CN117838284A - Control method of pulse ablation catheter and pulse ablation catheter - Google Patents
Control method of pulse ablation catheter and pulse ablation catheter Download PDFInfo
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- 238000000034 method Methods 0.000 title claims abstract description 41
- 238000004448 titration Methods 0.000 claims abstract description 40
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- 230000008859 change Effects 0.000 claims abstract description 13
- 238000012360 testing method Methods 0.000 claims description 22
- 238000011156 evaluation Methods 0.000 claims description 6
- 235000002595 Solanum tuberosum Nutrition 0.000 description 18
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- 208000003734 Supraventricular Tachycardia Diseases 0.000 description 10
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
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- A61B5/316—Modalities, i.e. specific diagnostic methods
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00613—Irreversible electroporation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00696—Controlled or regulated parameters
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Abstract
The invention provides a control method of a pulse ablation catheter and the pulse ablation catheter, wherein the control method of the pulse ablation catheter comprises the following steps: acquiring a pulse ablation index of the depth of an ablation focus of the pulse ablation catheter relative to the discharge parameter based on a titration method; acquiring a safe discharge relation of an electrocardiosignal change condition about the distance between an ablation target point of the pulse ablation catheter and an atrioventricular node and a discharge parameter based on a titration method; acquiring an actual distance between an ablation target point of the pulse ablation catheter and an atrioventricular node, obtaining an expected discharge parameter according to the actual distance and the safe discharge relation, and obtaining a predicted ablation range depth according to the expected discharge parameter and the pulse ablation index; and when the predicted depth of the ablation focus meets the expected requirement, performing discharge based on the expected discharge parameter. By the configuration, the situations such as conduction block and the like can be effectively avoided, and the clinical operation is facilitated.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a control method of a pulse ablation catheter and the pulse ablation catheter.
Background
Supraventricular tachycardia (SVT) is a common arrhythmia symptom caused by tachycardia. Supraventricular tachycardia (SVT) attacks with very fast heart rates (up to 100 or more beats per minute) and may last from a few minutes to several days, and patients often suffer from symptoms such as weakness and tiredness, chest pain, shortness of breath, sweating, dizziness and fainting. Over time, frequent episodes of supraventricular tachycardia (SVT) can weaken the heart and lead to heart failure, and in extreme cases, supraventricular tachycardia (SVT) episodes can lead to loss of consciousness or cardiac arrest.
Traditional cardiac radio frequency ablation can only ablate at a position far away from the atrioventricular node, but cannot ablate near the atrioventricular node, because the size and shape of a radio frequency ablation range are difficult to control accurately, and the radio frequency ablation near the atrioventricular node can easily cause electrocardio conduction block, and can cause death of a patient in serious cases.
Pulsed electric field ablation surgery is an emerging method of treating supraventricular tachycardia (SVT) that utilizes a high voltage (at or above 1000V) and short duration (microsecond) pulsed electric field to cause target tissue damage through an irreversible electroporation mechanism. Compared with radio frequency ablation, pulsed electric field ablation can accurately control the total energy of pulsed ablation by adjusting the single pulse discharge dose (minimum of 0.01J) and the pulse discharge times, so that the energy of pulsed electric field ablation is relatively easier to quantify.
However, even though the energy of pulsed electric field ablation can be quantified, the size and depth of pulsed electric field ablation foci are difficult to predict accurately, especially for ablation near the atrioventricular node, and when the size and depth of the ablation foci are outside of the expected range, electrocardiographic conduction blocks are easily caused.
Disclosure of Invention
The invention aims to provide a control method of a pulse ablation catheter and the pulse ablation catheter, so as to solve the problem that the depth of an ablation range is difficult to predict.
In order to solve the above technical problems, the present invention provides a control method of a pulse ablation catheter, which includes:
acquiring a pulse ablation index of the depth of an ablation focus of the pulse ablation catheter relative to the discharge parameter based on a titration method;
acquiring a safe discharge relation of an electrocardiosignal change condition about the distance between an ablation target point of the pulse ablation catheter and an atrioventricular node and a discharge parameter based on a titration method;
acquiring an actual distance between an ablation target point of the pulse ablation catheter and an atrioventricular node, obtaining an expected discharge parameter according to the actual distance and the safe discharge relation, and obtaining a predicted ablation range depth according to the expected discharge parameter and the pulse ablation index;
and when the predicted depth of the ablation focus meets the expected requirement, performing discharge based on the expected discharge parameter.
Optionally, the discharge parameters include a discharge voltage, a discharge pulse width, and a discharge number.
Optionally, the expression of the pulse ablation index is:
wherein D is depth of an ablation range, A is a constant, n is discharge times, U is discharge voltage, W is discharge pulse width, deltaZ is an impedance change value, F is an abutment force value, a, b, c, D and e are power indexes of parameters n, U, W, deltaZ and F respectively, and the value ranges of a, b, c, D and e are 0-3 respectively.
