JP2012034843A - Defibrillation system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a defibrillation system capable of performing defibrillation more reliably without depending on individual differences of patients.SOLUTION: Provided is a defibrillation system including an electrode section that is attached to a heart and applies electrical energy to the heart, a defibrillator that generates the electrical energy on the basis of a predetermined defibrillation wave, and a lead that electrically connects the electrode section and the defibrillator. Further, the defibrillation wave includes a first wave generating first energy, a second wave generating second energy higher than the first energy of the first wave behind the first wave, and an application stop period formed between the first wave and the second wave.

Description

  The present invention relates to a defibrillation system that is placed in the body.

Among cardiac arrhythmias, ventricular fibrillation is likely to cause death due to the immediate stoppage of blood from the heart and insufficient supply of blood to the whole body.
In order to eliminate ventricular fibrillation and normalize heart movement, a high-energy shock is applied to the heart to mitigate disordered contraction of individual tissue areas and to maintain order and systematically spread in the myocardium Means (defibrillation) are used to reconstruct the potential and restore the synchronous contraction of the heart tissue.

Patent Document 1 describes a device that can be implanted into the heart of a patient performing defibrillation therapy. The apparatus includes a plurality of main electrodes, at least one auxiliary electrode, a power source and a control circuit.
The plurality of main electrodes deliver a defibrillation pulse along a predetermined current path in the first portion of the heart, which current path defines a weak electric field region in the second portion of the heart. The auxiliary electrode delivers an auxiliary pulse to the weak electric field region, and a series of cardioversion pulses including a single-phase auxiliary pulse is sent through the auxiliary electrode, followed by biphasic (biphasic: biphasic) defibrillation pulses are delivered via the main electrode. The defibrillation pulse is sent within 20 milliseconds (msec) after sending the auxiliary pulse, and the first phase of the defibrillation pulse has the opposite polarity to the auxiliary pulse.
The control circuit controls the auxiliary pulse so that the auxiliary pulse does not exceed 40% or 50% of the peak current and does not exceed 20% or 30% of the defibrillation pulse transmission energy (in joule conversion).

Special table 2001-514567 gazette

  In the apparatus of Patent Document 1, in order to perform defibrillation more reliably, an auxiliary pulse is transmitted to the weak electric field region by at least one auxiliary electrode. However, it is necessary to newly install an auxiliary electrode in the heart, and the burden on the heart is not necessarily small. When an auxiliary electrode is provided in the coronary vein, it is not impossible to use it as a coronary vein lead (CS lead), but the auxiliary electrode has a certain size (length) to be used for the purpose of defibrillation. ) Is necessary, it is estimated that the defibrillation success rate is inferior in general coronary vein leads.

  Further, in the apparatus of Patent Document 1, it is preferable that the interval between the auxiliary pulse and the defibrillation pulse is changed variously, and the defibrillation pulse is transmitted within 20 msec after the auxiliary pulse is transmitted. However, the suitable interval time is not constant due to external factors such as individual differences. For this reason, the defibrillation success rate varies depending on the patient, and there is still a problem in further improving the defibrillation success rate.

  The present invention has been made in view of the circumstances as described above, and provides a defibrillation system that can perform defibrillation more reliably without being influenced by individual differences among patients. Objective.

  The defibrillation system of the present invention includes an electrode unit that is attached to a heart and applies electrical energy to the heart, a defibrillator that generates the electrical energy based on a predetermined defibrillation waveform, and the electrode unit And a lead for electrically connecting the defibrillator, and the defibrillation waveform is larger than the first waveform after the first waveform for generating the first energy and the first waveform. It has the 2nd waveform which generates 2nd energy, and the application stop period provided between said 1st waveform and said 2nd waveform, It is characterized by the above-mentioned.

  In the defibrillation waveform, the first waveform portion in which the first waveform and the application stop period are paired may be set a plurality of times before the second waveform.

  The application time of the first waveform is not less than 30 milliseconds and not more than 200 milliseconds, and the period of the first waveform portion, which is the sum of the application time of the first waveform and the duration of the application stop period, is 130 milliseconds. It may be greater than or equal to 2 seconds and less than or equal to 600 milliseconds.

  The absolute value of the maximum voltage of the first waveform may be 10 volts or more and 90 volts or less, and the absolute value of the maximum voltage of the second waveform may be 70 volts or more and 500 volts or less.

