Magnetic positioning type balloon and CT fusion navigation system for pericardium interventional operation

Abstract

The invention discloses a magnetic positioning type balloon and CT fusion navigation system for a pericardial interventional operation, and belongs to the technical field of medical surgical navigation and minimally invasive interventional instruments. The problems that in the prior art, the visual field of an endoscope is not clear due to pericardial fluid, and a preoperative CT three-dimensional model and an intraoperative magnetic positioning space are difficult to rapidly and accurately register are solved. According to the balloon type pericardium endoscope, the liquid is injected into the balloon to drain pericardium liquid, and a clear pericardium wall tissue image is collected; the position and the posture of an image sensor in the endoscope in a magnetic positioning space are determined; setting an in-vitro mark point on the body of the target person; constructing a three-dimensional model of the heart and pericardium region by collecting CT data of the target person containing the in-vitro mark points; calculating a registration transformation matrix between the two spaces; mapping the real-time position and posture of the balloon type pericardium endoscope into the three-dimensional model of the heart area; and generating and outputting a navigation image fusing the three-dimensional model of the heart area and the real-time position of the endoscope. The invention is suitable for the technical field of medical machinery.

Description

Technical Field

[0001] This invention belongs to the field of medical surgical navigation and minimally invasive interventional device technology. Background Technology

[0002] Current pericardial endoscopic surgery faces two major challenges: First, the pericardial fluid between the epicardium and the pericardial layer obstructs the field of vision, resulting in low visualization of epicardial tissue structures; second, there is a lack of navigation methods that can accurately fuse preoperative three-dimensional images (such as CT scans) with the real-time position of the endoscope during surgery, making the surgical operation dependent on the surgeon's hand-eye coordination and experience, and making it difficult to guarantee accuracy and safety.

[0003] Currently, there are some patented technologies involving endoscopic navigation, image registration, or balloon devices, but none of them have fully solved the specific challenges of the aforementioned pericardial surgery:

[0004] General-purpose electromagnetic navigation systems: For example, patent document US2016000806A1 discloses a general-purpose electromagnetic navigation system for guiding medical devices. Although this system involves electromagnetic positioning and image registration, it is a general framework and is not designed for the special environment of the pericardial cavity filled with mucus and containing cardiac pulsation. In particular, it lacks specific technical means to drain the mucus to improve the surgical field. Its image registration method relies heavily on software algorithms or anatomical markers, which have limited accuracy in soft tissues such as the pericardium.

[0005] Cardiac balloon endoscopic systems: Patent document EP2929852A1 discloses a balloon endoscopic system for intracardiac ablation (such as in the atria). This technology focuses on the balloon itself and its application within the cardiac chambers; its balloon function is primarily for device stabilization or occlusion, rather than for draining pericardial fluid between the pericardium and epicardium to achieve tissue visualization. Furthermore, this approach lacks a complete system architecture for high-precision magnetic localization and navigation fusion with preoperative CT images.

[0006] Location marker registration method: For example, patent document CN109009333A discloses an image registration method based on location markers for the fusion of ultrasound and CT three-dimensional models. This technology proves the effectiveness of location marker registration, but its application field (ultrasound), marker type (non-magnetic sensing) are completely different from the present invention, and it is not combined with any specific endoscopic instrument (especially a balloon-equipped pericardial endoscope), thus failing to constitute a complete surgical navigation solution.

[0007] In summary, existing patented technologies either only address the positioning and navigation problem while neglecting the specific visualization needs of the pericardial environment, or only provide one endoscopic tool without high-precision navigation capabilities, or only propose a registration method without deep integration with specific surgical instruments and clinical scenarios. Therefore, existing technologies suffer from the following systemic defects:

[0008] Intraoperative field of vision is limited, and pericardial fluid affects direct observation of tissue structures;

[0009] Preoperative images and intraoperative instrument placement are not accurately integrated, and there is a lack of stable and reliable registration benchmarks, especially in the cardiac soft tissue environment;

[0010] Existing solutions fail to provide a comprehensive technical solution that deeply integrates pericardial balloon endoscopy, high-precision registration (external magnetic labeling), and real-time navigation (CT-magnetic positioning fusion) for the specific clinical need of pericardial interventional surgery. Summary of the Invention

[0011] The present invention aims to solve the problems in the prior art where pericardial fluid causes unclear endoscopic vision and the difficulty in quickly and accurately aligning the preoperative CT three-dimensional model with the intraoperative magnetic positioning space. It provides a magnetic positioning balloon and CT fusion navigation system for pericardial interventional surgery.

