CN107212880B

CN107212880B - Implanted dynamic electrocardiogram monitor capable of dynamically adjusting electrode configuration

Info

Publication number: CN107212880B
Application number: CN201710518009.5A
Authority: CN
Inventors: 王志华; 姜汉钧; 杨闻笛; 张春; 李福乐
Original assignee: Tsinghua University
Current assignee: Tsinghua University
Priority date: 2017-06-29
Filing date: 2017-06-29
Publication date: 2020-02-21
Anticipated expiration: 2037-06-29
Also published as: CN107212880A

Abstract

The implanted dynamic electrocardiogram monitor comprises a shell, a plurality of electrodes are distributed on the shell, a circuit board and a battery are packaged in the shell, the electrodes are connected with the circuit board to acquire electrocardiogram signals, and the battery is connected with the circuit board to supply power; the electrodes can form a plurality of electrocardio leads, the acquisition circuit at the front end of the circuit board adopts a multi-channel design, the acquisition circuit is realized by connecting a plurality of acquisition channels each provided with an analog-digital converter in parallel, or is realized by adopting a mode of time division multiplexing one single-channel analog-digital converter among the plurality of acquisition channels, or simultaneously carries out analog-digital conversion on analog signals of each channel by adopting one or a plurality of multi-channel analog-digital converters.

Description

Implanted dynamic electrocardiogram monitor capable of dynamically adjusting electrode configuration

Technical Field

The invention relates to the technical field of implanted dynamic electrocardiogram monitors, in particular to an implanted dynamic electrocardiogram monitor capable of dynamically adjusting electrode configuration.

Background

Common implantable dynamic electrocardiograph monitors, such as Medtronic regenerative LINQ and other products, are both two electrodes and do not have the function of personalized adjustment of patients according to medical monitoring requirements.

In the united states patent (US 2014/0257072 a1), a three-electrode subcutaneous cardiac signal monitoring device is proposed, which has two mechanical arms, and three motors are distributed on two arms, one of which is an electrode and the other is two electrodes. Before subcutaneous implantation, two arms merge, implant subcutaneous back, utilize pivot column structure to open, and two arms pass through the string and connect and keep the angle. Two perpendicular electrocardiographic leads are formed. Although the patent adopts a structure of 3 electrodes, the leads formed by the electrodes are fixed leads, and the individualized dynamic adjustment of a patient cannot be carried out according to the medical monitoring requirement after the implantation.

In US patent (US 7212849B 2), a subcutaneous electrode array on an electrocardiograph is proposed, four electrodes are located on the narrow side of the implantable electrocardiograph implanted in the shoulder socket, and the four electrodes can be programmed to change on and off to detect cardiac signals. The electrode of this patent arranges the selection and only has 4 fixed modes, can set up according to the medical treatment demand. But does not function to dynamically adjust after implantation subcutaneously in a patient.

Disclosure of Invention

In order to overcome the disadvantages of the prior art, the present invention provides an implantable dynamic electrocardiograph with dynamically adjustable electrode configuration, which has a function of dynamic adjustment.

In order to achieve the purpose, the invention adopts the technical scheme that:

an implanted dynamic electrocardiogram monitor capable of dynamically adjusting electrode configuration comprises a shell 2, wherein a plurality of electrodes 1 are distributed on the shell 2, a circuit board 3 and a battery 4 are packaged in the shell 2, the electrodes 1 and the circuit board 3 are connected to realize acquisition of electrocardiogram signals, and the battery 4 and the circuit board 3 are connected to supply power;

the electrodes 1 can form a plurality of electrocardio leads, the electrocardio leads form a bipolar lead by the electrodes 1 at two different positions, the potential difference between the two electrodes 1 is measured, namely the bipolar lead electrocardiosignal, or the single electrode 1 and the electrocardio end form a unipolar lead, and the potential change of the heart at the position of the measuring electrode is measured, namely the unipolar lead electrocardiosignal; when adopting the unipolar lead, two or more electrodes 1 are needed to obtain a central electric end, and the central electric end is obtained by two or more reference electrodes through a circuit module on a circuit board;

the front-end acquisition circuit of the circuit board 3 is designed by adopting multiple channels, and each channel is provided with a corresponding analog power frequency filter, a low-noise low-power consumption high-gain amplifier, a gain adjustable amplifier, an impedance boosting loop, a common-mode noise suppression, an anti-aliasing filter and a low-power consumption high-precision analog-to-digital converter; the analog-to-digital converter on each acquisition channel is an independent analog-to-digital converter, or an analog-to-digital converter shared by other channels, or a channel in a multi-channel analog-to-digital converter, namely a front-end acquisition circuit comprises a plurality of independently configured single-channel analog-to-digital converters, each acquisition channel uses one single-channel analog-to-digital converter, and the acquisition channels are independent and can independently set parameters of filtering, gain and sampling rate; or only one single-channel analog-to-digital converter is included, each channel shares the same analog-to-digital converter through time division multiplexing, and each acquisition channel can be provided with independent filtering and gain, but the sampling rate is set uniformly; or one or more multi-channel analog-to-digital converters are included, each acquisition channel performs analog-to-digital conversion by using one channel in the multi-channel analog-to-digital converter, and each acquisition channel can be provided with independent filtering and gain, but the sampling rate is set uniformly.

