Device and method of non-invasive intracardial electrocardiography with formation of image with application of magnetic particles

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine. A method of non-invasive intracardial electrocardiography is realised by means of a device for non-invasive intracardial electrocardiography by the application of an interference device, possessing magnetic permeability and electric conductivity. ECG signals are registered by means of ECG. A magnetic field of selection is generated by means of selection with such a space diagram of the magnetic field intensity that the first auxiliary zone, possessing low magnetic field intensity, and the second auxiliary zone, possessing higher magnetic field intensity, is formed in the field of vision. Means of selection contains a unit of a selection field signal generator and an element of the selection field excitation, in particular magnets or coils of the selection field excitation. Space position of two auxiliary zones in the vision field is changed by means of excitation by the excitation magnetic field for the magnetisation of an interference device in the vision field to be changed locally. The excitation device contains a unit of the excitation field signal generator and an excitation coil of the excitation field. Detection signals are received by reception means. The detection signals depend on the magnetisation of the interference device in the field of vision, with the magnetisation being influenced by the change of the space position of the first and second auxiliary zones. Reception means contains a unit of signal reception and a reception coil for obtaining detection signals. Control over generation of respective magnetic fields is performed by control means for the movement of the interference device through the vascular system and heart in the direction, specified by commands of displacement and/or holding of the interference device in the constant position. Control means is intended for controlling the units of the signal generator for the generation and supply of controlling currents to respective excitation coils. Processing means are used to process the detection signals, which are received, when respective magnetic fields are applied, to determine the position of the interference device within the vascular system and heart by the processed detection signals. Evaluation means is used to evaluate the influence of the interference device on registered ECG signals.

EFFECT: application of inventions will make it possible to increase the accuracy of non-invasive intracardial electrocardiography.

10 cl, 8 dwg

 

The technical field to which the invention relates

The present invention relates to apparatus and method for non-invasive intracardiac electrocardiography (ECG) using having a magnetic permeability and electrical conductivity of the interference device.

Art

Electrocardiography (ECG) is a widely used and well known method for recording electrical activity of the heart over time. Therefore, ECG measurements can reliably confirm the diagnosis of heart failure, such as acute heart failure, arrhythmia, e.g. caused by dyssynchrony of cardiac contractions, atrial fibrillation or atrial fibrillation. The ECG device detects time the electrical impulses of the heart that arise in sinoatrial node and pass through the internal conducting system to the heart muscle. Under normal ECG wave front electric depolarization is usually measured by means of electrodes, which are placed in selected positions on the patient's skin. Then, the ECG displays the voltage between pairs of these electrodes over time. Therefore, the standard ECG describes the temporal characteristics of the electrical activity of the heart. Depending on the application these ECG measurements can also� use in the so-called vector ECG to describe the spatial characteristics of the electrical activity of the heart. In other words, in the framework of vector ECG ECG measurement data are used for imaging the spatial distribution of the wave front of depolarization over time. Thus, the image of the wave front of depolarization often get in the form of a three-dimensional vector (usually denoted as the mean electrical vector) at each point at each moment of time has a definite direction (the propagation direction) and a certain length (depending on the voltage drop at the wave front).

For many applications, which need a more accurate diagnosis, a standard ECG device is not accurate enough. In these cases, perform intracardial ECG. Intracardial EKG (also called ECG mapping) allows you to measure electric potentials within specific areas of the heart by placing electrodes inside the heart using a cardiac catheter. This method is particularly applicable when it is necessary to evaluate the electrical activity of the heart within the cardiac conduction system, for example in the region around the bundle of his where it is impossible to receive signals from an ECG with standard ECG device with electrodes on the body surface. Therefore, intracardiac mapping is much more accurate than standard ECG. Thus, ECG mapping is a very important method for planning a procedure called catheter ablation, which is used to remove the abnormal pathway of the heart.

The main disadvantage of intracardiac ECG is that it needs an invasive procedure where a catheter is inserted into the blood vessels of the patient, which go to the heart, usually either through the femoral vein, internal jugular vein or through the subclavian vein. This is a serious surgery, which is not only complex and require time-consuming, but also uncomfortable and poses a risk for the patient.

Unfortunately, until recently there were no non-invasive method of measurements with relatively high accuracy, such as intracardiac ECG.

The formation of images using magnetic particles (Magnetic Particle Imaging, MPI) is a new medical imaging technology. The first versions of MPI implementations were two-dimensional, namely the created two-dimensional image. Future versions of MPI will be three-dimensional (3D). Time-dependent, or 4D, the image of the object, non-static, can be created by combining a temporal sequence of 3D images in the film, provided that the object does not undergo significant changes in the data collection process for a single 3D image.

MPI - reconstructive method of imaging like computed tomography (CT) or MAG�Itno resonance imaging (MRI). Accordingly, MP-the image of interest in the volume of the object is generated in two stages. The first phase, called the data collection is performed using MPI scanner. MPI-the scanner has means of generating a static magnetic gradient field called "field of choice" (selection field) that has a single point of zero field free point, FFP) in the isocenter of the scanner. In addition, the scanner provides a means of generating a time-dependent magnetic field close to a spatially homogeneous. Essentially, this field is obtained by superposition of a fast-changing field with small amplitude, called "field excitation" (drive field), and slowly varying field with a large amplitude, called "field of focus" (focus field). By adding with time-dependent "excitation field" and "field of focus" static "field of choice" FFP-point can be moved along a predetermined FFP trajectory for scanned volume around the isocenter. The scanner also has a system of one or more, e.g. three, of the receiving coils and capable of detecting any voltage induced in these coils. To collect data object which is a subject of visualization, is placed on the scanner so that the volume of interest of the object was in the field of view of the scanner, which padrastro�Twomey of the scan volume.

The object must contain magnetic nanoparticles; if the object is an animal or person, prior to scanning a person or an animal is injected with a contrast agent, containing such particles. In the process of collecting data MPI scanner controls the passage of FFP-point along a carefully chosen path, drawing out the volume scan, or at least out of sight. Magnetic nanoparticles in the object are exposed to changing magnetic fields and react by changing its magnetization. The change in the magnetization of the nanoparticles produces a time-dependent voltage to each of the receiving coils. This voltage is sampled in the receiver associated with the receiving coil. Issued by the receivers of the sample are recorded and form the collected data. The parameters that control the details of data collection, prepare the minutes of the scan.

In a second step of generating image called image reconstruction, the image is calculated, or reconstructed, from data collected in the first stage. The image is a discrete 3D array of data representing results of the sample approximation of the position-dependent concentration of magnetic nanoparticles in the field of vision. Reconstruction is usually performed com�uterum, execute appropriate computer program. A computer and a computer program implementing the reconstruction algorithm. The reconstruction algorithm is based on a mathematical model of data collection. As with all methods of image generation, built on reconstruction, this model is an integral operator having an effect on the collected data; the reconstruction algorithm tries to "cancel", to the extent possible, the effect of the model.

Such MPI-device and method have the advantage that can be used for examination of arbitrary objects of study - for example the human body, - non-destructive manner and without causing any damage, with high spatial resolution, as close to the surface of the investigated object and the distance from it. This arrangement and method, in General, are known and were first described in document DE 101 51 778 A1 and in the living room, B. and Weizenecker, J. (2005), "Tomographic imaging using the nonlinear response of magnetic particles" in nature, volume 435, pp. 1214-1217. The scheme and method of forming image using magnetic particle (MPI) described in this publication make use of the advantages of the nonlinear magnetization curve of small magnetic particles.

Summary of the invention

The object of the present invention is to provide a device and method for noninvasive INTRAC�realnoi electrocardiography (ECG), which provide high accuracy in comparison with the known method of intracardiac ECG mapping, are easy and quick to use and does not require surgery and therefore more comfortable for the patient.

