Real-time positioning and shape sensing device and position and shape sensing method of bronchoscope

Abstract

The invention relates to the technical field of medical apparatus and instruments, and particularly provides a real-time positioning and shape sensing device, which is characterized by comprising a sensing catheter which comprises a flexible base rod and a plurality of sensors arranged on the flexible base rod; the magnetic field generator generates a working magnetic field; when the sensing guide pipe moves and changes the shape in the working magnetic field of the magnetic field generator, the control center tracks the position and the posture of each sensor in real time, and the position and the posture of each sensor are adjusted according to the installation position of each sensor on the flexible base rod and the position and the posture tracked in real time. The control hub reconstructs the position and three-dimensional shape of the sensing catheter in real time.

Description

Technical Field

[0001] The present invention generally relates to the field of medical device technology. Specifically, the present invention relates to a real-time positioning and shape sensing device and a method for sensing the position and shape of a bronchoscope. Background Art

[0002] In recent years, with advances in lung screening technology, the detection rate of peripheral lung lesions has gradually increased. Transbronchial bronchoscopy and computed tomography (CT)-guided percutaneous puncture are the most commonly used methods for the diagnosis and treatment of peripheral lung lesions. However, percutaneous puncture has a high diagnostic yield but also a high incidence of pneumothorax. Conventional bronchoscopy, while highly safe, has a relatively low diagnostic yield. Bronchoscopy navigation technology can significantly improve the diagnostic yield of bronchoscopy, with electromagnetic navigation and fiberoptic navigation bronchoscopy being the most commonly used methods.

[0003] Chinese patent CN 113662672 A discloses a bronchoscope robot system, comprising: an electromagnetic navigation layer, a slave operation layer, a master operation layer, and a network layer; the electromagnetic navigation layer realizes the positioning and navigation of the bronchoscope, adopting a master-slave control method, the doctor inputs the action through the force feedback joystick of the master operation layer, and the slave operation layer reproduces the doctor's hand action to complete the tracheal intubation operation, and the master operation layer and the slave operation layer are connected through the network layer to realize the doctor's remote operation function. The electromagnetic navigation layer includes: an electromagnetic navigation layer computer, an electromagnetic navigation layer medical imaging system, an electromagnetic positioning board, a navigation probe, a triplet sensor, and a CT machine. However, this type of electromagnetic navigation method can only track the position of the end point of the bronchoscope through the positioning guide wire, and cannot sense the complete shape information of the bronchoscope in real time, cannot compensate for the interference of bronchial structural deformation, and is prone to bronchial pathway navigation errors.

[0004] While fiber-optic shape sensing methods can sense bronchoscope shape information in real time, they suffer from limitations such as high equipment cost, the need for additional registration methods to establish a spatial relationship with the patient, and inconvenience. Therefore, improved configurations and methods are needed to accurately and conveniently achieve real-time position tracking and shape sensing of flexible bronchoscopes. Summary of the Invention

[0005] To at least partially solve the above-mentioned problems in the prior art, the present invention proposes a real-time positioning and shape sensing device, which is characterized by comprising:

[0006] A sensing catheter comprising a flexible base rod and a plurality of sensors disposed on the flexible base rod;

[0007] a magnetic field generator that generates an operating magnetic field; and

[0008] Control center,

[0009] When the sensing catheter moves and changes shape within the working magnetic field of the magnetic field generator, the control center tracks the position and posture of each sensor in real time. Based on the installation position of each sensor on the flexible base rod and the real-time tracked position and posture, the control center reconstructs the position and three-dimensional shape of the sensing catheter in real time.

[0010] In one embodiment of the present invention, the number of the plurality of sensors is at least three, and the sensors are magnetic positioning sensors.

[0011] In one embodiment of the present invention, the sensing catheter is built into the working channel of a bronchoscope; or

[0012] The sensing catheter is integrated into the interior of the bronchoscope; or

[0013] The sensing catheter is housed within the instrument using the working channel of a bronchoscope.

[0014] In one embodiment of the present invention, the sensors are respectively arranged on the sensing catheter at positions corresponding to the distal end point of the bronchoscope, the connection between the curved portion and the flexible portion, and positions at regular intervals on the flexible portion.

[0015] In one embodiment of the present invention, the sensors are respectively disposed at the distal end of the sensing catheter and at positions distributed at certain intervals from the distal end to the proximal end.

