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NAVIGATE SURGICAL TECHNOLOGIES Inc
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NAVIGATE SURGICAL TECHNOLOGIES Inc
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Publication of WO2017029203A1publicationCriticalpatent/WO2017029203A1/fr
A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
A61B90/06—Measuring instruments not otherwise provided for
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
A61B90/36—Image-producing devices or illumination devices not otherwise provided for
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
A61B90/90—Identification means for patients or instruments, e.g. tags
A61B90/94—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
A61B2034/101—Computer-aided simulation of surgical operations
A61B2034/102—Modelling of surgical devices, implants or prosthesis
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B2034/2046—Tracking techniques
A61B2034/2055—Optical tracking systems
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
A61B2034/2046—Tracking techniques
A61B2034/2065—Tracking using image or pattern recognition
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
A61B34/25—User interfaces for surgical systems
A61B2034/256—User interfaces for surgical systems having a database of accessory information, e.g. including context sensitive help or scientific articles
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
A61B90/06—Measuring instruments not otherwise provided for
A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
A61B2090/3937—Visible markers
A—HUMAN NECESSITIES
A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
A61B34/25—User interfaces for surgical systems
Definitions
the inventionrelates to location monitoring hardware and software systems. More specifically, the invention relates to determining the location and orientation of fiducial references during medical procedures.
a carrier assemblybears at least one fiducial marker onto an attachment element in a precisely repeatable position with respect to a patient's jaw bone, employing the carrier assembly for providing registration between the fiducial marker and the patient's jaw bone and implanting the tooth implant by employing a tracking system which uses the registration to guide a drilling assembly.
a method for determining the location and orientation in three dimensions of a vectorized fiducial referencecomprises disposing the fiducial reference to render a part of the fiducial reference observable by a tracker; obtaining from the tracker scan data of the part of the fiducial reference that is observable by the tracker; obtaining from a database predetermined geometric information about location points on the fiducial reference, the geometric information comprising three-dimensional coordinates of the location points relative to the structure of the fiducial reference; identifying within the scan data at least three location points having coordinates arranged along at least two non-parallel lines in the predetermined geometric information; and determining the three-dimensional location and orientation of the fiducial reference from the scan data and from the coordinates of the at least three identified location points in the predetermined geometric information.
the at least three location pointsmay comprise a plurality of location points and the plurality of points may be distributed in three dimensions.
the at least three location pointsmay be four location points having coordinates arranged along two non-parallel lines.
the methodmay further comprise storing the predetermined geometric information in the database.
a method for making a three- dimensionally trackable apparatus having a working tipcomprising monolithically forming a three-dimensional passive tracking marker integral with a rigid positioning and orienting portion of the apparatus, the rigid positioning and orienting portion having a predetermined spatial relationship with respect to the working tip; obtaining a first machine -vision image of the tracking marker and the rigid positioning and orienting portion; and vectorizing the marker by establishing based on the first machine -vision image and the predetermined spatial relationship a rotationally asymmetric pattern on the tracking marker.
the establishing a rotationally asymmetric patternmay comprise establishing a plurality of contrasting portions.
the methodmay further comprise associating a unique serial number with the rigid positioning and orienting portion; obtaining after the establishing a pattern a second machine vision image of the rigid positioning and orienting portion and the tracking marker comprising the rotationally asymmetric pattern; determining from the second machine -vision image an actual spatial relationship between the rotationally asymmetric pattern and the working tip; and recording the actual spatial relationship in association with the unique serial number.
the recordingmay comprise affixing an RFID chip to the at least one portion; and programming the actual spatial relationship into the RFID chip.
the establishing a plurality of contrasting portionsmay comprise establishing at least one contrasting portion having a mathematically describable perimeter.
the establishing a rotationally asymmetric patternmay comprise one of scribing, engraving, stamping, and embossing contrasting portions onto the tracking marker.
Figure 1is a schematic diagrammatic view of a network system in which embodiments of the present invention may be utilized.
Figure 2is a block diagram of a computing system (either a server or client, or both, as appropriate), with optional input devices (e.g., keyboard, mouse, touch screen, etc.) and output devices, hardware, network connections, one or more processors, and memory/storage for data and modules, etc. which may be utilized as controller and display in conjunction with embodiments of the present invention.
input devicese.g., keyboard, mouse, touch screen, etc.
output devicese.g., hardware, network connections, one or more processors, and memory/storage for data and modules, etc. which may be utilized as controller and display in conjunction with embodiments of the present invention.
Figures 3A-Jare drawings of hardware components of the surgical monitoring system according to embodiments of the invention.
Figures 4A-Cis a flow chart diagram illustrating one embodiment of the registering method of the present invention
Figure 5is a drawing of a dental fiducial key with a tracking pole and a dental drill according to one embodiment of the present invention
Figure 6is a drawing of an endoscopic surgical site showing the fiducial key, endoscope, and biopsy needle according to another embodiment of the invention.
Figure 7is a drawing of a biopsy needle showing an embodiment of a monolithically integrated vectorized passive tracking marker.
Figure 8ais a more detailed view of the fiducial reference of Figures 3 A-E and Figures 3 G-J.
Figure 8bshows a partial version of the fiducial reference of Figures 3 A-E and Figures 3 G-J.
Figure 9shows a flow chart of a method for making a three-dimensionally trackable apparatus.
a computergenerally includes a processor for executing instructions and memory for storing instructions and data, including interfaces to obtain and process imaging data.
a general-purpose computerhas a series of machine encoded instructions stored in its memory, the computer operating on such encoded instructions may become a specific type of machine, namely a computer particularly configured to perform the operations embodied by the series of instructions.
Some of the instructionsmay be adapted to produce signals that control operation of other machines and thus may operate through those control signals to transform materials far removed from the computer itself.
