Ultrasonic imaging ablation system and device

Abstract

The invention provides an ultrasonic imaging ablation system and device, and relates to the technical field of medical instruments, the ultrasonic imaging ablation system comprises a system interface module and an ultrasonic imaging radiofrequency ablation catheter; a sheathing canal component of the ultrasonic imaging radiofrequency ablation catheter comprises a main control chip, an ultrasonic transducer and an ablation device. The main control chip and the ablation device are connected to the host through the system interface module; the system interface module is used for responding to the control mode of the host to control the conduction state of the first communication interface and / or the second communication interface so as to carry out signal transmission on the ultrasonic transducer; and / or the operation state of the ablation device is controlled. The radiofrequency ablation function and 4D intracardiac ultrasound imaging are integrated on the same catheter, the advantages of the radiofrequency ablation function and the 4D intracardiac ultrasound imaging can be combined, and the clinical operation process is simplified. The ultrasonic transducer of the same catheter can provide accurate positioning for the radiofrequency ablation position, and can better control the operation process by combining real-time imaging and a feedback mechanism, so that only a predetermined target area is influenced, and the misoperation risk is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular, to an ultrasonic imaging ablation system and device. Background Art

[0002] In the field of cardiac electrophysiology treatment, ablation is often required to treat atrial fibrillation. However, for the determination of ablation targets, it is necessary to use rays to determine, especially the position between the ablation catheter and the target. 4D intracardiac echocardiography, as a real-time three-dimensional ultrasonic imaging technology, can establish a three-dimensional model of the heart cavity in real time and is radiation-free, which is particularly suitable for establishing a real-time heart cavity model and used to calibrate the position between the target and the ablation catheter. However, current surgeries mostly use independent ablation catheters, which increases the surgical cost. Summary of the Invention

[0003] In view of this, the purpose of the present invention is to provide an ultrasonic imaging ablation system and device, which can not only achieve ultrasonic imaging but also perform radiofrequency ablation simultaneously. Based on this, the radiofrequency ablation system with 4D ICE technology can simplify the transseptal puncture to a direct vision transseptal puncture, and the puncture site is more accurate and efficient; it can more clearly judge whether the catheter is attached to the target myocardial position.

[0004] In a first aspect, an embodiment of the present invention provides an ultrasonic imaging ablation system, including a system interface module and an ultrasonic imaging radiofrequency ablation catheter connected to the system interface module; one end of the system interface module is connected to the host, and the other end is connected to the ultrasonic imaging radiofrequency ablation catheter; one end of the ultrasonic imaging radiofrequency ablation catheter is connected to the system interface module, and the other end is provided with a sheath assembly; the sheath assembly includes a sheath and a sheath component connected in sequence; the system interface module includes a first communication interface and a second communication interface, and the sheath component includes a main control chip, an ultrasonic transducer device, and an ablation device; the main control chip is communicatively connected to the first communication interface, and the ultrasonic transducer device is connected to the main control chip; the ablation device is communicatively connected to the second communication interface; the system interface module is used to respond to the control mode of the host, and based on the control mode, control the conduction state of the first communication interface and / or the second communication interface, so that the main control chip and the host are conducted to transmit signals to the ultrasonic transducer device; and / or control the operating state of the ablation device.

[0005] Combined with the first aspect, an embodiment of the present invention provides a first implementation manner of the first aspect, wherein the sheath assembly further includes a manipulation structure, the manipulation structure is arranged at a preset position of the sheath, and the sheath component is integrated at the end of the sheath away from the manipulation structure; the sheath component further includes a flexible circuit board, and the flexible circuit board is arranged between the ultrasonic transducer device and the main control chip; the flexible circuit board is arranged inside the sheath, and the ablation device is arranged outside the sheath.

[0006] In combination with the first aspect, an embodiment of the present invention provides a second implementation of the first aspect, wherein the sheath component further includes a backing layer; the backing layer is arranged on a side of the main control chip away from the flexible circuit board.

[0007] In combination with the first aspect, an embodiment of the present invention provides a third implementation of the first aspect, wherein the ultrasonic transducer device includes multiple transducer array elements, and the multiple transducer array elements are arranged in a preset array manner to form a transducer array; the main control chip includes an array element control circuit corresponding to each transducer array element, and each transducer array element is connected to the main control chip through a flexible circuit board; wherein the flexible circuit board is provided with a via corresponding to each transducer array element, and the package of the main control chip is configured with a protrusion corresponding to each transducer array element; the protrusion matches the via; and signals are transmitted between the main control chip and the transducer array element through the protrusion and the via.

