Defibrillation electrical device and method of generating a defibrillation signal

Abstract

The present application provides a new defibrillation electrical device and a method for generating a defibrillation signal. The defibrillation electrical device has an electrocardio waveform input unit and a permission signal generating unit. The defibrillation electrical device is controlled to generate a permission signal from the permission signal generating unit after the peak of an event inferred as an R wave of an electrocardio waveform obtained from a human body and input from the electrocardio waveform input unit, and after the following condition 1 is met. (Condition 1) The differential value generated according to the event inferred as the R wave is less than or equal to a constant C3 value.

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 methods include automated external defibrillators (AEDs), implantable cardioverter defibrillators (ICDs), defibrillator systems, and defibrillation catheter systems.

[0003] As an example of such a defibrillation catheter system, Patent Document 1 discloses a system comprising: an input unit for receiving an ECG waveform, a processing unit for processing the ECG waveform based on a probability density function to form an output signal, a heart rate detection device, and a processing output unit. The processing output unit connects the processing unit and the heart rate detection device to a defibrillation pulse generator in a manner that initiates the release of a defibrillation shock when it receives a predetermined signal from at least one of the processing unit and the heart rate detection device. Furthermore, the heart rate detection device is described as having a wave detection unit, which includes a comparison unit that differentiates the ECG signal, extracts the absolute value of the differentiated signal to obtain a slewrate, and outputs a slewrate output signal when the slewrate exceeds a predetermined slewrate threshold.

[0004] Patent Document 1: Japanese Patent Publication No. 59-500895

[0005] Previously, in the treatment of atrial fibrillation, defibrillation was performed during the absolute unresponsive period, when the ventricles did not respond even to stimulation. There is a concern that ventricular fibrillation might occur if stimulation is applied outside this absolute unresponsive period. Therefore, in existing defibrillation catheter systems, voltage needs to be applied synchronously with the waveform during ventricular contraction, i.e., the R wave. Specifically, the defibrillation electrical device in existing defibrillation catheter systems generates a permission signal related to the application of defibrillation voltage from the rise of the R wave to its peak. However, there is a concern that misinterpreting the T wave as an R wave and applying defibrillation voltage could induce ventricular fibrillation. Therefore, in recent years, there has been a desire to develop a defibrillation electrical device with a new permission signal generation mechanism. Summary of the Invention

[0006] 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.

[0007] The defibrillation electrical device of the present invention, which can solve the above-mentioned problems, is as follows.

[0008] [1] An electrical device for defibrillation, comprising an electrocardiogram waveform input section and an enable signal generation section.

[0009] The aforementioned defibrillation electrical device is characterized in that it is controlled to:

[0010] After the peak of the event inferred to be an R-wave in the electrocardiogram waveform obtained from the human body and input from the aforementioned electrocardiogram waveform input unit is exceeded, and after condition 1 below is met, an enable signal is generated from the aforementioned enable signal generation unit.

[0011] (Condition 1) The differential value generated based on the event inferred to be the above-mentioned R wave is a negative constant C3 value or less.

[0012] As described above, the defibrillation device of the present invention is provided with a threshold (a negative constant C3 value) for the differential value of the R wave relative to the portion of the R wave that corresponds to the descent phase after the peak of the R wave in the electrocardiogram waveform, a structure not previously found in defibrillation devices. Furthermore, by providing this structure, only R waves with a typically steep descent can be detected with high precision, making it easier to determine whether the waveform to be applied is an R wave, thus easily avoiding the application of voltage that may result in false detection of the R wave.

[0013] Furthermore, the preferred embodiments of the defibrillation electrical device and the method for generating defibrillation signals of the present invention are as described below [2] to

[17] .

[0014] [2] The defibrillation electrical device described in [1] is characterized in that it is controlled to:

[0015] The above-mentioned permission signal is generated after both condition 2 and condition 1 are satisfied.

[0016] (Condition 2) The peak value of the differential waveform (hereinafter referred to as "positive wave"), which is a collection of differential values ​​generated based on the event that is inferred to be an R-wave, which is equivalent to the rising phase of the event that is inferred to be an R-wave earlier than the peak, is a positive constant C1 value or higher.

[0017] [3] The defibrillation electrical device described in [2] is characterized in that it is controlled to:

[0018] The above-mentioned permission signal is generated after condition 2 above, condition 3 below, and condition 1 above are all satisfied.

[0019] (Condition 3) In the above positive wave, the time when the above differential value is a positive constant C2 value smaller than the above C1 value is measured, and the time is more than 10 m seconds and less than 80 m seconds.

[0020] [4] The defibrillation electrical device according to any one of [1] to [3] is characterized in that it is controlled to:

[0021] The above-mentioned permission signal is generated after condition 4 below and condition 1 above are both satisfied.

[0022] (Condition 4) For events inferred from the ratio as the aforementioned R wave (hereinafter referred to as "R") n The event preceding the "R wave" (hereinafter referred to as "R wave") is inferred to be an R wave. n-1 The differential value generated by the wave reaches the above-mentioned C3 value according to the above-mentioned R n The time taken until the differential value generated by the wave reaches the C3 value is measured, and this time is 50 milliseconds or more.

[0023] [5] The defibrillation electrical device according to any one of [1] to [4] is characterized in that,

[0024] The section between the ECG waveform input section and the enable signal generation section is constructed using hardware circuitry.

[0025] [6] The defibrillation electrical device according to any one of [1] to [5] is characterized in that,

[0026] Equipped with a display unit that displays the aforementioned electrocardiogram waveform,

[0027] The aforementioned defibrillation electrical device is controlled as follows:

[0028] After the peak of the event that is inferred to be an R-wave is exceeded, and after condition 1 below is met, a mark display signal is generated from the mark display signal generation unit to mark the event that is inferred to be an R-wave on the display unit.

[0029] (Condition 1) The differential value generated based on the event inferred to be the above-mentioned R wave is a negative constant C3 value or less.

[0030] [7] The defibrillation electrical device according to [6] is characterized in that it is controlled to:

[0031] The above-mentioned mark display signal is generated after both condition 2 and condition 1 are satisfied.

[0032] (Condition 2) The peak value of the differential waveform (hereinafter referred to as "positive wave"), which is a collection of differential values ​​generated based on the event that is inferred to be an R-wave, which is equivalent to the rising phase of the event that is inferred to be an R-wave earlier than the peak, is a positive constant C1 value or higher.

[0033] [8] The defibrillation electrical device described in [7] is characterized in that it is controlled to:

[0034] After condition 2 above, condition 3 below, and condition 1 above are all satisfied, the above-mentioned mark display signal is generated.

[0035] (Condition 3) In the above positive wave, the time when the above differential value is a positive constant C2 value smaller than the above C1 value is measured, and the time is more than 10 m seconds and less than 80 m seconds.

[0036] [9] The defibrillation electrical device according to any one of [6] to [8] is characterized in that it is controlled to:

[0037] The above-mentioned mark display signal is generated after condition 4 below and condition 1 above are both satisfied.

