ablation system
By acquiring spatial location information of the ablation site through the information processing module and signal input/output module of the ablation system, and generating ablation prompt information, the problem of difficulty in determining the distribution of sympathetic nerves in the renal artery is solved, and the accurate positioning of the ablation catheter and the precision of the ablation effect are achieved.
Patent Information
- Application Number
- CN202111509147.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-08-11
- Publication Date
- 2025-12-02
- Estimated Expiration
- 2041-08-11
AI Technical Summary
In existing technologies, the distribution of sympathetic nerves in the renal artery is difficult to determine, leading to random selection of ablation sites. This may result in repeated ablation or missed ablation. Furthermore, traditional X-ray imaging is not clear, leading to inaccurate positioning of the ablation catheter and affecting the ablation effect.
The ablation system uses an information processing module and a signal input/output module to acquire spatial location information of the ablation site, and generates ablation prompts, including recommended ablation sites, non-recommended ablation sites, and ablation site movement prompts. Combined with a three-dimensional geometric model display, this ensures accurate positioning of the ablation catheter.
It enables real-time monitoring of the ablation catheter position during the ablation process, preventing repeated or ineffective ablation and ensuring the accuracy and precision of the ablation effect.
Smart Images

Figure CN115886989B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and in particular to an ablation system. Background Technology
[0002] With the development of minimally invasive interventional techniques, neuroablation has been increasingly used in clinical practice, mainly for the treatment of symptoms such as hypertension, diabetes, heart disease, and cancer tumors, and has achieved good results.
[0003] The distribution of sympathetic nerves in the renal artery region varies from person to person, making it difficult to determine whether the target tissue area for ablation contains sympathetic nerves. Therefore, the selection of ablation sites is currently usually random. This can lead to duplicate ablation or missed ablation, ultimately resulting in ablation failure. Furthermore, traditional techniques rely on X-ray imaging for catheter manipulation and ablation point positioning. However, X-ray imaging is two-dimensional and very unclear, leading to inaccurate catheter positioning and consequently, inaccurate ablation, resulting in unsatisfactory ablation outcomes. Summary of the Invention
[0004] Therefore, it is necessary to provide an ablation system that can output ablation prompts to enable accurate ablation, addressing the aforementioned technical problems.
[0005] An ablation system, the system comprising: an information processing module and a signal input / output module connected by communication;
[0006] The signal input / output module is used to connect at least one medical catheter. When the medical catheter outputs ablation energy, the signal input / output module obtains the spatial location information of the ablation site based on the current position of the medical catheter and sends the spatial location information of the ablation site to the information processing module.
[0007] The information processing module is used to obtain target spatial location information based on a target ablation point, and periodically calculate the comparison location information based on the spatial location information of the ablation site within a predetermined time period, and periodically compare the comparison location information with the target spatial location information to generate ablation prompt information.
[0008] In one embodiment, if the distance calculated based on the current location information to be compared and the target spatial location information within the current predetermined time period is less than or equal to a first preset distance, then when the medical catheter completes ablation, the target spatial location information is recorded as the spatial location information of an ablated point.
[0009] In one embodiment, if the distance calculated based on the current location information to be compared and the target spatial location information within the current predetermined time period is greater than the first preset distance, the information processing module outputs a prompt indicating that the ablation location has moved.
[0010] In one embodiment, the information processing module is further configured to compare the current location information to be compared within the current predetermined time period with the spatial location information of any previously ablated point. If the distance calculated between the current location information to be compared within the current predetermined time period and the spatial location information of any previously ablated point is less than a second preset distance, the information processing module outputs a prompt indicating repeated ablation.
[0011] In one embodiment, the system further includes:
[0012] A physiological stimulation module is connected to the medical catheter and is used to generate a stimulation signal according to stimulation parameters, so that the medical catheter outputs stimulation energy.
[0013] A physiological parameter detection module is used to detect physiological parameters generated under the stimulation signal and send the physiological parameters to the information processing module.
[0014] When the medical catheter outputs the stimulation energy, the signal input / output module obtains the spatial location information of the stimulation point based on the current position of the medical catheter, and sends the spatial location information of the stimulation point to the information processing module. The information processing module is also used to generate the ablation prompt information based on the physiological parameters and the spatial location information of the stimulation point. The ablation prompt information includes recommended ablation point information and non-recommended ablation point information.
[0015] In one embodiment, the information processing module is further configured to use the spatial location information of the stimulation point corresponding to the recommended ablation point information as the target spatial location information of the target ablation point, calculate the distance between the target spatial location information of the current target ablation point and the spatial location information of any previously ablated point, and output a repeat ablation prompt when the distance calculated based on the target spatial location information of the current target ablation point and the spatial location information of any previously ablated point is less than or equal to a third preset distance.
[0016] In one embodiment, the information processing module is further configured to use the spatial location information of the stimulation point corresponding to the recommended ablation point information as the target spatial location information of the target ablation point, calculate the distance between the target spatial location information of the current target ablation point and the comparison location information, and output a prompt indicating that the ablation position has moved when the distance between the target spatial location information of the current target ablation point and the comparison location information is greater than a fourth preset distance.
[0017] In one embodiment, the signal input / output module is further configured to obtain modeling spatial location information based on the spatial location information of the distal end of the medical catheter, and send the modeling spatial location information to the information processing module;
[0018] The information processing module is also used to construct a three-dimensional geometric model of the region where the distal end of the medical catheter is located based on the modeling spatial location information, and to mark the generated ablation prompt information in the three-dimensional geometric model.
[0019] In one embodiment, the system further includes:
[0020] An ablation energy module is connected to the medical catheter and is used to generate an ablation signal based on ablation parameters, so that the medical catheter outputs the ablation energy.
[0021] The display module is communicatively connected to the information processing module and is used to display the three-dimensional geometric model and the ablation prompt information.
[0022] In one embodiment, the ablation prompt information includes marker color information, and different marker types of ablation prompt information correspond to different marker color information.
[0023] In one embodiment, an ablation effect judgment module is also included, which is used to calculate an ablation effect index. The ablation effect index depends on the ablation parameters, which include ablation power, power loss, surface area of the ablation electrode, and ablation duration.
[0024] In one embodiment, the marker color information corresponds to the ablation effect index, with different color depths representing different ablation effects.
[0025] In one embodiment, the ablation effect index is calculated using the following formula:
[0026]
[0027] Where AE is the ablation effect index; n is the nth sampling point; N is the total number of sampling points for a single continuous ablation, which is equal to the ablation duration / sampling time interval; k is a proportionality coefficient, with a value between 0.3 and 0.9; Prf(n) is the ablation power recorded at the nth sampling point; S is the surface area of the ablation electrode; Δt is the sampling interval; Pco(n) is the loss power corresponding to the nth sampling point, where Pco(n) = hS[T(n) - T S h is the heat exchange coefficient, which ranges from 200 to 3000, and its unit is W / m. 2 *℃; T(n) is the electrode temperature at the nth sampling point, T S Temperature refers to the internal environment of the human body, expressed in °C.
[0028] In one embodiment, the ablation prompt information further includes ablation record information, and the information processing module is further configured to receive an instruction for invoking information at the ablation point marker. When the instruction is activated, the information processing module displays the ablation record information on the display module.
[0029] In one embodiment, the ablation record information includes at least one of the following: ablation point identifier, spatial location information of ablation points, order of ablation points, ablation power, ablation current, intensity of stimulation signal, frequency of stimulation signal, duration of stimulation signal, physiological parameter changes, temperature, ablation time, impedance, ablation recommendation degree, and ablation effect index.
[0030] In one embodiment, the three-dimensional geometric model includes renal artery vessels and / or abdominal aortic segments.
