CN116983085A - Ablation stove size prediction system and ablation equipment - Google Patents
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Abstract
The invention provides an ablation range size prediction system and ablation equipment, wherein the ablation range size prediction system comprises a parameter acquisition module, a storage module and a data processing module, and the data processing module is in communication connection with the parameter acquisition module and the storage module; the parameter acquisition module acquires ablation parameters; the storage module stores the prediction model; the data processing module calculates the predicted depth, the predicted length and the predicted width of the ablation focus based on the ablation parameters and the prediction model, and further calculates the predicted volume; the size prediction system predicts the size of the ablation focus through three dimensions of depth, length and width, and has high accuracy of prediction results, thereby improving the treatment effect of the ablation operation.
Description
Technical Field
The invention belongs to the technical field of medical equipment, and particularly relates to an ablation stove size prediction system and ablation equipment.
Background
In conventional ablation procedures, the electrodes of the ablation catheter are placed against the myocardium, and the extent and transmural depth of the ablation lesion is dependent on the stability of the ablation catheter when placed against, the catheter placement pressure, power, temperature of the tissue being ablated, and ablation time. An FTI (Force-Time Integral) exponential model, i.e., the Integral of contact Force-Time, was used earlier as a size indicator for the ablation focus. Later, the concept of AI (Ablation Index) exponential model was proposed, which calculates depth of the ablation lesion by a weighted formula of catheter abutment pressure, ablation time and power, the formula being:in the formula, CF (t) is the value of the instantaneous contact force applied to the tissue at the moment t during ablation, P (t) is the value of the instantaneous power lost at the moment t during ablation, t is the duration of ablation, k is the proportionality constant, a and b are constants not equal to 1, and the specific values of k, a and b are determined by regression analysis.
Hypertrophic cardiomyopathy (Hypertrophic cardiomyopathy, HCM) is a cardiomyopathy characterized by a cardiac hypertrophy, which is mainly manifested by a thickening of the left ventricular wall, with a ventricular septum or left ventricular wall thickness of 15mm or more. For hypertrophic cardiomyopathy, common treatment schemes include conventional drug treatment, interventional treatment, ventricular septal myocardial resection and implantation of a pacemaker, wherein the interventional treatment refers to the introduction of energy into a septal branch through a catheter, ablation to form an ablation focus, and myocardial infarction of a hypertrophic part is caused, so that a ventricular septal basal part is thinned to relieve obstruction.
In the prior art, an ablation catheter with a needle is provided, the distal end of the catheter is inserted into a human body through a certain path to reach a designated part of the heart, and meanwhile, a deeper ablation focus is generated by pouring cold saline into the needle and discharging the needle. Unlike conventional ablation catheters, needle-ablation catheters perform discharge ablation by penetrating into the myocardium and creating a lesion inside the tissue, rather than abutting against and creating a lesion at the myocardial surface. Compared with the traditional ablation catheter, the energy utilization of the catheter with the needle is more efficient, and the ablation stove generated under the condition of the same energy is larger, so that the catheter with the needle has a certain clinical risk, and therefore, the accurate prediction of the size of the ablation stove generated by the catheter with the needle is very important for improving the success rate of an ablation operation. Since the needle-bearing ablation catheter does not rest against the myocardial surface, the FTI index model and the AI index model are not suitable for prediction of the ablation size of the needle-bearing ablation catheter.
Disclosure of Invention
The invention aims to provide an ablation focus size prediction system and ablation equipment, which aim to accurately predict the size of an ablation focus generated by a needled ablation catheter so as to improve the success rate of an ablation operation executed by the needled ablation catheter.
In order to achieve the above purpose, the invention provides an ablation stove size prediction system, which comprises a parameter acquisition module, a storage module and a data processing module, wherein the data processing module is in communication connection with the parameter acquisition module and the storage module; wherein the parameter acquisition module is configured to acquire ablation parameters including an exit needle length of the needle electrode, ablation power, an average temperature of ablated tissue during ablation, and an ablation duration; the storage module stores a prediction model; the data processing module is configured to calculate a predicted depth, a predicted length, a predicted width of the ablation focus based on the ablation parameters and the prediction model, and further calculate a predicted volume of the ablation focus based on the predicted depth, the predicted length, and the predicted width; the depth refers to the dimension of the ablation stove in the extending direction of the needle electrode, the length refers to the length of the largest circumscribed rectangle of the projection of the ablation stove on the plane perpendicular to the extending direction of the needle electrode, and the width refers to the width of the largest circumscribed rectangle of the projection of the ablation stove on the plane perpendicular to the extending direction of the needle electrode.
