Tracing device and manufacturing method thereof

Abstract

The invention relates to a tracing device and a manufacturing method thereof. Comprising a base frame provided with an installation area used for installing an optical marking element; the optical marking element is fixed in the mounting area, and is configured to have the inverse reflectivity of a first electromagnetic wave with a specific wavelength greater than a preset value; the protection window is arranged on the outer side of the optical marking element and is configured to allow the first electromagnetic wave to penetrate through; and the sealing connection structure is used for connecting the protection window with the base frame in a sealing manner, so that the optical marking element is in a state of being isolated from the external environment. According to the technical scheme, on the premise that the signal response performance is not affected, the protection capability of the optical marking element can be enhanced.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a tracer device and its manufacturing method. Background Technology

[0002] In modern precision surgeries such as orthopedics and neurosurgery, optical surgical navigation systems achieve real-time positioning by tracking tracers attached to surgical instruments or the patient's bones. (Reference) Figure 1 and Figure 2 Existing technologies commonly employ the installation of detachable passive reflective elements 12 (such as reflective spheres or reflective bowls) on the ball base 11 of the tracer. These markers are typically composed of glass microbeads or ceramic spheres with a metal reflective film coated on their surface, enabling retroreflection of incident light.

[0003] However, existing tracers suffer from unstable reflected light intensity during surgery, which can easily lead to signal loss in the navigation system and interfere with the surgical procedure.

[0004] The information disclosed in this background section is intended only to enhance the understanding of the overall background of this application and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0005] In view of this, this application provides a tracer device and a method for manufacturing the same in order to solve at least one problem existing in the prior art.

[0006] To achieve the above objectives, the technical solution of this application is implemented as follows: In a first aspect, embodiments of this application provide a tracer device, including: The base frame has a mounting area for mounting optical marking elements; An optical marking element, fixed in the mounting area, is configured such that its retroreflectivity to a first electromagnetic wave of a specific wavelength is greater than a preset value; A protective window, disposed on the outside of the optical marking element, is configured to allow the first electromagnetic wave to pass through; and A sealed connection structure is used to seal the protective window to the base frame, thus isolating the optical marking element from the external environment.

[0007] In one optional embodiment, the optical marking element is a passive retroreflective element, consisting of an optical structure with a retroreflectivity greater than 60%, wherein the optical structure includes a microprism array film or a glass microbead film.

[0008] In one alternative embodiment, the optical marking element has a circular, polygonal, or annular geometry and forms a non-collinear marking dot matrix in space.

[0009] In one alternative embodiment, the protective window is made of a first material with a transmittance of more than 80% to the first electromagnetic wave, the first material being capable of repeatedly undergoing the steam sterilization process required for medical devices.

[0010] In one alternative embodiment, the first material includes one or more of sapphire, fused silica, calcium fluoride, and borosilicate glass.

[0011] In one alternative embodiment, the protective window is planar, dome-shaped, or freeform to match the contour of the installation area.

[0012] In an alternative embodiment, an optical coupling medium is filled between the optical marking element and the protective window to reduce interface reflection.

[0013] In one alternative embodiment, the sealing connection structure is a sealing material layer formed by one or more processes including dispensing curing, laser welding, ultrasonic sealing, and thermo-press sealing.

[0014] In one alternative embodiment, the base frame is provided with a mechanical interface for detachable connection to surgical instruments, implants, or positioning stents.

[0015] In one alternative embodiment, all components of the tracer device are capable of undergoing tolerance testing, which includes undergoing at least one steam sterilization process required for medical devices, and detecting a change in optical reflectance signal intensity of no more than 10% after sterilization.

[0016] Secondly, embodiments of this application provide a method for manufacturing a tracer device, the method comprising the following steps: Provide a base frame and perform surface treatment on its mounting area; The optical marking element is fixed to the mounting area; A protective window is provided on the outside of the optical marking element; The protective window is sealed to the base frame using a sealing connection process, thereby isolating the optical marking element from the external environment.

[0017] In an alternative implementation, the method further includes: The assembled tracer device was subjected to optical calibration and robustness verification.

[0018] In one alternative embodiment, the optical marking element is fixed to the mounting area by an adhesive that has undergone durability testing.

[0019] In an alternative implementation, the method further includes: An optical coupling medium is filled between the optical marking element and the protective window to reduce interface reflection.

[0020] The tracer device and its manufacturing method provided in this application include: a base frame with a mounting area for mounting an optical marker element; an optical marker element fixed to the mounting area and configured to have a retroreflectivity greater than a preset value for a first electromagnetic wave of a specific wavelength; a protective window disposed on the outside of the optical marker element and configured to allow the first electromagnetic wave to pass through; and a sealed connection structure that seals the protective window to the base frame, thus isolating the optical marker element from the external environment. It can be seen that the tracer device and its manufacturing method in this application, by fixing the optical marker element to the mounting area of ​​the base frame, providing a protective window on the outside that allows the first electromagnetic wave of a specific wavelength to pass through, and combining this with a sealed connection structure to isolate the optical marker element from the external environment, effectively improves the structural stability and optical reliability of the device under harsh operating conditions. This structural design enhances the protection capability of the optical marker element without affecting signal response performance, extends the reusable life of the device, maintains accurate identification capabilities, and adapts to demanding application scenarios.