[0031] The aforementioned ablation system includes an information processing module and a signal input / output module for communication connection. The signal input / output module acquires the spatial location information of the ablation site based on the current position of the medical catheter and sends this information to the information processing module. The information processing module acquires the target spatial location information based on a target ablation point and generates ablation prompt information based on the target spatial location information of the target ablation point and the spatial location information of the ablation site. This prevents problems such as repeated ablation or ineffective ablation caused by the medical catheter deviating from the target ablation point during the ablation process, thereby ensuring accurate ablation. Attached Figure Description
[0032] Figure 1 This is a structural block diagram of the ablation system in one embodiment;
[0033] Figure 2 This is a schematic diagram of the ablation system in a practical application of one embodiment;
[0034] Figure 3 for Figure 2 The diagram shows the functional modules of the ablation device in the embodiment shown.
[0035] Figure 4 This is a schematic diagram of renal artery ablation in one embodiment, where the dashed box represents the three-dimensional geometric model and ablation point markings displayed by the display module;
[0036] Figure 5 This is a flowchart of the ablation system in one embodiment;
[0037] Among them, 100 is the three-dimensional mapping system, 101 is the working module, 102 is the signal control unit, 103 is the signal receiving unit, 200 is the excitation field generator, 300 is the ablation device, 301 is the physiological parameter sensor, 302 is the neutral electrode, 303 is the medical catheter, 401 is the right kidney, 402 is the abdominal aorta, 403 is the right renal artery, and 404 is the left renal artery. Detailed Implementation
[0038] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.
[0039] In this article, "proximal" and "distal" refer to the relative orientation, position, and direction of the components or actions relative to each other from the perspective of the doctor using the product. Although "proximal" and "distal" are not restrictive, "proximal" usually refers to the end of the product that is closer to the doctor during normal operation, while "distal" and "head" usually refer to the end that first enters the patient's body.
[0040] In one embodiment, such as Figure 1 As shown, this application provides an ablation system, which includes an information processing module and a signal input / output module connected by communication. The signal input / output module is used to connect to at least one medical catheter 303. When the medical catheter 303 outputs ablation energy, the signal input / output module obtains the spatial location information of the ablation site based on the current position of the medical catheter 303 and sends this spatial location information to the information processing module. The information processing module is used to obtain target spatial location information based on a target ablation point, and periodically calculates comparison location information based on the spatial location information of the ablation site within a predetermined time period. It then periodically compares the comparison location information with the target spatial location information to generate ablation prompt information.
[0041] The target ablation point can be a recommended ablation point, such as one recommended after physiological stimulation (described in detail below), or a target ablation point determined through other means, such as one specified by the physician based on the ablation results. The spatial location information of the ablation site refers to the spatial location information of the electrode on the medical catheter 303 used for ablation. During the ablation process, the information processing module compares the real-time acquired spatial location information of the ablation site with the target spatial location information to generate ablation prompts. These prompts can be displayed and / or spoken to provide guidance to the user.
[0042] For example, the ablation prompt information can be output via voice. Different types of script templates can be pre-set. When the spatial location information of the ablation site and the target spatial location information meet certain requirements, the information processing module obtains the corresponding script template and outputs it.
[0043] The ablation notification can also be output via display. In one embodiment, the signal input / output module is further configured to obtain modeling spatial location information based on the spatial location information of the distal end of the medical catheter 303, and send the modeling spatial location information to the information processing module. The information processing module is further configured to construct a three-dimensional geometric model of the region where the distal end of the medical catheter 303 is located based on the modeling spatial location information, and mark the generated ablation notification in the three-dimensional geometric model. Preferably, the three-dimensional geometric model is displayed in the display module, and the display module and the construction of the three-dimensional geometric model will be described in detail below.
[0044] In the above embodiments, the spatial location information of the ablation site refers to the spatial location information of the distal end of the medical catheter 303 when the medical catheter 303 outputs ablation energy. Specifically, the spatial location information of the ablation site refers to the spatial location information of the ablation electrode at the distal end of the medical catheter 303 when the medical catheter 303 outputs ablation energy. The predetermined time period can be pre-set, such as 1 second. In other embodiments, the predetermined time period can be other values. The comparison location information is calculated based on the spatial location information of the ablation sites within the predetermined time period. This can be achieved by calculating the statistical information of the spatial location information of all ablation sites within the predetermined time period, such as taking the average value, i.e., the average position information of the ablation electrode of the medical catheter 303 within that time period. For example, the average position coordinates of the ablation electrode within 1 second. Alternatively, some obviously erroneous spatial location information of ablation sites within the predetermined time period can be removed through preliminary screening. The comparison location information can be obtained by calculating the statistical information of the spatial location information of other ablation sites within the predetermined time period. Alternatively, the comparison location information can be obtained by selecting the statistical information of the spatial location information of some representative ablation sites within the predetermined time period. This application does not limit this approach. The first preset distance is also preset, for example, 1 millimeter. In other embodiments, the first preset distance can be other values.
[0045] It should be noted that the ablation prompts may include at least one of the following: identification information for each location within the area to be ablated, and operational prompts. The identification information for each location includes, but is not limited to, information on recommended ablation points, information on non-recommended ablation points, and information on whether each recommended ablation point has already been ablated. The operational prompts are used to indicate whether the spatial location of the current ablation site meets the operational requirements based on the target spatial location information; these may include, but are not limited to, prompts regarding ablation site movement, prompts regarding repeated ablation, etc.
[0046] The aforementioned ablation system includes an information processing module and a signal input / output module for communication connection. The signal input / output module obtains the spatial location information of the ablation site based on the current position of the medical catheter 303 and sends this information to the information processing module. The information processing module obtains target spatial location information based on a target ablation point and generates ablation prompt information based on the target spatial location information of the target ablation point and the spatial location information of the ablation site. This prevents problems such as repeated ablation or ineffective ablation caused by the medical catheter 303 deviating from the target ablation point during the ablation process, thereby ensuring accurate positioning of the distal end of the medical catheter 303 and guaranteeing accurate ablation.
[0047] In one embodiment, combined Figure 1The signal input / output module can be connected to the medical catheter 303 to obtain the spatial location information of the ablation site based on the current position of the medical catheter 303. Specifically, the spatial location information of the ablation site refers to the spatial location information of the distal end of the medical catheter 303 when the medical catheter 303 outputs ablation energy. More specifically, the medical catheter 303 is provided with electrodes, which can be used for stimulation, ablation, or positioning, etc. The spatial location information of the ablation site refers to the spatial location information of the ablation electrode on the medical catheter 303 when the medical catheter 303 outputs ablation energy.
[0048] In the above embodiments, the medical catheter 303 may include one or more electrodes to output energy. Furthermore, it should be noted that the ablation system also includes a neutral electrode 302, or the ablation system is connected to a neutral electrode 302, which serves as an energy circuit. The distal end of the medical catheter 303 is equipped with a spatial position information acquisition device that communicates with a signal input / output module. This spatial position information acquisition device can be a three-dimensional positioning sensor, such as a magnetic positioning sensor. Thus, the position of the distal end of the medical catheter 303 can be located in real time through this spatial position information acquisition device. Of course, the electrodes on the medical catheter 303 can also function as three-dimensional positioning sensors to acquire spatial position information; this invention does not limit this.
[0049] Specifically, in practical applications, the ablation system may include a three-dimensional mapping system 100 and a radiofrequency ablation device 300. The three-dimensional mapping system 100 and the radiofrequency ablation device 300 may share a processor, or each may have its own dedicated processor. The processors of the three-dimensional mapping system 100 and the radiofrequency ablation device 300 are communicatively connected for information transmission. The processor mentioned here is the information processing module in this embodiment. That is, the information processing module in this embodiment may be shared by the three-dimensional mapping system 100 and the radiofrequency ablation device 300, or the information processing module may consist of two parts, one located in the three-dimensional mapping system 100 and the other in the radiofrequency ablation device 300, but these two parts can communicate with each other. In other embodiments, the ablation system may also integrate the functions of the three-dimensional mapping system 100 and the radiofrequency ablation device 300 into one unit, in which case a single information processing module can be used to process the relevant data.
