CN118615008B - A real-time monitoring system and device for ablation therapy based on a single-needle multipolar electrode needle - Google Patents
A real-time monitoring system and device for ablation therapy based on a single-needle multipolar electrode needle Download PDFInfo
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Abstract
本发明适用于医疗器械智慧医疗领域，提供了一种基于单针多极电极针的消融治疗实时监控系统和装置。在本实施例中，首先在术前影像上对重要组织及脏器进行标识，在执行进退针操作时，通过术前影像和消融电极针周围区域的超声影像可以实时监测电极针路径及相对位置，在距离重要组织过近时进行预警，这实现了进退针操作过程的实时监测。而在脉冲治疗过程中，通过超声影像能够实时显示消融范围，再根据消融范围判断是否完成预期，并判断是否需要对治疗参数进行调整或结束本次消融治疗，这实现了电场消融过程的实时监测。通过本申请，可以提高消融治疗手术过程中进退针、电场消融时的精确度，准确度，从而提高手术的安全性。
The present invention is applicable to the field of smart medical treatment of medical devices, and provides a real-time monitoring system and device for ablation treatment based on a single-needle multi-polar electrode needle. In this embodiment, important tissues and organs are first marked on the preoperative image. When performing the needle advancement and withdrawal operation, the electrode needle path and relative position can be monitored in real time through the preoperative image and the ultrasonic image of the area around the ablation electrode needle, and an early warning is issued when the distance to the important tissue is too close, which realizes the real-time monitoring of the needle advancement and withdrawal operation process. During the pulse treatment process, the ablation range can be displayed in real time through ultrasonic images, and then it is judged whether the expectation is achieved based on the ablation range, and whether it is necessary to adjust the treatment parameters or end the ablation treatment, which realizes the real-time monitoring of the electric field ablation process. Through this application, the precision and accuracy of needle advancement and withdrawal and electric field ablation during the ablation treatment operation can be improved, thereby improving the safety of the operation.
Description
Technical Field
The application relates to the field of medical instrument intelligent medical treatment, in particular to an ablation treatment real-time monitoring system and device based on a single-needle multipolar electrode needle.
Background
The electric field ablation technique is a medical technique that uses an electric field to athermalize biological tissue. This technique has received attention since the end of the 20 th century, and with the intensive study of cell electrophysiology and electroporation effects, electric field ablation has gradually evolved into an effective medical approach. Compared with the traditional thermal ablation technology, the electric field ablation can control the ablation area more accurately, and damage to surrounding normal tissues is reduced.
The single-needle multi-pole pulse electric field ablation probe is an innovative medical device, taking a single-needle bipolar electrode needle as an example, and the single-needle multi-pole pulse electric field ablation probe can generate a bipolar electric field through a single probe to ablate specific tissues. The design utilizes the nonlinear characteristic of the electric field, and can ablate target tissues under the condition of not damaging surrounding normal tissues by precisely controlling the intensity and pulse parameters of the electric field.
However, when the electrode needle is advanced and retracted, the operator is required to operate the ultrasonic probe with one hand and puncture with one hand, and the operation difficulty is high. At present, percutaneous ultrasound can have a certain influence on imaging precision and accuracy due to angle, depth and other reasons.
Disclosure of Invention
In view of the above, the application provides a real-time monitoring system and a real-time monitoring device for ablation treatment based on a single-needle multipolar electrode needle, which enable needle advancing and retreating operation in an ablation treatment operation to be quicker, more accurate and safer, and can precisely display an ablation range through ultrasonic imaging immediately after pulsed electric field ablation treatment, thereby realizing real-time monitoring of electric field ablation.