In the first aspect of the present invention presents a device that includes:

- a means for ECG signal acquisition ECG,

a selector comprising a block signal generator field of choice and elements of the field of choice, in particular the magnets or coils of the excitation field of choice, for generating a magnetic selection field having such a spatial diagram of the magnetic field to the first auxiliary zone having a low magnetic field strength and a second auxiliary zone having a higher magnetic field strength, were formed in the field of vision

the excitation means comprising a block signal generator excitation field and the field coil excitation field to change the spatial position of the two support areas in the field of view through the magnetic field excitation, the magnetization of the interference device into the field of vision changed locally

- a means of receiving, containing at least one signal receiving unit and at least one p�in Yemen coil for receiving the detection signals, moreover, the detection signals depend on the magnetization of the interference device into the field of view, wherein the magnetization is influenced by the change in the spatial position of the first and second support areas,

- management tool for management of blocks of signal generator for generating and passing control currents to the respective field coil to generate appropriate magnetic fields for moving the interference device through the vascular system and heart in the direction indicated by the navigation commands, and/or for maintaining the interference device in a standing position,

- processing means for processing the detection signals obtained when applied the appropriate magnetic field for determining the position of the interference device within the vascular system and heart on the processed detection signals and

- an evaluation tool to assess the impact of the interference device for ECG signals recorded by means of ECG.

In an additional aspect, the present invention proposes a corresponding method.

In another additional aspect, the present invention proposes a computer program comprising program code means to instruct a computer to control the device according to the present invent�the NIJ to perform steps of the method according to the present invention, when the computer program runs on your computer.

Preferred embodiments of the present invention are defined in the dependent claims. It should be understood that the claimed method and the claimed computer program have similar and/or identical preferred embodiments of implementation, as the claimed device, as defined in the dependent claims.

The inventors have determined that the main restrictive factor is known intracardiac ECG mapping, complex, requiring time-consuming and invasive surgery with the use of the catheter, can be overcome by using MPI technology. Consequently, the authors present invention have found a solution to use standard non-invasive ECG device by additional use having a magnetic permeability and electrical conductivity of the interference device, which is introduced into the object under examination before the examination, and then, during the study, actively move, monitor and shape his image with the use of specially adapted MPI device, wherein the interference device affects the ECG signals which can be evaluated. By and localization interferencing� device in a patient's heart using appropriate magnetic fields the MPI device of the present invention interference device changes the electrical field of the heart and, therefore, it is possible to reconstruct spatially localized ECG signals. In other words, the inventors found that the method of ECG mapping based on MPI, in which the interference device, which can be represented as a nonconductive rod containing a soft magnetic material is directed through a system of blood vessels and heart using a field-focusing and field of choice MPI system to affect the ECG signals. With the use of adapted means of the evaluation device of the present invention is the influence of the interference device in the ECG signal can be evaluated to achieve information with a spatial resolution relative to the electrical activity of the heart.

The main advantage of the device of the present invention is significantly higher accuracy compared to the standard ECG. By the use of magnetic interference of the ECG device required by this invention is intracardiac, but, nevertheless, invasive procedure is not required. Thereby, the accuracy and quality of the signals is comparable with known invasive ways intracardial ECG mapping, although not required surgical intervention with the use of the catheter. In addition, the presented method requires less hard�time t, is more comfortable and less risky for the patient.

Preferably, the interference device is very small having a magnetic permeability and electrical conductivity of the rod, which is moved using the selection means and means of excitation of the device of the present invention. Thus, the interference device can be moved to any area within the blood vessels or heart patient and, thereby, to provide information about the fabric and condition of the heart. As in the known methods must be used a catheter, the method is much more flexible and allows to obtain ECG signals even for areas in which the catheter must not be entered.

The apparatus and method can, for example, apply when planning a procedure called catheter ablation. This gives the advantage that you can split the planning and intervention procedure called catheter ablation, in contrast to the known method. In accordance with known in the art methods, these two phases cannot be separated, so intracardial ECG mapping necessarily performed simultaneously with the catheter ablation. The drawback to this is that often not all the causes of arrhythmia can be found during the ablation procedure, so maybe u�to require some surgical operations. In contrast, using the device of the present invention more durable, harmless and comfortable the planning phase, which is separated from actual interference, can be distributed over a period of several days so that you can securely diagnose the cause of your arrhythmia.

Having a magnetic permeability and electrical conductivity of the interference device can be represented, as already mentioned above, in the form of a small rod containing a soft magnetic material, which may be, for example, a small wire of pure iron. As for the size of the interference device, in one embodiment, the implementation uses a length of 3 mm and a diameter of 200 microns. It should be noted that the diameter of the device should not exceed 200 μm, to avoid block of the respective vessels. The length is preferably in the range from 1 mm to 10 mm, Although longer devices produce large signals, they can also pose a high risk of tissue damage, respectively of the vessel. It should be noted that the device may be even greater than the above size if it applies in the investigated objects, than the human heart. In addition, preferably, the interference device was made of pure iron, which is destroyed in the body of che�of owaka for a short time, so interference device dissolves in the blood.

According to a preferred embodiment of the present invention, the interference device is made of biodegradable polymeric material, such as polylactic acid, which are interspersed with small magnetic permeability and electrical conductivity of the particle. This further reduces the risk of tissue damage, respectively, of the vessel, as mentioned above breaks down in the body very quickly (within several minutes).

Other advantages of the device of the present invention is due to the MPI technology. Because the controls generate corresponding magnetic field (selection field and the field excitation) to move the interference device through the vascular system and heart in the direction indicated by the navigation commands, and/or for maintaining the interference device in a standing position, the interference device can be moved to any place inside the heart only through the application of magnetic forces, thus, the procedure of planning much easier, and greatly increases the accuracy of the placement of the interference device compared to the known catheter intervention. Thus, the controls are performed with the who�agnosto changes in the magnetic field very quickly to the movement and placement of the interference device can be performed in a very short time. As mentioned above, due to its noninvasive nature of the measurement can be repeated many times without risk for the patient.

Thereby, the displacement of the interference device preferably provides an indication of the navigation commands that can be defined at the planning stage. Preferably the interface for entering these commands into the control unit. Such an interface can be a user interface, such as a keyboard, pointer, mouse or joystick, or an interface for connection to another device, such as a navigation unit or the navigation tool on the computer where, for example, the planned move of the interference device, for example, by using image data of a patient obtained using the other methods of imaging, such as MRI or CT.

Due to the envisaged processing interference device can be localized and visualized at any time during the ECG measurement. In comparison with known intracardiac ECG mapping does not require additional equipment, such as a camera system or an x-ray system for visualizing and/or lo�the implementation of the interference device because this device can be moved and localize on the order or even simultaneously without additional equipment. Since x-ray radiation is not used in comparison with known methods, when you need to get the image of the catheter using x-ray radiation dose of the patient is also reduced.

According to a preferred embodiment of the present invention mentioned above, the ECG signals are recorded by means of ECG by using skin electrodes located on the patient's skin. This means that the ECG signals can be detected by conventional means ECG using electrodes on the body surface. However, the accuracy and quality of the signals, as indicated earlier, much higher than conventional ECG device. Moreover, the manufacturing costs of the device according to the present invention can be saved if you can use a normal ECG device, and only need to adapt them according to the present invention. To improve the signal quality and measurement accuracy, preferably, the use of multiple cutaneous ECG electrodes.

According to another preferred embodiment of the present invention, the ECG signals are measured for many of the provisions of the interference device. This means that �interferentsionnoe to a device positioned in a variety of positions within the heart, so that during the measurement the influence of the interference device on the ECG signals can be registered by means of assessment for all areas within the heart. Thus, you can set a "map" with a spatial resolution that shows the influence of the interference device on the ECG signals. Thus, it is possible to localize the area where possible arrhythmias or the appearance of scar tissue.

According to another preferred embodiment of the evaluator is configured to evaluate modulations of the ECG signals as a result of changes of the electric field caused by the interference device. If interference device positioned within the heart, the electrical conductivity varies in this position because of the characteristics of the electrical conductivity of the device, so that the ECG signal is modulated when the wave front of depolarization of the heart passes the position of the interference device. Thereby, interference device changes the lines of the electric field of the wave front of depolarization and, consequently, modulates the ECG signal. Interference device during measurement or is held in a certain position (using magnetic fields), while the wave front of depolarization will not pass interference device at least once, or it is from�umeno and, therefore, moves with the flow in an arbitrary way, while the position and orientation are not accurately followed using processing tools. In this case, the speed of the device may exceed 1 m/s, so that the ECG signal is now modulated at frequencies above 300 Hz. Therefore, the frequency modulations are in the frequency band that is different from ECG signals, so that the "handwriting" of the interference device can be readily identified in the Fourier space.

One of the advantages of these modulation signals on the ECG signal is that, for example, can be determined by scar tissue occurs because of weak modulation or she generally does not occur if the interference device is disposed at a position where the tissue is scarred. This is due to the fact that scar tissue has significantly reduced electrical conductivity, so you can imagine that the wave front of depolarization moves around scar tissue (wave front propagation "avoids" the wave front of depolarization).

