Needle guide locking device for puncture surgery and puncture navigation system

Abstract

The application discloses a needle guide locking device for puncture surgery and a puncture navigation system, a handle assembly; a micro-navigation module integrated in the handle assembly and configured to collect spatial posture data of a guide plate assembly and feed back to an external host computer; the guide plate assembly is arranged at the distal end of the handle assembly, and the guide plate assembly is configured to form at least one guide channel extending in the needle insertion direction, for placing and guiding the puncture needle; the locking assembly is arranged on the guide plate assembly and is switched to the needle placement state under the action of external force to release the guide channel for placing or adjusting the puncture needle, and is reset to the locking state under the action of elastic biasing force to close the guide channel and lock the puncture needle, thereby limiting the radial escape and axial retraction of the puncture needle, the puncture needle can be accurately guided through the guide channel, and the elastic biasing locking assembly can quickly clamp and release the needle, thereby improving the stability and safety of the puncture surgery.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a needle guide locking device and a puncture navigation system for puncture surgery. Background Technology

[0002] In modern interventional diagnosis and treatment, biopsy, radiofrequency ablation, microwave ablation, and various puncture and drainage procedures have become indispensable. The core of these procedures lies in the precise insertion of a puncture needle into the target tissue. To ensure the accuracy of the procedure, doctors usually need to use a guide device with a guiding function to assist in the needle insertion path.

[0003] However, existing guidance devices and navigation systems often have the following problems: 1. Ordinary angle locators and CT guides have simple structures and can only guide needle insertion externally. During needle insertion, especially when penetrating tissue resistance layers (such as skin, ligaments, or organ capsules), the needle is prone to deviation or movement, affecting puncture accuracy. Furthermore, in procedures such as ablation where the needle tip needs to be kept stationary, there is a lack of convenient and reliable locking mechanisms to fix the needle and prevent needle retraction or displacement. Additionally, existing guides cannot adjust the needle spacing between multiple needles according to the size of the lesion and the surgical plan.

[0004] 2. Existing puncture surgery navigation devices (such as optical navigation and robotic arm navigation robots) are expensive, have high maintenance and operating costs, and require highly specialized operation, making them difficult to widely adopt in primary hospitals. Moreover, in most cases, due to obstructed operating space or inherent design limitations, they can only perform single-needle procedures and cannot meet clinical needs such as multi-needle ablation.

[0005] Therefore, there is an urgent need for an integrated handheld device that is simple in structure, low in cost, easy to operate, and integrates rapid guidance and reliable locking functions to meet the needs of rapid, precise, multi-needle and stable operation in clinical surgery. Summary of the Invention

[0006] The technical objective of this invention is to provide a needle guide locking device and a puncture navigation system for puncture surgery, which can accurately guide the needle for puncture through a guide channel and achieve rapid locking and release of the needle through an elastic bias locking component, thereby improving the stability and safety of puncture surgery.

[0007] To solve the above problems, the technical solution of the present invention is as follows: This invention provides a needle guide locking device for puncture surgery, comprising: Handle assembly; The micro-navigation module, integrated into the handle assembly, is configured to collect spatial attitude data of the guide plate assembly and output it to an external host to achieve real-time navigation and positioning feedback; A guide plate assembly is disposed at the distal end of the handle assembly, the guide plate assembly being configured to form at least one guide channel extending in the needle insertion direction for inserting and guiding the puncture needle; A locking assembly, disposed on the guide plate assembly, is in a locked state under elastic bias to close the guide channel when no external force is applied. The locking assembly is configured to switch to a needle placement state under external force to release the guide channel for insertion or adjustment of the puncture needle, and to reset to the locked state under elastic bias to close the guide channel and lock the puncture needle, thereby limiting the radial dislodgement and axial retraction of the puncture needle.

[0008] Preferably, the guide plate assembly is provided with a plurality of guide channels extending along the needle insertion direction and arranged parallel to each other. The plurality of guide channels are arranged along the length direction of the guide plate assembly to form a multi-channel array, and the center distance between adjacent guide channels is a preset spacing.

[0009] Preferably, the guide plate assembly includes a first guide plate and a second guide plate, and a receiving cavity is formed between the first guide plate and the second guide plate; The outer surfaces of the first guide plate and the second guide plate are provided with a plurality of guide grooves extending along the needle insertion direction, forming a plurality of guide channels; The guide plate assembly has at least one opening that extends into the receiving cavity, and the plurality of openings and the plurality of guide grooves are arranged at intervals along the length direction of the guide plate assembly; The locking assembly is disposed within the receiving cavity. The locking assembly includes a pressing part and a locking part. The pressing part and the locking part are linked together. The pressing part extends at least partially out of the guide plate assembly through the opening to form a button. The locking part includes a plurality of blocking parts arranged at intervals along the length direction of the guide plate assembly, and each blocking part corresponds to each guide groove.

[0010] Preferably, the receiving cavity is provided with an elastic element, one end of which is connected to the locking part and the other end abuts against the inner wall of the receiving cavity, for applying an elastic bias force to the locking part so that the locking part is reset to the locked state when no external force is applied.

[0011] Preferably, when the pressing part is pressed, it causes the locking part to slide, and the blocking part avoids the corresponding guide groove, so as to switch from the locked state to the pin-positioning state; after the external force is released, the locking part slides back to reset under the elastic bias pressure of the elastic element, so that the blocking part covers the corresponding guide groove again, so as to restore the locked state.

[0012] Preferably, in the locked state, the blocking portion at least partially covers the open side corresponding to the guide groove to reduce the radial passage space of the guide channel, and abuts against the outer peripheral surface of the puncture needle under the action of elastic bias pressure to restrict the radial dislodgement and axial retraction of the puncture needle; in the needle placement state, each of the blocking portions avoids the open side corresponding to the guide groove to release the radial passage space for insertion or adjustment of the puncture needle.

