CN115886976B - A detection system for indicating the degree of contact of basket catheter electrodes - Google Patents
A detection system for indicating the degree of contact of basket catheter electrodesInfo
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Abstract
本发明涉及医用电生理导管技术领域，特别涉及一种用于指示网篮导管电极贴靠程度的检测系统，系统中，磁场定位模块用于获取网篮条上电极的位置信息；数据采集模块用于获取网篮条上电极自身与相邻电极之间阻抗，以及用于获取参考电极对之间的阻抗；贴靠检测模块根据位置信息在预先建立的模型中查找到对应的单元格，根据单元格中的预存的判别信息计算历史阻抗判别系数值，根据电极自身与相邻电极之间阻抗和参考电极对之间的阻抗计算电极的阻抗判别系数值，根据阻抗判别系数值大于或等于历史阻抗判别系数值的次数，确定网篮条上电极的贴靠指数。能实时得到网篮导管上各电极与组织的贴靠程度，便于对导管电极与组织贴靠的控制。
The present invention relates to the technical field of medical electrophysiology catheters, and more particularly to a detection system for indicating the degree of contact between electrodes in a basket catheter. In the system, a magnetic field positioning module is used to obtain position information of electrodes on a basket bar; a data acquisition module is used to obtain the impedance between the electrodes themselves and adjacent electrodes on the basket bar, as well as the impedance between a reference electrode pair; and an contact detection module locates a corresponding cell in a pre-established model based on the position information, calculates a historical impedance discrimination coefficient value based on pre-stored discrimination information in the cell, calculates an impedance discrimination coefficient value for the electrode based on the impedance between the electrode itself and adjacent electrodes and the impedance between the reference electrode pair, and determines the contact index of the electrodes on the basket bar based on the number of times the impedance discrimination coefficient value is greater than or equal to the historical impedance discrimination coefficient value. The system can obtain the degree of contact between each electrode on the basket catheter and tissue in real time, facilitating control of the contact between the catheter electrode and tissue.
Description
Technical Field
The invention relates to the technical field of medical electrophysiology catheters, in particular to a detection system for indicating the electrode leaning degree of a basket catheter.
Background
At present, the electrophysiological catheter is widely applied to the field of arrhythmia interventional diagnosis and treatment. The diagnosis and mapping process and the ablation treatment process have high requirements on the adhesion of the catheter electrode and the tissue in the cavity. In addition, the detection of the contact between the catheter electrode and the tissue can be used as an important basis for judging the effect of the treatment process.
The current catheters with the leaning detection in the market are mostly realized by arranging a pressure sensor at the head end of the catheter, the mounting position of the pressure sensor is limited, only the head end is mounted, the leaning detection of the head end of the catheter is realized, and the leaning detection of a non-head end part electrode cannot be realized. In particular, because the conduit of the basket structure is in an expanded state during operation, the electrode distribution on the basket strips is scattered, the electrode leaning degree is difficult to detect by installing the pressure sensor, and all the electrode leaning degrees are difficult to obtain simultaneously.
Disclosure of Invention
In order to overcome the problems, the invention provides a detection system for indicating the electrode leaning degree of the basket catheter.
In order to achieve the above object, the present invention provides the following technical solutions:
A detection system for indicating the leaning degree of a basket catheter electrode comprises a magnetic field positioning module, a data acquisition module and a leaning detection module,
The magnetic field positioning module is used for acquiring the position information of the upper electrode of the basket strip;
The data acquisition module is used for acquiring impedance between the electrode on the basket strip and the adjacent electrode and impedance between the reference electrode pair;
The leaning detection module searches corresponding cells in a pre-established model according to the position information, calculates historical impedance discrimination coefficient values according to pre-stored discrimination information in the cells, calculates impedance discrimination coefficient values of electrodes according to impedance between the electrodes and adjacent electrodes and impedance between the reference electrode pairs, and determines the leaning index of the electrodes on the basket strips according to the times that the impedance discrimination coefficient values are larger than or equal to the historical impedance discrimination coefficient values.