[0050] Combination Figure 2 and Figure 3 In this embodiment, the three-dimensional mapping system 100 and the radiofrequency ablation device 300 are each equipped with a processor, as an example. The information processing module includes... Figure 2 The working module 101 of the three-dimensional mapping system 100 is set in the middle and Figure 3The intelligent analysis module is installed in the radiofrequency ablation device 300, and the working module 101 and the intelligent analysis module can communicate. The medical catheter 303 is an ablation catheter connected to the radiofrequency ablation device 300. The system configuration is achieved by connecting the medical catheter 303 to the signal input / output module of the three-dimensional mapping system 100. Specifically, with... Figure 2 and Figure 3 The embodiment shown is illustrated in the diagram, wherein the signal input / output module of the three-dimensional mapping system 100 may include a signal receiving unit 103 and a signal control unit 102, and a part of the information processing module is... Figure 2 The other part is the working module 101. Figure 3 The intelligent analysis module in the system.
[0051] Among them, such as Figure 2 As shown, in use, the excitation field generator 200 of the three-dimensional mapping system 100 is first installed. The excitation field generator 200 is used to output an excitation field for three-dimensional positioning. Preferably, the excitation field generator 200 is placed under the bed, for example, under the bed corresponding to the location to be ablated. Taking the renal artery as an example, the excitation field generator 200 is placed under the bed near the patient's waist. The excitation field generator 200 can be a magnetic field, electric field, or other energy field generator, and its output signal is a low-power, low-to-medium frequency electric or magnetic field signal that is currently known to be harmless to the human body, thereby realizing the acquisition of spatial location information through magnetic field positioning, electric field positioning, or impedance positioning imaging technology.
[0052] The signal control unit 102 controls the output of the excitation field, so that the signal receiving unit 103 can receive the spatial position information collected by the spatial position information acquisition device at the distal end of the medical catheter 303 when the distal end of the medical catheter 303 enters the effective range of the excitation field, and send the spatial position information to the signal control unit 102. Optionally, the spatial position information received by the signal receiving unit 103 is an analog signal. Therefore, the signal receiving unit 103 first modulates and demodulates the analog signal and then digitizes it before sending it to the signal control unit 102. The signal control unit 102 processes and calculates the spatial position information to obtain three-dimensional positioning data, including three-dimensional coordinates, direction, and angle. Thus, the signal processing module can obtain the spatial position information from the signal control unit 102 to perform three-dimensional modeling and / or image processing, or combine it with other information to generate ablation prompt information, etc. In other embodiments, the working module 101 can also build a three-dimensional geometric model of the area where the distal end of the medical catheter 303 is located based on the spatial position information, and record the generated ablation prompt information in the three-dimensional geometric model for subsequent data recording and analysis.
[0053] For the aforementioned ablation system, the working module 101 in the information processing module is also used to record the spatial location information of the ablation points. Specifically, during the process of the medical catheter 303 outputting ablation energy, the working module 101 in the information processing module periodically calculates the comparison position based on the spatial location information of the ablation site within a predetermined time period; and periodically compares the comparison position information with the target spatial location information; if the distance calculated based on the current comparison position information and the target spatial location information within the current predetermined time period is less than or equal to a first preset distance, then when the medical catheter 303 completes ablation, the target spatial location information is recorded as the spatial location information of an ablated point.
[0054] Furthermore, the working module 101 in the information processing module can also be used to monitor whether the ablation site has moved. Specifically, the working module 101 in the information processing module is used to periodically calculate the comparison position based on the spatial location information of the ablation site within a predetermined time period during the output of ablation energy by the medical catheter 303; and periodically compare the comparison position information with the target spatial location information; if the distance calculated based on the current comparison position information and the target spatial location information within the current predetermined time period is greater than a first preset distance, the information processing module outputs a prompt indicating that the ablation site has moved.
[0055] Of course, in another embodiment, the working module 101 in the information processing module can be selectively used to record the spatial location information of the ablation point or monitor whether the ablation location has moved, and it is not required that it must have both functions at the same time; in yet another embodiment, the working module 101 or the signal control unit 102 can send information such as the spatial location information of the ablation site and the target spatial location information to the intelligent analysis module in the ablation device 300, and the intelligent analysis module can complete the function of recording the spatial location information of the ablation point or monitoring whether the ablation location has moved. The present invention does not limit this.
[0056] The working module 101 or intelligent analysis module in the information processing module can also determine whether they are the same ablation point by comparing the current location information to be compared with the target spatial location information.
[0057] If the distance calculated based on the current location information to be compared and the target spatial location information within the current predetermined time period is less than or equal to the first preset distance, it indicates that the distance change is within a certain range. When the medical catheter 303 completes ablation, the target spatial location information is recorded as the spatial location information of an ablated point. It should be noted that the spatial location information of an ablated point here can refer to the spatial location information of an ablation point that has completed the ablation time or reached a qualified ablation effect index, or it can refer to the spatial location information of an ablation point that the doctor considers to be ablated. This application does not impose any restrictions on this. The completion of ablation here can refer to the completion of the ablation duration set by the system or the end ablation time set by the system, or it can be based on the user's (doctor's) judgment of ablation completion based on experience. This application does not impose any restrictions on this.
[0058] If the distance calculated based on the current location information to be compared and the target spatial location information within the current predetermined time period is greater than the first preset distance, it indicates that the distance change exceeds a certain range, and an ablation location movement prompt is given. Specifically, when the information processing module determines that the ablation location has moved, it can send the prompt or alarm information to the display module so that the display module can issue the prompt or alarm information. In other embodiments, the ablation location movement prompt can also be output through voice prompts.
[0059] In practical applications, the working module 101 or intelligent analysis module in the information processing module calculates the average position coordinates of the ablation electrode in real time during each period of the ablation process. For example, it calculates and saves the average position coordinates of the ablation electrode every 1 second and compares them with the target spatial position information. If the distance change is within a certain range (e.g., 1 mm), it is considered to be the same ablation point. If the distance change exceeds a certain range, the user (doctor) is reminded that the ablation position has moved. The doctor can view the ablation effect index at the position corresponding to the target spatial position information to judge the ablation status at the target ablation point. Alternatively, the doctor can judge based on experience whether to continue ablation at that position or whether it is necessary to re-mark the ablation point, etc. The prompt information or alarm information of the ablation position movement is sent to the display module through the communication module so that the display module can issue prompt information or alarm information. The communication module will be described in detail below.
[0060] In the above embodiments, by monitoring the displacement between the ablation electrode and the target tissue during the ablation process, the electrode movement during the ablation process can be prevented from affecting the ablation effect.
[0061] In the above embodiments, the information processing module is further configured to compare the current location information to be compared within the current predetermined time period with the spatial location information of any previously ablated point. If the distance calculated based on the target spatial location information of the current location information to be compared within the current predetermined time period and any previously ablated point is less than a second preset distance, the information processing module outputs a prompt indicating repeated ablation.
[0062] Specifically, the second preset distance is also preset, for example, 2 millimeters. In other embodiments, the second preset distance can be other values. It is determined whether the distance calculated based on the current comparison location information within the current predetermined time period and the target spatial location information of any previously ablated point is less than the second preset distance. If so, the information processing module outputs a prompt for repeated ablation and determines whether repeated ablation is needed for this new ablation point location based on the user's selection. Here, the new ablation point location refers to the current comparison location within the current predetermined time period.
