WO2013144208A1

WO2013144208A1 - Soft body automatic registration and surgical location monitoring system and method with skin applied fiducial reference

Info

Publication number: WO2013144208A1
Application number: PCT/EP2013/056525
Authority: WO
Inventors: Udi DAON; Martin Gregory Beckett
Original assignee: Navigate Surgical Technologies, Inc.
Priority date: 2012-03-28
Filing date: 2013-03-27
Publication date: 2013-10-03
Also published as: CA2867534A1; EP2830527A1

Abstract

Embodiments of the present invention involve a surgical monitoring systems and methods for modeling surgical procedures. A multi-element fiducial reference pattern (710, 754, 764, 910, 910', 912, 912') observable by a tracker (508, 610, 730, 758, 768, 930, 932) may be transferred directly to the skin proximate the surgical site (), either through a stencil as a radio-opaque ink pattern or via transfer tape, or may be applied in prepared form on a surgical incise film. Alternatively the surgical incise film may be applied over the surgical site and the inked reference pattern applied to the film before surgery. A controller determines the three-dimensional location and orientation of the surgical site by comparing the position and orientation of the reference pattern in a prior scan with the position and orientation of the reference pattern in image information about the surgical site obtained from the tracker. The system may track the movement of instruments relative to the surgical site, or may be used to track changes in the surgical site itself.

Description

SOFT BODY AUTOMATIC REGISTRATION AND

SURGICAL LOCATION MONITORING SYSTEM AND METHOD WITH SKIN APPLIED FIDUCIAL REFERENCE

TECHNICAL FIELD [0001] The invention relates to location monitoring hardware and software systems. More specifically, the field of the invention is that of surgical equipment and software for monitoring surgical conditions.

BACKGROUND ART

[0002] Visual and other sensory systems are known, with such systems being capable of both observing and monitoring surgical procedures. With such observation and monitoring systems, computer aided surgeries are now possible, and in fact are being routinely performed. In such procedures, the computer software interacts with both clinical images of the patient and observed surgical images from the current surgical procedure to provide guidance to the physician in conducting the surgery. For example, in one known system 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. With this relatively new computer implemented technology, further improvements may further advance the effectiveness of surgical procedures.

SUMMARY OF THE INVENTION

[0003] Embodiments of the present invention involves a surgical monitoring system comprising a fiducial reference comprising radio-opaque elements, the fiducial reference adherable to a location on skin proximate a surgical site; a tracker arranged for obtaining image information about the surgical site; and a controller having access to pre-existing scan data of the surgical site with the fiducial reference adhered to the skin, the controller in communication with the tracker and comprising a processor with memory and a software program having a series of instructions that when executed by the processor determines the position and orientation of the fiducial reference based on the image information and the scan data.

[0004] The radio opaque elements may comprise a plurality of pattern segments, each segment configured for having a segmental three-dimensional location and orientation determinable based on the image information and the scan data. The plurality of pattern segments may be borne on a surgical incise film configured for application to the skin. The plurality of pattern segments may comprise at least one of radio-opaque ink and radio-opaque paint.

[0005] The plurality of pattern segments may have an adhesive property and is configured to be adhered directly to the skin.

[0006] The plurality of pattern segments may comprise a transfer film and the plurality of pattern segments is configured to be transferable from the transfer film to the skin. The plurality of pattern segments may comprise one of a radio-opaque ink pattern and a radio- opaque paint pattern applied directly to the skin. [0007] Each segment may be configured in at least one of marked and shaped to allow the segment to be uniquely identified from the scan data and from the image information. At least one of the plurality of pattern segments may have a unique differentiable shape that allows unique identification by the controller from at least one of the scan data and the image information. [0008] The controller may be configured for determining the locations and orientations of at least a selection of the pattern segments based on the image information and the scan data. The controller may be configured to calculate the locations and orientations of anatomical features in the proximity of the plurality of pattern segments. [0009] The surgical monitoring system may further comprise tracking markers attached to at least a selection of the pattern segments, the tracking markers having at least one of identifying marks and orientation marks that allow their three-dimensional orientations to be determined by the controller from the image information. The surgical monitoring system may yet further comprise at least one tracking marker attached to at least one implement proximate the surgery site, wherein the controller is configured for determining a location and an orientation of the at least one implement based on the image information and information about the at least one tracking marker.

