A mechanical sensing based surgical navigation device

Abstract

The utility model provides a kind of surgery navigation device based on mechanical sensing, including fixed component, fixed component is connected with support, angle identification component includes shell, shell rotation is connected with first turntable, and the inner chamber of shell is equipped with first sensor;First turntable is connected with line outlet, and line outlet includes line outlet cylinder, and wire coiler is installed in mounting piece, and the two side walls of mounting piece are respectively connected with second turntable and third turntable, and wire coiler is connected with second turntable, and third turntable is connected with guide pointer, and wire coiler outside is wound with tension silk thread;First turntable is connected with second sensor and third sensor;Tension silk thread is connected with detection pen, and first sensor, second sensor, third sensor and pressure sensor are connected with computing unit.The utility model solves the problems that traditional optical navigation is easy to be blocked, electromagnetic navigation is easy to be disturbed by metal, robot-assisted surgery navigation is high in cost, realizes high-precision, low-cost, anti-interference real-time navigation.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a surgical navigation device based on mechanical sensing. Background Technology

[0002] Currently, surgical navigation systems are mainly used to assist surgeons in accurately positioning surgical instruments, improving surgical precision, and reducing surgical errors. Existing technologies mainly include optical navigation, electromagnetic navigation, and robot-assisted surgical navigation, as detailed below:

[0003] Optical navigation systems, such as the Medtronic StealthStation and the Brainlab optical navigation system, rely on infrared cameras and reflective markers for position tracking. The surgeon needs to attach reflective balls or LED markers to surgical instruments or the patient's bones. The infrared camera captures the position of the markers and calculates the spatial coordinates of the surgical instruments.

[0004] Electromagnetic navigation systems, such as Medtronic EMNavigation and Stryker Nav3i, track the position and angle of surgical instruments using electromagnetic fields. The system calculates the position and orientation of the instruments by measuring changes in the magnetic field.

[0005] Robot-assisted surgical navigation (such as Stryker's Mako robot and China's TiRobot robot) combines optical and electromagnetic navigation technologies and is applied to surgeries such as spinal fixation, joint replacement, and fracture reduction.

[0006] However, the application of optical navigation systems, electromagnetic navigation systems, and robot-assisted surgical navigation in surgery has the following drawbacks:

[0007] Optical navigation systems are susceptible to obstruction; if the surgeon's arm, instruments, or other equipment block the camera, navigation accuracy will decrease or even be lost. Furthermore, additional markers are required, needing to be installed before surgery, increasing preparation time, and these markers may loosen during the procedure, leading to navigation errors.

[0008] Electromagnetic navigation systems are susceptible to interference from metals. Surgical instruments, electric operating tables, and operating room equipment may affect magnetic field stability and reduce navigation accuracy. The surgical range is limited, and the magnetic field strength decreases with distance, restricting its application in large surgeries. Furthermore, it requires an additional magnetic field generator, occupying surgical space and potentially interfering with the normal operation of other medical equipment.

[0009] Robot-assisted surgical navigation systems are expensive, complex, and require high maintenance costs, limiting their widespread application in small and medium-sized medical institutions. Furthermore, they rely on preoperative image planning, but intraoperative anatomical structures may change, and the robotic system lacks the ability to adjust in real time. Additionally, the operation of robot-assisted surgical navigation is complex, requiring additional training for surgeons to operate it proficiently, increasing surgical time and learning costs.

[0010] In summary, existing surgical navigation technologies have significant shortcomings in terms of accuracy, reliability, cost, and adaptability. Utility Model Content

[0011] The technical problem to be solved by this utility model is to provide a surgical navigation device based on mechanical sensing, which can solve the problems of easy obstruction of traditional optical navigation, easy interference of electromagnetic navigation by metal, and high cost of robot-assisted surgical navigation, and realize high-precision, low-cost, and interference-resistant real-time navigation.

[0012] This utility model is implemented as follows:

[0013] This utility model provides a surgical navigation device based on mechanical sensing, including a fixing component for fixing the navigation device in the surgical area, the fixing component is connected to a bracket, the bracket is connected to at least two angle recognition components, the angle recognition component includes a housing connected to the bracket, the housing is rotatably connected to a first turntable, and the inner cavity of the housing is provided with a first sensor for recognizing the rotation angle of the first turntable.

[0014] The first turntable is connected to a cable outlet, which includes a cable outlet cylinder. A U-shaped mounting component is connected to the inner wall of the cable outlet cylinder along its axial direction. A cable coiler is installed inside the mounting component. A second turntable and a third turntable are rotatably connected to the two side walls of the mounting component, respectively. One end of the cable coiler is connected to the second turntable through a transmission mechanism. A vertical rod is also provided inside the mounting component. A wire ring is fixedly connected to the vertical rod. A guide pointer is connected to the third turntable. A round hole is opened at the end of the guide pointer. The cable outlet cylinder is also provided with a cable outlet hole. Tension wire is wound around the outside of the cable coiler. After the tension wire is led out from the cable coiler, it passes through the wire ring, the round hole and the cable outlet hole in sequence and extends to the outside of the cable outlet cylinder.