An algorithmis here, and generally, conceived to be a self-consistent sequence of steps leading to a desired result. These steps are those requiring physical manipulations of physical quantities, observing and measuring scanned data representative of matter around the surgical site. Usually, though not necessarily, these quantities take the form of electrical or magnetic pulses or signals capable of being stored, transferred, transformed, combined, compared, and otherwise manipulated. It proves convenient at times, principally for reasons of common usage, to refer to these signals as bits, values, symbols, characters, display data, terms, numbers, or the like as a reference to the physical items or manifestations in which such signals are embodied or expressed to capture the underlying data of an image. It should be borne in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely used here as convenient labels applied to these quantities.
Data structuresgreatly facilitate data management by data processing systems, and are not accessible except through sophisticated software systems.
Data structuresare not the information content of a memory, rather they represent specific electronic structural elements that impart or manifest a physical organization on the information stored in memory. More than mere abstraction, the data structures are specific electrical or magnetic structural elements in memory, which simultaneously represent complex data accurately, often data modeling physical characteristics of related items, and provide increased efficiency in computer operation.
the manipulations performedare often referred to in terms, such as comparing or adding, commonly associated with mental operations performed by a human operator. No such capability of a human operator is necessary, or desirable in most cases, in any of the operations described herein that form part of the present invention; the operations are machine operations.
Useful machines for performing the operations of the present inventioninclude general-purpose digital computers or other similar devices. In all cases the distinction between the method operations in operating a computer and the method of computation itself should be recognized.
the present inventionrelates to a method and apparatus for operating a computer in processing electrical or other (e.g., mechanical, chemical) physical signals to generate other desired physical manifestations or signals.
the computeroperates on software modules, which are collections of signals stored on a media that represents a series of machine instructions that enable the computer processor to perform the machine instructions that implement the algorithmic steps.
Such machine instructionsmay be the actual computer code the processor interprets to implement the instructions, or alternatively may be a higher level coding of the instructions that is interpreted to obtain the actual computer code.
the software modulemay also include a hardware component, wherein some aspects of the algorithm are performed by the circuitry itself rather as a result of an instruction.
the present inventionalso relates to an apparatus for performing these operations.
This apparatusmay be specifically constructed for the required purposes or it may comprise a general-purpose computer as selectively activated or reconfigured by a computer program stored in the computer.
the algorithms presented hereinare not inherently related to any particular computer or other apparatus unless explicitly indicated as requiring particular hardware.
the computer programsmay communicate or relate to other programs or equipment through signals configured to particular protocols, which may or may not require specific hardware or programming to interact.
various general- purpose machinesmay be used with programs written in accordance with the teachings herein, or it may prove more convenient to construct more specialized apparatus to perform the required method steps. The required structure for a variety of these machines will appear from the description below.
the present inventionmay deal with "object-oriented” software, and particularly with an "object-oriented” operating system.
the "object-oriented” softwareis organized into “objects”, each comprising a block of computer instructions describing various procedures ("methods") to be performed in response to "messages" sent to the object or "events" which occur with the object.
Such operationsinclude, for example, the manipulation of variables, the activation of an object by an external event, and the transmission of one or more messages to other objects.
a physical objecthas a corresponding software object that may collect and transmit observed data from the physical device to the software system.
Such observed datamay be accessed from the physical object and/or the software object merely as an item of convenience; therefore where "actual data” is used in the following description, such "actual data” may be from the instrument itself or from the corresponding software object or module.
Messagesare sent and received between objects having certain functions and knowledge to carry out processes. Messages are generated in response to user instructions, for example, by a user activating an icon with a "mouse" pointer generating an event. Also, messages may be generated by an object in response to the receipt of a message. When one of the objects receives a message, the object carries out an operation (a message procedure) corresponding to the message and, if necessary, returns a result of the operation.
an operationa message procedure
Each objecthas a region where internal states (instance variables) of the object itself are stored and where the other objects are not allowed to access.
One feature of the object-oriented systemis inheritance. For example, an object for drawing a "circle" on a display may inherit functions and knowledge from another object for drawing a "shape" on a display.
a programmer"programs" in an object-oriented programming language by writing individual blocks of code each of which creates an object by defining its methods.
a collection of such objects adapted to communicate with one another by means of messagescomprises an object-oriented program.
Object-oriented computer programmingfacilitates the modeling of interactive systems in that each component of the system may be modeled with an object, the behavior of each component being simulated by the methods of its corresponding object, and the interactions between components being simulated by messages transmitted between objects.
An operatormay stimulate a collection of interrelated objects comprising an object-oriented program by sending a message to one of the objects.
the receipt of the messagemay cause the object to respond by carrying out predetermined functions, which may include sending additional messages to one or more other objects.
the other objectsmay in turn carry out additional functions in response to the messages they receive, including sending still more messages.
sequences of message and responsemay continue indefinitely or may come to an end when all messages have been responded to and no new messages are being sent.
a programmerneed only think in terms of how each component of a modeled system responds to a stimulus and not in terms of the sequence of operations to be performed in response to some stimulus. Such sequence of operations naturally flows out of the interactions between the objects in response to the stimulus and need not be preordained by the programmer.
object-oriented programmingmakes simulation of systems of interrelated components more intuitive, the operation of an object-oriented program is often difficult to understand because the sequence of operations carried out by an object-oriented program is usually not immediately apparent from a software listing as in the case for sequentially organized programs. Nor is it easy to determine how an object-oriented program works through observation of the readily apparent manifestations of its operation. Most of the operations carried out by a computer in response to a program are "invisible" to an observer since only a relatively few steps in a program typically produce an observable computer output.
the term “object”relates to a set of computer instructions and associated data, which may be activated directly or indirectly by the user.
the terms “windowing environment”, “running in windows”, and “object oriented operating system”are used to denote a computer user interface in which information is manipulated and displayed on a video display such as within bounded regions on a raster scanned video display.
the terms “network”, “local area network”, “LAN”, “wide area network”, or “WAN”mean two or more computers that are connected in such a manner that messages may be transmitted between the computers.
⁇typically one or more computers operate as a "server", a computer with large storage devices such as hard disk drives and communication hardware to operate peripheral devices such as printers or modems.
Other computerstermed “workstations”, provide a user interface so that users of computer networks may access the network resources, such as shared data files, common peripheral devices, and inter-workstation communication.