[0013] Preferably, the shielding part is provided with an anti-slip texture or elastic pad on the side facing the guide groove to increase the frictional clamping force between it and the puncture needle in the locked state, thereby limiting the axial retraction of the puncture needle.

[0014] Preferably, the guide plate assembly is detachably connected to the distal end of the handle assembly, and the outer surface of the guide plate assembly is provided with scale markings to indicate the position or spacing of the guide channel.

[0015] Preferably, an initialization connection block is also included, which is detachably connected to the distal end of the guide plate assembly. The initialization connection block is used to provide a spatial positioning reference for performing initialization calibration when cooperating with the coordinate registration module, and is detached from the guide plate assembly after the initialization calibration is completed, so as to form a sterile isolation between the guide plate assembly and the coordinate registration module.

[0016] Another aspect of the present invention provides a puncture navigation system, comprising: Such as the needle guide locking device mentioned above; and An external host unit communicates with the micro-navigation module of the needle guide locking device used in puncture surgery; The external host is configured as follows: Acquire medical imaging data of the target object, plan the puncture path based on the lesion location and the puncture needle insertion point location, and generate the planning spatial angle parameters corresponding to the puncture path; The system receives spatial attitude data collected by the micro-navigation module and compares the spatial attitude data with the planned spatial angle parameters to generate attitude deviation information. Output navigation guidance information containing the attitude deviation information to guide the needle guide locking device to adjust its attitude; And when the puncture needle is advanced along the guide channel to the preset puncture depth, a locking prompt message is output to release the locking component, so that the puncture needle is locked and fixed under the action of elastic bias, restricting the radial dislodgement and axial retraction of the puncture needle.

[0017] Because the present invention adopts the above technical solution, it has the following advantages and positive effects compared with the prior art: 1. Quick locking to prevent dislodgement and shrinkage: With the design of the locking component with elastic bias, the operator can open the channel for needle placement with one hand and automatically lock the needle by releasing the hand, which effectively prevents the needle from shaking when penetrating the resistance layer during puncture, as well as the needle from shrinking or shifting during the ablation operation, greatly improving the safety of the operation.

[0018] 2. Low cost and portable: Compared with expensive robotic surgical robots, this device has a simple structure, low manufacturing cost, and a handheld design that is portable and easy to use, making it easy to promote and popularize in primary hospitals.

[0019] 3. Multi-needle array and precise needle placement: Through multi-channel array design and scale marking, multiple puncture needles can be guided to puncture in parallel at the same time, and the needle spacing can be precisely controlled according to the size of the lesion, meeting the needs of complex ablation surgery and overcoming the limitations of single-needle operation of traditional navigation equipment.

[0020] 4. Sterile isolation and high compatibility: The detachable initialization connection block enables both spatial positioning benchmark calibration for navigation initialization and sterile isolation between the surgical area and the navigation device through disassembly, making it suitable for scenarios involving various imaging equipment such as ultrasound, CT, and DSA. Attached Figure Description

[0021] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention.

[0022] Figures 1a-1b This is a schematic diagram of the overall structure of the needle guide locking device used for puncture surgery in an embodiment of the present invention; Figure 2 This is a schematic diagram of the handle assembly in an embodiment of the present invention; Figure 3 This is a schematic diagram of the guide plate assembly in an embodiment of the present invention; Figures 4a-4b This is a schematic diagram of the locking component in an embodiment of the present invention; Figure 5 This is a schematic diagram of the structure of the initialization connection block in an embodiment of the present invention. Detailed Implementation

[0023] The following specific examples illustrate the embodiments of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of the present invention, unless otherwise stated, "a plurality of" means two or more.

[0024] It should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art will understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0025] like Figures 1a-1b , Figure 2 This embodiment provides a needle guide locking device for puncture surgery, including a handle assembly 1, a micro-navigation module, a guide plate assembly 2, and a locking assembly.

[0026] The micro-navigation module, integrated into the handle assembly 1, is configured to collect spatial attitude data of the guide plate assembly 2 and output it to an external host to achieve real-time navigation and positioning feedback; the handle assembly 1 is equipped with a PCB circuit board with micro-navigation function and a power supply.

[0027] A guide plate assembly 2 is disposed at the distal end of the handle assembly 1, and the guide plate assembly 2 is configured to form at least one guide channel 21 extending in the needle insertion direction for inserting and guiding the puncture needle. A locking component 3 is disposed on the guide plate assembly 2. The locking component 3 is in a locked state under the action of elastic bias, so that the locking component 3 closes the guide channel 21 when no external force is applied. The locking component 3 is configured to switch to the needle placement state under the action of external force to release the guide channel 21 for insertion or adjustment of the puncture needle, and to reset to the locked state under the action of elastic bias to close the guide channel 21 and lock the puncture needle, thereby limiting the radial dislodgement and axial retraction of the puncture needle, and keeping the puncture needle stable relative to the guide plate assembly 2.

[0028] In the needle-insertion state, the locking assembly 3 avoids the open side of the guide channel 21 to release radial passage space, facilitating smooth insertion of the puncture needle and preoperative posture adjustment; in the locking state, the locking assembly 3 closes the open side of the guide channel 21 and forms an elastic clamping and locking of the puncture needle placed therein, restricting the radial dislodgement and axial movement of the puncture needle, so that the puncture needle and the guide plate assembly 2 are relatively rigidly fixed, thereby maintaining the stability of the needle during and after puncture.

