WO2013180286A1 - Dispositif de détection de rythme, programme de détection de rythme, dispositif de commande d'iabp et programme de commande d'iabp - Google Patents
Dispositif de détection de rythme, programme de détection de rythme, dispositif de commande d'iabp et programme de commande d'iabp Download PDFInfo
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- WO2013180286A1 WO2013180286A1 PCT/JP2013/065237 JP2013065237W WO2013180286A1 WO 2013180286 A1 WO2013180286 A1 WO 2013180286A1 JP 2013065237 W JP2013065237 W JP 2013065237W WO 2013180286 A1 WO2013180286 A1 WO 2013180286A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/515—Regulation using real-time patient data
- A61M60/531—Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/021—Measuring pressure in heart or blood vessels
- A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
- A61B5/346—Analysis of electrocardiograms
- A61B5/349—Detecting specific parameters of the electrocardiograph cycle
- A61B5/352—Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6852—Catheters
- A61B5/6853—Catheters with a balloon
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7271—Specific aspects of physiological measurement analysis
- A61B5/7285—Specific aspects of physiological measurement analysis for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
- A61M60/139—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/295—Balloon pumps for circulatory assistance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/497—Details relating to driving for balloon pumps for circulatory assistance
Definitions
- the present invention relates to a timing detection device, a timing detection program, an IABP drive device, and an IABP drive program used for medical treatment, and more particularly, an IABP drive device that can automatically set and adjust the drive timing of a driven device, etc. About.
- IABP aortic balloon pumping
- a balloon which is a driven device
- IABP inflating and deflating the balloon as the heart beats. This supports the cardiac circulatory function.
- it is necessary to match the inflation / deflation timing of the balloon with the heart beat.
- a typical driving example of IABP there is a method in which a balloon is inflated (inflated) at the start of a diastole, and the balloon is deflated just before a systole.
- the conventional IABP driving device that realizes auto timing has a problem that the driving timing of IABP cannot be optimized sufficiently.
- the reason why the IABP drive timing cannot be sufficiently optimized is that the inventors of the present invention mentioned that the conventional technology cannot sufficiently utilize useful information inherent in blood pressure fluctuation data. Obtained knowledge. Further, as another reason why the driving timing of IABP cannot be sufficiently optimized, the inventors of the present invention have found that the prior art has many trigger detection failures that are the premise of driving timing determination. Obtained.
- the present invention has been made in view of such a situation, and an object thereof is a timing detection device and a timing detection program capable of accurately detecting a predetermined timing, an IABP driving device and an IABP capable of appropriately calculating and setting an IABP driving timing. It is to provide a driving program.
- a blood pressure fluctuation timing detection apparatus includes: A first data acquisition unit for acquiring first data corresponding to blood pressure fluctuations; A second data storage unit for storing second data corresponding to blood pressure fluctuations in a predetermined section; A determination unit for determining similarity between the first data and the second data; A timing calculation unit that calculates a predetermined timing in the heart beat period based on the determination result of the determination unit.
- the timing detection device includes a determination unit that determines the similarity between the first data corresponding to blood pressure fluctuation and the second data stored in the second data storage unit, and includes a timing calculation unit (BP expansion) / Shrinkage timing calculation unit) detects the timing based on the determination result of the determination unit.
- the timing detection apparatus uses not only the blood pressure fluctuation itself associated with the target timing but also the information on the second data relating to the past blood pressure fluctuation by using a similarity determination method called pattern recognition. Thus, the timing can be calculated, and the timing can be detected with high accuracy.
- it may have a start point detection unit that detects a predetermined point in the systole as a first start point from the first data, The determination unit compares the first data after the first start point with the second data after the second start point, which is the predetermined point in the second data. And a pattern recognition unit that determines the similarity between the second data and the second data.
- the characteristics of blood pressure fluctuations during systole are closely related to the timing of switching from systole to diastole and the length of the pulsatile cycle that combined systole and diastole.
- the second data storage unit may store a plurality of the second data
- the determination unit may determine the first data from the second data stored in the second data storage unit. You may have the 2nd data extraction part which extracts the thing most similar to data.
- the information of the first data can be more appropriately supplemented by the information of the second data, and the timing detection accuracy is improved.
- the second data may include a dichroic notch.
- the dichroic notch is a peak generated by blood pressure fluctuation accompanying the closure of the aortic valve, and is important timing information in the heart cycle.
- information about the dichroic notch can be supplemented to the first data even when the first data does not have the dichroic notch.
- the importance of acquiring the timing of the dichroic notch is high.
- the second data storage unit may store a part of the first data acquired by the first data acquisition unit as the second data.
- the timing detection device extracts stored data that extracts a part to be stored in the second data storage unit as the second data from the first data acquired by the first data acquisition unit.
- a data management unit that extracts and erases data to be erased from the second data stored in the second data storage unit.
- the timing detection device By adding and deleting the second data by the data management unit, the timing detection device according to the present invention appropriately updates the second data stored in the second data storage unit, and calculates the timing of the second data storage unit. Can be maintained and managed in an optimal state.
- the predetermined timing calculated by the timing calculation unit may be a future timing that occurs after the time when the first data is acquired by the first data acquisition unit.
- the first data corresponding to the current blood pressure fluctuation is supplemented with the information included in the second data stored in the second data storage unit, so that the future timing can be appropriately set. Can be estimated.
- the balloon as the driven device can be inflated at an appropriate timing by estimating the timing of the dichroic notch.
- the IABP driving device includes a receiving unit that acquires information on the predetermined timing from the timing detection device according to any one of the above.
- Pressure generating means for alternately applying a positive pressure and a negative pressure to a piping system communicating with the driven device so that the driven device repeatedly expands and contracts due to the flow of the driving fluid;
- Control means for controlling the pressure generating means based on the predetermined timing.
- the IABP driving device By driving the driven device using the information from the timing detection device, the IABP driving device according to the present invention can achieve the IABP effects such as the diastral augmentation effect and the systolic unloading effect. , Can be appropriately given to patients who are subjects of IABP.
- control unit performs normal driving for expanding the driven device at the predetermined timing and detection driving for expanding the driven device at a second timing delayed from the predetermined timing.
- the pressure generating means may be controlled.
- the dichroic notch becomes too close to blood pressure fluctuations associated with balloon inflation, Or since it overlaps, it becomes difficult to acquire the 1st data containing a dichroic notch, and to memorize this as the 2nd data. Therefore, by inflating the driven device at a predetermined frequency and at a second timing that is intentionally delayed, the blood pressure fluctuation associated with the inflation of the dichroic notch and the balloon is separated, and the second data storage unit is dichroic. An opportunity to update the second data including the notch can be increased.
- a blood pressure fluctuation timing detection program is stored in a computer. Obtaining first data corresponding to blood pressure fluctuations; A procedure for storing second data corresponding to blood pressure fluctuations in a predetermined section; Determining the similarity between the first data and the second data; And a procedure for calculating a predetermined timing in the heart beat cycle based on the similarity determination result.
- the blood pressure fluctuation timing detection program according to the present invention, as described above, it is possible to accurately detect a predetermined timing in the heart beat cycle.
- the IABP driving apparatus is: An electrocardiogram signal timing calculation unit for calculating electrocardiogram signal timing information related to the drive timing of the driven device based on the electrocardiogram signal; A first data acquisition unit that acquires first data corresponding to blood pressure fluctuation; a second data storage unit that stores second data corresponding to blood pressure fluctuation in a predetermined section; the first data and the second data; Blood pressure for calculating blood pressure timing information related to the drive timing of the driven device using the first data, the second data, and the determination result of the determination unit A timing calculation unit; Pressure generating means for alternately applying a positive pressure and a negative pressure to a piping system communicating with the driven device so that the driven device repeatedly expands and contracts due to the flow of the driving fluid; Control means for controlling the pressure generating means based on at least one of the electrocardiogram timing information and the blood pressure timing information.
- the IABP driving device acquires both the electrocardiogram signal timing information calculated based on the electrocardiogram signal and the blood pressure timing information calculated based on the blood pressure fluctuation data. Information is detected with high accuracy by using a determination method related to similarity called pattern recognition. Therefore, the IABP driving device according to the present invention can suppress the detection failure of the trigger and suppress the phenomenon that the driving timing is deviated from the proper state.
- the blood pressure timing calculation unit included in the IABP driving device determines not only the blood pressure fluctuation data (first data) relating to the currently progressing cardiac cycle by determining the similarity between the first data and the second data, It is possible to calculate the timing with reference to information included in the second data regarding the past blood pressure fluctuation. Therefore, such an IABP driving device can calculate blood pressure timing information with high accuracy by using not only the current blood pressure fluctuation data but also information included in the blood pressure fluctuation data accumulated in the past.