[0012] The present invention provides a magnetically positioned balloon-CT fusion navigation system for pericardial interventional surgery, comprising: a balloon-type pericardial endoscope, a magnetic positioning system, an image fusion and navigation calculation module, and a control and display module;

[0013] A balloon-type pericardial endoscope includes an inflatable balloon and a magnetic positioning sensor. An image sensor is installed inside the balloon. The balloon is emptied of pericardial fluid by injecting liquid, allowing the image sensor to acquire clear images of the pericardial wall tissue. The first magnetic positioning sensor is used to acquire the position and orientation of the image sensor in the magnetic positioning space in real time.

[0014] At least three second magnetic positioning sensors are placed around the target area of ​​the CT scan as positioning markers;

[0015] A magnetic positioning system is used to generate a magnetic field and track the specific locations of the first magnetic positioning sensor and the second magnetic positioning sensor.

[0016] The image fusion and navigation calculation module is used for:

[0017] Based on the pre-acquired CT data of the target area containing the positioning markers, a three-dimensional model of the heart and pericardium region is constructed.

[0018] Based on the spatial coordinates of the positioning markers in the CT image and the spatial coordinates obtained in real time by the magnetic positioning system, calculate the registration transformation matrix between the two spaces;

[0019] Using the registration transformation matrix, the real-time position and orientation of the balloon pericardial endoscope are mapped onto the three-dimensional model of the heart region; a navigation image is generated and output that fuses the three-dimensional model of the heart region and the real-time position of the endoscope.

[0020] The control and display module is used to receive user commands and display the navigation image and the real-time images acquired by the balloon pericardioscopic endoscope.

[0021] Furthermore, in this invention, the balloon-type pericardial endoscope includes a balloon, a handle, and a tube connecting the balloon and the handle;

[0022] The outer end of the handle is provided with an infusion port, which is used to inject liquid into the balloon through the tube connecting the balloon and the handle, so that the balloon expands and drains pericardial fluid.

[0023] Furthermore, in this invention, the image fusion and navigation calculation module uses an iterative nearest point algorithm or a least squares rigid transformation algorithm to map the real-time position and orientation of the image sensor into the three-dimensional model of the heart region.

[0024] Furthermore, in this invention, when mapping the real-time position and orientation of the image sensor to the three-dimensional model of the heart region, the registration error is also calculated in real time. When the registration error is less than a preset threshold, the registration is determined to be successful. The preset threshold is 1.0 mm.

[0025] Furthermore, in this invention, the navigation image synchronously displays the three-dimensional model of the heart region and the real-time image of the endoscope in a split-screen format, and the real-time position and viewing direction of the balloon pericardial endoscope are dynamically marked in the three-dimensional model with an endoscope model icon.

[0026] Furthermore, in this invention, the liquid injected into the balloon through the tube connecting the balloon and the handle is physiological saline.

[0027] Furthermore, in this invention, the magnetic positioning system includes:

[0028] A magnetic field generator is used to create a controllable magnetic field space around the patient's heart area.

[0029] The sensor interface unit is used to receive, amplify, and digitize signals from the first magnetic positioning sensor on the balloon pericardial endoscope and the second magnetic positioning sensor on the positioning marker point.

[0030] The control unit is used to control the operation of the magnetic field generator, receive and process data from the sensor interface unit to obtain the spatial position and attitude information of the first magnetic positioning sensor in the magnetic field space and the position information of the second positioning sensor, and transmit the obtained information to the image fusion and navigation calculation module.

