CN104138635B - Intracardiac defibrillation catheter system - Google Patents

Intracardiac defibrillation catheter system Download PDF

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Publication number
CN104138635B
CN104138635B CN201410177809.1A CN201410177809A CN104138635B CN 104138635 B CN104138635 B CN 104138635B CN 201410177809 A CN201410177809 A CN 201410177809A CN 104138635 B CN104138635 B CN 104138635B
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event
electrode group
supply unit
electrode
defibrillation
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CN104138635A (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)
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  • 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

The invention provides a kind of only when the different shapes such as premature contraction do not occur and Electrocardiographic R ripple synchronously apply DC voltage to carry out the intracardiac defibrillation catheter system of defibrillation.This intracardiac defibrillation catheter system possesses defibrillation catheter, supply unit and electrocardiogrph, supply unit possesses DC power supply unit (71), comprises energy the applying external switch (74) of switch 744, the arithmetic processing section (75) of control DC power supply unit, arithmetic processing section is control DC power supply unit in such a way, that is: successively sensing is inferred as the event of R ripple according to the electrocardiogram from electrocardiogrph input, and the event (V be sensed after energy applies the input of switch n) polarity with it previous sensed go out event (V n-1) polarity and the first two sensed go out event (V n-2) polarity consistent time, with this event (V n) synchronously DC voltage is applied to 1DC electrode group (31G) and 2DC electrode group (32G).

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 be inserted in the chambers of the heart, the supply unit of DC voltage and the conduit system of electrocardiogrph are applied to the electrode of this defibrillation catheter.
Background technology
As the defibrillator removing atrial fibrillation, known external formula defibrillator (AED).
In the defibrillation therapy utilizing AED, by patient body surface installing electrodes sheet and apply DC voltage, provide electric energy in the body of patient., flow to the electric energy normally 150 ~ 200J in the body of patient from electrode slice herein, a part wherein (usually, about a few % ~ 20%) 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 (such as 10 ~ 30J) efficiently to there is fibrillation.
That is, flow to the few situation of the ratio of heart (such as a few about %) in the electric energy from external supply under, sufficient defibrillation therapy cannot be carried out.
On the other hand, when the electric energy from external supply is to flow to heart at high proportion, what also have heart organizes the misgivings likely sustained damage.
In addition, in the defibrillation therapy utilizing AED, easily produce burn at the body surface installing electrode slice.Further, as mentioned above, when the ratio of the electric energy flowing to heart is few, repeatedly carry out the supply of electric energy, thus the degree of burn becomes heavy, for the patient accepting 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 in the chambers of the heart and 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, it is made up of multiple ring electrodes of the front end area being arranged on this duct member, 2DC electrode group, it is made up of the multiple ring electrodes being arranged on duct member at spaced intervals to base end side with 1DC electrode group, 1st lead wire set, its multiple lead-in wires be connected respectively by front end and the electrode forming described 1DC electrode group are formed, and the 2nd lead wire set, its multiple lead-in wires be connected respectively by front end and the electrode forming described 2DC electrode group are formed, and supply unit possesses: DC power supply unit, tubes connection adapter, 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 controls described DC power supply unit according to the input of external switch, and has the output circuit of the DC voltage from this DC power supply unit, and switching part, it is made up of the change-over switch of 1 circuit 2 contact, common junction connecting duct connects adapter, 1st contact connects electrocardiogrph and connects adapter, 2nd contact concatenation operation handling part, when the electrode (forming the electrode of IDC electrode group and/or 2DC electrode group) by defibrillation catheter measures heart potential, the 1st contact is selected at switching part, from the heart potential information of defibrillation catheter via the tubes connection adapter of supply unit, switching part and electrocardiogrph connect adapter and are imported into electrocardiogrph, when 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, from the output circuit of DC power supply unit via arithmetic processing section, switching part and tubes connection adapter, the 1DC electrode group of defibrillation catheter and 2DC electrode group are applied to the voltage (with reference to following patent documentation 1) of mutual opposed polarity.
Defibrillation catheter system according to patent documentation 1, reliably can to supply needed for defibrillation the heart that atrial fibrillation etc. occurs and electric energy fully in cardiac catheterization.In addition, also burn can not be produced at the body surface of patient and aggressive is also few.
In addition, when not needing defibrillation therapy, can will form the electrode catheter of defibrillation catheter of the present invention as heart potential mensuration.
In the conduit system described in patent documentation 1, be transfused to if external switch that is energy apply switch, then by arithmetic processing section, the contact of switching part is switched to the 2nd contact from the 1st contact, and the path arriving arithmetic processing section via switching part from tubes connection adapter is guaranteed.
After the contact of switching part is switched to the 2nd contact, from the DC power supply unit received from the control signal of arithmetic processing section via the output circuit of arithmetic processing section, switching part and tubes connection adapter, the 1DC electrode group of defibrillation catheter and 2DC electrode group are applied to 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 the heart potential synchronous waveform inputted via electrocardiogram input connector apply voltage.
Specifically, in such a way DC power supply unit is transmitted control signal, that is: in the heart potential waveform (electrocardiogram) being successively input to arithmetic processing section, 1 R ripple (peak-peak) is detected, obtain its peak height, next, reach from potential difference this peak height 80% height (triggering level) moment through certain hour (such as, R ripple spike width about 1/10 the extremely short time) after start apply.
Patent documentation 1: Japanese Patent Patent No. 4545216 publications
In order to carry out defibrillation therapy effectively, and bad influence is not caused to ventricle, defibrillation (applying of voltage) usually and R ripple synchronously carry out.
If synchronously carry out defibrillation with T ripple, then the danger causing the ventricular fibrillation of severe is high, therefore, must avoid synchronous with T ripple.
Therefore, in the conduit system described in patent documentation 1, the peak value arriving triggering level after energy being applied switch input is soon identified as R ripple, makes synchronously to apply voltage to the 1st electrode group and the 2nd electrode group with this peak value.
But, premature contraction is produced at the heart of the patient for accepting defibrillation therapy, or when the drift that the Electrocardiographic datum line (baseline) inputing to arithmetic processing section swings produces, in fact the peak value (being identified as the peak value of R ripple) sometimes reaching the potential difference of triggering level after energy applies the input of switch is not soon the peak value of R ripple.
Such as, under the heart of patient produces solitary extrasystolic situation, input to the electrocardiogram (heart potential waveform) of arithmetic processing section as shown in figure 19, R ripple is (in figure, R ripple from left several 4th) polarity inversion, and the peak value of its next T ripple has the trend of increase.
And, as shown in FIG., if have input electric energy soon to apply switch after creating premature contraction, then think that having T ripple false sense increase being reached triggering level to survey (detection) is R ripple, and synchronously apply voltage to implement the situation of defibrillation with this T ripple.
In addition, if Electrocardiographic datum line swings, then think the situation having and usual not sensed waveform is thought by mistake R ripple to sense.Such as, by the rising of datum line, the height having the waveform of the positive not being R ripple is higher than the situation of actual reading.Figure 20 illustrates that drift produces and datum line decline, and datum line rises and is returned to the electrocardiogram of original datum line afterwards.But before datum line rises, have input electric energy apply switch, thus the rising of datum line is thought by mistake R ripple to sense (detection), and synchronously apply voltage enforcement defibrillation therewith.
Summary of the invention
The present invention has come based on above-mentioned thing.
1st object of the present invention is, a kind of intracardiac defibrillation catheter system is provided, it can when accepting the heart generation premature contraction of patient of defibrillation therapy, not to the electrode application voltage of defibrillation catheter, and when there is not premature contraction, synchronously DC voltage being applied to the electrode of defibrillation catheter with the Electrocardiographic R ripple of input arithmetic processing section and carrying out defibrillation.
2nd object of the present invention is, a kind of intracardiac defibrillation catheter system is provided, when it can swing (drift) at the Electrocardiographic datum line inputing to arithmetic processing section, not to the electrode application voltage of defibrillation catheter, and when datum line is stablized, synchronously DC voltage is applied to the electrode of defibrillation catheter 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, find when the heart of patient there occurs premature contraction, in addition when the Electrocardiographic datum line of the arithmetic processing section being input to supply unit swings, the change in polarity of the event (being estimated to be the waveform of R ripple) successively sensed in this electrocardiogram; The polarity of this event is continuous when producing to equidirectional for three times, at least when sensing the event of third time, become steady statue premature contraction not occurring and does not also occur to drift about, and the event (waveform) of third time is the peak value of R ripple really; Only the polarity of the event being estimated to be R ripple is continuous produce to equidirectional for more than three times time (when the polarity of event that electric energy applies to sense after switch is transfused to is consistent with the polarity of the event sensed for twice before), by with this event synchronization apply voltage, thus reliably can carry out the defibrillation synchronous with R ripple, and complete the present invention based on these discoveries.