[0015] The first turntable is connected to a second sensor and a third sensor. The second sensor is positioned opposite to the second turntable to detect the rotation angle of the second turntable, and the third sensor is positioned opposite to the third turntable to detect the rotation angle of the third turntable.

[0016] The end of the tension wire is detachably connected to a probe pen with a built-in pressure sensor. The bracket is provided with a calibration point for calibrating the probe pen. The first sensor, the second sensor, the third sensor, and the pressure sensor are all connected to the computing unit.

[0017] Furthermore, the first sensor, the second sensor, and the third sensor are all magnetic rotary encoders;

[0018] The first, second, and third turntables are each equipped with a magnetic ring.

[0019] Furthermore, the fixing assembly includes a sleeve connected to the bracket, a telescopic rod slidably connected to the sleeve, two lugs connected to one end of the telescopic rod, each lug being hinged to a gripper, the gripper being hinged to a connecting rod, the connecting rod being hinged to the sleeve, the other end of the telescopic rod having a threaded portion, and a handle rotatably connected to the sleeve, the handle being connected to the threaded portion.

[0020] Furthermore, the mounting component is located in the middle of the cable outlet cylinder, dividing the inner cavity of the cable outlet cylinder into two chambers symmetrically distributed along the axis of the cable outlet cylinder. The first turntable is connected to two mounting cylinders, and the two mounting cylinders are located in the two chambers respectively. The second sensor and the third sensor are respectively encapsulated in the two mounting cylinders.

[0021] Furthermore, the housing and the bracket are connected by a first snap fastener; the cable outlet tube and the mounting tube are connected by a second snap fastener.

[0022] Furthermore, one end of the coiler has a toothed portion, and the transmission mechanism is a drive gear that meshes with the toothed portion. The drive gear is coaxially connected to the second turntable.

[0023] Furthermore, the coiler includes a coil drum and a coil base fixedly connected to the mounting component. The toothed portion is fixedly connected to the coil drum. A spiral spring is installed inside the coil drum. A fixed shaft is fixedly connected to the coil base. The fixed shaft is rotatably connected to the toothed portion. The spiral spring is connected to the fixed shaft.

[0024] Furthermore, the end of the tension wire is connected to a connecting assembly, which includes a first connector connected to the tension wire and a second connector detachably connected to the probe pen. The first connector is rotatably connected to a cross shaft, and the cross shaft is also connected to the second connector.

[0025] Furthermore, the second connector is made of magnetic stainless steel, and the probe pen has a mounting groove with a magnet for magnetically attracting the second connector inside the mounting groove.

[0026] Furthermore, the probe pen includes a pen body and a pen tip. The pen body is connected to a pressure sensor, and the pen tip is connected to a pressure sensor. The pen body has a corner portion, so that the axis of the pen tip coincides with the axis of the cross shaft.

[0027] The advantages of this utility model are:

[0028] 1. This utility model uses an angle sensor to measure the stretching length of the tension wire and the angle between the two tension wires in real time to measure the position of the probe pen. It does not require an optical camera and is not affected by the surgeon's arm or surgical instruments, thus ensuring navigation stability.

[0029] 2. This utility model uses an angle sensor to measure the position and angle of surgical instruments. It does not rely on a magnetic field and is not affected by metal surgical instruments, electric beds, etc. during surgical navigation, which helps to improve navigation accuracy.

[0030] 3. The system structure of this utility model is simple and can be integrated into existing surgical instruments. It does not require expensive robotic equipment or preoperative image planning, supports real-time adjustments during surgery, and improves applicability.

[0031] 4. The tension filament of this utility model is connected to the surgical instruments through a omnidirectional rotating connecting component and a magnetic connection. It does not require external markers or additional camera equipment, and can directly track the angle and position of the surgical instruments, reducing preoperative preparation time and improving surgical efficiency. Attached Figure Description

[0032] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0033] Figure 1 This is a schematic diagram of the structure of a surgical navigation device and method based on mechanical sensing according to this utility model. Figure 1 .

[0034] Figure 2 This is a schematic diagram of the structure of a surgical navigation device and method based on mechanical sensing according to this utility model. Figure 2 .

[0035] Figure 3 This is an exploded view of the angle recognition component and wire emitter of this utility model. Figure 1 .

[0036] Figure 4 This is an exploded view of the angle recognition component and wire emitter of this utility model. Figure 2 .

[0037] Figure 5 This is a schematic diagram of the structure of the present invention when the angle recognition component and the cable outlet are connected, with the cable outlet tube hidden. Figure 1 .

[0038] Figure 6 This is a schematic diagram of the structure of the present invention when the angle recognition component and the cable outlet are connected, with the cable outlet tube hidden. Figure 2 .

[0039] Figure 7 This is a schematic diagram of the cable outlet structure of this utility model.