Optionally, the prediction model includes a depth prediction model, a length prediction model, a width prediction model, and a volume prediction model; the calculating the predicted depth, predicted length, predicted width of the ablation focus based on the ablation parameters and the prediction model, and further calculating the predicted volume of the ablation focus based on the predicted depth, the predicted length, and the predicted width comprises: calculating a predicted depth of the ablation focus based on the ablation parameters and the depth prediction model; calculating the predicted length of the ablation focus based on the ablation parameters and the length prediction model; calculating a predicted width of the ablation focus based on the ablation parameters and the width prediction model; and calculating a predicted volume of the ablation focus based on the predicted depth, the predicted length, the predicted width, and the volume prediction model.
Optionally, the depth prediction model is:wherein S is depth Representing the predicted depth of the ablation focus, N representing the needle-out length of the needle electrode, P representing the ablation power, +.>Represents the average temperature of the ablated tissue during the ablation period, t is the duration of the ablation, C 1 As proportionality constants, α1, δ1, β1, γ1 are constants not equal to 1.
Optionally, the length prediction model is:wherein S is length Representing the predicted length of the ablation focus, N representing the needle-out length of the needle electrode, P representing the ablation power, +.>Represents the average temperature of the ablated tissue during the ablation period, t is the duration of the ablation, C 2 As proportionality constants, α2, δ2, β2, γ2 are constants not equal to 1.
Optionally, the width prediction model is:wherein S is width Representing the predicted width of the ablation focus, N representing the needle-out length of the needle electrode, P representing the ablation power, +.>Represents the average temperature of the ablated tissue during the ablation period, t is the duration of the ablation, C 3 As proportionality constants, α3, δ3, β3, γ3 are constants not equal to 1.
Optionally, the volume prediction model is:wherein EI represents the predicted volume, k, of the ablation focus 0 Is a proportionality constant S depth Representing the predicted depth of the ablation focus, S length Representing the predicted length of the ablation focus, S width Representing the predicted width of the ablation focus.
Optionally, the system for predicting the size of the ablation stove further comprises a judging module and an instruction generating module; the judging module is in communication connection with the data processing module and is configured to judge whether the predicted volume of the ablation stove is equal to a target volume; the instruction generation module is communicatively coupled to the determination module and configured to generate an ablation instruction when the predicted volume is equal to the target volume and to generate an ablation instruction when the predicted volume is less than the target volume.
To achieve the above object, the present invention also provides an ablation apparatus comprising: an ablation catheter comprising a catheter body assembly, a needle electrode, and a parameter monitoring device; the tube body assembly has a needle passage; the needle electrode is at least partially disposed in the needle channel and is movable in an axial direction of the needle channel to at least partially protrude from a distal end of the needle channel; the parameter monitoring device is disposed on the shaft assembly and/or on the needle electrode and is configured at least for monitoring a real-time temperature of ablated tissue; the real-time temperature of the ablated tissue is used for acquiring the average temperature of the ablated tissue; an energy generating device connected to the needle electrode of the ablation catheter and configured to provide ablation energy to the needle electrode; and a lesion size predicting system as described previously, the lesion size predicting system being communicatively coupled to the parameter monitoring device and the energy generating device and configured to stop providing ablation energy to the needle electrode when the predicted volume of the lesion is equal to a target volume and to provide ablation energy to the needle electrode when the predicted volume is less than the target volume.
Optionally, the parameter monitoring device is further configured to monitor the needle-out length of the needle electrode.
Optionally, the ablation device further comprises a display device, wherein the display device is in communication connection with the parameter monitoring device and the energy generating device and is configured to display at least one of an outgoing length of the needle electrode, the ablation power, a real-time temperature of ablated tissue, the ablation duration, and a predicted size of the ablation focus, and the predicted size of the ablation focus comprises the predicted depth, the predicted length, the predicted width, and the predicted volume of the ablation focus.
