A navigation system, a method of use, and a medical navigation system

Abstract

The present invention discloses a navigation system, a method of use, and a medical navigation system, comprising: a catheter body including a distal bending adjustment portion and a radially arranged working channel, the port of the working channel being located at the distal end of the bending adjustment portion; the bending adjustment portion being capable of bending and adjusting in any direction so that the port of the working channel is aligned with a target position; sensors embedded in the bending adjustment portion, which calculate the positional relationship between the sensors and the current bending condition of the bending adjustment portion through detection signals transmitted in real time by each sensor, and adjust the bending adjustment portion based on the bending condition so that, after the catheter body enters the target object, the port of the working channel is controlled to align with the target position of the target object. The present invention arranges multiple sensors on the bending adjustment portion at the distal end of the catheter body to achieve precise alignment with the target position, thereby facilitating the guidance of various instruments and practical tools through the working channel in the catheter body to contact the target position.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a navigation system, a method of use, and a medical navigation system. Background Art

[0002] Existing magnetic navigation-based bronchoscopic biopsy procedures involve navigating a catheter (sheath) equipped with a magnetic navigation sensor, a bronchoscope, or a guidewire to the lesion; confirming the location using radial ultrasound; and adjusting the catheter to the appropriate angle to ensure that the catheter's extension passes through the lesion. Therefore, this method places a single magnetic navigation sensor at the catheter tip to determine its position and orientation, indirectly determining the position and direction of the puncture needle.

[0003] To address this issue, existing patents CN215192193U, CN113116524A, and CN113116475A describe positioning the shape, position, and posture of the entire catheter. N sensors are placed in the catheter at different locations. After the catheter enters the physiological channel to be tested, the actual detection information from the N sensors is acquired. Based on the sensor detection information, the current curvature of the catheter is determined. Based on this current curvature information and reference curvature information, the catheter's position within the physiological channel to be tested is determined. However, the length of the catheter section between the first and last sensors is longer than the length between any two adjacent bifurcations in the physiological channel to be measured. Accordingly, a distribution strategy A = {the distribution distance of the N sensors is long enough so that the outlined curvature (i.e., at least part of the catheter section) can cover at least two bifurcations in the bronchial tree} can be formed. Conversely, if the distance (which can be understood as the distribution distance of the N sensors or the length of the catheter section between the first and last sensors) is not long enough, it will be difficult to align the current curvature information with the reference curvature information because the information of a single bifurcation is missing. In a bronchial navigation system based on magnetic navigation, multiple factors affect the accuracy of the entire system, including but not limited to the positioning accuracy of the magnetic navigation itself, the patient's breathing, the CT-body registration error, the catheter puncture angle, etc. The catheter insertion angle can affect the detection rate of punctures. For example, even if rEBUS confirms that the catheter has reached the lesion, an error in the catheter insertion angle can lead to a false-negative biopsy or require the surgeon to use ROSE (rapid on-site evaluation) to adjust the angle multiple times and perform multiple punctures to obtain a positive sample. Currently, catheter angle adjustment is based solely on the position of a single magnetic navigation sensor at the catheter tip, which can result in significant error in determining whether the expected position has been achieved. Summary of the Invention

[0004] The embodiments of the present invention provide a navigation system, a method of use, and a medical navigation system to solve the technical problem that the catheter of the existing in-vivo navigation device cannot be accurately aligned with the target lesion position during actual operation. It realizes real-time monitoring of the posture changes of the navigation distal end during actual operation, and realizes precise operation of the actual operation through the precise bending adjustment technology of the navigation distal end.

[0005] In a first aspect, an embodiment of the present invention provides a navigation system, comprising: a catheter body, a plurality of sensors;

[0006] The catheter body includes a distal bending portion and a radially arranged working channel, wherein the port of the working channel is located at the distal end of the bending portion; the bending portion can be bent and adjusted in any direction so that the port of the working channel is aligned with the target position;

[0007] The sensors are embedded in the bending adjustment part. The positional relationship between the sensors and the current bending condition of the bending adjustment part are calculated through the detection signals transmitted in real time by each of the sensors. The bending adjustment part is adjusted according to the bending condition so that after the catheter body enters the target object, the port of the working channel is controlled to align with the target position of the target object.

[0008] In one embodiment, a monitoring terminal is further included, and the monitoring terminal is electrically connected to each of the sensors to receive the detection signals transmitted by each of the sensors in real time so as to control the bending of the bending part.

[0009] In one embodiment, the monitoring terminal is configured with a first spatial coordinate model, which is a spatial coordinate system about the bending part constructed with the sensor at the proximal end of the bending part as a reference base point.

[0010] In one embodiment, after the monitoring terminal receives the detection signal transmitted by each of the sensors, it obtains the spatial coordinate data of each of the sensors in the first spatial coordinate model, calculates and obtains the first position posture data of the detection point of the bending adjustment part where each of the sensors is located, and calculates the positional relationship between the sensors.

[0011] In one embodiment, the monitoring terminal is configured with a second spatial coordinate model, wherein the second spatial coordinate model is a spatial coordinate system of the target object constructed with the target position as a reference base point;

[0012] In one embodiment, after the catheter body enters the target object, the monitoring terminal obtains the spatial coordinate data of each sensor in the second spatial coordinate model based on the detection signal transmitted by each sensor, calculates and obtains the second posture data of the detection point of the bending part where each sensor is located, and calculates and obtains the current bending condition of the bending part based on the positional relationship between the sensors and the second posture data.

[0013] In one embodiment, the monitoring terminal uses a spatial curve fitting algorithm to calculate and obtain the current bending condition of the bending adjustment portion.

[0014] In one embodiment, before adjusting the bending adjustment portion according to the bending condition so that the port of the working channel is aligned with the target position of the target object, it also includes performing spatial path planning according to the target position of the target object, and controlling the bending of the bending adjustment portion according to the bending angle required by the bending adjustment portion in the planned spatial path.