[0016] In one embodiment of the present invention, each sensor is connected to the control hub via a set of leads; or

[0017] Multiple sensors are connected to the data bus, and each sensor outputs data to the control center in an encoded manner.

[0018] In one embodiment of the present invention, the sensor is connected to the control hub in a digital manner.

[0019] In one embodiment of the present invention, the control center includes a decoder and an industrial computer. The decoder parses the sensor signal into a signal readable by the industrial computer. The industrial computer is used to convert the real-time sensor position and posture information into the three-dimensional shape information of the sensing catheter.

[0020] In one embodiment of the present invention, the industrial computer reconstructs the three-dimensional shape information of the sensing catheter using a third-order Bezier curve fitting based on the real-time position and posture information of multiple sensors. The formula of the third-order Bezier curve B is:

[0021]

[0022] Where τ represents the relative position of the point in the curve, represents the coordinates of the starting point of the curve, represents the control point in the middle of the curve, represents the control point in the middle of the curve, represents the coordinates of the end point of the curve,

[0023] The position of sensors S0 and S1 at the distal end of the sensing catheter, the connection between the curved part and the flexible part is and Starting point and end point The x-axis direction corresponding to sensor S1 for point to The unit direction vector The x-axis direction corresponding to sensor S0 for point to The unit direction vector make Then we have:

[0024]

[0025]

[0026] Solving by optimization method

[0027]

[0028] L C is the length of the catheter between sensors S0 and S1. Assuming that the curve is represented by m nodes, the corresponding estimated interpolation curve length L CE It can be expressed as:

[0029]

[0030] For the complete sensing catheter, n segments of Bezier curves are fitted piecewise to reconstruct the complete position and shape.

[0031] In one embodiment of the present invention, the industrial computer uses data-driven deep learning fitting to reconstruct the three-dimensional shape information of the sensing catheter based on real-time multiple sensor positions and posture information, including:

[0032] A high-precision 2D camera is used to build a catheter shape sensing calibration platform. Two square calibration plates are vertically combined to form a camera imaging space. Black metal balls are evenly arranged on the calibration plates to calibrate the 2D camera.

[0033] The sensing catheter is set to different shapes and positions within the camera imaging field of view. Two cameras capture the horizontal and vertical planes respectively, while the control center tracks the real-time position of each sensor in the sensing catheter. and direction The sensing catheter structure is extracted from the camera image by image segmentation and other methods, and the complete sensing catheter shape C is reconstructed. t , based on this, a data set of sensing catheters of different positions and shapes is constructed That is, a total of N data pairs with different positions and postures are collected.

[0034] Then, the sensor position and shape data and the sensing catheter shape data obtained using the calibration platform are divided into training samples and validation samples, which are used to train the deep learning model to obtain model parameters that meet the set number of iterations, thereby constructing a data-driven deep learning curve fitting model.

[0035] According to another embodiment of the present invention, a method for sensing the position and shape of a bronchoscope in a bronchus is provided, characterized by comprising:

[0036] Import the patient's personalized tracheal 3D model reconstructed from the patient's CT scan and the 3D model of the bronchoscope into the industrial computer of the control center;

[0037] Patient registration is performed using a magnetic sensor-based registration accessory attached to the patient's chest skin, thereby unifying the coordinate space of the magnetic navigation system and the patient's tracheal model;

[0038] When the bronchoscope is inserted into the trachea and moved forward, backward, or turned, the control center tracks and senses the position and shape of the catheter in real time. A real-time positioning and shape sensing device is installed inside the bronchoscope.

[0039] Combined with the relationship between the working channel and the entire bronchoscope body in the 3D model of the bronchoscope, the real-time position and shape of the bronchoscope are calculated, and the bronchoscope model is transformed in real time. The tracheal model and the bronchoscope model are simultaneously displayed on the monitor of the industrial computer.

[0040] In another embodiment of the present invention, a curve fitting method or a data-driven deep learning method is used to calculate the three-dimensional shape information of the sensing catheter based on the real-time position and posture information of multiple sensors.