(1) namely, intracardiac defibrillation catheter system of the present invention be possess be inserted into carry out defibrillation in the chambers of the heart defibrillation catheter, the supply unit of DC voltage and the conduit system of electrocardiogrph are applied to the electrode of this defibrillation catheter, it is characterized in that,
Above-mentioned defibrillation catheter possesses:
The duct member of insulating properties;
1st electrode group (IDC electrode group), it is made up of multiple ring electrodes of the front end area being arranged on above-mentioned duct member;
2nd electrode group (2DC electrode group), it is made up of multiple ring electrode, and described multiple ring electrode is installed on above-mentioned duct member by with above-mentioned 1DC electrode group at spaced intervals to base end side;
1st lead wire set, its multiple lead-in wires be connected respectively by front end and the electrode forming above-mentioned 1DC electrode group are formed; And
2nd lead wire set, its multiple lead-in wires be connected respectively by front end and the electrode forming above-mentioned 2DC electrode group are formed,
Above-mentioned supply unit possesses:
DC power supply unit;
Tubes connection adapter, 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 electric energy and applies switch;
Arithmetic processing section, it has the output circuit of the DC voltage from above-mentioned DC power supply unit, and controls above-mentioned DC power supply unit based on the input of 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,
When carrying out defibrillation by defibrillation catheter, from above-mentioned DC power supply unit via the output circuit of above-mentioned arithmetic processing section and above-mentioned tubes connection adapter, the above-mentioned 1DC electrode group of above-mentioned defibrillation catheter and 2DC electrode group are applied to the voltage of different (± contrary) polarity mutually
The arithmetic processing section of above-mentioned supply unit is carried out calculation process as follows and is controlled above-mentioned DC power supply unit, that is: successively sensing according to the event being inferred to be R ripple via above-mentioned electrocardiogram input connector by the electrocardiogram that inputs from above-mentioned electrocardiogrph, and the event (V that (n-th time) senses after above-mentioned electric energy applies the input of switch n) the polarity previous event (V sensed at least with it n-1) polarity and its before two event (V sensed n-2) polarity consistent time, with this event (V n) synchronously voltage is applied to above-mentioned 1DC electrode group and above-mentioned 2DC electrode group.
According to the intracardiac defibrillation catheter system of such formation, in the electrocardiogram of arithmetic processing section being input to supply unit, if three the event (V measured by sense of continuity n-2), (V n-1) and (V n) polarity inconsistent, being then judged as existing becomes unstable probability due to the heart generation premature contraction of patient or Electrocardiographic datum line drift etc., there is event (V n) be not the probability of the peak value of R ripple, thus not with this event (V n) synchronously apply voltage.And, at three event (V n-2), (V n-1) and (V n) polarity consistent time, be judged as third time event (V n) be the peak value of R ripple, with this event (V n) synchronously apply voltage, thus reliably can carry out the defibrillation synchronous with R ripple.
(2) in intracardiac defibrillation catheter system of the present invention, the arithmetic processing section of preferred above-mentioned supply unit controls above-mentioned DC power supply unit, so that after sensing the event being estimated to be R ripple between the shortest 50m second, between the longest 500m second, between preferred 260m second, voltage is not applied to above-mentioned 1DC electrode group and above-mentioned 2DC electrode group.
According to the intracardiac defibrillation catheter system of such formation, after sensing the event being estimated to be R ripple, the shortest between 50m second, voltage is not applied to above-mentioned 1DC electrode group and above-mentioned 2DC electrode group, therefore when the event sensed is the peak value of R ripple, the moment occurred at its next T ripple reliably can be avoided to carry out the situation of defibrillation, that is, can the peak value being inferred to be T ripple be shielded.
(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 being estimated to be R ripple between the shortest 10m second, the longest 150m second, between preferred 100m second, newly sensing is not estimated to be the event of R ripple.
According to the intracardiac defibrillation catheter system of such formation, after sensing the event being estimated to be R ripple, the shortest 10m does not sense new event between second, so can prevent in the event sensed is R crest value, then the peak value of S ripple that this peak value occurs round about increases and under reaching the situation (this state does not have special problem when carrying out defibrillation) of triggering level, senses the situation of the seriality impaired (counting of identical polar is reset) of the peak value of this S ripple and the polarity of event.
(4) in the intracardiac defibrillation catheter system of above-mentioned (2) or (3), the arithmetic processing section of preferred above-mentioned supply unit is after above-mentioned electric energy applies the input of switch between the shortest 10m second, between the longest 500m second, between preferred 260m second, above-mentioned DC power supply unit is controlled, not apply voltage to above-mentioned 1DC electrode group and above-mentioned 2nd electrode group.
According to the intracardiac defibrillation catheter system formed like this, 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, (with the noise of its last time and the event identical polar of last time again) sense mistakenly so the noise that can prevent the input owing to applying switch to produce is R, and with this Noise Synchronization carry out the situation of defibrillation.
In addition, the input owing to applying switch can be prevented and the noise (with the noise of its last time and the event identical polar of last time again) that produces, cause the situation of the seriality of the polarity of event impaired (counting of identical polar is reset).
Further, the variation of the datum line occurred in the near future in the input applying switch can be prevented to sense mistakenly as R ripple, and synchronously carry out the situation of defibrillation with it.
According to intracardiac defibrillation catheter system of the present invention, can when accepting the heart generation premature contraction of patient of defibrillation therapy, not to the electrode application voltage of defibrillation catheter, and when there is not premature contraction, synchronously DC voltage is applied to carry out defibrillation to the electrode of defibrillation catheter with the ECG R wave being input to arithmetic processing section.
In addition, when can swing (drift) at the Electrocardiographic datum line being input to arithmetic processing section, not to the electrode application voltage of defibrillation catheter, and when datum line is stablized, synchronously DC voltage is applied to the electrode of defibrillation catheter with this Electrocardiographic R ripple and carry out defibrillation.
Accompanying drawing explanation
Fig. 1 is the block diagram of the embodiment representing intracardiac defibrillation catheter system of the present invention.
Fig. 2 is the explanation top view of the fibrillation conduit representing the conduit system shown in pie graph 1.
Fig. 3 is the explanation top view (figure for illustration of size and hardness) of the fibrillation conduit representing the conduit system shown in pie graph 1.
Fig. 4 is the sectional elevation of the A-A section representing Fig. 2.
Fig. 5 is the sectional elevation representing the B-B section of Fig. 2, C-C section, D-D section.
Fig. 6 is the in-built axonometric chart of the handle of the embodiment representing the defibrillation catheter shown in Fig. 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 of the connecting state of the adapter of defibrillation catheter and the tubes connection adapter of supply unit.
Figure 10 is in the conduit system shown in Fig. 1, represents the block diagram of the flow direction being measured the heart potential information of Electrocardiographic situation by defibrillation catheter.
Figure 11 A is a part (step 1 ~ step 6) for the action of the supply unit represented in the conduit system shown in Fig. 1 and the flow chart of operation.
Figure 11 B is a part (step 7 ~ step 14) for the action of the supply unit represented in the conduit system shown in Fig. 1 and the flow chart of operation.
Figure 11 C is a part (step 15 ~ step 22) for the action of the supply unit represented in the conduit system shown in Fig. 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 the information that the measured value of the resistance between electrode group is correlated with and heart potential information.
Figure 14 is the block diagram of state when representing DC voltage applying under the defibrillation mode of the conduit system shown in Fig. 1.
The potential waveform figure that Figure 15 measures when being and imparting 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 the arithmetic processing section inputing 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 the arithmetic processing section inputing 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 the arithmetic processing section inputing 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 (the heart potential waveform of solitary extrasystolic situation occurs at the heart of patient) of the arithmetic processing section inputing 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 (the heart potential waveform in the extrasystolic situation of heart generation continuous print of patient) of arithmetic processing section at input power device, represents that input energy applies switch and applies the key diagram of time of DC voltage.
Figure 18 is in the electrocardiogram (heart potential waveform) changed at the datum line of the arithmetic processing section of input power device, represents that input energy applies switch and applies the key diagram of time of DC voltage.
Figure 19 is formed in the electrocardiogram (the heart potential waveform in the solitary extrasystolic situation of heart generation of patient) of the arithmetic processing section of the supply unit of conduit system in the past in input, represents that input energy applies the key diagram of the time of switch and applying DC voltage.
Figure 20 is in the electrocardiogram (heart potential waveform) of the datum line variation of the arithmetic processing section of the supply unit inputting the conduit system formed in the past, represents the key diagram of the time inputting energy applying switch and apply DC voltage.