[0008] In combination with the first aspect, an embodiment of the present invention provides a fourth implementation of the first aspect, wherein the flexible circuit board is a multi-layer flexible circuit board, each layer of the flexible circuit board is provided with vias, and the vias of each layer of the flexible circuit board coincide with the axes of the vias corresponding to the same transducer array element, or the axes are staggered by a preset distance.

[0009] In combination with the first aspect, an embodiment of the present invention provides a fifth implementation of the first aspect, wherein the sheath component includes an adapter plate, which is used to transfer the main control chip to the system interface module; the ultrasonic transducer device includes multiple transducer array elements, and each transducer array element is fixedly connected to the package body of the main control chip through a corresponding connecting member.

[0010] In combination with the first aspect, an embodiment of the present invention provides a sixth implementation of the first aspect, wherein the sheath tube component also includes a time gain compensation circuit; the time gain compensation circuit is arranged on the array element control circuit, or the time gain compensation circuit is arranged in a channel module on the main control chip.

[0011] In combination with the first aspect, an embodiment of the present invention provides a seventh implementation of the first aspect, wherein the system interface module includes a system connector and a first catheter connector connected to the system connector via a cable; wherein the system connector is used to connect to a host; and the first catheter connector is used to connect to an ultrasound imaging radiofrequency ablation catheter.

[0012] In combination with the first aspect, an embodiment of the present invention provides an eighth implementation of the first aspect, wherein a second catheter connector is provided at one end of the ultrasound imaging radiofrequency ablation catheter; the second catheter connector matches the first catheter connector; and the ultrasound imaging radiofrequency ablation catheter is connected to the first catheter connector through the second catheter connector.

[0013] Second aspect, an embodiment of the present invention provides an ultrasonic imaging ablation device, wherein the ultrasonic imaging ablation device is the ultrasonic imaging ablation system according to any of the above embodiments.

[0014] The embodiments of the present invention bring the following beneficial effects: An ultrasonic imaging ablation system and device provided by the embodiments of the present invention integrate the radiofrequency ablation function and 4D intracardiac ultrasonic imaging on the same catheter, which can combine the advantages of both and simplify the clinical operation process. Through the system interface module, the functions of ultrasonic imaging and ablation devices are integrated, and the coordinated control of the two can be realized. It not only realizes a highly integrated design and simplifies the operation process, but also can synchronize the imaging screen and ablation based on the same ultrasonic imaging radiofrequency ablation catheter, improving the treatment accuracy. The ultrasonic transducer device of the same catheter can provide accurate positioning for the radiofrequency ablation position, and can better control the surgical process in combination with real-time imaging and feedback mechanism, ensuring that only the predetermined target area is affected and reducing the risk of misoperation. At the same time, during ablation, the ablation degree of tissues can be observed through ultrasonic images, making the ablation process more effective and safe.

[0015] Other features and advantages of the present invention will be described in the following specification, and, in part, will be obvious from the specification, or will be understood by implementing the present invention. The objectives and other advantages of the present invention are realized and obtained by the structures specifically pointed out in the specification, claims, and drawings.

[0016] To make the above objectives, features, and advantages of the present invention more obvious and understandable, the following specific preferred embodiments are given, and in conjunction with the accompanying drawings, the detailed description is as follows. Description of the Drawings

[0017] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the following drawings are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0018] Figure 1 It is a schematic structural diagram of an ultrasonic imaging ablation system provided by an embodiment of the present invention;

[0019] Figure 2 It is a schematic structural diagram of a sheath tube component provided by an embodiment of the present invention;

[0020] Figure 3 It is a schematic encapsulation structure diagram of a sheath tube component provided by an embodiment of the present invention;

[0021] Figure 4Schematic diagram of a packaging structure corresponding to a multi-layer flexible circuit board provided by an embodiment of the present invention;

[0022] Figure 5 Schematic diagram of an array element and channel control circuit provided by an embodiment of the present invention;

[0023] Figure 6 Schematic diagram of another array element and channel control circuit provided by an embodiment of the present invention;

[0024] Figure 7 Schematic diagram of the structure of another ultrasonic imaging ablation system provided by an embodiment of the present invention;

[0025] Figure 8 Schematic diagram of another packaging structure of a sheath tube component provided by an embodiment of the present invention. Detailed implementation manners