[0021] Additional aspects and advantages of this application will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of this application. Attached Figure Description

[0022] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings: Figure 1 This is a schematic diagram of a tracer device in the prior art; Figure 2 This is a schematic diagram of another tracer device in the prior art; Figure 3 A schematic diagram of the tracer device provided in the embodiments of this application; Figure 4 Schematic diagram of the optical marker element and protective window in the tracer device provided in the embodiments of this application. Figure 1 ; Figure 5 Schematic diagram of the optical marker element and protective window in the tracer device provided in the embodiments of this application. Figure 2 ; Figure 6 A schematic flowchart illustrating the manufacturing method of the tracer device provided in the embodiments of this application; Figure 7 A detailed flowchart illustrating the manufacturing method of the tracer device provided in the embodiments of this application.

[0023] Explanation of reference numerals in the attached figures: 11. Ball mount; 12. Reflector; 20. Base frame; 21. Mounting area; 22. Mechanical interface; 30. Optical marking element; 40. Protective window. Detailed Implementation

[0024] To make the technical solutions and beneficial effects of this application more obvious and understandable, the technical solutions in the embodiments of this application are clearly and completely described below by listing specific embodiments. Obviously, the embodiments of this application are not exhaustive, and the described embodiments are only some embodiments of this application, not all embodiments.

[0025] The exemplary embodiments disclosed in this application will now be described in more detail with reference to the accompanying drawings, providing detailed structures and steps to illustrate the technical solution of this application. Note that the drawings are not necessarily drawn to scale, and local features may be enlarged or reduced to more clearly show the details of the local features.

[0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. The terminology used herein is for the purpose of describing particular embodiments only and should not be construed as limiting the technical solutions of this application.

[0027] The following description provides numerous specific details to offer a more thorough understanding of this application. However, it will be apparent to those skilled in the art that this application can be practiced without one or more of these details. To clearly define the inventive concept of this application and avoid confusion with its content, technical features well-known in the art and conventionally understood by those skilled in the art are not elaborated upon. Specifically, this document does not fully list all features of actual embodiments, nor does it provide a detailed description of well-known functions and structures.

[0028] The inventors of this application discovered during research and development that the reasons for the unstable intensity of reflected light in existing tracers during surgery include: 1) Contamination. The reflective element 12 in the prior art is easily contaminated. That is, during the operation, the surface of the exposed reflective ball is easily contaminated by blood, tissue fluid or mist, which seriously reduces the intensity of its reflected light and may even cause the navigation system signal to be lost, interfering with the operation.

[0029] 2) Introducing installation errors. During installation, the reflector 12 is generally fixed to the ball seat 11 of the tracer's base by extrusion deformation. This process results in positional inconsistencies of the reflector 12 due to each installation, ultimately introducing navigation and tracking errors into the system.

[0030] Furthermore, because the reflective element 12 is easily contaminated, it is designed as a detachable structure, which also presents the following drawbacks: 3) Cumbersome intraoperative procedures: During each surgical preparation, medical staff need to manually install multiple reflective balls or reflective bowls onto the tracer's ball base 11, increasing preoperative preparation time and potentially delaying surgery in emergencies. There is also a risk of contamination of the reflective balls or bowls during preparation; failure to prepare an additional quantity of these consumables will delay surgery or increase surgical costs.

[0031] 4) High cost of consumables: As medical consumables, reflective balls or reflective bowls are usually provided aseptically and are for single use. They require high manufacturing precision, are expensive, and are at risk of being knocked off or damaged during surgery, which increases the cost of consumables per surgery.

[0032] In summary, the four core problems existing in the clinical application of existing tracers all stem from the exposed and detachable structure of the reflective element 12. The "reflective ball" or "reflective bowl" refers to an independent optical component with retroreflective function, embedded in the tracer substrate in a spherical or bowl-shaped form. "Contamination" refers to biological or environmental media such as blood, tissue fluid, and water vapor adhering to its surface, causing light scattering or absorption, thereby reducing the effective reflected signal intensity. "Installation error" originates from the spatial positional offset of the reflective element 12 caused by material elastic deformation, inconsistent assembly forces, or accumulated tolerances of the ball seat 11 during mechanical pressing, which directly translates into coordinate recognition errors in the navigation system. These problems collectively limit the stability and economy of the tracer in high-reliability surgical navigation scenarios.

[0033] Therefore, through further research and development, the inventors proposed the following technical solution.