Symbol description
100 ... defibrillation catheter; 10 ... multi-lumen tube; 11 ... 1st tube chamber; 12 ... 2nd tube chamber; 13 ... 3rd tube chamber; 14 ... 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 ... 1st insulating properties pipe; 27 ... 2nd insulating properties pipe; 28 ... 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 ... 1st lead wire set; 41 ... lead-in wire; 42G ... 2nd lead wire set; 42 ... lead-in wire; 43G ... 3rd lead wire set; 43 ... lead-in wire; 50 ... the adapter of defibrillation catheter; 51,52,53 ... acicular terminal; 55 ... dividing plate; 58 ... resin; 61 ... 1st protecting tube; 62 ... 2nd protecting tube; 65 ... bracing wire; 700 ... supply unit; 71 ... DC power supply unit; 72 ... tubes connection 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 forming the defibrillation catheter system of 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, in the multi-lumen tube 10 (there is the duct member of the insulating properties of multi-cavity structure) forming defibrillation catheter 100, four tube chambers (the 1st tube chamber 11, the 2nd tube chamber 12, the 3rd tube chamber 13, the 4th tube chamber 14) are defined.
In Fig. 4 and Fig. 5,15 is the fluororesin layers dividing tube chamber, 16 is by (core) portion in the nylon elastomer of soft is formed, and 17 is outer (shell) portions be made up of the nylon elastomer of high rigidity, and 18 in Fig. 4 is the STAINLESS STEEL WIREs forming braiding blade.
The fluororesin layer 15 dividing tube chamber is such as made up of the material that the insulating properties such as tetrafluoroethylene-perfluoro alkoxy vinyl ethers copolymer (PFA), politef (PTFE) are high.
The nylon elastomer forming the outside 17 of multi-lumen tube 10 uses hardness according to axial and different material.Thus, multi-lumen tube 10 is configured to periodically uprise from front towards base end side hardness.
If illustrate a preferred example, then in figure 3, the hardness (hardness 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 be made up of STAINLESS STEEL WIRE is only formed in figure 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 such as 1.2 ~ 3.3mm.
Be not particularly limited as the method manufacturing multi-lumen tube 10.
The handle 20 forming the defibrillation catheter 100 in present embodiment possesses handle body 21, rope bolt 22 and strain relief 24.
By carrying out rotation process to rope bolt 22, the leading section of multi-lumen tube 10 can be made to deflect (shaking the head).
In the periphery (the inner front end area not forming 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 (there is identical polar) or, the aggregation of multiple electrodes installed with narrow interval (such as below 5mm) with identical object.
1DC electrode group, by the front end area of multi-lumen tube, is formed multiple electrode of same pole (-pole or+pole) with the installation of narrow interval and is formed.Herein, the number forming the electrode of 1DC electrode group also according to the width of electrode, configuration space and different, but is such as 4 ~ 13, is preferably 8 ~ 10.
In the present embodiment, 1DC electrode group 31G is made up of eight ring electrodes 31 of the front end area being installed on multi-lumen tube 10.
The electrode 31 forming 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, is connected to the tubes connection adapter of supply unit 700.
Herein, the width (axial length) of electrode 31 is preferably 2 ~ 5mm, if illustrate, a preferred example is, 4mm.
If the width of electrode 31 is narrow, then caloric value when voltage applies becomes excessive, thus may cause damage to perienchyma.On the other hand, if the width of electrode 31 is wide, then the flexibility being provided with the part of 1DC electrode group 31G in multi-lumen tube 10 and flexibility can be impaired.
The installation interval (adjacent electrode separated by a distance) of electrode 31 is preferably 1 ~ 5mm, if illustrate a preferred example, is 2mm.
When using defibrillation catheter 100 (when being configured in the chambers of the heart), 1DC electrode group 31G is positioned at such as Coronary vein.
2DC electrode group by spaced apart to base end side from the installation site of the 1DC electrode group of multi-lumen tube, and installed with narrow interval and is formed and multiple electrode of 1DC electrode group phase antipole (+pole or-pole) and being formed.Herein, the number forming the electrode of 2DC electrode group also according to the width of electrode, configuration space and different, but is such as 4 ~ 13, is preferably 8 ~ 10.
In the present embodiment, 2DC electrode group 32G is made up of eight ring electrodes 32 being installed on multi-lumen tube 10 from the installation site of 1DC electrode group 31G to base end side separatedly.
The electrode 32 forming 2DC electrode group 32G, via lead-in wire (forming the lead-in wire 42 of the 2nd lead wire set) and adapter described later, is connected to the tubes connection adapter of supply unit 700.
Herein, the width (axial length) of electrode 32 is preferably 2 ~ 5mm.If illustrate a preferred example, be 4mm.
If the width of electrode 32 is narrow, then caloric value when voltage applies becomes excessive, may cause damage to perienchyma.On the other hand, if the width of electrode 32 is wide, then the flexibility being provided with the part of 2DC electrode group 32G in multi-lumen tube 10 and flexibility can be impaired.
The installation interval (distance of adjacent electrode) of electrode 32 is preferably 1 ~ 5mm, if illustrate a preferred example, is 2mm.
When using defibrillation catheter 100 (when being configured in the chambers of the heart), 2DC electrode group 32G is positioned at such as right atrium.
In the present embodiment, base end side potential measurement electrode group 33G is made up of four ring electrodes 32 being installed on multi-lumen tube 10 from the installation site of 2DC electrode group 32G to base end side at spaced intervals.
The electrode 33 forming 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, is connected to the tubes connection adapter of supply unit 700.
Herein, the width (axial length) of electrode 33 is preferably 0.5 ~ 2.0mm, if illustrate a preferred example, is 1.2mm.
If the width of electrode 33 is wide, then the estimating precision of heart potential reduces, and the determination of the generating unit of abnormal potential becomes difficulty.
The installation interval (distance of adjacent electrode) of electrode 33 is preferably 1.0 ~ 10.0mm.If illustrate a preferred example, be 5mm.
When using defibrillation catheter 100 (when being configured in the chambers of the heart), base end side potential measurement electrode group 33G is positioned at the upper large vein such as easily producing abnormal potential.
In the front end of defibrillation catheter 100, front-end chip 35 is installed.
Not to this front-end chip 35 connecting lead wire, be not used as electrode in the present embodiment.But, electrode can also be used as 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 d2 separated by a distance 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 d3 separated by a distance 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 of formation 1DC electrode group 31G, 2DC electrode group 32G and base end side potential measurement electrode group 33G, in order to make the radiography for X-ray become good, be preferably made up of the alloy of platinum or platinum class.
The 1st lead-in wire 41G shown in Fig. 4 and Fig. 5 be eight of being connected respectively with eight electrodes (31) of formation 1DC electrode group (31G) go between 41 aggregation.
The 1st lead wire set 41G (lead-in wire 41) can be passed through, eight electrodes 31 of formation 1DC electrode group 31G are electrically connected with supply unit 700 respectively.
Eight electrodes 31 forming 1DC electrode group 31G connect from different lead-in wires 41 respectively.Lead-in wire 41 is soldered to the inner peripheral surface of electrode 31 respectively at its fore-end, and enters the 1st tube chamber 11 from the side opening of the tube wall being formed at multi-lumen tube 10.Eight lead-in wires 41 entering 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 be eight of being connected respectively with eight electrodes (32) of formation 2DC electrode group (32G) go between 42 aggregation.
The 2nd lead wire set 42G (lead-in wire 42) can be passed through, eight electrodes 32 of formation 2DC electrode group 32G are electrically connected with supply unit 700 respectively.
Eight electrodes 32 forming the 2nd electrode group connect from different lead-in wires 42 respectively.Lead-in wire 42 is soldered to the inner peripheral surface of electrode 32 respectively at its fore-end, and enters the 2nd tube chamber 12 (tube chambers different from the 1st tube chamber 11 that the 1st lead wire set 41G extends) from the side opening of the tube wall being formed at multi-lumen tube 10.Eight lead-in wires 42 entering 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, thus both are isolated by insulation completely in multi-lumen tube 10.Therefore, when being applied with the voltage needed for defibrillation, 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) reliably can be prevented.
The 3rd lead wire set 43G shown in Fig. 4 be go between with electrode (33) four of being connected respectively forming base end side potential measurement electrode (33G) 43 aggregation.
The 3rd lead wire set 43G (lead-in wire 43) can be passed through, the electrode 33 of formation base end side potential measurement electrode group 33G is electrically connected with supply unit 700 respectively.
Four electrodes 33 forming base end side potential measurement electrode 33G connect from different lead-in wires 43 respectively.Lead-in wire 43 is soldered to the inner peripheral surface of electrode 33 respectively at its fore-end, and enters the 3rd tube chamber 13 from the side opening of the tube wall being formed at multi-lumen tube 10.Four lead-in wires 43 entering 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 extended in the 3rd tube chamber 13 is insulated all completely with the 1st lead wire set 41G and the 2nd lead wire set 42G and is isolated.Therefore, when being applied with the voltage needed for defibrillation, 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) reliably can be prevented.