And the electrode 1 and the shell 2 are subjected to insulation treatment.

The electrode 1 is consistent in shape, size, area, thickness, material and coating.

The electrode 1 and the circuit board 3 are connected through a connecting wire with good conductivity, and the connecting wire is made of flexible materials to be bent to reduce the volume or made of hard materials to reduce the volume through distribution.

The battery 4 adopts a battery with low leakage current and high energy density.

The circuit board 3 is made of a PCB or a flexible material, and the circuit boards 3 are made into one or a plurality of spliced or stacked circuit boards, so that the optimized distribution is facilitated, the size is reduced, and the circuit noise is reduced.

The shell 2 is made of titanium material with good biocompatibility or other materials with biocompatibility.

The electrode 1 is made of titanium material or titanium alloy with good biocompatibility and good conductivity, or a structure of a TiN film sputtered on the Ti material.

The adjusting method of the implanted dynamic electrocardiogram monitor for dynamically adjusting the electrode configuration comprises the following steps:

1) presetting adjustment parameters: recording and generating a personalized electrocardio template of a patient, and setting dynamic adjustment time interval and reference characteristics including morphology, amplitude, duration, frequency spectrum, special waveform and appearance time and electrocardio axis deviation characteristics;

the electrocardio template selects an electrocardio waveform template from a special waveform library or artificially generates a new electrocardio waveform template;

the dynamic adjustment time interval is the time interval between two times of dynamic adjustment of electrode configuration;

when the reference characteristics are selected to be amplitude, duration, frequency spectrum and electrocardio-axis deviation characteristics, the reference characteristics are directly obtained by calculation through the acquired electrocardio data; when the characteristics such as form, special waveform, appearance time and the like are selected, an electrocardiogram template is needed to be used, the difference between the acquired data and the electrocardiogram template is compared, the algebraic operation is carried out through the indirect characteristics of the maximum value, the mean square error, the linear correlation and the wavelet decomposition coefficient by calculating, and the reference characteristics are indirectly obtained;

2) initial setting of electrode configuration: comprises setting an electrode configuration mode, an alternative lead list and the number of alternative leads,

the electrode configuration modes comprise a maximum lead mode, a multi-lead mode and a single-lead mode, and are configured in a wireless mode by using a program controller matched with the implanted dynamic electrocardiogram monitor; in use by patients with complex, unidentified heart disease, the electrode configuration is initially set to the maximum lead mode at the time of implantation; when only a plurality of special leads of the patient need to be recorded, the electrode configuration is initially set to a multi-lead mode, and the leads needed to be recorded are selected; when only a single lead needs to be recorded, selecting a single lead mode and selecting the lead required to be recorded;

the alternative lead list is the priority of adjusting lead selection when dynamically adjusting the electrode configuration, and the alternative lead list can be selected according to the sequence in the initially set alternative lead list when dynamically adjusting the electrode configuration; the default list of alternative leads is set according to the electrode position arrangement: the closer to the initially set lead, the higher the priority in the alternative lead list; the list of alternative leads is called a table, but is not limited to a linear table in data structure, and is a table, a tree or a directed graph; when the data structure is recorded in a table form, the priority is determined by the sequence of the table storage; when the data structure is recorded in a tree form, the priority is determined in a tree traversal mode; when the data structure is recorded in the form of a directed graph, the priority is determined by the direction of the directed graph;

the number N of the alternative leads is the number of the alternative leads which are selected from the alternative lead list and participate in comparison each time the dynamic adjustment is carried out;

3) recording electrocardiographic waveforms:

the implanted dynamic electrocardiogram monitor continuously records subcutaneous electrocardiogram waveforms of the patient according to the initial setting of the electrode configuration, and simultaneously times; after a dynamically adjusted time interval, step 4) is entered,

4) detecting the electric quantity and the data storage capacity of the primary battery:

when the battery power is too low, a power too-low identifier is recorded in a battery power state register; when the data storage capacity is not enough, recording an identifier with low storage capacity in a data storage capacity register;

after detecting the battery power and the data storage capacity, skipping is required according to the detection result of the battery power and the data storage capacity, and the following situations are adopted:

i. when the battery power and the data capacity are sufficient, entering the step 5);

adjusting the lead settings when the battery power is found to be too low and in the maximum lead mode or the multi-lead mode; at the moment, automatically adjusting the lead mode, entering a single lead mode, and closing the recording functions of other leads; if the priority is set during initial setting, the lead with the highest priority in the leads is reserved, and if the priority is not set, the lead with the largest dynamic adjustment characteristic value is reserved;

when the single lead mode is in or the lead adjusting mode enters the single lead mode, the function of dynamically adjusting the electrode configuration is stopped at the same time, the step 5) is skipped, and the step 6) is entered;

when the data storage capacity is found to be too low and the battery power is sufficient, and the lead is in the maximum lead mode and the multi-lead mode, the current lead setting is still kept, only the data volume of data recording is reduced, namely only the corresponding lead data with data abnormity is recorded, and the step 5 is entered;