[0040] Figure 8 This is an exploded structural diagram of the cable outlet device of this utility model when the cable outlet tube is concealed.

[0041] Figure 9 This is an exploded structural diagram of the wire coiler of this utility model.

[0042] Figure 10 This is a schematic diagram of the connection structure between the fixing component and the bracket of this utility model.

[0043] Figure 11 This is a schematic diagram of the connection structure between the connecting component and the probe pen of this utility model.

[0044] Figure 12 This is a schematic diagram of the connection structure of the connecting component, magnet, and probe pen of this utility model.

[0045] Figure 13 This utility model presents a schematic diagram of the contact unit structure on the connector.

[0046] Figure 14 Schematic diagram of the cross shaft structure of this utility model.

[0047] Explanation of the labels in the diagram:

[0048] 1. Fixing assembly; 11. Sleeve; 12. Telescopic rod; 121. Threaded part; 13. Ear seat; 14. Gripper; 15. Connecting rod; 16. Handle; 2. Bracket; 21. Connecting part; 22. Power supply contact; 23. Signal transmission contact; 24. Shielded grounding contact; 3. Angle recognition assembly; 31. Housing; 32. First turntable; 33. First sensor; 34. Second sensor; 35. Third sensor; 36. Mounting cylinder; 4. Cable outlet; 41. Cable outlet cylinder; 411. Cable outlet hole; 412. Chamber; 42. Mounting part; 43. Cable reel; 431. Tooth 432. Coil; 433. Coil base; 434. Spiral spring; 435. Fixed shaft; 44. Second turntable; 45. Third turntable; 46. Vertical rod; 47. Wire ring; 48. Guide pointer; 481. Circular hole; 49. Tension wire; 5. Probe pen; 51. Mounting slot; 52. Pen body; 53. Pen tip; 54. Pressure sensor; 55. Corner; 6. Magnetic ring; 7. Drive gear; 8. Connecting assembly; 81. First connector; 82. Second connector; 83. Cross shaft; 831. First shaft; 832. Second shaft; 9. Magnet. Detailed Implementation

[0049] Example 1, please refer to Figures 1 to 14 This utility model provides a surgical navigation device based on mechanical sensing, including a fixing component 1 for fixing the navigation device in the surgical area, the fixing component 1 is connected to a bracket 2, the bracket 2 is connected to at least two angle recognition components 3, the angle recognition component 3 includes a housing 31 connected to the bracket 2, the housing 31 is rotatably connected to a first turntable 32, and the inner cavity of the housing 31 is provided with a first sensor 33 for recognizing the rotation angle of the first turntable 32;

[0050] The first turntable 32 is connected to a cable outlet 4. The cable outlet 4 includes a cable outlet cylinder 41. A U-shaped mounting member 42 is connected to the inner wall of the cable outlet cylinder 41 along its axial direction. A cable coiler 43 is installed inside the mounting member 42. A second turntable 44 and a third turntable 45 are rotatably connected to the two side walls of the mounting member 42, respectively. One end of the cable coiler 43 is connected to the second turntable 44 through a transmission mechanism. A vertical rod 46 is also provided inside the mounting member 42. A wire ring 47 is fixedly connected to the vertical rod 46. A guide pointer 48 is fixedly connected to the center of the third turntable 45. A round hole 481 is opened at the end of the guide pointer 48. The cable outlet cylinder 41 is also provided with a cable outlet hole 411. Tension wire 49 is wound around the outside of the cable coiler 43. After the tension wire 49 is led out from the cable coiler 43, it passes through the wire ring 47, the round hole 481 and the cable outlet hole 411 in sequence and extends to the outside of the cable outlet cylinder 41.

[0051] When the surgical instrument is moved around the axis of the first turntable 32, the first turntable 32 rotates accordingly. By measuring the rotation angle of the first turntable 32, the angle of rotation of the surgical instrument around the axis of the first turntable 32 can be calculated.

[0052] When the surgical instruments move, the tension wire 49 is drawn out from the coiler 43. The coiler 43 drives the second turntable 44 to rotate through the transmission mechanism. The length of tension wire 49 pulled out can be calculated by the angle of rotation of the second turntable 44.

[0053] The guide ring 47 guides the tension wire 49 pulled from the coiler 43, preventing the tension wire 49 from swinging or deviating during the extraction process and ensuring that the tension wire 49 moves along a predetermined trajectory. When the surgical instrument moves up and down along the axis of the first turntable 32, the tension wire 49 pulls the guide pointer 48 to swing. At this time, the pitch angle of the tension wire 49 can be detected by the third sensor 35.

[0054] The first turntable 32 is connected to a second sensor 34 and a third sensor 35. The second sensor 34 is arranged opposite to the second turntable 44 to detect the rotation angle of the second turntable 44. The third sensor 35 is arranged opposite to the third turntable 45 to detect the rotation angle of the third turntable 45.