Lead-in wire 41, lead-in wire 42 and lead-in wire 43 are formed by the resin-coating line of the outer peripheral face of the plain conductor by resin-coating such as polyimides.Herein, it is about 2 ~ 30 μm as resin-coated thickness.
In Fig. 4 and Fig. 5,65 is bracing wires.
Bracing wire 65 extends in the 4th tube chamber 14, and the eccentricity of central axis ground of relative multi-lumen tube 10 extends.
The fore-end of bracing wire 65 is fixed on front-end chip 35 by soldering.In addition, also anticreep large-diameter portion (anti-delinking part) can be formed in the front end of bracing wire 65.Thus, front-end chip 35 and bracing wire 65 strong bonded, can reliably prevent coming off of front-end chip 35.
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 the need to being necessarily made up of metal.Bracing wire 65 also can be such as made up of the non-conductive line etc. of high strength.
In addition, the mechanism that the leading section of multi-lumen tube is deflected is not limited thereto, and such as, also can be the mechanism possessing leaf spring and formed.
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, when the deflecting operation of the leading section of multi-lumen tube 10, the situation causing lead-in wire damaged (such as, abrading) due to the bracing wire 65 of movement in the axial direction can be prevented.
Defibrillation catheter 100 in present embodiment, even if 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 by insulation isolation.
Fig. 6 is the axonometric chart of the internal structure of the handle of the defibrillation catheter 100 representing 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 cylindric adapter 50, the adapter 50 of this cylindrical shape configures the outstanding multiple acicular terminal (51,52,53) in forward end direction at front end face 50A.
In addition, as shown in Figure 6 to 8, extended in the inside of handle 20 by three insulating properties pipes (the 1st insulating properties pipe 26, the 2nd insulating properties pipe 27, the 3rd insulating properties pipe 28) that three lead wire set (the 1st lead wire set 41G, the 2nd lead wire set 42G, the 3rd lead wire set 43G) are inserted respectively.
As shown in Fig. 6 and Fig. 7, the leading section (from front end about 10mm) of the 1st insulating properties pipe 26 is inserted in 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 1st insulating properties pipe 26 being linked to the 1st tube chamber 11 extends near adapter 50 (being configured with the front end face 50A of acicular terminal) by the endoporus of the 1st protecting tube 61 extended in the inside of handle 20, defines the base end part of the 1st lead wire set 41G to guide to insert road near adapter 50.Thus, the 1st lead wire set 41G extended from multi-lumen tube 10 (the 1st tube chamber 11) can not extend in the inside (endoporus of the 1st insulating properties pipe 26) of handle 20 with tangling.
The 1st lead wire set 41G extended from the cardinal extremity opening of the 1st insulating properties pipe 26 is splitted into eight lead-in wires 41 of formation the 1st lead wire set 41G, and these lead-in wires 41 are connected and fixed on each of the acicular terminal of the front end face 50A being configured at adapter 50 respectively by soldering.Herein, the region of the acicular terminal (acicular terminal 51) being connected and fixed the lead-in wire 41 forming the 1st lead wire set 41G will be configured with as " the 1st terminal group region ".
The leading section (from front end about 10mm) 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 2nd insulating properties pipe 27 being linked to the 2nd tube chamber 12 extends near adapter 50 (being configured with the front end face 50A of acicular terminal) by the endoporus of the 2nd protecting tube 62 extended in the inside of handle 20, defines the base end part of the 2nd lead wire set 42G to guide to insert road near adapter 50.Thus, the 2nd lead wire set 42G extended from multi-lumen tube 10 (the 2nd tube chamber 12) can not extend in the inside (endoporus of the 2nd insulating properties pipe 27) of handle 20 with tangling.
The 2nd lead wire set 42G extended from the cardinal extremity opening of the 2nd insulating properties pipe 27 is splitted into eight lead-in wires 42 of formation the 2nd lead wire set 42G, and these lead-in wires 42 are connected and fixed on each of the acicular terminal of the front end face 50A being configured in adapter 50 respectively by soldering.Herein, the region of the acicular terminal (acicular terminal 52) of the lead-in wire 42 being fixedly connected with formation the 2nd lead wire set 42G will be configured with as " the 2nd terminal group region ".
The leading section (from front end about 10mm) 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 3rd insulating properties pipe 28 being linked to the 3rd tube chamber 13 extends near adapter 50 (being configured with the front end face 50A of acicular terminal) by the endoporus of the 2nd protecting tube 62 extended in the inside of handle 20, defines the base end part of the 3rd lead wire set 43G to guide to insert road near adapter 50.Thus, the 3rd lead wire set 43G extended from multi-lumen tube 10 (the 3rd tube chamber 13) can not extend in the inside (endoporus of the 3rd insulating properties pipe 28) of handle 20 with tangling.
The 3rd lead wire set 43G extended from the cardinal extremity opening of the 3rd insulating properties pipe 28 is splitted into four lead-in wires 43 of formation the 3rd lead wire set 43G, and these lead-in wires 43 are connected and fixed on each of the acicular terminal of the front end face 50A being configured at adapter 50 respectively by soldering.Herein, the region of the acicular terminal (acicular terminal 53) of the lead-in wire 43 being fixedly connected with formation the 3rd lead wire set 43G will be configured with as " the 3rd terminal group region ".
Herein, as the constituent material of insulating properties pipe (the 1st insulating properties pipe 26, the 2nd insulating properties pipe 27 and the 3rd insulating properties pipe 28), polyimide resin, polyamide, polyamide-imide resin etc. can be illustrated.Wherein, especially preferred hardness high and easily insert lead wire set, thin molded polyimide resin can be realized.
As the wall thickness of insulating properties pipe, being preferably 20 ~ 40 μm, if illustrate a preferred example, is 30 μm.
In addition, as the interior constituent material being inserted with the protecting tube (the 1st protecting tube 61 and the 2nd protecting tube 62) of insulating properties pipe, the nylon based elastomers of " Pebax " (registered trade mark of ARKEMA company) etc. can be illustrated.
According to the defibrillation catheter 100 had in the present embodiment of formation as described above, 1st lead wire set 41G extends in the 1st insulating properties pipe 26,2nd lead wire set 42G extends in the 2nd insulating properties pipe 27,3rd lead wire set 43G extends in the 3rd insulating properties pipe 28, even if thus in the inside of handle 20, the 1st lead wire set 41G, the 2nd lead wire set 42G and the 3rd lead wire set 43G also can be made to insulate completely isolation.Its result, when being applied with the voltage needed for defibrillation, the short circuit (short circuit between the lead wire set especially extended near the opening of tube chamber) between the 1st lead wire set 41G in the inside of handle 20, the 2nd lead wire set 42G and the 3rd lead wire set 43G reliably can be prevented.
And; in the inside of handle 20; 1st insulating properties pipe 26 is protected by the 1st protecting tube 61; 2nd insulating properties pipe 27 and the 3rd insulating properties pipe 28 are protected by the 2nd protecting tube 62; thus can prevent when the deflecting operation of the such as leading section of multi-lumen tube 10, because the component parts (movable parts) of bolt 22 of restricting contacts, rubs and cause the situation that insulating properties pipe sustains 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 the front end face 50A of the adapter 50 being configured with multiple acicular terminal separates by this dividing plate 55, makes lead-in wire 41, lead-in wire 42 and lead-in wire 43 mutually isolated.
Separate the 1st terminal group region, the dividing plate 55 in the 2nd terminal group region and the 3rd terminal group region formed by the water guide tubulose shaped by insulative resin as having tabular surface in both sides.As the insulative resin forming dividing plate 55, be not particularly limited, can the resins for universal use such as polyethylene be used.
The thickness of dividing plate 55 is such as 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 than the front end face 50A of adapter 50 and the distance of insulating properties pipe (the 1st insulating properties pipe 26 and the 2nd insulating properties pipe 27) high, when this distance is 7mm, the height of dividing plate 55 is such as 8mm.Highly be less than the dividing plate of 7mm if use, then its front edge cannot be made to be positioned at cardinal extremity than insulating properties pipe near front.
According to such formation, the lead-in wire 41 (the cardinal extremity part from the lead-in wire 41 that the cardinal extremity opening of the 1st insulating properties pipe 26 extends) of formation the 1st lead wire set 41G and the lead-in wire 42 (the cardinal extremity part from the lead-in wire 42 that the cardinal extremity opening of the 2nd insulating properties pipe 27 extends) of formation the 2nd lead wire set 42G reliably and fitly can be isolated.
When not possessing dividing plate 55, fitly cannot isolate (separating) lead-in wire 41 and lead-in wire 42, they are swinging cross likely.