[0026] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments. Apparently, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0027] Traditional catheter radiofrequency ablation is performed under the monitoring of an X-ray angiography machine. By puncturing blood vessels such as the femoral vein, femoral artery, or subclavian vein, part of the radiofrequency ablation catheter is placed into the heart cavity. Then, through the radiofrequency ablation catheter, the abnormal tissue (ablation target) causing tachycardia is determined by electrophysiological examination. Then, a high-frequency current of 100 kHz to 1.5 MHz is released at the abnormal tissue through the radiofrequency ablation catheter to generate high temperature at the abnormal tissue (ablation target), and the water in the tissue at the abnormal tissue is evaporated and dried and necrosed by heat energy to achieve the treatment purpose. The X-ray angiography machine has the disadvantages of great radiation damage and high initial operating costs in hospitals; traditional two-dimensional ultrasonic imaging technology has limited vision and can only present an image of one section. If the target or the area of interest is not within this section, it cannot be observed. The 4D ICE technology can provide real-time three-dimensional cardiac structure imaging, significantly improving the safety and efficiency of the operation.

[0028] The embodiments of the present invention provide an ultrasonic imaging ablation system and device that can both achieve ultrasonic imaging and perform radiofrequency ablation at the same time. Based on this, the radiofrequency ablation system with 4D ICE technology can simplify the transseptal puncture to a direct vision transseptal puncture, and the puncture site is more accurate and efficient; it can more clearly determine whether the catheter is attached to the target myocardial position.

[0029] To facilitate the understanding of this embodiment, first, a detailed introduction to an ultrasonic imaging ablation system disclosed in the embodiments of the present invention will be provided. Figure 1 The structural schematic diagram of an ultrasonic imaging ablation system provided by the embodiments of the present invention is shown, as Figure 1 shown. The ultrasonic imaging ablation system includes a system interface module and an ultrasonic imaging radiofrequency ablation catheter connected to the system interface module. The ultrasonic imaging radiofrequency ablation catheter can provide high-definition four-dimensional ultrasonic imaging during cardiac radiofrequency ablation surgery and has a radiofrequency ablation treatment function to improve the accuracy and safety of the surgery.

[0030] In specific implementation, one end of the system interface module is connected to the host, and the other end is connected to the ultrasonic imaging radiofrequency ablation catheter. In one embodiment, the diameter of the ultrasonic imaging radiofrequency ablation catheter is 12Fr (4mm) or less. The system interface module is responsible for signal communication between the catheter and the ultrasonic host and can be reused outside the disinfection area during the surgery; the ultrasonic imaging radiofrequency ablation catheter is the core component, responsible for 4D ultrasonic imaging and radiofrequency ablation, and is generally a disposable consumable inside the disinfection area during the surgery. The embodiments of the present invention closely combine the system interface module and the catheter, which not only reduces the overall volume and complexity of the device but also facilitates quick installation and configuration, making the operation more convenient.

[0031] Among them, one end of the ultrasonic imaging radiofrequency ablation catheter is connected to the system interface module 10, and the other end is provided with a sheath assembly; the sheath assembly includes a sheath tube ( Figure 1 not shown in the figure) and a sheath tube component 21 connected in sequence. The system interface module includes a first communication interface 11 and a second communication interface 12. The sheath tube component includes a main control chip 201, an ultrasonic transducer device 202, and an ablation device 203; the main control chip is communicatively connected to the first communication interface, and the ultrasonic transducer device is connected to the main control chip; the ablation device is communicatively connected to the second communication interface. The system interface module is used to respond to the control mode of the host, control the conduction state of the first communication interface and / or the second communication interface based on the control mode, so that the main control chip and the host are conducted to transmit signals to the ultrasonic transducer device; and / or control the operating state of the ablation device.

[0032] Among them, in the embodiments of the present invention, the system interface module integrates the functions of the ultrasonic imaging and ablation device, and can achieve the coordinated control of the two, not only realizing a highly integrated design and simplifying the operation process, but also being able to synchronize the imaging screen and ablation based on the same ultrasonic imaging radiofrequency ablation catheter, improving the treatment accuracy. When ultrasonic imaging is required, the host can select the ultrasonic imaging mode, control the main control chip through the system interface module, and then control the ultrasonic transducer device to emit and receive ultrasonic waves. When ablation operation is required, the host enters the ablation mode and controls the working state of the ablation device through the system interface module. Among them, it is possible to directly enter the ablation mode in the ultrasonic imaging mode to directly start the ablation process while staying in the imaging interface. Correspondingly, it is controlled that both the first communication interface and the second communication interface are in a conducting state.