[0029] In one embodiment, such as Figure 3 The guide plate assembly 2 is provided with multiple guide channels 21 extending parallel to each other along the needle insertion direction. These guide channels 21 are arranged along the length of the guide plate assembly 2 to form a multi-channel array, with a preset center-to-center distance between adjacent guide channels 21. This allows for parallel guidance of multiple puncture needles and achieves a fixed-spaced array. By setting multiple guide channels 21 with fixed spacing, the clinical application needs of multi-needle ablation, multi-needle sampling, or other applications requiring coordinated multi-needle arrangement can be met.

[0030] In one embodiment, the guide plate assembly 2 includes a first guide plate 22 and a second guide plate 23, with a receiving cavity formed between the first guide plate 22 and the second guide plate. The first guide plate 22 and the second guide plate 23 are spliced ​​and fixed together, for example by snapping them together to form a receiving locking component 3, providing a concealed and dustproof installation space, preventing external tissues or instruments from accidentally touching the locking mechanism during surgery, while maintaining the flatness and safety of the outer surface of the guide plate assembly 2.

[0031] The outer surfaces of the first guide plate 22 and the second guide plate 23 are provided with multiple guide grooves extending along the needle insertion direction, forming multiple guide channels 21. These guide grooves extend along the width direction of the guide plate assembly 2, i.e., the needle insertion direction. The guide grooves are preferably open groove structures with an open side, such as arc-shaped, U-shaped, or other shapes suitable for guiding and limiting the puncture needle, so that the puncture needle can be inserted or removed from the side of the guide channel 21 without having to be inserted from the end along the length direction of the guide channel 21, thereby facilitating needle placement and position adjustment during the operation. The multiple guide grooves are evenly arranged along the length direction of the guide plate assembly 2, and the center distance between adjacent guide grooves is a preset spacing, forming a multi-channel array.

[0032] To achieve the linkage between the external operation and internal movement of the locking component 3, the guide plate assembly 2 is provided with at least one opening 24 extending into the receiving cavity. The pressing part of the locking component 3 extends at least partially out of the guide plate assembly 2 through the opening to form a button for operator operation. Preferably, the opening is located near one side of the multiple guide grooves and is adapted to the movement path of the locking component 3, so that the operator can drive the locking component 3 to move within the receiving cavity by pressing the button. This structural design ensures convenient pressing operation while reserving reasonable space for the sliding of the locking part and the covering action of the multiple shielding parts on the guide grooves. This layout spatially separates the button operation area (the protruding part of the pressing part) from the needle insertion area (guide groove), preventing the operator's fingers from interfering with the puncture needle when pressing the button, and providing reasonable movement space for the subsequent lateral sliding of the locking part to cover the guide groove.

[0033] like Figures 4a-4b The locking assembly 3 is disposed within the receiving cavity, preferably as an integrated structure. The locking assembly 3 includes a pressing part 31 and a locking part 32, which are linked together. The pressing part 31 extends at least partially beyond the guide plate assembly 2 through the opening to form a button. The pressing part 31 is an integrated structure, such as an integrated U-shaped structure, where pressing the front end of the U-shape drives the rear end to move, and the L-shaped locking part 32 is disposed near the rear end of the U-shape. The operator can press the button to apply force to the pressing part 31, causing the locking part 32 to move within the receiving cavity, thereby enabling external operation of the locking assembly 3.

[0034] like Figure 4bThe locking part 32 includes multiple blocking parts spaced apart along the length of the guide plate assembly 2, each blocking part corresponding to a guide groove. The blocking parts 33 are preferably L-shaped. These L-shaped blocking parts can be integrally formed with the main body of the locking part 32, or connected by a connecting beam to form an integrated linkage structure, allowing the operator to activate multiple blocking parts 33 synchronously by pressing a single button. Based on this correspondence, when the pressing part 31 drives the locking part 32 to slide along the width of the guide plate assembly 2, each blocking part 33 moves synchronously with the locking part 32. In the pin-positioned state, each blocking part 33 slides to a position that avoids the open side of the corresponding guide groove, releasing the radial entry space of the guide channel 21; in the locked state, each blocking part 33 returns to a position covering the open side of the corresponding guide groove, closing the corresponding guide channel 21. Therefore, by pressing the button at a single point, multiple blocking parts 33 can be opened and closed simultaneously with multiple guide channels 21, thus taking into account both ease of operation, compact structure, and multi-channel synchronous locking effect.

[0035] In one embodiment, such as Figure 4a The receiving cavity is provided with an elastic element 34. One end of the elastic element 34 is connected to the locking part 32, and the other end abuts against the inner wall of the receiving cavity. It applies an elastic biasing force to the locking part 32, causing the locking part 32 to return to the locked state when no external force is applied. The elastic element 34 can be any one or a combination of a compression spring, tension spring, torsion spring, elastic sheet, wave spring, or elastic body. Preferably, the elastic element 34 is a compression spring, with one end abutting against the inner wall of the receiving cavity and the other end abutting against the locking part 32, so as to drive the locking part 32 to automatically return to its original position after the external force is released.

[0036] In one embodiment, when the pressing part 31 is pressed, it causes the locking part 32 to slide, and the blocking part 33 avoids the corresponding guide groove, so as to switch from the locked state to the pin-positioning state; after the external force is released, the locking part 32 slides back to reset under the elastic bias force of the elastic member 34, so that the blocking part 33 covers the corresponding guide groove again, so as to restore the locked state.

[0037] In one embodiment, in the locked state, the blocking portion 33 at least partially covers the open side corresponding to the guide groove to reduce the radial passage space of the guide channel 21, and abuts against the outer peripheral surface of the puncture needle under the action of elastic bias pressure to restrict the radial dislodgement and axial retraction of the puncture needle; in the needle placement state, each of the blocking portions 33 avoids the open side corresponding to the guide groove to release the radial passage space for insertion or adjustment of the puncture needle.

