Electrode state determination method, apparatus, device, and system

Abstract

The application discloses an electrode state determination method, device, electronic equipment and system. The method comprises the following steps: acquiring voltage signals of a plurality of measurement electrode groups, each of the measurement electrode groups comprising at least two electrodes in a multi-electrode catheter, and the voltage signals being signals obtained by voltage measurement on the measurement electrode groups; determining complex impedances of each of the measurement electrode groups based on the voltage signals of each of the measurement electrode groups; and determining target states of each of the electrodes in the multi-electrode catheter based on the complex impedances of the plurality of measurement electrode groups, wherein the target states comprise adhering to tissue and not adhering to tissue.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a method, device and system for determining electrode state. Background Technology

[0002] Pulse field ablation (PFA) technology uses electrodes on a catheter to precisely release high-voltage, microsecond / nanosecond-level pulsed electric fields, creating "irreversible electroporation" of cardiomyocytes. Its advantages, such as tissue specificity and non-thermal ablation, have led to its application in atrial fibrillation ablation. However, during ablation, poor electrode-tissue adhesion can result in insufficient ablation depth and imperfect transmural penetration, leading to treatment failure or recurrence. Therefore, ensuring proper electrode-tissue adhesion is a crucial issue that needs to be addressed. Summary of the Invention

[0003] Some embodiments of this application provide a method for determining electrode states, including: Acquire voltage signals from multiple measurement electrode groups, each of which includes at least two electrodes in a multi-electrode conduit, and the voltage signals are obtained by measuring the voltage of the measurement electrode groups. The complex impedance of each of the measuring electrode groups is determined based on the voltage signal of each measuring electrode group; Based on the complex impedance of the multiple measuring electrode groups, the target state of each electrode in the multi-electrode catheter is determined, and the target state includes tissue contact and non-tissue contact.

[0004] Some embodiments of this application also provide a control device, which includes: An acquisition unit is used to acquire voltage signals from multiple measurement electrode groups, each of the measurement electrode groups including at least two electrodes in a multi-electrode conduit, and the voltage signal is a signal obtained by measuring the voltage of the measurement voltage group. The first determining unit is configured to determine the complex impedance of each of the measuring electrode groups based on the voltage signal of each measuring electrode group. The first determining unit is used to determine the target state of each electrode in the multi-electrode catheter based on the complex impedance of the plurality of measuring electrode groups, wherein the target state includes tissue contact and non-tissue contact.

[0005] Some embodiments of this application also provide an electronic device, including an excitation device, a measuring device, and a control device; A control device is used to send an excitation control signal to an excitation device and a measurement control signal to a measurement device for each of a plurality of measurement electrode groups, wherein each measurement electrode group includes at least two electrodes in a multi-electrode conduit; An excitation device is used to receive excitation control signals and generate excitation signals, which are then output to the measuring electrode group. The measuring device is used to receive a measuring control signal, measure the voltage of the measuring electrode group to obtain a voltage signal, and send a voltage signal to the electrode state determination device. The control device is also used to receive voltage signals and determine the complex impedance of the measuring electrode group based on the voltage signals corresponding to the measuring electrode group; The control device is also used to determine the target state of each electrode in the multi-electrode catheter based on the complex impedance of multiple measuring electrode groups. The target state includes tissue contact and non-tissue contact.

[0006] Some embodiments of this application also provide an electrode state determination system, including: a multi-electrode conduit and the control device described above.

[0007] The electrode state determination method, apparatus, electronic device, and system provided in this application acquire voltage signals from multiple measurement electrode groups, each measurement electrode group including at least two electrodes in a multi-electrode conduit. The voltage signals are obtained by measuring the voltage of the measurement electrode groups. The method determines the complex impedance of each measurement electrode group based on its voltage signal. Based on the complex impedance of the multiple measurement electrode groups, the method determines the target state of each electrode in the multi-electrode conduit. Thus, by considering the complex impedance of multiple measurement electrode groups to determine the state of each electrode in the multi-electrode conduit, the method achieves a global perspective in electrode state determination. This helps avoid errors caused by judging the electrode state based on the complex impedance of a single measurement electrode group, thereby improving the accuracy of electrode state determination. Attached Figure Description

[0008] Figure 1 A flowchart illustrating an electrode state determination method provided in some embodiments of this application; Figure 2 A schematic diagram of the distribution of adjacent electrodes provided for some embodiments of this application; Figure 3 A schematic diagram of the structure of a control device provided in some embodiments of this application. Figure 4 This application provides a schematic diagram of the structure of an electronic device according to some embodiments; Figure 5 This application provides a schematic diagram of the structure of another electronic device according to some embodiments; Figure 6 This application provides a schematic diagram of the structure of a switching array according to some embodiments; Figure 7 A schematic diagram of the structure of an electrode state determination system provided in some embodiments of this application; Figure 8 A schematic diagram of a conduit electrode state determination system based on matrix switching and time-division multiplexing is provided as an application example of this application. Figure 9 A flowchart illustrating an impedance measurement method for determining catheter electrode contact based on matrix switching and time-division multiplexing, provided as an application example of this application; Figure 10 A schematic diagram of a standard bipolar measurement mode is provided as an application example of this application; Figure 11 A schematic diagram of the timing structure of a time-division multiplexing scan is provided as an application example of this application; Figure 12 A structural schematic diagram of a fine measurement mode provided as an application example of this application. Detailed Implementation

[0009] It should be understood that the examples and illustrations in this application are for illustrative purposes, and deviations and variations can be constructed and deployed based on the teachings of this application without departing from the scope of this application. Before detailing at least one embodiment of this application, it should be understood that this application is not necessarily limited to the detailed configuration and arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or embodiments. This application can have other embodiments or can be practiced or implemented in different ways.

[0010] Unless otherwise defined, all technical and / or scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. While similar or equivalent methods and materials to those described in this application may be used to practice or test embodiments of this application, exemplary methods and / or materials are described below. In the event of any conflict, the specification (including definitions) of this application shall prevail. Furthermore, these materials, methods, and embodiments are illustrative only and are not intended to impose necessary limitations.

[0011] In the description of this application, unless otherwise expressly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances. Furthermore, the terms "first," "second," etc., are used merely for descriptive distinction and have no special meaning.

[0012] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0013] In related technologies, the following methods are typically used to determine the state of electrodes in intracardiac catheters (i.e., whether the electrodes are in contact with tissue): The first approach, subjective judgment and indirect indicators, refers to the following: relevant staff (such as doctors) rely on the tactile feedback transmitted from the catheter to the handle, combined with the movement of the catheter tip under X-ray fluoroscopy (the degree of bending with the heartbeat), and the amplitude changes of surface electrocardiogram or intracardiac electrocardiogram to judge the state of the electrodes in the catheter; however, this approach is highly dependent on the doctor's experience and is highly subjective; moreover, the amplitude of intracardiac electrocardiogram is greatly affected by the degree of tissue health, which is prone to misjudgment. The second approach, direct sensing technology, involves integrating a miniature physical sensor at the tip of the catheter to directly measure the pressure applied to the electrodes, thereby determining the electrode state based on the pressure measurement results. Specifically, the miniature physical sensor may include one or more of the following (one or more can also be understood as at least one): Pressure sensor or strain gauge: Utilizing the deformation of the spring coil between the tip of the conduit and the shaft, combined with the minute displacement measured by the magnetic positioning coil, pressure data is calculated, which can be used to determine the state of the electrodes; Fiber Bragg grating sensor: It uses the principle that the wavelength of an optical fiber shifts when it is under pressure to measure the contact pressure between the electrode and the tissue. The contact pressure measurement results can be used to determine the state of the electrode. Temperature sensor: By measuring the temperature data of the electrodes in the conduit, the changes in temperature data (such as response speed) can be used to determine the state of the electrodes (such as slow heat dissipation when in close contact).

[0014] However, solutions using direct sensing technology suffer from high costs, complex manufacturing processes, precision sensors, low assembly yields, and extremely high expenses. Furthermore, sensors occupy additional space, making them difficult to apply to every electrode in high-density mapping catheters or ablation basket catheters; and miniature physical sensors are primarily sensitive to axial pressure, with relatively weak accuracy in determining electrode status through lateral contact pressure.