Compared with the prior art, the system for predicting the size of the ablation stove and the ablation equipment have the following advantages: the system for predicting the size of the ablation stove comprises a parameter acquisition module, a storage module and a data processing module, wherein the data processing module is in communication connection with the parameter acquisition module and the storage module; the parameter acquisition module is configured to acquire ablation parameters including the needle-out length of the needle electrode, the ablation power, the average temperature of ablated tissue, and the ablation duration; the storage module stores a prediction model; the data processing module is configured to calculate a predicted depth, a predicted length, a predicted width of the ablation focus based on the ablation parameters and the prediction model, and further calculate a predicted volume based on the predicted depth, the predicted length, and the predicted width; depth refers to the dimension of the ablation focus in the extending direction of the needle electrode, length refers to the length of the largest circumscribed rectangle of the projection of the ablation focus on the plane perpendicular to the extending direction of the needle electrode, and width refers to the width of the largest circumscribed rectangle of the projection of the ablation focus on the plane perpendicular to the extending direction of the needle electrode; the size of the ablation range is predicted in three dimensions of depth, length and width through the ablation parameters and the prediction model, the prediction volume of the ablation range is obtained, the prediction accuracy of the size of the ablation range is improved, and the success rate of the ablation operation executed by the needle-containing ablation catheter is further improved.
Drawings
The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention.
Fig. 1 is a schematic view of an application scenario of an ablation device according to an embodiment of the present invention.
Fig. 2 is a schematic frame diagram of a lesion size predicting system of an ablation device according to an embodiment of the present invention.
Fig. 3 is a schematic view showing definitions of depth, length and width of an ablation focus generated by an ablation device according to an embodiment of the present invention when the ablation device is applied.
Fig. 4 is a schematic diagram of the relationship between depth of an ablation focus and needle length of a needle electrode when performing an in vitro simulated ablation procedure with a needle ablation catheter.
Fig. 5 is a schematic diagram of the relationship between depth of an ablation focus and ablation power when performing an in vitro simulated ablation procedure with a needle ablation catheter.
Fig. 6 is a graphical representation of the relationship between depth of an ablation focus and average temperature of ablated tissue when performing an in vitro simulated ablation procedure with a needle ablation catheter.
Fig. 7 is a schematic diagram of the relationship between depth of an ablation focus and length of ablation time when performing an in vitro simulated ablation procedure with a needle ablation catheter.
Fig. 8 is a surgical flow chart of an ablation device provided in accordance with an embodiment of the present invention when performing an ablation procedure.
In the drawings: 10-an ablation stove, 100-an ablation catheter, 110-a tube body assembly, 120-a needle electrode, 200-an energy generating device, 310-a parameter acquisition module, 320-a storage module, 330-a data processing module, 340-a judging module, 350-a command generating module and 400-a display device.
Detailed Description
Additional advantages and features of the present invention will become readily apparent to those skilled in the art from the following detailed description, which describes the embodiments of the present invention with reference to the accompanying drawings. The invention may be practiced or carried out in other embodiments that depart from the specific details disclosed herein and that may be modified or varied from the spirit and scope of the present invention. It should be noted that, the schematic diagrams provided in the present embodiment only illustrate the basic concept of the present invention by the schematic formulas, and only the components related to the present invention are shown in the schematic formulas, rather than being drawn according to the number, shape and size of the components in actual implementation, and the form, number and proportion of each component in actual implementation may be changed at will, and the layout of the components may be more complex.
In addition, each embodiment of the following description has one or more features, respectively, which does not mean that the inventor must implement all features of any embodiment at the same time, or that only some or all of the features of different embodiments can be implemented separately. In other words, those skilled in the art can implement some or all of the features of any one embodiment or a combination of some or all of the features of multiple embodiments selectively, depending on the design specifications or implementation requirements, thereby increasing the flexibility of the implementation of the invention where implemented as possible.