[0031] Furthermore, in this invention, the image fusion and navigation calculation module includes:

[0032] The CT image segmentation unit is used to import and process the pre-acquired CT data to segment and extract a three-dimensional model of the heart and pericardial region containing all the positioning markers.

[0033] The registration calculation unit is used to receive the real-time spatial coordinates of all positioning markers acquired by the magnetic positioning system, match them with the coordinates of the corresponding markers in the three-dimensional model, and calculate the registration transformation matrix from the magnetic positioning space to the CT image space through a coordinate transformation algorithm.

[0034] The real-time coordinate mapping unit is used to map the position and attitude data fed back in real time by the first magnetic positioning sensor to the CT image space where the three-dimensional model of the heart region is located using the registration transformation matrix.

[0035] The image fusion rendering unit is used to fuse and render the graphic identifier representing the balloon-type pericardial endoscope with the three-dimensional model based on the mapped position and attitude data, generate the navigation image, and output it to the control and display module.

[0036] Furthermore, in this invention, at least three second magnetic positioning sensors are not collinear.

[0037] This invention directly links the CT image space and the intraoperative magnetic positioning space through external fixation markers, achieving a registration error of less than 1.0 mm and sub-millimeter-level operational precision. After balloon inflation, pericardial fluid is mechanically drained, providing a clear and stable observation window, ensuring that the navigation information is highly consistent with the actual anatomical structure. It realizes a closed-loop process of "planning-guidance-visualization-treatment operation-verification," reducing intraoperative blind operation and radiation exposure time, and lowering the risk of misoperation. The positioning markers are not affected by tissue movement and deformation within the body, ensuring stable and reliable registration results. Attached Figure Description

[0038] Figure 1 This is a block diagram illustrating the system principle of the present invention.

[0039] Figure 2 This is a schematic diagram of a balloon-type pericardial endoscope.

[0040] Figure 3 A schematic diagram illustrating the principles of marker point placement and registration;

[0041] Figure 4 A unified display interface for the control and display modules. Detailed Implementation

[0042] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. It should be noted that, unless otherwise specified, the embodiments and features in the embodiments of the present invention can be combined with each other.

[0043] Specific implementation method one: Refer to Figure 1 and Figure 2 This embodiment describes a magnetic positioning balloon and CT fusion navigation system for pericardial interventional surgery, comprising: a balloon pericardial endoscope 100, a magnetic positioning system 200, an image fusion and navigation calculation module 300, and a control and display module 400.

[0044] A balloon-type pericardial endoscope 100 includes an inflatable balloon 1011 and a magnetic positioning sensor 1013. An image sensor 1012 is disposed within the balloon 1011. By injecting fluid into the balloon to drain pericardial fluid, the image sensor 1012 acquires a clear image of the pericardial wall tissue. The first magnetic positioning sensor 1013 is used to acquire the position and orientation of the image sensor 1012 in the magnetic positioning space in real time.

[0045] At least three second magnetic positioning sensors 201 are set around the target area of ​​the CT scan as positioning markers;

[0046] The magnetic positioning system 200 is used to generate a magnetic field and track the specific positions of the first magnetic positioning sensor 1013 and the second magnetic positioning sensor.

[0047] Image fusion and navigation calculation module 300, used for:

[0048] Based on the pre-acquired CT data of the target area containing the positioning markers, a three-dimensional model of the heart and pericardium region is constructed.

[0049] Based on the spatial coordinates of the positioning markers in the CT image space and the spatial coordinates obtained in real time by the magnetic positioning system 200, the registration transformation matrix between the two spaces is calculated.

[0050] Using the registration transformation matrix, the real-time position and orientation of the balloon-type pericardial endoscope 100 are mapped onto the three-dimensional model of the heart region; a navigation image is generated and output that fuses the three-dimensional model of the heart region and the real-time position of the endoscope.

[0051] The control and display module 400 is used to receive user commands and display the navigation image and the real-time images acquired by the balloon pericardioscopic endoscope 100.

