Automated medical procedure system with accurate spatial calibration and registration

Abstract

The subject application presents an automated medical procedure system featuring accurate spatial calibration and registration capabilities. The system comprises a calibrated robotic subsystem with a position-accurate arm, a tracking subsystem, and processor-based modules for registration and calibration. Key innovations include the use of factory-defined geometric configurations for targets, systematic spatial recalibration before each procedure, and the ability to perform both rigid point-to-point and point cloud registrations. These features enable the system to maintain accurate spatial relationships between components and patient anatomy, allowing for highly accurate and adaptable automated medical procedures across various specialties.

Description

AUTOMATED MEDICAL PROCEDURE SYSTEM WITH ACCURATE SPATIAL CALIBRATION AND REGISTRATION

[0001] The subject application relates to the field of medical robotics, specifically to automated systems for performing medical procedures. Similar systems are known from US2024008933A1. This subject application addresses the need for highly accurate and adaptable robotic systems in various medical specialties, including but not limited to dentistry, orthopedics, and minimally invasive surgeries.

[0002] Existing medical robotic systems often require significant human intervention and lack the ability to adapt to dynamic surgical environments. These systems typically rely on pre-operative imaging and manual calibration, which can lead to inaccuracies during procedures.

[0003] Current systems face challenges in maintaining accurate spatial relationships between robotic components and patient anatomy throughout medical procedures. This is particularly problematic in scenarios where patient movement or tissue deformation occurs.

[0004] Moreover, traditional systems often struggle with real-time recalibration and registration, limiting their ability to perform complex procedures automatedly and with high accuracy.

[0005] These limitations can result in less accurate surgical interventions, potentially leading to suboptimal patient outcomes and increased risk of complications.

[0006] Furthermore, the reliance on manual calibration and the inability to adapt in real-time can extend procedure durations, increasing patient discomfort and surgical team fatigue.

[0007] The lack of automated adaptation capabilities may also restrict the range of procedures that can be performed robotically, limiting the potential benefits of robotic assistance in complex surgical scenarios.

[0008] These drawbacks underscore the need for a more advanced and efficient solution to the technical problem of maintaining accurate spatial relationships and adaptability in automated medical robotic systems within a timeframe acceptable for the targeted clinical workflow. While other systems may achieve similar levels of performance, their calibration times are often too long to be practically integrated into the intended clinical procedures.Summary of the subject application

[0009] As described in the accompanying claims, the subject application provides methods, systems and apparatuses for performing automated medical procedures, establishing precise and accurate spatial relationships between components, and maintaining accurate calibration and registration for enhanced medical interventions.

[0010] Dependent claims describe specific embodiments of the subject application.

[0011] These and other aspects of the subject application will be apparent from an elucidated based on the embodiments described hereinafter.

[0012] Further details, aspects and embodiments of the subject application will be described, by way of example only, with reference to the drawings. In the drawings, like reference numbers are used to identify like or functionally similar elements. Elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. Elements indicated by a solid line are mandatory, while elements indicated by a dotted line are optional.

[0013] shows a block diagram illustrating an automated medical system according to the subject application.

[0014] shows a rigid frame illustrated as a head holder according to the subject application.

[0015] shows a detachable element according to the subject application.

[0016] shows dedicated probe according to the subject application.

[0017] shows a calibration process of the detachable element ofwith the dedicated probe of

[0018] shows an illustration of a rigid point-to-point registration according to the subject application.

[0019] shows an illustration of a rigid point cloud registration according to the subject application.

[0020] shows a schematic flow diagram of a computer-implemented method according to the subject application.

[0021] - Preliminary Remarks

[0022] Because the illustrated embodiments of the subject application may, for the most part, be composed of components known to the skilled person, details will not be explained in any greater extent than that considered necessary for the understanding and appreciation of the underlying concepts of the subject application, in order not to obfuscate or distract from the teachings of the subject application.

[0023] - Structure of the Description

[0024] The description of the subject application is organized in a logical and comprehensive manner to facilitate understanding of the automated medical procedure system.

[0025] It begins with an overview of the system’s purpose and key components.

[0026] The description then delves into detailed explanations of each major subsystem, including the calibrated robotic subsystem, the tracking subsystem, and the processor-based modules for registration and calibration.

[0027] Each component is thoroughly defined, with specific attention given to technical terms and their contextual meanings within the subject application.

[0028] The description progresses to outline the system’s operational methods, including calibration, registration, and control processes.

[0029] Throughout the text, examples are provided to illustrate the application of various components and processes in different medical scenarios, enhancing the reader’s comprehension of the system’s versatility and precision in automated medical procedures.

[0030] - Objective of the subject application

[0031] One of the primary objectives of the subject application is to provide an automated medical procedure system capable of maintaining accurate spatial relationships between its components and the patient’s anatomy throughout the entire procedure.

[0032] To achieve this, the inventors propose an innovative system that integrates a calibrated robotic subsystem, a tracking subsystem, and sophisticated processor-based modules for registration and calibration.

[0033] This solution aims to enable the system to perform automated medical procedures with minimal human intervention, while continuously adapting to changes in the surgical environment.

[0034] The subject application specifically addresses the need for real-time recalibration and registration, allowing for enhanced precision and accuracy in various medical procedures, from dental surgeries to complex orthopedic interventions.

[0035] - Automated Medical procedure System with Accurate Spatial Component Relationships

[0036] As illustrated in, the subject application relates to a system 100 for performing automated medical procedures, and establishing accurate spatial relationships between components.

[0037] The term “automated” refers to the capability of the system 100 to perform medical procedures with minimal human intervention, following pre-programmed instructions and utilizing real-time data from various sensors.

[0038] For example, the term “automated” may refer to a robotic arm’s ability to execute a predefined toolpath without direct human guidance, the system 100's capacity to perform spatial recalibration according to programmed parameters before each medical procedure, or the ability to track and compensate for minor patient movements during the medical procedure within predetermined limits.

[0039] The term “medical procedure” encompasses a wide range of diagnostic, therapeutic, or surgical interventions performed on a patient using the automated system 100. These medical procedures are specifically designed to be carried out with high precision and repeatability by the system 100. For instance, the system 100 is capable of performing these procedures with a precision under 200 to 500 microns, preferably around 300 microns, when measured using a tracking system, ensuring a level of accuracy that is difficult to achieve consistently with manual techniques.

[0040] For example, the term “medical procedures” may include dental surgeries such as implant placement, crown preparation or veneer preparation, orthopedic medical procedures like joint replacements, or minimally invasive surgeries in various medical specialties.

[0041] The term “accurate” refers to the quality of a measurement or positioning that closely matches the true or intended target value. In the context of spatial relationships between medical system components, accuracy characterizes the ability to consistently reach or identify the correct target position.

[0042] For example, in a targeting task, an accurate system would reliably position instruments at the exact intended anatomical location, similar to hitting the bullseye in target practice. This differs from precision, which only indicates repeatability without necessarily achieving the correct target position. An accurate medical system ensures that when a specific anatomical target is designated, the system's components will be positioned at the genuine intended location rather than just repeatedly reaching the same incorrect position.

[0043] In the subject application, the system 100 comprises several components: a calibrated robotic subsystem 110, a tracking subsystem 120, a processor-based registration module 130, and a processor-based calibration module 140.

[0044] - - the calibrated robotic subsystem

[0045] In practice, the calibrated robotic subsystem 110 includes a position-accurate robotic arm 111.

[0046] The term “calibrated” in “calibrated robotic subsystem 110” refers to the process of establishing and maintaining accurate spatial relationships between the position-accurate robotic arm 111, its tools, and the tracking subsystem 120. This calibration ensures that the movements of the position-accurate robotic arm 111 correspond accurately to the intended actions in the patient’s anatomy.

[0047] For example, the term “calibrated” may refer to the initial factory setup that defines the baseline spatial relationships between system 100 components, the ongoing process of comparing current geometries to factory-defined configurations, or the act of updating the system 100’s spatial model based on recalibration results before each medical procedure.

[0048] In particular, the position-accurate robotic arm 111 refers to an articulated mechanical arm that is capable of executing accurate movements and manipulations in three-dimensional space. This position-accurate robotic arm 111 is designed to handle various medical tools 112 with a high degree of accuracy and repeatability.

[0049] For example, the position-accurate robotic arm 111 may refer to a multi-jointed robotic appendage capable of positioning a dental drill with sub-millimeter accuracy, a position-accurate robotic arm 111 designed to guide a surgical scalpel along a complex three-dimensional path, or a robotic manipulator that can delicately handle and position various surgical instruments during a medical procedure.

[0050] These position-accurate robotic arms 111 typically feature six degrees of freedom, allowing for comprehensive movement and positioning in three-dimensional space, which enhances their versatility and accuracy in performing complex medical procedures.

[0051] Specifically, the position-accurate robotic arm 111 is designed to operate with interchangeable medical tools 112, each tool 112 having a defined tool center point, TCP.

[0052] The term “medical tool” refers to any instrument or device that can be attached to and operated by the position-accurate robotic arm 111 to perform specific medical tasks. These tools are designed to be interchangeable, allowing the system 100 to perform various medical procedures.

[0053] For example, the term “medical tool” may include a high-speed dental drill for preparing teeth for crowns or veneers, a specialized probe for taking accurate measurements of anatomical structures, or a surgical cutting instrument for performing incisions or resections.

[0054] The term “tool center point (TCP)” refers to both a specific point on the medical tool 112 and its associated orientation that are used as references for positioning and movement during medical procedures. While in conventional robotics TCP typically refers only to a position point, in the context of this application, TCP encompasses both the position of a reference point and the orientation of the tool 112 relative to a reference coordinate system. This point is typically located at the functional end of the tool 112 and serves as the focus for the position-accurate robotic arm 111’s movements and the system 100’s spatial calculations.

[0055] For example, the term “tool center point (TCP)” may refer to the tip of a dental drill bit, the end of a surgical probe, or the cutting edge of a scalpel blade attached to the position-accurate robotic arm 111.

[0056] Furthermore, the position-accurate robotic arm 111 is capable of automatedly guiding at least one mounted tool 112 along a predefined toolpath linked to an anatomical structure of interest of a patient for executing medical procedures, utilizing the tool’s TCP as a reference point.

[0057] The term “toolpath” refers to a predefined trajectory or set of movements that the medical tool 112, guided by the position-accurate robotic arm 111, follows during a medical procedure. This path is typically planned based on pre-operative imaging and the specific requirements of the medical procedure.

[0058] For example, the term “toolpath” may refer to the accurate route a dental drill follows to prepare a tooth for a crown or a veneer, the sequence of movements a surgical instrument makes to perform a complex dissection, or the path a measurement probe takes to gather data about an anatomical structure of interest.

[0059] The term “anatomical structure of interest” refers to the specific part of the patient’s body that is the focus of the medical procedure. This structure is typically identified and modeled in the system 100’s three-dimensional digital representation of the patient.

[0060] For example, the term “anatomical structure of interest” may refer to a specific tooth or group of teeth in a dental medical procedure, a joint such as a knee or hip in an orthopedic surgery, or a particular organ or tissue targeted in a minimally invasive medical procedure.