To assess modulation signals as a result of changes of the electric field caused by the interference device, one embodiment of the present invention, furthermore, preferably, the assessment tools were arranged to obtain information about the modulation �of Ignatov ECG, caused by the interference device, the time correlation with the information on the position of the interference device within the blood vessels and heart, determined on the processed detection signals. The main improvement of this characteristic is that for this embodiment of the spatial location information of the interference device, which is obtained using MPI tracking method obtained in correlation with a time-dependent modulation of the ECG signal. This means that when the specific characteristics of the ECG is the most modulated when the device is in a certain position, the characteristic of the ECG occurs in a position that is obtained by MPI tracking.

If, for example, the interference device is about sinoatrial node, prong P of the ECG signal will be most modulated, since the degree of modulation is reduced further from P. prong integration of spatial information and temporal dependence in this example means that the time required for the propagation of the wave front of depolarization from sinoatrial node to a specific position where there is interference device, can be obtained by the ECG signal by measuring the time from the beginning of the ECG signal to the point the forces�Noah modulation, on the other hand, the position of the interference device can be accurately determined using the MPI processing device. In this way it is possible to accurately determine the temporal and spatial dependency of propagation of the wave front of depolarization.

According to another embodiment of the present invention, it is proposed that the assessment tools were adapted to determine the mean electrical vector wavefront polarization of the heart over time in a certain spatial position by obtaining information about the modulations of the ECG signal caused by the interference device, the time correlation with the information on the position of the interference device within the vascular system and heart, determined on the processed detection signals. Similarly, the normal vector ECG ECG data are used to form the image of the spatial distribution of the wave front of depolarization over time, the mean electrical vector which indicates the direction of propagation and the voltage drop at the wave front at each time point can be very accurately determined for each position in the heart. In contrast to the known non-invasive (conventional) ECG, where the average electric vector of the reconstructed only about�Nova modules of the approximate simulation, the mean electrical vector can be determined according to the present invention on the basis of specific measured signals and based on a specific mathematical calculations. This feature hitherto was known only for invasive catheter ECG mapping, which has the drawback that needs major surgery. If the average electric vector of the wave front of depolarization is determined for a sufficient number of provisions within the heart can be reconstructed very accurate distribution of the wave front of depolarization over time.

According to another embodiment of the present invention, the device of the present invention further comprises a means of improving quality to improve the estimation of the modulation signals by comparing the measured modulation signals with the expected modulation signals. Thus, the quality of the reconstruction of the wave front of depolarization increases. In practice, this is performed, for example, the use of measured values for mean electrical vector with the expected modulated values, for example, using interpolation.

According to another preferred embodiment of the present invention, the device comprises a means of forming images of distrib�of anemia wavefront of depolarization over time. Thus, modeling of the propagation of the wave front of depolarization can be shown, for example, on the computer screen to realistic visualization of abnormalities or heart failure. Thus, it is possible to significantly improve the diagnosis of diseases of the heart.

According to another preferred embodiment of the present invention, the device further comprises a means of focusing that contains the block of signal generator field of focus and the field coil of the field of focus to change the spatial position of the field of view through the magnetic field focusing. Such a field the focus has the same or similar spatial distribution to that of field excitation. Field focus mainly used for moving the spatial position of the field of view. This is especially necessary because the field of view has a very small size, so if the target element you want to move a greater distance within the object (patient), the focus should change the spatial position of the field of view to actively move and track interference device all the way, until it reaches the desired position within the patient's heart.

In other words, the field of focus replaces the act�VNOM mechanical movement of the patient. This means that the patient must be moved physically to move the field of vision if not provided a means of excitation of the field of focus. Similar to or even better than the exciter coil of the magnetic field excitation, can be used the excitation coil of the magnetic field focusing for moving the interference device into the patient's body. These coils allow you to generate a fairly uniform field in different directions at a sufficiently high speed and with a sufficiently high field strength is required to move the interference device. Consequently, the use of these excitation coils of the field-focusing provides high flexibility, since these fields can be created in any direction.

As mentioned above, the field of focus has the same or similar spatial distribution to that of field excitation. You can even use the same magnetic coil because coils are used to generate the magnetic excitation field. The main difference is that the frequencies are much lower (for example, < 1 kHz, typically < 100 Hz) for the field of focus than for the field excitation, but the amplitude of the field focusing is much higher (e.g., 200 MT, compared to 20 MT for the field excitation).

Brief description of the ERC�urchins

These and other aspects of the present invention will be apparent and explained with reference to the variant(s) of implementation indicated in this document. In the following figures:

Fig. 1 shows a first variant implementation of the MPI device,

Fig. 2 shows an example of a chart of the field of choice created by the device shown in Fig. 1,

Fig. 3 shows a second variant implementation of the MPI device,

Fig. 4 shows a block diagram of an embodiment of a device according to the present invention,

Fig. 5 schematically shows a practical application of the device according to the present invention,

Fig. 6A-6C illustrates the positioning of the electrically conducting interference device of the present invention in different positions in the heart,

Fig. 7 shows the influence of the interference device of the present invention on the ECG signal,

Fig. 8A shows the mean electrical vector wavefront of depolarization of the heart over time and

Fig. 8B shows the distribution of the wave front of depolarization of the heart over time.

Detailed description of the invention

Before explaining the details of the present invention will be explained in detail the main provisions of imaging using magnetic particles with reference to Fig. 1-3. In particular, I will describe two variations�the implementation of the MPI scanner, used for medical diagnosis. Also presents a narrative description of the data collection. Will be marked similarities and differences between these two versions of the implementation.

In the first embodiment 10 of the implementation of the MPI scanner shown in Fig. 1, there are three selected pairs 12, 14, 16 coaxial parallel annular coils, wherein each pair is positioned as shown in Fig. 1. These coil pairs 12, 14, 16 serve to generate the selection field and excitation field and the field of focus. Axis 18, 20, 22 of the three coil pairs 12, 14, 16 are mutually orthogonal and intersect at a point, designated as the isocenter 24 MPI scanner 10. In addition, these axes 18, 20, 22 serve as the axes of a 3D Cartesian coordinate system x-y-z associated with the isocenter 24. The vertical axis 20 corresponds to the y-axis, and the x and z-axes are horizontal axes. Coil pairs 12, 14, 16 are referred to by their axes. For example, the y-coil pair 14 is formed by coils located at the top and bottom of the scanner. In addition, the coil positive (negative) y-coordinate will be called y+-coil (y--coil), and also for the rest of the coils.

The scanner 10 is capable of passing a predetermined time-dependent electric current through each of these coils 12, 14, 16, and in each direction. If the current flows in the coil clockwise�Rilke, when viewed along the axis of this coil, it is considered positive, otherwise negative. For generating a static field of a choice of the positive constant current ISmust flow through the z+-the coil, and the current-ISmust flow through the z--coil. Z-coil pair 16 in this case works as antiparallel annular coil pair.

The magnetic field of choice, which, in General, a gradient magnetic field shown in Fig. 2 power lines 50 field. It has essentially a constant gradient in the direction (e.g., horizontal) z-axis 22 z-coil pair 16 that generates the select box and reaches zero value at the isocenter 24 on the axis 22. From this point of zero field (Fig. 2 not separately shown) of the magnetic field 50 of select increases in all three spatial directions with increasing distance from the zero point field. In the first auxiliary zone or area 52, indicated by the dotted line around the isocenter 24, the field strength is so small that the magnetization of the particles present in the first auxiliary area 52 does not reach the saturation level, while the magnetization of the particles present in the second auxiliary zone 54 (outside region 52), corresponds to the saturation state. The zero point field or the first digital�support area 52 of the field 28 of the review of the scanner preferably represents the area having spatial coherence; it can also be a spot zone, a straight or planar region. In the second auxiliary zone 54 (i.e. in the rest of the field 28 of the review of the scanner beyond the first auxiliary zone 52) the magnetic field of the field of choice is large enough to hold the magnetic particles in the saturation state.

With the position of the two support zones 52, 54 within the field 28 review (overall) magnetization in a field of 28 review of changes. Measuring the magnetization in a field of 28 review or physical parameters, which magnetization is influenced, it is possible to obtain information on the spatial distribution of magnetic particles in a field of 28 review. To change the relative spatial position of the two support zones 52, 54, located in box 28, box 50 selection in field 28 of the review or at least part of the field 28 of the review imposed additional magnetic field, namely the magnetic field excitation and, if possible, the magnetic field focusing.

