Defibrillation electrical device and method of generating a defibrillation signal

Abstract

This invention relates to an electrical device for defibrillation and a method for generating a defibrillation signal. The electrical device for defibrillation is controlled to generate a defibrillation signal from the nth R-wave (E) event inferred as an electrocardiogram waveform (50). n From the event inferred to be the (n+1)th R wave (E) n+1 The time interval up to the n+1th R wave (E) is the first time interval (T1) that exceeds the first predetermined time, and the time interval from the event (E) that is inferred to be the (n+1)th R wave is... n+1 When the rise time from the height of the waveform exceeding the first predetermined value (C1) to reaching the second predetermined value (C2) is less than the third predetermined time, the event (E) inferred to be the (n+1)th R wave is generated by the permit signal generation unit. n+1 A permit signal is generated when the first time interval (T1) is less than the first predetermined time, or when the event is inferred to be the (n+1)th R wave (E). n+1 When the rise time of the R wave exceeds the third specified time, the event (E) from the nth R wave of the inferred ECG waveform (50) is considered. n The event that is inferred to be the (n+2)th R wave (E) n+2 The time interval up to the second time interval (T2) exceeds the second specified time, and the event (E) that is inferred to be the (n+2)th R wave... n+2 When the rise time of the waveform from the height of the first predetermined value (C1) to the second predetermined value (C2) is less than or equal to the third predetermined time, the event (E) inferred to be the (n+2)th R wave is generated by the permit signal generation unit. n+2 Generate a permission signal.

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. The power supply device comprises: a DC power supply unit, an external switch including an energy application preparation switch and an energy application execution switch, and an arithmetic processing unit for controlling the DC power supply unit. During defibrillation, voltages of different polarities are applied from the DC power supply unit via the output circuit of the arithmetic processing unit and the catheter connection connector to the first and second electrode groups of the defibrillation catheter. The arithmetic processing unit of the power supply unit sequentially senses and detects events inferred as R waves from the electrocardiogram input from the electrocardiograph via the electrocardiogram input connector. The arithmetic processing controls the DC power supply unit so that after the input of the execution switch is applied, the sensed and detected events (V... n The polarity of ) is at least related to the previous event detected by the sensor (V). n-1 The polarity of ) and the events detected by its first two sensors (V n-2 The polarity of the signal is consistent, and when an abnormal waveform height event occurs between the input application preparation switch and the input application execution switch, the sensor detects the event (V) only after a constant standby time has elapsed since the occurrence of the abnormal waveform height event. n In the case of ), with the event (V) n Voltage is applied simultaneously to the first electrode group and the second electrode group.

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

[0006] However, in the intracardiac defibrillation catheter system described in Patent Document 1, there is a possibility that waveforms exceeding the trigger level, such as those appearing higher due to increased T waves or drift (baseline rise), which are not R waves, may be mistakenly detected as R waves. Furthermore, the intracardiac defibrillation catheter system described in Patent Document 1 requires confirmation of three consecutive events, and R wave detection takes time, often from the occurrence of atrial fibrillation to the application of voltage. Moreover, the intracardiac defibrillation catheter system described in Patent Document 1 cannot apply defibrillation voltage to patients with narrow intervals between R waves. Therefore, in recent years, there has been a desire to develop defibrillation devices with a new mechanism for generating licensed signals. Summary of the Invention

[0007] The present invention was made in view of the above circumstances, and its object 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 events inferred to be the nth, (n+1th), and (n+2th)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 event inferred to be the nth R wave of the electrocardiogram waveform to the event inferred to be the (n+1)th R wave (i.e., the first time interval) exceeds a first predetermined time, and the rise time from the height of the waveform inferred to be the (n+1)th R wave exceeding a first predetermined value to reaching a second predetermined value is less than a third predetermined time, the permission signal generation unit generates a permission signal for the event inferred to be the (n+1)th R wave.

[0016] (Requirement 2)

[0017] When the first time interval is less than the first predetermined time or the rise time of the event inferred to be the (n+1)th R wave exceeds the third predetermined time, the control is performed such that the second time interval (i.e., the time interval from the event inferred to be the nth R wave of the electrocardiogram to the event inferred to be the (n+2)th R wave exceeds the second predetermined time, and the rise time from the height of the waveform of the event inferred to be the (n+2)th R wave exceeding the first predetermined value to reaching the second predetermined value is less than the third predetermined time, the control is performed in such a way that the permission signal generation unit generates a permission signal for the event inferred to be the (n+2)th R wave.

[0018] In the aforementioned defibrillation electrical device, a permission signal is generated when the interval between events inferred to be R waves exceeds a constant time. Typically, the interval between an R wave and a subsequent T wave in an electrocardiogram waveform is shorter than the interval between the next R wave. Therefore, it is possible to suppress the misdetection of elevated T waves or drifting upward phases as R waves according to condition 1, and to detect R waves that can be applied as voltage using a minimum of two of the aforementioned events. Thus, the detection time for R waves can be shortened compared to conventional methods. Furthermore, even when condition 1 is not met, for example, even when the interval between R waves narrows, R waves can still be determined based on events inferred to be R waves according to condition 2.

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

[10] .

[0020] [2] According to the defibrillation electrical device described in [1], wherein,

[0021] The first specified time and the second specified time mentioned above are respectively between 100 milliseconds and 300 milliseconds.

[0022] [3] The defibrillation electrical device according to [1] or [2], wherein,

[0023] The first stipulated time is the same as the second stipulated time.

[0024] [4] The defibrillation electrical device according to any one of [1] to [3], wherein,

[0025] The third specified time is between 10 milliseconds and 50 milliseconds.

[0026] [5] The defibrillation electrical device according to any one of [1] to [4], wherein,

[0027] The aforementioned first time interval is the time interval from the peak value of the event inferred as the nth R wave of the electrocardiogram waveform to the peak value of the event inferred as the (n+1)th R wave.

[0028] The aforementioned second time interval is the time interval from the peak value of the event that is inferred as the nth R wave of the electrocardiogram waveform to the peak value of the event that is inferred as the (n+2)th R wave.

[0029] [6] The defibrillation electrical device according to any one of [1] to [5], wherein,

[0030] Control is performed so that, after condition 3 below is met, the aforementioned permission signal is generated from the permission signal generation unit.

[0031] (Requirement 3)

[0032] The rise time from the moment the height of the nth R wave of the ECG waveform inferred to be input from the ECG waveform input unit exceeds the first predetermined value until it reaches the second predetermined value is less than the third predetermined time.

[0033] [7] The defibrillation electrical device according to any one of [1] to [6] further comprises:

[0034] The arithmetic processing and control unit calculates the differential value by differentiating the electrocardiogram waveform.

[0035] Control is performed so that, after condition 4 below is met, the aforementioned permission signal is generated from the permission signal generation unit.

[0036] (Requirement 4)

[0037] After exceeding the peak value of the event inferred to be the (n+1)th R wave, and based on the event inferred to be the (n+1)th R wave, the differential value generated by the above-mentioned calculation processing control unit is less than or equal to the third predetermined value; or after exceeding the peak value of the event inferred to be the (n+2)th R wave, and based on the event inferred to be the (n+2)th R wave, the differential value generated by the above-mentioned calculation processing control unit is less than or equal to the third predetermined value.

[0038] [8] The defibrillation electrical device according to any one of [1] to [7], wherein,

[0039] Control is performed so that, after condition 5 below is met, the aforementioned permission signal is generated from the aforementioned permission signal generation unit.

[0040] (Requirement 5)

[0041] After exceeding the peak value of the event that was inferred to be the nth R-wave, and based on the event that was inferred to be the nth R-wave, the differential value generated by the above-mentioned calculation processing control unit is below the third predetermined value.