5) electrode dynamic adjustment: the dynamic electrode adjusting process comprises the following steps:

a. when the continuous recording time reaches the time interval of dynamic adjustment, selecting N leads with the highest priority from the alternative lead list of the current lead according to the number N of the alternative leads to be used as the alternative optimal leads;

b. starting acquisition channels corresponding to the N candidate optimal leads, acquiring electrocardiographic waveforms for a period of time, and respectively calculating corresponding reference characteristic calculation values;

c. comparing the reference feature calculated value with a reference feature threshold value: if the calculation result of the reference feature exceeds the threshold value of the reference feature, entering the next step d; if the calculated reference feature calculation values of the current lead and the alternative optimal lead are smaller than the set reference feature threshold, performing electrocardiographic waveform abnormality analysis according to the current lead, simultaneously, selecting N leads with the priority next to the current alternative optimal lead from the alternative lead list again to serve as new alternative optimal leads, and repeatedly recording electrocardiographic waveforms, calculating reference features and comparing the reference feature threshold until the calculation result of the reference features of the leads exceeds the reference feature threshold;

d. selecting the lead with the maximum reference characteristic calculation value from the leads with the reference characteristic calculation result exceeding the reference characteristic threshold value as a new optimal lead to replace the current lead;

e. recording the dynamically adjusted leads and the time stamp during adjustment;

f. resetting the timer and restarting timing;

6) the electrocardiographic waveform continues to be recorded: the implanted dynamic electrocardiogram monitor continuously records subcutaneous electrocardiogram waveforms of the patient according to the configuration of the electrode after dynamic adjustment, and simultaneously times; re-entering step 4) after a dynamically adjusted time interval;

7) manual modification: only when the program controller is used for programming the implanted dynamic electrocardiogram monitor and the manual modification function is selected, the step 7 is carried out through interruption, and other conditions can not be carried out; and after the manual modification is finished, re-entering the step 3), and continuing the dynamic adjustment.

The invention has the beneficial effects that:

the implanted dynamic electrocardiogram monitor and the adjusting method have the characteristics of individuation of a patient and dynamic configuration, and the obtained electrocardiogram signals are more accurate, more effective and higher in quality, so that better auxiliary medical diagnosis is realized.

By setting the electrocardiogram template and the reference characteristics, special waveforms and specific waveform characteristics which are helpful for medical diagnosis are defined. The special waveform and the specific waveform characteristics can be set individually for patients with different symptoms, and can be adjusted individually according to the occasional symptoms of the specific patient, so that the electrocardiographic waveform helpful for diagnosis can be obtained more accurately.

The electrode can be dynamically configured, so that the lead can be automatically and periodically optimized after the implantation operation. By automatically, timely configuring the optimal leads, the highest signal quality electrocardiographic waveform can be obtained from all possible leads. Meanwhile, the dynamic configuration method can also correct artificial artifact caused by implantation position offset and ensure the validity of the recorded signals.

Drawings

FIG. 1 is a schematic structural diagram of the present invention.

Fig. 2 is a schematic diagram of the housing and electrode arrangement of the present invention.

FIG. 3 is a schematic diagram of the circuit structure of the present invention.

FIG. 4 is a flow chart of the adjusting method of the present invention.

FIG. 5 is a flow chart of a dynamic electrode configuration.

Fig. 6 is a schematic diagram of an automatic electrode assignment priority list.

Fig. 7 is an example of an electrocardiographic waveform obtained using the present invention.

Detailed Description

The invention is described in detail below with reference to the figures and examples.

Referring to fig. 1 and 2, an implantable dynamic electrocardiograph with dynamically adjusted electrode configuration, comprising: the shell 2, the electrode 1, the circuit board 3 and the battery 4.

A plurality of electrodes 1 are arranged on a casing 2, and a circuit board 3 and a battery 4 are enclosed inside the casing 2. The circuit board 3 is distributed with a plurality of chips, antennas, resistors, capacitors, inductors and other components and connecting wires, and the components are electrically connected to form a complete electronic system. The electrode 1 is connected with the circuit board 3 through a lead to realize the acquisition of electrocardiosignals. The battery 4 is connected to the circuit board 3 through a wire to supply power.

Wherein the housing 2 is composed of two parallel placed symmetry planes and a side wall connecting the edges of the two symmetry planes. The symmetrical plane can be made into a rectangle, an ellipse, a circle or an arc, and a plurality of electrodes are distributed on the symmetrical plane. The side wall smoothly connects the two symmetrical planes. The whole shell is of a thin three-dimensional structure with a relatively large symmetrical plane and a relatively small side wall, so that the shell can be conveniently implanted under the skin. Each surface of the shell forms a smooth transition with radian, and is also provided with a hole or other structures required for fixing under the skin.

The battery 4 adopts a battery with low leakage current and high energy density, such as a LiCFx battery, a LiCFx-SVO battery, a LiMnO2 battery and the like, and the shape of the battery 4 is customized according to the space in the implanted dynamic electrocardiogram monitor, so that the battery volume is increased to the greatest extent, and larger battery capacity is obtained.