And, lead-in wire 41 that be applied in the voltage of mutual opposed polarity, that form the 1st lead wire set 41G is with to form the lead-in wire 42 of the 2nd lead wire set 42G mutually isolated and can not contact by dividing plate 55, so when using defibrillation catheter 100, even if the voltage needed for applying intracardiac defibrillation, also short circuit can not be produced between the lead-in wire 41 (the cardinal extremity part from the lead-in wire 41 that the cardinal extremity opening of the 1st insulating properties pipe 26 extends) of formation the 1st lead wire set 41G and the lead-in wire 42 (the cardinal extremity part from the lead-in wire 42 that the cardinal extremity opening of the 2nd insulating properties pipe 27 extends) forming the 2nd lead wire set 42G.
In addition, when manufacturing defibrillation catheter, when creating mistake when lead-in wire being connected and fixed on acicular terminal, such as, when the lead-in wire 41 of formation the 1st lead wire set 42G is connected and fixed on the acicular terminal in the 2nd terminal group region, this lead-in wire 41 can cross over dividing plate 55, so easily can find the mistake connected.
In addition, the lead-in wire 43 (acicular terminal 53) and lead-in wire 42 (acicular terminal 52) that form the 3rd lead wire set 43G are isolated by dividing plate 55 and 41 (acicular terminal 51) together, but be not limited to this, also can be isolated by dividing plate 55 and lead-in wire 42 (acicular terminal 52) together with lead-in wire 41 (acicular terminal 51).
In defibrillation catheter 100, the front edge of dividing plate 55 is positioned at than the cardinal extremity of the 1st insulating properties pipe 26 and the cardinal extremity of the 2nd insulating properties pipe 27 all near front.
Thus, between the lead-in wire extended from the cardinal extremity opening of the 1st insulating properties pipe 26 (forming the lead-in wire 41 of the 1st lead wire set 41G) and the lead-in wire (forming the lead-in wire 42 of the 2nd lead wire set 42G) extended from the cardinal extremity opening of the 2nd insulating properties pipe 27, all the time there is dividing plate 55, thus can reliably prevent by lead-in wire 41 with lead-in wire 42 contact the short circuit caused.
As shown in Figure 8, extend from the cardinal extremity opening of the 1st insulating properties pipe 26 and be connected and fixed on eight of the acicular terminal 51 of adapter 50 lead-in wires 41, extend from the cardinal extremity opening of the 2nd insulating properties pipe 27 and be connected and fixed on eight lead-in wires 42 of the acicular terminal 52 of adapter 50 and extend from the cardinal extremity opening of the 3rd insulating properties pipe 28 and be connected and fixed on four lead-in wires 43 of the acicular terminal 53 of adapter 50 maintenance secures respective shape by fixing their surrounding with resin 58.
Keep the resin 58 of the shape of lead-in wire to be configured as the cylindrical shape with adapter 50 same diameter, become and imbed acicular terminal, lead-in wire, the base end part of insulating properties pipe and the state of dividing plate 55 in the inside of this resin molded body.
And, the formation of the inside of resin molded body is embedded according to the base end part of insulating properties pipe, can be covered completely by resin 58 and extend from the cardinal extremity opening of insulating properties pipe the universe playing the lead-in wire till being connected and fixed on acicular terminal (cardinal extremity part), the shape of anchor leg (cardinal extremity part) can be kept completely.
In addition, the height (from cardinal extremity face to the distance of front end face) of resin molded body, preferably higher than the height of dividing plate 55, when the height of dividing plate 55 is 8mm, such as, is set to 9mm.
, as the resin 58 forming resin molded body, be not particularly limited herein, but preferably use heat-curing resin or light-cured resin.Specifically, the curable resin of urethane esters, epoxy resin, urethanes-epoxy resin can be illustrated.
According to formation as described above, owing to being kept the shape of anchor leg by resin 58, so when manufacturing defibrillation catheter 100 when inside mounted connector 50 () at handle 20, can prevent the lead-in wire extended from the cardinal extremity opening of insulating properties pipe from tangling or damage with the EDGE CONTACT of acicular terminal (such as, resin-coatedly cracking of going between).
As shown in Figure 1, the supply unit 700 forming the defibrillation catheter system of present embodiment possesses DC power supply unit 71, tubes connection 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.
Be built-in with capacitor in DC power supply unit 71, by the input of external switch 74 (charge switch 743), built-in capacitor charged.
Tubes connection adapter 72 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 and the tubes connection adapter 72 of supply unit 700 are linked by connector cable C1, thus be connected and fixed the eight lead-in wire acicular terminal 51 (being actually eight) of 41 and the terminal 721 (being actually eight) of tubes connection adapter 72 that form the 1st lead wire set, the eight lead-in wire acicular terminal 52 (being actually eight) of 42 and the terminal 722 (being actually eight) of tubes connection adapter 72 that form the 2nd lead wire set are connected and fixed, be connected and fixed the four lead-in wire acicular terminal 53 (being actually four) of 43 forming the 3rd lead wire set to be connected respectively with the terminal 723 (actual is four) of tubes connection adapter 72.
Herein, terminal 721 and the terminal 722 of tubes connection 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 determined by 1DC electrode group 31G and 2DC electrode group 32G is arrived electrocardiogrph via switching part 76 and connects adapter 73, and the heart potential information 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: the applying energy settings switch 742 of the electric energy applied during for switching mode selector switch 741, the setting defibrillation of heart potential mode determination and defibrillation mode, apply switch (discharge switch) 744 for the charge switch 743 that charges to DC power supply unit 71 and for applying electric energy to the energy carrying out defibrillation.Input signal from these external switches 74 is all sent to arithmetic processing section 75.
Arithmetic processing section 75, based on the input of external switch 74, comes control 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 electrode of defibrillation catheter 100 to via switching part 76 by the DC voltage from DC power supply unit 71.
DC voltage is applied by this output circuit 751, with the terminal 722 (being finally the 2DC electrode group 33G of defibrillation catheter 100) of the terminal 721 (being finally the 1DC electrode group 31G of defibrillation catheter 100) and tubes connection adapter 72 that make the tubes connection adapter 72 shown in Fig. 9 become mutual opposed polarity (the electrode group of a side is-pole time, the electrode group of the opposing party is+pole).
Switching part 76 is made up of the change-over switch of 1 circuit 2 contact (SinglePoleDoubleThrow: single-pole double throw), and the common junction connecting duct of the change-over switch of this 1 circuit 2 contact 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.
Namely, when have selected the 1st contact (when the 1st contact is connected with common junction), link tubes connection adapter 72 is connected adapter 73 path with electrocardiogrph is guaranteed, when have selected the 2nd contact (when the 2nd contact is connected with common junction), the path linking tubes 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 action of switching part 76 by arithmetic processing section 75.
Electrocardiogram input connector 77 is connected with arithmetic processing section 75, in addition, is also connected with the lead-out terminal of electrocardiogrph 800.
This electrocardiogram input connector 77 can be passed through, by (usual for the heart potential information exported from electrocardiogrph 800, 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 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 (mainly electrocardiogram (heart potential waveform)) inputing to arithmetic processing section 75 from electrocardiogram input connector 77, and operator can monitor that the heart potential information (electrocardiogram) being input to arithmetic processing section 75 carries out defibrillation therapy (input etc. of external switch).
The electrocardiogrph 800 (input terminal) of defibrillation catheter system forming present embodiment is connected adapter 73 with the electrocardiogrph of supply unit 700 and connects, and the heart potential information determined by defibrillation catheter 100 (1DC electrode group 31G, 2DC electrode group 32G and base end side potential measurement electrode group 33G form electrode) is input to electrocardiogrph 800 from electrocardiogrph connection adapter 73.
In addition, electrocardiogrph 800 (other input terminals) is also connected with potential measurement unit 900, and the heart potential information determined by heart potential determination unit 900 is also input to electrocardiogrph 800.
Herein, as heart potential determination unit 900, can list to measure 12 induction electrocardiograms and the electrode slice pasted at the body surface of patient, the electrode catheter (electrode catheters different from defibrillation catheter 100) installed in the heart of patient.
Electrocardiogrph 800 (lead-out terminal) is connected with the electrocardiogram input connector 77 of supply unit 700, a part for the heart potential information (the heart potential information from defibrillation catheter 100 and the heart potential information from heart potential determination unit 900) being 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 without the need to carrying out defibrillation therapy, can be used as the electrode catheter that heart potential measures.
Figure 10 illustrates when carrying out cardiac catheterization (such as high-frequency treatment), the flow direction of heart potential information when measuring heart potential by the defibrillation catheter 100 of present embodiment.Now, the switching part 76 of supply unit 700 have selected the 1st contact being connected with electrocardiogrph and connecting adapter 73.
By forming the 1DC electrode group 31G Yi of defibrillation catheter 100 Ji the heart potential that the determination of electrode of ∕ or 2DC electrode group 32G goes out is input to electrocardiogrph 800 via tubes connection adapter 72, switching part 76 and electrocardiogrph connection adapter 73.
