CN115349944A

CN115349944A - Pulse ablation system

Info

Publication number: CN115349944A
Application number: CN202211085639.5A
Authority: CN
Inventors: 王慧; 赵乾成; 赵峰; 郭文娟; 张维
Original assignee: Shanghai Shangyang Medical Technology Co ltd
Current assignee: Shanghai Shangyang Medical Technology Co ltd
Priority date: 2022-09-06
Filing date: 2022-09-06
Publication date: 2022-11-18

Abstract

The invention discloses a pulse ablation system, and belongs to the technical field of pulse ablation. The pulse ablation system includes: a pulse ablation catheter and a pulse energy output device. The pulse ablation catheter comprises a distal tube body and an electrode arranged on the distal tube body, wherein the electrode is used for forming a focus on target tissues. The pulse energy output device is electrically connected with the electrode and used for providing a pulse ablation signal for the electrode, and the pulse energy output device further comprises: the impedance detection module is electrically connected with the electrode and used for outputting a test signal to the electrode so as to obtain the basic impedance of an ablated target and the contact impedance of the current environment of the electrode; and the abutting degree determining module is electrically connected with the impedance detecting module and used for determining the abutting degree of the electrode and the target tissue according to the basic impedance and the contact impedance.

Description

Pulse ablation system

Technical Field

The invention relates to the technical field of pulse ablation, in particular to a pulse ablation system.

Background

Arrhythmias pose a variety of dangerous conditions, including asynchronous atrioventricular contractions and blood flow stagnation, leading to a variety of illnesses and even death. The main cause of atrial arrhythmias is stray electrical signals within the left or right atrium of the heart.

Ablation therapy with a pulsed ablation system can be used to treat atrial arrhythmias. The electrode is delivered to the target tissue through a pulse catheter in the pulse ablation system, and irreversible micropores are formed on the cell membrane of the target tissue through the instantaneous discharge of the electrode, so that the target tissue is irreversibly damaged. Accordingly, non-thermal ablation is achieved, and stray electrical signals causing arrhythmia are avoided. Due to the fact that different tissue cells have different voltage thresholds, the target tissue cells can be selectively ablated by adopting pulse ablation, and non-target tissue cells are not affected.

The sticking degree of the electrode in the pulse ablation catheter and the target tissue directly influences the pulse ablation effect, so that the pulse ablation system has a need of confirming whether the electrode of the pulse ablation catheter is stuck to the target tissue or not in place when in use.

Disclosure of Invention

The invention provides a pulse ablation system, aiming at overcoming the defect that whether an electrode and target tissue are attached in place or not is inconvenient to judge when a pulse ablation catheter in the prior art is used.

The invention solves the technical problems through the following technical scheme:

an embodiment of the present invention provides a pulse ablation system, including: the pulse ablation system includes: a pulse ablation catheter and a pulse energy output device;

the pulse ablation catheter comprises a far-end tube body and an electrode arranged on the far-end tube body, wherein the electrode is used for forming a focus on target tissues;

the pulse energy output device is electrically connected with the electrode and used for providing a pulse ablation signal for the electrode, and the pulse energy output device further comprises:

the impedance detection module is electrically connected with the electrode and used for outputting a test signal to the electrode so as to obtain the basic impedance of an ablated target and the contact impedance of the current environment of the electrode;

and the abutting degree determining module is electrically connected with the impedance detecting module and is used for determining the abutting degree of the electrode and the target tissue according to the basic impedance and the contact impedance.

In one embodiment, a plurality of electrodes are disposed on the distal tube, two of the electrodes forming a set of electrode pairs; the impedance detection module includes:

a first output unit for outputting the test signal to the pair of electrodes;

the first determining unit is used for acquiring voltage generated by the electrode pair based on the test signal and determining the basic impedance or the contact impedance according to the test signal and the voltage.

In one embodiment, the degree of alignment determination module includes:

a second determination unit for determining a difference between the contact impedance and the base impedance;

and the third determining unit is used for determining the attaching degree of the electrode and the target tissue according to the difference value and a preset threshold value.

