Patent Application
20230137702
The present invention generally relates to computer-assisted medical procedures, and more particularly to a system and method for checking the calibration of a digitizer to ensure the digitizer functions accurately during a computer-assisted medical procedure.
Throughout a lifetime, bones and joints become damaged and worn through normal use, disease, and traumatic events. Arthritis is a leading cause of joint damage that leads to cartilage degradation, pain, stiffness, and bone loss overtime. Arthritis can also cause the muscles articulating the joints to lose strength and become very painful.
If the pain associated with the dysfunctional joint is not alleviated by less-invasive therapies, a joint arthroplasty procedure is considered as a treatment. Joint arthroplasty is an orthopedic procedure in which an arthritic or dysfunctional joint surface is replaced with an orthopedic prosthesis.
The accurate placement and alignment of an implant is a large factor in determining the success of joint arthroplasty. A slight misalignment may result in poor wear characteristics, reduced functionality, poor clinical outcomes, and decreased prosthetic longevity.
Computer-assisted orthopedic surgery is an expanding field having applications in total joint arthroplasty (TJA), bone fracture repair, maxillofacial reconstruction, and spinal reconstruction. For example, the TSOLUTION ONE® Surgical System (THINK Surgical, Inc., Fremont, Calif.) aids in the planning and execution of total hip arthroplasty (THA) and total knee arthroplasty (TKA). The TSOLUTION ONE® Surgical System includes: a pre-operative planning software program to generate a surgical plan using an image data set of the patient's bone and computer-aided design (CAD) files of several implants; and an autonomous surgical robot that precisely mills the bone to receive an implant according to the surgical plan.
In order to achieve accurate implant placement and alignment, a surgical plan is typically generated using 3-D bone models of the patient's bones and one or more implant models of a desired implant. A user positions the implant models relative to the bone models to designate the best fit, fill, and/or alignment of the implants on the bones. The plan is then transferred to a robotic-assisted surgical device in the operating room (OR) to accurately execute the plan.
For any robotic-assisted surgical device, the bone's position and orientation (POSE) needs to be known relative to the device and the surgical plan to accurately create the cuts in bone according to the plan. The bone's POSE relative to the device and plan may be initially determined using a process called registration. Several registration procedures are known in the art, illustratively including pin-based, point-to-point, point-to-surface, laser scanning, image-free, and image registration, as described in U.S. Pat. Nos. 5,951,475; 6,033,415; 8,287,522; and 8,010,177. After registration, the bone needs to be tracked to update the bone's POSE in real-time relative to the surgical device as there is bone movement as cutting the adjustment of tension on the bone occurs.
Conventional tracking systems include optical tracking systems, electromagnetic tracking systems, and mechanical tracking systems. Each of these tracking prior art systems requires a tracking reference device fixed to the patient's bone prior to registration to provide a link for the tracking system to track the bone. Then after registration, the prior art tracking system can accurately track the bone in real-time. For example, an optical tracking system utilizes a tracking array fixed to the patient's bone, an electromagnetic tracking system, utilizes a magnetic field transmitter fixed to the bone, and a mechanical tracking system utilizes a distal end of one or more articulating linkages fixed to the bone.
A digitizer is a tool used during computer-assisted surgery to primarily assist in the collection of points on a bone. The collected points are used to register the bone to imaging data and/or surgical planning data relative to a fixed coordinate reference frame.
In order to accurately collect points on the bone with a tracked digitizer 10, the geometric relationship between the tracking array 16 and the digitizer tip 14 needs to be defined. In other words, the position of the digitizer tip 14 needs to be known relative to the tracked POSE of the tracking array 16, such that the position of the digitizer tip 14 can be accurately tracked by the tracking system. The geometric relationship may be defined or established based on the known geometric relationship between the digitizer tip and to the tracking array when the digitizer is manufactured (e.g., the tip 14 is positioned 20 mm from the center of the tracking array 16). This is only applicable when the tracking array 16 is an integral part of the digitizer 10. Due to manufacturing errors, and in cases where the tracking array 16 is a separate part that is assembled with the other components to form the digitizer, the digitizer 10 is calibrated using techniques known in the art to accurately define the geometric relationship. It is of note that at least the tip 14 must be amendable to sterilization. In the operating room (OR), the calibration of the digitizer 10 is checked to ensure the tracking system is accurately tracking the digitizer tip 14 since the digitizer may have been bent or damaged before use. It is desirable that the intra-operative calibration check of the digitizer be as efficient as possible from both a time and accuracy perspective and the conventional devices and methods of use could be more efficient.