To generate the excitation field through both x-coils 12 is skipped time-dependent current ID1through both y-coil 14 - time-dependent current ID2and through both z-coil 16 is a time-dependent current ID3. Thus, each of the three reel p�R operates as a parallel annular coil pair. Similarly, to generate a field of focus, using both x-coils 12 is skipped time-dependent current IF1through both y-coil 14 - time-dependent current IF2and through both z-coil 16 is a time-dependent current IF3.

It should be noted that z-coil 16 is a pair of special couple: it generates not only its share of the field excitation and the field of focus, but also the field of choice. The current flowing through the z±-the coil is ID3+The IF3+The IS. The current flowing through the remaining two coil pairs 12, 14, is IDk+The IFkwhere k=1, 2. Due to its geometry and symmetry of the three coil pairs 12, 14, 16 unleashed between them. You want this condition to be fulfilled.

Being generated antiparallel annular coil pair, the selection field is axisymmetric around the z-axis, while its z-component is almost linear in z and does not depend on the coordinates x and y in a sizeable volume around the isocenter 24. In particular, the selection box has a single zero point field (FFP) at the isocenter. Conversely, contributions to a field of a field excitation and focusing of the generated parallel annular coil pairs are close to homogeneous in space�government in respect of a sizeable volume around the isocenter 24 and parallel to the axis of the respective coil pairs. Field excitation and the field of focus, generated jointly by all three parallel annular coil pairs are close to homogeneous in terms of space and can have any direction and any level of tension up to a certain maximum value of tension. Field excitation and the field of focus are also time-dependent. The difference between the field-focusing and field excitation is that the field focus changes slowly in time and has a large amplitude, while the field excitation is changed quickly and has small amplitude. There are physical and biomedical reason to treat these fields separately. Rapidly changing field with high amplitude are difficult to generate, and it poses a danger to patient.

In the embodiment 10 the implementation of the MPI scanner includes at least one additional pair of, preferably three additional pairs of parallel circular coils, again oriented along the x-, y - and z-axes. These coil pairs, which in Fig. 1, not shown, serve as receiving coils. As in the case of coil pairs 12, 14, 16 for the field excitation and the field focusing, the magnetic field generated by a constant current flowing through one of these offices of coil pairs is nearly uniform in a simple�antenna respect within the field of view and parallel to the axis of the respective coil pairs. It is assumed that the pick up coils untied among themselves. Time-dependent voltage induced in the receiving coil, is subjected to amplification and is measured by a receiver attached to the coil. If to speak more precisely, to cope with the processing of this signal in a huge dynamic range, the receiver measures the difference between the received signal and some reference signal. The transfer function of the receiver is non-zero from DC to the point where the expected signal level is reduced below the noise level.

In the embodiment 10 the implementation of the MPI scanner shown in Fig. 1, there is a cylindrical tunnel 26 located along the z-axis 22, i.e. along the axis of the field of choice. All coils are located outside of the tunnel 26. For data collection the patient (or object) that must be rendered (or treatment), placed in a tunnel 26 so that the volume of interest of the patient, - the volume of the patient (or object) that will be visualized (or subjected to treatment), was covered by a field of 28 overview of scanner - the volume of the scanner, the contents of which the scanner is able to visualize. The patient (or object) is, for example, on the table for the patient. Field 28 is geometrically simple isocentrically volume in the inner space of the tunnel 26, for example, in the form of a cube, sphere or cylinder Cubic box 28 overview shown in Fig. 1.

The size of the first auxiliary zone 52 depends, on the one hand, the magnitude of the gradient of the magnetic field of choice, but on the other hand, on the magnetic field required for saturation. For a sufficient saturation of the magnetic particles when the magnetic field intensity equal to 80 A/m and a gradient (in a given spatial direction) of the magnetic field of choice, up to 50×103A/m2the first auxiliary zone 52 in which the magnetization of the particles below the saturation level, has dimensions of approximately 1 mm (in a given spatial direction).

Of interest, the volume of the patient must contain magnetic nanoparticles. Before therapeutic and/or diagnostic procedures in relation to, for example, tumors of the magnetic particles is placed in a volume of interest, for example, by means of a liquid containing magnetic particles, which are injected into the patient (the object) by injection, or administered to the patient in any other way, such as orally.

In one embodiment of the magnetic particles contain, for example, a spherical glass substrate provided with a layer of magnetically soft material, the thickness of which is, for example, 5 nm and which is, for example, iron-Nickel alloy (e.g., permalloy). This layer can be coated, you�olnine, for example, a covering layer which protects the particle from chemically and/or physically aggressive environments, such as acid. The magnetic field strength of 50 selection, which is required for magnetic saturation of such particles depends on various parameters, such as diameter of the particles used in the magnetic material for the magnetic layer and other parameters.

When a diameter of 10 μm, for example, will require a magnetic field of 800 A/m (which corresponds to the magnetic flux density of 1 MT) and a diameter of 100 μm will be sufficient magnetic field of 80 A/m. Even lower values are get, when you select a coating of a material having a lower magnetic saturation, or when the layer has a smaller thickness. Magnetic particles, which, in General, can be used available on the market under the brand name of Resovist.

For more information about commonly used magnetic particles and compositions of the particles can be addressed to the publications EP 1304542, WO 2004/091386, WO 2004/091390, WO 2004/091394, WO 2004/091395, WO 2004/091396, WO 2004/091397, WO 2004/091398, WO 2004/091408 that are included in this description by reference. In these documents you can also find a more detailed description of the MPI method in General.

Data collection begins at the moment of time tsand ending at time te. In the process of collecting �data x-, y -, and z-coil pairs 12, 14, 16 generate a magnetic field, depending on position in space and time, i.e. the applied field. This is achieved by passing through the respective coil currents. Essentially, the field excitation and the field focusing effect on the selection box so that FFP is moved along a preselected FFP trajectory, outlining the amount of scanning that is part of the field of vision. The applied field gives the orientation of the magnetic nanoparticles in the patient. When changing the applied field, the resulting magnetization also varies, although her reaction to the applied field is non-linear. Changing the applied field and the changing magnetization in the amount of induce time-dependent voltage Vkon the findings of a reception coil pair along the xk-axes. The corresponding receiver converts this voltage into a signal Sk(t), which he measures and outputs.

It is preferable to receive and record signals from the magnetic particles located in the first auxiliary zone 52, in a different frequency range (shifted to higher frequencies) than the frequency range in which there are changes in the magnetic field excitation. This is possible because frequency components appear more� high frequency harmonics of the magnetic field excitation due to the change in the magnetization of magnetic particles in a field of 28 overview of the scanner due to the nonlinearity of the magnetization characteristics.

As in the first embodiment 10 of the implementation shown in Fig. 1, in a second embodiment 30 of the implementation of the MPI scanner shown in Fig. 3, there are three annular mutually orthogonal coil pairs 32, 34, 36, however, these coil pairs 32, 34, 36 generate only the selection field and the field of focus. Z-coil 36, which again generate the select box filled with ferromagnetic material 37. Z-axis 42 in this embodiment 30 of the implementation are oriented vertically, while the x - and y-axes 38, 40 are oriented horizontally. The tunnel 46 of the scanner parallel to the x-axis 38 and, therefore, perpendicular to the axis 42 of the field of choice. Field excitation is generated by a solenoid (not shown) along the x-axis 38 and a pair of deflecting coils (not shown) along the remaining two axes 40, 42. These coils are wound around the tube, forming a tunnel. Coil excitation field also serve as receiving coils. Signals received through receiving coils pass through a high-pass filter, which suppresses component brought in by the applied field.

Some typical parameters in this version of the implementation: the z-gradient field of choice, G has the value G/μ0=2.5 T/m, where μ0- magnetic permeability of vacuum. Generated field, select either do not change in time, or its change is relatively slow, preferably with a frequency of from about 1 �C to about 100 Hz. The temporal frequency spectrum of the excitation field is concentrated in a narrow band of frequencies around 25 kHz (approximately 100 kHz). Range of useful frequencies of the received signal lies between 50 kHz and 1 MHz (sometimes up to about 10 MHz). The tunnel diameter is 120 mm. the edge Length of the largest cube 28 which can fit in the tunnel 46 is 120 mm/2≈84 mm.