[0033] Specifically, the system interface module, as a key part connecting the host and the ultrasonic imaging radiofrequency ablation catheter, is responsible for transmitting control signals and data. The ultrasonic imaging radiofrequency ablation catheter is a flexible catheter body, providing a flexible channel that allows internal components to safely reach the target position through the body cavity. Its distal end is equipped with a 4D ICE ultrasonic transducer device and an ablation device. In one embodiment, the ultrasonic transducer device consists of a 2D acoustic element array and an ASIC, and can perform real-time 2D, 3D, and multi-plane intracardiac imaging. The ablation device can be the following device types: 1 - Cryoablation: Using a gas at an extremely low temperature to freeze and destroy abnormal tissues through a special probe. This technique is commonly used to treat certain types of arrhythmias, tumors, etc. 2 - Microwave ablation: Using microwave energy to heat and destroy the target tissue. It can reach a relatively high temperature in a short time and is suitable for treating tumors in various organs such as the liver and lungs. 3 - Laser ablation: Using a high-energy laser beam to directly irradiate the lesion site, causing the local temperature to rise rapidly to achieve selective destruction of the lesion tissue. 4 - Ultrasound ablation: Also known as high-intensity focused ultrasound, it can accurately focus ultrasonic waves from outside the body on the internal lesion site to generate a high-temperature effect without surgery to achieve the purpose of eliminating the lesion. 5 - Chemical ablation: Injecting chemical substances (such as alcohol or acetic acid) into a specific area, and these chemical substances can cause cell dehydration and protein denaturation, thereby leading to tissue necrosis. 6 - Photodynamic therapy: First, the patient takes a special photosensitizer, and after a period of time, the diseased area is illuminated with light of a specific wavelength to activate the photosensitizer to produce reactive oxygen species to kill cancer cells. 7 - Particle implantation: The tumor can be controlled by means of brachytherapy.

[0034] In an embodiment of the present invention, the ablation device can be a radiofrequency ablation electrode. The radiofrequency ablation electrode of the catheter can generate high-frequency current and use radiofrequency energy to destroy abnormal tissues, which can be used to treat diseases such as arrhythmias and tumors. The high-frequency alternating current is transmitted to the target tissue through the catheter to generate a thermal effect, so that the target tissue is heated and destroyed, thereby achieving a therapeutic effect. In the specific implementation, the embodiment of the present invention uses a sheath to protect the device. The sheath is a slender, hollow catheter used in medical procedures, usually made of a soft and elastic material. The ultrasonic imaging device and the radiofrequency ablation device are integrated at the end of the sheath to provide a protection channel for the interventional device. Through 4D ICE (four-dimensional intracardiac ultrasound), doctors can not only obtain static three-dimensional anatomical information, but also capture the movement of the heart in different cardiac cycles, which is crucial for evaluating cardiac function and determining the optimal ablation position. The 4D ICE ultrasonic transducer is coupled with a 3D position sensor, which can realize position mapping in a compatible navigation system, providing doctors with dynamic three-dimensional display of cardiac structure and two-dimensional imaging of any section.

[0035] The embodiment of the present invention adds the function of radiofrequency ablation on the basis of realizing 4D ultrasonic imaging, that is, in the field of intracardiac electrophysiology applications, ultrasound can be used to model the cardiac cavity, and the same catheter can be used for ablation. The movement of the heart can be observed in different cardiac cycles, and a detailed cardiac cavity model can be established. Based on the clear anatomical information provided by 4D ultrasound, the target area for radiofrequency ablation can be accurately planned, and the position of the radiofrequency ablation electrode can be manipulated using the same catheter to heat and destroy the diseased tissue. On this basis, ultrasonic imaging can be used to monitor the ablation effect in real time to ensure that only the predetermined target area is affected and unnecessary tissue damage is avoided. All key functions are centrally managed by the main control chip, which can achieve highly accurate time synchronization and spatial positioning to ensure that each operation step is completed within the expected range.

[0036] In summary, the ultrasonic imaging ablation system provided by the embodiment of the present invention integrates the radiofrequency ablation function and 4D intracardiac ultrasonic imaging on the same catheter, which can combine the advantages of both and simplify the clinical operation process. The ultrasonic transducer device of the same catheter can provide precise positioning of the radiofrequency ablation position, and can better control the surgical process by combining real-time imaging and feedback mechanism, ensuring that only the predetermined target area is affected, reducing the risk of misoperation.

[0037] Furthermore, based on the above embodiment, the embodiment of the present invention also provides another ultrasound imaging ablation system. Figure 2Fig. 0 shows a schematic structural diagram of another ultrasonic imaging ablation system provided by an embodiment of the present invention. Among them, the sheath component further includes a flexible printed circuit board (FPC) 51. The flexible printed circuit board 51 is arranged between the ultrasonic transducer device 202 and the main control chip 201 and serves as a connection structure between the main control chip and the system interface module. Among them, the flexible printed circuit board 51 is arranged inside the sheath, which can avoid displacement caused by external pressure or vibration. The ablation device 203 is arranged outside the sheath and can be connected to the second communication interface through a preset connection structure, such as Figure 2 in 121.