[0015] In one embodiment, when the bending adjustment part is being bent, the second posture data is used to perform three-dimensional curvature calculation to obtain curvature data of the interval segment between the current detection points of the bending adjustment part to determine whether the current bending condition of the bending adjustment part conforms to the spatial path planning.

[0016] In one embodiment, after completing the curvature data calculation, the monitoring terminal further uses the second posture data to perform three-dimensional space projection to fit the bending part and reflect the current bending condition of the bending part.

[0017] In one embodiment, when there is a deviation between the current bending condition of the bending adjustment portion and the planned spatial path, the bending angle of the bending adjustment portion continues to be adjusted until the bending condition of the bending adjustment portion meets the planned angle and the port of the working channel is aligned with the target position of the target object.

[0018] In one embodiment, the number of the sensors is at least 2, and the sensors are spaced apart from each other; when the number of the sensors is 2, they are respectively arranged at the head and tail ends of the bending portion.

[0019] In one embodiment, the bending portion adopts a bendable snake-bone structure, so that any two of the sensors can be bent.

[0020] In one embodiment, the sensors are arranged on the same side or opposite sides of the bending portion.

[0021] In one embodiment, before the catheter body performs navigation, the monitoring terminal calibrates the bending and adjustment portion using the sensor, and adjusts the bending and adjustment portion to an initial state required for spatial path planning according to the first posture data.

[0022] In one embodiment, when the initial state is required to be a straight line, the bending portion is adjusted to the straight line required for the initial state by utilizing the positional relationship of the sensors at the head and tail ends.

[0023] In one embodiment, a wiring channel is further provided in the radial direction of the catheter body, and the wiring channel is not connected to the working channel. The data lines derived from the several sensors are arranged through the wiring channel to transmit the detection signals of the sensors to the monitoring terminal.

[0024] In one embodiment, the sensor may be, but is not limited to, a magnetic conduit sensor, an optical fiber sensor, or a shape sensor.

[0025] In one embodiment, the proximal end of the catheter body is connected to an operating part; when the bending adjustment part is manually adjusted, the operating part is a bending adjustment handle.

[0026] In one embodiment, when the bending adjustment portion adopts electric bending, the operating portion is an interface matched with a motor drive device, and the bending of the bending adjustment portion is controlled by the motor drive device.

[0027] In one embodiment, the monitoring terminal uses kinematics and statics to model the bending and adjustment part to construct the first spatial coordinate model, and uses the detection signals transmitted by each of the sensors to automatically calculate the movement distance required by the motor drive device, thereby controlling the bending and adjustment part to bend to the desired angle.

[0028] In one embodiment, the bending adjustment portion can be adjusted in four directions: up, down, left, and right. The up and down components and the left and right components are combined to achieve adjustment in any direction, and bending adjustment of ±270° can be achieved in any direction.

[0029] In one embodiment, the spatial curve fitting algorithm may be, but is not limited to, Bezier curve fitting, Lagrangian fitting, piecewise cubic Hermite fitting, circular spline curve fitting, and NURBS spline curve fitting.

[0030] In a second aspect, an embodiment of the present invention provides a method for using a navigation system, which is applicable to the navigation system of the first aspect, and the method includes:

[0031] S100: Catheter pre-processing: In response to a plurality of sensors provided on a bending portion at the distal end of the catheter body, the bending portion is controlled to bend to a desired angle of an initial state according to detection signals transmitted by each of the sensors received in real time;

[0032] S200: Catheter entry processing: in response to a pre-configured spatial planning path for the movement of the catheter body in the target object, controlling the catheter body to move toward a target position in the target object along the planned spatial path using a detection signal received in real time after entering the target object;

[0033] S300: Bending processing: A working channel is provided in response to the radial direction of the catheter body, and the port of the working channel is located at the distal end of the bending portion; when the distal end of the bending portion reaches the bending range of the target position, the bending portion is controlled to bend according to the bending angle in the planned spatial path, so that the port of the working channel is aligned with the target position of the target object.

[0034] In a third aspect, an embodiment of the present invention provides a medical navigation system, which applies the navigation system in the first aspect and includes a catheter body, a plurality of sensors, and a monitoring terminal;

[0035] The catheter body includes a distal bending portion and a radially arranged working channel, and the port of the working channel is located at the distal end of the bending portion; the bending portion can be bent and adjusted in any direction, so that when the catheter body enters the physiological channel and the port of the working channel is aligned with the target position, the instrument tool passes through the working channel and extends out of the port to touch the target position of the physiological channel;

[0036] The sensors are embedded in the bending and adjustment part, and are used to transmit detection signals related to third posture data of detection points of the bending and adjustment part where the sensors are located;

[0037] The monitoring terminal is pre-configured with a third space coordinate model of the physiological channel; the monitoring terminal is electrically connected to each of the sensors, and after receiving the detection signal transmitted by each of the sensors, obtains the third posture data of each of the sensors in the third space coordinate model, and controls the movement of the catheter body in the physiological channel and the bending adjustment part according to the third posture data, so that the port of the working channel is aligned with the target position and the extension line of the distal end of the bending adjustment part touches the target position.

[0038] In one embodiment, the third spatial coordinate model is a spatial coordinate system about the physiological channel constructed with the target position as a reference base point, so that after the catheter body enters the physiological channel, each of the sensors and the target position are located in the same spatial coordinate system.

[0039] In one embodiment, when the catheter body enters the physiological channel and moves, the third posture data of the distal end of the bending adjustment portion in the third space coordinate model is obtained by the sensor at the distal end of the bending adjustment portion, and whether the distal end of the bending adjustment portion has reached the bending range of the target position is judged according to the third posture data, and the bending of the bending adjustment portion is controlled so that the port of its working channel is aligned with the target position.