[0038] (Condition 4) For events inferred from the ratio as the aforementioned R wave (hereinafter referred to as "R") n The event preceding the "R wave" (hereinafter referred to as "R wave") is inferred to be an R wave. n-1 The differential value generated by the wave reaches the above-mentioned C3 value according to the above-mentioned R n The time taken until the differential value generated by the wave reaches the C3 value is measured, and this time is 50 milliseconds or more.

[0039]

[10] A method for generating a defibrillation signal, characterized by comprising the following steps:

[0040] After exceeding the peak of an event inferred as an R wave in electrocardiogram waveforms obtained from the human body, determine whether the following condition 1 is met; and

[0041] Once condition 1 above is met, an enable signal is generated.

[0042] (Condition 1) The differential value generated based on the event inferred to be the above-mentioned R wave is a negative constant C3 value or less.

[0043]

[11] The method for generating a defibrillation signal as described in

[10] is characterized in that,

[0044] The next step is to determine whether condition 2 is met.

[0045] (Condition 2) The peak value of the differential waveform (hereinafter referred to as "positive wave"), which is a collection of differential values ​​generated based on the event that is inferred to be an R-wave, which is equivalent to the rising phase of the event that is inferred to be an R-wave earlier than the peak, is a positive constant C1 value or higher.

[0046]

[12] The method for generating a defibrillation signal as described in

[11] is characterized in that,

[0047] The next step is to determine whether condition 3 below is met.

[0048] (Condition 3) In the above positive wave, the time when the above differential value is a positive constant C2 value smaller than the above C1 value is measured, and the time is more than 10 m seconds and less than 80 m seconds.

[0049]

[13] The method for generating a defibrillation signal according to any one of

[10] to

[12] is characterized in that,

[0050] The next step is to determine whether condition 4 below is met.

[0051] (Condition 4) For events inferred from the ratio as the aforementioned R wave (hereinafter referred to as "R") n The event preceding the "R wave" (hereinafter referred to as "R wave") is inferred to be an R wave. n-1 The differential value generated by the wave reaches the above-mentioned C3 value according to the above-mentioned R n The time taken until the differential value generated by the wave reaches the C3 value is measured, and this time is 50 milliseconds or more.

[0052]

[14] The method for generating a defibrillation signal according to any one of

[10] to

[13] is characterized by comprising the following steps:

[0053] After exceeding the peak of an event inferred as an R wave in electrocardiogram waveforms obtained from the human body, determine whether the following condition 1 is met; and

[0054] After condition 1 above is met, a mark display signal is generated to mark the event that is inferred to be an R-wave on the display unit.

[0055] The method for generating the defibrillation signal described above includes a step of generating the permission signal after the step of generating the marker display signal described above.

[0056] (Condition 1) The differential value generated based on the event inferred to be the above-mentioned R wave is a negative constant C3 value or less.

[0057]

[15] The method for generating a defibrillation signal as described in

[14] is characterized by comprising the following steps:

[0058] Determine whether condition 2 is satisfied; and

[0059] After both condition 2 and condition 1 are satisfied, a mark display signal is generated to mark the event that is inferred to be an R-wave on the display unit.

[0060] (Condition 2) The peak value of the differential waveform (hereinafter referred to as "positive wave"), which is a collection of differential values ​​generated based on the event that is inferred to be an R-wave, which is equivalent to the rising phase of the event that is inferred to be an R-wave earlier than the peak, is a positive constant C1 value or higher.

[0061]

[16] The method for generating a defibrillation signal as described in

[15] is characterized by comprising the following steps:

[0062] Determine whether the following condition 3 is met; and

[0063] After conditions 2 and 3 above, as well as condition 1 above, are satisfied, a mark display signal is generated for marking the event that is inferred to be an R-wave on the display unit.

[0064] (Condition 3) In the above positive wave, the time when the above differential value is a positive constant C2 value smaller than the above C1 value is measured, and the time is more than 10 m seconds and less than 80 m seconds.

[0065]

[17] The method for generating a defibrillation signal according to any one of

[14] to

[16] is characterized by comprising the following steps:

[0066] Determine whether the following condition 4 is met; and

[0067] After condition 4 and condition 1 are both satisfied, a mark display signal is generated to mark the event that is inferred to be an R-wave on the display unit.

[0068] (Condition 4) For events inferred from the ratio as the aforementioned R wave (hereinafter referred to as "R") n The event preceding the "R wave" (hereinafter referred to as "R wave") is inferred to be an R wave. n-1 The differential value generated by the wave reaches the above-mentioned C3 value according to the above-mentioned R n The time taken until the differential value generated by the wave reaches the C3 value is measured, and this time is 50 milliseconds or more.

[0069] According to the present invention, a new electrical device for defibrillation and a method for generating defibrillation signals can be provided by means of the above-described structure. Attached Figure Description

[0070] Figure 1This 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.

[0071] Figure 2 This is a diagram showing an example of an electrocardiogram (ECG) waveform displayed on the display of an ECG machine, and a differential waveform, which is a collection of differential values ​​of the ECG waveform.

[0072] Figure 3 This is a diagram representing another example of a differential waveform that is a collection of differential values ​​of an electrocardiogram waveform.

[0073] Figure 4 This is a block diagram of a defibrillation catheter system that includes the defibrillation electrical device according to the first embodiment of the present invention.

[0074] Figure 5 This is a block diagram of an electrical device for defibrillation according to the second embodiment of the present invention.

[0075] Figure 6 This is a flowchart illustrating an example of the processing steps performed by the defibrillation electrical device according to the second embodiment of the present invention. Detailed Implementation

[0076] The present invention will now be described in more detail based on the embodiments described below. However, the present invention is not limited to the embodiments described below, and may be implemented by appropriate modifications within the scope of the foregoing or following spirit, all of which are included within the technical scope of the present invention. Furthermore, in the various drawings, for convenience, reference numerals for components may be omitted; however, in such cases, please refer to the specification or other drawings. Additionally, the dimensions of various components in the drawings are chosen to facilitate understanding of the features of the present invention, and therefore may differ from the actual dimensions.

[0077] The defibrillation electrical device of the present invention includes an electrocardiogram waveform input section and an enable signal generation section. The defibrillation electrical device is characterized in that it is controlled to generate an enable signal from the enable signal generation section after the peak of an event inferred to be an R wave in the electrocardiogram waveform obtained from the human body and input from the electrocardiogram waveform input section is exceeded, and after condition 1 is satisfied.

[0078] (Condition 1) The differential value generated based on the event inferred to be the above-mentioned R wave is a negative constant C3 value or less.

[0079] As described above, the defibrillator sets a threshold (a negative constant C3 value) for the differential value of the event inferred as an R wave relative to the ECG waveform, which corresponds to the portion of the decline phase after the peak of the event inferred as an R wave. Defibrillator devices with this structure have not existed previously. Furthermore, by having this structure, it is easy to determine whether the waveform to be applied is an R wave, thereby easily avoiding the application of voltage that may result in false detection of an R wave.