As a preferable scheme of the invention, the pre-stored distinguishing information comprises a minimum impedance difference value and a maximum impedance difference value, wherein the impedance difference value is the difference value between the impedance of the adjacent electrode on the basket strip and the impedance of the reference electrode pair.
As a preferable scheme of the invention, the attaching indexes of the electrodes on the basket strips are obtained by summing the times of attaching labels to be true in a period of time, and the condition that the attaching labels are true is that the impedance judging coefficient value of the current electrode is larger than or equal to the historical impedance judging coefficient value in the corresponding unit cell, and the historical impedance judging coefficient value is calculated according to prestored judging information.
As a preferable embodiment of the present invention, the calculation formula of the impedance discrimination coefficient value of the current electrode is:
Wherein, the Is the impedance discrimination coefficient value of the current electrode; The impedance of the ith pair of adjacent electrodes t on the basket strips is the impedance at the moment of t; Is the impedance at time t between the reference electrodes; is a first standard deviation coefficient; is the standard deviation of the impedance data set within the cell.
As a preferred embodiment of the present invention, the calculation formula of the historical impedance discrimination coefficient value in the unit cell is:
Wherein, the Is a historical impedance discrimination coefficient value in the cell; for the impedance of the ith pair of adjacent electrodes t on the basket strip, For the impedance at time t between the reference electrodes,Recorded centrally for historical dataIs set to be a minimum value of (c),Recorded centrally for historical dataIs the maximum value of (2); is a second standard deviation coefficient.
As a preferred scheme of the present invention, the finding of the corresponding cell in the pre-established model is obtained through a cell index value, and a solution formula of the cell index value is as follows:
Wherein, the Respectively representing the sizes of the cells in the X, Y, Z directions; Dividing the number of parts in X, Y, Z directions for the target area respectively; is the position information of the electrode on the basket strip.
As a preferred embodiment of the present invention, the step of creating the pre-created model includes:
S1, inputting position information and impedance information of an electrode;
s2, dividing the space region where the electrode is located into cells, wherein the cells store data sets comprising position information and impedance information of the electrode, and the data sets of the impedance information are expressed as WhereinFor the impedance of the ith pair of adjacent electrodes t on the basket side,For the impedance at time t between the reference electrodes,Recorded centrally for historical dataIs set to be a minimum value of (c),Recorded centrally for historical dataIs set at the maximum value of (c),Is a reference baseline value;
S3, recording a cell index value for the cell.
As a preferred embodiment of the present invention, the pre-established model update process includes the steps of:
A1, when a data set of current impedance information is stored in a cell, calculating the impedance of adjacent electrodes t in the data set of the current impedance information Impedance between the pair of reference electrodesImpedance difference betweenIf the impedance difference is less than or equal toAnd greater than or equal toAnd storing the data set of the current impedance information into the cells, otherwise, deleting the data of the current impedance information.
As a preferred embodiment of the present invention,
Recorded in a set of historical dataMinimum value of (2)The updated calculation formula is:
recorded in a set of historical data Maximum value of (2)The calculation formula of (2) is as follows:
Wherein, the Is the impedance at time t of the adjacent electrode in the data set of the current impedance informationImpedance between the pair of reference electrodesImpedance difference between; recorded centrally for historical data Is set to be a minimum value of (c),Recorded centrally for historical dataIs set at the maximum value of (c),For a reference baseline value offset, the reference baseline value offset characterizes differential impedance values between electrode and tissue in-and-out-of-abutment when the reference baseline value offsetWhen the content is less than or equal to 10%,。
As a preferred embodiment of the present invention, there is also included a computer system for displaying the degree of abutment, a graphical user interface of the computer system, including,
The preset leaning index setting area is used for displaying the preset numerical value of the leaning index and the bar-shaped schematic block;
the method comprises the steps of (1) setting a rectangular color block along an X-axis direction and a Y-axis direction in a two-dimensional graph, wherein the X-axis direction refers to the number of each wire basket catheter, the Y-axis direction refers to the electrode number of each catheter on each side, and the gray scale of the rectangular color block and the leaning index are in corresponding relation;
The electrode position diagram is characterized in that a plurality of concentric circles are used for representing electrode numbers on each basket strip, line segments from the circle center to the outermost circle are used for representing each basket strip, intersection points of the line segments and the concentric circles are used for representing positions of electrodes on the basket strips, and the area of the intersection points is in direct proportion to the abutting degree.