In addition, the heart potential gone out by the determination of electrode of the base end side potential measurement electrode group 33G forming defibrillation catheter 100 does not directly connect adapter 73 via electrocardiogrph by switching part 76 from tubes connection adapter 72 and is input to electrocardiogrph 800.
Heart potential information (electrocardiogram) from defibrillation catheter 100 is shown in the display (omitting diagram) of electrocardiogrph 800.
In addition, a part for heart potential information from defibrillation catheter 100 (potential difference between the electrode 31 (the 1st pole and the 2nd pole) such as, forming 1DC electrode group 31G) can be inputed to display unit 78 from electrocardiogrph 800 via electrocardiogram input connector 77 and arithmetic processing section 75 to show.
As mentioned above, when not needing defibrillation therapy in cardiac catheterization, defibrillation catheter 100 can be used as the electrode catheter that heart potential measures.
And, when there occurs atrial fibrillation in cardiac catheterization, can utilize and be made the defibrillation catheter 100 being used as electrode catheter carry out defibrillation therapy immediately.Its result, when there occurs atrial fibrillation, can save the new trouble such as conduit inserted for defibrillation.
Arithmetic processing section 75, according to a part (electrocardiogram) for the heart potential information of sending from electrocardiogrph 800 via electrocardiogram input connector 77, successively senses this Electrocardiographic event (waveform) being estimated to be R ripple.
The sensing being estimated to be the event of R ripple is such as undertaken by following mode, that is: detect for the waveform of the peak-peak in the previous cycle in the cycle (beating) of sensing and the peak-peak waveform in the first two cycle, calculate the average height of these peak-peak waveforms, detect the situation that potential difference reaches the height (triggering level) of 80% of this average height.
In addition, arithmetic processing section 75 carries out calculation process in such a way to control DC power supply unit 71, that is: its polarity (direction of the peak value represented with ± symbol) is identified respectively to the event sensed, after input energy applies switch 744, the event (V sensed in the cycle of n-th time n) the event (V that senses in the previous cycle with it of polarity n-1) polarity and the first two cycle in the event (V that senses n-2) polarity consistent time, with this event (V n) synchronously voltage is applied to the terminal 721 (1DC electrode group 31G) of tubes connection adapter 72 and the terminal 722 (2DC electrode group 32G) of tubes connection adapter 72.
In the electrocardiogram shown in Figure 16 A to Figure 16 D, be estimated to be R ripple and in six events sensed, be (-) (its peak value waveform down) from the polarity of left side number the 3rd event, the polarity of other five events is (+) (its peak value waveform is upward).
As shown in Figure 16 A, the event (V from left side number second is being sensed 0) after have input energy apply switch 744 when, the 3rd event (V 1) polarity (-) and previous cycle in second event (V sensing 0) polarity (+) different, so not with this event (V 1) synchronously apply voltage.
In addition, the 4th event (V 2) polarity (+) and the 3rd event (V sensing in the previous cycle 1) polarity (-) different, so not with this event (V 2) synchronously apply voltage.
In addition, the 5th event (V 3) polarity (+) and the 3rd event (V sensing in the first two cycle 1) polarity (-) different, so not with this event (V 3) synchronously apply voltage.
6th event (V 4) polarity (+) and the 5th event (V sensing in the previous cycle 3) polarity (+) and the 4th event (V sensing in the first two cycle 2) polarity (+) identical, so with this event (V 4) synchronously voltage is applied to 1DC electrode group 31G and 2DC electrode group 32G.
As shown in fig 16b, sensing from left side number the 3rd event (V 0) after have input energy apply switch 744 when, the 4th event (V 1) polarity (+) and the 3rd event (V sensing in the previous cycle 0) polarity (-) different, 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 (-) different, so not with this event (V 2) synchronously apply voltage.
6th event (V 3) polarity (+) and the 5th event (V sensing in the previous cycle 2) polarity (+) and the 4th event (V sensing in the first two cycle 1) polarity (+) identical, so with this event (V 3) synchronously voltage is applied to 1DC electrode group 31G and 2DC electrode group 32G.
As shown in figure 16 c, sensing from left side number the 4th event (V 0) after have input energy apply switch 744 when, the 5th event (V 1) polarity (+) and the 3rd event (V sensing in the first two cycle -1) polarity (-) different, so not with this event (V 1) synchronously apply voltage.
6th event (V 2) polarity (+) and the 5th event (V sensing in the previous cycle 1) polarity (+) and the 4th event (V sensing in the first two cycle 0) polarity (+) identical, so with this event (V 2) synchronously voltage is applied to 1DC electrode group 31G and 2DC electrode group 32G.
As seen in fig. 16d, sensing from left side number the 5th event (V 0) after have input energy apply switch 744 when, the 6th event (V 1) polarity (+) and the 5th event (V sensing in the previous cycle 0) polarity (+) and the 4th event (V sensing in the first two cycle -1) polarity (+) identical, so with this event (V 1) synchronously voltage is applied to 1DC electrode group 31G and 2DC electrode group 32G.
As mentioned above, even if when the arbitrary time shown in Figure 16 A to Figure 16 D have input energy applying switch 744, the 3rd event (from left side number the 6th event) when all continuous with identical polar (+) three times synchronously applies voltage.
In addition, arithmetic processing section 75 sensed between the 260m second after the event being estimated to be R ripple in the electrocardiogram be transfused to, and controlled DC power supply unit 71, not apply voltage to 1DC electrode group 31G and 2DC electrode group 32G.
Thus, when the event sensed is the peak value of R ripple, the moment occurred at its next T ripple can be reliably avoided to carry out defibrillation.That is, shielding is carried out to make it cannot defibrillation to the peak value being estimated to be T ripple.
In addition, after sensing event, during not applying DC voltage, be not limited to 260m second, the shortest is 50m second, and the longest is 500m second.When during this period short than 50m second, sometimes cannot the peak value being estimated to be T ripple be shielded.On the other hand, when during this period long than 500m second, the R ripple in the next cycle (beating) cannot sometimes be sensed.
In addition, arithmetic processing section 75 after sensing the event being estimated as R ripple between 100m second, carry out programming so as not newly sensing be estimated to be the event of R ripple.
Thus, then R ripple, the peak value of the S ripple occurred in the direction (contrary polarity) contrary with this R ripple increases and in the situation (even if carrying out defibrillation in this condition also do not have special problem) reaching triggering level, the peak value by sensing this S ripple can being prevented, causing the situation of the seriality of the polarity of event impaired (counting of identical polar is reset).
In addition, after sensing event, as not newly sensing be estimated to be the event of R ripple during (between inhibitory stage), be not limited to 100m second, the shortest is 10m second, and the longest is 150m second.
Further, arithmetic processing section 75 is after energy applies the input of switch 744 between 260m second, and controls DC power supply unit 71, so that not to 1DC electrode group 31G and 2DC electrode group 32G applying voltage.
Thereby, it is possible to the noise preventing to apply the input of switch 744 due to energy and produce (with before once and the noise of the event opposed polarity of front secondary) sense mistakenly as R ripple, and with this Noise Synchronization carry out the such situation of defibrillation.
In addition, the input by applying switch 744 due to energy can be prevented and produce noise (with before once and/or the noise of the event opposed polarity of front secondary) and damage the situation of the seriality (counting of identical polar is reset) of the polarity of event.
Further, the variation of the datum line that also can prevent the input that energy is applied switch 744 from producing afterwards senses mistakenly as R ripple, and synchronously carries out the situation of defibrillation therewith.
In addition, after energy applies the input of switch 744, during not applying DC voltage, be not limited between 260m second, 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 of present embodiment example is described.
(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 a part for the heart potential information (12 induction electrocardiogram) being input to electrocardiogrph 800 from heart potential determination unit 900 (electrode slice body surface is pasted), be input to the arithmetic processing section 75 (step 1 of Figure 11 A) of supply unit 700 from electrocardiogram input connector 77.Now, the part being input to the heart potential information of arithmetic processing section 75 is shown in display unit 78 (with reference to Figure 12).In addition, from the formation electrode of the 1DC electrode group 31G of defibrillation catheter 100 and/or 2DC electrode group 32G via tubes connection adapter 72, switching part 76, electrocardiogrph connect adapter 73 be input to electrocardiogrph 800 heart potential information, connect via tubes connection adapter 72, electrocardiogrph the display (omitting diagram) that heart potential information that adapter 73 is input to electrocardiogrph 800 is shown in electrocardiogrph 800 from the formation electrode of the base end side potential measurement electrode group 33G of defibrillation catheter 100.
(2) following, input the mode selector switch 741 as external switch 74.Supply unit 700 in present embodiment is " heart potential mode determination " in an initial condition, and switching part 76 selects the 1st contact, and the path arriving electrocardiogrph connection adapter 73 via switching part 76 from tubes connection adapter 72 is guaranteed.Become " defibrillation mode " (step 2) by the input of mode selector switch 741.
