Defibrillation electrical device and method of generating a defibrillation signal

By detecting the R-wave interval in the electrocardiogram waveform and generating a permission signal under specific conditions, the problem of unreliable defibrillation voltage application when the R-wave interval is narrow in the prior art is solved, achieving a safe and efficient defibrillation effect, and is applicable to intracardiac defibrillation catheter systems.

CN115884808BActive Publication Date: 2026-08-04KANEKA CORP
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
KANEKA CORP
Filing Date
2021-05-19
Publication Date
2026-08-04

AI Technical Summary

Technical Problem

Existing defibrillation catheter systems cannot reliably deliver defibrillation voltage in patients with narrow R-wave intervals, which may lead to the transfer of ventricular fibrillation.

Method used

By detecting the R-wave interval in the electrocardiogram waveform, a permission signal generation unit generates a permission signal under specific time interval conditions to ensure that the voltage is applied at the appropriate R-wave and avoid T-wave interference. This includes controlling the charging and voltage application sequence of the power supply unit.

Benefits of technology

This technology enables reliable selection of the appropriate R wave for voltage application even when the R wave interval is narrowed, improving the safety and effectiveness of defibrillation and reducing the burden on patients.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to a defibrillation electrical device and a method of generating a defibrillation signal. The defibrillation electrical device is controlled so that, when a time interval from an n-th R wave (R n ) to an n+1-th R wave (R n+1 ) of an electrocardiogram (50) exceeds a first prescribed time, a permission signal is generated from a permission signal generating section for the n+1-th R wave (R n+1 ) after the first prescribed time. When the first time interval (T1) is equal to or less than the first prescribed time, a permission signal is generated from the permission signal generating section for an n+2-th R wave (R n ) after a second prescribed time when a time interval from the n-th R wave (R n+2 ) to the n+2-th R wave (R n+2 ) of the electrocardiogram (50) exceeds the second prescribed time.
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Description

Technical Field

[0001] This invention relates to electrical devices for defibrillation and methods for generating defibrillation signals. Background Technology

[0002] In the treatment of arrhythmias such as atrial fibrillation and ventricular fibrillation, defibrillation is performed by applying electrical stimulation to restore the heart rhythm to normal. Defibrillation uses automated external defibrillators (AEDs), implantable cardioverter defibrillators (ICDs), defibrillator paddle systems, and defibrillation catheter systems.

[0003] In particular, in the treatment of atrial fibrillation, voltage needs to be applied during the absolute refractory period to prevent ventricular myocardial inactivity. If stimulation is applied outside the absolute refractory period, a ventricular myocardial response may occur, potentially leading to ventricular fibrillation. Therefore, in defibrillation catheter systems, voltage needs to be applied synchronously with the R wave.

[0004] As an example of a defibrillation catheter system used in such treatment, Patent Document 1 discloses a catheter system comprising: a defibrillation catheter inserted into the heart chamber for defibrillation, a power supply device for applying a DC voltage to the electrodes of the defibrillation catheter, and an electrocardiograph.

[0005] Patent Document 1: Japanese Patent Application Publication No. 2018-68981

[0006] However, in the intracardiac defibrillation catheter system described in Patent Document 1, a defibrillation voltage cannot be applied to patients with a narrow interval between the R waves. Therefore, in recent years, there has been a desire to develop defibrillation devices with a new licensed signal generation mechanism. Summary of the Invention

[0007] The present invention was made to solve the above-mentioned situation, and its purpose is to provide a new electrical device for defibrillation and a method for generating defibrillation signals.

[0008] The defibrillation electrical device of the present invention, which can solve the above-mentioned problems, is described below.

[0009] [1] An electrical device for defibrillation, comprising:

[0010] ECG waveform input unit; and

[0011] The permission signal generation unit generates a permission signal that permits the application of a voltage for defibrillation.

[0012] The defibrillation electrical device satisfies either requirement 1 or requirement 2 below.

[0013] Among them, the nth, (n+1)th, and (n+2)th R-waves are detected in this order, where n is an integer greater than or equal to 1.

[0014] (Requirement 1)

[0015] The control is implemented such that when the time interval from the nth R wave to the (n+1)th R wave of the electrocardiogram waveform, i.e., the first time interval, exceeds a first predetermined time, a permission signal is generated for the (n+1)th R wave from the aforementioned permission signal generation unit.

[0016] (Requirement 2)

[0017] When the first time interval is less than the first predetermined time, and the time interval from the nth R wave to the (n+2)th R wave of the electrocardiogram waveform, i.e., the second time interval, exceeds the second predetermined time, the permission signal generation unit generates a permission signal for the (n+2)th R wave.

[0018] Typically, the interval between an R wave and the subsequent T wave in an electrocardiogram waveform is shorter than the interval between the next R wave. Therefore, in the aforementioned defibrillation electrical device, the T wave contained in the R wave detected according to requirement 1 can be reliably removed from the voltage application target. Furthermore, even if the interval between R waves becomes narrower, an appropriate R wave can be easily selected as the voltage application target according to requirement 2, and a voltage for defibrillation can be applied.

[0019] Furthermore, the present invention also includes the defibrillation electrical devices described below [2] to

[10] .

[0020] [2] The defibrillation electrical device according to [1] further includes a power supply unit for generating an applied voltage.

[0021] Control is performed so that, after further satisfying requirement 3 in either requirement 1 or requirement 2, a permission signal is generated from the permission signal generation unit.

[0022] (Requirement 3)

[0023] The charging process ends when the required voltage is applied in the power supply section described above.

[0024] [3] The defibrillation electrical device according to [1] or [2], wherein,

[0025] Control is performed so that, after further satisfying requirement 4 in either requirement 1 or requirement 2, a permission signal is generated from the permission signal generation unit.

[0026] (Requirement 4)

[0027] The voltage for defibrillation is not applied to the preceding R wave of the object that is being given a signal for defibrillation.

[0028] [4] The defibrillation electrical device according to any one of [1] to [3], wherein,

[0029] The first specified time and the second specified time mentioned above are respectively between 100 milliseconds and 300 milliseconds.

[0030] [5] The defibrillation electrical device according to any one of [1] to [4], wherein,

[0031] The first stipulated time is the same as the second stipulated time.

[0032] [6] The defibrillation electrical device according to any one of [1] to [5], wherein,

[0033] The first time interval mentioned above is the time interval from the peak value of the nth R wave to the peak value of the (n+1)th R wave in the electrocardiogram waveform.

[0034] The second time interval mentioned above is the time interval from the peak value of the nth R wave of the electrocardiogram waveform to the peak value of the (n+2)th R wave.

[0035] [7] The defibrillation electrical device according to any one of [1] to [5], wherein,

[0036] The aforementioned first time interval is the time interval from the moment when the height of the nth R wave in the electrocardiogram exceeds a first predetermined value to the moment when the height of the (n+1)th R wave exceeds the aforementioned first predetermined value.

[0037] The aforementioned second time interval is the time interval from the moment when the height of the nth R wave in the electrocardiogram exceeds the aforementioned first predetermined value to the moment when the height of the (n+2)th R wave exceeds the aforementioned first predetermined value.

[0038] The third specified time is shorter than the time interval from the start of the R wave to its peak.