The application provides an ablation treatment real-time monitoring system based on a single-needle multipolar electrode needle, which comprises a treatment parameter control module, a pulse electric field generation module, an ultrasonic monitoring module, a data storage processing module, a multimode image data fusion module, a single-needle multipolar visualization electrode needle module and a needle advancing and retreating module;
The treatment parameter control module is used for obtaining treatment parameters of a preoperative ablation scheme, adjusting the treatment parameters through the treatment effect of the pulsed electric field ablation treatment determined by the ultrasonic monitoring module, and sending the treatment parameters to the pulsed electric field generation module;
the pulse electric field generation module is used for carrying out pulse electric field ablation treatment on a target patient according to the treatment parameters sent by the treatment parameter control module;
The ultrasonic monitoring module is used for performing needle advancing and retreating operation on the ablation electrode needle and performing ultrasonic imaging on the surrounding area of the ablation electrode needle when performing pulsed electric field ablation treatment, so that an intraoperative real-time ultrasonic image is obtained and sent to the multimode image data fusion module;
Monitoring the needle insertion path of an ablation electrode needle according to the fusion image generated by the multimode image data fusion module, accurately positioning the position and depth of the ablation electrode needle, monitoring the treatment effect of pulsed electric field ablation treatment and sending the treatment effect to the treatment parameter control module;
The multimode image data fusion module is used for fusing the preoperative image with the intraoperative real-time ultrasonic image to generate a fusion image;
The single-needle multi-pole visual electrode needle module comprises an electrode head and an ablation electrode needle with at least one electrode ring, and is used for discharging through the electrode head and the electrode ring to form a high-voltage pulse electric field required by ablation treatment;
The needle advancing and retreating module is used for determining the needle advancing and retreating path of the ablation electrode needle according to the fusion image, and sending out alarm information when determining that the distance between the ablation electrode needle and the predetermined protective tissue reaches a threshold value when performing needle advancing and retreating operation.
Optionally, the monitoring the therapeutic effect of the pulsed electric field ablation therapy includes:
setting a treatment period according to the preoperative ablation scheme, wherein the treatment period comprises a group of treatment pulses and a group of ultrasonic imaging pulses, and the treatment pulses comprise a plurality of electronic pulses;
And determining an ablation range after a plurality of treatment periods through real-time ultrasonic images, comparing the ablation range with an ablation range preset in preoperative planning, and determining the treatment effect of the pulsed electric field according to a comparison result.
Optionally, the protection tissue includes a target tissue and an organ manually or automatically drawn according to the preoperative image.
Optionally, before the pulsed electric field generating module performs pulsed electric field ablation treatment on the target patient according to the treatment parameters sent by the treatment parameter control module, the pulsed electric field generating module further includes:
Performing pulse electric field simulation and determining a simulated pulse electric field ablation area;
Comparing the simulated pulse electric field ablation area with an ablation range preset in preoperative planning, and executing the step of performing pulse electric field ablation treatment on the target patient according to the treatment parameters sent by the treatment parameter control module when the repetition rate of the preset ablation range and the simulated pulse electric field ablation area exceeds a preset value.
Optionally, the performing pulse electric field simulation, determining the simulated pulse electric field ablation area includes:
By equation of A kind of electronic deviceThe electric field strength E is determined, wherein,The electric conductivity is that U is a potential, the boundary potential of the positive electrode of the U is a preset value U0, and the boundary potential of the negative electrode of the U is grounded by 0V;
will be Is determined as an analog pulsed electric field ablation region, wherein,Respectively radial, axial and tangential coordinates,As a function of the time parameter,Is the ablation threshold field strength.
In a second aspect, the present application provides an ablation treatment real-time monitoring device based on a single-needle multipolar electrode needle, the device comprising:
the ultrasonic imaging unit is used for carrying out ultrasonic imaging on the surrounding area of the ablation electrode needle when the needle advancing and retreating operation is carried out and the ablation treatment is carried out, so as to generate an intraoperative real-time ultrasonic image;
The image fusion unit is used for fusing the preoperative image with the intraoperative real-time ultrasonic image to generate a fusion image;
The needle advancing and retreating monitoring unit is used for positioning the position and depth of the ablation electrode needle in real time according to the fusion image when the needle advancing and retreating operation is executed, and sending out alarm information when the distance between the ablation electrode needle and a preset protective tissue reaches a threshold value;
And the treatment effect determining unit is used for monitoring the treatment effect of the pulse electric field according to the fusion image when performing the pulse electric field ablation treatment and determining and adjusting the treatment parameters or ending the pulse electric field ablation treatment according to the treatment effect.