- the electrocardiogram signal timing calculation unit includes a third data acquisition unit that acquires third data corresponding to the electrocardiogram signal, and fourth data obtained by applying a second variation method to the third data. You may have the 4th data calculation part to calculate, and the R wave detection part which detects the timing of the R wave in the said electrocardiogram signal from the said 4th data.
- Such an electrocardiogram signal timing calculation unit applies the second variational method to the third data, so that the electrocardiogram signal (waveform) changes rapidly (a change in the value of the first data per unit time is abrupt).
- R wave that is the steepest peak in the electrocardiogram signal (waveform) can be detected with high accuracy. Therefore, the IABP driving device that can use the electrocardiogram timing information calculated by the electrocardiogram signal timing calculation unit can suppress the detection failure of the trigger and highly optimize the driving timing.
- the blood pressure timing calculation unit may include a start point detection unit that detects a predetermined point in a systole as a first start point from the first data. By comparing the first data after the first start point and the second data after the second start point, which is the predetermined point in the second data, the first data and the second data You may have a pattern recognition part which judges the said similarity.
- the characteristics of blood pressure fluctuations during systole are closely related to the timing of switching from systole to diastole and the length of the pulsatile cycle that combined systole and diastole.
- the second data stored in the second data storage unit may include a dichroic notch
- the blood pressure timing calculation unit determines that the determination unit determines that the determination unit is similar to the first data.
- the ECG signal timing information may be calculated with reference to the position of the dichroic notch included in two data.
- the dichroic notch is a peak generated by a blood pressure fluctuation accompanying the closure of the aortic valve, and is extremely useful information for determining the inflation timing of the balloon that is the driven device, but during the IABP, the balloon inflation is performed. It is difficult to detect due to the influence of blood pressure fluctuations.
- the above-described blood pressure timing calculation unit accurately refers to the position of the dichroic notch included in the second data, which is the past blood pressure fluctuation data, so that the timing of the dichroic notch can be accurately determined even during IABP. Can be estimated.
- the blood pressure timing calculation unit compares the first data with the second data, particularly in the systole, and refers to the position of the dichroic notch included in the second data similar to the first data. It is possible to accurately predict the timing of the dichroic notch to be performed.
- both the electrocardiogram signal timing information and the blood pressure timing information may be input to the control means.
- the electrocardiogram signal timing calculation unit and the blood pressure timing calculation unit calculate the timing of applying positive pressure / negative pressure, respectively, and transmit this to the control unit as electrocardiogram signal timing information and blood pressure timing information. Can be arbitrarily selected to determine the application timing of the positive pressure / negative pressure. Therefore, such an IABP driving device can avoid a state where the application timing of the positive pressure and the negative pressure cannot be acquired, and can appropriately drive the driven device.
- control means may control the pressure generating means based on the blood pressure timing information.
- the control means may control the pressure generating means using any information, but as described above, the blood pressure timing information Because the timing is calculated by referring not only to the blood pressure fluctuation data (first data) relating to the ongoing cardiac cycle but also to information held by the continuous blood pressure fluctuation data (second data) in a predetermined interval in the past. By using this with priority, the control can be optimized more suitably.
- the second data storage unit may store a part of the first data acquired by the first data acquisition unit as the second data.
- a storage data extraction unit that extracts a portion to be stored in the second data storage unit as the second data from the first data acquired by the first data acquisition unit
- the data management unit may include a stored data erasing unit that extracts and erases data to be erased from the second data stored in the memory.
- the IABP driving device By adding and deleting the second data by the data management unit, the IABP driving device according to the present invention appropriately updates the second data stored in the second data storage unit, and calculates the timing of the second data storage unit. Can be maintained and managed in an optimal state.
- control means performs normal driving for expanding the driven device in accordance with the start of cardiac expansion and detection driving for expanding the driven device at a timing delayed from the normal driving.
- the pressure generating means may be controlled.
- the dichroic notch In IABP, it is important to obtain information about the timing of the dichroic notch, but when the IABP drive device performs normal driving, the dichroic notch is too close to or overlaps with blood pressure fluctuations associated with balloon inflation, It is difficult to acquire the first data including the dichroic notch and store it as the second data. Therefore, by inflating the driven device at a predetermined frequency and at a second timing that is intentionally delayed, the blood pressure fluctuation associated with the inflation of the dichroic notch and the balloon is separated, and the second data storage unit is dichroic. An opportunity to update the second data including the notch can be increased.
- the blood pressure timing calculation unit may calculate the driving timing of the pressure generating unit by the control unit from the blood pressure timing information and the first data used by the control unit for controlling the pressure generating unit, You may have a delay time calculation part which calculates delay time with the timing which the said to-be-driven device generates a blood-pressure fluctuation
- a predetermined delay time is generated between the driving timing of the pressure generating means and the timing at which the blood pressure fluctuation is actually generated, but this delay time may vary depending on the state of the driving fluid and the like. Therefore, an IABP driving apparatus having a delay time calculation unit that calculates such a delay time calculates an appropriate drive timing according to a change in the delay time while monitoring the delay time during IABP driving, and is highly optimal. Automatic timing can be implemented.
- An IABP driving apparatus is A third data acquisition unit that acquires third data corresponding to an electrocardiogram signal; a fourth data calculation unit that calculates fourth data obtained by applying a second variation method to the third data; and the fourth data
- An electrocardiogram signal for calculating electrocardiogram signal timing information relating to the drive timing of the driven device based on the timing detected by the R wave detector
- a timing calculation unit A blood pressure timing calculation unit that calculates blood pressure timing information related to the drive timing of the driven device based on blood pressure fluctuation data
- Pressure generating means for alternately applying a positive pressure and a negative pressure to a piping system communicating with the driven device so that the driven device repeatedly expands and contracts due to the flow of the driving fluid
- Control means for controlling the pressure generating means based on at least one of the electrocardiogram timing information and the blood pressure timing information.
- the IABP driving device acquires both the electrocardiogram signal timing information calculated based on the electrocardiogram signal and the blood pressure timing information calculated based on the blood pressure fluctuation data, and the electrocardiogram signal
- the timing information applies the second variation method to the third data to emphasize the slowness of the ECG signal (waveform), and the R wave, which is the steepest peak in the ECG signal (waveform), is accurately obtained. Can be detected. Therefore, the IABP driving device according to the present invention can suppress the detection failure of the trigger and suppress the phenomenon that the driving timing is deviated from the proper state.
- An IABP driving program is stored in a computer.
- the IABP drive program according to the present invention it is possible to suppress the detection failure of the trigger, to suppress the phenomenon that the drive timing deviates from the appropriate state, and to store the blood pressure fluctuation data accumulated in the past.
- blood pressure timing information can be calculated with high accuracy.
- An electrocardiogram signal timing detection apparatus includes a third data acquisition unit that acquires third data corresponding to an electrocardiogram signal; A fourth data calculation unit for calculating fourth data obtained by applying a second variational method to the third data; And a detection unit for detecting a predetermined timing in the electrocardiogram signal from the fourth data.
- the timing detection apparatus for an electrocardiogram signal includes a fourth data calculation unit that calculates the fourth data by applying the second variation method to the third data corresponding to the electrocardiogram signal.
- the second variational method By applying the second variational method to the third data, the slowness of the electrocardiogram signal (waveform) (whether the change per unit time of the value of the first data is rapid or gradual) is emphasized. . Therefore, by appropriately setting parameters for calculating the second data, it is possible to obtain the fourth data in which a predetermined peak included in the electrocardiogram signal is emphasized, thereby detecting the timing in the detection unit. The accuracy can be increased and accurate timing detection is possible.
- the predetermined timing detected by the detection unit may be an R wave timing.
- the R wave has the highest peak in the electrocardiogram signal (waveform) and is therefore suitable for timing detection using only the conventional third data.
- the R wave is the highest in the electrocardiogram signal (waveform). Since it is a steep peak, only the peak of the R wave can be emphasized relatively easily by the second variational method. Therefore, by detecting the timing of the R wave using the fourth data to which the second variation method is applied, it is possible to realize accurate timing detection as compared with the conventional technique.
- the timing detection device determines the amount of noise included in the electrocardiogram signal from the fourth data, and stops the detection of the predetermined timing when the noise is large You may have a noise judgment part which outputs a signal with respect to the said detection part.
- the noise determination unit can correctly detect an abnormality of the electrocardiogram signal.
- the detection unit may include a reference value calculation unit that calculates a reference value for detecting the predetermined timing, and a comparison unit that compares the reference value with the fourth data.
- the detection unit may detect a timing at which the fourth data is recognized as exceeding the reference value as the predetermined timing using a comparison result of the comparison unit.
- the detection unit to detect the predetermined timing is not particularly limited, for example, using a reference value calculation unit and a comparison unit, the timing when the fourth data exceeds the reference value is set to the predetermined timing. As a result, it is possible to detect the predetermined timing accurately and easily. Also, such a timing detection device can continue to detect the timing accurately even when the state of the ECG signal changes with time.