[0034] This application provides a tracer device. (See reference...) Figures 3-5 The tracer device includes: The base frame 20 has a mounting area 21 for mounting the optical marking element 30; An optical marking element 30 is fixed to the mounting area 21 and configured to have a retroreflectivity to a first electromagnetic wave of a specific wavelength that is greater than a preset value. A protective window 40, disposed on the outside of the optical marking element 30, is configured to allow the first electromagnetic wave to pass through; and The sealed connection structure seals the protective window 40 to the base frame 20, thus isolating the optical marking element 30 from the external environment.

[0035] Here, "base frame 20" refers to the rigid component that constitutes the main support structure of the tracer device. It is usually made of metal or high-strength engineering plastic and has a "mounting area 21" on it. This is a local surface specifically used to support and position the optical marking element 30. This area can be a plane, groove, step or curved surface, and its geometry matches the optical marking element 30.

[0036] The "optical marker element 30" is the core functional unit of this application. Its function is to perform efficient retroreflection of electromagnetic waves of a specific wavelength (such as near-infrared light) emitted by the external navigation system. "Retroreflection" refers to the reflection behavior of incident light returning along a path close to its original direction, which is different from diffuse reflection or specular reflection. "Configured as...retroreflectivity greater than a preset value" indicates that the element has a sufficiently strong signal response capability to ensure reliable identification by the navigation system.

[0037] The "protective window 40" is a transparent cover located on the side of the optical marking element 30 facing the external environment. Its material has high transmittance to electromagnetic waves in the navigation system's operating band, thus allowing signals to enter and exit without loss.

[0038] "Sealed connection structure" refers to the construction or process of joining the edge of the protective window 40 with the base frame 20. Its effect is to form a physical barrier to prevent liquids, gases or particles from entering the interior, so that the optical marking element 30 is in a clean and stable environment for a long time.

[0039] Furthermore, the mounting area 21 can be pre-machined with micro-positioning references (such as cross-shaped lines or conical recesses), which, in conjunction with the corresponding features on the back of the optical marking element 30, achieve higher assembly repeatability and further suppress systematic errors. In addition, the sealing connection structure can be designed as an interface with a stress buffer ring to alleviate the shear stress generated by the difference in thermal expansion coefficients of different materials during high-temperature sterilization cycles, preventing seal failure.

[0040] The tracer device of this application embodiment, by fixing the optical marker element 30 to the mounting area 21 of the base frame 20 and providing a protective window 40 on the outside that allows the transmission of a first electromagnetic wave of a specific wavelength, combined with a sealed connection structure, isolates the optical marker element 30 from the external environment, thereby effectively improving the structural stability and optical reliability of the device under harsh operating conditions. This structural design can significantly enhance the protection capability of the optical marker element 30 without affecting the signal response performance, extend the reusable life of the device, maintain accurate identification capability continuously, and adapt to high-requirement application scenarios.

[0041] The phrase "fixed to" emphasizes that the connection between the optical marking element 30 and the base frame 20 is permanent or semi-permanent, unlike the temporary plug-and-play installation of existing technologies, thus eliminating positional deviations caused by repeated assembly. "Allowing the transmission of specific wavelengths of the first electromagnetic wave" indicates that the material of the protective window 40 has undergone optical screening, exhibiting high transmittance only for the wavelengths used in the navigation system (such as 850 nm near-infrared light), while selectively shielding other wavelengths, helping to suppress ambient light interference. "Isolation from the external environment" refers not only to protection against liquid intrusion but also to protection against dust, chemical vapors, and biological contaminants, ensuring the long-term cleanliness of the internal optical interface. The resulting "structural stability" is manifested in the unchanged geometric position, and "optical reliability" is manifested in the small fluctuation of reflected signal intensity; both together support the key clinical value of "reusability."

[0042] Furthermore, since the optical marker element 30 is fully encapsulated, the risk of detachment or breakage due to accidental collisions during surgery can be avoided, improving surgical safety. At the same time, because there is no need to replace consumables each time, hospitals can establish standardized disinfection and reuse procedures, reducing the complexity of supply chain management.

[0043] In some other embodiments of this application, the optical marking element 30 is a passive retroreflective element, composed of an optical structure with a retroreflectivity greater than 60%, the optical structure including a microprism array film or a glass microbead film.

[0044] Here, passive retroreflective elements refer to elements that do not rely on external power sources or active light-emitting mechanisms, but only on their own microstructures to achieve light return, unlike active light sources such as LEDs or OLEDs. The "microprism array film" is a thin sheet structure formed by a large number of micro-triangular right-angled prisms arranged in a regular pattern, achieving efficient retroreflection using the principle of total internal reflection; the "glass microsphere film" is composed of high-refractive-index glass microspheres embedded in a resin matrix, achieving retroreflection through spherical refraction-reflection-rerefraction. This application integrates these components into a sealed structure, enabling them to operate stably for extended periods in polluted environments. "Retroreflectivity greater than 60%" is a qualitative performance requirement, ensuring that the signal strength meets the signal-to-noise ratio requirements of the navigation system.