As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural form "the" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, as for example, they may be fixed, they may be removable, or they may be integrally connected. Either mechanically or electrically. Can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. Relational terms such as first, second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions, nor does it indicate or imply relative importance or number of technical features indicated. It is to be understood that the terms "center," "longitudinal," "transverse," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "axial," "radial," "circumferential," and the like, as indicated by the azimuth or positional relationship shown in the drawings, are merely for convenience of description and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular azimuth, be configured and operated in a particular azimuth, and therefore should not be construed as limiting the invention. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
Reference herein to "proximal" and "distal" refer to the relative positional relationship, relative orientation, between the various components of the medical device, and, although not limiting, "distal" generally refers to the end of the medical device that first enters the patient during normal use, and "proximal" is the opposite end from "distal".
The invention aims to provide an ablation stove size prediction system and an ablation device comprising the same, the ablation device further comprises an ablation catheter with a needle, and the ablation stove size prediction system can accurately predict the size of an ablation stove generated when the ablation catheter with the needle executes an ablation operation, so that the ablation stopping time is judged in an auxiliary mode, the success rate of the ablation operation is improved, and the treatment effect is improved.
The invention will be further described in detail with reference to the accompanying drawings, in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are all of very simplified formulas and all use non-precise proportions for convenience and clarity in assisting in describing embodiments of the invention. The same or similar reference numbers in the drawings refer to the same or similar parts.
Fig. 1 shows a schematic diagram of an application scenario of an ablation device according to an embodiment of the present invention. As shown in fig. 1, the ablation device includes an ablation catheter 100, an energy generating device 200, and a lesion size prediction system (not labeled in fig. 1).
Wherein the ablation catheter 100 includes a shaft assembly 110, a needle electrode 120, and a parameter monitoring device (not shown). The shaft assembly 110 has a needle passage (not shown). The needle electrode 120 is at least partially disposed in the needle channel and is movable in an axial direction of the needle channel to at least partially protrude from a distal end of the needle channel. The parameter monitoring device is disposed on the shaft assembly 110 and/or the needle electrode 120 and is configured to monitor a portion of an ablation parameter. The ablation parameters include real-time temperature of the tissue being ablated, needle length of the needle electrode 120, etc. Correspondingly, the parameter monitoring module comprises a temperature monitoring module and a needle outlet length monitoring module. The temperature monitoring module may be disposed within the needle electrode 120 and configured to monitor a real-time temperature of the ablated tissue for obtaining an average temperature of the ablated tissue. The needle length monitoring module may be disposed on the shaft assembly 110 and used to monitor the needle length of the needle electrode 120. Those skilled in the art will appreciate that the ablation catheter 100 is prior art and thus the specific structure thereof will not be described in detail herein.
The energy generating device 200 is adapted to be coupled to the needle electrode 120 and to provide ablation energy to the needle electrode 120 such that the needle electrode 120 delivers the ablation energy to the ablated tissue to form the ablation site 10 (shown in fig. 3) on the ablated tissue.
The lesion size prediction system is in communicative connection with the parameter monitoring device and the energy generating device 200 and is configured to obtain at least a real-time temperature of tissue being ablated from the monitoring device; the lesion size prediction system is further configured for obtaining a predicted size of the lesion 10 based on the ablation parameters. The predicted size of the ablation lesion 10 is used to determine whether it is necessary to stop performing an ablation operation.
Fig. 2 shows a schematic frame diagram of the lesion size prediction system. As shown in fig. 2, the system for predicting the size of the ablation focus includes a parameter acquisition module 310, a storage module 320 and a data processing module 330, wherein the data processing module 330 is communicatively connected with the parameter acquisition module 310 and the storage module 320. Wherein the parameter obtaining module 310 is configured to obtain ablation parameters, and the ablation parameters according to the embodiment of the present invention include an outgoing length of the needle electrode 120, an ablation power, an average temperature of an ablated tissue during ablation, and an ablation duration. Wherein the average temperature of the ablated tissue during ablation can be obtained according to the real-time temperature of the ablated tissue at different moments during ablation, and the parameter obtaining module 310 is in communication with the parameter monitoring module and is at least used for obtaining the real-time temperature of the ablated tissue. The needle length and the ablation power of the needle electrode 120 may be predetermined according to the tissue thickness of the tissue to be ablated, specifically, the target size of the ablation focus 10 is determined according to the tissue thickness, the target size includes a target depth, a target length, a target width and a target volume, and then the needle length and the ablation power of the needle electrode 120 are determined according to the target size of the ablation focus 10. For example, when the target depth is between 6mm and 12mm, the needle electrode 120 may be determined to have a specific value of between 6mm and 10mm, the ablation power may be determined to have a specific value of between 10W and 30W, and the determined needle length and the ablation power may be transmitted to the parameter acquisition module 310. Typically, the needle exit length remains constant during ablation and the ablation power is substantially constant during ablation. Of course, the needle-out length may also be obtained by the needle-out length monitoring module of the parameter monitoring device. The ablation time period may be acquired by the parameter acquisition module 310 via a timer, which may be disposed at any suitable location, such as at the energy generating device 200, that obtains the ablation time period by counting the time period during which the energy generating device 200 provides ablation energy to the needle electrode 120.