[0061] - - the tracking subsystem

[0062] In the subject application, the tracking subsystem 120 consists of a tracking device 121 and at least two targets. The tracking can be implemented through various technologies, such as optical tracking (including camera-based systems and laser-based tracking systems), electromagnetic tracking, ultrasonic positioning systems, capacitive or inductive sensing systems, or other position sensing technologies capable of tracking targets without requiring a wired signal transmission connection to the robotic subsystem.

[0063] - - - the tracking device

[0064] In practice, the tracking device 121 is a specialized instrument that is designed to detect, monitor, and record the position and movement of multiple targets in real-time. This device utilizes advanced tracking technology to accurately locate and track the spatial coordinates of specific markers 10 or patterns attached to various components of the system 100.

[0065] For example, the tracking device 121 may refer to a high-resolution camera system that uses infrared light to detect reflective markers, a stereoscopic vision system that creates a 3D map of the operating field, an electromagnetic tracking system using field generators and sensors, a laser-based tracking system that measures the exact position of targets through time-of-flight or triangulation methods, an ultrasonic positioning system that uses ultrasound waves for spatial localization, a capacitive or inductive sensing system that detects target positions through electric or magnetic field variations without direct electrical connection, a radio frequency identification (RFID) based tracking system, or any other position sensing technology capable of providing accurate spatial tracking without requiring a wired signal transmission connection between the targets and the robotic subsystem.

[0066] Furthermore, the term “target” refers to a specifically designed object or set of markers 10 that can be detected and tracked by the tracking device 121. These targets have a predefined geometric configuration that allows the tracking subsystem 120 to determine their accurate position and orientation in three-dimensional space.

[0067] For example, the term “target” may refer to a cluster of reflective spheres arranged in a unique pattern, electromagnetic sensors with specific configurations, a flat marker with a distinctive pattern, or any other trackable element compatible with the chosen tracking technology .

[0068] In particular, the tracking device 121 is designed to track multiple targets simultaneously.

[0069] In other words, the tracking corresponds to a continuous process of detecting, identifying, and monitoring the position and movement of multiple targets simultaneously within the system 100’s workspace. This tracking involves real-time data acquisition and processing to maintain an accurate understanding of the spatial relationships between various components of the system 100, regardless of the specific tracking technology employed.

[0070] For example, the tracking may refer to continuously updating the coordinates of multiple surgical instruments during a medical procedure, monitoring patient movement to adjust the position-accurate robotic arm 111's position accordingly, simultaneous tracking of both the position-accurate robotic arm 111 and the patient's anatomy to maintain accurate alignment, or using any suitable tracking technology that achieves the required accuracy and real-time performance.

[0071] Additionally, the tracking device 121 is designed to be positioned and fixed at a distance of at least a predetermined value from the patient, wherein the predetermined value is selected to allow both tracking and sufficient workspace for the position-accurate robotic arm 111. This predetermined value may vary depending on the specific tracking technology used.

[0072] The term “positioned and fixed” refers to the specific placement and securing of the tracking device 121 within the system 100’s setup. This positioning is carefully determined to ensure optimal tracking performance of all relevant targets while maintaining a safe and unobstructed workspace for the position-accurate robotic arm 111 and medical personnel.

[0073] For example, the term “positioned and fixed” may refer to mounting the tracking device 121 on a stable overhead boom above the operating table, securing the tracking device 121 to a dedicated stand at a specific angle and distance from the patient, such as at a distance greater than 100 cm, preferably 130 cm or 150 cm, integrating the tracking device 121 into the ceiling of a specially designed operating room to provide comprehensive coverage of the surgical field, positioning electromagnetic field generators at optimal locations, or any other configuration that ensures reliable tracking performance while maintaining the required workspace.

[0074] In the subject application, the targets are designed to be tracked without physical connection to the calibrated robotic subsystem 110.

[0075] The term “tracked without physical connection” refers to the ability of the tracking subsystem 120 to monitor and record the position and movement of targets without requiring any direct mechanical or electrical connection between the targets and the calibrated robotic subsystem 110. While some tracking technologies may require power or signal cables, the tracking itself operates without mechanical linkage to the robotic system, enhancing flexibility and adaptability.

[0076] For example, the term “tracked without physical connection” may refer to optical targets (such as reflective markers) detected by cameras without physical linkage, electromagnetic sensors that communicate wirelessly with their field generator, laser-based tracking systems that detect target positions via reflected laser light, ultrasonic tracking systems that use sound waves for position determination, capacitive or inductive sensing systems that operate without direct electrical connection, radio frequency identification (RFID) systems, or markers that can be freely interchanged and tracked without mechanical coupling to the robotic system. In all these examples, the tracking operates without requiring a wired signal transmission connection between the targets and the calibrated robotic subsystem 110, although the targets may be physically attached to components of the system. This approach encompasses any tracking method that maintains spatial tracking through contactless sensing technologies, whether optical, electromagnetic, acoustic, capacitive, inductive, or based on other physical principles, provided that no wired signal cables are required between the tracked targets and the robotic subsystem.

[0077] It is important to distinguish between mechanical attachment and signal transmission in the context of "tracked without physical connection." The targets (robot target 122 and patient target 123) are mechanically attached to their respective components (the position-accurate robotic arm 111 and the detachable element 150) to maintain fixed spatial relationships. However, these targets do not require wired signal transmission connections to the calibrated robotic subsystem 110 or to the tracking device 121. Instead, the tracking device 121 detects the targets through contactless means, which may include but are not limited to: detection of reflected light (optical), detection of emitted or reflected electromagnetic signals, detection of reflected ultrasonic waves, measurement of capacitive or inductive field variations, detection of radio frequency signals, or other contactless sensing principles. This contactless detection approach eliminates the need for signal cables while maintaining the benefits of secure mechanical attachment for spatial stability.

[0078] Notably, each target has a factory-defined geometric configuration created by an arrangement of multiple tracking markers 10, which typically consists of a specific number of markers 10, such as three or more, arranged in a predefined pattern to enable accurate spatial tracking. The specific arrangement and number of markers depends on the tracking technology employed, but typically consists of a configuration that enables accurate spatial tracking and unique identification of each target.

[0079] The term “factory-defined” refers to a predetermined and standardized configuration or characteristic of a component, which is established during the manufacturing process and serves as a reference point for the system 100’s calibration and operation. This factory-defined attribute ensures consistency and reliability across different units of the same component and provides a baseline for the system 100 to perform accurate measurements and adjustments, regardless of the tracking technology used.

[0080] As an example, the term “factory-defined” may designate the specific arrangement and spacing of markers on a target, the electromagnetic properties and configuration of tracking sensors, the exact dimensions and geometry of a rigid body marker cluster, the calibration parameters of various tracking elements, or any other standardized configuration that enables reliable tracking and system calibration.

[0081] The use of factory-defined configurations is essential for maintaining the high precision required in automated medical procedures. These predefined parameters allow the system 100 to detect any deviations from the original specifications, which may occur due to wear, environmental factors, or accidental alterations. By comparing the current state of components to their factory-defined characteristics, the system 100 can perform accurate recalibrations and maintain the spatial relationships necessary for safe and effective operation.

[0082] Furthermore, the term “tracking marker” refers to a specific element or feature of a target that is designed to be easily and accurately detected by the tracking device 121. These markers 10 are specifically designed for the chosen tracking technology to ensure reliable tracking.

[0083] For example, the term “tracking marker” may refer to a spherical retroreflective ball for optical tracking, an electromagnetic sensor coil, a flat disc with a high-contrast geometric pattern, an active signal emitter, or any other element that enables precise position and orientation tracking with the selected technology.

[0084] The configuration of each target allows the tracking device 121 to locate each target within a three-dimensional digital model of the workspace associated with the anatomical structure of interest, built from data acquired by the tracking device 121.

[0085] The term “three-dimensional digital model” refers to a virtual environment that accurately reflects the spatial relationships between the patient’s anatomy, the position-accurate robotic arm 111, and other elements of the system 100. This model is continuously updated based on real-time tracking data, regardless of the tracking technology employed.

[0086] For example, the term “three-dimensional digital model” may refer to a detailed volumetric rendering of a patient’s skull and brain based on preoperative CT or MRI scans, updated in real-time with intraoperative tracking data, a dynamic model of a patient’s knee joint that incorporates both preoperative imaging and live tracking information for accurate robotic-assisted surgery, a comprehensive spatial map of the operating room that includes the positions of all tracked instruments, the patient, and the position-accurate robotic arm 111 for enhanced situational awareness and procedure planning, or any other digital representation that maintains accurate spatial relationships using tracking data.

[0087] - - - the targets

[0088] In the subject application, the targets include at least one robot target 122 and at least one patient target 123.

[0089] Specifically, the robot target 122 has a first factory-defined geometric configuration and is designed to be attached to the position-accurate robotic arm 111. The specific implementation of this target depends on the tracking technology selected but must maintain the required accuracy for robotic positioning.

[0090] On the other hand, the patient target 123 has a second factory-defined geometric configuration different from the first factory-defined geometric configuration and is designed to be attached to or in proximity to a detachable element 150 fixedly secured to the anatomical structure of interest, as illustrated inandThe patient target's configuration is optimized for the chosen tracking technology while ensuring patient comfort and stability.

[0091] The term “attached to or in proximity to” describes two possible configurations for positioning the patient target relative to the anatomical structure of interest, applicable across different tracking technologies. The first configuration, “attached to,” indicates a direct physical connection between the patient target and the detachable element. The second configuration, “in proximity to,” allows for a close spatial association without necessitating direct contact, providing flexibility in target placement while maintaining accurate tracking.

[0092] As an example, the term “attached to or in proximity to” may designate a patient target directly mounted on a dental splint for oral procedures, electromagnetic sensors integrated into a headband , tracking markers positioned on a nearby reference frame, or any other configuration that maintains a stable spatial relationship with the patient's anatomy .

[0093] The detachable element 150 is an intermediary between the patient’s body and the patient target, that provides a stable reference point for the tracking subsystem 120. The detachable nature of this element allows for its easy removal after the procedure and enables its potential reuse or replacement, while being compatible with the chosen tracking technology.

[0094] As an example, the detachable element 150 may include a custom-molded dental tray with integrated tracking markers or sensors and that fits over a patient’s teeth during maxillofacial procedures, a non-invasive skull clamp with mounting points for various types of targets and used in neurosurgical interventions, a specially designed bracket compatible with different tracking technologies and temporarily attached to a bone surface during orthopedic surgeries, or any other removable element that provides stable target mounting while ensuring accurate tracking.

[0095] - - the processor-based registration module

[0096] In the subject application, the processor-based registration module 130 is designed to perform a registration process that systematically aligns coordinate systems and establishes transformations between the position-accurate robotic arm 111, the tracking device 121, and the anatomical structure of interest.

[0097] The term “registration process” refers to a fundamental computational procedure in the system 100 which establishes accurate spatial relationships between different components and reference frames. This process ensures that all elements of the system 100 operate within an unified spatial framework, which is essential for the accurate execution of medical procedures.