  Furthermore, in the plurality of first waveform portions, the polarity of at least one first waveform may be different from other first waveforms.

  According to the defibrillation electrode and defibrillation system of the present invention, it is possible to perform defibrillation more reliably without being influenced by individual differences among patients.

It is a figure showing the schematic structure of the defibrillation system of a 1st embodiment of the present invention. It is an enlarged view of the 1st electrode in the electrode part of the defibrillation system. It is a figure which shows the electrocardiogram waveform at the time of ventricular fibrillation. It is a schematic diagram which shows generation | occurrence | production and meandering of the spiral reentry in a heart. It is a figure which shows the defibrillation waveform of the defibrillation system. It is a schematic diagram which shows the state from which a spiral reentry moves from deep heart etc. to a surface layer part. It is a figure which shows the example of the electrocardiogram waveform when the defibrillation system is performing defibrillation. It is a figure which shows the structure of the defibrillation system of 2nd Embodiment of this invention. It is a figure which shows the electrode part and lead | read | reed of the defibrillation system. It is a figure which shows the defibrillation waveform of the defibrillation system. It is a figure which shows the example of the defibrillation waveform in the modification of this invention. It is a figure which shows the example of the defibrillation waveform in the other modification of this invention. It is a figure which shows the example of the defibrillation waveform in the other modification of this invention.

In recent years, reentry (spiral reentry) due to spiral-shaped excitement waves (Spiral Waves) generated in the heart has been considered to be one of the causes of ventricular fibrillation due to optical mapping techniques. It is known that this spiral reentry moves by performing a wandering movement (meandering) in the heart, and further, a chain division occurs, and the entire ventricle reaches a fibrillation state.
Recently, the biphasic defibrillation waveform has been frequently used, but depending on the patient's condition, etc., the first defibrillation using the electrical energy set in the defibrillator completely prevents ventricular fibrillation. In some cases, the defibrillation cannot be stopped and the second defibrillation is performed by increasing the electric energy. Successful defibrillation as soon as possible after the occurrence of ventricular fibrillation is important for improving the quality of life (QOL) of the patient, but defibrillation due to large electrical energy occurs at the electrode. Since heat affects surrounding living tissue, it is considered desirable to perform defibrillation using a minimum amount of electrical energy from the viewpoint of reducing invasion.

  The defibrillation system of the present invention is configured to provide a higher defibrillation success rate based on the above-described findings. Hereinafter, each embodiment will be described in detail.

  FIG. 1 is a diagram showing a schematic configuration of a defibrillation system 1 according to a first embodiment of the present invention. As shown in FIG. 1, a defibrillation system 1 includes a defibrillator 10 that generates electrical energy for defibrillation, an electrode unit 20 attached to the heart 100, a defibrillator 10 and an electrode unit. 20 and a lead 30 that connects to 20.

  The defibrillator 10 includes a battery as a power source, a capacitor that stores electrical energy, a detection circuit that detects an electrocardiogram, a determination circuit that determines the state of the heart based on the electrocardiogram, and a defibrillation drive circuit that releases energy from the capacitor Etc. (all not shown) are provided inside. Electrical energy is released from the defibrillation drive circuit based on a predetermined defibrillation waveform, which will be described in detail later.

  The electrode unit 20 includes a first electrode 21 and a second electrode 22 having the same structure. As shown in FIG. 1, the first electrode 21 is placed on the pericardial membrane 101 on the right ventricular side, and the second electrode 22 faces the first electrode 21 with the heart 100 in between (see the upper side of FIG. 1). ) As shown above on the left ventricular pericardium 101.

FIG. 2 is an enlarged view of the first electrode 21. The first electrode 21 includes a sheet-like insulating member 23 and an application lead 24 attached to the insulating member 23.
As a material for forming the insulating member 23, a material having elasticity, flexibility, and insulating property and biocompatibility is preferable, and silicone is used in the present embodiment. The thickness of the insulating member 23 is set so that the maximum value is about 0.5 millimeters (mm), for example. In this embodiment, the insulating member is formed in a substantially oval shape, but the shape thereof is not particularly limited.

