CN101147676A - Endocardium three-dimension navigation system and navigation method - Google Patents

Endocardium three-dimension navigation system and navigation method Download PDF

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CN101147676A
CN101147676A CNA2006101161773A CN200610116177A CN101147676A CN 101147676 A CN101147676 A CN 101147676A CN A2006101161773 A CNA2006101161773 A CN A2006101161773A CN 200610116177 A CN200610116177 A CN 200610116177A CN 101147676 A CN101147676 A CN 101147676A
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electric field
catheter
calibration
electrode
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CN100546540C (en
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张勇
沈海东
徐丹红
叶有利
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SHANGHAI HONGTONG INDUSTRY Co Ltd
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SHANGHAI HONGTONG INDUSTRY Co Ltd
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Abstract

The present invention discloses an endocardial three-dimensional guide system and guide method. Said system includes excitation device, three pairs of excitation electrodes, catheter position signal obtaining device, respiratory impedance regulating device and cardiac chambers mechanical external form synchronization device. Said excitation device contains digital control logic and constant-current generation module. The above-mentioned catheter position signal obtaining device includes catheter, positioning amplifier, A/D converter, digital demodulator and coordinate converter. Said respiratory impedance regulating device includes body surface electric field signal collecting circuit, positioning amplifier, A/D converter, respiratory data extraction module and respiratory correction module.

Description

Endocardium three-dimensional navigation system and navigation method
Technical Field
The invention relates to a surgical navigation system, in particular to a system for performing catheter navigation in catheter interventional operation of cardiology.
Background
In an intracardiac catheter interventional procedure, a catheter needs to be navigated by a navigation technique. The navigation technique of the catheter is briefly described as follows: a three-dimensional heart cavity model is constructed by acquiring position signals of the catheter on the endocardium, and the position of the catheter signals is observed on the three-dimensional heart cavity model to obtain the actual position of the catheter on the endocardium, so that the operation of a doctor in an operation is facilitated.
The existing endocardium three-dimensional navigation method generally comprises the following steps: placing three pairs of excitation electrodes with orthogonal spatial positions on a body surface, and electrifying the excitation electrodes to form a three-dimensional electric field; the conduit electrode acquires an electric field signal of the position of the conduit in the three-dimensional electric field, and calculates the position information of the conduit according to the electric field signal; considering the influence of the deformation caused by respiration on the electric field, the position information of the catheter needs to be corrected; synchronizing the corrected catheter position information at a specific time; and forming a three-dimensional heart cavity model according to the synchronized catheter position information.
U.S. patent application publication No. US2004/0254437, METHOD AND APPARATUS FOR CATHETER NAVIGATION AND LOCATION AND MAPPING IN THE HEART, discloses a navigational positioning system that drives excitation electrodes IN a time-sharing manner to obtain data carrying respiratory information, AND subtracts THE data from THE obtained CATHETER position data after linearly weighting THE data. The disadvantages of this application are: (a) Aiming at the respiratory wave processing technology, a time division system is adopted to collect respiratory wave shape data, and excitation and collection must be carried out between electrode pairs which are not orthogonal to each other in the same plane, so that the mode of an electrode assembly which can be collected is limited, the extracted respiratory related information is not rich enough, and the circuit structure is complex; (b) The influence of the respiration waveform is compensated by adopting a linear weighting method, the model is simple, and the calculation error is large; (c) The external excitation is generated in the form of current pulse, the external excitation is easily influenced by the contact capacitance of an electrode system, and the precision of the acquired respiratory wave data processing algorithm is limited.
Disclosure of Invention
The invention aims to solve the problems and provides an endocardium three-dimensional navigation system and a navigation method, which improve the intracavity catheter positioning technology, and have simple structure and high navigation precision.