Thus, there exists a need to efficiently check the calibration of a tracked digitizer to ensure the digitizer tip is accurately tracked during a computer-assisted medical procedure to address at least some of the aforementioned issues with the prior art.
A system for verifying the calibration of a tracking member relative to a feature is provided. The system includes a first tracking member with a first feature and a second tracking member with a second feature. A first calibration definition of the first feature and a second calibration definition of the second feature is stored on a tracking system. The tracking includes a processor and software executable instructions that when executed by the processor computes the deviations between the tracked position of the first feature and the tracked position of the second feature when assembled together using: a) a recorded position and orientation (POSE) of the first tracking member and the second tracking member when the first feature is assembled to the second feature; and b) the uploaded first calibration definition and the uploaded second calibration definition. The tracking system verifies the calibration when the computed deviations between the first feature and second feature are within pre-defined acceptable criteria.
A method for verifying the calibration of a digitizer during a computer-assisted medical procedure is provided utilizing a digitizer and a bone tracking array. The digitizer has a digitizer tip, a digitizer tracking array, and a stored calibration definition of the tip position, and the bone tracking array having a stored calibration definition of the feature position. The stored calibration definition of the tip position is transmitted to a tracking system in an operating room where the computer-assisted medical procedure is taking place. The stored calibration definition of the feature position is transmitted to the tracking system. The position and orientation (POSE) of the digitizer tracking array and the bone tracking array when the digitizer tip and feature are assembled together are recorded with the tracking system. The deviation between the tracked position of the digitizer tip and the tracked position of the feature is recorded using: a) the recorded POSE of the digitizer tracking array and the bone tracking array; and b) the transmitted calibration definition of the tip position and the transmitted calibration definition of the feature position. The calibration is accepted if the deviation is within pre-defined acceptable criteria.
A method for verifying the calibration of a digitizer during a computer-assisted surgical procedure is provided that includes a bone tracking array being attached to a bone subject to the surgical procedure. A position of a digitizer tip at a distal end of a digitizer is calibrated relative to a digitizer tracking array mounted at a proximal end of the digitizer. The digitizer tip is placed in physical contact with a feature on the bone tracking array. The digitizer is pivoted around in space while the digitizer tip remains in the feature. A center of rotation of the digitizer is calculated, where the center of rotation is indicative of the position of the digitizer tip. The calculated center of rotation is compared with the calibrated position of the digitizer, where if the comparison is in agreement, then the calibration check is accepted.
A medical system for performing the computerized method for checking and verifying the calibration of a digitizer during a computer-assisted medical procedure is provided. The system includes a surgical robot or hand-held surgical device with an end effector tool. A workstation includes a computer, user-peripherals, and a monitor for displaying a graphical user interface (GUI). At least one of a mechanical digitizer or a non-mechanical tracking system is provided. The computer also includes a processor, non-transient storage memory, and other hardware, software, data and utilities to execute the method. The user peripherals allow a user to interact with the GUI and include user input mechanisms including at least one of a keyboard, mouse, controller, joystick, foot pedal, pendant, digitizer, or a monitor with touchscreen capabilities.
A method for verifying the calibration of a tracking array relative to a feature with the aforementioned system includes a first calibration definition and a second calibration definition to being uploaded to the tracking system. A first feature and a second feature together are assembled. The calibration is verified by computing, with the tracking system, the deviations between the tracked position of the first feature and the tracked position of the second feature using: a) a recorded position and orientation (POSE) of the first tracking array and the second tracking array; and b) the uploaded first calibration definition and the uploaded second calibration definition.