In one embodiment, when the electrodes participate in at least two sets of the electrode pairs receiving the test signal,

the second determining unit is specifically configured to obtain a difference between a base impedance and a contact impedance of each group of the electrode pairs in which the electrode participates;

the third determining unit is specifically configured to determine an abutting degree of the electrode with the target tissue according to a maximum value of the difference values and the preset threshold value.

In one embodiment, the pulse ablation system further comprises a control module,

the control module is electrically connected with the impedance detection module and used for determining a pulse ablation signal according to the contact impedance;

the control module is also electrically connected with the electrode and used for outputting the pulse ablation signal to the electrode so as to generate an ablation electric field.

In one embodiment, the control module is specifically configured to determine a voltage of the pulsed ablation signal as a function of the contact impedance.

In one embodiment, the pulse ablation system further comprises a muscle stimulation monitoring module and a control module,

the muscle stimulation monitoring module is used for monitoring the muscle stimulation intensity of an ablated target;

the control module is electrically connected with the muscle stimulation monitoring module and is used for determining a pulse ablation signal according to the muscle stimulation intensity; the control module is also electrically connected with the electrode and used for sending the pulse ablation signal to the electrode to generate an ablation electric field.

In one embodiment, the control module is specifically configured to determine a voltage and/or a pulse width of the pulsed ablation signal as a function of the muscle stimulation intensity.

In one embodiment, the muscle stimulation monitoring module comprises:

the monitoring unit is used for acquiring the basic amplitude of an ablated target and the muscle stimulation amplitude of the ablated target in the pulse ablation process;

a fourth determination unit for determining the muscle stimulation intensity from the base amplitude and the muscle stimulation amplitude.

In one embodiment, the pulse ablation system further comprises a display assembly,

the display component is used for being electrically connected with the sticking degree determining module and displaying the sticking degree of the electrode and the target tissue.

The positive progress effects of the invention are as follows:

the pulse ablation system provided by the embodiment of the invention can judge whether the electrode on the pulse ablation catheter is attached in place or not by detecting the impedance of the ablated target, and quantize the attachment degree of the electrode and the target component, thereby providing clear reference for the subsequent treatment of pulse ablation. The pulse ablation system performs characteristic setting on pulse ablation parameters based on the impedance of an ablated target, and achieves good pulse ablation effect for different individuals. And moreover, a muscle stimulation monitoring function is added, and the muscle stimulation amplitude of the ablated target is ensured to be within an acceptable range by monitoring the pulse energy release period in real time, so that the catheter in the body is prevented from shifting due to muscle stimulation vibration, and the pulse ablation treatment effect is further optimized.

Drawings

FIG. 1 is a graph illustrating the effect of electrode-to-target tissue distance on ablation depth in a pulsed ablation catheter according to an exemplary embodiment;

FIG. 2 is a schematic diagram of a pulse ablation system according to an exemplary embodiment;

FIG. 3 is a schematic diagram illustrating the structure of an annular circle segment in accordance with an exemplary embodiment;

FIG. 4 is a waveform diagram illustrating a pulsed ablation signal according to an exemplary embodiment;

FIG. 5 is a block diagram illustrating an impedance detection module in accordance with an exemplary embodiment;

FIGS. 6A and 6B are schematic diagrams illustrating electrodes placed in different positions according to an exemplary embodiment;

FIG. 7 is a block diagram illustrating an orientation determination module according to an exemplary embodiment;

FIG. 8 is a schematic diagram of a display interface shown in accordance with an exemplary embodiment;

FIG. 9 is a graph illustrating the effect of impedance values on ablation depth according to an exemplary embodiment;

FIG. 10 is a block diagram of a muscle stimulation monitoring module shown in accordance with an exemplary embodiment;

FIG. 11 is a schematic diagram illustrating a use state of a muscle stimulation monitoring module according to an exemplary embodiment;

FIG. 12A is a waveform diagram illustrating a long pulse width pulsed ablation signal in accordance with an exemplary embodiment;

FIG. 12B is a graph of frequency versus energy of a pulsed ablation signal according to the pulsed ablation signal of FIG. 12A;

FIG. 13A is a waveform diagram illustrating a short pulse width pulsed ablation signal in accordance with an exemplary embodiment;

FIG. 13B is a plot of frequency versus energy of the pulsed ablation signal according to the pulsed ablation signal shown in FIG. 13A;