The technical scheme of the invention is as follows: an endocardial three-dimensional navigation system for navigation of an endocardial catheter, the system comprising:
an excitation device comprising:
the digital control logic and constant current generation module simultaneously generates three different continuous sine waves lower than 10 KHz; and
the three pairs of excitation electrodes are positioned on the body surface, are mutually orthogonal in spatial position and are connected with the digital control logic and the constant current generation module, and the three continuous sine waves are loaded on the three pairs of excitation electrodes respectively to form a three-dimensional low-frequency stable and constant electric field in the body;
a catheter position signal acquisition device, comprising:
the catheter is positioned on the endocardium, and is attached with an electrode and used for extracting an electric field signal of the catheter in a three-dimensional electric field formed by the exciting electrode;
the first positioning amplifier is connected with the catheter electrode and used for amplifying the extracted electric field signal;
the first analog-to-digital converter is connected with the first positioning amplifier and is used for converting the amplified electric field signal into a digital signal;
the digital demodulator is connected with the first analog-to-digital converter and used for extracting electric field signal strength information of the position of the conduit from the converted digital signal; and
the coordinate conversion module is used for converting the electric field signal intensity information of the position of the conduit into a conduit position signal;
a respiratory impedance adjustment apparatus comprising:
the body surface electric field signal acquisition electrode is used for acquiring body surface electric field signals, wherein the acquired body surface electric field signals contain information of lung volume change;
the second positioning amplifier is connected with the body surface electric field signal acquisition electrode and is used for amplifying the acquired body surface electric field signals;
the second analog-to-digital converter is connected with the second positioning amplifier and is used for converting the amplified body surface electric field signal into a digital signal;
the breath data extraction module is connected with the second analog-to-digital converter and used for extracting the change information of the breath impedance; and
the input end of the respiration calibration module is connected with the respiration data extraction module and a digital demodulator in the catheter position signal acquisition device, the output end of the respiration calibration module is connected with the input end of a coordinate conversion module in the catheter position signal acquisition device, the artifact caused by the variation information of respiration impedance is removed from the electric field signal intensity information of the catheter position, and a calibrated catheter position signal is output;
a cardiac chamber mechanical profile synchronization device, comprising:
the heart synchronous signal extraction module is used for acquiring electrophysiological signals containing heart beating cycle information; and
and the input end of the synchronous processing module is connected with the output end of the heart synchronous signal extraction module and the output end of the coordinate conversion module, and the updating of the catheter position signal and the periodic change of the endocardium appearance are synchronously processed.
In the endocardium three-dimensional navigation system, the frequency ranges of the three different continuous sine waves which are lower than 10KHz and are generated by the digital control logic and constant current generation module are 4-6 KHz; the first and second analog-to-digital converters are high-resolution audio analog-to-digital converters.
In the above endocardium three-dimensional navigation system, the body surface electric field signal collecting electrode in the respiratory impedance adjusting device includes the excitation electrode and the body surface ECG electrode.
In the endocardium three-dimensional navigation system, the signal source of the heart synchronization signal extraction module in the heart chamber mechanical shape synchronization device includes hemodynamic index and biochemical index.
In the aforementioned endocardium three-dimensional navigation system, the first positioning amplifier and/or the second positioning amplifier are further provided with an automatic calibration device, and the device includes:
the temperature detector is used for detecting whether the ambient temperature changes;
the calibration control module is connected with the temperature detector, starts a calibration process after the temperature detector detects that the temperature changes, and controls the first positioning amplifier and/or the second positioning amplifier to enter a calibration mode;
the calibration signal generator is connected with the calibration control module and generates an initial calibration signal after the calibration control module starts a calibration process;
the input end of the amplitude extraction module is connected with the digital demodulator, the output end of the amplitude extraction module is connected with the calibration control module, the amplitude extraction module outputs the intensity of the calibration signal with the error to the calibration control module, the calibration control module calculates the amplification error according to the intensity of the initial calibration signal and the intensity of the calibration signal with the error, and the error is used as the amplification gain of the compensation control amplifier.
The endocardium three-dimensional navigation system, wherein the breath calibration module further comprises:
the input end of the filtering unit receives the fixed position signals of the catheter electrodes and the impedance change information acquired by the body surface electrodes and outputs the impedance change information of the catheter electrodes and the impedance change information of the body surface electrodes;
the input end of the breathing model parameter extraction unit is connected with the output end of the filtering unit, the resistance change information of the body surface electrode is used as an input signal, the combined input signal is converted to enable the combined input signal to approach a fixed position signal of the catheter electrode, and the parameter of the breathing model is output after the optimal approximation is achieved;
the input end of the parameter application unit is connected with the filtering unit and the breathing model parameter extraction unit, and the parameter application unit is used for transforming and combining impedance change information of the body surface electrodes according to parameters of the breathing model and outputting a calibration waveform signal;
and the input end of the subtraction unit is connected with the digital demodulator and the parameter application unit, and the subtraction unit subtracts the calibration waveform signal from the catheter electrode position signal and outputs the calibration waveform signal to obtain a calibrated catheter position signal.
The endocardium three-dimensional navigation system further comprises a graphic display device, wherein the input end of the graphic display device is connected with the synchronous processing module, and the graphic display device is used for establishing a three-dimensional model of the heart cavity according to the synchronized catheter position signal.