[0098] As an example, the term “registration process” may designate the act of aligning a pre-operative CT scan of a patient’s spine with the real-time position of the patient on the operating table, using markers 10 and anatomical landmarks. It may also include the procedure of mapping the workspace of the robotic arm to the coordinate system 100 of the tracking device, ensuring that the movements of the arm correspond accurately to the tracked positions in three-dimensional space. Additionally, the term “registration process” may comprise the calibration routine that establishes the relationship between the tip of a surgical instrument and the markers 10 attached to its body, allowing for accurate tracking of the instrument’s position during a procedure.

[0099] It is important to note that the processor-based registration module 130 and the processor-based calibration module 140 are distinct modules with different functional responsibilities within the system 100. The processor-based registration module 130 performs registration processes to align coordinate systems between the position-accurate robotic arm 111, the tracking device 121, and the anatomical structure of interest. The processor-based calibration module 140 performs recalibration processes to verify and update the spatial relationship between the calibrated robotic subsystem 110 and the tracking subsystem 120. These are separate functions: registration addresses anatomical alignment while calibration addresses equipment spatial relationships. This separation of functional responsibilities distinguishes the system from approaches where calibration and registration are treated as interchangeable or synonymous processes.

[0100] - - the processor-based calibration module

[0101] In the subject application, the processor-based calibration module 140 includes at least a memory and is designed to perform a recalibration process.

[0102] As part of this process, the processor-based calibration module 140 stores, in the memory, an initial factory calibration establishing a spatial relationship between the calibrated robotic subsystem 110 and the tracking subsystem 120. This factory calibration is typically performed once during manufacturing in a controlled environment and serves as a baseline reference for all subsequent recalibration processes.

[0103] Moreover, the processor-based calibration module 140 performs systematic spatial recalibration of the calibrated robotic subsystem 110 and the tracking subsystem 120 as a preparatory step that must be completed prior to initiating each medical procedure, as well as upon any tool 112 exchange. The recalibration process is executed in its entirety before the system 100 allows the medical procedure to commence, ensuring that all spatial relationships are verified and updated before any surgical intervention begins.

[0104] During this recalibration process, the processor-based calibration module 140 first measures the current physical geometry of each target through detection via the tracking device 121. The tracking device 121 detects the positions of the multiple tracking markers 10 on each target and determines the current geometric configuration based on the detected marker positions. Subsequently, the processor-based calibration module 140 compares this measured current physical geometry of each target to its factory-defined geometric configuration stored in the memory to establish a new spatial relationship. This comparison reveals any deformation, displacement, or modification that has occurred since the initial factory calibration. Mathematically, this comparison consists of calculating a spatial transformation (comprising a translation vector and a rotation matrix) that best aligns the current geometry with the factory-defined geometry. The calculation may use well-known algorithms such as singular value decomposition (SVD) or iterative closest point (ICP) algorithm to determine the optimal transformation that minimizes the distance between corresponding marker positions in the current and factory-defined configurations.

[0105] The result of the comparison step is a set of 'new recalibration results' comprising, for each target, the calculated spatial transformation (translation vector and rotation matrix) as well as quality metrics that quantify the accuracy of the recalibration. These quality metrics may include the mean residual error after transformation (i.e., the average distance between corresponding marker positions after applying the calculated transformation), the standard deviation of residual errors, the maximum residual error, confidence intervals, or other statistical measures of fit quality. Subsequently, the module generates new recalibration results based on the comparison and implements the new spatial relationship between the calibrated robotic subsystem 110 and the tracking subsystem 120 using these new recalibration results.

[0106] Finally, upon successful completion of the recalibration process, the processor-based calibration module 140 releases control to allow the medical procedure to proceed using the newly spatially recalibrated system 100. The actual execution of the medical procedure is then controlled by the position-accurate robotic arm 111 under guidance from the tracking subsystem 120 and the processor-based registration module 130.

[0107] In some embodiments, before implementing the new recalibration results, the calibration module 140 may verify that discrepancies between current and factory-defined geometry are within acceptable predefined limits. For example, the system may verify that the spatial deviation is less than a predetermined threshold, which may be in the range of 0.1 to 1.0 millimeters for translation and 0.1 to 1.0 degrees for rotation, with preferred values around 0.5 millimeters and 0.5 degrees respectively.

[0108] - Rigid frame for Anatomical Structure Immobilization in Automated Medical procedures

[0109] In an embodiment of the subject application, as illustrated in, the system 100 further comprises a rigid frame 160.

[0110] The term “rigid frame” refers to a sturdy and inflexible structure that is designed to securely hold the anatomical structure of interest in a fixed position during medical procedures. The rigid frame 160 works in conjunction with the tracking subsystem 120 and the position-accurate robotic arm 111 to maintain a stable reference point for the medical procedure.

[0111] For example, the term “rigid frame” may refer to a head frame used in neurosurgical medical procedures to keep the patient’s skull perfectly still, a dental bite block that secures the patient’s jaw in a specific position for oral surgeries, or a specialized body restraint system 100 used in orthopedic medical procedures to immobilize a limb or joint.

[0112] Additionally, the system 100 incorporates a safety mechanism designed to actively prevent the start of any medical procedure until both the registration process and the recalibration process are successfully completed. This active prevention is implemented by blocking movement of the position-accurate robotic arm 111 through a combination of software interlocks and hardware safety systems. Specifically, the system 100 disables motor control signals to the position-accurate robotic arm 111 and maintains the arm in a locked or parked position until validation signals are received from both the processor-based registration module 130 and the processor-based calibration module 140 indicating successful completion of their respective processes. This blocking mechanism ensures that the robotic arm cannot initiate any movement along a toolpath until all spatial relationships have been accurately established and verified. The prevention mechanism operates automatically without requiring manual intervention, thereby eliminating the risk of inadvertently starting a medical procedure with inaccurate or unverified spatial calibration. Only after both the registration and recalibration processes have successfully completed and generated valid results does the system 100 release the blocking mechanism and enable the position-accurate robotic arm 111 to begin executing the planned medical procedure.

[0113] At the software level, the system 100 may maintain status indicators tracking the completion state of the registration and recalibration processes. In one embodiment, the system 100 maintains a boolean status flag (or equivalent logical state) for each of the two modules: a 'REGISTRATION_OK' flag managed by the registration module 130, and a 'CALIBRATION_OK' flag managed by the calibration module 140. The start of the medical procedure (i.e., authorization of the first movement of position-accurate robotic arm 111 toward the patient) is granted if and only if REGISTRATION_OK = TRUE AND CALIBRATION_OK = TRUE. If either condition is not met, any command to move the robotic arm toward the patient is blocked at the software level. In alternative embodiments, the status tracking may be implemented through state machines, status registers, enumerated types, or other software constructs that provide equivalent functionality for tracking process completion and controlling procedure authorization.

[0114] At the hardware level, the system 100 may incorporate additional safety mechanisms to reinforce the software-based prevention. In a first embodiment, an electromechanical lock is integrated into one or more joints of the position-accurate robotic arm 111. This lock remains engaged (physically blocking joint movement) as long as the REGISTRATION_OK and CALIBRATION_OK flags (or equivalent status indicators) are not both TRUE. In a second embodiment, the electrical power supply to the actuator motors of the robotic arm joints is interrupted at the motor control system level (for example, via safety relays or solid-state switching devices) as long as the required conditions are not met. In a third embodiment, the motor control commands are intercepted and blocked at the servo controller level, preventing any motion commands from reaching the motor drivers until validation is complete. These hardware-level mechanisms provide redundant safety in addition to software interlocks, ensuring that even in the event of software malfunction, the robotic arm cannot move toward the patient until all spatial validations have been successfully completed. The specific hardware implementation may vary depending on the robotic arm architecture and safety standards applicable to the medical device classification.

[0115] In an advanced embodiment combining the rigid frame 160 with the systematic spatial recalibration capabilities, the processor-based calibration module 140 is configured to detect and compensate for residual patient movements that are not completely eliminated by the rigid frame 160. While the rigid frame 160 provides substantial immobilization of the anatomical structure of interest, minor movements may still occur due to physiological factors such as breathing, muscle tension, or subtle shifts in patient positioning over the course of extended procedures. The processor-based calibration module 140 addresses these residual movements through its systematic spatial recalibration process, which compares the current physical geometry of tracked targets to their factory-defined baseline configurations. When deviations exceeding predetermined thresholds are detected (indicating residual patient movement), the module generates updated recalibration results that compensate for the detected displacement, thereby maintaining accurate spatial relationships despite the presence of minor movements. This approach provides a synergistic combination of partial immobilization (through the rigid frame 160) and active calibration compensation (through the recalibration module 140), wherein the rigid frame minimizes gross movements while the calibration system actively corrects for residual micro-movements, resulting in superior positioning accuracy compared to either approach alone.

[0116] Specifically, this rigid frame 160 is designed to immobilize the anatomical structure of interest.

[0117] The term “immobilize” refers to the act of preventing or significantly restricting movement of the anatomical structure of interest during the medical procedure. This immobilization ensures that the pre-operative planning and intra-operative guidance remain accurate throughout the medical procedure.

[0118] For example, the term “immobilize” may encompass the action of securing a patient’s spine in a fixed position for a delicate spinal surgery, restraining a patient’s chest to minimize respiratory movement during a cardiothoracic medical procedure, or fixing a patient’s eye in place for an ophthalmic intervention.

[0119] The goal of immobilization is to create a stable and predictable environment for the automated system 100 to operate with maximum precision and safety.

[0120] Furthermore, the purpose of this immobilization is to minimize unintended patient movement during medical procedures.

[0121] - Dual-Configuration Probe System with Integrated Tracking for Automated Medical procedures

[0122] In an embodiment of the subject application, the system 100 further comprises at least one probe.

[0123] The term “probe” refers to a specialized instrument within the automated system 100 that is designed for accurate measurement, data collection, or interaction with the anatomical structure of interest.

[0124] For example, the term “probe” may refer to a high-precision dental measurement tool 112 that can be attached to the position-accurate robotic arm 111 for automated scanning of a patient’s dentition. It may also encompass a handheld surgical probe with markers 10 that can be tracked by the system 100 for manual exploration or measurement during a medical procedure. Additionally, the term “probe” could include a specialized tissue sampling instrument that can be used both automatedly by the position-accurate robotic arm 111 and manually by a surgeon, with the system 100 tracking its position in either case.

[0125] Furthermore, in the context of orthopedic medical procedures, the “probe” might refer to a device used for accurate bone surface mapping, capable of being operated by the position-accurate robotic arm 111 or used as a handheld tool 112 for more intuitive surgeon-guided measurements.

[0126] Specifically, this probe exists in two distinct configurations, which enhances the system 100’s versatility in various medical procedures.

[0127] In its first configuration, the probe functions as one of the interchangeable medical tools 112 that can be attached to the position-accurate robotic arm 111. This configuration features a defined tip that serves as a reference point for the system 100’s spatial calculations and movements.

[0128] Alternatively, in its second configuration, as illustrated in, the probe operates as a dedicated instrument 170 that is associated with a third target, referred to as the pointer target 124. This dedicated probe 170 is integrated into the tracking subsystem 120 and also possesses a defined point at its tip.