[0045] In some other embodiments of this application, the optical marking element 30 has a circular, polygonal, or annular geometry and forms a non-collinear marking dot matrix in space.

[0046] Here, the geometric shape refers to the projected outline of the optical marker element 30 on the mounting area 21. A circle facilitates isotropic reflection, polygons (such as triangles and hexagons) are conducive to close arrangement, and an annular shape can be arranged around the central interface to save space. "Non-collinear marker array" means that the positions of multiple optical marker elements 30 in three-dimensional space are not located on the same straight line. This is the mathematical premise for the optical positioning system to calculate pose (position and attitude) - at least three non-collinear points are required to uniquely determine the spatial coordinate system of the rigid body.

[0047] In other embodiments of this application, the protective window 40 is made of a first material with a transmittance of more than 80% to the first electromagnetic wave, and the first material can be repeatedly subjected to the steam sterilization process required for medical devices.

[0048] Here, a transmittance greater than 80% indicates that the protective window 40 material has low energy loss to electromagnetic waves in the navigation band, ensuring a sufficiently strong reflected signal returns to the receiver. "Able to repeatedly withstand the steam sterilization process required for medical devices" means that the material does not crack, fog, discolor, or degrade in mechanical properties under typical high-temperature and high-pressure steam sterilization conditions (e.g., 134°C, 205 kPa, 18 minutes).

[0049] In other embodiments of this application, the first material includes one or more of sapphire, fused silica, calcium fluoride, and borosilicate glass.

[0050] Here, "sapphire" refers to single-crystal alumina (Al2O3), which has high hardness, strong chemical inertness, and good infrared transmission; "fused silica" is amorphous silicon dioxide (SiO2), which has an extremely low coefficient of thermal expansion and is resistant to thermal shock; "calcium fluoride" (CaF2) has excellent transmittance in the mid- and far-infrared bands; and "borosilicate glass" has good thermal stability and chemical resistance. All of these materials can be used as high-performance wave-transmitting windows.

[0051] Furthermore, the protective window 40 can employ a composite layer structure, such as a sapphire substrate with an anti-reflective coating, balancing mechanical strength and optical efficiency. In addition, the surface of the protective window 40 can be treated with hydrophobic or anti-fouling agents, allowing liquids to quickly slide off even if they come into contact with the exterior, reducing signal obstruction.

[0052] In other embodiments of this application, the protective window 40 is planar, dome-shaped, or freeform to match the contour of the mounting area 21.

[0053] Here, "planar" applies when the installation area 21 is a flat surface; "dome-shaped" refers to a convex curved surface, which can expand the field of view and enhance the structural compressive strength; "free-form surface" refers to an irregular geometric curved surface, which can be customized according to the overall streamlined design of the base frame 20 to achieve a unity of aesthetics and function. "Matching the contour of the installation area 21" ensures that a continuous and seamless joint interface is formed between the protective window 40 and the base frame 20, which is beneficial to the sealing reliability and appearance integrity.

[0054] In other embodiments of this application, an optical coupling medium is filled between the optical marking element and the protective window to reduce interface reflection.

[0055] Here, the "optical coupling medium" is a transparent material (such as silicone oil, optical gel, or UV-curable adhesive) with a refractive index between the substrate material of the optical marker element 30 and the material of the protective window 40, which fills the gap between them to eliminate Fresnel reflection caused by the air layer. "Reducing interface reflection" aims to improve the overall transmission efficiency of electromagnetic waves entering from the outer surface of the protective window 40, reaching the optical marker element 30, and then returning, thereby enhancing the intensity of the effective retroreflection signal. Without filling, the air-solid interface typically causes a 4% to 8% single-sided reflection loss, and the superposition of multiple interfaces will significantly weaken the signal-to-noise ratio.

[0056] In other embodiments of this application, the sealing connection structure is a sealing material layer formed by one or more processes including dispensing curing, laser welding, ultrasonic sealing, and thermo-press sealing.

[0057] The "sealed connection structure" here does not refer to a single component, but rather to a functional sealing interface or sealing material layer formed in the joint area between the protective window 40 and the base frame 20 through a specific process. Specifically, "dispensing and curing" refers to applying liquid medical sealant (such as silicone or epoxy resin) and then curing it under heat or ultraviolet light to form an elastic sealing layer; "laser welding" is suitable for light-transmitting and light-absorbing material pairs (such as sapphire-metallized coatings), achieving a seamless connection through localized melting; "ultrasonic sealing" utilizes high-frequency vibration to fuse the interfaces of thermoplastic materials; and "thermo-pressure sealing" achieves material diffusion bonding under the combined action of heating and pressure. These processes can be used individually or in combination (e.g., dispensing for positioning followed by localized laser reinforcement). The resulting "sealing material layer" includes adhesive layers, melt-and-re-solidified layers, and interfaces without additional materials formed through direct metallurgy or molecular bonding. This design ensures that the optical marking element 30 remains in a stable environment isolated from external liquids, gases, and contaminants for extended periods, meeting the clinical requirements of repeated high-temperature steam sterilization.