The application lead 24 is formed of a platinum-based material, preferably a platinum iridium alloy, and is electrically connected to the lead 30. The application lead 24 of the present embodiment has, for example, a base structure with a wire diameter of about 0.2 mm so as to be flexible enough to cope with the continuous shape change of the pericardial sac associated with the pulsation of the heart. ing. The application lead 24 has four straight portions 24A and a curved portion 24B. The straight portion 24A is exposed on one surface of the insulating member 23, and the curved portion 24B is buried in the insulating member 23 so as to be inside the body. It is attached to the insulating member 23 so as to be insulated from the organ. Each linear part 24A consists of four base lines, and is arranged in parallel to each other. All the base lines constituting the straight portion 24A are connected to the curved portion 24B, and even when one base line is disconnected, the electric energy can be reliably supplied to the heart.

In the insulating member 23, a plurality of through holes 23 </ b> A are provided in the region between the four straight portions 24 </ b> A to increase the flexibility of the insulating member and reduce the contact area with the pericardial membrane. In the present embodiment, the through hole is circular as shown in FIG. 2, but the shape is not limited. Moreover, as long as the 1st electrode 21 and the 2nd electrode 22 can maintain the fixed intensity | strength required as an electrode, there is no restriction | limiting in the number of through-holes 23A.
Since the second electrode 22 has substantially the same structure as the first electrode except for the connection position of the lead 30 and the like, description thereof is omitted, but the first electrode 21 and the second electrode 22 configured as described above are It is very flexible as a whole, and even if it is placed on the pericardial membrane 101, it has a low risk of preventing the heart 100 from pulsating and inducing arrhythmia.

  The configuration of the lead 30 is not particularly limited as long as it can transmit electrical energy from the defibrillator 10 to the electrode unit 20 while maintaining electrical insulation. In this embodiment, for example, an MP35N alloy wire having a core wire containing 41% silver at the center is wound in a coil shape in a polyurethane tube having an outer diameter φ of about 2 mm. In such a configuration, since the MP35N alloy is shaped into a coil shape, strong tensile strength and repeated bending strength are realized.

  As shown in FIG. 2, the lead 30 is connected to the curved portion 24 </ b> B of the application lead 24 from the back side, which is the opposite side of the surface of the insulating member 23 where the linear portion 24 </ b> A is exposed. The lead 30 and the application lead 24 are firmly fixed by welding, mechanical caulking connection, or the like, and the connection portion is covered with the insulating member 23 so as not to be exposed.

The operation at the time of use of the defibrillation system 1 configured as described above will be described.
In the defibrillation system 1, the electrode unit 20 is placed on the pericardium 101 on the surface of the patient's heart 100 before use. The electrode portion 20 is placed on the pericardial membrane 101 by passing sutures through the four suture locations indicated by x in FIG. At the time of suturing, a needle such as a curved needle and a suture thread are penetrated in the thickness direction of the insulating member 23, and the suture is performed so as to penetrate only the pericardial membrane 101 and not the heart myocardium. Thereby, the electrode part 20 is fixed only to the pericardial membrane 101. Therefore, the heart 100 can move freely within the pericardial membrane 101 without being affected by the electrode portion 20, and the risk of occurrence of arrhythmia due to the movement of the heart being hindered can be suppressed.

The electrode unit 20 may be installed under thoracotomy or may be performed under a thoracoscope using a trocar or the like, but it is installed under a thoracoscope from the viewpoint of suppressing patient invasion. Is preferred. Since the first electrode 21 and the second electrode 22 are excellent in flexibility, when they are placed under a thoracoscope, these electrodes are rolled up into a shape that can pass through a trocar or the like and then delivered into the chest cavity. You only need to perform the installation procedure after expanding it.
The lead 30 and the defibrillator 10 drawn out of the body may be held outside the body or may be embedded and held under the skin.

The defibrillation system 1 attached to the patient constantly monitors the patient's electrocardiogram by a detection circuit provided in the defibrillator 10. When ventricular fibrillation occurs during monitoring, an electrocardiogram of ventricular fibrillation as shown in FIG. 3 is acquired and the occurrence of ventricular fibrillation is detected.
During ventricular fibrillation, the heart beats violently at 200 times or more per minute, but the beat is irregular, and there is no variability in the size and period of the electrocardiogram waveform. This is because, as shown in FIG. 4, a plurality of spiral reentries 110 are meandering, and conduction of electrical stimulation occurs randomly on the surface and inside of the heart 100, and each part contracts randomly. It is considered to be one cause.