The endocardium three-dimensional navigation system, wherein the system further comprises an electrophysiological signal mapping device, the electrophysiological signal mapping device comprising:
the electrophysiological signal acquisition electrode comprises an ECG electrode and a catheter electrode and is used for acquiring electrophysiological signals of a human body;
the electrophysiological signal amplifier is connected with the electrophysiological signal collecting electrode and is used for amplifying the collected electrophysiological signals of the human body;
the analog-to-digital converter is connected with the electrophysiological signal amplifier and converts the amplified human electrophysiological signals into digital signals;
and the electrophysiological signal extraction module is connected with the analog-to-digital converter and used for extracting electrophysiological activity information of a specific position in the heart cavity from the digital signal and outputting the electrophysiological activity information.
In another aspect, the invention also features a method of endocardial three-dimensional navigation for navigation of an endocardial catheter, the method including:
three pairs of excitation electrodes which are orthogonal in spatial position are arranged on the body surface, and three pairs of excitation electrodes are electrified by using three continuous sine wave constant currents with different frequencies and lower than 10KHz to form a three-dimensional low-frequency constant electric field;
the method comprises the following steps that a conduit electrode collects electric field signals of a conduit in a three-dimensional electric field, and the electric field signal intensity information of the position of the conduit is extracted after signal amplification, analog-to-digital conversion and digital demodulation;
the body surface electrodes and the ECG electrodes collect body surface electric field signals, and change information of respiratory impedance is extracted after signal amplification and analog-to-digital conversion;
eliminating errors caused by respiratory impedance change information from the electric field signal strength information, and outputting a calibrated catheter position signal;
acquiring electrophysiological signals containing heart beating cycle information, and synchronously processing calibrated catheter position signals and the periodic change of the heart appearance;
and establishing a three-dimensional model of the heart according to the catheter position signals after synchronous processing.
In the aforementioned three-dimensional endocardium navigation method, the removing the error caused by the respiratory impedance variation information from the electric field signal strength information further includes:
fixing a catheter electrode, taking a positioning signal collected by the electrode as a calibration input signal, and extracting low-frequency change information of human body impedance through filtering;
acquiring impedance change information through an excitation electrode and an ECG electrode, converting and combining the impedance change information after filtering to enable the impedance change information to approach a calibration input signal, and extracting parameters of a mathematical model after optimal approximation is achieved;
transforming and combining the impedance change information according to the mathematical model parameters extracted in the last step, and outputting a calibration waveform signal;
the calibration waveform signal is subtracted from the catheter electrode position signal to output a calibrated catheter position signal.
Compared with the prior art, the invention has the following beneficial effects: the present invention distinguishes the following features of the prior art: the driving electrode is a sampling electrode at the same time by a frequency division sine wave excitation technology and a multi-body surface electrode respiration data collection technology. And carrying out analog-to-digital conversion and then carrying out digital demodulation on the acquired electric field signals. The ECG electrodes and the excitation electrodes are used together to acquire the electric field signals in the aspect of processing the respiration signals. The dynamic or biochemical indicators of the blood are used as inputs to the synchronization signal to determine the position of the catheter at a certain time during the heart beat cycle. The positioning amplifier is automatically calibrated. The invention has the advantages of simple structure, simple and convenient calibration, advanced processing algorithm, high navigation precision and the like.
Drawings
FIG. 1 is a block diagram of a preferred embodiment of the endocardial three-dimensional navigation system of the present invention.
FIG. 2 is a schematic diagram of an embodiment of an excitation electrode of the present invention.
FIG. 3 is a block diagram of an embodiment of the breath calibration module of the present invention.
Detailed Description
The invention is further described below with reference to the figures and examples.
FIG. 1 shows a preferred embodiment of the endocardial three-dimensional navigation system of the present invention. Referring to fig. 1, an endocardial three-dimensional navigation system 10 includes the following components: the device comprises an excitation device, a catheter position signal acquisition device, a breathing impedance adjusting device, a heart cavity mechanical shape synchronizing device, a graph display device and an electrophysiological signal mapping device.
The excitation device consists of a digital control logic and constant current generation module 11 and an excitation electrode group 12 connected with the module. Referring also to fig. 2, the excitation electrode set 12 is located on the body surface and includes three pairs of excitation electrodes orthogonal in spatial position: an X-direction excitation electrode 121, a Y-direction excitation electrode 122, and a Z-direction excitation electrode 123. The digital control logic and constant current generation module 11 generates three different continuous sine waves lower than 10KHz, which are loaded on the three pairs of excitation electrodes 121-123 respectively, and a three-dimensional low-frequency stable and constant electric field is formed in the body. Preferably, the frequency of the sine wave is controlled to be 4-6 KHz.