[0055] As shown in the figure, the first sensor 33 is used to detect the rotation angle of the surgical instrument around the axis of the first turntable 32, and the third sensor 35 is used to detect the pitching and swaying of the tension wire 49.

[0056] The end of the tension wire 49 is detachably connected to a probe pen 5 with a built-in pressure sensor 54. The bracket 2 is provided with a calibration point (not shown) for calibration of the probe pen 5. During initialization, the tip of the probe pen 5 touches the calibration point; the calibration point is a blind hole on the bracket, the size of which is adapted to the probe pen tip. The calibration point provides a stable and repeatable spatial reference coordinate in the assembly design. The first sensor 33, the second sensor 34, the third sensor 35, and the pressure sensor 54 are all connected to the computing unit.

[0057] When the surgical instrument is moved, the tension wire 49 is pulled, and one or more of the first turntable 32, the second turntable 44 or the third turntable 45 rotate. The first sensor 33, the second sensor 34 or the third sensor 35 measures the rotation angle of the corresponding turntable and feeds back the measured rotation angle to the calculation unit in real time. The calculation unit calculates the real-time position of the tip 53 of the probe pen 5.

[0058] The following example illustrates the process using two angle recognition components 3 (i.e., two tension wires 49 connected to a surgical instrument) mounted on a support 2:

[0059] After the device is fixed in a stable position in the surgical area, the positions of the two thread outlets 4 are known as P0 according to the dimensions of the device. Therefore, at this time, the axis positions of the cross shafts 83 at the ends of the two tension threads 49 are known. The axis position of each cross shaft 83 is the intersection of the axis of the first shaft 831 and the axis of the second shaft 832, which are A0 and B0 respectively. After moving the surgical instruments, the endpoints of the ends of the two tension threads 49 are A1 and B1 respectively.

[0060] Through spherical coordinate transformation, based on the thread length L A and L B and rotation angle θ A φ A θ B and φ B It can be calculated that:

[0061]

[0062] In the formula:

[0063] θ A and θ B These are the rotation angles of the two first turntables 32 (measured by the first sensor 33);

[0064] φ A and φ B These are the pitch angles of the two tension wires 49 (measured by the third sensor 35);

[0065] L A and L B These are the lengths pulled out by the two tension wires 49 (measured by the second sensor 34);

[0066] At this point, the midpoints of the two cross axes 83 are:

[0067]

[0068] Detecting the direction of pen tip 53:

[0069]

[0070] The position of the probe pen tip 53 is:

[0071] Ptip = C + dV

[0072] d is the fixed distance from the tip 53 of the probe pen 5 to the center point of the two coupling shafts.

[0073] Specifically, the first sensor 33, the second sensor 34, and the third sensor 35 are all magnetic rotary encoders;

[0074] The signal transmission and power supply of the first sensor 33, the second sensor 34, and the third sensor 35 are all achieved through Pogo Pin contacts. Preferably, the bracket 2 is provided with a circularly shaped connector 21, with the two angle recognition components 3 respectively disposed on the upper and lower sides of the connector 21. Pogo Pin contact assemblies are respectively disposed on the upper and lower sides of the connector 21; each Pogo Pin contact assembly includes three Pogo Pin contact units, which correspond to the first sensor 33, the second sensor 34, and the third sensor 35, respectively. Each Pogo Pin contact unit includes a power supply contact 22, a signal transmission contact 23, and a shielded ground contact 24. The three power supply contacts 22 are located at the center of the connector 21, and the signal transmission contact 23 and the shielded ground contact 24 surround the power supply contacts 22, with the signal transmission contact 23 and the shielded ground contact 24 adjacent to each other within the same Pogo Pin contact unit.

[0075] The power supply contact, signal contact, and shielding ground contact of the first sensor 33 are located at the bottom of the housing 31. The power supply contact, signal contact, and shielding ground contact of the second sensor 34 and the third sensor 35 are also located at the bottom of the housing 31 after being led out through cables and plugs. After the angle recognition component 3 is connected to the connector 21, the power supply contact, signal contact, and shielding ground contact of the three sensors are connected to the corresponding power supply contact 22, signal transmission contact 23, and shielding ground contact 24 to realize the conduction of power and signal.

[0076] The first turntable 32, the second turntable 44 and the third turntable 45 are each provided with a magnetic ring 6.

[0077] Specifically, the fixing assembly 1 includes a sleeve 11 connected to the bracket 2. A telescopic rod 12 is slidably connected to the sleeve 11. One end of the telescopic rod 12 is connected to two ear seats 13, each ear seat 13 being hinged to a gripper 14. The gripper 14 is hinged to a connecting rod 15, which is hinged to the sleeve 11. The other end of the telescopic rod 12 has a threaded portion 121. A handle 16 is rotatably connected to the sleeve 11, and the handle 16 is connected to the threaded portion 121. Rotating the handle 16 moves the telescopic rod 12 along the axis of the sleeve 11, causing the two grippers 14 to open and close, thereby fixing the device in the surgical area.