[0063] Optionally, after the information processing module outputs a prompt indicating repeated ablation, the user can confirm whether to continue ablation at the new ablation point location. If the user confirms to continue ablation at the new ablation point location, the new ablation point location information is used as the target spatial location information, and the comparison location information is calculated periodically based on the spatial location information of the ablation sites within a predetermined time period during the ablation process, and the processing described above continues.
[0064] In the above embodiments, by monitoring the displacement between the ablation electrode and the target tissue during the ablation process, ineffective ablation caused by electrode movement during the ablation process can be avoided.
[0065] In the above embodiments, by calculating the change in the position coordinates of the ablation electrode during the ablation process, the displacement of the ablation electrode during the ablation process is monitored and prompts or alarms are issued to avoid ineffective ablation.
[0066] The ablation system described above also includes a physiological stimulation module and a physiological parameter detection module. In this embodiment, the physiological stimulation module and the physiological parameter detection module are installed in the ablation device 300. The physiological parameter detection module can collect physiological parameters through the physiological parameter sensor 301. The physiological stimulation module is connected to the medical catheter 303. The physiological stimulation module is used to generate a stimulation signal based on the stimulation parameters, so that the medical catheter 303 outputs stimulation energy. The physiological parameter detection module is used to detect the physiological parameters generated under the stimulation signal and send the physiological parameters to the information processing module. When the medical catheter 303 outputs stimulation energy, the information input / output module obtains the spatial location information of the stimulation point based on the current position of the medical catheter 303 and sends the spatial location information of the stimulation point to the information processing module. The information processing module is also used to generate ablation prompt information based on the physiological parameters and the spatial location information of the stimulation point. The ablation prompt information includes recommended ablation point information and non-recommended ablation point information.
[0067] Specifically, the physiological stimulation module is used to output physiological stimulation signals, which are generally low-power energy stimulations. Optionally, stimulation parameters can be input through a human-computer interaction module, such as a display module. The physiological stimulation module then generates a physiological stimulation signal based on these parameters and outputs the stimulation energy through an electrode at the distal end of the medical catheter 303, so that the patient's stimulation point receives the stimulation signal and produces a corresponding physiological response.
[0068] The physiological parameter detection module is used to detect physiological parameters generated under stimulation signals. This module can be at least one of blood pressure, heart rate, body temperature, or bioelectrical activity. Preferably, the physiological parameter detection module is a blood pressure detection module, which is connected to a blood pressure sensor to detect the patient's blood pressure. The blood pressure sensor can include a blood pressure monitoring sensor and associated accessories. In this embodiment, invasive blood pressure monitoring can be used, or non-invasive blood pressure monitoring can be used as an alternative. When using invasive blood pressure monitoring, taking the renal artery as an example, radial artery puncture can be selected. The puncture point is placed at the same level as the heart and fixed, and real-time blood pressure monitoring and recording begin. In other embodiments, the physiological parameter detection module can be replaced by other physiological parameter monitoring units that reflect sympathetic nerve excitation, such as heart rate, body temperature, and bioelectrical activity. Body temperature can be collected by installing a temperature sensor at the distal end of the medical catheter 303.
[0069] When the medical catheter 303 outputs stimulation energy, the physiological parameter detection module collects physiological parameters, processes them to obtain measurement results, and sends these results to the intelligent analysis module of the information processing module. The intelligent analysis module generates ablation prompts based on the physiological parameters and the spatial location information of the stimulation point. These prompts include recommended and not recommended ablation points. Specifically, the intelligent analysis module generates recommended and not recommended ablation point information based on the physiological parameters during stimulation, thus avoiding repeated physiological stimulation or ineffective ablation at not recommended points, and preventing missed effective ablation at recommended points.
[0070] Of course, in another embodiment, the intelligent analysis module or the physiological parameter detection module can also send the physiological parameters and the spatial location information of the stimulation point to the working module 101 of the three-dimensional mapping system 100, and the working module 101 generates ablation prompt information. The present invention does not limit this.
[0071] In one embodiment, the information processing module is further configured to use the spatial location information of the stimulation point corresponding to the recommended ablation point information as the target spatial location information of the target ablation point, calculate the distance between the target spatial location information of the current target ablation point and the spatial location information of any previously ablated point, and output a repeat ablation prompt when the distance calculated based on the target spatial location information of the current target ablation point and the spatial location information of any previously ablated point is less than or equal to a third preset distance. Specifically, in the above embodiment, the recommended ablation point information can be obtained through analysis by the information processing module, for example, based on the physiological parameters at the stimulation point location. When the physiological parameters meet the requirements, it indicates that the stimulation point location meets the ablation requirements and is a recommended ablation point. The spatial location information of the stimulation point at this time, i.e., the spatial location information of this recommended ablation point, is used as the target spatial location information of the target ablation point, where the target spatial location information is also the location information of the target point. The repeat ablation prompt is output when the distance between the two ablation points (the current recommended ablation point and the ablated point) is less than or equal to the third preset distance. Each time the recommended ablation point is determined based on physiological parameters, the information processing module calculates the distance between the current target ablation point (i.e., the current recommended ablation point) and any already ablated point, and determines the relationship between this distance and the third preset distance. If the distance is less than or equal to the third preset distance, the current recommended ablation point is a duplicate ablation point.
[0072] The third preset distance can be pre-set, for example, it can be 2 mm. In other embodiments, the third preset distance can be other values. Preferably, the third preset distance can be the same as the second preset distance, because the second preset distance is a threshold used to distinguish whether ablation points are the same ablation point, thereby unifying the standard and improving the consistency of the system's judgment.
[0073] In the above embodiments, when the currently recommended ablation point is within a certain distance (e.g., 2mm) of an existing ablation point, the operator is reminded to avoid repeated ablation. By comparing the coordinates of the current ablation electrode with the coordinates of existing ablation points, repeated ablation at the same location or excessively adjacent locations is avoided.
[0074] In one embodiment, the working module 101 or the intelligent analysis module in the information processing module is further used to take the spatial location information of the stimulation point corresponding to the recommended ablation point information as the target spatial location information of the target ablation point, calculate the distance between the target spatial location information of the current target ablation point and the location information to be compared, and output a prompt that the ablation position has moved when the distance between the target spatial location information of the current target ablation point and the location information to be compared is greater than a fourth preset distance.
[0075] Specifically, the ablation position movement can be caused by the deviation of the medical catheter 303 during the ablation process at the target ablation point, or it can be caused by the medical catheter 303 deviating from the target ablation point before ablation. In this embodiment, if the medical catheter 303 deviates from the target ablation point after the ablation energy is output, a reminder of ablation position movement will be issued.
[0076] Optionally, the fourth preset distance can be equal to the first preset distance.
[0077] Furthermore, the signal input / output module in the above ablation system is also used to obtain modeling spatial location information based on the spatial location information of the distal end of the medical catheter 303, and send the modeling spatial location information to the working module 101 or the intelligent analysis module in the information processing module; the information processing module is also used to construct a three-dimensional geometric model of the area where the distal end of the medical catheter 303 is located based on the modeling spatial location information, and mark the generated ablation prompt information in the three-dimensional geometric model.
[0078] Specifically, the establishment of the three-dimensional geometric model is achieved before or during ablation by inserting the medical catheter 303 into the ablation site to obtain a precise model of that location. When the distal end of the medical catheter 303 enters the effective range, the signal input / output module receives the modeling spatial position information, allowing the information processing module to begin modeling. Optionally, to ensure the accuracy of the medical catheter 303's trajectory, the information processing module can store a pre-generated reference three-dimensional model based on medical imaging equipment. This reference model allows the module to determine the direction of the medical catheter 303 and provides cross-referencing with the real-time generated three-dimensional geometric model, improving accuracy. Therefore, in actual processing, the information processing module can obtain the reference 3D model, and then advance the medical catheter 303 to the preset position to be ablated based on the reference 3D model. When the distal end of the medical catheter 303 enters the effective range, the signal input / output module can receive the modeling spatial position information and send the modeling spatial position information to the information processing module, so that the information processing module can start modeling. During the modeling process, the reference 3D model can be used as a reference to determine whether there are unmodeled areas and to correct position information, etc.
