Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
  • A61C1/00—Dental machines for boring or cutting ; General features of dental machines or apparatus, e.g. hand-piece design
  • A61C1/08—Machine parts specially adapted for dentistry
  • A61C1/082—Positioning or guiding, e.g. of drills
• • 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
• • 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
  • 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
  • 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
  • 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
  • A61B2090/3966—Radiopaque markers visible in an X-ray image
• • 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
  • A61B2090/3983—Reference marker arrangements for use with image guided surgery

Definitions

• the invention relates to location monitoring hardware and software systems.
• the invention relates to determining the location and orientation of fiducial references during medical procedures.
• a carrier assembly bears 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.
• an apparatus comprising a rigid positioning and orienting portion and a three-dimensional tracking marker is monolithically integrated with the rigid positioning and orienting portion.
• the apparatus of the invention may be a medical instrument comprising a rigid positioning and orienting portion and a three-dimensional tracking marker monolithically integrated with the rigid positioning and orienting portion. More particularly, the medical instrument may be a medical hand instrument. More specifically, the medical hand instrument may be a surgical hand instrument.
• the monolithically integrated tracking marker may be shaped for having its location and/or its orientation determined. More particularly, the monolithically integrated tracking marker may be shaped for having its location and/or its orientation determined by a two-dimensional imaging tracker.
• the tracking marker may comprise positioning and orienting markings for having its location and/or its orientation determined and the positioning and orienting markings may be monolithically integrated with the tracking marker. In some embodiments the positioning and orienting markings may be scribed or engraved on the monolithically integrated tracking marker.
• a surgical monitoring system comprising a tracker having a field of view; a surgical instrument comprising a rigid positioning and orienting portion; and a three-dimensional tracking marker monolithically integrated with the rigid positioning and orienting portion of the surgical instrument and trackable by the tracker within the field of view of the tracker.
• the tracking marker may shaped and/or marked for having its location and/or its orientation determined by the tracker, which may be a two- dimensional imaging tracker.
• Positioning and orienting marks may be monolithically integrated with the monolithically integrated tracking marker.
• a method for making a three dimensionally tracakble rigid positioning and orienting portion of an apparatus comprising making a three-dimensional tracking marker monolithically integrated with the rigid positioning and orienting portion.
• Positioning and orienting markings may be monolithically integrated with the tracking marker during manufacture of the rigid positioning and orienting portion.
• a surgical monitoring system comprising a tracker having a field of view; and a surgical instrument comprising a three-dimensional tracking marker bearing markings, the markings comprising a plurality of contrasting portions arranged in a rotationally asymmetric partem; wherein the three-dimensional tracking marker is trackable by the tracker within the field of view of the tracker and is monolithically integrated with a rigid positioning and orienting portion of the surgical instrument.
• the markings may be monolithically integrated with the tracking marker and may be scribed, engraved, stamped, or embossed on the tracking marker.
• the tracker may a non-stereo optical tracker.
• the surgical monitoring system may further comprise a single fiducial reference bearing at least three identifiable location points disposed along at least two non-parallel lines.
• the at least three identifiable location points may be a plurality of identifiable location points.
• the plurality of location points may be distributed in three dimensions.
• a method for determining the location and orientation in three dimensions of a fiducial reference comprises disposing the fiducial reference to render a portion of the fiducial reference observable by a scanner; obtaining from the scanner scan data of the portion of the fiducial reference that is observable by the scanner; 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 points may comprise a plurality of location points and the plurality of points may be distributed in three dimensions.
• the at least three location points may be four location points having coordinates arranged along two non-parallel lines.
• the method may further comprise storing the predetermined geometric information in the database.
• a method for determining the location and orientation of a tracking marker in three dimensions comprising disposing the tracking marker to render a portion of the tracking marker observable by a tracker; obtaining from the tracker image information of the portion of the tracking marker that is observable by the tracking marker; obtaining from a database predetermined geometric information about location points on the tracking marker, the geometric information comprising three-dimensional coordinates of the location points relative to a structure of the tracking marker; identifying within the image information 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 tracking marker from the image information and from the coordinates of the at least three identified location points in the predetermined geometric information.