[0040] In one embodiment, when the distal extension direction of the bending portion cannot reach the target position, the deviation between the third posture data of the detection point at the distal end of the bending portion and the planned position is calculated, and the bending portion is controlled to bend so that the distal end of the bending portion is located within the bending range of the target position.

[0041] In one embodiment, based on the third posture data of several detection points, a spatial curve fitting algorithm is used to fit the curvature of the bending adjustment part, obtain the direction vector of the distal detection point of the bending adjustment part in the third spatial coordinate model, and obtain the port direction of the working channel when the instrument tool is operated.

[0042] The technical solutions provided in the embodiments of the present invention have at least the following technical effects:

[0043] 1. Since a bending adjustment portion that can be adjusted is provided at the distal end of the catheter body, after the catheter body enters the target object, in addition to using multiple sensors for guidance and positioning, the target position can also be accurately aligned at the navigation target position, thereby facilitating the guidance of various instruments and practical tools through the working channel in the catheter body for subsequent operations.

[0044] 2. Since the sensor is embedded in the bending part, and the data line led out of the sensor is also embedded in the catheter body through the wiring channel, the entire catheter body is not affected by the obstruction of the sensor when entering the target object, and the real-time posture data of the bending part in the catheter body can be monitored in real time. By utilizing the bending and adjusting performance of the bending part, when changing instruments and tools during actual operation or when physiological reactions occur, the end of the bending part of the catheter body and the planned path / direction are calculated based on continuous posture error feedback, and the position and orientation of the bending part can be continuously adjusted to ensure that it is always aligned with the target position. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 Schematic diagram of the structure of the catheter body in Example 1 of the present invention;

[0046] Figure 2 This is a schematic structural diagram of a catheter body equipped with an instrument tool in the first embodiment of the present invention;

[0047] Figure 3 Schematic diagram of the arrangement of sensors on one side of the bending adjustment unit in the first embodiment of the present invention;

[0048] Figure 4 Schematic diagram of the arrangement of sensors on opposite sides of the bending adjustment unit in the first embodiment of the present invention;

[0049] Figure 5 A method for using the navigation system in the second embodiment of the present invention;

[0050] Figure 6 Schematic diagram of the bending orientation of the bending adjustment portion in the third embodiment of the present invention.

[0051] Figure Number:

[0052] The catheter body 100 , the bending adjustment portion 110 , the sensor 200 , the operating portion 120 , and the instrument tool 130 . DETAILED DESCRIPTION

[0053] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0054] In the description of the specification of the present invention, it should be understood that the orientation or positional relationship indicated by the terms "upper part", "lower part", "upper end", "lower end", "lower surface", "upper surface", etc. is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In the description of the specification of the present invention, the terms "first" and "second" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "multiple" is multiple, such as two, three, four, etc., unless otherwise clearly and specifically defined. In the description of the present invention, unless otherwise specified or limited, the term "connection" and other terms should be understood in a broad sense. For example, it can mean fixed connection, detachable connection, or integration; it can mean mechanical connection, electrical connection, or mutual communication; it can mean direct connection or indirect connection through an intermediate medium; it can mean internal communication between two elements or interaction between two elements. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0055] The following specific embodiments are used to describe the technical solution of the present invention in detail. The following specific embodiments can be combined with each other, and the same or similar concepts or processes may not be described in detail in some embodiments.

[0056] Example 1

[0057] Before describing the technical solution in detail with reference to the accompanying drawings and specific implementation methods, it is first further explained that the steps of bronchoscopic biopsy based on magnetic navigation in the background technology include: (1) obtaining the patient's bronchial tree and lesion location based on preoperative CT images, establishing a model, and performing optimal path planning; (2) performing intraoperative registration based on the magnetic navigation system and the preoperative CT images; (3) navigating to the lesion location through a catheter (sheath), bronchoscope or guidewire with a magnetic navigation sensor 200; (4) confirming through radial ultrasound; (5) adjusting the catheter to a suitable angle to ensure that the extension line of the catheter passes through the lesion; and (6) passing a biopsy tool such as a biopsy needle / biopsy forceps through the working channel of the catheter or bronchoscope to perform biopsy sampling on the lesion.

[0058] Reference Attachment Figure 1-2 As shown, an embodiment of the present invention provides a navigation system, including: a catheter body 100 and a plurality of sensors 200 .

[0059] The catheter body 100 in this embodiment includes a distal bending portion 110 and a radially arranged working channel, with the working channel port located at the distal end of the bending portion 110. The bending portion 110 in this embodiment can be bent and adjusted in any direction so that the working channel port is aligned with the target location.

[0060] The sensors 200 in this embodiment are embedded in the bending adjustment portion 110. The positional relationship between the sensors 200 and the current bending condition of the bending adjustment portion 110 are calculated through the detection signals transmitted in real time by each sensor 200. The bending adjustment portion 110 is adjusted according to the bending condition so that after the catheter body enters the target object, the port of the working channel is controlled to align with the target position of the target object.

[0061] To further illustrate, the catheter body 100 in this embodiment also includes a proximal guide portion connected to the proximal end of the bending and adjustment portion 110. A working channel extends through the guide portion and the bending and adjustment portion 110. The bending and adjustment portion 110 allows for arbitrary bending adjustments, thereby aligning the end of the working channel in any direction. This allows the catheter body 100 to bend into the target subject, forming a navigation channel with a curvature tailored to the target subject's actual location, after entering the target subject.

[0062] The target objects in this embodiment are not limited to physiological channels or soft tissue channels; navigation channels can be constructed in any closed environment. In medical applications, this embodiment uses physiological channels or soft tissue channels of laboratory animals as examples of target objects, such as bronchial trees, physiological channels to be tested, urinary system channels, digestive system channels, and other application scenarios.