[0080] The following is for reference Figures 1-3 The structure of the defibrillation electrical device and the defibrillation catheter system including 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 showing an example of an electrocardiogram (ECG) waveform displayed on the display unit (not shown) of an electrocardiograph, and a differential waveform that is a collection of differential values ​​of the ECG waveform. Figure 2 The horizontal axis of the electrocardiogram waveform represents time (seconds), and the vertical axis represents voltage difference (mV). Figure 2 The dashed line C1 extending along the time axis of the differential waveform represents the value of the constant C1 with a positive value (differential value) on the vertical axis; the dashed line C2 extending along the time axis represents the value of the constant C2 with a positive value (differential value) on the vertical axis; and the dashed line C3 extending along the time axis represents the value of the constant C3 with a negative value (differential value) on the vertical axis. Figure 2 In the diagram, the solid line B extending along the time axis is the baseline of the differential waveform. Figure 3 This is a diagram representing another example of a differential waveform that is a collection of differential values ​​of an electrocardiogram waveform.

[0081] Figure 1 The defibrillator 2 includes an electrocardiogram (ECG) waveform input unit 3 and an enable signal generation unit 7. The defibrillator 2 receives an ECG waveform obtained from surface electrodes 19 disposed on the body surface via an electrocardiograph 40 or similar device from the ECG waveform input unit 3. Furthermore, the defibrillator 2 is controlled to: when exceeding... Figure 2 After the peak 51p of the event 51, which is inferred to be an R wave from the ECG waveform 50 shown, is reached, and after condition 1 is met, an enable signal is generated from the enable signal generation unit 7.

[0082] (Condition 1) The differential value generated based on event 51, which is inferred to be an R-wave, is a negative constant C3 value or less.

[0083] Figure 2The differential waveform 60 is an example of a collection of differential values ​​generated based on the electrocardiogram waveform 50. The negative wave 61N of the differential waveform 60 corresponds to a collection of differential values ​​generated based on the falling phase 51d following the peak 51p of the event 51 inferred to be an R wave from the electrocardiogram waveform 50. (See below for further details.) Figure 2 The differential waveform 60 illustrates the timing of the enable signal generation. Point G of the differential waveform 60 corresponds to the moment when the differential value reaches a negative constant C3 value. The defibrillation electrical device 2 only needs to be controlled to generate the enable signal at a time after point G. Figure 2 In this context, waveforms below point G exist only in the negative wave 61N generated based on event 51, which is inferred to be an R wave. Therefore, it is easy to determine whether the waveform of the applied object is an R wave through condition 1. By setting such a threshold (a negative constant C3 value), it is easy to avoid the application of voltage that accompanies the false detection of R waves. On the other hand, the defibrillation device 2 is preferably controlled to generate an allow signal before the peak 61b of the negative wave 61N. This allows defibrillation to be easily completed within the absolute no-response period. Furthermore, the defibrillation device 2 is preferably controlled to generate an allow signal within 60ms from when the differential value reaches a negative constant C3 value (point G), more preferably within 50ms, even more preferably within 10ms, and particularly preferably when the differential value reaches a negative constant C3 value. In addition, the peak 61b of the negative wave 61N corresponds to the inflection point 51c in the falling phase 51d of event 51, which is inferred to be an R wave.

[0084] 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 relative to the power supply unit 9 (described later), permission signals for pulse voltage generation, permission signals for voltage application, and permission signals for switching on relative to the switching unit 10 (described later). When condition 1 is met, the permission signal generation unit 7 only needs to generate at least one of the above permission signals. On the other hand, permission signals can also be generated by operation of the operation unit 6 (described later), regardless of condition 1. Furthermore, the permission signal generation unit 7 is not limited to the operation processing control unit 8 (described later) and can also be provided in the power supply unit 9, etc.

[0085] Examples of differential values ​​generated based on event 51, which is inferred to be the aforementioned R-wave, include differential values ​​obtained through the differential circuit 4 described later, and differential values ​​obtained through conventional differential calculations. Furthermore, the differential value generated based on event 51, which is inferred to be the aforementioned R-wave, is preferably a first-order differential value. Compared to second-order differential values, first-order differential values ​​have a shorter generation time, thus shortening the time from acquiring ECG information to generating the permitted signal.

[0086] The aforementioned negative constant C3 value is, for example, in Figure 2 In the differential waveform 60, the value of the vertical axis (differential value) is below the baseline B. 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 51p of event 51, which is inferred to be an R-wave, i.e., the O point of the differential waveform 60. Additionally, the negative constant C3 value can also be a value different from the type of differential circuit 4, etc.

[0087] The ECG waveform 50 is preferably obtained through lead II, where events easily detectable and inferred to be R waves. However, the ECG waveform 50 is not limited to lead II and can be obtained through other leads depending on the orientation of the patient's heart. For example, when obtaining the ECG waveform through 12 leads, the ECG waveform 50 can also be obtained through leads V1, V2, V3, V4, V5, V6, lead I, lead II, lead III, aVR, aVL, or aVF. Furthermore, the ECG waveform 50 can be the average waveform of two or more leads, the average waveform of three or more leads, or the average waveform of 12 leads.

[0088] The defibrillation electrical device 2 is preferably controlled to generate an enable signal after condition 2 and condition 1 are satisfied.

[0089] (Condition 2) The peak value of the differential waveform (hereinafter referred to as "positive wave 61P"), which is a collection of differential values ​​generated based on the rising phase 51r of the event 51 that is inferred to be an R-wave, is above a positive constant C1 value.

[0090] The defibrillation electrical device 2 is set with a threshold (positive constant C1 value) relative to the peak value of the positive wave 61P as described in condition 2 above. This makes it easy to determine whether the waveform of the applied object is an R wave, thus avoiding the application of voltage that may be falsely detected along with the R wave.

[0091] The aforementioned positive constant C1 value is, for example, in Figure 2 In the differential waveform 60, the value of the vertical axis (differential value) is above the baseline B. Additionally, the positive constant C1 value can be different from the value corresponding to the type of differential circuit 4, etc.

[0092] The defibrillation electrical device 2 is preferably controlled to generate an enable signal after the conditions 2, 3 and 1 above are met.

[0093] (Condition 3) In the positive wave 61P, the time when the differential value is a positive constant C2 value smaller than C1 value is measured, which is greater than 10 m seconds and less than 80 m seconds.

[0094] The defibrillator 2 is configured with a threshold related to the upper limit of the time during which the differential value of the positive wave 61P is above the constant C2 value, as described in condition 3 above. This facilitates the avoidance of false detections of the R wave. Specifically, the differential waveform 62 generated based on the patient's T wave 52 may be similar to the differential waveform 61 generated based on the event 51 that is inferred to be an R wave. However, with the aforementioned threshold, the differential waveform 62 generated by the longer T wave 52 specified in condition 3 above can be easily removed from the voltage application target. This time is more preferably 70 ms or less, and more preferably 60 ms or less. On the other hand, with a time of 10 ms or more, high-frequency noise with a short peak width can be easily removed. As a result, the detection sensitivity of the R wave can be improved. This time is more preferably 15 ms or more, and more preferably 20 ms or more.