[0039] [8] The defibrillation electrical device according to any one of [1] to [5], wherein,

[0040] The aforementioned first time interval is the time interval from the moment when the height of the nth R wave in the electrocardiogram waveform falls below the second predetermined value to the moment when the height of the (n+1)th R wave falls below the aforementioned second predetermined value.

[0041] The aforementioned second time interval is the time interval from the moment when the height of the nth R wave in the electrocardiogram waveform falls below the aforementioned second specified value to the moment when the height of the (n+2)th R wave falls below the aforementioned second specified value.

[0042] Among them, the fourth specified time is shorter than the time interval from the peak of the R wave to its end.

[0043] [9] The defibrillation electrical device according to any one of [1] to [8], wherein,

[0044] Control is performed so that, after the aforementioned first time interval exceeds the aforementioned first predetermined time, a mark display signal assigning a mark to the (n+1)th R wave is generated.

[0045] Control is performed so that after the second time interval exceeds the second predetermined time, a mark display signal is generated to mark the (n+2)th R wave.

[0046]

[10] The defibrillation electrical device according to any one of [1] to [9], wherein,

[0047] It is an electrical device used for intracardiac defibrillation.

[0048] In addition, the present invention includes the following

[11] intracardiac defibrillation catheter system.

[0049]

[11] An intracardiac defibrillation catheter system comprising:

[0050] A catheter, inserted into the heart chamber, has a distal end and a proximal end, and multiple electrodes are disposed in the distal portion; and

[0051] The defibrillation electrical device described in any one of [1] to

[10] that applies voltage to the aforementioned electrodes.

[0052] Furthermore, the present invention also includes the following

[12] method for generating defibrillation signals.

[0053]

[12] A method for generating a defibrillation signal, comprising the following steps:

[0054] The step of determining whether the time interval from the nth R wave to the (n+1)th R wave of the electrocardiogram waveform, i.e., the first time interval, exceeds a first predetermined time; and

[0055] After the aforementioned first time interval exceeds the aforementioned first predetermined time, a permit signal is generated synchronously with the (n+1)th R wave.

[0056] When the first time interval is less than the first predetermined time, the step of determining whether the time interval from the nth R-wave to the (n+2)th R-wave, i.e., the second time interval, exceeds the second predetermined time, and then generating a permit signal synchronously with the (n+2)th R-wave after the second time interval exceeds the second predetermined time, is as follows:

[0057] Among them, the nth, n+1th, and n+2th R waves mentioned above are detected in this order, where n is an integer greater than or equal to 1.

[0058] According to the above-described method for generating defibrillation signals, T waves contained in detected R waves can be reliably removed from the voltage application target. Furthermore, even if the intervals between R waves become narrower, appropriate R waves can be easily selected as voltage application targets, enabling the application of defibrillation voltage.

[0059] According to the above-described defibrillation electrical device and defibrillation signal generation method, the T wave contained in the detected R wave can be reliably removed from the voltage application target. Furthermore, even if the interval between R waves narrows, a suitable R wave can be easily selected as the voltage application target, and a voltage for defibrillation can be applied. Attached Figure Description

[0060] Figure 1 This is a schematic diagram showing the structure of a defibrillation catheter system that includes the defibrillation electrical device according to the first embodiment of the present invention.

[0061] Figure 2 This is a diagram representing an example of an electrocardiogram (ECG) waveform.

[0062] Figure 3 This is a flowchart illustrating a method for generating a defibrillation signal according to an embodiment of the present invention.

[0063] Figure 4 This is a block diagram of a defibrillation catheter system that includes the defibrillation electrical device according to the first embodiment of the present invention.

[0064] Figure 5 This is a block diagram of an electrical device for defibrillation according to a second embodiment of the present invention. Detailed Implementation

[0065] The present invention will now be specifically described with reference to the accompanying drawings. However, the invention is not limited to the examples shown in the drawings, and may be implemented with appropriate modifications that conform to the spirit of the preceding / following description, all of which are included within the technical scope of the invention. For convenience, shading, symbols, etc., are sometimes omitted in the drawings; in such cases, please refer to the specification and other drawings. Furthermore, the dimensions of the various components in the drawings are preferably helpful in understanding the features of the invention, and therefore may sometimes differ from the actual dimensions.

[0066] An electrical device for defibrillation according to one embodiment of the present invention includes: an electrocardiogram waveform input unit and a permission signal generation unit that generates a permission signal for applying a voltage permitted for defibrillation, satisfying either condition 1 or condition 2 below. Wherein, the nth, (n+1), and (n+2)th R waves are detected in this order, where n is an integer of 1 or more.

[0067] (Requirement 1)

[0068] Control is performed so that when the time interval from the nth R wave to the (n+1)th R wave of the electrocardiogram waveform, i.e., the first time interval, exceeds the first predetermined time, a permission signal is generated for the (n+1)th R wave from the permission signal generation unit.

[0069] (Requirement 2)

[0070] Control is performed so that when the first time interval is less than the first predetermined time, and after the time interval from the nth R wave to the (n+2)th R wave of the electrocardiogram waveform, i.e., the second time interval, exceeds the second predetermined time, a permission signal is generated for the (n+2)th R wave from the permission signal generation unit.

[0071] Typically, the interval between an R wave and the subsequent T wave in an electrocardiogram waveform is shorter than the interval between the next R wave. Therefore, in the aforementioned defibrillation electrical device, the T wave contained in the R wave detected by element 1 can be reliably removed from the voltage application target. Furthermore, even if the interval between R waves becomes narrower, an appropriate R wave can be easily selected as the voltage application target according to element 2, and a voltage for defibrillation can be applied.

[0072] The following is for reference Figures 1-3 The structure of the defibrillation electrical device according to the first embodiment of the present invention will be described. Figure 1 This is a schematic diagram showing the structure of the defibrillation catheter system of the defibrillation electrical device according to the first embodiment of the present invention. Figure 2 This is a diagram representing an example of an electrocardiogram (ECG) waveform. Figure 3 This is a flowchart illustrating a method for generating a defibrillation signal according to an embodiment of the present invention. Figure 2 In the diagram, the solid line B extending along the time axis is the baseline of the electrocardiogram waveform.

[0073] Figure 1 The defibrillation electrical device 2 is a device equipped with an electrocardiogram (ECG) waveform input unit 3 and a permit signal generation unit 7. For example, an ECG waveform obtained from surface electrodes 19 disposed on the body surface is input to the defibrillation electrical device 2 via an electrocardiograph 40 or the like from the ECG waveform input unit 3. Furthermore, the defibrillation electrical device 2 satisfies either requirement 1 or requirement 2 described above. Specifically, as... Figures 2-3 As shown, calculate the nth R wave from ECG waveform 50. nUp to the (n+1)th R wave n+1 The time interval up to that point, i.e., the first time interval T1, is used to determine whether the first time interval T1 exceeds a first predetermined time (step S1). Control is performed so that if the first time interval T1 exceeds the first predetermined time, after the first time interval T1 exceeds the first predetermined time, the permission signal generation unit 7 sends a signal to the (n+1)th R wave R. n+1 A permission signal for defibrillation is generated (step S2). When the first time interval T1 is less than the first predetermined time, the nth R wave R from the ECG waveform 50 is calculated. n To the (n+2)th R wave n+2 The time interval up to that point, i.e., the second time interval T2, is used to determine whether the second time interval T2 exceeds the second predetermined time (step S3). Control is performed so that if the second time interval T2 exceeds the second predetermined time, after the second time interval T2 exceeds the second predetermined time, the permission signal generation unit 7 sends a signal to the (n+2)th R wave R. n+2 A clearance signal for defibrillation is generated (step S4).

