CN104138635A - Intracardiac defibrillation catheter system - Google Patents

Intracardiac defibrillation catheter system Download PDF

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Publication number
CN104138635A
CN104138635A CN201410177809.1A CN201410177809A CN104138635A CN 104138635 A CN104138635 A CN 104138635A CN 201410177809 A CN201410177809 A CN 201410177809A CN 104138635 A CN104138635 A CN 104138635A
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China
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event
electrode group
supply unit
defibrillation
polarity
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CN104138635B (en
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小野寺泰
堀内修一
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Japan Lifeline Co Ltd
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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)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Otolaryngology (AREA)
  • Electrotherapy Devices (AREA)

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

Intracardiac defibrillation catheter system
Technical field
The present invention relates to chambers of the heart inner catheter defibrillation system, more specifically, relate to and possess the defibrillation catheter being inserted in the chambers of the heart, the conduit system that the electrode of this defibrillation catheter is applied to supply unit and the electrocardiogrph of DC voltage.
Background technology
As the defibrillator of removing atrial fibrillation, known external formula defibrillator (AED).
In the defibrillation therapy of utilizing AED, by the body surface installing electrodes sheet patient and apply DC voltage, to providing electric energy in patient's body., flow to the normally 150~200J of electric energy in patient's body from electrode slice herein, a part (a few %~20% left and right conventionally) wherein flows to heart and for defibrillation therapy.
But, in cardiac catheterization, easily cause atrial fibrillation, also need in this case to carry out electric defibrillation.
But, by the AED from external supply of electrical energy, be difficult to the heart supply of electrical energy (for example 10~30J) efficiently to there is fibrillation.
, for example,, in the few situation of the ratio that flows to heart from the electric energy of external supply (several % left and right), cannot carry out sufficient defibrillation therapy.
On the other hand, in the case of from the electric energy of external supply to flow at high proportion heart, also there are the misgivings that organizing of heart likely sustains damage.
In addition, in the defibrillation therapy of utilizing AED, easily produce burn at the body surface that electrode slice has been installed.And, as mentioned above, in the case of flow to the ratio of electric energy of heart few, repeatedly carry out the supply of electric energy, heavy thereby the degree of burn becomes, for accepting the patient of catheterization, become suitable burden.
In view of such thing, the present inventors propose a kind of conduit defibrillation system, and this conduit defibrillation system possesses defibrillation catheter, and it is inserted into and in the chambers of the heart, carries out defibrillation, supply unit, its electrode to this defibrillation catheter applies DC voltage, and electrocardiogrph, wherein, defibrillation catheter possesses: the duct member of insulating properties, 1DC electrode group, its multiple ring electrodes by the front end area that is arranged on this duct member form, 2DC electrode group, its by with 1DC electrode group to base end side spaced apart be arranged on duct member multiple ring electrodes form, the 1st lead wire set, it is made up of with multiple lead-in wires that the electrode that forms described 1DC electrode group is connected respectively front end, and the 2nd lead wire set, it is made up of with multiple lead-in wires that the electrode that forms described 2DC electrode group is connected respectively front end, and supply unit possesses: DC power supply unit, conduit connects adapter, and it is connected with the 1st lead wire set of described defibrillation catheter and the base end side of the 2nd lead wire set, electrocardiogrph connects adapter, and it is connected with the input terminal of described electrocardiogrph, arithmetic processing section, it is controlled described DC power supply unit according to the input of external switch, and has the output circuit from the DC voltage of this DC power supply unit, and switching part, its change-over switch by 1 circuit 2 contacts forms, common junction connecting duct connects adapter, the 1st contact connects electrocardiogrph and connects adapter, the 2nd contact concatenation operation handling part, in the time that the electrode by defibrillation catheter (forming the electrode of IDC electrode group and/or 2DC electrode group) is measured heart potential, select the 1st contact at switching part, heart potential information from defibrillation catheter connects adapter via the conduit of supply unit, switching part and electrocardiogrph connect adapter and are imported into electrocardiogrph, in the time carrying out defibrillation by defibrillation catheter, by the arithmetic processing section of supply unit, the contact of switching part is switched to the 2nd contact, output circuit from DC power supply unit via arithmetic processing section, switching part and conduit connect adapter, 1DC electrode group to defibrillation catheter and 2DC electrode group apply the voltage (with reference to following patent documentation 1) of mutual opposed polarity.
According to the defibrillation catheter system described in patent documentation 1, can be in cardiac catheterization the heart that atrial fibrillation etc. occurs be supplied with to the required and sufficient electric energy of defibrillation reliably.In addition, can be not few at patient's body surface generation burn and aggressive yet yet.
In addition, in the time not needing defibrillation therapy, can the electrode catheter of defibrillation catheter of the present invention as heart potential mensuration use will be formed.
In the conduit system described in patent documentation 1, if applying switch, external switch that is energy be transfused to,, by arithmetic processing section, the contact of switching part is switched to the 2nd contact from the 1st contact, connects adapter guaranteed via the path of switching part arrival arithmetic processing section from conduit.
The contact of switching part is switched to after the 2nd contact, from having accepted to connect adapter from the DC power supply unit of the control signal of arithmetic processing section via output circuit, switching part and the conduit of arithmetic processing section, the 1DC electrode group to defibrillation catheter and 2DC electrode group apply the DC voltage of mutual opposed polarity.
Herein, arithmetic processing section is carried out calculation process and is transmitted control signal to DC power supply unit, so as with heart potential synchronous waveform via electrocardiogram input connector input apply voltage.
Particularly, in such a way DC power supply unit is transmitted control signal, that is: 1 R ripple of detection (peak-peak) in the heart potential waveform (electrocardiogram) that is successively input to arithmetic processing section, obtain its peak height, next, for example, start afterwards to apply through certain hour (, the extremely short time of 1/10 left and right of the spike width of R ripple) having arrived from potential difference moment of 80% height (triggering level) of this peak height.
Patent documentation 1: No. 4545216 communiques of Japanese laid-open patent
In order to carry out defibrillation therapy effectively, and ventricle is not caused to bad influence, defibrillation (applying of voltage) conventionally and R ripple synchronously carry out.
If synchronously carry out defibrillation with T ripple, the danger of ventricular fibrillation of causing severe is high, therefore, must avoid synchronizeing with T ripple.
Therefore, in the conduit system described in patent documentation 1, energy is applied to the peak value that arrives soon triggering level after switch input and be identified as R ripple, make synchronously the 1st electrode group and the 2nd electrode group to be applied to voltage with this peak value.
But, the heart of accepting the patient of defibrillation therapy in wish produces premature contraction, or in the situation that the drift that the Electrocardiographic datum line (baseline) that inputs to arithmetic processing section swings produces, in fact the peak value (being identified as the peak value of R ripple) that has sometimes arrived soon the potential difference of triggering level after energy applies the input of switch is not the peak value of R ripple.
For example, produce in the extrasystolic situation of single-shot at patient's heart, input to the electrocardiogram (heart potential waveform) of arithmetic processing section as shown in figure 19, R ripple is (in figure, from the R ripple of left several the 4th) polarity inversion, and the peak value of its next T ripple has the trend of increase.
And, as shown in FIG., apply switch if inputted soon electric energy after having produced premature contraction, think that having the T ripple false sense that increase has been arrived to triggering level to survey (detections) is R ripple, and synchronously apply voltage and implement the situation of defibrillation with this T ripple.
In addition, if Electrocardiographic datum line swings, think to have and think common not sensed waveform by mistake R ripple carry out the situation of sensing.For example, by the rising of datum line, the height that has the positive waveform that is not R ripple is higher than actual situation about reading.Figure 20 illustrates that drift produces and datum line declines, and datum line rises and is returned to the electrocardiogram of original datum line afterwards.But before datum line rises, input electric energy and applied switch, thereby thought the rising of datum line by mistake R ripple carry out sensing (detection), and synchronously applied therewith voltage enforcement defibrillation.
Summary of the invention
The present invention is that the thing based on above-mentioned completes.
The 1st object of the present invention is, a kind of intracardiac defibrillation catheter system is provided, it can be in the time accepting patient's the heart generation premature contraction of defibrillation therapy, the not electrode application voltage to defibrillation catheter, and in the time there is not premature contraction, synchronously the electrode of defibrillation catheter is applied to DC voltage with the Electrocardiographic R ripple of input arithmetic processing section and carry out defibrillation.
The 2nd object of the present invention is, a kind of intracardiac defibrillation catheter system is provided, it can be in the time that the Electrocardiographic datum line that inputs to arithmetic processing section swings (drift), the not electrode application voltage to defibrillation catheter, and in the time that datum line is stablized, synchronously the electrode of defibrillation catheter is applied to DC voltage with this Electrocardiographic R ripple and carry out defibrillation.
In order to reach above-mentioned purpose, the result that the present inventors attentively study repeatedly, found in the time that premature contraction has occurred patient's heart, in addition in the time that the Electrocardiographic datum line of arithmetic processing section that is input to supply unit swings, the change in polarity of the event of sensing (being estimated to be the waveform of R ripple) successively in this electrocardiogram; When continuous the generation to equidirectional for three times of polarity of this event, at least in the moment that senses event for the third time, become the steady statue that premature contraction does not occur does not also occur drift, and event (waveform) is for the third time the peak value of R ripple really; Only the polarity of event that is estimated to be R ripple is continuous while more than three times producing to equidirectional when consistent (electric energy apply the polarity of the polarity of the event sensing after switch is transfused to and the event sensing for twice before), by with this event synchronization apply voltage, thereby can carry out reliably the defibrillation of synchronizeing with R ripple, and complete the present invention based on these discoveries.