[0129] The dual nature of the probe’s configuration provides the system 100 with enhanced flexibility in its probing capabilities, allowing for both automated and manual data collection or interaction with the patient’s anatomy.

[0130] - Calibrated Recess System for Accurate Tip Position Determination in Automated Medical procedures

[0131] In an embodiment of the subject application, as illustrated in, the detachable element 150 comprises at least one calibrated recess 151 with predetermined characteristics, which may include a predetermined depth, shape, position, orientation, and material properties.

[0132] The term “recess” refers to an accurately engineered cavity or indentation within the detachable element 150. This recess 151 is specifically calibrated with predetermined characteristics to interact with the probe tip in a controlled manner.

[0133] For example, the term “recess” may refer to an accurately machined conical depression in a dental implant guide that allows a probe to rotate and establish its exact tip position relative to the patient’s jaw. It may also encompass a spherical indentation on a bone-mounted reference marker 10 used in orthopedic surgeries, which enables the system 100 to calibrate different probe types by analyzing their rotational behavior within the recess 151.

[0134] Additionally, the term “recess” could include a multi-faceted cavity in a neurosurgical reference frame that accommodates various probe tip geometries, allowing the system 100 to determine the precise tip position for both robotic-arm-mounted tools and handheld probes.

[0135] Furthermore, in the context of minimally invasive medical procedures, the “recess” might refer to a specialized port in a surgical template that allows for the calibration and position tip determination of endoscopic probes and instruments.

[0136] Specifically, as illustrated in, the calibrated recess 151 is structured to engage all or part of the probe tip and allow rotational movement of the probe when the probe tip is engaged in the recess 151. As a result of this design, the tracking device 121 can determine the exact position of the probe tip in response to the rotation.

[0137] In other words, the recess 151 acts as a reference point for the system 100, providing a consistent and known environment for probe interaction and measurement.

[0138] Furthermore, the tracking device 121 determines the probe tip position from the detected rotational characteristics in conjunction with either the robot target 122 or the pointer target 124. The choice between these targets depends on whether the probe is one of the interchangeable medical tools 112 or a dedicated probe 170.

[0139] This dual functionality enables accurate position tip determination for different probe configurations.

[0140] The process of determining the accurate probe tip position using the calibrated recess system can be further elucidated by examining the principles of pivot calibration. This method, which is fundamental to the system 100’s ability to accurately locate the tip of various probes, leverages the geometric properties of rotational movement to establish the spatial relationship between the tracked markers 10 and the probe tip.

[0141] In the context of the system 100, the calibrated recess 151 serves as a pivoting point for the probe. When the probe tip is engaged in the recess 151, it creates a fixed point around which the rest of the probe rotates.

[0142] The tracking device 121 captures the movement of the markers 10 on the probe as it rotates within the recess 151. Each position of the markers 10 during this rotation corresponds to a point on the surface of an imaginary sphere. The center of this sphere represents the probe tip position, which remains stationary at the bottom of the recess during the rotational movement.

[0143] To determine the probe tip position, the system 100 employs a least-squares fitting algorithm to solve the equation of the sphere formed by the marker 10 positions. The general form of this equation is:(x - x₀)² + (y - y₀)² + (z - z₀)² = r²where (x0, y0, z0) represents the coordinates of the sphere’s center (i.e., the probe tip position), and r is the radius of the sphere (i.e., the distance from the markers 10 to the probe tip).

[0144] The system 100 collects multiple data points as the probe rotates, forming a system of equations that can be solved to find the optimal values for x0, y0, and z0. These coordinates directly correspond to the position of the position of the tip in the tracking device’s coordinate system.

[0145] The precision of this method is enhanced by the carefully designed characteristics of the calibrated recess 151. The predetermined depth, shape, and orientation of the recess ensure that the probe tip is consistently positioned at the same point, reducing variability in the calibration process. The material properties of the recess may also contribute to the stability of the pivot point, potentially mitigating issues related to tip sharpness or surface deformation that can affect traditional pivot calibration on flat surfaces.

[0146] The system 100’s ability to use either the robot target 122 or the pointer target 124 for probe tip position determination adds flexibility to the calibration process. When using the robot target 122, the system 100 can directly relate the probe tip position to the robotic arm’s coordinate system, facilitating accurate control of tool movements. Conversely, when using the pointer target 124, the system 100 can calibrate handheld probes or verify the calibration of robotic tools independently of the arm’s position.

[0147] The accuracy of the probe tip position determination is further improved by the system 100’s ability to collect and process a large number of data points during the rotational movement. This high volume of data allows the system to employ robust known statistical methods to identify and exclude potential outliers, thereby enhancing the reliability of the calibration.

[0148] While traditional pivot calibration methods may be susceptible to errors due to tip shape or surface properties, the use of the calibrated recess 151 mitigates these issues. The accurately engineered characteristics of the calibrated recess 151 ensure a consistent pivot point, reducing the impact of variations in tool tip geometry or wear over time. This consistency is particularly valuable in maintaining calibration accuracy across multiple procedures or extended surgical sessions.

[0149] It is important to note that the system 100’s calibration process extends beyond mere probe tip position determination. The comprehensive spatial recalibration performed by the processor-based calibration module 140 integrates the probe tip position information with the broader spatial relationships between the robotic subsystem 110 and the tracking subsystem 120. This integration ensures that the probe tip is accurately positioned within the overall surgical workspace, enabling accurate navigation and tool manipulation during medical procedures.

[0150] In conclusion, the calibrated recess system for probe tip position determination represents a significant advancement in the field of systems. By combining the principles of pivot calibration with accurately engineered physical references and sophisticated software algorithms, the system achieves a level of accuracy and reliability that is essential for performing complex medical procedures with minimal human intervention.

[0151] - Advanced Calibration Module Capabilities: Deviation Detection, Temporal Validation, Deformation Classification, and Predictive Maintenance

[0152] - - Deviation Parameter Calculation with Threshold-Based Procedure Blocking

[0153] In an advanced embodiment of the subject application, the processor-based calibration module 140 is configured to calculate, during the systematic spatial recalibration process, a deviation parameter that quantifies the discrepancy between the measured current physical geometry of each target and its corresponding factory-defined geometric configuration. This deviation parameter serves as a quantitative metric for assessing the magnitude of geometric drift that has occurred since the factory calibration was established. The deviation parameter is calculated by determining the spatial transformation (comprising both translational and rotational components) required to align the measured current geometry with the factory-defined baseline, and then extracting scalar metrics that represent the magnitude of this transformation.

[0154] The processor-based calibration module 140 implements a threshold-based safety mechanism wherein the start of the medical procedure is actively blocked if the calculated deviation parameter exceeds a predefined threshold. This threshold comprises two components: a translational component of 0.5 millimeters (representing the maximum acceptable positional displacement) and a rotational component of 0.5 degrees (representing the maximum acceptable angular misalignment). If either component of the deviation parameter exceeds its corresponding threshold value, the calibration module 140 determines that the current geometry has deviated excessively from the factory-defined configuration, indicating that the spatial relationships may not be sufficiently accurate for safe procedure execution. In this case, the module prevents the position-accurate robotic arm 111 from initiating movement through the same blocking mechanisms described previously (software interlocks and hardware safety systems), and generates an alert signal indicating that corrective action (such as target repositioning, hardware inspection, or system maintenance) is required before the medical procedure can proceed. The 0.5 millimeter translational threshold and 0.5 degree rotational threshold are selected to ensure that positioning accuracy remains within acceptable bounds for high-precision medical procedures while providing a safety margin that accounts for measurement uncertainties and minor variations in target mounting.

[0155] - - Temporal Validity Constraint for Recalibration Process

[0156] In a further embodiment addressing temporal efficiency requirements, the processor-based calibration module 140 is configured to complete the systematic spatial recalibration process within a short time delay prior to initiating the medical procedure. In various embodiments, this time delay may range from approximately 10 seconds to approximately 60 seconds, with a typical implementation completing recalibration in approximately 30 seconds. This temporal constraint ensures that the recalibration results remain temporally valid (i.e., that the measured geometric relationships accurately reflect the current state of the system at the time of procedure initiation) while simultaneously maintaining procedural efficiency by minimizing the time interval between patient preparation and procedure execution. The specific time delay achieved depends on factors such as the complexity of the target geometries, the number of poses in multi-pose recalibration, and the computational resources available. The short time delay (whether 10, 30, or 60 seconds) is sufficiently brief that significant geometric changes beyond those already detected and quantified by the recalibration process are unlikely to occur within this timeframe, thereby maintaining the temporal validity of recalibration results.This rapid recalibration capability is particularly valuable in clinical workflows where extended delays between calibration and procedure execution could result in:(1) minor shifts in patient positioning or target placement that would invalidate the recalibration results,(2) reduced procedural efficiency that could impact patient comfort or operating room utilization, or(3) workflow disruptions that could affect the coordination between surgical team members. By completing recalibration within a short time delay, the system 100 ensures that the spatial relationships determined during recalibration remain valid at the moment of procedure initiation, thereby enhancing both the accuracy and the clinical practicality of the automated medical procedures. The temporal validity of recalibration results is maintained because the 30-second interval is sufficiently brief that significant geometric changes (beyond those already detected and quantified by the recalibration process) are unlikely to occur within this timeframe.

[0157] - - Deformation Detection Module with Classification and Maintenance Alert Generation

[0158] In an advanced diagnostic embodiment, the system 100 further comprises a deformation detection module integrated with or communicatively coupled to the processor-based calibration module 140. This deformation detection module is configured to analyze the discrepancies between the measured current physical geometry of each target and its factory-defined geometric configuration, and to classify these detected discrepancies into distinct categories based on their physical nature and temporal characteristics. The classification system distinguishes among: (i) reversible elastic deformation, which represents temporary geometric changes caused by applied forces or stresses that return to the original configuration when the forces are removed (for example, minor flexing of mounting structures due to handling or vibration), (ii) permanent plastic deformation, which represents irreversible geometric changes caused by forces exceeding the elastic limit of the materials, resulting in permanent shape alterations (for example, bending of mounting brackets due to accidental impact or excessive tightening forces), and (iii) transient tracking error, which represents apparent geometric discrepancies that arise not from physical changes to the targets themselves but rather from temporary limitations in the tracking subsystem's ability to accurately determine target positions (for example, partial marker occlusion, lighting variations, or brief signal interference).

[0159] The deformation detection module performs this classification by analyzing temporal patterns in the discrepancies across multiple measurement cycles. Reversible elastic deformation is identified by detecting discrepancies that vary in magnitude with measurable external factors (such as robotic arm position or tool mounting forces) but return to baseline values when these factors are removed. Permanent plastic deformation is identified by detecting discrepancies that remain consistent across multiple measurement cycles and different system configurations, indicating a stable geometric change that does not reverse over time. Transient tracking error is identified by detecting discrepancies that exhibit high temporal variability or that correlate with known tracking subsystem limitations. The deformation detection module is further configured to generate an alert signal if permanent plastic deformation exceeding a maintenance threshold of 1 millimeter (translational component) is detected, indicating the necessity for system maintenance. This alert signal notifies the operator or system administrator that hardware components (such as target mounting structures, detachable elements, or rigid frames) may have sustained damage requiring inspection, adjustment, or replacement before continued safe operation. The 1-millimeter maintenance threshold is selected to provide early warning of significant hardware issues while avoiding excessive false alerts from minor variations within normal operating tolerances.