The present invention is further detailed with respect to the following drawings that are intended to show certain aspects of the present of invention, but should not be construed as limit on the practice of the invention, wherein:
The present invention has utility as a system and method to efficiently check the calibration of a digitizer to ensure the digitizer tip is accurately tracked during a robotic procedure as exemplified by a computer-assisted surgical procedure. The present invention will now be described with reference to the following embodiments. As is apparent by these descriptions, this invention can be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. For example, features illustrated with respect to one embodiment can be incorporated into other embodiments, and features illustrated with respect to a particular embodiment may be deleted from the embodiment. In addition, numerous variations and additions to the embodiments suggested herein will be apparent to those skilled in the art in light of the instant disclosure, which do not depart from the instant invention. Hence, the following specification is intended to illustrate some particular embodiments of the invention, and not to exhaustively specify all permutations, combinations, and variations thereof.
Patent documents and publications mentioned in the specification are indicative of the levels of those skilled in the art to which the invention pertains. These documents and publications are incorporated herein by reference to the same extent as if each individual document or publication was specifically and individually incorporated herein by reference in their entirety.
It is to be understood that in instances where a range of values are provided that the range is intended to encompass not only the end point values of the range but also intermediate values of the range as explicitly being included within the range and varying by the last significant figure of the range. By way of example, a recited range of from 1 to 4 is intended to include 1-2, 1-3, 2-4, 3-4, and 1-4.
Unless indicated otherwise, explicitly or by context, the following terms are used herein as set forth below.
As used in the description of the invention and the appended claims, the singular forms “a,” “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.
Also as used herein, “and/or” refers to and encompasses any and all possible combinations of one or more of the associated listed items, as well as the lack of combinations when interpreted in the alternative (“or”).
As used herein, the term “pre-procedure data” refers to data used to plan a medical procedure prior to making modifications to tissue. The pre-procedure data may include one or more of the following: an image data set of tissue (e.g., an image data set acquired via computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, x-ray, laser scan, etc.), a virtual generic model of the tissue, a physical model of the tissue, a virtual patient-specific model of the tissue generated from an image data set of the tissue, a set of data collected directly on the tissue intra-operatively (commonly used with imageless computer-assist devices), etc. As used herein, the term “pre-operative bone data” refers to pre-procedure data involving a bone.
As used herein, the term “digitizer” refers to a device capable of measuring, collecting, recording, and/or designating the location of physical locations (e.g., points, lines, planes, boundaries, etc.) or tissue structures in three-dimensional space. By way of example but not limitation, the “digitizer” may be: a “mechanical digitizer” having passive links and joints, such as the high-resolution electro-mechanical sensor arm described in U.S. Pat. No. 6,033,415 (which U.S. patent is hereby incorporated herein by reference); a non-mechanically tracked digitizer probe (e.g., optically tracked, electromagnetically tracked, acoustically tracked, and equivalents thereof) as described for example in U.S. Pat. No. 7,043,961 (which U.S. patent is hereby incorporated herein by reference); an end-effector of a robotic device; or a laser scanner.
As used herein, the term “digitizing” refers to the collecting, measuring, and/or recording of physical locations or tissue structures in space with a digitizer.
Also described herein are “computer-assisted medical systems.” A computer assisted medical system refers to any system requiring a computer to aid in a medical procedure. Examples of computer-assisted medical systems include 1-N degree of freedom hand-held surgical systems, tracking systems, tracked passive instruments, active or semi-active hand-held surgical devices and systems, autonomous serial-chain manipulator systems, haptic serial chain manipulator systems, parallel robotic systems, or master-slave robotic systems, as described in U.S. Pat. Nos. 5,086,401; 7,206,626; 8,876,830; 8,961,536; and 9,707,043; and the robotic surgical system described in U.S. patent application Ser. No. 16/875,173. In particular inventive embodiments, the computer-assisted medical system is a computer-assisted surgical system such as a robotic surgical system as described below. In particular inventive embodiments, the surgical system is a 2-DOF articulating device as described in U.S. Patent Publication 2018/0344409. The surgical system may provide autonomous, semi-autonomous, or haptic control and any combinations thereof. In addition, a user may manually maneuver a tool attached to the surgical system while the system provides at least one of power, active, or haptic control to the tool.