[0079] The following explanation uses the renal artery as an example to illustrate the establishment of a three-dimensional geometric model. The medical catheter 303 enters the body through the femoral artery in the right leg. The distal end of the medical catheter 303 advances upward along the femoral artery and enters the abdominal aorta 402. Simultaneously, when the distal end of the medical catheter 303 enters the effective magnetic field excitation range, the signal input / output module can acquire the spatial position information of the distal end of the medical catheter 303. At this point, it can be selected to begin establishing a three-dimensional geometric model of this segment of the artery. When the distal end of the medical catheter 303 is observed to be close to a branch of the renal artery in the reference three-dimensional model, the distal end of the medical catheter 303 is controlled to enter the right (or left) renal artery, and a three-dimensional model of the right (or left) renal artery is established simultaneously. Alternatively, without relying on the reference three-dimensional model, the distal end of the medical catheter 303 can be controlled to enter the right (or left) renal artery when observed to be close to a branch of the renal artery under X-ray imaging, and a three-dimensional model of the right (or left) renal artery is established simultaneously.
[0080] Optionally, the three-dimensional geometric model includes the renal artery and / or the abdominal aorta segment 402. To establish a more accurate three-dimensional vascular model, the medical catheter 303 can be controlled to move along the vessel wall near the renal artery branch area, covering as many locations as possible. The three-dimensional modeling range can be selected to cover the area near the renal artery branches around the abdominal aorta 402 (i.e., the proximal and distal ends of the abdominal aorta 402) to better reflect the structural information of this region. This is because the adventitia of the abdominal aorta 402 contains the main trunk of the renal sympathetic nerves; finding target points with concentrated sympathetic nerve distribution will result in better ablation effects. Thus, the three-dimensional localization and modeling of the abdominal aorta segment 402, extending from the renal artery to its vicinity, and the subsequent localization and ablation of sympathetic nerve ablation targets based on this, will lead to better ablation results.
[0081] The signal input / output module sends the modeling spatial location information to the working module 101 or the intelligent analysis module in the information processing module. The working module 101 or the intelligent analysis module is used to establish a three-dimensional geometric model based on the modeling spatial location information and generate ablation prompt information based on the target spatial location information corresponding to the target ablation point and the spatial location information of the ablation site. The ablation prompt information includes one or more of the following: whether the stimulation point determined by physiological stimulation is a recommended ablation point or not recommended ablation point; and ablation information generated by ablation treatment at the target ablation point, such as ablation point, ablation location movement, repeated ablation, etc. The ablation information of the ablation point includes, but is not limited to, ablation parameters and ablation result information. The ablation parameters are the parameters corresponding to the output energy of the medical catheter 303, and the ablation result information is the evaluation information of the ablation effect after ablation at the ablation point.
[0082] Optionally, in one embodiment, the information processing module displays recommended ablation point information and unrecommended ablation point information in the three-dimensional geometric model. Further, the information processing module displays the recommended ablation point information and unrecommended ablation point information in the three-dimensional geometric model as recommended ablation point markers and unrecommended ablation point markers.
[0083] Specifically, please combine Figure 2 and Figure 3 As shown, where Figure 3 The physiological stimulation module mentioned above is the same as the physiological stimulation module in this embodiment. Figure 3 The multi-parameter detection module and blood pressure detection module are the physiological parameter detection modules in this embodiment.
[0084] exist Figure 3In the illustrated embodiment, the renal artery is used as an example. The distal electrode of the medical catheter 303 is inserted into one renal artery. The ablation electrode is attached to the vessel wall and kept in a fixed position. The information processing module simultaneously marks the coordinates of this location and displays it on the three-dimensional geometric model using a predefined marker. Then, stimulation parameters are set in the corresponding window of the user interface of the display module, and a certain amount of physiological stimulation pulses are output to the renal artery wall. The information processing module determines whether the vessel wall contains sympathetic nerves (or parasympathetic nerves, vagus nerves) based on physiological parameters during stimulation, such as the change pattern of blood pressure, and records the judgment result. If the judgment result is that there are only sympathetic nerves or the sympathetic nerves are dominant at this location, the location is determined as a recommended ablation point. If the judgment result is that there are no sympathetic nerves or the sympathetic nerves are not dominant, the location is determined as a non-recommended ablation point. Optionally, the information processing module displays the recommended ablation point information and the non-recommended ablation point information on the three-dimensional geometric model.
[0085] In one embodiment, the ablation system further includes an ablation energy module and a display module. The ablation energy module is connected to the medical catheter 303, and the display module is communicatively connected to the information processing module. The ablation energy module generates an ablation signal based on ablation parameters, causing the medical catheter 303 to output ablation energy. The display module displays a three-dimensional geometric model and ablation prompts.
[0086] When the medical catheter 303 outputs ablation energy, the signal input / output module obtains the spatial location information of the ablation site based on the current position of the medical catheter 303, and sends the spatial location information of the ablation site to the information processing module. The information processing module is used to obtain the target spatial location information based on a target ablation point, and generate ablation prompt information based on the target spatial location information and the spatial location information of the ablation site. The ablation prompt information includes a mark of the ablated point, which is displayed on the three-dimensional geometric model.
[0087] Specifically, the ablation energy module is mainly used to output ablation energy. For example, it can generate ablation energy through radio frequency generation, and then output the ablation energy through the medical catheter 303. The ablation energy can be measured by ablation power or ablation current. Optionally, the display module can be a human-computer interaction display module, through which the parameters of the ablation energy can be set, so that the ablation energy module can generate the corresponding ablation energy according to the parameters. When the medical catheter 303 outputs ablation energy, the information processing module generates ablation prompt information based on the target spatial location information and the spatial location information of the ablation site. That is, the information processing module is used to obtain the target spatial location information based on a target ablation point, and periodically calculate the comparison location information based on the spatial location information of the ablation site within a predetermined time period, and periodically compare the comparison location information with the target spatial location information to generate ablation prompt information. The ablation prompt information is, for example, a mark of the ablated point, and the mark of the ablated point is displayed at the corresponding position in the three-dimensional geometric model.
[0088] In the above embodiments, the number of display modules can be set as needed, and the content displayed by the display modules can be preset according to user habits, etc. Optionally, there can be one display module, which can communicate with the information processing module to display all the information that needs to be displayed. In other embodiments, there can be two display modules, one of which is located in the three-dimensional mapping system 100, and the other is located in the radiofrequency ablation device 300. The display content of the two display modules can be set as needed. The content displayed by the two display modules can be completely identical, partially overlapping, or completely different. Taking two display modules as an example, one display module communicates with the working module 101 to display location-related information, and the other display module communicates with the intelligent analysis module to display ablation-related information. In other embodiments, the display module communicating with the working module 101 can also display ablation-related information, and the display module communicating with the intelligent analysis module can also display location-related information. Figure 3 As shown, Figure 3 This is a schematic diagram of the ablation device 300 in one embodiment. In this embodiment, the radio frequency generation module of the ablation device 300 is the ablation energy module, and the human-machine interaction module is the display module. The ablation device 300 communicates with the working module 101 of the three-dimensional mapping system 100 via a communication module to transmit ablation-related information to the working module 101. The power supply module of the ablation device 300 supplies power to the ablation device 300, enabling all parts of the ablation device 300 to operate normally.