[0160] - - Historical Tracking and Predictive Maintenance Through Statistical Trend Analysis

[0161] In a predictive maintenance embodiment, the processor-based calibration module 140 is configured to store in its memory a historical record of recalibration results for a plurality of prior medical procedures. This historical record comprises, for each past procedure, the calculated deviation parameters, the timestamp of the recalibration, the identity of the mounted tool, and other relevant system state information. By maintaining this historical record over an extended period (for example, spanning hundreds or thousands of procedures), the system 100 accumulates a comprehensive dataset that captures the temporal evolution of the system's geometric characteristics.

[0162] The processor-based calibration module 140 is further configured to analyze temporal trends in this historical record through statistical processing techniques.These techniques may include:(1) calculation of running averages or moving averages of deviation parameters to identify gradual drift trends,(2) regression analysis to model the rate of change in geometric parameters over time,(3) detection of sudden discontinuities in the historical data that might indicate discrete events (such as impacts or component replacements),(4) comparison of current deviation parameters against historical baseline distributions to identify anomalous measurements, and(5) identification of correlations between deviation trends and specific operational parameters (such as cumulative operating hours, number of tool exchanges, or specific mounted tools).Based on the analyzed temporal trends, the processor-based calibration module 140 generates a predictive maintenance indication when the analysis reveals patterns suggesting impending hardware degradation or the approach toward maintenance threshold limits. For example, if the historical trend analysis shows that deviation parameters are gradually increasing over time (indicating progressive wear or loosening of mounting hardware), the module can generate a predictive maintenance indication alerting that proactive maintenance should be scheduled before the deviation exceeds critical thresholds. This predictive capability enables proactive maintenance scheduling during planned downtime rather than reactive maintenance in response to threshold violations or system failures, thereby enhancing system availability and reducing unplanned procedure cancellations.

[0163] - - Multi-Pose Recalibration with Error Minimization for Enhanced Robustness

[0164] In a robust recalibration embodiment, the systematic spatial recalibration process implemented by the processor-based calibration module 140 comprises the acquisition of measurements of the current physical geometry of targets in at least three different poses of the position-accurate robotic arm 111. A "pose" in this context refers to a distinct configuration of the robotic arm characterized by specific joint angles and end-effector position and orientation. By measuring the target geometry in multiple different poses, the recalibration process captures geometric information across a range of system configurations, thereby providing a more comprehensive assessment of spatial relationships than would be obtained from measurements in a single pose.For example, the three or more different poses might include:(1) a home or parked position where the robotic arm is in a neutral configuration,(2) a position representative of typical working configurations during medical procedures, and(3) one or more additional positions selected to maximize geometric diversity or to probe specific aspects of the workspace.

[0165] The processor-based calibration module 140 is configured to calculate the new spatial relationship between the calibrated robotic subsystem 110 and the tracking subsystem 120 using an error minimization algorithm applied over the entire set of measurements acquired in the different poses. Rather than calculating the spatial relationship based solely on measurements from a single pose (which could be affected by pose-specific factors such as mechanical deflections, backlash, or measurement artifacts), the error minimization algorithm determines the spatial relationship parameters that best satisfy all measurements across all poses simultaneously.This multi-pose validation approach enhances robustness by:(1) averaging out pose-specific measurement errors or variations,(2) detecting and identifying anomalous measurements that might arise from temporary tracking errors or occlusions in particular poses,(3) providing redundant geometric constraints that improve the conditioning of the mathematical problem and reduce sensitivity to measurement noise, and(4) enabling validation that the calculated spatial relationship is consistent across the range of poses that will be utilized during the actual medical procedure.The error minimization algorithm may employ techniques such as least-squares optimization, robust estimation methods that downweight outlier measurements, or iterative refinement procedures that progressively improve the solution accuracy. The result is a more reliable and accurate determination of spatial relationships compared to single-pose recalibration approaches, thereby enhancing the overall positioning accuracy and safety of the automated medical procedures performed by the system 100.

[0166] - Rigid Point-to-Point Registration System for Accurate Spatial Alignment of Physical Anatomy with 3D Digital Models in Automated Medical procedures

[0167] In an embodiment of the subject application, as illustrated in, the processor-based registration module 130 is further designed to perform by computational algorithm a rigid point-to-point registration in response to touching predefined registration points on the anatomical structure of interest with the probe tip, where the number of predefined registration points may be, for instance more than three.

[0168] Specifically, the module performs a rigid point-to-point registration between the acquired registration points and corresponding predefined points on a three-dimensional digital model 20 of the anatomical structure of interest.

[0169] The term “rigid point-to-point registration” refers to an accurate computational process performed by computational algorithm that uses mathematical techniques to establish an exact spatial correspondence between specific points on the physical anatomical structure of the patient and their corresponding points in the digital model.

[0170] For example, the term “rigid point-to-point registration” may refer to the process of touching specific landmarks on a patient’s skull with the probe and aligning these points with corresponding markers 10 in a CT scan for neurosurgical planning. It may also encompass the act of registering key points on a patient’s knee joint to a pre-operative MRI model for robotic-assisted orthopedic surgery.

[0171] Additionally, this term could include the registration of dental implant sites on a patient’s jaw to a 3D model derived from cone beam CT imaging for accurate implant placement.

[0172] Furthermore, in the context of spinal surgery, “rigid point-to-point registration” might involve matching vertebral landmarks touched by the probe to their corresponding points on a spinal column model for accurate screw placement guidance.

[0173] The term “three-dimensional digital model of the anatomical structure of interest” refers to a detailed, computer-generated representation of the specific part of the patient’s body that is the focus of the medical procedure, as illustrated inand

[0174] This digital model 20 is typically created from pre-operative imaging data such as CT, MRI or optical scans and serves as a virtual reference for the automated system 100.

[0175] The model contains accurate spatial information about the anatomy, including the location of important structures, landmarks, and the predefined points used in the registration process.

[0176] This digital representation allows the system 100 to plan and simulate medical procedures, guide the position-accurate robotic arm 111, and provide real-time feedback during the actual medical intervention.

[0177] For example, the term “three-dimensional digital model of the anatomical structure of interest” may refer to a highly detailed virtual representation of a patient’s heart, including its chambers, valves, and coronary arteries, used for planning and guiding minimally invasive cardiac medical procedures. It may also encompass a 3D model of a patient’s hip joint, complete with bone density information and optimal implant positioning, used in robotic-assisted hip replacement surgery. Additionally, this term could include an accurate digital replica of a patient’s facial bones and soft tissues used for planning complex craniofacial reconstructions.

[0178] Furthermore, in the context of neurosurgery, the “three-dimensional digital model of the anatomical structure of interest” might refer to a detailed brain model showing tumor location, critical neural pathways, and blood vessels for planning and executing accurate tumor resections.

[0179] In practice, the rigid point-to-point registration process involves the probe tip touching predefined registration points on the patient’s anatomy, which are then matched to predetermined points in the digital representation.

[0180] The “rigid” aspect of this registration implies that the spatial relationships between the points remain fixed and do not allow for deformation or scaling.

[0181] This rigid registration is typically implemented using robust mathematical techniques for finding the optimal rigid transformation between two sets of corresponding points. These techniques provide an efficient and accurate solution for aligning the patient’s physical anatomy with the digital model.

[0182] This registration method ensures that the system 100 can accurately translate between the physical space of the patient and the virtual space of the digital model, which is essential for accurate guidance of the position-accurate robotic arm 111 and medical tools 112 during medical procedures.

[0183] The rigid registration process can be summarized in the following steps:- collection of corresponding point pairs from the physical anatomy and the digital model,- calculation of the centroids of both point sets,- computation of optimal transformation matrices,- determination of the optimal rotation and translation parameters.This mathematical approach ensures a highly accurate and computationally efficient registration process.

[0184] Finally, the registration process enables the system 100 to establish an accurate spatial relationship between the physical anatomical structure and its digital representation. By utilizing the probe tip and predefined registration points, the system 100 ensures accurate alignment between the real-world patient anatomy and the three-dimensional digital model.

[0185] The implementation of advanced mathematical methods in the rigid registration process confers significant benefits to the system 100. These approaches minimize the distance between corresponding points, thereby ensuring optimal alignment between the physical and digital representations. The computational efficiency facilitates real-time registration updates during procedures when necessary, enhancing the system 100’s responsiveness to dynamic surgical environments. Furthermore, the robustness to input data noise substantially improves the reliability of the registration process in clinical settings, where various factors may introduce minor discrepancies in measurements.

[0186] The implementation of the rigid registration method in the system 100 has significant implications for the overall performance and reliability of the medical procedures. This mathematical approach not only ensures accurate alignment between the physical anatomy and the digital model but also contributes to the system 100’s ability to adapt to various clinical scenarios.

[0187] In the context of automated medical procedures, the registration method’s ability to handle noisy data is particularly valuable. Medical environments can introduce various sources of error, such as minor patient movements or small inaccuracies in probe positioning. The algorithm’s robustness helps mitigate these issues, maintaining registration accuracy even under less-than-ideal conditions.

[0188] Furthermore, the computational efficiency of the registration method allows for potential real-time updates to the registration during the procedure. This capability could be essential in scenarios where the anatomical structure of interest may shift slightly during the intervention, such as in soft tissue surgeries or procedures involving patient repositioning.

[0189] The integration of the registration method with other system components, including the tracking subsystem and the processor-based calibration module, establishes a comprehensive spatial awareness framework.

[0190] This integrated approach enables the system to perform continuous verification and updates of spatial relationships among all components.

[0191] Consequently, the system can adapt to subtle changes in the surgical environment without compromising its accuracy.

[0192] Moreover, this integration allows the system to provide real-time feedback to the position-accurate robotic arm 111, facilitating dynamic adjustments to the toolpath as required during the medical procedure.

[0193] These capabilities collectively enhance the system 100’s ability to maintain accurate spatial relationships and execute accurate interventions throughout the duration of complex medical procedures.

[0194] - Enhanced Spatial Alignment System Using Point Cloud Registration for Comprehensive Anatomical Surface Mapping in Automated Medical procedures

[0195] In an embodiment of the subject application, as illustrated in, the processor-based registration module 130 is further designed to perform by iterative computational algorithm a point cloud registration in response to acquiring surface data of predefined surfaces on the anatomical structure of interest with the probe tip, where the acquired surface data comprises information from at least two zones of one or more predefined surfaces on the anatomical structure of interest.

[0196] Specifically, the processor-based registration module 130 performs a point cloud registration between the acquired surface data and the three-dimensional digital model 20 of the anatomical structure of interest.

[0197] The term “point cloud registration” refers to an advanced computational process performed by iterative computational algorithm that aligns a set of three-dimensional points, known as a point cloud, acquired from the surface of the patient’s anatomical structure of interest with a corresponding set of points in the three-dimensional digital model. This process involves the probe tip collecting numerous data points from predefined surfaces on the patient’s anatomy, which are then matched to the digital model 20 of the anatomical structure of interest using sophisticated algorithms.