[0038] Among them, the flexible printed circuit board plays a role in electrically connecting the transducer array and the main control chip, and at the same time conducts the input and output signals of the main control chip. In the prior art, the ultrasonic transducer array elements are connected to the main control chip through wires. As the number of transducer array elements increases, the number of required wires will also increase accordingly, resulting in an increase in the overall volume and affecting the flexibility and operability of the catheter. The flexible printed circuit board can significantly reduce the required space, making the catheter thinner and more flexible, and facilitating passing through narrow or complex blood vessel paths. In the embodiment of the present invention, the flexible printed circuit board can not only provide denser electrical connections, enabling each element in the ultrasonic transducer array to be directly connected to the control chip through thin and flexible lines, which helps to improve the efficiency and accuracy of signal transmission. Also, because the flexible printed circuit board has good flexibility and bendability, it can better adapt to complex spatial structures, simplifies the internal wiring, and reduces the volume limitation that may be brought by traditional rigid circuit boards. Further, the sheath component further includes a backing layer 52; the backing layer is arranged on the side of the main control chip away from the flexible printed circuit board. The backing plays a role in absorbing the backward-propagating ultrasound.

[0039] Further, the ablation device is used to generate radio frequency energy for ablation. In the embodiment of the present invention, the ablation device is connected to the second communication interface of the system interface module to be connected to the corresponding ablation host. Among them, the ablation device can be connected to the second communication interface through a wire. The wire can achieve an effective connection with the ablation electrode without affecting the overall design of the catheter, saving valuable internal space. Moreover, the length and path of the wire can be flexibly adjusted according to specific needs, improving the adaptability of the entire system. Based on this, the embodiment of the present invention forms a modular integrated product. The ultrasonic imaging function and the ablation function can work as independent functional units, and can be easily connected through interfaces to achieve plug-and-play function expansion and maintenance, and have compatibility and interchangeability. Due to the combination of the flexible printed circuit board and the wire, the entire system can accommodate more functional modules without increasing the catheter diameter, realizing the high integration of multiple functions, maintaining a compact design, and maximizing the use of limited internal space. The modular design enables the product to adapt to different application scenarios and demand changes, and has good ductility and flexibility.

[0040] In addition, the integration of different functions by using the dual communication interfaces of the system interface module can not only be responsible for different tasks respectively, increasing the flexibility and reliability of the system and better meeting the requirements of different application scenarios. Moreover, even if a problem occurs in a certain connection part, the other part can still work normally, enhancing the fault tolerance of the system. Furthermore, the embodiment of the present invention can also provide real-time image feedback and physiological parameter monitoring based on an integrated design, and can also dynamically adjust various parameters during the ablation process based on this design.

[0041] Among them, the distance between the ablation electrode and the ultrasonic transducer in the embodiment of the present invention is fixed. During the working process, after the target point is determined by ultrasonic imaging, the ablation electrode can be moved a specific distance through the operation of the doctor to confirm that the ablation electrode is aligned with the target point. Based on this, the presence of the ultrasonic image provides real-time feedback for real-time adjustment of the ablation power. The doctor can adjust the ablation power and duration in real time by observing the ultrasonic image of the tissue to achieve a safer and more effective ablation. Especially when ablating deep tissues, since the ultrasonic image can provide images of deep tissues, the doctor can better observe the ablation status of deep tissues and can better judge when to stop ablation.

[0042] Furthermore, the sheath component further includes passive devices 53, mainly including decoupling capacitors and thermistors, etc. In summary, Figure 2 shows a schematic structural diagram of the sheath component of the embodiment of the present invention. Referring to Figure 2 , the passive devices are arranged on the flexible circuit board.

[0043] Furthermore, the ultrasonic transducer device includes a plurality of transducer elements, and the plurality of transducer elements form a transducer array in a preset array manner. Among them, the ultrasonic transducer device can be a common 1D linear array, and can also include ultrasonic transducers made of various materials such as PZT, CMUT, or PMUT. The main control chip (ASIC) includes an element control circuit corresponding to each transducer element, and each transducer element is connected to the main control chip through a flexible circuit board. In specific implementation, the main control chip is used for transmitting, receiving, and delay control, and each transducer element corresponds to a transmitting, receiving, and delay circuit to achieve independent control of the transducer element.