- the timing detection device includes a storage unit that stores information about the predetermined timing, and an average value that calculates an average value of the predetermined timing interval from the information stored in the storage unit. And a calculation unit.
- Such a timing detection device can accurately calculate the heart rate.
- the timing detection device includes an abnormality detection unit that detects an abnormality of the electrocardiogram signal when a first time has elapsed from the predetermined timing last detected by the detection unit. May be.
- Such a timing detection device can detect an abnormality in an electrocardiogram signal and perform an operation such as issuing a warning to the user of the device or transmitting a signal to another device as necessary. It is.
- An electrocardiogram signal timing detection program includes: On the computer, A procedure of calculating a fourth data by applying a second variational method to the third data corresponding to an electrocardiogram signal; Detecting a predetermined timing in the electrocardiogram signal from the fourth data.
- FIG. 1 is a conceptual diagram illustrating an example of use of an IABP driving device according to an embodiment of the present invention.
- FIG. 2 is a schematic block diagram of the IABP driving device shown in FIG.
- FIG. 3 is a flowchart showing an example of processing in IABP performed by the IABP driving device shown in FIG.
- FIG. 4 is a schematic block diagram showing an electrocardiogram signal timing calculation unit included in the IABP driving device shown in FIG.
- FIG. 5 is a flowchart showing an example of processing performed in ECG signal timing information calculation (step S004) in FIG.
- FIG. 6 is a schematic block diagram showing a blood pressure timing calculation unit included in the IABP driving device shown in FIG. FIG.
- FIG. 7 is a flowchart showing an example of processing performed in blood pressure timing information calculation (step S005) in FIG.
- FIG. 8 is a graph showing an example of third data and fourth data acquired and calculated by the electrocardiogram timing calculation unit shown in FIG.
- FIG. 9 is a graph showing another example of the third data and the fourth data acquired and calculated by the electrocardiogram timing calculation unit shown in FIG.
- FIG. 10 is a conceptual diagram showing the start point detection process performed by the start point detection unit in the blood pressure timing calculation unit shown in FIG.
- FIG. 11 is a conceptual diagram showing the start point determination process performed by the start point detection unit in the blood pressure timing calculation unit shown in FIG. FIG.
- FIG. 12 is a conceptual diagram illustrating processing performed by the determination unit and the BP inflation / deflation timing calculation unit in the blood pressure timing calculation unit illustrated in FIG.
- FIG. 13 is a conceptual diagram showing an instantaneous difference determination process performed by the systolic pattern recognition unit in the blood pressure timing calculation unit shown in FIG.
- FIG. 14 is a conceptual diagram illustrating a cumulative difference determination process performed by the systolic pattern recognition unit in the blood pressure timing calculation unit illustrated in FIG.
- FIG. 15 is a conceptual diagram illustrating an example of a calculation process performed by the BP inflation / deflation timing calculation unit in the blood pressure timing calculation unit illustrated in FIG. 6.
- FIG. 16 is a conceptual diagram illustrating an example of calculation processing performed by the data management unit in the blood pressure timing calculation unit illustrated in FIG.
- FIG. 17 is a conceptual diagram illustrating another example of the arithmetic processing performed by the data management unit in the blood pressure timing calculation unit illustrated in FIG.
- FIG. 18 is a conceptual diagram illustrating an example of a calculation process performed by the delay time calculation unit in the blood pressure timing calculation unit illustrated in FIG.
- FIG. 19 is a flowchart illustrating an example of processing performed in the trigger synchronization determination (step S006) in FIG.
- FIG. 20 is a conceptual diagram illustrating normal driving and detection driving performed by the IABP driving device shown in FIG.
- FIG. 21 is a conceptual diagram showing the necessity of the start point check process performed by the start point detection unit shown in FIG.
- FIG. 1 is a conceptual diagram showing an example of use of an IABP driving device 10 according to an embodiment of the present invention.
- the IABP drive device 10 includes an electrocardiogram signal timing calculation unit 11, a blood pressure timing calculation unit 70, and an IABP drive control main body unit 60.
- the electrocardiogram signal timing calculation unit 11 calculates the electrocardiogram signal timing information 55 related to the drive timing of the balloon 68 that is the driven device, and outputs it to the IABP drive control main body unit 60.
- the electrocardiogram signal timing calculation unit 11 can acquire an electrocardiogram signal representing the electrical activity of the heart in the implementation target via the electrode 14 attached to the human body or the like that is the implementation target of the IABP.
- the electrocardiogram signal timing calculation unit 11 may be integrated with the IABP drive control main body 60 that performs drive control of the balloon 68, or may be removed from the IABP drive control main body 60 and used as a timing detection device. good. Details of the electrocardiogram signal timing calculation unit 11 will be described later in detail with reference to FIGS. 4, 5, 8 and 9.
- the blood pressure timing calculation unit 70 calculates blood pressure timing information 75 related to the driving timing of the balloon 68 based on the blood pressure fluctuation data, and outputs the blood pressure timing information 75 to the IABP drive control main body 60.
- the blood pressure timing calculation unit 70 can acquire arterial pressure fluctuation information via an optical sensor, a pressure transducer, or the like, but the blood pressure fluctuation acquisition method is not particularly limited. Details of the blood pressure timing calculation unit 70 will be described later in detail with reference to FIGS. 6, 7, and 10 to 18.
- the IABP drive control main body 60 receives information related to the drive timing of the balloon 68 from the electrocardiogram signal timing calculation unit 11 and the blood pressure timing calculation unit 70, and performs IABP based on these information.
- FIG. 2 is a schematic block diagram showing the overall configuration of the IABP driving device 10. As shown in FIG. 2, the IABP drive control main body 60 includes a pressure generation unit 66 and a control unit 61.
- the pressure generating means 66 alternately applies positive pressure and negative pressure to the piping system communicating with the balloon 68 so that the balloon 68 repeats expansion and contraction due to the flow of a driving fluid such as helium gas.
- the control means 61 controls the pressure generating means 66 based on the electrocardiogram signal timing information 55 and the blood pressure timing information 75 so that the balloon 68 is inflated / deflated in synchronization with a predetermined timing of the heart beat cycle.
- the control means 61 has a receiving unit 62 and a synchronization determining unit 65.
- the receiving unit 62 receives the electrocardiogram signal timing information 55 and the blood pressure timing information 75.
- the synchronization determination unit 65 determines which of the electrocardiogram signal timing information 55 and the blood pressure timing information 75 is used to control the pressure generating unit 66.
- the control unit 61 is described using an example in which the synchronization determination unit 65 selects either one of the electrocardiogram signal timing information 55 and the blood pressure timing information 75 to control the pressure generation unit 66.
- the control method of the pressure generating means 66 by the control means 61 is not limited to this.
- the control unit 61 may control the pressure generating unit 66 using both the electrocardiogram signal timing information 55 and the blood pressure timing information 75.
- FIG. 3 is a flowchart showing an example of processing in IABP performed by the IABP driving apparatus 10 shown in FIG.
- step S001 the IABP driving device 10 is activated.
- step S001 or in step S001 as shown in FIG. 1, the electrode 14, the balloon 68, etc. are arrange
- step S002 of FIG. 3 the IABP drive control main body 60 shown in FIG. 2 acquires information necessary for future IABP drive and performs setting as necessary.
- the control means 61 acquires the input information of the operator via the operation unit or the like, and the synchronization determination unit 65 can appropriately hold the electrocardiogram signal timing information 55 and the blood pressure timing information 75 to be input in the future. Set the data holding area.
- step S003 of FIG. 3 the IABP drive control main body 60 shown in FIG. 2 performs auto timing setting.
- the IABP drive control main body 60 first sets whether to perform IABP at manual timing or at auto timing.
- the IABP drive control main body 60 shifts to the manual mode when obtaining information that the operator has selected the manual mode for performing IABP at the manual timing.
- the IABP drive control main body 60 when obtaining information indicating that the operator has selected auto timing, the IABP drive control main body 60 further requests input from the operator or communicates with the electrocardiogram signal timing calculation unit 11 and the blood pressure timing calculation unit 70. Acquire and set information necessary for auto timing. For example, the IABP drive control main body 60 acquires information such as a device used for acquiring an electrocardiogram signal and blood pressure fluctuation data, and sets a priority order when using the input information as necessary. To do.
- the electrocardiogram signal timing calculation unit 11 of the IABP driving apparatus 10 illustrated in FIG. 2 calculates the electrocardiogram signal timing information 55.
- the calculation process (step S004) of the electrocardiogram signal timing information 55 will be described in detail with reference to FIG. 4, FIG. 5, FIG. 8, FIG.