[0063] The guide portion in this embodiment is not limited to a hose and can be replaced according to actual application scenarios.

[0064] To accommodate the aforementioned target objects, the bending portion 110 in this embodiment utilizes a hollow sheath that is bendable and adjustable, and has positioning and guidance capabilities. The hollow sheath may include an integrated optical lens (e.g., a CMOS lens), allowing this embodiment to be used in endoscopic technology. In one embodiment, the bending portion 110 is adjustable in four directions: up, down, left, and right. The up and down components, combined with the left and right components, can be adjusted in any direction. Adjustable bending angles of ±270° are possible in any direction, equivalent to the bending portion 110 in this embodiment being able to bend in any spatial direction. Based on this, the working channel in this embodiment can serve as a navigation channel for surgical instruments 130, such as biopsy needles, forceps, and brushes. Therefore, this embodiment, based on the bendability of the bending portion 110, not only facilitates access to curved physiological channels / soft tissue channels, but also, after reaching the target location, the bending portion 110 can be adjusted to align the end of the working channel with the target location (e.g., a lesion that can be punctured), thereby ensuring successful completion of the procedure.

[0065] The navigation system in this embodiment further includes a monitoring terminal, which is electrically connected to each sensor 200 and is used to receive detection signals transmitted by each sensor 200 in real time, so as to control the bending of the bending unit 110 .

[0066] To further illustrate, the monitoring terminal is configured with a first spatial coordinate model. This first spatial coordinate model is a spatial coordinate system for the bending unit 110, constructed with the sensors 200 located near the bending unit 110 as reference points. After receiving detection signals from each sensor 200, the monitoring terminal obtains the spatial coordinate data of each sensor 200 within the first spatial coordinate model, calculates the first position data of each sensor 200's detection point on the bending unit 110, and calculates the positional relationships between the sensors 200.

[0067] To further illustrate, the sensor 200 proximal to the bending portion 110 is used as a reference base point. The spatial coordinate data of the reference base point in the first spatial coordinate model is [0, 0, 0]. The X, Y, and Z axes are defined. When the sensors 200 are located on the same straight line, such as a straight line along the Z axis, the spatial coordinate data of each sensor 200 differs in the Z axis direction, while the data in the X and Y axes are the same. When the bending portion 110 bends, the spatial coordinate data of all sensors 200 changes, except for the spatial coordinate data of the sensor 200 proximal to the bending portion 110. The purpose of constructing the first spatial coordinate model in this embodiment is to obtain the positional relationship between the sensors 200 before the catheter body 100 enters the target object, so as to control the bending portion 110 from its initial state after entering the target object, thereby facilitating better planning of the movement path.

[0068] The monitoring terminal in this embodiment is configured with a second spatial coordinate model. This second spatial coordinate model is a spatial coordinate system for the target object, constructed with the target location as a reference point. After the catheter body 100 enters the target object, the monitoring terminal obtains the spatial coordinate data of each sensor 200 in the second spatial coordinate model based on the detection signals transmitted by each sensor 200. It then calculates and obtains the second pose data for the detection point on the bending and adjustment section 110 at which each sensor 200 is located. Based on the positional relationship between the sensors 200 and the second pose data, the monitoring terminal then calculates and obtains the current bending state of the bending and adjustment section 110.

[0069] To further explain, in this embodiment, a coordinate system related to the target object can also be directly used. However, the first spatial coordinate model and the second spatial coordinate model have different functions. In the first spatial coordinate model, relative to the static sensor 200 proximal to the bending portion 110, the spatial coordinate data of other sensors 200 dynamically changes relative to the spatial coordinate data of the sensor 200 proximal to the bending portion 110 because the bending portion 110 can be bent. Therefore, the positional relationship between the sensors 200 is obtained using the first spatial coordinate model. In the second spatial coordinate model, relative to the static target position, the spatial coordinate data of the sensor 200 dynamically changes relative to the spatial coordinate data of the target position because the sensor 200 on the bending portion 110 moves with the bending portion 110 within the target object.

[0070] In this embodiment, before the catheter body 100 performs navigation, the monitoring terminal calibrates the bending and maneuvering section 110 using sensors 200. Based on the first pose data, the bending and maneuvering section 110 is adjusted to the initial state required for spatial path planning. If the initial state requires a straight line, the positional relationship between the sensors 200 at the distal and distal ends is used to adjust the bending and maneuvering section 110 to the desired straight line. In other words, before navigation is performed, the bending and maneuvering section 110 must be calibrated to control its initial state to a straight line. At this point, the positional relationship between the sensors 200 at the distal and proximal ends of the bending and maneuvering section 110 is analyzed to determine whether the section 110 is aligned with a straight line.

[0071] Based on the second pose data of each sensor 200 in the second spatial coordinate model, the monitoring terminal in this embodiment calculates the current bending state of the bending adjustment unit 110 using a spatial curve fitting algorithm. Further, the spatial curve fitting algorithm may include, but is not limited to, Bezier curve fitting, Lagrangian fitting, piecewise cubic Hermite fitting, circular spline curve fitting, and NURBS spline curve fitting.

[0072] In this embodiment, before adjusting the bending unit 110 based on the curvature to align the end of the working channel with the target position of the target object, the system further includes performing spatial path planning based on the target position of the target object and controlling the bending unit 110 to bend according to the desired bending angle of the bending unit 110 within the planned spatial path. During the bending of the bending unit 110, three-dimensional curvature calculation is performed using the second pose data to obtain curvature data for the interval between the detection points of the bending unit 110 to determine whether the current curvature of the bending unit 110 conforms to the planned spatial path. After the curvature data calculation is completed, the monitoring terminal also uses the second pose data to perform a three-dimensional spatial projection to fit the bending unit 110 and reflect the current curvature of the bending unit. If there is a deviation between the current curvature of the bending unit and the planned spatial path, the bending angle of the bending unit is continuously adjusted until the curvature conforms to the planned angle and the end of the working channel is aligned with the target position of the target object.