(1), intracardiac defibrillation catheter system of the present invention is to possess to be inserted into the conduit system of carrying out the defibrillation catheter of defibrillation in the chambers of the heart, the electrode of this defibrillation catheter being applied to supply unit and the electrocardiogrph of DC voltage, it is characterized in that,
Above-mentioned defibrillation catheter possesses:
The duct member of insulating properties;
The 1st electrode group (IDC electrode group), its multiple ring electrodes by the front end area that is arranged on above-mentioned duct member form;
The 2nd electrode group (2DC electrode group), it is made up of multiple ring electrodes, described multiple ring electrodes by with above-mentioned 1DC electrode group to base end side spaced apart be installed on above-mentioned duct member;
The 1st lead wire set, it is made up of with multiple lead-in wires that the electrode that forms above-mentioned 1DC electrode group is connected respectively front end; And
The 2nd lead wire set, it is made up of with multiple lead-in wires that the electrode that forms above-mentioned 2DC electrode group is connected respectively front end,
Above-mentioned supply unit possesses:
DC power supply unit;
Conduit connects adapter, and it is connected with the 1st lead wire set of above-mentioned defibrillation catheter and the base end side of the 2nd lead wire set;
External switch, it comprises that electric energy applies switch;
Arithmetic processing section, it has the output circuit from the DC voltage of above-mentioned DC power supply unit, and above-mentioned DC power supply unit is controlled in input based on said external switch; And
Electrocardiogram input connector, it is connected with the lead-out terminal of above-mentioned arithmetic processing section and above-mentioned electrocardiogrph,
In the time carrying out defibrillation by defibrillation catheter, connect adapter from above-mentioned DC power supply unit via output circuit and the above-mentioned conduit of above-mentioned arithmetic processing section, above-mentioned 1DC electrode group to above-mentioned defibrillation catheter and 2DC electrode group apply the voltage of mutual difference (± contrary) polarity
The arithmetic processing section of above-mentioned supply unit is carried out as follows calculation process above-mentioned DC power supply unit is controlled, that is: successively sensing according to the event that is inferred to be R ripple via above-mentioned electrocardiogram input connector from the electrocardiogram of above-mentioned electrocardiogrph input, and the event (V that (the n time) senses after above-mentioned electric energy applies the input of switch n) the polarity previous event (V sensing at least with it n-1) polarity with and two event (V that sense before n-2) polarity when consistent, with this event (V n) synchronously above-mentioned 1DC electrode group and above-mentioned 2DC electrode group are applied to voltage.
According to the intracardiac defibrillation catheter system of such formation, in the electrocardiogram of arithmetic processing section that is input to supply unit, if three event (V that measured by sense of continuity n-2), (V n-1) and (V n) polarity inconsistent, be judged as exist because patient's heart generation premature contraction or Electrocardiographic datum line drift etc. become unsettled probability, there is event (V n) be not the probability of the peak value of R ripple, thereby not with this event (V n) synchronously apply voltage.And, at three event (V n-2), (V n-1) and (V n) polarity when consistent, be judged as event (V for the third time n) be the peak value of R ripple, with this event (V n) synchronously apply voltage, thus can carry out reliably the defibrillation of synchronizeing with R ripple.
(2) in intracardiac defibrillation catheter system of the present invention, the arithmetic processing section of preferred above-mentioned supply unit is controlled above-mentioned DC power supply unit, so that after sensing the event that is estimated to be R ripple between short 50m second, between long 500m second, preferably, between 260m second, above-mentioned 1DC electrode group and above-mentioned 2DC electrode group are not applied to voltage.
According to the intracardiac defibrillation catheter system of such formation, after sensing the event that is estimated to be R ripple, the shortest between 50m second, above-mentioned 1DC electrode group and above-mentioned 2DC electrode group are not applied to voltage, therefore the peak value that is R ripple in the event sensing, can avoid reliably the moment occurring at its next T ripple to carry out the situation of defibrillation, that is to say, can shield the peak value that is inferred to be T ripple.
(3) in the intracardiac defibrillation catheter system of above-mentioned (2), the arithmetic processing section of preferred above-mentioned supply unit after sensing the event that is estimated to be R ripple between short 10m second, the longest 150m second, preferably, between 100m second, new sensing is estimated to be the event of R ripple.
According to the intracardiac defibrillation catheter system of such formation, after sensing the event that is estimated to be R ripple, the new event of sensing not between the shortest 10m second, so can prevent that in the event sensing be R crest value, the peak value of the S ripple that then this peak value occurs round about increases and has arrived in the situation (this state does not have special problem in the time carrying out defibrillation) of triggering level, the situation of the seriality impaired (counting of identical polar is reset) of the polarity of the peak value of this S ripple of sensing and event.
(4) in the intracardiac defibrillation catheter system of above-mentioned (2) or (3), the arithmetic processing section of preferred above-mentioned supply unit after above-mentioned electric energy applies the input of switch between short 10m second, between long 500m second, preferably between 260m second, above-mentioned DC power supply unit is controlled, to above-mentioned 1DC electrode group and above-mentioned the 2nd electrode group are not applied to voltage.
According to the intracardiac defibrillation catheter system of such formation, after applying the input of switch at electric energy, the shortest 10m does not apply voltage to 1DC electrode group and 2DC electrode group between second, so can prevent by due to apply the noise that the input of switch produces (with its last time and the noise of the event identical polar of last time again) mistakenly sensing be R, and with this Noise Synchronization carry out the situation of defibrillation.
In addition, can prevent from, owing to applying the noise that the input of switch produces (with its last time and the noise of the event identical polar of last time again), causing the situation of the seriality impaired (counting of identical polar is reset) of the polarity of event.
And, can prevent by the variation of the datum line occurring in the near future in the input that applies switch mistakenly sensing be R ripple, and synchronously carry out the situation of defibrillation with it.
According to intracardiac defibrillation catheter system of the present invention, can be in the time accepting patient's the heart generation premature contraction of defibrillation therapy, the not electrode application voltage to defibrillation catheter, and in the time there is not premature contraction, synchronously the electrode of defibrillation catheter is applied to DC voltage with the ECG R wave that is input to arithmetic processing section and carry out defibrillation.
In addition, can be in the time that the Electrocardiographic datum line that is input to arithmetic processing section swings (drift), the not electrode application voltage to defibrillation catheter, and in the time that datum line is stablized, synchronously the electrode of defibrillation catheter is applied to DC voltage with this Electrocardiographic R ripple and carry out defibrillation.
Brief description of the drawings
Fig. 1 is the block diagram that represents an embodiment of intracardiac defibrillation catheter system of the present invention.
Fig. 2 is the explanation top view that represents the fibrillation conduit of the conduit system shown in pie graph 1.
Fig. 3 is the top view for explanation (for the figure of size and hardness is described) that represents the fibrillation conduit of the conduit system shown in pie graph 1.
Fig. 4 is the sectional elevation of the A-A section of presentation graphs 2.
Fig. 5 is B-B section, the C-C section of presentation graphs 2, the sectional elevation of D-D section.
Fig. 6 is the in-built axonometric chart of the handle of an embodiment of the defibrillation catheter shown in presentation graphs 2.
Fig. 7 is the partial enlarged drawing of the handle inside (front) shown in Fig. 6.
Fig. 8 is the partial enlarged drawing of the handle inside (base end side) shown in Fig. 6.
Fig. 9 is in the conduit system shown in Fig. 1, schematically shows the key diagram that the adapter of defibrillation catheter and the conduit of supply unit are connected the connecting state of adapter.
Figure 10 is in the conduit system shown in Fig. 1, represents to measure by defibrillation catheter the block diagram of the flow direction of the heart potential information of Electrocardiographic situation.
Figure 11 A is a part (step 1~step 6) for the action of the supply unit in the conduit system shown in presentation graphs 1 and the flow chart of operation.
Figure 11 B is a part (step 7~step 14) for the action of the supply unit in the conduit system shown in presentation graphs 1 and the flow chart of operation.
Figure 11 C is a part (step 15~step 22) for the action of the supply unit in the conduit system shown in presentation graphs 1 and the flow chart of operation.
Figure 12 is in the conduit system shown in Fig. 1, represents the block diagram of the flow direction of the heart potential information under heart potential mode determination.
Figure 13 is under the defibrillation mode of the conduit system shown in Fig. 1, represents the block diagram of the flow direction of information that the measured value of the resistance between electrode group is relevant and heart potential information.
Figure 14 is the block diagram that is illustrated under the defibrillation mode of the conduit system shown in Fig. 1 state when DC voltage applies.
Figure 15 is the potential waveform figure measuring while having given the electric energy of regulation by the defibrillation catheter of the conduit system shown in pie graph 1.
Figure 16 A is in the electrocardiogram of the arithmetic processing section of input power device, represents that energy applies the key diagram of the input (SW-ON) of switch and the application time of DC voltage (DC).
Figure 16 B is in the electrocardiogram of arithmetic processing section that inputs to supply unit, represents that energy applies the key diagram of the input of switch and the application time of DC voltage.
Figure 16 C is in the electrocardiogram of arithmetic processing section that inputs to supply unit, represents that energy applies the key diagram of the input of switch and the application time of DC voltage.
Figure 16 D is in the electrocardiogram of arithmetic processing section that inputs to supply unit, represents that energy applies the key diagram of the input of switch and the application time of DC voltage.
Figure 17 A is in the electrocardiogram (at the heart potential waveform of patient's the extrasystolic situation of heart generation single-shot) of arithmetic processing section that inputs to supply unit, represents that energy applies the key diagram of the input of switch and the application time of DC voltage.
Figure 17 B is in the electrocardiogram of the arithmetic processing section of input power device (the heart potential waveform of continuous extrasystolic situation occurring at patient's heart), represents that input energy applies switch and applies the key diagram of the time of DC voltage.
Figure 18 is in the electrocardiogram (heart potential waveform) of the datum line variation of the arithmetic processing section of input power device, represents to input the key diagram that energy applies switch and applies the time of DC voltage.
Figure 19 forms in the electrocardiogram (at the heart potential waveform of patient's the extrasystolic situation of heart generation single-shot) of the arithmetic processing section of the supply unit of conduit system in the past in input, represents that input energy applies switch and applies the key diagram of the time of DC voltage.
Figure 20 forms in the electrocardiogram (heart potential waveform) of datum line variation of the arithmetic processing section of the supply unit of conduit system in the past in input, represents to input the key diagram that energy applies switch and applies the time of DC voltage.