[0078] Of course, in this application, the fixation component 1 can also be a bone screw.

[0079] Specifically, the mounting component 42 is located in the middle of the cable outlet cylinder 41, dividing the inner cavity of the cable outlet cylinder 41 into two chambers 412 symmetrically distributed along the axis of the cable outlet cylinder 41. The first turntable 32 is connected to two mounting cylinders 36, which are located in the two chambers 412 respectively. The second sensor 34 and the third sensor 35 are respectively encapsulated in the two mounting cylinders 36.

[0080] Specifically, the housing 31 and the bracket 2 are connected by a first snap-fit ​​(not shown in the figure); the cable outlet tube 41 and the mounting tube 36 are connected by a second snap-fit ​​(not shown in the figure). The snap-fit ​​connection achieves rapid assembly of components through the elastic engagement and disengagement of the male and female snap-fits. As an efficient and convenient detachable connection method, the snap-fit ​​connection is widely used in component connections. Therefore, the specific structure of the snap-fit ​​connection will not be further elaborated in this utility model.

[0081] In this device, the bracket 2, fixing component 1, housing 31, mounting cylinder 36 and first turntable 32 are all made of stainless steel, preferably medical grade 316L stainless steel.

[0082] After the housing 31 is removed from the support 2, the support 2 can be sterilized by high temperature and high pressure (121℃, 30min) or by low temperature sterilization with ethylene oxide (EO).

[0083] The housing 31, the first turntable 32, and the mounting cylinder 36 fixed on the first turntable 32 are wiped with alcohol and sterilized with ultraviolet light to prevent liquid from seeping in and damaging electronic components. Through a detachable structure and the use of corrosion-resistant materials, the bracket 2, the fixing assembly 1, the housing 31, the mounting cylinder 36, the first turntable 32, and the first sensor 33 encapsulated in the housing 31 and the second sensor 34 and third sensor 35 encapsulated in the mounting cylinder 36 can be reused.

[0084] Specifically, one end of the coiler 43 has a toothed portion 431, and the transmission mechanism is a drive gear 7 that meshes with the toothed portion 431. The drive gear 7 is coaxially connected to the second turntable 44.

[0085] Specifically, the end of the tension wire 49 is connected to a connecting assembly 8. The connecting assembly 8 includes a first connecting member 81 connected to the tension wire 49 and a second connecting member 82 detachably connected to the probe pen 5. The first connecting member 81 is rotatably connected to a cross shaft 83, which is also connected to the second connecting member 82. The cross shaft 83 consists of a first shaft 831 and a second shaft 832, whose axes are perpendicular. The first shaft 831 is rotatably connected to the first connecting member 81, and the second shaft 832 is rotatably connected to the second connecting member 82. The axis of the second shaft 832 coincides with the axis of the pen tip 53. The rotatable connection between the cross shaft 83 and the first connecting member 81 and the second connecting member 82 allows the connecting assembly 8 to rotate in all directions. When the probe pen rotates, if the tension wire is directly connected to the probe pen, the rotation center of the bent portion of the tension wire is unknown, resulting in errors. The cross shaft 83 allows the rotation center to coincide with the axis of the pen tip.

[0086] Specifically, the second connector 82 is made of magnetic stainless steel, and the probe pen 5 has a mounting groove 51, in which a magnet 9 for magnetically attracting the second connector 82 is provided.

[0087] Specifically, the probe pen 5 includes a pen body 52 and a pen tip 53. The pen body 52 is connected to a pressure sensor 54, and the pen tip 53 is also connected to the pressure sensor 54. The pen body 52 has a corner portion 55, so that the axis of the pen tip 53 coincides with the axis of the cross shaft 83. The connecting assembly 8 can also be connected to a screwdriver, osteotome saw, or Kirschner wire. The screwdriver, osteotome saw, or Kirschner wire also has a mounting groove 51, and a magnet 9 is installed in the mounting groove 51. After the probe pen 5 is removed, the connecting assembly 8 can be connected to the screwdriver, osteotome saw, or Kirschner wire by magnetic attraction.

[0088] Specifically, the coiler 43 includes a coil drum 432 and a coil base 433 fixedly connected to the mounting component 42. The toothed portion 431 is fixedly connected to the coil drum 432. A spiral spring 434 is installed inside the coil drum 432. A fixed shaft 435 is fixedly connected to the coil base 433. The fixed shaft 435 is rotatably connected to the toothed portion 431. The spiral spring 434 is connected to the fixed shaft 435. The coil drum 432 is also provided with a spiral groove to ensure that the tension threads 49 wound on the coil drum 432 do not overlap.

[0089] Example 2: A method for surgical navigation using this surgical navigation device, comprising the following steps:

[0090] Step S1: The patient undergoes preoperative imaging examinations; the imaging examinations are CT or MRI.