Optionally, the expression of the pulse ablation index is:
wherein D is the depth of the ablation range, A and B are constants, n is the number of discharges, U is the discharge voltage, W is the discharge pulse width, deltaZ is the impedance variation value, F is the abutment force value, a, B, c, D and e are the power indexes of parameters n, U, W, deltaZ and F respectively, and the value ranges of a, B, c, D and e are 0-3 respectively.
Optionally, the control method of the pulse ablation catheter further comprises:
and acquiring an abutting force value of the pulse ablation catheter, and executing discharge based on the expected discharge parameter when the abutting force value is within a preset force value interval.
Optionally, the control method of the pulse ablation catheter further comprises:
on the premise of fixing discharge parameters, acquiring the pressure relation of the depth of an ablation stove relative to the contact force value of the pulse ablation catheter by a titration method;
in the step of obtaining the predicted depth of the ablation focus according to the expected discharge parameter and the pulse ablation index, the predicted depth of the ablation focus is corrected based on the actual abutting force value of the pulse ablation catheter and the pressure relation.
Optionally, the control method of the pulse ablation catheter further comprises:
on the premise of fixing discharge parameters, acquiring the stability relation of the depth of an ablation stove relative to the head end position of the pulse ablation catheter by a titration method;
in the step of obtaining a predicted ablation focus depth according to the expected discharge parameter and the pulse ablation index, the predicted ablation focus depth is corrected based on the actual head end position of the pulse ablation catheter and the stability relationship.
Optionally, the step of performing the discharge based on the expected discharge parameter comprises:
performing a single test discharge based on the expected discharge parameter;
and evaluating the result of the single trial discharge, and if the evaluation result meets the set condition, executing the discharge according to the expected discharge times.
In order to solve the above technical problem, the present invention further provides a pulse ablation catheter, which includes: a catheter body, electrodes, and a control module;
the electrode is arranged on the catheter body;
the control module is configured to control the electrode discharge according to the control method of the pulse ablation catheter as described above.
Optionally, the pulse ablation catheter further includes a pressure sensor, where the pressure sensor is disposed on the catheter body, and the pressure sensor is configured to obtain an abutment force value and send the abutment force value to the control module.
In summary, in the control method of the pulse ablation catheter and the pulse ablation catheter provided by the invention, the control method of the pulse ablation catheter comprises the following steps: acquiring a pulse ablation index of the depth of an ablation focus of the pulse ablation catheter relative to the discharge parameter based on a titration method; acquiring a safe discharge relation of an electrocardiosignal change condition about the distance between an ablation target point of the pulse ablation catheter and an atrioventricular node and a discharge parameter based on a titration method; acquiring an actual distance between an ablation target point of the pulse ablation catheter and an atrioventricular node, obtaining an expected discharge parameter according to the actual distance and the safe discharge relation, and obtaining a predicted ablation range depth according to the expected discharge parameter and the pulse ablation index; and when the predicted depth of the ablation focus meets the expected requirement, performing discharge based on the expected discharge parameter.
So configured, the pulse ablation index is obtained by titration, and the depth of the ablation range of a pulse ablation catheter of a certain type under different discharge parameters can be obtained. And acquiring a safe discharge relation by a titration method, and guiding to select a safe expected discharge parameter based on the actual distance between the ablation target and the atrioventricular node. And then discharge is carried out according to expected discharge parameters when the depth of the predicted ablation focus meets the expectation, thereby effectively avoiding the situations of conduction block and the like and helping the clinical operation to be carried out smoothly.
Drawings
Those of ordinary skill in the art will appreciate that the figures are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention. Wherein:
FIG. 1 is a schematic illustration of a pulse ablation catheter in accordance with an embodiment of the present invention;
FIG. 2 is a schematic diagram of an ablation focus for performing test discharge on potatoes by titration according to an embodiment of the invention;
FIG. 3 is a schematic view of the depth of the lesion of the potato at different discharge voltages and discharge times based on the test discharge of FIG. 2;
FIG. 4 is a schematic diagram of the accuracy range of a pulse ablation index in accordance with an embodiment of the present invention;
FIGS. 5a and 5b are schematic views of an embodiment of the present invention showing an electrocardiogram of 1 discharge with a 1500V discharge voltage near the atrioventricular node;
FIGS. 5c and 5d are specific electrocardiographic representations of embodiments of the present invention discharged multiple times with a discharge voltage of 1500V near the atrioventricular node;
FIG. 6 is a schematic diagram of the relationship between the distance of an ablation target from an atrioventricular node and a safety voltage according to an embodiment of the invention;
FIG. 7a is a schematic top view of an ablation focus of a pulse ablation catheter of an embodiment of the invention at different abutment distances;
FIG. 7b is a schematic side view of a pulse ablation catheter of an embodiment of the invention at different abutment distances;
FIG. 8 is a schematic diagram of performing a discharge when the contact force value is within a preset force value interval according to an embodiment of the present invention;
fig. 9a, 9b, 9c are schematic diagrams of titration ablation versus depth of ablation focus at different abutment stabilities according to embodiments of the present invention.