Symbol description
100 ... defibrillation catheter; 10 ... multi-lumen tube; 11 ... the 1st tube chamber; 12 ... the 2nd tube chamber; 13 ... the 3rd tube chamber; 14 ... the 4th tube chamber; 15 ... fluororesin layer, 16 ... in (core) portion; 17 ... (shell) portion outward; 18 ... STAINLESS STEEL WIRE; 20 ... handle; 21 ... handle body; 22 ... rope bolt; 24 ... strain relief; 26 ... the 1st insulating properties pipe; 27 ... the 2nd insulating properties pipe; 28 ... the 3rd insulating properties pipe; 31G ... 1DC electrode group; 31 ... ring electrode; 32G ... 2DC electrode group; 32 ... ring electrode; 33G ... base end side potential measurement electrode group; 33 ... ring electrode; 35 ... front-end chip; 41G ... the 1st lead wire set; 41 ... lead-in wire; 42G ... the 2nd lead wire set; 42 ... lead-in wire; 43G ... the 3rd lead wire set; 43 ... lead-in wire; 50 ... the adapter of defibrillation catheter; 51,52,53 ... needle-like terminal; 55 ... dividing plate; 58 ... resin; 61 ... the 1st protecting tube; 62 ... the 2nd protecting tube; 65 ... bracing wire; 700 ... supply unit; 71 ... DC power supply unit; 72 ... conduit connects adapter; 721,722,723 ... terminal; 73 ... electrocardiogrph connects adapter; 74 ... external switch (input block); 741 ... mode selector switch; 742 ... apply energy settings switch; 743 ... charge switch; 744 ... energy applies switch (discharge switch); 75 ... arithmetic processing section; 76 ... switching part; 77 ... electrocardiogram input connector; 78 ... display unit; 800 ... electrocardiogrph; 900 ... heart potential determination unit.
Detailed description of the invention
As shown in Figure 1, the intracardiac defibrillation catheter system of present embodiment possesses defibrillation catheter 100, supply unit 700, electrocardiogrph 800 and heart potential determination unit 900.
As shown in Figures 2 to 5, the defibrillation catheter 100 of the defibrillation catheter system of formation present embodiment possesses multi-lumen tube 10, handle 20,1DC electrode group 31G, 2DC electrode group 32G, base end side potential measurement electrode group 33G, the 1st lead wire set 41G, the 2nd lead wire set 42G and the 3rd lead wire set 43G.
As shown in FIG. 4 and 5, forming in the multi-lumen tube 10 (thering is the duct member of the insulating properties of multi-cavity structure) of defibrillation catheter 100, four tube chambers (the 1st tube chamber the 11, the 2nd tube chamber the 12, the 3rd tube chamber the 13, the 4th tube chamber 14) have been formed.
In Fig. 4 and Fig. 5, the 15th, the fluororesin layer of division tube chamber, the 16th, (core) portion in being formed by the nylon elastomer of soft, the 17th, outer (shell) portion being formed by the nylon elastomer of high rigidity, 18 in Fig. 4 is the STAINLESS STEEL WIREs that form braiding blade.
The fluororesin layer 15 of dividing tube chamber is for example made up of the high material of the insulating properties such as tetrafluoroethene-perfluorinated alkoxy vinyl ether copolymer (PFA), politef (PTFE).
The nylon elastomer that forms the outside 17 of multi-lumen tube 10 is used hardness according to axial and different material.Thus, multi-lumen tube 10 is configured to from front and periodically uprises towards base end side hardness.
If a preferred example is shown, in Fig. 3, the hardness (hardness being obtained by D type hardness tester meter) in the region shown in L1 (length 52mm) is that the hardness in the region shown in 40, L2 (length 108mm) is 55, the hardness in the region shown in L3 (length 25.7mm) is 63, the hardness in the region shown in L4 (length 10mm) is 68, the hardness of L5 (length 500mm) is 72.
The braiding blade being made up of STAINLESS STEEL WIRE only forms in Fig. 3 in the region shown in L5, as shown in Figure 4, is located between inner portion 16 and outside 17.
The external diameter of multi-lumen tube 10 is for example 1.2~3.3mm.
Be not particularly limited as the method for manufacturing multi-lumen tube 10.
The handle 20 that forms the defibrillation catheter 100 in present embodiment possesses handle body 21, rope bolt 22 and strain relief 24.
By rope bolt 22 is rotated to operation, can make the leading section deflection (shaking the head) of multi-lumen tube 10.
In the periphery (the inner front end area that does not form braiding) of multi-lumen tube 10,1DC electrode group 31G, 2DC electrode group 32G and base end side potential measurement electrode group 33G are installed.Herein, so-called " electrode group " refer to form same pole (thering is identical polar) or, the aggregation of multiple electrodes of for example, installing with narrow interval (5mm is following) with identical object.
1DC electrode group is by the front end area of multi-lumen tube, installs and forms multiple electrodes of same pole (utmost point or+utmost point) and form with narrow interval.Herein, form the number of electrode of 1DC electrode group also according to the width of electrode, configuration space and difference, but be for example 4~13, be preferably 8~10.
In the present embodiment, 1DC electrode group 31G is made up of eight ring electrodes 31 of the front end area that is installed on multi-lumen tube 10.
Form the electrode 31 of 1DC electrode group 31G via lead-in wire (forming the lead-in wire 41 of the 1st lead wire set 41G) and adapter described later, the conduit that is connected in supply unit 700 connects adapter.
Herein, the width of electrode 31 (axial length) is preferably 2~5mm, if illustrate, a preferred example is for 4mm.
If the width of electrode 31 is narrow, caloric value when voltage applies becomes excessive, thereby may cause damage to perienchyma.On the other hand, if the width of electrode 31 is wide, flexible the and flexibility of the part that is provided with 1DC electrode group 31G in multi-lumen tube 10 can be impaired.
The installation interval (partition distance of adjacent electrode) of electrode 31 is preferably 1~5mm, if illustrate, a preferred example is 2mm.
In the time using defibrillation catheter 100 (while being disposed in the chambers of the heart), 1DC electrode group 31G is positioned at for example Coronary vein.
2DC electrode group is spaced apart to base end side by the installation site from the 1DC electrode group of multi-lumen tube, and installs to form with multiple electrodes of 1DC electrode group phase the antipole (+utmost point or-utmost point) with narrow interval and form.Herein, form the number of electrode of 2DC electrode group also according to the width of electrode, configuration space and difference, but be for example 4~13, be preferably 8~10.
In the present embodiment, eight ring electrodes 32 that 2DC electrode group 32G is installed on multi-lumen tube 10 by the installation site from 1DC electrode group 31G separatedly to base end side form.
Form the electrode 32 of 2DC electrode group 32G via lead-in wire (forming the lead-in wire 42 of the 2nd lead wire set) and adapter described later, the conduit that is connected in supply unit 700 connects adapter.
Herein, the width of electrode 32 (axial length) is preferably 2~5mm.If illustrate, a preferred example is 4mm.
If the width of electrode 32 is narrow, caloric value when voltage applies becomes excessive, may cause damage to perienchyma.On the other hand, if the width of electrode 32 is wide, flexible the and flexibility of the part that is provided with 2DC electrode group 32G in multi-lumen tube 10 can be impaired.
The installation interval (distance of adjacent electrode) of electrode 32 is preferably 1~5mm, if illustrate, a preferred example is 2mm.
In the time using defibrillation catheter 100 (while being disposed in the chambers of the heart), 2DC electrode group 32G is positioned at for example right atrium.
In the present embodiment, base end side potential measurement electrode group 33G by the installation site from 2DC electrode group 32G to base end side spaced apart be installed on multi-lumen tube 10 four ring electrodes 32 form.
Form the electrode 33 of base end side potential measurement electrode group 33G via lead-in wire (forming the lead-in wire 43 of the 3rd lead wire set 43G) and adapter described later, the conduit that is connected in supply unit 700 connects adapter.
Herein, the width of electrode 33 (axial length) is preferably 0.5~2.0mm, if illustrate, a preferred example is 1.2mm.
If the width of electrode 33 is wide, the mensuration precision of heart potential reduces, definite difficulty that becomes at the generation position of abnormal potential.
The installation interval (distance of adjacent electrode) of electrode 33 is preferably 1.0~10.0mm.If illustrate, a preferred example is 5mm.
In the time using defibrillation catheter 100 (while being disposed in the chambers of the heart), base end side potential measurement electrode group 33G is positioned at the upper large vein that for example easily produces abnormal potential.
At the front end of defibrillation catheter 100, front-end chip 35 is installed.
, to these front-end chip 35 connecting lead wires, be not used as in the present embodiment electrode.But, can also be used as electrode by connecting lead wire.The constituent material of front-end chip 35 can be platinum, stainless steel and other metal materials, various resin materials etc., is not particularly limited.
The partition distance d2 of 1DC electrode group 31G (electrode 31 of base end side) and 2DC electrode group 32G (electrode 32 of front) is preferably 40~100mm, if illustrate, a preferred example is 66mm.
The partition distance d3 of 2DC electrode group 32G (electrode 32 of base end side) and base end side potential measurement electrode group 33G (electrode 33 of front) is preferably 5~50mm, if illustrate, a preferred example is 30mm.
As the electrode 31,32,33 that forms 1DC electrode group 31G, 2DC electrode group 32G and base end side potential measurement electrode group 33G, in order to make to become well for the radiography of X ray, preferably formed by the alloy of platinum or platinum class.
Shown in Fig. 4 and Fig. 5 the 1st lead-in wire 41G is go between 41 aggregations of eight of being connected respectively with eight electrodes (31) that form 1DC electrode group (31G).
Can pass through the 1st lead wire set 41G (lead-in wire 41), eight electrodes 31 that form 1DC electrode group 31G are electrically connected with supply unit 700 respectively.
Eight electrodes 31 that form 1DC electrode group 31G connect from different lead-in wires 41 respectively.Lead-in wire 41 is soldered to respectively electrode 31 inner peripheral surface at its fore-end, and enter the 1st tube chamber 11 from the side opening of the tube wall that is formed at multi-lumen tube 10.Eight lead-in wires 41 that enter the 1st tube chamber 11 extend in the 1st tube chamber 11 as the 1st lead wire set 41G.
The 2nd lead wire set 42G shown in Fig. 4 and Fig. 5 is and go between 42 aggregation of eight electrodes (32) is connected respectively eight that form 2DC electrode group (32G).
Can pass through the 2nd lead wire set 42G (lead-in wire 42), eight electrodes 32 that form 2DC electrode group 32G are electrically connected with supply unit 700 respectively.
Eight electrodes 32 that form the 2nd electrode group connect from different lead-in wires 42 respectively.Lead-in wire 42 is soldered to respectively electrode 32 inner peripheral surface at its fore-end, and enter the 2nd tube chamber 12 (the different tube chambers of the 1st tube chamber 11 that extend from the 1st lead wire set 41G) from the side opening of the tube wall that is formed at multi-lumen tube 10.Eight lead-in wires 42 that enter the 2nd tube chamber 12 extend in the 2nd tube chamber 12 as the 2nd lead wire set 42G.