As used herein, the term “real-time” refers to the processing of input data within milliseconds such that calculated values are available within 2 seconds of computational initiation
As used herein, the term “registration” refers to: the determination of the spatial relationship between two or more objects; the determining of a coordinate transformation between two or more coordinate systems associated with those objects; and/or the mapping of an object onto another object. Examples of objects routinely registered in an operating room (OR) illustratively include: computer-assisted systems/devices; anatomy (e.g., bone); pre-procedure data (e.g., 3-D virtual bone models); medical planning data (e.g., an implant model positioned relative to pre-operative bone data, a cut-file defined relative to an implant model and/or pre-operative bone data, virtual boundaries defined relative to an implant model and/or pre-operative bone data, virtual planes defined relative to an implant model and/or pre-operative bone data, or other cutting parameters associated with or defined relative to an implant model and/or the pre-operative bone data); and any external landmarks (e.g., a tracking array affixed to a bone, an anatomical landmark, a designated point/feature on a bone, etc.) associated with the tissue (if such landmarks exist). Methods of registration known in the art are described in U.S. Pat. Nos. 6,033,415; 8,010,177; 8,036,441; and 8,287,522; and U.S. Patent Application Publication 2016/0338776, which patents and publications are hereby incorporated herein by reference. In particular embodiments with orthopedic procedures, the registration procedure relies on the manual collection of several points (i.e., point-to-point, point-to-surface) on the bone using a tracked digitizer where the surgeon is prompted to collect several points on the bone that are readily mapped to corresponding points or surfaces on a representation of the bone (e.g., a 3-D bone model). The points collected from the surface of a bone with the digitizer may be matched using iterative closest point (ICP) algorithms to generate a transformation matrix. The transformation matrix provides the correspondence between the position of the bone in an operating room (OR) with the bone model to permit the surgical device to execute the plan.
Also used herein is the term “optical communication” which refers to wireless data transfer via infrared or visible light that are described in U.S. Pat. No. 10,507,063 and assigned to the assignee of the present application.
Embodiments of the present invention describe a system and method to efficiently check the calibration of a digitizer to ensure that a tip of the digitizer is accurately tracked by a tracking system. While the present invention is further detailed with respect to a TKA procedure in the accompanying drawings, it is to be understood that the present invention is applicable to computer-assisted medical procedures in general and regardless of anatomy, as well as manufacturing processes. By way of example but not limitation, the system and method of the present invention may be applicable to medical procedures performed on: a) hard tissues (e.g., bones, teeth) including bones in the hip, ankle, shoulder, spine, jaw, skull, elbow, wrist, hands, fingers, feet, toes, etc., as well as revision of initial repair or replacement of any joints or bones; and b) soft tissues (e.g., organs, muscles, connective tissue) including the brain, ligaments, tendons, lungs, heart, skin, etc. Exemplary manufacturing processes that benefit from the present invention include composite material part adhesive bead line application and cutting of composite materials. Composite materials are routinely used in the aerospace, vehicle, and sporting goods manufacturing sectors.
With reference now to the figures,
Continuing with
In some inventive embodiments, the tracking system 26 filters the data when computing the center of rotation to ensure the data is not poorly weighted due to the user's input (i.e., the input being the pivoting of the digitizer 10 in the feature 24). In other inventive embodiments, the tracking system 26 detects the motion of the digitizer 10 and determines whether the range of the user's input was adequate. In other inventive embodiments, the tracking system 26 and/or another component of the computer-assisted medical system provides guidance for the medical workflow and the exceptions when the calibration check fails.