[0073] In this embodiment, several sensors 200 are embedded in the bending portion 110. The number of sensors 200 in this embodiment is at least two, and the sensors 200 are spaced apart. When there are two sensors 200, they are arranged at the beginning and end of the bending portion. Each sensor 200 is used to collect position data and posture data (abbreviated as posture data) at the point where each sensor 200 is located. The bending portion 110 in this embodiment adopts a bendable serpentine structure, allowing bending between any two sensors 200. That is, when there are two sensors 200, the bending portion 110 between the beginning and end can be completely bent in a predetermined direction. When there are an infinite number of sensors 200, the bending portion 110 between any two adjacent sensors 200 can still be bent. The sensors 200 in this embodiment can be, but are not limited to, magnetic conduit sensors, optical fiber sensors, or shape sensors.

[0074] To further illustrate, several sensors 200 are arranged at different locations on the bending section 110, and the number of sensors 200 and the spacing between sensors 200 are configured based on actual needs. In this embodiment, when the catheter body 100 enters the target object, the bending section 110 is located at the distal end of the catheter body 100. Therefore, the sensors 200 on the bending section 110 can detect the position data of the point at which they are located in real time. Furthermore, the sensors 200 in this embodiment are not arranged at any arbitrary location along any length of the entire catheter body 100. Instead, they are sequentially arranged at different locations along the length of the bending section 110 at the distal end of the catheter body 100. To measure the curvature of the bending section 110, adjacent sensors 200 are spaced a distance apart. When the number of sensors 200 exceeds two, the positional relationship between the sensors 200 is configured to be equal or unequal spacing based on actual needs. In other words, the spacing between the sensors 200 can be uniform or uneven. The number of sensors 200 is greater than or equal to 2, for example, 2, 3, 4, 5, etc. are not limited. The required number of sensors 200 can be arbitrarily selected according to actual requirements such as the length of the bending part 110 and detection accuracy.

[0075] To further illustrate, this embodiment utilizes a spatial coordinate system to calculate the positional relationships between sensors 200 and between sensors 200 and the target location. In addition to utilizing the spatial coordinate system to obtain spatial coordinate data, the bending and adjustment unit also utilizes Euler angles for positional relationship calculations. In this embodiment, the second spatial coordinate model is constructed for the entire target object, using the target location as a reference point. After a sensor 200 enters the target object, it transmits real-time detection signals to a monitoring terminal, which uses these detection signals to obtain the current position and posture data for each sensor 200.

[0076] In this embodiment, when the sensors 200 are positioned on the bending section 110, they can detect the position and posture data of the bending section 110 where the sensors 200 are located. This allows the bending of the bending section 110 to be determined using a spatial fitting algorithm, using the spacing between the sensors 200 and the second posture data (position and posture data) of the detection points on the bending section 110. In actual operation, the target object is scanned to obtain a scanned image (e.g., a CT scan image), and a second spatial coordinate model (i.e., a three-dimensional navigation model) is established. The detection points on the bending section 110 where the sensors 200 are located are dynamically detected within the second spatial coordinate model. The position of the catheter body 100 within the navigation model is continuously adjusted based on the second posture data. When the catheter body 100 reaches the bending range of the target position, radial ultrasound is used to reconfirm the target position, control the bending of the bending section 110, and align the port of the working channel with the target position. For example, the target object is a physiological channel, and the target position is located on the inner wall of the channel of the target object. When the distal end of the catheter body 100 reaches the target position, it is necessary to control the bending adjustment portion 110 to bend toward the target position, and then move the catheter body 100 again to drive the port of the working channel to align with the target position.

[0077] Of course, in actual operation, this embodiment requires pre-navigation spatial path planning. The bending unit 110 is then bent according to the desired bending angle in the planned spatial path. After the bending is completed, pose data from the multiple sensors 200 within the bending unit 110 is acquired. Three-dimensional curvature calculation is performed using this pose data. Curvature data for the intervals between detection points of the bending unit 110 is calculated and fitted. A curve relationship diagram is formed using this curvature data fitting, and this is mapped into the three-dimensional space of the second spatial coordinate model to determine the current curvature of the bending unit 110. If the current curvature of the bending unit 110 deviates from the planned spatial path, a prompt is provided to continue adjusting the angle of the bending unit 110 until the bending unit 110 reaches the planned angle.

[0078] To further illustrate, the sensor 200 in this embodiment uploads the posture data to the monitoring terminal. If the posture data of the 5-degree-of-freedom sensor 200 is used, it is expressed as [X, Y, Z, Pitch, Yaw]; if the posture data of the 6-degree-of-freedom sensor 200 is used, it is expressed as [X, Y, Z, Pitch, Yaw, Roll], where X, Y, and Z are used to represent spatial coordinate data, and Pitch, Yaw, and Roll are used to represent the pitch, yaw, and roll in the corresponding Euler angles, thereby constituting the spatial posture information of the point at which the bending adjustment part 110 is located detected by each sensor 200.

[0079] In one embodiment, the number of sensors 200 is 3, and the bending portion 110 is bent using a single-peak curve, and the three detection points are evenly distributed in the bending portion 110, and then a polynomial fitting or Bezier curve fitting algorithm is used to obtain a better fitting calculation result.