FIG. 14 is a graph illustrating pulse width, voltage, and muscle stimulation intensity of a pulsed ablation signal according to an exemplary embodiment;

in the various figures above, the reference numerals have the following meanings:

100. a pulse ablation catheter 110, a distal catheter body 111, an electrode 101, a first electrode 102, a second electrode 103 and a third electrode; 110a, an annular circular section, 120, a tail end hard tube, 130, a middle tube body, 131, a main tube, 132, a flexible bendable section, 140, a handle, 141, an electrode socket, 142 and a knob;

200. an impedance detection module 210, a first output unit 220, a first determination unit;

300. an alignment degree determining module 310, a second determining unit 320 and a third determining unit;

400. a control module;

500. a display component, 510, a first icon, 520, a second icon, 520a, a first sub-icon, 520b, a second sub-icon, 520c, a third sub-icon;

600. a detector means;

700. a muscle stimulation module 710, a monitoring unit 711, a sensor 712, a data acquisition card 720 and a fourth determination unit;

800. a pulsed energy output device.

Detailed Description

The invention is further illustrated by the following examples, which are not intended to limit the invention thereto.

Embodiments of the present invention provide a pulse ablation system that can determine whether an electrode is in place against a target tissue to optimize the pulse ablation treatment. FIG. 1 is a graph illustrating the effect of electrode-to-target tissue distance on ablation depth in a pulsed ablation catheter according to an exemplary embodiment. The sticking degree of the ablation electrode and the ablation tissue has certain influence on the ablation effect. Taking bipolar discharge as an example, under the condition of the same voltage, electrode and medium, analyzing the effect of the distance between the ablation electrode and the tissue on the ablation effect, as shown in fig. 1, it can be seen from the analysis result that when the electrode is well attached to the tissue, the ablation effect is better, and when a gap exists between the electrode and the tissue, the ablation depth of the tissue is reduced along with the increase of the gap, so that it is necessary to ensure the attachment of the distal ablation electrode of the catheter to the tissue.

Fig. 2 is a schematic diagram illustrating a pulse ablation system according to an exemplary embodiment, and as shown in fig. 2, an embodiment of the present invention provides a pulse ablation system including a pulse ablation catheter 100, a pulse energy output device 800, and a wave detection arrangement 600.

As shown in fig. 2, the pulse ablation catheter 100 includes a distal tube 110, a distal stiffening tube 120, an intermediate tube 130, and a handle 140, arranged in series. One end of the distal tube 110 is a free end, and the other end is connected to the end hard tube 120. An annular circular segment 110a is formed at a portion of the distal tube body 110 away from the tip rigid tube 120, the annular circular segment 110a is formed in a spiral shape, and an electrode 111 is disposed on the distal tube body 110 in the annular circular segment 110 a. The electrodes 111 are used to receive pulsed ablation signals to apply an ablation electric field to the target region. FIG. 3 is a schematic diagram illustrating the structure of an annular circle segment according to an exemplary embodiment. As shown in fig. 3, a plurality of annular electrodes 111 are provided on the distal catheter body 110. Alternatively, the plurality of electrodes 111 are connected to the distal tube 110 by bonding and are equally spaced along the axial direction of the distal tube 110. The electrode 111 may be made of platinum-iridium alloy, gold, or the like. The distal tube 110 is used to carry the electrode 111 into the target tissue within the ablated target, and has high insulation, flexibility and biocompatibility, and is made of polyurethane, for example.

The pulse ablation catheter 100 includes a lumen extending from the handle 140 to the distal tube 110. The inner cavity is used for accommodating a cable, one end of the cable is used for being electrically connected with the electrode 111, and the other end of the cable is used for being electrically connected with the electrode socket 141 on the handle 140. When the pulse ablation catheter 100 is used, the control module 400 is electrically connected to the electrode socket 141 to provide a pulse ablation signal to the electrode 111 through the cable, so that the electrode 111 generates an ablation electric field to form a lesion at a target tissue.

Further, the intermediate tube body 130 includes a main tube 131 connected to the handle 140, and a flexible bendable section 132 connected to the main tube 131 and the end wand 120. The flexible bendable section 132 is capable of bending in different directions. The handle 140 is further provided with a control member 142 (e.g., a knob), the control member 142 is connected to the flexible bendable section 132 via a pulling member disposed in the lumen, and the control key 142 controls the flexible bendable section 132 to bend towards a desired direction, thereby adjusting the position of the electrode 111 in the body of the ablated object.