[0089] In practical applications, the intelligent analysis module can be used to process information related to ablation, and the working module 101 can be used to process information related to location. In other embodiments, the types of information processed by the intelligent analysis module and the working module 101 can be preset, without specific restrictions. The intelligent analysis module first obtains the parameters of the ablation energy through the human-computer interaction module, and then calculates the ablation information based on the parameters of the ablation energy to control the radio frequency generation module to generate ablation energy and output the ablation energy to the medical catheter 303 to ablate the ablation point. During the ablation process, the working module 101 displays the spatial location information of the ablation site in the three-dimensional geometric model, and communicates with the ablation device 300 through the communication module of the ablation device 300. Based on the target spatial location information and the spatial location information of the ablation site, it generates ablation prompt information. The information processing module is used to obtain the target spatial location information based on a target ablation point, and periodically calculate the comparison location information based on the spatial location information of the ablation site within a predetermined time period. It then periodically compares the comparison location information with the target spatial location information to generate ablation prompt information, and displays the ablation prompt information in the three-dimensional geometric model. In the above embodiments, the ablation prompt information can be generated by the intelligent analysis module based on the target spatial location information and the spatial location information of the ablation site. For example, when the physiological parameter information at the target spatial location (i.e., the target location) meets the requirements, an ablation point marker is generated, and the working module 101 displays the ablation point marker in the three-dimensional geometric model to complete one ablation. In other embodiments, the intelligent analysis module can send the physiological parameter information at the target spatial location (i.e., the target location) to the working module 101, and the working module 101 can determine that when the physiological parameter information meets the requirements, an ablation point marker is generated and displayed in the three-dimensional geometric model to complete one ablation.
[0090] Taking the renal artery as an example, when using the recommended ablation point as the target ablation point, the ablation electrode is kept in close contact with the vessel wall at the recommended ablation point. Ablation parameters are set in the corresponding window of the user interface of the display module, and ablation begins. The intelligent analysis module calculates ablation information based on the parameters of the ablation energy, thereby controlling the radiofrequency generator to produce ablation energy and outputting it to the medical catheter 303 to ablate the ablation point. During ablation, the intelligent analysis module determines whether the ablation at the recommended ablation point has met the requirements based on real-time physiological information obtained from the recommended ablation point, such as blood pressure information. If the ablation requirement has been met, ablation can be stopped; otherwise, ablation needs to continue. During ablation, ablation-related information is recorded according to the location point. After processing one location point, the medical catheter 303 is manipulated to move the ablation electrode to other locations on the renal artery vessel wall, and the above process is repeated. Generally, several ablation points need to be processed on one side of the renal artery to ensure the blockage of the sympathetic nerves on that side, based on the criterion of not finding an area on that side that would cause an increase in blood pressure due to stimulation. After the ablation of one renal artery is completed, the medical catheter 303 is manipulated to insert the ablation electrode into the other renal artery for the same procedure.
[0091] In the above embodiments, ablation energy is generated by the ablation energy module for ablation, and the information processing module displays the generated ablation prompts in the corresponding three-dimensional geometric model. This allows users to view the relevant ablation prompts in the three-dimensional geometric model, making the process more intelligent, improving the user experience, reducing the learning curve for surgeons, and enhancing the effectiveness and safety of the surgery.
[0092] In one embodiment, the ablation prompt information includes marker color information, and different marker types of ablation prompt information are matched with different marker color information.
[0093] Specifically, different locations in a 3D geometric model are distinguished using different marker types, such as color information. See also Figure 4 As shown, for example, recommended ablation points where the sympathetic nervous system is dominant after physiological stimulation are marked with a yellow hollow box, while unrecommended ablation points where the sympathetic nervous system is not dominant are marked with a gray hollow box, and ablated points are marked with a solid red dot. Optionally, the marking color information corresponds to the ablation effect index, with different color depths representing different ablation effects. The ablation prompts of the above different marking types can be ablation point markers, recommended ablation point markers, and unrecommended ablation point markers, or other marking types of ablation prompts, which can be set according to user needs; this application does not impose any restrictions on this.
[0094] Specifically, such as Figure 4In the diagram, the dashed box represents the area where three-dimensional geometric modeling can be performed, including the right kidney 401. R01 to R04 are ablation point markers displayed after electrode stimulation or ablation in the medical catheter 303 in the right renal artery 403 of the three-dimensional geometric model. L01 to L02 are ablation point markers displayed after electrode stimulation or ablation in the medical catheter 303 in the left renal artery 404 of the three-dimensional geometric model. M01 to M02 are ablation point markers displayed after electrode stimulation or ablation in the medical catheter 303 in the abdominal aorta 402 of the three-dimensional geometric model. In this embodiment, the ablation point markers include: recommended ablation point markers, not recommended ablation point markers, and ablated point markers.
[0095] In one embodiment, the ablation system further includes an ablation effect judgment module for calculating an ablation effect index. The ablation effect index depends on ablation parameters, including ablation power, power loss, surface area of the ablation electrode, and ablation duration.
[0096] Specifically, this ablation effect assessment module is mainly used to calculate the ablation effect index. This index determines the effectiveness of ablation at a given ablation point based on parameters and algorithms. The index depends on ablation parameters, including ablation power, power loss, the surface area of the ablation electrode, and ablation duration. Ablation power refers to the output power of the ablation energy module; power loss refers to the energy carried away by blood flow and cold saline perfusion per unit time; and the surface area of the ablation electrode is obtained based on pre-entered electrode shape and effective surface area information. Electrode shape is generally described as the outer surface dimensions, such as a ring electrode with an outer diameter of 2.0 mm, a width of 1.5 mm, and a surface area of 9.4 mm². 2 The ablation duration refers to the time from the point where the ablation energy module outputs energy to the end of the energy output. The sampling point is the data record of the ablation parameters. One sampling point corresponds to one data record. The number of sampling points refers to the total number of sampling points in one continuous ablation, which is equal to the ablation time divided by the upsampling time interval. For example, if the continuous ablation time of a certain ablation point is 60 seconds and the data sampling time interval is 10 milliseconds, then the total number of sampling points N = 6000.
[0097] In one embodiment, the ablation effect index can be calculated using the following formula:
[0098]
[0099] Where AE is the ablation effect index; n is the nth sampling point; N is the total number of sampling points for a single continuous ablation, which is equal to the ablation duration of a certain ablation point / sampling time interval; k is the proportionality coefficient, with a value between 0.3 and 0.9; Prf(n) is the ablation power recorded at the nth sampling point; S is the surface area of the ablation electrode; Δt is the sampling time interval; Pco(n) is the power loss corresponding to the nth sampling point, that is, the energy carried away by blood flow and cold saline perfusion per unit time, which is determined by the surface area and temperature of the ablation electrode, the body temperature, and the blood heat transfer coefficient, as well as the temperature of the cold saline, the body temperature, and the saline heat transfer coefficient. Therefore, this invention proposes Pco(n) = hS[T(n) - T S h is the heat exchange coefficient, which can be selected empirically, with a value between 200 and 3000, and the unit is W / m. 2 *℃; T(n) is the electrode temperature at the nth sampling point, T S This refers to the temperature of the human body's internal environment. This temperature is the actual internal temperature measured under conditions such as non-ablation and non-perfusion modes. It can be a fixed value, such as 37°C, or it can be the average internal temperature measured over a period of time. T(n) and Tn... S The unit is ℃.
[0100] In the above embodiments, the ablation effect index is calculated to determine whether the ablation of the ablation point is effective, and different colors are used to represent the ablation effect index for users to check.
[0101] In one embodiment, the ablation notification information also includes ablation record information. The information processing module is further configured to receive an instruction to retrieve information at the ablation point marker. When the instruction is activated, the information processing module displays the ablation record information on the display module. Specifically, by touching, pressing, or clicking the ablation point marker in the corresponding window of the user interface of the display module, the information processing module receives the touch, press, or click instruction, retrieves the information at the ablation point marker, and displays the ablation record information in the display module.