As mentioned above, the 1st lead wire set 41G extends in the 1st tube chamber 11, and the 2nd lead wire set 42G extends in the 2nd tube chamber 12, thereby both are insulated isolation completely multi-lumen tube 10 is interior.Therefore,, in the time having applied the required voltage of defibrillation, can prevent reliably the short circuit between the 1st lead wire set 41G (1DC electrode group 31G) and the 2nd lead wire set 42G (2DC electrode group 32G).
The 3rd lead wire set 43G shown in Fig. 4 is and go between 43 aggregation of the electrode (33) is connected respectively four that forms base end side potential measurement electrode (33G).
Can pass through the 3rd lead wire set 43G (lead-in wire 43), the electrode 33 that forms base end side potential measurement electrode group 33G is electrically connected with supply unit 700 respectively.
Four electrodes 33 that form base end side potential measurement electrode 33G connect from different lead-in wires 43 respectively.Lead-in wire 43 is soldered to respectively electrode 33 inner peripheral surface at its fore-end, and enter the 3rd tube chamber 13 from the side opening of the tube wall that is formed at multi-lumen tube 10.Four lead-in wires 43 that enter the 3rd tube chamber 13 extend in the 3rd tube chamber as the 3rd lead wire set 43G.
As mentioned above, the 3rd lead wire set 43G extending in the 3rd tube chamber 13 is all completely insulated and is isolated with the 1st lead wire set 41G and the 2nd lead wire set 42G.Therefore, in the time having applied the required voltage of defibrillation, can prevent reliably the short circuit between the 3rd lead wire set 43G (base end side potential measurement electrode group 33G) and the 1st lead wire set 41G (1DC electrode group 31G) or the 2nd lead wire set 42G (2DC electrode group 32G).
Lead-in wire 41, lead-in wire 42 and lead-in wire 43 by by resin-coating such as polyimides plain conductor outer peripheral face resin-coating line form.Herein, be 2~30 μ m left and right as resin-coated thickness.
In Fig. 4 and Fig. 5, the 65th, bracing wire.
Bracing wire 65 is extended in the 4th tube chamber 14, and the eccentricity of central axis of multi-lumen tube 10 ground extends relatively.
The fore-end of bracing wire 65 is fixed on front-end chip 35 by soldering.In addition, also can form large-diameter portion (anti-delinking part) for anticreep at the front end of bracing wire 65.Thus, front-end chip 35 and bracing wire 65 strong bonded, can prevent coming off of front-end chip 35 etc. reliably.
On the other hand, the cardinal extremity part of bracing wire 65 is connected with the rope bolt 22 of handle 20, and by operating rope bolt 22, bracing wire 65 is stretched, thus, and the leading section deflection of multi-lumen tube 10.
Bracing wire 65 is made up of rustless steel, Ni-Ti class superelastic alloy, but without necessarily being formed by metal.Bracing wire 65 also can for example be made up of high-intensity non-conductive line etc.
In addition, making the mechanism of the leading section deflection of multi-lumen tube be not limited to this, for example, can be also to possess leaf spring and the mechanism that forms.
In the 4th tube chamber 14 of multi-lumen tube 10, only have bracing wire 65 to extend, lead-in wire (group) does not extend.Thus, in the time of the deflection operation of the leading section of multi-lumen tube 10, for example can prevent, due to mobile in the axial direction bracing wire 65 cause the going between situation of damaged (, scratch).
Defibrillation catheter 100 in present embodiment, even in the inside of handle 20, the 1st lead wire set 41G, the 2nd lead wire set 42G, the 3rd lead wire set 43 are also insulated isolation.
Fig. 6 is the axonometric chart that represents the internal structure of the handle of the defibrillation catheter 100 of present embodiment, and Fig. 7 is the partial enlarged drawing of handle inside (front), and Fig. 8 is the partial enlarged drawing of handle inside (base end side).
As shown in Figure 6, the base end part of multi-lumen tube 10 is inserted into the front opening of handle 20, and thus, multi-lumen tube 10 is connected with handle 20.
As shown in Fig. 6 and Fig. 8, in the base end part of handle 20, be built-in with adapter 50 cylindraceous, this adapter 50 cylindraceous is to form at the outstanding multiple needle-like terminals (51,52,53) of front end face 50A configuration forward end direction.
In addition, as shown in Figure 6 to 8, three insulating properties pipes (the 1st insulating properties pipe the 26, the 2nd insulating properties pipe the 27, the 3rd insulating properties pipe 28) of being inserted respectively by three lead wire set (the 1st lead wire set 41G, the 2nd lead wire set 42G, the 3rd lead wire set 43G) extend in the inside of handle 20.
As shown in Fig. 6 and Fig. 7, the leading section of the 1st insulating properties pipe 26 (10mm left and right from front end) is inserted into the 1st tube chamber 11 of multi-lumen tube 10, and thus, the 1st insulating properties pipe 26 is linked to the 1st tube chamber 11 that the 1st lead wire set 41G extends.
The endoporus of the 1st protecting tube 61 that the 1st insulating properties pipe 26 that is linked to the 1st tube chamber 11 extends by the inside at handle 20 extends near of adapter 50 (disposing the front end face 50A of needle-like terminal), formed by the base end part of the 1st lead wire set 41G guide to adapter 50 near insert road.Thus, prolonging from multi-lumen tube 10 (the 1st tube chamber 11) the 1st lead wire set 41G can not tangle and extend in the inside of handle 20 (endoporus of the 1st insulating properties pipe 26).
Prolong the 1st lead wire set 41G that from the cardinal extremity opening of the 1st insulating properties pipe 26 and splitted into eight lead-in wires 41 that form the 1st lead wire set 41G, these lead-in wires 41 are connected and fixed on respectively each of needle-like terminal of the front end face 50A that is disposed at adapter 50 by soldering.Herein, using the region that disposes the needle-like terminal (needle-like terminal 51) that has been connected and fixed the lead-in wire 41 that forms the 1st lead wire set 41G as " the 1st terminal group region ".
The leading section (10mm left and right from front end) of the 2nd insulating properties pipe 27 is inserted into the 2nd tube chamber 12 of multi-lumen tube 10, and thus, the 2nd insulating properties pipe 27 is linked to the 2nd tube chamber 12 that the 2nd lead wire set 42G extends.
The endoporus of the 2nd protecting tube 62 that the 2nd insulating properties pipe 27 that is linked to the 2nd tube chamber 12 extends by the inside at handle 20 extends near of adapter 50 (disposing the front end face 50A of needle-like terminal), formed by the base end part of the 2nd lead wire set 42G guide to adapter 50 near insert road.Thus, prolonging from multi-lumen tube 10 (the 2nd tube chamber 12) the 2nd lead wire set 42G can not tangle and extend in the inside of handle 20 (endoporus of the 2nd insulating properties pipe 27).
Prolong the 2nd lead wire set 42G that from the cardinal extremity opening of the 2nd insulating properties pipe 27 and splitted into eight lead-in wires 42 that form the 2nd lead wire set 42G, these lead-in wires 42 are connected and fixed on respectively each of needle-like terminal of the front end face 50A that is configured in adapter 50 by soldering.Herein, using the region that disposes the needle-like terminal (needle-like terminal 52) that is fixedly connected with the lead-in wire 42 that forms the 2nd lead wire set 42G as " the 2nd terminal group region ".
The leading section (10mm left and right from front end) of the 3rd insulating properties pipe 28 is inserted into the 3rd tube chamber 13 of multi-lumen tube 10, and thus, the 3rd insulating properties pipe 28 is linked to the 3rd tube chamber 13 that the 3rd lead wire set 43G extends.
The endoporus of the 2nd protecting tube 62 that the 3rd insulating properties pipe 28 that is linked to the 3rd tube chamber 13 extends by the inside at handle 20 extends near of adapter 50 (disposing the front end face 50A of needle-like terminal), formed by the base end part of the 3rd lead wire set 43G guide to adapter 50 near insert road.Thus, prolonging from multi-lumen tube 10 (the 3rd tube chamber 13) the 3rd lead wire set 43G can not tangle and extend in the inside of handle 20 (endoporus of the 3rd insulating properties pipe 28).
Prolong the 3rd lead wire set 43G that from the cardinal extremity opening of the 3rd insulating properties pipe 28 and splitted into four lead-in wires 43 that form the 3rd lead wire set 43G, these lead-in wires 43 are connected and fixed on respectively each of needle-like terminal of the front end face 50A that is disposed at adapter 50 by soldering.Herein, using the region that disposes the needle-like terminal (needle-like terminal 53) that is fixedly connected with the lead-in wire 43 that forms the 3rd lead wire set 43G as " the 3rd terminal group region ".
As the constituent material of insulating properties pipe (the 1st insulating properties pipe the 26, the 2nd insulating properties pipe 27 and the 3rd insulating properties pipe 28), can illustrate polyimide resin, polyamide, polyamide-imide resin etc. herein.Wherein, especially preferred hardness high and easily insert lead wire set, can realize thin molded polyimide resin.
As the wall thickness of insulating properties pipe, be preferably 20~40 μ m, if illustrate, a preferred example is 30 μ m.
In addition, as the constituent material of the interior protecting tube (the 1st protecting tube 61 and the 2nd protecting tube 62) that is inserted with insulating properties pipe, can illustrate the nylon based elastomers of " Pebax " (registered trade mark of ARKEMA company) etc.
According to the defibrillation catheter 100 having in the present embodiment of formation as described above, the 1st lead wire set 41G is in the interior extension of the 1st insulating properties pipe 26, the 2nd lead wire set 42G is in the interior extension of the 2nd insulating properties pipe 27, the 3rd lead wire set 43G is in the interior extension of the 3rd insulating properties pipe 28, even if thereby in the inside of handle 20, also can make the 1st lead wire set 41G, the 2nd lead wire set 42G and the 3rd lead wire set 43G isolation of insulating completely.Its result, in the time having applied the required voltage of defibrillation, can prevent reliably the 1st lead wire set 41G, the 2nd lead wire set 42G in the inside of handle 20 and short circuit (especially near the short circuit of prolonging the opening of tube chamber between the lead wire set) between the 3rd lead wire set 43G.
And; in the inside of handle 20; the 1st insulating properties pipe 26 is protected by the 1st protecting tube 61; the 2nd insulating properties pipe 27 and the 3rd insulating properties pipe 28 are protected by the 2nd protecting tube 62; thereby can prevent in the time of the deflection operation of for example leading section of multi-lumen tube 10, due to component parts (movable part) contact of rope bolt 22, the situation that friction causes insulating properties pipe to sustain damage.