The pulse energy output device 800 includes an impedance detection module 200, a degree of engagement determination module 300, a control module 400, and a display assembly 500.

The control module 400 is configured to output a pulse ablation signal to the electrode 111, where the pulse ablation signal is a high-voltage biphasic pulse. Fig. 4 is a waveform diagram illustrating a pulsed ablation signal according to an exemplary embodiment. As shown in fig. 4, the control module 400 outputs a high-voltage short-pulse-width pulse waveform to the electrode 111, wherein the output voltage is 500-2000V and the pulse width is 0.1-50 us.

The display assembly 500 is used to display an interactive interface on which icons corresponding to each electrode 111 are displayed. For example, serial number icons arranged in the circumferential direction are displayed on the interactive interface, and different serial numbers correspond to different electrodes 111. The display assembly 500 is further electrically connected to the control module 400, and the control module 400 outputs a pulse ablation signal to the electrode 111 corresponding to the icon in response to detecting the triggering operation on the icon, so as to form a pulse electric field at the electrode 111.

Display assembly 500 is also used to provide an interface for setting ablation parameters for receiving user input of ablation parameters for control module 400 to generate a pulsed ablation signal based on the ablation parameters.

The pulse ablation system provided by the embodiment of the present invention can determine whether the electrode 111 is in place with respect to the target tissue, and in such a case, the display assembly 500 is further configured to display the placement of the electrode 111 with respect to the target tissue, which is described in detail below with reference to the impedance detection module 200 and the placement determination module 300.

The detector device 600 is used to extract the heart rate signal of the ablated target to ensure that the pulse ablation signal released by the control module 400 is synchronized with the heart rate. Optionally, the detector device 600 is used for detecting an R-wave of an ablated object, and the control module 400 releases the pulse ablation signal after a set time (e.g., 20ms to 200 ms) in response to the detector device 600 detecting the R-wave. Also, after each time the control module 400 outputs a pulse ablation signal, the electrode 111 of the pulse ablation catheter may acquire an ECG signal, which the control module 400 receives to determine the immediate ablation effect. In addition, the electrodes 111 are also used to acquire intracardiac signals for intracardiac modeling and mapping of electrical signals.

When the user uses the pulse ablation catheter, the pulse ablation catheter is delivered to the target tissue in the ablated target body by the aid of a three-position navigation system or an external contrast system matched with the pulse ablation system. Different electrode icons are triggered through the display component 500, so that the control circuit of the control component 300 is communicated with the corresponding electrodes 111, and the electrodes 111 can receive the pulse ablation signals. In turn, in response to the pulse ablation trigger operation, the control assembly 300 sends a pulse ablation signal to the electrode 111 to generate an ablation electric field at the target tissue. In the ablation process, the pulse ablation system can also monitor the voltage, the current and the impedance between the electrodes in the circuit in real time so as to ensure the stable output of pulse energy; when the monitoring value exceeds a preset threshold value, an alarm is given immediately, and the release of the pulse ablation energy is cut off, namely, the ablation is stopped.

In the embodiment of the present invention, the pulse ablation system is provided with an impedance detection module 200 and an adherence degree determination module 300, by which the adherence degree of the electrode 111 to the target tissue can be determined, so as to guide the user to adjust the electrode position or ablation parameters.

Specifically, the impedance detection module 200 is electrically connected to the electrode 111 of the pulse ablation catheter 100, and optionally, the impedance detection module 200 is electrically connected to the electrode 111 through the electrode socket 141 and the data line in the lumen, for outputting a test signal to the electrode 111 to obtain a base impedance of an ablated target and a contact impedance of an environment where the electrode is currently located. Specifically, the test signal is a current signal, and the electrode pair receiving the test signal forms a circuit with the target tissue and blood surrounding the target tissue. At this time, the base impedance or the contact impedance is obtained by dividing the voltage by the current value of the test signal.