Usersactivate computer programs or network resources to create “processes” which include both the general operation of the computer program along with specific operating characteristics determined by input variables and its environment.
an agentsometimes called an intelligent agent
an agentusing parameters typically provided by the user, searches locations either on the host machine or at some other point on a network, gathers the information relevant to the purpose of the agent, and presents it to the user on a periodic basis.
the term "desktop”means a specific user interface which presents a menu or display of objects with associated settings for the user associated with the desktop.
the desktopaccesses a network resource, which typically requires an application program to execute on the remote server, the desktop calls an Application Program Interface, or "API", to allow the user to provide commands to the network resource and observe any output.
APIApplication Program Interface
the term “Browser”refers to a program which is not necessarily apparent to the user, but which is responsible for transmitting messages between the desktop and the network server and for displaying and interacting with the network user. Browsers are designed to utilize a communications protocol for transmission of text and graphic information over a worldwide network of computers, namely the "World Wide Web" or simply the "Web”.
Browsers compatible with the present inventioninclude the Intemet Explorer program sold by Microsoft Corporation (Internet Explorer is a trademark of Microsoft Corporation), the Opera Browser program created by Opera Software ASA, or the Firefox browser program distributed by the Mozilla Foundation (Firefox is a registered trademark of the Mozilla Foundation).
Internet Exploreris a trademark of Microsoft Corporation
Opera Browser program created by Opera Software ASAor the Firefox browser program distributed by the Mozilla Foundation (Firefox is a registered trademark of the Mozilla Foundation).
Browsersdisplay information, which is formatted in a Standard Generalized Markup Language (“SGML”) or a HyperText Markup Language (“HTML”), both being scripting languages, which embed non-visual codes in a text document through the use of special ASCII text codes.
SGMLStandard Generalized Markup Language
HTMLHyperText Markup Language
Files in these formatsmay be easily transmitted across computer networks, including global information networks like the Internet, and allow the Browsers to display text, images, and play audio and video recordings.
the Webutilizes these data file formats to conjunction with its communication protocol to transmit such information between servers and workstations.
Browsersmay also be programmed to display information provided in an extensible Markup Language (“XML”) file, with XML files being capable of use with several Document Type Definitions (“DTD”) and thus more general in nature than SGML or HTML.
XMLextensible Markup Language
the XML filemay be analogized to an object, as the data and the stylesheet formatting are separately contained (formatting may be thought of as methods of displaying information, thus an XML file has data and an associated method).
PDApersonal digital assistant
WW ANwireless wide area network
synchronizationmeans the exchanging of information between a first device, e.g. a handheld device, and a second device, e.g. a desktop computer, either via wires or wirelessly. Synchronization ensures that the data on both devices are identical (at least at the time of synchronization).
communicationprimarily occurs through the transmission of radio signals over analog, digital cellular, or personal communications service (“PCS”) networks. Signals may also be transmitted through microwaves and other electromagnetic waves.
PCSpersonal communications service
CDMAcode-division multiple access
TDMAtime division multiple access
GSMGlobal System for Mobile Communications
3GThird Generation
4GFourth Generation
PDCpersonal digital cellular
CDPDpacket-data technology over analog systems
AMPSAdvance Mobile Phone Service
Mobile Softwarerefers to the software operating system, which allows for application programs to be implemented on a mobile device such as a mobile telephone or PDA.
Examples of Mobile Softwareare Java and Java ME (Java and JavaME are trademarks of Sun Microsystems, Inc. of Santa Clara, California), BREW (BREW is a registered trademark of Qualcomm Incorporated of San Diego, California), Windows Mobile (Windows is a registered trademark of Microsoft Corporation of Redmond, Washington), Palm OS (Palm is a registered trademark of Palm, Inc.
Symbian OSSymbian is a registered trademark of Symbian Software Limited Corporation of London, United Kingdom
ANDROID OSANDROID is a registered trademark of Google, Inc. of Mountain View, California
iPhone OSiPhone is a registered trademark of Apple, Inc. of Cupertino, California
Windows Phone 7“Mobile Apps” refers to software programs written for execution with Mobile Software. [0034] The terms “scan,” “fiducial reference”, “fiducial location”, “marker,” “tracker” and “image information” have particular meanings in the present disclosure.
scanor derivatives thereof refer to x-ray, magnetic resonance imaging (MRI), computerized tomography (CT), sonography, cone beam computerized tomography (CBCT), or any system that produces a quantitative spatial representation of a patient.
MRImagnetic resonance imaging
CTcomputerized tomography
CBCTcone beam computerized tomography
the term “fiducial location”refers to a useful location to which a fiducial reference is attached. A “fiducial location” will typically be proximate a surgical site.
the term “marker” or “tracking marker”refers to an object or reference that may be perceived by a sensor proximate to the location of the surgical or dental procedure, where the sensor may be an optical sensor, a radio frequency identifier (RFID), a sonic motion detector, an ultra-violet or infrared sensor.
RFIDradio frequency identifier
the term “tracker”refers to a device or system of devices able to determine the location of the markers and their orientation and movement continually in 'real time' during a procedure. As an example of a possible implementation, if the markers are composed of printed targets then the tracker may include a stereo camera pair. In other implementations, the tracker may be a non-stereo tracker and may in particular be a non- stereo optical tracker.
image informationis used in the present specification to describe information obtained by the tracker, whether optical or otherwise, about one or more tracking markers and usable for determining the location of the markers and their orientation and movement continually in 'real time' during a procedure.
vectorizedis used in this specification to describe fiducial keys and tracking markers that are at least one of shaped and marked so as to make their orientation in three dimensions uniquely determinable from their appearance in a scan or in image information. If their three-dimensional orientation is determinable, then their three-dimensional location is also known.
Figure 1is a high-level block diagram of a computing environment 100 according to one embodiment.
Figure 1illustrates server 110 and three clients 112 connected by network 114. Only three clients 112 are shown in Figure 1 in order to simplify and clarify the description.