[0091] Step S2: Secure the device to a stable location in the surgical area;

[0092] Step S3: Register the navigation device; the registration specifically involves:

[0093] S31. Initialize the device and align the pen tip with the calibration point on the holder to calibrate the zero point;

[0094] During the initialization phase of the navigation system, in order to ensure measurement accuracy and subsequent navigation stability, this system adopts an initialization calibration method based on "multi-attitude alignment with a single calibration point".

[0095] The bracket 2 has a pre-set unique mechanical calibration point, which has a stable and repeatable spatial reference coordinate (denoted as P) in the assembly design. ref Before the procedure, the operator is guided through an interface to align the probe tip with the mechanical calibration point sequentially from multiple (e.g., more than three) different angles and postures. The probe pen has a built-in pressure sensor, and after each stable contact with the calibration point, the system automatically collects the current magnetic rotary encoder data and the length of the tension wire pulled out, using this as a set of initialization reference data.

[0096] By analyzing the differences between the aforementioned sets of data and based on the principle of minimizing errors, the system deduces the initial zero-point offsets of each magnetic rotary encoder and the coiler 43 in the current device, thereby completing the automatic correction of the internal spatial model and the establishment of the coordinate system mapping. The calibration process does not rely on external optical or electromagnetic equipment and takes approximately 15 seconds to complete. After completion, the system will activate the generated compensation parameters in real time for subsequent spatial position and angle calculations, improving the accuracy and consistency of navigation.

[0097] This method allows for rapid initialization during surgery, avoiding navigation failures caused by external device obstruction and sensor zero-point drift in traditional navigation systems. It has high clinical applicability and ease of operation.

[0098] Step S32: Establish coordinate alignment between the preoperative imaging data and the navigation device; specifically, spatial registration is performed by touching known anatomical landmarks (such as bony landmarks, nasal tip, canthus, etc.) with the probe pen to ensure that the imaging data matches the actual surgical location.

[0099] Implementation method: In order to establish a correspondence between preoperative image data and spatial coordinate data collected by this navigation system, the system provides a general preoperative image registration function.

[0100] The surgeon can use a probe to touch the patient's body surface or bony landmarks (such as the tip of the nose, the canthus of the eye, the spinous process, the anterior superior iliac spine, etc.) in sequence. The system automatically collects the spatial coordinates of the anatomical point and establishes a spatial mapping relationship with the landmark in the preoperative image.

[0101] Taking bony landmarks as an example, when the probe detects 10 points on the bone surface during surgery, the algorithm used in the registration process can call common rigid body registration, affine registration, or three-point spatial mapping algorithms based on anatomical landmarks in image navigation platforms. The goal is to ensure that the relationship between the 10 detected points on the bone surface and the bone model established by preoperative imaging is minimized: the total distance between the 10 points and the surface of the bone model is minimized.

[0102] In this way, after the probe completes the acquisition of known anatomical landmarks during the operation, the spatial coordinates of the registration points are mapped to the coordinates of the preoperative images, so as to realize the spatial alignment of the image data with the actual surgical area and provide image support for surgical navigation.

[0103] The system supports multiple image interface formats (such as DICOM) and can be nested with third-party image processing libraries to achieve coordinate synchronization.

[0104] This invention supports registration with preoperative images (such as CT or MRI) data, and the registration method is compatible with commonly used spatial registration methods in existing medical image processing tools or navigation systems. This registration method serves as an auxiliary module of the navigation system of this invention, and its specific implementation is not limited; existing publicly available or commercially available image registration technologies can also be used. This invention does not limit the technical details of the specific registration method; surgeons can select appropriate tools to complete the spatial registration process according to the actual usage scenario.

[0105] Step S33: Perform dynamic testing on the device, specifically: the operator holds the probe pen and moves it within a certain range, and observes whether the navigation system can provide real-time feedback on the position of the probe pen.

[0106] When acquiring site coordinates, slight pressure is applied to allow the pen tip to penetrate the soft tissue until the pressure sensor records contact with the bone surface. Each time the pressure sensor records bone surface contact, the system automatically records the spatial coordinates of the pen tip. This coordinate data is transmitted in real time to the computing unit for subsequent registration and surgical planning.

[0107] Step S4, during intraoperative navigation:

[0108] If the current surgery is a spinal screw placement surgery with navigation, then the specific intraoperative navigation is as follows:

[0109] The probe pen confirms the screw placement point: After registration, the monitor displays the relative spatial relationship between the probe pen tip and the vertebral body in real time, and marks the pre-planned screw placement point. The surgeon adjusts the position of the probe pen so that its tip completely coincides with the screw placement point, confirming the optimal screw placement position.

[0110] Drilling preparation: At the confirmed screw placement point, the surgeon uses a drill to penetrate the cortical bone layer, creating a guide hole to prepare for subsequent screw implantation. Because the cortical bone layer is relatively thin, drilling through it will not affect the screw implantation angle, and the screw will enter the cancellous bone in the predetermined direction.