[0015] As can be seen from the above description, there is an urgent need for an electrode state determination scheme that can meet the requirements for electrode state determination.

[0016] At least one embodiment of this application provides an electrode state determination method, applied to a control device, such as... Figure 1 As shown, it includes: Step 101: Acquire voltage signals from multiple measurement electrode groups.

[0017] Step 102: Determine the complex impedance of each of the measuring electrode groups based on the voltage signal of each measuring electrode group; Step 103: Based on the complex impedance of the plurality of measuring electrode groups, determine the target state of each electrode in the multi-electrode catheter, the target state including tissue contact and non-tissue contact.

[0018] The multi-electrode catheter may be a mapping catheter or an ablation catheter, etc., and this application does not limit the type of catheter. The distal end of the multi-electrode catheter is provided with multiple electrodes, and the number of electrodes N can be 10, 12, 32, 64 or 128, etc., and this application does not limit the type of electrode catheter.

[0019] In one possible implementation, the multi-electrode catheter can also be understood as a high-density catheter, etc. The multi-electrode catheter can be basket-shaped, star-shaped, or balloon-shaped. In the case of a basket-shaped or star-shaped multi-electrode catheter, the multi-electrode catheter may contain one or more splines, each spline containing at least two electrodes. In the case of a balloon-shaped multi-electrode catheter, the electrodes can be placed on the balloon, and there are multiple rows of electrodes on the balloon, each row containing at least two electrodes.

[0020] Because tissue impedance and environmental impedance (i.e., the impedance of the environment in which the electrode is located when it is not in contact with tissue) often differ—for example, in cardiac ablation, the impedance of myocardial tissue is significantly higher than that of blood—the target state of the electrode can be determined using software methods based on impedance information (such as complex impedance) between electrodes in a multi-electrode catheter. The target state includes whether the electrode is in contact with or not in contact with tissue. This eliminates the need for physical pressure sensors, thus requiring no additional hardware costs. Standard catheters can be used directly, and accurate determination of the electrode state can be achieved through system upgrades.

[0021] In one possible implementation, during the electrode state determination process, the multiple electrodes in the multi-electrode conduit can be divided into multiple measurement electrode groups. By measuring the voltage signal of each measurement electrode group, the complex impedance of the measurement electrode group is determined, thereby obtaining the target state of each electrode in the multi-electrode conduit. In some embodiments, each measurement electrode group contains at least two electrodes, and any two electrodes on the multi-electrode conduit can constitute a measurement electrode group. The same electrode may exist in different measurement electrode groups.

[0022] In at least one embodiment, the selection of electrodes in the measuring electrode group satisfies one or more of the following: Based on the distance between the electrodes; Depending on the spline where the electrodes are located, a multi-electrode conduit contains one or more splines, and each spline contains at least two electrodes.

[0023] The distance between electrodes in a multi-electrode conduit refers to the physical distance between electrodes. Specifically, it can be determined by combining the physical structure of the multi-electrode conduit 110 with the Euclidean distance formula. For example, for each electrode, it can be grouped with adjacent electrodes within a preset distance as a measurement electrode group.

[0024] In a multi-electrode conduit, the spline where the electrode is located refers to the spline to which the electrode belongs. The measurement electrode group can include any two or more electrode combinations such as adjacent electrodes on the same spline, non-adjacent electrodes on the same spline, adjacent electrodes on different splines, and non-adjacent electrodes on different splines, in order to adapt to different measurement needs.

[0025] By dividing the measurement electrode groups, it is possible to set the measurement electrode groups according to actual needs. For example, when a multi-electrode conduit contains multiple splines, and each spline contains at least two electrodes, at least two electrodes located on different splines can be used as a measurement electrode group, or at least two electrodes located on the same spline can be used as a measurement electrode group, which is beneficial to meet flexible measurement needs.

[0026] In at least one embodiment, the complex impedance of each of the measuring electrode groups is determined based on the voltage signal of each measuring electrode group: The voltage signal is quadrature demodulated to obtain the demodulation result; Acquire excitation signal parameters, which are used to generate an excitation signal output to the measuring electrode group; Based on the demodulation results and the excitation signal parameters, the complex impedance of the measuring electrode group is determined.

[0027] In some implementations, the excitation signal parameters may include at least one of frequency, amplitude, and phase.

[0028] Using digital quadrature demodulation (also known as coherent demodulation) technology to determine complex impedance has the advantages of high anti-interference capability and high accuracy, with low error. It can obtain accurate complex impedance values, which helps to improve the accuracy of subsequent processing (such as determining the contact status).

[0029] In at least one embodiment, determining the state of the measuring electrode group based on the complex impedance of the measuring electrode group includes: For each measuring electrode group, the state of the measuring electrode group is determined based on the complex impedance of the measuring electrode group; For each electrode in the multi-electrode conduit, the measurement electrode group containing the electrode in the plurality of measurement electrode groups is determined as the verification electrode group; Based on the state of the verification electrode group, the target state of the electrode is determined.

[0030] In one possible implementation, the state of each set of verification electrodes can include one of the following: In the context of contact, the state of all electrodes in the verification electrode set can be considered to include contact (which can also be understood as good contact between the electrode and the tissue). Critical contact state: In this case, it can be assumed that the state of all electrodes in the verification electrode set includes the critical contact state (which can also be understood as unstable contact between the electrode and the tissue). In the case of non-attached state, it can be assumed that the state of all electrodes in the verification electrode set includes the non-attached state (which can also be understood as the non-attachment between the electrode and the tissue).

[0031] In at least one embodiment, an electrode in a contacting state has better contact with the target tissue than an electrode in a critically contacting state (intermediate state). For an electrode in a critically contacting state, its contact with the target tissue is better than that of an electrode in a non-contacting state; therefore, the critically contacting state is between the contacting state and the non-contacting state. Thus, the states of the electrode assembly are arranged in descending order of contact condition: contacting state, critically contacting state, and non-contacting state.

[0032] When dividing electrode measurement groups, it is possible that a certain electrode belongs to at least two measurement electrode groups simultaneously. Therefore, for each electrode, the measurement electrode group including that electrode is determined as a verification electrode group. For example, in the determination of independent measurements of at least two measurement electrode groups, at least two different states are obtained, namely, contact state, critical contact state, and non-contact state. Therefore, when determining the target state of each electrode, by considering the states of all verification electrode groups including that electrode, the accuracy of the obtained electrode target state can be improved. This helps to avoid the error in determining the electrode target state (or misjudgment of the target state) caused by the measurement deviation (such as measurement error) of a single measurement electrode group.

[0033] In at least one embodiment, determining the state of the measuring electrode group based on the complex impedance of the measuring electrode group includes: Obtain the baseline value of the measuring electrode group; The amplitude of the complex impedance is determined based on the complex impedance of the measuring electrode group; Determine the difference between the baseline value and the complex impedance amplitude; If the difference is greater than the first value, it is determined that the measuring electrode group is in contact. If the difference is less than or equal to the first value and the difference is greater than the second value, the measuring electrode group is determined to be in a critical contact state. If the difference is less than or equal to the second value, it is determined that the measuring electrode group is in a non-contact state.

[0034] In some implementations, the baseline value is a pre-calibrated reference impedance value stored in the storage unit of the control device, which can be obtained through pre-calibration. For example, in a simulated solution similar to the electrical characteristics of human blood, the reference impedance values ​​of electrode pairs with different electrode spacings and areas can be measured when the electrode pairs are fully immersed in the solution environment. For example, when multiple initial measurement electrode groups are predetermined, the pre-calibration described above is performed on each initial measurement electrode group to determine the reference impedance value for each initial measurement electrode group.

[0035] In some implementations, the difference between the baseline value and the complex impedance amplitude can intuitively reflect the degree of deviation of the current measuring electrode group's measuring impedance from the baseline value. The larger the difference, the more sufficient the contact between the electrodes in the measuring electrode group and the target tissue.