As shown in the above embodiments, different magnetic fields can be generated by coils of the same coil pairs by providing these coils accordingly generated currents. However, particularly for the purpose of decoding the signal at higher signal-to-noise, it may be preferred to be constant in time (or quasi-constant) the field of selection and variable in time field excitation and the field of focus were generated by a separate coil pairs. In General, these coils can be used both in single and pairs of Helmholtz type, which, in General, known, for example, from the scope of the magnetic resonance device with open magnets (open MRI type) in which radiofrequency (RF) coil pair is situated above and below of interest by region, wherein said RF coil pair �posebna to generate an alternating magnetic field. Thus, the design of these coils does not need further explanation.

In alternative implementation to generate the selection fields can be used permanent magnets (not shown). In the space between two such poles (opposite) of permanent magnets (not shown), the magnetic field, similar to that shown in Fig. 2, i.e. in the case when the opposite poles have the same polarity. In another alternative embodiment of the selection field can be generated by combining at least one permanent magnet and at least one coil.

Fig. 4 shows a block diagram of a device 100 according to one embodiment of the present invention. General principles of imaging with magnetic particles, explained above, are also valid and applicable to this variant implementation, unless otherwise indicated.

Variant implementation of the device 100 shown in Fig. 4, contains a set of different coils to generate the required magnetic fields. First, it should be clarified coils and their main functions in MPI mode.

For generating a gradient magnetic field of choice, described above, provides the means of choice, containing a set of coils 116 of the excitation field of choice (SF), preferably with�argasi at least one pair of coil elements. The selector further comprises a block 110 of the generator of the signal selection fields. Preferably a separate auxiliary generator unit is provided for each coil (or each pair of coil elements) of the set 116 of the excitation coils of the field of choice. Block generator 110 of the signal selection fields contains the managed source 112 of the excitation current of the field of choice (which typically contains the amplifier) and the block (114) filter, which provides a flow of excitation current selection fields to corresponding coil elements of the excitation field of choice to install separately the magnitude of the gradient of the field of choice in the desired direction. Preferably, the supplied direct current. If the coil excitation elements selection fields are arranged one against the other coils, for example on opposite sides of the field of view, the excitation currents of the field of choice in the opposite coils preferably proceed in opposite directions.

Block generator 110 of the signal selection fields is controlled by the block 150 controls, which preferably carries out the control unit 110 of the signal generator of the field of choice so that the total field strength and the total gradient magnitude in all spatial parts of the field of choice was maintained at the specified level.

For generating a magnetic field focus�toos device 100 further comprises a means of focusing contains a set of excitation coils of the field-focusing (FF), preferably containing three pairs 126a, 126b, 126c are located against each other the elements of the excitation coils of the field of focus. The excitation coils of the magnetic field focusing controls unit 120 of the signal generator of the field of focus, preferably containing a separate auxiliary unit of the signal generator of the field of focus for each coil element (or at least each pair of coil elements) of the specified sets of excitation coils of the field of focus. Unit 120 of the signal generator of the field of focus contains a source 122 of the excitation current of the field of focus (preferably containing the current amplifier) and a block filter 124 for supplying the excitation current of the field focusing on the corresponding auxiliary coil set coils 126a, 126b, 126c, which should be used to generate a magnetic field focusing. Unit 120 of the excitation current of the field of focus is also controlled by the unit 150 of the control.

Field of focus and the above-mentioned means of generating a field of focus of the present invention are not mandatory. The means of excitation of a field focusing can be used as a means of excitation of the excitation field (described in detail later), to move the interference device 210 via SOS�dy of the patient 300, until it reaches its final desired position within the heart 220 of the patient 300. Interference device 210, thus, moved by magnetic forces that arise due to the applied field focus (respectively, thanks to the applied field excitation). In addition, the focus is preferable, since the field 28 of the review has a very limited size, so if the interference device 210 needs to be moved for a longer distance through the blood vessels of the patient 300, the focus should change the spatial position of the field 28 of the review so that you can actively move and track interference device 210 in all his ways, until it reaches the desired position within the heart 220 of the patient 300. In other words, the field of focus replaces the active mechanical movement of the patient 300. If not provided the means of excitation of the field of focus, the patient 300 has to move physically to move the field 28 of the review.

For generating a magnetic field excitation device 100 further comprises a means of initiation containing auxiliary unit exciting coils excitation field (DF), preferably containing three pairs 136a, 136b, 136c of oppositely situated coil elements of the excitation field �of sbordone. Coil excitation field excitation is controlled by the block 130 of the signal generator field excitation, preferably containing a separate auxiliary unit of the signal generator excitation field for each coil element (or at least each pair of coil elements) of the said set of excitation coils of the field excitation. The mentioned block 130 signal generator excitation field comprises a source 132 of the excitation current excitation field (preferably containing the current amplifier) and a filter 134 for supplying excitation current excitation field to the corresponding field excitation coil excitation. The source 132 of the excitation current field excitation is arranged to generate an alternating current and is also controlled by the unit 150 of the control.

To detect signals provided by the receiving means 148, in particular receiving coil, and a control unit 140 receiving signals receiving signals recognized mentioned receiving means 148. The mentioned block 140 receiving signals contains the block 142 of the filter for filtering the received signals detection. The purpose of such filtering is to separate the measured values caused by the magnetization in the study area, which is influenced by the change of position of the two sub-regions (52, 54), from other signals, obrazowe� interference. To this end, the block 142 of the filter can be designed so that, for example, signals having temporal frequencies lower than temporal frequency, with which a take-up spool 148, or less than the value twice as high as those temporal frequencies that are not allowed by the block 142 of the filter. The signals then go through a gain block 144 to an analog-to-digital Converter 146 (ADC). The digitized signals issued from the analog-digital Converter 146 are received in block 152 image processing (also known as a tool for image reconstruction, which reconstructs the image of the position of the interference device 210 to the interference device 210 can be accurately and continuously monitor during the measurement. The reconstructed image of the position of the magnetic interference device 210 is eventually dispatched by the tool 150 control computer 154, which displays it on the monitor 156. Thus, it can be displayed an image showing the position of the interference device 210.

Additionally, a block 158 of the input, such as keyboard. The user, therefore, can set the desired direction of higher resolution and, in turn, to obtain the corresponding image region of the action on the monitor 156. If necessary, the direction in �oterom you want to get a higher resolution is the deviation from the direction set by the user, the user, however, can change the direction manually to get the following image with increased resolution. The process of increasing the resolution may also be performed in automatic mode unit 150 controls and the computer 154.

According to the present invention, the block 150 is a control with the ability to control units 110, 120, 130 of signal generators, in particular unit 120 of the signal generator of the field of focus and/or block 130 signal generator field excitation, to generate and apply control currents to the coils of the respective fields, in particular, coils 126a, 126b, 126c of the excitation of the field of focus and/or coils 136a, 136b, 136c of the excitation field excitation to generate appropriate magnetic fields for moving the interference device 210 through a system of blood vessels and the heart 220 in the direction indicated by the navigation commands, and/or for maintaining the interference device 210 in a permanent position. Thus, the interference device 210 can be moved to the desired position in the heart 220 of the patient 300. This movement can be performed very quickly and moreover more comfortable and without risk to the patient 300.

For the introduction of the navigation commands provided interface 162. The interface 162 may be osushestvlenie ways. For example, an interface 162 may provide a user interface through which the user can manually enter a custom command, for example, via keyboard, remote control, joystick or navigation tool, for example, installed on a separate computer (not shown).

In practice, therefore, the device of the present invention may move the interference device 210 through the patient's body 300, in particular to control the direction of movement of the interference device 210, based on the navigation commands, regardless of its form, and from whom or what are the commands provided.

The move command can also be received from the external unit 170 motion control that is connected to the interface 162 and which contains a display 172, for example, to display the image data of the heart 220 of the patient and a means 174 operator control to enter control commands for planning the movement of the interference device 210.

In the practical interference measurement can be scheduled in advance with the use of block 70 motion control. The navigation plan, in particular the management team move, then fed via the interface 162 to the control unit 150 of the device 100. With tre�creating (for example, regular) intervals of movement of the interference device 210 is terminated, and his current position is obtained by applying the sequence of MPI, preferably while moving along the FFP trajectory through the region in which the interference device 210 may be located at the current point, and receiving the detection signals, which are then processed to locate the current position of the interference device 210.