With reference now to
A method 200 for checking the calibration of the digitizer 10′ using the components of
The position of the digitizer tip 14 and the position of the feature 24 are initially calibrated prior to the use of the device (e.g., before entering the operating room, before the device is opened from its packaging, or before verifying the calibration as described herein). The calibration of the digitizer tip 14 may be performed using calibration techniques well known in the art such as those described in U.S. Pat. Nos. 10,792,109 and 7,043,961, which results in a calibration definition of the position of the digitizer tip 14 relative to the digitizer tracking array 16 that is stored in the computing components 30 of the digitizer 10′. The stored calibration definition of the tip position may be stored as a mathematical or geometric expression such as a point (or coordinate (x, y, z)), an axis (or vector {right arrow over (V)}), an axis and a point, or a transformation (i.e., a transformation matrix or a component thereof) that defines the position of the digitizer tip 14 relative to the digitizer tracking array 16. For example, the calibration definition of the tip position may be defined as: (i) a point that relates the tip position to the digitizer tracking array 14; (ii) an axis that relates the axis of the shaft 12 to the digitizer tracking array 14; (iii) an axis and a point that relates the axis of the shaft 12 and the coordinates of the tip position relative to the digitizer tracking array 16; or (iv) a full or partial transformation matrix that can be applied to the tracked position of the digitizer tracking array 16 to determine the tip position. As for the feature 24 on the bone tracking array 20′, the position of the feature 24 may be calibrated using techniques known in the art, or the techniques further described below, which results in a calibration definition of the position of the feature 24 relative to the bone tracking array fiducial markers 22 that is then stored in the computing components 26 of the bone tracking array 20′. The calibration definition of the feature position may be stored as a mathematical or geometric expression such as a point (or coordinate (x, y, z), an axis (or vector {right arrow over (V)}), an axis and a point, or a transformation (i.e., a transformation matrix or a component thereof) that defines the position of the feature 24 relative to the bone tracking array fiducial markers 22. For example, the calibration definition of the feature position may be defined as: (i) a point (or coordinates) that relate the position of the feature 24 to the fiducial markers 22; (ii) an axis that relates an axis that is normal to the plane of the bone tracking array 20′ and originates at or intersects through the feature 24 to the bone tracking array fiducial markers 22; or (iii) a full or partial transformation matrix that can be applied to the tracked position of the digitizer tracking array 16 to determine the feature position.
The position of the feature 24 on the bone tracking array 20 may be calibrated (i.e., the position of the feature 24 on the bone tracking array 20 is defined and/or determined relative to the positions of the fiducial markers (22a, 22b, 22c)) using techniques known in the art (e.g., utilizing coordinate-measuring-machines). In a particular embodiment, the position of the feature 24 is calibrated using the method steps Block 102 to Block 106 in the method 100 shown in
In particular inventive embodiments, there may not be a need for calibrating the position of the feature 24 using the method steps of Blocks 102 to 106. The manufacturing of the bone tracking array 20 may already be within well-defined and narrow manufacturing tolerances, such that the position of the feature 24 is accurate enough when manufactured. An occasional test on specific production batches could check that the tolerances are within range. Even a rough approximation of the position of the feature 24 that considers the manufacturing tolerances may be accurate enough, where the approximated position of the feature 24 can be stored and recorded in the bone tracking array 20. As an additional safety step, a user may need to pivot the digitizer 10 in at least one specific complete circular motion (at least one axis) for a few seconds to safely guarantee a rejected calibration check when the exact position of the feature 24 is not calibrated.