[0036] In some implementations, the control device has a first value and a second value preset internally, wherein the first value is greater than the second value. The first value and the second value together constitute three consecutive judgment intervals, namely a first judgment interval with the first value as the lower boundary, a second judgment interval with the first value as the upper boundary and the second value as the lower boundary, and a third judgment interval with the second value as the upper boundary.

[0037] In some implementations, during intracardiac electrophysiological mapping using a multi-electrode catheter, after the multi-electrode catheter enters the heart chamber but before contacting the myocardial tissue, the baseline values ​​of the blood environment of all measurement electrode groups can be obtained by scanning. Then, combined with a preset impedance rise ratio, the first and second values ​​corresponding to each measurement electrode group can be automatically calculated and generated.

[0038] In some implementations, the first value can be set to any value in the range of 9Ω (ohms) to 25Ω, and the second value can be set to any value in the range of 3Ω to 8Ω.

[0039] In some implementations, differentiated first and second values ​​can be set for measurement electrode groups with different structures. For example, a measurement electrode group consisting of two adjacent electrodes on the same spline or in the same column has a smaller electrode spacing and a lower baseline value; a measurement electrode group consisting of electrodes at corresponding positions on adjacent splines has a larger electrode spacing and a higher baseline value. Therefore, the first value of the measurement electrode group corresponding to adjacent splines can be greater than the first value of the measurement electrode group corresponding to the same spline, and the second value of the measurement electrode group corresponding to adjacent splines can be greater than the second value of the measurement electrode group corresponding to the same spline. By setting differentiated first and second values, it is beneficial to eliminate the influence of electrode structure differences on the judgment results and ensure that the judgment criteria for different electrode combinations are adapted to their own electrical characteristics.

[0040] In some implementations, the control device determines the state of the measuring electrode group based on the judgment interval into which the difference between the complex impedance amplitude and the baseline value falls.

[0041] For example, when the difference falls within the first judgment interval, it indicates that the complex impedance amplitude of the current measuring electrode group is significantly higher than the baseline value, a stable and sufficient physical contact has been formed between the electrode and the target tissue, and the current transmission path mainly passes through the target tissue rather than blood. The control device determines that the intermediate state of each electrode in the measuring electrode group is the contact state. The contact state means that the electrode can stably acquire the electrical signal of the target tissue, providing a reliable contact basis for mapping or ablation.

[0042] For example, when the difference falls within the second judgment interval, it indicates that the complex impedance amplitude of the current measuring electrode group is higher than the baseline value, but has not yet reached a stable contact level. The electrode may be in a state of slight contact, intermittent contact, or close to the tissue but not in complete contact. The control device determines that the intermediate state of each electrode in the measuring electrode group is a critical contact state. The critical contact state serves as an intermediate transition state to mark electrodes with unclear contact conditions that require further verification and confirmation, which helps to avoid affecting subsequent treatment operations due to ambiguous judgments.

[0043] For example, when the difference falls into the third judgment interval, it indicates that the complex impedance amplitude of the current measuring electrode group is basically consistent with the baseline value, the electrode is completely immersed in the blood, and no effective physical contact is formed with the target tissue. The control device determines that the intermediate state of each electrode in the initial measuring electrode group is a non-contact state. The non-contact state means that the electrode cannot effectively collect the electrical signal of the target tissue, nor can it reliably transmit ablation energy.

[0044] By dividing the impedance difference into three intervals and corresponding to three intermediate states, the contact between the electrode and the target tissue can be precisely differentiated. This helps identify suspicious contact areas, improves the overall accuracy of contact judgment, and reduces the possibility of false positives and false negatives.

[0045] In at least one embodiment, determining the target state of the electrodes based on the state of the verification electrode group includes: Based on the state of the verification electrode group, the intermediate states of the electrode are determined, including the contact state, the critical contact state, and the non-contact state. If the intermediate state is a critical contact state or a non-contact state, the state of the electrode is checked to obtain the target state of the electrode; When the intermediate state is the contact state, the target state of the electrode is determined to be the contact state with the tissue.

[0046] In at least one embodiment, the method further includes: The worst state among the states of the verification electrode group is determined as the intermediate state of the electrode; The states of the verification electrode group are arranged in order from best to worst as follows: in contact state, critically in contact state, and not in contact state.

[0047] In some implementations, for each electrode, if its state in the verification electrode group does not include a non-contact state but includes at least one critical contact state, the control device determines the intermediate state of that electrode as a critical contact state. For example, if an electrode belongs to two measurement electrode groups simultaneously, and in the determinations of the two independent measurements, two different states are obtained: a contact state and a critical contact state, then the control device determines the intermediate state of that electrode as a critical contact state. This processing method can accurately filter out electrodes with ambiguous contact conditions, without directly determining such electrodes as contact states, but retaining their critical contact attributes. This facilitates subsequent verification of electrodes with ambiguous contact conditions, helping to further improve the rigor and accuracy of contact condition identification.

[0048] In some implementations, an electrode is included in at least two measuring electrode groups, but is determined to be in the same state in each of its respective measuring electrode groups. In this case, the control device directly determines the state of one of the measuring electrode groups as the intermediate state of the electrode. For example, if an electrode belongs to three measuring electrode groups, and in the determination of three independent measurements, all measuring electrode groups are in a contact state, then the control device determines the intermediate state of the electrode as the contact state.

[0049] By identifying different measurement electrode groups containing the same electrode, the logical conflict problem of multiple judgment results due to multiple independent measurements of the same electrode is resolved. This ensures that each electrode on the multi-electrode conduit can ultimately obtain a definite intermediate state, providing a data foundation for the subsequent process of determining the final target state of the electrode based on the intermediate state.

[0050] In some embodiments, the above-described process for determining the intermediate state of the electrode can also be understood as a coarse measurement or a standard bipolar measurement, etc., and this application does not limit it in this way.

[0051] In one possible implementation, in order to more accurately determine whether each critical contact electrode (which can also be understood as an electrode in the intermediate state of critical contact) is in contact with the tissue, a more refined measurement method can be used to make a more accurate judgment on the contact state between the critical contact electrode and the tissue, that is, to determine whether the target state of the critical contact electrode is in contact or not in contact.

[0052] In at least one embodiment, verifying the state of the electrode to obtain a target state of the electrode includes: When the intermediate state of the electrode is a critical contact state, at least three adjacent electrodes adjacent to the electrode are identified. Based on the electrode and the at least three adjacent electrodes, a fine measurement electrode group and an excitation electrode group are determined, wherein the excitation electrode group includes at least one of the electrode and the at least three adjacent electrodes, and the fine measurement electrode group includes at least two of the at least three adjacent electrodes, and the excitation electrode group and the measurement electrode group include different electrodes; The complex impedance of the fine measurement electrode group is obtained, and the target state of the electrode is determined based on the complex impedance of the fine measurement electrode group.

[0053] In one possible implementation, such as Figure 2 As shown, for each electrode in the intermediate state of critical contact state ( Figure 2 The electrode in the dashed circle (referring to the electrode in the diagram) is used to determine the fine measurement electrode group and the excitation electrode group when there are many adjacent electrodes (e.g., more than three). The control device selects at least three adjacent electrodes from all adjacent electrodes according to a preset rule, and determines these based on the selected at least three adjacent electrodes and the electrode itself. The measuring device connects to the fine measurement electrode group (i.e., the electrode group for the measured voltage signal), and the excitation device connects to the excitation electrode group (i.e., the electrode group used to form the excitation circuit). After the electrodes in the excitation electrode group receive the excitation signal, the control device measures the voltage across the fine measurement electrode group using the measuring device to obtain the voltage signal, and then derives the complex impedance based on this voltage signal.

[0054] When the excitation electrode group includes this electrode, if the excitation electrode group is in contact with the tissue, the impedance is greater than that of blood. Therefore, the excitation electrode group exhibits a high impedance characteristic, which increases the electric field between the excitation electrode groups and thus increases the voltage of the measuring electrode group. Therefore, if the difference between the complex impedance between the measuring electrode groups and the baseline impedance is greater than a preset value, it indicates that the electrodes in the excitation electrode group are in contact; otherwise, they are not in contact. For example, the preset value can be any value from 3 to 8 Ω.