Defibrillation pipe 100 in present embodiment possesses dividing plate 55, it is the 1st terminal group region, the 2nd terminal group region and the 3rd terminal group region that this dividing plate 55 separates the front end face 50A of adapter 50 that disposes multiple needle-like terminals, makes to go between 41, lead-in wire 42 and lead-in wire 43 isolation mutually.
The dividing plate 55 that separates the 1st terminal group region, the 2nd terminal group region and the 3rd terminal group region forms by water guide tubulose insulative resin being shaped for have tabular surface in both sides.As the insulative resin that forms dividing plate 55, be not particularly limited, can use the resins for universal use such as polyethylene.
The thickness of dividing plate 55 is for example 0.1~0.5mm, if illustrate, a preferred example is 0.2mm.
The height (distance from proximate edge to front edge) of dividing plate 55 need to be higher than the distance of the front end face 50A of adapter 50 and insulating properties pipe (the 1st insulating properties pipe 26 and the 2nd insulating properties pipe 27), in the situation that this distance is 7mm, the height of dividing plate 55 is for example 8mm.If use the dividing plate that is highly less than 7mm, cannot make its front edge be positioned at than the cardinal extremity of insulating properties pipe near front.
According to such formation, can reliably and fitly isolate the lead-in wire 41 (prolonging the cardinal extremity part of the lead-in wire 41 from the cardinal extremity opening of the 1st insulating properties pipe 26) that forms the 1st lead wire set 41G and the lead-in wire 42 (prolonging the cardinal extremity part of the lead-in wire 42 from the cardinal extremity opening of the 2nd insulating properties pipe 27) that forms the 2nd lead wire set 42G.
In the situation that not possessing dividing plate 55, cannot fitly isolate (separating) lead-in wire 41 and lead-in wire 42, they are swinging cross likely.
And, the lead-in wire 41 voltage, that form the 1st lead wire set 41G that is applied in mutual opposed polarity is mutually isolated by dividing plate 55 and can not contact with the lead-in wire 42 that forms the 2nd lead wire set 42G, so in the time using defibrillation catheter 100, even if apply the required voltage of intracardiac defibrillation, also can between the lead-in wire 41 (prolonging the cardinal extremity part of the lead-in wire 41 from the cardinal extremity opening of the 1st insulating properties pipe 26) of formation the 1st lead wire set 41G and the lead-in wire 42 (prolonging the cardinal extremity part of the lead-in wire 42 from the cardinal extremity opening of the 2nd insulating properties pipe 27) of formation the 2nd lead wire set 42G, not produce short circuit.
In addition, in the time manufacturing defibrillation catheter, in the time that being connected and fixed on to needle-like terminal, lead-in wire produces wrong in the situation that, for example, in the case of the lead-in wire 41 that forms the 1st lead wire set 42G is connected and fixed on the needle-like terminal in the 2nd terminal group region, this lead-in wire 41 can be crossed over dividing plate 55, so can easily find the mistake connecting.
In addition, the lead-in wire 43 (needle-like terminal 53) and lead-in wire 42 (the needle-like terminals 52) that form the 3rd lead wire set 43G are isolated by dividing plate 55 and 41 (needle-like terminal 51) together, but be not limited to this, also can be by dividing plate 55 and lead-in wire 42 (needle-like terminal 52) isolation together with lead-in wire 41 (needle-like terminals 51).
In defibrillation catheter 100, the front edge of dividing plate 55 is positioned at than the cardinal extremity of the cardinal extremity of the 1st insulating properties pipe 26 and the 2nd insulating properties pipe 27 all near front.
Thus, prolonging the lead-in wire that (forming the lead-in wire 41 of the 1st lead wire set 41G) from the cardinal extremity opening of the 1st insulating properties pipe 26 and prolonging from the cardinal extremity opening of the 2nd insulating properties pipe 27 between the lead-in wire (lead-in wire 42 of formation the 2nd lead wire set 42G) that, all the time there is dividing plate 55, thereby can prevent reliably the short circuit causing that contacts by lead-in wire 41 and lead-in wire 42.
As shown in Figure 8, from the cardinal extremity opening of the 1st insulating properties pipe 26 prolong and be connected and fixed on eight of needle-like terminal 51 lead-in wires 41 of adapter 50, from the cardinal extremity opening of the 2nd insulating properties pipe 27 prolong and be connected and fixed on adapter 50 needle-like terminal 52 eight lead-in wires 42 and prolong from the cardinal extremity opening of the 3rd insulating properties pipe 28 four lead-in wires 43 that and be connected and fixed on the needle-like terminal 53 of adapter 50 and kept fixing shape separately by the surrounding of fixing them with resin 58.
Keep the resin 58 of shape of lead-in wire to be configured as cylindric with adapter 50 same diameter, become and imbed the base end part of needle-like terminal, lead-in wire, insulating properties pipe and the state of dividing plate 55 in the inside of this resin molded body.
And, be embedded in the formation of the inside of resin molded body according to the base end part of insulating properties pipe, can cover completely from the cardinal extremity opening of insulating properties pipe and prolong the universe that to play to be connected and fixed on the lead-in wire (cardinal extremity part) till needle-like terminal by resin 58, can keep the shape of anchor leg (cardinal extremity part) completely.
In addition, the height of resin molded body (distance from cardinal extremity face to front end face), higher than the height of dividing plate 55, is preferably 8mm at the height of dividing plate 55, for example, be made as 9mm.
Herein, as the resin 58 that forms resin molded body, be not particularly limited, but preferably use heat-curing resin or light-cured resin.Particularly, can illustrate the curable resin of urethane esters, epoxy resin, urethanes-epoxy resin.
According to formation as described above, owing to keeping the shape of anchor leg by resin 58, so manufacturing when defibrillation catheter 100 (at the inside of handle 20 mounted connector 50 time), can prevent that prolonging from the cardinal extremity opening of insulating properties pipe the lead-in wire tangles or damage (resin-coated the cracking for example, going between) with the EDGE CONTACT of needle-like terminal.
As shown in Figure 1, the supply unit 700 of the defibrillation catheter system of formation present embodiment possesses DC power supply unit 71, conduit connects adapter 72, electrocardiogrph connection adapter 73, external switch (input block) 74, arithmetic processing section 75, switching part 76, electrocardiogram input connector 77 and display unit 78.
In DC power supply unit 71, be built-in with capacitor, by the input of external switch 74 (charge switch 743), built-in capacitor charged.
Conduit connects adapter 72 and is connected with the adapter 50 of defibrillation catheter 100, is electrically connected with the base end side of the 1st lead wire set (41G), the 2nd lead wire set (42G) and the 3rd lead wire set (43G).
As shown in Figure 9, the adapter 50 of defibrillation catheter 100 is connected adapter 72 with the conduit of supply unit 700 and links by connector cable C1, thereby the needle-like terminal 51 (being actually eight) that has been connected and fixed eight lead-in wires 41 that form the 1st lead wire set is connected the terminal 721 (being actually eight) of adapter 72 with conduit, the needle-like terminal 52 (being actually eight) that has been connected and fixed eight lead-in wires 42 that form the 2nd lead wire set is connected the terminal 722 (being actually eight) of adapter 72 with conduit, being connected and fixed the needle-like terminal 53 (being actually four) that forms four of the 3rd lead wire set lead-in wires 43 is connected adapter 72 terminal 723 (actual is four) with conduit connects respectively.
Herein, terminal 721 and terminal 722 that conduit connects adapter 72 are connected with switching part 76, and terminal 723 is not directly connected to electrocardiogrph and connects adapter 73 via switching part 76.
Thus, the heart potential information determining by 1DC electrode group 31G and 2DC electrode group 32G arrives electrocardiogrph via switching part 76 and connects adapter 73, and the heart potential information being determined by base end side potential measurement electrode group 33G does not arrive electrocardiogrph via switching part 76 and connects adapter 73.
Electrocardiogrph connects adapter 73 and is connected with the input terminal of electrocardiogrph 800.
External switch 74 as input block comprises: for switch heart potential mode determination and defibrillation mode mode selector switch 741, set applying energy settings switch 742, applying switch (discharge switch) 744 for the charge switch 743 that DC power supply unit 71 is charged and the energy that carries out defibrillation for applying electric energy of the electric energy that applies when defibrillation.Input signal from these external switches 74 is all sent to arithmetic processing section 75.
The input of arithmetic processing section 75 based on external switch 74, controls DC power supply unit 71, switching part 76 and display unit 78.
This arithmetic processing section 75 has output circuit 751, and this output circuit 751 is for exporting the DC voltage from DC power supply unit 71 to the electrode of defibrillation catheter 100 via switching part 76.
Apply DC voltage by this output circuit 751, so that connecting the terminal 721 (being finally the 1DC electrode group 31G of defibrillation catheter 100) of adapter 72 is connected adapter 72 terminal 722 (being finally the 2DC electrode group 33G of defibrillation catheter 100) with conduit, conduit shown in Fig. 9 becomes mutual opposed polarity (side electrode group is-when the utmost point, the opposing party's electrode group is+utmost point).
Switching part 76 is made up of the change-over switch of 1 circuit 2 contacts (Single Pole Double Throw: single-pole double throw), and the common junction connecting duct of the change-over switch of these 1 circuit, 2 contacts connects adapter 72 (terminal 721 and terminal 722), the 1st contact connects electrocardiogrph and connects adapter 73, the 2nd contact concatenation operation handling part 75.
; in the time having selected the 1st contact (when the 1st contact is connected with common junction); link conduit connection adapter 72 is connected the path of adapter 73 to be guaranteed with electrocardiogrph; in the time having selected the 2nd contact (when the 2nd contact is connected with common junction), the path that links conduit connection adapter 72 and arithmetic processing section 75 is guaranteed.
According to the input of external switch 74 (mode selector switch 741, energy apply switch 744), controlled the switching of switching part 76 by arithmetic processing section 75 and move.
Electrocardiogram input connector 77 is connected with arithmetic processing section 75, in addition, is also connected with the lead-out terminal of electrocardiogrph 800.
Can pass through this electrocardiogram input connector 77, by the heart potential information of exporting from electrocardiogrph 800 (conventionally, be input to a part for the heart potential information of electrocardiogrph 800) input to arithmetic processing section 75, in arithmetic processing section 75, can be according to this heart potential information control DC power supply unit 71 and switching part 76.