[0058] In other embodiments of this application, the base frame 20 is provided with a mechanical interface 22 for detachable connection with surgical instruments, implants or positioning stents.

[0059] Here, "mechanical interface 22" refers to the standardized connection structure provided on the base frame 20, such as threaded holes, quick-change bayonets, magnetic connectors, or dovetail grooves, used to temporarily but securely mount the tracer device onto surgical tools (such as bone drills, navigation probes), implants (such as pedicle screw prototypes), or external positioning brackets. "Detachable connection" emphasizes that this interface supports multiple assembly and disassembly, facilitating the adaptation of the same tracer device to various instruments and improving equipment utilization.

[0060] In other embodiments of this application, all components of the tracer device are capable of undergoing tolerance testing; the tolerance testing includes undergoing at least one steam sterilization process required for medical devices, and detecting a change rate of optical reflection signal intensity of no more than 10% after sterilization.

[0061] Here, all components, including the base frame 20, optical marking elements 30, protective window 40, adhesives, and sealing structures, emphasize that the entire device as a whole possesses sterilization tolerance, rather than just individual parts meeting the standards. "Tolerance verification" is a test procedure simulating actual usage conditions. "Optical reflection signal intensity change rate not exceeding 10%" is a quantitative indicator of performance stability, indicating that signal attenuation after sterilization is within an acceptable range and does not affect navigation accuracy.

[0062] This application also provides a method for manufacturing a tracer device, see reference. Figure 6 The method includes the following steps: Step 601: Provide a base frame and perform surface treatment on its mounting area; Step 602: Fix the optical marking element to the mounting area; Step 603: Set a protective window on the outside of the optical marking element; Step 604: Use a sealing connection process to seal the protective window to the base frame, thus isolating the optical marking element from the external environment.

[0063] Here, "surface treatment" includes processes such as cleaning, plasma activation, chemical etching, or applying a primer, with the aim of improving the adhesion of subsequent bonding or sealing. "Fixing" can be achieved through methods such as bonding, hot pressing, or laser welding, as long as positional stability is achieved. "Setting the protective window 40" refers to placing the pre-fabricated wave-transparent window in the designated position. "Sealing connection process" encompasses post-dispensing curing, laser welding, and ultrasonic sealing, with the goal of forming a continuous, leak-free closed cavity that completely encloses the optical marking element 30 in an internal clean environment.

[0064] The manufacturing method of the tracer device in this application avoids the risk of contamination caused by open assembly by fixing and sealing the optical marker element 30 in a controlled environment, and ensures that the relative positions of each element are permanently locked during the manufacturing stage, thereby eliminating systematic errors caused by repeated disassembly and assembly from the source.

[0065] In other embodiments of this application, the method further includes: The assembled tracer device was subjected to optical calibration and robustness verification.

[0066] Here, optical calibration refers to the process of determining the spatial coordinates of the packaged tracer device using high-precision measuring equipment (such as a multi-camera optical navigation system or a laser tracker). Its purpose is to accurately obtain the three-dimensional position of each optical marker element 30 in the coordinate system of the base 20. "Tolerance verification" involves applying environmental stress tests to the tracer device under simulated actual usage conditions to confirm that its structure and function remain stable under harsh conditions. Incorporating these two steps into the manufacturing process ensures that the finished product possesses both accurate geometric references and meets the reliability requirements for clinical reuse.

[0067] In other embodiments of this application, the optical marking element 30 is fixed to the mounting area 21 by an adhesive that can withstand durability testing.

[0068] Here, "fixed by adhesive" refers to applying a liquid or paste adhesive to the mounting area 21 or the back of the optical marking element 30, which then cures to form a strong bond. This method offers advantages such as uniform stress distribution, low processing temperature, and adaptability to complex curved surfaces. "The adhesive can withstand tolerance testing" means that the selected adhesive material, after undergoing testing conditions such as steam sterilization, chemical disinfection, or mechanical vibration, does not detach, crack, yellow, or release harmful substances, and its bonding strength is sufficient to maintain the positional stability of the optical marking element 30. Specifically, the adhesive includes medical-grade silicone, modified epoxy resin, or polyurethane systems.

[0069] Furthermore, adhesives can combine optical transparency with refractive index matching properties, making them part of the optical path and reducing interface scattering.

[0070] In other embodiments of this application, the sealing connection process includes one or more of the following: dispensing curing, laser welding, ultrasonic sealing, and thermoforming.