[0042] [9] The defibrillation electrical device according to any one of [1] to [8], wherein,

[0043] Control is performed so that, after the first time interval exceeds the first predetermined time, and the rise time from the height of the waveform of the event inferred to be the (n+1)th R-wave exceeding the first predetermined value to reaching the second predetermined value is less than the third predetermined time, a mark display signal for marking the event inferred to be the (n+1)th R-wave is generated.

[0044] Control is performed so that when the first time interval is less than the first predetermined time, or when the rise time of the event inferred to be the (n+1)th R wave exceeds the third predetermined time, and after the second time interval exceeds the second predetermined time, and the rise time from the height of the waveform of the event inferred to be the (n+2)th R wave exceeding the first predetermined value to reaching the second predetermined value is less than the third predetermined time, a mark display signal for marking the event inferred to be the (n+2)th R wave is generated.

[0045]

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

[0046] It is an electrical device used for intracardiac defibrillation.

[0047] In addition, the present invention also includes the following

[11] intracardiac defibrillation catheter system.

[0048]

[11] An intracardiac defibrillation catheter system comprising:

[0049] 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

[0050] The defibrillation electrical device described in any one of [1] to

[10] that applies voltage to the aforementioned electrodes.

[0051] Furthermore, the present invention also includes the following

[12] method for generating defibrillation signals.

[0052]

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

[0053] The step of determining whether the time interval from the event inferred to be the nth R wave of the electrocardiogram waveform to the event inferred to be the (n+1)th R wave, i.e., the first time interval, exceeds a first predetermined time.

[0054] The step of determining whether the rise time from when the height of the waveform of the event inferred to be the (n+1)th R wave exceeds a first predetermined value to when it reaches a second predetermined value is less than a third predetermined time;

[0055] After the first time interval exceeds the first predetermined time, and the rise time from the height of the waveform of the event inferred to be the (n+1)th R-wave exceeding the first predetermined value to reaching the second predetermined value is less than the third predetermined time, a permit signal is generated synchronously with the event inferred to be the (n+1)th R-wave.

[0056] When the first time interval is less than the first predetermined time, or when the rise time of the event inferred to be the (n+1)th R-wave exceeds the third predetermined time, the step of determining whether the second time interval, i.e., the time interval from the event inferred to be the nth R-wave to the event inferred to be the (n+2)th R-wave exceeds the second predetermined time, and whether the rise time from the height of the waveform of the event inferred to be the (n+2)th R-wave exceeding the first predetermined value to reaching the second predetermined value is less than the third predetermined time, and after the second time interval exceeds the second predetermined time and the rise time from the height of the waveform of the event inferred to be the (n+2)th R-wave exceeding the first predetermined value to reaching the second predetermined value is less than the third predetermined time, the step of generating a permit signal synchronously with the event inferred to be the (n+2)th R-wave.

[0057] Among them, the events inferred to be the nth, n+1th, and n+2th R-waves 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, it is possible to suppress the misdetection of elevated T waves and drifting rising phases as R waves. By using events inferred to be two R waves in the shortest possible time, R waves that can be applied as voltage can be detected. Therefore, the detection time of R waves can be shortened compared to the past. In addition, for example, even when the interval between R waves is narrowed, R waves can still be detected based on events inferred to be R waves.

[0059] According to the aforementioned defibrillation electrical device and defibrillation signal generation method, it is possible to suppress the misdetection of an elevated T wave or a drifting rising phase as an R wave. By using the shortest possible time to infer two R waves, it is possible to detect R waves that can be applied as voltage. Therefore, the R wave detection time can be shortened compared to the past. Furthermore, even when the interval between R waves is narrowed, R waves can still be detected based on events inferred to be R waves. 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 diagram representing an example of an electrocardiogram (ECG) waveform.

[0064] Figure 5 It means Figure 3 A flowchart illustrating a variation of the method for generating defibrillation signals.

[0065] Figure 6 This is a diagram representing an example of an electrocardiogram (ECG) waveform and a differential waveform that is a collection of differential values ​​of the ECG waveform.

[0066] Figure 7 It means Figure 3 Flowcharts of other variations of the method for generating defibrillation signals shown.

[0067] Figure 8 It means Figure 3 Flowcharts of other variations of the method for generating defibrillation signals shown.

[0068] Figure 9 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.

[0069] Figure 10 This is a block diagram of an electrical device for defibrillation that includes a second embodiment of the present invention. Detailed Implementation

[0070] 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.

[0071] 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.

[0072] (Requirement 1)

[0073] The control is implemented such that when the time interval from the event inferred to be the nth R wave of the electrocardiogram waveform to the event inferred to be the (n+1)th R wave (i.e., the first time interval) exceeds a first predetermined time, and the rise time from the height of the waveform inferred to be the (n+1)th R wave exceeding a first predetermined value to reaching a second predetermined value is less than a third predetermined time, the permission signal generation unit generates a permission signal for the event inferred to be the (n+1)th R wave.

[0074] (Requirement 2)

[0075] When the first time interval is less than the first predetermined time or the rise time of the event inferred to be the (n+1)th R wave exceeds the third predetermined time, the control is performed such that the second time interval (i.e., the time interval from the event inferred to be the nth R wave of the electrocardiogram to the event inferred to be the (n+2)th R wave exceeds the second predetermined time, and the rise time from the height of the waveform of the event inferred to be the (n+2)th R wave exceeding the first predetermined value to reaching the second predetermined value is less than the third predetermined time, the control is performed in such a way that the permission signal generation unit generates a permission signal for the event inferred to be the (n+2)th R wave.

[0076] In the aforementioned defibrillation electrical device, a permission signal is generated when the interval between events inferred to be R waves exceeds a constant time. Typically, the interval between an R wave and a subsequent T wave in an electrocardiogram waveform is shorter than the interval between the next R wave. Therefore, it is possible to suppress the misdetection of elevated T waves or drifting upward phases as R waves according to condition 1, and to detect R waves that can be applied as voltage using a minimum of two of the aforementioned events. Thus, the detection time for R waves can be shortened compared to conventional methods. Furthermore, when condition 1 is met, for example, even when the interval between R waves narrows, R waves can still be detected based on events inferred to be R waves according to condition 2.

[0077] The following is for reference Figures 1-4 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 a defibrillation catheter system that includes 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 4 This is a diagram showing an example of an electrocardiogram (ECG) waveform. Figure 2 as well as Figure 4 In the diagram, the solid line B extending along the time axis is the baseline of the electrocardiogram waveform, the dashed line C1 represents the first specified value, and the dashed line C2 represents the second specified value.

[0078] 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 2-4 As shown, the event E is calculated from the nth R wave inferred as ECG waveform 50. n Event E, which is inferred to be the (n+1)th R wave n+1 The time interval up to this 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). If the first time interval T1 exceeds the first predetermined time, the event E, which is inferred to be the (n+1)th R wave, is identified. n+1 Whether the rise time of the waveform from the height exceeding the first predetermined value C1 to reaching the second predetermined value C2 is less than the third predetermined time (step S2). Control is performed so that event E, which is inferred to be the (n+1)th R wave, is... n+1 When the rise time of the waveform is 50w or less than the third predetermined time, the event E, which is inferred to be the (n+1)th R wave, is generated from the above-mentioned permission signal generation unit 7. n+1 A permission signal for defibrillation is generated (step S3). This occurs when the first time interval T1 is less than the first predetermined time, or during event E, which is inferred to be the (n+1)th R wave. n+1 When the rise time 50w exceeds the third specified time, the event E from the nth R wave inferred as ECG waveform 50 is calculated. n Event E, which is inferred to be 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 then determined whether the second time interval T2 exceeds the second predetermined time (step S4). If the second time interval T2 exceeds the second predetermined time, the event E, which is inferred to be the (n+2)th R wave, is identified. n+2 Whether the rise time of the waveform from the height exceeding the first predetermined value C1 to reaching the second predetermined value C2 is less than the third predetermined time (step S5). Control is performed on event E, which is inferred to be the (n+2)th R wave. n+2 When the rise time of the waveform is 50w or less than the third predetermined time, the event E, which is inferred to be the (n+2)th R wave, is generated from the above-mentioned permit signal generation unit 7. n+2 A permission signal for defibrillation is generated (step S6). Although not illustrated, this can also be achieved by identifying event E, which is inferred to be the (n+1)th R wave. n+1After determining whether the rise time 50w from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is less than the third predetermined time (step S2), it is then determined whether the first time interval T1 exceeds the first predetermined time (step S1). Similarly, it is also possible to determine whether the event E inferred to be the (n+2)th R wave... n+2 After determining whether the rise time 50w from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is below the third predetermined time (step S5), determine whether the second time interval T2 exceeds the second predetermined time (step S4).