• the at least three location points may comprise a plurality of location points.
• the plurality of points may be distributed in three dimensions.
• the at least three location points may be four location points having coordinates arranged along two non-parallel lines.
• the method may further comprise storing the predetermined geometric information in the database.
• Figure 1 is a schematic diagrammatic view of a network system in which embodiments of the present invention may be utilized.
• Figure 2 is 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.
• Figures 3 A- J are drawings of hardware components of the surgical monitoring system according to embodiments of the invention.
• Figures 4A-C is a flow chart diagram illustrating one embodiment of the registering method of the present invention.
• Figure 5 is a drawing of a dental fiducial key with a tracking pole and a dental drill according to one embodiment of the present invention.
• Figure 6 is a drawing of an endoscopic surgical site showing the fiducial key, endoscope, and biopsy needle according to another embodiment of the invention.
• Figure 7 is a drawing of a biopsy needle showing an embodiment of a monolithically integrated tracking marker.
• Figure 8a is a more detailed view of the fiducial reference of Figures 3 A-E and Figures 3 G-J.
• Figure 8b shows a partial version of the fiducial reference of Figures 3 A-E and Figures 3 G-J.
• a computer generally includes a processor for executing instructions and memory for storing instructions and data, including interfaces to obtain and process imaging data.
• a general-purpose computer has 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 instructions may 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 algorithm is 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.
• Data structures greatly facilitate data management by data processing systems, and are not accessible except through sophisticated software systems.
• Data structures are 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 performed are 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 invention include 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 invention relates 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 computer operates 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 instructions may 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 module may 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 invention also relates to an apparatus for performing these operations.
• This apparatus may 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 herein are not inherently related to any particular computer or other apparatus unless explicitly indicated as requiring particular hardware.
• the computer programs may communicate or relate to other programs or equipments through signals configured to particular protocols, which may or may not require specific hardware or programming to interact.
• various general-purpose machines may 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 invention may deal with "object-oriented” software, and particularly with an "object-oriented” operating system.
• the "object-oriented” software is 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 operations include, 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 object has a corresponding software object that may collect and transmit observed data from the physical device to the software system.
• Such observed data may 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.
• Messages are 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 operation a message procedure
• Each object has 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 system is 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 messages comprises an object-oriented program.
• Object-oriented computer programming facilitates 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 operator may stimulate a collection of interrelated objects comprising an object-oriented program by sending a message to one of the objects.
• the receipt of the message may cause the object to respond by carrying out predetermined functions, which may include sending additional messages to one or more other objects.
• the other objects may in turn carry out additional functions in response to the messages they receive, including sending still more messages.
• sequences of message and response may continue indefinitely or may come to an end when all messages have been responded to and no new messages are being sent.
• 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.
• 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.
• Users activate 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 agent sometimes called an intelligent agent
• an agent uses 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 desktop accesses 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.
• API Application 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 invention include 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 Explorer is a trademark of Microsoft Corporation
• 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).
• SGML Markup Language
• HTML HyperText Markup Language
• XML extensible Markup Language
• DTD Document Type Definitions
• the XML file may 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).
• PDA personal digital assistant
• WW AN wireless wide area network
• synchronization means 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).
• communication primarily 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.
• PCS personal communications service
• CDMA code-division multiple access
• TDMA time division multiple access
• GSM Global System for Mobile Communications
• 3G Third Generation
• 4G fourth Generation
• PDC personal digital cellular
• CDPD cellular digital packet data
• AMPS Advance Mobile Phone Service
• Mobile Software refers 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 Software are 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. of Sunnyvale, California), Symbian OS (Symbian is a registered trademark of Symbian Software Limited Corporation of London, United Kingdom), ANDROID OS (ANDROID is a registered trademark of Google, Inc. of Mountain View, California), and iPhone OS (iPhone is a registered trademark of Apple, Inc. of Cupertino, California) , and Windows Phone 7.