[0052] Furthermore, in this invention, the balloon-type pericardial endoscope 100 includes a balloon 1011, a handle, and a tube 1014 connecting the balloon 1011 and the handle;

[0053] The outer end of the handle is provided with an infusion port, which is used to inject liquid into the balloon 1011 through the tube 1014 connecting the balloon 1011 and the handle, so that the balloon 1011 expands and drains pericardial fluid.

[0054] Furthermore, the present invention also includes an external constant pressure injection device, wherein the infusion passage connecting pipe 1014 of the external constant pressure injection device is connected to the balloon 1011 to control the inflation and deflation of the balloon 1011.

[0055] In this embodiment, the balloon-type pericardial endoscope 100 has an image acquisition cable interface 1015 on its handle and a positioning component cable interface (1016). The image acquisition cable interface 1015 and the positioning component cable interface 1016 are respectively connected to the signal output terminals of the image sensor and the positioning component via corresponding cables, which are housed within the tube 1014. A cold light source is also provided inside the balloon, consisting of an LED light source at its outer end. The light signal is transmitted to the balloon via optical fiber. An optical fiber port 1017 is also provided on the handle. The image processing unit 102 adjusts the brightness of the LED light source according to the brightness of the image acquired by the image sensor, ensuring image clarity. The image processing unit 102 is also used to preprocess the image acquired by the image sensor 1012 and transmit the preprocessed image to the image fusion and navigation calculation module 300.

[0056] Furthermore, in this invention, the image fusion and navigation calculation module 300 uses an iterative nearest point algorithm or a least squares rigid transformation algorithm to map the real-time position and attitude of the image sensor 1012 to the three-dimensional model of the heart region.

[0057] Furthermore, in this invention, when mapping the real-time position and orientation of the image sensor 1012 to the three-dimensional model of the heart region, the registration error is also calculated in real time. When the registration error is less than a preset threshold, the registration is determined to be successful. The preset threshold is 1.0 mm.

[0058] Furthermore, in this invention, the navigation image synchronously displays the three-dimensional model of the heart region and the real-time image of the endoscope in a split-screen format, and the real-time position and viewing direction of the balloon pericardial endoscope 100 are dynamically marked in the three-dimensional model with an endoscope model icon.

[0059] Furthermore, in this invention, the liquid injected into the balloon 1011 through the tube 1014 connecting the balloon 1011 and the handle is physiological saline.

[0060] Furthermore, in this invention, the magnetic positioning system 200 includes:

[0061] Magnetic field generator 202 is used to generate a controllable magnetic field space around the patient's heart region;

[0062] The sensor interface unit 204 is used to receive, amplify and digitize signals from the first magnetic positioning sensor on the balloon pericardial endoscope 100 and the second magnetic positioning sensor of the positioning marker point.

[0063] The control unit 203 is used to control the operation of the magnetic field generator 202, receive and calculate data from the sensor interface unit 204 to obtain the spatial position and attitude information of the first magnetic positioning sensor in the magnetic field space and the position information of the second positioning sensor, and transmit the obtained information to the image fusion and navigation calculation module 300.

[0064] Furthermore, in this invention, the image fusion and navigation calculation module 300 includes:

[0065] The CT image segmentation unit 301 is used to import and process the pre-acquired CT data to segment and extract a three-dimensional model of the heart and pericardial region containing all the positioning markers.

[0066] The registration calculation unit 303 is used to receive the real-time spatial coordinates of all positioning markers acquired by the magnetic positioning system 200, match them with the coordinates of the corresponding markers in the three-dimensional model, and calculate the registration transformation matrix from the magnetic positioning space to the CT image space through a coordinate transformation algorithm.

[0067] The real-time coordinate mapping unit 304 is used to map the position and attitude data fed back in real time by the first magnetic positioning sensor 1013 to the CT image space where the three-dimensional model of the heart region is located using the registration transformation matrix.

[0068] The image fusion rendering unit 302 is used to fuse and render the graphic identifier representing the balloon pericardial endoscope 100 with the three-dimensional model according to the mapped position and attitude data, generate the navigation image and output it to the control and display module 400.