In the accompanying drawings:
10-catheter body; 11-electrodes; 111-head electrode; 112-ring electrode; 12-an insulating layer; 13-pressure sensor.
Detailed Description
The invention will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.
As used in this disclosure, the singular forms "a," "an," "the," and "the" include plural referents, the term "or" is generally used in the sense of comprising "and/or" and the term "several" is generally used in the sense of comprising "at least one," the term "at least two" is generally used in the sense of comprising "two or more," and, furthermore, the terms "first," "second," "third," are used for descriptive purposes only and are not to be construed as indicating or implying any particular importance or quantity of technical features indicated. Thus, a feature defining "first," "second," "third," or the like, may explicitly or implicitly include one or at least two such features, with "one end" and "another end" and "proximal end" and "distal end" generally referring to the corresponding two portions, including not only the endpoints. The terms "proximal" and "distal" are defined herein with respect to a pulsed ablation catheter having one end for intervention into the human body and a manipulation end extending outside the body. The term "proximal" refers to a position closer to the manipulation end of the pulse ablation catheter that extends outside the body, and the term "distal" refers to a position closer to the end of the pulse ablation catheter that is to be inserted into the body and thus further from the manipulation end of the pulse ablation catheter. Alternatively, in a manual or hand-operated application scenario, the terms "proximal" and "distal" are defined herein with respect to an operator, such as a surgeon or clinician. The term "proximal" refers to a location closer to the operator, and the term "distal" refers to a location closer to the pulsed ablation catheter and thus farther from the operator. Furthermore, as used in this disclosure, "mounted," "connected," and "disposed" with respect to another element should be construed broadly to mean generally only that there is a connection, coupling, mating or transmitting relationship between the two elements, and that there may be a direct connection, coupling, mating or transmitting relationship between the two elements or indirectly through intervening elements, and that no spatial relationship between the two elements is to be understood or implied, i.e., that an element may be in any orientation, such as internal, external, above, below, or to one side, of the other element unless the context clearly dictates otherwise. 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. Furthermore, directional terms, such as above, below, upper, lower, upward, downward, left, right, etc., are used with respect to the exemplary embodiments as they are shown in the drawings, upward or upward toward the top of the corresponding drawing, downward or downward toward the bottom of the corresponding drawing.
The invention aims to provide a control method of a pulse ablation catheter, a readable storage medium and the pulse ablation catheter, so as to solve the problem that the depth of an ablation range is difficult to predict. The following description refers to the accompanying drawings.
Referring to fig. 1, an embodiment of the present invention provides a pulse ablation catheter, which includes a catheter body 10, an electrode 11 and a control module (not shown); the electrode 11 is arranged on the catheter body 10; the control module is used for controlling the discharge of the electrode 11. In an alternative example, the electrode 11 includes a head electrode 111 and a plurality of ring electrodes 112 (the example shown in fig. 1 includes 3 ring electrodes, namely, ring electrode 112a, ring electrode 112b and ring electrode 112 c), wherein the head electrode 111 is disposed at the distal end (left end in fig. 1) of the catheter body 10, the diameter of the head electrode 111 is 1.5mm to 3mm, and the width (distance in the axial direction) of the head electrode 111 is 1mm to 4mm. The diameter of the ring electrode 112 is 1.5mm to 3mm, and the width (the distance along the axial direction) of the ring electrode 112 is 0.5mm to 4mm. Preferably, the pulse ablation catheter further comprises a plurality of insulating layers 12, wherein the insulating layers 12 are arranged between the head electrode 111 and the plurality of ring electrodes 112 for separating the electrodes (including the head electrode 111 and the ring electrodes 112, etc.). It should be noted that the pulse ablation catheter shown in fig. 1 is only an exemplary embodiment of the pulse ablation catheter and is not a limitation of the structure of the pulse ablation catheter, and those skilled in the art may modify the structure of the pulse ablation catheter according to the actual embodiment, which is not limited in this invention.
In order to solve the problem that the depth of an ablation focus is difficult to predict, the embodiment of the invention provides a control method of a pulse ablation catheter, which comprises the following steps:
step S1: acquiring a pulse ablation index of the depth of an ablation focus of the pulse ablation catheter relative to the discharge parameter based on a titration method;
step S2: acquiring a safe discharge relation of an electrocardiosignal change condition about the distance between an ablation target point of the pulse ablation catheter and an atrioventricular node and a discharge parameter based on a titration method;
step S3: acquiring an actual distance between an ablation target point of the pulse ablation catheter and an atrioventricular node, obtaining an expected discharge parameter according to the actual distance and the safe discharge relation, and obtaining a predicted ablation range depth according to the expected discharge parameter and the pulse ablation index;
step S4: and when the predicted depth of the ablation focus meets the expected requirement, performing discharge based on the expected discharge parameter.