Thus, direct feedback can be obtained regardless of whether the actual position of the interference device 210 to the desired position, so that can be made immediate adjustments either manually or through block 150 controls.

As indicated above, the device 100 is provided with the use of the MPI method of imaging and tracking. According to the present invention, the device 100 further contains a means 151 for ECG signal ECG of the heart 220 of the patient. These funds 151 ECG can be performed by using a standard ECG device that records signals by the use of skin electrodes 230 (see Fig. 5). The ECG signals are then passed to the tool 153 evaluation, which is performed with the possibility of assessing the influence of the interference device 210 on the ECG signal. This means� assessment 153 may be, for example, another processing unit, which is also connected to the block 150 controls and a means of reception. In the tool 153 evaluation information about heart activity of the patient and the influence of the interference device 210 on the ECG signal, adopted by means 151 ECG, receive along with information about the positioning of the interference device 210, adopted by the receiving means.

To understand the principle of this evaluation is performed by means 153 evaluation, the following examples and further detail the principle.

Fig. 5 schematically shows a variant implementation of the practical measurement settings of the devices of the present invention. The device 100 thus includes the MPI tool 10, 30 as indicated in Fig. 1 and 3, the device 151 ECG and the computer 200, which causes the data acquired from MPI means 10, 30 and means 151 ECG in accordance with each other, and evaluates the measurement results. In detail, the interference device 210, which is preferably introduced into the patient's body 300 before measurement, move (in this case, preferably, by a continuous tracking) 220 to heart of a patient using the above-mentioned method MPI. Unit 150, the control unit 152 of the processing of image formation and the tool 153 evaluation in this variant implementation is included in the computer 200, and running a graphically not shown in detail. �disorder 100, in addition, the device contains 151 ECG, which measures the ECG signals by using standard or adapted several cutaneous electrodes 230. It should be noted that suitable electrodes 230 are preferably not magnetic, for example, such electrodes as are known in the field of Mr imaging (magnetic resonance imaging).

If the interference device 210 is positioned in the heart 220 of the patient 300, it increases the electrical conductivity in this position due to its characteristics of electrical conductivity. As a result of the interference device 210 electric field changes activity of the heart, when the wave front of depolarization of the heart 220 passes the interference device 210. This effect then leads to a modulation of the ECG signal, which is received by the device 151 ECG. Modulation may even increase, if the interference device 210 to turn (with the help of magnetic fields the MPI device), while holding it in a fixed position in the heart. An example of this modulation 240 shown in Fig. 7A, which shows the modulation prong 240 P on the example of the ECG signal. Frequency modulation, which is caused by the interference device 210, even higher (above 300 Hz) than in the example shown in Fig. 7A. It should also be noted that the amplitude modulation in reality usually less�, than shown in Fig. 7, which is exaggerated for illustrative purposes only. The measured signal shown in Fig. 7A may correspond to the position of the interference device 210, an example of which is shown in Fig. 6A. Fig. 6A interference device 210 is located near sinoatrial site. Because the wave P ECG signal corresponds to depolarization of about sinoatrial node, it is obvious that in the case of the interference device 210 that is located in this region, the wave P is also modulated, as shown in Fig. 7.

Fig. 7A shows the modulation signal 240, caused by the interference device 210 when it is in the position shown in Fig. 6A. Fig. 7B shows the modulation signal 240, when the interference device 210 is in the position shown in Fig. 6B. In Fig. 7C shows the modulation signal 240, caused by the interference device 210 when it is in the position shown in Fig. 6C.

It should be noted that modulation of 240 in Fig. 7 is shown only schematically. In practice, the entire signal is modulated ECG (not just the wave P signal ECG). However, the strongest modulation 40 in the above example fixed to the appropriate part of the ECG signal (in this example, the wave P). During the measurement of the interference device 210 is moved through the heart of the 220 patients in� a variety of positions (examples are shown in Fig. 6A, 6B and 6C) using the above-mentioned method MPI. At the same time, the position of the interference device 210 is monitored by the device 10, 30 MPI, and the ECG signal is recorded for each position of the interference device device 151 ECG. As mentioned above, these two pieces of information are then put in correspondence with each other in the assessment tool which is performed as follows.

At the first stage determine the position of the highest modulation 240 in the ECG signal. By measuring the time from the beginning of the ECG signal up to a certain position where the highest modulation 240, you can determine the time required to move the wave front of depolarization from sinoatrial node to the position where there is interference device 210. In the next stage the position of the interference device 210 within the heart 220 of the patient 300 can be accurately determined using MPI imaging. Bringing time-dependent information along with information about the spatial position of the interference device, thus, means can be accurately determined, the wave of depolarization to spread to some known position. If this measurement procedure is repeated for a large number of provisions within the heart 22 of the patient 300, it is possible to reconstruct a very accurate image showing the distribution of the wave front of depolarization of the heart 220 of the patient over time.

In this simulation of propagation of the wave front of depolarization can be used to detect many diseases of the heart. For example, if the tissues of the heart have scars in a particular area, it can be seen in the simulation, since the wave front of depolarization passes this area, i.e. it moves around the field.

An example of simulation of propagation of the wave front of depolarization shown in Fig. 8B. The shaded region on it are electronegative region, through which passed the wave front.

In practice, this modeling is usually performed by using assessment tools (e.g., computer). Similarly, the normal vector ECG of the mean electrical vector is determined according to the measured values for each point in time. Fig. 8A shows an example of the mean electrical vector of time points with t1up to t10. Here the mean electrical vector is schematically indicated by the arrow. The length of the arrow indicates the electric field and the direction of the arrow indicates the amount of electric potential wave front.

In the end, it is proposed a device and method that allow very spot�about to perform intracardiac electrocardiography by using having a magnetic permeability and electrical conductivity of the interference device. Since measurements are performed intracardial, can be achieved very accurate detection of heart disease. Even though the measurement is performed intracardial, no need for major surgical intervention compared with procedures ECG mapping with the use of the catheter. In addition, the proposed device and method are preferred because of their interference device can be positioned in a patient's heart very precisely and in every desired position using the MPI. Consequently, the device and method according to the present invention reflect the efforts in the right direction in modern systems of diagnostics of the heart.

Although the invention is illustrated and described in detail in the drawings and in the foregoing description, such illustrations and descriptions should be regarded as illustrative and provided as an example and not limiting, the invention is not limited to the disclosed variants of implementation. Specialists in the art will be able to propose other changes to the disclosed embodiments, implementing the claimed invention, having examined the drawings, the description and the attached claims.

In the claims the term "containing" does not exclude other elements or steps, and the singular not the IP�includes the plural. A single element or other unit may fulfill the functions of several objects in the claims. The fact that certain of the characteristics mentioned in mutually different claims does not mean that the combination of these characteristics cannot be used profitably.

None of the reference positions in the claims should not be construed as limiting the scope of the invention.

1. The device (100) for non-invasive intracardiac electrocardiography (ECG) through the use of having a magnetic permeability and electrical conductivity of the interference device (210) that contains:
means (151, 230) for ECG signal acquisition ECG,
the picker that contains the block (110) of the generator of the signal selection fields and elements (116) of the excitation field of choice, in particular the magnets or coils of the excitation field of choice, for generating a magnetic field (50) having such a spatial diagram of the magnetic field to the first auxiliary zone (52) having a low magnetic field strength and a second auxiliary zone (54) having a higher magnetic field strength, were formed in the (28) review
means of initiation containing block (130) of the signal generator field excitation and coil (a, 136b, s) �of sbordone excitation field to change the spatial position of the two support zones (52, 54) in (28) the review by the magnetic field excitation, the magnetization of the interference device (210) in the (28) review changed locally
the pump containing at least one unit (140) of the reception signal and at least one receiving coil (148) for receiving the detection signals, the detection signals depend on the magnetization of the interference device (210) in the (28) of the review and the magnetization is affected by the change in the spatial position of the first and second auxiliary zones (52, 54),
means (150) to control blocks (110, 130) of signal generator for generating and passing control currents to the respective field coil to generate appropriate magnetic fields for moving the interference device through the vascular system and heart in the direction indicated by the navigation commands, and/or for maintaining the interference device (210) in a permanent position,
means (154) for processing the detection signals obtained when applied the appropriate magnetic field for determining the position of the interference device (210) within a system of blood vessels and the heart on the processed detection signals and
means (153) evaluation to assess the impact of the interference device for ECG signals, zareqistriro�record means (151, 230) ECG.