[0069] Specifically, such as Figure 3 and 4 As shown, Figure 3 In the magnetic positioning spatial point set After rotation and translation transformations, the coordinates of the corresponding point in the CT image space are obtained. In the formula for calculating registration error, This represents the Euclidean distance between marker i in CT space and the same marker i in magnetic positioning space after registration and transformation. This represents the space defined by a Cartesian coordinate system. It describes the rotational transformation required to change the orientation of an object from its magnetic positioning space to its alignment with the orientation in the CT image space. Figure 4 The system's fusion display interface shows a 3D fusion model of the balloon endoscope projected into the CT image space on the left, and a diagram of the tissue structure of the balloon endoscope within the pericardial cavity on the right.

[0070] Furthermore, in this invention, at least three second magnetic positioning sensors are not collinear.

[0071] Furthermore, in this invention, the control and display module 400 includes a display 401 and a system control unit 402;

[0072] The display 401 is used to receive and display the navigation image generated by the image fusion rendering unit 302.

[0073] The system control unit 401 receives user commands and coordinates the operation of various modules. This invention achieves high-precision navigation based on a registration mechanism using positioning markers. This technology directly uses the magnetic positioning sensor as a marker in CT scans, giving two independent spaces a common, identifiable physical reference point, effectively solving the problem of the lack of inherent registration markers in soft tissue structures. Balloon inflation is combined with visualization. After the balloon is filled with saline, it not only drains mucus but also provides a stable observation window for the endoscope, ensuring that the pericardioscopic position and viewing angle displayed by the navigation system are highly consistent with the actual anatomical structure of the surgical field. The entire solution's processing logic is "physical markers → dual-space data acquisition → coordinate transformation solution → real-time mapping navigation," forming a high-precision, reliable, and stable navigation link. It forms a closed loop of "planning-guidance-visualization-treatment operation-verification," with the core advantage being real-time feedback, ensuring safety and precision. Magnetic positioning provides the real-time position and orientation of the balloon pericardial endoscope, while the endoscope provides a clear real-time field of view. The two mutually verify each other. At the same time, through "CT fluoroscopy" and a clear endoscopic surgical field, blind operation is avoided, critical tissues are protected, and sub-millimeter-level operational precision is achieved.

[0074] Applications of the system described in this invention:

[0075] Hardware environment: including a sterile operating room equipped with radiation protection, the main unit and workstation of the navigation system described in this invention (including an image fusion and navigation calculation module and a control and display module), etc.

[0076] Software environment: Runs the system's dedicated navigation software (integrating image processing, registration algorithms, and visualization functions, etc.).

[0077] Main consumables and instruments: sterile magnetic positioning sensor (for body surface marking), disposable balloon pericardioscopic endoscope, pericardiocentesis kit, normal saline, and stem cell suspension.

[0078] Specific implementation steps:

[0079] Step 1: Preoperative preparation and CT scan

[0080] Patient preparation: The patient is assessed and anesthetized before surgery, and is placed in a supine position.

[0081] Place positioning markers: Select four non-coplanar locations around the patient's chest that are not easily moved by breathing (such as the manubrium of the sternum, the left and right subclavian parts, and near the xiphoid process), and firmly attach four magnetic positioning sensors (as markers) to ensure that these sensors will not shift during subsequent procedures.

[0082] 3. CT Data Acquisition: The patient's chest is scanned using a 64-slice or higher CT scanner. During the scan, the positioning markers are also scanned into the CT image data, serving as the reference for subsequent registration.

[0083] Step 2: System and Data Initialization

[0084] Data import and 3D reconstruction: Import the acquired DICOM format CT data into this image fusion and navigation calculation module 300, and use the image processing unit of the system software to automatically segment the heart and pericardial structures to generate a 3D visualization model of the heart.

[0085] CT reference point identification: On the 3D view of the system software, manually or automatically click to identify four clearly visible marker points (represented by bright metallic dots) in the CT image. The software then records their precise 3D coordinates in the CT coordinate system. .