[0071] Here, "dispensing and curing" refers to applying liquid sealant to the joint between the protective window 40 and the base frame 20, followed by curing at room temperature, heating, or ultraviolet irradiation to form a seal; "laser welding" is suitable for the overlap of light-transmitting and light-absorbing materials, using laser energy to melt and fuse at the interface to form a seamless seal; "ultrasonic sealing" uses high-frequency vibration friction to generate heat, causing the thermoplastic material to locally melt and bond; "hot-press sealing" uses the simultaneous action of heating and pressure to diffuse and bond the material interface. These processes can be used individually or in combination (e.g., initial positioning with dispensing followed by laser welding to enhance the seal) to adapt to different material systems (metal-glass, plastic-ceramic, etc.) and production cycle requirements.

[0072] In some other embodiments of this application, the optical calibration includes: acquiring the spatial coordinates of each optical marker element 30 and writing the coordinate data into the navigation system database.

[0073] Here, obtaining the spatial coordinates of each optical marker element 30 refers to calculating the precise X, Y, and Z values ​​of the center point of each optical marker element 30 in a known world coordinate system using multi-view imaging or triangulation principles. The "navigation system database" is a data module within the surgical navigation device that stores the geometric model of the tracer. After the coordinate data is written, the system can calculate the pose of the tracer device in real time during surgery. This step binds the physical device to the digital model, which is beneficial for achieving sub-millimeter tracking accuracy. Because the tracer device in this application has a permanently encapsulated structure, the calibration data has long-term validity, avoiding the cumbersome process of recalibrating traditional detachable tracers before each use.

[0074] In other embodiments of this application, the tolerance test includes undergoing at least one steam sterilization process required for the medical device, and detecting a change in the intensity of the optical reflection signal of no more than 10% after sterilization.

[0075] Here, "the steam sterilization process required for medical devices" refers to a saturated steam sterilization procedure that conforms to medical standards. "Detection of the rate of change in optical reflection signal intensity" refers to measuring the signal amplitude returned by the same optical marker element 30 before and after sterilization using the same light source and detector configuration, and calculating the relative percentage change. "Not exceeding 10%" sets a performance degradation tolerance boundary to ensure that the device can still be reliably identified by the navigation system after sterilization. This verification not only reflects the material's durability but also serves as a comprehensive test of the overall integrated reliability of the device.

[0076] In other embodiments of this application, the method further includes: An optical coupling medium is filled between the optical marking element 30 and the protective window 40 to reduce interface reflection.

[0077] Here, the "optical coupling medium" is a transparent material (such as silicone oil, optical gel, or UV-curable adhesive) with a refractive index between the substrate material of the optical marker element 30 and the material of the protective window 40, which fills the gap between them to eliminate Fresnel reflection caused by the air layer. "Reducing interface reflection" aims to improve the overall transmission efficiency of electromagnetic waves entering from the outer surface of the protective window 40, reaching the optical marker element 30, and then returning, thereby enhancing the intensity of the effective retroreflection signal. Without filling, the air-solid interface typically causes a 4% to 8% single-sided reflection loss, and the superposition of multiple interfaces will significantly weaken the signal-to-noise ratio.

[0078] To better understand the manufacturing method of the tracer device provided in the embodiments of this application, a more detailed process of the manufacturing method is described below. (Reference) Figure 7 The process includes: Step 701: Start. Initiate the manufacturing process of the tracer device, and prepare the necessary raw materials, tooling fixtures, and testing equipment.

[0079] Step 702: Substrate Preparation and Surface Pretreatment. First, the substrate 20 body is obtained through machining, precision casting, or additive manufacturing, ensuring that the geometric accuracy of its mechanical interface 22 and mounting area 21 meets design requirements. Then, the mounting area 21 undergoes surface pretreatment, including ultrasonic cleaning to remove oil, plasma activation to increase surface energy, or application of a primer to enhance subsequent bonding strength. This step provides a clean and highly adhesive base interface for the reliable fixation of the optical marking element.

[0080] Step 703: Attaching the optical marking element. The pre-cut or shaped optical marking element 30 (such as a microprism array film) is coated with a high-temperature resistant adhesive using a dispensing process and then precisely attached to the mounting area 21 of the substrate 20. Appropriate pressure and curing conditions (such as heating or UV irradiation) are applied to firmly fix it in place. This step ensures the stable position of the optical marking element 30 during subsequent use and sterilization, avoiding navigation errors caused by displacement.

[0081] Step 704: Protective Window Assembly. Align and place the protective window 40, made of sapphire, fused silica, or other high-transmittance infrared material, outside the fixed optical marker element 30, ensuring it covers the entire effective reflection area without obstruction. The assembly process is performed in a clean environment to prevent dust or fibers from falling into the internal optical path area.

[0082] Step 705: Formation of the sealed connection structure. A sealing connection process is implemented at the junction of the edge of the protective window 40 and the base frame 20. One or more of the following methods can be used: adhesive application followed by thermosetting, laser welding, ultrasonic sealing, or thermo-press sealing. This forms a continuous and dense sealed structure, so that the optical marking element 30 is completely isolated from the external environment in a closed cavity, thereby achieving long-term protection against liquid, dust, and pollution.

