Electrocardiogram analysis device and electrocardiogram analysis method

Abstract

To provide an apparatus that prevents overlooking of cardiac arrhythmias (increases detectivity), and at the same time, reduces incorrect detection (increases detection specificity).SOLUTION: An apparatus has: an electrocardiogram measurement unit 110 for measuring an electrocardiogram from an electrocardiogram signal of an electrode worn in a subject; a dynamic state measurement unit 120 for measuring a dynamic state from activity information of a sensor worn in the subject; and an analysis unit 150 for analyzing the occurrence of a serious cardiac arrhythmias from the electrocardiogram measured by the electrocardiogram measurement unit 110 and the dynamic state measured by the dynamic state measurement unit 120.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to an electrocardiogram analysis device and an electrocardiogram analysis method. [Background technology]

[0002] Conventional electrocardiogram analyzers analyze the electrocardiogram waveform measured from a patient against predetermined arrhythmia judgment criteria, and if they detect arrhythmia, they notify medical personnel by issuing an alarm or the like (Patent Document 1).

[0003] When a patient experiences serious arrhythmias such as ventricular fibrillation or cardiac arrest, the heart is unable to pump blood around the body, which can lead to serious aftereffects or death. For this reason, medical professionals must respond immediately to the occurrence of serious arrhythmias. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2014-150826 A Summary of the Invention [Problem to be solved by the invention]

[0005] However, patients who have recovered from the acute phase and are hospitalized in general wards or undergoing rehabilitation are highly active, and so artifacts (noise) caused by the patient's body movements are likely to be mixed into the ECG waveform. Conventional ECG analysis devices may erroneously determine that an ECG waveform containing artifacts is an arrhythmia, generating a false alarm.

[0006] For this reason, conventional electrocardiogram analyzers are provided with measures to prevent artifacts mixed in the electrocardiogram waveform from being erroneously analyzed as arrhythmia, such as an artifact removal filter or an artifact determination function.

[0007] However, it is not easy to accurately separate artifacts, especially those whose frequency components are close to those of the ECG. If too many artifacts are removed, true arrhythmias may be mistakenly removed, increasing the likelihood of arrhythmias being overlooked.

[0008] On the other hand, if artifacts cannot be properly removed, noise will be judged as arrhythmia, resulting in false alarms. Frequent false alarms will reduce medical staff's attention to alarms and slow their reaction. As a result, there is a possibility that treatment for patients with true serious arrhythmias will be delayed.

[0009] Therefore, the present invention provides an electrocardiogram analysis device and an electrocardiogram analysis method that can satisfy the conflicting requirements of preventing arrhythmia from being overlooked (increasing detection sensitivity) while simultaneously reducing false positives (increasing detection specificity) by changing the criteria for determining the occurrence of arrhythmia in accordance with the subject's dynamic information. [Means for solving the problem]

[0010] The electrocardiogram analysis device of the present invention includes an electrocardiogram measurement unit that measures an electrocardiogram from an electrocardiogram signal of electrodes attached to a subject, a dynamics measurement unit that measures dynamics from dynamics information of a sensor attached to the subject, and an analysis unit that analyzes the occurrence of a serious arrhythmia from the electrocardiogram measured by the electrocardiogram measurement unit and the dynamics measured by the dynamics measurement unit. the analysis unit includes an arrhythmia analysis unit that analyzes the occurrence of arrhythmia from the measured electrocardiogram, a dynamics analysis unit that analyzes the type of measured dynamics, and a validity analysis unit that, when the occurrence of arrhythmia is analyzed by the arrhythmia analysis unit, evaluates the type of dynamics analyzed by the dynamics analysis unit retroactively from the time when the occurrence of the arrhythmia was analyzed, and analyzes the validity of determining that the arrhythmia is a serious arrhythmia; has. Another electrocardiogram analysis device of the present invention has an electrocardiogram measurement unit that measures an electrocardiogram from an electrocardiogram signal from electrodes attached to the subject, a dynamics measurement unit that measures dynamics from dynamics information from a sensor attached to the subject, and an analysis unit that analyzes the occurrence of a serious arrhythmia from the electrocardiogram measured by the electrocardiogram measurement unit and the dynamics measured by the dynamics measurement unit, and the analysis unit has an arrhythmia analysis unit that analyzes the occurrence of arrhythmia from the measured electrocardiogram, a dynamics analysis unit that analyzes the measured type of dynamics and exercise intensity over time, and a validity analysis unit that analyzes the measured type of dynamics and exercise intensity retrospectively when the occurrence of arrhythmia is analyzed, and analyzes the validity of determining that the measured arrhythmia is a serious arrhythmia from the analyzed type of dynamics and exercise intensity.

[0011] The electrocardiogram analysis method of the present invention includes a step of measuring an electrocardiogram from an electrocardiogram signal of an electrode attached to a subject, a step of measuring a dynamic state from dynamic information of a sensor attached to the subject, and a step of analyzing the occurrence of a serious arrhythmia from the measured electrocardiogram and the measured dynamic state. fruit , The analyzing step includes a step of analyzing the occurrence of arrhythmia from the measured electrocardiogram, a step of analyzing the type of the measured dynamics, and a step of evaluating the type of the dynamics analyzed when the occurrence of arrhythmia is analyzed, retroactively from the time when the occurrence of the arrhythmia was analyzed, and analyzing the appropriateness of determining that the arrhythmia is a serious arrhythmia. . Another electrocardiogram analysis method of the present invention includes a step of measuring an electrocardiogram from an electrocardiogram signal of electrodes attached to the subject, a step of measuring dynamics from dynamic information of a sensor attached to the subject, and a step of analyzing the occurrence of serious arrhythmia from the measured electrocardiogram and the measured dynamics, wherein the analyzing step includes a step of analyzing the occurrence of arrhythmia from the measured electrocardiogram, a step of analyzing the measured type of dynamics and exercise intensity over time, and a step of analyzing the measured type of dynamics and exercise intensity retrospectively when the occurrence of arrhythmia is analyzed, and analyzing the validity of determining that the measured arrhythmia is serious arrhythmia from the analyzed type of dynamics and exercise intensity. Effect of the Invention