[0074] like Figure 2 As shown, the nth, (n+1)th, and (n+2)th R-waves are detected in this order, where n is an integer greater than or equal to 1. Furthermore, in requirements 1 and 2, the method for detecting the R-waves is not particularly limited, and known methods can be used for detection.

[0075] The first time interval T1 is the nth R wave in the ECG waveform 50. n Up to the (n+1)th R wave n+1 The time interval up to this point (in seconds). While the method for setting the first time interval T1 is not specifically limited, however... Figure 2 As shown, the preferred first time interval T1 is from the nth R wave of the ECG waveform 50. n The peak value of 51p to the (n+1)th R wave n+1 The time interval up to the peak value 51p. The peak position of the ECG waveform 50 is easily determined, so the first time interval T1 can be calculated in a short time using this method. As a result, the R wave, which is the target of voltage application, can be detected in advance, and voltage can be applied to the patient in advance.

[0076] The calculation of the first time interval T1 can also use the specific time interval between adjacent R waves other than their peak values. For example, the first time interval T1 can also be calculated by comparing the time before the peak values ​​of adjacent R waves. Although not illustrated, it is also preferred that the first time interval T1 is calculated from the nth R wave of the ECG waveform 50. n The moment when the height of the waveform exceeds the first specified value, up to the (n+1)th R wave. n+1The time interval T1 is the period from the moment when the height of the waveform exceeds the aforementioned first predetermined value. The first predetermined value is set to a value between the waveform height from the start of the R wave (51s) to the peak value (51p) of that R wave. When the baseline height is set to 0% and the maximum peak height is set to 100% in the ECG waveform, the first predetermined value can also be set to a value greater than 10%, 50%, or 90%. By setting the first predetermined value in this way, the first time interval T1 can be calculated at an earlier stage. Furthermore, the first time interval T1 can also be the time interval from the nth R wave of the ECG waveform 50. n From the beginning of 51 seconds to the (n+1)th R wave n+1 The time interval up to the beginning of 51 seconds. Additionally, the nth R wave... n The moment when the height of the waveform exceeds the specified value refers to the moment when it first exceeds that specified value. The same applies in subsequent explanations.

[0077] As another implementation, the first time interval T1 can also start from the nth R wave of the ECG waveform 50. n The moment when the height of the waveform is lower than the second specified value, up to the (n+1)th R wave. n+1 The time interval is the period from the moment when the height of the waveform falls below the second specified value. The second specified value is set to a value between the peak height of the R wave (51p) and the end height (51f) of the waveform. When the baseline height is set to 0% and the maximum peak height is set to 100% in the ECG waveform, the second specified value can also be set to, for example, less than 95%, less than 50%, or less than 20%. By setting the second specified value in this way, the first time interval T1 can also be calculated. Furthermore, the first time interval T1 can also be the time interval from the nth R wave of the ECG waveform 50. n The end of wave 51f to the (n+1)th R wave n+1 The time interval up to the end of 51f. Furthermore, the nth R wave R... n The moment when the waveform height falls below a specified value refers to the moment when it initially falls below that specified value. The same applies in subsequent explanations.

[0078] The second time interval T2 is the nth R wave in the ECG waveform 50. n To the (n+2)th R wave n+2 The time interval up to this point (in seconds). While there are no specific limitations on how the second time interval T2 is set, it can be... Figure 2 As shown, in the first time interval T1, it is from the nth R wave of the ECG waveform 50 n The peak value of 51p to the (n+1)th R wave n+1 In the case of a time interval up to the peak value 51p, the second time interval T2 is preferably from the nth R wave of the ECG waveform 50. nThe peak value of 51p to the (n+2)th R wave n+2 The time interval up to the peak value 51p. Since the peak position of the ECG waveform 50 is easy to determine, the second time interval T2 can be calculated in a short time using the above method, similar to the first time interval T1.

[0079] Similar to the first time interval T1, the second time interval T2 can also be a specific interval between times other than the peak. Although not illustrated, for example, in the first time interval T1, it is from the nth R wave of the ECG waveform 50. n The time from when the height of the waveform exceeds the first specified value to the (n+1)th R wave n+1 In the case where the time interval up to the moment when the height of the waveform exceeds the first specified value mentioned above, it is also preferable that the second time interval T2 starts from the nth R wave of the ECG waveform 50. n The moment when the height of the waveform exceeds the first specified value mentioned above, up to the (n+2)th R wave. n+2 The time interval up to the moment when the height of the waveform exceeds the first predetermined value. By setting the first predetermined value in this way, the second time interval T2 can be calculated at an earlier stage.

[0080] As another implementation, in the first time interval T1, the nth R wave of the electrocardiogram waveform 50 is... n The moment when the height of the waveform is lower than the second specified value, up to the (n+1)th R wave. n+1 If the time interval up to the moment when the height of the waveform is lower than the second specified value mentioned above, the second time interval T2 can also be from the nth R wave of the ECG waveform 50. n The moment when the height of the waveform is lower than the second specified value mentioned above, up to the (n+2)th R wave. n+2 The time interval up to the moment when the height of the waveform falls below the second specified value. By setting the second specified value in this way, the second time interval T2 can also be calculated.

[0081] The first time interval T1 is from the nth R wave of the ECG waveform 50. n From the beginning of 51 seconds to the (n+1)th R wave n+1 In the case of a time interval up to the beginning of 51 seconds, the second time interval T2 can also start from the nth R wave of the ECG waveform at 50 seconds. n From the beginning of 51 seconds to the (n+2)th R wave n+2 The time interval from the start of the first 51 seconds to the start of the second time interval. Additionally, in the first time interval T1, the nth R wave of the ECG waveform 50 is... n The end of wave 51f to the (n+1)th R wave n+1 In the case of the time interval ending at 51f, the second time interval T2 can also start from the nth R wave of the ECG waveform 50.n The end of wave 51f to the (n+2)th R wave n+2 The time interval up to the end of 51f.

[0082] The first time interval T1 and the second time interval T2 can be calculated by the arithmetic processing control unit 8, which will be described later.

[0083] The first specified time can be set according to the patient, for example, preferably more than 100 milliseconds, more preferably more than 150 milliseconds, and even more preferably more than 200 milliseconds. In addition, the first specified time is preferably less than 300 milliseconds, more preferably less than 290 milliseconds, and even more preferably less than 280 milliseconds.

[0084] The second specified time is the same as the first specified time and can be set according to the patient. For example, it is preferably 100 milliseconds or more, more preferably 150 milliseconds or more, and even more preferably 200 milliseconds or more. In addition, the second specified time is preferably 300 milliseconds or less, more preferably 290 milliseconds or less, and even more preferably 280 milliseconds or less.