The circuit board 3 is made of a PCB or a flexible material, and the circuit boards 3 are made into one or a plurality of circuit boards which are spliced or stacked, so that the optimized distribution is facilitated, the volume is reduced, and the circuit noise is reduced, for example, the circuit boards wrap the battery or are bent into a plurality of small pieces; the modules in the circuit may be distributed on different circuit boards, such as the transceiver and the acquisition channel distributed on different circuit boards, to reduce noise interference of the transceiver to the acquisition channel.

The shell 2 is made of titanium material with good biocompatibility or other materials with biocompatibility, such as ABS and the like. When the shell 2 is made of metal material, the connection between the shell 2 and the electrode 1, and the connection between the electrode 1 and the circuit board 3 need to be insulated, and the shell 2 needs to be covered with a layer of insulating material film with good biocompatibility so as to achieve the purposes of insulation and biocompatibility; when the housing 2 is made of non-conductive material such as ABS, the housing 2 does not need to be specially insulated.

The electrode 1 adopts a titanium material or a titanium alloy (such as TiN and the like) with good biocompatibility and good electrical conductivity, or a TiN film and other structures are sputtered on the Ti material; every two pairs of electrodes 1 form an electrode pair (possibly an acquisition electrode pair for acquiring electrocardiosignals and possibly a reference electrode pair for acquiring reference signals); noise interference is introduced due to the difference between the two electrodes 1 in the electrode pair, and the quality of the acquired electrocardiosignals is influenced; the electrocardiosignals collected by the implanted dynamic electrocardioscanner are about microvolts to hundreds of microvolts, so that the noise introduced by the difference between the electrode pairs can far exceed the signal amplitude; therefore, the electrode 1 needs to have good consistency in the shape, size, area, thickness, material and coating (such as manufacturing a Ti-TiN electrode) distribution; on the other hand, the connection lines of the electrode 1, the electrode 1 and the circuit board 3 (acquisition path) and the conductivity of other structures can also seriously affect the quality of the acquired electrocardiosignals, the human body is equivalent to a signal source, the connection of the electrode 1, the electrode 1 and the circuit board 3 (acquisition path) and the impedance of the human body are equivalent to the internal resistance of the signal source, and the equivalent input impedance of the circuit is equivalent to a load; the larger the internal resistance of the signal source is, the smaller the amplitude of the actually acquired signal is. It is therefore important to reduce the impedance of the connection of the

electrodes

1, 1 to the circuit board 3 (acquisition path) in addition to the matching of the differential electrodes.

A plurality of electrodes 1 are distributed on the shell 2. The electrode 1 and the housing 2 are insulated from each other. The plurality of electrodes 1 have good consistency in shape, size, area, thickness, material and plating. The electrode 1 and the circuit board 3 are connected through a connecting wire with good conductivity, and the connecting wire is made of flexible materials to be bent to reduce the volume or made of hard materials to reduce the volume through reasonable distribution.

The electrodes 1 on the shell 2 are distributed on a symmetrical plane, or the electrodes 1 are distributed on two symmetrical planes; the electrode 1 on one surface is used as a collecting electrode for collecting electrocardiosignals, and the electrode 1 on the other surface is used as a reference electrode for noise processing or forming an electrode pair to record auxiliary waveforms (such as myoelectricity and the like) so as to help diagnosis.

Referring to fig. 3, a plurality of chips, antennas, resistors, capacitors, inductors, other components and connecting wires are distributed on the circuit board 3, and the components are electrically connected to form a complete electronic system; the circuit board 3 can be made of common PCB or flexible material, and the circuit board 3 can be made into one or more than one circuit board which can be spliced or stacked, so that the optimized distribution is facilitated, the volume is reduced, and the circuit noise is reduced, for example, the circuit board is wrapped by a battery or is bent into a plurality of small pieces. The modules in the circuit board 3 may be distributed on different circuit boards, for example, the transceivers and the acquisition channels are distributed on different circuit boards, so as to reduce noise interference of the transceivers on the acquisition channels.

The circuit structure comprises: the device comprises a front-end acquisition circuit, a digital filter, a special electrocardiosignal processing circuit, a control unit, a transceiver, a power management circuit, a clock circuit, a bus, a starting circuit, a reference circuit, a memory, a resistor, a capacitor and other components.

The front-end acquisition circuit comprises an analog power frequency filter, a chopping modulator, a demodulator, a low-noise low-power-consumption high-gain amplifier, a gain adjustable amplifier, an anti-aliasing filter and a low-power-consumption high-precision analog-to-digital converter. The low-noise low-power-consumption high-gain amplifier also comprises an impedance boosting loop, a common-mode noise suppression loop, a direct-current servo loop and the like so as to realize the effects of improving input impedance, reducing common-mode noise, eliminating baseline drift and the like.