[0038] In one embodiment, the shielding portion 33 is provided with an anti-slip texture or elastic pad on the side facing the guide groove. The anti-slip texture can be raised dots, stripes, mesh patterns, or other surface structures that can increase contact friction, and the elastic pad can be made of silicone, rubber, thermoplastic elastomer, or other materials with elastic deformation capabilities. When the shielding portion 33 is in the locked state and covers the open side of the corresponding guide groove, the anti-slip texture or elastic pad can form frictional contact or elastic compression with the outer wall of the puncture needle placed in the guide channel 21, thereby improving the limiting and locking effect on the puncture needle and reducing the risk of axial slippage or radial dislodgement of the puncture needle. At the same time, the elastic pad can also adapt to the outer diameter tolerance of puncture needles of different specifications to a certain extent, which is beneficial to improving the compatibility and buffering of the locking structure.

[0039] In one embodiment, the guide plate assembly 2 is detachably connected to the distal end of the handle assembly 1, and the outer surface of the guide plate assembly 2 is provided with scale markings to indicate the position or spacing of the guide channels 21. The guide plate assembly 2 and the handle assembly 1 can be connected by snap-fit, plug-in, clip-on connection, or other detachable connection methods to allow for the replacement of guide plate assemblies 2 with different specifications, numbers of channels, or channel spacings according to different surgical needs. By detachably setting the guide plate assembly 2 at the distal end of the handle assembly 1, it facilitates assembly, disassembly, cleaning, disinfection, or replacement, and also improves the modularity of the device. Furthermore, the scale markings can be set in the visible area of ​​the outer surface of the guide plate assembly 2, corresponding to the position of each guide channel 21, or corresponding to the spacing between adjacent guide channels 21, so that the operator can quickly identify the target guide channel 21, determine the needle placement relationship, and assist in the selection and spacing control of multi-needle puncture paths during surgery.

[0040] In one embodiment, an initialization connection block 4 is further included. This initialization connection block is detachably connected to the distal end of the guide plate assembly 2. It provides a spatial positioning reference for initialization calibration when used in conjunction with the coordinate registration module, and is detached from the guide plate assembly 2 after initialization calibration, thus establishing a sterile isolation between the guide plate assembly 2 and the coordinate registration module. The initialization connection block serves as a transitional positioning component during the initialization phase. It connects to the guide plate assembly 2 before use and establishes a relatively fixed spatial positional relationship with the coordinate registration module, thereby providing a stable spatial positioning reference for the system to perform initialization calibration. After initialization calibration, the initialization connection block can be detached from the guide plate assembly 2, eliminating the need for non-sterile components involved in registration to remain near the surgical area, thereby reducing interference with aseptic operation. Through this configuration, the initialization connection block can be used to establish the coordinate system or perform spatial registration during the initialization phase, and can be removed during the formal puncture operation phase to establish a sterile isolation between the guide plate assembly 2 and the coordinate registration module, thus balancing positioning accuracy requirements with aseptic operation requirements.

[0041] In one embodiment, the micro-navigation module is integrated inside the grip portion of the handle assembly 1. It is used to monitor the spatial attitude of the needle guide locking device in real time and wirelessly transmit the attitude data to an external host (planning and navigation module) to assist in the precise insertion and adjustment of the puncture needle. The micro-navigation module includes an inertial measurement unit (IMU), a communication unit, and a power management unit. The IMU is preferably an inertial measurement unit (IMU) integrating a three-axis gyroscope, a three-axis accelerometer, and a three-axis magnetometer. The gyroscope is used to detect angular velocity information in real time, the accelerometer is used to detect the gravitational acceleration component, and the magnetometer is used to sense the geomagnetic direction. The system can calculate the current attitude of the needle guide locking device in space in real time by integrating the three-axis angular velocities and fusing the data from the accelerometer and magnetometer. To reduce long-term drift errors caused by gyroscope integration, the micro-navigation module can incorporate complementary filtering, Kalman filtering, extended Kalman filtering, or other attitude fusion algorithms. It utilizes low-frequency reference information provided by the accelerometer and magnetometer to dynamically correct the gyroscope integration results, thereby improving attitude stability and angle accuracy during prolonged use. The communication unit can employ Bluetooth Low Energy, 2.4G wireless protocols, or other wired / wireless communication methods to transmit drift-compensated spatial attitude angle data to an external host in real time. The power management unit can utilize micro-lithium batteries, button batteries, rechargeable micro-power modules, or external power supply structures, and can be configured with standby, sleep, wake-up, and low-battery alarm mechanisms to meet the miniaturization and low-power requirements of reusable instruments or disposable consumables.

[0042] This embodiment also provides a puncture navigation system, characterized in that it includes: Such as the needle guide locking device mentioned above; and An external host unit communicates with the micro-navigation module of the needle guide locking device used in puncture surgery; The external host is configured as follows: Acquire medical imaging data of the target object, plan the puncture path based on the lesion location and the puncture needle insertion point location, and generate the planning spatial angle parameters corresponding to the puncture path; The system receives spatial attitude data collected by the micro-navigation module and compares the spatial attitude data with the planned spatial angle parameters to generate attitude deviation information. Output navigation guidance information containing the attitude deviation information to guide the needle guide locking device to adjust its attitude; And when the puncture needle is inserted into the guide channel 21 to the preset puncture depth, a locking prompt message is output to release the locking component 3, so that the puncture needle is locked and fixed under the action of elastic bias, restricting the radial dislodgement and axial retraction of the puncture needle.