[0198] The iterative computational algorithm achieves alignment by progressively refining the transformation between the two point sets through successive iterations.In each iteration, the algorithm:(1) establishes correspondences between points in the acquired surface data and points in the digital model,(2) computes an updated transformation thatminimizes distances between corresponding points, and(3) evaluates convergence criteria to determine whether additional iterations are required.This iterative refinement process continues until the alignment converges to an acceptable accuracy threshold, thereby providing a more comprehensive spatial mapping compared to the rigid point-to-point registration, as it captures the contours and topography of the anatomical surfaces rather than just individual points.

[0199] For example, the term “point cloud registration” may refer to the accurate preparation of teeth for crowns or veneers requiring sub-millimeter precision, where the position-accurate robotic arm 111 can follow a pre-planned toolpath to remove exactly the right amount of tooth structure with minimal margin for error. The sub-millimeter precision is essential for these procedures because crown and veneer preparations require extremely accurate reduction of tooth enamel and dentin to ensure proper fit of the dental restoration while preserving maximum healthy tooth structure. It may also encompass the placement of dental implants on external tooth surfaces (specifically, implant site preparation on the external bone surface accessible through the alveolar ridge), where the system 100 can use its tracking and registration capabilities to navigate the drill to the exact position, angle, and depth required for optimal implant placement with sub-millimeter positioning accuracy. It may also encopass the process of scanning or “painting” the surface of a patient’s knee joint with the probe to create a dense set of data points, which are then aligned with the knee model derived from pre-operative imaging for accurate robotic-assisted knee replacement surgery. It may also encompass the act of capturing the contours of a patient’s spine by running the probe along the vertebrae and matching this data to a spinal column model for accurate guidance in minimally invasive spinal medical procedures.

[0200] Additionally, this term could include complex orthodontic medical procedures performed on external tooth surfaces, such as the accurate placement of brackets or the creation of custom-fit aligners based on highly accurate 3D scans of the patient's dentition. The limitation to external tooth surfaces ensures that these dental procedures focus on accessible external anatomical structures (tooth enamel, external bone surfaces) rather than requiring deep tissue penetration into internal tooth structures such as the pulp cavity or requiring extensive penetration of gingival tissue beyond what is necessary for external access. It also can encompass the registration of a patient’s facial features by acquiring surface data points and aligning them with a 3D facial model for planning and executing complex craniofacial reconstructions.

[0201] Furthermore, in the context of cardiac medical procedures, “point cloud registration” might involve mapping the internal surface of a heart chamber by collecting numerous data points with a specialized probe and aligning this information with a pre-operative 3D heart model for accurate catheter navigation during electrophysiology studies or ablation medical procedures.

[0202] This point cloud registration process enhances the system 100’s ability to account for subtle anatomical variations and potential tissue deformations, thereby improving the overall accuracy and reliability of the automated medical procedures.

[0203] Finally, the point cloud registration process enables the system 100 to establish a more comprehensive spatial relationship between the physical anatomical structure and its digital representation. By utilizing the probe tip to acquire surface data from predefined surfaces, the system 100 enhances the accuracy of the alignment between the real-world patient anatomy and the three-dimensional digital model.

[0204] - Specialized Automated System for High-Precision Dental Medical procedures Utilizing Advanced Robotic and Tracking Technologies

[0205] In an embodiment of the subject application, the system 100 is applicable to specific medical procedures. In particular, the medical procedures performed by the system 100 are dental medical procedures.

[0206] The term “dental medical procedures” refers to a specific subset of medical interventions that focus on the diagnosis, treatment, and prevention of conditions affecting the oral cavity, particularly the teeth and gums.

[0207] In the context of the system 100, dental medical procedures encompass a range of highly accurate and specialized interventions that are performed using the system 100’s advanced capabilities, including the position-accurate robotic arm 111, tracking subsystem 120, and sophisticated registration processes. These medical procedures leverage the system 100’s ability to navigate complex oral anatomies with high accuracy and repeatability, while maintaining a level of autonomy that enhances the precision and efficiency of dental treatments.

[0208] For example, the term “dental medical procedures” may refer to the accurate preparation of teeth for crowns or veneers, where the position-accurate robotic arm 111 can follow a pre-planned toolpath to remove exactly the right amount of tooth structure with minimal margin for error. It may also encompass the placement of dental implants, where the system 100 can use its tracking and registration capabilities to navigate the drill to the exact position and depth required for optimal implant placement.

[0209] Additionally, this term could include complex orthodontic medical procedures, such as the accurate placement of brackets or the creation of custom-fit aligners based on highly accurate 3D scans of the patient’s dentition.

[0210] Furthermore, in the context of this system 100, “dental medical procedures” might involve minimally invasive periodontal treatments, where the position-accurate robotic arm 111 can perform tasks like targeted plaque and calculus removal with a level of precision that surpasses human capabilities. The system 100’s ability to perform point cloud registration could be particularly valuable in medical procedures requiring extensive surface mapping, such as full-mouth rehabilitations or complex cosmetic dentistry cases, ensuring that the final result closely matches the pre-planned digital design.

[0211] -Interchangeable Dental Tools with Factory-Calibrated Tool Center Point Specifications

[0212] In the context of dental medical procedures, the system 100 employs a range of interchangeable medical tools 112 specifically designed for different dental interventions. These tools include specialized dental drills for veneer preparation (typically featuring fine diamond or carbide burs designed to remove thin layers of external enamel in the range of 0.3 to 0.5 millimeters), dental drills for crown preparation (featuring coarser burs designed to remove larger amounts of external tooth structure, typically 1 to 2 millimeters of circumferential reduction), and implant drills (featuring precise pilot drills, widening drills, and final drills designed to create implant sites in bone with exact diameter and depth specifications).

[0213] Each of these interchangeable medical tools 112 has factory-calibrated tool center point (TCP) specifications that are determined during manufacturing under controlled conditions and stored in the memory of the processor-based calibration module 140. The tool center point represents the functional tip or working point of the tool relative to the robot target 122 attached to the position-accurate robotic arm 111. During factory calibration, each tool's TCP is measured with high precision (typically within 50 micrometers) using calibrated measurement systems, and these TCP coordinates are recorded as the tool's factory-defined baseline geometry. When a tool is mounted on the position-accurate robotic arm 111, the system 100 retrieves the stored factory TCP specifications from memory and uses them as the reference baseline for the systematic spatial recalibration process. This approach ensures that each tool's positioning accuracy is maintained relative to its precisely known factory-calibrated specifications, enabling the system to achieve the sub-millimeter precision required for accurate dental procedures such as crown preparation, veneer preparation, and implant placement.

[0214] The factory-calibrated TCP specifications stored in memory include not only the three-dimensional coordinates of the tool tip relative to the robot target 122, but also additional parameters such as tool geometry (diameter, length, working angle), tool type identification (veneer preparation drill, crown preparation drill, or implant drill), and quality metrics from the factory calibration process (such as measurement uncertainty and calibration date). This comprehensive information enables the processor-based calibration module 140 to perform intelligent recalibration that accounts for the specific characteristics of each tool type, thereby optimizing positioning accuracy for the particular dental procedure being performed.

[0215] -Method for Operating an Automated Medical procedure System with Integrated Calibration, Registration, and Precision Control

[0216] As shown inthe subject application also relates to a computer-implemented method 200 for operating the system 100 as described above.

[0217] The computer-implemented method 200 comprises several steps involving the calibrated robotic subsystem 110, the tracking subsystem 120, targets, and various processes for registration, calibration, and control.

[0218] The computer-implemented method 200 operates on a system 100 comprising a calibrated robotic subsystem 110 with a position-accurate robotic arm 111 designed for interchangeable medical tools 112 (each having a defined center point, TCP), and a tracking subsystem 120 with a tracking device 121 positioned at a distance allowing both tracking and sufficient workspace for the robotic arm. The system includes at least two targets designed to be tracked without physical connection to the calibrated robotic subsystem 110, each having a factory-defined geometric configuration created by an arrangement of multiple tracking markers 10: at least one robot target 122 (with a first factory-defined geometric configuration) attached to the position-accurate robotic arm 111, and at least one patient target 123 (with a second factory-defined geometric configuration different from the first) attached to or in proximity to a detachable element 150 fixedly secured to an anatomical structure of interest. The method utilizes a three-dimensional digital model of the workspace associated with the anatomical structure of interest, built from images acquired by the tracking device 121, and employs a registration process that systematically aligns coordinate systems and establishes transformations between the position-accurate robotic arm 111, the tracking device 121, and the anatomical structure of interest.

[0219] The computer-implemented method 200 involves storing 210 in a memory an initial factory calibration establishing a spatial relationship between the calibrated robotic subsystem 110 and the tracking subsystem 120. This factory calibration serves as a baseline reference for subsequent recalibration processes.

[0220] A key step in the computer-implemented method 200 is performing 220 systematic spatial recalibration of the calibrated robotic subsystem 110 and the tracking subsystem 120 as a preparatory step prior to initiating each medical procedure, as well as upon any tool 112 exchange.

[0221] The recalibration process includes the following processor-executable sub-steps::- measuring 221 the current physical geometry of each target through detection via the tracking device 121,- comparing 222 the measured current physical geometry to the factory-defined geometric configuration stored in the memory to establish a new spatial relationship,- computationally generating 223 new recalibration results based on the comparison, and- implementing 224 the new spatial relationship between the calibrated robotic subsystem 110 and the tracking subsystem 120 using the new recalibration results. These sub-steps ensure that the spatial relationships are accurately updated to reflect the current state of the system components before initiating any medical procedure.

[0222] As a safety measure, the computer-implemented method 200 prevents 230 by processor control the start of any medical procedure by blocking actuation of the position-accurate robotic arm 111 until both the immediately preceding registration process and recalibration process are successfully completed. This active prevention step involves maintaining the robotic arm in a locked state with disabled motor controls, and only releasing this block once validation signals confirm successful completion of both the registration and recalibration processes..

[0223] In one implementation of the prevention step 230, the method maintains software status flags indicating completion of each process, and authorizes procedure start only when all required flags indicate successful completion. For example, the method may maintain a REGISTRATION_OK flag and a CALIBRATION_OK flag, granting authorization for the first movement of the position-accurate robotic arm 111 toward the patient only when both flags are TRUE. In another implementation, the method may additionally engage hardware-level blocking mechanisms such as electromechanical locks integrated into robotic arm joints, power interruption systems that cut electrical supply to actuator motors, or command signal interlocks that block motion commands at the servo controller level. The prevention step 290 may be implemented through software-only means, hardware-only means, or preferably through a combination of both software and hardware mechanisms to ensure robust prevention even in degraded operating conditions. The multi-level approach (software validation combined with hardware blocking) ensures that no movement of the robotic arm toward the patient can occur accidentally or due to a software fault if the registration and recalibration processes have not been completed successfully.