[00010] In another embodiment the fiducial reference may comprise a plurality of non- unique elements configured in a spatially arbitrary arrangement. The plurality of non-unique elements may comprise one of a plurality of radio-opaque ink marks and a plurality of radio- opaque paint marks, which marks may be dots.

[0001 1] Another aspect of the invention involves a method for tracking in real time changes in a surgical site of a patient, the method comprising the steps of: removably adhering a fiducial reference to a fiducial location on the patient body proximate the surgical site, the fiducial reference comprising a plurality of pattern segments individually locatable based on scan data; performing a scan with the fiducial reference attached to the fiducial location to obtain the scan data; determining the three-dimensional locations and orientations of at least a selection of the pattern segments based on the scan data; obtaining real time image information of the surgical site; determining in real time the three-dimensional locations and orientations of the at least a selection of the pattern segments from the image information; and deriving in real time the spatial distortion of the surgical site by comparing in real time the three-dimensional locations and orientations of the at least a selection of the pattern segments as determined from the image information with the three-dimensional locations and orientations of the at least a selection of the pattern segments as determined from the scan data. [00012] Yet another aspect of the invention involves a method for relating in real time a three-dimensional location and orientation of a surgical site to a location and orientation of the surgical site in a scan of the surgical site, the method comprising the steps of: applying a fiducial reference in the form of a radio-opaque marker on skin proximate the surgical site; performing the scan to obtain scan data; determining three-dimensional location and orientation of the fiducial reference from the scan data; obtaining real time image information of the surgical site; determining in real time three-dimensional location and orientation information of the fiducial reference from the image information; and deriving a spatial transformation matrix for expressing in real time the three-dimensional location and orientation of the fiducial reference as determined from the image information in terms of the three-dimensional location and orientation of the fiducial reference as determined from the scan data. The fiducial reference may include a plurality of pattern segments individually locatable based on the scan data; the step of determining the three-dimensional location and orientation of the fiducial reference from the scan data comprises determining the three- dimensional location and orientation of at least one of the plurality of pattern segments from the scan data; and the step of determining in real time the three-dimensional location and orientation of the fiducial reference from the image information comprises determining the three-dimensional location and orientation of the at least one of the plurality of pattern segments from the image information.

[00013] The step of applying the fiducial reference to the skin proximate the surgical site may comprise applying a surgical incise film bearing the fiducial reference. The step of applying the fiducial reference on the skin proximate the surgical site may comprise:

applying a surgical incise film to the skin over the surgical site; and applying the fiducial reference pattern to the surgical incise film proximate the surgical site before surgery. [00014] The step of applying a fiducial reference on the skin proximate the surgical site may comprise applying one of radio-opaque ink and radio-opaque paint directly to the skin proximate the surgical site. In a further embodiment the step of applying the fiducial reference may comprise transferring the plurality of pattern segments from a transfer tape. In yet a further embodiment the step of applying the plurality of pattern segments can comprise applying one of radio-opaque ink and radio-opaque paint directly to the skin using one of a mask and a stencil bearing the plurality of pattern segments.

[00015] A further aspect of the invention involves a method for tracking in real time changes in a surgical site, the method comprising the steps of: applying a multi-element fiducial reference to skin proximate the surgical site, the multi-element fiducial reference comprising a plurality of pattern segments individually locatable based on scan data;

performing a scan of the surgical site to obtain the scan data; determining three-dimensional locations and orientations of at least a selection of the pattern segments based on the scan data; obtaining real time image information of the surgical site; determining in real time three-dimensional locations and orientations of the at least one of the pattern segments from the image information; and deriving in real time the spatial distortion of the surgical site by comparing in real time the three-dimensional locations and orientations of the at least one of the pattern segments as determined from the image information with the three-dimensional locations and orientations of the at least one of the pattern segments as determined from the scan data.