[0041] The present invention uses a flexible base rod as the basis and embeds multiple magnetic sensors to construct a sensing catheter that can be placed in the working channel of a flexible bronchoscope. The magnetic positioning system is used to track the real-time spatial position and posture of each magnetic sensor, and the complete three-dimensional shape of the sensing catheter is reconstructed in real time through a curve fitting method, thereby effectively compensating for the navigation error introduced by bronchial deformation during bronchoscopic examination and treatment, and improving the surgical positioning accuracy and safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] To further illustrate the advantages and features of various embodiments of the present invention, a more detailed description of various embodiments of the present invention will be presented with reference to the accompanying drawings. It will be understood that these drawings depict only typical embodiments of the present invention and are not to be considered as limiting the scope of the present invention. In the drawings, for clarity, identical or corresponding components will be represented by the same or similar reference numerals.

[0043] Figure 1 A schematic structural diagram of a flexible bronchoscope real-time positioning and shape sensing device according to an embodiment of the present invention is shown.

[0044] Figure 2 A schematic cross-sectional view of a sensing catheter 200 according to one embodiment of the present invention is shown.

[0045] Figure 3 A flow chart of a method for sensing the position and shape of a bronchoscope in a bronchus according to one embodiment of the present invention is shown.

[0046] Figure 4 A schematic diagram of reconstructing the curve shape of a sensing catheter using a third-order Bezier curve fitting method according to an embodiment of the present invention is shown.

[0047] Figure 5 A catheter shape sensing and calibration platform based on a two-dimensional high-precision camera according to one embodiment of the present invention is shown.

[0048] Figure 6 A sensing catheter curve fitting method based on data-driven deep learning according to one embodiment of the present invention is shown. DETAILED DESCRIPTION

[0049] It should be noted that the components in the drawings may be shown exaggeratedly for the sake of illustration and are not necessarily correct to scale. In the drawings, identical or functionally identical components are provided with the same reference numerals.

[0050] In the present invention, unless otherwise specified, the phrases "disposed on," "disposed above," and "disposed above" do not exclude the presence of intermediate components. Furthermore, "disposed on or above" merely indicates the relative positional relationship between two components and, in certain circumstances, such as after reversing the product orientation, can be converted to "disposed below or below," and vice versa.

[0051] In the present invention, each embodiment is only intended to illustrate the aspects of the present invention and should not be construed as limiting.

[0052] In the present invention, unless otherwise specified, the quantifiers "a" and "an" do not exclude the presence of multiple elements.

[0053] It should also be noted that in the embodiments of the present invention, for the sake of clarity and simplicity, only a portion of the parts or components may be shown, but those skilled in the art will understand that, under the teachings of the present invention, the required parts or components can be added according to the needs of the specific scenario. In addition, unless otherwise stated, the features of different embodiments of the present invention can be combined with each other. For example, a feature in the second embodiment can be used to replace a corresponding or functionally identical or similar feature in the first embodiment, and the resulting embodiment also falls within the scope of disclosure or description of this application.

[0054] It should also be noted that, within the scope of the present invention, terms such as "same," "equal," and "equal to" do not imply absolute equality of values, but rather allow for a certain reasonable error. In other words, such terms also encompass "substantially the same," "substantially equal," and "substantially equal." Similarly, in the present invention, terms such as "perpendicular to" and "parallel to" indicating direction also encompass the meaning of "substantially perpendicular to" and "substantially parallel to."

[0055] In addition, the numbering of the steps of the methods of the present invention does not limit the order in which the steps of the methods are to be performed. Unless otherwise specified, the steps of the methods may be performed in different orders.

[0056] The present invention will be further described below with reference to the accompanying drawings in conjunction with specific embodiments.

[0057] The present invention proposes a real-time positioning and shape sensing device and method for a flexible bronchoscope constructed based on a flexible base rod and a multi-magnetic positioning sensor.

[0058] Figure 1A schematic structural diagram of a real-time positioning and shape sensing device for a flexible bronchoscope according to one embodiment of the present invention is shown. The real-time positioning and shape sensing device includes a sensing catheter 110, a magnetic field generator 120, and a control center 130. The sensing catheter 110 includes a flexible base rod and multiple sensors disposed on the flexible base rod. For example, a number of positioning sensors are arranged in a regular pattern along the axial direction of the flexible base rod to form a sensor network, thereby forming a sensing catheter for positioning and shape sensing. As the sensing catheter 110 moves and changes shape within the effective working area of the magnetic field generator, the control center 130 can track the position and posture of each sensor in real time. Based on the designed installation position of each sensor on the flexible base rod and the real-time tracked position and posture, the control center 130 uses curve fitting and other similar methods to reconstruct the position and three-dimensional shape of the base rod, and thus the sensing catheter, in real time.