[0224] Following recalibration, the tracking device 121 is reconfigured 240 to recognize and track the targets based on their current physical geometry as reference, rather than the factory-defined configuration, as determined by the new recalibration results. This means that pattern recognition and tracking algorithms operating within the tracking device 121 use the current relative positions of markers 10 as measured and validated during the recalibration process. This reconfiguration ensures accurate real-time tracking during the medical procedure, even in the presence of slight target deformations that may have occurred since the factory calibration.

[0225] Finally, the computer-implemented method 200 involves controlling 250 by processor command the position-accurate robotic arm 111 to automatedly guide at least one mounted interchangeable medical tool 112 along a predefined anatomical toolpath. The control allows precise tool guidance based on the accurately recalibrated and tracked spatial relationships established through the preceding steps, utilizing the tool's defined center point, TCP, as a reference point.

[0226] The computer-implemented method 200 provides a technical contribution in the field of computer-assisted medical procedures by implementing calibration drift detection through systematic comparison of current target geometry with factory-defined baseline stored in memory, combined with safety-critical gating that prevents unsafe tool advancement through processor-controlled blocking of robotic arm actuation until spatial validation is complete. This technical approach ensures that medical procedures are only initiated when accurate spatial relationships have been verified, addressing the technical problem of preventing surgical interventions with potentially incorrect spatial calibration that could lead to tool misalignment or patient harm. The method's technical character is established through its role in maintaining accurate spatial relationships between robotic components and patient anatomy, which is essential for safe and precise execution of automated medical procedures.

[0227] - Method for Operating an Automated Medical procedure System with Integrated Calibration, Registration, and Precision Control

[0228] In an embodiment of the subject application, the computer-implemented method 200 operates on a system 100 that further comprises a rigid frame 160. The rigid frame 160 is designed to immobilize the anatomical structure of interest to minimize unintended patient movement during the medical procedures, thereby enhancing patient stability and maintaining accurate spatial relationships throughout the procedure execution.

[0229] - Computational Point-to-Point Registration Algorithm for Anatomical-Digital Alignment in Automated Medical Procedures

[0230] In an embodiment of the subject application, the registration process employed by the computer-implemented method 200 comprises performing by computational algorithm a rigid point-to-point registration. This algorithmic approach establishes accurate spatial alignment between the physical anatomical structure and its three-dimensional digital model 20 by computing the optimal rigid transformation that maps acquired registration points to their corresponding predefined points in the digital model.

[0231] The registration points are acquired using a probe with a defined tip that contacts predefined locations on the anatomical structure of interest. The computational algorithm processes the coordinates of these acquired points and calculates the rigid transformation (comprising rotation and translation components) that minimizes the distance between the acquired points and their corresponding predefined points in the three-dimensional digital model 20. This rigid point-to-point registration ensures accurate spatial correspondence between the physical anatomy and its digital representation, enabling precise robotic guidance during the medical procedure.

[0232] - Iterative Point Cloud Registration Algorithm for Enhanced Spatial Alignment in Automated Medical Procedures

[0233] In an embodiment of the subject application, the registration process employed by the computer-implemented method 200 comprises performing by iterative computational algorithm a point cloud registration. This algorithmic approach processes acquired surface data representing multiple points on the anatomical structure of interest and iteratively computes the optimal transformation to align this point cloud with the three-dimensional digital model 20.

[0234] The iterative computational algorithm operates by repeatedly refining the transformation parameters through successive iterations until convergence criteria are met. In each iteration, the algorithm computes correspondences between points in the acquired surface data and points on the three-dimensional digital model 20, calculates an updated transformation that minimizes the distances between corresponding points, and evaluates whether the alignment has converged to an acceptable accuracy threshold. This iterative point cloud registration provides enhanced spatial alignment by processing dense surface data rather than discrete points, enabling more comprehensive and robust registration especially for complex anatomical geometries.

[0235] - Use of System for High-Precision Calibration Method with Deterministic Drift Detection

[0236] In a further aspect of the subject application, the system 100 as described in the preceding embodiments is particularly adapted for use in a calibration method characterized by deterministic calibration drift detection capabilities. This use leverages the system's unique combination of factory-baseline comparison, automatic tool exchange detection, and safety-critical gating to maintain sub-millimeter precision in automated medical procedures.

[0237] The calibration method employs systematic factory-geometry comparison performed prior to initiating each medical procedure. Specifically, the processor-based calibration module 140 compares the current physical geometry of each target (as measured through the tracking device 121) to the factory-defined geometric configuration stored in memory. This comparison is performed systematically before every procedure initiation, ensuring that any geometric drift, deformation, or displacement that has occurred since the factory calibration is detected and quantified. The systematic nature of this comparison provides deterministic calibration drift detection, meaning that deviations from factory specifications are reliably identified through computational comparison rather than relying on operator judgment or periodic manual inspection.

[0238] The calibration method incorporates a tool exchange recalibration trigger executed automatically upon detection of tool change. When the system 100 detects that an interchangeable medical tool 112 has been exchanged (for example, through sensor detection, RFID identification, or operator input confirmation), the processor-based calibration module 140 automatically initiates a recalibration process. This automatic triggering ensures that the tool center point (TCP) of the newly mounted tool is accurately determined relative to the factory-defined baseline, maintaining spatial accuracy across tool changes without requiring manual recalibration initiation by the operator.

[0239] The calibration method implements a procedure prevention safety gate through processor-controlled blocking of robotic arm actuation. As described in the system embodiments, the processor-based calibration module 140 (in coordination with other system control modules) prevents the position-accurate robotic arm 111 from initiating any movement toward the patient until both the registration process and the recalibration process have been successfully completed. This processor-controlled blocking is implemented through software interlocks that disable motor control signals and, in some embodiments, hardware-level blocking mechanisms such as electromechanical locks or power interruption systems. The safety gate ensures that automated medical procedures cannot commence with potentially inaccurate spatial calibration.

[0240] The technical purpose of this calibration method is maintaining sub-millimeter precision in automated medical procedures. The combination of systematic factory-geometry comparison, automatic tool exchange recalibration, and procedure prevention gating enables the system 100 to reliably detect and correct calibration drift that could otherwise compromise positioning accuracy. By ensuring that spatial relationships are validated against factory-defined baselines before each procedure and after each tool exchange, the method maintains positioning precision within 300 micrometers (0.3 millimeters), which is essential for applications such as dental crown preparation, veneer preparation, and other high-precision medical procedures where sub-millimeter accuracy is required. This precision level is achievable because the deterministic calibration drift detection identifies even small geometric deviations that would accumulate over time in systems lacking systematic factory-baseline comparison.

[0241] - Use of System for Automated Dental Calibration with Rapid Tool Exchange and High-Precision Tooth Preparation

[0242] In a specific dental application embodiment, the system 100 is used for automated dental calibration whereby factory-verified target geometries and rapid tool exchange capabilities enable high-precision tooth surface preparation for treatment of dental conditions. This dental-specific use exploits the system's sub-millimeter precision and automatic recalibration capabilities to perform crown preparation, veneer preparation, and implant site preparation procedures on external tooth surfaces with exceptional positioning accuracy.

[0243] In this dental calibration use, factory-verified target geometries ensure sub-millimeter drill precision for tooth surface preparation. The factory-defined geometric configurations of the targets (robot target 122 and patient target 123) are verified during manufacturing under controlled conditions and stored in the system memory as baseline references. During dental procedures, the system 100 continuously verifies that the current target geometries match these factory-verified baselines within acceptable tolerances (typically within 300 micrometers for translation and 0.3 degrees for rotation). This verification ensures that dental drill positioning accuracy remains within the sub-millimeter precision required for accurate tooth surface preparation, where even small positioning errors could result in excessive material removal or inadequate preparation that would compromise the dental restoration.

[0244] The dental calibration use is further characterized by tool exchange completed within a short time delay that maintains tool center point accuracy during crown preparation, veneer preparation, or implant site preparation procedures. Dental procedures frequently require multiple tool exchanges (for example, switching from a rough preparation bur to a fine finishing bur, or from a drilling tool to a polishing tool). The system 100's automatic tool exchange recalibration trigger, combined with its rapid recalibration algorithms (such as the iterative closest point algorithm described in preceding embodiments), enables the recalibration process to be completed within a short time delay of tool exchange. This rapid recalibration maintains the tool center point (TCP) accuracy within the required sub-millimeter tolerance while minimizing procedure interruption time. The 30-second recalibration time is achievable because the system only needs to determine the new tool's TCP relative to existing spatial relationships, rather than performing a complete system recalibration.

[0245] This use of the system 100 is specifically for treatment of dental conditions requiring high-precision automated tooth preparation on external tooth surfaces. The dental procedures enabled by this calibration approach include crown preparation (where external tooth enamel and dentin are removed to create a prepared surface for crown placement), veneer preparation (where a thin layer of external enamel is removed to prepare the tooth surface for veneer bonding), and implant site preparation (where external bone surface is prepared to receive a dental implant fixture). Importantly, these procedures are limited to external tooth surfaces that are accessible without tissue penetration beyond the tooth structure itself. This limitation excludes deeply invasive procedures such as endodontic treatments that penetrate into the tooth pulp cavity, or procedures requiring penetration of gingival tissue beyond what is necessary for access to the external tooth surface. By focusing on external tooth surface preparation, this dental calibration use provides the precision advantages of robotic automation for procedures where sub-millimeter accuracy significantly improves clinical outcomes, while remaining within the scope of non-therapeutic calibration and positioning functions rather than surgical treatment methods.

[0246] The technical function provided by this dental calibration use is the maintenance of geometric accuracy through systematic verification of target positions against factory-defined baselines, combined with rapid recalibration upon tool exchange. This technical function addresses the technical problem of maintaining sub-millimeter positioning accuracy in dental robotic systems where tool exchanges are frequent and where even small calibration drift could compromise the precision required for successful dental restorations. The use provides a technical solution (deterministic calibration drift detection combined with automatic recalibration triggering) to a technical problem (maintaining positioning accuracy across multiple tool exchanges), distinguishing it from merely using a known system for its intended purpose.

[0247] - Conclusion

[0248] The description of the subject application has been presented for purposes of illustration and description but is not intended to be exhaustive or limited to the application in the form disclosed. The embodiments were chosen and described to better explain the principles of the application and the practical application, and to enable the skilled person to understand the application for various embodiments with various modifications as are suited to the particular use contemplated.

[0249] In particular, when an expression uses the term “at least one,” it means that the element or characteristic in question may be present in a single occurrence or in multiple occurrences, thus including one, two, three, or more elements or characteristics, without a specified upper limit.

[0250] On the other hand, when an element is “designed” to fulfill a particular function, it means that this element is created specifically for the purpose of fulfilling this particular function.

[0251] However, depending on the needs and available resources, it may be considered to use an existing element, which will be modified or adapted to fulfill this particular function, without requiring substantial modifications to the subject application.

[0252] Regarding the expression “all or part,” it indicates flexibility in the selection or use of the mentioned elements or data. This expression means that the described action or characteristic can apply to the complete set of elements or data in question, or only to a selected portion thereof. The use of “all or part” thus encompasses a wide range of possibilities, from full use to partial use, without specifying a precise lower or upper limit as to the quantity or proportion concerned.