[0012] According to the electrocardiogram analysis device and electrocardiogram analysis method of the present invention, the occurrence of serious arrhythmias is analyzed from the electrocardiogram and dynamics, thereby satisfying the conflicting demands of preventing arrhythmias from being overlooked (increasing detection sensitivity) while at the same time reducing false positives (increasing detection specificity). [Brief description of the drawings]

[0013] [Figure 1] FIG. 1 is a block diagram of an electrocardiogram analysis device common to embodiments 1 to 5. [Diagram 2] FIG. 2 is a block diagram of an analysis unit in FIG. 1. [Diagram 3] FIG. 3 is a block diagram of the validity analysis unit of FIG. 2. [Figure 4] 1 is a main flowchart (electrocardiogram analysis method) of an electrocardiogram analysis device common to embodiments 1 to 5. [Diagram 5] 5 is a subroutine flowchart of the process of S300 (determining the validity of arrhythmia detection) in the main flowchart of FIG. 4 (first embodiment). [Figure 6] 5 is a subroutine flowchart of the process of S300 (determining the validity of arrhythmia detection) in the main flowchart of FIG. 4 (embodiment 2). [Figure 7] 5 is a subroutine flowchart of the process of S300 (determining the validity of arrhythmia detection) in the main flowchart of FIG. 4 (Embodiment 3). [Figure 8] 5 is a subroutine flowchart of the process of S300 (determining the validity of arrhythmia detection) in the main flowchart of FIG. 4 (Embodiment 4). [Figure 9] 5 is a subroutine flowchart of the process of S300 (determining the validity of arrhythmia detection) in the main flowchart of FIG. 4 (Embodiment 5). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] Next, embodiments of the electrocardiogram analysis device and electrocardiogram analysis method of the present invention will be described in [Embodiment 1] to [Embodiment 5] with reference to the drawings. Figs. 1 to 3 show an example of a device configuration common to embodiments 1 to 5 of the electrocardiogram analysis device of the present invention. Figs. 4 to 9 show an example of the operation of each of embodiments 1 to 5 of the electrocardiogram analysis device of the present invention, and an example of the procedure of each of embodiments 1 to 5 of the electrocardiogram analysis method of the present invention. Note that the technical ideas of the electrocardiogram analysis device and electrocardiogram analysis method of the present invention are not limited to those described in embodiments 1 to 5 described below.

[0015] [Embodiment 1] (Configuration of electrocardiogram analyzer) 1 is a block diagram of an electrocardiogram analysis device common to embodiments 1 to 5. As shown in the figure, an electrocardiogram analysis device 100 has an electrocardiogram measurement section 110, a dynamic measurement section 120, an analysis section 150, and a notification section 160.

[0016] The electrocardiogram measurement unit 110 measures an electrocardiogram from an electrocardiogram signal from electrodes attached to the subject. It is desirable that two or more electrodes are attached to the subject. The electrodes may be attached to the surface of the subject's body or may be embedded inside the subject's body. The number of electrocardiogram waveforms to be measured may be one or more.

[0017] The behavior measurement unit 120 measures the behavior from the behavior information of the sensor attached to the subject. It is preferable to use an acceleration sensor or a gyro sensor as the sensor attached to the subject. The sensor may be directly attached to the body of the subject, may be stored in a pocket of a bag or clothing worn by the subject, or may be embedded in the body of the subject. The sensor may be integrated with the electrodes attached to the subject, or may be integrated with the telemeter attached to the subject. By integrating the sensor with the electrodes or the telemeter, the sensor can be made smaller.

[0018] The sensor to be worn by the subject may be any sensor other than an acceleration sensor, as long as it can detect the subject's dynamics, activity amount, and momentum, such as whether the subject is walking (specifically, whether the subject is walking steadily or unsteadily), whether the subject is not walking, whether the subject has stopped from unsteady walking, whether the subject has sat down from unsteady walking, whether the subject has suddenly crouched down from walking, whether the subject has fallen, etc. Also, in order to detect the dynamics, activity amount, and momentum of the subject, a sensor configured by combining a plurality of types of sensors other than an acceleration sensor may be worn by the subject.

[0019] The analysis unit 150 analyzes the occurrence of a serious arrhythmia from the electrocardiogram measured by the electrocardiogram measurement unit 110 and the dynamics measured by the dynamics measurement unit 120. Here, the serious arrhythmia is at least one of cardiac arrest, asystole, ventricular tachycardia, extreme tachycardia, and extreme bradycardia. The analysis unit 150 can analyze the occurrence of any of cardiac arrest, asystole, ventricular tachycardia, extreme tachycardia, and extreme bradycardia as serious arrhythmia. The analysis unit 150 analyzes the occurrence of a serious arrhythmia at intervals of several milliseconds to several seconds, or at the time of detection of a heartbeat obtained from an electrocardiogram. The analysis of the occurrence of arrhythmia by the analysis unit 150 is performed continuously in parallel with the measurement of an electrocardiogram by the electrocardiogram measurement unit 110 and the measurement of dynamics by the dynamics measurement unit 120. When the analysis of the occurrence of arrhythmia determines that it is appropriate to determine that the arrhythmia is a serious arrhythmia, the analysis unit 150 outputs an alarm signal.

[0020] The notification unit 160 notifies the occurrence of serious arrhythmia by outputting sound or light upon receiving an alarm signal output from the analysis unit 150 when the analysis unit 150 analyzes the occurrence of serious arrhythmia. By providing the notification unit 160, the subject, people around the subject, medical personnel monitoring the subject, and the like can easily know the occurrence of serious arrhythmia.

[0021] Fig. 2 is a block diagram of the analysis section of Fig. 1. As shown in the figure, the analysis section 150 includes an arrhythmia analysis section 152, a dynamics analysis section 154, and a validity analysis section 140.

[0022] The arrhythmia analysis unit 152 analyzes the occurrence of arrhythmia from an electrocardiogram measured by the electrocardiogram measurement unit 110 (see FIG. 1). The arrhythmia analyzed by the arrhythmia analysis unit 152 is intended to be one that induces ventricular fibrillation or cardiac arrest, and is, for example, at least one of cardiac arrest, asystole, ventricular tachycardia, extreme tachycardia, and extreme bradycardia.