- FIG. 4 is a schematic block diagram showing the internal configuration of the electrocardiogram signal timing calculation unit 11 shown in FIG. 2, and FIG. 5 shows the detailed processing of the calculation process (step S004) of the electrocardiogram signal timing information 55 shown in FIG. It is a flowchart.
- the electrocardiogram signal timing calculation unit 11 includes a third data acquisition unit 16, a fourth data calculation unit 20, an R wave timing detection unit 24, a noise determination unit 30, a storage unit 40, and an ECG average value calculation unit. 42, an abnormality detection unit 50, and an ECG expansion / contraction timing calculation unit 52.
- the third data acquisition unit 16 illustrated in FIG. 4 acquires the third data 18.
- the 3rd data acquisition part 16 can acquire the 3rd data 18 by performing A / D conversion etc. with respect to the electrocardiogram signal 12 input via the electrode 14 (refer FIG. 1). .
- the third data acquisition unit may acquire the third data 18 by receiving the third data 18 from the outside of the IABP driving device 10.
- the third data acquisition unit 16 may include a memory that temporarily stores the third data 18.
- the third data acquisition unit 16 outputs the acquired third data 18 to the fourth data calculation unit 20.
- the fourth data calculation unit 20 illustrated in FIG. 4 calculates the fourth data 22 obtained by applying the second variation method to the third data 18.
- the fourth data calculation unit 20 calculates the fourth data 22 using the following mathematical formula (1), which is an example of a calculation formula for the second variational method.
- a (t) (V (t) ⁇ V (t ⁇ )) ⁇ (V (t ⁇ ) ⁇ V (t ⁇ ⁇ 2)) ⁇ (V (t ⁇ ) ⁇ V (T ⁇ 2 ⁇ ⁇ )) ⁇ (V (t ⁇ ) ⁇ V (t ⁇ )) Equation (1)
- Equation (1) A (t) is the value of the fourth data 22 at time t
- V (t) is the value of the third data 18 at time t
- ⁇ and ⁇ are time delays.
- FIG. 8 shows the third data 18 acquired by the third data acquisition unit 16 and the fourth data 22 calculated by the fourth data calculation unit 20 with the same time.
- the upper graph in FIG. 8 represents the third data 18.
- the third data 18 corresponds to an electrocardiogram signal representing the electrical activity of the heart, and the vertical axis is mV.
- the sampling period of the third data 18 is not particularly limited, but can be set to about 0.5 to 2.0 ms, for example.
- the lower graph (solid line) in FIG. 8 represents the fourth data 22 calculated by applying the above formula (1) to the third data 18.
- an electrocardiogram waveform can be understood from the fact that the amount of change of the third data 18 (V (t)) accompanying the time change of the delay time ⁇ is multiplied (see equation (1)).
- the calculated value A (t) fluctuates greatly depending on whether the time variation of the third data 18 is rapid or moderate.
- the fourth data calculation unit 20 can acquire the fourth data 22 in which a predetermined peak included in the electrocardiogram signal is emphasized by appropriately setting the time delays ⁇ and ⁇ .
- the fourth data calculation unit 20 sets the delay times ⁇ and ⁇ so as to emphasize the R wave (change in QRS) in the electrocardiogram signal.
- Specific values of time delays ⁇ and ⁇ are adjusted according to the measurement target and are not particularly limited. For example, ⁇ may be 17 ms and ⁇ may be 11 ms.
- the calculated value of the fourth data 22 calculated by the fourth data calculating unit 20 is an abstracted value.
- the vertical axis (calculated value) is higher than the third data 18 in the portion of the R wave (QRS) where the steepest value change occurs in the electrocardiogram signal (waveform). It can be seen that the change is emphasized.
- the fluctuation of the baseline of the electrocardiogram signal and other waveforms such as a P wave and a T wave show a gradual change in the third data 18 as compared with the R wave. Therefore, in the fourth data 22 calculated by the fourth data calculation unit 20, the baseline fluctuation of the electrocardiogram signal, the P wave, and the T wave are weakened in the relative comparison with the R wave.
- the fourth data calculation unit 20 may perform a calculated value peak cut when the value calculated by the mathematical formula (1) exceeds a predetermined value. . This is because it is sufficient that the portion corresponding to the R wave can be clearly distinguished from the other portions in the processing by the electrocardiogram signal timing calculation unit 11. As shown in FIG. 4, the fourth data calculation unit 20 outputs the calculated fourth data 22 to the R wave timing detection unit 24 and the noise determination unit 30.
- the noise determination unit 30 illustrated in FIG. 4 determines the amount of noise included in the electrocardiogram signal.
- the noise determination unit 30 determines the amount of noise included in the electrocardiogram signal using the fourth data 22 calculated by the fourth data calculation unit 20, and if it is determined that there is a lot of noise, R-wave timing detection A stop signal 32 for stopping timing detection is output to the unit 24.
- the noise determination unit 30 can also perform noise determination based on the third data 18 corresponding to the electrocardiogram signal. However, as shown in FIG. 4, the noise determination unit 30 preferably performs noise determination using the fourth data 22 in the same manner as the R wave timing detection unit 24 from the viewpoint of preventing erroneous detection. This is because the noise mixed in the electrocardiogram signal may have a steep change that is easily emphasized by the second variational method.
- FIG. 9 shows another example of the third data 18 and the fourth data 22.
- the upper graph in FIG. 9 represents the third data 18, and the lower graph represents the fourth data 22.
- the noise determination unit 30 aggregates whether or not the calculated value of the fourth data 22 exceeds a preset threshold for noise detection. Then, when the ratio of the calculated value of the fourth data 22 exceeding the noise detection threshold during a predetermined counting time (for example, 750 ms) becomes a certain value (for example, 60%) or more, the noise determination unit 30. It can be determined that there is a lot of noise in the electrocardiogram signal.
- the noise determination unit 30 recognizes that the ratio of the calculated value of the fourth data 22 that exceeds the noise detection threshold after the time t ⁇ b> 1 is greater than or equal to a certain value, and the R wave timing detection unit 24. In response to this, a stop signal 32 for stopping timing detection is output.
- the R-wave timing detection unit 24 that has received the stop signal 32 can reduce erroneous detection of timing by temporarily stopping timing detection.
- the R wave timing detection unit 24 shown in FIG. 4 detects the timing of the R wave in the electrocardiogram signal using the fourth data 22.
- the R wave timing detection unit 24 includes a reference value calculation unit 26 and a comparison unit 28.
- the reference value calculation unit 26 calculates an R trigger determination threshold 25 (see FIG. 8) that is a reference value for detecting an R wave.
- the reference value calculation unit 26 may set the trigger determination threshold based on input by the user of the apparatus, and may use a fixed value determined by a predetermined condition as the trigger determination threshold. In the example shown in FIG. The reference value calculation unit 26 calculates the R trigger determination threshold 25 using the fourth data 22 calculated by the fourth data calculation unit 20.
- the reference value calculation unit 26 acquires the maximum value of the fourth data 22 within a certain time (for example, a time including one heartbeat), and several tens percent (for example, about 40%) of the maximum value. ) Is the R trigger determination threshold 25. In this way, by calculating the R trigger determination threshold 25 based on the actually acquired fourth data 22, even when the acquired ECG signal and the amplitude of the third data 18 change, the timing Misdetection and false detection can be prevented.
- the calculation method of the R trigger determination threshold 25 in the reference value calculation unit 26 is not limited to the above-described method.
- the maximum value of the fourth data 22 used for calculating the R trigger determination threshold 25 is a plurality of maximum values. May be an average value.
- Correction may be performed so as to decrease the R trigger determination threshold 25.
- the R trigger determination threshold value 25 calculated by the reference value calculation unit 26 is output to the comparison unit 28.
- the comparison unit 28 in the R-wave timing detection unit 24 mainly detects the R-wave timing (particularly the R-wave rise timing) in the electrocardiogram signal.
- the comparison unit 28 compares the fourth data 22 shown in FIG. 4 with the R trigger determination threshold 25, and whether the fourth data 22 is equal to or greater than the R trigger determination threshold 25 or less than the R trigger determination threshold 25. Recognize
- the R wave timing detection unit 24 uses the comparison result of the comparison unit 28 to detect the timing at which the fourth data 22 is recognized as exceeding the R trigger determination threshold 25 as the R trigger detection timing.
- the R wave timing detection unit 24 has the latest calculated value of the fourth data 22 equal to or greater than the R trigger determination threshold 25 and the immediately preceding calculated value of the fourth data 22 is equal to or less than the R trigger determination threshold 25.
- the timing is detected as the R trigger detection timing.
- the timing at which it is recognized that the fourth data 22 has exceeded the R trigger determination threshold 25 has not passed a predetermined time (for example, 250 ms) from the immediately preceding R trigger detection timing, the R wave timing detection unit 24 The timing is excluded from the R trigger detection timing.