[0111] Assisted Screw Placement: Tool Change: Disconnect the probe. Align the connecting component with the screwdriver's magnetic locator to form a secure connection. Real-time Angle Navigation: Because the axis of the magnetically connected component is parallel to the screwdriver's central axis, the navigation system can accurately track the screwdriver's angle. The monitor displays the direction and value of the screwdriver's angle deviation in real time, allowing the operator to adjust it at any time to keep it within a reasonable range.

[0112] Screw insertion: Guided by the navigation system, the surgeon advances the screwdriver along the drilling direction to insert the screw. During insertion, the navigation system continuously monitors the screwdriver angle. If the angle deviates from the planned angle by more than a set threshold (e.g., ±3°), the system will issue an audio-visual alert to assist the surgeon in adjusting the angle. The surgeon needs to manually operate the screw to ensure the deviation is within a reasonable range and complete the insertion.

[0113] If the current surgery is a fixation surgery for a limb fracture, then the specific intraoperative navigation will be as follows:

[0114] Screw placement confirmation: After registration, the monitor displays the relative spatial relationship between the probe tip and the distal fracture site in real time. The pre-set screw placement path is displayed on the fracture surface. The surgeon aligns the probe tip with the screw placement point by observing the navigation interface to determine the drilling location. A drill is used at the screw placement point to penetrate the cortical bone layer, forming a guide hole to prepare for subsequent screw or intramedullary nail implantation.

[0115] Screw or intramedullary nail implantation: The connecting component is separated from the probe, and the connecting component is magnetically connected to the screwdriver or intramedullary nail guide. At this time, the monitor displays the real-time angular deviation direction and value of the screwdriver (or guide). The surgeon needs to manually adjust the screwdriver during placement to ensure the angular error is controlled within a reasonable range, allowing the screw to advance along the planned path. During intramedullary nail implantation, the navigation system continuously updates the axial alignment of the intramedullary nail. The surgeon adjusts the nail insertion direction based on the real-time deviation to ensure the nail enters the center of the medullary cavity.

[0116] If the current surgery is an osteotomy or orthopedic procedure for the knee joint, then the intraoperative navigation will be as follows:

[0117] Osteotomy line confirmation: After registration, the monitor displays the relative spatial relationship between the probe tip and the bone surface in real time. The osteotomy line planned before the operation is displayed on the joint surface. The surgeon adjusts the position of the probe and moves it along the osteotomy line to confirm the optimal cutting position.

[0118] Osteotomy: The connecting component 8 is separated from the probe pen, and then magnetically connected to the osteotomy saw. At this point, the monitor displays the angle deviation and value of the osteotomy saw. During the osteotomy, the surgeon adjusts the saw blade angle in real-time according to the navigation interface to ensure the osteotomy direction matches the pre-operative plan. When the saw blade deviates from the predetermined trajectory by more than a set threshold (e.g., ±2°), the system issues a warning. The surgeon adjusts the saw blade direction based on the feedback until a precise osteotomy is completed.

[0119] Furthermore, if three angle recognition components are installed on the support, and these components are positioned along the X, Y, and Z axes respectively, then this device can be used for fracture reduction navigation. The fracture reduction navigation is as follows:

[0120] This navigation device is fixed to the proximal bone of the fracture to provide a stable reference coordinate. A Kirschner wire is fixed to the distal fracture site and connected to the magnetic attraction points of three tension wires, forming a stable tracking system. The three magnetic attraction points are not collinear. The system can calculate the pitch, yaw, and roll angles of the Kirschner wire using data from angle sensors, and can real-time calculate the three-dimensional coordinates (X, Y, Z) and rotation angles (Pitch, Yaw, Roll) of the distal fracture site.

[0121] The navigation interface displays the real-time positional deviation and angular error of the distal fracture fragment, allowing the surgeon to adjust the reduction direction accordingly. This system can be applied to long bone fracture reduction, pelvic fracture reduction, osteotomy and corrective surgery, reducing reliance on intraoperative fluoroscopy and improving reduction accuracy.

[0122] In this navigation device, the probe pen, cable, and output device are disposable components and are disposed of as medical waste after the operation. The fixing components, bracket, and angle recognition components are sterilized for reuse.

[0123] The advantages of this invention are as follows: This invention uses an angle sensor to measure the stretching length of the tension wires and the angle between the two tension wires in real time to measure the position of the probe pen. It eliminates the need for an optical camera and is unaffected by obstructions from the surgeon's arm or surgical instruments, ensuring navigation stability. This invention uses an angle sensor to measure the position and angle of surgical instruments, is independent of magnetic fields, and is unaffected by metal surgical instruments or electric beds during surgical navigation, thus improving navigation accuracy. This invention has a simple system structure and can be integrated into existing surgical instruments, eliminating the need for expensive robotic equipment or preoperative image planning. It supports real-time adjustments during surgery, improving applicability. The tension wires of this invention connect to the surgical instruments via a omnidirectionally rotating connecting component and a magnetic connection, eliminating the need for external markers or additional camera equipment. It directly tracks the angle and position of the surgical instruments, reducing preoperative preparation time and improving surgical efficiency.