Embodiments of the computing environment 100may have thousands or millions of clients 112 connected to network 114, for example the Internet. Users (not shown) may operate software 116 on one of clients 112 to both send and receive messages network 114 via server 110 and its associated communications equipment and software (not shown).
FIG. 2depicts a block diagram of computer system 210 suitable for implementing server 110 or client 112.
Computer system 210includes bus 212 which interconnects major subsystems of computer system 210, such as central processor 214, system memory 217 (typically RAM, but which may also include ROM, flash RAM, or the like), input/output controller 218, external audio device, such as speaker system 220 via audio output interface 222, external device, such as display screen 224 via display adapter 226, serial ports 228 and 230, keyboard 232 (interfaced with keyboard controller 233), storage interface 234, disk drive 237 operative to receive floppy disk 238, host bus adapter (HBA) interface card 235A operative to connect with Fibre Channel network 290, host bus adapter (HBA) interface card 235B operative to connect to SCSI bus 239, and optical disk drive 240 operative to receive optical disk 242. Also included are mouse 246 (or other point-and-click device, coupled to bus 212 via serial port 228), modem 247 (coupled
Bus 212allows data communication between central processor 214 and system memory 217, which may include read-only memory (ROM) or flash memory (neither shown), and random access memory (RAM) (not shown), as previously noted.
RAMis generally the main memory into which operating system and application programs are loaded.
ROM or flash memorymay contain, among other software code, Basic Input-Output system (BIOS), which controls basic hardware operation such as interaction with peripheral components.
BIOSBasic Input-Output system
Applications resident with computer system 210are generally stored on and accessed via computer readable media, such as hard disk drives (e.g., fixed disk 244), optical drives (e.g., optical drive 240), floppy disk unit 237, or other storage medium. Additionally, applications may be in the form of electronic signals modulated in accordance with the application and data communication technology when accessed via network modem 247 or interface 248 or other telecommunications equipment (not shown).
Storage interface 23may connect to standard computer readable media for storage and/or retrieval of information, such as fixed disk drive 244.
Fixed disk drive 244may be part of computer system 210 or may be separate and accessed through other interface systems.
Modem 247may provide direct connection to remote servers via telephone link or the Internet via an Internet service provider (ISP) (not shown).
ISPInternet service provider
Network interface 248may provide direct connection to remote servers via direct network link to the Internet via a POP (point of presence).
Network interface 248may provide such connection using wireless techniques, including digital cellular telephone connection, Cellular Digital Packet Data (CDPD) connection, digital satellite data connection or the like.
CDPDCellular Digital Packet Data
Software source and/or object codes to implement the present disclosuremay be stored in computer-readable storage media such as one or more of system memory 217, fixed disk 244, optical disk 242, or floppy disk 238.
the operating system provided on computer system 210may be a variety or version of either MS-DOS® (MS-DOS is a registered trademark of Microsoft Corporation of Redmond, Washington), WINDOWS® (WINDOWS is a registered trademark of Microsoft Corporation of Redmond, Washington), OS/2® (OS/2 is a registered trademark of International Business Machines Corporation of Armonk, New York), UNIX® (UNIX is a registered trademark of X/Open Company Limited of Reading, United Kingdom), Linux® (Linux is a registered trademark of Linus Torvalds of Portland, Oregon), or other known or developed operating system.
MS-DOSMS-DOS is a registered trademark of Microsoft Corporation of Redmond, Washington
WINDOWS®WINDOWS is a registered trademark of Microsoft Corporation of Redmond, Washington
OS/2®OS/2 is a registered
a signalmay be directly transmitted from a first block to a second block, or a signal may be modified (e.g., amplified, attenuated, delayed, latched, buffered, inverted, filtered, or otherwise modified) between blocks.
a signalmay be directly transmitted from a first block to a second block, or a signal may be modified (e.g., amplified, attenuated, delayed, latched, buffered, inverted, filtered, or otherwise modified) between blocks.
modified signalsin place of such directly transmitted signals as long as the informational and/or functional aspect of the signal is transmitted between blocks.
a signal input at a second blockmay be conceptualized as a second signal derived from a first signal output from a first block due to physical limitations of the circuitry involved (e.g., there will inevitably be some attenuation and delay). Therefore, as used herein, a second signal derived from a first signal includes the first signal or any modifications to the first signal, whether due to circuit limitations or due to passage through other circuit elements which do not change the informational and/or final functional aspect of the first signal.
the present inventionrelates to a surgical hardware and software monitoring system and method which allows for surgical planning while the patient is available for surgery, for example while the patient is being prepared for surgery so that the system may model the surgical site.
the systemuses a particularly configured piece of hardware, namely a vectorized fiducial reference, represented as fiducial key 10 in Figure 3A, to orient tracking marker 12 of the monitoring system with regard to the critical area of the surgery.
Fiducial key 10is attached to a location near the intended surgical area, in the exemplary embodiment of the dental surgical area of Figure 3 A, fiducial key 10 is attached to a dental splint 14.
Vectorized tracking marker 12may be connected to fiducial key 10 by tracking pole 11.
a tracking markermay be attached directly to the fiducial reference, being fiducial key 10 in the present embodiment.
the dental tracking marker 12may be used to securely locate the fiducial 10 near the surgical area.
the fiducial key 10may be used as a point of reference, or a fiducial, for the further image processing of data acquired from tracking marker 12 by the tracker.
the fiducial key 10may be disposed in a location or in such orientation as to be at least in part non-visible to the tracker of the system.
additional vectorized tracking markers 12may be attached to items independent of the fiducial key 10 and any of its associated tracking poles 11 or tracking markers 12. This allows the independent items to be tracked by the tracker. Further embodiments of such additional tracking markers are discussed in detail below at the hand of Figures 6 and 7.