[0059] During use, the sensing catheter 110 can be inserted into the working channel of the flexible bronchoscope, with its distal end aligned with the end of the hard portion of the front end of the bronchoscope. The outer diameter of the sensing catheter 110 can match the inner diameter of the working channel. When the bronchoscope body is moved within the bronchial tree, the bronchoscope control end can control its curved portion, achieving advance, retreat, and steering within the bronchial tree by bending at different angles. Its flexible portion is constrained by the shape of the bronchial structure and deforms accordingly under the interaction between the two. At the same time, the sensing catheter 110 deforms accordingly as the flexible and curved portions of the bronchoscope deform. Since the sensing catheter fits well with the bronchoscope, the position and shape information of the sensing catheter 110 is used to represent the position and shape of the flexible bronchoscope.

[0060] Figure 2 FIG. 2 is a cross-sectional view of a sensing catheter 200 according to an embodiment of the present invention. The sensing catheter comprises a flexible base rod 210 and a plurality of sensors S0-S1 disposed on the flexible base rod. n .like Figure 2 As shown, the flexible base rod 210 can be a hollow base rod. n There can be multiple magnetic positioning sensors. The number of multiple sensors is at least three. Multiple magnetic sensors S0-S n The corresponding wires are arranged in the base rod along the central axis. When the sensor is embedded, a local coordinate axis of the sensor (such as the x-axis) is made to coincide with the base rod axis, and the positive direction of the sensor coordinate axis is uniformly pointed to the distal end or the proximal end (such as the distal end). C ) and the flexible part (length L S ) are arranged at each connection; and at a certain interval L on the flexible part Δ Arrange a magnetic sensor and record the number of each sensor (i = 0, 1, 2, ..., n).

[0061] In embodiments of the present invention, the sensing catheter can be built into a bronchoscope. For example, the sensing catheter can be integrated into the bronchoscope or disposed within the working channel of the bronchoscope. Alternatively, the sensing catheter can be disposed within other instruments that utilize the working channel of the bronchoscope. For example, the sensing catheter can be integrated within instruments such as bronchial biopsy forceps, biopsy brushes, guide sheaths, and transbronchial ablation catheters.

[0062] In an embodiment of the present invention, the embedded magnetic sensor can transmit analog signals to the control center for processing; alternatively, analog-to-digital conversion can be performed within the sensor chip, and the signals can be transmitted to the control center for processing in the form of digital signals via fewer and thinner wires, while different sensor signals can be distinguished by digital numbers. When the sensor position and direction signals are transmitted digitally, they can be encoded, with different sensor signals distinguished by different numbers, thereby reducing the number of leads. That is, each sensor can be connected to the control center via a set of leads; or each sensor can be connected to the same set of data buses, with each sensor outputting data to the control center in an encoded manner.

[0063] In an embodiment of the present invention, the magnetic field generator 120 can use permanent magnets or electromagnetics to generate a relatively uniform weak working magnetic field. For example, by properly setting the magnetic field direction, the working magnetic field can cover the entire bronchial tree area as much as possible with the lung target as the relative center.

[0064] In an embodiment of the present invention, a control hub 130 is connected to the multi-core sensor wires extending from the sensing catheter. Control hub 130 includes a decoder and an industrial computer. The decoder interprets the sensor signals into signals readable by the industrial computer. The industrial computer is used to convert the real-time position and posture information of the multiple magnetic sensors into the three-dimensional shape information of the sensing catheter. The industrial computer uses a curve fitting algorithm, such as Bezier curve fitting or data-driven deep learning methods. Using the real-time position and shape information of the sensing catheter, the user can display the real-time position and shape of the flexible bronchoscope within the bronchus.

[0065] Figure 3 A flow chart of a method for sensing the position and shape of a bronchoscope in a bronchus according to one embodiment of the present invention is shown.

[0066] First, in step 310, the patient's personalized tracheal three-dimensional model and the three-dimensional model of the bronchoscope reconstructed from the patient's CT scan are imported into the industrial computer of the control center.