- the R-wave timing detection unit 24 outputs R-wave timing information 29 that is information related to the R trigger detection timing to the storage unit 40, the ECG expansion / contraction timing calculation unit 52, and the abnormality detection unit 50. .
- the storage unit 40 stores R wave timing information 29 (for example, an R trigger detection timing interval 44 (see FIG. 4)).
- step S106 in FIG. 5 the ECG average value calculation unit 42 shown in FIG. 4 reads the R trigger detection timing interval 44 from the storage unit 40, and calculates the RR average corresponding to the R wave detection cycle of the electrocardiogram signal. To do.
- the ECG average value calculation unit 42 can calculate the moving average of the R trigger detection timing intervals 44 (for example, the average value of the intervals 44 for the latest four times) as the RR average.
- the calculation method of the RR average by the ECG average value calculating unit 42 is not limited to the above-described method, and for example, the weighted average of the interval 44 of the R trigger detection timing may be the RR average.
- the ECG average value calculation unit 42 calculates the latest R trigger detection timing interval 44 read from the storage unit 40 and the RR average calculated immediately before. Ventricular extrasystole (PVC) may be detected by comparing the values.
- PVC Ventricular extrasystole
- the ECG average value calculation unit 42 is in the PVC state when the latest R trigger detection timing interval 44 read from the storage unit 40 is less than 70% of the RR average value calculated immediately before. Can be detected.
- step S107 shown in FIG. 5 the ECG inflation / deflation timing calculation unit 52 shown in FIG. 4 calculates an inflation timing for inflating the balloon 68 and a deflation timing for deflating the balloon 68. More specifically, the expansion timing calculated here is a timing at which the pressure generating means 66 of the IABP drive control main body 60 applies a positive pressure to the piping system for transmitting the pressure to the balloon 68, and the contraction The timing is a timing at which the pressure generating means 66 applies a negative pressure to the piping system.
- the ECG expansion / contraction timing calculation unit 52 calculates the expansion timing and the contraction timing based on the R wave timing information 29 detected by the R wave timing detection unit 24 and the RR average calculated by the ECG average value calculation unit 42. Can be calculated.
- the specific calculation method in the ECG expansion / contraction timing calculation unit 52 is not particularly limited.
- the ECG expansion / contraction timing calculation unit 52 determines a predetermined ratio from the timing at which the R wave is detected to the RR average. The timing when the time multiplied by is further passed can be the expansion timing and the contraction timing.
- the abnormality detection unit 50 checks the abnormality of the electrocardiogram signal.
- the abnormality detection unit 50 detects an abnormality of the electrocardiogram signal when a predetermined time (for example, 10 seconds) has elapsed from the R trigger detection timing last detected by the R wave timing detection unit 24.
- the abnormality detection unit 50 also detects an abnormality in the electrocardiogram signal even when the third data 18 corresponding to the electrocardiogram signal has not changed over a predetermined time (for example, 3 seconds).
- the abnormality detection unit 50 can perform a warning operation to notify the user of the apparatus of the abnormality or output an abnormality detection signal to the IABP drive control main body unit 60.
- the electrocardiogram signal timing calculation unit 11 transmits the electrocardiogram signal timing information 55 to the control means 61 of the IABP drive control main body unit 60.
- the ECG signal timing information 55 includes the R wave timing information 29 detected by the R wave timing detection unit 24, the RR average calculated by the ECG average value calculation unit 42, and the ECG expansion / contraction timing calculation unit 52.
- Information calculated based on the electrocardiogram signal 12, such as the calculated inflation / deflation timing, and information related to the driving timing of the balloon 68 is included. Note that the transmission processing of the electrocardiogram signal timing information 55 does not need to be performed in a lump, and may be sequentially transmitted to the IABP drive control main body 60 when each piece of information is detected or calculated.
- the calculation processing of the electrocardiogram signal timing information 55 by the electrocardiogram signal timing calculation unit 11 ends.
- the electrocardiogram signal timing calculation unit 11 applies the second variation method to the third data 18 corresponding to the electrocardiogram signal, calculates the fourth data 22, and detects the timing of the R wave from the fourth data 22. . Since the rapid rise of the R wave is converted into the absolute value of the calculated value by the second variational method, the R wave (change in QRS) is easily separated from other parts of the electrocardiogram signal in the fourth data 22. Can be recognized separately. Therefore, the electrocardiogram signal timing calculation unit 11 can accurately detect the timing of the R wave and calculate accurate electrocardiogram signal timing information 55.
- step S005 the blood pressure timing calculation unit 70 in the IABP driving apparatus 10 shown in FIG. Note that either the calculation process of the electrocardiogram signal timing information 55 (step S004) or the calculation process of the blood pressure timing information 75 (step S005) may be performed first, or both processes are performed simultaneously. May be.
- FIG. 6 is a schematic block diagram showing the internal structure of the blood pressure timing calculation unit 70 shown in FIG. 2
- FIG. 7 is a flowchart showing detailed processing of the blood pressure timing information 75 calculation processing (step S005) shown in FIG. is there.
- the blood pressure timing calculation unit 70 calculates blood pressure timing information 75 related to the driving timing of the balloon 68 based on blood pressure fluctuation data. As shown in FIG. 6, the blood pressure timing calculation unit 70 includes a first data acquisition unit 74, a second data storage unit 84, a determination unit 86, and a BP inflation / deflation timing calculation unit 92. The blood pressure timing calculation unit 70 includes a start point detection unit 76, a data management unit 78, an interval storage unit 94, a BP average value calculation unit 95, a delay time calculation unit 96, and the like.
- the first data acquisition unit 74 illustrated in FIG. 2 acquires first data 71 corresponding to blood pressure fluctuation.
- the first data acquisition unit 74 can acquire the first data 71 by performing A / D conversion or the like on a signal input to the blood pressure timing calculation unit 70 via an optical sensor or a pressure transducer. . Further, the first data acquisition unit 74 may acquire the first data 71 by receiving the first data 71 from the outside of the blood pressure timing calculation unit 70.
- the first data acquisition unit 74 can continuously acquire the first data 71 at a sampling interval of, for example, about 1 ms, but the sampling interval when acquiring the first data 71 is not particularly limited.
- the first data acquisition unit 74 outputs the acquired first data 71 to the start point detection unit 76.
- FIG. 10 is a conceptual diagram showing the start point detection process by the start point detection unit 76.
- the start point detection unit 76 detects an increase in blood pressure accompanying the start of the systole from the first data 71 and sets it as the first start point 72. More specifically, the start point detection unit 76 holds the minimum value of the first data 71 after a predetermined reset timing (the R wave timing 97 in the electrocardiogram waveform in FIG. 10), and the held minimum value and the current When the blood pressure difference ⁇ H1 of the first data 71 becomes 5 mmHg or more, that point is set as a first start point 72.
- a predetermined reset timing the R wave timing 97 in the electrocardiogram waveform in FIG. 10
- the start point detection unit 76 does not perform the detection process of the first start point 72 during the period in which the balloon 68 is inflated in order to avoid erroneous detection (see the exclusion period in FIG. 10). ).
- the reset timing for detecting the start point is the R-wave timing 97, but the reset timing is not limited to this.
- the point in time when the first start point 72 is discarded and the combination thereof can be set as the reset timing.
- step S203 shown in FIG. 7 the start point detection unit 76 correctly detects the rising period of blood pressure accompanying the start of the systole for the first start point 72 detected in step S202. Check if it exists.
- the start point detection unit 76 performs the start point check process until the time ⁇ t3 after detecting the first start point 72 reaches 100 ms (see FIG. 11).
- the start point detection unit 76 detects that the first start point 72 and the blood pressure value after detection of the first start point 72 are out of a predetermined range, or the holding time of the minimum value that is a reference for detection is long. If the balloon 68 is inflated at the time of the first start point 72 or if the blood pressure fluctuation exceeds a predetermined range after the first start point 72 is detected, the detected first start point 72 is detected. Is discarded. When the start point is discarded in step S203, the start point detection unit 76 returns to step S202 and detects the first start point 72.
- FIG. 21 is a conceptual diagram illustrating the necessity of the start point check process performed by the start point detection unit 76 in step S203.
- the start point detection unit 76 sets a timing that is not an increase period of blood pressure accompanying the start of the systole.
- the first start point 72 may be detected by mistake.
- the start point check unit 76 erroneously detects the timing that is not in the rise period of the blood pressure accompanying the start of the systole as the first start point 72 due to the disturbance of the blood pressure waveform or the like by the start point check process, In addition, such detection points can be discarded and erroneous detection can be suppressed.
- step S204 in FIG. 7 the start point detection unit 76 performs a necessary check and then determines the first start point 72.
- FIG. 11 is a conceptual diagram illustrating a start point determination process performed by the start point detection unit 76.