[0102] The ablation record information includes at least one of the following: ablation point identifier, spatial location information of ablation points, order of ablation points, ablation power, ablation current, intensity of stimulation signal, frequency of stimulation signal, duration of stimulation signal, changes in physiological parameters, temperature, ablation time, impedance, ablation recommendation degree, and ablation effect index.
[0103] The ablation point identification can be performed according to predefined rules, and the spatial location information of the ablation points is obtained through the input / output module. The order of the ablation points indicates which point was ablated, and the marking time can also be recorded here. Furthermore, parameters acquired in real time, such as ablation power, ablation current, stimulation signal intensity, impedance, and temperature, can be displayed on the data, such as in charts or numerical formats, for easy observation.
[0104] The ablation effect index is a more in-depth analysis of ablation parameters by combining pre-entered information on electrode shape and effective surface area, as well as parameters such as real-time perfusion flow rate.
[0105] The specific ablation record information can be found in the table below, which shows the record information corresponding to a specific ablation point:
[0106]
[0107]
[0108] In the above embodiments, selecting a marker point in the three-dimensional geometric model displays information corresponding to that point, such as stimulation information, ablation recommendation information, and ablation-related information. Simultaneously, based on the location distribution of existing ablation point markers, the distribution and direction of the arterial nerves are determined, aiding in the detection of new ablation points and preventing the omission of ablation of arterial nerves. Furthermore, since the ablation record information includes multi-parameter detection and graphical display of parameters such as ablation energy, time, temperature, impedance, blood pressure, and ablation effect, combined with the three-dimensional geometric model, the information display is more intuitive, facilitating ablation operations, avoiding duplicate ablation and missed ablation targets, and facilitating the search for effective ablation targets, thus improving the safety and effectiveness of the ablation process.
[0109] Specifically, see Figure 5 As shown, Figure 5 This is a flowchart of the ablation system in one embodiment, using renal artery ablation as an example. The first step is equipment installation, where the excitation field generator 200 is installed under the bed. Figure 2 The dashed box in the diagram represents the communication connection between the medical catheter 303 and the ablation device 300. The medical catheter 303 is also connected to the signal receiving unit 103 of the three-dimensional mapping system 100. The signal control unit 102 of the three-dimensional mapping system 100 is connected to the excitation field generator 200. The neutral electrode 302 serves as the energy circuit and is communicationally connected to the ablation device 300. If invasive blood pressure monitoring is used, radial artery puncture is selected. The puncture point is positioned at the same level as the heart and fixed in place. Real-time blood pressure monitoring and recording then begin.
[0110] During ablation, the medical catheter 303 information is typically selected and set first, including the type of medical catheter 303 and ablation electrode parameters. Optionally, three-dimensional images containing the renal artery and surrounding arterial tissue, such as CT or MRI images, are imported into the system. These images are then imported into the information processing module, and the three-dimensional structures of the renal artery and abdominal aorta 402 are segmented through image processing. The medical catheter 303 is then inserted into the blood vessel through the incised skin tissue and reaches the abdominal aorta 402 and renal artery region along the vessel lumen. Other equipment may be needed during this process. Once the tip of the medical catheter 303 is within the effective range of three-dimensional spatial positioning, i.e., within the effective working range of the excitation field generator 200, the distal end of the medical catheter 303 can be spatially located in real time, and corresponding spatial position information, including three-dimensional coordinates, direction, and angle, can be obtained. Simultaneously, an invasive blood pressure probe can be inserted into an appropriate blood vessel location, such as the radial artery, to begin blood pressure monitoring. After the distal end of the medical catheter 303 reaches the effective range, the real-time acquired coordinates can be used to perform three-dimensional modeling of the corresponding blood vessel area, resulting in a more intuitive three-dimensional geometric model of the blood vessel.
[0111] By manipulating the medical catheter 303, the electrode at the distal end of the catheter 303 locates the target ablation point within the renal artery and the adjacent abdominal aorta 402. This includes: a physiological stimulation module generating a stimulation signal based on stimulation parameters, causing the medical catheter 303 to output stimulation energy; and a physiological parameter detection module detecting the physiological parameters generated under the stimulation signal. The signal input / output module obtains the spatial location information of the stimulation point based on the current position of the medical catheter 303 and sends this information to the information processing module. The information processing module generates ablation prompts based on the physiological parameters and the spatial location information of the stimulation point. These prompts include recommended and discouraged ablation points. Preferably, the recommended and discouraged ablation point information is displayed in a three-dimensional geometric model. In other words, the information processing module records the identifiers and parameters involved in finding the target ablation point and associates them with corresponding markers in the three-dimensional geometric model for easy viewing.
[0112] Furthermore, based on the recommended ablation points, these points can be used as target ablation points. Ablation begins at these points, while relevant ablation information is recorded, such as power, temperature, impedance, and cold saline perfusion flow rate. A quantitative index of ablation effect is calculated based on the ablation parameters, and combined with the patient's responses to other physiological parameters, it is determined whether the recommended ablation point has achieved its objective. If so, ablation at that recommended ablation point can be stopped; otherwise, ablation can continue.
[0113] After desympathectomy at multiple ablation targets, it is determined whether the ablation target has been achieved. If it has, the ablation can be terminated; otherwise, other ablation targets can be sought to continue ablation until the final target is reached.
[0114] In the above embodiments, the medical catheter 303 enables three-dimensional spatial positioning of its distal end within the renal artery, and allows for modeling of the intravascular structure of both renal arteries and / or the abdominal aorta segment 402 based on the distal positioning of the medical catheter 303. The combination of three-dimensional spatial positioning and modeling technology with radiofrequency ablation technology elevates traditional renal artery ablation from a two-dimensional approach with fuzzy positioning to a three-dimensional approach capable of precise positioning and three-dimensional modeling. This significantly reduces or even completely eliminates the use of X-ray imaging, minimizing the impact on the health of patients and physicians. Real-time positioning of the medical catheter 303 is possible, with seamless data connection, displaying the coordinates of each ablation point and relevant technical parameters for the ablation operation.
[0115] Furthermore, it should be noted that the above embodiments of this application are based on... Figure 2 and Figure 3 The hardware structure shown is used as an example for illustration, but the hardware structure of the ablation system in this application is not limited to this. Figure 2 and Figure 3 As shown, for example, the information processing module in this application may include Figure 2 Working module 101 and Figure 3 The intelligent analysis module in the other embodiments, Figure 2 Working module 101 and Figure 3 The intelligent analysis module can include only one module, and the functions of the working module 101 and the intelligent analysis module can be pre-configured into this one module as needed. The display module in this application can be as follows: Figure 2 and Figure 3 As shown, only Figure 3 In other embodiments, the display module of this application may include at least two, with one display module located in... Figure 2 The three-dimensional mapping system 100 in the middle, another display module is located in Figure 2 The content displayed by the two display modules of the radiofrequency ablation device 300 can be pre-configured as needed, and no specific restrictions are imposed here.
[0116] It should be understood that, although Figure 5 The steps in the flowchart are shown sequentially as indicated by the arrows, but these steps are not necessarily executed in the order indicated by the arrows. Unless otherwise specified herein, there is no strict order in which these steps are executed, and they can be performed in other orders. Figure 5At least some of the steps in the process may include multiple steps or multiple stages. These steps or stages are not necessarily completed at the same time, but may be executed at different times. The execution order of these steps or stages is not necessarily sequential, but may be executed in turn or alternately with other steps or at least some of the steps or stages in other steps.