[0085] The first and second predetermined times are preferably 100 milliseconds or more, more preferably 150 milliseconds or more, and even more preferably 200 milliseconds or more. Furthermore, the first and second predetermined times are preferably 300 milliseconds or less, more preferably 290 milliseconds or less, and even more preferably 280 milliseconds or less. By setting the first and second predetermined times in this way, it is easier to select the R-wave that is the target for voltage application from the detected R-waves.

[0086] At least one of the first and second predetermined times can also be set based on the average time interval of adjacent R waves detected during the fifth predetermined time period before the nth R wave. The fifth predetermined time (in milliseconds) can, for example, be set to a time period containing three to ten ECG waveforms. This allows the first and second predetermined times to be set according to the characteristics of the patient's ECG waveform. This is particularly effective for patients with narrowed intervals between R waves.

[0087] Preferably, the first and second predetermined times are the same. This makes it easier to select the R-wave to which the voltage is applied from the detected R-waves, even when the interval between the R-waves becomes narrower. Alternatively, the first and second predetermined times can be different.

[0088] Preferably, the first and second predetermined times are stored in the memory described later. Furthermore, they do not need to be stored in the same memory; they can be stored in different memories. Additionally, in the defibrillation electrical device 2 of the first embodiment, the first and second predetermined times are stored in memory 5.

[0089] In requirement 1, the permission signal can be generated from the permission signal generation unit 7 as long as the first time interval T1 exceeds the first predetermined time. For example, it is preferable to generate the permission signal within 60 milliseconds from the time the first time interval T1 exceeds the first predetermined time, more preferably within 50 milliseconds, and even more preferably within 10 milliseconds. It is also preferable to generate the permission signal when the first time interval T1 exceeds the first predetermined time.

[0090] In requirement 2, the permission signal can be generated from the permission signal generation unit 7 as long as the second time interval T2 exceeds the second predetermined time. For example, it is preferable to generate the permission signal within 60 milliseconds from the time the second time interval T2 exceeds the second predetermined time, more preferably within 50 milliseconds, and even more preferably within 10 milliseconds. It is also preferable to generate the permission signal when the second time interval T2 exceeds the second predetermined time.

[0091] Preferably, control is performed so that when the second time interval T2 is less than or equal to the second predetermined time, no license signal is generated from the license signal generation unit 7. Alternatively, when the second time interval T2 is less than or equal to the second predetermined time, the (n+2)th R wave can also be... n+2 Reidentified as the nth R wave n Determine whether the first time interval T1 exceeds the first predetermined time. Alternatively, if the second time interval T2 is less than the second predetermined time, it can also be done as follows: Figure 3 As shown, it will continue with the (n+2)th R wave. n+2 The detected R wave was re-identified as the nth R wave. n It is determined whether the first time interval T1 exceeds the first predetermined time. By repeatedly determining whether the R-wave detected in this way meets the predetermined time specified in requirement 1 or requirement 2, the R-wave that is the object of voltage application can be selected and the voltage can be applied appropriately.

[0092] The permission signal is not particularly limited as long as it relates to the application of voltage for defibrillation. Examples include permission signals for charging the power supply unit 9 (described later), permission signals for generating pulse voltages, permission signals for applying voltage, and permission signals for turning on the switch of the switching unit 10 (described later). In either requirement 1 or requirement 2, the permission signal generating unit 7 only needs to generate at least one of the above permission signals. Alternatively, a portion of the above permission signals can be generated through operation of the operation unit 6 (described later). Furthermore, the permission signal generating unit 7 is not limited to the arithmetic processing control unit 8 (described later) and can also be provided in the power supply unit 9, etc.

[0093] Figure 2The electrocardiogram (ECG) waveform 50 shown is displayed, for example, on the display unit of the electrocardiograph 40. Preferably, the ECG waveform 50 is obtained through a second-order induction that facilitates the detection of the R wave. However, the ECG waveform 50 is not limited to the second-order induction; it can also be obtained through other inductions depending on the orientation of the patient's heart. For example, in the case where the ECG waveform 50 is obtained through 12 inductions, the ECG waveform 50 can also be obtained through V1 induction, V2 induction, V3 induction, V4 induction, V5 induction, V6 induction, the first induction, the second induction, the third induction, aVR induction, aVL induction, or aVF induction. Furthermore, the ECG waveform 50 can be an average waveform of two or more inductions, an average waveform of three or more inductions, or an average waveform of 12 inductions.

[0094] Preferably, the defibrillation electrical device 2 also includes a power supply unit 9 that generates an applied voltage. In either condition 1 or condition 2, control is performed after condition 3 is met so that a permission signal is generated from the permission signal generation unit 7.

[0095] (Requirement 3)

[0096] The charging process ends when the required voltage is applied to the power supply unit 9.

[0097] The power supply unit 9 is a component that generates the applied voltage for defibrillation, and as described later, it preferably includes a capacitor for charging the applied voltage. For example, it can be controlled so that charging of the capacitor can be started by operating the operation unit 6, which will be described later. After the charging of the voltage required for applying the voltage in the power supply unit 9 is completed, the defibrillation electrical device 2 generates a permission signal, thereby preventing defibrillation from occurring in a state of insufficient charging.

[0098] Furthermore, the power supply unit 9 preferably includes at least one of a power supply, a boost circuit for boosting DC voltage, a charging circuit, and a waveform generation circuit for generating pulse voltage. Additionally, at least some of the above-mentioned components may be located outside the power supply unit 9. The location of the power supply unit 9 is not particularly limited; for example, it may be located as follows: Figure 1 It can be installed outside the arithmetic processing control unit 8, or it can be installed inside the arithmetic processing control unit 8. When the power supply unit 9 is installed outside the arithmetic processing control unit 8, it is preferable that the power supply unit 9 is connected to the arithmetic processing control unit 8.

[0099] It can be determined whether the above requirement 3 is met, and then whether the first time interval T1 exceeds the first predetermined time. Alternatively, it can be determined whether the first time interval T1 exceeds the first predetermined time, and then whether the above requirement 3 is met. In addition, it can also be determined whether the above requirement 3 is met after determining whether the first time interval T1 exceeds the first predetermined time, or after determining whether the second time interval T2 exceeds the second predetermined time.

[0100] Preferably, the defibrillator electrical device 2 is provided with an operation unit 6 for charging the capacitor. The operation unit 6 can be a known input mechanism such as a push-button switch or a control lever. Operation of the operation unit 6 can also generate a portion of the aforementioned permission signals.

[0101] Preferably, the operation unit 6 is connected to the power supply unit 9. Therefore, input signals from the operation unit 6 are transmitted to the power supply unit 9. Alternatively, the operation unit 6 may be connected to the arithmetic processing control unit 8, which will be described later. Therefore, input signals from the operation unit 6 are transmitted to the power supply unit 9 via the arithmetic processing control unit 8.

[0102] Preferably, the defibrillation electrical device 2 is controlled after the following condition 4 is met, in accordance with condition 1 or condition 2, so as to generate an authorization signal from the authorization signal generation unit 7.

[0103] (Requirement 4)

[0104] The voltage for defibrillation is not applied to the preceding R wave that becomes the object for which a defibrillation permit signal is generated.