Optionally, the monitoring the treatment effect of the pulsed electric field ablation treatment in the treatment effect determining unit includes:
setting a treatment period according to the preoperative ablation scheme, wherein the treatment period comprises a group of treatment pulses and a group of ultrasonic imaging pulses, and the treatment pulses comprise a plurality of electronic pulses;
And determining an ablation range after a plurality of treatment periods through real-time ultrasonic images, comparing the ablation range with an ablation range preset in preoperative planning, and determining the treatment effect of the pulsed electric field according to a comparison result.
Optionally, the protection tissue in the needle advancing and retreating monitoring unit comprises target tissue and viscera which are manually or automatically drawn according to the preoperative image.
Optionally, the apparatus further includes:
The simulation calculation unit is used for carrying out pulse electric field simulation and determining a simulated pulse electric field ablation area before carrying out pulse electric field ablation treatment;
Comparing the simulated pulsed electric field ablation region with an ablation range preset in a preoperative planning, and executing the step of performing pulsed electric field ablation treatment when the repetition rate of the preset ablation range and the simulated pulsed electric field ablation region exceeds a preset value.
Optionally, the simulation calculation unit performs pulse electric field simulation, and determining the simulated pulse electric field ablation area includes:
By equation of A kind of electronic deviceThe electric field strength E is determined, wherein,The electric conductivity is that U is a potential, the boundary potential of the positive electrode of the U is a preset value U0, and the boundary potential of the negative electrode of the U is grounded by 0V;
Will be Is determined as an analog pulsed electric field ablation region, wherein,Respectively radial, axial and tangential coordinates,As a function of the time parameter,Is the ablation threshold field strength.
In the embodiment provided by the application, firstly, important tissues and organs are marked on the preoperative image, when the needle advancing and retreating operation is executed, the path and the relative position of the electrode needle can be monitored in real time through the preoperative image and the ultrasonic image of the surrounding area of the ablation electrode needle, and early warning is carried out when the distance from the electrode needle is too close to the important tissues, so that the real-time monitoring of the needle advancing and retreating operation process is realized. In the pulse treatment process, the ablation range can be displayed in real time through the ultrasonic image, whether the expectation is finished or not is judged according to the ablation range, whether the treatment parameters need to be adjusted or the ablation treatment is finished is judged, and the real-time monitoring of the electric field ablation process is realized. The application can improve the accuracy of advancing and retreating the needle in the process of ablation treatment operation and electric field ablation, thereby improving the safety of the operation.
Drawings
FIG. 1 is a system block diagram provided by an embodiment of the present application;
FIG. 2 is a timing diagram of a treatment cycle according to an embodiment of the present application;
FIG. 3 is a schematic view of a single-needle multipolar electrode needle according to an embodiment of the present application;
FIG. 4 is a block diagram of a device according to an embodiment of the present application;
fig. 5 is a schematic diagram of an internal structure of a computer device according to an embodiment of the present application.
Detailed Description
Reference will now be made in detail to exemplary embodiments, examples of which are illustrated in the accompanying drawings. When the following description refers to the accompanying drawings, the same numbers in different drawings refer to the same or similar elements, unless otherwise indicated. The implementations described in the following exemplary examples do not represent all implementations consistent with the application. Rather, they are merely examples of apparatus and methods consistent with aspects of the application as detailed in the accompanying claims.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in this specification and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the term "and/or" as used herein refers to and encompasses any or all possible combinations of one or more of the associated listed items.
It should be understood that although the terms first, second, third, etc. may be used herein to describe various information, these information should not be limited by these terms. These terms are only used to distinguish one type of information from another. For example, first information may also be referred to as second information, and similarly, second information may also be referred to as first information, without departing from the scope of the application. The term "if" as used herein may be interpreted as "at..once" or "when..once" or "in response to a determination", depending on the context.
The application provides an ablation treatment real-time monitoring system based on a single-needle multipolar electrode needle, which is used for improving the safety of an ablation treatment operation.
The technical scheme of the application is described in detail below by specific examples. The specific embodiments may be combined with each other and some embodiments may not be repeated for the same or similar concepts or processes.