Titration is an effective method for quantifying depth of an ablation focus and electrocardiosignal variation. Due to the energy controllability of pulse electric field ablation and the microminiaturization of single pulse discharge energy, different pulse energies can be adopted to perform titration ablation to obtain corresponding ablation depth and electrocardiosignal change conditions, so that a pulse ablation index and safe discharge relationship can be obtained to guide actual ablation.
If the discharge energy of the single pulse electric field is small enough, all discharge parameters can be exhausted, and the depth of an ablation stove of a certain pulse ablation catheter or a certain type of pulse ablation catheter under each discharge parameter can be theoretically obtained. For the same root or the same type of pulse ablation catheter, different discharge parameters are set to ablate a test object (such as potatoes, animals and the like), and after ablation is finished, the depth of an ablation range under the different discharge parameters is measured, so that the pulse ablation index under the discharge parameters of the type of pulse ablation catheter can be obtained.
Furthermore, in the prior art, ablation near the atrioventricular node of the heart belongs to an industry pain point, and the problems of electrocardio conduction block and the like are easily caused. Aiming at the electrocardiosignal change condition, the safe discharge relationship under different distances can be obtained according to the titration and ablation data in-vitro experiments or animal experiments at the positions which are easy to cause electrocardiosignal conduction block, such as the vicinity of the atrioventricular node of the heart. And then according to the actual distance between the ablation target point of the pulse ablation catheter and the atrioventricular node, the appropriate expected discharge parameter can be selected in combination with the safe discharge relation, and the expected depth of the ablation range can be predicted and obtained based on the expected discharge parameter and the pulse ablation index. And then discharge is carried out according to expected discharge parameters when the depth of the predicted ablation focus meets the expectation, thereby effectively avoiding the situations of conduction block and the like and helping the clinical operation to be carried out smoothly.
In an alternative example, step S1 may be implemented by performing in vitro tests on a test object (e.g., potato, etc.) using titration. The method comprises the following steps:
by adopting a controlled variable method, only the discharge times or discharge voltage are changed, other discharge parameters are fixed, the test discharge is carried out on the potatoes, and the depth of the potato ablation range is changed. Optionally, the discharge parameters herein include, for example, a discharge voltage, a discharge pulse width, and a discharge number. The relation of the depth of the ablation stove on the discharge times or the discharge voltage can be obtained by testing and discharging potatoes according to different discharge times or discharge voltages and actually measuring the depth of the ablation stove under different discharge times or discharge voltages. In one example, as shown in fig. 2 and 3, tests were performed according to three discharge voltages of 1000V, 1100V and 1200V, respectively, 10 times, 20 times, 30 times and 40 times, and as a result, it was found that increasing the discharge voltage or increasing the discharge frequency can increase the depth of the ablation focus on the premise of fixing other discharge parameters.
It should be noted that, the examples shown in fig. 2 and 3 are only used to test by controlling the discharge voltage and the discharge frequency, and in other embodiments, the discharge voltage or the discharge frequency may be fixed and the test may be performed by controlling the discharge pulse width.
In a preferred embodiment, the expression of the pulse ablation index is provided based on data obtained by titration of a test object in vitro:
wherein D is depth of an ablation range, A is a constant, n is discharge times, U is discharge voltage, W is discharge pulse width, deltaZ is an impedance change value, F is an abutment force value, a, b, c, D and e are power exponents of parameters n, U, W, deltaZ and F respectively, and the value ranges of the power exponents a, b, c, D and e are 0-3 respectively. The impedance change Δz can be detected by an impedance detection module provided on the pulse ablation catheter. The abutment force value F can be detected by a force value detection module arranged on the pulse ablation catheter. The constant A and the exponentiations a, b, c, d and e can be obtained by fitting the measured data after processing by titration. As shown in FIG. 4, the accuracy of the depth of the ablation focus calculated by the expression of the pulse ablation index is less than or equal to 1mm.
In another preferred embodiment, the expression of the pulse ablation index is proposed based on data obtained by titration of a test object in vitro:
wherein D is the depth of the ablation range, A and B are constants, n is the number of discharges, U is the discharge voltage, W is the discharge pulse width, deltaZ is the impedance variation value, F is the abutment force value, a, B, c, D and e are the power indexes of parameters n, U, W, deltaZ and F respectively, and the value ranges of a, B, c, D and e are 0-3 respectively. Wherein the impedance change ΔZ is detected by an impedance detection module disposed on the pulsed ablation catheter. The abutment force value F can be detected by a force value detection module arranged on the pulse ablation catheter. The constant A, B and the exponentiations a, b, c, d and e can be obtained by fitting the measured data after processing by titration.