[0023] The movement analysis unit 154 analyzes the type of movement measured by the movement measurement unit 120 (see FIG. 1). The movement analysis unit 154 analyzes the acceleration data output by the movement measurement unit 120, and analyzes the type of movement from the movement data such as the state of the subject walking or running, the amount of activity, and the amount of exercise. Examples of the type of movement include whether the subject is walking (specifically, whether the subject is walking steadily or unsteadily), whether the subject is not walking, whether the subject has stopped from unsteady walking, whether the subject has sat down from unsteady walking, whether the subject has suddenly crouched down from walking, and whether the subject has fallen. As for whether the subject is walking or not, if the next walking is not detected even after 1 second has elapsed since the detection of the walking, it is determined that the subject is not walking, and if the next walking is detected within 1 second since the detection of the walking, it is determined that the subject is walking. This is because it usually takes 0.6 seconds per step. For this reason, if the walking is extremely slow, it is determined that the subject is not walking.

[0024] When the arrhythmia analysis unit 152 analyzes the occurrence of arrhythmia, the validity analysis unit 140 analyzes the validity of determining that the arrhythmia is a serious arrhythmia, taking into account the type of dynamics analyzed by the dynamics analysis unit 154. Therefore, even if the arrhythmia analysis unit 152 determines that an arrhythmia has occurred, if the validity analysis unit 140 analyzes that it is not valid to determine that the arrhythmia is a serious arrhythmia, an alarm signal is not output. On the other hand, if the validity analysis unit 140 analyzes that it is valid to determine that the arrhythmia is a serious arrhythmia, an alarm signal is output.

[0025] Fig. 3 is a block diagram of the validity analysis unit of Fig. 2. As shown in the figure, the validity analysis unit 140 has a criterion setting unit 142 and a judgment unit 144.

[0026] The determination criterion setting unit 142 sets a determination criterion for analyzing the appropriateness of determining that an arrhythmia is a severe arrhythmia.

[0027] Specifically, the criterion setting unit 142 sets a plurality of stages of detection sensitivity corresponding to the type of dynamics analyzed by the dynamics analysis unit 154 (see FIG. 2) as criterion for analyzing the appropriateness of determining that the arrhythmia is a serious arrhythmia. By providing a plurality of stages of detection sensitivity corresponding to the type of dynamics, it becomes possible to appropriately determine that the arrhythmia is a serious arrhythmia according to the type of dynamics.

[0028] In the case of the first embodiment, the detection sensitivity of the judgment criterion A (medium sensitivity) is set for the subject's movement other than walking or running, and the detection sensitivity of the judgment criterion B (low sensitivity) is set for the subject's movement while walking or running. If the detection sensitivity is low, it is difficult to judge that the detected arrhythmia is a serious arrhythmia. This is because it is presumed that the possibility of the occurrence of a serious arrhythmia is low when the subject is able to walk or run. On the other hand, if the detection sensitivity is medium sensitivity, it is easier to judge that the detected arrhythmia is a serious arrhythmia than when the detection sensitivity is low.

[0029] The judgment criteria are determined so as to achieve a good balance between detection sensitivity and detection specificity at the start of measurement. In the case of embodiment 1, judgment criteria A is used as a default from the start of measurement, and is therefore determined to be an optimal value so as to achieve a good balance between detection sensitivity and detection specificity.

[0030] The determination section 144 refers to the determination criteria set in the determination criteria setting section 142 and determines whether the arrhythmia is a severe arrhythmia.

[0031] In the case of the first embodiment, the detection sensitivity of the judgment criterion A (medium sensitivity) is set for the subject's movement other than walking or running, and the detection sensitivity of the judgment criterion B (low sensitivity) is set for the subject's walking or running movement. The judgment unit 144 refers to the judgment criterion A and the judgment criterion B to judge whether the arrhythmia is a serious arrhythmia. (Operation of electrocardiogram analyzer) Fig. 4 is a main flowchart (electrocardiogram analysis method) of the electrocardiogram analysis device common to the first to fifth embodiments. The processing of this flowchart is carried out at very high speed, at intervals of several milliseconds to several seconds. The processing of this flowchart will be described below with reference to Fig. 1.

[0032] The electrocardiogram measurement unit 110 measures an electrocardiogram from an electrocardiogram signal from electrodes attached to the subject (S100). At the same time, the behavior measurement unit 120 measures the behavior from behavior information of the sensor attached to the subject (S200).

[0033] Next, the analysis unit 150 analyzes the occurrence of a serious arrhythmia from the electrocardiogram measured by the electrocardiogram measurement unit 110 and the dynamics measured by the dynamics measurement unit 120. When the occurrence of arrhythmia is analyzed, the validity of arrhythmia detection is analyzed in consideration of the type of the measured dynamics (S300).

[0034] The analysis unit 150 judges whether the detection of arrhythmia is appropriate (S400). If it is judged that the detection of arrhythmia is appropriate (S400: YES), the notification unit 160 notifies the subject, people around the subject, medical staff monitoring the subject, and the like of the occurrence of arrhythmia (S500). On the other hand, if it is judged that the detection of arrhythmia is not appropriate (S400: NO), the process proceeds to step S600.

[0035] The analysis unit 150 judges whether or not all the processes for arrhythmia detection have been completed (S600). If it is judged that all the processes for arrhythmia detection have been completed (S600: YES), the process is terminated. If it is judged that all the processes for arrhythmia detection have not been completed (S600: NO), the process returns to the process of steps S100 and S200.

[0036] Fig. 5 is a subroutine flowchart of the process of S300 (determining the validity of arrhythmia detection) in the main flowchart of Fig. 4. In the first embodiment, the validity of arrhythmia detection is determined in the following procedure. The process of this flowchart will be described below with reference to Figs. 1 to 3.

[0037] The validity analysis unit 140 first sets the standard for determining whether the arrhythmia detected by the arrhythmia analysis unit 152 is a serious arrhythmia to a default determination standard A (medium sensitivity) (S310). Next, the dynamics analysis unit 154 analyzes the dynamics measured by the dynamics measurement unit 120 (S311). The dynamics analyzed here are whether the subject is walking or running, or performing an action other than walking or running.

[0038] Next, it is determined whether the dynamic analysis unit 154 detects walking or running (S312). If the dynamic analysis unit 154 detects walking or running (S312: YES), the validity analysis unit 140 sets the criterion for determining that the arrhythmia detected by the arrhythmia analysis unit 152 is a serious arrhythmia to the judgment criterion B (low sensitivity) (S314). On the other hand, if the dynamic analysis unit 154 does not detect walking or running (S312: NO), the validity analysis unit 140 sets the criterion for determining that the arrhythmia detected by the arrhythmia analysis unit 152 is a serious arrhythmia to the judgment criterion A (medium sensitivity) (S313).