Here, as shown in fig. 3, the depth of the ablation lesion 10 refers to a dimension D of the ablation lesion 10 in the extending direction of the needle electrode 120, the length of the ablation lesion 10 refers to a length L of a maximum circumscribed rectangle of a projection of the ablation lesion 10 on a plane perpendicular to the extending direction of the needle electrode 120, and the width of the ablation lesion 10 refers to a width W of a maximum circumscribed rectangle of a projection of the ablation lesion 10 on a plane perpendicular to the extending direction of the needle electrode 120.
The storage module 320 stores a predictive model. In addition, the storage module 320 may be further communicatively connected to the parameter acquisition module 310, and store the ablation parameters acquired by the parameter acquisition module 310.
The data processing module 330 is configured to calculate a predicted size of the ablation lesion 10 based on the ablation parameters and the predictive model. The predicted dimensions include a predicted depth, a predicted length, a predicted width, and a predicted volume. Specifically, the data processing module 330 calculates the predicted depth, the predicted length, and the predicted width of the ablation focus 10, and calculates the predicted volume of the ablation focus 10 based on the predicted depth, the predicted length, and the predicted width of the ablation focus 10. In other words, the size prediction system predicts the size of the ablation scope 10 from three dimensions of depth, length and width, so that the size prediction of the ablation scope 10 is more accurate, the time for stopping ablation can be more accurately judged, and the treatment effect of the ablation operation is improved.
In detail, the prediction models stored by the storage module 320 include a depth prediction model, a length prediction model, a width prediction model, and a volume prediction model. And, the data processing module 330 is configured to calculate a predicted depth of the ablation lesion 10 based on the ablation parameters and the depth prediction model; calculating a predicted length of the ablation focus 10 based on the ablation parameters and the length prediction model; calculating a predicted width of the ablation focus 10 based on the ablation parameters and the width prediction model; and calculating a predicted volume of the ablation lesion 10 based on the predicted depth, the predicted length, the predicted width of the ablation lesion 10, and the volume prediction model.
Wherein the depth prediction model is expressed as formula (1):in the formula (1), S depth Represents the predicted depth at the ablation focus 10, N represents the needle-out length of the needle electrode, P represents the ablation power,/->Represents the average temperature of the ablated tissue during the ablation period, t is the duration of the ablation, C 1 All of α1, δ1, β1, and γ1 are constants not equal to 1.
The length prediction model is expressed as formula (2):in the formula (2), S length Represents the predicted length of the ablation focus 10, N represents the needle-out length of the needle electrode 120, P represents the ablation power, +.>Represents the average temperature of the ablated tissue during the ablation period, t is the duration of the ablation, C 2 All of α2, δ2, β2, and γ2 are constants not equal to 1.
The width prediction model is expressed as formula (3):in the formula (3), S width Represents the predicted width of the ablation focus 10, N represents the needle-out length of the needle electrode 120, P represents the ablation power, +.>Represents the average temperature of the ablated tissue within the time from 0 to t, t is the ablation time length, C 3 All of α3, δ3, β3, and γ3 are constants not equal to 1.
The volume prediction model is tabulatedShown as formula (4):in the formula (4), EI represents the predicted volume, k, of the ablation stove 10 0 Is a proportionality constant.
The derivation of the depth prediction model is described next.
