Three-dimensional imaging mapping catheter

Abstract

The application relates to a three-dimensional imaging mapping catheter, which comprises a catheter assembly, the distal end of which is used for interventional cardiac cavity; an image acquisition assembly, which comprises a core and an ultrasonic transducer, the core is arranged inside the catheter assembly, and the ultrasonic transducer is connected to the distal end of the core; the ultrasonic transducer is used for scanning the contour of the cardiac cavity to construct a three-dimensional image model of the cardiac cavity; and an electrocardio mapping assembly, which comprises a plurality of mapping electrodes arranged at the distal end of the catheter assembly; the mapping electrodes are used for collecting electrocardio signals of a plurality of cardiac cavity sites to construct a three-dimensional mapping model of the cardiac cavity. Through the technical scheme of the application, the problem that two separate catheters are implanted to respectively acquire the anatomical structure information and electrocardio signals of the heart in the related art is solved, and the operation is complicated.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to three-dimensional imaging mapping catheters. Background Technology

[0002] In the field of cardiac electrophysiological ablation, intracardiac ultrasound catheters have become a core auxiliary medical device in clinical applications. Currently, there are commercially available intracardiac ultrasound catheters with 3D imaging capabilities. These catheters can construct a 3D image model of the heart chambers using ultrasound and display any plane within the 3D image model to the physician, helping them to more accurately understand the spatial anatomical structure within the heart chambers. Therefore, intracardiac ultrasound catheters with 3D imaging capabilities can better depict target structures within the heart chambers, thus enabling more precise treatment.

[0003] For cardiac electrophysiological ablation surgery, it is far from enough to only obtain information on the spatial anatomical structure within the heart chambers. It is also necessary to simultaneously collect electrocardiogram signal information from the heart chambers. Only by combining the two can the target ablation point be accurately located, thereby ensuring the therapeutic effect of the ablation surgery.

[0004] In current clinical techniques, the acquisition of these two types of data requires two separate interventional catheters: an ultrasound imaging catheter and an electrocardiogram mapping catheter are implanted into the patient. These two sets of instruments operate independently to collect anatomical information and electrocardiogram signal information from within the heart chambers, respectively. However, this method of independently implanting two catheters prolongs the surgical procedure, increases the difficulty for the surgeon, and reduces the accuracy of identifying the location of abnormal cardiac potentials. Summary of the Invention

[0005] Therefore, it is necessary to provide a three-dimensional imaging mapping catheter to address at least one of the problems of the prior art.

[0006] A three-dimensional imaging mapping catheter, comprising:

[0007] A catheter assembly, the distal end of which is used for intervention in the cardiac chamber;

[0008] The image acquisition component includes a core and an ultrasonic transducer. The core is located inside the catheter assembly, and the ultrasonic transducer is connected to the distal end of the core. The ultrasonic transducer is used to scan the contour of the heart chamber to construct a three-dimensional image model of the heart chamber.

[0009] The electrocardiogram mapping component includes several mapping electrodes arranged at the distal end of the catheter assembly. The mapping electrodes are used to acquire electrocardiogram signals from multiple cardiac chamber sites to construct a three-dimensional mapping model of the cardiac chambers.

[0010] In one embodiment, the ultrasonic transducer can be driven by the core to present a first operating state or a second operating state:

[0011] In the first working state, the ultrasonic transducer moves and rotates axially relative to the catheter assembly to obtain a three-dimensional image model of the heart chamber.

[0012] In the second operating state, the ultrasound transducer approaches and rotates to the distal end of the catheter assembly to obtain an ultrasound verification image showing the relative positional relationship between the mapping electrode and the heart chamber.

[0013] In one embodiment, the ECG mapping assembly includes a first position sensor, which has a predetermined first spatial offset from at least one mapping electrode;

[0014] The image acquisition component includes a second position sensor, which has a preset second spatial offset from the ultrasonic transducer and no relative angular displacement.

[0015] The first position sensor and the second position sensor respond to the spatial magnetic field generated by the same magnetic field generator and are positioned in the magnetic positioning coordinate system generated by the spatial magnetic field.

[0016] In one embodiment, the mapping electrode is disposed at the distal end of the conduit assembly, and the distal end of the conduit assembly is also provided with an outlet. The outlet and the first position sensor are both arranged at the proximal end of the mapping electrode.

[0017] The calibration electrode, the outlet, and the first position sensor are staggered along the axial direction, or the outlet and the first position sensor are located on opposite sides of the conduit assembly and their orthogonal projections on the axis overlap.

[0018] In one embodiment, the ECG mapping assembly further includes a plurality of flexible elements, which are isolated from each other and connected to the distal end of the catheter assembly.

[0019] Several measuring electrodes are distributed on any flexible component.

[0020] In one embodiment, a first position sensor is disposed at the distal end of the catheter assembly. The flexible member includes a reinforcing section and a flexible section, the reinforcing section being connected between the distal end of the catheter assembly and the flexible section, the reinforcing section having a higher rigidity than the flexible section.

[0021] The calibration electrode includes a calibration electrode, which is disposed in the reinforcing section of the flexible member, and the calibration electrode has a preset first spatial offset from the first position sensor.

[0022] In one embodiment, for any two adjacent flexible members, at least one parameter among their length, number of calibration electrodes, and spacing of calibration electrodes has a different value.

[0023] In one embodiment, the catheter assembly includes an axially extending sheath, with a core axially disposed inside the catheter assembly; the core drives an ultrasonic transducer movably disposed relative to the sheath, and / or, the core drives the ultrasonic transducer rotatably disposed relative to the sheath about an axis of the sheath.

[0024] In one embodiment, the ultrasonic transducer is initially axially offset from the first position sensor and the calibration electrode.

[0025] In one embodiment, the catheter assembly includes a retraction tube and a handle, the handle being connected to the proximal end of the retraction tube, the retraction tube being sleeved on the outside of the sheath and being able to slide relative to the sheath, and the handle and the core being able to be driven together to move axially synchronously relative to the sheath.