[0080] In order to arrange the plurality of sensors 200 and transmit the detection signals of the sensors 200, a wiring channel is provided in the radial direction of the catheter body 100. Data cables extending from the plurality of sensors 200 are arranged through the wiring channel to transmit the detection signals of the sensors 200 to the monitoring terminal. In other words, the two ends of the data cable connect the sensors 200 and the monitoring terminal, and the data cable transmits the detection signals of the corresponding points of the catheter body 100 collected by the sensors 200 to the monitoring terminal. To further explain, since the sensors 200 are embedded in the bending portion 110 of the catheter body 100, the corresponding wiring channel is equivalent to embedding the data cable into the catheter body 100, thereby leading the data cable out at the proximal end of the catheter body 100 and connecting it to the monitoring terminal via a specific interface, so that the posture data detected by each sensor 200 can be displayed on the monitoring terminal.

[0081] In one embodiment, referring to the attached Figure 3-4 As shown, the sensors 200 are arranged on the same side or opposite sides of the bending portion. Further, the sensors 200 can be embedded on the same side or opposite sides of the bending portion 110. When the sensors 200 are embedded on both sides of the bending portion 110, the rotation angle of the bending portion 110 can be obtained through the sensors 200 on both sides, thereby more accurately fitting the bending posture.

[0082] To further illustrate, the catheter body 100 in this embodiment is provided with a working channel and a wiring channel in the radial direction. Since the working channel is used to navigate and position various operating tools, the working channel is defined as a closed channel with openings at both ends, while the wiring channel is used to arrange data cables. It can be seen that the two have different uses, so it can be configured that the working channel and the wiring channel are not connected to each other.

[0083] In this embodiment, the proximal end of the catheter body 100 is connected to an operating handle. When the bending and adjustment portion 110 is manually adjusted, the operating portion 120 serves as a bending handle. When the bending and adjustment portion 110 is electrically adjusted, the operating portion 120 serves as an interface that matches a motor drive device, and the motor drive device controls the bending of the bending and adjustment portion 110. The monitoring terminal in this embodiment uses kinematics and statics to model the bending and adjustment portion 110, constructing a first spatial coordinate model. Using the detection signals transmitted by each sensor 200, it automatically calculates the movement distance required by the motor drive device, thereby controlling the bending and adjustment portion 110 to bend to the desired angle.

[0084] Example 2

[0085] This embodiment provides a method for using a navigation system, which is applicable to the navigation system in the first embodiment.

[0086] Reference Attachment Figure 5 As shown, the method for using the navigation system in this embodiment includes the following steps.

[0087] S100: Catheter preprocessing: In response to multiple sensors 200 provided on the bending portion 110 at the distal end of the catheter body 100, the bending portion 110 is controlled to bend to the angle required for the initial state according to the detection signals transmitted by each sensor 200 received in real time.

[0088] S200: Catheter entry processing: In response to a pre-configured spatial planning path for the catheter body 100 to move in the target object, the catheter body 100 is controlled to move toward a target position in the target object along the planned spatial path using real-time received detection signals after entering the target object.

[0089] S300: Bending processing: A working channel is provided in response to the radial direction of the catheter body 100, and the port of the working channel is located at the distal end of the bending portion 110; when the distal end of the bending portion 110 reaches the bending range of the target position, the bending portion 110 is controlled to bend according to the bending angle in the planned spatial path so that the port of the working channel is aligned with the target position of the target object.

[0090] Example 3

[0091] Based on the navigation system in the first embodiment, this embodiment provides a medical navigation system for application in the field of medical devices.

[0092] This embodiment provides a medical navigation system including a catheter body 100 , a plurality of sensors 200 , and a monitoring terminal.

[0093] The catheter body 100 in this embodiment includes a distal bending adjustment portion 110 and a working channel arranged in a radial direction, and the port of the working channel is located at the distal end of the bending adjustment portion 110; the bending adjustment portion 110 can be bent and adjusted in any direction, so that when the catheter body 100 enters the physiological channel and the port of the working channel is aligned with the target position, the instrument tool 130 passes through the working channel and extends out of the port, touching the target position of the physiological channel.

[0094] The sensors 200 in this embodiment are embedded in the bending and adjustment part 110 to transmit detection signals related to the third posture data of the detection points of the bending and adjustment part 110 where the sensors 200 are located.

[0095] The monitoring terminal in this embodiment is pre-configured with a third space coordinate model related to the physiological channel; the monitoring terminal is electrically connected to each sensor 200, and after receiving the detection signal transmitted by each sensor 200, obtains the third posture data of each sensor 200 in the third space coordinate model, and controls the movement of the catheter body 100 in the physiological channel and the bending adjustment part 110 according to the third posture data, so that the port of the working channel is aligned with the target position and the extension line of the distal end of the bending adjustment part 110 touches the target position.

[0096] To further illustrate, the third spatial coordinate model is a spatial coordinate system of the physiological channel constructed with the target position as a reference base point, so that after the catheter body 100 enters the physiological channel, each sensor 200 and the target position are located in the same spatial coordinate system.

[0097] In this embodiment, when the catheter body 100 enters the physiological channel and moves, the third posture data of the distal end of the bending and adjustment portion 110 in the third space coordinate model is obtained through the sensor 200 at the distal end of the bending and adjustment portion 110. According to the third posture data, it is determined whether the distal end of the bending and adjustment portion 110 has reached the bending range of the target position and the bending and adjustment portion 110 is controlled to bend so that the port of its working channel is aligned with the target position.

[0098] When the distal extension direction of the bending part 110 cannot reach the target position, the deviation between the third posture data of the detection point at the distal end of the bending part 110 and the planned position is calculated, and the bending part 110 is controlled to bend so that the distal end of the bending part 110 is located within the bending range of the target position.

[0099] Based on the third posture data of several detection points, the spatial curve fitting algorithm is used to fit the bending of the bending adjustment part 110, obtain the direction vector of the distal detection point of the bending adjustment part 110 in the third space coordinate model, and obtain the port direction of the working channel when the instrument tool 130 is operated.