Those skilled in the art will appreciate that the primary factors affecting the size of the ablation focus 10 include: the diameter of the needle electrode 120, the contact area of the needle electrode 120 with the tissue, the electrical conductivity of the ablated tissue, the temperature of the ablated tissue during ablation, the ablation power, the ablation time. Thus, the depth of the ablation focus 10 may be estimated according to equation (5), equation (5) being:in the formula (5), S 0 Representing the estimated depth, k, of the ablation lesion 10 1 Is a proportionality constant, T is the temperature of the ablated tissue, D ζ For the diameter of the needle electrode 120, ΔR is the impedance change of the ablated tissue during ablation, and t is the duration of ablation. Wherein the temperature of the ablated tissue during ablation is substantially unchanged, so that the mean temperature +.>The temperature T is indicated.
In practice, the diameter D of the needle electrode 120 ζ A constant value may be considered a constant. The ablated tissue has a correlation between the impedance change Δr during ablation and the ablation power P, and the person skilled in the art knows how to determine this correlation according to the specific ablation device.
According to equation (5), the estimated depth of the ablation focus 10 is linearly related to any one of the needle length of the needle electrode 120, the ablation power, the temperature of the ablated tissue (or the average temperature of the ablated tissue), and the ablation time period. However, the simulated ablation procedure is performed by the controlled variable method, and a relationship between the depth of the ablation focus 10 and the needle-out length of the needle electrode 120, which is the simulated ablation procedure, is shown in fig. 4, a relationship between the depth of the ablation focus 10 and the ablation power is shown in fig. 5, a relationship between the depth of the ablation focus 10 and the average temperature of the tissue to be ablated is shown in fig. 6, and a relationship between the depth of the ablation focus 10 and the ablation time period is shown in fig. 7. As can be seen from fig. 4 to 7, the actual depth of the ablation focus 10 is not in a linear relationship with any one of the needle length, the ablation power, the average temperature of the ablated tissue, and the ablation time period of the needle electrode 120, but in an exponential relationship.
Thereby, a nonlinear equation (6) is reconstructed to calculate the predicted depth of the ablation site 10, where equation (6) is:in the formula (6), S depth Representing the predicted depth of the ablation focus 10,as a proportionality constant, N (T) represents the instantaneous needle-out length of the needle electrode 120, P (T) represents the instantaneous ablation power, T (T) represents the temperature of the ablated tissue, and δ1, α1, β1, and γ1 are constants other than 1.
As before, the needle-out length of the needle electrode 120 remains constant during ablation. Thus, equation (6) can be rewritten as equation (7), equation (7) being:，/>is a proportionality constant, which is equal to->Are not equal.
Further, the ablation power throughout the ablation period fluctuates up and down at the set ablation power, which can be approximately considered constant, i.e., the ablation power remains constant during the ablation period. Thus, equation (7) is further rewritten as equation (8), equation (8) being:。
the temperature of the ablated tissue during ablation is almost unchanged, then equation (9) exists, equation (9) being:in formula (9), ∈>Representing the average temperature of the ablated tissue during ablation.
Substituting the formula (9) into the formula (8) to obtain a depth prediction model of the ablation stove 10 as formula (1):。
wherein C is 1 The values of α1, β1, γ1 can be determined experimentally and calibrated. The specific process is that the logarithm of the formula (1) is firstly taken and adjusted to obtain the formula (10), and the formula (10) is as follows:. Then substituting the numerical value obtained by the in vitro simulated ablation experiment into a formula (10) to obtain C 1 Specific values of α1, β1, γ1, δ1. In addition, in the process of obtaining C 1 After specific values of α1, β1, γ1, δ1, linear regression analysis can also be used to evaluate the C found 1 Accuracy of α1, β1, γ1, δ1.
Based on the same method, the length prediction model and the width prediction model may be derived, which are not described here in detail. Furthermore, for the volume prediction model, a proportionality constant k therein 0 The specific value of (2) is calculated by simulating the result of the ablation operation in vitro.
The inventors have shown through extensive experimentation that the predicted volume of the ablation lesion 10 has good repeatability for a given type of myocardial structure and a given tissue characteristic. Therefore, for a given myocardial structure and tissue characteristics, after obtaining a corresponding prediction model through in vitro performed simulated ablation surgery test, the prediction model is stored in the storage module 320 of the ablation focus size prediction system, so that the prediction model can be directly called when performing ablation surgery on the corresponding myocardial structure and tissue characteristics. Furthermore, the predicted volume of the ablation focus 10 may be different for different myocardial structures and tissue characteristics.