At least one of the items or instruments near the surgical sitemay optionally have a tracker attached to function as tracker for the monitoring system of the invention and to thereby sense the orientation and the position of the tracking marker 12 and of any other additional tracking markers relative to the scan data of the surgical area.
the tracker attached to an instrumentmay be a miniature digital camera and it may be attached, for example, to a dentist's drill. Any other vectorized markers to be tracked by the tracker attached to the item or instrument must be within the field of view of the tracker.
fiducial key 10allows computer software stored in memory and executed in a suitable controller, for example processor 214 and memory 217 of computer 210 of Figure 2, to recognize its relative position within the surgical site from the scan data, so that further observations may be made with reference to both the location and orientation of fiducial key 10.
the fiducial referenceincludes a marking that is apparent as a recognizable identifying symbol when scanned.
the fiducial referenceincludes a shape that is distinct in the sense that the body apparent on the scan has an asymmetrical form allowing the front, rear, upper, and lower, and left/right defined surfaces that may be unambiguously determined from the analysis of the scan, thereby to allow the determination not only of the location of the fiducial reference, but also of its orientation.
the marking and/or shape of fiducial key 10allows it to be used as the single and only fiducial key employed in the surgical hardware and software monitoring system.
prior art systemstypically rely on a plurality of fiducials.
the trackermay track several vectorized tracking markers within the monitoring system, only a single vectorized fiducial reference or key 10 of known shape or marking is required.
Figure 5shows vectorized tracking markers 506 and 502 tracked by tracker 508, but there is only one vectorized fiducial reference or key 502 in the system.
Figure 6similarly shows three vectorized markers 604, 606, and 608 being tracked by tracker 610, while there is only a single vectorized fiducial reference or key 602 in the system.
the vectorized tracking markers employed in the present inventionmay be passive.
Passiveis used in the present specification to describe markers that do not rely on any own electronic, electrical, optoelectronic, optical, magnetic, wireless, inductive, or other active signaling function or on any incorporated electronic circuit, whether powered or unpowered, to be identified, located, or tracked.
own active signalingis used in this specification to describe a signal that is temporally modulated by, on, or within the tracking marker.
the tracking markersdo not rely on motion, location, or orientation sensing devices, whether powered or unpowered, to be tracked. They cannot sense their own motion, location, or orientation, nor have they any ability to actively communicate.
fiducial references 502 and 602 of Figure 5 and Figure 6are also passive, as are fiducial references 10 and 10' in Figures 3 A to 3 J, as well as in Figures 8A and 8B later discussed in more detail.
LEDsLight Emitting Diodes
LEDsare not suited as tracking markers, or as components of tracking markers or fiducial references, in respect of the present invention, as there is not enough specificity on the point origin of the light of an LED to serve is a reference point for determining the location or orientation of the tracking marker or fiducial reference.
the chip sizes, packaging and/or lenses employed in the manufacture of LEDsmake it impossible to assign a precise enough point location to the source of the light. For this reason, LEDs are specifically not employed in the tracking markers or fiducial references of the present invention.
the computer softwaremay create a coordinate system for organizing objects in the scan, such as teeth, jaw bone, skin and gum tissue, other surgical instruments, etc.
the coordinate systemrelates the images on the scan to the space around the fiducial and locates the instruments bearing markers both by orientation and position.
the model generated by the monitoring systemmay then be used to check boundary conditions, and in conjunction with the tracker display the arrangement in real time on a suitable display, for example display 224 of Figure 2.
the computer systemhas a predetermined knowledge of the physical configuration of vectorized fiducial key 10 and examines slices/sections of the scan to locate fiducial key 10. Locating of fiducial key 10 may be on the basis of its distinct shape, or on the basis of distinctive identifying and orienting markings upon the fiducial key or on attachments to the fiducial key 10 as tracking marker 12. Fiducial key 10 may be rendered distinctly visible in the scans through higher imaging contrast by the employ of radio-opaque materials or high-density materials in the construction of the fiducial key 10. In other embodiments the material of the distinctive identifying and orienting markings may be created using suitable high density or radio-opaque inks or materials.
fiducial key 10Once vectorized fiducial key 10 is identified, the location and orientation of the fiducial key 10 is determined from the scan segments, and a point within fiducial key 10 is assigned as the center of the coordinate system. The point so chosen may be chosen arbitrarily, or the choice may be based on some useful criterion.
a modelis then derived in the form of a transformation matrix to relate the fiducial system, being vectorized fiducial key 10 in one particular embodiment, to the coordinate system of the surgical site.
the resulting virtual constructmay be used by surgical procedure planning software for virtual modeling of the contemplated procedure, and may alternatively be used by instrumentation software for the configuration of the instrument, for providing imaging assistance for surgical software, and/or for plotting trajectories for the conduct of the surgical procedure.
the monitoring hardwareincludes a tracking attachment to the fiducial reference.
the tracking attachment to vectorized fiducial key 10is vectorized tracking marker 12, which is attached to fiducial key 10 via tracking pole 11.
Vectorized tracking marker 12may have a particular identifying pattern.
the trackable attachment, for example tracking marker 12, and even associated tracking pole 11may have known configurations so that observational data from tracking pole 11 and/or tracking marker 12 may be precisely mapped to the coordinate system, and thus progress of the surgical procedure may be monitored and recorded.
vectorized fiducial key 10may have hole 15 in a predetermined location specially adapted for engagement with insert 17 of tracking pole 11.
tracking poles 11may be attached with a low force push into hole 15 of fiducial key 10, and an audible haptic notification may thus be given upon successful completion of the attachment.
reorient the tracking pole during a surgical proceduremay be in order to change the location of the procedure, for example where a dental surgery deals with teeth on the opposite side of the mouth, where a surgeon switches hands, and/or where a second surgeon performs a portion of the procedure.
the movement of the tracking polemay trigger a re -registration of the tracking pole with relation to the coordinate system, so that the locations may be accordingly adjusted.