  In the defibrillation system 1 of this embodiment, when the occurrence of ventricular fibrillation is detected, the defibrillation drive circuit of the defibrillator 10 generates electrical energy based on the defibrillation waveform as shown in FIG. Let The generated electrical energy is transmitted to the electrode portion 20 through the lead 30 and is applied between the first electrode 21 and the second electrode 22.

  A defibrillation waveform generated by the defibrillation drive circuit includes a first waveform portion W1 that aligns the period of spiral reentry (hereinafter referred to as “SR”) in the heart, and a ventricle following the first waveform portion W1. And a second waveform W2 for removing fibrillation. In this embodiment, electrical energy (second energy) generated based on the second waveform W2 is applied to the heart immediately after the first waveform portion W1 is applied to the heart twice, and a series of defibrillation is performed. Done.

The first waveform portion W1 has a rectangular wave (first waveform) W1A that generates electrical energy (first energy) of a predetermined magnitude, and an application stop period W1B that follows the rectangular wave W1A. When the rectangular wave W1A is applied to the heart, SR generated in the surface layer of the heart 100 and a relatively shallow portion (hereinafter collectively referred to as “surface layer portion”) is attracted to and captured by the potential of the rectangular wave W1A. The meandering stops (first energy application step: S1 in the electrocardiogram waveform shown in FIG. 7).
When the application of the rectangular wave W1A is completed, the application stop period W1B is entered, and the capture of SR is canceled. However, since it has been captured for a predetermined time, it disappears because re-excitation is not input. As a result, most of the SR generated in the surface layer portion of the heart 100 disappears (energy application stop process: S2 in the electrocardiogram waveform shown in FIG. 7). Further, it occurs in the deep part of the myocardium near the ventricle, the heart septum (hereinafter, collectively referred to as “heart deep part etc.”), and propagates as shown in FIG. Most of the SRs 110 that have reached the point are captured by the rectangular wave W1A and disappear. That is, when the rectangular wave W1A is applied to the heart, many SRs having low synchronism with the application period of the rectangular wave W1A disappear.

  Although the SR of the surface layer disappears due to the rectangular wave W1A that generates electric energy smaller than the second waveform W2, it is synchronized with the application period of the rectangular wave W1A mainly in the deep part of the myocardium near the ventricle or the heart septum. Highly functional SR remains. These SRs spread to the surface layer as shown in FIG. 6 during the application stop period W1B. However, the disordered state is improved as compared with that before the action of the rectangular wave W1A. Regardless of the order, they come to a certain period. In the present embodiment, by performing the first waveform portion W1 twice, the total amount of SR in the heart is further reduced, and the second waveform W2 is applied after further increasing the degree of alignment of the cycles.

  The second waveform W2 is a biphasic waveform as described in Patent Document 1. In the present embodiment, the second waveform W2 is applied immediately after the end of the second application stop period W1B of the first waveform portion W1 (second energy application step: S3 in the electrocardiogram waveform shown in FIG. 7). Defibrillation is performed by applying electrical energy to the heart in a more synchronized manner with the ventricular fibrillation cycle aligned by the waveform portion W1. In other words, the electrical energy of the second waveform W2 can be applied at the timing closest to when the entire heart is electrically excited by the SR having a certain period of time. Thereby, it is possible to easily suppress the electrical excitement of the heart, and the defibrillation success rate is improved. In the electrocardiogram waveform shown in FIG. 7, the heart beat is normalized after the second energy application step.