As shown in FIG. 1, a module diagram of an ablation treatment real-time monitoring system based on a single-needle multipolar electrode needle provided by the application comprises a treatment parameter control module, a pulse electric field generation module, an ultrasonic monitoring module, a data storage processing module, a multimode image data fusion module, a single-needle multipolar visualization electrode needle module and a needle advancing and retreating module.
The functions of the respective modules are described below:
1. And a treatment parameter control module. The module is used for obtaining the treatment parameters of the preoperative ablation scheme, adjusting the treatment parameters through the treatment effect of the pulsed electric field ablation treatment determined by the ultrasonic monitoring module, and sending the treatment parameters to the pulsed electric field generation module.
In the module, a doctor determines a preoperative ablation scheme of a patient according to preoperative information of the patient, such as preoperative MRI or CT images, preoperative diagnosis and the like, wherein treatment parameters such as pulse electric field intensity, pulse frequency, pulse width and the like of ablation treatment of the patient are recorded in the scheme. When the patient is subjected to primary ablation treatment, pulse electric field ablation treatment is performed through the treatment parameters. After the first ablation treatment, the treatment parameters such as the pulse electric field intensity, the pulse frequency, the pulse width and the like are required to be adjusted according to the treatment effect of the patient. For example, when the ablation area of the first ablation treatment reaches or exceeds the expected value, the treatment parameters such as the pulse electric field intensity, the pulse frequency, the pulse width and the like need to be reduced, and when the expected value is not reached, the treatment parameters need to be increased.
In another embodiment, the monitoring the therapeutic effect of pulsed electric field ablation therapy comprises:
a treatment period is set according to the preoperative ablation scheme, wherein the treatment period comprises a group of treatment pulses and a group of ultrasonic imaging pulses, and the treatment pulses comprise a plurality of electronic pulses, as shown in fig. 2.
And determining an ablation range after the treatment period through real-time ultrasonic images, comparing the ablation range with an ablation range preset in preoperative planning, and determining the treatment effect of the pulsed electric field according to a comparison result.
In this embodiment, after a set of therapeutic pulses is performed in each therapeutic cycle, a set of ultrasound imaging pulses is performed again, so as to generate a real-time ultrasound image of the area around the ablation electrode needle, and the actual ablation range of the present therapy can be determined through the real-time ultrasound image. And comparing the actual ablation range with an estimated ablation range generated in a treatment period preset in preoperative planning, and determining the treatment effect. For example, based on coverage of the actual ablation range and the estimated ablation range, when the coverage is greater than a first threshold, such as 95%, the treatment effect of the current ablation treatment is determined to be satisfactory. And when the coverage rate is smaller than a second threshold value, such as 60%, determining that the treatment effect of the ablation treatment is poor, and the like. And then adjusting the treatment parameters or stopping the electric field ablation treatment according to different treatment effects. Thereby realizing real-time adjustment in operation and improving the accuracy and the precision of electric field ablation.
2, A pulse electric field generating module. The module is used for conducting pulsed electric field ablation treatment on the target patient according to the treatment parameters sent by the treatment parameter control module.
In this module, the treatment parameters include the treatment parameters determined in the preoperative ablation protocol, as well as the treatment parameters determined in the intraoperative readjustment according to the treatment effect.
In another embodiment, pulse electric field simulation can be performed to determine a simulated pulse electric field ablation region before pulse electric field ablation treatment is performed on the target patient according to the treatment parameters;
the simulation method comprises the following steps:
By passing through A kind of electronic deviceThe electric field strength E of the region to be treated is determined, wherein,For conductivity, the formula can be usedIt is shown that the conductivity is related to the temperature and the applied ablation electric field, and that specific values can be measured in real time by the sensor. U is a potential, the positive electrode boundary potential of U is a preset value U0, U0 can be set to different values according to different ablation devices, and the negative electrode boundary potential is ground 0V.
The main to-be-solved parameters of the electric field strength E and the electric potential U in the equation can be solved by COMSOL finite element software or other similar software.
After the electric field intensity E is determined, a region with the electric field intensity not smaller than a preset ablation threshold field intensity can be determined as an estimated pulse electric field ablation region, so thatIs determined as the simulated pulsed electric field ablation region.For a preset ablation threshold field strength,As a function of the time parameter,Is a three-dimensional spatial parameter of the whole region to be treated.