- the start point detection unit 76 performs the start point determination process when the time ⁇ t3 from when the first start point 72 is detected reaches 100 ms. Therefore, the condition for performing the process of step S204 is that the first start point 72 detected in step S202 is not discarded for 100 ms by the check process of step S203.
- step S204 the start point detection unit 76 firstly compares the blood pressure difference between the minimum value of blood pressure (blood pressure at the time 98 when blood pressure is minimum) and the current time (after 100 ms from the first start point 72) as a reference for detecting the first start point 72. It is checked whether ⁇ H2 is within a predetermined range (for example, 5 mm to 100 mmHg) (Check 1 at the time of determination). Furthermore, the start point detector 76 checks that the first data 71 from the first start point 72 to the current time does not contain excessive noise (check 2 at the time of determination).
- a predetermined range for example, 5 mm to 100 mmHg
- the start point detection unit 76 determines the first data from the first start point 72 to the current time. It can be determined that one data 71 contains excessive noise.
- the start point detection unit 76 has a short interval between the immediately preceding first start point and the current first start point 72 (for example, 500 ms or less), and the blood pressure value at the current first start point 72 is the immediately preceding value. It is checked that the blood pressure value at the first start point is not larger than a predetermined ratio (for example, 1.5 times) or more (check 3 at the time of confirmation). When these determination checks 1 to 3 are passed, the start point detection unit 76 determines the first start point 72. However, if the first data 71 from the first start point 72 to the present does not satisfy any of the conditions at the time of confirmation checks 1 to 3, the detected first start point 72 is discarded and the process proceeds to step S202. Return.
- the reason why the start point detector 76 performs the final check 1 to 3 is that the timing at which the blood pressure does not increase due to the start of the systole is erroneously detected as the first start point 72 as in the case of the start point check in step S203. This is to avoid this.
- the start point detection unit 76 illustrated in FIG. 6 uses the first data 71 as the first data 71 and information regarding the determined first start point 72 and the start point determination time 99 (at the time of blood pressure trigger), which is the time when the first start point 72 is determined. And output to the determination unit 86 and the data management unit 78. In addition, the start point detection unit 76 outputs information regarding the determined first start point 72 to the interval storage unit 94.
- the interval storage unit 94 and the BP average value calculation unit 95 of the blood pressure timing calculation unit 70 calculate the average interval of the first start points 72.
- the interval storage unit 94 stores the detection timing of the first start point 72 detected and confirmed by the start point detection unit 76.
- the BP average value calculation unit 95 calculates the average interval of the first start points 72 at the timing when the newly determined first start point 72 is output from the start point detection unit 76 or the like.
- the BP average value calculation unit 95 reads the detection timing of the past first start point 72 stored in the interval storage unit 94 and calculates the average interval of the first start points 72.
- the BP average value calculation unit 95 calculates the moving average of the intervals of the first start points 72 (for example, the average value of the intervals of the first start points 72 for the latest four times) as the average interval of the first start points 72.
- the calculation method of the average interval by the BP average value calculation unit 95 is not limited to the method described above, and for example, a weighted average of the intervals of the first start points 72 may be used as the calculation value.
- the interval storage unit 94 and the BP average value calculation unit 95 calculate the average interval of the start point determination time 99 with reference to the start point determination time 99 (at the time of blood pressure trigger) instead of the average interval of the first start point 72. You may ask.
- the BP average value calculation unit 95 may detect ventricular extrasystole (PVC) in addition to calculating the average value.
- the average interval calculated by the BP average value calculation unit 95 corresponds to a heartbeat cycle. When the interval between the current and previous first start points 72 is significantly shorter than the average interval so far, ventricular extrasystole ( It can be recognized that PVC) is occurring.
- the BP average value calculation unit 95 can detect that the current state is the PVC state when the interval between the current and previous first start points 72 is less than 70% of the average interval until then.
- the determination unit 86 in FIG. 6 determines the similarity between the first data 71 received from the start point detection unit 76 and the second data 81 read from the second data storage unit 84. to decide. Similar to the first data 71, the second data storage unit 84 stores second data 81 corresponding to blood pressure fluctuations. The second data storage unit 84 stores a plurality of second data 81 having different waveform shapes, and the determination unit 86 can refer to the plurality of second data 81 for comparison with the first data 71. .
- the second data 81 stored in the second data storage unit 84 corresponds to blood pressure fluctuations in a predetermined section, and the predetermined section can be about 1 to 2 heartbeat cycles, but is not particularly limited. .
- the length of the second data 81 may be less than one heartbeat period, but the second data 81 preferably includes a dichroic notch. This is because when the second data 81 includes a dichroic notch, the information regarding the dichroic notch can be supplemented to the first data 71 even when the first data 71 does not have a dichroic notch.
- the second data storage unit 84 may store a plurality of second data 81 in advance regardless of the acquisition of the blood pressure waveform by the first data acquisition unit 74, but the second data storage unit 84 includes the first data storage unit 84. A part of the first data 71 acquired by the data acquisition unit 74 may be stored as the second data 81. More specifically, the data management unit 78 shown in FIG. 6 manages the second data 81 of the second data storage unit 84 and updates the data as necessary. The processing performed by the data management unit 78 is as follows. This will be described in step S210.
- the determination unit 86 illustrated in FIG. 6 is based on the pattern recognition unit 87 that calculates the similarity between the first data 71 and the second data 81 by a method such as pattern recognition, and the similarity calculated by the pattern recognition unit 87. And a second data extraction unit 90 that extracts second data 81 similar to the first data 71.
- the pattern recognizing unit 87 mainly includes a prebeat comparing unit 88 that determines similarity using numerical values representative of the entire one heartbeat cycle (heartbeat cycle, systolic blood pressure value, diastolic blood pressure value, etc.), and mainly systolic contraction.
- a systolic pattern recognition unit 89 that determines similarity using only data corresponding to the period.
- step S206 in FIG. 7 the preceding beat comparison unit 88 shown in FIG. 6 roughly determines the similarity between the first data 71 and the second data 81, and candidates for the second data 81 for which detailed determination is made in step S207. Is selected.
- the prebeat comparison unit 88 is set to a cycle immediately before the heartbeat cycle currently in progress (corresponding to one beat immediately before the systole including the first start point 72 determined in step S204). It is possible to use indices such as the wavelength (heart rate), the systolic blood pressure value, the diastolic blood pressure value, and the timing to reach the systolic blood pressure value.
- the anterior beat comparing unit 88 is similar to the first data 71 in that the wavelength (heart rate), the maximum blood pressure value, the minimum blood pressure value, An index such as the timing of reaching the hypertension value can be used.
- the previous beat comparison unit 88 sets the second wavelength (heart rate cycle) and the like related to the previous cycle for the two beats.
- the portion related to the posterior period used as a feature of the data 81 is used in a systolic pattern recognition (step S207) described later.
- the anterior beat comparison unit 88 compares the characteristics of the first data 71 and the second data 81 described above, and determines that the difference is within a predetermined range as a candidate for performing systolic pattern recognition in step S207. Select.
- the determination unit 86 performs screening (step S206) using the characteristics of the previous beat before performing systolic pattern recognition (step S207), which will be described later, thereby reducing the amount of calculation of the determination unit 86 and similarity. The accuracy of sex determination can be increased.
- FIG. 12 is a conceptual diagram illustrating processing performed by the determination unit 86 including the systolic pattern recognition unit 89 and the BP expansion / contraction timing calculation unit 92.
- the systolic pattern recognition unit 89 compares the first data 71 from the first start point 72 to the current time with the second data 81 after the second start point 82, and compares the first data 71 and the second data 81. Judge similarity. Note that the second start point 82 of the second data 81 is the same as the first start point 72 of the first data 71, in which the blood pressure rise period associated with the start of the systole period is detected.
- the start point determination unit 76 performs the start point determination process (step S204) 100 ms after the first start point 72 is detected in step S202 ( ⁇ t3)
- the systolic pattern At the time of performing the recognition process, the first data 71 of at least 100 ms ( ⁇ t3) from the first start point 72 is acquired. Accordingly, the systolic pattern recognition unit 89 determines similarity between the first data 71 at least between the first start point 72 and 100 ms and the second data 81 (100 ms from the second start point 82) corresponding thereto. It can be used as information for determination.
- the second data 81 used by the systolic pattern recognition unit 89 to determine similarity it is preferable to use the data selected in the prebeat comparison process described in step S206 (see FIG. 7).
- the systolic pattern recognition unit 89 can determine the similarity of each of the plurality of second data 81 with the first data 71 and output the result. Furthermore, if the first systolic pattern recognition unit 89 can acquire the first data 71 after the start point determination time 99 (100 ms from the first start point 72), the first data 71 after the start point determination time 99 and The second data 81 corresponding to this can be used as information for determining similarity.
- the method used when the systolic pattern recognition unit 89 determines the similarity between the first data 71 and the second data 81 is not particularly limited. For example, a correlation coefficient, an instantaneous difference, a cumulative difference, etc. An indicator can be used.