One of the invention points of the invention is that: the signals applied to the excitation electrodes are different continuous sine waves of a few KHz. Mainly based on the following considerations: there are many non-linear effects inside the human body due to the electrodes and the human body. For some excitation modes with rich harmonic waves, such as a mode of high-frequency pulse excitation or a mode of sine wave time-sharing excitation, large errors are easily caused, and the measurement errors caused by the nonlinearity can be reduced to the minimum only by adopting a continuous sine wave with a single frequency. Secondly, in clinical application, some products need to obtain the isoimpedance information related to physiological parameters such as respiration of a patient, the stroke volume of heartbeat and the like by means of electric pulse excitation, and the excitation signals adopted by the test equipment are dozens of KHz, so that the working frequency range of the equipment can be effectively avoided by the excitation frequency of the KHz selected by the application, and the compatibility of the equipment in use is improved.
The catheter position signal acquisition device includes a catheter positioned on the endocardium 13, a positioning amplifier 15, an analog-to-digital converter 16, a digital demodulator 17, and a coordinate conversion module 18. The respiratory impedance adjusting device comprises an excitation electrode group 12 and a body surface ECG electrode 19 for collecting body surface electric field signals, a positioning amplifier 15, an analog-to-digital converter 16, a respiratory data extraction module 20 and a respiratory calibration module 21. In addition, a buffer 22 is provided between these electrodes and the positioning amplifier 15. In this embodiment, the positioning amplifier and the analog-to-digital converter of the respiratory impedance adjusting apparatus and the catheter position signal acquiring apparatus are the same, and this embodiment is only an example, and the positioning amplifier and the analog-to-digital converter of the respiratory impedance adjusting apparatus and the catheter position signal acquiring apparatus may be separately provided.
In the conduit position signal acquisition device, a conduit electrode 14 is arranged on the conduit, an electric field signal of the conduit in a three-dimensional electric field is acquired, the electric field signal is amplified in a positioning amplifier 15 through a buffer 22, the electric field signal is converted into a digital signal through an analog-to-digital converter 16, and the electric field signal strength information of the conduit position is extracted from the digital signal through a digital demodulator 17. In the present embodiment, the frequency of the sine wave is reduced to several KHz, which is in a typical audio frequency range, so that a high-resolution audio analog-to-digital converter can be used as the analog-to-digital converter 16. The use of the audio analog-to-digital converter can improve the signal-to-noise ratio of the system, further reduce the complexity of amplifier design, and the interface has mature industry standards.
In the digital demodulator 17, the usual signal processing methods can be used to extract the representative catheter position at that momentThe amplitude of the sinusoidal signal of (a). There are many processing algorithms that can be used for amplitude extraction of single frequency sinusoidal signals in this embodiment, and the DFT algorithm is a common and efficient processing algorithm. A typical equation for DFT is as follows:
Figure A20061011617700121
in order to obtain the signal amplitude of the Fx frequency, for example, X (k) is a value of a certain frequency of DFT of the normalized sampling signal, and the three excited frequency signals are Fx, fy, and Fz, it is required that the X (j) sequence having the length N in the formula includes an integer number of waveform periods having the frequencies Fx and (Fx-Fy), (Fx-Fz) in order to prevent spectrum leakage. The calculation of the three frequencies X, Y and Z is required to ensure the efficiency of algorithm implementation, and the same sequence length is adopted, while the algorithm period for demodulation is expected to be 20ms if the algorithm is in the working environment of a 50Hz power supply. A balance is required between the sampling rates Fs and Fx, fy, fz to satisfy these conditions.
The complex information contained in the result of DFT conversion prompts phase information in the signal modulated by human body, i.e. the phase difference between local sine signal and the signal of excitation source, but useful information is the module of the final result, because the ADC conversion and the excitation signal of the invention are completed in the same digital chip, the excited and sampled signals can be strictly synchronized, so that the phase difference after demodulation can be controlled to be about 0 degree by adjusting the phase of local oscillator, further the imaginary part of the final DFT result can be always zero, the calculation of DFT module can be simplified to the calculation of only real part, thus the calculation overhead of DFT can be reduced by 50%.
Another inventive point of the present invention is: the collected electric field signals are firstly subjected to analog-to-digital conversion and then subjected to digital demodulation processing. The low frequency improves the precision of digital demodulation based on that the excitation signal is a sine wave of a few KHz, so that the intensity of the extracted electric field signal is more accurate.