Alternatively, step S2 may be implemented by using titration for animal experiments. The method comprises the following steps:
by adopting a controlled variable method, only the discharge times or discharge voltage are changed, other discharge parameters are fixed, the animal is tested and discharged, the electrocardiosignals of the animal can be changed differently, the conduction block condition can be caused when the electrocardiosignals are serious, and some more serious conduction blocks can not be recovered, as shown in the table 1:
TABLE 1
Referring to fig. 5a and 5b, which are specific electrocardiographic representations of 1 discharge with a discharge voltage of 1500V near the atrioventricular node, fig. 5a shows that after 1 discharge with a discharge voltage of 1500V, the electrocardiograph is changed from a normal electrocardiograph signal to a conduction block, and fig. 5b shows that after several minutes of completion of the discharge to cause the conduction block, the electrocardiograph signal is restored to a normal heart rhythm.
Referring to fig. 5c and 5d, which are specific electrocardiographic representations of a plurality of discharges with a discharge voltage of 1500V near the atrioventricular node, the electrocardiographic representation of fig. 5c shows that after a plurality of discharges with a discharge voltage of 1500V, the electrocardiograph is changed from a normal electrocardiograph signal to a conduction block, and the electrocardiograph representation of fig. 5d shows that the electrocardiograph signal does not return to a normal heart rhythm for a long time after the discharge is completed.
Further, the distance between the ablation target point of the pulse ablation catheter and the atrioventricular node (i.e., the his bundle) also affects the electrocardiographic signal variation. The method can be used for testing and discharging animals by adopting a controlled variable method, only changing the distance between an ablation target point and an atrioventricular node and the discharge voltage and fixing other discharge parameters.
Referring to fig. 6, in an alternative example, the distance between the ablation target and the atrioventricular node is selected to be 2 mm-10 mm, and discharge ablation is performed by using different discharge voltages at each different distance point, so that the maximum voltage which can be applied at different distances and does not cause the conduction block of the electrocardiograph signal can be obtained as the reference maximum voltage, and the reference maximum voltage is the safety voltage at the distance. Thus, a safe discharge relationship, namely a relationship between the distance between the ablation target and the atrioventricular node and the discharge voltage, can be obtained. As shown in fig. 6, the safety voltage is in a situation of increasing magnitude as the distance from the atrioventricular node increases as a whole.
It should be noted that, the example shown in fig. 6 only uses the control discharge voltage to perform the test, and in other embodiments, the discharge voltage may be fixed, and the test may be performed by controlling the number of discharges or the discharge pulse width.
After the pulse ablation index and safe discharge relationship are obtained based on step S1 and step S2, step S3 may be applied to actual ablation. In step S3, the actual distance between the ablation target point of the pulse ablation catheter and the atrioventricular node can be measured, for example, by a three-dimensional mapping module. In an alternative exemplary embodiment, the heart can be three-dimensionally modeled before operation, and then after the pulse ablation catheter is inserted into the body, the position of the distal end of the pulse ablation catheter can be obtained through the three-dimensional mapping module, so that the actual distance between the ablation target point and the atrioventricular node is obtained. The specific principles of which are referred to in the prior art and which are not described herein.
After the actual distance between the ablation target and the atrioventricular node is obtained, the current safe discharge parameters (including safe voltage, or safe pulse width, safe discharge times and the like) can be known according to the safe discharge relation obtained in the step S2. The proper expected discharge parameters are selected according to the safe discharge parameters, so that the discharge voltage, the discharge pulse width and the like can be controlled within a safe range, the occurrence of conduction block and the like is effectively reduced or avoided, and the ablation safety is improved.
Further, after the expected discharge parameters are determined, the predicted depth of the ablation focus can be obtained by back-pushing according to the pulse ablation index. It will be appreciated that the predicted lesion depth is a theoretically calculated lesion depth corresponding to an expected discharge parameter, and the predicted lesion depth may be compared with an expected value or an expected range, for example, an expected value or an expected range may be set for the lesion depth when evaluated preoperatively, and if the predicted lesion depth matches the expected value or is within the expected range, the predicted lesion depth is considered to satisfy the expectation, at which time the discharge may be performed based on the expected discharge parameter. In some embodiments, the predicted depth of the lesion may also be provided to the operator for reference by the operator, who determines whether or not discharge needs to be performed.
So configured, the pulse ablation index is obtained by titration, and the depth of the ablation range of a pulse ablation catheter of a certain type under different discharge parameters can be obtained. And acquiring a safe discharge relation by a titration method, and guiding to select a safe expected discharge parameter based on the actual distance between the ablation target and the atrioventricular node. And then discharge is carried out according to expected discharge parameters when the depth of the predicted ablation focus meets the expectation, thereby effectively avoiding the situations of conduction block and the like and helping the clinical operation to be carried out smoothly.