2. The device (100) according to claim 1, wherein the ECG signals are recorded by means (151, 230) ECG by the use of skin electrodes located on the patient's skin.

3. The device (100) according to claim 1, wherein the ECG signals are measured for many of the provisions of the interference device (210).

4. The device (100) according to claim 1, wherein the means (153) evaluation is made with the ability to assess modulations of the ECG signals as a result of changes of the electric field caused by the interference device (210).

5. The device (100) according to claim 4 in which the means (153) assessments are arranged to align in time the information about the modulation of the ECG signal caused by the interference device, with information about the position of the interference device (210) within a system of blood vessels and heart, determined on the processed detection signals.

6. The device (100) according to claim 4 in which the means (153) evaluation is arranged to determine the mean electrical vector wavefront of depolarization of the heart in time in a certain spatial position by aligning it according to time information about modulations of the ECG signal caused by the interference device (210), with information about the position of the interference device (210) within a system of blood vessels and heart, some at about�processed detection signals.

7. The device (100) according to claim 4, further comprising a means of improving quality to improve the estimation of the modulation signals by comparing the measured modulation signals with the expected modulation signals.

8. The device (100) according to claim 6, further comprising means (153) imaging for imaging of propagation of the wave front of depolarization over time.

9. The device (100) according to claim 1, further comprising means for focusing, comprising a block (120) of the signal generator field of the focusing coil (126A, 126b, C) excitation of the field of focus to change the spatial position of the field (28) review by the magnetic field of focus.

10. Method of non-invasive intracardiac electrocardiography (ECG) by use having a magnetic permeability and electrical conductivity of the interference device (210), wherein the method includes the stages at which:
record the ECG signals,
generating a magnetic field (50) of choice with such a spatial diagram of the magnetic field to the first auxiliary zone (52) having a low magnetic field strength and a second auxiliary zone (54) having a higher magnetic field strength, were formed in the (28) review
change the spatial position of the DV�x auxiliary zones (52, 54) in (28) the review by the magnetic field excitation, the magnetization of the interference device (210) in the (28) review changed locally
receive the detection signals and the detection signals depend on the magnetization of the interference device (210) in the (28) of the review and the magnetization is affected by the change in the spatial position of the first and second auxiliary zones (52, 54),
manage generate appropriate magnetic fields for moving the interference device through the vascular system and heart in the direction indicated by the navigation commands, and/or for maintaining the interference device (210) in a permanent position,
process the detection signals obtained when applied the appropriate magnetic field for determining the position of the interference device (210) within a system of blood vessels and the heart on the processed detection signals and
assess the influence of the interference device (210) to the registered ECG signals.



 

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2 cl, 3 dwg

FIELD: medicine; obstetrics.

SUBSTANCE: fetal cardiac rhythm is registered. Additionally cardiointervalography is performed with determination of spectral power density of maternal and fetal cardiac rhythm waves and selection of very low frequency VLF, low frequency LF and high frequency HF levels, regulator system tension index TI, cortizol and adrenaline level in maternal and fetal blood. Physiological pregnancy course is defined at adrenaline level of 28 ng/mol, cortizol level of 360 ng/ml, indices of VLF=120 relative units, LF=40 r.u., HF=20 r.u., TI=70 r.u., for the mother and at indices of VLF=25 r.u., LF=2 r.u., HF=1 r.u., TI=250 r.u. for the fetus; compensated form of chronic fetoplacental deficiency is detected at the adrenaline level of 46 ng/ml, cortizol level of 695 ng/ml, VLF=180 r.u., LF=50 r.u., HF=100 r.u., TI=160 r.u. for the mother and at VLF=45 r.u., LF=5 r.u., HF=1 r.u., TI=400 r.u. for the fetus; and decompensated form of chronic fetoplacental deficiency is detected at the adrenaline level of 2 ng/ml, cortizol level of 1003 ng/ml, VLF=900 r.u., LF=25 r.u., HF=10 r.u., TI=30 r.u. for the mother and at VLF=3 r.u., LF=1 r.u., HF=0 r.u., TI=700 r.u. for the fetus.

EFFECT: improved accuracy and information capacity of diagnostics of physiological pregnancy course and chronic fetoplacental deficiency forms.

1 dwg, 9 tbl

FIELD: medical engineering.

SUBSTANCE: system has device for measuring and recording biopotentials, device for measuring and recording movement parameters having the first accelerometer, the second accelerometer, the third accelerometer, the first instrumentation amplifier, the second instrumentation amplifier, the third instrumentation amplifier, multi-channel analog-to-digital converter, microcontroller, long-term storage, the first external interface adapter, timer, data analysis device comprising computer, graphic display unit, the second external interface adapter and system interface backbone. The first, the second and the third accelerometers are connected via the first, the second and the third instrumentation amplifiers to multi-channel analog-to-digital converter input cannels. The analog-to-digital converter is connected to the microcontroller. The microcontroller has long-term storage, external interface adapter and timer. The external interface adapter input/output serves as external interface adapter input/output of the device measuring and recording movement parameters. The device for measuring and recording biopotentials is connected to input channel of the device for measuring and recording movement parameters comprising microcontroller input via the second data transfer channel. The first and the second external interface adapters are connected to each other via the first data transfer channel. The computer and the second external interface adapter are connected to each other via system interface backbone. The graphic display unit is connected to the computer.

EFFECT: wide range of functional applications; high diagnosis accuracy.

7 cl, 1 dwg

FIELD: medical engineering.

SUBSTANCE: device has electrodes, preamplifier, microprocessor, memory units of upper and lower level, comparison units, threshold units, unit for producing alarm signal, magnetic recorder, acoustic signalization unit, high frequency generator, amplitude modulator, modulating code oscillator, phase manipulator, power amplifier, transmitting antenna, retuning unit, heterodyne, mixers, intermediate frequency amplifier, detector (selector), amplitude restrictors, synchronous detector, phase detectors, spectrum width measurement units, phase doubler, phase rotator by +90°, adder, multiplier, narrow band filters, amplitude detector, phase divider by 2, phase rotator by +30°, phase rotator by -30° and subtraction units.

EFFECT: improved noise immunity.

3 dwg

FIELD: medicine; cardiology.

SUBSTANCE: device for registering resulting electrocardiogram at front and horizontals planes has amplifier, analog-to-digital converter provided with multiplexer, arithmetic device, increment code analyzer, first switching unit, digital modem, first memory unit and control-unit, second switching unit, unit for finding direction of electrical axis of heart, first multiplier and first storing adder.

EFFECT: widened functional capabilities.

2 cl, 4 dwg

FIELD: medicine; cardiology.

SUBSTANCE: device for registering electric cardiosignals has amplifier, analog-to-digital converter with multiplexer and arithmetic unit as well as increment code analyzer, switch unit, digital modem, increment code number counter, memory unit, control unit, heart electro-motive force vector projection forming unit, heart electro-motive force vector value determination unit and heart electro-motive force vector direction determination unit. Device has widened functional capabilities of electric cartographic testing by means of finding spatial disposition of electric axis of heart. Projection of heart vector to frontal plane is found from standard abstracts from extremities and to horizontal plane - from chest abstracts. Projection of vector of heart to sagittal plane is determined from projections of vector of heart to frontal and horizontal planes. Direction and value of projection of heart electro-motive force is determined from known projections in three-dimensional space.

EFFECT: improved efficiency.

4 cl, 7 dwg

FIELD: medicine; medical engineering.

SUBSTANCE: method involves measuring physical characteristic of body surface. Micro-vibration power is measured in rest state on the body area under study during 0.5-5 min. Device has micro-vibration transducer and spectrum analyzer connected to visual recording device. The micro-vibration transducer is designed as electronic phonendoscope having pass band of 1-300 Hz. The visual recording device records variations of total micro-vibration spectral power in time. Mean micro-vibration power is determined. Its deviation from a reference value being equal to or greater than 40%, pathological process is considered to be available in the zone.

EFFECT: high accuracy in determining vestibular dysfunction cases.

2 cl, 3 dwg

FIELD: medicine; cardiology.