Considering the change of the electric field caused by the respiratory deformation, even if the catheter is fixed, the electric field in the cavity slightly changes under the influence of the respiratory deformation, and the electric field signal at the position of the catheter changes accordingly. When the catheter is at a fixed position, the electric field signal of the catheter will also change, obviously resulting in the error of the subsequent derivation of the position signal. The respiratory impedance adjusting device plays a role in adjusting respiratory deformation errors. The excitation electrode group 12 forms a three-dimensional electric field in the cavity and also forms an electric field on the body surface, and the change of the lung impedance caused by breathing can be reflected on the change of the body surface electric field, so that the system directly uses the electrodes to acquire data related to the impedance from the body surface. The set of excitation electrodes 12 and the plurality of ECG electrodes 19 (only one shown) located on the body surface acquire body surface electric field signals at their own location, which signals convey information about the changes in lung volume. The body surface electric field signal is amplified by the positioning amplifier 15, and after being converted into a digital signal by the analog-to-digital converter 16, the change information of the respiratory impedance is extracted in the respiratory data extraction module 20. The respiration calibration module 21 receives the respiration impedance variation information of the respiration extraction module 20 and the conduit position electric field signal strength information of the digital demodulator 17, eliminates the artifact caused by the respiration impedance variation information from the conduit position electric field signal strength information, and outputs a calibrated conduit position signal.
Referring to fig. 3, the respiratory calibration module 21 is composed of a filtering unit 211, a respiratory model parameter extraction unit 212, a parameter application unit 213 and a subtraction unit 214. The workflow of the breath calibration module 21 can be divided into two steps: model parameter extraction and data application.
The catheter electrodes need to be temporarily fixed and the positioning signal collected from the catheter electrodes 14 is then used as a calibration input signal Xc, which can be omitted if a certain catheter is always in a fixed position during the use of the apparatus (e.g. the coronary sinus electrode catheter is usually stationary in the coronary sinus), and the position signal of the fixed electrode is directly used as the calibration input signal.
Xc carries data on the impedance of the human body, transient displacement of the catheter caused by the beating of the heart itself and the static position of the space in which the catheter itself is located. These three signals are separated in the frequency domain and calibration is performed only for the human body impedance data, so information on the low frequency variation of the human body impedance can be extracted by the filtering unit 211, which can be a 0.01-0.5 Hz band pass filter. The impedance information Yi collected from the body surface ECG electrodes 19 and the excitation electrode group 12 is also sent to the respiratory model parameter extraction unit 212 after passing through the filtering unit 211. The breathing model parameter extraction unit 212 is used for receiving the impedance information Yi as input, transforming and combining Yi signals by a certain mathematical method, such as a standard LMS least mean square algorithm, so as to enable the result after changing and combining to approach Xc, and after reaching the optimal approximation (for example, the error after approximation is used as a judgment condition, the precision of 0.2mm that the error is less than equivalent is the optimal approximation), outputting the parameters of the optimal mathematical model, ending the model parameter extraction process, and entering the data application step.
In the data application process, the Yi signal is filtered and then continuously enters the parameter application unit 213, the unit 213 transforms and combines the Yi signal according to the mathematical model extracted in the previous step, the output is a waveform Oc which is close to the waveform Oc after being filtered, and then data related to the waveform Oc in the normal electric field intensity signal Mi can be eliminated by subtraction, so that the calibrated conduit electric field intensity signal Ni can be obtained.
Another aspect of the present invention is: in the use environment of the system, a body surface ECG electrode is generally connected to the body of a patient, and on the basis of only little cost increase, the existing design structure is utilized to collect impedance change information of the human body through the ECG electrode, so that more information can be provided for a respiratory calibration measure. This information acquisition is much simpler to implement than the patent application described in the background section, and the detection of the pulmonary impedance is also continuous in time and space due to the continuous excitation using frequency division. More importantly, the way that the ECG electrodes are compatible with the impedance electrodes to provide the breathing data can acquire more calibration information, so that the calibration accuracy can be further improved.
The electric field signal strength information for the calibrated catheter position is converted to a catheter position signal in the coordinate conversion module 18. Since the catheter is beating with the heart inside the body, the catheter position signals correspond to different times, and the actual shape of the heart cannot be determined. In order to accurately obtain the exact position of the catheter relative to the heart, it is necessary to synchronize the updating of the position data of the catheter to the periodic changes in the shape of the heart chamber.
The endocardial mechanical contour synchronization apparatus includes a cardiac synchronization signal extraction module 22 and a synchronization processing module 23. In addition to using conventional electrophysiological signals such as body surface electrocardiogram and intracavitary electrocardiogram as the heart synchronization signals, other synchronization methods more conforming to the mechanical shape structure of the heart are also used for synchronization, such as using the dynamic or biochemical indexes of blood as the synchronization signal source 35 for input, the signals in the synchronization signal source 35 can be intracavitary blood pressure signals, non-invasive blood pressure signals, blood oxygen saturation signals, etc., the measurement techniques of these signals are very mature, and have more correlation with the mechanical shape period of the heart. The electrophysiological signals are directly collected by the intracardiac catheter and the body surface electrodes (such as the ECG electrode 19, the excitation electrode group 12, etc.) of the present invention and then enter the cardiac synchronization signal extraction module 22, and the synchronization signal interface can receive physiological signals such as blood pressure, blood oxygen saturation, etc. from other devices. These signals enter the heart synchronous signal extraction module 22, and one or more of them can be selected to extract synchronous information, and the extraction mode can be that a certain time in the signal waveform cycle, such as the time when the instantaneous blood pressure changes fastest, the time when the blood sample concentration is lowest, or a certain time before these times, is selected as output and sent to the synchronous processing module 23 to determine the position of the catheter at a certain time in the heart beating cycle.
