voltage are applied. An illustration of the time. FIG. 20 is an explanatory diagram showing an input of an energy application switch and a time when a DC voltage is applied, in an electrocardiogram (cardiac potential waveform) in which a reference line fluctuation of a calculation processing unit of a power supply device constituting a conventional catheter system is input.

Claims (4)

一種心腔內除顫導管系統,具備:除顫導管,其被插入至心腔內進行除顫;電源裝置,其對該除顫導管的電極施加直流電壓;以及心電計,該除顫導管具備: 絕緣性的管部件; 第一電極組,其由安裝在該管部件的前端區域的多個環狀電極構成; 第二電極組,其由多個環狀電極構成,該多個環狀電極被與該第一電極組向基端側隔開間隔地安裝於該管部件; 第一引線組,其由前端與構成該第一電極組的電極分別連接的多個引線構成;以及 第二引線組,其由前端與構成該第二電極組的電極分別連接的多個引線構成, 該電源裝置具備: DC電源部; 導管連接連接器,其與該除顫導管的第一引線組以及第二引線組的基端側連接; 外部開關,其包括電能施加開關; 運算處理部,其具有來自該DC電源部的直流電壓的輸出電路,並基於該外部開關的輸入來控制該DC電源部;以及 心電圖輸入連接器,其與該運算處理部以及該心電計的輸出端子連接, 在透過該除顫導管進行除顫時,從該DC電源部經由該運算處理部的輸出電路以及該導管連接連接器,對該除顫導管的該第一電極組和第二電極組施加互不相同極性的電壓, 該電源裝置的運算處理部按下述方式進行運算處理來對該DC電源部進行控制,即:逐次感測根據經由該心電圖輸入連接器被從該心電計輸入的心電圖而被推斷為R波的事件,並在該電能施加開關的輸入之後感測到的事件Vn的極性至少與之前一個感測到的事件Vn-1的極性以及之前二個感測到的事件Vn-2的極性一致時,與該事件Vn同步地對該第一電極組以及該第二電極組施加電壓。An intracardiac defibrillation catheter system comprising: a defibrillation catheter inserted into a cardiac chamber for defibrillation; a power supply device applying a DC voltage to an electrode of the defibrillation catheter; and an electrocardiograph, the defibrillation catheter The invention comprises: an insulating tube member; a first electrode group comprising a plurality of annular electrodes mounted in a front end region of the tube member; and a second electrode group comprising a plurality of annular electrodes, the plurality of rings The electrode is attached to the tube member at a distance from the first electrode group toward the proximal end side; the first lead group is composed of a plurality of leads respectively connected to the electrodes constituting the first electrode group; and a second a lead set comprising a plurality of leads respectively connected to the electrodes constituting the second electrode group, the power supply device comprising: a DC power supply unit; a conduit connection connector, the first lead set and the first lead set of the defibrillation catheter The base end side of the two lead sets is connected; the external switch includes an electric energy application switch; an arithmetic processing unit having an output circuit of a DC voltage from the DC power supply unit, and controlling based on an input of the external switch a DC power supply unit; and an electrocardiogram input connector connected to the arithmetic processing unit and an output terminal of the electrocardiograph, and when defibrillating through the defibrillation catheter, the output circuit of the arithmetic processing unit is passed from the DC power supply unit And the catheter connection connector, wherein the first electrode group and the second electrode group of the defibrillation catheter are applied with voltages having mutually different polarities, and the arithmetic processing unit of the power supply device performs arithmetic processing on the DC power supply as follows. Controls, that is, sequentially sensing an event inferred to be an R wave according to an electrocardiogram input from the electrocardiograph via the electrocardiogram input connector, and an event Vn sensed after the input of the electric energy application switch When the polarity is at least coincident with the polarity of the previous one sensed event Vn-1 and the polarity of the previous two sensed events Vn-2, the first electrode group and the second electrode group are synchronized with the event Vn Apply voltage. 如請求項1所述的心腔內除顫導管系統,該電源裝置的運算處理部對該DC電源部進行控制,以便在感測到被推定為R波的事件後最短50m秒間、最長500m秒間,不對該第一DC電極組以及該第二DC電極組施加電壓。The intracardiac defibrillation catheter system according to claim 1, wherein the arithmetic processing unit of the power supply unit controls the DC power supply unit so as to be between a minimum of 50 m seconds and a maximum of 500 m seconds after sensing an event estimated to be an R wave. No voltage is applied to the first DC electrode group and the second DC electrode group. 如請求項2所述的心腔內除顫導管系統,該電源裝置的運算處理部在感測到被推定為R波的事件後最短10m秒間、最長150m秒間,不新感測被推定為R波的事件。The intracardiac defibrillation catheter system according to claim 2, wherein the arithmetic processing unit of the power supply device senses the shortest of 10 m seconds and the longest time of 150 m after sensing the event estimated to be the R wave, and the new sensing is estimated to be R Wave event. 如請求項2或3所述的心腔內除顫導管系統,該電源裝置的運算處理部對該DC電源部進行控制,以便在該電能施加開關的輸入後最短10m秒間、最長500m秒間,不對該第一電極組以及該第二電極組施加電壓。The intracardiac defibrillation catheter system according to claim 2 or 3, wherein the arithmetic processing unit of the power supply device controls the DC power supply unit so as to be shortest between 10 m seconds and a maximum of 500 m seconds after the input of the electric energy application switch, A voltage is applied to the first electrode group and the second electrode group.
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