[0055] In some implementations, the excitation electrode group and the fine measurement electrode group include different electrodes, so that the voltage signal obtained after voltage measurement of the fine measurement electrode group is independent of the voltage drop flowing through the leads of the excitation electrode group (i.e., independent of the voltage drop caused by the excitation circuit). This eliminates the influence of the resistance of long wires and the contact between the electrodes and the tissue on the measurement results, and helps to ensure that the measured complex impedance purely reflects whether the excitation electrode group is in contact with the tissue, thereby significantly improving the measurement accuracy.

[0056] In some implementations, the preset rule for selecting at least three adjacent electrodes may include: selecting at least three adjacent electrodes according to a predetermined distance order (e.g., from closest to furthest), with any two adjacent electrodes also being adjacent; or, selecting at least three adjacent electrodes based on the intermediate state of each adjacent electrode, with any two adjacent electrodes also being adjacent. Since if any two of the adjacent electrodes are not adjacent, resulting in a large distance between the electrodes in the fine measurement electrode group and the excitation electrode group, the detected complex impedance of the fine measurement electrode group may be affected by other electrodes or noise.

[0057] In some possible implementations, the control device may determine the adjacent electrodes of each electrode in the multi-electrode conduit by: acquiring the adjacent electrodes of each electrode predetermined according to the structure of the multi-electrode conduit, or by determining the adjacent electrodes of each electrode based on relevant information of the multi-electrode conduit (such as spatial position information of each electrode). This application embodiment does not limit this.

[0058] In one possible implementation, after determining the fine measurement electrode group and excitation electrode group corresponding to the electrode whose intermediate state is a critical contact state, the method further includes: The excitation control signal is sent to the excitation device, the measurement control signal is sent to the measuring device, and the switching control signal is sent to the switching device. The excitation control signal is used to output the excitation signal from the excitation device to the excitation electrode group, and the measurement control signal is used to instruct the measuring device to perform voltage measurement on the fine measuring electrode group to obtain the voltage signal. The complex impedance of the finely measured electrode group is obtained, and based on the complex impedance of the finely measured electrode group, the target state of the electrode with the intermediate state being the critical contact state is determined.

[0059] More precise measurements using electrodes in the intermediate state of critical contact help to accurately determine whether the electrode is in a contact state or not (i.e., accurately determine the target state of the critical contact electrode), thereby helping to improve the accuracy of operations based on the contact state of the electrode (such as ablation operations).

[0060] In at least one embodiment, verifying the state of the electrode to obtain a target state of the electrode includes: When the intermediate state of the electrode is an unattached state, the target state of the adjacent electrode is obtained; The target state of the electrode is determined based on the target state of the adjacent electrodes.

[0061] In some embodiments, an electrode in the intermediate state of not being attached can also be understood as an electrode not being attached.

[0062] For each non-attached electrode, the control device determines the corresponding adjacent electrode. An adjacent electrode refers to all electrodes whose spatial distance from the non-attached electrode is less than or equal to a preset distance threshold. The preset distance threshold can be adaptively set according to the electrode arrangement density and electrode spacing of the multi-electrode conduit. For example, the preset distance threshold can be set as the center-to-center distance between two adjacent electrodes on the same strip, thereby ensuring that adjacent electrodes and non-attached electrodes are located in the same local area of ​​the target tissue, and that the contact between adjacent electrodes and the target tissue has strong reference value.

[0063] In some implementations, the target states of adjacent electrodes are all deterministic states that have already been determined, including both contacting and non-contacting tissues. For electrodes whose intermediate state is contacting tissue, the control device directly determines that the target state of the electrode is contacting tissue. For electrodes whose intermediate state is a critical contacting state, the control device has completed the final determination of the target state through a verification stage.

[0064] For example, the endocardium is a continuous curved structure, and the electrodes on a multi-electrode catheter are typically arranged in a high-density, small-spaced configuration. If all the surrounding electrodes of a particular electrode are stably attached to the myocardial tissue, the probability of that electrode being completely detached and not in contact with the myocardium is extremely low. The initial determination of this electrode's non-attachment state is likely due to measurement deviations caused by accidental factors such as momentary swaying of the multi-electrode catheter or electrical signal interference. Conversely, if most of the surrounding electrodes of a particular electrode are not in contact with the myocardium, the initial determination of this electrode's non-attachment state will have a higher degree of agreement with the actual situation.

[0065] By using the target state of adjacent electrodes for logical correction, random measurement errors in the initial testing stage can be effectively filtered out, avoiding results that do not conform to clinical reality, such as "all surrounding electrodes are stably attached, but only a single electrode is judged to be not attached", thus achieving accurate identification of the contact between the electrode and the target tissue.

[0066] In at least one embodiment, if the target state of the adjacent electrodes satisfies the contact condition, the target state of the electrodes is determined to be in contact with tissue; wherein the contact condition includes one or more of the following: The target state of the adjacent electrodes is that they are in contact with tissue; The number of electrodes in the adjacent electrodes whose target state is in contact with tissue is greater than the number of electrodes whose target state is not in contact with tissue. The distance between the electrode and the adjacent electrode whose target state is not in contact with the tissue is greater than the distance between the electrode and the adjacent electrode whose target state is in contact with the tissue.

[0067] In some implementations, the control device performs a statistical analysis of the target states of all adjacent electrodes corresponding to the non-attached electrode, determines the number of electrodes whose target state is attached to the tissue, and the number of electrodes whose target state is not attached to the tissue.

[0068] In some embodiments, as a first correction rule, the control device determines that the target state of a non-attached electrode is attached to tissue when the number of adjacent electrodes whose target state is attached to tissue is greater than the number of adjacent electrodes whose target state is not attached to tissue. For example, if a non-attached electrode has a total of 6 adjacent electrodes, with 4 adjacent electrodes whose target state is attached to tissue and 2 adjacent electrodes whose target state is not attached to tissue, the control device 100 can correct the target state of the non-attached electrode to be attached to tissue. If the non-attached electrode has a total of 5 adjacent electrodes, with 2 attached to tissue and 3 not attached to tissue, the control device 100 will not correct the target state of the non-attached electrode to be attached to tissue.

[0069] In some implementations, the control device also calculates the spatial distance between the non-attached electrode and all adjacent electrodes, and identifies the adjacent electrode that is spatially closest to the non-attached electrode.

[0070] In some embodiments, as a second correction rule, the control device determines the target state of the non-attached electrode as attached tissue when the target state of the adjacent electrode closest to the non-attached electrode in spatial distance is attached tissue. For example, spline 5 includes electrode 1, electrode 2, and electrode 3. The adjacent electrodes of electrode 2 are only electrode 1 and electrode 3, and the spatial distance between electrode 2 and electrode 1 is less than the spatial distance between electrode 2 and electrode 3. If electrode 2 is a non-attached electrode, and the target state of electrode 1 is attached tissue, then regardless of the target state of electrode 3, the target state of electrode 2 is determined to be attached tissue.

[0071] In some implementations, the control device can determine the target state of the non-attached electrode solely based on the first correction rule, or solely based on the second correction rule, or simultaneously based on both rules, thus adapting to different measurement scenarios. For example, for high-density mapping conduits with 64 or more electrodes, where the electrode arrangement is dense and the number of adjacent electrodes is large, the first correction rule can be prioritized to quickly complete the target state correction; for large basket conduits with larger electrode spacing and fewer adjacent electrodes, the second correction rule can be prioritized to ensure the accuracy of the target state correction.

[0072] By using the first and second correction rules, the overall adhesion of the local area of ​​the non-adhesive electrode and the strong reference of the nearest electrode are taken into account. This can effectively filter out misjudgments caused by random errors in the initial measurement stage, and also help avoid contact identification errors caused by over-correction, thereby further improving the accuracy of the final determination result of the electrode target state.

[0073] In some embodiments, when multi-electrode catheters are used in high-voltage ablation scenarios, measurement protection may be challenging. Specifically, in high-voltage ablation scenarios, the catheter electrodes carry high voltage energy. Since impedance measurement circuits typically operate at the microvolt or millivolt level, bulky isolation transformers, high-order filters, or relays are usually required to prevent the measurement circuit from burning out during ablation, inevitably increasing the circuit board area. Furthermore, the introduced filtering often causes phase delay, affecting the accuracy of algorithms based on phase analysis of electrode states.