The second waveform W2 in the present embodiment may be, for example, a plus-side maximum voltage of 160 volts (V), an energization time of 6 msec, a minus-side maximum voltage of 100 V, and an energization time of 6 msec. With a general defibrillator, it is difficult and almost impossible to remove ventricular fibrillation with a biphasic waveform of this magnitude, but in the defibrillation system 1 of this embodiment, By using a defibrillation waveform that combines the first waveform portion W1 and the second waveform W2, the maximum voltage value of the biphasic waveform in the second waveform W2 is kept low compared to the conventional defibrillator. Can be defibrillated.
As a result, when the threshold of one defibrillation energy by the biphasic waveform as described in Patent Document 1 is about 3 joules (J), for example, the electrical energy of the second waveform W2 of the present embodiment is On the other hand, the energy content of about 1/3 to 1/2 (about 1 to 1.5 J) can be reduced. Thereby, the impact on the patient generated by defibrillation can be remarkably reduced, and the QOL of the patient wearing the defibrillation system 1 can be improved while suppressing the invasion.
In the defibrillation system of the present invention, it is preferable that the defibrillator can set the absolute value of the maximum voltage of the second waveform in the range of 70 volts to 500 volts. If the maximum voltage of the second waveform can be set in such a range, not only when the electrode part is placed on the pericardial membrane as in this embodiment, but also when the electrode part is placed intravenously in the heart It can respond suitably.

In the present embodiment, the voltage value and length (time) of the first waveform portion W1 are also important and are preferably set within a predetermined range.
If the voltage value of the rectangular wave W1A is too low, it becomes difficult to capture the SR while the meandering is stopped, and the area of the region where the SR is captured in the heart is also reduced. On the other hand, if the voltage value is too high, even SR in the deep part is captured, making it difficult to align the SR cycles. Considering these, the voltage value of the rectangular wave W1A is preferably 10 volts (V) or more and 90 V or less, and more preferably 40 V or more and 60 V or less.
If the application time of the rectangular wave W1A is too short, the SR can be captured only for an instant, and it is difficult to suppress re-excitation, so that the SR is difficult to disappear. On the other hand, if the length is too long, the time for the heart to stop increases and the burden on the patient increases. The application time of the rectangular wave W1A is preferably 30 msec or more and 200 msec or less, and more preferably 50 msec or more and 100 msec or less.

If the application stop period W1B is too short, the SR generated in the deep part of the heart, the septum, etc. has not yet reached the surface layer part, and the significance of the subsequent first waveform and second waveform is diminished. On the other hand, if the application stop period W1B is too long, after the SR reaches the surface layer portion, it further expands and becomes the same state as before the application of the rectangular wave W1A. Therefore, it is preferable that the length of the application stop period W1B is set to be substantially the same as the time until SR generated in the deep part of the heart or the septum reaches the surface part. It takes about 100 msec to 400 msec for the SR generated in the deep heart to reach the surface layer through the process shown in FIG. Therefore, the length of the application stop period W1B is preferably 100 msec or more and 400 msec or less, and more preferably 100 msec or more and 200 msec or less.
From the above, the period T of the first waveform portion W1, which is the sum of the rectangular wave W1A and the application stop period W1B, is preferably 130 msec to 600 msec, and more preferably 150 msec to 300 msec.

  As described above, according to the defibrillation system 1 of the present invention, the defibrillation waveforms generated by the defibrillation drive circuit of the defibrillator 10 are the first waveform portion W1 and the second waveform W2. Therefore, defibrillation can be performed more reliably without being influenced by individual differences among patients. In addition, since defibrillation can be performed with less energy than conventional defibrillation systems, the invasion of the patient is reduced, and the period until the battery needs to be replaced after the system is placed (lifetime) is longer. can do.

  In the present embodiment, the example in which the first waveform portion W1 is applied twice before the application of the second waveform W2 has been described. However, the first waveform portion is determined depending on the severity of the ventricular fibrillation, the state of the patient, and the like. The second waveform W2 may be applied after W1 is applied once, or may be applied three or more times. As the number of times of application of the first waveform portion W1 is increased, the total number of SRs is reduced and the period is aligned. Therefore, unless deviating from the original purpose of defibrillation for saving the patient, the first waveform is used in the defibrillation waveform. It is preferable to set as many portions W1 as possible.

  Next, a second embodiment of the present invention will be described with reference to FIGS. The difference between the defibrillation system 41 of the present embodiment and the above-described defibrillation system 1 is the shape of the electrode part and the lead and the mode of the defibrillation waveform. In the following description, components that are the same as those already described are assigned the same reference numerals and redundant description is omitted.