[0026] The aforementioned 3D imaging mapping catheter features an image acquisition component core housed within the catheter assembly, with an ultrasound transducer connected to the distal end of the core. The mapping electrodes of the electrocardiogram (ECG) mapping component are positioned at the distal end of the catheter assembly, allowing the ultrasound transducer and mapping electrodes to share the same catheter assembly as a carrier. Specifically, when the catheter assembly is inserted into the heart cavity, the ultrasound transducer and mapping electrodes can reach their predetermined positions within the heart cavity along with the catheter assembly. In other words, the ultrasound transducer and ECG mapping electrodes can utilize the same catheter assembly to complete heart cavity contour scanning and ECG signal acquisition. Compared to related technologies where ultrasound imaging and ECG mapping require separate catheters and batch insertions into the heart cavity, this approach allows for a single insertion of the catheter assembly into the heart cavity. The ultrasound transducer and mapping electrodes can then be positioned within the heart cavity to scan the heart cavity contour and acquire ECG signals, facilitating subsequent ablation procedures without requiring two separate interventions, thus reducing operational complexity. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the structure of a three-dimensional imaging mapping catheter with the mapping electrode disposed on the distal end of the sheath, according to one embodiment of the present application.

[0028] Figure 2 This is a cross-sectional view of a three-dimensional imaging mapping catheter with the mapping electrode disposed on the distal end of the sheath, according to an embodiment of the present application.

[0029] Figure 3 for Figure 2 A partial structural diagram at point A in the middle;

[0030] Figure 4 This is a schematic diagram of the structure of a three-dimensional imaging mapping conduit with mapping electrodes disposed on a flexible component according to an embodiment of the present application.

[0031] Figure 5 for Figure 4 A schematic diagram of the local structure at point D;

[0032] Figure 6 This is a schematic diagram showing the state in which the mapping electrode of a three-dimensional imaging mapping catheter is disposed on a flexible component and the distal end of the catheter extends into the heart cavity, according to an embodiment of the present application.

[0033] Figure 7 for Figure 2 A schematic diagram of the local structure at point B;

[0034] Figure 8 for Figure 2 A schematic diagram of the local structure at point C.

[0035] Explanation of reference numerals in the attached figures:

[0036] 10. Conduit assembly; 101. Outlet;

[0037] 11. Sheath; 111. Proximal end of sheath; 112. Distal end of sheath;

[0038] 12. Retraction tube; 1201. Infusion port; 121. Sealing element; 122. Hemostatic valve;

[0039] 13. Handle; 1301. Handle proximal end; 131. Socket interface;

[0040] 20. Image acquisition component; 21. Core; 211. Connector; 22. Ultrasonic transducer; 23. Second position sensor;

[0041] 30. ECG mapping assembly; 31. Mapping electrode; 311. Calibration electrode; 32. First position sensor; 33. Flexible component; 331. Reinforcing segment; 332. Flexible segment. Detailed Implementation

[0042] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0043] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0044] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0045] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0046] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0047] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0048] In specific implementations, "distal" and "proximal" refer to the part of the corresponding component that is furthest from the surgeon or operator, typically the end of the component that enters the patient's body or surgical area. "Proximal" refers to the part of the corresponding component that is closest to the surgeon or operator, typically the end held or manipulated by the surgeon or operator. In other words, for the entire 3D imaging mapping catheter, the proximal end refers to the end of the catheter that can be connected to a connector, i.e., the end closer to the doctor and external manipulation equipment. The distal end refers to the farthest end of the catheter that can be inserted into the patient's body, i.e., the end that penetrates deeper into the patient's body. The distal tip is the farthest end of the catheter that can be inserted into the patient's body. For a single component, unless other definitions are explicitly mentioned, the definitions of distal and proximal ends are assumed to follow the overall reference frame of the catheter. Thus, the end closer to the surgeon or operator is the proximal end, and the end furthest from the surgeon or operator is the distal end. That is, the definitions of distal and proximal ends of this component are unrelated to whether the entire component is inside or outside the body during actual operation, but only to its positional relationship.

[0049] See Figures 1 to 3 The three-dimensional imaging mapping catheter includes a catheter assembly 10, an image acquisition assembly 20, and an electrocardiogram mapping assembly 30. The catheter assembly 10 has a distal end for intervening in the heart chamber; the image acquisition assembly 20 includes a core 21 and an ultrasound transducer 22. The core 21 is disposed inside the catheter assembly 10, and the ultrasound transducer 22 is connected to the distal end of the core 21. The ultrasound transducer 22 is used to scan the contour of the heart chamber to construct a three-dimensional image model of the heart chamber; the electrocardiogram mapping assembly 30 includes several mapping electrodes 31 arranged at the distal end of the catheter assembly 10. The mapping electrodes 31 are used to acquire electrocardiogram signals from multiple heart chamber sites to construct a three-dimensional mapping model of the heart chamber.

[0050] The image acquisition component 20, with its core 21 positioned within the catheter assembly 10, utilizes the aforementioned three-dimensional imaging mapping catheter. An ultrasound transducer 22 is connected to the distal end of the core 21, and the mapping electrode 31 of the electrocardiogram mapping component 30 is positioned at the distal end of the catheter assembly 10. This allows the ultrasound transducer 22 and the mapping electrode 31 to share the same catheter assembly 10 as a carrier. Specifically, when the catheter assembly 10 is inserted into the heart chamber, the ultrasound transducer 22 and the mapping electrode 31 can reach a predetermined position within the heart chamber along with the catheter assembly 10. In other words, the ultrasound transducer 22 and the electrocardiogram mapping electrode 31 can utilize the same catheter assembly 10 to complete heart chamber contour scanning and electrocardiogram signal acquisition. Compared to related technologies where ultrasound imaging and electrocardiogram mapping require separate catheters and multiple interventions into the heart chamber, this solution allows for a single intervention of the catheter assembly 10 into the heart chamber. The ultrasound transducer 22 and mapping electrode 31 can then be inserted into predetermined positions within the heart chamber via the catheter assembly 10 to scan the heart chamber contour and collect electrocardiogram signals, respectively. This facilitates subsequent ablation surgery without the need for two interventions, reducing operational complexity, shortening surgical time, and improving the accuracy of identifying abnormal potential locations within the heart chamber.

[0051] It should be noted that the catheter assembly 10 has a proximal end and a distal end disposed opposite to each other along its extension direction. The distal end of the catheter assembly 10 is used for implantation into the heart chamber, and the proximal end of the catheter assembly 10 is used for manipulation by the operator. By manipulating the proximal end of the catheter assembly 10, the distal end of the catheter assembly 10 can be moved within the heart chamber.

[0052] Understandably, the ultrasonic transducer 22 can transmit and receive ultrasonic signals from the heart cavity. After processing, the ultrasonic signals are converted into two-dimensional ultrasonic images. The ultrasonic signals can be transmitted to an external processing unit through a signal cable connected to the ultrasonic transducer 22.

[0053] This scheme does not limit the specific method of using the ultrasonic transducer 22 to perform cardiac cavity contour scanning.