(3) as shown in figure 13, if mode selector switch 741 is transfused to and is switched to defibrillation mode, then by the control signal of arithmetic processing section 75, the contact of switching part 76 is switched to the 2nd contact, and guaranteed from tubes connection adapter 72 to arrive arithmetic processing section 75 path via switching part 76, arrive via switching part 76 path cut-off (step 3) that electrocardiogrph connects adapter 73 from tubes connection adapter 72.When switching part 76 have selected the 2nd contact, heart potential information from the 1DC electrode group 31G of defibrillation catheter 100 and the formation electrode of 2DC electrode group 32G cannot be input to electrocardiogrph 800 and (therefore, also this heart potential information cannot be sent to arithmetic processing section 75.)。But the heart potential information not via the formation electrode from base end side potential measurement electrode group 33G of switching part 76 is imported into electrocardiogrph 800.
(4) when the contact of switching part 76 is switched to the 2nd contact, the resistance (step 4) between the 1DC electrode group (31G) of defibrillation catheter 100 and the 2nd electrode group (32G) is measured.The resistance value being input to arithmetic processing section 75 from tubes connection adapter 72 via switching part 76 is shown in display unit 78 (with reference to Figure 13) together with a part for the heart potential information from heart potential determination unit 900 being input to arithmetic processing section 75.
(5) contact of switching part 76 is switched to the 1st contact, and (step 5) is recovered in the path arriving electrocardiogrph connection adapter 73 via switching part 76 from tubes connection adapter 72.In addition, the contact of switching part 76 have selected the time (above-mentioned steps 3 ~ step 5) of the 2nd contact is such as between 1 second.
(6) arithmetic processing section 75 judges whether the resistance determined in step 4 has exceeded certain value, when not exceeding, enter following step 7 (for applying the preparation of DC voltage), in the case of exceeding, step 1 (location confirmation of the electrode of defibrillation catheter 100) (step 6) is returned.
Herein, when resistance has exceeded certain value, mean that 1DC electrode group and/or the 2nd electrode group reliably do not abut to the position (such as, the tube wall of Coronary vein, the inwall of right atrium) of regulation, so need to return step 1, readjust the position of electrode.
Like this, owing to only reliably abutting to the position of regulation (such as in the 1DC electrode group of defibrillation catheter 100 and 2DC electrode group, the tube wall of Coronary vein, the inwall of right atrium) time can apply voltage, so can efficient defibrillation therapy be carried out.
(7) input is as the applying energy settings switch 742 of external switch 74, sets the applying energy (step 7 of Figure 11 B) during defibrillation.Supply unit 700 according to the present embodiment, from 1J to 30J, can set applying energy with the scale of 1J.
(8) input is as the charge switch 743 of external switch 74, the built-in capacitor of DC power supply unit 71 is carried out to the charging (step 8) of energy.
(9) after charging complete, the energy inputted as external switch 74 applies switch 744 (step 9).
(10) as the current event (V representing sensing in step 12 described later n) be the number (n) that input energy applies the event of switch 744 which time sensing rear, make " 1 " produce (step 10).
(11) arithmetic processing section 75 is to sense previous event (V n-1) (energy applies the event that the input of switch 744 senses not long ago) afterwards 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 couples of event (V n) carry out sensing (step 12).
(13) arithmetic processing section 75 judges the event (V that senses in step 12 n) polarity whether with the event (V of last time (previous sense) n-1) polarity consistent, when consistent, enter step 14, in the case of inconsistencies, in step 10 ' in, 1 is added to above-mentioned number (n) and returns step 11 (step 13).
(14) arithmetic processing section 75 judges the event (V that senses in step 12 n) polarity whether with the event (V of last time again (the first two sense) n-2) polarity consistent, when consistent, enter step 15, in the case of inconsistencies, in step 10 ' in, 1 is added to above-mentioned number (n) and returns step 11 (step 14).
(15) arithmetic processing section 75 judges from sensing event (V last time n-1) play sensed event (V n) till time whether more than 260m second, in the case of exceeding, enter step 16, when not exceeding, in step 10 ' in, 1 is added to above-mentioned number (n) and returns 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 more than 260 seconds, in the case of exceeding, enter step 17, when not exceeding, in step 10 ' in, 1 is added to above-mentioned number (n) and returns step 11 (step 16).
(17) by arithmetic processing section 75, the contact of switching part 76 is switched to the 2nd contact, the path arriving arithmetic processing section 75 from tubes connection adapter 72 via switching part 76 is guaranteed, arrives the path cut-off (step 17) that electrocardiogrph connects adapter 73 from tubes connection adapter 72 via switching part 76.
(18) after the contact of switching part 76 is switched to the 2nd contact, from the DC power supply unit 71 received from the control signal of arithmetic processing section 75 via the output circuit 751 of arithmetic processing section 75, switching part 76 and tubes connection adapter 72, the 1DC electrode group of defibrillation catheter 100 and 2DC electrode group are applied to the DC voltage (step 18, with reference to Figure 14) of mutual opposed polarity.
Herein, arithmetic processing section 75 is carried out calculation process and is transmitted control signal to DC power supply unit 71, so as with the event (V that senses in step 12 n) synchronously DC voltage is applied to 1DC electrode group and 2DC electrode group.
Specifically, from sensing event (V n) moment while rising (next R ripple) rise through certain hour (such as, event (V n) R ripple spike width about 1/10 the extremely short time) after start apply.
Figure 15 is the figure representing the potential waveform that the defibrillation catheter 100 by present embodiment measures when imparting electric energy (such as, the setting output=10J) of regulation.In the figure, horizontal axis representing time, the longitudinal axis represents current potential.
First, rise through certain hour (t in arithmetic processing section 75 sensed event (Vn) 0) after, making that 1DC electrode group 31G becomes-pole, 2DC electrode group 32G becomes+mode of pole to applying DC voltage between the two, thus is supplied to electric energy and measures current potential and to rise (E 1it is crest voltage now.)。Through certain hour (t 1) after, making that 1DC electrode group 31G becomes+pole, 2DC electrode group 32G becomes-mode of pole to applying between the two to have reversed ± DC voltage, thus be supplied to electric energy and measure current potential and to rise (E 2it is crest voltage now.)。
Herein, from sensed event (V n) play the time (t till starting to apply 0) be such as 0.01 ~ 0.05 second, if illustrate a preferred example, be 0.01 second, time (t=t 1+ t 2) be such as 0.006 ~ 0.03 second, if illustrate a preferred example, be 0.02 second.Thereby, it is possible to the event (V as R ripple n) synchronously apply voltage, can efficient defibrillation therapy be carried out.
Crest voltage (the E measured 1) be such as 300 ~ 600V.
(19) from sensed event (V n) rise through certain hour (t 0+ t) after, accept the control signal from arithmetic processing section 75 and stop applying voltage (step 19) from DC power supply unit 71.
(20) after the applying of voltage stops, applying record (heart potential waveform during applying as shown in Figure 15) and be shown in display unit 78 (step 20).It is such as 5 seconds as displaying time.
(21) contact of switching part 76 is switched to the 1st contact, the path arriving electrocardiogrph connection adapter 73 via switching part 76 from tubes connection adapter 72 is recovered, and the heart potential information from the 1DC electrode group 31G of defibrillation catheter 100 and the formation electrode of 2DC electrode group 32G is input to electrocardiogrph 800 (step 21).
(22) observe be shown in the display of electrocardiogrph 800, the heart potential information (electrocardiogram) from 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 the heart potential information from heart potential determination unit 900 (12 induction electrocardiogram), if " normally " then terminates, when " abnormal (atrial fibrillation is not cured) ", return step 2 (step 22).
Conduit system according to the present embodiment, can directly provide electric energy to the heart that fibrillation occurs by the 1DC electrode group 31G of defibrillation catheter 100 and 2DC electrode group 32G, and can only reliably to provide needed for defibrillation therapy and electricity irritation (surge) fully heart.
And, due to directly electric energy can be provided to heart, so also burn can not be produced at the body surface of patient.
In addition, do not connected adapter 73 via switching part 76 via electrocardiogrph from tubes connection adapter 72 be input to electrocardiogrph 800 by the heart potential information that electrode 33 determines of forming of base end side potential measurement electrode group 33G, and, this electrocardiogrph 800 is connected with heart potential determination unit 900, even if thus when 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, (switching part 76 is switched to contact 2, from tubes connection adapter 72 via switching part 76 arrive electrocardiogrph connect the path of adapter 73 be cut off time), electrocardiogrph 800 also can obtain the heart potential information determined by base end side potential measurement electrode group 33G and heart potential determination unit 900, and can while monitor that in electrocardiogrph 800 (monitoring) heart potential is while carry out defibrillation therapy.