[0086] Step 3: Intraoperative system registration

[0087] Patient positioning and sensor connection: Transfer the patient to the operating room, keeping the patient's position as consistent as possible with the CT scan. Connect the four marker sensors on the patient's body surface to the control interface of the magnetic positioning system (such as NDI Aurora).

[0088] Establish magnetic positioning space: Fix the magnetic field generator under the operating table and make its working space cover the patient's heart area, start the magnetic positioning system and make it work stably.

[0089] Perform registration:

[0090] Click the "Registration" button in the navigation software.

[0091] The system uses a magnetic positioning system to collect the coordinates of four surface markers in a magnetic coordinate system in real time. .

[0092] The software invokes a built-in registration algorithm (e.g., the nearest iteration point ICP algorithm or the least squares rigid transformation algorithm) to calculate a set of optimal spatial transformation matrices T (containing rotation matrix R and translation vector t) such that... The registration error is minimized.

[0093] The system calculates and displays the registration error (usually expressed as the root mean square error of the fit of all marker points). In this embodiment, the error is required to be <1.0 mm. After the surgeon confirms, the registration is complete, and the system enters real-time navigation mode.

[0094] Step 4: Application in pericardioscopic interventional surgery

[0095] Pericardiocentesis: In the subxiphoid region, routine disinfection and draping are performed. Pericardiocentesis is performed under ultrasound (or DSA) guidance, and a guidewire and dilation sheath are inserted, followed by placement of the working pericardial sheath.

[0096] Endoscopic insertion and tracking:

[0097] Once the balloon-type pericardial endoscope is positioned at the target location, the magnetic positioning sensor at the tip of the endoscope is immediately identified by the system and begins tracking.

[0098] On the navigation screen, a virtual 3D icon representing the tip of the endoscope is displayed in real time on the 3D model of the heart. The icon updates its position and direction synchronously as the endoscope moves, thus achieving "vision" navigation of the endoscope.

[0099] Specific applications of balloon inflation:

[0100] The surgeon observes the navigation screen and guides the endoscope tip to the target area.

[0101] Once the general area is reached, pause movement. Slowly inflate the balloon by injecting 3-5 ml of normal saline through the balloon channel of the endoscope.

[0102] After the balloon inflates, it drains the mucus and fluid between the epicardium and pericardium, creating a locally clear, "dry" observation window. The endoscopic video image changes from blurry and reflective to clearly showing the epicardial vessels and fatty tissue. At this point, the doctor can compare the position of the virtual endoscope on the navigation screen with the real video image to verify the navigation accuracy.

[0103] While the invention has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely examples of the principles and applications of the invention. Therefore, it should be understood that many modifications can be made to the exemplary embodiments, and other arrangements can be designed without departing from the spirit and scope of the invention as defined by the appended claims. It should be understood that different dependent claims and features described herein can be combined in ways different from those described in the original claims. It is also understood that features described in conjunction with individual embodiments can be used in other described embodiments.

Claims

1. A magnetic positioning balloon and CT fusion navigation system for pericardial intervention surgery, characterized in that, The balloon pericardioscope (100), the magnetic positioning system (200), the image fusion and navigation calculation module (300), and the control and display module (400); The balloon pericardioscope (100) comprises a balloon (1011) and a magnetic positioning sensor (1013), the balloon (1011) is provided with an image sensor (1012) therein, the balloon (1011) is inflated by injecting liquid to expel pericardial fluid, so that the image sensor (1012) can collect clear pericardial wall tissue images; the first magnetic positioning sensor (1013) is used to obtain the position and posture of the image sensor (1012) in the magnetic positioning space in real time; At least three second magnetic positioning sensors (201) are arranged around the target region of CT scanning as positioning marker points; The magnetic positioning system (200) is used to generate a magnetic field and track the specific positions of the first magnetic positioning sensor (1013) and the second magnetic positioning sensor; The image fusion and navigation calculation module (300) is used for: Based on the pre-acquired CT data of the target region containing the positioning marker points, a three-dimensional model of the heart and pericardial region is constructed; According to the CT image space coordinates of the positioning marker points and the real-time space coordinates obtained by the magnetic positioning system (200), a registration transformation matrix between the two spaces is calculated; The real-time position and posture of the balloon pericardioscope (100) are mapped into the three-dimensional model of the heart region by using the registration transformation matrix; A navigation image fused with the three-dimensional model of the heart region and the real-time position of the endoscope is generated and outputted; The control and display module (400) is used to receive user instructions and display the navigation image and the real-time image collected by the balloon pericardioscope (100). The balloon pericardioscope (100) comprises a balloon (1011) and a handle and a pipe (1014) connecting the balloon (1011) and the handle; 2. The magnetic positioning balloon-CT fusion navigation system for pericardial intervention according to claim 1, wherein, The outer end of the handle is provided with a perfusion port, the perfusion port is used to inject liquid into the balloon (1011) through the pipe (1014) connecting the balloon (1011) and the handle, so that the balloon (1011) is inflated to expel pericardial fluid. The image fusion and navigation calculation module (300) uses the iterative closest point algorithm or the least squares rigid transformation algorithm to map the real-time position and posture of the image sensor (1012) into the three-dimensional model of the heart region.