Optionally, in the pulse ablation catheter provided in this embodiment, the control module is configured to control the electrode 11 to discharge according to the control method of the pulse ablation catheter as described above.
With continued reference to fig. 1, the pulsed ablation catheter preferably further includes an impedance detection module and/or a force value detection module. The force value detection module comprises a pressure sensor 13, wherein the pressure sensor 13 is arranged on the catheter body 10, and the pressure sensor 13 is used for acquiring an abutting force value and sending the abutting force value to the control module. In an alternative example, the electrode 11 of the pulse ablation catheter includes a ring electrode 112a, a ring electrode 112b, and a ring electrode 112c sequentially spaced from the distal end to the proximal end, and the pressure sensor 13 is located between the ring electrode 112a and the ring electrode 112 b. Preferably, the pressure sensor 13 is covered by an insulating layer 12. Preferably, the distance between the head electrode 111 and the ring electrode 112a is 1mm to 3mm, the distance between the ring electrode 112a and the ring electrode 112b is 4mm to 7mm, and the distance between the ring electrode 112b and the ring electrode 112c is 1mm to 3mm. The impedance detection module is arranged with reference to the prior art and will not be described here.
In use, the electrode actually discharging may be selected among the electrodes 11, for example, in some embodiments, the head electrode 111 may discharge the ring electrode 112b and the ring electrode 112c, and in other embodiments, the head electrode 111 may discharge the ring electrode 112a, the ring electrode 112b, and the ring electrode 112 c. Alternatively, the head electrode 111 may be provided with a filling hole, which plays a role in filling saline. Optionally, a temperature sensor may be provided on the head electrode 111 to monitor the temperature of the tissue. Alternatively, the head electrode 111 may be annular in the circumferential direction, and may be disposed inside or outside the insulating layer 12. Alternatively, the distal end of the head electrode 111 may be notched proximally to act to focus the head energy. Optionally, the distal end of the catheter body 10 may be provided with a position sensor to facilitate the three-dimensional mapping module to obtain distal end position information of the catheter body 10.
The pressure sensor 13 is configured to obtain a force value of the catheter body 10 against the ablation target, which force value can be provided to the operator for reference by the operator.
In some embodiments, factors affecting the depth of the ablation focus further include the abutment distance, the abutment force value, the abutment angle, the abutment stability, etc. of the pulse ablation catheter. As shown in fig. 7a and 7b, only the abutment distance and/or the abutment force value are changed, other discharge parameters are fixed, the potato is tested and discharged, and the depth of the potato ablation range is also changed.
Fig. 7a and 7b show the results of the ablation focus when the tip of the pulse ablation catheter is 0mm,2mm and 4mm from the potato surface (i.e. the abutment distance), respectively, wherein 0mm represents that the tip of the pulse ablation catheter is well abutted against the potato surface (the abutment force value is 5 g-10 g), and the depth of the ablation focus is about 5mm.2mm and 4mm indicate that the tip of the pulse ablation catheter is not in contact with the potato surface, and the depth of the ablation focus is about 3mm and 1mm, respectively. Overall, the sum of the depth of the ablation lesion and the distance of the tip of the pulse ablation catheter from the potato surface was about 5mm. It can be appreciated that the depth of the ablation lesion can be effectively increased while ensuring good abutment of the tip of the pulse ablation catheter with the potatoes (i.e., while the abutment distance is relatively small and the abutment force value is in a suitable range).
In the actual clinical process, as the heart of a patient continuously beats, an operator can hardly lean the pulse ablation catheter against an ablation target point with a certain constant leaning force value, and the leaning force value is in a fluctuation trend along with the heartbeat period in most time. In the pulse ablation catheter provided in this embodiment, the control module may implement the function of automatic discharge when the preset force value interval is satisfied according to the abutment force value acquired by the pressure sensor 13. Optionally, the control method of the pulse ablation catheter further comprises: and acquiring an abutting force value of the pulse ablation catheter, and executing discharge based on the expected discharge parameter when the abutting force value is within a preset force value interval.
The preset force value interval can be set according to different ablation parts. For example, the preset force value interval may be set to a low force value interval [0g to 10g ], a medium force value interval [10g to 30g ], and a high force value interval [30g to 100g ] corresponding to different ablation sites. When the contact force value falls in a preset force value interval corresponding to the corresponding ablation part, the discharge can be automatically executed. Further, a reference example of automatically performing the discharge when the abutment force value is within the preset force value interval is as follows: for every 1 heartbeat period, taking the R wave signal as a reference, after the R wave is delayed for a period of time (such as 0-500 ms), judging the force value, and if the contact force value is in a preset force value interval, executing discharging, as shown in fig. 8.