Based on the same conception, the invention also provides a detection system for the leaning degree, which comprises the detection system for indicating the leaning degree of the electrode of the basket catheter and also comprises the basket catheter, wherein the basket catheter comprises a handle part (201), a push rod component (202), a pipe body part (203), a moving component (209) and a distal end part (204) provided with the electrode;
The distal end portion (204) comprises a catheter head end in a basket layout, the catheter head end in the basket layout comprises basket strips (208), the basket strips (208) are driven to shrink or expand through movement of a moving member (209) located in the center of the basket, electrodes are axially arranged along the basket strips (208), and a reference electrode is arranged on the moving member (209).
Compared with the prior art, the invention has the beneficial effects that:
1. By adopting the system provided by the invention, the detection of the adhesion degree of each electrode on the basket strip and the tissue can be obtained in real time, and the calculated adhesion index is used for quantification, so that an operator can accurately obtain the adhesion information. The adhesion index with the tissue, and the adhesion degree of each electrode with the tissue is displayed in real time, so that the operation and the control are convenient.
2. The contact index of the electrode and the tissue is judged by prestored judging information in the unit cell, wherein the prestored judging information comprises a minimum impedance difference value and a maximum impedance difference value. Through the two values, a historical impedance discrimination coefficient value can be obtained, when the impedance discrimination coefficient value of the front electrode is larger than or equal to the historical impedance discrimination coefficient value in the corresponding cell, the leaning label is set to be true, and the leaning indexes of the electrodes on the basket strips are obtained by summing the number of times that the leaning label is true in a period of time. The method for judging the contact index by using the prestored judging information is based on the conception formed by the characteristics of the field, and the judging process is reliable and effective.
3. In order to judge more accurately, the data in the unit cell is not a layer of unchanged data, but is updated in real time according to the acquired data, and the part exceeding the threshold value is deleted. Also taking into account the differences in impedance values due to changes in the test environment, parameters are introducedAccording to the current timeAt a certain preset value, parameters cannot be ignored when updating the modelThe effect of this is that, otherwise, parameters can be usedThis is an adaptive improvement based on impedance changes caused by blood concentration changes in practical applications.
Drawings
FIG. 1A is a diagram of a system for detecting the degree of contact in embodiment 1 of the present invention;
FIG. 1B is a graphical user interface diagram of a computer system of the system for detecting a degree of abutment in embodiment 1 of the present invention;
FIG. 2A is a schematic view of the whole basket catheter of embodiment 1 of the present invention;
FIG. 2B is a schematic view of the tip of the basket catheter of example 1;
FIG. 3 is a schematic view showing the attachment of the electrode to the tissue in the basket catheter of example 1 of the present invention;
FIG. 4 is a diagram showing impedance acquisition on basket catheter in accordance with embodiment 1 of the present invention;
FIG. 5 is a flowchart of the calculation of the adherence index in embodiment 1 of the present invention;
FIG. 6 is a schematic diagram of dividing cells in a target region during the establishment of an impedance model in embodiment 1 of the present invention;
FIG. 7 is a flow chart of the impedance model establishment in the embodiment 1 of the present invention;
Fig. 8 is a flowchart of the impedance model application in embodiment 1 of the present invention.
Detailed Description
The present invention will be described in further detail with reference to test examples and specific embodiments. It should not be construed that the scope of the above subject matter of the present invention is limited to the following embodiments, and all techniques realized based on the present invention are within the scope of the present invention.