[0044] In the embodiment of the present invention, for each element in the transducer array, there is a set of high-voltage pulse generator, high-voltage switch, amplifier, TGC, and corresponding control circuits. This ensures that a single element can be independently controlled by the ultrasonic host. The main control chip controls the emission period, frequency, amplitude, delay, etc. of each transducer element of the ultrasonic transducer device according to the control signal provided by the ultrasonic system host. When receiving ultrasonic waves, the return signals of several elements are amplified and delayed and superimposed according to the delay signal provided by the ultrasonic system host and then transmitted to the system host channel. Specifically, Figure 5 、Figure 6 Schematic diagrams of the array element and the channel control circuit are respectively shown. As shown in the figure, the HV Pulser generates high-voltage pulse signals for driving the ultrasonic transducer to emit ultrasonic waves. The TR Switch is used to switch between the transmit and receive modes. In the transmit mode, it transfers the high-voltage pulse signals to the ultrasonic transducer device; in the receive mode, it transfers the weak signals received by the ultrasonic transducer device to the subsequent circuit. The LNA is a low-noise amplifier for amplifying the weak signals received by the transducer while maintaining a low noise level. The SH Delay is a sample-and-hold circuit for sampling signals at specific time points and holding the value for a period of time for subsequent processing. Σ represents analog addition, which is used to add signals from various channels, and together with the preceding SH Delay, it forms an analog delay addition circuit. The Cable Driver is used to drive the signal transmission in the cable to ensure that the signal does not distort during long-distance transmission. Further, the sheath component further includes a time gain compensation circuit for adjusting the gain of echo signals at different depths to compensate for the energy attenuation of ultrasonic waves during propagation in the medium.

[0045] Referring to Figure 6 , the time gain compensation circuit is provided on the array element control circuit to perform TGC compensation amplification for each array element. Alternatively, referring to Figure 5 , the time gain compensation circuit is provided in the channel module on the main control chip to ensure that the received signals of each channel can be timely and accurately gain-adjusted, thereby improving the response speed and accuracy of the entire system.

[0046] The flexible circuit board is provided with vias 61 corresponding to each transducer array element, and the package body of the main control chip is configured with protrusions 60 corresponding to each transducer array element; the protrusions are matched with the vias. Signals are transmitted between the main control chip and the transducer array elements through the protrusions and vias. Figure 3 The schematic diagram of the corresponding package structure according to the embodiment of the present invention is shown. Among them, the protrusions can be made by using the flip-chip packaging process in semiconductor packaging technology. During packaging, each transducer array element corresponds to a via on the flexible circuit board and also corresponds to a protrusion on the main control chip. The flexible circuit board and the transducer array element array and the main control chip can be connected by using the anisotropic conductive film (ACF) process. In this way, when emitting ultrasonic waves, the high-voltage electrical pulses generated by the main control chip are applied to the transducer array elements through the protrusions and vias; when receiving ultrasonic waves, the voltage generated by the ultrasonic waves received by the transducer array elements is conducted to the circuit of the main control chip through the protrusions and vias. The embodiment of the present invention only requires the positions of the protrusions and vias to correspond to each other, and the same main control chip can be used to adapt to transducer arrays with different pitches. It can not only ensure the one-to-one connection between each transducer array element and the main control chip, but also reduce the length of the signal transmission path, and can also avoid the misalignment or poor contact problems that may occur in traditional wire connections.

[0047] In one embodiment, the flexible printed circuit board is a multi-layer flexible printed circuit board. Each layer of the flexible printed circuit board is provided with vias, and the axes of the vias of each layer of the flexible printed circuit board coincide with the axes of the vias corresponding to the same transducer element, or the axes are staggered by a preset distance. Specifically, a four-layer flexible printed circuit board can be used, and vias can be made on the upper and lower layers respectively. Figure 4 The schematic diagram of the package structure corresponding to the multi-layer flexible printed circuit board is shown. Copper wires can be laid in the middle of the four-layer flexible printed circuit board, and the vias on the upper and lower layers can be staggered by a certain position. Based on this, the spacing between the transceiver circuits on the main control chip and the spacing between the transducer elements can be inconsistent, so that the same chip can be adapted to transducer arrays with different spacings, reducing the design cost.