The method 200 also includes recording the POSE of the digitizer tracking array 16 and the bone tracking array 20′ when the digitizer tip 14 and feature 24 are assembled together. In particular embodiments, the feature 24 is a divot where the user places the digitizer tip 14 in the divot to assemble the digitizer tip 14 with the feature 24. The tracking system 26 then records the POSE of the digitizer tracking array 16 and the bone tracking array 20′. The tracking system 26 (or a computer in communication with the tracking system 26) computes the deviations between the position of the digitizer tip 14 and the feature 24 using: a) the recorded POSE of the digitizer tracking array 16 and the bone tracking array 20′; and b) the transmitted calibration definition of the tip position and the transmitted calibration definition of the feature position. In a specific embodiment, the tracking system 26 calculates the deviation in the following manner. The tracking system 26 calculates the position of the digitizer tip 14 in space by applying the transmitted calibration definition of the tip position (e.g., a transformation matrix) to the recorded POSE of the digitizer tracking. In other words, the position of the digitizer tip 14 as tracked by the tracking system 26 is calculated by transforming the recorded POSE of the digitizer tracking array 16 by the calibration definition of the tip position. The tracking system 26 likewise calculates the position of the feature 24 in space by applying the transmitted calibration definition of the feature position with the recorded POSE of the digitizer tracking array 20′. In other words, the position of the feature 24 as tracked by the tracking system is calculated by transforming the recorded POSE of the bone tracking array 20′ by the calibration definition of the feature position. The difference between the calculated position of the digitizer tip 14 and the feature 24 is the deviation. Since the calibrated position of the feature 24 is known with a high degree of accuracy as described above, any deviation suggests that the digitizer tip 14 is not being accurately tracked (i.e., the calibrated definition of the tip position is not accurate). In such a case, the user is prompted to repeat the calibration check or obtain a new digitizer for use. If the deviation is within pre-defined acceptable criteria, then the calibration is verified. The pre-defined acceptable criteria may be chosen according to the application. For example, in computer-assisted surgical procedures, there is a need for a high degree of accuracy, where the pre-defined acceptable criteria may require at least one of the following: an exact match; 0.01-0.1 mm (millimeter) deviation; 0.01-0.5 mm deviation; 0.01-1 mm deviation; 0.01-2 mm deviation; 0.01-5 mm deviation; or 0.01-10 mm deviation. However, the pre-defined acceptable criteria can vary based on the needs and accuracy requirements, so as long as there is a pre-defined acceptable criteria established, the calibration can be verified accordingly.
Another particular inventive embodiment of a system and method for checking the calibration of one or more devices is also described herein. The system may generally include a first tracking member (e.g., a first tracking array) with a first feature, a second tracking member (e.g., a second tracking array) with a second feature, a first calibration definition of the first feature, a second calibration definition of the second feature, where the first calibration definition and the second calibration definition are stored by a tracking system 26. The first calibration definition and the second calibration definition may be pre-stored on the tracking system 26 prior to the procedure, or the calibration definitions may be transmitted (e.g., uploaded) to the tracking system 26 in the OR (by way of the tracking members) and then stored on the tracking system. To check the calibration of the first feature and/or the second feature, a user assembles the first feature and the second feature together, where the tracking system computes the deviations between the first feature and the second feature using: a) the tracked POSEs of the first tracking member and the second tracking member; and b) the first calibration definition and the second calibration definition. Specific embodiments of the system and method are further described below.
The first tracking member and second tracking member are the elements that a tracking system identifies to track an object. For example, the tracking members may be tracking arrays (e.g., tracking arrays (16, 20)) of an optical tracking system, electromagnetic sensors of an electromagnetic tracking system, a distal end of an electro-mechanical tracking system, transponders of a radio-frequency location system, and the like. In particular embodiments, the first tracking member is a bone tracking array 24 having a first feature. The second tracking is the digitizer tracking array 16, where the second feature is a shaft 12, or digitizer tip, of a digitizer 10. In a particular embodiment, with reference to
The deviations between the first feature and the second feature may be computed in the same manner as described above, where the tracking system 26 applies the first calibration definition to the recorded POSE of the first tracking array to determine the tracked position of the first feature, and applies the second calibration definition to the recorded POSE of the second tracking array to determine the tracked position of the second feature. Any difference between the determined tracked position of the first feature and second feature is the deviation. If the deviation is within pre-defined acceptable criteria, then the calibration of the first feature and/or second feature is verified. If the deviation is outside or does not coincide with the pre-defined acceptable criteria, then the user is prompted as such and instructed to proceed accordingly.