[0079] like Figure 2 As shown, the events E that are inferred to be 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.

[0080] In the electrocardiogram (ECG) waveform 50, there is no particular limitation on which waveform is used to detect the event E that is inferred to be an R wave. Although not illustrated, for example, events with a fourth predetermined value C4 (in mV) or higher in the ECG waveform 50 are detected as events inferred to be R waves. The fourth predetermined value C4 can be appropriately set according to the ECG waveform 50 obtained by the ECG machine 40. For example, it is preferable that the fourth predetermined value C4 is a value higher than the baseline B. When the height of the baseline B is set to 0% and the height of the maximum peak value is set to 100% in the ECG waveform 50, the fourth predetermined value C4 can also be set to a value of 50% or higher, 70% or higher, or 85% or higher. The baseline B can be set, for example, as a straight line connecting the starting points of adjacent P waves or a straight line connecting the starting points of events inferred to be adjacent R waves. Alternatively, as another method, the maximum peak value can be calculated separately in multiple cycles of the ECG waveform 50, the average height of multiple maximum peak values ​​can be calculated, and events that reach a height of 70% or 80% or more of the average height can be detected as events E that are inferred to be R waves.

[0081] The first time interval T1 is from the event E, which is inferred to be the nth R wave in the ECG waveform 50. n Event E, which is inferred to be 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 event E, which is inferred to be the nth R wave of the ECG waveform 50. n The peak value of 51p to the event E that is inferred to be the (n+1)th R wave n+1 The time interval up to the peak value 51p. Since the peak position of the ECG waveform 50 is easily determined, 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.

[0082] The calculation of the first time interval T1 can also use the interval between specific times other than the peak of events E that are inferred to be adjacent R waves. For example, the first time interval T1 can also be calculated by comparing the times before the peak of events E that are inferred to be adjacent R waves. Although not illustrated, it is preferred that the first time interval T1 is from the nth R wave inferred to be ECG waveform 50. n The time from when the height of the waveform exceeds the fifth specified value to the event E that is inferred to be the (n+1)th R wave. n+1 The time interval from the moment when the height of the waveform exceeds the aforementioned fifth specified value. Here, the fifth specified value is a value between the height of the waveform from the start of event E, which is inferred to be an R wave, to the peak value 51p of event E. When the height of the baseline B is set to 0% and the height of the maximum peak value is set to 100% in the ECG waveform 50, the fifth specified value can also be set to a value of 10% or more, 50% or more, or 90% or more. By setting the fifth specified value in this way, the first time interval T1 can be calculated at an earlier stage. In addition, the first time interval T1 can also be from the moment when the height of the waveform exceeds the fifth specified value. n From the beginning of 51 seconds to the event E that is inferred to be the (n+1)th R wave n+1 The time interval up to 51 seconds from the start of the wave. Event E, inferred to be the nth R-wave. n The moment when the height of the waveform exceeds a specified value refers to the event E that is inferred to be the nth R-wave. n The moment when the height of the waveform initially exceeds the specified value. The same applies in subsequent explanations.

[0083] As another implementation, the first time interval T1 can also be from the event E, which is inferred to be the nth R wave of the electrocardiogram waveform 50. n The time when the height of the waveform is lower than the sixth specified value, up to the event E that is inferred to be the (n+1)th R wave. n+1 The time interval up to the moment when the height of the waveform falls below the sixth specified value. Here, the sixth specified value is a value between the peak 51p of the event E that is inferred to be an R wave and the end 51f. When the height of the baseline B is set to 0% and the height of the maximum peak is set to 100% in the ECG waveform 50, the sixth specified value can also be set to a value of 95% or less, 50% or less, or 20% or less. By setting the sixth specified value in this way, it is also possible to determine the R wave that can be used as the target of voltage application from the event E that is inferred to be an R wave. In addition, 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 51f to the event E that is inferred to be the (n+1)th R wave n+1The time interval up to the end of 51f. Event E, inferred to be the nth R-wave. n The moment when the height of the waveform is below a specified value refers to the event E that is inferred to be the nth R-wave. n The moment when the height of the waveform initially falls below the specified value. The same applies in subsequent explanations.

[0084] The second time interval T2 is from the event E, which is inferred to be the nth R wave in the ECG waveform 50. n Event E, which is inferred to be 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, as follows... Figure 2 As shown, in the first time interval T1, it is from the event E that is inferred to be the nth R wave of the ECG waveform 50. n The peak value of 51p to the event E that is inferred to be the (n+1)th R wave n+1 In the case of the time interval up to the peak 51p, the second time interval T2 is preferably from the event E of the nth R wave inferred as ECG waveform 50. n The peak value of 51p to the event E that is inferred to be 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.

[0085] Similar to the first time interval T1, the second time interval T2 can also be a specific time interval between each other other than the peak. Although not illustrated, for example, in the first time interval T1, it is from the event E of the nth R wave, which is inferred to be the ECG waveform 50. n The time from when the height of the waveform exceeds the fifth specified value mentioned above to the event E that is inferred to be 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 fifth specified value mentioned above, it is preferable that the second time interval T2 is from the event E of the nth R wave inferred as ECG waveform 50. n The moment when the height of the waveform exceeds the fifth specified value mentioned above, up to the event E that is inferred to be the (n+2)th R wave. n+2 The time interval up to the moment when the height of the waveform exceeds the fifth specified value mentioned above. By setting the fifth specified value in this way, the second time interval T2 can be calculated at an earlier stage.

[0086] As another implementation, the first time interval T1 is from the event E that is inferred to be the nth R wave of the electrocardiogram waveform 50. n The time when the height of the waveform is lower than the sixth specified value mentioned above, up to the event E that is inferred to be the (n+1)th R wave. n+1In the case where the time interval up to the moment when the height of the waveform is lower than the sixth specified value mentioned above, it is preferable that the second time interval T2 is from the event E of the nth R wave inferred as ECG waveform 50. n The time when the height of the waveform is lower than the sixth specified value mentioned above, up to the event E that is inferred to be the (n+2)th R wave. n+2 The time interval up to the moment when the height of the waveform falls below the sixth specified value mentioned above. By setting the sixth specified value in this way, the second time interval T2 can also be calculated.

[0087] The first time interval T1 is from the event E, which is inferred to be the nth R wave of the ECG waveform 50. n From the beginning of 51 seconds to the event E that is inferred to be the (n+1)th R wave n+1 In the case of the time interval up to the beginning of 51 seconds, the second time interval T2 can also be from the event E of the nth R wave inferred as ECG waveform 50. n From the beginning of 51 seconds to the event E that is inferred to be the (n+2)th R wave n+2 The time interval from the start of 51 seconds. Additionally, in the first time interval T1, the event E is the nth R wave in the ECG waveform 50. n The end of 51f to the event E that is inferred to be the (n+1)th R wave n+1 In the case of the time interval up to the end of 51f, the second time interval T2 can also be from the event E of the nth R wave inferred as ECG waveform 50. n The end of 51f to the event E that is inferred to be the (n+2)th R wave n+2 The time interval up to the end of 51f.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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 determine the R-wave from the event E that is inferred to be an R-wave.

[0092] Preferably, the first and second predetermined times are the same. Therefore, even when the intervals between R-waves become narrower, it is easy to determine the R-wave from the event E that is inferred to be an R-wave. Alternatively, the first and second predetermined times can be different from each other.