[0074] In some embodiments, at least one embodiment of this application also provides a schematic diagram of the structure of a control device, such as... Figure 3 As shown, the control device includes: an acquisition unit for acquiring voltage signals of multiple measurement electrode groups, each of the measurement electrode groups including at least two electrodes in a multi-electrode conduit, and the voltage signal being a signal obtained by measuring the voltage of the measurement voltage group; The first determining unit is configured to determine the complex impedance of each of the measuring electrode groups based on the voltage signal of each measuring electrode group. The second determining unit is used to determine the target state of each electrode in the multi-electrode catheter based on the complex impedance of the plurality of measuring electrode groups, wherein the target state includes tissue contact and non-tissue contact.

[0075] This control device and the above-mentioned electrode state determination method belong to the same inventive concept. For details of its implementation process, please refer to the method embodiment, which will not be repeated here.

[0076] In some embodiments, at least one embodiment of this application also provides an electronic device, such as... Figure 4 As shown, the device includes: A control device is used to send an excitation control signal to an excitation device and a measurement control signal to a measurement device for each of a plurality of measurement electrode groups, wherein each measurement electrode group includes at least two electrodes in a multi-electrode conduit; An excitation device is used to receive excitation control signals and generate excitation signals, which are then output to the measuring electrode group. The measuring device is used to receive a measuring control signal, measure the voltage of the measuring electrode group to obtain a voltage signal, and send a voltage signal to the electrode state determination device. The control device is also used to receive voltage signals and determine the complex impedance of the measuring electrode group based on the voltage signals corresponding to the measuring electrode group; The control device is also used to determine the target state of each electrode in the multi-electrode catheter based on the complex impedance of multiple measuring electrode groups. The target state includes tissue contact and non-tissue contact.

[0077] In some implementations, the control device, based on an electrode scan list, can measure the voltage signal of each measurement electrode group in a time-division multiplexed manner using an excitation device and a measurement device. This helps ensure that the same excitation source and measurement hardware are used in determining the voltage signal of each measurement electrode group.

[0078] In one possible implementation, when measuring the voltage signals of different measurement electrode groups, the connection relationship between the excitation device, the measuring device and the electrode measurement group can be adjusted to ensure that the excitation signal output by the excitation device can form a loop between the electrodes contained in the new measurement electrode group, and to ensure that the measuring device can accurately measure the voltage signals between the electrodes in the new measurement electrode group.

[0079] In at least one embodiment, when determining the complex impedance between each electrode, the excitation signal output by the excitation device is used as the excitation source, ensuring that the excitation sources corresponding to the current loops are completely identical; furthermore, a measuring device is used to measure the voltage signal, ensuring that the measurement hardware corresponding to different measurement electrode groups is completely identical. Thus, at the physical level, the relative gain error and phase drift that may exist when measuring voltage signals for different measurement electrode groups are completely eliminated. Without the need for complex factory pairing calibration or real-time self-calibration algorithms, the consistency of environmental factors during voltage signal measurement can be guaranteed. Consequently, the accuracy of the complex impedance obtained based on the voltage signal is high, enabling more accurate determination of electrode states.

[0080] In some embodiments, for each measuring electrode group, the control device controls the excitation device to generate an excitation signal through an excitation control signal and outputs it to the measuring electrode group. In this way, a current loop (or excitation loop) can be formed between the electrodes of the measuring electrode group to generate a voltage between the electrodes of the measuring electrode group. The measurement control signal controls the measuring device to measure the voltage between the electrodes of the measuring electrode group, and the complex impedance of the measuring electrode group is determined based on the measurement result fed back by the measuring device.

[0081] In at least one embodiment, the control device is further configured to: After a preset duration for sending the excitation control signal, a measurement control signal is sent.

[0082] During the process of the excitation device outputting an excitation signal to form a current loop between the excitation device and the measuring electrode group, there may be a certain period of circuit oscillation, which may cause the voltage between the electrodes in the measuring electrode group to be unstable, affecting the accuracy of the voltage signal measured by the measuring device. Therefore, by waiting for a preset time, the stability of the analog signal chain when the measuring device performs voltage signal measurement can be ensured, which is beneficial to improving the measurement accuracy.

[0083] In some implementations, the excitation device may also be a current excitation device or a current excitation source, etc.; the output port of the excitation device may include a positive output terminal and a negative output terminal.

[0084] In one possible implementation, the excitation device is configured to generate an adjustable-frequency, constant-amplitude excitation signal (which can also be understood as an AC excitation signal or an excitation current signal, etc.) according to an excitation control signal sent by a control device. This excitation signal is then output to the measuring electrode group via its positive output terminal (which can also be understood as the positive terminal of the excitation source) and received from its negative output terminal (which can also be understood as the negative terminal of the excitation source), thereby forming a signal loop between the excitation device and the measuring electrode group. Therefore, in this case, the current flow in the excitation current loop can be described as: positive output terminal, electrode in the measuring electrode group connected to the positive output terminal, electrode in the measuring electrode group connected to the negative output terminal, and negative output terminal.

[0085] In some implementations, the excitation control signal may carry at least one of amplitude, frequency, and phase information. The excitation control signal is used to instruct the excitation device to generate an excitation signal based on at least one of amplitude, frequency, and phase information, and to output the excitation signal to the electrode group. By configuring the excitation signal through the signal parameters carried by the excitation control signal, the excitation device can output different excitation signals to adapt to different measurement scenarios.

[0086] In at least one embodiment, the measuring device measures the voltage of the measuring electrode group upon receiving a measuring control signal, obtaining a voltage signal for the measuring electrode group. The control device then uses this voltage signal to obtain the complex impedance of the measuring electrode group, thereby determining the state of each electrode based on the complex impedance of all the measuring electrode groups. When an excitation signal output by the excitation device acts on an electrode in the measuring electrode group, a voltage signal is generated between the electrodes. This voltage signal is measured by the measuring device through a signal loop between the measuring electrode group and the measuring device.

[0087] In some embodiments, the input port of the measuring device may include a positive input terminal and a negative input terminal. The measuring device is configured to measure the voltage across the electrode assembly via the positive input terminal and the negative input terminal according to a measurement control signal sent by the control device, thereby obtaining a voltage signal.

[0088] In one possible implementation, the measuring device includes a high-impedance differential amplifier, an anti-aliasing filter, and a high-sampling-rate analog-to-digital converter. For example, the high-impedance differential amplifier is used to differentially amplify the acquired voltage signal, the anti-aliasing filter is used to filter the differentially amplified voltage signal, and the high-sampling-rate analog-to-digital converter is used to convert the filtered analog voltage signal into a digital signal for subsequent processing and analysis (such as calculating complex impedance). In some embodiments, by amplifying, filtering, and converting the voltage signal, high-precision acquisition and digital processing of the voltage signal are achieved, which is beneficial for subsequent identification of the contact between the measuring electrode group and the target tissue based on the voltage signal.

[0089] In at least one embodiment, such as Figure 5 As shown, the electronic device may further include a switching device configured to connect the excitation device to the electrodes in the measurement electrode group, and to connect the measurement device to the electrodes in the measurement electrode group, according to a switching control signal sent by the control device. Thus, by deploying the switching device, it can be ensured that the voltage of different measurement electrode groups is measured using the same excitation source and measurement hardware for different measurements and electrode groups.

[0090] In at least one embodiment, by adding a switching device, the excitation signal output by the excitation device is used as the excitation source during the measurement of the voltage signal of each of the multiple measurement electrode groups by the electronic device, ensuring that the excitation source corresponding to the current loop is exactly the same; and the voltage signal is measured by the measurement device, ensuring that the measurement hardware corresponding to different measurement electrode groups is exactly the same. Thus, the relative gain error and phase drift that may exist when measuring voltage signals for different measurement electrode groups are completely eliminated at the physical level. Without the need for complex factory pairing calibration or real-time self-calibration algorithms, the consistency of environmental factors during the voltage signal measurement process can be guaranteed. Consequently, the accuracy of the complex impedance obtained based on the voltage signal is high, and it can be used to more accurately determine the electrode state.