[0095] The aforementioned positive constant C2 value is, for example, in Figure 2 In the differential waveform 60, the value of the vertical axis (differential value) is above the baseline B. Additionally, the positive constant C2 value can be a different value corresponding to the type of differential circuit 4, etc.

[0096] The defibrillation electrical device 2 can also be controlled to generate an enable signal after condition 3 and condition 1 are met, but condition 2 is not met.

[0097] The defibrillation electrical device 2 is preferably controlled to generate an enable signal after condition 4 and condition 1 are satisfied.

[0098] (Condition 4) For events inferred as R waves from the ratio (hereinafter referred to as "R waves") n The event preceding the "R wave" (hereinafter referred to as "R wave") is inferred to be an R wave. n-1 The differential value generated by the wave reaches a negative constant C3 value according to R. n The time taken until the differential value generated by the wave reaches a negative constant C3 is measured, and this time is more than 50 milliseconds.

[0099] The following is for reference Figure 3 Condition 4 will be explained. Figure 3 This is a diagram representing another example of a differential waveform that is a collection of differential values ​​of an electrocardiogram waveform. Figure 3 The differential waveform 60 has R as a function based on the electrocardiogram waveform. n The differential waveform n, and the differential values ​​of the collection generated by the wave (not shown), are based on the ratio R. n The R wave that comes first n-1 The differential waveform n-1 is a collection of differential values ​​generated by a wave (not shown). Figure 3In this case, satisfying condition 4 means that the value of the vertical axis (differential value) of the differential waveform n-1 reaches a negative value of the constant C3, G. n-1 The value of the differential waveform n on the vertical axis (differential value) reaches a negative constant C3 value. n The time up to point (hereinafter, there exists a term called G) n-1 -G n (In the case of time) it is 50 ms or more. By setting this time to 50 ms or more, the differential waveform 62 generated by the T-wave can be easily removed from the voltage application target, thus easily avoiding the application of voltage accompanied by false detection. G n-1 -G n The time is more preferably 100 ms or more, further preferably 200 ms or more, even more preferably 240 ms or more, and particularly preferably 260 ms or more. On the other hand, G n-1 -G n The upper limit of the time is not specifically limited, but it can be, for example, less than 2 seconds, less than 1 second, less than 800m seconds, less than 600m seconds, less than 400m seconds, or less than 350m seconds.

[0100] The defibrillation electrical device 2 can also be controlled to generate an enable signal after at least one of conditions 2 and 3, condition 4, and condition 1 are met.

[0101] The defibrillation electrical device 2 is preferably controlled to generate an enable signal after condition 5 and condition 1 are satisfied.

[0102] (Condition 5) The time from point O of the differential waveform 60, which is the part corresponding to the peak 51p of the event 51 that is inferred to be an R wave, to point G, where the differential value reaches the negative value of the constant C3, is measured. This time is more than 2 (m seconds) and less than 20 (m seconds).

[0103] By setting a threshold for the time from point O to point G in the differential waveform 60 as described in condition 5 above, the defibrillation electrical device 2 can easily avoid false detection of the R wave.

[0104] The defibrillation electrical device 2 can also be controlled to generate an enable signal after at least one condition selected from the group consisting of condition 2, condition 3 and condition 4, condition 5 and condition 1 are met.

[0105] The above-mentioned negative constant C3 value, positive constant C2 value, positive constant C1 value, G n-1 -G nThe time threshold and the time threshold from point O to point G are preferably stored in the memory described later or set in the comparator. Alternatively, they do not need to be stored in the same memory, or they can be stored in different memories. Furthermore, they do not need to be stored in the same comparator, or they can be stored in different comparators.

[0106] The above mainly describes the structure related to the generation of the permission signal for the defibrillation electrical device 2, but the following will refer to... Figure 1 , Figure 2 The structure of the defibrillation electrical device 2 of the first embodiment and the defibrillation catheter system 1 including the defibrillation electrical device 2 is described in detail. Figure 4 This is a block diagram showing a defibrillation catheter system 1 that includes the defibrillation electrical device 2 of the first embodiment.

[0107] exist Figure 1 , Figure 4 In the defibrillation catheter system 1, electrocardiographic information obtained from a surface electrode 19 disposed on the body surface is transmitted to an electrocardiograph 40 via a first lead 31. The electrode for acquiring the electrocardiographic information is not limited to a surface electrode; it can also be an electrode for measuring intracardiac potentials. Surface electrodes are preferred because they have excellent sensitivity in detecting R waves. A 12-lead electrode is preferred as the surface electrode.

[0108] Figure 1 , Figure 4 The defibrillation electrical device 2 includes: a first connection portion 11 connected to a plurality of electrodes disposed distal to a catheter 20; a second connection portion 12 connected to an electrocardiograph 40; a power supply portion 9 that generates an applied voltage; and a switching portion 10 connected to the power supply portion 9 to switch to an applied voltage mode. Furthermore, the first connection portion 11 is connected to the power supply portion 9 via the switching portion 10, but the first connection portion 11 is not connected to the second connection portion 12 via the switching portion 10. Because the first connection portion 11 is not connected to the second connection portion 12 via the switching portion 10, local potentials in each electrode can be measured even during defibrillation.

[0109] In addition, the defibrillator 2 includes an electrocardiogram (ECG) waveform input unit 3, which inputs information of the ECG waveform output from the electrocardiograph 40 into the internal system via a second lead 32 or the like. The ECG waveform input unit 3 is not particularly limited, but it is preferably capable of withstanding a 5kV discharge input through a 50Ω resistor.

[0110] The electrocardiogram (ECG) waveform input from the ECG waveform input unit 3 is 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 satisfies conditions related to thresholds such as the negative constant C3 value stored in the memory 5, i.e., condition 1. If condition 1 is satisfied, the allowable signal generation unit 7 within the arithmetic processing control unit 8 generates a voltage application allowable signal. This allowable signal is transmitted to the power supply unit 9, thereby enabling the application of DC voltages of different polarities to the first electrode group 21 and the second electrode group 22. The applied waveform can be biphasic with polarity reversing midway or uniphasic with constant polarity, but biphasic waveforms are preferred because they can stimulate with less energy. The applied electrical energy to the organism can be set to, for example, 1J or more and 30J or less.

[0111] Differentiator circuit 4 and memory 5 can use known structures; they can be housed within the arithmetic processing control unit 8 or installed separately. Alternatively, differential circuit 4 and memory 5 can be integrated within the FPGA described later. Furthermore, although defibrillation device 2 is not shown, it can have a display unit 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 display unit 73 in the second embodiment.