After determining the simulated pulsed electric field ablation region, it is compared with the preset ablation range in the preoperative treatment scheme. If the repetition rate of the two is smaller than the preset value, the effect of ablation treatment through the treatment parameters is not expected, and the comparison is estimated again after the adjustment is needed. And executing the step of performing pulsed electric field ablation treatment on the target patient according to the treatment parameters until the repetition rate exceeds a preset value.
In this module, the treatment parameters are simulated prior to performing the ablation treatment so that optimal treatment parameters can be determined prior to performing the ablation treatment. Thereby improving the accuracy and safety of the ablation procedure.
And 3, an ultrasonic monitoring module. The module is used for executing needle advancing and retreating operation on the ablation electrode needle and performing ultrasonic imaging on the surrounding area of the ablation electrode needle when performing pulsed electric field ablation treatment, so that an intraoperative real-time ultrasonic image is obtained and sent to the multimode image data fusion module.
In the module, the ultrasonic imaging is carried out on the surrounding area of the ablation electrode needle by executing the needle advancing and retreating operation on the ablation electrode needle, so that the visualization of the needle advancing path can be realized, and the position and depth of the ablation electrode needle can be accurately positioned during needle advancing and retreating. And when the pulse electric field ablation treatment is carried out, the surrounding area of the ablation electrode needle is subjected to ultrasonic imaging, the ablation effect accords with the expectation through real-time determination of the treatment effect, the maximization of the ablation range is realized, and the damage to surrounding normal tissues can be reduced.
And 4, a multimode image data fusion module. The module is used for fusing preoperative images, such as preoperative MRI or CT images, with intraoperative real-time ultrasonic images to generate fused images.
In this module, the preoperative patient is subjected to a Magnetic Resonance (MRI) or CT image examination to obtain detailed image data of the target tissue, and then three-dimensionally reconstructed to form a stereoscopic visualization model. After the ultrasonic image is obtained in the operation, the ultrasonic image is fused with the ultrasonic image on the basis of the stereoscopic visual model, so that the spatial accurate matching of the two image data is ensured.
And 5, a single-needle multi-pole visual electrode needle module. The module has an ablation electrode needle comprising an electrode head, an ultrasound probe and a plurality of electrode rings, as shown in fig. 3. The electrode head and the electrode ring are used for discharging to form a high-voltage pulse electric field for ablation treatment.
The module integrates the ultrasonic probe onto the ablation electrode needle, so that the hand-held ultrasonic probe is not required when the needle advancing and retreating operation is performed, and the module can concentrate on needle distribution puncture.
And 6, advancing and retreating the needle module. The module is used for determining the needle advancing and retracting path of the ablation electrode needle according to the fusion image, and sending out alarm information when the distance between the ablation electrode needle and the preset protective tissue reaches a threshold value when the needle advancing and retracting operation is carried out.
Thus, the system module description shown in fig. 1 is completed.
In the above embodiment, first, the important tissues and organs are identified on the preoperative image, and when the needle advancing and retreating operation is performed, the path and the relative position of the electrode needle can be monitored in real time through the preoperative image and the ultrasonic image of the surrounding area of the ablation electrode needle, and early warning is performed when the distance from the important tissues is too close, so that the real-time monitoring of the needle advancing and retreating operation process is realized. In the pulse treatment process, the ablation range can be displayed in real time through the ultrasonic image, whether the expectation is finished or not is judged according to the ablation range, whether the treatment parameters need to be adjusted or the ablation treatment is finished is judged, and the real-time monitoring of the electric field ablation process is realized. The application can improve the accuracy of advancing and retreating the needle in the process of ablation treatment operation and electric field ablation, thereby improving the safety of the operation.