[0091] In at least one embodiment, the switching device includes a switching switch array, such as... Figure 6 As shown, the switching device includes a switch between the positive output terminal (which can be represented as I+) of the excitation device and each electrode, a switch between the negative output terminal (which can be represented as I-) and each electrode (e.g., electrode 1, electrode 2, ..., electrode N), and a switch between the positive input terminal (which can be represented as V+) of the measurement device and each electrode, and a switch between the negative input terminal (which can be represented as V-) of the measurement device and each electrode.

[0092] In one possible implementation, when the control device performs state detection for each measuring electrode group, it is also used to generate a switching control signal and send the switching control signal to the switching device. Accordingly, the switching device, after receiving the switching control signal, is used to close the switches between the positive and negative output terminals of the excitation device and the electrodes in the measuring electrode group, respectively, and the switches between the positive and negative input terminals of the measuring device and the electrodes in the measuring electrode group, respectively, while keeping other switches open (which can also be understood as being in an open state). This connects the excitation device to the electrodes in the measuring electrode group, and connects the measuring device to the electrodes in the measuring electrode group. In this way, a loop can be generated in the measuring electrode group, thereby enabling the determination of whether the electrode is in contact with the tissue based on the measured impedance.

[0093] When performing measurements on different groups of measuring electrodes, the control device can flexibly switch the connections between the excitation device, the measuring device, and each group of measuring electrodes through the switching device. This reduces the wiring complexity between the excitation device, the measuring device, and each electrode, optimizing the hardware layout. Simultaneously, it enables flexible and rapid switching of connection relationships, improving measurement efficiency. Furthermore, the switching unit can be used as a physical isolation barrier to forcibly disconnect all measurement channels (i.e., disconnect all switches) or bypass them to ground during ablation pulse delivery, eliminating the need for bulky relays or complex filtering circuits. It can utilize the existing switching matrix to achieve complete isolation between the low-voltage measurement circuit and the high-voltage ablation energy, reducing system complexity and failure rate.

[0094] In some embodiments, the control device is further configured to: Send a disconnect command, which instructs the switching device to disconnect the switches between the positive and negative output terminals of the excitation device and all electrodes, as well as the switches between the positive and negative input terminals of the measurement device and all electrodes.

[0095] For example, a disconnect command can also be understood as a disconnect signal, etc.

[0096] In one possible implementation, when the multi-electrode catheter includes an ablation catheter, if the ablation generator is detected to be outputting high-power energy, which could potentially damage the tissue, the control device can immediately send a disconnect command to the switching device 314. Then, the switching device will place all analog switches in the switch array in a high-impedance disconnect state, thereby protecting the circuit. Simultaneously, the switch matrix itself has high voltage withstand characteristics, forming a natural physical isolation barrier that cuts off the path of high-voltage energy to the low-voltage measuring device 313, protecting the precision measuring circuit without the need for a bulky isolation transformer.

[0097] At least one embodiment of this application also provides an electrode state determination system, such as Figure 7 As shown, it includes: a multi-electrode conduit and a control device, the control device being used at least to determine the target state of each electrode in the multi-electrode conduit.

[0098] It should be noted that the electrode state determination method provided in the above embodiments is only illustrated by the division of the above-described program units during the electrode state determination process. In practical applications, the above processing can be assigned to different program units as needed, that is, the internal structure of the device can be divided into different program units to complete all or part of the processing described above. In addition, the control device provided in the above embodiments and the electrode state determination method embodiments belong to the same concept, and its specific implementation process can be found in the method embodiments, which will not be repeated here.

[0099] The solution provided in this application has the following advantages: In terms of hardware topology, a topology is proposed that includes a single excitation source (i.e., the excitation device mentioned above), a single measurement unit (i.e., the measurement device mentioned above), and a full matrix switching network (i.e., the switching device mentioned above). This topology can completely decouple the front-end measurement circuit from the back-end physical electrodes using a high-speed analog switch array. In this way, no matter how many electrodes the conduit has (e.g., 64 electrodes or 128 electrodes), only one set of core measurement circuit is needed, which can significantly reduce cost and size. At the same time, when the number of electrodes needs to be increased, only a low-cost switching matrix needs to be expanded, without the need to replicate the expensive analog signal chain. In terms of precision control, channel consistency is maintained at the physical level (i.e., using a single excitation source and measurement unit), and time-division multiplexing is adopted so that the measurement signals of all electrode combinations flow through the exact same physical path, the same excitation source, and the same voltage measurement unit to acquire signals. In this way, inconsistencies between channels are eliminated from the physical principle, and channel pairing calibration is not required. At the same time, when performing baseline comparison or comparison of adjacent electrode groups, since the same measurement path is shared, the relative changes in data fully reflect tissue characteristics rather than circuit errors, which greatly improves accuracy. In terms of algorithm and timing design, a dynamic adaptive scanning strategy can be implemented, establishing a dynamic scanning timing based on real-time feedback (i.e., redesigning the scanning list according to measurement results). Specifically, the controller (i.e., the aforementioned control device) can intelligently adjust the matrix switching sequence for the next iteration based on the previous impedance data; for example, when a critical / intermittent contact state of the electrode in a certain area is detected, a high-density four-wire retest sequence is automatically inserted into that area; furthermore, the scanning frequency is reduced for identified suspended areas (i.e., non-contact areas). Thus, with a limited total bandwidth, focus on the point of interest can be achieved, ensuring both the global refresh rate of the entire conduit and providing high signal-to-noise ratio data exceeding traditional measurement methods for suspicious contact points. In terms of safety and compatibility, a physical isolation protection mechanism under high-voltage ablation is established. The matrix switching unit itself is used as a physical isolation barrier. During the ablation pulse delivery, the matrix switches of all measurement channels can be forcibly disconnected or bypassed to ground through logic control. In this way, there is no need for additional bulky relays or complex filtering circuits. The switching matrix can achieve complete isolation between the low-voltage measurement circuit and the high-voltage ablation energy, which helps to reduce the complexity and failure rate of the system.

[0100] The following is a more detailed description of this application with reference to application examples: This application provides an application example of a catheter electrode state determination system based on matrix switching and time-division multiplexing, such as... Figure 8 As shown, the system includes: a timing controller, an excitation source, a measurement unit, a switching matrix unit, and a multi-electrode conduit; the excitation source and the measurement unit are electrically connected to multiple electrodes (electrode 1 to electrode N) on the conduit through the switching matrix unit. The timing controller achieves dynamic mapping between the excitation and measurement channels by controlling the on / off state of the matrix switching unit and controlling the excitation source and the measurement unit.

[0101] Multi-electrode catheters can be mapping catheters or ablation catheters, with multiple electrodes at their distal end (e.g., Figure 8 (Medium electrode 1 to electrode N), the number of N can be 64, 128 or more.

[0102] The current excitation source (i.e., the excitation device described above) can be configured to generate an AC excitation signal with adjustable frequency and constant amplitude. The excitation source has a pair of output ports: an excitation positive terminal (I+) and an excitation negative terminal (I-).

[0103] Measurement Unit: Configurable for acquiring voltage signals. It includes a high-impedance differential amplifier, an anti-aliasing filter, and a high-sampling-rate analog-to-digital converter. The unit has a pair of input ports: a positive measurement terminal (V+) and a negative measurement terminal (V-).

[0104] Matrix switching unit (i.e., the aforementioned switching device), such as Figure 5 As shown, the matrix switching unit consists of a 4×N crosspoint analog switch array. Its "column lines" (i.e., the aforementioned vertical buses) are connected to the aforementioned four buses I+, I-, V+, and V-; its "row lines" (i.e., the aforementioned horizontal buses) are respectively connected to the N physical electrodes of the conduit, and each crosspoint is equipped with a switch controlled by a timing controller, forming a crosspoint switch array.

[0105] In some implementations, the matrix switching unit circuit includes four "column lines" (i.e., vertical buses) connected to excitation positive (I+), excitation negative (I-), measurement positive (V+), and measurement negative (V-), respectively. N "row lines" (i.e., electrode lines) are provided horizontally, connected to the N electrodes of the conduit, with an independent controllable switch at the intersection of each horizontal bus and vertical electrode line.