[0112] The power supply unit 9 preferably includes, for example, a power supply, a boost circuit for boosting DC voltage, a charging circuit, a capacitor for charging the applied voltage, and a waveform generation circuit for generating pulse voltage. Furthermore, at least some of these components may be located outside the power supply unit 9. The location of the power supply unit 9 is not particularly limited; for example, it may be as follows: Figure 4 It can be installed outside the arithmetic processing control unit 8 as shown, or it can be installed inside the arithmetic processing control unit 8.

[0113] When the electrocardiogram waveform input from the electrocardiogram waveform input unit 3 meets condition 1, the enable signal generation unit 7 in the arithmetic processing control unit 8 can also be controlled to generate an enable signal for switching on. This enable signal is transmitted to the first switch 10A and the second switch 10B of the switching unit 10, thereby changing the first switch 10A and the second switch 10B from the off state to the on state, thereby enabling power to the first electrode group 21 and the second electrode group 22. Furthermore, as... Figure 4 As shown, when the switch constituting the switching unit 10 is in the off state, the first electrode group 21 and the second electrode group 22 are insulated from the power supply unit 9, so that the first electrode group 21 and the second electrode group 22 can be used to measure the intracardiac potential without defibrillation.

[0114] 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 enable signal generation unit 7, the arithmetic processing 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).

[0115] The defibrillation electrical device 2 may also include a computer that executes program commands. This program is software used to implement the functions of at least one of the following: ECG waveform input unit 3, differentiating circuit 4, memory 5, enable 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 above functions are achieved by the processor executing the program stored on the computer-readable recording medium. As the processor, a CPU (Central Processing Unit) can be used. As the recording medium, ROM (Read Only Memory) or similar media can be used. Additionally, RAM (Random Access Memory) can also be included in the recording medium. 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.

[0116] In addition, Figure 1 , Figure 3 In the defibrillation electrical device 2, an operation unit 6 is preferably provided for performing various operations such as starting, stopping, setting applied energy, charging, applying voltage, and selecting applied electrodes. The operation unit 6 is preferably a known input unit such as a push-button switch or lever. The operation unit 6 is preferably 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 enable signal, a portion of the aforementioned enable signals, can be generated through the operation of the operation unit 6.

[0117] The first electrode group 21 and the second electrode group 22 are preferably not connected to the electrocardiograph 40 via the switching unit 10, and more preferably not connected to the electrocardiograph 40 via any of the switching units. This ensures that the first electrode group 21 and the second electrode group 22 are always connected to the electrocardiograph 40, allowing for easy performance of various procedures while simultaneously checking the intracardiac potentials displayed on the display unit (not shown) of the electrocardiograph 40.

[0118] The switching unit 10 may also have one or more switches. For example... Figure 4 As shown, the switching unit 10 preferably 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 switch 10A, and the second electrode group 22 is connected to the power supply unit 9 via the second switch 10B. That is, the first electrode group 21 and the second electrode group 22 are preferably connected to the power supply unit 9 via different switches. This allows for electrical isolation of each electrode group, thus enabling the acquisition of intracardiac potentials independently of each electrode group.

[0119] Defibrillation electrical device 2 can also be as follows Figure 1 As shown, a third electrode group 23, which is located closer to the positional side than the first electrode group 21 and the second electrode group 22, is provided as a dedicated electrode for measuring intracardiac potentials. Since the third electrode group 23 is located proximally, it can be positioned, for example, at a location corresponding to the ascending aorta. Preferably, the third electrode group 23 is not connected to the power supply unit 9. Therefore, the third electrode group 23 can be easily used as a dedicated electrode for measuring intracardiac potentials.

[0120] The number of electrodes constituting each electrode group is not particularly limited; they can be the same or different in each electrode group. 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 easier to make the surface areas of the first electrode group 21 and the second electrode group 22 identical. By ensuring that the surface areas of each first electrode group 21 and each second electrode group 22 are identical and that the same number of electrodes are evenly distributed, efficient defibrillation can be performed, and the accuracy of intracardiac electrocardiogram measurements can be improved.

[0121] The number of electrodes constituting the third electrode group 23 is preferably 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 8, and the number of electrodes in the third electrode group 23 can be set to 4. By setting the number of electrodes in the third electrode group 23 in this way, the potential at the position corresponding to the ascending aorta can be appropriately measured.

[0122] Each electrode assembly is preferably located in more than half of the outer periphery of the resin tubing 27, and more preferably 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.

[0123] 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.

[0124] like Figure 1 As shown, a tip blade 25 may also be provided at the distal end of the catheter 20. The tip blade 25 preferably has a tapered portion whose outer diameter decreases towards the distal side. The tip blade 25 may also be made of a conductive material. This allows the tip blade 25 to function as an electrode. Alternatively, the tip blade 25 may also be made of a polymer material, and to protect the tissues within the body from contact with the catheter 20, the hardness of the tip blade 25 may be lower than that of the resin tubing 27.

[0125] An operating line and spring component for bending the distal side of the catheter 20 may also be provided inside the resin tubing 27. Specifically, preferably, the distal end of the operating line is fixed to the distal end of the resin tubing 27 or the front blade 25, and the proximal end of the operating line is fixed to the handle 26 described later.

[0126] like Figure 4 As shown, it is preferable that a third wire 33 (wire) is connected to each electrode group. The other end of the third wire 33 connected to the first electrode group 21 and the second electrode group 22 is preferably connected to the first connection portion 11 of the defibrillation electrical device 2. The other end of the third wire 33 connected to the third electrode group 23 is preferably connected to the third connection portion 13 of the defibrillation electrical device 2. The third wire 33 may also be multiple wires connected by connecting components such as connectors.

[0127] The third connecting portion 13 and the fourth connecting portion 14 are preferably connected via the seventh conductor 37. Here, the seventh conductor 37 may be wiring material or part of a wiring pattern disposed on a printed circuit board.

[0128] The first connecting part 11 and the switching part 10 are preferably 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 part 9, voltage can be applied. The first electrode group 21 and the second electrode group 22 can also be connected to the power supply part 9 via different connecting components such as connectors.

[0129] The second connection portion 12 preferably connects to 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. Furthermore, the second connection portion 12 is preferably connected to the fifth lead 35 by the sixth lead 36. Switches are preferably not 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.

[0130] like Figure 1 As shown, a handle 26 for the user to hold when operating the catheter 20 may also be provided on the proximal side of the resin hose 27. The shape of the handle 26 is not particularly limited, but in order to alleviate stress concentration at the connection between the resin hose 27 and the handle 26, it is preferable to form a tapered shape with the outer diameter decreasing towards the distal side.

[0131] The electrocardiograph 40 measures intracardiac potentials using various electrodes. The electrocardiograph 40 can utilize a known structure.