[00016] The step of applying the fiducial reference on the skin proximate the surgical site may comprise applying a surgical incise film bearing the plurality of pattern segments. In other embodiments the step of applying the fiducial reference on the skin proximate the surgical site may comprise: applying a surgical incise film to the skin over the surgical site; and transferring the plurality of pattern segments to the surgical incise film proximate the surgical site before surgery. [00017] In yet further embodiments the step of applying the fiducial reference on the skin proximate the surgical site may comprise applying the plurality of pattern segments in the form of one of radio-opaque ink and radio-opaque paint directly to the skin proximate the surgical site. The step of applying the fiducial reference may comprise transferring the plurality of pattern segments from a transfer tape.In an alternative embodiment the step of applying the plurality of pattern segments may comprise applying one of radio-opaque ink and radio-opaque paint directly to the skin using one of a mask and a stencil bearing the plurality of pattern segments.

[00018] Another aspect of the invention involves a method for real time monitoring three-dimensional location and orientation of an object in relation to a surgical site of a patient, the method comprising: applying a fiducial reference on the skin proximate the surgical site; performing a scan of the surgical site to obtain scan data; determining three- dimensional location and orientation of the fiducial reference from the scan data; obtaining real time image information of the surgical site; determining in real time three-dimensional location and orientation of the fiducial reference from the image information; deriving a spatial transformation matrix for expressing in real time the three-dimensional location and orientation of the fiducial reference as determined from the image information in terms of the three-dimensional location and orientation of the fiducial reference as determined from the scan data; determining in real time three-dimensional location and orientation of the object from the image information; and relating the three-dimensional location and orientation of the object to the three-dimensional location and orientation of the fiducial reference as determined from the image information. The step of determining in real time the three- dimensional location and orientation of the object from the image information may comprise attaching to the object a tracking marker. [00019] In another aspect there is provided a method for determining the position and orientation of a tracker with respect to a surgical site, the method comprising the steps of: applying proximate the surgical site an arbirtrarily arranged a plurality of non-unique elements, each element including one of radio-opaque ink and radio-opaque paint, at least a portion of said plurality of elements defining a constellation; obtaining scan data of the surgical site; obtaining image information about the surgical site from a tracker; determining a postion and orientation of at least one of the plurality of elements in the scan data and;

determining a postion and orientation of the constellation in the image information; deriving a three-dimensional transformation matrix to relate the multi-element fiducial pattern to a coordinate system of the surgical site based on the position and orientation of the

constellation in the scan data and the position and orientation of the constellation in the image information; and determining the position and orientation of a tracker with respect to the surgical site. The step of applying the fiducial pattern may include depositing one of a radio-opaque ink and a radio-opaque paint in an arbitrary arrangement of elements. The step of depositing may comprise applying a surgical incise film to the skin over the surgical site; and depositing the one of radio-opaque ink and radio-opaque paint on the surgical incise film.

BRIEF DESCRIPTION OF THE DRAWINGS [00020] The above mentioned and other features and objects of this invention, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of an embodiment of the invention taken in conjunction with the accompanying drawings, wherein:

[00021] Figure 1 is a schematic diagrammatic view of a network system in which embodiments of the present invention may be utilized.

[00022] 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. [00023] Figures 3A-J are drawings of hardware components of the surgical monitoring system according to embodiments of the invention.

[00024] Figures 4A-C is a flow chart diagram illustrating one embodiment of the registering method of the present invention.

[00025] 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.

[00026] 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.

[00027] Figures 7A, 7B , 7C, 7D , 7E, and 7F are drawings of a multi-element fiducial pattern comprising a plurality of pattern segments in respectively a default condition and a condition in which the body of a patient has moved to change the mutual spatial relation of the pattern segments.

[00028] Figures 8A-C is a flow chart diagram illustrating one embodiment of the registering method of the present invention as applied to the multi-element fiducial pattem of Figures 7 A and 7B.

[00029] Figures 9A, 9B, 9C and 9D are drawings of a multi-element arbitrary pattern comprising a plurality of pattern points in respectively a default condition and a condition in which the surgical site has changed thereby changing the mutual spatial relation of pattern segments.

[00030] Figure 10 is a flow chart diagram illustrating one embodiment of a registering method as applied to the arbitrary marker arrangement of Figures 9 A and 9B [00031] Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent embodiments of the present invention, the drawings are not necessarily to scale and certain features may be exaggerated in order to better illustrate and explain the present invention. The flow charts and screen shots are also representative in nature, and actual embodiments of the invention may include further features or steps not shown in the drawings. The exemplification set out herein illustrates an embodiment of the invention, in one form, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.

DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION [00032] The embodiments disclosed below are not intended to be exhaustive or limit the invention to the precise form disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may utilize their teachings.

[00033] The detailed descriptions that follow are presented in part in terms of algorithms and symbolic representations of operations on data bits within a computer memory representing alphanumeric characters or other information. The hardware components are shown with particular shapes and relative orientations and sizes using particular scanning techniques, although in the general case one of ordinary skill recognizes that a variety of particular shapes and orientations and scanning methodologies may be used within the teaching of the present disclosure. A computer generally includes a processor for executing instructions and memory for storing instructions and data, including interfaces to obtain and process imaging data. When 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. These descriptions and representations are the means used by those skilled in the art of data processing arts to most effectively convey the substance of their work to others skilled in the art. [00034] 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. 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.

[00035] Some algorithms may use data structures for both inputting information and producing the desired result. 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. [00036] Further, 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 embodiments of the present invention; the operations are machine operations. Useful machines for performing the operations of embodiments 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. Some embodiments of the present invention relate 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. [00037] Further embodiments of the present invention also relate 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. In some cases, 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. In particular, 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.

[00038] Embodiments of 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. Often, but not necessarily, 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. [00039] 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. 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. [00040] 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.

[00041] 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. In this manner, 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. When modeling systems utilizing an object-oriented language, a programmer need 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. [00042] Although object-oriented programming makes 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. [00043] In the following description, several terms that are used frequently have specialized meanings in the present context. 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. In such computer networks, 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 computers, termed "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. Similar to a process is an agent (sometimes called an intelligent agent), which is a process that gathers information or performs some other service without user intervention and on some regular schedule. Typically, an agent, using 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.

[00044] 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. When 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. 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". Examples of Browsers compatible with embodiments of the present invention include the Internet

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). Although the following description details such operations in terms of a graphic user interface of a Browser, embodiments of the present invention may be practiced with text based interfaces, or even with voice or visually activated interfaces, that have many of the functions of a graphic based Browser.

[00045] Browsers display 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. Files in these formats may 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 Web utilizes these data file formats to conjunction with its communication protocol to transmit such information between servers and workstations. Browsers may 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. 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). [00046] The terms "personal digital assistant" or "PDA", as defined above, means any handheld, mobile device that combines computing, telephone, fax, e-mail and networking features. The terms "wireless wide area network" or "WW AN" mean a wireless network that serves as the medium for the transmission of data between a handheld device and a computer. The term "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). [00047] In wireless wide area networks, 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. At the present time, most wireless data communication takes place across cellular systems using second generation technology such as code-division multiple access ("CDMA"), time division multiple access ("TDMA"), the Global System for Mobile Communications ("GSM"), Third Generation (wideband or "3G"), Fourth Generation (broadband or "4G"), personal digital cellular ("PDC"), or through packet-data technology over analog systems such as cellular digital packet data (CDPD") used on the Advance Mobile Phone Service ("AMPS"). [00048] The terms "wireless application protocol" or "WAP" mean a universal specification to facilitate the delivery and presentation of web-based data on handheld and mobile devices with small user interfaces. "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.

[00049] The terms "scan," "fiducial reference", "fiducial location", "marker,"

"tracker" and "image information" have particular meanings in the present disclosure. For purposes of the present disclosure, "scan" or 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. The term "fiducial 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. In the present specification 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. 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. The term "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.

[00050] 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. 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).

[00051] Figure 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 235 A 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).

[00052] 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. 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). [00053] Storage interface 234, as with other storage interfaces of computer system

210, 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). 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.

[00054] Many other devices or subsystems (not shown) may be connected in a similar manner (e.g., document scanners, digital cameras and so on), including the hardware components of Figures 3A-I, which altematively may be in communication with associated computational resources through local, wide-area, or wireless networks or communications systems. Thus, while the disclosure may generally discuss an embodiment where the hardware components are directly connected to computing resources, one of ordinary skill in this area recognizes that such hardware may be remotely connected with computing resources. Conversely, all of the devices shown in Figure 2 need not be present to practice the present disclosure. Devices and subsystems may be interconnected in different ways from that shown in Figure 2. Operation of a computer system such as that shown in Fig. 2 is readily known in the art and is not discussed in detail in this application. 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.