Display unit 78 is connected with arithmetic processing section 75, display unit 78 shows the heart potential information (being mainly electrocardiogram (heart potential waveform)) that inputs to arithmetic processing section 75 from electrocardiogram input connector 77, and operator can monitor and be input to the heart potential information (electrocardiogram) of arithmetic processing section 75 while carry out defibrillation therapy (input of external switch etc.).
The electrocardiogrph 800 (input terminal) that forms the defibrillation catheter system of present embodiment is connected adapter 73 with the electrocardiogrph of supply unit 700 and connects, and the heart potential information being determined by defibrillation catheter 100 (the formation electrode of 1DC electrode group 31G, 2DC electrode group 32G and base end side potential measurement electrode group 33G) connects adapter 73 from electrocardiogrph and is input to electrocardiogrph 800.
In addition, electrocardiogrph 800 (other input terminals) is also connected with potential measurement unit 900, and the heart potential information being determined by heart potential determination unit 900 is also input to electrocardiogrph 800.
As heart potential determination unit 900, can list in order to measure 12 induction electrocardiograms the electrode catheter (electrode catheters different from defibrillation catheter 100) of installing in the electrode slice pasted at patient's body surface, heart patient herein.
Electrocardiogrph 800 (lead-out terminal) is connected with the electrocardiogram input connector 77 of supply unit 700, a part for the heart potential information (from the heart potential information of defibrillation catheter 100 and from the heart potential information of heart potential determination unit 900) that is input to electrocardiogrph 800 can be sent to arithmetic processing section 75 via electrocardiogram input connector 77.
The defibrillation catheter 100 of present embodiment, when carrying out defibrillation therapy, can be measured as heart potential the electrode catheter of use.
Figure 10 is for example illustrated in, while carrying out cardiac catheterization (high-frequency treatment), the flow direction of the heart potential information while measuring heart potential by the defibrillation catheter 100 of present embodiment.Now, the switching part 76 of supply unit 700 has selected to be connected with the 1st contact that electrocardiogrph connects adapter 73.
Ji connecting adapter 72, switching part 76 and electrocardiogrph connection adapter 73 via conduit, the heart potential that the determination of electrode of ∕ or 2DC electrode group 32G goes out is input to electrocardiogrph 800 by the 1DC electrode group 31G Yi that forms defibrillation catheter 100.
In addition, the heart potential being gone out by the determination of electrode of base end side potential measurement electrode group 33G that forms defibrillation catheter 100 connects adapter 72 from conduit and does not directly connect adapter 73 via electrocardiogrph by switching part 76 and be input to electrocardiogrph 800.
Be shown in the display (omitting diagram) of electrocardiogrph 800 from the heart potential information (electrocardiogram) of defibrillation catheter 100.
In addition, a part for heart potential information from defibrillation catheter 100 (for example, the potential difference between the electrode 31 (the 1st utmost point and the 2nd utmost point) of formation 1DC electrode group 31G) can be inputed to display unit 78 from electrocardiogrph 800 via electrocardiogram input connector 77 and arithmetic processing section 75 shows.
As mentioned above, do not need defibrillation therapy in cardiac catheterization time, defibrillation catheter 100 can be measured to the electrode catheter of use as heart potential.
And, there is atrial fibrillation in cardiac catheterization time, can utilize the defibrillation catheter 100 being made as electrode catheter to carry out immediately defibrillation therapy.Its result, in the time having there is atrial fibrillation, can save new insertion for troubles such as the conduits of defibrillation.
Arithmetic processing section 75 is according to a part (electrocardiogram) for the heart potential information of sending from electrocardiogrph 800 via electrocardiogram input connector 77, successively this Electrocardiographic event (waveform) that is estimated to be R ripple of sensing.
The sensing that is estimated to be the event of R ripple is for example undertaken by following mode, that is: the peak-peak waveform in waveform and the first two cycle of the peak-peak in the previous cycle in the cycle (beating) of detection wish sensing, calculate the average height of these peak-peak waveforms, detect potential difference and arrived the situation of 80% height (triggering level) of this average height.
In addition, arithmetic processing section 75 is carried out in such a way calculation process and is controlled DC power supply unit 71, that is: the event sensing is identified respectively to its polarity (with the direction of ± peak value that symbol represents), apply after switch 744 event (the V sensing in the cycle of the n time at input energy n) the event (V that senses in the previous cycle with it of polarity n-1) polarity and the event (V sensing in two cycles before n-2) polarity when consistent, with this event (V n) synchronously conduit is connected to the terminal 721 (1DC electrode group 31G) of adapter 72 is connected adapter 72 terminal 722 (2DC electrode group 32G) with conduit and apply voltage.
In the electrocardiogram shown in Figure 16 A to Figure 16 D, in six events that are estimated to be R ripple and sense, be (-) (its peak value waveform down) from the polarity of the 3rd event of left side number, the polarity of other five events is (+) (its peak value waveform is upward).
As shown in Figure 16 A, sensing from the event (V of second of left side number 0) after inputted energy and applied in the situation of switch 744, the 3rd event (V 1) polarity (-) and previous cycle in second event (V sensing 0) polarity (+) difference, so not with this event (V 1) synchronously apply voltage.
In addition, the 4th event (V 2) polarity (+) and the 3rd event (V of sensing in the previous cycle 1) polarity (-) difference, so not with this event (V 2) synchronously apply voltage.
In addition, the 5th event (V 3) polarity (+) and the 3rd event (V of sensing in the first two cycle 1) polarity (-) difference, so not with this event (V 3) synchronously apply voltage.
The 6th event (V 4) polarity (+) and the 5th event (V sensing in the previous cycle 3) polarity (+) and the 4th event (V of sensing in the first two cycle 2) polarity (+) identical, so with this event (V 4) synchronously 1DC electrode group 31G and 2DC electrode group 32G are applied to voltage.
As shown in Figure 16 B, sensing from the 3rd event (V of left side number 0) after inputted energy and applied in the situation of switch 744, the 4th event (V 1) polarity (+) and the 3rd event (V sensing in the previous cycle 0) polarity (-) difference, so not with this event (V 1) synchronously apply voltage.
In addition, the 5th event (V 2) polarity (+) and the 3rd event (V sensing in the first two cycle 0) polarity (-) difference, so not with this event (V 2) synchronously apply voltage.
The 6th event (V 3) polarity (+) and the 5th event (V sensing in the previous cycle 2) polarity (+) and the 4th the event (V sensing in the first two cycle 1) polarity (+) identical, so with this event (V 3) synchronously 1DC electrode group 31G and 2DC electrode group 32G are applied to voltage.
As shown in Figure 16 C, sensing from the 4th event (V of left side number 0) after inputted energy and applied in the situation of switch 744, the 5th event (V 1) polarity (+) and the 3rd event (V of sensing in the first two cycle -1) polarity (-) difference, so not with this event (V 1) synchronously apply voltage.
The 6th event (V 2) polarity (+) and the 5th event (V sensing in the previous cycle 1) polarity (+) and the 4th the event (V sensing in the first two cycle 0) polarity (+) identical, so with this event (V 2) synchronously 1DC electrode group 31G and 2DC electrode group 32G are applied to voltage.
As shown in Figure 16 D, sensing from the 5th event (V of left side number 0) after inputted energy and applied in the situation of switch 744, the 6th event (V 1) polarity (+) and the 5th event (V sensing in the previous cycle 0) polarity (+) and the 4th the event (V sensing in the first two cycle -1) polarity (+) identical, so with this event (V 1) synchronously 1DC electrode group 31G and 2DC electrode group 32G are applied to voltage.
As mentioned above, apply switch 744 even inputted energy in the time arbitrarily shown in Figure 16 A to Figure 16 D, the 3rd event (from the 6th event of left side number) during all with continuous three times of identical polar (+) synchronously applies voltage.
In addition, arithmetic processing section 75 sensed between the 260m second after the event that is estimated to be R ripple in the electrocardiogram being transfused to, and DC power supply unit 71 was controlled, to 1DC electrode group 31G and 2DC electrode group 32G are not applied to voltage.
Thus, the event sensing is in the situation of peak value of R ripple, can avoid reliably the moment occurring at its next T ripple to carry out defibrillation.That is to say, shield to make it cannot defibrillation to being estimated to be the peak value of T ripple.
In addition, sensing after event, during not applying DC voltage, be not limited to 260m second, the shortest is 50m second, and the longest is 500m second.During this period short than 50m second in the situation that, sometimes cannot shield the peak value that is estimated to be T ripple.On the other hand, during this period long than 500m second in the situation that, R ripple that sometimes cannot be in the next cycle of sensing (beating).
In addition, arithmetic processing section 75, sensing after the event that is estimated as R ripple between 100m second, is programmed so that new sensing is estimated to be the event of R ripple.
Thus, then R ripple, the peak value of the S ripple occurring in the direction contrary with this R ripple (contrary polarity) increases and has arrived in the situation (also there is no special problem even if carry out defibrillation under this state) of triggering level, can prevent by the peak value of this S ripple of sensing, cause the situation of the seriality impaired (counting of identical polar is reset) of the polarity of event.
In addition, after sensing event, be estimated to be (between inhibitory stage) during the event of R ripple as new sensing, be not limited to 100m second, the shortest is 10m second, and the longest is 150m second.
And arithmetic processing section 75 applied at energy after the input of switch 744 between 260m second, controlled DC power supply unit 71, to 1DC electrode group 31G and 2DC electrode group 32G are not applied to voltage.
Thus, the noise that can prevent the input that applies switch 744 due to energy to produce (with before once and the noise of the event opposed polarity of front secondary) mistakenly sensing be R ripple, and with this Noise Synchronization carry out the such situation of defibrillation.
In addition, can prevent the noise that the input by apply switch 744 due to energy produces (with before once and/or the noise of the event opposed polarity of front secondary) damage the situation of the seriality (counting of identical polar is reset) of the polarity of event.
And the variation that also can prevent the energy to apply the datum line that the input of switch 744 produces afterwards mistakenly sensing is R ripple, and synchronously carries out therewith the situation of defibrillation.
In addition, energy applies after the input of switch 744, during not applying DC voltage, is not limited between 260m second, and the shortest is between 10m second, and the longest is between 500m second.
Below, according to the flow chart shown in Figure 11, the defibrillation therapy of the intracardiac defibrillation catheter system to present embodiment example describes.