Such a re- registrationmay be automatically initiated when, for example in the case of the dental surgery embodiment, tracking pole 11 with its attached vectorized tracking marker 12 are removed from hole 15 of vectorized fiducial key 10 and another tracking marker with its associated tracking pole is connected to an alternative hole on fiducial key 10.
boundary conditionsmay be implemented in the software so that the user is notified when observational data approaches and /or enters the boundary areas.
the tracker of the systemmay comprise a single optical imager obtaining a two- dimensional image of the site being monitored.
the system and method described in the present specificationallow three-dimensional locations and orientations of tracking markers to be obtained using non-stereo-pair two-dimensional imagery.
more than one imagermay be employed as tracker, but the image information required and employed is nevertheless two-dimensional. Therefore the two imagers may merely be employed to secure different perspective views of the site, each imager rendering a two- dimensional image that is not part of a stereo pair. This does not exclude the employment of stereo-imagers in obtaining the image information about the site, but the system and method are specifically not reliant on stereo imagery of the site.
a surgical instrument or implementherein termed a "hand piece" (see Figures 5, 6 and 7), may also have a particular configuration that may be located and tracked in the coordinate system and may have suitable vectorized tracking markers as described herein.
a boundary conditionmay be set up to indicate a potential collision with virtual material, so that when the hand piece is sensed to approach the boundary condition an indication may appear on a screen, or an alarm sound.
target boundary conditionsmay be set up to indicate the desired surgical area, so that when the trajectory of the hand piece is trending outside the target area an indication may appear on screen or an alarm sound indicating that the hand piece is deviating from its desired path.
FIG. 3G- IAn alternative embodiment of some hardware components are shown in Figures 3G- I.
Vectorized fiducial key 10'has connection elements with suitable connecting portions to allow a tracking pole 11' to position a tracking marker 12' relative to the surgical site.
fiducial key 10'serves as an anchor for pole 11' and tracking marker 12' in much the same way as the earlier embodiment, although it has a distinct shape.
the software of the monitoring systemis pre-programmed with the configuration of each particularly identified fiducial key, tracking pole, and tracking marker, so that the location calculations are only changed according to the changed configuration parameters.
the materials of the hardware componentsmay vary according to regulatory requirements and practical considerations.
the key or fiducial componentis made of generally radio opaque material such that it does not produce noise for the scan, yet creates recognizable contrast on the scanned image so that any identifying pattern associated with it may be recognized.
the materialshould be lightweight and suitable for connection to an apparatus on the patient.
the materials of the fiducial keymust be suitable for connection to a plastic splint and suitable for connection to a tracking pole.
the materials of the fiducial keymay be suitable for attachment to the skin or other particular tissue of a patient.
the tracking markersare clearly identified by employing, for example without limitation, high contrast pattern engraving.
the materials of the vectorized tracking markersare chosen to be capable of resisting damage in autoclave processes and are compatible with rigid, repeatable, and quick connection to a connector structure.
the vectorized tracking markers and associated tracking poleshave the ability to be accommodated at different locations for different surgery locations, and, like the fiducial keys, they should also be relatively lightweight as they will often be resting on or against the patient.
the tracking polesmust similarly be compatible with autoclave processes and have connectors of a form shared among tracking poles.
the tracker employed in tracking the fiducial keys, tracking poles and tracking markersshould be capable of tracking with suitable accuracy objects of a size of the order of 1.5 square centimeters.
the trackermay be, by way of example without limitation, a stereo camera or stereo camera pair. In other embodiments, the tracker may specifically be a non- stereo tracker, as already described. In particular, the tracker may be a non-stereo optical tracker. While the tracker is generally connected by wire to a computing device to read the sensory input, it may optionally have wireless connectivity to transmit the sensory data to a computing device. [0056] In embodiments that additionally employ a trackable piece of instrumentation, such as a hand piece, tracking markers attached to such a trackable piece of instrumentation may also be light-weight; capable of operating in a 3 object array with 90 degrees relationship; optionally having a high contrast pattern engraving and a rigid, quick mounting mechanism to a standard hand piece. In other embodiments the tracking markers are monolithically integrated with a rigid positioning and orienting portion of the hand piece, as described in more detail at the hand of Figures 6 and 7.
Figure 4A and Figure 4Btogether present, without limitation, a flowchart of one method for determining the three- dimensional location and orientation of the fiducial reference from scan data.
Figure 4Cpresents a a flow chart of a method for confirming the presence of a suitable tracking marker in image information obtained by the tracker and determining the three-dimensional location and orientation of the fiducial reference based on the image information.
the systemobtains a scan data set [404] from, for example, a CT scanner and checks for a default CT scan Hounsfield unit (HU) value [at 406] for the vectorized fiducial which may or may not have been provided with the scan based on a knowledge of the fiducial and the particular scanner model, and if such a threshold value is not present, then a generalized predetermined default value is employed [408].
HUHounsfield unit
the CT value thresholdis adjusted [at 416], the original value restored [at 418], and the segmenting processing scan segments continues [at 410]. Otherwise, with the existing data a center of mass is calculated [at 420], along with calculating the X, Y, and Z axes [at 422]. If the center of mass is not at the cross point of the XYZ axes [at 424], then the user is notified [at 426] and the process stopped [at 428]. If the center of mass is at the XYZ cross point then the data points are compared with the designed fiducial data [430].
the useris notified [at 434] and the process ends [at 436]. If not, then the coordinate system is defined at the XYZ cross point [at 438], and the scan profile is updated for the HU units [at 440].
an imageis obtained [442] from the tracker, being a suitable camera or other sensor.
the image informationis two-dimensional and is not required to be a stereo image pair.
the image informationmay be sourced from a single imaging device in the tracker, or may be sourced from multiple imaging devices in the tracker. It bears pointing out that the presence of multiple imaging devices in a tracker does not automatically imply stereo imaging.
the image informationis analyzed [444] to determine whether a vectorized tracking marker is present in the image information. If not, then the user is queried [446] as to whether the process should continue or not. If not, then the process is ended [448].
the processis to continue, then the user can be notified [450] that no tracking marker has been found in the image information, and the process returns to obtaining image information [442]. If a tracking marker has been found based on the image information, or one has been attached by the user upon the above notification [450], the offset and relative orientation of the tracking marker to the fiducial reference is obtained
databaseis used in this specification to describe any source, amount or arrangement of such information, whether organized into a formal multi-element or multi-dimensional database or not.
a single data set comprising offset value and relative orientationmay suffice in a simple implementation of this embodiment of the invention and may be provided, for example, by the user or may be within a memory unit of the controller or in a separate database or memory.
the offset and relative orientation of the tracking markeris used to define the origin of a coordinate system at the fiducial reference and to determine [454] the three-dimensional orientation of the fiducial reference based on the image information and the registration process ends [458].
the processmay be looped back from step [454] to obtain new image information from the camera [at step 442].
a suitable query pointmay be included to allow the user to terminate the process.