[0106] The timing controller (i.e. the control device mentioned above) is used to control the parameters of the excitation source, the sampling of the synchronous trigger voltage measurement unit, and the switching timing of the matrix switching unit.

[0107] Based on the above system, this application also provides an application example of an impedance measurement method for determining catheter electrode contact based on matrix switching and time-division multiplexing. This method employs a standard bipolar mode and uses time-division multiplexing to complete a full scan of the catheter electrodes using a single measurement circuit. This solves the following problems existing in impedance measurement: The high-density catheter detection system suffers from hardware redundancy, high cost, and large size. The measurement topology is fixed and cannot flexibly adapt to complex clinical scenarios; Multi-channel systems suffer from poor inter-channel consistency, limited measurement accuracy, and complex calibration issues. The problem of complex protection for measurement circuits under high voltage ablation interference.

[0108] like Figure 9 As shown, the method may include the following steps: Step 901: Output the switching command; In some implementations, the controller sends a switching command to the switching matrix unit according to a preset scan list, causing the switching matrix unit to simultaneously connect the excitation port and the measurement port to the two electrodes (i.e., electrode groups) currently to be measured in the scan list, according to the switching command. For example, Figure 10 As shown, when the electrode group to be measured in the scan list includes electrode 1 and electrode 2, the switching matrix unit closes the switch connecting I+ to electrode 1 and I- to electrode 2 according to the switching command, simultaneously closes the switch connecting V+ to electrode 1 and V- to electrode 2, and disconnects the switches between other electrodes and I+, I-, V+, and V-. At this time, the system is configured to measure the bipolar impedance of electrode 1-electrode 2.

[0109] In some implementations, the electrode arrays are pre-configured, either sequentially, by distance, or by spline, without particular limitation.

[0110] Step 902: Signal establishment; In some implementations, the controller waits for a preset setup time to eliminate oscillations caused by the switching action and to wait for the analog signal chain to stabilize.

[0111] Step 903: Data Acquisition; In some implementations, the controller triggers the measurement unit to acquire voltage waveforms within a sampling window.

[0112] Steps 901 to 903 can also be understood as performing time-sharing multiplexing scans.

[0113] Step 904: Impedance calculation; In some implementations, the control device performs quadrature demodulation on the acquired voltage signal and calculates the complex impedance of the current electrode group by combining the known amplitude and phase of the excitation current.

[0114] In some implementations, the control device quickly switches to the next combination of electrodes 2-3 in the list, repeating the above steps. For example... Figure 11 As shown, the system configures the matrix to the first connection state during time slot T1. After the signal setup time, the ADC triggers sampling. Then, in time slot T2, it switches to the second connection state. This cycle continues until all combinations in the scan list are completed.

[0115] As can be seen, the time-division multiplexing strategy ensures that the measurement signals of all electrode groups flow through the exact same excitation source and measurement circuit. This completely eliminates relative gain errors and phase drift between channels at the physical level, guaranteeing extremely high consistency of measurement data without the need for complex factory pairing calibration or real-time self-calibration algorithms.

[0116] Step 905: Determine the state of the electrode group (i.e., the state of the above-mentioned measuring electrode group). In some implementations, the control device determines the baseline impedance based on the actual application scenario, and judges the state of the electrode group based on the baseline impedance and the impedance calculation results (which can also be understood as the measured value).

[0117] In some implementations, if the current impedance calculation result is greater than a first value, the electrode group is determined to be in good contact; or, if the current impedance calculation result is significantly less than a second value, the electrode group is determined to be not in contact (or poorly in contact); or, if the current impedance calculation result is greater than a second value and less than a first value, the electrode group is determined to be in critical contact.

[0118] In some implementations, the measurement methods of steps 901 to 905 can also be understood as standard bipolar mode. At this time, the impedance amplitude calculated by the control device is compared with the baseline impedance. If the calculated impedance amplitude is significantly greater than the baseline impedance, the electrode group is determined to be in good contact. In this way, the standard bipolar mode has good compatibility. At the same time, the same physical measurement channel is shared, eliminating the gain error between channels.

[0119] Step 906: Determine the intermediate state of the electrode; In some implementations, for each electrode, the control device uses the worst state among all the states of the electrode's electrode groups as the intermediate state of that electrode.

[0120] In some implementations, for electrodes in the intermediate state of not being in contact, step 907 is executed followed by step 909; correspondingly, for electrodes in the intermediate state of being critically in contact, step 908 is executed followed by step 909; for electrodes determined to be in good contact, step 909 is executed directly.

[0121] Step 907: For an electrode whose intermediate state is not attached, perform state correction based on the target state of the adjacent electrodes to determine the final state of the electrode (i.e., the aforementioned target state). In some implementations, for an electrode whose intermediate state is not attached, if the target state of the adjacent electrodes of the electrode is attached, then the final attached state of the electrode is determined to be attached (which can also be understood as attached to tissue); or, if the target state of the adjacent electrodes of the electrode that are closer to each other is attached and the target state of the adjacent electrodes that are farther apart is not attached, then the target state of the electrode is determined to be attached; or, if the number of the adjacent electrodes of the electrode whose target state is attached is greater than the number of the electrodes whose target state is not attached, then the final state of the electrode is determined to be attached.

[0122] Step 908: For the electrode in the intermediate state of critical contact, determine the final state of the electrode through fine measurement; In some implementations, for electrodes in a critical contact state, the fine measurement process may include: a control device selecting at least three adjacent electrodes from the adjacent electrodes of the electrode, forming an excitation electrode group with the electrode and at least one of the three electrodes, and using the remaining adjacent electrodes as a fine measurement electrode group; subsequently connecting the excitation electrode group to an excitation source and connecting the fine measurement electrode group to a measurement unit, so that after a signal loop is generated in the excitation electrode group, the voltage of the fine measurement electrode group is measured to obtain a voltage signal; finally, the control device calculates the complex impedance using the voltage signal and uses the complex impedance to determine the target state of the electrode.

[0123] For example, such as Figure 12 As shown, if electrode 1 is in the intermediate state of critical contact, the control device controls the switching matrix to connect I+ / I- to electrodes 1 and 4 (i.e., the excitation electrode group), and V+ / V- to electrodes 2 and 3 (i.e., the fine measurement electrode group). In this case, if the excitation electrode group is in contact, the impedance of the tissue is greater than that of the blood, so the excitation electrode group exhibits a high impedance characteristic, which increases the electric field between the excitation electrode groups, thereby increasing the voltage of the measurement electrode group. Therefore, if the difference between the complex impedance between the measurement electrode groups and the baseline impedance is greater than a preset value, it indicates that the electrodes in the excitation electrode group are in contact; otherwise, they are in non-contact state.

[0124] Step 909: Output (e.g., display) the final snap-in state.

[0125] In some implementations, during ablation, the system can immediately send a full disconnect command to the matrix switching unit upon detecting that the ablation generator is outputting high-power energy, thereby placing all analog switches in a high-impedance disconnected state. The high voltage withstand characteristics of the matrix switches themselves form a natural physical isolation barrier, cutting off the path of high-voltage energy to the low-voltage measurement unit, eliminating the need for a bulky isolation transformer and protecting the precision measurement circuitry.

[0126] In the application example of this application, the system first performs a rapid time-division scanning based on a preset list to calculate the complex impedance. Then, it makes a preliminary judgment based on the baseline value and performs logical correction using the states of adjacent electrodes. If a questionable state is found, a high-precision measurement sequence is dynamically inserted, and the final result is output. In other words, it implements a multi-channel hardware parallel signal processing architecture, a fixed-pair impedance measurement topology, and a conflict handling mechanism for high-voltage ablation and low-voltage measurement. It can be applied to arrhythmia ablation and pacing catheter procedures, and can solve the aforementioned technical problems.