Optionally, the control method of the pulse ablation catheter further comprises:
step S51: on the premise of fixing discharge parameters, acquiring the pressure relation of the depth of an ablation stove relative to the contact force value of the pulse ablation catheter by a titration method;
step S52: in the step of obtaining the predicted depth of the ablation focus according to the expected discharge parameter and the pulse ablation index, the predicted depth of the ablation focus is corrected based on the actual abutting force value of the pulse ablation catheter and the pressure relation.
Step S51 is similar to steps S1 and S2 described above and can be performed by titration of a test object (e.g., potato). For example, only the abutting force value can be changed, other discharging parameters are fixed, and the potato is tested and discharged, so that the pressure relation of the depth of the ablation stove relative to the abutting force value is obtained. In step S52, the predicted depth of the ablation focus can be corrected by using the actual contact force value obtained by the pressure sensor 13 and combining the pressure relationship obtained in step S51, which can further improve the accuracy of predicting the depth of the ablation focus.
Optionally, the control method of the pulse ablation catheter further comprises:
step S61: on the premise of fixing discharge parameters, acquiring the stability relation of the depth of an ablation stove relative to the head end position of the pulse ablation catheter by a titration method;
step S62: in the step of obtaining a predicted ablation focus depth according to the expected discharge parameter and the pulse ablation index, the predicted ablation focus depth is corrected based on the actual head end position of the pulse ablation catheter and the stability relationship.
Step S61 is similar to steps S1 and S2 described above and can be performed by titration of a test object (e.g., potato). For example, only the abutting stability can be changed, other discharging parameters are fixed, and the potato is tested and discharged, so that the stability relation of the depth of the ablation focus with respect to the abutting stability is obtained. In step S62, the position sensor and the three-dimensional mapping module are used to obtain the reliability of the actual head end position of the ablation catheter, and the predicted depth of the ablation catheter can be corrected by combining the stability relationship, so that the accuracy of predicting the depth of the ablation catheter can be further improved.
Referring to fig. 9a to 9c, there are shown contrast cases of titration ablation for depth of focus at different abutment stabilities. Specifically, in the examples shown in fig. 9a to 9c, 3 sets of titration ablation comparisons with different contact stabilities were performed, the first set G1 is to be fixed for discharge at a certain position (single-point discharge), the second set G2 is to be multi-point discharge at a certain area (area multi-point discharge), the third set G3 is to be continuously discharged at a certain position until one of them turns red, and the first set G1, the second set G2 and the third set G3 are respectively denoted by G1, G2 and G3, wherein the number of discharge times of the first set G1 and the second set G2 is 20, and the number of discharge times of the third set G3 is 40. Comparing the results of the three groups of ablation ranges, the depth of the three groups of ablation ranges is respectively that the first group of the ablation ranges is G1=6.8 mm, the second group of the ablation ranges is G2=5.5 mm, the third group of the ablation ranges is G3=7.8 mm, the same discharge is performed for 20 times, and the single-point discharge (namely, the close stability is good) of the first group of the ablation ranges is deeper; if the contact stability is not good (for example, the third group G3), the number of discharges needs to be increased at a certain position to reach the depth of the ablation focus with good contact stability. Alternatively, the reliability of the contact may be quantified according to a certain rule, for example, by setting a weight coefficient according to the number of discharge points. The person skilled in the art can set up according to the actual situation to obtain a quantitatively comparable stability relationship of the depth of the ablation focus with respect to the abutment stability.
Optionally, in step S4, the step of performing the discharge based on the expected discharge parameter includes:
step S41: performing a single test discharge based on the expected discharge parameter;
step S42: and evaluating the result of the single trial discharge, and if the evaluation result meets the set condition, executing the discharge according to the expected discharge times.
Since the expected discharge parameter is theoretically calculated based on data obtained by a titration method in an in vitro experiment, the effect and safety of performing discharge according to the expected discharge parameter can be estimated by trial discharge. Firstly, according to step S41, a single test discharge is performed, where the number of times of discharge is set to be 1, and other discharge parameters are set according to the expected discharge parameters calculated in the foregoing steps S1 to S3 to perform discharge.
In step S42, the result of the single test discharge is evaluated, which may be performed based on a comparison of the set conditions (e.g., whether or not the electrocardiographic signal is blocked) set in advance. In practice, the evaluation may be implemented based on a program built in the control module, or may be implemented by manually comparing by an operator, and the implementation manner of the evaluation is not limited in this embodiment. And after the evaluation result meets the set condition, performing discharge according to the expected discharge times in the expected discharge parameters calculated in the steps S1-S3.
Based on the control method of the pulse ablation catheter as described above, the embodiment of the present invention further provides a readable storage medium having a program stored thereon, which when executed, implements the steps of the control method of the pulse ablation catheter as described above. The readable storage medium may be provided independently or may be attached to the pulse ablation catheter, for example, in a control module of the pulse ablation catheter, as the invention is not limited in this regard.