[0083] Step 706: Optical Calibration. The encapsulated tracer is placed in a high-precision optical measurement platform. Spatial coordinate data of each optical marker element 30 are collected using a multi-camera navigation system or laser tracker. The precise three-dimensional position of each element in the coordinate system of the base frame 20 is calculated, and the coordinate set is written into the database of the surgical navigation system as a reference model for subsequent real-time tracking during the operation.

[0084] Step 707: Tolerance Validation. The tracer device is subjected to rigorous testing under simulated clinical use conditions, including at least one standard medical device steam sterilization cycle (e.g., 134°C, 205 kPa, 18 minutes), and its optical reflection signal intensity and spatial coordinate stability are tested again after sterilization; if the signal attenuation does not exceed 10% and there is no structural damage, it is considered to have passed the validation.

[0085] Step 708: Is the product qualified? If yes, proceed to step 709; otherwise, return to step 702. A comprehensive assessment is made of the accuracy of the optical calibration data, the integrity of the seal, and the durability verification results: if all indicators meet the preset quality standards, the product is deemed qualified and proceeds to the next step; if any step fails to meet the standards, the product is deemed unqualified, and the process returns to step 702 to re-prepare the base frame 20 or adjust the process parameters to ensure the consistency and reliability of the final product.

[0086] Step 709: End. Once qualified products have completed packaging, pre-sterilization labeling, and warehousing, the manufacturing process terminates.

[0087] It should be noted that the various embodiments or implementation methods in this document can be described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Similar or identical parts between embodiments can be referred to mutually. It should be understood that in the various embodiments of this application, the embodiment numbers are merely for descriptive purposes and do not represent the superiority or inferiority of the embodiments.

[0088] Understandably, without conflict, the technical features in the technical solutions described in each embodiment can be arbitrarily combined to form new embodiments. For example, each structure in each embodiment can be implemented as an independent embodiment, and the structures can be arbitrarily combined; some or all of the structures in different embodiments can be arbitrarily combined. Each step in each embodiment can be implemented as an independent embodiment, and the steps can be arbitrarily combined; the order of the steps can be arbitrarily interchanged; some or all of the steps in different embodiments can be arbitrarily combined. Furthermore, regarding the table in the embodiments, each element, each row, or each column in the table can be implemented as an independent embodiment.

[0089] In this document, when the terms "embodiment," "implementation," or "example" are used, it means that the specific features described in connection with these implementations or examples are included in at least one implementation, embodiment, or example of this application. It should be noted that the illustrative expressions of the above terms do not necessarily refer to the same implementation, embodiment, or example. Furthermore, the specific features described, such as structures or steps, can be appropriately combined in any one or more implementations, embodiments, or examples.

[0090] In some embodiments, prefixes such as "first" and "second" are used merely to distinguish different descriptive objects and do not impose restrictions on the position, order, priority, or value of the descriptive objects. The description of the descriptive objects is given in the context of the embodiments, and the use of prefixes does not constitute unnecessary restrictions. For example, the numerical value of a descriptive object is not limited by ordinal numbers and can be one or more. Taking "first device" as an example, the numerical value of "device" can be one or more. Furthermore, objects modified by different prefixes can be the same or different. For example, if the descriptive object is "device," then "first device" and "second device" can be the same device or different devices, and their types can be the same or different. Describing "first" does not necessarily imply the existence of "second," and discussing "second" does not necessarily imply the existence of "first."

[0091] In some embodiments, unless otherwise stated, elements expressed in the singular form, such as "a," "the," "the," "the," "the," "the," etc., can mean "one and only one," or "one or more," "at least one," etc. For example, when using articles such as "a," "an," "the," etc. in translation, the noun following the article can be understood as either a singular or a plural expression. In some embodiments, "multiple" refers to two or more.

[0092] In some embodiments, the terms “at least one of”, “one or more”, “a plurality of”, “multiple”, etc., may be used interchangeably.

[0093] In some embodiments, the notation "at least one of A and B", "A and / or B", "A in one case, B in another", "A in one case, B in another", etc., may include the following technical solutions depending on the situation: in some embodiments, A (A is executed regardless of B); in some embodiments, B (B is executed regardless of A); in some embodiments, execution is selected from A and B (A and B are selectively executed); in some embodiments, both A and B are executed. The same applies when there are more branches such as A, B, C, etc.

[0094] In some embodiments, the notation "A or B" may include the following technical solutions, depending on the situation: in some embodiments, A (execution of A regardless of B); in some embodiments, B (execution of B regardless of A); in some embodiments, selective execution from A and B (A and B are selectively executed). The same applies when there are more branches such as A, B, and C.

[0095] In some embodiments, unless otherwise expressly defined, the terms "installation," "connection," "linking," "fixing," "setting," etc., should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral part; it can be a mechanical connection, an electrical connection, or a communication connection; it can be a direct connection or an indirect connection through an intermediate medium; it can also refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this embodiment according to the specific circumstances.