[0124] While specific embodiments of the present invention have been described above, those skilled in the art should understand that the specific embodiments described are merely illustrative and not intended to limit the scope of the present invention. Equivalent modifications and variations made by those skilled in the art in accordance with the spirit of the present invention should be covered within the scope of protection of the claims of the present invention.

Claims

1. A surgical navigation device based on mechanical sensing, characterized in that: It includes a fixing assembly for fixing the navigation device in the surgical area, the fixing assembly is connected to a bracket, the bracket is connected to at least two angle recognition components, the angle recognition component includes a housing connected to the bracket, the housing is rotatably connected to a first turntable, and the inner cavity of the housing is provided with a first sensor for recognizing the rotation angle of the first turntable; The first turntable is connected to a cable outlet, which includes a cable outlet cylinder. A U-shaped mounting component is connected to the inner wall of the cable outlet cylinder along its axial direction. A cable coiler is installed inside the mounting component. A second turntable and a third turntable are rotatably connected to the two side walls of the mounting component, respectively. One end of the cable coiler is connected to the second turntable through a transmission mechanism. A vertical rod is also provided inside the mounting component. A wire ring is fixedly connected to the vertical rod. A guide pointer is connected to the third turntable. A round hole is opened at the end of the guide pointer. The cable outlet cylinder is also provided with a cable outlet hole. Tension wire is wound around the outside of the cable coiler. After the tension wire is led out from the cable coiler, it passes through the wire ring, the round hole and the cable outlet hole in sequence and extends to the outside of the cable outlet cylinder. The first turntable is connected to a second sensor and a third sensor. The second sensor is positioned opposite to the second turntable to detect the rotation angle of the second turntable, and the third sensor is positioned opposite to the third turntable to detect the rotation angle of the third turntable. The end of the tension wire is detachably connected to a probe pen with a built-in pressure sensor. The first sensor, the second sensor, the third sensor, and the pressure sensor are all connected to the computing unit. The bracket is also equipped with a calibration point for calibrating the probe.

2. The surgical navigation device based on mechanical sensing as described in claim 1, characterized in that: The first sensor, the second sensor, and the third sensor are all magnetic rotary encoders; The first, second, and third turntables are each equipped with a magnetic ring.

3. The surgical navigation device based on mechanical sensing as described in claim 1, characterized in that: The fixing assembly includes a sleeve connected to the bracket, a telescopic rod slidably connected to the sleeve, two lugs connected to one end of the telescopic rod, each lug being hinged to a gripper, the gripper being hinged to a connecting rod, the connecting rod being hinged to the sleeve, the other end of the telescopic rod having a threaded portion, and a handle rotatably connected to the sleeve, the handle being connected to the threaded portion.

4. The surgical navigation device based on mechanical sensing as described in claim 1, characterized in that: The mounting component is located in the middle of the cable outlet cylinder, dividing the inner cavity of the cable outlet cylinder into two chambers symmetrically distributed along the axis of the cable outlet cylinder. The first turntable is connected to two mounting cylinders, and the two mounting cylinders are located in the two chambers respectively. The second sensor and the third sensor are respectively encapsulated in the two mounting cylinders.

5. A surgical navigation device based on mechanical sensing as described in claim 4, characterized in that: The housing and the bracket are connected by a first snap fastener; the cable outlet tube and the mounting tube are connected by a second snap fastener.

6. The surgical navigation device based on mechanical sensing as described in claim 1, characterized in that: One end of the coiler has a toothed portion, and the transmission mechanism is a drive gear that meshes with the toothed portion. The drive gear is coaxially connected to the second turntable.

7. A surgical navigation device based on mechanical sensing as described in claim 6, characterized in that: The coiler includes a coil drum and a coil base fixedly connected to a mounting component. The toothed portion is fixedly connected to the coil drum. A spiral spring is installed inside the coil drum. A fixed shaft is fixedly connected to the coil base. The fixed shaft is rotatably connected to the toothed portion. The spiral spring is connected to the fixed shaft.

8. The surgical navigation device based on mechanical sensing as described in claim 1, characterized in that: The end of the tension wire is connected to a connecting assembly, which includes a first connector connected to the tension wire and a second connector detachably connected to the probe pen. The first connector is rotatably connected to a cross shaft, and the cross shaft is also connected to the second connector.

9. A surgical navigation device based on mechanical sensing as described in claim 8, characterized in that: The second connector is made of magnetic stainless steel. The probe pen has a mounting groove, and a magnet for magnetically attracting the second connector is provided in the mounting groove.

10. A surgical navigation device based on mechanical sensing as described in claim 8, characterized in that: The probe pen includes a pen body and a pen tip. The pen body is connected to a pressure sensor, and the pen tip is also connected to a pressure sensor. The pen body has a corner portion, so that the axis of the pen tip coincides with the axis of the cross shaft.

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