Preferably, the ablation apparatus further comprises a display device 400, said display device 400 being communicatively connected to the data processing module 330 of the lesion size prediction system and being at least configured for receiving and displaying the predicted size.
In some embodiments, the operator may manually determine whether ablation needs to be stopped based on the predicted size displayed. In other embodiments, the lesion size prediction system further comprises a judgment module 340 and an instruction generation module 350. Wherein the determination module 340 is communicatively coupled to the data processing module 330 and configured to determine whether the predicted volume of the ablation focus 10 is equal to the target volume. The instruction generation module 350 is communicatively coupled to the determination module 340 and configured to generate an ablation instruction when the predicted volume of the ablation focus 10 is less than the target volume and to generate a stop ablation instruction when the predicted volume of the ablation focus 10 is equal to the target volume.
Meanwhile, the energy generating device 200 is in communication with the instruction generating module 350, and provides ablation energy to the needle electrode 120 according to the ablation instruction, so that the ablation catheter 100 continues to perform the ablation operation, or stops providing ablation energy to the needle electrode 120 according to the ablation stopping instruction, so that the ablation operation is stopped.
In addition, the display device 400 may be communicatively coupled to the parameter monitoring device and configured to receive and display the needle length of the needle electrode 120, the real-time temperature of the tissue being ablated. The display device 400 may also be communicatively coupled to the energy generating device 200 and configured to receive and display ablation power. The display device 400 may also display the ablation time period. Of course, the display device 400 may also display other images of interest, such as images of the heart.
Thus, a flowchart of performing cardiac ablation operation with the ablation device and automatically determining whether ablation needs to be stopped according to the predicted size of the ablation lesion 10 by the ablation device is shown in fig. 8. Referring to fig. 8, the procedure of the ablation procedure includes the following steps S1 to S10.
Step S1, obtaining the thickness of the ablated tissue and the target volume of the ablation focus 10.
And S2, determining ablation parameters.
Step S3, controlling the energy generating device 200 to supply ablation energy to the needle electrode 120, and performing an ablation operation.
Step S4, the parameter obtaining module 310 of the ablation focus size prediction system obtains an ablation parameter.
Step S5, the data processing module 330 of the ablation focus size prediction system calculates the predicted depth, the predicted length and the predicted width of the ablation focus 10 based on the ablation parameters and the prediction model stored by the storage module 320.
Step S6, the data processing module 330 calculates the predicted volume based on the predicted depth, the predicted length, and the predicted width of the ablation focus 10.
Step S7, the judging module 340 judges whether the predicted volume of the ablation stove 10 is equal to the target volume, if yes, step S8 and step S9 are executed, and if the predicted volume is smaller than the target volume, step S10 is executed.
Step S8, the instruction generating module 350 generates an ablation stopping instruction.
Step S9, the energy generating module 200 stops supplying ablation energy to the needle electrode 120 to stop ablation.
Step S10, the instruction generating module 350 generates an ablation instruction, and continues to execute step S3 and the subsequent steps.
Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, it is intended that the present invention also include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.
Claims (10)
1. The system for predicting the size of the ablation stove is characterized by comprising a parameter acquisition module, a storage module and a data processing module, wherein the data processing module is in communication connection with the parameter acquisition module and the storage module; wherein,,
the parameter acquisition module is configured to acquire ablation parameters including an exit needle length of the needle electrode, ablation power, an average temperature of ablated tissue during ablation, and an ablation duration;
the storage module stores a prediction model;
the data processing module is configured to calculate a predicted depth, a predicted length, a predicted width of the ablation focus based on the ablation parameters and the prediction model, and further calculate a predicted volume of the ablation focus based on the predicted depth, the predicted length, and the predicted width; the depth refers to the dimension of the ablation stove in the extending direction of the needle electrode, the length refers to the length of the largest circumscribed rectangle of the projection of the ablation stove on the plane perpendicular to the extending direction of the needle electrode, and the width refers to the width of the largest circumscribed rectangle of the projection of the ablation stove on the plane perpendicular to the extending direction of the needle electrode.