3. The magnetic positioning balloon-CT fusion navigation system for pericardial intervention according to claim 1 or 2, characterized in that, When the real-time position and posture of the image sensor (1012) are mapped into the three-dimensional model of the heart region, the registration error is also calculated in real time, and when the registration error is less than a preset threshold, it is determined that the registration is successful.

4. The magnetic positioning balloon-CT fusion navigation system for pericardium intervention according to claim 1 or 2, characterized in that, The navigation image synchronously displays the three-dimensional model of the heart region and the real-time image of the endoscope in a split screen form, and dynamically indicates the real-time position and viewing angle direction of the balloon pericardioscope (100) in the form of an endoscope model icon in the three-dimensional model.

5. The magnetic positioning balloon-CT fusion navigation system for pericardial intervention according to claim 4, wherein, The liquid injected into the balloon (1011) through the pipe (1014) connecting the balloon (1011) and the handle is normal saline.

6. The magnetic positioning balloon-CT fusion navigation system for pericardial intervention according to claim 5, wherein, The magnetic positioning system (200) comprises:

7. The magnetic positioning balloon-CT fusion navigation system for pericardium intervention according to claim 1 or 2, characterized in that, ​ a magnetic field generator (202) for generating a controllable magnetic field space around the heart region of a patient; a sensor interface unit (204) for receiving, amplifying and digitizing signals from the first magnetic positioning sensor on the balloon pericardioscope (100) and the second magnetic positioning sensor of the positioning marker points; a control unit (203) for controlling the operation of the magnetic field generator (202), receiving and solving data from the sensor interface unit (204) to obtain spatial position and attitude information of the first magnetic positioning sensor in the magnetic field space and position information of the second positioning sensor, and transmitting the obtained information to the image fusion and navigation calculation module (300).

8. The magnetic positioning balloon-CT fusion navigation system for pericardial intervention according to claim 7, wherein, The image fusion and navigation calculation module (300) comprises: a CT image segmentation unit (301) for importing and processing the pre-acquired CT data to segment and extract a three-dimensional model of the heart and pericardium region containing all positioning marker points; a registration calculation unit (303) for receiving real-time spatial coordinates of all positioning marker points obtained by the magnetic positioning system (200), and matching the coordinates of the corresponding marker points in the three-dimensional model, and calculating a registration transformation matrix from the magnetic positioning space to the CT image space through a coordinate conversion algorithm; a real-time coordinate mapping unit (304) for mapping the position and attitude data fed back by the first magnetic positioning sensor (1013) in real time to the CT image space where the three-dimensional model of the heart region is located by using the registration transformation matrix; an image fusion rendering unit (302) for fusing and rendering a graphical representation of the balloon pericardioscope (100) with the three-dimensional model according to the mapped position and attitude data, generating the navigation image and outputting to the control and display module (400).

9. The magnetic positioning balloon-CT fusion navigation system for pericardial intervention according to claim 1, wherein, The at least three second magnetic positioning sensors are not collinear.

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