[0054] In some embodiments, the ultrasonic transducer 22 includes multiple matrix-arranged ultrasonic elements. In this configuration, the core 21 can acquire two-dimensional ultrasound images of different regions within the heart cavity without rotating the ultrasonic transducer 22. Then, by stitching and fusing the two-dimensional ultrasound images of different regions, a three-dimensional image model of the heart cavity can be constructed.

[0055] In some embodiments, the ultrasonic transducer 22 can be driven by the core 21 to present a first working state or a second working state: in the first working state, the ultrasonic transducer 22 moves and rotates axially relative to the catheter assembly 10 to obtain a three-dimensional image model of the heart chamber; in the second working state, the ultrasonic transducer 22 approaches the distal end of the catheter assembly 10 and rotates to obtain an ultrasonic verification image showing the relative positional relationship between the mapping electrode 31 and the heart chamber. By driving the ultrasonic transducer 22 to move through the core 21, the ultrasonic transducer 22 can scan the entire inner wall of the heart chamber in the first working state to obtain a three-dimensional image model of the heart chamber, and perform a circular scan of the local area where the mapping electrode 31 is located in the second working state to obtain an ultrasonic verification image, which is used to monitor the degree of contact between the mapping electrode 31 and the inner wall of the heart chamber. By switching the ultrasonic transducer 22 between the first and second working states driven by the core 21, the need for both full-area scanning and local scanning of the heart chamber can be met without additional complex operations.

[0056] Understandably, in the first operating state, the ultrasonic transducer 22 can perform a circular scan of the inner wall of the heart cavity by rotating, and at the same time, the ultrasonic transducer 22 can achieve a full-coverage scan of different positions in the heart cavity by moving axially. Through the combined helical motion of axial and rotational movements, the ultrasonic transducer 22 can construct a three-dimensional image model of the entire area of ​​the heart cavity. For example, the core 21 drives the ultrasonic transducer 22 to retract during rotation to scan the entire contour of the heart cavity.

[0057] In the second working state, the ultrasound transducer 22, near the distal end of the catheter assembly 10 and close to the mapping electrode 31, scans the intracardiac wall of the area where the mapping electrode 31 is located by rotating, forming a three-dimensional image model of the area where the mapping electrode 31 is located, i.e., an ultrasound verification image. The ultrasound verification image is used to monitor the degree of contact between the mapping electrode 31 and the intracardiac wall. If the contact of the mapping electrode 31 is insufficient, the posture of the catheter assembly 10 is adjusted to change the contact state between the mapping electrode 31 and the intracardiac wall, and the ultrasound verification image is acquired again by rotating the ultrasound transducer 22 until the ultrasound verification image shows that the contact between the mapping electrode 31 and the intracardiac wall meets the contact standard. After that, the electrocardiogram signal of the corresponding intracardiac site is collected through the mapping electrode 31 to improve the accuracy of the three-dimensional mapping model.

[0058] In some embodiments, the ECG mapping component 30 includes a first position sensor 32, which has a preset first spatial offset from at least one mapping electrode 31; the image acquisition component 20 includes a second position sensor 23, which has a preset second spatial offset from the ultrasound transducer 22 and no relative angular displacement; the first position sensor 32 and the second position sensor 23 respond to a spatial magnetic field generated by the same magnetic field generator and are positioned in a preset magnetic positioning coordinate system generated by the spatial magnetic field.

[0059] For example, both the preset first spatial offset and the preset second spatial offset are stored in the positioning processor.

[0060] A spatial magnetic field is generated in the surgical area by a magnetic field generator, and this spatial magnetic field generates a preset magnetic positioning coordinate system. The first position sensor 32 can sense the signal of the spatial magnetic field and calculate its own three-dimensional spatial position information in the preset magnetic positioning coordinate system. Since the first position sensor 32 and at least one mapping electrode 31 have a preset first spatial offset, the positioning processor receives the three-dimensional spatial position information of the first position sensor 32 in the preset magnetic positioning coordinate system. Based on this three-dimensional spatial position information and the preset first spatial offset, the positioning processor calculates the position information of the corresponding mapping electrode 31 in the preset magnetic positioning coordinate system. Furthermore, among the multiple mapping electrodes 31, each mapping electrode 31 has a preset spatial offset from at least one of the other mapping electrodes 31. Based on the spatial offsets between each mapping electrode 31, as long as the spatial relationship between the first position sensor 32 and at least one mapping electrode 31 is determined, the positions of the other mapping electrodes 31 in the preset magnetic positioning coordinate system can be calculated. Based on the positions of each mapping electrode 31 in the magnetic positioning coordinate system, a three-dimensional mapping model of the heart chamber in the magnetic positioning coordinate system is constructed.

[0061] Similarly, the second position sensor 23 can sense the signal of the magnetic field in the space and can calculate its own three-dimensional spatial pose information in the preset magnetic positioning coordinate system. Since the second position sensor 23 and the ultrasonic transducer 22 have a preset second spatial offset and no relative angular displacement, the positioning processor receives the three-dimensional spatial pose information of the second position sensor 23 in the preset magnetic positioning coordinate system. Based on the three-dimensional spatial pose information and the preset second spatial offset, the positioning processor calculates the pose information of the ultrasonic transducer 22 in the preset magnetic positioning coordinate system.

[0062] In some embodiments, during the operation of the core 21, the motion state of the second position sensor 23 is consistent with the motion state of the ultrasonic transducer 22. For example, when the ultrasonic transducer 22 slides a preset distance along a preset direction, the second position sensor 23 simultaneously slides the same distance along the same direction; when the ultrasonic transducer 22 rotates a preset angle along a preset direction, the second position sensor 23 also simultaneously rotates a preset angle along the preset direction. The second position sensor 23 calculates its own three-dimensional spatial position information in a preset magnetic positioning coordinate system. Since the second position sensor 23 and the ultrasonic transducer 22 have a preset second spatial offset and no relative angular displacement, the positioning processor calculates the pose information of the ultrasonic transducer 22 in the preset magnetic positioning coordinate system. The image acquisition component 20 constructs a three-dimensional image model of the heart cavity in the magnetic positioning coordinate system by fitting the two-dimensional ultrasound image obtained during the scanning process with the corresponding pose information.