[0067] Subsequently, at step 320 , the patient is registered using a magnetic sensor-based registration accessory attached to the patient's chest skin, thereby unifying the coordinate space of the magnetic navigation system and the patient's tracheal model.

[0068] In step 330, as the doctor inserts the bronchoscope into the trachea, performing maneuvers such as forward, backward, and turning, the control center tracks the position and shape of the sensing catheter in real time. Because the sensing catheter fits tightly against the bronchoscope's working channel, the position and shape of the sensing catheter can be used to indicate the position and shape of the bronchoscope's working channel.

[0069] In step 340, the real-time position and shape of the bronchoscope are calculated based on the relationship between the working channel and the entire bronchoscope body in the 3D model. In step 350, the bronchoscope model undergoes real-time position and shape transformation. In step 360, the tracheal model and bronchoscope model are simultaneously displayed on the industrial computer monitor to provide the physician with operational reference. In step 370, a determination is made as to whether tracking should be stopped. If the bronchoscopic examination is complete, the process ends; if not, the process returns to step 330.

[0070] Specifically, the registration attachment contains CT image-recognizable markers that are used to construct the registration attachment's local coordinate system, thereby enabling registration between the patient's CT image, specifically the bronchial model, and the registration attachment's local coordinate system. The registration attachment incorporates a high-precision six-degree-of-freedom magnetic sensor, which is calibrated to establish a spatial transformation relationship between this magnetic sensor and the registration attachment's local coordinate system. Based on this calibration result and the registration of the bronchial model with the registration attachment's local coordinate system, registration of the bronchial model with the magnetic navigation space is achieved.

[0071] In an embodiment of the present invention, the three-dimensional shape information of the sensing catheter is calculated based on the real-time position and posture information of multiple sensors, and a Bezier curve fitting method, a data-driven deep learning method, etc. can be used.

[0072] Next, the Bezier curve fitting method process is explained in detail.

[0073] Because the distal end of the sensing catheter may experience varying loads and deformation, the constant curvature assumption no longer holds. Bezier curves, however, offer excellent smooth curve modeling capabilities and are therefore used to reconstruct the sensing catheter's curved shape. Since each pair of adjacent sensor positions can serve as the starting and ending points of a Bezier curve, and the axial directions of the two sensors provide two control point constraints, a third-order Bezier curve is chosen for segmented fitting of the sensing catheter's curved shape.

[0074] Figure 4 A schematic diagram of reconstructing the curve shape of a sensing catheter using a third-order Bezier curve fitting method according to an embodiment of the present invention is shown.

[0075] At time t, the position of the i-th sensor Si (i=0,1,2,…,n) is expressed as: The posture of sensor Si is expressed as in, Represents the three-dimensional coordinates of sensor Si at time t. The x-axis direction corresponding to sensor Si can be expressed as

[0076] like Figure 4 As shown, the curve from Start along Move in the direction of Arrival in the direction Generally not through or These two points only provide information about the orientation of the curve. The distance between them determines the curve's tendency to turn Before, along The length of the direction movement. The third-order Bezier curve can be expressed by the following formula:

[0077]

[0078] Where τ represents the relative position of the point in the curve, are the control points of the third-order Bezier curve. and is the starting point and the end point, and is known, and It is the middle control point and is unknown.

[0079] To sense the distal end of the catheter, the bend (length L C ) and the flexible part (length L S ) sensor S0 and S1 at the connection point, its position and Starting point and end point Right now point to The unit direction vector Right now point to The unit direction vector make Then we have:

[0080]

[0081]

[0082] According to formula (1), we can solve or That is to solve M 01 and M 23Two unknowns can be used to obtain the corresponding third-order Bezier curve equation. Considering that the sensing catheter in the configuration proposed in this patent only has radial bending motion and no axial extension or compression motion, the catheter length information can be used to establish the optimization objective function. Still taking sensors S0 and S1 as an example, the corresponding catheter length is L C Assuming that the curve is represented by m nodes, the corresponding estimated interpolation curve length L CE It can be expressed as:

[0083]

[0084] Ideally, L C =L CE But in fact, it is impossible to solve M by analytical methods. 01 and M 23 Therefore, the optimization method is used to solve

[0085]

[0086] For a complete sensing catheter, the complete position and shape can be reconstructed by fitting n Bezier curves segment by segment.

[0087] Next, the data-driven deep learning fitting method process is explained in detail.