In addition, since artifacts are often inevitably generated in the single physiological signal during the acquisition process, for example, the invasive blood pressure signal may cause the measurement result to be jittered due to the jittering of the catheter, thereby introducing a measurement error, and the probability that the electrophysiological signals generate the artifacts simultaneously is very small, the multiple physiological signals representing the heart beating period are compared with each other to ensure the accuracy of the synchronization signal.
Another aspect of the present invention is: the traditional technology only uses the conventional electrophysiological signals of body surface electrocardiogram, intracavity electrocardiogram and the like as the synchronous signals of the heart, the invention adopts other synchronous modes which are more in line with the mechanical appearance structure of the heart chamber to carry out synchronization, such as the input of the synchronous signals of the dynamics or the biochemical indexes of blood, and the signals can be intracavity blood pressure signals, noninvasive blood pressure signals, blood oxygen saturation signals and the like, so that the synchronization precision is higher.
The synchronous processing module 23 transmits the position signal of the catheter at a certain moment of the heart beating cycle to the graphic display device 25, and establishes a three-dimensional image model of the heart cavity, and the current position of the catheter is marked on the model.
The electrophysiology mapping device comprises an ECG electrode 19 and a catheter electrode 14 for acquiring electrophysiology signals of a human body, an ECG amplifier 27 connected with the ECG electrode 19, an EP signal amplifier 26 connected with the catheter electrode 14, analog-to- digital converters 28, 29 and an electrophysiology signal extraction module 30. The ECG amplifier 27 and the EP signal amplifier 26 amplify the acquired electrophysiological signals of the human body and then convert the signals into digital signals via the analog-to- digital converters 28, 29. The electrophysiological signal extraction module 30 is connected to the analog-to- digital converters 28, 29, extracts electrophysiological activity information at a specific location in the heart chamber from the digital signal, outputs the electrophysiological activity information to the graphic display device 25, and marks the electrophysiological activity information on the three-dimensional graphic model of the heart chamber.
The accuracy of the amplifier gain has a crucial influence on the positioning performance of the system, and especially the matching of the amplification parameters between each channel in a positioning system in which multiple catheters are used simultaneously is very important for the accuracy of the system. Although the present invention employs a simplified, high-quality analog amplification system, errors between channels of the amplifier are not adjusted due to manufacturing errors of passive devices such as capacitors and resistors and variations in ambient temperature, and such errors are intolerable even when using high-quality components. For this purpose, such errors must be compensated in digital systems. The system is also provided with an automatic calibration device on the positioning amplifier 15, adopts full-automatic compensation, and can automatically calibrate the amplifier system without manual work after starting and the working temperature obviously changes. The apparatus comprises a temperature detector 31, a calibration control module 32, a calibration signal generator 33 and an amplitude extraction module 34.
After the temperature detector 31 detects that the ambient temperature has changed, the calibration control module 32 starts the calibration signal generator 33 to generate a calibration signal and controls the positioning amplifier 15 to enter a calibration mode, in which all input paths of the positioning amplifier are switched to the calibration signal. After a period of several tens of ms, the positioning amplifier 15 and the amplitude extraction module 34 enter a stable state, and the output of the amplitude extraction module 34 is the actually measured intensity Y of the calibration signal carrying the error information. Since the amplitude X of the calibration signal is known, the amplification error a = Y/X is calculated in the calibration control module 32, and the error result is retained by the calibration control module 32. After the calibration mode is exited, the amplification gain of the positioning amplifier 15 is controlled with the amplification error a as compensation, thereby achieving calibration of the amplification system.
The amplifier system adopts a high-frequency narrow-band structure, so that the amplifier can enter a stable state within tens of ms, calibration work can be completed within a sampling period of positioning signal output, and the rapid calibration process ensures that the amplification treatment of normal signals is hardly influenced, so that the system can automatically start the calibration process when the temperature detection device detects that the signals have obvious changes, such as 1 ℃, and finally the amplifier is in an optimal working state without influencing the normal work of the system.