[0093] like Figure 4 As shown, event E, which is inferred to be the (n+1)th R wave, n+1 The rise time of the waveform, 50w, is from event E, which is inferred to be the (n+1)th R wave. n+1 The time required for the height of the waveform to exceed the first specified value C1 until it reaches the second specified value C2.

[0094] like Figure 4 As shown, event E, which is inferred to be the (n+2)th R wave, n+2 The rise time of the waveform, 50w, is from event E, which is inferred to be the (n+2)th R wave. n+2 The time required for the height of the waveform to exceed the first specified value C1 until it reaches the second specified value C2.

[0095] Preferably, the first predetermined time, the second predetermined time, and the third predetermined time 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 predetermined time, the second predetermined time, and the third predetermined time are stored in memory 5.

[0096] In requirement 1, the permission signal is generated from the permission signal generation unit 7 if the first time interval T1 exceeds the first predetermined time, and the event E is inferred to be the (n+1)th R wave. n+1 The waveform height exceeding the first predetermined value C1 and rising for 50 milliseconds until reaching the second predetermined value C2 is below the third predetermined time. For example, it is preferable to generate the permit signal within 60 milliseconds from the time interval T1 exceeding the first predetermined time, more preferably within 50 milliseconds, and even more preferably within 10 milliseconds. Preferably, the permit signal is generated after the first predetermined time interval T1 exceeds the first predetermined time and from the event E inferred to be the (n+1)th R wave. n+1A permission signal is generated when the rise time of the waveform from the first specified value C1 to the second specified value C2 is 50w or less than the third specified time.

[0097] In requirement 2, the permission signal is generated from the permission signal generation unit 7 only if the first time interval is less than or equal to the first predetermined time, or if it occurs during event E, which is inferred to be the (n+1)th R wave. n+1 When the aforementioned rise time 50w exceeds the aforementioned third specified time, and the second time interval T2 exceeds the second specified time, the event E, which is inferred to be the (n+2)th R wave, is considered to be... n+2 The waveform height exceeding the first predetermined value C1 and rising for 50 milliseconds until reaching the second predetermined value C2 is below the third predetermined time. For example, it is preferable to generate the permit 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. Alternatively, the permit signal may be generated after the second time interval T2 exceeds the second predetermined time, and from the event E inferred to be the (n+2)th R wave. n+2 When the rise time of the waveform from the height of the first specified value C1 to the second specified value C2 is 50w or less than the third specified time, a permission signal is generated.

[0098] Preferably, control is implemented so that a permit signal is not generated from the permit signal generation unit 7 when the second time interval T2 is less than or equal to the second predetermined time. Alternatively, the event E, which is inferred to be the (n+2)th R wave, may be generated when the second time interval T2 is less than or equal to the second predetermined time. n+2 Reidentified as event E, which was previously inferred to be the nth R-wave. n To determine whether the first time interval T1 exceeds the first predetermined time. Alternatively, it can be determined when the second time interval T2 is less than the second predetermined time, such as... Figure 3 As shown, event E, which will be inferred as the (n+2)th R wave, n+2 Subsequently detected event E, which was initially inferred to be an R-wave, was re-identified as event En, which was previously inferred to be the nth R-wave. n It is determined whether the first time interval T1 exceeds the first predetermined time. The event E, which is thus detected and inferred to be an R-wave, is repeatedly determined to satisfy the predetermined time specified in requirement 1 or requirement 2, thereby enabling the appropriate application of voltage to the R-wave.

[0099] 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.

[0100] Figure 2 The ECG waveform 50 shown is displayed, for example, on the display unit of an electrocardiogram (ECG) device. Preferably, the ECG waveform 50 is obtained through a second-order induction that readily detects an event E that can be inferred to be an 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.

[0101] Next, refer to Figures 4-5 The structure used for high-precision detection of R-waves is described. Figure 5 It means Figure 3 A flowchart illustrating a variation of the method for generating defibrillation signals. (For example...) Figures 4-5 As shown, the defibrillation electrical device 2 of the preferred embodiment of the present invention is controlled so that a permission signal is generated from the permission signal generation unit 7 after the following requirement 3 is met. More specifically, the defibrillation electrical device 2 is preferably controlled so that the permission signal in the above-mentioned requirement 1 or requirement 2 is generated after the following requirement 3 is met.

[0102] (Requirement 3)

[0103] The event E, which is inferred to be the nth R wave of ECG waveform 50, is input from ECG waveform input unit 3. n The rise time from when the height of the waveform exceeds the first specified value C1 to when it reaches the second specified value C2 is 50w or less than the third specified time.

[0104] For example, Figure 5 As shown, the event E detected and inferred to be the nth R wave is first identified.n Whether condition 3 is met (step S7), and then whether the first time interval T1 exceeds the first predetermined time (step S1). In this way, condition 3 is used to filter events E that are inferred to be the nth R wave. n This can improve the detection accuracy of R-waves. Furthermore, although not illustrated, the event E inferred to be an R-wave can also be identified after determining whether the first time interval T1 exceeds the first predetermined time (step S1), or after determining whether the second time interval T2 exceeds the second predetermined time (step S4). n Does condition 3 meet (step S7)?

[0105] By using condition 3, the increased T-wave and the rising situation after drift can be removed from the event E of the R-wave that is inferred to be applicable to condition 1 or condition 2, and the application of voltage accompanied by false detection of R-wave can be easily avoided. The width of R-wave is usually narrower than that of T-wave, but the same trend can be seen in the case of increased T-wave. Therefore, by using condition 3, it is easy to avoid false application of voltage to increased T-wave and rising situation after drift.

[0106] The waveform height indicates the potential value on the vertical axis of the ECG waveform 50. For example... Figure 4 As shown, the rise time 50w from when the waveform height exceeds the first predetermined value C1 to when it reaches the second predetermined value C2 refers to the length of the time axis when the waveform height is greater than the first predetermined value C1 and less than the second predetermined value C2. The rise time 50w can be calculated by the arithmetic processing control unit 8 described later.

[0107] The first specified value C1 can be appropriately set based on the electrocardiogram waveform 50 obtained from the electrocardiogram monitor 40. The first specified value C1 is as follows: Figure 4 As shown, a value higher than baseline B is preferred. When the height of baseline B is set to 0% and the height of the maximum peak value is set to 100% in the ECG waveform 50, the first specified value C1 can also be set to a value of 15% or less, 10% or less, or 5% or less. Furthermore, the unit of the first specified value C1 is mV.

[0108] The second specified value C2 can be appropriately set based on the electrocardiogram waveform 50 obtained from the electrocardiogram machine 40. For example... Figure 4 As shown, when the height of baseline B is set to 0% and the height of the maximum peak value is set to 100% in the ECG waveform 50, the second specified value C2 can also be set to a value of 60% or more, 80% or more, or 90% or more. Furthermore, the unit of the second specified value C2 is mV.

[0109] The third specified time is preferably 10 milliseconds or more, more preferably 15 milliseconds or more, and even more preferably 20 milliseconds or more. This avoids the application of voltage to high-frequency noise with a rise time of less than 10 milliseconds. Furthermore, the third specified time is preferably 60 milliseconds or less, more preferably 55 milliseconds or less, and even more preferably 50 milliseconds or less. Generally, the rise time of a T-wave tends to exceed 60 milliseconds. Therefore, by setting the third specified time to 60 milliseconds or less, it is possible to prevent the increased T-wave or the drifted rise phase from being mistakenly detected as an R-wave.

[0110] Preferably, the first predetermined value C1, the second predetermined value C2, and the third predetermined time are stored in the memory described later. Moreover, they do not necessarily have to be stored in the same memory, or they can be stored in different memories.