[0096] In some embodiments, the terms “center,” “longitudinal,” “lateral,” “length,” “width,” “thickness,” “height,” “up,” “down,” “front,” “rear,” “left,” “right,” “vertical,” “horizontal,” “top,” “bottom,” “inner,” “outer,” “clockwise,” and “counterclockwise” indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only used for the purpose of simplifying the description of this application and do not indicate that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. That is, they should not be construed as limitations on this application.

[0097] In some embodiments, unless otherwise expressly defined, "above" or "below" the second feature can mean that the first and second features are in direct contact, or indirect contact via an intermediate medium, or that they are not in contact, but simply indicate that the horizontal level of the first feature is higher than that of the second feature. Furthermore, "above" or "below" the second feature can mean that the first feature is directly above or diagonally above, directly below, or diagonally below the second feature.

[0098] In some embodiments, spatial relation terms such as “upper” and “lower” may be used for convenience of description to describe the relationship of one element or feature shown in the figures to other elements or features. It should be understood that, in addition to the orientation shown in the figures, spatial relation terms are intended to also include different orientations of the device in use and operation. For example, if the device in the figures is flipped, the description of an element or feature “below” other elements or features will change it to “upper” other elements or features. Therefore, the exemplary terms “upper” and “lower” can include both upper and lower orientations. The device may also be otherwise oriented (rotated 90 degrees or otherwise), and the spatial descriptive terms used herein will be interpreted accordingly.

[0099] It should be understood that the above embodiments are exemplary and are not intended to encompass all possible implementations of the technical solutions of this application. Various modifications and changes can be made to the above embodiments without departing from the scope of this application. Similarly, the various technical features of the above embodiments can be arbitrarily combined to form other embodiments of this application that may not be explicitly described. Therefore, the above embodiments only illustrate several implementations of this application and do not limit the scope of protection of this patent application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

Claims

1. A tracer device, characterized in that, include: The base frame has a mounting area for mounting optical marking elements; An optical marking element, fixed in the mounting area, is configured such that its retroreflectivity to a first electromagnetic wave of a specific wavelength is greater than a preset value; A protective window, located on the outside of the optical marking element, is configured to allow the first electromagnetic wave to pass through; as well as A sealed connection structure is used to seal the protective window to the base frame, thus isolating the optical marking element from the external environment.

2. The tracer device as claimed in claim 1, characterized in that, The optical marking element is a passive retroreflective element, composed of an optical structure with a retroreflectivity greater than 60%, the optical structure including a microprism array film or a glass microbead film.

3. The tracer device as described in claim 1, characterized in that, The optical marking elements are circular, polygonal, or annular in shape, and form a non-collinear marking dot matrix in space.

4. The tracer device as claimed in claim 1, characterized in that, The protective window is made of a first material with a transmittance of more than 80% to the first electromagnetic wave, and the first material can be repeatedly subjected to the steam sterilization process required by the medical device.

5. The tracer device as described in claim 4, characterized in that, The first material includes one or more of sapphire, fused silica, calcium fluoride, and borosilicate glass.

6. The tracer device as claimed in claim 1, characterized in that, The protective window is flat, dome-shaped, or free-form to match the contour of the installation area.

7. The tracer device as claimed in claim 1, characterized in that, An optical coupling medium is filled between the optical marking element and the protective window to reduce interface reflection.

8. The tracer device as claimed in claim 1, characterized in that, The sealing connection structure is a sealing material layer formed by one or more processes including dispensing curing, laser welding, ultrasonic sealing and hot pressing sealing.

9. The tracer device as claimed in claim 1, characterized in that, The base frame is equipped with a mechanical interface for detachable connection to surgical instruments, implants, or positioning stents.

10. The tracer device as claimed in claim 1, characterized in that, All components of the tracer device are capable of withstanding tolerance testing, which includes undergoing at least one steam sterilization process required for medical devices, and detecting a change rate of optical reflection signal intensity of no more than 10% after sterilization.

11. A method for manufacturing a tracer device, characterized in that, The method includes the following steps: Provide a base frame and perform surface treatment on its mounting area; The optical marking element is fixed to the mounting area; A protective window is provided on the outside of the optical marking element; The protective window is sealed to the base frame using a sealing connection process, thereby isolating the optical marking element from the external environment.

12. The method for manufacturing the tracer device as claimed in claim 11, characterized in that, The method further includes: The assembled tracer device was subjected to optical calibration and robustness verification.

13. The method for manufacturing the tracer device as claimed in claim 11, characterized in that, The optical marking element is fixed to the mounting area by an adhesive that has undergone tolerance testing.

14. The method for manufacturing the tracer device as claimed in claim 11, characterized in that, The method further includes: An optical coupling medium is filled between the optical marking element and the protective window to reduce interface reflection.

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