The pre-acquisition circuit adopts a multi-channel design, and each channel is provided with a corresponding analog power frequency filter, a low-noise low-power-consumption high-gain amplifier, a gain adjustable amplifier, an impedance boosting loop, a common-mode noise suppression filter, a low-power-consumption high-precision analog-to-digital converter. The analog-to-digital converter on each acquisition channel may be an independent analog-to-digital converter, may also be an analog-to-digital converter shared with other channels, and may also be one channel in a multi-channel analog-to-digital converter. That is, the front-end acquisition circuit may include a plurality of independently configured single-channel analog-to-digital converters, each acquisition channel uses one single-channel analog-to-digital converter, and each acquisition channel is independent and can independently set parameters such as filtering, gain, sampling rate, and the like; or only one single-channel analog-to-digital converter can be contained, each channel shares the same analog-to-digital converter through time division multiplexing, and each acquisition channel can be provided with independent filtering and gain, but the sampling rate is set uniformly. The system can also comprise one or more multi-channel analog-to-digital converters, each acquisition channel uses one channel in the multi-channel analog-to-digital converter to perform analog-to-digital conversion, and each acquisition channel can be provided with independent filtering and gain, but the sampling rate is set uniformly. . The connection mode of the electrodes and each channel, and the opening and closing of the channels are controlled by a dynamic adjustment method.

The digital filter includes: digital power frequency wave trap and digital band-pass filter. The digital band-pass filter can be completed by low-pass filtering and high-pass filtering superposition. Each digital filter is implemented using a corresponding hardware circuit for real-time processing and low power consumption requirements. The infinite impulse response filter has a lower order than the finite impulse response filter, so in order to reduce the operation amount, namely the operation time and the circuit turnover power consumption, the method of the infinite impulse response filter is adopted to specifically realize the digital low-pass, high-pass and band-pass filters.

The special electrocardiosignal processing circuit comprises a QRS wave extraction circuit, an R-R interval calculation circuit, a QRS wave width calculation circuit, a correlation calculation circuit, a maximum value calculation circuit, a maximum variance calculation circuit and other real-time processing circuits and programs.

And the control unit realizes the control of the whole electronic system by using an MCU singlechip or a state machine or a micro code controller.

The transceiver comprises a radio frequency transceiver and a near field transceiver, the radio frequency transceiver is used for uploading data at regular time and giving an alarm when the electrocardio is abnormal, the near field transceiver is used for communicating with a program controller or a handheld device to realize the functions of reading, deleting stored data, reading, modifying set parameters, reading and resetting state bits, marking and storing currently acquired data and the like; the transceiver also needs to be equipped with an antenna.

The power management circuit comprises a charge pump and a plurality of LDO voltage stabilizing sources controlled by the control unit, so that the power is managed by the circuit module in a blocking mode, the circuit which is not in the working state is powered off, and the leakage power consumption is reduced. For example, a transmitter module in a transceiver turns off a corresponding LDO voltage regulator when data is not transmitted, and turns on the corresponding LDO voltage regulator before data is transmitted, so that the power consumption of a transistor during power-on but no action of a module circuit is eliminated.

The clock comprises a fast-frequency clock and a slow-frequency clock module, the fast-frequency clock is applied to the radio frequency transceiver, and the slow-frequency clock is applied to other modules such as a control unit, a digital filter, an acquisition circuit and power management. The clock module is composed of a ring oscillator, an amplifier, a crystal oscillator, a calibration circuit, a frequency division circuit, a phase-locked loop and the like.

The bus comprises a data bus, a control bus, an address bus and the like, is used for connecting circuit modules and realizes information interaction.

The starting circuit comprises an ultralow-current sensing circuit, a counting module and a hysteresis module, wherein the ultralow-current sensing circuit outputs and changes when detecting that the implanted dynamic electrocardiogram monitor configured by the dynamic adjustment electrode leaves a storage state, the counting module starts counting, when the continuous counting exceeds a starting threshold value, the starting circuit generates a starting signal, and other circuit modules in the electronic system start to be electrified and work; when the counting is interrupted, the hysteresis module clears the counter, the starting circuit does not send a starting signal, and other circuit modules in the electronic system are in a power-off state, do not work and consume no power.

The reference circuit generates a plurality of reference voltages, a plurality of reference currents and a central electric terminal used in the electrocardio acquisition.

The memory stores information such as electrocardiogram data, time, lead state change and the like.

Referring to fig. 4, a flow chart of an adjusting method of an implantable dynamic electrocardiograph for dynamically adjusting electrode configuration includes the following steps:

1) presetting adjustment parameters: recording and generating a personalized electrocardio template of a patient, and setting dynamic adjustment time interval and reference characteristics, wherein the characteristics specifically comprise morphology, amplitude, duration, frequency spectrum, special waveform and appearance time, electrocardio axis deviation and the like;

the electrocardio template can select an electrocardio waveform template from a special waveform library, and can also artificially generate a new electrocardio waveform template; for the electrocardiographic waveforms which are sporadic, difficult to occur when the electrocardiographic template is recorded, possibly suffered by the patient and have clinical diagnosis significance, the corresponding electrocardiographic waveforms such as typical electrocardiograms of the early-onset repolarization syndrome and the like can be selected from the existing special waveform library through program control setting, and are set as the personalized electrocardiographic template of the patient; for the waveform which is not recorded in the special waveform library, a digitalized waveform file can be recorded through an external interface of the program controller, the digitalized waveform file is added into the special waveform library to generate a new special electrocardiographic waveform template, and then the newly recorded waveform is set as the electrocardiographic template;