FIG. 5 is a block diagram illustrating an impedance detection module according to an example embodiment. As shown in fig. 5, the impedance detecting module 200 includes a first output unit 210 and a first determining unit 220. The first output unit 210 is used for outputting the test signal to the pair of electrodes formed by the two electrodes. The first determining unit 220 is configured to obtain a voltage generated by the electrode pair based on a test signal, and determine a base impedance or a contact impedance according to the test signal and the voltage. The basic impedance refers to an impedance value obtained when the electrode is placed in the blood of an ablated target in a suspended manner, and the contact impedance refers to an impedance value obtained when the electrode is in contact with a target tissue.

Fig. 6A and 6B are schematic diagrams illustrating electrodes placed in different positions according to an exemplary embodiment. As shown in fig. 6A, the circular segment 110a of the impulse ablation catheter 100 is suspended in the blood of the target being ablated, e.g., with external navigation assistance, the circular segment 110a of the impulse ablation catheter is placed in the left atrium. In the case where the electrode 111 does not contact the tissue of the target to be ablated, the impedance detecting module 200 can obtain the fundamental impedance of the target to be ablated in cooperation with the electrode 111.

As shown in fig. 6B, the annular circular segment 110a of the pulse ablation catheter 100 is placed at the target tissue (for example). For example, with the Left Superior Pulmonary Vein (LSPV) as the target tissue, with the aid of external navigation, the annular circular segment 110a of the impulse ablation catheter is placed at the LSPV, with the electrodes 111 contacting the tissue at the LSPV. In such a case, the impedance detection module 200 can acquire a contact impedance value in cooperation with the electrode 111.

As shown in fig. 3, two electrodes 111 are arbitrarily selected to form an electrode pair when detecting contact resistance. To distinguish between the different electrodes 111, the electrodes 111 along the axial direction of the distal shaft 110 are named first electrode 101, second electrode 102, third electrode 103 in that order. In detecting the contact impedance, any two of the plurality of electrodes 111 may be selected as an electrode pair, for example, the first electrode 101 and the second electrode 102 may be set as a set of electrode pairs, or the first electrode 101 and the third electrode 103 may be set as a set of electrode pairs. It should be noted that, the base impedances corresponding to different electrode pair combinations are different, and in the embodiment of the present invention, the impedance detecting module 200 obtains the base impedance and the contact impedance for the same group of electrode pairs.

Referring again to fig. 2, the degree of alignment determination module 300 is electrically connected to the impedance detection module 200 for determining the degree of alignment of the electrode with the target tissue according to the base impedance and the contact impedance. FIG. 7 is a block diagram of an orientation determination module shown in accordance with an exemplary embodiment. As shown in fig. 7, the degree of alignment determination module 300 includes a second determination unit 310 and a third determination unit 320. The second determination unit 310 is used to determine the difference between the contact impedance and the base impedance. The third determining unit 320 is configured to determine a degree of contact between the electrode and the target tissue according to the difference and a preset threshold.

Since the impedance of the myocardial tissue is higher than that of the blood, if the electrode is in contact with the target tissue, the contact impedance obtained from the electrode pair differs from the base impedance. And, the larger the difference value is, the better the contact condition of the electrode and the target tissue is represented. Wherein the preset threshold is related to the relative position of the two electrodes forming the electrode pair. Taking an example that two adjacent electrodes form an electrode pair, the difference value Re is:

if the difference is greater than or equal to 0 and less than or equal to 10%, it indicates that the electrode pair is located in blood, i.e., the electrode pair is poorly attached to the target tissue; if the difference is larger than 10% and smaller than or equal to 20%, indicating that the electrode is in general contact with the target tissue; if the difference is larger than 20%, the electrode is well attached to the target tissue.

With reference to fig. 3, if the first electrode 101 and the third electrode 103 are selected as an electrode pair to participate in impedance detection, the corresponding preset threshold is smaller than the preset threshold used when the first electrode 101 and the second electrode 102 are selected as electrodes to participate in impedance detection, so as to accurately determine the contact degree between the electrodes and the target tissue.