[0132] Although not shown, the defibrillator electrical device 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. The location of the electrode selection switch is not particularly limited, but it is preferable to connect it to the power supply unit 9, and more preferably, to install it within the arithmetic processing control unit 8. The electrode selection switch may 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, the defibrillator electrical device 2 may also include a safety switch. This provides a fault-tolerant 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. Additionally, although not shown, the defibrillator electrical device 2 may also include a protection circuit to absorb high voltage generated when the switch is open. This prevents damage to the switches. Additionally, although not shown, an overvoltage protection circuit can be provided between the power supply unit 9 in the defibrillator 2 and the electrocardiograph 40 to protect the electrocardiograph 40 from overvoltage. This prevents the electrocardiograph 40 from being damaged by the application of overvoltage. Furthermore, although not shown, the defibrillator 2 may also include an impedance measurement circuit. The impedance measurement circuit is preferably connected between the first electrode group 21 and the second electrode group 22 in a manner that measures the impedance between the first electrode group 21 and the second electrode group 22.

[0133] Next, refer to Figure 5 The structure of the defibrillation electrical device 70 of the second embodiment is described in detail. Figure 5 This is a block diagram of the defibrillation electrical device 70 according to the second embodiment. Furthermore, structures identical to those in the defibrillation electrical device 2 of the first embodiment are labeled with the same reference numerals, and descriptions are omitted.

[0134] like Figure 5 As shown, in the second embodiment, the defibrillation electrical device 70 preferably displays the ECG information input from the ECG waveform input unit 3 as an ECG waveform on the display unit 73 via an A / D converter 71 and a first arithmetic processing control unit 72 (CPU). Alternatively, the ECG information input from the ECG waveform input unit 3 is used to generate a differential waveform via a differentiating circuit 4. Next, the differential waveform is preferably passed to a comparator 74, which has a negative constant C3 value set. If condition 1 is met, a signal is transmitted to the second arithmetic processing control unit 75 (FPGA), which generates a marker display signal. After the marker display signal is transmitted to the first arithmetic processing control unit 72 (CPU), a marker is displayed on the display unit 73 for events inferred to be R-waves. Examples of marker shapes include circles, triangles, quadrilaterals, polygons, and lines. Examples of marker positions include the peak of events inferred to be R-waves. In addition, the marker display signal can be generated by the first arithmetic processing control unit 72 (CPU) simply by displaying a marker on the display unit 73 for events that are inferred to be R waves.

[0135] As described above, the defibrillation electrical device 70 preferably includes a display unit 73 for displaying electrocardiogram waveforms, and is controlled to generate a marker display signal from the marker display signal generation unit 76 for marking the event predicted as an R wave on the display unit 7 after the peak of an event predicted as an R wave has been exceeded and after condition 1 is met. If the event predicted as an R wave is marked on the display unit 73 in this way, the operator can visually confirm the state of the R wave.

[0136] (Condition 1) The differential value generated based on the event inferred to be an R-wave is a negative constant C3 value or less.

[0137] The defibrillation electrical device 70 is further preferably controlled to generate a marker display signal after condition 2 and condition 1 are satisfied.

[0138] (Condition 2) The peak value of the differential waveform (hereinafter referred to as "positive wave 61P"), which is a collection of differential values ​​generated based on events that are inferred to be R-waves and whose peaks are equivalent to the rising phase preceding the peak of the event that is inferred to be R-waves, is above the positive constant C1 value.

[0139] The defibrillation electrical device 70 is further preferably controlled to generate a marker display signal after condition 2, condition 3 below, and condition 1 are satisfied.

[0140] (Condition 3) In the positive wave 61P, the time when the differential value is greater than or equal to C2, which is less than C1, is measured. This time is greater than or equal to 10 m seconds and less than 80 m seconds.

[0141] The defibrillation electrical device 70 is further preferably controlled to generate a marker display signal after condition 4 and condition 1 are satisfied.

[0142] (Condition 4) For events inferred as R waves from the ratio (hereinafter referred to as "R waves") n The event preceding the "R wave" (hereinafter referred to as "R wave") is inferred to be an R wave. n-1 The differential value generated by the wave reaches the C3 value according to R. n The time taken for the differential value generated by the wave to reach the C3 value is measured, and this time is more than 50 milliseconds.

[0143] Furthermore, for details of conditions 1 to 4 above, please refer to the description of the defibrillation electrical device 2 in the first embodiment.

[0144] Furthermore, the defibrillation electrical device 70 can preferably 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. Simultaneously with switching this mode, the applied energy can be set, and the charging of the capacitor can begin or be completed. Furthermore, a pulse voltage can be automatically generated after charging is complete. The non-permitted mode is a mode in which no defibrillation-related permitted signal is generated even if the aforementioned condition 1 is met, while the permitted mode is a mode in which a defibrillation-related permitted signal is generated if the aforementioned condition 1 is met. 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, thus facilitating defibrillation. The defibrillation-related permitted signal is not particularly limited to any signal related to the application of defibrillation voltage; examples include permitted signals for charging relative to the power supply unit 9, permitted signals for pulse voltage generation, permitted signals for voltage application, and permitted signals for switching on relative to the switching unit 10. Further details regarding the defibrillation-related permitted signal can be found in the description of the first embodiment.

[0145] Furthermore, the defibrillation electrical device 70 is preferably configured such that: the electrocardiogram information input from the electrocardiogram waveform input unit 3 is generated into a differential waveform by the differential circuit 4, and the differential waveform is transmitted to a comparator 74 which has a negative constant C3 value set, etc. If the above conditions 1 are met, a signal is transmitted to the second arithmetic processing control unit 75 (FPGA), and the second arithmetic processing control unit 75 (FPGA) generates an enable signal.

[0146] That is, preferably, the section from the ECG waveform input unit 3 to the enable signal generation unit 7 is constructed using hardware circuitry. This hardware circuitry is a circuit that does not perform signal processing by software, thus speeding up signal processing. As a result, the time from acquiring ECG information to generating the enable signal can be shortened. Furthermore, the signal from the ECG waveform input unit 3 to the enable signal generation unit 7 can be either an analog signal or a digital signal.

[0147] Furthermore, at least one of the functions of the defibrillation electrical device 70, such as the ECG waveform input unit 3, the differentiating circuit 4, the comparator 74, the enable 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 in the first embodiment.

[0148] Figure 6 This is a flowchart illustrating an example of the procedures performed by the defibrillation electrical device 70. Figure 6 In this example, the differentiating circuit 4 generates a differential waveform value based on the ECG information input from the ECG waveform input unit 3 (step S1). Next, a comparator 74, with a negative constant C3 value set, determines whether the differential value satisfies condition 1 (step S2). If condition 1 is satisfied, the comparator 74 transmits a signal to the second arithmetic processing control unit 75 (FPGA); if condition 1 is not satisfied, the comparator 74 does not transmit a signal to the second arithmetic processing control unit 75 (FPGA). The second arithmetic processing control unit 75 (FPGA) generates an enable signal based on the above signal (step S3). In this case, the second arithmetic processing control unit 75 (FPGA) is equivalent to the enable signal generation unit 7.

[0149] The defibrillation signal generation method according to an embodiment of the present invention includes the following steps: after exceeding the peak 51p of an event 51 inferred as an R wave in an electrocardiogram waveform 50 obtained from a human body, determining whether the following condition 1 is satisfied; and generating an allow signal after condition 1 is satisfied.