[0063] In contrast, existing technologies involve implanting separate ultrasound catheters and electrocardiogram (ECG) mapping catheters into the heart cavity. These catheters operate in independent coordinate systems, allowing for the separate acquisition of anatomical information and ECG signals. However, subsequent registration of these two data points can easily lead to registration errors, affecting the accuracy of identifying abnormal ECG signal sites. In this application, the image acquisition component 20 constructs a three-dimensional image model of the heart cavity within a shared magnetic positioning coordinate system. This ultrasound three-dimensional image model provides a more intuitive and accurate representation of the heart cavity's anatomical structure, avoiding the errors introduced by algorithms like interpolation during mapping, which are purely used in conventional techniques to derive the three-dimensional cardiac anatomy. Similarly, the ECG mapping component 30 maps ECG signals at different sites within the heart cavity within this shared magnetic positioning coordinate system. This setup allows the three-dimensional image model to provide spatial positioning references for the acquired ECG signal sites, resulting in a precise registration and superposition of the fused three-dimensional anatomical physical model and the ECG data electrical model. This facilitates the determination of the location of abnormal ECG signal sites on the inner surface of the heart cavity, further improving the accuracy of identifying abnormal ECG signal sites.

[0064] In some embodiments, both the first position sensor 32 and the second position sensor 23 are electromagnetic positioning sensors, and they are configured to respond to a spatial magnetic field generated by the same magnetic field generator, so that both the first position sensor 32 and the second position sensor 23 are in the same magnetic positioning coordinate system. It should be noted that a single magnetic field generator establishes a unique spatial coordinate system, and this generator generates a spatial magnetic field covering the cardiac cavity region. Both the first position sensor 32 and the second position sensor 23 are within the magnetic field range generated by this generator. Since both the first position sensor 32 and the second position sensor 23 are electromagnetic positioning sensors, when both are in the same magnetic field, the position information of the mapping electrode 31 acquired by the first position sensor 32 and the pose information of the ultrasound transducer 22 acquired by the second position sensor 23 are both in the same preset magnetic positioning coordinate system, which is the spatial coordinate system established based on the magnetic field generator. With the above setup, no additional coordinate system transformation is required, and the comparison of the three-dimensional mapping model and the three-dimensional image model in a unified coordinate system can be directly achieved.

[0065] In some embodiments, the second position sensor 23 is fixed relative to and moves synchronously with the ultrasonic transducer 22. The position change of the ultrasonic transducer 22 in the magnetic positioning coordinate system is calculated by the pose change of the second position sensor 23 in the magnetic positioning coordinate system, eliminating the need to integrate a position sensor for detecting its pose information into the ultrasonic transducer 22.

[0066] In some embodiments, the second position sensor 23 is a six-degree-of-freedom position sensor. During the scanning of the heart chamber by the ultrasound transducer 22, movement or rotation may occur. The second position sensor 23, being a six-degree-of-freedom position sensor, can improve the accuracy of capturing changes in the pose of the ultrasound transducer 22 and enhance the accuracy of constructing the three-dimensional image model.

[0067] In some embodiments, the first position sensor 32 is a five-degree-of-freedom sensor, which includes a magnetic coil sleeved around the outer periphery of the distal end of the conduit assembly 10. This configuration allows the magnetic coil to be energized by a matching magnetic field generator, thereby obtaining the position information of the first position sensor 32 in a magnetic positioning coordinate system. Furthermore, this configuration facilitates the installation of the first position sensor 32.

[0068] In some embodiments, the mapping electrode 31 is disposed at the distal end of the catheter assembly 10, and the distal end of the catheter assembly 10 is also provided with an outlet 101. Physiological saline is injected into the inner cavity of the catheter assembly 10 through the infusion port 1201, and the physiological saline flows out from the outlet 101 to expel the air in the inner cavity of the catheter assembly 10.

[0069] In some embodiments, the outlet 101 and the first position sensor 32 are both arranged near the end of the calibration electrode 31; the calibration electrode 31, the outlet 101, and the first position sensor 32 are staggered along the axial direction, such as... Figure 3 As shown, the mapping electrode 31 is positioned at the distal end of the catheter assembly 10, and the first position sensor 32 is positioned at the proximal end of the mapping electrode 31. When the catheter assembly 10 is inserted into the heart chamber, there are no other components at the distal end of the mapping electrode 31, which facilitates direct contact between the mapping electrode 31 and the inner wall of the heart chamber, thus improving the accuracy of ECG signal acquisition. Furthermore, an outlet 101 is provided at the distal end of the catheter assembly 10. Before the procedure, physiological saline can be injected into the catheter assembly 10, and the saline flows out through the outlet 101 to expel air from the catheter assembly 10, improving the accuracy of ultrasound signal transmission and enhancing the two-dimensional imaging effect. Moreover, the mapping electrode 31, the outlet 101, and the first position sensor 32 are staggered along the axial direction, which reduces electromagnetic interference and physical obstruction between them.

[0070] In some embodiments, the outlet 101 and the first position sensor 32 are respectively located on opposite sides of the catheter assembly 10, and their orthogonal projections on the axis overlap. In other words, the outlet 101 and the first position sensor 32 are positioned opposite each other, which can prevent the first position sensor 32 from obstructing the outlet 101 and improve the smoothness of the saline flow. At the same time, the overlap of the orthogonal projections of the outlet 101 and the first position sensor 32 on the axis allows them to be as close as possible to the distal end of the catheter assembly 10. The compact layout of the outlet 101 and the first position sensor 32 allows the ultrasonic transducer 22 to move closer to the calibration electrode 31 without shielding it, so as to facilitate the acquisition of ultrasonic verification images and improve the recognition accuracy in the second working state.

[0071] In some of these embodiments, such as Figure 3 As shown, the calibration electrode 31 is embedded in the distal end of the sheath 11. In some specific embodiments, the end of the calibration electrode 31 may have a stepped structure, with the stepped structure of the calibration electrode 31 embedded in the distal end of the sheath 11 and fixed to the distal end of the sheath 11 by adhesive. This arrangement can improve the convenience and firmness of the connection between the calibration electrode 31 and the distal end of the sheath 11.