[0117] Those skilled in the art will understand that all or part of the processes in the methods of the above embodiments can be implemented by a computer program instructing related hardware. The computer program can be stored in a non-volatile computer-readable storage medium, and when executed, it can include the processes of the embodiments of the methods described above. Any references to memory, storage, databases, or other media used in the embodiments provided in this application can include at least one of non-volatile and volatile memory. Non-volatile memory can include read-only memory (ROM), magnetic tape, floppy disk, flash memory, or optical storage, etc. Volatile memory can include random access memory (RAM) or external cache memory. By way of illustration and not limitation, RAM can be in various forms, such as static random access memory (SRAM) or dynamic random access memory (DRAM), etc.
[0118] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered within the scope of this specification. Moreover, although the innovation of this invention originates from renal artery ablation, those skilled in the art will understand that this invention can also be applied to ablation of different sites such as the heart and bronchus. In addition, radiofrequency ablation energy is listed in the embodiments of this invention. This invention can also use other ablation energies such as pulse ablation and microwave ablation, and this invention does not limit it.
[0119] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.
Claims
1. An ablation system, characterized in that, The system includes: an information processing module and a signal input / output module with communication connection; The signal input / output module is used to connect at least one medical catheter. When the medical catheter outputs ablation energy, the signal input / output module obtains the spatial location information of the ablation site based on the current position of the medical catheter and sends the spatial location information of the ablation site to the information processing module. The information processing module is used to obtain target spatial location information based on a target ablation point, and generate ablation prompt information based on the target spatial location information and the spatial location information of the ablation point. The information processing module is also used to periodically calculate the comparison position information based on the spatial position information of the ablation site within a predetermined time period during the process of the medical catheter outputting the ablation energy. If the distance calculated based on the current comparison position information and the target spatial position information within the current predetermined time period is greater than a first preset distance, the information processing module outputs a prompt indicating that the ablation position has moved.
2. The ablation system according to claim 1, characterized in that, The ablation prompts are output via display and / or voice.
3. The ablation system according to claim 1, characterized in that, The signal input / output module is also used to obtain modeling spatial location information based on the spatial location information of the distal end of the medical catheter, and send the modeling spatial location information to the information processing module; the information processing module is also used to construct a three-dimensional geometric model of the area where the distal end of the medical catheter is located based on the modeling spatial location information, and mark the generated ablation prompt information in the three-dimensional geometric model.
4. The ablation system according to claim 3, characterized in that, The system also includes: An ablation energy module is connected to the medical catheter and is used to generate an ablation signal based on ablation parameters, so that the medical catheter outputs the ablation energy. The display module is communicatively connected to the information processing module and is used to display the three-dimensional geometric model and the ablation prompt information.
5. The ablation system according to claim 4, characterized in that, The ablation prompt information also includes ablation record information. The information processing module is also used to receive an instruction, which is used to retrieve information at the ablation point marker. When the instruction is activated, the information processing module displays the ablation record information on the display module.
6. The ablation system according to claim 5, characterized in that, The ablation record information includes at least one of the following: ablation point identifier, spatial location information of ablation points, order of ablation points, ablation power, ablation current, intensity of stimulation signal, frequency of stimulation signal, duration of stimulation signal, physiological parameter changes, temperature, ablation time, impedance, ablation recommendation degree, and ablation effect index.
7. The ablation system according to claim 3, characterized in that, The three-dimensional geometric model includes renal artery vessels and / or abdominal aortic segments.
8. The ablation system according to claim 1, characterized in that, The ablation system includes a three-dimensional mapping system and a radiofrequency ablation device; the information processing module is disposed in the three-dimensional mapping system; or the information processing module is disposed in the radiofrequency ablation device; or a part of the information processing module is disposed in the three-dimensional mapping system, and another part of the information processing module is disposed in the radiofrequency ablation device, and the part and the other part of the information processing module are communicatively connected to each other.
9. The ablation system according to claim 8, characterized in that, The distal end of the medical catheter is equipped with a spatial location information acquisition device, which is connected to the three-dimensional mapping system. The spatial location information acquisition device is used to acquire the spatial location information of the ablation site in real time.
10. The ablation system according to claim 9, characterized in that, The three-dimensional mapping system includes: An excitation field generator is installed under the hospital bed; the excitation field generator is used to output an excitation field for three-dimensional positioning. A signal receiving unit, wherein the receiving end of the signal receiving unit is connected to a three-dimensional positioning sensor at the distal end of the medical catheter, and is used to receive the positioning signal collected by the positioning sensor of the medical catheter and process the positioning signal. The signal control unit has its control terminal connected to the input terminal of the excitation field generator and its output terminal connected to the information processing module. The input terminal of the signal control unit is also connected to the output terminal of the signal receiving unit. The signal control unit controls the output of the excitation field generator and calculates the spatial location information of the ablation site from the signal output of the signal receiving unit, then sends the obtained spatial location information of the ablation site to the information processing module. The information processing module is used to perform three-dimensional modeling based on the spatial location information of the ablation site, and to display the three-dimensional position of the electrodes of the medical catheter on the three-dimensional image obtained from the modeling.
11. The ablation system according to any one of claims 1 to 10, characterized in that, The ablation system also includes: A physiological stimulation module is connected to the medical catheter and is used to generate a stimulation signal according to stimulation parameters, so that the medical catheter outputs stimulation energy. A physiological parameter detection module is used to detect physiological parameters generated under the stimulation signal and send the physiological parameters to the information processing module. When the medical catheter outputs the stimulation energy, the signal input / output module obtains the spatial location information of the stimulation point based on the current position of the medical catheter, and sends the spatial location information of the stimulation point to the information processing module. The information processing module is also used to generate the ablation prompt information based on the physiological parameters and the spatial location information of the stimulation point. The ablation prompt information includes recommended ablation point information and non-recommended ablation point information.
12. The ablation system according to claim 11, characterized in that, The information processing module is further configured to use the spatial location information of the stimulation point corresponding to the recommended ablation point information as the target spatial location information of the target ablation point, calculate the distance between the target spatial location information of the current target ablation point and the spatial location information of any previously ablated point, and output a repeat ablation prompt when the distance calculated based on the target spatial location information of the current target ablation point and the spatial location information of any previously ablated point is less than or equal to a third preset distance.
13. The ablation system according to claim 11, characterized in that, The information processing module periodically calculates the comparison location information based on the spatial location information of the ablation site within a predetermined time period. The information processing module is also used to take the spatial location information of the stimulation point corresponding to the recommended ablation point information as the target spatial location information of the target ablation point, calculate the distance between the target spatial location information of the current target ablation point and the comparison location information, and output a prompt of ablation location movement when the distance between the target spatial location information of the current target ablation point and the comparison location information is greater than a fourth preset distance.
14. The ablation system according to claim 1, characterized in that, The ablation prompt information includes marker color information, and different marker types correspond to different marker color information.
15. The ablation system according to claim 14, characterized in that, It also includes an ablation effect judgment module for calculating the ablation effect index, which depends on the ablation parameters, including ablation power, power loss, surface area of the ablation electrode, and ablation duration.
16. The ablation system according to claim 15, characterized in that, The marker color information corresponds to the ablation effect index, with different color depths representing different ablation effects.
17. The ablation system according to claim 15, characterized in that, The ablation effect index is calculated using the following formula: Where AE is the ablation effect index; n is the nth sampling point; N is the total number of sampling points for a single continuous ablation, which is equal to the ablation duration / sampling time interval; k is a proportionality coefficient, with a value between 0.3 and 0.9; Prf(n) is the ablation power recorded at the nth sampling point; S is the surface area of the ablation electrode; Δt is the sampling interval; Pco(n) is the loss power corresponding to the nth sampling point, where Pco(n) = hS[T(n) - T S h is the heat exchange coefficient, which ranges from 200 to 3000, and its unit is W / m. 2 *℃; T(n) is the electrode temperature at the nth sampling point, T S Temperature refers to the internal environment of the human body, expressed in °C.
Citation Information
Patent Citations
Automatic ablation tracking
CN103385705A