[0105] Therefore, it is possible to suppress continuous R waves selected as targets for voltage application and to continuously apply voltage for defibrillation, thus improving safety.

[0106] The aforementioned defibrillation electrical device 2 may also include a memory 5 for storing whether or not a voltage is applied to the R-wave for defibrillation. Known memory types can be used as the memory 5, such as volatile memory like random access memory or non-volatile memory like flash memory. Preferably, the memory 5 is connected to a permission signal generation unit 7. This allows a signal indicating whether or not a voltage is applied to any R-wave for defibrillation to be transmitted from the permission signal generation unit 7 to the memory 5. Figure 1 In this configuration, the memory 5 is located outside the arithmetic processing control unit 8 and is connected to the arithmetic processing control unit 8. Although not shown in the figure, the memory 5 may also be located inside the arithmetic processing control unit 8.

[0107] Alternatively, it can be determined whether the above requirement 4 is met, and then whether the first time interval T1 exceeds the first predetermined time. Alternatively, it can be determined whether the first time interval T1 exceeds the first predetermined time, and then whether the above requirement 4 is met. Furthermore, it can be determined whether the above requirement 4 is met after determining whether the first time interval T1 exceeds the first predetermined time, or after determining whether the second time interval T2 exceeds the second predetermined time.

[0108] The aforementioned defibrillation electrical device 2 can also be controlled so that no voltage is applied to an R-wave detected after a voltage has been applied according to requirement 1 or requirement 2. This suppresses the application of voltage to continuous R-waves, thus improving the safety of the device.

[0109] Alternatively, the operator can confirm whether any waveform in the ECG waveform 50 conforms to the structure of an R-wave that can be the target of voltage application. For example, it is preferable to control the generation of an R-wave for the (n+1)th R-wave after the first time interval T1 exceeds the first predetermined time. n+1 The marker display signal is assigned to the marker and controlled so that, after the second time interval T2 exceeds the second predetermined time, a signal for the (n+2)th R wave is generated. n+2 The marker is assigned a display signal.

[0110] Preferably, the control is configured such that a marker display signal is generated after the first time interval T1 exceeds a first predetermined time and before a permission signal for defibrillation is generated. Additionally, the control is preferably configured such that the marker display signal is generated after the second time interval T2 exceeds a second predetermined time and before a permission signal for defibrillation is generated.

[0111] The markings assigned to the R wave can also be displayed on the display unit that displays the electrocardiogram waveform. For details regarding the display unit and markings, please refer to the description of the display unit 73 in the second embodiment, which will be described later.

[0112] By employing the methods described above, such as using markers assigned to the R waves as indicators and visually confirming the RR interval to assess the heart's condition, the non-permitted mode for defibrillation can be switched to permitted mode. This facilitates defibrillation and improves safety.

[0113] Preferred defibrillation electrical device 2 is an intracardiac defibrillation electrical device. Compared with external defibrillators, intracardiac defibrillation electrical devices can use low-energy voltage waveforms, thus reducing the burden on patients and enabling their use in catheterization and cauterization procedures for arrhythmias.

[0114] The above mainly describes the structure related to the generation of the permission signal for the defibrillation electrical device 2. The following refers to... Figure 1 as well as Figure 4 The structure of the defibrillation electrical device 2 and the defibrillation catheter system 1 including the first embodiment is described in detail. Figure 4 This is a block diagram of a defibrillation catheter system 1 that includes the defibrillation electrical device 2 according to an embodiment of the present invention.

[0115] like Figure 4As shown, the present invention includes an intracardiac defibrillation catheter system 1, which comprises: a catheter 20 inserted into a cardiac chamber, having a distal end and a proximal end, and having a plurality of electrodes disposed in the distal portion; and the aforementioned defibrillation electrical device 2 for applying voltage to the plurality of electrodes.

[0116] Here, the proximal side of the catheter refers to the side of the operator's hand relative to the direction of the catheter's extension, and the distal side refers to the opposite direction of the proximal side (i.e., the direction of the treatment object). Additionally, the proximal portion of the catheter refers to half of the side of the operator's hand relative to the direction of the catheter's extension, and the distal portion of the catheter refers to the portion other than the proximal portion (i.e., the half of the catheter on the treatment object side).

[0117] exist Figure 1 as well as Figure 4 In the defibrillation catheter system 1, electrocardiographic information obtained from a surface electrode 19 disposed on the body surface is transmitted to an electrocardiograph 40 via a first lead 31. The electrode for obtaining electrocardiographic information is not limited to a surface electrode; it can also be an electrode for measuring intracardiac potentials. However, surface electrodes are preferred due to their excellent sensitivity to R-wave detection. A 12-sensor electrode is preferred as the surface electrode.

[0118] Figure 1 as well as Figure 4 The defibrillation electrical device 2 includes: a first connection portion 11 connected to a plurality of electrodes disposed at the distal portion of a catheter 20; a second connection portion 12 connected to an electrocardiograph 40; a power supply portion 9 for generating an applied voltage; and a switching portion 10 connected to the power supply portion 9 for switching to an applied voltage mode. Furthermore, the first connection portion 11 is connected to the power supply portion 9 via the switching portion 10, and the first connection portion 11 is connected to the second connection portion 12 without going through the switching portion 10. Because the first connection portion 11 is connected to the second connection portion 12 without going through the switching portion 10, the local potential of each electrode can be measured even during defibrillation.

[0119] Furthermore, the defibrillation electrical device 2 includes an electrocardiogram waveform input unit 3, through which information of the electrocardiogram waveform output from the electrocardiograph 40 is input to the internal device via the second lead wire 32 and the like.

[0120] The electrocardiogram (ECG) waveform input from the ECG waveform input unit 3 can also be transmitted to the arithmetic processing control unit 8. The arithmetic processing control unit 8 can determine whether the first time interval T1 exceeds a first predetermined time and whether the second time interval T2 exceeds a second predetermined time from the transmitted ECG waveform 50. A permission signal generation unit 7 is provided within the arithmetic processing control unit 8. The permission signal generation unit 7 can generate a permission signal for the (n+1)th R wave after the first time interval T1 exceeds the first predetermined time. n+1A permit signal for voltage application is generated. Furthermore, the permit signal generation unit 7 can, when the first time interval T1 is less than the first predetermined time, and after the second time interval T2 exceeds the second predetermined time, generate a permit signal for the (n+2)th R wave. n+2 A permit signal for voltage application is generated. This permit signal is transmitted to the power supply unit 9, enabling the application of DC voltages of different polarities to the first electrode group 21 and the second electrode group 22. The energizing waveform can be two phases with polarity reversal midway, or it can be a single phase with constant polarity, but since two phases can provide stimulation with less energy, two phases are preferred. The energizing energy applied to the organism can be set, for example, to between 1J and 30J.

[0121] The defibrillation electrical device 2 may also have a display section (not shown) for displaying electrocardiogram waveforms, and may also display markings for the R wave in the display section. For details regarding the display section and markings, please refer to the description of the display section 73 in the second embodiment.