[0039] The arrhythmia analysis unit 152 analyzes the occurrence of arrhythmia from the electrocardiogram measured by the electrocardiogram measurement unit 110 (S315). Next, the arrhythmia analysis unit 152 judges whether or not an arrhythmia has been detected from the electrocardiogram measured by the electrocardiogram measurement unit 110 (S316). If the arrhythmia analysis unit 152 detects an arrhythmia (S316: YES), the judgment unit 144 judges the validity of the detection of the arrhythmia (S317). The validity of the detection of the arrhythmia is judged based on the judgment criteria set in steps S314 and S313. On the other hand, if the arrhythmia analysis unit 152 does not detect an arrhythmia (S316: NO), the process proceeds to step 400 in FIG. 4. The flowchart in FIG. 5 is processed at high speed, so that the judgment criteria are changed in real time when the subject transitions from a walking or running state to a non-walking or non-running state, or vice versa.

[0040] As described above, in the first embodiment, when the subject is walking or running, the validity of the arrhythmia detection is determined with low sensitivity, and when the subject is not walking or running, the validity of the arrhythmia detection is determined with medium sensitivity. Therefore, in the first embodiment, an arrhythmia alarm is more likely to be issued when the subject is not walking or running than when the subject is walking or running.

[0041] In this way, the criteria for determining the occurrence of arrhythmia are changed depending on the subject's dynamic information (whether they are walking or running, or not walking or running), which makes it possible to prevent arrhythmias from being overlooked while at the same time reducing false detection of arrhythmias.

[0042] [Embodiment 2] (Configuration of electrocardiogram analyzer) The electrocardiogram analysis device 100 of embodiment 2 is identical to the electrocardiogram analysis device 100 of embodiment 1 except that the judgment criteria set in the judgment criteria setting unit 142 (see Figure 3) are different from those of the judgment criteria setting unit 142 of embodiment 1.

[0043] In the criterion setting unit 142 of the second embodiment, the criterion for analyzing the validity of determining that an arrhythmia is a serious arrhythmia is set as follows: As the criterion, the detection sensitivity of criterion C (high sensitivity) is set for the subject's falling dynamics, the detection sensitivity of criterion B (low sensitivity) is set for the subject's walking or running dynamics, and the detection sensitivity of criterion A (medium sensitivity) is set for the subject's walking or running dynamics and dynamics other than falling.

[0044] If the detection sensitivity is lower, it is difficult to determine that the detected arrhythmia is a serious arrhythmia. On the other hand, if the detection sensitivity is higher, it is easier to determine that the detected arrhythmia is a serious arrhythmia than when the detection sensitivity is lower. The determination criterion is set so that the detection sensitivity and the detection specificity are well balanced at the start of measurement. In the case of the second embodiment, the determination criterion A is used as a default from the start of measurement, and is set to an optimal value so that the detection sensitivity and the detection specificity are well balanced.

[0045] The determination section 144 refers to the determination criteria set in the determination criteria setting section 142 and determines whether the arrhythmia is a severe arrhythmia.

[0046] In the case of embodiment 2, the detection sensitivity of judgment criterion C (high sensitivity) is set for the subject's falling dynamics, the detection sensitivity of judgment criterion A (medium sensitivity) is set for the subject's walking / running and dynamics other than falling, and the detection sensitivity of judgment criterion B (low sensitivity) is set for the subject's walking or running dynamics, so that the judgment unit 144 can appropriately judge that the arrhythmia is a severe arrhythmia for each dynamics by referring to judgment criterion A, judgment criterion B, and judgment criterion C.

[0047] (Operation of electrocardiogram analyzer) Fig. 6 is a subroutine flowchart of the process of S300 (determining the validity of arrhythmia detection) in the main flowchart of Fig. 4. In the second embodiment, the validity of arrhythmia detection is determined in the following procedure. The process of this flowchart will be described below with reference to Figs. 1 to 3.

[0048] The validity analysis unit 140 first sets the standard for determining whether the arrhythmia detected by the arrhythmia analysis unit 152 is a serious arrhythmia to the default determination standard A (medium sensitivity) (S321). Next, the dynamics analysis unit 154 analyzes the dynamics measured by the dynamics measurement unit 120 (S322). The dynamics analyzed here are whether the subject has fallen, whether the subject is walking or running, or whether the subject is performing a motion other than walking, running, or falling.

[0049] Next, it is determined whether the dynamic analysis unit 154 detects a fall (S323). If the dynamic analysis unit 154 detects a fall (S323: YES), the validity analysis unit 140 sets the criterion for determining that the arrhythmia detected by the arrhythmia analysis unit 152 is a serious arrhythmia to the criterion C (high sensitivity) (S324). Note that when the dynamic analysis unit 154 detects a fall, the criterion may be set to the criterion C (high sensitivity) after notifying the subject, people around the subject, and medical staff monitoring the subject of the fall. On the other hand, if the dynamic analysis unit 154 does not detect a fall (S323: NO), it is next determined whether the dynamic analysis unit 154 detects walking or running (S325).

[0050] If the dynamic analysis unit 154 detects walking or running (S325: YES), the validity analysis unit 140 sets the criterion for determining whether the arrhythmia detected by the arrhythmia analysis unit 152 is a serious arrhythmia to criterion B (low sensitivity) (S327). On the other hand, if the dynamic analysis unit 154 does not detect walking or running (S325: NO), the validity analysis unit 140 sets the criterion for determining whether the arrhythmia detected by the arrhythmia analysis unit 152 is a serious arrhythmia to criterion A (medium sensitivity) (S326).

[0051] The arrhythmia analysis unit 152 analyzes the occurrence of arrhythmia from the electrocardiogram measured by the electrocardiogram measurement unit 110 (S328). Next, the arrhythmia analysis unit 152 judges whether or not an arrhythmia has been detected from the electrocardiogram measured by the electrocardiogram measurement unit 110 (S329). If the arrhythmia analysis unit 152 detects an arrhythmia (S329: YES), the judgment unit 144 judges the validity of the detection of the arrhythmia (S330). The validity of the detection of the arrhythmia is judged based on the judgment criteria set in steps S324, S326, and S327. On the other hand, if the arrhythmia analysis unit 152 does not detect an arrhythmia (S329: NO), the process proceeds to step 400 in FIG. 4.