In summary, in the control method of the pulse ablation catheter, the readable storage medium and the pulse ablation catheter provided by the invention, the control method of the pulse ablation catheter comprises the following steps: acquiring a pulse ablation index of the depth of an ablation focus of the pulse ablation catheter relative to the discharge parameter based on a titration method; acquiring a safe discharge relation of an electrocardiosignal change condition about the distance between an ablation target point of the pulse ablation catheter and an atrioventricular node and a discharge parameter based on a titration method; acquiring an actual distance between an ablation target point of the pulse ablation catheter and an atrioventricular node, obtaining an expected discharge parameter according to the actual distance and the safe discharge relation, and obtaining a predicted ablation range depth according to the expected discharge parameter and the pulse ablation index; and when the predicted depth of the ablation focus meets the expected requirement, performing discharge based on the expected discharge parameter. So configured, the pulse ablation index is obtained by titration, and the depth of the ablation range of a pulse ablation catheter of a certain type under different discharge parameters can be obtained. And acquiring a safe discharge relation by a titration method, and guiding to select a safe expected discharge parameter based on the actual distance between the ablation target and the atrioventricular node. And then discharge is carried out according to expected discharge parameters when the depth of the predicted ablation focus meets the expectation, thereby effectively avoiding the situations of conduction block and the like and helping the clinical operation to be carried out smoothly.
It should be noted that the above embodiments may be combined with each other. The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present invention.
Claims (10)
1. A method of controlling a pulse ablation catheter, comprising:
acquiring a pulse ablation index of the depth of an ablation focus of the pulse ablation catheter relative to the discharge parameter based on a titration method;
acquiring a safe discharge relation of an electrocardiosignal change condition about the distance between an ablation target point of the pulse ablation catheter and an atrioventricular node and a discharge parameter based on a titration method;
acquiring an actual distance between an ablation target point of the pulse ablation catheter and an atrioventricular node, obtaining an expected discharge parameter according to the actual distance and the safe discharge relation, and obtaining a predicted ablation range depth according to the expected discharge parameter and the pulse ablation index;
and when the predicted depth of the ablation focus meets the expected requirement, performing discharge based on the expected discharge parameter.
2. The method of claim 1, wherein the discharge parameters include discharge voltage, discharge pulse width, and number of discharges.
3. The method of claim 1, wherein the pulse ablation index is expressed as:
wherein D is depth of an ablation range, A is a constant, n is discharge times, U is discharge voltage, W is discharge pulse width, deltaZ is an impedance change value, F is an abutment force value, a, b, c, D and e are power indexes of parameters n, U, W, deltaZ and F respectively, and the value ranges of a, b, c, D and e are 0-3 respectively.
4. The method of claim 1, wherein the pulse ablation index is expressed as:
wherein D is the depth of the ablation range, A and B are constants, n is the number of discharges, U is the discharge voltage, W is the discharge pulse width, deltaZ is the impedance variation value, F is the abutment force value, a, B, c, D and e are the power indexes of parameters n, U, W, deltaZ and F respectively, and the value ranges of a, B, c, D and e are 0-3 respectively.
5. The method of controlling a pulse ablation catheter according to claim 1, further comprising:
and acquiring an abutting force value of the pulse ablation catheter, and executing discharge based on the expected discharge parameter when the abutting force value is within a preset force value interval.
6. The method of controlling a pulse ablation catheter according to claim 1, further comprising:
on the premise of fixing discharge parameters, acquiring the pressure relation of the depth of an ablation stove relative to the contact force value of the pulse ablation catheter by a titration method;
in the step of obtaining the predicted depth of the ablation focus according to the expected discharge parameter and the pulse ablation index, the predicted depth of the ablation focus is corrected based on the actual abutting force value of the pulse ablation catheter and the pressure relation.
7. The method of controlling a pulse ablation catheter according to claim 1, further comprising:
on the premise of fixing discharge parameters, acquiring the stability relation of the depth of an ablation stove relative to the head end position of the pulse ablation catheter by a titration method;
in the step of obtaining a predicted ablation focus depth according to the expected discharge parameter and the pulse ablation index, the predicted ablation focus depth is corrected based on the actual head end position of the pulse ablation catheter and the stability relationship.
8. The method of controlling a pulse ablation catheter according to claim 1, wherein the step of performing a discharge based on the desired discharge parameter comprises:
performing a single test discharge based on the expected discharge parameter;
and evaluating the result of the single trial discharge, and if the evaluation result meets the set condition, executing the discharge according to the expected discharge times.
9. A pulse ablation catheter, comprising: a catheter body, electrodes, and a control module;
the electrode is arranged on the catheter body;
the control module is configured to control the electrode discharge according to the control method of the pulse ablation catheter according to any one of claims 1 to 8.
10. The pulse ablation catheter of claim 9, further comprising a pressure sensor disposed on the catheter body for acquiring an abutment force value and transmitting to the control module.
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