[0122] It can also be controlled so that, in at least one of requirements 1 and 2, the permission signal generating unit 7 generates a permission signal for switch activation. This permission signal is transmitted to the first switch 10A and the second switch 10B of the switching unit 10, enabling the first switch 10A and the second switch 10B to change from an off state to an on state, thereby energizing the first electrode group 21 and the second electrode group 22. Additionally, as... Figure 4 As shown, when the switch constituting the switching unit 10 is in the off state, since the first electrode group 21 and the second electrode group 22 are insulated from the power supply unit 9, the first electrode group 21 and the second electrode group 22 can be used to measure the intracardiac potential without defibrillation.

[0123] The defibrillation electrical device 2 possesses at least one function, such as the ECG waveform input unit 3, memory 5, permission signal generation unit 7, arithmetic processing and control unit 8, power supply unit 9, and switching unit 10, which can be implemented in hardware or software. Examples of hardware include logic circuits formed on integrated circuits such as LSI (Large Scale Integration), ASIC (Application Specific Integrated Circuit), and FPGA (Field-Programmable Gate Array).

[0124] The defibrillation electrical device 2 may also include a computer that executes commands for a program that performs the functions of at least one of the following: ECG waveform input unit 3, memory 5, permission signal generation unit 7, arithmetic processing and control unit 8, power supply unit 9, and switching unit 10. Preferably, the computer includes a processor and a computer-readable recording medium storing the aforementioned program. The processor performs the aforementioned functions by executing the program stored on the computer-readable recording medium. A CPU (Central Processing Unit) can be used as the processor. A ROM (Read Only Memory) or similar medium can be used as the recording medium. Alternatively, the recording medium may include RAM (Random Access Memory). The aforementioned program can also be supplied to the computer via any transmission medium capable of transmitting the program. Examples of transmission media include communication networks and communication lines.

[0125] The switching unit 10 may also have one or more switches. For example... Figure 4 As shown, the preferred switching unit 10 has a plurality of first switches 10A connected in parallel and a plurality of second switches 10B connected in parallel. When the catheter 20 has a first electrode group 21 and a second electrode group 22, it is preferable that the first electrode group 21 is connected to the power supply unit 9 via the first switches 10A, and the second electrode group 22 is connected to the power supply unit 9 via the second switches 10B. That is, it is preferable that the first electrode group 21 and the second electrode group 22 are connected to the power supply unit 9 via different switches. This allows for electrical isolation of each electrode group, enabling independent acquisition of intracardiac potentials through each electrode group.

[0126] like Figure 1 As shown, the defibrillator 2 may also have a third electrode group 23, which is closer to the position than the first electrode group 21 and the second electrode group 22, and is a dedicated electrode for measuring intracardiac potentials. Since the third electrode group 23 is located proximally, it can be positioned, for example, at a position corresponding to the superior aorta. Preferably, the third electrode group 23 is not connected to the power supply unit 9. Thus, the third electrode group 23 can be easily used as a dedicated electrode for measuring intracardiac potentials.

[0127] The number of electrodes constituting each electrode group is not particularly limited; each electrode group can be the same or different. Preferably, the number of electrodes constituting the first electrode group 21 is the same as the number of electrodes constituting the second electrode group 22. This makes it easy to ensure that the surface areas of the first electrode group 21 and the second electrode group 22 are the same. With each first electrode group 21 and each second electrode group 22 having the same surface area and an equal number of electrodes, efficient defibrillation can be performed, and the accuracy of intracardiac electrocardiogram (ECG) measurements can be improved.

[0128] Preferably, the number of electrodes constituting the third electrode group 23 is less than or equal to the number of electrodes constituting the first electrode group 21 and the number of electrodes constituting the second electrode group 22. For example, the number of electrodes in the first electrode group 21 and the second electrode group 22 can each be set to eight, and the number of electrodes in the third electrode group 23 can be set to four. By setting the number of electrodes in the third electrode group 23 in this way, the potential at the position corresponding to the superior aorta can be appropriately measured.

[0129] For example, a resin tube 27 can be used as the catheter 20. A first electrode group 21 and a second electrode group 22 can be disposed at the distal portion of the resin tube 27. Preferably, each electrode group is located in more than half of the outer periphery of the resin tube 27, and more preferably, it is formed in a ring shape. By forming the electrodes in this way, the contact area with the heart is increased, thus facilitating the measurement of intracardiac potentials and the application of electrical stimulation.

[0130] Each electrode assembly only needs to contain conductive materials such as platinum and stainless steel, but in order to make it easier to determine the position of the electrodes under X-ray fluoroscopy, it is preferable to contain X-ray-impermeable materials such as platinum.

[0131] like Figure 1 As shown, a front contact 25 may also be provided at the distal end of the catheter 20. Preferably, the front contact 25 has a tapered portion whose outer diameter decreases toward the distal side. The front contact 25 may also contain a conductive material. Thus, the front contact 25 can function as an electrode. Alternatively, the front contact 25 may also be made of a polymer material. In order to protect the tissue in the body from contact with the catheter 20, the hardness of the front contact 25 may be lower than that of the resin tube 27.

[0132] An operating line and a spring component for bending the distal side of the catheter 20 may also be provided inside the resin tube 27. Specifically, it is preferable that the distal end of the operating line is fixed to the distal end or the front contact 25 of the resin tube 27, and the proximal end of the operating line is fixed to the handle 26 described later.

[0133] like Figure 4 As shown, each electrode group is preferably connected to a third wire 33 (wire). Preferably, the other end of the third wire 33 connected to the first electrode group 21 and the second electrode group 22 is connected to the first connection portion 11 of the defibrillation electrical device 2. Preferably, the other end of the third wire 33 connected to the third electrode group 23 is connected to the third connection portion 13 of the defibrillation electrical device 2. The third wire 33 may also be multiple wires connected by a connector or other connecting component.

[0134] Preferably, the third connecting portion 13 and the fourth connecting portion 14 are connected via the seventh conductor 37. Here, the seventh conductor 37 can be a wiring material or a part of a wiring pattern disposed on a printed circuit board.

[0135] Preferably, the first connecting part 11 and the switching part 10 are connected via the fifth wire 35. Therefore, since the first electrode group 21 and the second electrode group 22 are connected to the power supply unit 9, voltage can be applied. Alternatively, the first electrode group 21 and the second electrode group 22 can be connected to the power supply unit 9 via different connecting components such as connectors.

[0136] Preferably, the other end of the fourth lead 34, which is connected to the input terminal of the electrocardiograph 40 corresponding to the first electrode group 21 and the second electrode group 22, is connected to the second connection portion 12. Furthermore, it is preferable that the second connection portion 12 is connected to the fifth lead 35 via the sixth lead 36. It is preferable that no switching portion is provided on the fifth lead 35 and the sixth lead 36. Therefore, even during defibrillation, intracardiac potentials can be measured using the first electrode group 21 and the second electrode group 22. Here, the fifth lead 35 and the sixth lead 36 can be wiring material or part of a wiring pattern provided on a printed circuit board.

[0137] like Figure 1 As shown, a handle 26 for the operator to hold when the catheter 20 is operated may also be provided on the proximal side of the resin tube 27. Although there is no particular limitation on the shape of the handle 26, in order to alleviate the concentration of stress at the connection point between the resin tube 27 and the handle 26, it is preferable to have a frustoconical shape in which the outer diameter decreases toward the distal side.