2. The lesion size prediction system according to claim 1, wherein the prediction model comprises a depth prediction model, a length prediction model, a width prediction model, and a volume prediction model;
the calculating the predicted depth, predicted length, predicted width of the ablation focus based on the ablation parameters and the prediction model, and further calculating the predicted volume of the ablation focus based on the predicted depth, the predicted length, and the predicted width comprises:
calculating a predicted depth of the ablation focus based on the ablation parameters and the depth prediction model;
calculating the predicted length of the ablation focus based on the ablation parameters and the length prediction model;
calculating a predicted width of the ablation focus based on the ablation parameters and the width prediction model; the method comprises the steps of,
a predicted volume of the ablation focus is calculated based on the predicted depth, the predicted length, the predicted width, and the volume prediction model.
3. The lesion size prediction system according to claim 2, wherein the depth prediction model is:
wherein S is depth Representing the predicted depth of the ablation focus, N representing the needle-out length of the needle electrode, P representing ablation power,represents the average temperature of the ablated tissue during the ablation period, t is the duration of the ablation, C 1 As proportionality constants, α1, δ1, β1, γ1 are constants not equal to 1.
4. The lesion size prediction system according to claim 2, wherein the length prediction model is:
wherein S is length Represents the predicted length of the ablation focus, N represents the needle-out length of the needle electrode, P represents the ablation power,representing the ablated tissue during ablationAverage temperature, t is ablation duration, C 2 As proportionality constants, α2, δ2, β2, γ2 are constants not equal to 1.
5. The lesion size prediction system according to claim 2, wherein the width prediction model is:
wherein S is width Represents the predicted width of the ablation focus, N represents the needle outlet length of the needle electrode, P represents the ablation power,represents the average temperature of the ablated tissue during the ablation period, t is the duration of the ablation, C 3 As proportionality constants, α3, δ3, β3, γ3 are constants not equal to 1.
6. The lesion size prediction system according to claim 2, wherein the volumetric prediction model is:
wherein EI represents the predicted volume, k, of the ablation focus 0 Is a proportionality constant S depth Representing the predicted depth of the ablation focus, S length Representing the predicted length of the ablation focus, S width Representing the predicted width of the ablation focus.
7. The system of claim 1, further comprising a determination module and an instruction generation module; the judging module is in communication connection with the data processing module and is configured to judge whether the predicted volume of the ablation stove is equal to a target volume; the instruction generation module is communicatively coupled to the determination module and configured to generate an ablation instruction when the predicted volume is equal to the target volume and to generate an ablation instruction when the predicted volume is less than the target volume.
8. An ablation device, comprising:
an ablation catheter comprising a catheter body assembly, a needle electrode, and a parameter monitoring device; the tube body assembly has a needle passage; the needle electrode is at least partially disposed in the needle channel and is movable in an axial direction of the needle channel to at least partially protrude from a distal end of the needle channel; the parameter monitoring device is disposed on the shaft assembly and/or on the needle electrode and is configured at least for monitoring a real-time temperature of ablated tissue; the real-time temperature of the ablated tissue is used for acquiring the average temperature of the ablated tissue;
an energy generating device connected to the needle electrode of the ablation catheter and configured to provide ablation energy to the needle electrode; the method comprises the steps of,
the lesion size prediction system according to any of claims 1-7, communicatively coupled to the parameter monitoring device and the energy generating device, and configured to stop providing ablation energy to the needle electrode when the predicted volume of the lesion is equal to a target volume, and to provide ablation energy to the needle electrode when the predicted volume is less than the target volume.
9. The ablation apparatus of claim 8, wherein the parameter monitoring device is further configured to monitor an exit needle length of the needle electrode.
10. The ablation apparatus of claim 8, further comprising a display device communicatively coupled to the parameter monitoring device and the energy generating device and configured to display at least one of an outgoing length of the needle electrode, the ablation power, a real-time temperature of ablated tissue, the ablation duration, a predicted size of the ablation focus, the predicted size of the ablation focus including the predicted depth, the predicted length, the predicted width, and the predicted volume of the ablation focus.
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