It is further contemplated, that the first feature and/or second feature need not be fixedly attached to another object. For example, it is not necessary for a bone tracking array 20′ to be fixedly attached to a bone to verify the calibration of a digitizer 10′. Both the first feature and second feature can be floating in space, and as long as the tracking system can track and record the first tracking array and the second tracking array while the first feature and second feature are assembled together, then the verification of the calibration can occur in the same manner as described herein.
Furthermore, it should be appreciated that the first tracking member or second tracking member may be any tracking member that the tracking system tracks. For example, the first tracking member may be coupled to a surgical device that operates a first tool as described above. Then, the second tracking member may be a calibration tracking member dedicated only for the purpose of verifying the calibration of the first tool. Or, the second tracking member may be coupled or integrated with a second tool, where the second tracking member is still used to verify the calibration of the first tool.
Continuing with
The 2-DoF device 40′ may receive power via an input/output port (e.g., from an external power source) and/or from on-board batteries (not shown).
The actuators (70a, 70b) and motor 64 of the 2-DoF device 40′ may be controlled using a variety of methods. By way of example but not limitation, according to one method of the present invention, control signals may be provided via an electrical connection to an input/output port. By way of further example but not limitation, according to another method of the present invention, control signals are communicated to the 2-DoF device 40′ via a wireless connection, thereby eliminating the need for electrical wiring. In a specific embodiment, the wireless connection may be made via optical communication, where the 2-DoF device 40′ includes a transmitting LED 47. In a particular embodiment, the 2-DoF device 40′ includes a receiver for receiving control signals from the computing system 52. The receiver may be, for example, an input port for a wired connection (e.g., Ethernet port, serial port), a transmitter, a modem, a wireless receiver (e.g., Wi-Fi receiver, Bluetooth® receiver, a radiofrequency receiver, an optical receiver (e.g., photosensor, photodiode, camera)), or a combination thereof. The receiver may send control signals from the computing system 52 directly to the actuators (70a, 70b) and/or motor 64 of the 2-DoF device 40′, or the receiver may be in communication with a processor (e.g., an on-board device computer 80 as further described below) to pre-process the control signals before sending to the actuators (70a, 70b) and/or motor 64.
Referring again to
The computing system 52 may include: a device computer 80 (or controller) including a processor; a planning computer 82 (or controller) including a processor; a tracking computer 84 (or controller) including a processor; and peripheral devices. Processors operate in the computing system 52 to perform computations and execute software associated with the inventive system and method. The device computer 80, the planning computer 82, and the tracking computer 84 may be separate entities as shown in
The peripheral devices allow a user to interface with the computing system 52 and may include, but are not limited to, one or more of the following: one or more user-interfaces, such as a display or monitor 86 to display a graphical user interface (GUI); and user-input mechanisms, such as a keyboard 88, mouse 90, pendent 92, joystick 94, and foot pedal 96. If desired, the monitor 86 may have touchscreen capabilities, and/or the digitizer (10, 10′) and/or the 2-DoF device 40 may include one or more input mechanisms (e.g., voice commands, triggers, buttons, switches, etc.) to interface with the computing system 52.