Detailed methods for determining orientations and locations of predetermined shapes or marked tracking markers from image dataare known to practitioners of the art and will not be dwelt upon here.
the coordinate system so derivedis then used for tracking the motion of any items bearing vectorized tracking markers in the proximity of the surgical site.
Other registration systemsare also contemplated, for example using current other sensory data rather than the predetermined offset, or having a fiducial with a transmission capacity.
FIG. 5One example of an embodiment of the invention is shown in Figure 5.
an additional instrument or implement 506for example a hand piece which may be a dental drill, may be observed by a camera 508 serving as tracker of the monitoring system.
the cameramay be, for example, a non-stereo optical camera.
FIG. 6Another example of an embodiment of the invention is shown in Figure 6.
Surgery site 600for example a human stomach or chest, may have fiducial key 602 fixed to a predetermined position to support tracking marker 604.
Other apparatus with suitable tracking markersmay be in use in the process of the surgery at surgery site 600.
endoscope 606may have a further tracking marker, and biopsy needle 608 may also be present bearing a tracking marker at surgery site 600.
Sensor 610serving as tracker for the system, may be for example a camera, infrared sensing device, or RADAR.
the trackermay be a two-dimensional imaging tracker that produces a two dimensional image of the surgery site 600 for use as image information for the purposes of embodiments of the invention, including two dimensional image information of any vectorized tracking markers in the field of view of the tracker.
the cameramay be, for example, a non-stereo optical camera.
Surgery site 600, endoscope 606, biopsy needle 608, fiducial key 602 and vectorized tracking marker 604may all be in the field of view of tracker 610.
Figure 6shows one embodiment of a tracking marker used to track biopsy needle 608.
Figure 7shows another embodiment of a vectorized tracking marker of, for example, biopsy needle 608.
vectorized tracking marker 618is monolithically integrated with a rigid positioning and orienting portion of biopsy needle 608.
the phrase "monolithically integrated"is used to describe items that are fashioned together from one piece of material; this to be contrasted with a situation where the items are joined together after manufacture, either detachably or through a non-integral coupling.
a suitable rigid positioning and orienting portion of biopsy needle 608is its handle 612.
Handle 612may, for example be molded, cast, machined or otherwise fashioned from one monolithic piece of material and vectorized tracking marker 618 is fashioned, formed or made from the same monolithic piece of material.
Vectorized tracking marker 618may be formed during the same process as that within which the rigid handle portion 612 of the biopsy needle 608 is made.
Handle 612itself may in some embodiments comprise two or more sections, but, when assembled, the two or more sections create a rigid whole that dictates where and how the working end of the apparatus, in this case the point of biopsy needle 608, will be positioned and oriented in three dimensions relative to handle 612.
vectorized tracking marker 618is monolithically integrated with a rigid part of the handle 612 of biopsy needle 608, and the position and orientation of monolithically integrated tracking marker 618 relative to the point of biopsy needle 608 is fixed and known
knowledge of the three-dimensional position and orientation of tracking marker 618 within the field of view of tracker 610provides the user with the location and orientation of the point of biopsy needle 608.
the relevant rigid positioning and orienting portion of biopsy needle 608is the half of handle 612 with which vectorized tracking marker 618 is monolithically integrated.
the monolithic integration of three-dimensional vectorized tracking markers with a rigid positioning and orienting portion of an instrumentis not limited to surgical devices. It may be applied to any medical instrument having a suitable rigid positioning and orienting portion and, indeed, to any apparatus having a suitable rigid positioning and orienting portion.
vectorized tracking marker 618may be shaped in three dimensions so as to allow its orientation to be determined from a two-dimensional image of biopsy needle 608 within the field of view of tracker 610.
monolithically integrated tracking marker 618may have a monolithically integrated marking so as to allow its orientation to be determined from a two- dimensional image of biopsy needle 608 within the field of view of tracker 610.
the vectorized tracking markermay be both shaped and marked to allow its orientation, its location, or both to be determined.
positioning and orienting markingsmay be scribed, engraved, stamped, embossed or otherwise formed on tracking marker 618.
Useful markings for determining the location and orientation of vectorized tracking marker 618are described in United States Patent US8,908,918 and in co-pending United States Patent Application 14/613,827, both titled “System and method for determining the three-dimensional location and orientation of identification markers", both hereby incorporated by reference in full.
the markings on vectorized tracking marker 618 as described in U.S. Patent No. 8,908,918comprise a plurality of contrasting portions arranged in a rotationally asymmetric pattern and at least one of the contrasting portions has a perimeter that has a mathematically describable curved section.
the perimeter of the contrasting portionmay comprise a conic section, including for example an ellipse or a circle.
the markingsmay be monolithically integrated with the tracking marker. In other embodiments the markings may be scribed, engraved, stamped, embossed or otherwise formed on tracking marker 618. Geometric information about the asymmetric pattern may be stored in a database.
a suitable controllerfor example processor 214 and memory 217 of computer 210 of Figure 2, may be used to compare the image information obtained from tracker 610 with the geometric information about vectorized tracking marker 618 in order to determine the three dimensional location and orientation of vectorized tracking marker 618 and its associated biopsy needle 608.
the markingsmay be borne on tracking markers that have a three-dimensional shaped surface.
the tracking systemmay be implemented in a surgical monitoring system in which the markings are on pattern tags attached to tracking markers, or the pattern tags may themselves tracking markers.
the contrasting portionsmay be implemented as contrasting pattern elements on a close-packed tiled background of tiles of at least two mutually contrasting colors.