On the other hand, the navigation method using the endocardium three-dimensional navigation system is as follows:
(1) Three pairs of excitation electrodes which are orthogonal in spatial position are arranged on the body surface, and three continuous sine wave constant currents with different frequencies and lower than 10KHz are used for electrifying the three pairs of excitation electrodes to form a three-dimensional low-frequency constant electric field.
(2) The conduit electrode collects electric field signals of the conduit in a three-dimensional electric field, and the electric field signal intensity information of the conduit position is extracted after signal amplification, analog-to-digital conversion and digital demodulation.
(3) The body surface electrodes and the ECG electrodes collect body surface electric field signals, and change information of respiratory impedance is extracted after signal amplification and analog-to-digital conversion.
(4) And eliminating errors caused by respiratory impedance change information from the electric field signal strength information, and outputting a calibrated catheter position signal.
(5) Acquiring electrophysiological signals containing heart beating period information, and synchronizing the calibrated catheter position signals with the periodic changes of the heart outline.
(6) And establishing a three-dimensional model of the heart cavity according to the catheter position signals after synchronous processing.
It should be understood that the embodiments described above are provided for persons skilled in the art to make or use the invention and that modifications or variations can be made to the embodiments described above without departing from the inventive concept of the present invention, and therefore the scope of protection of the present invention is not limited by the embodiments described above but should be accorded the widest scope consistent with the innovative features set forth in the claims.

Claims (10)

1. An endocardial three-dimensional navigation system for navigation of an endocardial catheter, the system comprising:
an excitation device comprising:
the digital control logic and constant current generation module generates three different continuous sine waves lower than 10KHz at the same time; and
the three pairs of excitation electrodes are positioned on the body surface, are mutually orthogonal in spatial position and are connected with the digital control logic and the constant current generation module, and the three continuous sine waves are loaded on the three pairs of excitation electrodes respectively to form a three-dimensional low-frequency stable and constant electric field in the body;
a catheter position signal acquisition device, comprising:
the catheter is positioned on the endocardium, and is attached with an electrode and used for extracting an electric field signal of the catheter in a three-dimensional electric field formed by the exciting electrode;
the first positioning amplifier is connected with the catheter electrode and used for amplifying the extracted electric field signal;
the first analog-to-digital converter is connected with the first positioning amplifier and is used for converting the amplified electric field signal into a digital signal;
the digital demodulator is connected with the first analog-to-digital converter and used for extracting electric field signal strength information of the position of the conduit from the converted digital signal; and
the coordinate conversion module is used for converting the electric field signal intensity information of the position of the conduit into a conduit position signal;
a respiratory impedance adjustment apparatus comprising:
the body surface electric field signal acquisition electrode is used for acquiring body surface electric field signals, wherein the acquired body surface electric field signals contain information of lung volume change;
the second positioning amplifier is connected with the body surface electric field signal acquisition electrode and is used for amplifying the acquired body surface electric field signals;
the second analog-to-digital converter is connected with the second positioning amplifier and is used for converting the amplified body surface electric field signal into a digital signal;
the breath data extraction module is connected with the second analog-to-digital converter and used for extracting the change information of the breath impedance; and
the input end of the respiration calibration module is connected with the respiration data extraction module and a digital demodulator in the catheter position signal acquisition device, the output end of the respiration calibration module is connected with the input end of a coordinate conversion module in the catheter position signal acquisition device, the artifact caused by the variation information of respiration impedance is removed from the electric field signal intensity information of the catheter position, and a calibrated catheter position signal is output;
a cardiac chamber mechanical profile synchronization device, comprising:
the heart synchronous signal extraction module is used for acquiring an electrophysiological signal containing heart beating period information; and
and the input end of the synchronous processing module is connected with the output end of the heart synchronous signal extraction module and the output end of the coordinate conversion module, and the updating of the catheter position signal and the periodical change of the endocardium appearance are synchronously processed.
2. The endocardial three-dimensional navigation system according to claim 1, wherein the frequency range of three different continuous sinusoids generated by the digital control logic and constant current generation module, which is lower than 10KHz, is 4-6 KHz; the first and second analog-to-digital converters are high-resolution audio analog-to-digital converters.
3. The endocardial three-dimensional navigation system according to claim 1, wherein the body surface electric field signal acquisition electrodes in the respiratory impedance adjustment device comprise the excitation electrodes and body surface ECG electrodes.
4. The endocardium three-dimensional navigation system according to claim 1, wherein the signal source of the heart synchronous signal extraction module in the heart chamber mechanical contour synchronization device comprises a hemodynamic index and a biochemical index.