[0150] (Condition 1) The differential value generated based on event 51, which is inferred to be an R-wave, is a negative constant C3 value or less.

[0151] The method for generating the defibrillation signal preferably further includes a step of determining whether the following condition 2 is met.

[0152] (Condition 2) The peak value of the differential waveform (hereinafter referred to as "positive wave 61P"), which is a collection of differential values ​​generated based on the rising phase 51r of the event 51 that is inferred to be an R-wave, is above a positive constant C1 value.

[0153] The method for generating the defibrillation signal preferably further includes a step of determining whether the following condition 3 is met.

[0154] (Condition 3) In the positive wave 61P, the time when the differential value is greater than or equal to the positive constant C2 value which is smaller than the positive constant C1 value is measured, and the time is greater than or equal to 10 m seconds and less than or equal to 80 m seconds.

[0155] The method for generating the defibrillation signal preferably further includes a step of determining whether the following condition 4 is met.

[0156] (Condition 4) For events inferred as R waves from the ratio (hereinafter referred to as "R waves") n The event preceding the "R wave" (hereinafter referred to as "R wave") is inferred to be an R wave. n-1 The differential value generated by the wave reaches the C3 value according to R. n The time taken for the differential value generated by the wave to reach the C3 value is measured, and this time is more than 50 milliseconds.

[0157] The method for generating a defibrillation signal preferably includes the following steps: after satisfying at least one condition selected from the group consisting of conditions 2, 3 and 4, and condition 1, a permission signal is generated.

[0158] The defibrillation signal generation method preferably includes the following steps: after exceeding the peak 51p of event 51, which is inferred to be an R wave in the electrocardiogram waveform obtained from the human body, determining whether the following condition 1 is met; and after condition 1 is met, generating a marker display signal for marking event 51, which is inferred to be an R wave, on the display unit 73. The defibrillation signal generation method includes a step of generating an enable signal after the step of generating the marker display signal.

[0159] (Condition 1) The differential value generated based on event 51, which is inferred to be an R-wave, is a negative constant C3 value or less.

[0160] By having a step of generating an allowable signal after the step of generating the marker display signal, for example, after assessing the heart's state by marking events inferred to be R waves with markers and confirming the RR interval through visual observation, the disallowed mode of defibrillation can be switched to an allowable mode. This makes defibrillation easier to perform, thereby improving safety.

[0161] The method for generating a defibrillation signal preferably includes the following steps: determining whether condition 2 is satisfied; and, after condition 2 and condition 1 are satisfied, generating a marker display signal for marking the event 51 that is inferred to be an R wave on the display unit 73.

[0162] (Condition 2) The peak value of the differential waveform (hereinafter referred to as "positive wave 61P"), which is a collection of differential values ​​generated based on the rising phase of the event 51 that is inferred to be an R-wave, is above a positive constant C1 value.

[0163] The defibrillation signal generation method preferably includes the following steps: determining whether condition 3 is satisfied; and after condition 2, condition 3 and condition 1 are satisfied, generating a mark display signal for marking the event 51 that is inferred to be an R wave on the display unit 73.

[0164] (Condition 3) In the positive wave 61P, the time when the differential value is a positive constant C2 value smaller than C1 value is measured, which is greater than 10 m seconds and less than 80 m seconds.

[0165] The method for generating a defibrillation signal preferably includes the following steps: after at least one condition selected from the group consisting of condition 2 and condition 3 above, and condition 1 above, a marker display signal is generated.

[0166] The method for generating a defibrillation signal preferably includes the following steps: determining whether condition 4 is satisfied; and, after condition 4 and condition 1 are satisfied, generating a marker display signal for marking the event 51 that is inferred to be an R wave on the display unit 73.

[0167] (Condition 4) For events inferred as R waves from the ratio (hereinafter referred to as "R waves") n The event preceding the "R wave" (hereinafter referred to as "R wave") is inferred to be an R wave. n-1 The differential value generated by the wave reaches the C3 value according to R. n The time taken for the differential value generated by the wave to reach the C3 value is measured, and this time is more than 50 milliseconds.

[0168] The method for generating a defibrillation signal preferably includes the following steps: after at least one condition selected from the group consisting of the above conditions 2, 3 and 4, and condition 1, is satisfied, a marker display signal is generated.

[0169] The steps for determining whether conditions 1 to 4 above are met can be performed, for example, by using the differentiating circuit, arithmetic processing control unit, memory, comparator, power supply unit, etc. of the defibrillator electrical device 2 and the defibrillator electrical device 70. For details, please refer to the descriptions of each condition of the defibrillator electrical device 2 and the defibrillator electrical device 70.

[0170] In this invention, the method for generating defibrillation signals does not need to be performed within a defibrillation electrical device, but can be performed separately in different devices.

[0171] This application claims the benefit of priority based on Japanese Patent Application No. 2020-040144, filed on March 9, 2020. The entire contents of the description of Japanese Patent Application No. 2020-040144, filed on March 9, 2020, are incorporated herein by reference.

[0172] Explanation of reference numerals in the attached figures

[0173] 1…Defibrillation catheter system; 2…Defibrillation electrical device; 3…ECG waveform input unit; 4…Differentiating circuit; 5…Memory; 6…Operating unit; 7…Allow signal generation unit; 8…Arithmetic processing and control unit; 9…Power supply unit; 10…Switching unit; 10A…First switch; 10B…Second switch; 11…First connection unit; 12…Second connection unit; 13…Third connection unit; 14…Fourth connection unit; 19…Surface electrode; 20…Catheter; 21…First electrode group; 22…Second electrode group; 23…Third electrode group; 25…Tip blade; 26…Handle; 27…Resin tubing; 31…First lead; 32…Second lead; 33…Third lead; 34…Fourth lead; 35…Fifth lead; 36…Sixth lead; 37…Seventh lead; 40…Electrocardiograph; 5 0… ECG waveform; 51… Event inferred as an R wave; 51c… Inflection point in the falling phase of the event inferred as an R wave; 51d… Falling phase of the event inferred as an R wave; 51p… Peak of the event inferred as an R wave; 51r… Rising phase of the event inferred as an R wave; 52… T wave; 60… Differential waveform; 61… Differential waveform generated based on the event inferred as an R wave; 61P… Positive wave; 61N… Negative wave; 61b… Peak of the negative wave; 62… Differential waveform generated based on the T wave; 70… Defibrillation device; 71… A / D converter; 72… First arithmetic processing control unit; 73… Display unit; 74… Comparator; 75… Second arithmetic processing control unit; 76… Marker display signal generation unit.