In one example, one electrode may participate in impedance detection with a different electrode comprising an electrode pair. At this time, the second determining unit 310 is specifically configured to obtain a difference between the base impedance and the contact impedance of each group of electrode pairs in which the electrode participates. Illustratively, in conjunction with fig. 3, the second electrode 102 forms an electrode pair with the first electrode 101 to obtain the first difference Re ₁ The second electrode 102 and the third electrode 103 form an electrode pair to obtain a second difference Re ₂ 。

The third determining unit 320 is specifically configured to determine the degree of electrode contact with the target tissue according to the maximum value of the difference values acquired by the second determining unit 310 and a preset threshold. Similarly, taking the example that the second electrode 102 and the first electrode 101 and the third electrode 103 respectively form an electrode pair to participate in impedance detection, the third determining unit 320 is used for determining the first difference Re ₁ And a second difference Re ₂ Maximum value of

According to the maximum value

And the preset threshold value determines the contact degree of the second electrode 102 and the target tissue. Specifically, if

The second electrode 102 is not in abutment with the target tissue; if it is

The second electrode 102 is well attached to the target tissue; if it is

The second electrode 102 is in close contact with the target tissue. In this way, the accuracy of the determination by the alignment degree determination module 300 is optimized by taking into account all impedance detections in which the electrodes 111 participate.

In one example, the display assembly 500 is also used to display the electrode abutment. With continued reference to fig. 2, the display component 500 is electrically connected to the degree of alignment determining module 300 for displaying the degree of alignment of the electrode and the target tissue determined by the degree of alignment determining module 300. The specific display manner of the display module 500 is not limited, for example, the display module 500 displays in a text form or displays in a differentiated icon form.

FIG. 8 is a schematic diagram of a display interface shown in accordance with an exemplary embodiment. As shown in fig. 8, the display assembly 500 displays a first icon 510 representing a distal tube and a second icon 520 representing an electrode. The display component 500 displays a first sub-icon 520a (representing electrodes that are not in contact with the target tissue), a second sub-icon 520b (representing electrodes that are in general contact), and a third sub-icon 520c (representing electrodes that are in good contact) in an icon differentiated manner according to the determined contact. By adopting the mode, the sticking condition of the electrode and the target tissue is visually shown, so that the user can shift, rotate and the like the far-end tube body according to the display result of the display assembly 500, the electrode of the annular ring section is well stuck to the tissue, and the ablation effectiveness is ensured.

In summary, in the pulse ablation system provided in the embodiment of the present invention, the impedance detection module 200 and the adhesion degree determination module 300 are configured to obtain the adhesion degrees of different electrodes and the target tissue, so as to provide an intuitive and clear guidance for the pulse ablation treatment, so as to achieve the purposes of effectively adhering the electrodes to the target tissue and optimizing the ablation effect.

In practical applications, the in-vivo impedance of different subjects is different, and the different impedances can also affect the pulse ablation effect under the condition of using the same pulse parameters. Fig. 9 is a graph illustrating the effect of impedance values on ablation depth according to an exemplary embodiment. As shown in fig. 9, in the case of the two-electrode discharge, when the impedance value is increased under the condition of the same voltage, electrode, and pulse parameters, the current value in the loop is decreased, and the corresponding ablation depth is also decreased. In other words, the in-vivo impedance of the subject affects the ablation depth with the other ablation parameters being the same.

Based on the characteristic, in the embodiment of the invention, the pulse ablation system reflects individual impedance difference according to the contact impedance, and further establishes individualized pulse ablation parameters according to the contact impedance. With continued reference to fig. 2, the control module 400 is electrically connected to the impedance detection module 200 for determining a pulsed ablation signal based on the monitored contact impedance. Optionally, the control module 400 determines the voltage of the pulsed ablation signal from the contact impedance.

Optionally, the relationship between the voltage of the pulsed ablation signal and the contact impedance of the subject is:

wherein U is the voltage of the pulse ablation signal, R _t Contact impedance, k, of the object to be ablated ₁ 、k ₂ 、k ₃ Are fitting coefficients. In this way, the pulse ablation effect of the pulse ablation system is optimized in combination with the individualized differences.

In the pulse ablation process, the pulse electric field can generate electric stimulation, so that nerve fibers are excited to generate action electricity to further cause muscle contraction. When muscle stimulation occurs, the shaking of the ablated target body may cause the electrodes to shift, thereby affecting the pulse ablation effect.