[0072] In some of these embodiments, see Figures 4 to 6The ECG mapping assembly 30 also includes multiple flexible elements 33, which are isolated from each other and connected to the distal end of the catheter assembly 10. Each flexible element 33 has a plurality of mapping electrodes 31 distributed on it. The mapping electrodes 31 are disposed on the flexible element 33, which, after entering the heart chamber, can naturally bend to conform to the surface structure of the heart chamber. This arrangement helps the mapping electrodes 31 to conform to the heart chamber wall. The distribution structure of the multiple flexible elements 33 can be such that the entire flexible element 33 radiates circumferentially around the distal end of the catheter assembly 10. Alternatively, it can be as follows... Figure 4 , 5 As shown, the flexible element 33 includes a reinforcing section 331 and a flexible section 332. The reinforcing section 331 is connected between the distal end of the conduit assembly 10 and the flexible section 332, presenting a shape in which the reinforcing section 331 radiates circumferentially around the distal end of the conduit assembly 10, while the flexible sections 332 are parallel to each other. Of course, those skilled in the art can adapt the shape of the multiple flexible elements 33 as needed, which is still within the scope of protection of this application. For example, Figure 6 The distal end of the middle catheter assembly 10 is connected to a flexible element 33, and a calibration electrode 31 is disposed on the flexible element 33; and Figure 6 The ellipse in the diagram represents the acquisition area of ​​the ultrasound transducer 22 and does not indicate that the boundary of the acquisition area can be directly observed. When multiple flexible elements 33 have the ability to conform to the natural curvature of the intracardiac surface structure, the relationship between the flexible element 33 and the ultrasound transducer 22 becomes non-linear, thereby facilitating the entry of the mapping electrode 31 on the flexible element 33 into the detection range of the ultrasound transducer 22 to obtain ultrasound verification images.

[0073] In some embodiments, a first position sensor 32 is disposed at the distal end of the catheter assembly 10. A flexible member 33 includes a reinforcing section 331 and a flexible section 332. The reinforcing section 331 connects the distal end of the catheter assembly 10 to the flexible section 332. The rigidity of the reinforcing section 331 is higher than that of the flexible section 332. A calibration electrode 31 includes a calibration electrode 311, which is disposed in the reinforcing section 331 of the flexible member 33. The calibration electrode 311 has a preset first spatial offset from the first position sensor 32. The reinforcing section 331 of the flexible member 33 is connected to the distal end of the catheter assembly 10 and has minimal deformation. The calibration electrode 311 is disposed in the reinforcing section 331 of the flexible member 33. During operation of the catheter assembly 10, the higher rigidity of the reinforcing section 331 compared to the flexible section 332 helps maintain a fixed relative distance and synchronous movement between the calibration electrode 311 and the first position sensor 32. The position information of the calibration electrode 311 in the magnetic positioning coordinate system is calculated using the position information of the first position sensor 32 in the magnetic positioning coordinate system. Since the spacing between the calibration electrode 311 and the other measurement electrodes 31 on the flexible member 33 along the extension direction of the flexible member 33 is known and fixed, the spatial position of each of the other measurement electrodes 31 in the magnetic positioning coordinate system can be calculated using an electro-positioning algorithm based on the position information of the calibration electrode 311 in the magnetic positioning coordinate system and the known spacing between the other measurement electrodes 31 and the calibration electrode 311. With this configuration, the corresponding position information of each measurement electrode 31 in the magnetic positioning coordinate system can be obtained using only a single first position sensor 32.

[0074] In some embodiments, the flexible member 33 has multiple mapping electrodes 31, which are spaced apart along the extension direction of the flexible member 33, and the distance between any two adjacent mapping electrodes 31 is preset. This arrangement can increase the number of ECG signal acquisition points in the heart chambers and improve the ECG signal acquisition efficiency.

[0075] In some embodiments, at least one calibration electrode 311 is provided on the reinforcing section 331 of each flexible member 33, and at least one calibration electrode 31 is provided on the flexible section 332 of each flexible member 33. This improves the spatial distribution density and coverage of the calibration electrodes 31, thereby enhancing the accuracy of the calibration.

[0076] In some embodiments, for any two adjacent flexible members 33, at least one of the following parameters—length, number of calibration electrodes 31, and spacing of calibration electrodes 31—is different. This arrangement reduces the likelihood of calibration electrodes 31 sticking together when two adjacent flexible members 33 are close in position, thus reducing the possibility of electrical signal distortion and improving the accuracy of calibration data. For example, if the spacing of calibration electrodes 31 on any two adjacent flexible members 33 is different, even if the lengths and number of calibration electrodes 31 of the two adjacent flexible members 33 are the same, the sticking of calibration electrodes on adjacent flexible members 33 can be avoided. Similarly, if the lengths of adjacent flexible members 33 are different but the number of calibration electrodes 31 is the same, it is beneficial for the calibration electrodes on adjacent flexible members 33 to be staggered. Likewise, even if the lengths of adjacent flexible members 33 are the same and the number of calibration electrodes is the same, but the spacing varies, the sticking of calibration electrodes on adjacent flexible members 33 can still be avoided. The above settings also result in different densities between two adjacent flexible elements 33, improving the mapping adaptability to different anatomical regions. This allows the mapping electrode 31 to adapt to the differences in diameter and curvature of different anatomical regions of the heart during scanning, balancing large-scale rapid anatomical location mapping with local high-resolution electrophysiological fine sampling, and optimizing the electrode adhesion effect.

[0077] In some embodiments, any two flexible elements 33 have different lengths, the number of mapping electrodes 31, and the spacing between them. This arrangement can further reduce the situation where the mapping electrodes 31 on the flexible elements 33 stick together, and can also further improve the mapping adaptability of different anatomical regions.

[0078] In some embodiments, the flexible member 33 is a tubular structure, which makes it easier for the distal end of the flexible member 33 to adhere to the inner surface of the heart cavity when it moves within the heart cavity, thus reducing damage to the endocardium.

[0079] In some embodiments, the flexible element 33 includes a flexible tube body and a nickel-titanium alloy wire embedded within the flexible tube body. The flexible tube body is made of a flexible polymer material, and the nickel-titanium alloy wire embedded within the flexible tube body can improve the resilience of the flexible element 33.

[0080] In some of these embodiments, see Figure 2 and Figure 3 The catheter assembly 10 includes an axially extending sheath 11, and a core 21 is axially disposed inside the catheter assembly 10; the core 21 drives an ultrasonic transducer 22 to be movably disposed relative to the sheath 11, and / or, the core 21 drives the ultrasonic transducer 22 to be rotatably disposed relative to the sheath 11 about the axis of the sheath 11.