[0111] Reference Figures 6-8 Other structures for high-precision detection of R-waves are explained. Figure 6 This is a diagram showing an example of an electrocardiogram (ECG) waveform (upper segment) and a differential waveform (lower segment) that is a collection of differential values ​​of the ECG waveform. Figure 7 as well as Figure 8 It means Figure 3 A flowchart illustrating a variation of the method for generating defibrillation signals. In Figure 6 In the diagram, the dashed line extending along the time axis indicates that the value (differential value) of the vertical axis is the third specified value C3. Figure 6 In the diagram, the solid line B extending along the time axis shows the baseline of the differential waveform.

[0112] like Figure 1 As shown, the defibrillation electrical device 2 also includes an arithmetic processing control unit 8 that calculates the differential value by differentiating the electrocardiogram waveform 50, such as... Figures 6-7 As shown, it is preferable to control the generation of a permission signal from the permission signal generation unit 7 after further satisfying the following requirement 4. More specifically, it is preferable to control the defibrillation electrical device 2 so that a permission signal is generated after satisfying the following requirement 4 in requirement 1 or after satisfying the following requirement 4 in requirement 2.

[0113] (Requirement 4)

[0114] In events E that are inferred to be the (n+1)th R wave n+1 After the peak of 51p, and based on event E, which is inferred to be the (n+1)th R wave. n+1 The differential value generated by the arithmetic processing control unit 8 is below the third predetermined value C3, or exceeds the event E that is inferred to be the (n+2)th R wave. n+2 After the peak of 51p, and based on event E, which is inferred to be the (n+2)th R wave. n+2The differential value generated by the arithmetic processing control unit 8 is the third specified value C3 or less.

[0115] exist Figure 7 In the process, firstly, it is determined whether the first time interval T1 exceeds the first predetermined time (step S1). If the first time interval T1 exceeds the first predetermined time, the event E, which is inferred to be the (n+1)th R wave, is identified. n+1 Whether the rise time of the waveform from the first predetermined value C1 to the second predetermined value C2 is less than the third predetermined time (step S2). In event E, which is inferred to be the (n+1)th R wave... n+1 When the rise time of the waveform is 50W or less than the third specified time, the event E that is detected and inferred to be an R-wave is identified. n+1 Does condition 4 (step S8) meet? When the first time interval T1 is less than the first predetermined time, or during event E, which is inferred to be the (n+1)th R wave. n+1 When the rise time 50w exceeds the third predetermined time, determine whether the second time interval T2 exceeds the second predetermined time (step S4). When the second time interval T2 exceeds the second predetermined time, determine whether the event E, which is inferred to be the (n+2)th R wave, is... n+2 Whether the rise time of the waveform from the first predetermined value C1 to the second predetermined value C2 is 50w or less than the third predetermined time (step S5). In event E, which is inferred to be the (n+2)th R wave. n+2 When the rise time of the waveform is 50W or less than the third specified time, the event E detected is inferred to be the (n+2)th R wave. n+2 Does condition 4 satisfy (step S9)? By using condition 4 to filter events E that are inferred to be R-waves, the detection accuracy of R-waves can be improved. Furthermore, although not illustrated, events E inferred to be the (n+1)th R-wave can also be identified after determining whether the first time interval T1 exceeds the first predetermined time (step S1), or after determining whether the second time interval T2 exceeds the second predetermined time (step S4). n+1 Or it could be inferred to be event E of the (n+2)th R wave. n+2 Does condition 4 (step S8 or step S9) meet?

[0116] like Figure 1 As shown, the preferred defibrillation electrical device 2 has an arithmetic processing control unit 8 that calculates the differential value by differentiating the electrocardiogram waveform 50, such as... Figure 6 as well as Figure 8 As shown, control is performed so that a permission signal is generated from the permission signal generation unit 7 after condition 5 is met. More specifically, the defibrillation electrical device 2 is controlled so that the permission signal in condition 1 or condition 2 is generated after condition 5 is met.

[0117] (Requirement 5)

[0118] In events E that are inferred to be the nth R-wave as mentioned above n After the peak of 51p, and according to event E, which is inferred to be the nth R wave. n The differential value generated by the aforementioned calculation and processing control unit 8 is the third specified value C3 or less.

[0119] exist Figure 8 In the process, the first step is to identify events E that are inferred to be the nth R wave. n Following the peak and based on event E, which is inferred to be the nth R wave. n After determining whether the differential value generated by the arithmetic processing control unit 8 is below the third predetermined value C3 (step S10), it is determined whether the first time interval T1 exceeds the first predetermined time (step S1). By using element 5 to filter events E that are inferred to be R-waves, the detection accuracy of R-waves can be improved. Furthermore, although not illustrated, it is also possible to filter events E that are inferred to be R-waves after determining whether the first time interval T1 exceeds the first predetermined time (step S1), or after determining whether the first time interval T1 exceeds the first predetermined time (step S1). n+1 After determining whether the rise time 50w from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is below the third predetermined time (step S2), or after determining whether the second time interval T2 exceeds the second predetermined time (step S4), or after determining whether the event E inferred to be the (n+2)th R wave... n+2 After determining whether the rise time of the waveform from the height exceeding the first predetermined value C1 to reaching the second predetermined value C2 is less than the third predetermined time (step S5), the event E inferred to be an R-wave is identified. n Does condition 5 meet (step S10)?

[0120] Figure 6 Differential waveform 60 is an example of a collection of differential values ​​generated from ECG waveform 50. Differential waveform 61 shows a portion generated from an event E in differential waveform 60, which is inferred to be an R wave. The negative wave 61N of differential waveform 60 corresponds to a collection of differential values ​​generated from the descending phase 51d of event E, which is inferred to be an R wave, following the peak 51p of event E inferred to be an R wave in ECG waveform 50. See below for further details. Figure 6 The differential waveform 60 describes the timing of the generation of the permission signal. Point G of the differential waveform 60 corresponds to the moment when the differential value reaches the third predetermined value C3. The defibrillation electrical device 2 can be controlled by generating a permission signal at a time after point G. Figure 6In this process, waveforms below point G do not exist except for the negative wave 61N generated based on event E, which is inferred to be an R wave, so it is easy to identify whether the waveform of the applied object is an R wave. By setting such a threshold (third predetermined value C3), it is easy to avoid the application of voltage that accompanies the false detection of R waves. On the other hand, it is preferable to control the defibrillation electrical device 2 so as to generate a permission signal before the peak value 61b of the negative wave 61N. As a result, defibrillation can be easily completed within the absolute refractory period. Moreover, it is preferable to control the defibrillation electrical device 2 so as to generate a permission signal within 60 milliseconds from when the differential value reaches the third predetermined value C3 (point G), more preferably to control it so as to generate a permission signal within 50 milliseconds, further preferably to control it so as to generate a permission signal within 10 milliseconds, and even more preferably to control it so as to generate a permission signal when the differential value exceeds the third predetermined value C3. In addition, the peak value 61b of the negative wave 61N corresponds to the inflection point 51c of the decline phase 51d of event E, which is inferred to be an R wave.

[0121] Examples of differential values ​​generated based on the event E, which is inferred to be an R-wave, include differential values ​​obtained through the differential circuit 4 described later, and differential values ​​obtained through general differential calculations. Furthermore, it is preferable that the differential value generated based on the event E, which is inferred to be an R-wave, is a first-order differential value. The time before the first-order differential value is generated is shorter than the time before the second-order differential value is generated, thus shortening the time from obtaining ECG information to the generation of the permissive signal.

[0122] The aforementioned third specified value C3 is, for example, in Figure 6 In the differential waveform 60, the value of the vertical axis (differential value) below the baseline B, the third specified value C3, is preferably negative. Furthermore, the value of the vertical axis (differential value) of the baseline B is the same as the value of the vertical axis (differential value) of the portion corresponding to the peak value 51p of the event E inferred as an R-wave, i.e., the O point of the differential waveform 60. Moreover, the third specified value C3 can also be a value that varies depending on the type of differential circuit 4, etc.