The pulse ablation system provided by the embodiment of the invention also comprises a muscle stimulation monitoring module to detect the muscle stimulation intensity of the ablated target. Fig. 10 is a block diagram of a muscle stimulation monitoring module shown according to an exemplary embodiment, as shown in fig. 10, a muscle stimulation monitoring module 700 includes a monitoring unit 710 and a fourth determination unit 720. The monitoring unit 710 is used to obtain the fundamental amplitude of the ablated target, as well as the muscle stimulation amplitude of the ablated target during the pulse ablation process. The fourth determination unit 720 is configured to determine a muscle stimulation intensity from the base amplitude and the muscle stimulation amplitude.

FIG. 11 is a schematic diagram illustrating a use state of a muscle stimulation monitoring module according to an exemplary embodiment. Specifically, the monitoring unit 710 includes a sensor 711 and a data acquisition card 712, and the sensor 711 is attached to the body surface (e.g. chest or abdomen) of the ablated object for moving synchronously with the vibration fluctuation of the ablated object. Optionally, the sensor 711 is an acceleration sensor, a displacement sensor, or a force sensor. The data acquisition card 712 is electrically connected to the sensor 711, and is configured to receive the basic amplitude data and the muscle stimulation amplitude data output by the sensor 711. Optionally, the fourth determination unit 720 is a data processing chip integrally disposed within the data acquisition card 712. The fourth determination unit 720 determines the muscle stimulation intensity from the muscle stimulation amplitude and the fundamental amplitude of the ablated object.

The basic amplitude is the natural vibration amplitude caused by the respiration of the ablated target, and the muscle stimulation amplitude is the muscle vibration amplitude monitored in the pulse energy release process. The fourth determining unit 720 specifically determines the muscle stimulation amplitude increment according to the muscle stimulation amplitude and the basic amplitude of the ablated target, and further determines the muscle stimulation intensity according to the muscle stimulation amplitude increment and the preset threshold.

Optionally, the fourth determining unit 720 determines the muscle stimulation amplitude by:

wherein SS is the muscle stimulation intensity, W _p Is the amplitude of muscle stimulation, W _o Is the base amplitude.

The smaller the muscle stimulation intensity SS, the smaller the stimulation degree. Specifically, when 0-ss-s 2 were used, it was indicated that the current stimulation level was within an acceptable range; when SS is more than or equal to 2 and less than 4, the current stimulation degree is obvious; when SS ≧ 4, the current degree of irritation is indicated to be severe.

In addition, the fourth determining unit 720 is further electrically connected to the display module 500, and the display module 500 is configured to display the muscle stimulation intensity determined by the fourth determining unit 720, for example, displaying a relationship graph of the muscle stimulation intensity changing with time in real time.

In addition, referring to fig. 2, the muscle stimulation monitoring module 700 is further electrically connected to the control module 400 to send the monitored muscle stimulation intensity to the control module 400, so that the control module 400 determines the pulse ablation signal according to the muscle stimulation intensity. In particular, the control module 400 is specifically configured to determine the voltage and/or pulse width of the pulsed ablation signal as a function of the muscle stimulation intensity.

Illustratively, when the muscle stimulation intensity is obvious or serious, the control can be carried out by reducing the pulse width of the pulse ablation signal. The pulse width variation of the pulse ablation signal has a correlation with the frequency variation, and the frequency of the pulse ablation signal can be adjusted by adjusting the pulse width of the pulse ablation signal, so as to change the muscle stimulation intensity of the pulse ablation signal to an ablated target, which is schematically described in the following with reference to the attached drawings.

Fig. 12A is a waveform diagram illustrating a long pulse width pulsed ablation signal according to an exemplary embodiment, and fig. 12B is a plot of frequency versus energy of the pulsed ablation signal according to the pulsed ablation signal illustrated in fig. 12A. As shown in FIGS. 12A and 12B, the frequency of the long-pulse-width pulse ablation signal is relatively concentrated at 10 ³ At Hz. Fig. 13A is a waveform diagram illustrating a short pulse width pulsed ablation signal according to an exemplary embodiment, and fig. 13B is a plot of frequency versus energy of the pulsed ablation signal according to the pulsed ablation signal illustrated in fig. 13A. As shown in FIGS. 13A and 13B, the frequency of the short-pulse-width ablation signal is relatively concentrated at 10 ⁴ ～10 ⁵ At Hz. That is, the short pulse width ablation signal has a higher frequency content than the longer pulse width ablation signal. Thus, by reducing the pulse width of the pulse ablation signal, the ablation signal can be reducedThe frequency of the pulse ablation signal can be increased, and muscle stimulation generated by the pulse ablation electric field is weakened.