(1) first, pass through radioscopic image, confirm the position of the electrode (the formation electrode of 1DC electrode group 31G, 2DC electrode group 32G and base end side potential measurement electrode group 33G) of defibrillation catheter 100, and select to be input to from heart potential determination unit 900 (electrode slice of pasting at body surface) part for the heart potential information (12 induction electrocardiogram) of electrocardiogrph 800, be input to the arithmetic processing section 75 (step 1 of Figure 11 A) of supply unit 700 from electrocardiogram input connector 77.Now, a part that is input to the heart potential information of arithmetic processing section 75 is shown in display unit 78 (with reference to Figure 12).In addition, connecting adapter 72, switching part 76, electrocardiogrph from the 1DC electrode group 31G of defibrillation catheter 100 and/or the formation electrode of 2DC electrode group 32G via conduit connects adapter 73 and is input to the heart potential information of electrocardiogrph 800, connects via conduit the display (omitting diagram) that adapter 72, electrocardiogrph connect heart potential information that adapter 73 is input to electrocardiogrph 800 and be shown in electrocardiogrph 800 from the formation electrode of the base end side potential measurement electrode group 33G of defibrillation catheter 100.
(2) next, input is as the mode selector switch 741 of external switch 74.Supply unit 700 in present embodiment is " heart potential mode determination " under original state, and switching part 76 is selected the 1st contact, and the path that arrives electrocardiogrph connection adapter 73 via switching part 76 from conduit connection adapter 72 is guaranteed.Input by mode selector switch 741 becomes " defibrillation mode " (step 2).
(3) as shown in figure 13, if being transfused to, mode selector switch 741 is switched to defibrillation mode, by the control signal of arithmetic processing section 75, the contact of switching part 76 is switched to the 2nd contact, and connect from conduit adapter 72 arrives arithmetic processing section 75 path via switching part 76 and guaranteed, connect adapter 72 from conduit and arrive via switching part 76 path that electrocardiogrph connects adapter 73 and be cut off (step 3).In the time that switching part 76 has been selected the 2nd contact, cannot be input to electrocardiogrph 800 from the heart potential information of the 1DC electrode group 31G of defibrillation catheter 100 and the formation electrode of 2DC electrode group 32G and (therefore, also this heart potential information cannot be sent to arithmetic processing section 75.)。But, be not imported into electrocardiogrph 800 via the heart potential information of the formation electrode from base end side potential measurement electrode group 33G of switching part 76.
(4) in the time that the contact of switching part 76 is switched to the 2nd contact, the resistance (step 4) between 1DC electrode group (31G) and the 2nd electrode group (32G) of mensuration defibrillation catheter 100.Together with connecting adapter 72 is input to arithmetic processing section 75 resistance value via switching part 76 and be input to the part of the heart potential information from heart potential determination unit 900 for arithmetic processing section 75 from conduit, be shown in display unit 78 (with reference to Figure 13).
(5) contact of switching part 76 is switched to the 1st contact, connects adapter 72 arrive via switching part 76 the path recovery (step 5) that electrocardiogrph connects adapter 73 from conduit.In addition, to have selected the time (above-mentioned steps 3~step 5) of the 2nd contact be for example between 1 second to the contact of switching part 76.
(6) arithmetic processing section 75 judges whether the resistance determining in step 4 has exceeded certain value, in the situation that not exceeding, enter following step 7 (for applying the preparation of DC voltage), in the situation that exceeding, return to step 1 (location confirmation of the electrode of defibrillation catheter 100) (step 6).
Herein, exceed certain value at resistance, meaned that 1DC electrode group and/or the 2nd electrode group do not abut to the position of regulation (for example, the inwall of the tube wall of Coronary vein, right atrium) reliably, so need to return to step 1, readjust the position of electrode.
Like this, due to the position that only abuts to reliably regulation in the 1DC electrode group of defibrillation catheter 100 and 2DC electrode group (for example, the tube wall of Coronary vein, the inwall of right atrium) time can apply voltage, so can carry out efficient defibrillation therapy.
(7) input as external switch 74 apply energy settings switch 742, while setting defibrillation, apply energy (step 7 of Figure 11 B).According to the supply unit 700 in present embodiment, can, from 1J to 30J, set and apply energy with the scale of 1J.
(8) input, as the charge switch 743 of external switch 74, is carried out the charging (step 8) of energy to the built-in capacitor of DC power supply unit 71.
(9), after charging completes, input applies switch 744 (step 9) as the energy of external switch 74.
(10) as the current event (V that represents sensing in step 12 described later n) be the number (n) that input energy applies the event of switch 744 rear which time sensings, make " 1 " produce (step 10).
(11) arithmetic processing section 75 is with the previous event (V of sensing n-1) after (energy applies the event that the input of switch 744 senses not long ago) between 100m second as between inhibitory stage, carry out standby and do not carry out new sensing (step 11).
(12), after between inhibitory stage, arithmetic processing section 75 is to event (V n) carry out sensing (step 12).
(13) arithmetic processing section 75 is judged the event (V sensing in step 12 n) polarity whether with the event (V of last time (previous sensing) n-1) polarity consistent, consistent in the situation that, enter step 14, in inconsistent situation, in step 10 ' in, above-mentioned number (n) is added to 1 and return to step 11 (step 13).
(14) arithmetic processing section 75 is judged the event (V sensing in step 12 n) polarity whether with the event (V of last time (two sense before) again n-2) polarity consistent, consistent in the situation that, enter step 15, in inconsistent situation, in step 10 ' in, above-mentioned number (n) is added to 1 and return to step 11 (step 14).
(15) arithmetic processing section 75 is judged from sensing event (V last time n-1) play sensed event (V n) till time whether exceed 260m second, in the situation that exceeding, enter step 16, in the situation that not exceeding, in step 10 ' in, above-mentioned number (n) is added to 1 and return to step 11 (step 15 of Figure 11).
(16) arithmetic processing section 75 judges that applying switch 744 from input energy plays sensed event (V n) till time whether exceed 260 seconds, in the situation that exceeding, enter step 17, in the situation that not exceeding, in step 10 ' in, above-mentioned number (n) is added to 1 and return to step 11 (step 16).
(17) by arithmetic processing section 75, the contact of switching part 76 is switched to the 2nd contact, connect from conduit adapter 72 arrives arithmetic processing section 75 path via switching part 76 and guaranteed, connect adapter 72 from conduit and arrive via switching part 76 path that electrocardiogrph connects adapter 73 and be cut off (step 17).
(18) be switched to after the 2nd contact at the contact of switching part 76, connect adapter 72 from receiving from the DC power supply unit 71 of the control signal of arithmetic processing section 75 via output circuit 751, switching part 76 and the conduit of arithmetic processing section 75,1DC electrode group to defibrillation catheter 100 and 2DC electrode group apply the DC voltage (step 18, with reference to Figure 14) of mutual opposed polarity.
Herein, arithmetic processing section 75 is carried out calculation process DC power supply unit 71 is transmitted control signal, so as with step 12 in the event (V that senses n) synchronously 1DC electrode group and 2DC electrode group are applied to DC voltage.
Particularly, from sensing event (V n) moment while rising (next R ripple) for example rise, through certain hour (, event (V n) extremely short time of 1/10 left and right of spike width of R ripple) start afterwards to apply.
Figure 15 is the figure that represents the potential waveform of for example, having measured while having given the electric energy (, setting output=10J) of regulation by the defibrillation catheter 100 of present embodiment.In the figure, transverse axis express time, the longitudinal axis represents current potential.
First, rise through certain hour (t in arithmetic processing section 75 sensed event (Vn) 0) after, so that the mode of the become-utmost point of 1DC electrode group 31G, the become+utmost point of 2DC electrode group 32G is to applying DC voltage between the two, thereby is supplied to electric energy and measures the current potential (E that rises 1it is crest voltage now.)。Through certain hour (t 1) afterwards so that the mode of the become+utmost point of 1DC electrode group 31G, the become-utmost point of 2DC electrode group 32G reversed to applying between the two ± DC voltage, thereby be supplied to electric energy and measure the current potential (E that rises 2it is crest voltage now.)。
Herein, from sensed event (V n) play the time (t till starting to apply 0) be for example 0.01~0.05 second, if illustrate, a preferred example is 0.01 second, time (t=t 1+ t 2) be for example 0.006~0.03 second, if illustrate, a preferred example is 0.02 second.Thus, can with the event (V as R ripple n) synchronously apply voltage, can carry out efficient defibrillation therapy.
Crest voltage (the E measuring 1) be for example 300~600V.
(19) from sensed event (V n) rise through certain hour (t 0+ t) after, accept to stop applying voltage (step 19) from DC power supply unit 71 from the control signal of arithmetic processing section 75.
(20), after applying of voltage stops, applying record (heart potential waveform when applying as shown in Figure 15) and be shown in display unit 78 (step 20).It is for example 5 seconds as displaying time.
(21) contact of switching part 76 is switched to the 1st contact, connect adapter 72 from conduit and arrive via switching part 76 the path recovery that electrocardiogrph connects adapter 73, be input to electrocardiogrph 800 (step 21) from the heart potential information of the 1DC electrode group 31G of defibrillation catheter 100 and the formation electrode of 2DC electrode group 32G.
(22) observe be shown in electrocardiogrph 800 display, from the heart potential information (electrocardiogram) of the formation electrode (the formation electrode of 1DC electrode group 31G, 2DC electrode group 32G and base end side potential measurement electrode group 33G) of defibrillation catheter 100 and from the heart potential information (12 induction electrocardiogram) of heart potential determination unit 900, if " normally " finishes, " undesired (atrial fibrillation is not cured) " in the situation that, return to step 2 (step 22).
According to the conduit system of present embodiment, 1DC electrode group 31G and 2DC electrode group 32G by defibrillation catheter 100 can directly provide electric energy to the heart that fibrillation occurs, and can only provide reliably the required and sufficient electricity irritation of defibrillation therapy (surge) to heart.
And, owing to can directly providing electric energy to heart, so also can not produce burn at patient's body surface.
In addition, the heart potential information that electrode 33 determines of forming by base end side potential measurement electrode group 33G connects adapter 72 from conduit and does not connect adapter 73 via switching part 76 via electrocardiogrph and be input to electrocardiogrph 800, and, this electrocardiogrph 800 is connected with heart potential determination unit 900, even if thereby (switching part 76 is switched to contact 2 in the time that electrocardiogrph 800 cannot obtain the defibrillation therapy from the 1DC electrode group 31G of defibrillation catheter 100 and the heart potential of 2DC electrode group 32G, when connecting adapter 72 and arrive electrocardiogrph and connect the path of adapter 73 and be cut off via switching part 76 from conduit), electrocardiogrph 800 also can obtain the heart potential information being determined by base end side potential measurement electrode group 33G and heart potential determination unit 900, and can in electrocardiogrph 800, monitor that (monitoring) heart potential carries out defibrillation therapy on one side on one side.