[0048] Further, in addition to Figure 1 the structure of Figure 7 it further includes a system connector 11, a first catheter connector 31, a second catheter connector 32, and a manipulation structure 40. Referring to Figure 7 the above system interface module includes a system connector, and a first catheter connector connected to the system connector through a cable; wherein, the system connector is used to connect to the host; the first catheter connector is used to connect to the ultrasonic imaging radiofrequency ablation catheter. Further, one end of the ultrasonic imaging radiofrequency ablation catheter is provided with a second catheter connector; the second catheter connector is matched with the first catheter connector; the ultrasonic imaging radiofrequency ablation catheter is connected to the first catheter connector through the second catheter connector.

[0049] In the embodiment of the present invention, the system connector is connected to the preset host. In the embodiment of the present invention, the system connector is connected to the ultrasonic imaging and radiofrequency ablation host. Physically, the socket of the system connector is directly connected to the socket of the host, playing a dual role of electrical connection and mechanical fixation. Among them, circuits can be placed inside the system connector to implement functions such as harmonic tuning circuits, low-voltage power supply modules, digital signal level conversion, and storing catheter IDs. The low-voltage power supply module is responsible for further dividing and stabilizing the low-voltage power supply provided by the ultrasonic host system. In actual use, due to different design requirements of the chips inside the catheter, multiple different low-voltage power supplies may be required. While the host generally only provides 1 to 2 low-voltage power supplies, so multiple low-voltage power supplies need to be generated inside the system connector. At the same time, in order to further compensate for the cable voltage drop caused by the cable, the low-voltage power supply module also provides a cable voltage drop compensation function. Further, a matching pair of catheter connectors is used to connect the system connector and the ultrasonic imaging radiofrequency ablation catheter, and the two catheter connectors are docked to achieve electrical and mechanical connections. Usually, an EEPROM is integrated as the catheter identifier. According to needs, a digital circuit buffer can be set inside the catheter connector to buffer the attenuation of digital signals caused by the cable length.

[0050] The sheath assembly of the embodiment of the present invention also includes a manipulation structure, which is arranged at a preset position of the sheath, and the sheath component is integrated at the end of the sheath away from the manipulation structure. Among them, the embodiment of the present invention controls the bending of the sheath through the manipulation structure (such as a handle), and the doctor can conveniently control the bending direction and degree of the distal end of the sheath during operation. In one embodiment, the manipulation structure includes two rotating wheels to pull four traction ropes to achieve the sheath bending function. Among them, a knob and a bending adjustment knob can be provided on the manipulation structure to allow the catheter to deflect left and right and rotate 360° to meet different surgical needs. The sheath is the part that enters the blood vessel, and plays the role of mechanically connecting the manipulation structure and the distal end of the sheath (i.e., the sheath component), while also protecting the internal electrical connection. Generally speaking, the sheath wall will pass through four traction wires to achieve four-way bending of the distal end of the sheath.

[0051] Furthermore, in addition to using a flexible circuit board to conduct signals, an adapter board can also be used for signal transfer. In a specific implementation, the sheath tube component includes an adapter board 54, which is used to transfer the main control chip to the system interface module; the ultrasonic transducer device includes a plurality of transducer array elements, each of which is fixedly connected to the package of the main control chip through a corresponding connector 63. Figure 8 Another schematic diagram of the packaging structure of the sheath tube component of the embodiment of the present invention is shown. Figure 8 This method removes the flexible circuit board connection between the transducer array and the main control chip, and the main control chip communicates with the outside world by connecting to an adapter board by wire bonding. Furthermore, cables or flexible circuit boards can be used to communicate with the outside world.

[0052] In summary, by using the ultrasonic transducer device of the embodiment of the present invention to implement 4D ICE imaging, doctors can conduct a detailed assessment and planning of the heart structure before surgery to determine the optimal ablation path and target area. During the operation, 4D ICE provides real-time imaging of the heart structure to help doctors accurately navigate the catheter to the target position. After reaching the target position, high-frequency current can be released through the radiofrequency ablation electrode to perform ablation treatment on the origin point of the abnormal heart rhythm. Furthermore, 4D ICE imaging can also be used to evaluate the ablation area, ensure the treatment effect, and monitor possible complications. Throughout the operation, the 4D ICE catheter can monitor the patient's cardiac function and hemodynamic changes to ensure the safety of the operation.

[0053] Further, on the basis of the above embodiments, the embodiments of the present invention further provide an ultrasonic imaging ablation device, which includes the ultrasonic imaging ablation system of any one of the above embodiments. For the ultrasonic imaging ablation device provided by the embodiments of the present invention, the implementation principle and the technical effects produced are the same as those of the foregoing embodiments of the ultrasonic imaging ablation system. For the sake of brief description, for the parts not mentioned in the embodiments of the ultrasonic imaging ablation device, reference may be made to the corresponding content in the foregoing embodiments of the ultrasonic imaging ablation system.