the dynamic adjustment time interval is the time interval between two dynamic adjustment electrode configurations;

when the reference characteristics are selected from the characteristics of amplitude, duration, frequency spectrum, electrocardiographic axis offset and the like, the reference characteristics can be obtained by directly calculating the acquired electrocardiographic data; when the characteristics such as form, special waveform, appearance time and the like are selected, an electrocardiogram template is needed to be used, the difference between the acquired data and the electrocardiogram template is compared, the algebraic operation is carried out through the indirect characteristics such as the maximum value, the mean square error, the linear correlation, the wavelet decomposition coefficient and the like by calculating, and the reference characteristics are indirectly obtained;

the electrocardio template and the reference characteristics can describe and classify waveforms of specific categories, so that the occurrence time of the waveforms and the electrocardio waveforms in a period of time before and after the occurrence time of the waveforms can be accurately identified and recorded, and medical diagnosis is facilitated; the electrocardiogram template and the reference characteristics are adopted, so that personalized adjustment can be conveniently carried out on each patient; the medical staff can conveniently set a personalized specific waveform screening mechanism for the patient according to the symptoms, medical examination results, medical history and other information of the patient, so that the electrocardiographic waveform helpful for diagnosis can be more accurately obtained;

2) initial setting of electrode configuration: setting an electrode configuration mode, an alternative lead list and the number of alternative leads;

the electrode configuration mode comprises a maximum lead mode, a multi-lead mode and a single-lead mode, the program control instrument matched with the implanted dynamic electrocardioscanner is configured in a wireless mode, when the program control instrument is used by a complex patient with heart diseases of unknown reasons, the electrode configuration can be initially set to the maximum lead mode during implantation, the electrocardio leads can be recorded as much as possible, and lead signals as much as possible are provided for accurate diagnosis of a doctor so as to facilitate accurate diagnosis of the diseases; after the attending physician analyzes the individual patient, the physician only needs to record a plurality of special leads of the patient, the electrode configuration can be initially set to a multi-lead mode, and the lead required to be recorded is selected; when the attending physician analyzes the individual patient to consider that only a single lead needs to be recorded, the single lead mode can be selected, and the lead required to be recorded is selected;

the alternative lead list is the priority of adjusting lead selection when dynamically adjusting the electrode configuration, and the alternative lead list can be selected according to the sequence in the initially set alternative lead list when dynamically adjusting the electrode configuration; the default list of alternative leads is set according to the electrode position arrangement: the closer to the initially set lead, the higher the priority in the alternative lead list; the alternative lead list is called a table, but is not limited to a linear table in data structure, and can be a table, a tree or a directed graph; when the data structure is recorded in a table form, the priority is determined by the sequence of the table storage; when the data structure is recorded in a tree form, the priority is determined in a tree traversal mode; when the data structure is recorded in the form of a directed graph, the priority is determined by the direction of the directed graph;

in some applications, a multi-lead electrocardiogram is required to be acquired, the connection mode of electrodes and electrodes can be configured according to the maximum electrode pair mode, a plurality of channels are opened to form the required multi-lead electrocardiogram, the multi-lead electrocardiogram is recorded, the electrocardiographic axis is calculated, and the multi-lead recording of the electrical activity characteristics of the heart is completed; for example in complex, ill-defined cardiac diseases.

In some applications, after the doctor asks for an analysis of individual patient, only a few specific leads of the patient need to be recorded, a plurality of channels can be started before or during implantation to acquire the multi-lead electrocardiograms, then the leads and the electrode pairs required for diagnosis are selected by a special programming instrument according to the analysis of the doctor on the individual condition of the patient, and other channels which are not used are closed, so that the optimal electrocardiogram for diagnosing and monitoring the individual patient is acquired.

In some applications, after a doctor analyzes the individual condition of a patient, if there is a detection requirement for a specific electrocardiographic waveform, the characteristics of the waveform to be monitored by the programmer (for example, characteristics such as selecting a channel with the largest R-wave amplitude or a channel most similar to the specific waveform) and the channel update frequency can be used; in the recording process of the implanted dynamic electrocardiogram monitor, the electrocardiographic waveform characteristics required to be monitored are automatically collected and calculated according to the set time interval of dynamic adjustment, and the channel with the corresponding waveform characteristics is selected for recording, so that the automatically updated optimal electrocardiogram of individual patients for diagnosis and monitoring is obtained.

In some applications, under the conditions that electromagnetic interference in the environment of a patient is strong, or noise collected by the patient is relatively large due to the fact that a large amount of movement needs to be carried out on the patient, one or a pair of or a plurality of electrodes can be selected to serve as reference electrodes, a noise elimination method is adopted, noise cancellation is carried out on collected electrocardiosignals, background noise is eliminated, and an electrocardiogram which is better in signal-to-noise ratio and more beneficial to diagnosis is obtained; for example, a pair of reference electrodes may be selected, a reference signal may be recorded through one channel, one or more pairs of collecting electrodes may be selected, an electrocardiographic signal may be recorded through a corresponding channel, and then the reference signal may be used to perform adaptive filtering processing on the recorded electrocardiographic signal, so as to eliminate electromagnetic interference. Or, one or more electrodes can be selected by referring to a Wilson center middle end mode commonly used by an electrocardiograph, and the average potential is obtained through calculation and is used as an equivalent shared negative electrode of the differential electrode, so that noise cancellation is realized, and a clear electrocardiogram is obtained;