And, due to the arithmetic processing section 75 of supply unit 700 by with the heart potential synchronous waveform of inputting via electrocardiogram input connector 77 apply voltage system and carry out calculation process and control (from the potential difference heart potential waveform arrives triggering level, for example, after certain hour (0.01 second), starting to apply) for DC power supply unit 71, so can be to the 1DC electrode group 31G of defibrillation catheter 100 and 2DC electrode group 32G, with heart potential synchronous waveform apply voltage, merger can be carried out efficient defibrillation therapy.
And, the resistance of arithmetic processing section 75 in the case of between the electrode group of defibrillation catheter 100 does not exceed certain value,, the position that only abuts to reliably regulation at 1DC electrode group 31G and 2DC electrode group 32G (for example, the tube wall of Coronary vein, the inwall of right atrium) time, control to can enter the preparation for applying DC voltage, therefore can carry out effective defibrillation therapy.
And, arithmetic processing section 75 is carried out in such a way computing DC power supply unit 71 is controlled, that is: the electrocardiogram of inputting from electrocardiogrph 800 via electrocardiogram input connector 77, successively sensing is estimated to be the event of R ripple, after energy applies the input of switch 744, the event (V sensing for the n time n) polarity and the front event (V once sensing n-1) polarity and the event (V that secondary sensing goes out before n-2) polarity when consistent, with event (V n) synchronously 1DC electrode group 31G and 2DC electrode group 32 are applied to voltage, thus if three event (V that sense of continuity measures n-2), (V n-1) and (V n) polarity inconsistent, not with event (V n) synchronously apply voltage, and only at three event (V n-2), (V n-1) and (V n) polarity when consistent, with event (V for the third time n) synchronously apply voltage, therefore can carry out reliably the defibrillation of synchronizeing with R ripple.
Figure 17 A is the electrocardiogram (with the identical heart potential waveform shown in Figure 19) that is imported into arithmetic processing section 75 in the time of patient's heart generation single-shot premature contraction.In Figure 17 A, from the R ripple (event (V of the 4th of left side number 0)) polarity be (-), the peak value of the T ripple of following increases, this T ripple is sensed to be event (V 1).
As shown in the drawing, sensing event (V 0) after inputted energy and applied in the situation of switch 744, the event (V that it senses in the near future 1) polarity (+) previous event (V sensing with it 0) polarity (-) difference, therefore not with this event (V 1) synchronously apply voltage.Thus, can avoid increasing with peak value and the T ripple that is mistaken as R ripple synchronously applies voltage.
In addition, event (V 1) the event (V that senses of the next one 2) be the peak value of R ripple, but its polarity (+) and the first two event (V sensing 0) polarity (-) difference, therefore not with this event (V 2) synchronously apply voltage.
And, due to event (V 2) the event (V that senses of the next one 3) polarity (+) and the previous event (V sensing 2) polarity (+) and the event (V that the first two senses 1) polarity (+) identical, so with the event (V that can be sure of for the peak value of R ripple 3) synchronously 1DC electrode group 31G and 2DC electrode group 32G are applied to voltage.
Figure 17 B is in the time that patient's heart continuously premature contraction occurs, and is input to the electrocardiogram of arithmetic processing section 75.
As shown in the drawing, at the event (V that senses the polarity inversion one-tenth (-) due to premature contraction 0) after inputted energy and applied in the situation of switch 744, the event (V that it in the near future senses 1) polarity be (+), the event (V that the next one senses 2) polarity be (-), the event (V that the next one senses 3) polarity be (+), the event (V that the next one senses 4) polarity be (-), the event (V that the next one senses 5) polarity be (+), the alternating polarity of event ground changes.Therefore, in this wise, under the inconsistent state of polarity of three events that measure at sense of continuity, each that is judged as these events may not be the peak value of R ripple, thus not with this event synchronization apply voltage.
In addition, event (V 5) the event (V that senses of the next one 6) polarity (+) be the peak value of R ripple, but its polarity (+) and the first two event (V sensing 4) polarity (-) difference, so not with this event (V 6) synchronously apply voltage.
And, due to event (V 6) the event (V that senses of the next one 7) polarity (+) and event (V 6) polarity (+) and event (V 5) polarity (+) identical, so be judged as at event (V 7) sensing time premature contraction cure reliably, with the event (V that can be sure of for the peak value of R ripple 7) synchronously 1DC electrode group 31G and 2DC electrode group 32G are applied to voltage.
Figure 18 is that drift occurs and datum line decline, afterwards, datum line rises and returns to the electrocardiogram (with the identical heart potential waveform shown in Figure 20) of original level, and the decline of datum line and rising are mistaken as R ripple, are sensed to be respectively event (V -1) and event (V 1).
As shown in figure 18, the in the situation that of having inputted energy applied switch 744 before datum line rise, the event (V that it senses in the near future 1) polarity (+) and the previous event (V sensing 0) polarity (+) identical, but with the first two event (V sensing -1) polarity (-) difference, so not with this event (V 1) synchronously apply voltage, thus, can avoid be mistaken as R ripple the rising of datum line time synchronously apply voltage.
And, due to event (V 1) the event (V that senses of the next one 2) polarity (+) and the previous event (V sensing 1) polarity (+) and the event (V that the first two senses 0) polarity (+) identical, so be judged as at event (V 2) sensing time datum line stable, with the event (V that can be sure of for the peak value of R ripple 2) synchronously 1DC electrode group 31G and 2DC electrode group 32G are applied to voltage.
And, arithmetic processing section 75 sensed after the event that is estimated to be R ripple between 260m second, control DC power supply unit 71, to 1DC electrode group 31G and 2DC electrode group 32G are not applied to DC voltage, so the peak value that is R ripple in the event sensing, can avoid reliably the moment occurring at next T ripple to carry out defibrillation.
And, arithmetic processing section 75 was programmed between the 100m second after sensing the event that is estimated to be R ripple, so that not new sensing is estimated to be the event of R ripple, therefore be the peak value of R ripple in the event sensing, the peak value of the S ripple that then this R ripple in the opposite direction occurs increases and arrives in the such situation of triggering level, can prevent the peak value of this S ripple of sensing and situation that the counting of identical polar is reset.
And, because arithmetic processing section 75 is after energy applies the input of switch 744 between 260m second, control DC power supply unit 71, to 1DC electrode group 31G and 2DC electrode group 32G are not applied to DC voltage, so can prevent that by the noise error ground sensing that applies the input of switch 744 by energy and produce be R ripple, and with this Noise Synchronization carry out defibrillation or the situation that the counting of identical polar is reset due to this noise.
Above, one embodiment of the present invention is illustrated, but defibrillation catheter system of the present invention is not limited to this, can carries out various changes.
For example, the arithmetic processing section of supply unit also can be carried out as follows calculation process and be controlled DC power supply unit, applies the event (V sensing after the input of switch at energy that is: n) the polarity previous event (V sensing with it n-1) polarity, two event (V that sense before n-2) polarity and three event (V that sense before n-3) polarity when consistent (identical polar continuous four times time), with the event (V of the 4th time n) synchronously 1DC electrode group and 2DC electrode group are applied to voltage.

Claims (4)

1. an intracardiac defibrillation catheter system, possesses: defibrillation catheter, and it is inserted into and in the chambers of the heart, carries out defibrillation; Supply unit, its electrode to this defibrillation catheter applies DC voltage; And electrocardiogrph, this intracardiac defibrillation catheter system is characterised in that,
Described defibrillation catheter possesses:
The duct member of insulating properties;
The 1st electrode group, its multiple ring electrodes by the front end area that is arranged on described duct member form;
The 2nd electrode group, it is made up of multiple ring electrodes, described multiple ring electrodes by with described the 1st electrode group to base end side spaced apart be installed on described duct member;
The 1st lead wire set, its multiple lead-in wires that are connected respectively with the electrode that forms described the 1st electrode group by front end form; And
The 2nd lead wire set, its multiple lead-in wires that are connected respectively with the electrode that forms described the 2nd electrode group by front end form,
Described supply unit possesses:
DC power supply unit;
Conduit connects adapter, and it is connected with the 1st lead wire set of described defibrillation catheter and the base end side of the 2nd lead wire set;
External switch, it comprises that electric energy applies switch;
Arithmetic processing section, it has the output circuit from the DC voltage of described DC power supply unit, and described DC power supply unit is controlled in input based on described external switch; And
Electrocardiogram input connector, it is connected with the lead-out terminal of described arithmetic processing section and described electrocardiogrph,
In the time carrying out defibrillation by described defibrillation catheter, connect adapter from described DC power supply unit via output circuit and the described conduit of described arithmetic processing section, described the 1st electrode group to described defibrillation catheter and the 2nd electrode group apply the voltage of mutual opposed polarity,
The arithmetic processing section of described supply unit is carried out in the following manner calculation process described DC power supply unit is controlled, that is: successively sensing according to the event that is inferred to be R ripple via described electrocardiogram input connector from the electrocardiogram of described electrocardiogrph input, and the event V sensing after described electric energy applies the input of switch nthe polarity previous event V sensing at least with it n-1polarity and two event V that sense before n-2polarity when consistent, with this event V nsynchronously described the 1st electrode group and described the 2nd electrode group are applied to voltage.
2. intracardiac defibrillation catheter system according to claim 1, is characterized in that,
The arithmetic processing section of described supply unit is controlled described DC power supply unit, to sensing after the event that is estimated to be R ripple between short 50m second, between long 500m second, described 1DC electrode group and described 2DC electrode group are not applied to voltage.
3. intracardiac defibrillation catheter system according to claim 2, is characterized in that,
The arithmetic processing section of described supply unit is sensing after the event that is estimated to be R ripple between short 10m second, between long 150m second, and new sensing is estimated to be the event of R ripple.
4. according to the intracardiac defibrillation catheter system described in claim 2 or 3, it is characterized in that,
The arithmetic processing section of described supply unit is controlled described DC power supply unit, to apply at described electric energy after the input of switch between short 10m second, between long 500m second, described the 1st electrode group and described the 2nd electrode group are not applied to voltage.
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CN109922861A (en) * 2016-11-04 2019-06-21 日本来富恩株式会社 Intracardiac defibrillation catheter system
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