[0123] As described above, the preferred defibrillation electrical device 2 sets a threshold (third predetermined value C3) for the differential value of the event E, which is inferred to be an R wave, corresponding to the portion of the decline phase after the peak 51p of the event E, which is inferred to be an R wave of the electrocardiogram waveform 50. With this structure, it is easy to identify whether the waveform of the applied object is an R wave, and it is easy to avoid the application of voltage accompanied by false detection of R waves.

[0124] Preferably, the third specified value C3 is stored in the memory described later or set in the comparator described later.

[0125] Alternatively, the operator can confirm which R wave event E in the inferred ECG waveform 50 conforms to the structure of an R wave event E that is inferred to be a target for voltage application. For example, it is preferable to control the event so that the first time interval T1 exceeds the first predetermined time, and the event E inferred to be the (n+1)th R wave... n+1 When the rise time of the waveform from the first predetermined value C1 to the second predetermined value C2 is less than the third predetermined time, an event E is generated for the inferred (n+1)th R wave. n+1 The marker display signal is assigned to control the signal so that when the first time interval T1 is less than the first predetermined time, or when event E is inferred to be the (n+1)th R wave. n+1 When the aforementioned rise time 50w exceeds the third specified time, and the aforementioned second time interval T2 exceeds the aforementioned second specified time, and from the event E inferred as the (n+2)th R wave... n+2 When the rise time of the waveform from the first predetermined value C1 to the second predetermined value C2 is less than the third predetermined time, an event E is generated for the inferred (n+2)th R wave. n+2 The marker is assigned a display signal.

[0126] Preferably, control is performed so that the first time interval T1 exceeds a first predetermined time, and from the event E inferred to be the (n+1)th R wave. n+1 When the rise time 50° from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is less than the third predetermined time, a marker display signal is generated before a clearance signal for defibrillation is generated. Furthermore, it is preferable to control this so that when the aforementioned first time interval T1 is less than the aforementioned first predetermined time, or when the E wave is inferred to be the (n+1)th R wave... n+1 When the aforementioned rise time 50w exceeds the third specified time, the second time interval T2 exceeds the second specified time, and from the event E inferred as the (n+2)th R wave... n+2 When the rise time from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is 50w or less than the third predetermined time, a marker display signal is generated before a permission signal for defibrillation is generated.

[0127] The aforementioned markings assigned to event E, which is inferred to be an R wave, can also be displayed on the display unit absorbing 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.

[0128] By employing the methods described above, such as assigning a marker to event E that is inferred to be an R wave, and visually confirming the RR interval to assess the heart's condition, the non-permitted defibrillation mode is switched to permitted mode. This facilitates defibrillation and improves safety.

[0129] 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.

[0130] The above mainly describes the structure related to the generation of the permission signal for the defibrillation electrical device 2. The following will refer to... Figure 1 as well as Figure 9 The structure of the defibrillation electrical device 2 and the defibrillation catheter system 1 including the first embodiment is described in detail. Figure 9 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.

[0131] like Figure 9 As 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.

[0132] 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).

[0133] exist Figure 1 as well as Figure 9 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.

[0134] Figure 1 as well as Figure 9The 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.

[0135] 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.

[0136] 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 in the transmitted ECG waveform 50, and identify the event E that is inferred to be the (n+1)th R wave. n+1 Whether the rise time 50w from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is below the third predetermined time, whether the second time interval T2 exceeds the second predetermined time, and whether the event E inferred to be the (n+2)th R wave. n+2 The rise time 50w from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is determined to be less than the third predetermined time. 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 from the event E, which is inferred to be the (n+1)th R wave, when the first time interval T1 exceeds the first predetermined time. n+1 When the rise time of the waveform from the first predetermined value C1 to the second predetermined value C2 is less than the third predetermined time, the event E, which is inferred to be the (n+1)th R wave, is determined. n+1 A permit signal for voltage application is generated. Furthermore, the permit signal generation unit 7 can generate the permit signal when the first time interval T1 is less than or equal to the first predetermined time, or during an event E that is inferred to be the (n+1)th R wave. n+1 When the aforementioned rise time exceeds the third predetermined time, the second time interval T2 exceeds the second predetermined time, and the event E, which is inferred to be the (n+2)th R wave, is... n+2 When the rise time of the waveform from the first predetermined value C1 to the second predetermined value C2 is less than the third predetermined time, the event E, which is inferred to be the (n+2)th R wave, is considered to be... n+2A 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.

[0137] The memory 5 can be any known memory, such as volatile memory like random access memory or non-volatile memory like flash memory. The memory 5 can also be housed within the arithmetic processing control unit 8. Furthermore, the defibrillator 2 can also have a display unit (not shown) for displaying electrocardiogram waveforms, and can also display markers for events inferred to be R waves. For details regarding the display unit and markers, please refer to the description of the display unit 73 in the second embodiment.

[0138] The differentiating circuit 4 can be a known differentiating circuit. The differentiating circuit 4 can also be housed within the arithmetic processing control unit 8. The differentiating circuit 4 and the memory 5 can also be integrated within the FPGA described later, for example.

[0139] The electrocardiogram (ECG) waveform input from the ECG waveform input unit 3 can also be transmitted to the arithmetic processing control unit 8 via the differentiating circuit 4. The arithmetic processing control unit 8 determines whether the transmitted differential waveform 60 is below the third predetermined value C3 stored in the memory 5, exceeds the first predetermined time interval T1, and is related to the event E that is inferred to be the (n+1)th R wave. n+1 When the rise time 50w from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is less than the third predetermined time, the permission signal generation unit 7 can then transmit the event E, which is inferred to be the (n+1)th R wave. n+1 A permit signal for voltage application is generated. Additionally, the arithmetic processing control unit 8 generates a permit signal when the first time interval T1 is less than a first predetermined time, or when the event E is inferred to be the (n+1)th R wave. n+1 When the aforementioned rise time exceeds the third predetermined time, the second time interval T2 exceeds the second predetermined time, and the event E, which is inferred to be the (n+2)th R wave, is... n+2 When the rise time 50w from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is less than the third predetermined time, the permission signal generation unit 7 can then process the event E, which is inferred to be the (n+2)th R wave. n+2 Generate a permission signal for voltage application.

[0140] Preferably, the power supply unit 9 includes, for example, a power supply, a boost circuit for increasing DC voltage, a charging circuit, a capacitor for charging the applied voltage, and a waveform generation circuit for generating pulse voltage. Alternatively, at least some of the above may be located outside the power supply unit 9. While the location of the power supply unit 9 is not particularly limited, it can be, for example, as shown below. Figure 9 It can be set outside the arithmetic processing control unit 8, or it can be set inside the arithmetic processing control unit 8.

[0141] 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 9 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.

[0142] The defibrillation electrical device 2 possesses at least one function, such as the ECG waveform input unit 3, the differentiating circuit 4, the memory 5, the permission signal generation unit 7, the arithmetic processing and control unit 8, the power supply unit 9, and the switching unit 10. These functions 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).

[0143] 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, differentiating circuit 4, 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 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.

[0144] Moreover, preferred in Figure 1 as well as Figure 9 The defibrillator electrical device 2 is equipped with an operation unit 6 for performing various operations such as starting, stopping, setting applied energy, charging, applying voltage, and selecting applied electrodes. The operation unit 6 can use known input mechanisms such as push-button switches or levers. Preferably, the operation unit 6 is connected to an arithmetic processing control unit 8, whereby input signals from the operation unit 6 are transmitted to the arithmetic processing control unit 8. Furthermore, an authorization signal, a portion of the aforementioned authorization signals, can be generated through the operation of the operation unit 6.

[0145] The switching unit 10 may also have one or more switches. For example... Figure 9 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.

[0146] like Figure 1As 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.

[0147] 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.

[0148] 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.

[0149] 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.

[0150] 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.

[0151] 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.

[0152] 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.

[0153] like Figure 9 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.

[0154] 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.

[0155] 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.

[0156] 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.