[0043] Furthermore, the external host is also configured to: determine the target number of needles and the corresponding target guide channel 21 based on the size characteristics of the lesion and the preset distance between adjacent guide channels 21 on the guide plate assembly 2, and generate multi-needle needle placement planning information; output the posture deviation guidance information and the multi-needle needle placement planning information to instruct the operator to place multiple puncture needles into the corresponding target guide channel 21 and lock them in place under the elastic bias of the locking assembly 3, thereby performing a fixed-distance multi-needle array puncture operation.

[0044] In one embodiment, the micro-navigation module is integrated into the handle assembly 1, used to collect spatial attitude data of the needle guide locking device in real time and output it to an external host. To enable accurate comparison between the spatial attitude data collected by the micro-navigation module and the puncture path parameters planned based on medical images in the same reference frame, thus achieving the aforementioned navigation guidance function, the puncture navigation system also employs coordinate registration and navigation logic based on a fixed reference frame. Specifically, the system further includes a coordinate registration module: In one embodiment, the coordinate registration module includes: an initialization bracket, fixedly disposed at a predetermined position having a defined spatial correspondence with the fixed reference system, and whose spatial pose remains constant after installation and positioning, for repeated initialization calibration in multiple procedures; the predetermined position can be the edge of the CT equipment scanning bed, the side of the bed board, the auxiliary fixing part of the operating table, or other structural positions that remain stable in spatial position and posture relative to the imaging equipment coordinate system after installation. The initialization bracket is provided with a calibration positioning part; the calibration positioning part can adopt a boss, slot, insertion hole, magnetic attraction mating surface, limiting surface, or other mating structure that can achieve repeated positioning and posture constraint. Correspondingly, the needle guide locking device uses an initialization connecting block detachably connected at its distal end as a positioning mating part. The initialization connecting block is used to connect with the calibration positioning part of the initialization bracket during initialization calibration to detachably fix and constrain the needle guide locking device to the predetermined calibration position and keep it stationary, thereby providing a physical basis for establishing the correspondence between the coordinate system of the needle guide locking device itself and the fixed reference system. Since the initialization bracket forms a definite spatial correspondence with the imaging equipment coordinate system once it is installed, the same fixed reference benchmark can be quickly reused in different procedures by repeatedly docking the needle guide locking device with the calibration positioning part through the initialization connecting block, without having to re-establish a complex external spatial calibration relationship each time.

[0045] During initial calibration, the external host (planning and navigation module) and the micro-navigation module are configured to: when in a reference frame binding state, acquire the currently collected initial attitude sensing data. The reference frame binding state is the state in which the needle guide locking device establishes a definite spatial correspondence with the fixed reference frame via the initialization connection block and initialization bracket. The reference frame binding state can be understood as the needle guide locking device being reliably connected to the initialization bracket, and the current attitude being physically constrained and remaining stationary. In this state, the attitude data output by the micro-navigation module is no longer simply derived from the drift coordinates of the device's own sensors, but rather forms a correspondence with the fixed reference datum provided by the coordinate registration module.

[0046] Based on the initial attitude sensing data, the current attitude of the needle guide locking device is set as the attitude reference. This attitude reference is defined as a zero point, ensuring that the current attitude angle is displayed as zero upon completion of the initial calibration. Furthermore, the spatial attitude angle data displayed by the external host after calibration is the relative angle change relative to the attitude reference. In other words, after the initial calibration is completed, all subsequent displayed and calculated spatial attitude angle data are relative angle changes relative to the attitude reference. This allows the external host to compare the planned spatial angle parameters obtained from medical image planning with the spatial attitude angle data acquired in real-time by the micro-navigation module and processed after attitude zeroing, all within the same reference system. This avoids the incomparability of angles caused by inconsistencies between the image coordinate system and the sensor's local coordinate system.

[0047] Furthermore, in this embodiment, to represent the three-dimensional spatial orientation of the planned puncture path in a way that is more suitable for clinical operation understanding and guidance, intersecting first and second reference projection planes are set under the fixed reference system, and a preset reference axis is determined. Preferably, the CT equipment coordinate system is used as the fixed reference system, the head-to-foot direction is defined as the HF direction, the left-right direction as the LR direction, the direction perpendicular to the corresponding reference plane is defined as the Z direction, and the Z-axis is used as the preset reference axis. The first reference projection plane can be the HF-Z plane, and the second reference projection plane can be the LR-Z plane; preferably, they are perpendicular to each other. Based on this, the planned spatial angle parameters include a first planned angle and a second planned angle; the first planned angle is the angle between the projection of the puncture path onto the first reference projection plane and the preset reference axis, and the second planned angle is the angle between the projection of the puncture path onto the second reference projection plane and the preset reference axis; the spatial posture angle data includes a first real-time angle and a second real-time angle; the first real-time angle is the angle between the projection of the current guide axis of the needle guide locking device onto the first reference projection plane and the preset reference axis, and the second real-time angle is the angle between the projection of the current guide axis of the needle guide locking device onto the second reference projection plane and the preset reference axis. Through the above dual-projection-plane angle definition method, the original puncture direction problem in three-dimensional space can be transformed into two independent but collaboratively reflective planar angle control problems, allowing the operator to more intuitively adjust the puncture direction based on the angles within the two projection planes.

[0048] In a preferred embodiment, the physician can select the lesion location 'a' and the puncture needle insertion point location 'b' on the display and planning software interface corresponding to the planning and navigation module. The system automatically reads the three-dimensional spatial coordinates of the two points in a fixed reference frame, denoted as the coordinates of point a (Xa, Ya, Za) and point b (Xb, Yb, Zb), respectively. The planning and navigation module determines the planned puncture path based on the three-dimensional spatial coordinates between the lesion location and the puncture needle insertion point location, and calculates the length of the planned puncture path as the puncture depth. The puncture depth L can preferably be obtained according to the three-dimensional spatial distance formula: Wherein, L represents the straight-line distance from the puncture point to the lesion location along the planned puncture path.