FIG. 8 is a view showing the electrode part 42 and the lead 50 of the defibrillation system 41. The electrode part 42 and the lead 50 are generally called RV leads (transvenous leads), and as shown in FIG. 9, the tip electrode 43 and the lead electrode 43 used for detecting an electrocardiogram or pacing the heart. A ring electrode 44 is provided near the tip of the electrode portion 42. An RV-def electrode 45 to which a defibrillation waveform is applied is provided at an intermediate part of the electrode part 42. Each electrode of the electrode part 42 and the lead 50 are electrically connected by an in-electrode lead (not shown). Further, the lead 50 is connected to the defibrillator 10 by an IS1 connector 51 and a pair of DF1 connectors 52 provided at the proximal end.
Unlike the electrode unit 20 of the first embodiment, the electrode unit 42 is delivered to the heart 100 via a blood vessel using a catheter or the like. The RV-def electrode 45 is installed so as to be generally located in the right ventricle 102 in a state where the electrode portion 42 is indwelled.

In the defibrillation system 41, the defibrillation waveform generated by the defibrillation drive circuit is applied between the defibrillator 10 and the RV-def electrode 45.
FIG. 10 is a diagram showing a defibrillation waveform of the defibrillation system 41. Also in the defibrillation system 41, the first waveform portion is applied twice, but as shown in the figure, a rectangular wave W1C having a polarity different from that of the rectangular wave W1A is applied to the first waveform portion W3 for the second time. The The voltage value of the rectangular wave W1C is minus 40V, and the absolute value thereof is set to be the same as that of the rectangular wave W1A.

  In the present embodiment, the polarity of the first energy is reversed in the first waveform portion W3 applied for the second time, and a rectangular wave W3A having a negative polarity and having an absolute voltage value similar to that of the rectangular wave W1A is applied. As a result, the heart 100 is less likely to be charged with positive polarity. Even if the polarity of the applied electrical energy is negative, it can be captured while stopping the meandering of the SR generated on the surface layer of the heart 100, as in the case of the positive polarity electrical energy. Then, after the application of the rectangular wave W3A, the captured SR similarly disappears and the total number is reduced.

  Also in the defibrillation system 41 of this embodiment, as with the defibrillation system 1 of the first embodiment, the total number of SRs is reduced, and the ventricular fibrillation cycle and the application timing of the second waveform are more synchronized. Defibrillation can be performed reliably.

In addition, since the first waveform portion W3 including the negative polarity rectangular wave W1C is applied subsequent to the first waveform portion W1, it is possible to apply a correct polarity voltage to the heart 100 during defibrillation by the second waveform W2. it can. As a result, the bias voltage remaining in the heart can be canceled to prevent the voltage shift of the biphasic waveform.
In this embodiment, the example in which the first waveform portion W1 is set first and the first waveform portion W3 is set later has been described, but it goes without saying that the same effect can be obtained even if this order is changed.

  As mentioned above, although each embodiment of this invention was described, the technical scope of this invention is not limited to the said embodiment, A various change can be added in the range which does not deviate from the meaning of this invention.

First, the defibrillation waveform generated by the defibrillation drive circuit of the defibrillator can take various forms other than those shown in the above embodiments.
FIG. 11 is a diagram showing an example of a defibrillation waveform in a modification of the present invention. In this modification, in the first waveform portion W4, a biphasic waveform W1D is used as the first waveform instead of the rectangular waves W1A and W3A. However, the voltage value and the total application time are the same as those of the rectangular wave W1A, the voltage value is lower than the second waveform W2, and the application time is longer than the second waveform W2.

Even with such a defibrillation waveform, defibrillation can be performed more reliably than in the conventional defibrillation system, as in the above-described embodiments. Further, the point that the positive polarity is less likely to occur in the heart 100 is the same as in the second embodiment.
Furthermore, since the first waveform is the same biphasic waveform as the second waveform, the configuration of the defibrillation drive circuit in the defibrillator 10 can be further simplified, and the manufacturing cost can be reduced.

  FIG. 12 is a diagram showing an example of a defibrillation waveform in another modification of the present invention. In this modification, the first waveform and the application stop period are set once before the second waveform W2, that is, the first waveform portion W5 is set only once. The voltage value of the rectangular wave W11A applied as the first waveform is plus 40V, which is the same as that of the rectangular wave W1A, but the application time is longer than the rectangular wave W1A and is set to 400 msec. The application time of the rectangular wave W11A is preferably set slightly longer than the preferable application time range in the case where the first waveform portion described above is performed twice. Even if the defibrillation waveform is set in this way, although the effect is slightly inferior to the above-described embodiments, the total number of SR is reduced prior to the application of the second waveform, and less energy than the conventional defibrillation system. Thus, defibrillation can be performed more reliably.