[0253] It should be noted that the examples provided throughout this description are presented for illustrative purposes and are not limiting. These examples aim to facilitate the understanding of the subject application by the person skilled in the art, by providing concrete illustrations of possible implementation.

[0254] However, the subject application is not limited to these specific examples. The person skilled in the art will understand that these examples can be generalized, adapted, or modified according to specific needs, technological advances, or particular constraints, without departing from the spirit of the subject application. Thus, whenever an example is given, it should be interpreted as encompassing not only the specific example mentioned, but also all technically equivalent variants and alternatives that fulfill the same function or achieve the same objective in the context of the subject application.

[0255] The subject application may be subject to numerous variants and applications other than those described above. In particular, unless otherwise specified, the various structural and functional characteristics of each particular implementation described above should not be considered as combined and / or closely and / or inextricably linked to each other, but, on the contrary, as simple juxtapositions. Moreover, the structural and / or functional characteristics of the different embodiments described above may be subject in whole or in part to any different juxtaposition or any different combination.

Claims

A system (100) for performing automated medical procedures, the system (100) comprising,- a calibrated robotic subsystem (110) comprising,-- a position-accurate robotic arm (111), designed to operate with interchangeable medical tools (112), each tool (112) having a defined center point, TCP, the position-accurate robotic arm (111) being capable of automatedly guiding at least one mounted tool (112) along a predefined toolpath linked to an anatomical structure of interest of a patient for executing medical procedures, utilizing the tool’s TCP as a reference point,- a tracking subsystem (120) comprising,-- a tracking device (121) designed to--- track multiple targets, and--- be positioned and fixed, at a distance of at least a predetermined value from a patient, wherein the predetermined value is selected to allow both tracking and sufficient workspace for the position-accurate robotic arm (111),-- at least two targets designed to be tracked without requiring a wired signal transmission connection to the calibrated robotic subsystem (110), each having a factory-defined geometric configuration created by an arrangement of multiple tracking markers (10), allowing the tracking device (121) to locate each target within a three-dimensional digital model of the workspace associated with the anatomical structure of interest, built from images acquired by the tracking device (121), including,--- at least one robot target (122), with a first factory-defined geometric configuration, designed to be attached to the position-accurate robotic arm (111), and--- at least one patient target (123), with a second factory-defined geometric configuration different from the first factory-defined geometric configuration, designed to be attached to or in proximity to a detachable element (150) fixedly secured to anatomical structure of interest,- a processor-based registration module (130) designed to perform a registration process to systematically align coordinate systems and establish transformations between the position-accurate robotic arm (111), the tracking device (121), and the anatomical structure of interest,characterized in that,- the system (100) comprises a processor-based calibration module (140) including at least a memory, the processor-based calibration module (140) being designed to perform a recalibration process, comprising,-- storing in the memory an initial factory calibration establishing a spatial relationship between the calibrated robotic subsystem (110) and the tracking subsystem (120),-- performing systematic spatial recalibration of the calibrated robotic subsystem (110) and the tracking subsystem (120) as a preparatory step completed prior to initiating each medical procedure, as well as upon any tool (112) exchange, wherein the recalibration process,--- measures the current physical geometry of each target through detection via the tracking device (121),--- compares the measured current physical geometry of each target with its factory-defined geometric configuration stored in the memory to establish a new spatial relationship,--- generates new recalibration results based on the comparison,--- implements the new spatial relationship between the calibrated robotic subsystem (110) and the tracking subsystem (120) using the new recalibration results,and wherein,-- the system (100) is designed to actively prevent the start of any medical procedure by blocking movement of the position-accurate robotic arm (111) until both the immediately preceding registration process and recalibration process are successfully completed, and-- the tracking device (121) is configured to recognize and track the targets based on their current physical geometry, as determined by the new recalibration results, ensuring accurate real-time tracking during the medical procedure.The system (100) of claim 1 further comprising a rigid frame (160) designed to immobilize the anatomical structure of interest, wherein the processor-based calibration module (140) is configured to detect and compensate for residual patient movements not eliminated by the rigid frame (160) through the systematic spatial recalibration process, thereby providing synergistic combination of partial immobilization and active calibration compensation.The system (100) of any one of claims 1 to 2 further comprising at least one probe, wherein the probe is either,- one of the interchangeable medical tools (112) with a defined position at its tip, or- a dedicated probe (170) associated with a third target, called pointer target (124), the pointer target (124) being comprised in the tracking subsystem (120), the dedicated probe (170) having a defined position at its tip.The system (100) of claim 3, wherein the detachable element (150) comprises at least one calibrated recess (151) with predetermined characteristics, structured to,- engage all or part of the probe tip when inserted in the recess (151),- allow rotational movement of the probe about fixed point corresponding to bottom of and,- enabling the tracking device (121) to determine the position tip of the probe in response to detecting rotational movement, by computational resolution of a sphere equation: (x - x₀)² + (y - y₀)² + (z - z₀)² = r², wherein determination of probe tip position is performed in conjunction with either the robot target (122) or the pointer target (124), thereby enabling precise pivot calibration of the system.The system (100) of any one of claims 3 to 4, wherein the processor-based registration module (130) is further designed to, in response to touching predefined registration points on the anatomical structure of interest with the probe tip, perform by computational algorithm a rigid point-to-point registration between the acquired registration points and corresponding predefined points on a three-dimensional digital model (20) of the anatomical structure of interest.The system (100) of any one of claims 3 to 5, wherein the processor-based registration module (130) is further designed to in response to acquiring surface data of predefined surfaces on the anatomical structure of interest with the probe tip, perform by iterative computational algorithm a point cloud registration between the acquired surface data and the three-dimensional digital model (20) of the anatomical structure of interest.The system (100) of any one of claims 1 to 6, wherein the processor-based calibration module (140) is configured to calculate, during recalibration process, a deviation parameter quantifying discrepancy between measured current geometry and factory-defined configuration, and to block start if deviation parameter exceeds predefined threshold, wherein threshold comprises translational component of 0.5 millimeters and rotational component of 0.5 degrees.The system (100) of any one of claims 1 to 7, wherein the processor-based calibration module (140) is configured to complete systematic spatial recalibration within a short time delay prior to initiating medical procedure, thereby ensuring temporal validity of recalibration results while maintaining procedural efficiency.The system (100) of any one of claims 1 to 8, wherein processor-based calibration module (140) and processor-based registration module (130) are distinct software modules executed by one or more processors, calibration module configured to communicate its completion status to system control module, and wherein system authorizes start only when both modules have communicated successful completion status.The system (100) of any one of claims 1 to 9, further comprising deformation detection module configured to:- analyze discrepancies between measured current geometry and factory-defined configuration,- classify detected discrepancies into categories: (i) reversible elastic deformation, (ii) permanent plastic deformation, (iii) transient tracking error, and- generate alert signal if permanent plastic deformation exceeding maintenance threshold of 1 millimeter is detected, indicating necessity for system maintenance.The system (100) of any one of claims 1 to 10, wherein processor-based calibration module (140) is configured to:- store in memory historical record of recalibration results for plurality of prior medical procedures,- analyze temporal trends in historical record through statistical processing, and- generate predictive maintenance indication based on analyzed temporal trends.The system (100) of any one of claims 1 to 11, wherein systematic spatial recalibration process comprises acquisition of measurements of current geometry in at least three different poses of position-accurate robotic arm (111), and wherein calibration module configured to calculate new spatial relationship using error minimization algorithm over set of measurements acquired in different poses, thereby enhancing robustness through multi-pose validation.The system (100) of any one of claims 1 to 12, wherein the medical procedures are dental medical procedures requiring sub-millimeter precision for crown preparation, veneer preparation, or implant placement on external tooth surfaces.The system (100) of claim 13, wherein the interchangeable medical tool (112) is selected from a dental drill for veneers preparation, or a dental drill for crown preparation, and an implant drill, each tool having factory-calibrated tool center point (TCP) specifications stored in memory of calibration module (140).A computer-implemented method (200) for operating a system (100) for performing automated medical procedures, having technical character in establishing and maintaining accurate spatial relationships between robotic components and patient anatomy, the computer-implemented method (200) comprising processor-executable steps of,- storing (210) in a memory an initial factory calibration establishing a spatial relationship between the calibrated robotic subsystem (110) and the tracking subsystem (120),- performing (220) systematic spatial recalibration of the calibrated robotic subsystem (110) and the tracking subsystem (120) as a preparatory step prior to initiating each medical procedure, as well as upon any tool (112) exchange, including,-- measuring (221) the current physical geometry of each target through detection via the tracking device (121),-- comparing (222) the measured current physical geometry to the factory-defined geometric configuration stored in the memory to establish a new spatial relationship,-- computationally generating (223) new recalibration results based on the comparison,-- implementing (224) the new spatial relationship between the calibrated robotic subsystem (110) and the tracking subsystem (120) using the new recalibration results,- preventing (230) by processor control the start of any medical procedure by blocking actuation of the position-accurate robotic arm (111) until both the immediately preceding registration process and recalibration process are successfully completed,- reconfiguring (240) by processor instruction the tracking device (121) to recognize and track the targets based on their current physical geometry, as determined by the new recalibration results,- controlling (250) by processor command the position-accurate robotic arm (111) to automatedly guide at least one mounted interchangeable medical tool (112) along a predefined anatomical toolpathwherein the computer-implemented method (200) provides technical contribution of calibration drift detection via factory-baseline comparison and safety-critical gating preventing unsafe tool advancement .The computer-implemented method (200) of claim 15, wherein the method operates on a system (100) further comprising a rigid frame (160) designed to immobilize the anatomical structure of interest to minimize unintended patient movement during medical procedures.The computer-implemented method (200) of any one of claims 15 to 16, wherein the registration process employed by the method (200) comprises performing by computational algorithm a rigid point-to-point registration between acquired registration points on the anatomical structure of interest and corresponding predefined points on a three-dimensional digital model (20) of the anatomical structure of interest.The computer-implemented method (200) of claim 15 to 17, wherein the registration process employed by the method (200) comprises performing by iterative computational algorithm a point cloud registration between acquired surface data of the anatomical structure of interest and the three-dimensional digital model (20) of the anatomical structure of interest.The computer-implemented method (200) of any one of claims 17 to 18, wherein the medical procedures are automated dental procedures on external tooth surfaces accessible without tissue penetration, and wherein the tool exchange verification ensures tool center point accuracy is maintained within 300 micrometers for crown preparation or veneer preparation procedures.The system (100) of any one of claims 1 to 14 for use in a calibration method characterized by,- systematic factory-geometry comparison performed prior to initiating each medical procedure,- tool exchange recalibration trigger executed automatically upon detection of tool change, and- procedure prevention safety gate implemented through processor-controlled blocking; for the technical purpose of maintaining sub-millimeter precision in automated medical procedures through deterministic calibration drift detection.The system (100) of any one of claims 1 to 14 for use in automated dental calibration whereby,- factory-verified target geometries ensure sub-millimeter drill precision for tooth surface preparation, and- tool exchange completed within a short time delay maintains tool center point accuracy during crown preparation, veneer preparation, or implant site preparation,for treatment of dental conditions requiring high-precision automated tooth preparation on external tooth surfaces.

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