[0081] In some embodiments, the sheath 11 has a proximal sheath 111 and a distal sheath 112 positioned opposite each other in the direction of extension. The distal sheath 112 forms the distal end of the catheter assembly 10, and the electrocardiogram mapping assembly 30 is disposed on the distal sheath 112. One end of the core 21 is close to the proximal sheath 111, and the other end passes through the sheath 11 and is close to the distal sheath 112. The end of the core 21 close to the proximal sheath 111 is operable, while the other end of the core 21 is movable relative to the distal sheath 112. The image acquisition assembly 20 is disposed at the end of the core 21 close to the distal sheath 112. With this configuration, after the distal sheath 112 extends into the heart chamber, the other end of the sheath 11, i.e., the proximal sheath 111, is located outside the patient's body, and the end of the core 21 away from the proximal sheath 111 is inside the distal sheath 112. By manipulating the sheath 11, the distal end 112 of the sheath moves the ECG mapping component 30 within the heart chamber, enabling the ECG mapping component 30 to perform mapping within the heart chamber. By manipulating the proximal end of the core 21, the end of the core 21 near the distal end 112 of the sheath moves the ultrasound transducer 22 within the sheath 11 to scan the contour of the heart chamber. Compared to integrating the image acquisition component 20 and the ECG mapping component 30 onto the same catheter, this solution allows for independent ultrasound scanning and ECG mapping. During ultrasound scanning, the sheath 11 does not need to be manipulated, reducing stimulation to the inner surface of the heart chamber or blood vessels. During ECG mapping, the core 21 does not need to be manipulated to move the ultrasound transducer 22, providing greater operational flexibility.

[0082] In some embodiments, the core 21 is movably disposed relative to the sheath 11 along the axial direction of the sheath 11. This arrangement facilitates the advancement and retraction of the ultrasonic transducer 22 within the sheath 11 by the core 21, enabling scanning of different depths within the cardiac chamber.

[0083] In some embodiments, the core 21 is rotatably disposed relative to the sheath 11 about its axis. This arrangement facilitates the image acquisition assembly 20 in performing circumferential scanning within the cardiac chambers, such as... Figure 6 The annular area shown schematically represents the current ultrasound detection range of the ultrasound transducer 22, which facilitates the construction of a three-dimensional graphic model of the heart cavity.

[0084] In some embodiments, while the core 21 is movable relative to the sheath 11 along its axial direction, it can also rotate about the axis of the sheath 11. This arrangement facilitates rotational scanning of the ultrasound transducer 22 by the core 21 during retraction or advancement. This further improves the accuracy and coverage of ultrasound scanning of cardiac anatomical structures.

[0085] In some embodiments, the ultrasonic transducer 22 and the second position sensor 23 are both located inside the sheath 11 and are both positioned at the end of the core 21 near the distal end 112 of the sheath. This arrangement ensures that when the core 21 is operated, the core 21, the ultrasonic transducer 22, and the second position sensor 23 all move within the sheath 11. The second position sensor 23 can also identify the position of the rotating ultrasonic transducer 22 in real time, preventing the ultrasonic transducer 22 from being directly pressed against the patient's tissue and thus affecting its rotation and / or movement, and correspondingly avoiding stimulation of the inner surface of the cardiac chambers.

[0086] In some embodiments, the ultrasonic transducer 22 is axially offset from the first position sensor 32 and the mapping electrode 31 in the initial state. Both the first position sensor 32 and the mapping electrode 31 have metallic components. In the initial state, the axial offset between the ultrasonic transducer 22 and the first position sensor 32 prevents the metallic components of the first position sensor 32 and the mapping electrode 31 from shielding the ultrasonic transducer, thus preventing the representation of the actual cardiac cavity contour. Limiting the position of the ultrasonic transducer 22 in the initial state also helps to limit the axial limit of its movement, allowing for the provision of a stroke locking structure (not shown) at the proximal end of the catheter to ensure the image quality of the ultrasonic transducer 22. Furthermore, as mentioned above, when considering the aforementioned embodiments, whether it is an implementation in which multiple flexible elements 33 are respectively provided with multiple mapping electrodes 31 or an implementation in which the mapping electrodes 31 are directly provided at the distal end of the sheath 11, providing the distal end of the sheath 11 or the flexible element 33 with sufficient flexibility and bendable length can ensure that the first position sensor 32 is not within the detection range of the ultrasonic transducer 22, while ensuring that the mapping electrodes 31 on the distal end of the sheath 11 or the flexible element 33 are within the detection field of the ultrasonic transducer 22. In particular, when the distal end of the sheath 11 or the flexible element 33 is in a shape that fits against the heart cavity wall and bends close to the ultrasonic transducer 22, it is easier to observe the contact and relative positional relationship between the mapping electrodes 31 and the heart cavity tissue.

[0087] For example, after the distal end of the catheter assembly 10 is inserted into the heart cavity, the mapping electrode 31 and the first position sensor 32 are located in a first preset position; by operating the core 21, the ultrasonic transducer 22 is brought close to the distal end of the catheter assembly 10 and located in a second preset position. At this time, the ultrasonic transducer 22 is axially offset from the first position sensor 32 and the mapping electrode 31. This second position is the initial state of the ultrasonic transducer 22; then, the core 21 is operated so that the ultrasonic transducer 22 is rotated and retracted to scan the contour of the heart cavity.

[0088] In some of these embodiments, such as Figure 3As shown, the second position sensor 23 and the ultrasonic transducer 22 are spaced apart along the axial direction of the core 21. The ultrasonic transducer 22 is located at the distal end of the core 21, and the second position sensor 23 is located on one side of the proximal end of the ultrasonic transducer 22. This arrangement allows the ultrasonic transducer 22 to be located at the very end of the core 21, facilitating its insertion into the sheath 11 and enabling scanning of the contours within the heart chambers.

[0089] In some of these embodiments, see Figure 2 , Figure 3 , Figure 7 and Figure 8 The catheter assembly 10 also includes a retraction tube 12 and a handle 13. The handle 13 is connected to the proximal end of the retraction tube 12 and has a proximal handle end 1301, which is the proximal end of the catheter assembly 10. The retraction tube 12 is sleeved on the outside of the sheath 11 and can slide relative to the sheath 11. The handle 13 and the core 21 can be driven together to move axially synchronously relative to the sheath 11. With the above configuration, it is convenient to achieve dual adjustment of the axial displacement and circumferential rotation of the core 21 relative to the sheath 11.