3) recording electrocardiographic waveforms:

the implanted dynamic electrocardiogram monitor continuously records subcutaneous electrocardiogram waveforms of the patient according to the initial setting of the electrode configuration, and simultaneously times; entering step 4) after a dynamically adjusted time interval;

when the battery power is too low, a power too-low identifier is recorded in a battery power state register;

when the data storage capacity is not enough, recording an identifier with low storage capacity in a data storage capacity register;

the state information of the battery electric quantity and the data storage capacity is uploaded when the abnormal electrocardio data is transmitted back; after the data is returned, the patient terminal or the medical platform can judge the state information, when the electric quantity is too low or the storage capacity is too low, the patient terminal can send out sound and image-text prompts to remind the patient to return to visit as soon as possible, the medical platform can send out image-text prompts and sound to remind the doctor of needing to contact the corresponding patient, the storage capacity of the implanted dynamic electrocardiogram monitor with too low data storage capacity is released, and the implanted dynamic electrocardiogram monitor with too low battery electric quantity is replaced.

adjusting the lead settings when the battery power is found to be too low and in the maximum lead mode or the multi-lead mode; because the maintenance of a plurality of lead records has relatively large electricity consumption, the monitor needs to ensure normal work before the return visit of the patient and does not generate error operation due to insufficient battery electricity; at the moment, automatically adjusting the lead mode, entering a single lead mode, and closing the recording functions of other leads; if the priority is set during initial setting, the lead with the highest priority in the leads is reserved, and if the priority is not set, the lead with the largest dynamic adjustment characteristic value is reserved;

in order to reduce power consumption and ensure that a monitor normally collects and records electrocardiosignals before a patient visits back, when the monitor is in a single-lead mode or a lead adjusting mode enters the single-lead mode, the function of dynamically adjusting electrode configuration is stopped at the same time so as to ensure that false operation caused by insufficient electric quantity does not occur before the patient visits back, and the problems of recording wrong data, deleting misoperation of recorded but not uploaded data and the like are avoided; skipping step 5), entering step 6);

5) electrode dynamic adjustment: referring to fig. 5, the dynamic electrode adjustment process is divided into the following steps:

c. comparing the reference feature calculated value with a reference feature threshold value; if the calculation result of the reference feature exceeds the threshold value of the reference feature, entering the next step d; if the calculated reference feature calculation values of the current lead and the alternative optimal lead are smaller than the set reference feature threshold, performing electrocardiographic waveform abnormality analysis according to the current lead, simultaneously, selecting N leads with the priority next to the current alternative optimal lead from the alternative lead list again to serve as new alternative optimal leads, and repeatedly recording electrocardiographic waveforms, calculating reference features and comparing the reference feature threshold until the calculation result of the reference features of the leads exceeds the reference feature threshold;

e. recording the dynamically adjusted leads and the time stamp during adjustment so as to distinguish when the electrocardiogram data is read;

f. resetting the timer and restarting timing;

6) the electrocardiographic waveform continues to be recorded:

the implanted dynamic electrocardiogram monitor continuously records subcutaneous electrocardiogram waveforms of the patient according to the configuration of the electrode after dynamic adjustment, and simultaneously times; re-entering step 4) after a dynamically adjusted time interval;

7) manual modification: only when the program controller is used for programming the implanted dynamic electrocardiogram monitor and the manual modification function is selected, the step 7 is carried out through interruption, and other conditions can not be carried out;

when a patient visits back, an attending physician can exchange information on the skin surface of the implanted position of the patient in a wireless mode through the program controller, and acquire and modify one or more of preset adjustment parameters and initial settings of electrode configuration, such as acquiring and modifying a current electrode configuration mode, acquiring and modifying a current lead and the like;

in some applications, after the implantable dynamic electrocardiograph is implanted into the subcutaneous part of a patient, position deviation is generated due to external force influence or fixation looseness, and the electrode dynamic adjustment presents an obvious track. The doctor can modify the initial setting of the electrode configuration by a special programming instrument, namely, modify the electrode connection mode, select the electrodes at proper positions to form new leads to replace the old leads, and avoid the interference of human introduction of the measured data due to the position deviation of the electrodes so as to avoid misdiagnosis.

In addition, when the storage capacity is found to be too low, the program controller can read and delete the abnormal electrocardio data record stored in the implanted dynamic electrocardio monitor, and then the identifier of the data storage capacity register is reset. After part of the stored data is deleted, the free memory space continues to store abnormal electrocardiogram data.

When the battery capacity is too low, the implanted dynamic electrocardiogram monitor should be replaced as soon as possible.

And after the manual modification is finished, re-entering the step 3), and continuing the dynamic adjustment.