[0100] To further illustrate, in this embodiment, multiple sensors 200 are used to detect the posture data of the bending and adjustment portion 110 and to perform navigation and positioning based on the posture data. In actual operation, positioning and navigation of the bending and adjustment portion 110 is the first step in the operation. When the end of the bending and adjustment portion 110 reaches the bending range of the target position, the port of the working channel is aligned with the target position, and each instrument tool 130 is guided through the working channel and extended out of the port of the working channel to perform subsequent operations, such as biopsy sampling. Due to the need to replace the instrument tool 130 during the actual operation and the basic response of the physiological channel, the posture data of the end of the bending and adjustment portion 110 is constantly changing. Since the existing catheter design cannot adapt to operations after continuous posture changes, this embodiment calculates the end of the bending and adjustment portion 110 and the planned path / direction based on continuous posture error feedback, and continuously adjusts the position and orientation of the bending and adjustment portion 110 to ensure that the port of the working channel is always aligned with the target position. Therefore, it can be known that the purpose of this technical solution is to monitor the sensor 200 to receive the detection signals of each sensor in real time, obtain the posture data of the detection point of the bending and adjustment part 110 where the sensor 200 is located, obtain the position and direction required for navigation, and fit the spatial curve of the bending and adjustment part 110 based on the posture data of multiple detection points to perform precise bending operations on the bending and adjustment part 110.

[0101] Reference Attachment Figure 6 As shown, a plurality of sensors 200 are embedded in the bending and adjustment portion 110 of this embodiment, which are respectively arranged at detection points A, B, and C of the bending and adjustment portion 110. The monitoring terminal receives the posture data of each sensor 200 in real time, and obtains the spatial coordinate data and direction vector data of the end of the bending and adjustment portion 110 in the third spatial coordinate model based on the posture data of the sensor 200 at point A.

[0102] Among them, the third spatial coordinate model is a spatial coordinate system of the physiological channel based on the target position as the reference base point. When the bending adjustment part 110 enters the physiological channel, the sensor 200 and the target position are in the same coordinate system. When the direction vector in the posture data of the sensor 200 at A is extended by a certain length (for example, the length of the biopsy tool extending out of the catheter), as shown in FIG. Figure 6 When the dotted line in FIG touches the lesion (target position), it indicates that the position of the sensor 200 at position A is a punctureable position. When the extended line cannot reach the lesion (target position), the deviation between the posture data of the sensor 200 at position A and the planned posture range is calculated, and the bending unit 110 is controlled to bend so that the posture data of the sensor 200 at position A is within the bending range of the target position. Figure 5In the figure, points A, B, and C are detection points in the third spatial coordinate model, where the arrows represent the posture data of the detection points where the sensor 200 is located. Based on the posture data, this embodiment can fit the bending condition of the bending and adjustment portion 110 in the third spatial coordinate model, and based on the posture data of the sensor 200 at point A, obtain the direction vector of the distal end of the bending and adjustment portion 110, and further obtain the port direction of the working channel when the instrument tool 130 is operated. The monitoring terminal obtains the posture data of the sensors 200 at points A, B, and C, fits the curve shape of the bending and adjustment portion 110, and characterizes the bending condition of the bending and adjustment portion 110, thereby confirming whether the actual instrument tool 130 can reach the target position. If it cannot reach the target position, after calculating the deviation, the bending and adjustment portion 110 is controlled to bend, and finally the actual instrument tool 130 can be aligned to the target position. During the replacement and use of the instrument tool 130, the posture data of the sensor 200 at A and the bending deformation of the bending adjustment part 110 are monitored in real time. If deformation occurs or the posture data of the sensor 200 at A changes, resulting in the actual instrument tool 130 being unable to reach the target position, continue to adjust the bending angle of the bending adjustment part 110 so that the actual instrument tool 130 can reach the target position.

[0103] Although the preferred embodiments of the present invention have been described, those skilled in the art may make additional changes and modifications to these embodiments once they have learned the basic creative concept. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the present invention.

[0104] Obviously, those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if such changes and modifications fall within the scope of the claims and their equivalents, the present invention is intended to include such changes and modifications.

Claims

1. A navigation system, characterized in that: include: A catheter body and several sensors; The catheter body includes a distal bending portion and a radially arranged working channel, wherein the port of the working channel is located at the distal end of the bending portion; the bending portion can be bent and adjusted in any direction so that the port of the working channel is aligned with the target position; The sensors are embedded in the bending adjustment portion, and the positional relationship between the sensors and the current bending condition of the bending adjustment portion are calculated through the detection signals transmitted in real time by the sensors. The bending adjustment portion is adjusted according to the bending condition so that after the catheter body enters the target object, the port of the working channel is controlled to align with the target position of the target object; It also includes a monitoring terminal, which is electrically connected to each of the sensors and is used to receive the detection signals transmitted by each of the sensors in real time so as to control the bending of the bending part; The monitoring terminal is configured with a first spatial coordinate model, wherein the first spatial coordinate model is a spatial coordinate system of the bending part constructed with the sensor at the proximal end of the bending part as a reference base point; After receiving the detection signal transmitted by each sensor, the monitoring terminal obtains the spatial coordinate data of each sensor in the first spatial coordinate model, calculates and obtains the first position data of the detection point of the bending adjustment part where each sensor is located, and calculates the positional relationship between the sensors; The monitoring terminal is configured with a second spatial coordinate model, wherein the second spatial coordinate model is a spatial coordinate system of the target object constructed with the target position as a reference base point; After the catheter body enters the target object, the monitoring terminal obtains spatial coordinate data of each sensor in the second spatial coordinate model based on the detection signal transmitted by each sensor, calculates and obtains second posture data of the detection point of the bending portion where each sensor is located, and calculates and obtains the current bending condition of the bending portion based on the positional relationship between the sensors and the second posture data; The monitoring terminal calculates the current bending condition of the bending adjustment part using a spatial curve fitting algorithm; Before adjusting the bending adjustment portion according to the bending condition so that the port of the working channel is aligned with the target position of the target object, it also includes performing spatial path planning according to the target position of the target object, and controlling the bending of the bending adjustment portion according to the bending angle required by the bending adjustment portion in the planned spatial path.