[0049] Furthermore, based on the angle relationship between the projections of the planned puncture path and the preset reference axis in the mutually perpendicular first and second reference projection planes, the first planning angle α and the second planning angle β are determined. For example, when the HF-Z plane and LR-Z plane are used as the two reference projection planes, and the Z-axis is used as the preset reference axis, the planning and navigation module can calculate the first planning angle α and the second planning angle β using trigonometric functions based on the coordinate difference between the lesion location and the puncture needle insertion point location. Specifically, the difference in the head-to-foot direction of the path vector in the fixed reference system can be set as ΔHF, the difference in the left-right direction as ΔLR, and the difference in the axial direction as ΔZ. Then, the first planning angle α and the second planning angle β can be calculated using atan2(ΔHF, ΔZ) and atan2(ΔLR, ΔZ) or other equivalent methods to ensure the correctness of the angle definition in different quadrants. The first planning angle α can characterize the degree of deflection of the puncture path relative to the Z-axis in the first reference projection plane, and the second planning angle β can characterize the degree of deflection of the puncture path relative to the Z-axis in the second reference projection plane. It should be noted that as long as the relationship between the planned path direction and the current direction of the guide structure can be represented under a unified reference system, the above angles can also be expressed in the form of Euler angles, direction vectors, direction cosines, quaternion transformation results or other equivalent parameters, and are not limited to the specific definition of the angle between the two projection planes.

[0050] After initial calibration, the attitude monitoring and communication module acquires the attitude change information of the needle guide locking device in real time and continuously sends the spatial attitude angle data to the planning and navigation module. The inertial measurement unit in the attitude monitoring and communication module can collect three-axis angular velocity information, acceleration information, and geomagnetic direction information in real time. The system can calculate the current spatial attitude of the needle guide locking device by integrating the three-axis angular velocity and combining it with accelerometer and magnetometer data for correction. In a preferred implementation, the short-term attitude change can be obtained by gyroscope integration first, and then the long-term drift can be corrected by complementary filtering or Kalman filtering using accelerometer and magnetometer as reference quantities. Then, the attitude result calculated in the local coordinate system of the sensor can be converted to the fixed reference system to obtain the first real-time angle α′ and the second real-time angle β′. The communication unit can use a Bluetooth communication module, a low-power Bluetooth module, a 2.4G wireless transmission module, or other wired / wireless data transmission methods to send the first real-time angle α′ and the second real-time angle β′ to the planning and navigation module in real time at a preset refresh frequency, so that the planning and navigation module can continuously obtain the real-time angle information corresponding to the current posture of the needle guide locking device.

[0051] After initial calibration, the external host acquires the first real-time angle and the second real-time angle in real time, and calculates the first angular deviation and the second angular deviation between them and the first planned angle and the second planned angle, respectively. Specifically, if the first planned angle is α, the second planned angle is β, the first real-time angle is α′, and the second real-time angle is β′, then the first angular deviation Δα and the second angular deviation Δβ can be calculated. Here, α is the angle between the projection of the puncture path ab in the first reference projection plane (HF-Z plane) ab' and the Z-axis; β is the angle between the projection of the puncture path ab in the second reference projection plane (LR-Z plane) ab'' and the Z-axis; α′ is the angle between the projection of the current axis of the needle guide locking device in the first reference projection plane and the Z-axis; β′ is the angle between the projection of the current axis of the needle guide locking device in the second reference projection plane and the Z-axis. Δα is used to characterize the degree of deviation of the current guide axis from the planned path in the first reference projection plane, and Δβ is used to characterize the degree of deviation of the current guide axis from the planned path in the second reference projection plane. The deviation can be represented as a directional difference or as an absolute deviation value, depending on the interface guidance requirements. By monitoring the angular deviations within two mutually perpendicular reference projection planes, the system can transform the question of whether the guiding posture matches the planned puncture path into whether the deviations within the two planes fall within the allowable threshold range, without requiring the operator to perform complex three-dimensional spatial visualization. This significantly reduces the operational threshold.

[0052] In a preferred embodiment, the system calculates a first angular deviation Δα = α′ - α and a second angular deviation Δβ = β′ - β, and compares the first and second angular deviations with a preset static tolerance threshold. When both |Δα| and |Δβ| are less than or equal to the preset static tolerance threshold, it is determined that the current posture of the needle guide locking device matches the planned puncture path direction; when either |Δα| or |Δβ| is greater than the preset static tolerance threshold, it is determined that the current posture does not yet match the planned puncture path direction.

[0053] The external host can further output corresponding posture guidance information based on the magnitude and direction of Δα and Δβ, such as prompting adjustments towards the head, feet, left, or right, or providing real-time feedback to the operator through directional indicator lines, deviation values, and color changes in the graphical interface. In this way, the doctor can hold the needle guide locking device and gradually adjust its direction, so that the first real-time angle α′ and the second real-time angle β′ approach the first planned angle α and the second planned angle β, respectively.

[0054] When the first real-time angle α′ coincides with the first planned angle α, and the second real-time angle β′ coincides with the second planned angle β, the axial direction of the needle guide groove or needle guide hole on the needle guide locking device is consistent with the spatial direction of the planned puncture path ab, and the two are parallel to each other. Subsequently, the doctor moves the needle guide locking device to the patient's body surface, so that the puncture point b is located on the axis of the guide groove or guide hole, and the guide axis and the planned puncture path ab are collinear. At this time, puncture is performed along the direction of the guide axis, so that the actual puncture direction is consistent with the planned puncture path.