Referring to fig. 6, fig. 6 shows an example of an automatic electrode allocation priority list, which cannot be listed in all due to the increased number of selectable leads caused by the increased number of electrodes. Thus for the electrode distribution given in the example, a default list of alternative leads set by distance is given for one particular lead. It should be noted here that although the list of alternative leads is named "table", the actual data structure may also be presented in the form of a tree or directed graph to facilitate searching when electrodes are automatically assigned. As shown in fig. 6, the current lead in the embodiment is composed of two electrodes at two ends of the housing, and the default candidate list is arranged in a binary tree manner. In the search, the number N of the alternative leads searched each time is 2, so that in the first search, two alternative leads in the first layer are selected, the electrocardiogram data of the corresponding leads are collected, the reference characteristics are calculated and compared, and when the requirements are not met, the alternative leads in the second layer are selected. Alternative leads in the second tier, with default left branch priority higher than right branch. Referring to fig. 7, fig. 7 is an example of an electrocardiographic waveform obtained by the embodiment.

Claims

1. The adjusting method of the implanted dynamic electrocardiogram monitor for dynamically adjusting the electrode configuration is characterized by comprising the following steps of:

when the reference characteristics are selected as the characteristics of amplitude, duration, frequency spectrum and electrocardio-axis deviation, the reference characteristics are directly obtained by calculation through the acquired electrocardio data; when the features of morphology, special waveform and appearance time are selected, an electrocardiogram template is needed to be used, the difference between the acquired data and the electrocardiogram template is compared, the algebraic operation is carried out through the indirect features of the maximum value, the mean square error, the linear correlation and the wavelet decomposition coefficient by calculation, and the reference feature is indirectly obtained;

3) recording electrocardiographic waveforms:

f. resetting the timer and restarting timing;

7) manual modification: only when the program controller is used for programming the implanted dynamic electrocardiogram monitor and the manual modification function is selected, the step 7 is carried out through interruption, and other conditions can not be carried out; after the manual modification is finished, re-entering the step 3), and continuing to dynamically adjust;

the implantable dynamic electrocardiogram monitor with the dynamically adjusted electrode configuration comprises a shell (2), wherein a plurality of electrodes (1) are distributed on the shell (2), a circuit board (3) and a battery (4) are packaged in the shell (2), the electrodes (1) and the circuit board (3) are connected to acquire electrocardiogram signals, and the battery (4) and the circuit board (3) are connected to supply power; the method is characterized in that:

the electrodes (1) can form a plurality of electrocardio leads, the electrocardio leads form a bipolar lead by the electrodes (1) at two different positions, the potential difference between the two electrodes (1) is measured, namely the bipolar lead electrocardiosignal, or a single electrode (1) and the electrocardio end form a unipolar lead, and the potential change of the heart at the position of the measuring electrode is measured, namely the unipolar lead electrocardiosignal; when the unipolar lead is adopted, two or more reference electrodes are required to be obtained through a circuit module on a circuit board;

the front-end acquisition circuit of the circuit board (3) adopts a multi-channel design, and each channel is provided with a corresponding analog power frequency filter, a low-noise low-power consumption high-gain amplifier, a gain adjustable amplifier, an impedance boosting loop, a common-mode noise suppression, an anti-aliasing filter and a low-power consumption high-precision analog-to-digital converter; the analog-to-digital converter on each acquisition channel is an independent analog-to-digital converter, or an analog-to-digital converter shared by other channels, or a channel in a multi-channel analog-to-digital converter, namely a front-end acquisition circuit comprises a plurality of independently configured single-channel analog-to-digital converters, each acquisition channel uses one single-channel analog-to-digital converter, and the acquisition channels are independent and can independently set parameters of filtering, gain and sampling rate; or only one single-channel analog-to-digital converter is included, each channel shares the same analog-to-digital converter through time division multiplexing, and each acquisition channel can be provided with independent filtering and gain, but the sampling rate is set uniformly; or one or more multi-channel analog-to-digital converters are included, each acquisition channel performs analog-to-digital conversion by using one channel in the multi-channel analog-to-digital converter, and each acquisition channel can be provided with independent filtering and gain, but the sampling rate is set uniformly.

2. The method of claim 1, wherein the method comprises the steps of: and an insulating treatment is carried out between the electrode (1) and the shell (2).

3. The method of claim 1, wherein the method comprises the steps of: the shape, size, area, thickness, material and coating of the electrode (1) are consistent.

4. The method of claim 1, wherein the method comprises the steps of: the electrode (1) and the circuit board (3) are connected through a connecting line with good conductivity, and the connecting line is made of flexible materials to reduce the volume by bending or is made of hard materials to reduce the volume by distribution.

5. The method of claim 1, wherein the method comprises the steps of: the battery (4) adopts a battery with low leakage current and high energy density.

6. The method of claim 1, wherein the method comprises the steps of: the circuit board (3) is made of a PCB or a flexible material, and the circuit board (3) is made into one or more than one circuit board which are spliced or stacked, so that the distribution is optimized, the size is reduced, and the circuit noise is reduced.

7. The method of claim 1, wherein the method comprises the steps of: the shell (2) is made of titanium material with good biocompatibility or other materials with biocompatibility.

8. The method of claim 1, wherein the method comprises the steps of: the electrode (1) adopts a titanium material or titanium alloy with good biocompatibility and good electrical conductivity, or a structure of sputtering a TiN film on the Ti material.