Illustratively, when the muscle stimulation intensity is obvious or serious, the control can be carried out by reducing the voltage of the pulse ablation signal. Specifically, the higher the voltage of the pulse ablation signal, the higher the corresponding pulse energy, and the more severe the resulting muscle stimulation, for the same pulse width. Therefore, the muscle stimulation caused by the pulse electric field can be effectively improved by reducing the voltage of the pulse ablation signal.

Optionally, the pulse ablation system further comprises a storage module, which stores corresponding data of pulse parameters and muscle stimulation intensities to form a database of pulse parameter and muscle stimulation intensity correspondences. FIG. 14 is a graph illustrating pulse width, voltage and muscle stimulation intensity of a pulse ablation signal according to an exemplary embodiment, with acceptable muscle stimulation intensity as a target value, and based on the database, obtaining a corresponding pulse width range without changing the pulse ablation signal voltage, as shown in FIG. 14; or, when the pulse width of the pulse ablation signal is not changed, the corresponding voltage range is obtained, so that the corresponding pulse parameters can be quickly matched according to the stimulation degree in the acceptable range of the patient.

In summary, the pulse ablation system provided by the embodiment of the invention can determine whether the electrode on the pulse ablation catheter is attached in place by detecting the impedance of the ablated target, and quantify the attachment degree of the electrode and the target component, so as to provide a clear reference for the subsequent treatment of pulse ablation. The pulse ablation system performs characteristic setting on pulse ablation parameters based on the impedance of an ablated target, and achieves good pulse ablation effect for different individuals. And moreover, a muscle stimulation monitoring function is added, and the muscle stimulation amplitude of the ablated target is ensured to be within an acceptable range by monitoring the pulse energy release period in real time, so that the catheter in the body is prevented from shifting due to muscle stimulation vibration, and the pulse ablation treatment effect is further optimized.

While specific embodiments of the invention have been described above, it will be appreciated by those skilled in the art that this is by way of example only, and that the scope of the invention is defined by the appended claims. Various changes or modifications to these embodiments may be made by those skilled in the art without departing from the principle and spirit of this invention, and these changes and modifications are within the scope of this invention.

Claims

1. A pulse ablation system, comprising: a pulse ablation catheter and a pulse energy output device;

the pulse ablation catheter comprises a distal tube body and an electrode arranged on the distal tube body, wherein the electrode is used for forming a focus on target tissues;

2. The pulse ablation system of claim 1, wherein a plurality of the electrodes are disposed on the distal tube, two of the electrodes forming a set of electrode pairs; the impedance detection module includes:

a first output unit for outputting the test signal to the pair of electrodes;

3. The pulse ablation system of claim 2, wherein the degree of apposition determination module comprises:

and the third determining unit is used for determining the attaching degree of the electrode and the target tissue according to the difference and a preset threshold.

4. The pulse ablation system of claim 3, wherein when said electrodes participate in at least two sets of said electrode pairs receiving said test signal,

the third determining unit is specifically configured to determine the degree of contact between the electrode and the target tissue according to the maximum value of the difference and the preset threshold.

5. The pulse ablation system of claim 1, further comprising a control module,

the control module is also electrically connected with the electrode and used for outputting the pulse ablation signal to the electrode to generate an ablation electric field.

6. A pulse ablation system according to claim 5, wherein the control module is specifically configured to determine the voltage of the pulse ablation signal as a function of the contact impedance.

7. The pulse ablation system of claim 1, further comprising a muscle stimulation monitoring module and a control module,

8. The pulse ablation system according to claim 7, wherein the control module is specifically configured to determine a voltage and/or a pulse width of the pulse ablation signal as a function of the muscle stimulation intensity.

9. The pulse ablation system of claim 7, wherein the muscle stimulation monitoring module comprises:

10. The pulse ablation system according to any one of claims 1-9, further comprising a display assembly,