Example 1
1. System description
As shown in fig. 1A, 100 is a catheter electrode tissue abutment recognition system. 101 is the patient, 102 is the reference applied to the body surface, 103 is the distal end of the endocardial catheter, 104 is the catheter tube, and 105 is the catheter handle. 106 is a magnetic field generator, 107 is a body surface reference hub, and 108, 109, 110 are connection cables. 111 is a display screen, 112 is a preset adherence index setter, and is considered to be stable and effective adherence when the adherence index is greater than the preset adherence index set by the preset adherence index setter 112, otherwise is intermittently adherence or non-adherence. Reference numeral 113 denotes a schematic view of the degree of electrode abutment, 114 denotes the number of each side of the basket catheter, 115 denotes the electrode number of the catheter on each side, and 116 denotes a schematic view of the degree of electrode abutment of the catheter. 113 and 116 mark the degree of the contact between each electrode and the tissue by different gray scales or different colors, and have the characteristic of clear and striking, the size of the mark can be changed along with the difference of the contact degree except the difference of gray scales and colors when the mark is marked by the contact degree of the electrode of the catheter 116, and the better the contact is, the larger the mark is.
The preset adherence index setting area includes a value of a preset adherence index and a preset adherence index setter 112 of a bar-shaped schematic block shape, and as shown in fig. 1B, when the preset adherence index is set to 7, a pointer on the preset adherence index setter 112 of the bar-shaped schematic block shape is also pointed to 7. The method is characterized in that the number of times of labeling is more than or equal to 7 in a period of time, the labeling is considered to be stable and effective, the output effective value of the ablation energy is high, otherwise, the intermittent labeling or non-labeling is considered, and the output effective value of the ablation energy is low or none. Further, it may be configured to count the number of times the label is attached to the device for 7 or more times during a period of time, so that the device is considered to be stable and effective in attachment, and ablation energy can be output, otherwise, the device is considered to be intermittently attached or not attached, and ablation energy cannot be output.
And 117 is a magnetic field positioning module responsible for body surface reference and positioning of the position of each electrode of the catheter in the heart cavity. 118 are data acquisition modules, one of which is direct measurement, and directly acquires the impedance between adjacent electrodes, as shown in the lower right part of fig. 4, and the other is indirect measurement, and acquires the impedance between each electrode of the catheter relative to the body surface reference, and then indirectly acquires the impedance between each electrode of the basket relative to the reference electrode through calculation, as shown in the upper left part of fig. 4.
Fig. 4 is a schematic diagram of electrode impedance collection, 400 is a schematic diagram of impedance measurement principle, the lower right part of fig. 4 is for directly measuring impedance between electrodes on each side of the basket and the basket reference electrode, and the upper left part of fig. 4 is for indirectly measuring impedance between the torus electrode and the reference electrode.
2. Catheter description
As shown in fig. 2A and 2B, 200 is a schematic view of a catheter, and generally includes 201 a handle portion, 202A pusher member, 203 a shaft portion, and 204 a distal portion to which an electrode is mounted. The distal end of the catheter comprises a bendable section 205 that controls the degree of bending by 202 the push rod. The head end of the catheter is in a basket layout, and comprises 5 basket edges 208 and a movement member 209 with the center capable of stretching to realize basket expansion. The reference electrode 206 is arranged on the moving member 209, against the electrode 207 being arranged on the basket side.
3. Schematic drawing of sticking
As shown in fig. 3, 300 is a schematic diagram of the attachment of a catheter to an endoluminal vessel, 301 is the left atrium, 302 is the right superior pulmonary vein, 303 is the right inferior pulmonary vein, 304 is the left inferior pulmonary vein, 305 is the left superior pulmonary vein, 306 is the catheter, 307 is the electrode.
4. Description of the impedance acquisition mode
As shown in fig. 4, 400 is a schematic diagram of a system impedance acquisition mode, 401 is an electrode installed on the basket edge, 402 is a reference electrode, and the system acquires impedance between the reference electrodesImpedance between adjacent electrodes on basket edge
5. Description of System flow
As shown in fig. 5, 500 is a diagram of a system for catheter electrode tissue apposition detection process. The system 502 acquires the spatial position data of the catheter to obtain the spatial coordinate position of each electrode of the catheter, the system 504 acquires the impedance data to obtain the impedance data between the adjacent electrodes, the system 506 is the space cell division of the target area, the system 508 is the establishment of a spatial impedance model, and the system 510 is the application process of model leaning detection. 510 outputs an index of the degree of contact between each electrode and the tissue, 512 displays the index as an image on the screen 111, and shows the state of real-time contact between the catheter and the heart chamber tissue.