[0052] The flowchart in FIG. 6 is processed at high speed, so that the judgment criteria are changed in real time each time the subject falls, the subject walks or runs, or the subject performs any action other than walking, running, or falling.

[0053] Therefore, when the type of the analyzed movement is a fall and the detection sensitivity is set to the judgment criterion C (high sensitivity), the judgment criterion setting unit 142 sets the detection sensitivity to the judgment criterion A (low sensitivity) when the type of the movement analyzed by the movement analysis unit 154 becomes walking or running. Therefore, it is possible to appropriately determine whether the arrhythmia is a serious arrhythmia according to the change in the movement.

[0054] As described above, in the second embodiment, when the subject falls, the validity of the arrhythmia detection is determined with high sensitivity, when the subject is walking or running after the fall, the validity of the arrhythmia detection is determined with low sensitivity, and when the subject is not walking or running or falling, the validity of the arrhythmia detection is determined with medium sensitivity. Therefore, in the second embodiment, the arrhythmia alarm is most likely to be notified when the subject falls, the arrhythmia alarm is next most likely to be notified when the subject is walking or running or not falling, and the arrhythmia alarm is least likely to be notified when the subject is walking or running after the fall.

[0055] In this way, the criteria for determining whether or not an arrhythmia has occurred are changed in accordance with the dynamic information of the subject, so that it is possible to prevent arrhythmia from being overlooked and at the same time reduce erroneous detection of arrhythmia.

[0056] [Embodiment 3] (Configuration of electrocardiogram analyzer) The electrocardiogram analysis device 100 of embodiment 3 is identical to the electrocardiogram analysis device 100 of embodiment 1 except that the judgment criteria set in the judgment criteria setting unit 142 (see FIG. 3) are different from those of the judgment criteria setting unit 142 of embodiment 1. Other than the judgment criteria setting unit 142, the configuration of the electrocardiogram analysis device 100 of embodiment 3 is the same as that of the electrocardiogram analysis device 100 of embodiment 1.

[0057] In the judgment criterion setting unit 142 of the third embodiment, judgment criteria for analyzing the validity of judging that an arrhythmia is a serious arrhythmia are set as follows. As judgment criteria, the detection sensitivity of judgment criterion 5 (highest sensitivity) is set for the subject's motion after detecting a fall, the detection sensitivity of judgment criterion 4 is set for the subject's walking motion of stopping, sitting, or suddenly squatting after walking after unsteady walking, and judgment criterion 3 is set as the default judgment criterion for the subject. Furthermore, the detection sensitivity of judgment criterion 2 is set for the subject's motion of unstable walking, and the detection sensitivity of judgment criterion 1 (lowest sensitivity) is set for the subject's motion of stable walking.

[0058] As the judgment criteria decrease from judgment criterion 5 to judgment criterion 1, the detection sensitivity changes stepwise from high to low sensitivity. If the detection sensitivity is lower, it becomes more difficult to judge that the detected arrhythmia is a serious arrhythmia. On the other hand, if the detection sensitivity is higher, it becomes easier to judge that the detected arrhythmia is a serious arrhythmia than when the detection sensitivity is lower.

[0059] The judgment criteria are determined so that a good balance between detection sensitivity and detection specificity is achieved at the start of measurement. In the case of embodiment 3, judgment criteria 3 is used as a default judgment criterion from the start of measurement, and is therefore determined to be an optimal value so that a good balance between detection sensitivity and detection specificity is achieved.

[0060] The determination section 144 refers to the determination criteria set in the determination criteria setting section 142 and determines whether the arrhythmia is a severe arrhythmia.

[0061] In the case of embodiment 3, the detection sensitivity of judgment criterion 5 (the most sensitive) is set when the subject's dynamic state is after a fall is detected, the detection sensitivity of judgment criterion 4 is set when the subject's walking dynamic state is when the subject stops, sits, or suddenly crouches down after walking after unsteady walking, judgment criterion 3 is set as the default judgment criterion for the subject, the detection sensitivity of judgment criterion 2 is set when the subject's dynamic state is during unsteady walking, and the detection sensitivity of judgment criterion 1 (the least sensitive) is set when the subject's dynamic state is during stable walking, so that the judgment unit 144 can appropriately judge that the arrhythmia is a severe arrhythmia for each dynamic state by referring to judgment criteria 1 to 5.

[0062] (Operation of electrocardiogram analyzer) Fig. 7 is a subroutine flowchart of the process of S300 (determining the validity of arrhythmia detection) in the main flowchart of Fig. 4. In the third embodiment, the validity of arrhythmia detection is determined in the following procedure. The process of this flowchart will be described below with reference to Figs. 1 to 3.

[0063] The validity analysis unit 140 first sets the standard for determining whether the arrhythmia detected by the arrhythmia analysis unit 152 is a serious arrhythmia to the default determination standard 3 (normal monitoring: medium sensitivity) (S340). Next, the dynamics analysis unit 154 analyzes the dynamics measured by the dynamics measurement unit 120 (S341). The dynamics analyzed here are whether the subject has fallen, whether the subject has stopped or sat down after unsteady walking, or whether the subject has suddenly crouched down after walking, whether the subject is in a normal monitoring state, whether the subject is walking unsteadily, or whether the subject is walking steadily.

[0064] Next, the validity analysis unit 140 sets criteria for determining whether the arrhythmia detected by the arrhythmia analysis unit 152 is a serious arrhythmia based on whether the subject has fallen, whether the subject has stopped, sat down, or suddenly squatted down after walking unsteadily, whether the subject is in a normal monitoring state, whether the subject is walking unsteadily, or whether the subject is walking steadily (S342).

[0065] Specifically, the validity analysis unit 140 sets the detection sensitivity to criterion 5 (the most sensitive) if the subject's walking behavior is after a fall, sets the detection sensitivity to criterion 4 if the subject's walking behavior is a behavior in which the subject stops, sits, or suddenly crouches down after walking, sets the detection sensitivity to criterion 4 if the subject is walking unsteadily, sets the detection sensitivity to criterion 2 if the subject is walking steadily, sets the detection sensitivity to criterion 1 (the least sensitive), and sets the detection sensitivity to criterion 3 if the subject's walking behavior is other than these.