• “Mobile Apps” refers to software programs written for execution with Mobile Software.
• scan refers 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.
• MRI magnetic resonance imaging
• CT computerized tomography
• CBCT cone beam computerized tomography
• imaging reference or simply “fiducial” refers to an object or reference on the image of a scan that is uniquely identifiable as a fixed recognizable point.
• 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.
• RFID radio frequency identifier
• 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.
• the tracker may be a non-stereo optical tracker, for example a camera.
• the camera may, for example, operate in the visible or near-infrared range.
• image information is used in the present specification to describe information obtained by the tracker, whether optical or otherwise, and usable for determining the location of the markers and their orientation and movement continually in 'real time' during a procedure.
• Figure 1 is a high-level block diagram of a computing environment 100 according to one embodiment.
• Figure 1 illustrates 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 100 may have thousands or millions of clients 112 connected to network 114, for example the Internet.
• FIG. 2 depicts a block diagram of computer system 210 suitable for implementing server 110 or client 112.
• Computer system 210 includes 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 to bus 212 via serial port 230), and network interface 248 (coupled directly to bus 212).
• Bus 212 allows 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.
• RAM is generally the main memory into which operating system and application programs are loaded.
• ROM or flash memory may contain, among other software code, Basic Input-Output system (BIOS), which controls basic hardware operation such as interaction with peripheral components.
• BIOS Basic Input-Output system
• Applications resident with computer system 210 are 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 23 may connect to standard computer readable media for storage and/or retrieval of information, such as fixed disk drive 244.
• Fixed disk drive 244 may be part of computer system 210 or may be separate and accessed through other interface systems.
• Modem 247 may provide direct connection to remote servers via telephone link or the Internet via an Internet service provider (ISP) (not shown).
• ISP Internet service provider
• Network interface 248 may provide direct connection to remote servers via direct network link to the Internet via a POP (point of presence).
• Network interface 248 may provide such connection using wireless techniques, including digital cellular telephone connection, Cellular Digital Packet Data (CDPD) connection, digital satellite data connection or the like.
• CDPD Cellular Digital Packet Data
• Software source and/or object codes to implement the present disclosure may 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 210 may 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-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
• a signal may 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 signal may 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 signals in 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 block may 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 invention relates to embodiments of surgical hardware and software monitoring systems and methods which allow 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 system uses a particularly configured piece of hardware, represented as single fiducial key 10 in Figure 3A, to orient tracking marker 12 of the monitoring system with regard to the critical area of the surgery.
• Single fiducial key 10 is 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.
• Tracking marker 12 may be connected to fiducial key 10 by tracking pole 11.
• a tracking marker may be attached directly to the fiducial reference.
• the tracker may be a non- stereo optical tracker.
• the dental tracking marker 12 may be used to securely locate the fiducial 10 near the surgical area.
• the single fiducial key 10 may 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.
• additional tracking markers 12 may 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 site may 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 tracking marker 12 and of any other additional tracking markers relative to the scan data of the surgical area.
• the tracker attached to an instrument may be a miniature digital camera and it may be attached, for example, to a dentist's drill. Any other markers to be tracked by the tracker attached to the item or instrument must be within the field of view of the tracker.
• the patient is scanned to obtain an initial scan of the surgical site.
• the particular configuration of single fiducial key 10 allows 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 reference includes a marking that is apparent as a recognizable identifying symbol when scanned.
• the fiducial reference includes 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 computer software may 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 system relates 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 system may 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 system has a predetermined knowledge of the physical configuration of 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 10 Once single 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 model is then derived in the form of a transformation matrix to relate the fiducial system, being fiducial key 10 in one particular embodiment, to the coordinate system of the surgical site.
• the resulting virtual construct may 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 hardware includes a tracking attachment to the fiducial reference.