As shown in fig. 4, the present application further provides an ablation treatment real-time monitoring device based on a single-needle multi-electrode needle, the device comprising:
An ultrasound imaging unit 401, configured to perform ultrasound imaging on a surrounding area of the ablation electrode needle when performing a needle advancing and retracting operation and performing ablation treatment, and generate an intra-operative real-time ultrasound image;
An image fusion unit 402, configured to fuse the preoperative image with the intra-operative real-time ultrasound image, and generate a fused image;
a needle advance and retreat monitoring unit 403, configured to, when performing a needle advance and retreat operation, locate, in real time, a position and a depth of the ablation electrode needle according to the fusion image, and determine that an alarm message is sent when a distance between the ablation electrode needle and a predetermined protective tissue reaches a threshold value;
and the treatment effect determining unit 404 is configured to monitor the treatment effect of the pulsed electric field according to the fused image when performing the pulsed electric field ablation treatment, and determine to adjust the treatment parameter or end the pulsed electric field ablation treatment according to the treatment effect.
In another embodiment, the monitoring of the treatment effect of the pulsed electric field ablation treatment in the treatment effect determination unit comprises:
setting a plurality of treatment periods according to the preoperative ablation scheme, wherein the treatment periods comprise a group of treatment pulses and a group of ultrasonic imaging pulses, and the group of treatment pulses comprise a plurality of pulses;
And determining an ablation range after a plurality of treatment periods through real-time ultrasonic images, comparing the ablation range with an ablation range preset in preoperative planning, and determining the treatment effect of the pulsed electric field according to a comparison result.
In another embodiment, the protection tissue in the needle advance and retreat monitoring unit includes a target tissue and an organ manually or automatically delineated according to the preoperative image.
In another embodiment, the apparatus further comprises:
A simulation calculation unit 405, configured to perform a pulse electric field simulation before performing a pulse electric field ablation treatment, and determine a simulated pulse electric field ablation area;
Comparing the simulated pulsed electric field ablation region with an ablation range preset in a preoperative planning, and executing the step of performing pulsed electric field ablation treatment when the repetition rate of the preset ablation range and the simulated pulsed electric field ablation region exceeds a preset value.
In another embodiment, the performing pulse electric field simulation in the simulation calculation unit, determining a simulated pulse electric field ablation region includes:
By equation of A kind of electronic deviceThe electric field strength E is determined, wherein,The electric conductivity is that U is a potential, the boundary potential of the positive electrode of the U is a preset value U0, and the boundary potential of the negative electrode of the U is grounded by 0V;
Will be Is determined as an analog pulsed electric field ablation region, wherein,Respectively radial, axial and tangential coordinates,As a function of the time parameter,Is the ablation threshold field strength.
According to the embodiment of the invention, the real-time ablation treatment monitoring system based on the single-needle multi-electrode needle is provided, and the real-time ablation treatment monitoring device based on the single-needle multi-electrode needle is provided based on the system.
The embodiment also discloses a computer device, as shown in fig. 5, where the computer device includes a processor and a memory, where at least one instruction is stored in the memory, and the at least one instruction is loaded and executed by the processor to implement the function of any of the ablation real-time monitoring systems based on the single needle multipolar electrode needle.
In addition, in the embodiment of the ablation treatment real-time monitoring device based on the single-needle multi-electrode needle, the logic division of each program module is merely illustrative, and in practical application, the function allocation may be completed by different program modules according to needs, for example, in view of configuration requirements of corresponding hardware or convenience of implementation of software, that is, the internal structure of the ablation treatment real-time monitoring device based on the single-needle multi-electrode needle is divided into different program modules to complete all or part of functions described above.
The foregoing description of the preferred embodiments of the application is not intended to be limiting, but rather to enable any modification, equivalent replacement, improvement or the like to be made within the spirit and principles of the application.
Claims (8)
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| CN202411087940.9A CN118615008B (en) | 2024-08-09 | 2024-08-09 | A real-time monitoring system and device for ablation therapy based on a single-needle multipolar electrode needle |
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| CN119139016B (en) * | 2024-11-15 | 2025-03-14 | 卡本(深圳)医疗器械有限公司 | Prostate ablation planning method, system, electronic equipment and medium based on urethra reconstruction |
| CN119548233A (en) * | 2024-12-26 | 2025-03-04 | 杭州睿笛生物科技有限公司 | A pulse ablation surgical system and method for pulmonary hypertension |
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