The device computer 80 may include one or more processors, controllers, software, data, utilities, and/or storage medium(s) (e.g., RAM, ROM or other non-volatile or volatile memory) to perform functions related to the operation of the 2-DoF device 40. By way of example but not limitation, the device computer 80 may include software, data, and utilities to control the POSE of the working portion 58, receive and process tracking data, control the speed of the motor 64, execute registration algorithms, execute calibration routines, provide workflow instructions to the user throughout a surgical procedure, as well as any other suitable software, data or utilities required to successfully perform the procedure in accordance with embodiments of the invention. The device computer 80 may be located separate from the 2-DoF device 40 as shown in
The planning computer 82 is preferably dedicated to planning the procedure either pre-operatively or intra-operatively. By way of example but not limitation, the planning computer 82 may contain hardware (e.g., processors, controllers, memory, etc.), software, data, and utilities capable of: receiving and reading medical imaging data; segmenting imaging data; constructing and manipulating three-dimensional (3D) virtual models; storing and providing computer-aided design (CAD) files such as implant CAD files, bone pin CAD files; planning the POSE of implants, bone tunnels, and/or 3-D virtual ligament or tendon grafts relative to the bone; generating the surgical plan data for use with the system 50; and/or providing other various functions to aid a user in planning the surgical procedure. The final surgical plan data may include pre-procedure data (e.g., an image data set of the bone), bone registration data, subject identification information, and/or the POSE of one or more implants, virtual boundaries, virtual axes, virtual planes, cut-files (e.g., cutting instructions/parameters), soft tissue boundaries, targeted soft tissues, etc. defined relative to the desired tissue. The device computer 80 and the planning computer 82 may be directly connected in the operating room, or may exist as separate entities in different locations. The final surgical plan is readily transferred to the device computer 80 and/or tracking computer 84 through a wired (e.g., electrical connection) or a wireless connection (e.g., optical communication) in the operating room (OR); or transferred via a non-transient data storage medium (e.g., a compact disc (CD), or a portable universal serial bus (USB drive)) if the planning computer 82 is located outside the OR. As described above, the computing system 52 may include one or more computers, with multiple processors capable of performing the functions of the device computer 80, the tracking computer 84, the planning computer 82, or any combination thereof.
The tracking system 26′ (
In specific inventive embodiments, the tracking system 26′ may be incorporated into a surgical light 98 (
The tracking data is preferably determined using the position of the fiducial markers detected from the optical cameras (28a, 28b) and operations/processes such as image processing, image filtering, triangulation algorithms, geometric relationship processing, registration algorithms, calibration algorithms, and coordinate transformation processing.
The tracking system 26′ may further receive and store data related to the calibration definitions described herein, and perform the comparisons/calculations for the calibration checks of a device (e.g., check the calibration of a digitizer (10, 10′) or a 2-DoF device 40 with the methods described herein). The tracking system 26′ may further include a transmitter for transmitting data to the 2-DoF device 40.
Bi-directional optical communication may occur between the 2-DoF device 40 and the tracking system 26′ by way of a modulated light source (e.g., light emitting diode (LED)) and a photosensor (e.g., photodiode, camera). The 2-DoF device 40 may include an LED 47 and a photosensor (i.e., a receiver) disposed on the working portion 58 or hand-held portion 56, where the LED and photosensor are in communication with at least one of a modem, a processor, or an on-board device computer. Data generated internally by the 2-DoF device 40 may be sent to the tracking system 26′ by modulating the LED, where the light signals (e.g., infrared, visible light) created by the modulation of the LED are detected by the tracking system optical detectors (e.g., cameras) or a dedicated photosensor and processed by the tracking system computer 84. The tracking system 106 may likewise send data to the 2-DoF device 40 with a modulated LED associated with the tracking system 26′. Data generated by the tracking system 26′ may be sent to the 2-DoF device 40 by modulating the LED on the tracking system 26′, where the light signals are detected by the photosensor on the 2-DoF device 40 and processed by a processor in the 2-DoF device 40. Examples of data sent from the tracking system 26′ to the 2-DoF device 40 includes operational data, medical planning data, informational data, control data, positional or tracking data, pre-procedure data, or instructional data. Examples of data sent from the 2-DoF device 40 to the tracking system 26′ may include motor position data, battery life, operating status, logged data, operating parameters, warnings, or faults.
While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or exemplary embodiments are only examples, and are not intended to limit the scope, applicability, or configuration of the described embodiments in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient roadmap for implementing the exemplary embodiment or exemplary embodiments. It should be understood that various changes may be made in the function and arrangement of elements without departing from the scope as set forth in the appended claims and the legal equivalents thereof.
This application claims priority benefit of U.S. Provisional Application Ser. No. 63/006,765 filed 8 Apr. 2020; the content of which is hereby incorporated by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/026350 | 4/8/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63006765 | Apr 2020 | US |