[0054] Finally, it should be noted that the above embodiments are only specific implementation manners of the present invention, which are used to illustrate the technical solutions of the present invention, rather than to limit it. The protection scope of the present invention is not limited thereto. Although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that any person skilled in the art within the technical scope disclosed by the present invention can still modify the technical solutions recorded in the foregoing embodiments, or can easily think of changes, or perform equivalent replacements on some of the technical features; and these modifications, changes or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present invention, and should all be covered by the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. An ultrasonic imaging ablation system, characterized in that: It comprises a system interface module, and an ultrasonic imaging radiofrequency ablation catheter connected to the system interface module; wherein one end of the system interface module is connected to a host, and the other end is connected to the ultrasonic imaging radiofrequency ablation catheter; one end of the ultrasonic imaging radiofrequency ablation catheter is connected to the system interface module, and the other end is provided with a sheath assembly; wherein the sheath assembly comprises a sheath and a sheath component connected in sequence; Wherein, the system interface module includes a first communication interface and a second communication interface, and the sheath tube component includes a main control chip, an ultrasonic transducer device and an ablation device; the main control chip is communicatively connected to the first communication interface, and the ultrasonic transducer device is connected to the main control chip; the ablation device is communicatively connected to the second communication interface; The system interface module is used to respond to the control mode of the host, and control the conduction state of the first communication interface and / or the second communication interface based on the control mode, so that the main control chip and the host are turned on to transmit signals to the ultrasonic transducer device; and / or control the operating state of the ablation device.

2. The ultrasonic imaging ablation system according to claim 1, characterized in that: The sheath tube assembly further comprises a manipulation structure, which is arranged at a preset position of the sheath tube, and the sheath tube component is integrated at an end of the sheath tube away from the manipulation structure; The sheath tube component further includes a flexible circuit board, and the flexible circuit board is arranged between the ultrasonic transducer device and the main control chip; Wherein, the flexible circuit board is arranged inside the sheath tube, and the ablation device is arranged outside the sheath tube.

3. The ultrasonic imaging ablation system according to claim 2, characterized in that: The sheath tube component further comprises a backing layer; the backing layer is arranged on a side of the main control chip away from the flexible circuit board.

4. The ultrasonic imaging ablation system according to claim 2, characterized in that: The ultrasonic transducer device comprises a plurality of transducer array elements, and the plurality of transducer array elements form a transducer array in a preset array manner; The main control chip includes an array element control circuit corresponding to each of the transducer array elements, and each of the transducer array elements is connected to the main control chip through the flexible circuit board; The flexible circuit board is provided with a via hole corresponding to each of the transducer array elements, and the package of the main control chip is provided with a protrusion corresponding to each of the transducer array elements; the protrusion matches the via hole; Signals are transmitted between the main control chip and the transducer array element through the protrusion and the via hole.

5. The ultrasonic imaging ablation system according to claim 4, characterized in that: The flexible circuit board is a multi-layer flexible circuit board, each layer of the flexible circuit board is provided with vias, and the vias of each layer of the flexible circuit board coincide with the axes of the vias corresponding to the same transducer array element, or the axes are staggered by a preset distance.

6. The ultrasonic imaging ablation system according to claim 1, characterized in that: The sheath tube component includes an adapter plate, and the adapter plate is used to transfer the main control chip to the system interface module; The ultrasonic transducer device comprises a plurality of transducer array elements, and each of the transducer array elements is fixedly connected to the packaging body of the main control chip through a corresponding connecting piece.

7. The ultrasound imaging ablation system according to claim 4, characterized in that: The sheath tube component also includes a time gain compensation circuit; The time gain compensation circuit is arranged on the array element control circuit, or the time gain compensation circuit is arranged in a channel module on the main control chip.

8. The ultrasound imaging ablation system according to claim 1, characterized in that: The system interface module includes a system connector, and a first conduit connector connected to the system connector via a cable; Wherein, the system connector is used to connect with the host; The first catheter connector is used to be connected to the ultrasound imaging radiofrequency ablation catheter.

9. The ultrasonic imaging ablation system according to claim 8, characterized in that: One end of the ultrasound imaging radiofrequency ablation catheter is provided with a second catheter connector; The second conduit connector mates with the first conduit connector; The ultrasound imaging radiofrequency ablation catheter is connected to the first catheter connector via the second catheter connector.

10. An ultrasonic imaging ablation device, characterized in that: The ultrasound imaging ablation device comprises the ultrasound imaging ablation system according to any one of claims 1-9.

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