[0055] In one embodiment, the external host can construct a two-dimensional dynamic view on the display interface corresponding to the first and second reference projection planes, and display the planned projection baseline and the real-time projection line respectively. The planned projection baseline indicates the direction of the planned puncture path within the corresponding projection plane, and the real-time projection line indicates the direction of the current axis of the needle guide locking device within the corresponding projection plane. Further, tolerance display areas corresponding to preset angle guidance thresholds are set in the two-dimensional dynamic view. When the real-time projection lines are located within their respective tolerance display areas, angle matching prompts are output; when any real-time projection line is outside its corresponding tolerance display area, guidance prompts for posture adjustment direction are output. Thus, tolerance display areas corresponding to preset angle guidance thresholds can be set in the two-dimensional dynamic view, for example, with the planned projection baseline as the center, forming a visible tolerance band with a certain angle range on both sides. When the real-time projection lines are located within their respective tolerance display areas, the planning and navigation module outputs angle matching prompts, such as color indicators, text prompts, graphic prompts, or voice prompts, to inform the operator that the current posture meets the needle insertion requirements. When any real-time projection line is outside its corresponding tolerance display area, the module outputs guidance prompts for posture adjustment, such as prompting the operator to adjust towards the head or foot in the first projection plane, or to the left or right in the second projection plane, so that the real-time projection lines gradually enter the corresponding tolerance areas. Thus, the operator can simultaneously complete angle adjustments in both projection planes under the guidance of the display interface until the current guide axis of the needle guide locking device is consistent with the planned puncture path direction or reaches within the allowable error range. In an optional embodiment, the preset angle guidance threshold can also be adaptively adjusted according to the puncture depth, lesion size, lesion risk level, distribution of adjacent dangerous structures, or specific clinical scenarios. For example, a smaller allowable threshold can be used in superficial high-risk areas or areas adjacent to large blood vessels or nerve structures, while the allowable threshold can be appropriately relaxed in relatively low-risk scenarios, thereby achieving a balance between safety and operational convenience.

[0056] In addition to angle navigation, the planning navigation module can also provide needle insertion depth navigation. During needle insertion, the needle displacement data along the guide structure is acquired, and the remaining needle insertion depth is determined based on the difference between the puncture depth and the needle displacement data to generate depth navigation information characterizing the current needle insertion progress. The needle displacement data can be obtained in various ways, such as by manual input by the operator according to the needle body scale, or automatically acquired by a displacement sensor, encoder, sliding detection mechanism, or other displacement detection structure set on the guide assembly. Let the needle insertion displacement be L. in Then the remaining needle depth ΔL can be expressed as: ΔL = LL inWherein, L is the planned puncture depth calculated by the planning and navigation module based on the lesion location and the puncture needle insertion point location, and ΔL represents the remaining theoretical distance between the current needle tip and the target point. The planning and navigation module can also fuse and visualize the first planned angle, the second planned angle, the remaining needle insertion depth, and the angle deviation information obtained by comparing the spatial posture angle data with the planned spatial angle parameters, and output warning information or target point arrival prompt information when the remaining needle insertion depth reaches a preset safety threshold or is zero.

[0057] During the needle insertion along the guide structure, the first and second angle deviations are continuously monitored. When either angle deviation exceeds a preset allowable needle insertion deviation threshold, an angle deviation alarm is output. Specifically, the preset allowable needle insertion deviation threshold can be the same as the posture allowable threshold before needle insertion, or it can be set to a more stringent dynamic threshold to reduce the risk of path deviation caused by instrument force sway, patient respiratory movements, operator hand tremors, or changes in tissue resistance during needle insertion. In a preferred embodiment, the system can also be configured to ensure that the depth navigation prompt is in an effective advancement state only when the current angle deviation meets the preset range; if a significant angle deviation is detected, the current depth advancement prompt is frozen, weakened, or marked to prevent the operator from continuing to advance based on depth information when the direction is inaccurate, leading to target deviation. In clinical scenarios where respiratory movements are significantly affected, initial calibration, posture matching judgment, and key needle insertion steps can also be combined with the patient's breath-holding time, or, if necessary, initial calibration or intraoperative path update can be re-executed to further improve navigation accuracy.

[0058] To ensure that the puncture needle can advance along the planned puncture path during insertion and stop in time when it reaches the target point, the needle guide locking device is synchronously aligned in two planes before insertion, based on the planned puncture path under a fixed reference system. During insertion, the angle deviation and remaining insertion depth are monitored in real time, and the state judgment logic realizes direction priority, depth linkage and out-of-tolerance alarm control.

[0059] After initial calibration is completed and the planned puncture depth L, first planned angle α, and second planned angle β are loaded, at each sampling time k, the following joint state determination steps are executed: Step 1: Obtain the current first real-time angle αk′ and second real-time angle βk′ of the needle guide locking device, and calculate the dual-plane angle deviation; when the dual-plane angle deviation is not greater than the preset static tolerance θ static When the needle insertion is detected, the output indicates that the needle can be inserted and the depth pedometer is unlocked; otherwise, the output indicates that the direction adjustment is enabled and the depth pedometer is kept at zero. Step 2: After detecting the needle insertion displacement, the current dual-plane angle deviation is calculated and compared with the dynamic tolerance θ. dyn Compare; when any angular deviation is greater than θdyn When the angle deviation is triggered, an angle deviation alarm is activated and a depth freeze mechanism is triggered to pause depth counting; when the angle deviation falls back into θ dyn Within the range, and continuously maintaining the state for a preset stable duration Δt. stable Then, release the deep freeze mechanism; Step 3: Based on the current needle displacement d k Calculate the remaining needle depth ΔL k When the ΔL k When the preset end-approach condition is met, the currently allowed angle alarm threshold is reduced to the preset end-approach threshold θ. end , where θ end Less than the θ dyn Step 4: Based on the current remaining needle depth ΔL k Based on the current dual-plane angular deviation, estimate the comprehensive prediction offset E. k When the E k Greater than or equal to the preset safe radius R of the lesion safe At that time, a combined circuit breaker operation is executed, simultaneously outputting an angle over-limit alarm and locking depth advancement. Estimate the comprehensive prediction offset E. k The steps include: calculating the end offset E within the first reference projection plane respectively. α,k =ΔL k ·tan|Δα k | and the end offset E within the second reference projection plane β,k =ΔL k ·tan|Δβ k |, where Δα k Δβ k The current biplane angular deviation; according to E α,k and E β,k Calculate the overall prediction offset E k E k The absolute linear offset distance of the needle tip relative to the planned endpoint in three-dimensional space is equal to the square root of the sum of the squares of the offset components of the first and second projection planes.