[0138] The electrocardiogram (ECG) device 40 measures intracardiac potentials using various electrodes. The ECG device 40 can use known components.

[0139] Although not shown, the defibrillator 2 may also have an electrode selection switch for selecting the electrode to which voltage is applied. This allows electrical stimulation to be applied only to specific electrodes. While the location of the electrode selection switch is not particularly limited, it is preferable that the electrode selection switch be connected to the power supply unit 9, and more preferably, that it be located within the arithmetic processing control unit 8. The electrode selection switch may also be separate from the switches constituting the switching unit 10 (e.g., the first switch 10A and the second switch 10B), and at least one of the switches constituting the switching unit 10 may also be an electrode selection switch. Furthermore, although not shown, a safety switch may be provided in the defibrillator 2. This provides a fail-safe function to prevent accidental voltage application to the patient in case of a malfunction in the switching unit 10. The safety switch is preferably connected between the switching unit 10 and the power supply unit 9, and more preferably between the arithmetic processing control unit 8 and the switching unit 10. Moreover, although not shown, the defibrillator 2 may also have a protection circuit to absorb high voltage generated when the switches are turned off. This prevents damage to the switches. Furthermore, although not shown, an overvoltage protection circuit can be provided between the power supply unit 9 and the electrocardiograph 40 in the defibrillator electrical device 2 to protect the electrocardiograph 40 from overvoltage. This prevents the electrocardiograph 40 from being damaged by the application of overvoltage. Also, although not shown, the defibrillator electrical device 2 can also include an impedance measuring circuit. Preferably, the impedance measuring circuit is connected, for example, between the first electrode group 21 and the second electrode group 22, to measure the impedance between the first electrode group 21 and the second electrode group 22.

[0140] Next, refer to Figure 5 The structure of the defibrillation electrical device 70 of the second embodiment will be described in detail. Figure 5 This is a block diagram of the defibrillation electrical device 70 according to the second embodiment. Furthermore, structures identical to those in the defibrillation electrical device 2 of the first embodiment are labeled with the same reference numerals, and descriptions are omitted.

[0141] like Figure 5As shown, the defibrillation electrical device 70 of the preferred second embodiment displays the electrocardiogram (ECG) information input from the ECG waveform input unit 3 on the display unit 73 via an A / D converter 71 and a first arithmetic processing control unit 72 (CPU). Alternatively, the ECG information input from the ECG waveform input unit 3 is preferably transmitted to a comparator (comparison circuit) 74 that compares the waveform height. When the ECG waveform exceeds a set predetermined value, it is transmitted to a second arithmetic processing control unit 75 (FPGA) with a set first predetermined time, a second predetermined time, etc. After the first time interval T1 exceeds the first predetermined time, a signal is transmitted to the second arithmetic processing control unit 75 (FPGA), generating a marker display signal. After the marker display signal is transmitted to the first arithmetic processing control unit 72 (CPU), a marker for the R wave is displayed on the display unit 73. Examples of marker shapes include circles, triangles, quadrilaterals, polygons, and lines. Examples of marker positions include the peak value of the R wave. Furthermore, the marker display signal can be simply the signal for displaying the marker on the R-wave in the display unit 73, or it can be generated from the first arithmetic processing control unit 72 (CPU).

[0142] As described above, the defibrillation electrical device 70 preferably includes a display unit 73 for displaying electrocardiogram waveforms. Preferably, in this case, control is performed so that after the first time interval T1 exceeds a first predetermined time, or after the first time interval T1 is less than the first predetermined time and the second time interval T2 exceeds a second predetermined time, a marker display signal for marking the R wave is generated in the display unit 73 from the marker display signal generation unit 76. Thus, if the R wave is marked in the display unit 73, the operator can visually observe and confirm the state of the R wave of the object to which the voltage is applied.

[0143] Furthermore, the preferred defibrillation electrical device 70 can be switched from a non-permitted mode to a permitted mode within the second arithmetic processing control unit 75 (FPGA) by operating the operation unit 6. Moreover, the applied energy can be set, the charging of the capacitor can begin, and the charging can be completed simultaneously with switching modes. Furthermore, a pulse voltage can be automatically generated after charging is completed. The non-permitted mode is a mode in which a defibrillation-related permit signal is not generated even if the time interval between R-waves meets the specified time as described in requirement 1 or requirement 2. The permitted mode is a mode in which a defibrillation-related permit signal is generated if the time interval between R-waves meets the specified time as described in requirement 1 or requirement 2. Therefore, the operator can switch to the non-permitted mode when defibrillation energy is unsuitable and switch to the permitted mode after defibrillation energy is required, thus enabling safer defibrillation. For information on the defibrillation-related permit signal, please refer to the description of the first embodiment.

[0144] Furthermore, the preferred defibrillation electrical device 70 is configured to transmit the electrocardiogram information input from the electrocardiogram waveform input unit 3 to a comparator (comparison circuit) 74 that compares the height of the waveform. When the electrocardiogram waveform exceeds a set predetermined value, the signal is transmitted to a second arithmetic processing control unit 75 (FPGA) that has a first predetermined time and a second predetermined time set. When the first time interval T1 exceeds the first predetermined time, or when the first time interval T1 is less than or equal to the first predetermined time and the second time interval T2 exceeds the second predetermined time, a permission signal is generated from the second arithmetic processing control unit 75 (FPGA).

[0145] Ideally, the circuit from the ECG waveform input unit 3 to the permission signal generation unit 7 should be constructed using hardware circuitry. Since this hardware circuitry is not a software-processed circuit, signal processing is faster. As a result, the time from acquiring ECG information to generating the permission signal can be shortened. Furthermore, the signal from the ECG waveform input unit 3 to the permission signal generation unit 7 can be either an analog signal or a digital signal.

[0146] Furthermore, at least one of the functions of the defibrillation electrical device 70, such as the ECG waveform input unit 3, comparator (comparison circuit) 74, permission signal generation unit 7, first arithmetic processing control unit 72, second arithmetic processing control unit 75, arithmetic processing control unit 8, power supply unit 9, and switching unit 10, can be implemented in hardware or software. For details, please refer to the description in the first embodiment.

[0147] The present invention also includes a method for generating a defibrillation signal. For example, such as Figure 2 As shown, a method for generating a defibrillation signal according to an embodiment of the present invention includes the following steps: calculating the nth R wave R from the electrocardiogram waveform. n Up to the (n+1)th R wave n+1 The time interval up to this point, also known as the first time interval T1, is used to determine whether the first time interval T1 exceeds the first predetermined time; after the first time interval T1 exceeds the first predetermined time, it is compared with the (n+1)th R wave R. n+1 A permit signal is generated synchronously, and when the first time interval T1 is less than the first predetermined time, the calculation is performed from the nth R wave R. n To the (n+2)th R wave n+2 The time interval up to that point is also known as the second time interval T2. It is determined whether the second time interval exceeds the second predetermined time. After the second time interval T2 exceeds the second predetermined time, it is compared with the (n+2)th R wave R... n+2 The steps for synchronously generating permit signals. The nth, (n+1)th, and (n+2)th R-waves are detected in this order, where n is an integer greater than or equal to 1.

[0148] The preferred method for generating the defibrillation signal may further include, for example, a step of determining whether the following requirement 3 is met.