  Furthermore, the first waveform may be composed of a large number of pulses P having a sufficiently short application time as in the modification shown in FIG. In this modification, the application time of each pulse P is 10 msec, and 19 pulses are generated with an interval of 10 msec between each pulse P, so that the first application can be regarded as a single rectangular wave with a total application time of 370 msec. One waveform W11B is formed. In this way, the power consumption of the first waveform W11B can be apparently reduced to one half of the first waveform W11A while obtaining the same effect as the modification shown in FIG. Power supply life can be improved. When the first waveform is composed of a large number of pulses, the pulse interval may be set sufficiently faster than the SR meandering speed, and the application time of each pulse and the interval between pulses are not limited to the above. For example, both the pulse application time and the interval between pulses may be set to 1 msec. If the pulse train is several msec, substantially the same effect can be obtained. Such a first waveform may be used when the first waveform portion is set a plurality of times.

  Further, an application stop time different from the application stop period may be provided between the first waveform portion and the second waveform applied immediately before the second waveform. In this case, since the sum of the first waveform portion and the application stop time can be regarded as a substantial period of the first waveform portion, the period regarded as such is the preferred range described above. If it is within the range, it is included in the present invention, and the same effect can be obtained. The first waveform portion is composed of the preceding application stop period and the subsequent first waveform, and the first waveform portion is between the first waveform and the second waveform applied immediately before the second waveform. The same applies when the application stop time is set separately.

  Furthermore, the specific aspects of each configuration described in each of the above-described embodiments change the combination of components within a range that does not depart from the gist of the present invention, add various changes to each component, or delete them. It is possible.

Further, the present invention includes technical ideas described in the following supplementary notes.
(Additional item 1)
A defibrillation method for the heart,
A first energy application step of applying a first energy to the heart;
A first energy application step of applying a second energy greater than the first energy to the heart;
An application stopping step that is set between the first energy applying step and the second energy applying step, and stops applying electric energy for a predetermined time;
Is provided.
(Appendix 2)
A defibrillation method according to appendix 1, wherein
The application time of the first energy application process is not less than 30 milliseconds and not more than 200 milliseconds, and the sum of the application time and the time of the application stop process is not less than 130 milliseconds and not more than 600 milliseconds.
(Additional Item 3)
The defibrillation method according to attachment 1, wherein the absolute value of the maximum voltage in the first energy application step is not less than 10 volts and not more than 90 volts, and the absolute value of the maximum voltage in the second energy application step is 70. It is not less than 500 volts and not more than bolts.

1, 41 Defibrillation system 10 Defibrillator 20, 42 Electrode unit 30, 43 Lead 100 Heart W1, W3, W4, W5 First waveform unit W1A, W1C, W11A Rectangular wave (first waveform)
W1B Application stop period W1D Biphasic waveform (first waveform)
W2 second waveform

Claims (5)

An electrode part attached to the heart for applying electrical energy to the heart;
A defibrillator that generates the electrical energy based on a predetermined defibrillation waveform;
A lead for electrically connecting the electrode portion and the defibrillator;
With
The defibrillation waveform is
A first waveform for generating first energy;
After the first waveform, a second waveform that generates a second energy larger than the first waveform;
A defibrillation system comprising: an application stop period provided between the first waveform and the second waveform.   2. The defibrillation waveform, wherein a first waveform portion in which the first waveform and the application stop period are set is set a plurality of times before the second waveform. Defibrillation system as described.   The application time of the first waveform is not less than 30 milliseconds and not more than 200 milliseconds, and the period of the first waveform portion, which is the sum of the application time of the first waveform and the duration of the application stop period, is 130 milliseconds. The defibrillation system according to claim 1 or 2, wherein the defibrillation system is not less than second and not more than 600 milliseconds.   The absolute value of the maximum voltage of the first waveform is 10 volts or more and 90 volts or less, and the absolute value of the maximum voltage of the second waveform is 70 volts or more and 500 volts or less. The defibrillation system according to item 1.   5. The defibrillation system according to claim 2, wherein in the plurality of first waveform portions, the polarity of at least one of the first waveforms is different from other first waveforms.

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