And, due to supply unit 700 arithmetic processing section 75 by with the heart potential synchronous waveform inputted via electrocardiogram input connector 77 apply voltage system and carry out calculation process DC power supply unit 71 is carried out controlling (starting to apply from the potential difference in heart potential waveform arrives triggering level after certain hour (such as 0.01 second)), so can to the 1DC electrode group 31G of defibrillation catheter 100 and 2DC electrode group 32G, with heart potential synchronous waveform apply voltage, merger can carry out efficient defibrillation therapy.
And, the resistance of arithmetic processing section 75 when between the electrode group of defibrillation catheter 100 does not exceed certain value, namely, only reliably abut to the position of regulation (such as at 1DC electrode group 31G and 2DC electrode group 32G, the tube wall of Coronary vein, the inwall of right atrium) time, carry out controlling the preparation for applying DC voltage can be entered, therefore, it is possible to carry out effective defibrillation therapy.
And, arithmetic processing section 75 is carried out computing in such a way and is controlled DC power supply unit 71, that is: via electrocardiogram input connector 77 from the electrocardiogram that electrocardiogrph 800 inputs, successively sensing is estimated to be the event of R ripple, after energy applies the input of switch 744, the event (V sensed for n-th time n) polarity and the front event (V once sensed n-1) polarity and the event (V that goes out of secondary sensing before n-2) polarity consistent time, with event (V n) synchronously voltage is applied to 1DC electrode group 31G and 2DC electrode group 32, if thus three event (V measuring of sense of continuity n-2), (V n-1) and (V n) polarity inconsistent, then not with event (V n) synchronously apply voltage, and only at three event (V n-2), (V n-1) and (V n) polarity consistent time, with third time event (V n) synchronously apply voltage, therefore, it is possible to reliably carry out the defibrillation synchronous with R ripple.
Figure 17 A is the electrocardiogram (heart potential waveform same as shown in Figure 19) being imported into arithmetic processing section 75 when solitary premature contraction occurs the heart of patient.In Figure 17 A, from the R ripple (event (V of left side number the 4th 0)) polarity be (-), the peak value of T ripple then increases, and this T ripple is sensed to be event (V 1).
As shown in the drawing, event (V is being sensed 0) after have input energy apply switch 744 when, the event (V that it senses in the near future 1) polarity (+) previous event (V sensed with it 0) polarity (-) different, therefore not with this event (V 1) synchronously apply voltage.Thereby, it is possible to avoid increasing with peak value and the T ripple being 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 the event (V that its polarity (+) senses with the first two 0) polarity (-) different, 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 sensed 2) polarity (+) and event (V that the first two senses 1) polarity (+) identical, so with the event (V of the peak value can be sure of for R ripple 3) synchronously voltage is applied to 1DC electrode group 31G and 2DC electrode group 32G.
Figure 17 B is when premature contraction occurs the heart of patient continuously, is input to the electrocardiogram of arithmetic processing section 75.
As shown in the drawing, at the event (V sensing polarity inversion one-tenth (-) due to premature contraction 0) after have input energy apply switch 744 when, 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 change of the alternating polarity of event ground.Therefore, in this wise, under the state that the polarity of three events measured at sense of continuity is inconsistent, each being 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 the event (V that its polarity (+) senses with the first two 4) polarity (-) different, 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 reliably cure, with the event (V of the peak value can be sure of for R ripple 7) synchronously voltage is applied to 1DC electrode group 31G and 2DC electrode group 32G.
Figure 18 is that drift occurs and datum line decline, afterwards, datum line rises and returns to the electrocardiogram (heart potential waveform same as shown in Figure 20) of original level, and the decline of datum line and rising are mistaken as R ripple, are sensed to be event (V respectively -1) and event (V 1).
As shown in figure 18, when have input energy applying switch 744 before datum line rises, the event (V that it senses in the near future 1) polarity (+) and the previous event (V sensed 0) polarity (+) identical, but with the first two event (V to sense -1) polarity (-) different, so not with this event (V 1) synchronously apply voltage, thereby, it is possible to avoid synchronously applying voltage during the rising with the datum line being mistaken as R ripple.
And, due to event (V 1) the event (V that senses of the next one 2) polarity (+) and the previous event (V sensed 1) polarity (+) and event (V that the first two senses 0) polarity (+) identical, so be judged as at event (V 2) sensing time datum line stablize, with the event (V of the peak value can be sure of for R ripple 2) synchronously voltage is applied to 1DC electrode group 31G and 2DC electrode group 32G.
And, arithmetic processing section 75 is after sensing the event being estimated to be R ripple between 260m second, control DC power supply unit 71, not apply DC voltage to 1DC electrode group 31G and 2DC electrode group 32G, so when the event sensed is the peak value of R ripple, the moment occurred at next T ripple can be reliably avoided to carry out defibrillation.
And, arithmetic processing section 75 is programmed sensing between the 100m second after the event being estimated to be R ripple, so that newly sensing is not estimated to be the event of R ripple, therefore be the peak value of R ripple in the event sensed, then the peak value of S ripple that this R ripple in the opposite direction occurs increases and arrives triggering level under such circumstances, can prevent from sensing the peak value of this S ripple 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, not apply DC voltage to 1DC electrode group 31G and 2DC electrode group 32G, so the noise error that can prevent from being applied the input of switch 744 by energy and produce to sense be R ripple, and with this Noise Synchronization carry out defibrillation, or due to this noise the situation that the counting of identical polar is reset.
Above, one embodiment of the present invention is illustrated, but defibrillation catheter system of the present invention is not limited thereto, can various changes be carried out.
Such as, the arithmetic processing section of supply unit also can carry out calculation process as follows to control DC power supply unit, that is: the event (V sensed after energy applies the input of switch n) the polarity previous event (V sensed with it n-1) polarity, the first two event (V to sense n-2) polarity and first three event (V to sense n-3) polarity consistent time (identical polar continuous four times time), with the event (V of the 4th time n) synchronously voltage is applied to 1DC electrode group and 2DC electrode group.

Claims (4)

1. an intracardiac defibrillation catheter system, possesses: defibrillation catheter, and it is inserted in the chambers of the heart and carries out defibrillation; Supply unit, its electrode to this defibrillation catheter applies DC voltage; And electrocardiogrph, the feature of this intracardiac defibrillation catheter system is,
Described defibrillation catheter possesses:
The duct member of insulating properties;
1st electrode group, it is made up of multiple ring electrodes of the front end area being arranged on described duct member;
2nd electrode group, it is made up of multiple ring electrode, and described multiple ring electrode is installed on described duct member by with described 1st electrode group at spaced intervals to base end side;
1st lead wire set, its multiple lead-in wires be connected respectively by front end and the electrode forming described 1st electrode group are formed; And
2nd lead wire set, its multiple lead-in wires be connected respectively by front end and the electrode forming described 2nd electrode group are formed,
Described supply unit possesses:
DC power supply unit;
Tubes connection adapter, 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 electric energy and applies switch;
Arithmetic processing section, it has the output circuit of the DC voltage from described DC power supply unit, and controls described DC power supply unit based on the input of described external switch; And
Electrocardiogram input connector, it is connected with the lead-out terminal of described arithmetic processing section and described electrocardiogrph,
When carrying out defibrillation by described defibrillation catheter, from described DC power supply unit via the output circuit of described arithmetic processing section and described tubes connection adapter, the described 1st electrode group of described defibrillation catheter and the 2nd electrode group are applied to the voltage of mutual opposed polarity,
The arithmetic processing section of described supply unit is carried out calculation process in the following manner and is controlled described DC power supply unit, that is: successively sensing according to the event being inferred to be R ripple via described electrocardiogram input connector by the electrocardiogram that inputs from described electrocardiogrph, and the event V sensed after described electric energy applies the input of switch nthe polarity previous event V sensed at least with it n-1polarity and the first two event V to sense n-2polarity consistent time, with this event V nsynchronously voltage is applied to described 1st electrode group and described 2nd electrode group.
2. intracardiac defibrillation catheter system according to claim 1, is characterized in that,
The arithmetic processing section of described supply unit controls described DC power supply unit, so that after sensing the event being estimated to be R ripple between the shortest 50m second, between the longest 500m second, do not apply voltage to described 1st electrode group and described 2nd electrode group.
3. intracardiac defibrillation catheter system according to claim 2, is characterized in that,
The arithmetic processing section of described supply unit is not after sensing the event being estimated to be R ripple between the shortest 10m second, between the longest 150m second, newly sensing is estimated to be the event of R ripple.
4. the intracardiac defibrillation catheter system according to claim 2 or 3, is characterized in that,
The arithmetic processing section of described supply unit controls described DC power supply unit, so that apply the input of switch at described electric energy after between the shortest 10m second, between the longest 500m second, do not apply voltage to described 1st electrode group and described 2nd electrode group.
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