[0149] (Requirement 3)

[0150] The charging process ends when the required voltage is applied in the power supply section 9.

[0151] The preferred method for generating the defibrillation signal may further include, for example, a step of determining whether the following requirement 4 is met.

[0152] (Requirement 4)

[0153] The voltage for defibrillation is not applied to the preceding R wave of the object that is being given a signal for defibrillation.

[0154] The above steps can be performed, for example, by using the arithmetic processing control unit, memory, comparator, power supply, etc. of the defibrillation electrical device 2 and the defibrillation electrical device 70. For details, please refer to the descriptions of the components of the defibrillation electrical device 2 and the defibrillation electrical device 70.

[0155] The above-described method for generating defibrillation signals does not require the steps to be performed within a single defibrillation electrical device; they can be performed separately in different devices.

[0156] This application claims the benefit based on priority of Japanese Patent Application No. 2020-099558, filed on June 8, 2020. The entire contents of the description of Japanese Patent Application No. 2020-099558, filed on June 8, 2020, are incorporated herein by reference.

[0157] Explanation of reference numerals in the attached figures

[0158] 1: Defibrillation catheter system

[0159] 2: Electrical defibrillation devices

[0160] 3: ECG waveform input unit

[0161] 5: Memory

[0162] 6: Operations Department

[0163] 7: Permission signal generation unit

[0164] 8: Computation and Processing Control Unit

[0165] 9: Power Supply Section

[0166] 10: Switching Unit

[0167] 10A: First switch

[0168] 10B: Second switch

[0169] 11: First connecting part

[0170] 12: Second connecting part

[0171] 13: Third connecting part

[0172] 14: Fourth connecting part

[0173] 19: Surface electrodes

[0174] 20: Catheter

[0175] 21: First electrode group

[0176] 22: Second electrode group

[0177] 23: Third electrode group

[0178] 25: Front contact

[0179] 26: Handle

[0180] 27: Resin tube

[0181] 31: First conductor

[0182] 32: Second conductor

[0183] 33: Third conductor

[0184] 34: Fourth conductor

[0185] 35: Fifth conductor

[0186] 36: Sixth conductor

[0187] 37: Seventh conductor

[0188] 40: Electrocardiogram (ECG)

[0189] 50: Electrocardiogram waveform

[0190] R n The nth R wave

[0191] R n+1 The (n+1)th R wave

[0192] R n+2 The (n+2)th R wave

[0193] 51f: End of R wave

[0194] 51p: Peak value of the R wave

[0195] 51s: The start of the R wave

[0196] 70: Electrical defibrillation devices

[0197] 71: A / D Converter

[0198] 72: First Computation Processing Control Unit

[0199] 73: Display Section

[0200] 74: Comparator (Comparison Circuit)

[0201] 75: Second Operation Processing Control Unit

[0202] 76: Marker indicates signal generation unit

[0203] T1: First time interval

[0204] T2: Second time interval.

Claims

1. An electrical device for defibrillation, characterized in that, have: ECG waveform input unit; and The permission signal generation unit generates a permission signal that permits the application of a voltage for defibrillation. The defibrillation electrical device satisfies the following control method. Among them, the nth, (n+1)th, and (n+2)th R-waves are detected in this order, where n is an integer greater than or equal to 1. Step 1: Calculate the time interval from the nth R wave to the (n+1)th R wave in the ECG waveform, i.e., the first time interval, and determine whether the above first time interval exceeds the first predetermined time. Step 2: Perform control so that, if the first time interval exceeds the first predetermined time, after the first time interval exceeds the first predetermined time, a permission signal is generated from the permission signal generation unit for the (n+1)th R wave. Step 3: When the first time interval is less than the first predetermined time, calculate the time interval from the nth R wave to the (n+2)th R wave of the ECG waveform, i.e., the second time interval, and determine whether the second time interval exceeds the second predetermined time. Step 4: Perform control so that if the second time interval exceeds the second predetermined time, after the second time interval exceeds the second predetermined time, a permission signal is generated from the permission signal generation unit for the (n+2)th R wave.

2. The defibrillation electrical device according to claim 1, wherein, It also has a power supply section for generating the applied voltage. Control is performed so that, in the above control method, after further satisfying the following requirement 3, a permission signal is generated from the above permission signal generation unit. Requirement 3: The charging process is complete when the required voltage is applied to the power supply unit as described above.

3. The defibrillation electrical device according to claim 1 or 2, wherein, Control is performed so that, in the above control method, after further satisfying condition 4 below, a permission signal is generated from the above permission signal generation unit. Requirement 4: Do not apply a voltage for defibrillation to the preceding R wave of the object that is being issued a signal for defibrillation.

4. The defibrillation electrical device according to claim 1 or 2, wherein, The first specified time and the second specified time mentioned above are respectively between 100 milliseconds and 300 milliseconds.

5. The defibrillation electrical device according to claim 1 or 2, wherein, The first stipulated time is the same as the second stipulated time.

6. The defibrillation electrical device according to claim 1 or 2, wherein, The first time interval mentioned above is the time interval from the peak value of the nth R wave to the peak value of the (n+1)th R wave in the electrocardiogram waveform. The second time interval mentioned above is the time interval from the peak value of the nth R wave of the electrocardiogram waveform to the peak value of the (n+2)th R wave.

7. The defibrillation electrical device according to claim 1 or 2, wherein, The aforementioned first time interval is the time interval from the moment when the height of the nth R wave in the electrocardiogram exceeds a first predetermined value to the moment when the height of the (n+1)th R wave exceeds the aforementioned first predetermined value. The aforementioned second time interval is the time interval from the moment when the height of the nth R wave in the electrocardiogram exceeds the aforementioned first predetermined value to the moment when the height of the (n+2)th R wave exceeds the aforementioned first predetermined value. The first specified value is set as a value between the height of the waveform from the beginning of the R-wave to its peak value.

8. The defibrillation electrical device according to claim 1 or 2, wherein, The aforementioned first time interval is the time interval from the moment when the height of the nth R wave in the electrocardiogram waveform falls below the second predetermined value to the moment when the height of the (n+1)th R wave falls below the aforementioned second predetermined value. The aforementioned second time interval is the time interval from the moment when the height of the nth R wave in the electrocardiogram waveform falls below the aforementioned second specified value to the moment when the height of the (n+2)th R wave falls below the aforementioned second specified value. The second specified value is set as a value between the height of the waveform from the peak of the R wave to its end.

9. The defibrillation electrical device according to claim 1 or 2, wherein, Control is performed so that, after the aforementioned first time interval exceeds the aforementioned first predetermined time, a mark display signal assigning a mark to the (n+1)th R wave is generated. Control is performed so that after the second time interval exceeds the second predetermined time, a mark display signal is generated to mark the (n+2)th R wave.

10. The defibrillation electrical device according to claim 1 or 2, wherein, It is an electrical device used for intracardiac defibrillation.

11. An intracardiac defibrillation catheter system, comprising: A catheter, inserted into a heart chamber, has a distal end and a proximal end, and multiple electrodes are disposed at the distal end of the catheter; and The defibrillation electrical device according to claim 1 or 2 that applies voltage to the plurality of electrodes.