- the systolic pattern recognition unit 89 acquires the blood pressure value ai of the first data 71 and the blood pressure value bi of the second data 81 at 10 ms intervals, and uses the following formula (2) to The linear correlation coefficient r of the second data 81 can be obtained.
- the systolic pattern recognition unit 89 determines the similarity between the first data 71 and the second data 81 using the instantaneous difference between the first data 71 and the second data 81 as an index. You can also The systolic pattern recognition unit 89 determines whether or not there is a point between the first data 71 and the second data 81 where the instantaneous blood pressure difference ⁇ H4 is a predetermined value (for example, 20 mmHg) or more. Similarity can be judged by using whether it exists at a frequency.
- the systolic pattern recognition unit 89 determines the similarity between the first data 71 and the second data 81 using the cumulative difference between the first data 71 and the second data 81 as an index. You can also The systolic pattern recognition unit 89 obtains the blood pressure difference ⁇ H3 between the first data 71 and the second data 81 at an interval of 10 ms, and can determine similarity using the total or average value as an index.
- the second data extraction unit 90 shown in FIG. 6 changes from the second data 81 stored in the second data storage unit 84 to the first data 71 based on the determination result by the pattern recognition unit 87. Extract the most similar.
- the extraction method by the second data extraction unit 90 is not particularly limited. For example, each index calculated by the systolic pattern recognition unit 89 is within a predetermined range and the linear correlation coefficient r is closest to 1.
- a method of extracting the data 81 and a method of comprehensively judging and extracting the linear correlation coefficient r calculated by the systolic pattern recognition unit 89, the index based on the instantaneous difference, and the index based on the cumulative difference are cited. It is done.
- the second data extraction unit 90 of the determination unit 86 outputs information regarding the extracted second data 81 to the BP expansion / contraction timing calculation unit 92.
- the BP inflation / deflation timing calculation unit 92 calculates the inflation timing for inflating the balloon 68 and the deflation timing for deflating the balloon 68 based on the determination result of the determination unit 86 and the like. More specifically, the inflation / deflation timing calculated here is the same as the expansion / deflation timing calculated by the ECG inflation / deflation timing calculation unit 52, and the pressure generating means 66 of the IABP drive control main body 60 uses the balloon. This is the timing at which positive / negative pressure is applied to the piping system for transmitting pressure to 68.
- step S209 the BP inflation / deflation timing calculation unit 92 calculates the inflation timing of the balloon 68.
- the BP expansion / contraction timing calculation unit 92 reads the dichroic notch timing (D notch timing 83) included in the second data 81 extracted in step S208 from the second data storage unit 84, and currently proceeds. This is used to estimate the timing at which the middle systole ends and switches to the diastole (the timing of the dichroic notch in the current heart cycle at which the first start point 72 is detected).
- the BP inflation / deflation timing calculation unit 92 acquires the current heartbeat period (acquired).
- the interval from the first start point 72 to the dichroic notch in the second data 81 is estimated to be the same as the interval from the second start point 82 to the D notch timing 83 in the second data 81.
- the BP inflation / deflation timing calculation unit 92 sets the time calculated in consideration of the balloon inflation delay time ⁇ t 4 to the estimated D notch timing 83 as the inflation timing 93. Can do.
- the BP expansion / contraction timing calculation unit 92 performs a predetermined correction on the interval from the second start point 82 to the D notch timing 83 (
- the interval from the first start point 72 to the dichroic notch in the first data 71 is estimated by adding a correction value ⁇ D shown in FIG.
- the BP expansion / contraction timing calculation unit 92 calculates the pressure difference ⁇ A from the first start point 72 to the current time t5 and the pressure from the second start point 82 to the time corresponding to the current time t5.
- the correction value ⁇ D can be calculated in consideration of the difference ⁇ P, the time ⁇ t6 from the first start point to the D notch timing 83, and the time ⁇ t7 from the first start point to the current time t5. Also in this case, the BP inflation / deflation timing calculation unit 92 can set the time calculated in consideration of the balloon inflation delay time ⁇ t 4 to the estimated D notch timing 83 as the inflation timing 93.
- the second data 81 determined to be similar to the first data 71 by the determination unit 86 is also included in the first data 71 for portions other than the portion directly compared by the determination unit 86. This is because they are considered to be similar.
- the first start point 72 is a detection of the rise in blood pressure immediately after the start of the systole, and the similarity determination performed by the systole pattern recognition unit 89 is determined by the systole. Pattern recognition was performed on the waveform shape of the period.
- the time point when the timing is calculated by the BP expansion / contraction timing calculation unit 92 is the current time t5
- the BP expansion / contraction timing calculation unit 92 can acquire only the first data 71 up to the current time t5 at the maximum.
- the BP expansion / contraction timing calculation unit 92 shown in FIG. 6 uses the information of the second data 81 extracted by the second data extraction unit 90 to accurately determine the future timing occurring after the current time t3. Can be calculated.
- the expansion delay time ⁇ t4 may be a fixed value set at the start of IABP, or may be a fluctuation value updated by a predetermined method. A method for calculating the expansion delay time ⁇ t4 will be described in step S211. In addition, as shown in FIG.
- the contraction timing detection device 70 may repeat the process from the systolic pattern recognition (step S207) to the BP expansion / contraction timing calculation (step S209) after adding the first data 71.
- a predetermined length for example, 10 ms or more
- the contraction timing detection device 70 may repeat the process from the systolic pattern recognition (step S207) to the BP expansion / contraction timing calculation (step S209) after adding the first data 71.
- the systolic pattern recognition unit 89 can perform similarity determination using the first data from the middle to the latter half of the systole, and the timing estimation accuracy can be improved.
- the BP expansion / contraction timing calculation unit 92 uses the average interval calculated by the BP average value calculation unit 95. Thus, the expansion timing can be calculated. Further, the BP expansion / contraction timing calculation unit 92 calculates the contraction timing using the average interval calculated by the BP average value calculation unit 95. In this case, the BP expansion / contraction timing calculation unit 92 sets the timing when the time obtained by multiplying the average interval by a predetermined ratio from the first start point 72 or the start point determination time 99 as the expansion timing and the contraction timing. be able to.
- the data management unit 78 shown in FIG. 6 updates the second data 81 in the second data storage unit 84.
- the data management unit 78 includes a storage data extraction unit 79 and a storage data erasure unit 80.
- the stored data extraction unit 79 stores the second data 81 as the second data 81 from the first data 71 input via the first data acquisition unit 74 or the start point detection unit 76. Extract the part to be used.
- the stored data extraction unit 79 performs a predetermined time from when the peak (maximum value) of the blood pressure value is formed after the first start point 72 (at the time of the self-pressure maximum point 91 in FIG. 16). After a lapse of (for example, 250 ms), a predetermined check is performed on the first data 71. If the check is passed, the first data 71 is registered as the second data 81.
- Check items for registering the first data 71 as the second data 81 include that the blood pressure value of the first data 71 is within a predetermined range and the waveform length of the first data 71 is within a predetermined range. There are some things. As shown in FIG. 17, the stored data extraction unit 79 may use a check item that the slope from the first start point 72 to the self-pressure maximum point 91 is within a predetermined range.
- the stored data extraction unit 79 When the stored data extraction unit 79 registers the first data 71 that has passed the check in the second data storage unit 84 as the second data 81, the stored data extraction unit 79 can store related information in association with the second data 81. it can.
- the storage data extraction unit 79 stores information related to the first start point 72 of the first data 71 that is the basis of the second data 81 to be registered as information related to the second start point 82 of the second data 81. be able to.
- the storage data extraction unit 79 includes information on the dichroic notch included in the second data 81 to be registered (for example, an interval from the second start point 82 to the dichroic notch), information on the self-pressure maximum point 91, and the like. It can be memorized.
- step S210 the stored data erasure unit 80 erases unnecessary or less important data among the second data 81 stored in the second data storage unit 84.
- the stored data erasure unit 80 can erase the second data 81 that has never been extracted by the second data extraction unit 90 even after a predetermined time has elapsed.
- the blood pressure timing detection device 70 updates the second data 81 in the second data storage unit 84 by the data management unit 78, thereby determining the probability that the determination unit 86 can extract the second data 81 similar to the first data 71. Can be increased. Thereby, the blood pressure timing detection device 70 can perform accurate timing detection. Further, the data management unit 78 manages the second data 81 stored in the second data storage unit 84, thereby reducing the storage capacity required for the second data storage unit 84. The processing burden can be reduced. The data management unit 78 may classify the second data 81 into a plurality of groups based on information on the waveform shape and the like, and store and manage the second data 81 in the second data storage unit 84 for each group. By managing the second data 81 stored in the second data storage unit 84 in groups, the determination process by the determination unit 86 is made more efficient and the storage capacity required for storing the second data 81 is suppressed. Is possible.