[0066] The arrhythmia analysis unit 152 analyzes the occurrence of arrhythmia from the electrocardiogram measured by the electrocardiogram measurement unit 110 (S343). Next, the arrhythmia analysis unit 152 judges whether or not an arrhythmia has been detected from the electrocardiogram measured by the electrocardiogram measurement unit 110 (S344). If the arrhythmia analysis unit 152 detects an arrhythmia (S344: YES), the judgment unit 144 judges the validity of the detection of the arrhythmia (S345). The validity of the detection of the arrhythmia is judged based on the judgment criterion set in step S342. On the other hand, if the arrhythmia analysis unit 152 does not detect an arrhythmia (S344: NO), the process proceeds to step 400 in FIG. 4.

[0067] As described above, in the third embodiment, after the subject falls, the validity of the arrhythmia detection is judged with the highest sensitivity (judgment criterion 5), and when the subject stops from unsteady walking, sits down, or suddenly crouches down from walking, the detection sensitivity is slightly lowered (judgment criterion 4) to judge the validity of the arrhythmia detection, and when the subject is walking steadily, the validity of the arrhythmia detection is judged with the lowest sensitivity (judgment criterion 1), and when the subject is walking unsteadily, the sensitivity is slightly increased (judgment criterion 2) to judge the validity of the arrhythmia detection, and when the subject is in a state other than these, the validity of the arrhythmia detection is judged with the default sensitivity (judgment criterion 3). Therefore, in the third embodiment, the higher the set detection sensitivity, the easier it is to report an arrhythmia alarm.

[0068] In this way, the criteria for determining whether arrhythmia has occurred are changed according to five types of dynamic information about the subject, thereby preventing arrhythmia from being overlooked while at the same time reducing false positive detections of arrhythmia.

[0069] [Embodiment 4] (Configuration of electrocardiogram analyzer) The electrocardiogram analysis device 100 of embodiment 4 is identical to the electrocardiogram analysis device 100 of embodiment 1 except that the judgment criteria set in the judgment criteria setting unit 142 (see Figure 3) are different from those of the judgment criteria setting unit 142 of embodiment 1.

[0070] In the determination criterion setting unit 142 of the fourth embodiment, the determination criterion for analyzing the validity of determining that an arrhythmia is a serious arrhythmia is set as follows. The determination criterion is set to have a higher detection sensitivity as the exercise intensity of the subject's motion type is lower. By setting the determination criterion in this manner, it is possible to reduce false detection of arrhythmia when the exercise intensity is high.

[0071] Specifically, when the type of movement analyzed by the movement analysis unit 154 is walking, if the walking interval exceeds a certain range for a predetermined walking distance, the detection sensitivity is set to low sensitivity. Also, when the type of movement analyzed is walking, if the walking interval is within a certain range for a predetermined walking distance, the detection sensitivity is set to a sensitivity lower than low sensitivity. Furthermore, when the type of movement analyzed by the movement analysis unit 154 is walking and the detection sensitivity is low sensitivity, if walking stops, the detection sensitivity is set to high sensitivity.

[0072] In this way, the lower the dynamic type exercise intensity, the higher the detection sensitivity is set, and conversely, the higher the dynamic type exercise intensity, the lower the detection sensitivity is set, so that an arrhythmia alarm can be appropriately issued regardless of the magnitude of the exercise intensity. This makes it possible to prevent arrhythmia from being overlooked and to reduce erroneous detection of arrhythmia.

[0073] The judgment criteria are determined so as to achieve a good balance between detection sensitivity and detection specificity at the start of measurement. In the case of embodiment 4, judgment criteria A is used as the default judgment criteria from the start of measurement, and is therefore determined to be an optimal value so as to achieve a good balance between detection sensitivity and detection specificity.

[0074] The determination section 144 refers to the determination criteria set in the determination criteria setting section 142 and determines whether the arrhythmia is a severe arrhythmia. (Operation of electrocardiogram analyzer) Fig. 8 is a subroutine flowchart of the process of S300 (determining the validity of arrhythmia detection) in the main flowchart of Fig. 4. In the fourth embodiment, the validity of arrhythmia detection is determined in the following procedure. The process of this flowchart will be described below with reference to Figs. 1 to 3.

[0075] The validity analysis unit 140 first sets the standard for determining whether the arrhythmia detected by the arrhythmia analysis unit 152 is a serious arrhythmia to a default determination standard A (medium sensitivity) (S350). Next, the dynamics analysis unit 154 analyzes the dynamics measured by the dynamics measurement unit 120 (S351). The dynamics analyzed here are, for example, whether the walking interval exceeds a certain range for a predetermined walking distance when the subject is walking, whether the walking interval is within a certain range for a predetermined walking distance when the subject is walking, whether the subject is walking and has stopped walking when the detection sensitivity is low, etc.

[0076] Next, the validity analysis unit 140 sets an optimal value as a criterion for determining whether the arrhythmia detected by the arrhythmia analysis unit 152 is a serious arrhythmia, depending on whether the walking interval exceeds a certain range or is within a certain range for a predetermined walking distance when the subject is walking, and whether the subject stops walking while the detection sensitivity is low. Specifically, when the subject is walking and the walking interval exceeds a certain range for a predetermined walking distance, the detection sensitivity is set to low. Also, when the subject is walking and the walking interval is within a certain range for a predetermined walking distance, the detection sensitivity is set to a sensitivity lower than low. Furthermore, when the subject is walking and the detection sensitivity is low, the detection sensitivity is set to high when the subject stops walking (S352).

[0077] The arrhythmia analysis unit 152 analyzes the occurrence of arrhythmia from the electrocardiogram measured by the electrocardiogram measurement unit 110 (S353). Next, the arrhythmia analysis unit 152 judges whether or not an arrhythmia has been detected from the electrocardiogram measured by the electrocardiogram measurement unit 110 (S354). If the arrhythmia analysis unit 152 detects an arrhythmia (S354: YES), the judgment unit 144 judges the validity of the detection of the arrhythmia (S355). The validity of the detection of the arrhythmia is judged based on the judgment criterion set in step S352. On the other hand, if the arrhythmia analysis unit 152 does not detect an arrhythmia (S354: NO), the process proceeds to step 400 in FIG. 4.