Claims

1. An electrical device for defibrillation, comprising an electrocardiogram waveform input unit, an enable signal generation unit, a first electrode group, a second electrode group, and a power supply unit. The defibrillation electrical device is characterized in that it is controlled to: After the peak of an event inferred to be an R-wave in the electrocardiogram waveform obtained from the human body and input from the electrocardiogram waveform input unit is exceeded, and after conditions 2 and 3 below are satisfied, and condition 1 below is also satisfied, an enable signal is generated from the enable signal generation unit, and a voltage is applied to the first electrode group and the second electrode group from the power supply unit based on the enable signal. Condition 1: The differential value generated based on the event inferred to be an R-wave is a negative constant C3 value or less. Condition 2: The differential waveform of the set of differential values ​​generated based on the event inferred to be an R-wave, i.e., the peak value of the positive wave, is a positive constant C1 value or higher. This is a subset of the rising phase of the event that is inferred to be an R-wave, which corresponds to the portion of the rising phase preceding the peak of the event inferred to be an R-wave. Condition 3: In the positive wave, the time during which the differential value is greater than or equal to a positive constant C2 value smaller than the C1 value is measured, and this time is greater than or equal to 10ms and less than 80ms.

2. The defibrillation electrical device according to claim 1, characterized in that, Controlled as: The enable signal is generated after conditions 2, 3, and 4 above, as well as condition 1, are met. Condition 4: For events inferred to be R-waves based on the comparison, i.e., R... n The event preceding the wave is inferred to be an R-wave, i.e., R... n-1 The differential value generated by the wave reaches the value of C3 according to the R n The time taken for the differential value generated by the wave to reach the C3 value is measured, and this time is greater than 50 ms.

3. The defibrillation electrical device according to claim 1 or 2, characterized in that, The section from the ECG waveform input unit to the enable signal generation unit is constructed using hardware circuitry.

4. The defibrillation electrical device according to claim 1 or 2, characterized in that, Equipped with a display unit that displays the electrocardiogram waveform, The defibrillation electrical device is controlled as follows: After the peak of the event that is inferred to be an R-wave is exceeded, and after condition 1 below is met, a mark display signal for marking the event that is inferred to be an R-wave is generated from the mark display signal generation unit. Condition 1: The differential value generated based on the event inferred to be an R-wave is a negative constant C3 value or less.

5. The defibrillation electrical device according to claim 4, characterized in that, Controlled as: The marker display signal is generated after both condition 2 and condition 1 are satisfied. Condition 2: The differential waveform, i.e. the peak value of the positive wave, which is a collection of differential values ​​generated based on the rising phase of the event that is inferred to be an R-wave, which is equivalent to the portion of the rising phase preceding the peak of the event that is inferred to be an R-wave, is a positive constant C1 value or higher.

6. The defibrillation electrical device according to claim 5, characterized in that, Controlled as: The marker display signal is generated after condition 2, condition 3 below, and condition 1 are all satisfied. Condition 3: In the positive wave, the time during which the differential value is greater than or equal to a positive constant C2 value smaller than the C1 value is measured, and this time is greater than or equal to 10ms and less than 80ms.

7. The defibrillation electrical device according to claim 6, characterized in that, Controlled as: The marker display signal is generated after conditions 2, 3, and 4 above, as well as condition 1, are satisfied. Condition 4: For events inferred to be R-waves based on the comparison, i.e., R... n The event preceding the wave is inferred to be an R-wave, i.e., R... n-1 The differential value generated by the wave reaches the value of C3 according to the R n The time taken for the differential value generated by the wave to reach the C3 value is measured, and this time is greater than 50 ms.

8. A method for generating a defibrillation signal, characterized in that, It has the following steps: After exceeding the peak of an event inferred as an R wave in the electrocardiogram waveform obtained from the human body, determine whether conditions 2 and 3 below are satisfied, and whether condition 1 below is also satisfied; and After conditions 2 and 3 are satisfied, and condition 1 is also satisfied, an enable signal is generated, and based on the enable signal, voltage is applied to the first electrode group and the second electrode group from the power supply unit. Condition 1: The differential value generated based on the event inferred to be an R-wave is a negative constant C3 value or less. Condition 2: The differential waveform of the set of differential values ​​generated based on the event inferred to be an R-wave, i.e., the peak value of the positive wave, is a positive constant C1 value or higher. This is a subset of the rising phase of the event that is inferred to be an R-wave, which corresponds to the portion of the rising phase preceding the peak of the event inferred to be an R-wave. Condition 3: In the positive wave, the time during which the differential value is greater than or equal to a positive constant C2 value smaller than the C1 value is measured, and this time is greater than or equal to 10ms and less than 80ms.

9. The method for generating a defibrillation signal according to claim 8, characterized in that, The next step is to determine whether condition 4 below is met. In the step of generating the permission signal, the permission signal is generated after conditions 2, 3, and 4 are satisfied, and condition 1 is also satisfied. Condition 4: For events inferred to be R-waves based on the comparison, i.e., R... n The event preceding the wave is inferred to be an R-wave, i.e., R... n-1 The differential value generated by the wave reaches the value of C3 according to the R n The time taken for the differential value generated by the wave to reach the C3 value is measured, and this time is greater than 50 ms.

10. The method for generating a defibrillation signal according to claim 8, characterized in that, It has the following steps: After exceeding the peak of an event inferred as an R wave in electrocardiogram waveforms obtained from the human body, determine whether the following condition 1 is met; and After condition 1 is met, a marker display signal is generated to mark the event that is inferred to be an R-wave on the display unit. The method for generating the defibrillation signal includes a step of generating the enable signal after the step of generating the marker display signal. Condition 1: The differential value generated based on the event inferred to be an R-wave is a negative constant C3 value or less.

11. The method for generating a defibrillation signal according to claim 10, characterized in that, It has the following steps: Determine whether condition 2 is satisfied; and After both condition 2 and condition 1 are satisfied, a marker display signal is generated to mark the event inferred to be an R-wave on the display unit. Condition 2: The differential waveform, i.e. the peak value of the positive wave, which is a collection of differential values ​​generated based on the rising phase of the event that is inferred to be an R-wave, which is equivalent to the portion of the rising phase preceding the peak of the event that is inferred to be an R-wave, is a positive constant C1 value or higher.

12. The method for generating a defibrillation signal according to claim 11, characterized in that, It has the following steps: Determine whether the following condition 3 is met; and After conditions 2, 3, and 1 are satisfied, a marker display signal is generated to mark the event inferred to be an R-wave on the display unit. Condition 3: In the positive wave, the time during which the differential value is greater than or equal to a positive constant C2 value smaller than the C1 value is measured, and this time is greater than or equal to 10ms and less than 80ms.

13. The method for generating a defibrillation signal according to claim 10, characterized in that, It has the following steps: Determine whether the following condition 4 is met; and After condition 4 and condition 1 are both satisfied, a marker display signal is generated to mark the event that is inferred to be an R-wave on the display unit. Condition 4: For events inferred to be R-waves based on the comparison, i.e., R... n The event preceding the wave is inferred to be an R-wave, i.e., R... n-1 The differential value generated by the wave reaches the value of C3 according to the R n The time taken for the differential value generated by the wave to reach the C3 value is measured, and this time is greater than 50 ms.

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