[0090] In some of these embodiments, such as Figure 2 As shown, the handle 13, retraction tube 12, sheath 11, and core 21 are coaxially arranged. A connector 211 is located at the proximal end of the core 21, and an interface (not shown) is located inside the handle 13. The connector 211 is rotatably disposed within the interface and connects to a connector, which drives the core 21 to rotate. The other end of the core 21 extends through the interior of the retraction tube 12 to the distal end 112 of the sheath. Preferably, both ends of the handle 13 are connected to the connector and the retraction tube 12 respectively, so that the connector can drive the retraction tube 12 to move axially synchronously via the handle 13. The steps of assembling the three-dimensional imaging mapping catheter include: inserting the core 21 into the sheath 11, positioning the end of the core 21 equipped with the second position sensor 23 and the ultrasonic transducer 22 inside the distal end 112 of the sheath 11, and assembling the handle 13, retraction tube 12, and sheath 11.

[0091] Thus, because the sheath 11 is filled with a liquid medium between itself and the core 21, and because the sheath 11 and the retraction tube 12 are in sliding fit, the position of the sheath 11 will not be moved and will remain essentially in place. Since the connector 211 and the proximal end of the interface are both connected to the connector, the core 21 and the retraction tube 12 are indirectly connected to the connector. The core 21 and the retraction tube 12 can be driven by the axially moving connector to move axially relative to the sheath 11 as a whole. The core 21 can be driven by the connector 211 to rotate independently relative to the sheath 11. The above describes the implementation of the core being driven to rotate or move axially. When the connector moves axially and drives the connector 211 to rotate, a compound movement of the core 21 rotating while simultaneously advancing or retracting axially can be achieved. This configuration facilitates the axial advancement, retraction, and circumferential rotation control of the core 21, enabling the ultrasonic transducer 22 of the three-dimensional imaging mapping catheter of this application to scan and obtain dynamic images of the heart chambers and acquire a wide range of physical anatomical structures while the sheath 11 remains stationary. Specifically, it provides multiple annular images around the catheter along its axis (the image range acquired at any given moment can be as follows...). Figure 6 As shown in the image of the collection area, for the sheath that has been bent into a curved shape, since the design of this application does not cause motion interference to the sheath, the motion trajectory of the ultrasonic transducer 22 still follows the existing curved shape of the sheath, avoiding the phenomenon of ultrasonic section jumping. The operator does not need to repeatedly adjust to obtain the required ultrasonic image due to the instability of the ultrasonic section. Therefore, the structure of this embodiment can effectively adjust the axial movement and / or rotation of the transducer on the basis of the existing bent shape of the sheath to obtain continuous high-quality ultrasonic images of the target direction and pose, providing a good data source for establishing a three-dimensional ultrasonic image model.

[0092] In some embodiments, a first penetration channel is formed inside the catheter assembly 10, through which the wires connecting the first position sensor 32 of the ECG mapping assembly 30 and the wires connecting the mapping electrode 31 pass to the proximal end of the catheter assembly 10. This arrangement avoids exposing the wires connecting the first position sensor 32 and the mapping electrode 31, improving the overall structural compactness and operational safety of the device.

[0093] In some embodiments, a second through-channel is formed inside the catheter assembly 10, through which the wires connecting the second position sensor 23 and the signal transmission lines connecting the ultrasonic transducer 22 pass to the proximal end of the catheter assembly 10. This arrangement avoids exposing the wires connecting the second position sensor 23 and the signal transmission lines connecting the ultrasonic transducer 22, further improving the structural compactness and operational safety of the device.

[0094] In some embodiments, the first and second penetration channels are independent of each other. Of course, in other embodiments, the spaces within the conduits occupied by various signal transmission lines can be fluidly connected to each other. If necessary, the wires of the first position sensor 32, the wires of the calibration electrode 31, the wires of the second position sensor 23, and the signal transmission lines connecting the ultrasonic transducer 22 can also be respectively encased in protective sleeves to isolate the various signal lines and prevent tangling and interference between them. This arrangement facilitates the identification of each wire while reducing the risk of signal interference.

[0095] In some embodiments, the sheath 11, retraction tube 12, and handle 13, when connected as a whole, form a first annular through-channel with the core 21. A second through-channel is formed inside the core 21. This arrangement facilitates the independent placement of the first and second through-channels.

[0096] In some of these embodiments, such as Figure 2 As shown, a socket interface 131 is connected to the handle 13 via a connecting tube. The wires connecting the first position sensor 32 and the wires connecting the calibration electrode 31 can be led out through the connecting tube and the socket interface 131 (not shown). The wires connecting the second position sensor 23 and the signal transmission line connecting the ultrasonic transducer 22 can also be led out through the connecting tube and the socket interface 131.

[0097] In some of these embodiments, such as Figure 2 , 3 As shown in Figure 4, the retraction tube 12 is provided with an irrigation port 1201, which can be configured as a Luer connector; the distal end 112 of the sheath is provided with an outlet 101, and the irrigation port 1201 and the outlet 101 are respectively connected to the first perforation channel. With this configuration, physiological saline can be injected into the first perforation channel through the irrigation port 1201 before the operation, and the physiological saline flows out through the outlet 101 to expel air from the first perforation channel, thereby improving the accuracy of ultrasound signal transmission and enhancing the two-dimensional imaging effect.

[0098] In some embodiments, the three-dimensional imaging mapping catheter also includes a seal 121 and a hemostatic valve 122, such as Figure 7 and 8 As shown, both the sealing element 121 and the hemostatic valve 122 are disposed within the retraction tube 12 and are located on opposite sides of the infusion port 1201. The hemostatic valve 122 is located proximal to the infusion port 1201 and is made of silicone, with the core 21 penetrating through it. The sealing element 121 is installed inside the distal end of the inner cavity of the retraction tube 12 and is sandwiched between the retraction tube 12 and the sheath 11, with the sheath 11 penetrating through the sealing element 121. This arrangement prevents leakage of saline solution and improves the sealing performance during saline infusion.

[0099] In the foregoing embodiments, the imaging method for mapping the catheter using this three-dimensional imaging may include the following steps:

[0100] S1, Water injection and air release: Physiological saline is injected into the connected or isolated first and second penetration channels through the injection port 1201, and the physiological saline flows out from the outlet 101 to release the air in each penetration channel.

[0101] S2, Insert the three-dimensional imaging mapping catheter: Insert the distal end of the sheath 11 into the heart chamber through the established vascular access. Depending on the actual situation, the distal end of the sheath 11 can be inserted into the left atrium, right atrium, or each ventricle.

[0102] S3, Start ultrasound imaging: Maintain the shape of the distal end of the sheath 11, operate the proximal end of the core 21, and scan imaging can be performed by rotating the core 21. At the same time, pull back the handle 13 to start the retraction operation. The second position sensor 23 obtains the position and pose information of the ultrasound transducer 22 in the magnetic positioning coordinate system during the scanning process and obtains the two-dimensional ultrasound image of the ultrasound scan. A three-dimensional ultrasound image model of the scanning area is constructed in the magnetic positioning coordinate system.