[0078] As described above, in the case of embodiment 4, the lower the exercise intensity of the subject's dynamic type, the higher the detection sensitivity is set, and conversely, the higher the exercise intensity of the subject's dynamic type, the lower the detection sensitivity is set, so that the judgment unit 144 can appropriately judge whether the arrhythmia is a serious arrhythmia according to the set detection sensitivity.

[0079] As described above, in the fourth embodiment, the criteria for determining the occurrence of arrhythmia are changed according to the dynamic information of the subject, so that it is possible to prevent arrhythmia from being overlooked and at the same time reduce erroneous detection of arrhythmia.

[0080] [Embodiment 5] (Configuration of electrocardiogram analyzer) The electrocardiogram analysis device 100 of the fifth embodiment differs from the electrocardiogram analysis device 142 of the first embodiment in the judgment criteria set in the judgment criteria setting unit 142 (see FIG. 3). Also, the electrocardiogram analysis device 100 of the fifth embodiment differs from the electrocardiogram analysis device 154 of the first embodiment in that the dynamics analysis unit 154 (see FIG. 2) analyzes the type of dynamics and the exercise intensity measured over time. Furthermore, the validity analysis unit 140 of the fifth embodiment differs from the validity analysis unit 140 of the first embodiment in that the type of dynamics and the exercise intensity measured when the occurrence of arrhythmia is analyzed are analyzed retrospectively, and the validity of determining that the measured arrhythmia is a serious arrhythmia is analyzed from the type of dynamics and the exercise intensity analyzed. The configuration other than these is the same as that of the electrocardiogram analysis device 100 of the first embodiment.

[0081] The determination criterion setting unit 142 of the fifth embodiment determines the appropriateness of determining that an arrhythmia is a serious arrhythmia as follows. For example, it evaluates the presence or absence of walking detection and the amount of exercise going back from the time when the possibility of ventricular fibrillation or cardiac arrest was detected, and suppresses an alarm if stable walking or exercise continues. Otherwise, it outputs an alarm.

[0082] Specifically, the validity of an alarm is verified by determining whether walking occurred Y times within a period separated by X seconds (for example, X=L, Y=3), whether a certain walking speed or cadence (for example, speed 3.2 km / hr, cadence 100 steps / min) continued for Y seconds (for example, Y=3), whether the elapsed time since the last detected walking is within Y seconds (for example, Y=1), whether stable movement (for example, 3.0 METs) continued for Y seconds (for example, Y=3), etc.

[0083] In addition, the system may evaluate the presence or absence of walking and the amount of movement by going back from the point in time when the possibility of ventricular fibrillation or cardiac arrest was detected, and if unstable walking (speed 1.0-3.1 km / hr) or weak movement (1.0 to 2.9 METs) continues, the alarm may be withheld, and if stable walking or movement is not detected within the following N (for example, 1) seconds, the alarm may finally be output.

[0084] The judgment criteria are determined so that the detection sensitivity and the detection specificity are well balanced at the start of the measurement. In the case of the fifth embodiment, the judgment criteria A is used as the default judgment criteria from the start of the measurement, and is therefore determined to be an optimal value so that the detection sensitivity and the detection specificity are well balanced.

[0085] The determination section 144 refers to the determination criteria set in the determination criteria setting section 142 and determines whether the arrhythmia is a severe arrhythmia.

[0086] (Operation of electrocardiogram analyzer) Fig. 9 is a subroutine flowchart of the process of S300 (determining the validity of arrhythmia detection) in the main flowchart of Fig. 4. In the fifth embodiment, the validity of arrhythmia detection is determined in the following procedure. The process of this flowchart will be described below with reference to Figs. 1 to 3.

[0087] The validity analysis unit 140 first sets the standard for determining whether the arrhythmia detected by the arrhythmia analysis unit 152 is a serious arrhythmia to a default determination standard A (medium sensitivity) (S360). Next, the dynamics analysis unit 154 analyzes the dynamics measured by the dynamics measurement unit 120 (S361).

[0088] The dynamics analyzed here are the presence or absence of walking detection and the amount of movement going back from the time when the possibility of ventricular fibrillation or cardiac arrest was detected. Specifically, whether walking occurred Y times in a period divided into X seconds, whether a certain walking speed or gait continued for Y seconds, whether the time elapsed since the last walking detection was within Y seconds, whether stable movement continued for Y seconds, whether unstable walking or weak movement continued, whether stable walking or movement was detected in the following N seconds, etc.

[0089] The arrhythmia analysis unit 152 analyzes the occurrence of arrhythmia from the electrocardiogram measured by the electrocardiogram measurement unit 110 (S362). Next, the arrhythmia analysis unit 152 judges whether or not an arrhythmia has been detected from the electrocardiogram measured by the electrocardiogram measurement unit 110 (S363). If the arrhythmia analysis unit 152 detects an arrhythmia (S33: YES), the judgment unit 144 judges the validity of the detection of the arrhythmia in light of the dynamics analyzed in step S361 against the judgment criterion (S364). On the other hand, if the arrhythmia analysis unit 152 does not detect an arrhythmia (S363: NO), the process proceeds to step 400 in FIG. 4.

[0090] As described above, in the fifth embodiment, the presence or absence of walking detection and the amount of exercise are evaluated retroactively from the point in time when the possibility of ventricular fibrillation or cardiac arrest was detected, and if stable walking or exercise continues, an alarm is suppressed, and if not, an alarm is output, thereby preventing arrhythmia from being overlooked while at the same time reducing erroneous detection of arrhythmia.