[0127] As used herein, when used in conjunction with numerical values ​​and / or ranges, the terms “about” and / or “approximately” generally refer to those numerical values ​​and / or ranges that are close to the stated numerical value and / or range. In some cases, the terms “about” and “approximately” may mean within ±10% of the stated value. For example, in some cases, “about 100 [units]” may mean within ±10% of 100 (e.g., 90 to 110). The terms “about” and “approximately” may be used interchangeably.

[0128] As used in this application, the singular forms “an,” “a,” and “the” include the plural forms unless the context clearly specifies otherwise. For example, the terms “a compound” or “at least one compound” can include a variety of compounds, including mixtures thereof.

[0129] The term "basically composed of" means that the composition, method, or structure may include additional ingredients, steps, and / or components, provided that these additional ingredients, steps, and / or components do not significantly alter the fundamental and novel properties of the claimed composition, method, or structure.

[0130] The implementation of the methods and / or systems of this application may include performing or fully performing selected tasks manually, automatically, or in a combination thereof. Furthermore, the actual instruments and equipment used in the implementation of the methods and / or systems of this application, using an operating system, may implement several selected tasks via hardware, software, firmware, or a combination thereof.

[0131] For example, the hardware used to perform the selected task according to embodiments of this application can be implemented in the form of a chip or circuit. As software, the task selected according to embodiments of this application can be implemented in the form of multiple software instructions executable by a computer using any suitable operating system. In exemplary embodiments of this application, one or more tasks of exemplary embodiments of the methods and / or systems according to this application are performed by an electrode state determiner, such as a computing platform for executing multiple instructions. Optionally, the electrode state determiner includes volatile memory for storing instructions and / or data and / or non-volatile memory for storing instructions and / or data, such as a magnetic hard disk and / or removable media. Optionally, a network connection is also provided. A display and / or user input devices such as a keyboard or mouse are also optionally provided.

[0132] It should be understood that certain features of this application described in the context of a single implementation for clarity can also be provided in combination in a single implementation. Conversely, multiple features of this application described in the context of a single implementation for brevity can also be provided individually or in any suitable sub-combination or, as appropriate, in any other described implementation of this application. Certain features described in the context of multiple implementations should not be considered essential features of those implementations unless the implementation does not function without these elements.

[0133] Although this application has been described in conjunction with its specific embodiments, it will be apparent to those skilled in the art that many alternatives, modifications, and variations are possible. Therefore, it is intended to include all such alternatives, modifications, and variations falling within the spirit and broad scope of the appended claims.

Claims

1. A method for determining electrode state, characterized in that, include: The voltage signals of multiple measuring electrode groups are acquired, each measuring electrode group including at least two electrodes in a multi-electrode conduit, and the voltage signals are signals obtained by measuring the voltage of the measuring electrode groups; The complex impedance of each of the measuring electrode groups is determined based on the voltage signal of each measuring electrode group; Based on the complex impedance of the multiple measuring electrode groups, the target state of each electrode in the multi-electrode catheter is determined, and the target state includes tissue contact and non-tissue contact.

2. The method according to claim 1, characterized in that, Determining the target state of each electrode in the multi-electrode catheter based on the complex impedance of the plurality of measuring electrode groups includes: For each measuring electrode group, the state of the measuring electrode group is determined based on the complex impedance of the measuring electrode group; For each electrode in the multi-electrode conduit, the measurement electrode group containing the electrode in the plurality of measurement electrode groups is determined as the verification electrode group; Based on the state of the verification electrode group, the target state of the electrode is determined.

3. The method according to claim 2, characterized in that, Determining the state of the measuring electrode group based on its complex impedance includes: Obtain the baseline value of the measuring electrode group; The amplitude of the complex impedance is determined based on the complex impedance of the measuring electrode group; Determine the difference between the complex impedance amplitude and the baseline value; If the difference is greater than the first value, it is determined that the measuring electrode group is in contact. If the difference is less than or equal to the first value and the difference is greater than the second value, the measuring electrode group is determined to be in a critical contact state. If the difference is less than or equal to the second value, it is determined that the measuring electrode group is in a non-contact state.

4. The method according to claim 2, characterized in that, Based on the state of the verification electrode group, the target state of the electrode is determined, including: Based on the state of the verification electrode group, the intermediate states of the electrode are determined, including the contact state, the critical contact state, and the non-contact state. If the intermediate state is a critical contact state or a non-contact state, the state of the electrode is checked to obtain the target state of the electrode; When the intermediate state is the contact state, the target state of the electrode is determined to be the contact state with the tissue.

5. The method according to claim 4, characterized in that, Based on the state of the verification electrode group, the intermediate state of the electrode is determined, including: The worst state among the states of the verification electrode group is determined as the intermediate state of the electrode; The states of the verification electrode group are arranged in order from best to worst as follows: in contact state, critically in contact state, and not in contact state.

6. The method according to claim 4, characterized in that, The state of the electrode is verified to obtain the target state of the electrode, including: When the intermediate state of the electrode is a critical contact state, at least three adjacent electrodes adjacent to the electrode are identified. Based on the electrode and the at least three adjacent electrodes, a fine measurement electrode group and an excitation electrode group are determined, wherein the excitation electrode group includes at least one of the electrode and the at least three adjacent electrodes, and the fine measurement electrode group includes at least two of the at least three adjacent electrodes, and the excitation electrode group and the measurement electrode group include different electrodes; The complex impedance of the fine measurement electrode group is obtained, and the target state of the electrode is determined based on the complex impedance of the fine measurement electrode group.

7. The method according to claim 4, characterized in that, The state of the electrode is verified to obtain the target state of the electrode, including: When the intermediate state of the electrode is an unattached state, the target state of the adjacent electrode is obtained; The target state of the electrode is determined based on the target state of the adjacent electrodes.

8. The method according to claim 7, characterized in that, Determining the target state of the electrode based on the target state of the adjacent electrodes includes: If the target state of the adjacent electrodes meets the contact condition, the target state of the electrodes is determined to be in contact with tissue; wherein the contact condition includes one or more of the following: The target state of the adjacent electrodes is that they are in contact with tissue; The number of electrodes in the adjacent electrodes whose target state is in contact with tissue is greater than the number of electrodes whose target state is not in contact with tissue. The distance between the electrode and the adjacent electrode whose target state is not in contact with the tissue is greater than the distance between the electrode and the adjacent electrode whose target state is in contact with the tissue.

9. The method according to any one of claims 1 to 8, characterized in that, The selection of electrodes in the measuring electrode group satisfies one or more of the following: Configure according to the electrode serial number; Configured according to the distance between the electrodes; The multi-electrode conduit is configured according to the spline where the electrodes are located. It contains one or more splines, and each spline contains at least two electrodes.

10. A control device, characterized in that, The control device includes: An acquisition unit is used to acquire voltage signals from multiple measurement electrode groups, each of the measurement electrode groups including at least two electrodes in a multi-electrode conduit, and the voltage signal is a signal obtained by measuring the voltage of the measurement voltage group. The first determining unit is configured to determine the complex impedance of each of the measuring electrode groups based on the voltage signal of each measuring electrode group. The first determining unit is used to determine the target state of each electrode in the multi-electrode catheter based on the complex impedance of the plurality of measuring electrode groups, wherein the target state includes tissue contact and non-tissue contact.

11. An electronic device, characterized in that, It includes an excitation device, a measuring device, and a control device; A control device is used to send an excitation control signal to an excitation device and a measurement control signal to a measurement device for each of a plurality of measurement electrode groups, wherein each measurement electrode group includes at least two electrodes in a multi-electrode conduit; An excitation device is used to receive excitation control signals and generate excitation signals, which are then output to the measuring electrode group. The measuring device is used to receive a measuring control signal, measure the voltage of the measuring electrode group to obtain a voltage signal, and send a voltage signal to the electrode state determination device. The control device is also used to receive voltage signals and determine the complex impedance of the measuring electrode group based on the voltage signals corresponding to the measuring electrode group; The control device is also used to determine the target state of each electrode in the multi-electrode catheter based on the complex impedance of multiple measuring electrode groups. The target state includes tissue contact and non-tissue contact.

12. An electrode state determination system, characterized in that, include: A multi-electrode conduit and a control device for performing the electrode state determination method as described in any one of claims 1-9.

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