[0103] S4, Acquire ECG signals within the heart chamber and construct a three-dimensional mapping model: Acquire ECG signals within the range of the completed three-dimensional ultrasound image model. Operate the sheath 11 so that the distal end of the sheath 11 drives the mapping electrode 31 to move within the heart chamber and acquire ECG signals at different locations. Obtain the position information of different locations acquired by the mapping electrode 31 in the magnetic positioning coordinate system through the first position sensor 32. The ECG mapping component 30 constructs a three-dimensional mapping model in the magnetic positioning coordinate system by fitting the position information of different locations in the magnetic positioning coordinate system and the ECG signals at different locations.

[0104] S5, Fusion of anatomical images and potential distribution information: Precise registration and overlay of three-dimensional ultrasound image model and three-dimensional mapping model to obtain a fusion model of three-dimensional anatomical physical model and electrocardiogram data electrical model, so that potential information is presented on ultrasound image model. The fusion model is used by the operator to judge the location of abnormal electrocardiogram signals and guide the precise location of subsequent ablation.

[0105] Furthermore, by comparing the three-dimensional mapping model and the three-dimensional ultrasound image model, it is possible to verify the contact status between the mapping electrode 31 and the heart chamber during the electrocardiogram mapping process, as well as the accuracy of the three-dimensional mapping model construction. If there is a misjudged electrocardiogram signal, the positioning error of the mapping electrode 31 can be corrected by filtering out the deviation measurement signal, thereby improving the accuracy of the three-dimensional mapping model established by the electrocardiogram signal.

[0106] After identifying the sites of abnormal ECG signals, these sites can be ablated using conventional ablation methods. During ablation, the transducer 22 can be used to monitor the ultrasound image of the target ablation location in real time by axially advancing or retracting the core, thus reducing the radiation dose. For the ablated sites, the ECG signal can be re-measured using the mapping electrode 31 to confirm the ablation effect. If the ablation effect is not as expected, the site will be repositioned and ablated again; if the ablation effect is as expected, the three-dimensional imaging mapping catheter will be withdrawn.

[0107] It should be noted that in the above embodiments, Figure 1 The single-electrode three-dimensional imaging mapping catheter used is Figure 4 Although the three-dimensional imaging mapping catheters with multiple mapping electrodes used are described separately, in actual implementation, the two types of catheters can be used in combination. Because they are in the same magnetic positioning coordinate system, it is beneficial to match different three-dimensional imaging mapping catheters for specific cardiac chamber locations and improve the modeling speed of three-dimensional ultrasound image models.

[0108] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0109] 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 patent application. 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. A three-dimensional imaging mapping catheter, comprising: include: A catheter assembly, the distal end of which is used for intervention in the cardiac chamber; An image acquisition component includes a core and an ultrasonic transducer. The core is disposed inside the catheter assembly, and the ultrasonic transducer is connected to the distal end of the core. The ultrasonic transducer is used to scan the contour of the heart chamber to construct a three-dimensional image model of the heart chamber. The electrocardiogram mapping component includes several mapping electrodes arranged at the distal end of the catheter assembly. The mapping electrodes are used to acquire electrocardiogram signals at multiple cardiac chamber sites to construct a three-dimensional mapping model of the cardiac chambers. The electrocardiogram mapping component includes a first position sensor, which has a pre-set first spatial offset from at least one mapping electrode. The image acquisition component includes a second position sensor, which has a preset second spatial offset from the ultrasonic transducer and no relative angular displacement. The first position sensor and the second position sensor respond to the spatial magnetic field generated by the same magnetic field generator and are positioned in the magnetic positioning coordinate system generated by the spatial magnetic field.

2. The three-dimensional imaging mapping catheter of claim 1, wherein, The ultrasonic transducer can be driven by the core to present either a first working state or a second working state: The ultrasonic transducer moves and rotates axially relative to the catheter assembly in the first working state to obtain a three-dimensional image model of the heart chamber. The ultrasound transducer approaches and rotates at the distal end of the catheter assembly in the second operating state to obtain an ultrasound verification image showing the relative positional relationship between the mapping electrode and the heart chamber.

3. The three-dimensional imaging mapping catheter according to claim 1, characterized in that, The calibration electrode is disposed at the distal end of the conduit assembly, and the distal end of the conduit assembly is also provided with an outlet. The outlet and the first position sensor are both arranged at the proximal end of the calibration electrode. The calibration electrode, the water outlet, and the first position sensor are staggered along the axial direction, or the water outlet and the first position sensor are located on opposite sides of the conduit assembly and their orthogonal projections on the axis overlap.

4. The three-dimensional imaging mapping catheter of claim 1, wherein, The electrocardiogram mapping component also includes multiple flexible components, which are isolated from each other, and the flexible components are connected to the distal end of the catheter assembly; A plurality of the measuring electrodes are distributed on any of the flexible components.

5. The three-dimensional imaging mapping catheter of claim 4, wherein, The first position sensor is disposed at the distal end of the catheter assembly. The flexible member includes a reinforcing section and a flexible section. The reinforcing section is connected between the distal end of the catheter assembly and the flexible section. The stiffness of the reinforcing section is higher than that of the flexible section. The calibration electrode includes a calibration electrode, which is disposed in the reinforcing section of the flexible member, and the calibration electrode has a preset first spatial offset from the first position sensor.

6. The three-dimensional imaging mapping catheter of claim 4, wherein, For any two adjacent flexible components, at least one of the following parameters—length, number of calibration electrodes, and spacing of calibration electrodes—may have different values.

7. The three-dimensional imaging mapping catheter of claim 1, wherein, The catheter assembly includes an axially extending sheath, and the core is axially disposed inside the catheter assembly; the core drives the ultrasonic transducer to be movably disposed relative to the sheath, and / or, the core drives the ultrasonic transducer to be rotatably disposed relative to the sheath about the axis of the sheath.

8. The three-dimensional imaging mapping catheter according to claim 7, characterized in that, The ultrasonic transducer is initially offset from the first position sensor and the calibration electrode by an axial direction.

9. The three-dimensional imaging mapping catheter according to claim 7, characterized in that, The catheter assembly includes a retraction tube and a handle. The handle is connected to the proximal end of the retraction tube. The retraction tube is sleeved on the outside of the sheath and can slide relative to the sheath. The handle and the core can be driven together to move axially synchronously relative to the sheath.

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