[0091] The electrocardiogram analysis device and electrocardiogram analysis method of the present invention have been described above in the first to fifth embodiments. However, the technical scope of the electrocardiogram analysis device and electrocardiogram analysis method of the present invention is not limited to the scope described in these embodiments. It goes without saying that any invention having the same technical idea as the present invention is included in the technical scope of the present invention. [Explanation of symbols]

[0092] 100 Electrocardiogram analyzer 110 Electrocardiogram measuring section 120 Dynamic measurement section 140 Validity analysis section 142 Judgment criteria setting section 144 Judgment section 150 Analysis Department 152 Arrhythmia Analysis Department 154 Dynamic Analysis Department 160 Notification Department

Claims

1. an electrocardiogram measuring unit that measures an electrocardiogram from an electrocardiogram signal of electrodes attached to a subject; A behavior measurement unit that measures behavior from behavior information of a sensor attached to the subject; and an analysis unit that analyzes the occurrence of a serious arrhythmia from the electrocardiogram measured by the electrocardiogram measurement unit and the dynamics measured by the dynamics measurement unit, The analysis unit is an arrhythmia analysis unit that analyzes the occurrence of arrhythmia from the measured electrocardiogram; A dynamics analysis unit that analyzes the type of dynamics measured; a validity analysis unit that, when the arrhythmia analysis unit analyzes the occurrence of arrhythmia, evaluates the type of dynamics analyzed by the dynamics analysis unit retroactively from the time when the arrhythmia occurrence was analyzed, and analyzes the validity of determining that the arrhythmia is a serious arrhythmia; An electrocardiogram analysis device comprising:

2. The validity analysis unit a determination criterion setting unit in which a determination criterion for analyzing the appropriateness of determining that the arrhythmia is a serious arrhythmia is set; a determination unit that determines that the arrhythmia is a serious arrhythmia by referring to the determination criterion; 2. The electrocardiogram analyzer according to claim 1, further comprising:

3. The judgment criterion setting unit, 3. The electrocardiogram analysis device according to claim 2, wherein a plurality of stages of detection sensitivity corresponding to the type of the analyzed dynamics are set as a judgment criterion for analyzing the appropriateness of judging the arrhythmia to be a serious arrhythmia.

4. The judgment criterion setting unit, 4. The electrocardiogram analyzer according to claim 3, wherein the detection sensitivity is set to low sensitivity when the type of analyzed motion is walking or running, the detection sensitivity is set to high sensitivity when the type of analyzed motion is falling, and the detection sensitivity is set to medium sensitivity when the type of analyzed motion is other than walking, running, and falling.

5. The judgment criterion setting unit, 5. The electrocardiogram analysis device of claim 4, wherein when the type of analyzed motion is a fall and the detection sensitivity is set to high sensitivity, and then when the type of analyzed motion becomes walking or running, the detection sensitivity is set to medium sensitivity.

6. The judgment criterion setting unit, 4. The electrocardiogram analyzer according to claim 3, wherein when the type of analyzed movement is walking, the detection sensitivity is set to low sensitivity when the walking interval exceeds a certain range for a predetermined walking distance.

7. The judgment criterion setting unit, 7. The electrocardiogram analyzer according to claim 6, wherein, when the type of analyzed movement is walking, if a walking interval is within a certain range for a predetermined walking distance, the detection sensitivity is set to a sensitivity lower than the low sensitivity.

8. The judgment criterion setting unit, 7. The electrocardiogram analyzer according to claim 6, wherein when the type of analyzed movement is walking and the detection sensitivity is set to the low sensitivity, if walking is stopped, the detection sensitivity is set to the high sensitivity.

9. The judgment criterion setting unit, 4. The electrocardiogram analyzer according to claim 3, wherein the detection sensitivity is set to medium sensitivity when the type of analyzed movement is other than walking, running, or falling.

10. The electrocardiogram analyzer according to claim 3 , wherein the determination criterion setting unit sets the detection sensitivity to high sensitivity when the type of the analyzed motion is a fall.

11. The judgment criterion setting unit, The electrocardiogram analyzer according to claim 3 , wherein the detection sensitivity is set higher as the exercise intensity of the analyzed type of movement is lower.

12. An electrocardiogram measuring unit for measuring an electrocardiogram from an electrocardiogram signal of electrodes attached to a subject; A behavior measurement unit that measures behavior from behavior information of a sensor attached to the subject; and an analysis unit that analyzes the occurrence of a serious arrhythmia from the electrocardiogram measured by the electrocardiogram measurement unit and the dynamics measured by the dynamics measurement unit, The analysis unit is an arrhythmia analysis unit that analyzes the occurrence of arrhythmia from the measured electrocardiogram; A motion analysis unit that analyzes the type of motion and the exercise intensity measured over time; a validity analysis unit that analyzes the type of movement and the exercise intensity measured when the occurrence of arrhythmia is analyzed, and analyzes the validity of determining that the measured arrhythmia is a serious arrhythmia based on the type of movement and the exercise intensity analyzed; An electrocardiogram analysis device comprising:

13. moreover, 13. The electrocardiogram analyzer according to claim 1, further comprising a notification unit that notifies the user when the analysis unit determines that a serious arrhythmia has occurred.

14. 14. An electrocardiogram analysis device according to claim 1, wherein the sensor is mounted integrally with an electrode attached to the subject, or is mounted integrally with a telemeter attached to the subject.

15. 15. The electrocardiogram analyzer according to claim 1, wherein the serious arrhythmia is at least one of cardiac arrest, asystole, ventricular tachycardia, extreme tachycardia, and extreme bradycardia.

16. measuring an electrocardiogram from electrocardiogram signals of electrodes attached to the subject; Measuring a movement of the subject from movement information of a sensor attached to the subject; analyzing the occurrence of a serious arrhythmia from the measured electrocardiogram and the measured dynamics; Including, The analyzing step includes: analyzing the occurrence of arrhythmia from the measured electrocardiogram; analyzing the types of behavior measured; a step of evaluating a type of analyzed dynamics when the occurrence of arrhythmia is analyzed, retroactively from the time when the occurrence of the arrhythmia was analyzed, and analyzing the appropriateness of determining that the arrhythmia is a serious arrhythmia; 13. An electrocardiogram analysis method comprising:

17. A step of measuring an electrocardiogram from an electrocardiogram signal of electrodes attached to a subject; Measuring a movement of the subject from movement information of a sensor attached to the subject; analyzing the occurrence of a serious arrhythmia from the measured electrocardiogram and the measured dynamics; Including, The analyzing step includes: analyzing the occurrence of arrhythmia from the measured electrocardiogram; analyzing the type of movement and the intensity of the movement measured over time; a step of retrospectively analyzing the type of movement and the exercise intensity measured when the occurrence of arrhythmia is analyzed, and analyzing the appropriateness of determining that the measured arrhythmia is a serious arrhythmia based on the analyzed type of movement and the exercise intensity; 13. An electrocardiogram analysis method comprising:

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