[0088] Figure 5 The following is a diagram showing a catheter shape sensing calibration platform based on a two-dimensional high-precision camera according to an embodiment of the present invention. First, a high-precision 2D camera is constructed to design a catheter shape sensing calibration platform. Figure 5 As shown in Figure 1, two square calibration plates are vertically combined to form a camera imaging space, and black metal balls are evenly arranged on the calibration plates for calibrating the two-dimensional camera.

[0089] The sensing catheter is set to different shapes and positions within the camera imaging field of view. Two cameras respectively capture the horizontal plane (camera B) and the vertical plane (camera A). At the same time, the control center set by the present invention tracks the real-time position of each magnetic sensor in the sensing catheter. and direction The sensing catheter structure is extracted from the image of camera AB by image segmentation and other methods, and the complete sensing catheter shape C is reconstructed. t Based on this, a data set of sensing catheters with different positions and shapes is constructed. That is, a total of N data pairs with different positions and postures are collected.

[0090] Then, by Figure 6The data-driven deep learning-based curve fitting method for a sensing catheter according to one embodiment of the present invention divides sensor position and shape data, as well as sensing catheter shape data, obtained using a calibration platform, into training samples and validation samples. These samples are used to train a deep learning model to obtain model parameters that meet a set number of iterations, thereby constructing a data-driven deep learning curve fitting model. The deep learning model can employ structures such as a BP neural network or a one-dimensional convolutional neural network.

[0091] In the above embodiments of the present invention, the method for converting real-time multi-magnetic sensor position and posture information into three-dimensional shape information of a sensing catheter can be implemented as a computer program product. An industrial computer can be a computer system capable of implementing the method for converting real-time multi-magnetic sensor position and posture information into three-dimensional shape information of a sensing catheter according to the present invention. The computer system of the present invention can include various types of computer systems, such as handheld devices, laptop computers, personal digital assistants (PDAs), multiprocessor systems, microprocessor-based or programmable consumer electronic devices, network PCs, minicomputers, mainframe computers, network servers, tablet computers, and the like. The industrial computer is equipped with software for converting real-time multi-magnetic sensor position and posture information into three-dimensional shape information of a sensing catheter; the software is implemented based on a curve fitting algorithm and may utilize Bezier curve fitting methods, data-driven deep learning methods, and the like. Using the real-time position and shape information of the sensing catheter, the real-time position and shape of the flexible bronchoscope within the bronchus can be displayed to the user.

[0092] Furthermore, the methods for converting real-time multi-magnetic sensor position and posture information into sensed three-dimensional catheter shape information as described in various embodiments can be provided as a computer program product that can include one or more machine-readable media having machine-executable instructions stored thereon, such that when executed by one or more machines, such as computers, computer networks, or other electronic devices, the instructions can cause the one or more machines to perform operations according to various embodiments of the present invention. The machine-readable media can include, but are not limited to, floppy disks, optical disks, CD-ROMs (compact disk read-only memories) and magneto-optical disks, ROMs (read-only memories), RAMs (random access memories), EPROMs (erasable programmable read-only memories), EEPROMs (electrically erasable programmable read-only memories), magnetic or optical cards, flash memories, or other types of media / machine-readable media suitable for storing machine-executable instructions.

[0093] Furthermore, various embodiments may be downloaded as a computer program product, wherein the program may be transmitted from a remote computer (e.g., a server) to a requesting computer (e.g., a client) via a communication link (e.g., a modem and / or a network connection) using one or more data signals implemented and / or modulated by a carrier wave or other propagation medium. Thus, a machine-readable medium as used herein may, but is not required to, include such a carrier wave.

[0094] Existing bronchial navigation technology can significantly improve the accuracy of transbronchial examinations and treatments. However, current electromagnetic navigation methods can only track the position of the bronchoscope's distal end using a positioning guidewire. They cannot sense the bronchoscope's complete shape in real time, nor can they compensate for interference from bronchial structural deformation, which can easily lead to navigation errors in the bronchial pathway. While fiber-optic shape sensing methods can sense bronchoscope shape information in real time, they suffer from limitations such as high equipment cost, the need for additional registration methods to establish a spatial relationship with the patient, and inconvenience.