6. Description of the procedure for the detection of the abutment
Electrode and tissue proximity indication solutions are divided into modeling processes and model application processes. The cell division process of the target area realizes the cell division of the heart chamber area, the initial position of the catheter can be selected as the center of the target area, and the three axial distributions of X, Y, Z are expanded outwards for a certain distance, such as 350mm, and the cells are set according to the positioning precision, such as 10 (mm) x10 (mm) x10 (mm), and various cell sizes can be set according to the actual situation, wherein the cell size represents the resolution of the system leaning detection, and the smaller the cell size is, the higher the resolution is. And in the modeling process, the cell division of the heart cavity area and the recording and description of impedance information in the area corresponding to each cell are realized. And in the model application process, solving an electrode and tissue adhesion degree index according to the record and description of the unit to which the electrode belongs. The output contact index of each electrode is displayed in the form of an image on the screen 111.
(1) Target zone cell partition description
As shown in fig. 6, 602 is the patient's heart, the target region is a portion of the space within the heart, 604 is the target region cell division, 606 is the cell description, and the cells are smaller rectangular spaces that further divide the target region. The initial position of the catheter is selected as the model center of modeling of the target area, and the X, Y, Z axial distributions are expanded for a certain distance, such as 350mm, and as the target area, the cells are set according to the positioning precision, such as 10 (mm) x10 (mm) x10 (mm), and various cell sizes can be set according to actual conditions, wherein the cell sizes represent the resolution of the system leaning detection, and the smaller the cell size, the higher the resolution. Representing a three-dimensional spatial range with reference to 606 cells is described asK is a cell index, and data is input at time tThe cell index is solved as follows:
Wherein, the Respectively representing the sizes of the cells in the X, Y, Z directions; dividing the target area into parts in X, Y, Z directions, wherein k is a cell index number, and the input data at the moment t is ,Is the spatial position coordinates of the electrodes,For the spatial position coordinates of the reference point corresponding to the electrode,O is the impedance of the electrode relative to the reference point) Is the origin coordinates of the three-dimensional space.
(2) Modeling process description
As shown in fig. 7, 700 is a lean detection modeling process. And 704, deleting unreasonable data, wherein the unreasonable data is related to sampling frequency, for example, when a catheter moves fast, the sampling frequency is lower relative to the moving speed of the catheter, the acquired data cannot reflect the moving track of the catheter in real time, so that the obtained coordinate position is inaccurate, and the positioning unit is inaccurate, and therefore, the removal is needed. As a preferable scheme, the space distance between the front and rear acquisition points is larger than 5mm, and then the acquisition points are eliminated. 706 is a cell index corresponding to the calculated electrode position, 708 is to judge whether the historical data is stored in the index cell, if not, comprehensively processing the impedance information of each electrode according to 710, setting the impedance information as a basic value into the cell, and setting a common comprehensive processing method such as average value or weighted average, 712 is to judge whether the number of the stored historical data of the cell exceeds a preset number, if so, 714 is the earliest data is removed, 716 is stored in the latest impedance information, and 718 is updated.
706 Is described in terms of a cell index solution to a spatial impedance model in such a way that the three-dimensional spatial extent of the cell representation is described asK is a cell index, and data is input at time tThe cell index is solved as follows:
Wherein, the Respectively representing the sizes of the cells in the X, Y, Z directions; dividing the target area into parts in X, Y, Z directions, wherein k is a cell index number, and the input data at the moment t is ,Is the spatial position coordinates of the electrodes,For the spatial position coordinates of the reference point corresponding to the electrode,O is the impedance of the electrode relative to the reference point) Is the origin coordinates of the three-dimensional space.