[00055] Moreover, regarding the signals described herein, those skilled in the art recognize that 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. Although the signals of the above-described embodiments are characterized as transmitted from one block to the next, other embodiments of the present disclosure may include 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. To some extent, 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.

[00056] Embodiments of the present invention relate 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. In one implementation the system uses a particularly configured piece of hardware, 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 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. In

embodiments in which the fiducial reference is directly visible to a suitable tracker (see for example Figure 5 and Figure 6) that acquires image information about the surgical site, a tracking marker may be attached directly to the fiducial reference. For example a dental surgery, the dental tracking marker 14 may be used to securely locate the fiducial 10 near the surgical area. The 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.

[00057] In other embodiments 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.

[00058] In a further embodiment 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 embodiments 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. By way of example, 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. [00059] Using the dental surgery example, the patient is scanned to obtain an initial scan of the surgical site. The particular configuration of 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. In some embodiments, the fiducial reference includes a marking that is apparent as a recognizable identifying symbol when scanned. In other embodiments, 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. [00060] In addition, 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.

[00061 ] In one embodiment, 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 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.

[00062] Once 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. [00063] In some embodiments, the monitoring hardware includes a tracking attachment to the fiducial reference. In the embodiment pertaining to dental surgery 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. For example, as particularly shown in Figure 3J, fiducial key 10 may have hole 15 in a predetermined location specially adapted for engagement with insert 17 of tracking pole 11. In such an arrangement, for example, 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.

[00064] 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. For example, 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. Additionally, boundary conditions may be implemented in the software so that the user is notified when

observational data approaches and /or enters the boundary areas.

[00065] In a further embodiment, a surgical instrument or implement, herein termed a

"hand piece" (see Figures 5 and 6), 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. Further, 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.

[00066] An alternative embodiment of some hardware components are shown in

Figures 3G-I. 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.

Conceptually, 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. [00067] The materials of the hardware components may vary according to regulatory requirements and practical considerations. Generally, 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. In addition, because it is generally located on the patient, the material should be lightweight and suitable for connection to an apparatus on the patient. For example, in the dental surgery example, the materials of the fiducial key must be suitable for connection to a plastic splint and suitable for connection to a tracking pole. In the surgical example the materials of the fiducial key may be suitable for attachment to the skin or other particular tissue of a patient. [00068] 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.

[00069] 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.

[00070] 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 3D object array with 90 degrees relationship; optionally having a high contrast pattern engraving and a rigid, quick mounting mechanism to a standard hand piece.

[00071 ] In another aspect there is presented an automatic registration method for tracking surgical activity, as illustrated in Figures 4A-C. 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 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. [00072] Once the process starts [402], as described in Figures 4A and 4B, 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]. Next the data is processed by removing scan segments with Hounsfield data values outside expected values associated with the fiducial key values [at 410], following the collection of the remaining points [at 412]. If the data is empty [at 414], 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]. If the cumulative error is larger than the maximum allowed error [432] then the user is 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].

[00073] Turning now to Figure 4C, an image is obtained from the tracker, being a suitable camera or other sensor [442]. The image information is analyzed to determine whether a tracking marker is present in the image information [444] . 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]. If 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]. The term "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 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.

[00074] 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]. In order to monitor the location and orientation of the fiducial reference in real time, 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. Other registration systems are also contemplated, for example using current other sensory data rather than the predetermined offset, or having a fiducial with a transmission capacity.

[00075] One exemplary embodiment is shown in Figure 5. In addition to fiducial key

502 mounted at a predetermined tooth and having a rigidly mounted tracking marker 504, an additional instrument or implement 506, for example a hand piece which may be a dental drill, may be observed by a camera 508 serving as tracker of the monitoring system.