Figure 8ashows a vectorized fiducial key 13.
the vectorized fiducial key 10may be marked or shaped, or both, in order to allow its location and orientation to be determined in three dimensions.
vectorized fiducial key 10is marked to allow its location and orientation to be determined in three dimensions.
five identifiable location points on vectorized fiducial key 10are shown, being marked as "A", "B", “C”, “D”, "E”. At least five different non-parallel lines may be drawn between these highly identifiable points.
At least four different distinctive trianglesmay be formed from lines joining the five points. It is clear that, with a minimum of three identifiable points, for example "A”, “B”, and “C", the position and orientation of vectorized fiducial key 10 may be determined uniquely. In the case of Figure 8a there are several other points that may be similarly employed to form other triangles that may be used in similar fashion.
FIG. 8bshows the same vectorized fiducial reference or key 10, but it is either broken or only partially observable so as to present only portion 10' for observation by a suitable tracker.
the term "observable”is used here to describe the image-wise detectability of the fiducial reference by the tracker with the tracker employing whatever particular penetrating radiation it is designed to employ. Under both of these circumstances only points “A”, “B”, “C”, and “E” are visible to a tracker (not shown in Figure 8a).
points "A" and "B"for example, together with either of points "C", or “E” suffices. The more points that are available, the more accurately the position and orientation in three dimensions may be determined.
four identifiable pointsdistributed as two sets of two points each along two straight non-parallel lines may be employed to fully determine the three dimensional location and orientation of vectorized fiducial reference 10, or portion 10' of fiducial reference 10.
the line between points "A” and "B", on the one hand, and the line between points "C” and “E” on the other hand,may be employed in this embodiment.
the identifiable points on vectorized fiducial reference 10, or on portion 10' of fiducial reference 10, required to fully determine the location and orientation of fiducial reference 10, or portion 10' of fiducial reference 10,need not be located along two straight lines, but the three-dimensional spatial relationship between the points must be known.
the underlying requirement to fully determine the location and orientation of vectorized fiducial reference 10, or of a portion 10' of fiducial reference 10,is for there to be at least three identifiable location points, for example "A”, "B", and "C", defining two non- parallel lines, observable by the tracker, and identifiable from a from a preexisting database in which their three-dimensional locations are known relative to the structure of fiducial reference 10 or 10'.
fiducial reference 10 or 10' in relation to the at least three identifiable location pointsis specified by the operator of the tracker, for example by data entry of the relevant parameters or by scanning vectorized fiducial reference 10 prior to its use or by scanning a replica of fiducial reference 10, so that upon recognition of at least three location points the location and orientation of fiducial reference 10 or 10' may be determined accordingly.
the systemmay use information relating to the at least three identifiable location points and other image information about fiducial reference 10 or 10', for example at least a portion of an exterior edge, or specific observable shapes or markers on fiducial reference 10 or 10', may be used by image recognition software to identify a specific type or instance of a vectorized fiducial reference and match to a known image of a fiducial reference from a database of known fiducial references, wherein the database has information relating to the specific corresponding structure and relation of the at least three identifiable location points.
the entire vectorized fiducial reference employeddoes not have to be observable to the tracker, as long as at least three pre-identified points are observable by the tracker and the three-dimensional locations of those three pre-identified points are known relative to the structure of the fiducial reference.
the structure of the vectorized fiducial referencemay be entered directly by the operator, or be derived from a suitable database.
the method described above for determining the location and orientation in three dimensions of a general fiducial reference of any of the above embodimentscomprises disposing the vectorized fiducial reference to render a part of the fiducial reference observable by a tracker; obtaining from the tracker scan data of the part of the fiducial reference that is observable by the tracker; obtaining predetermined geometric information about location points on the fiducial reference, the geometric information comprising three-dimensional coordinates of the location points relative to the structure of the fiducial reference; identifying within the scan data at least three location points having coordinates arranged along at least two non-parallel lines in the predetermined geometric information; and determining the three-dimensional location and orientation of the fiducial reference from the scan data and from the coordinates of the at least three identified location points in the predetermined geometric information.
a method for making a three dimensionally trackable rigid positioning and orienting portion of an apparatuscomprises monolithically forming a three-dimensional passive tracking marker integral with the rigid positioning and orienting portion of the apparatus.
the methodmay further comprise monolithically forming positioning and orienting markings integral with the tracking marker to render it vectorized.
the methodmay further comprise scribing, engraving, stamping, embossing or otherwise forming positioning and orienting markings on the three-dimensional tracking marker.
a method [900] for making a three- dimensionally trackable apparatus having a working tipcomprising monolithically forming [910] a three-dimensional passive tracking marker integral with a rigid positioning and orienting portion of the apparatus, the rigid positioning and orienting portion having a predetermined spatial relationship with respect to the working tip; obtaining
a first machine -vision image of the tracking marker and the rigid positioning and orienting portioncomprising [920] a first machine -vision image of the tracking marker and the rigid positioning and orienting portion; and vectorizing [930] the marker by establishing based on the first machine -vision image and the predetermined spatial relationship a rotationally asymmetric pattern on the tracking marker.
the establishing [930] a rotationally asymmetric patternmay comprise establishing a plurality of contrasting portions.
the methodmay further comprise associating [940] a unique serial number with the rigid positioning and orienting portion; obtaining [950] after the establishing a pattem a second machine vision image of the rigid positioning and orienting portion and the tracking marker comprising the rotationally asymmetric pattern; determining [960] from the second machine -vision image an actual spatial relationship between the rotationally asymmetric pattem and the working tip; and recording [970] the actual spatial relationship in association with the unique serial number.
the recordingmay comprise affixing an RFID (Radio Frequency Identification) chip to the at least one portion; and programming the actual spatial relationship into the RFID chip.
RFIDRadio Frequency Identification
the establishing a plurality of contrasting portionsmay comprise establishing at least one contrasting portion having a mathematically describable perimeter.
the establishing a rotationally asymmetric patternmay comprise one of scribing, engraving, stamping, and embossing contrasting portions onto the tracking marker.