• the tracking attachment to fiducial key 10 is tracking marker 12, which is attached to fiducial key 10 via tracking pole 11.
• Tracking marker 12 may have a particular identifying pattern.
• the trackable attachment, for example tracking marker 12, and even associated tracking pole 11 may 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.
• single fiducial key 10 may have hole 15 in a predetermined location specially adapted for engagement with insert 17 of tracking pole 11.
• tracking poles 11 may 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. [00052] It is further possible to reorient the tracking pole during a surgical procedure.
• Such reorientation may 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 pole may 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-registration may be automatically initiated when, for example in the case of the dental surgery embodiment, tracking pole 11 with its attached tracking marker 12 are removed from hole 15 of fiducial key 10 and another tracking marker with its associated tracking pole is connected to an alternative hole on fiducial key 10.
• boundary conditions may be implemented in the software so that the user is notified when observational data approaches and /or enters the boundary areas.
• a surgical instrument or implement herein 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 tracking markers as described herein.
• a boundary condition may 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 conditions may 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-I An alternative embodiment of some hardware components are shown in Figures 3G-I.
• Single 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 system is 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 components may vary according to regulatory requirements and practical considerations.
• the key or fiducial component is 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 material should be lightweight and suitable for connection to an apparatus on the patient.
• the materials of the fiducial key must be suitable for connection to a plastic splint and suitable for connection to a tracking pole.
• the materials of the fiducial key may be suitable for attachment to the skin or other particular tissue of a patient.
• the tracking markers are clearly identified by employing, for example without limitation, high contrast pattern engraving.
• the materials of the tracking markers are chosen to be capable of resisting damage in autoclave processes and are compatible with rigid, repeatable, and quick connection to a connector structure.
• the tracking markers and associated tracking poles have 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 poles must 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 markers should be capable of tracking with suitable accuracy objects of a size of the order of 1.5 square centimeters.
• the tracker may be, by way of example without limitation, a stereo camera or stereo camera pair. 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.
• 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.
• 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 4B together present, without limitation, a flowchart of one method for determining the three- dimensional location and orientation of the fiducial reference from scan data.
• Figure 4C presents 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 system obtains 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 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].
• HU Hounsfield unit
• the CT value threshold is 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 process is to continue, then the user can be notified that no tracking marker has been found in the image information [450], 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 from a suitable database [452].
• database is 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 orientation may 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 marker is used to define the origin of a coordinate system at the fiducial reference and to determine the three-dimensional orientation of the fiducial reference based on the image information [454] and the registration process ends [458].
• the process may be looped back from step [454] to obtain new image information from the camera [442].
• a suitable query point may 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 data are known to practitioners of the art and will not be dwelt upon here.
• the coordinate system so derived is then used for tracking the motion of any items bearing tracking markers in the proximity of the surgical site.
• FIG. 5 One example of an embodiment of the invention is shown in Figure 5.
• additional instrument or implement 506 for example a hand piece which may be a dental drill, may be observed by camera 508 serving as tracker of the monitoring system.
• Surgery site 600 for 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 markers may be in use in the process of the surgery at surgery site 600.
• endoscope 606 may have a further tracking marker, and biopsy needle 608 may also be present bearing a tracking marker at surgery site 600.
• Sensor 610 serving as tracker for the system, may be for example a camera, infrared sensing device, or RADAR.
• the tracker may 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 tracking markers in the field of view of the tracker.
• tracker 610 may be a non- stereo optical tracker.
• Surgery site 600, endoscope 606, biopsy needle 608, fiducial key 602 and tracking marker 604 may all be in the field of view of tracker 610.
• FIG 6 shows one embodiment of a tracking marker used to track biopsy needle 608.
• Figure 7 shows another embodiment of a tracking marker of, for example, biopsy needle 608.
• tracking marker 618 is 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 608 is its handle 612.