[0157] 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.

[0158] The electrocardiogram (ECG) device 40 measures intracardiac potentials using various electrodes. The ECG device 40 can use known components.

[0159] 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.

[0160] Next, refer to Figure 10 The structure of the defibrillation electrical device 70 of the second embodiment will be described in detail. Figure 10 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.

[0161] like Figure 10 As shown, the defibrillation electrical device 70 of the preferred second embodiment displays the electrocardiogram (ECG) waveform on the display unit 73 via the ECG waveform input unit 3, the ECG information input from the ECG waveform input unit 3, the A / D converter 71, and the first arithmetic processing control unit 72 (CPU). On the other hand, 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, a signal is transmitted to the second arithmetic processing control unit 75 (FPGA), which has a first predetermined time and a second predetermined time, etc. Preferably, the event E, which is inferred to be the (n+1)th R wave, is considered to have exceeded the first predetermined time in the first time interval T1. n+1When the rise time from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is less than the third predetermined time, or when the first time interval T1 is less than the aforementioned first predetermined time, or when the event E is inferred to be the (n+1)th R wave... n+1 When the aforementioned rise time 50w exceeds the third specified time, the second time interval T2 exceeds the second specified time, and from the event E inferred as the (n+2)th R wave... n+2 When the rise time 50w from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is less than the third predetermined time, the signal is transmitted to the second arithmetic processing control unit 75 (FPGA). The second arithmetic processing control unit 75 (FPGA) generates a marker display signal. After transmitting the marker display signal to the first arithmetic processing control unit 72 (CPU), a marker is displayed on the display unit 73 for the event E inferred to be an R-wave. Examples of marker shapes include circles, triangles, quadrilaterals, polygons, and lines. Examples of marker positions include the peak value of the event E inferred to be an R-wave. Furthermore, the marker display signal can be generated from the first arithmetic processing control unit 72 (CPU) simply as a signal displaying a marker for the event E inferred to be an R-wave on the display unit 73.

[0162] 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 the first time interval T1 exceeds a first predetermined time, and the event E, which is inferred to be the (n+1)th R wave, is... n+1 The waveform rises from the first predetermined value C1 to the second predetermined value C2 after a rise time of 50°C is less than a third predetermined time, or after the first time interval T1 is less than the first predetermined time, or during the event E that is inferred to be the (n+1)th R wave. n+1 When the aforementioned rise time 50w exceeds the third specified time, the second time interval T2 exceeds the second specified time, and from the event E inferred as the (n+2)th R wave... n+2 When the rise time 50w from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is less than the third predetermined time, a mark display signal is generated from the mark display signal generation unit 76 in the display unit 73 to mark the event that is inferred to be an R-wave. In this way, if the event that is inferred to be an R-wave is marked in the display unit 73, the operator can visually observe and confirm the state of the R-wave.

[0163] 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, while switching modes, it is possible to set the applied energy, start charging the capacitor, and complete the charging process. Furthermore, a pulse voltage can be automatically generated after charging is complete. The non-permitted mode is a mode in which no defibrillation-related permit signal is generated even if the time interval between events E that are inferred to be R-waves meets the predetermined time specified in either 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 events E that are inferred to be R-waves meets the predetermined time specified in either requirement 1 or requirement 2. Therefore, the operator can set the mode to non-permitted when the patient's condition is poor and switch to permitted mode when the patient's condition improves, making defibrillation easier to perform. For information on the defibrillation-related permit signal, please refer to the description of the first embodiment.

[0164] 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 which is set with a first predetermined value C1, a second predetermined value C2, etc., when the first time interval T1 exceeds the first predetermined time and the event E that is inferred to be the (n+1)th R wave... n+1 The waveform height exceeds the first predetermined value C1 and the rise time from the second predetermined value C2 is 50w or less than the third predetermined time, or the first time interval T1 is less than the first predetermined time, or in the event E that is inferred to be the (n+1)th R wave. n+1 When the aforementioned rise time exceeds the third predetermined time, the second time interval T2 exceeds the second predetermined time, and the event E, which is inferred to be the (n+2)th R wave, is... n+2 If the rise time of the waveform from the height of the first predetermined value C1 to the second predetermined value C2 is 50w or less than the third predetermined time, the signal is transmitted to the second arithmetic processing control unit 75 (FPGA), and a permission signal is generated from the second arithmetic processing control unit 75 (FPGA).

[0165] 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.

[0166] Furthermore, at least one function of the defibrillation electrical device 70, such as the ECG waveform input unit 3, the differentiating circuit 4, the comparator 74, the permission signal generation unit 7, the first arithmetic processing control unit 72, the second arithmetic processing control unit 75, the arithmetic processing control unit 8, the power supply unit 9, and the switching unit 10, can be implemented in hardware or software. For details, please refer to the description of the first embodiment.

[0167] The present invention also includes a method for generating a defibrillation signal. For example, such as Figure 2 as well as Figure 3 As shown, a defibrillation signal generation method according to an embodiment of the present invention includes the following steps: calculating the event E from the nth R wave inferred as an electrocardiogram waveform. n Event E, which is inferred to be the (n+1)th R wave n+1 The time interval up to that point, also known as the first time interval T1, is used to determine whether the first time interval T1 exceeds the first predetermined time (step S1); the step of determining whether the event E, which is inferred to be the (n+1)th R wave, is used to determine the time interval from that point to that point. n+1 The step (step S2) determines whether the rise time 50w from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is less than the third predetermined time; the first time interval T1 exceeds the first predetermined time, and from the event E inferred to be the (n+1)th R wave. n+1 When the rise time of the waveform from the first predetermined value C1 to the second predetermined value C2 is less than the third predetermined time, and the event E is inferred to be the (n+1)th R wave, then... n+1 Synchronously generate a permit signal (step S3); when the first time interval T1 is less than the first predetermined time, or at event E which is inferred to be the (n+1)th R wave. n+1 When the aforementioned rise time 50w exceeds the third predetermined time, determine whether the second time interval T2 exceeds the second predetermined time (step S4); and determine whether the event E, which is inferred to be the (n+2)th R wave, exceeds the second predetermined time. n+2 Whether the rise time 50w from the height of the waveform exceeding the first predetermined value C1 to reaching the second predetermined value C2 is below the third predetermined time (step S5); if the second time interval T2 exceeds the second predetermined time, and from the event E inferred to be the (n+2)th R wave... n+2 When the rise time of the waveform from the first predetermined value C1 to the second predetermined value C2 is less than the third predetermined time, the event E, which is inferred to be the (n+2)th R wave, is considered to be the R wave. n+2 The step of synchronously generating a permit signal (step S6). In this step, the events inferred to be R-waves are detected in the order of the nth, (n+1)th, and (n+2)th, where n is an integer greater than or equal to 1.

[0168] For example, Figure 4 , Figure 5 As shown, the preferred method for generating the defibrillation signal includes: identifying the event E of the nth R wave from the electrocardiogram waveform 50 that is inferred to be obtained from the human body. n Whether the rise time of the waveform from the first specified value C1 to the second specified value C2 is 50w is a step below the third specified time.

[0169] For example, Figure 6 , Figure 7 , Figure 8 As shown, the preferred method for generating the defibrillation signal includes the step of identifying whether the differential value of the electrocardiogram 50 is below a third predetermined value C3 after the peak value 51p of the event E exceeding the R wave of the electrocardiogram waveform 50 which is inferred to be obtained from the human body. For example, as Figure 7 As shown, it preferably has: the first time interval T1 exceeds a first predetermined time, and from the event E inferred to be the (n+1)th R wave. n+1 When the rise time of the waveform from the first predetermined value C1 to the second predetermined value C2 is 50w or less than the third predetermined time, the event E, which is inferred to be the (n+1)th R wave, is identified. n+1 The step of determining whether the differential value is below the third predetermined value C3 (step S8). Additionally, it is preferable to have: when the aforementioned second time interval T2 exceeds the second predetermined time, and from the event E inferred to be the (n+2)th R wave... n+2 When the rise time of the waveform from the first predetermined value C1 to the second predetermined value C2 is less than the third predetermined time, the event E that is inferred to be the (n+2)th R wave is identified. n+2 The step (step S9) determines whether the differential value is less than or equal to the third specified value C3. Furthermore, as... Figure 8 As shown, it preferably has the ability to distinguish events E that are inferred to be the nth R wave. n After the peak, and based on the event E inferred as the nth R wave by the calculation and processing control unit 8. n The step of determining whether the generated differential value is below the third specified value C3 (step S10).