SUBSTANCE: device can be used in clinical and experimental tests for registration; analysis and transmission of electrocardiographic signal. Parameters of electrocardiographic signal are determined at any point of patient's body due to finding projection of vector of electrocardiographic signal of heart at any preset direction. Device has amplifier, analog-to-digital converter with multiplexer, arithmetic unit, increment code analyzer, switch unit, digital modem, increment code number counter, memory and control units, unit for forming projections of vector of electrocardiographic signal of heart and unit for finding value of vector of electrocardiographic signal of heart at preset direction.

EFFECT: widened operational capabilities.

3 cl, 5 dwg

FIELD: medical equipment.

SUBSTANCE: system intends for transmitting cardiologic signals along radio channels; it can be used in hospitals, clinics, for ambulance service and at consultation-diagnostic medical centers. System has equipment for serving patient and control board equipment. Patient serving equipment has electrodes, preamplifier, high frequency first generator, first amplitude modulator, modulating code generator, first phase manipulator, first power amplifier, first receiving-transmitting aerial, second heterodyne, second mixer, first intermediate frequency amplifier, first aerial switch, second power amplifier, third heterodyne, third mixer, second intermediate frequency amplifier, second amplitude limiter, second sync detector, registration unit, multiplier, band-pass filter and second phase detector. Control board equipment has microprocessor, comparison unit, lower and top level's memory units, adjusted threshold unit, alarm signal forming unit, magnet registrar, sound signal unit, second receiving-transmitting aerial, tuning unit, first mixer, second intermediate frequency amplifier, detector, delay line, switch, first amplitude limiter, first sync detector, second delay line, first phase detector, high frequency second generator, analog messages source, second phase manipulator, fourth heterodyne, fourth mixer, intermediate frequency amplifier, third and fourth power amplifiers, second aerial switch. Detector has spectrum width measuring unit, phase doubler, second comparison unit and first threshold unit. Radio channel is used in duplex (two-directional) mode when analog and discrete information is transmitted not only from patient to control board but from control board - to patient or to doctor treating the patient.

EFFECT: improved efficiency.

5 dwg

FIELD: medical engineering.

SUBSTANCE: device has electrodes, preamplifier, microprocessor, memory units of upper and lower level, comparison units, threshold units, unit for producing alarm signal, magnetic recorder, acoustic signalization unit, high frequency generator, amplitude modulator, modulating code oscillator, phase manipulator, power amplifier, transmitting antenna, retuning unit, heterodyne, mixers, intermediate frequency amplifier, detector (selector), amplitude restrictors, synchronous detector, phase detectors, spectrum width measurement units, phase doubler, phase rotator by +90°, adder, multiplier, narrow band filters, amplitude detector, phase divider by 2, phase rotator by +30°, phase rotator by -30° and subtraction units.

EFFECT: improved noise immunity.

3 dwg

FIELD: medical engineering.

SUBSTANCE: system has device for measuring and recording biopotentials, device for measuring and recording movement parameters having the first accelerometer, the second accelerometer, the third accelerometer, the first instrumentation amplifier, the second instrumentation amplifier, the third instrumentation amplifier, multi-channel analog-to-digital converter, microcontroller, long-term storage, the first external interface adapter, timer, data analysis device comprising computer, graphic display unit, the second external interface adapter and system interface backbone. The first, the second and the third accelerometers are connected via the first, the second and the third instrumentation amplifiers to multi-channel analog-to-digital converter input cannels. The analog-to-digital converter is connected to the microcontroller. The microcontroller has long-term storage, external interface adapter and timer. The external interface adapter input/output serves as external interface adapter input/output of the device measuring and recording movement parameters. The device for measuring and recording biopotentials is connected to input channel of the device for measuring and recording movement parameters comprising microcontroller input via the second data transfer channel. The first and the second external interface adapters are connected to each other via the first data transfer channel. The computer and the second external interface adapter are connected to each other via system interface backbone. The graphic display unit is connected to the computer.

EFFECT: wide range of functional applications; high diagnosis accuracy.

7 cl, 1 dwg

FIELD: medicine; obstetrics.

SUBSTANCE: fetal cardiac rhythm is registered. Additionally cardiointervalography is performed with determination of spectral power density of maternal and fetal cardiac rhythm waves and selection of very low frequency VLF, low frequency LF and high frequency HF levels, regulator system tension index TI, cortizol and adrenaline level in maternal and fetal blood. Physiological pregnancy course is defined at adrenaline level of 28 ng/mol, cortizol level of 360 ng/ml, indices of VLF=120 relative units, LF=40 r.u., HF=20 r.u., TI=70 r.u., for the mother and at indices of VLF=25 r.u., LF=2 r.u., HF=1 r.u., TI=250 r.u. for the fetus; compensated form of chronic fetoplacental deficiency is detected at the adrenaline level of 46 ng/ml, cortizol level of 695 ng/ml, VLF=180 r.u., LF=50 r.u., HF=100 r.u., TI=160 r.u. for the mother and at VLF=45 r.u., LF=5 r.u., HF=1 r.u., TI=400 r.u. for the fetus; and decompensated form of chronic fetoplacental deficiency is detected at the adrenaline level of 2 ng/ml, cortizol level of 1003 ng/ml, VLF=900 r.u., LF=25 r.u., HF=10 r.u., TI=30 r.u. for the mother and at VLF=3 r.u., LF=1 r.u., HF=0 r.u., TI=700 r.u. for the fetus.

EFFECT: improved accuracy and information capacity of diagnostics of physiological pregnancy course and chronic fetoplacental deficiency forms.

1 dwg, 9 tbl

FIELD: medicine.

SUBSTANCE: electrodes of electric ECG potential registration are placed in zone of aorta and in zone of cardiac apex. Changes of electric potential on body in time are registered in form of diagram of ECG function. Near each electrode of ECG electric potential registration additional electrode is installed, onto which high-frequency signal from generator is supplied, and from electrodes of ECG electric potential registration modulated by fluctuations of arterial blood flow signal is obtained synchronously, said signal is amplified, converted into digital code and transmitted for rheogram registration to information processing unit, after which connection of ECG electric potential with change of pressure according to rheogram is connected in each phase, and phase peculiarities of arterial pressure change are diagnosed. Device for synchronous registration of rheogram from ECG electrodes consists of two ECG electrodes, commutator, first amplifier, first band filter, analogue-digital converter, controller, IR transmitter and information processing unit with first detector, commutator being inserted between electrodes and first amplifier, whose outlet through band filter is connected with first inlet of analogue-digital converter, whose outlet is joined to controller, whose first outlet is connected with commutator, and second outlet - with IR transmitter, connected with first detector of information processing unit. Two additional electrodes, second amplifier, second band filter, second detector and generator, switched to additional electrodes, are introduced into it, second commutator outlet is connected to inlet of second detector, whose output through second amplifier and second band filter is connected with second inlet of analogue-digital converter.

EFFECT: synchronous registration of phase characteristics of cardiac cycle and corresponding fluctuations of arterial pressure in heart vessels and aorta.

2 cl, 3 dwg

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to devices of medico-biological purpose, intended for registration and evaluation of fast-proceeding physiological reactions, emerging as response to produced stimuli. Device contains microcontroller, analogue-digital converter (ADC), first commutator, sensors of breast breathing, abdominal breathing, skin-galvanic response, arterial pressure, cardio-vascular activity, sensor of motor activity, power unit, preliminary amplifiers, signal amplifiers, filters, first and second digital-analogue converters (DAC), tool amplifier and unit of connection with personal computer, supplied with galvanic attenuator. Via amplifiers and filters sensors are connected with corresponding inputs of commutator whose controlling input is connected with first microcontroller bus, and output - with first input of tool amplifier. Second input of tool amplifier is connected to output of first DAC, third input - to output of second DAC, and output - to ADC input. Inputs of first and second DAC and group of inputs-outputs of ADC are connected with second microcontroller bus, whose third bus is connected to unit of connection with personal computer. Additional channel has possibility of connection to its input of face mimics sensor, piezoplethysmogram or variable component of skin-galvanic response and includes second electronic commutator, to whose outputs subchannels of processing of signals from corresponding sensor are connected. First subchannel includes successively connected preliminary amplifier and filter, second subchannel - preliminary amplifier, filter, signal amplifier and additional filter, and outputs of subchannels via third electronic commutator are connected to first commutator input. Controlling input of third commutator is connected with microcontroller.

EFFECT: registration of maximal number of physiological parametres and ensuring objectivity of obtained information.

2 cl, 2 dwg

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