[0095] The setting and method proposed in the present invention use a flexible base rod as the basis to embed multiple magnetic sensors to construct a sensing catheter that can be placed in the working channel of a flexible bronchoscope. The magnetic positioning system is used to track the real-time spatial position and posture of each magnetic sensor, and the complete three-dimensional shape of the sensing catheter is reconstructed in real time through Bessel curve fitting or deep learning curve fitting methods. Through real-time spatial matching with the patient's personalized three-dimensional bronchial model and dynamic display of the doctor's positional relationship, the navigation error introduced by bronchial deformation during bronchoscopic examination and treatment is effectively compensated, the risk of bronchial pathway errors is reduced, and the positioning accuracy and safety of bronchial examination and treatment are improved.

[0096] Although various embodiments of the present invention have been described above, it should be understood that they are presented by way of example only and not limitation. It will be apparent to those skilled in the relevant art that various combinations, modifications, and variations may be made thereto without departing from the spirit and scope of the present invention. Therefore, the breadth and scope of the present invention disclosed herein should not be limited by the exemplary embodiments disclosed above, but should be defined solely in accordance with the appended claims and their equivalents.

Claims

1. A real-time positioning and shape sensing device, characterized in that: include: A sensing catheter comprising a flexible base rod and a plurality of sensors disposed on the flexible base rod; A magnetic field generator, wherein the magnetic field generator generates a working magnetic field; as well as Control center, When the sensing catheter moves and changes shape within the working magnetic field of the magnetic field generator, the control center tracks the position and posture of each sensor in real time. Based on the installation position of each sensor on the flexible base rod and the real-time tracked position and posture, the control center reconstructs the position and three-dimensional shape of the sensing catheter in real time.

2. The real-time positioning and shape sensing device according to claim 1, wherein: The number of the multiple sensors is at least three, and the sensors are magnetic positioning sensors.

3. The real-time positioning and shape sensing device according to claim 1, wherein: The sensing catheter is built into the working channel of the bronchoscope; or The sensing catheter is integrated into the interior of the bronchoscope; or The sensing catheter is housed within the instrument using the working channel of a bronchoscope.

4. The real-time positioning and shape sensing device according to claim 3, wherein: The sensors are respectively arranged on the sensing catheter at positions corresponding to the distal end point of the bronchoscope, the connection between the curved portion and the flexible portion, and positions at regular intervals on the flexible portion.

5. The real-time positioning and shape sensing device according to claim 1, wherein: The sensors are respectively arranged at the distal end of the sensing catheter and at positions distributed at certain intervals from the distal end to the proximal end.

6. The real-time positioning and shape sensing device according to claim 5, wherein: Each sensor is connected to the control hub via a set of wires; or Multiple sensors are connected to the data bus, and each sensor outputs data to the control center in an encoded manner.

7. The real-time positioning and shape sensing device according to claim 6, wherein: The sensor is connected to the control center in a digital manner.

8. The real-time positioning and shape sensing device according to claim 1, wherein: The control center includes a decoder and an industrial computer. The decoder parses the sensor signal into a signal readable by the industrial computer. The industrial computer is used to convert the real-time sensor position and posture information into the three-dimensional shape information of the sensing catheter.

9. A method for sensing the position and shape of a bronchoscope in a bronchus, characterized in that: include: Import the patient's personalized tracheal 3D model reconstructed from the patient's CT scan and the 3D model of the bronchoscope into the industrial computer of the control center; Patient registration is performed using a magnetic sensor-based registration accessory attached to the patient's chest skin, thereby unifying the coordinate space of the magnetic navigation system and the patient's tracheal model; When the bronchoscope is inserted into the trachea and is moved forward, backward, or turned, the control center tracks and senses the position and shape of the catheter in real time, wherein the bronchoscope is provided with a real-time positioning and shape sensing device according to any one of claims 1 to 8; Combined with the relationship between the working channel and the entire bronchoscope body in the 3D model of the bronchoscope, the real-time position and shape of the bronchoscope are calculated, and the bronchoscope model is transformed in real time. The tracheal model and the bronchoscope model are simultaneously displayed on the monitor of the industrial computer.

10. The method for sensing the position and shape of a bronchoscope in a bronchus according to claim 9, wherein: Based on the real-time position and posture information of multiple sensors, the three-dimensional shape information of the sensing catheter is calculated using curve fitting methods or data-driven deep learning methods.

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