[0170] The above steps can be performed, for example, by using the differential circuit, arithmetic processing control unit, memory, comparator, power supply, etc. of the defibrillation electrical device 2 and defibrillation electrical device 70. For details, please refer to the description of each component of the defibrillation electrical device 2 and defibrillation electrical device 70.

[0171] 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.

[0172] This application claims the benefit based on priority of Japanese Patent Application No. 2020-099550, filed on June 8, 2020. The entire contents of the description of Japanese Patent Application No. 2020-099559, filed on June 8, 2020, are incorporated herein by reference.

[0173] Explanation of reference numerals in the attached figures

[0174] 1: Defibrillation catheter system

[0175] 2: Electrical defibrillation devices

[0176] 3: ECG waveform input unit

[0177] 4: Differentiating circuit

[0178] 5: Memory

[0179] 6: Operations Department

[0180] 7: Permission signal generation unit

[0181] 8: Computation and Processing Control Unit

[0182] 9: Power Supply Section

[0183] 10: Switching Unit

[0184] 10A: First switch

[0185] 10B: Second switch

[0186] 11: First connecting part

[0187] 12: Second connecting part

[0188] 13: Third connecting part

[0189] 14: Fourth connecting part

[0190] 19: Surface electrodes

[0191] 20: Catheter

[0192] 21: First electrode group

[0193] 22: Second electrode group

[0194] 23: Third electrode group

[0195] 25: Front contact

[0196] 26: Handle

[0197] 27: Resin tube

[0198] 31: First conductor

[0199] 32: Second conductor

[0200] 33: Third conductor

[0201] 34: Fourth conductor

[0202] 35: Fifth conductor

[0203] 36: Sixth conductor

[0204] 37: Seventh conductor

[0205] 40: Electrocardiogram (ECG)

[0206] 50: Electrocardiogram waveform

[0207] 50w: Rising time

[0208] E: Events inferred to be R-waves

[0209] E n Events inferred to be the nth R-wave

[0210] E n+1 Events inferred to be the (n+1)th R-wave

[0211] E n+2 Events inferred to be the (n+2)th R wave

[0212] 51c: The inflection point of the declining trend of events inferred to be R-waves.

[0213] 51d: The decline of events inferred to be R-waves

[0214] 51f: The end of the event inferred to be an R-wave.

[0215] 51p: The peak value of the event inferred to be an R-wave.

[0216] 51r: The rising trend of events inferred to be R-waves

[0217] 51s: The beginning of the event inferred to be an R-wave.

[0218] 60: Differential waveform

[0219] 61: Differential waveform generated from an event inferred to be an R-wave

[0220] 61P: Positive wave

[0221] 61N: Negative wave

[0222] 61b: Peak value of the negative wave

[0223] 70: Electrical defibrillation devices

[0224] 71: A / D Converter

[0225] 72: First Computation Processing Control Unit

[0226] 73: Display Section

[0227] 74: Comparator (Comparison Circuit)

[0228] 75: Second Operation Processing Control Unit

[0229] 76: Marker indicates signal generation unit

[0230] T1: First time interval

[0231] T2: Second time interval

[0232] C1: First specified value

[0233] C2: Second specified value

[0234] C3: The third specified value.

Claims

1. An electrical defibrillation device, characterized in that, has: a cardiac electrical waveform input section; and a permission signal generation section that generates a permission signal that permits application of a voltage for defibrillation, the defibrillation electrical device satisfies the following requirement 1 or the following requirement 2, wherein the event inferred as the nth R wave, the event of the n+1th R wave, and the event of the n+2th R wave are detected in the order of the event inferred as the nth R wave, the event of the n+1th R wave, and the event of the n+2th R wave, n being an integer of 1 or more, requirement 1: the manner in which the permission signal generation section generates the permission signal for the event inferred as the n+1th R wave is controlled so that, after the time interval from the event inferred as the nth R wave to the event inferred as the n+1th R wave, i.e., a first time interval exceeds a first prescribed time, and the rise time from the height of the waveform of the event inferred as the n+1th R wave exceeding a first prescribed value to reaching a second prescribed value is third prescribed time or less, requirement 2: the manner in which the permission signal generation section generates the permission signal for the event inferred as the n+2th R wave is controlled so that, after the time interval from the event inferred as the nth R wave to the event inferred as the n+2th R wave, i.e., a second time interval exceeds a second prescribed time, and the rise time from the height of the waveform of the event inferred as the n+2th R wave exceeding the first prescribed value to reaching the second prescribed value is the third prescribed time or less, when the first time interval is the first prescribed time or less or the rise time of the event inferred as the n+1th R wave exceeds the third prescribed time.

2. The defibrillation electrical device according to claim 1, wherein the first prescribed time and the second prescribed time are each 100 milliseconds or more and 300 milliseconds or less.

3. The defibrillation electrical device according to claim 1 or 2, wherein the first prescribed time and the second prescribed time are the same.

4. The defibrillation electrical device according to claim 1 or 2, wherein the third prescribed time is 10 milliseconds or more and 50 milliseconds or less.

5. The defibrillation electrical device according to claim 1 or 2, wherein the first time interval is the time interval from the peak of the event inferred as the nth R wave of the cardiac electrical waveform to the peak of the event inferred as the n+1th R wave, the second time interval is the time interval from the peak of the event inferred as the nth R wave of the cardiac electrical waveform to the peak of the event inferred as the n+2th R wave.

6. The defibrillation electrical device according to claim 1 or 2, wherein the permission signal is generated from the permission signal generation section after the following requirement 3 is satisfied, requirement 3: the rise time from the height of the waveform of the event inferred as the nth R wave of the cardiac electrical waveform input from the cardiac electrical waveform input section exceeding the first prescribed value to reaching the second prescribed value is the third prescribed time or less.

7. The defibrillation electrical device according to claim 1 or 2, further comprising: an operation processing control section that calculates a differential value by differentiating the electrocardiogram waveform, control is performed so that the permission signal is generated from the permission signal generation section after the following requirement 4 is satisfied, Requirement 4: the differential value generated by the operation processing control section is third prescribed value or less after the peak of the event inferred as the n+1th R wave and according to the event inferred as the n+1th R wave, or the differential value generated by the operation processing control section is the third prescribed value or less after the peak of the event inferred as the n+2th R wave and according to the event inferred as the n+2th R wave.

8. The defibrillation electrical device according to claim 1 or 2, wherein control is performed so that the permission signal is generated from the permission signal generation section after the following requirement 5 is satisfied, Requirement 5: the differential value generated by the operation processing control section is third prescribed value or less after the peak of the event inferred as the n+1th R wave and according to the event inferred as the n+1th R wave.

9. The defibrillation electrical device according to claim 1 or 2, wherein control is performed so that the permission signal is generated from the permission signal generation section after the following requirement 5 is satisfied, control is performed so that the permission signal is generated from the permission signal generation section after the following requirement 5 is satisfied, 10. The defibrillation electrical device according to claim 1 or 2, wherein it is an intracardiac defibrillation electrical device.

11. An intracardiac defibrillation catheter system comprising: a catheter that is inserted into a cardiac chamber, has a distal end and a proximal end, and has a plurality of electrodes provided at a distal portion of the catheter; and the defibrillation electrical device according to any one of claims 1 to 10 that applies a voltage to the plurality of electrodes.

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