[0060] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they shall still fall within the protection scope of the present invention.

Claims

1. A needle guide locking device for puncture surgery, characterized in that, include: Handle assembly; The micro-navigation module, integrated into the handle assembly, is configured to collect spatial attitude data of the guide plate assembly and output it to an external host to achieve real-time navigation and positioning feedback. A guide plate assembly is disposed at the distal end of the handle assembly, the guide plate assembly being configured to form at least one guide channel extending in the needle insertion direction for inserting and guiding the puncture needle; A locking assembly, disposed on the guide plate assembly, is in a locked state under elastic bias to close the guide channel when no external force is applied. The locking assembly is configured to switch to a needle placement state under external force to release the guide channel for insertion or adjustment of the puncture needle, and to reset to the locked state under elastic bias to close the guide channel and lock the puncture needle, thereby limiting the radial dislodgement and axial retraction of the puncture needle.

2. The needle guide locking device for puncture surgery according to claim 1, characterized in that, The guide plate assembly is provided with multiple guide channels that extend along the needle insertion direction and are arranged parallel to each other. The multiple guide channels are arranged along the length direction of the guide plate assembly to form a multi-channel array, and the center distance between adjacent guide channels is a preset spacing.

3. The needle guide locking device for puncture surgery according to claim 1, characterized in that, The guide plate assembly includes a first guide plate and a second guide plate, and a receiving cavity is formed between the first guide plate and the second guide plate; The outer surfaces of the first guide plate and the second guide plate are provided with a plurality of guide grooves extending along the needle insertion direction, forming a plurality of guide channels; The guide plate assembly has at least one opening that extends into the receiving cavity, and the opening and a plurality of guide grooves are arranged at intervals along the length direction of the guide plate assembly; The locking assembly is disposed within the receiving cavity. The locking assembly includes a pressing part and a locking part. The pressing part and the locking part are linked together. The pressing part extends at least partially out of the guide plate assembly through the opening to form a button. The locking part includes a plurality of blocking parts arranged at intervals along the length direction of the guide plate assembly, and each of the blocking parts corresponds to each of the guide grooves.

4. The needle guide locking device for puncture surgery according to claim 3, characterized in that, The cavity is provided with an elastic element, one end of which is connected to the locking part and the other end of which abuts against the inner wall of the cavity. The elastic element is used to apply an elastic bias force to the locking part so that the locking part is reset to the locked state when no external force is applied.

5. The needle guide locking device for puncture surgery according to claim 3, characterized in that, When the pressing part is pressed, it causes the locking part to slide, and the blocking part avoids the corresponding guide groove, so as to switch from the locked state to the pin-positioning state; after the external force is released, the locking part slides back to reset under the elastic bias pressure of the elastic element, so that the blocking part covers the corresponding guide groove again, so as to restore the locked state.

6. The needle guide locking device for puncture surgery according to claim 5, characterized in that, In the locked state, the blocking part at least partially covers the open side corresponding to the guide groove to reduce the radial passage space of the guide channel, and abuts against the outer peripheral surface of the puncture needle under the action of elastic bias pressure to restrict the radial dislodgement and axial retraction of the puncture needle; in the needle placement state, each of the blocking parts avoids the open side corresponding to the guide groove to release the radial passage space for the puncture needle to be inserted or adjusted.

7. The needle guide locking device for puncture surgery according to claim 3, characterized in that, The shielding part is provided with anti-slip texture or elastic pad on the side facing the guide groove.

8. The needle guide locking device for puncture surgery according to claim 1, characterized in that, The guide plate assembly is detachably connected to the distal end of the handle assembly, and the outer surface of the guide plate assembly is provided with scale markings to indicate the position or spacing of the guide channel.

9. The needle guide locking device for puncture surgery according to claim 1, characterized in that, It also includes an initialization connection block, which is detachably connected to the distal end of the guide plate assembly. The initialization connection block is used to provide a spatial positioning reference for performing initialization calibration when cooperating with the coordinate registration module, and is detached from the guide plate assembly after the initialization calibration is completed, so as to form a sterile isolation between the guide plate assembly and the coordinate registration module.

10. A puncture navigation system, characterized in that, include: The needle guide locking device as described in any one of claims 1-9; as well as An external host unit communicates with the micro-navigation module of the needle guide locking device used in puncture surgery; The external host is configured as follows: Acquire medical imaging data of the target object, plan the puncture path based on the lesion location and the puncture needle insertion point location, and generate the planning spatial angle parameters corresponding to the puncture path; The system receives spatial attitude data collected by the micro-navigation module and compares the spatial attitude data with the planned spatial angle parameters to generate attitude deviation information. Output navigation guidance information containing the attitude deviation information to guide the needle guide locking device to adjust its attitude; And when the puncture needle is advanced along the guide channel to the preset puncture depth, a locking prompt message is output to release the locking component, so that the puncture needle is locked and fixed under the action of elastic bias, restricting the radial dislodgement and axial retraction of the puncture needle.

Images