• Handle 612 may, for example be molded, cast, machined or otherwise fashioned from one monolithic piece of material and tracking marker 618 is fashioned, formed or made from the same monolithic piece of material. Tracking marker 618 may be formed during the same process as that within which the rigid handle portion 612 of the biopsy needle 608 is made.
• Handle 612 itself 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.
• tracking marker 618 is 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 610 provides the user with the location and orientation of the point of biopsy needle 608.
• the relevant rigid positioning and orienting portion of biopsy needle 608 is the half of handle 612 with which tracking marker 618 is monolithically integrated.
• tracking marker As with tracking markers described in other embodiments, tracking marker
• tracking marker 618 may 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 618 may 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.
• tracking marker may be both shaped and marked to allow its orientation, its location, or both to be determined.
• positioning and orienting markings may be scribed, engraved, stamped, embossed or otherwise formed on tracking marker 618.
• Useful markings for determining the location and orientation of tracking marker 618 may comprise 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 portion may comprise a conic section, including for example an ellipse or a circle.
• the markings may be monolithically integrated with the tracking marker.
• 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 controller for 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 tracking marker 618 in order to determine the three dimensional location and orientation of tracking marker 618 and its associated biopsy needle 608.
• a method for making a three dimensionally trackable rigid positioning and orienting portion of an apparatus comprises monolithically forming a three-dimensional tracking marker integral with the rigid positioning and orienting portion of the apparatus.
• the method may further comprise monolithically forming positioning and orienting markings integral with the tracking marker.
• the method may further comprise scribing, engraving, stamping, embossing or otherwise forming positioning and orienting markings on the three-dimensional tracking marker.
• FIG 8a shows fiducial key 13.
• fiducial key 10 may be marked or shaped, or both, in order to allow its location and orientation to be determined in three dimensions.
• fiducial key 10 is marked to allow its location and orientation to be determined in three dimensions.
• five identifiable location points on fiducial key 10 are 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 triangles may be formed from lines joining the five points.
• fiducial key 10 may be determined uniquely.
• Figure 8a there are several other points that may be similarly employed to form other triangles that may be used in similar fashion.
• FIG 8b shows the same tag 10, but it is either broken or only partially observable so as to present only portion 10' for observation by a suitable scanner.
• the term "observable” is used here to describe the image-wise detectability of the fiducial reference by the scanner with the scanner 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 scanner (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.
• the identifiable points on 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.
• fiducial reference 10 The underlying requirement to fully determine the location and orientation of 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 scanner, and identifiable from a from a preexisting database in which their three-dimensional locations are known relative to the structure of fiducial reference 10.
• fiducial reference 10 In general a plurality of identifiable points arranged in a general distribution on fiducial reference 10, or on portion 10' of fiducial reference 10, may be employed, the accuracy of the method improving with the number of identifiable points employed.
• the entire fiducial reference employed does not have to be observable to the scanner, as long as at least three pre-identified points are observable by the scanner and the three-dimensional locations of those three pre-identified points are known relative to the structure of the fiducial reference 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 embodiments comprises disposing the fiducial reference to render a portion of the fiducial reference observable by a scanner; obtaining from the scanner scan data of the portion of the fiducial reference that is observable by the scanner; 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 points may comprise a plurality of location points and the plurality of points may be distributed in three dimensions.
• a method for determining the location and orientation of a tracking marker in three dimensions comprising disposing the tracking marker to render a portion of the tracking marker observable by a tracker; obtaining from the tracker image information of the portion of the tracking marker that is observable by the tracking marker; obtaining from a database predetermined geometric information about location points on the tracking marker, the geometric information comprising three-dimensional coordinates of the location points relative to a structure of the tracking marker; identifying within the image information 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 tracking marker from the image information and from the coordinates of the at least three identified location points in the predetermined geometric information.
• the at least three location points may comprise a plurality of location points.
• the plurality of points may be distributed in three dimensions.
• the at least three location points may be four location points having coordinates arranged along two non-parallel lines.
• the method may further comprise storing the predetermined geometric information in the database.

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