5. The endocardial three-dimensional navigation system of claim 1, wherein the first and/or second location magnifier is further provided with an automatic calibration device, the device comprising:
the temperature detector is used for detecting whether the ambient temperature changes;
the calibration control module is connected with the temperature detector, starts a calibration process after the temperature detector detects that the temperature changes, and controls the first positioning amplifier and/or the second positioning amplifier to enter a calibration mode;
the calibration signal generator is connected with the calibration control module and generates an initial calibration signal after the calibration control module starts a calibration process;
the input end of the amplitude extraction module is connected with the digital demodulator, the output end of the amplitude extraction module is connected with the calibration control module, the amplitude extraction module outputs the intensity of the calibration signal with the error to the calibration control module, the calibration control module calculates the amplification error according to the intensity of the initial calibration signal and the intensity of the calibration signal with the error, and the error is used as the amplification gain of the compensation control amplifier.
6. The endocardial three-dimensional navigation system of claim 1, wherein the respiratory calibration module further comprises:
the input end of the filtering unit receives the fixed position signals of the catheter electrodes and the impedance change information acquired by the body surface electrodes and outputs the impedance change information of the catheter electrodes and the impedance change information of the body surface electrodes;
the input end of the breathing model parameter extraction unit is connected with the output end of the filtering unit, the resistance change information of the body surface electrode is used as an input signal, the combined input signal is converted to enable the combined input signal to approach the fixed position signal of the catheter electrode, and the parameter of the breathing model is output after the optimal approximation is achieved;
the input end of the parameter application unit is connected with the filtering unit and the breathing model parameter extraction unit, and the parameter application unit carries out transformation combination on impedance change information of the body surface electrodes according to parameters of the breathing model and outputs a calibration waveform signal;
and the input end of the subtraction unit is connected with the digital demodulator and the parameter application unit, and the subtraction unit subtracts the calibration waveform signal from the catheter electrode position signal and outputs the calibration waveform signal to obtain a calibrated catheter position signal.
7. The endocardium three-dimensional navigation system according to claim 1, further comprising a graphic display device, the input end of which is connected to the synchronous processing module, for establishing a three-dimensional model of the heart chamber according to the synchronized catheter position signal.
8. The endocardial three-dimensional navigation system of claim 1, wherein the system further comprises an electrophysiological signal mapping device, the electrophysiological signal mapping device comprising:
the electrophysiological signal acquisition electrode comprises an ECG electrode and a catheter electrode and is used for acquiring electrophysiological signals of a human body;
the electrophysiological signal amplifier is connected with the electrophysiological signal collecting electrode and is used for amplifying the collected electrophysiological signals of the human body;
the analog-to-digital converter is connected with the electrophysiological signal amplifier and converts the amplified human electrophysiological signals into digital signals;
and the electrophysiological signal extraction module is connected with the analog-to-digital converter and used for extracting electrophysiological activity information of a specific position in the heart cavity from the digital signal and outputting the electrophysiological activity information.
9. An endocardial three-dimensional navigation method for navigation of an endocardial catheter, the method comprising:
three pairs of excitation electrodes which are orthogonal in spatial position are arranged on the body surface, and three pairs of excitation electrodes are electrified by using three continuous sine wave constant currents with different frequencies and lower than 10KHz to form a three-dimensional low-frequency constant electric field;
the conduit electrode collects electric field signals of the conduit in a three-dimensional electric field, and the electric field signal intensity information of the position of the conduit is extracted after signal amplification, analog-to-digital conversion and digital demodulation;
the body surface electrodes and the ECG electrodes collect body surface electric field signals, and change information of respiratory impedance is extracted after signal amplification and analog-to-digital conversion;
eliminating errors caused by respiratory impedance change information from the electric field signal strength information, and outputting a calibrated catheter position signal;
acquiring electrophysiological signals containing heart beating cycle information, and synchronously processing calibrated catheter position signals and the periodic change of the heart appearance;
and establishing a three-dimensional model of the heart according to the catheter position signals after synchronous processing.
10. The endocardial three-dimensional navigation method according to claim 9, wherein the step of removing the error caused by the respiratory impedance variation information from the electric field signal strength information further comprises:
fixing a catheter electrode, taking a positioning signal collected by the electrode as a calibration input signal, and extracting low-frequency change information of human body impedance through filtering;
acquiring impedance change information through an excitation electrode and an ECG electrode, converting and combining the impedance change information after filtering to enable the impedance change information to approach a calibration input signal, and extracting parameters of a mathematical model after optimal approximation is achieved;
transforming and combining the impedance change information according to the mathematical model parameters extracted in the last step, and outputting a calibration waveform signal;
the calibration waveform signal is subtracted from the catheter electrode position signal to output a calibrated catheter position signal.
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