The method of comprehensively analyzing impedance information of all electrodes of the catheter without history data in the cell depicted at 710 is described as follows:
One of the methods is averaging, electrode impedance The expression is as follows:
Another method is weighted average processing, electrode impedance The expression is as follows:
wherein i is the electrode number, nR is the impedance number collected by the electrode, Is the distance between the kth electrode and the reference electrode.
716 Into cell data sets, the data sets stored in the cells being represented asWhereinFor the impedance of the ith pair of adjacent electrodes t on the basket side,For the impedance at time t between the reference electrodes,Recorded centrally for historical dataIs set to be a minimum value of (c),Recorded centrally for historical dataIs set at the maximum value of (c),Is a reference baseline value.
718 Refers to updating the relevant discrimination parameters of the electrode and tissue of the cell where the catheter electrode is located, and mainly comprisesThe specific method is described as follows:
Parameter updating if the impedance between the reference electrodes at time t and the baseline value thereof If the comparison difference is larger than the preset value, the difference cannot be ignored, and if the difference is smaller than or equal to the preset value, the difference can be considered to be absent, and the zero setting treatment is performed.Parameter for updating difference value before and after updatingThe empirically preset value is typically 10% of the differential impedance between the electrode and tissue in contact and not in contact, which approximates the impedance change caused by the change in blood concentration during surgery, such as by a patient's saline drip.
In particular, the method comprises the steps of,The formula of parameter update is:
The formula of parameter update is:
after the parameter at time t is updated, when the difference is smaller than or equal to a preset value, the difference can be considered to be absent, Zero setting treatment:
(3) Model application description
As shown in fig. 8, electrode position and impedance information are input 802, the index of the model table corresponding to the current electrode position is solved 804, 806 is the impedance acquired by applying the discrimination information of the index cell to the current electrode, and 808 is the abutment index. The i electrode t moment, the adhesion discrimination is described as follows:
If it is Greater thanWhen the electrode is identified as being in contact with the electrode at time t, the electrode is identified asOtherwise, it is identified as not being in contact with the surface and recorded as。And (3) withHas the corresponding relation with the corresponding relation between the two parts,In the time-course of which the first and second contact surfaces,. Wherein, the Is the standard deviation of the impedance data set within the cell.
The i electrode t moment, the adherence index is described as follows:
Wherein, the The time distance is pushed forward for time t.The meaning of the expression is the time t and the stability of the contact during a period of time. When (when)If the preset adherence index is greater than the preset adherence index set by the preset adherence index setter 112, the adherence is considered to be stable and effective, otherwise, the adherence is intermittent or not.
512 Displays the update of the contact index of each electrode on the screen 111, updates 113 and 115 the contact degree indication information corresponding to each electrode, and visually presents the contact degree information. The information of whether the electrode is effectively attached or not can be used as an important basis for modeling, mapping and ablation of the heart electrophysiology three-dimensional mapping system.
While the fundamental principles and principal features of the invention and advantages thereof have been shown and described, it will be apparent to those skilled in the art that the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.
Furthermore, it should be understood that although the present disclosure describes embodiments, the embodiments do not include only a single embodiment, and this description is for clarity only, and those skilled in the art should consider the disclosure as a whole, and embodiments may be suitably combined to form other embodiments that will be understood by those skilled in the art.
Claims (7)
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| CN116370062B (en) * | 2023-06-07 | 2023-08-01 | 四川锦江电子医疗器械科技股份有限公司 | Catheter head end and catheter for heart mapping and ablation |
| CN119423952A (en) * | 2023-07-31 | 2025-02-14 | 上海鸿电医疗科技有限公司 | Radiofrequency ablation catheter and radiofrequency ablation device |
| CN119564327B (en) * | 2025-02-10 | 2025-10-03 | 四川锦江电子医疗器械科技股份有限公司 | A catheter capable of performing local ablation |
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| JP7106644B2 (en) * | 2017-12-19 | 2022-07-26 | セント・ジュード・メディカル，カーディオロジー・ディヴィジョン，インコーポレイテッド | A method for assessing contact between electrodes and tissue using complex impedance measurements |
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