- the delay time calculation unit 96 in FIG. 6 calculates the expansion delay time ⁇ t4.
- the delay time calculation unit 96 stores the first data 71 for a predetermined time (for example, 20 ms to 150 ms) after the expansion timing, which is the timing at which the pressure generating means 66 applies a positive pressure to the piping system. Monitoring is performed to detect a change point 85 where the slope of the first data 71 changes from falling to rising. Further, the delay time calculation unit 96 calculates the expansion delay time ⁇ t4 based on the time from the expansion timing to the change point 85, and outputs it to the BP expansion / contraction timing calculation unit 92.
- the delay time calculation unit 96 may use the time from the expansion timing to the change point 85 itself as the expansion delay time ⁇ t4, but may also use the moving average value of the time from the expansion timing to the change point 85 as the expansion delay time ⁇ t4. good. Further, the delay time calculation unit 96 may calculate not only the inflation delay time ⁇ t4 but also the delay time until the blood pressure fluctuation effect actually occurs from the contraction timing.
- the blood pressure timing calculation unit 70 transmits the blood pressure timing information 75 to the control means 61 of the IAPB drive control main body unit 60.
- the blood pressure timing information 75 includes an average interval calculated by the BP average value calculation unit 95, an expansion / deflation timing calculated by the BP expansion / deflation timing calculation unit 92, and a first start determined by the start point detection unit 76. Information calculated based on the first data 71 corresponding to the blood pressure fluctuation, such as the point 72 or the start point determination time 99, and information related to the drive timing is included.
- the transmission processing of the blood pressure timing information 75 does not need to be performed at once, and is sequentially transmitted to the IABP drive control main body 60 when each information is detected or calculated. Also good.
- the blood pressure timing calculation unit 70 calculates blood pressure timing information 75 (step S005 in FIG. 3).
- the blood pressure timing calculation unit 70 uses not only a current blood pressure fluctuation waveform (first data 71) but also a past blood pressure fluctuation waveform (second data) similar to the current blood pressure fluctuation waveform by using a determination method such as pattern recognition. 81) can be used to calculate timing. More specifically, as shown in FIG. 12, the blood pressure timing detection device 70 detects a rise in blood pressure accompanying the start of the systole as a first start point 72, and the blood pressure waveforms in the systole are similar. The second data 81 is used to estimate the timing of the dichroic notch.
- the blood pressure timing calculation unit 70 can accurately estimate future waveform fluctuations using the past blood pressure fluctuation waveform information similar to the current blood pressure fluctuation waveform, and accurately calculate the inflation / deflation timing. it can.
- the dichroic notch is a peak that occurs at the timing when the systole ends and switches to the diastole, so the timing is closely related to the blood pressure waveform of the immediately preceding systole, By performing pattern recognition using the systolic blood pressure waveform, it is possible to improve the timing calculation accuracy.
- step S006 shown in FIG. 3 the control means 61 of FIG. 2 performs trigger synchronization determination.
- the control unit 61 includes a receiving unit 62 and a synchronization determining unit 65.
- the receiving unit 62 receives the electrocardiogram signal timing information 55 from the electrocardiogram signal timing calculation unit 11 and the blood pressure timing information 75 from the blood pressure timing calculation unit 70.
- step S006 the synchronization determination unit 65 of the control unit 61 determines a control method of the pressure generation unit 66 based on the electrocardiogram signal timing information 55 and the blood pressure timing information 75 received by the reception unit 62.
- FIG. 19 is a flowchart illustrating an example of processing performed in the trigger synchronization determination (step S006) in FIG.
- step S301 of FIG. 19 the synchronization determination unit 65 checks whether or not the blood pressure timing information 75 is normal.
- the synchronization determination unit 65 checks whether the inflation / deflation timing included in the blood pressure timing information 75 is a normal value, whether the blood pressure timing information 75 is not input for a predetermined time (for example, 3 seconds), or the like. .
- the synchronization determination unit 65 proceeds to step S302 and employs the blood pressure timing information 75 as information for controlling the pressure generating means 66.
- the control means 61 controls the pressure generating means 66 based on the inflation / deflation timing calculated by the blood pressure timing calculation unit 70 in step S007 of FIG.
- step S301 if it is determined in step S301 that the blood pressure timing information 75 is not normal, the synchronization determination unit 65 proceeds to step S303 and checks whether the electrocardiogram signal timing information 55 is normal.
- step S303 the synchronization determination unit 65 is in a state where the expansion / contraction timing included in the electrocardiogram signal timing information 55 is a normal value, or the electrocardiogram signal timing information 55 is not input for a predetermined time (for example, 3 seconds) or longer. Check if there is any.
- the synchronization determination unit 65 proceeds to step S304, and adopts the electrocardiogram signal timing information 55 as information for controlling the pressure generating means 66.
- control means 61 controls the pressure generating means 66 based on the expansion / contraction timing calculated by the electrocardiogram signal timing calculation unit 11 in step S007 of FIG.
- the synchronization determination unit 65 ends the process as it is.
- the control means 61 controls the pressure generating means 66 based on the expansion / contraction timing employed in the trigger synchronization determination process of step S006.
- the control means 61 shown in FIG. 2 gives priority to the blood pressure timing information 75 when both the electrocardiogram signal timing information 55 and the blood pressure timing information 75 are normally input by the processing of the synchronization determination unit 65 as shown in FIG. To use.
- the blood pressure timing information 75 is calculated with reference to information included in past blood pressure fluctuation data (second data 81) having a predetermined time width, the timing calculation accuracy is high.
- the control means 61 can optimize the control of the pressure generating means 66 by using this with priority.
- the IABP driving apparatus 10 shown in FIG. 2 can perform IABP at auto timing by repeating steps S004 to S007 shown in FIG. Further, when a stop signal or the like is input, the IABP drive device 10 proceeds to step S008 in FIG. 3 and ends the IABP drive control.
- the IABP driving apparatus 10 acquires both the electrocardiogram signal timing information 55 calculated based on the electrocardiogram signal and the blood pressure timing information 75 calculated based on the blood pressure fluctuation data. Moreover, the blood pressure timing information 75 is calculated with high accuracy using pattern recognition, and the electrocardiogram signal timing information 55 is calculated with high accuracy using the second variational method. Therefore, the IABP driving device 10 can suppress trigger detection failure and detection error, and can highly optimize the expansion / contraction timing.
- the IABP driving device 10 not only performs normal driving for inflating the balloon 68 at the start of diastole a1 (dichroic notch) but also at a timing a2 delayed from the start of diastole.
- the detection drive for inflating may be performed at a predetermined frequency.
- the dichroic notch is too close to or overlaps with the blood pressure fluctuation accompanying the inflation of the balloon 68, so the blood pressure timing calculation unit 70 obtains the first data 71 including the dichroic notch. It becomes difficult to store this as the second data 81.
- the dichroic notch and the blood pressure fluctuation associated with the inflation of the balloon 68 are separated, whereby the second data storage unit 84 New second data 81 including a dichroic notch can be stored.
- the block diagram showing the internal configuration of the IABP driving device 10 shown in FIGS. 2, 4, and 6 is a conceptual diagram for explaining the processing in the IABP driving device 10.
- the processing may be performed using a central processing unit (CPU) or may be performed by combining a plurality of arithmetic circuits.
- CPU central processing unit
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Abstract
Le problème décrit par la présente invention est de procurer un dispositif de détection de rythme, et analogue, pouvant calculer de façon appropriée un rythme de commande de ballon de contrepulsion intra-aortique (IABP). La solution selon l'invention porte sur un dispositif de détection de rythme de variation de pression artérielle, comprenant : une première partie d'acquisition de données (74) destinée à acquérir des premières données (71) correspondant à une variation de pression artérielle ; une seconde partie d'enregistrement de données (84) destinée à enregistrer des secondes données (81) correspondant à une variation de pression artérielle (PA) sur un intervalle prédéterminé ; une partie de détermination (86) destinée à déterminer la similarité entre les premières données et les secondes données ; et une partie de calcul de rythme (92) destinée à calculer un rythme prédéterminé pendant un cycle de pulsations cardiaques, sur la base du résultat de détermination de la partie de détermination.
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Cited By (3)
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WO2016208152A1 (fr) * | 2015-06-25 | 2016-12-29 | パナソニックIpマネジメント株式会社 | Dispositif de détection de potentiel cardiaque et procédé de détection de potentiel cardiaque |
JP2018171175A (ja) * | 2017-03-31 | 2018-11-08 | 日本ゼオン株式会社 | Iabp用バルーンカテーテルの駆動装置 |
JP2019198417A (ja) * | 2018-05-15 | 2019-11-21 | 東レ・メディカル株式会社 | 弁形成用バルーンポンピングシステム |
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