2. The navigation system according to claim 1, wherein: When the bending part is being bent, the three-dimensional curvature is calculated using the second posture data to obtain the curvature data of the interval between the detection points of the current bending part, and to determine whether the current bending condition of the bending part conforms to the spatial path planning.

3. The navigation system according to claim 2, wherein: After completing the curvature data calculation, the monitoring terminal also uses the second posture data to perform three-dimensional space projection to fit the bending part and reflect the current bending condition of the bending part.

4. The navigation system according to claim 2, wherein: When there is a deviation between the current bending condition of the bending adjustment portion and the planned spatial path, the bending angle of the bending adjustment portion continues to be adjusted until the bending condition of the bending adjustment portion conforms to the planned angle and the port of the working channel is aligned with the target position of the target object.

5. The navigation system according to claim 1, wherein: The number of the sensors is at least 2, and the sensors are spaced apart from each other; when the number of the sensors is 2, they are respectively arranged at the beginning and end of the bending portion.

6. The navigation system according to claim 5, wherein: The bending portion adopts a bendable snake-bone structure, so that any two sensors can be bent.

7. The navigation system according to claim 5, wherein: The sensors are arranged on the same side or opposite sides of the bending portion.

8. The navigation system according to claim 1, wherein: Before the catheter body performs navigation, the monitoring terminal calibrates the bending and adjustment part using the sensor, and adjusts the bending and adjustment part to an initial state required in spatial path planning according to the first posture data.

9. The navigation system according to claim 8, wherein: When the initial state is required to be a straight line, the bending portion is adjusted to the straight line required for the initial state by utilizing the positional relationship of the sensors at the beginning and the end.

10. The navigation system according to claim 1, wherein: A wiring channel is further provided in the radial direction of the catheter body. The wiring channel is not connected to the working channel. Data lines derived from the sensors are arranged through the wiring channel to transmit the detection signals of the sensors to the monitoring terminal.

11. The navigation system according to claim 1, wherein: The sensor is any one of a magnetic conduit sensor, an optical fiber sensor, and a shape sensor.

12. The navigation system according to claim 1, wherein: The proximal end of the catheter body is connected to the operating part; when the bending adjustment part is manually adjusted, the operating part is a bending adjustment handle.

13. The navigation system according to claim 12, wherein: When the bending adjustment part adopts electric bending, the operating part is an interface matched with a motor drive device, and the bending of the bending adjustment part is controlled by the motor drive device.

14. The navigation system according to claim 13, wherein: The monitoring terminal uses kinematics and statics to model the bending part, constructs the first spatial coordinate model, and uses the detection signals transmitted by each sensor to automatically calculate the movement distance required by the motor drive device, thereby controlling the bending part to bend to the required angle.

15. The navigation system according to claim 1, wherein: The bending adjustment portion can be adjusted in four directions, namely up, down, left, and right. The up and down components and the left and right components can be combined to achieve adjustment in any direction, and bending adjustment of ±270° can be achieved in any direction.

16. The navigation system according to claim 1, wherein: The spatial curve fitting algorithm adopts any one of: Bezier curve fitting, Lagrange fitting method, piecewise cubic Hermite fitting method, circular arc spline curve fitting method, and NURBS spline curve fitting method.

17. A medical navigation system using the navigation system according to any one of claims 1 to 16, characterized in that: It includes a catheter body, several sensors and a monitoring terminal; The catheter body includes a distal bending portion and a radially arranged working channel, and the port of the working channel is located at the distal end of the bending portion; the bending portion can be bent and adjusted in any direction, so that when the catheter body enters the physiological channel and the port of the working channel is aligned with the target position, the instrument tool passes through the working channel and extends out of the port to touch the target position of the physiological channel; The sensors are embedded in the bending and adjustment part, and are used to transmit detection signals related to third posture data of detection points of the bending and adjustment part where the sensors are located; The monitoring terminal is pre-configured with a third space coordinate model of the physiological channel; the monitoring terminal is electrically connected to each of the sensors, and after receiving the detection signal transmitted by each of the sensors, obtains the third posture data of each of the sensors in the third space coordinate model, and controls the movement of the catheter body in the physiological channel and the bending adjustment part according to the third posture data, so that the port of the working channel is aligned with the target position and the extension line of the distal end of the bending adjustment part touches the target position.

18. The medical navigation system according to claim 17, wherein: The third spatial coordinate model is a spatial coordinate system about the physiological channel constructed with the target position as a reference base point, so that after the catheter body enters the physiological channel, each sensor and the target position are located in the same spatial coordinate system.

19. The medical navigation system according to claim 17, wherein: When the catheter body enters the physiological channel and moves, the third posture data of the distal end of the bending adjustment part in the third space coordinate model is obtained through the sensor at the distal end of the bending adjustment part. According to the third posture data, it is judged whether the distal end of the bending adjustment part has reached the bending range of the target position and the bending part is controlled to bend so that the port of its working channel is aligned with the target position.

20. The medical navigation system according to claim 18, wherein: When the distal extension direction of the bending portion cannot reach the target position, the deviation between the third posture data of the detection point at the distal end of the bending portion and the planned position is calculated, and the bending portion is controlled to bend so that the distal end of the bending portion is located within the bending range of the target position.

21. The medical navigation system according to claim 17, wherein: According to the third posture data of several detection points, the spatial curve fitting algorithm is used to fit the curvature of the bending adjustment part, obtain the direction vector of the distal detection point of the bending adjustment part in the third spatial coordinate model, and obtain the port direction of the working channel when the instrument tool is operated.

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