[00076] Another exemplary embodiment is shown in Figure 6. 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. Endoscope 606 may have further tracking markers, and biopsy needle 608 may also be present bearing a tracking marker at surgery site 600. Sensor 610 may be for example a camera, infrared sensing device, or RADAR. [00077] In another embodiment, shown schematically in Figure 7A, the fiducial key may comprise a multi-element fiducial pattern 710. In one implementation the multi-element fiducial pattern 710 may be a dissociable pattern. The term "dissociable pattern" is used in this specification to describe a pattern comprising a plurality of pattern segments 720 that topologically fit together to form a contiguous whole pattern, and which may temporarily be separated from one another, either in whole or in part. The term "breakable pattern" is used as an alternative term to describe such a dissociable pattern. In other implementations the segments of the multi-element fiducial pattern 710 do not form a contiguous pattern, but instead their positions and orientations with respect to one another are known when the multi-element fiducial pattern 710 is applied on the body of the patient near a critical area of a surgical site. Each pattern segment 720 is individually locatable based on scan data of a surgical site to which multi-element fiducial pattern 710 may be attached.

[00078] Pattern segments 720 are uniquely identifiable by tracker 730, being differentiated from one another in one or more of a variety of ways. Pattern segments 720 may be mutually differentiable shapes that also allow the identification of their orientations. Pattern segments 720 may be uniquely marked in one or more of a variety of ways, including but not limited to barcoding or orientation-defining symbols. The marking may be directly on the pattern segments 720, or may be on tracking markers 740 attached to pattern segments 720. The marking may be accomplished by a variety of methods, including but not limited to engraving and printing. In the embodiment shown in Figures 7A and 7B, by way of non- limiting example, the letters F, G, J, L, P, Q and R have been used.

[00079] The materials of the multi-element fiducial pattern 710 and pattern segments

720, and of any tracking markers 740 attached to them, may vary according to regulatory requirements and practical considerations. Generally, 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 multi-element fiducial pattern 710 and pattern segments 720 may have a distinct coloration difference from human skin in order to be more clearly differentiable by tracker 730. In addition, because it is generally located on the patient, the material should be lightweight. The materials should also be capable of resisting damage in autoclave processes.

[00080] A suitable tracker of any of the types already described is used to locate and image multi-element fiducial pattern 710 within the surgical area. Multi-element fiducial pattern 710 may be rendered distinctly visible in scans of the surgical area through higher imaging contrast by the employ of radio -opaque materials or high-density materials in the construction of the multi-element fiducial pattem 710. In other embodiments the distinctive identifying and orienting markings on the pattern segments 720 or on the tracking markers 740 may be created using suitable high-density materials or radio-opaque inks, thereby allowing the orientations of pattern segments 720 to be determined based on scan data.

[00081] During surgery the surgical area may undergo changes in position and orientation. This may occur, for example, as a result of the breathing or movement of the patient. In this process, as shown in Figure 7B, pattern segments 720 of multi-element fiducial pattern 710 change their relative locations and also, in general, their relative orientations. Information on these changes may be used to gain information on the subcutaneous motion of the body of the patient in the general vicinity of the surgical site by relating the changed positions and orientations of pattern segments 720 to their locations and orientations in a scan done before surgery. [00082] Using abdominal surgery as example, the patient is scanned, for example by an x-ray, magnetic resonance imaging (MRI), computerized tomography (CT), or cone beam computerized tomography (CBCT), to obtain an initial image of the surgical site. The particular configuration of multi-element fiducial pattern 710 allows computer software to recognize its relative position within the surgical site, so that further observations may be made with reference to both the location and orientation of multi-element fiducial pattern

710. In fact, the computer software may create a coordinate system for organizing objects in the scan, such as skin, organs, bones, and other tissue, other surgical instruments bearing suitable tracking markers, and segments 720 of multi-element fiducial pattern 710 etc.

[00083] In one embodiment, the computer system has a predetermined knowledge of the configuration of multi-element fiducial pattern 710 and examines slices of a scan of the surgical site to locate pattern segments 720 of multi-element fiducial pattern 710 based on one or more of the radio-opacity density of the material of the pattern segments 720, their shapes and their unique tracking markers 740. Once the locations and orientations of the pattern segments 720 have been determined, a point within or near multi-element fiducial pattern 710 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 transformation matrix is derived to relate multi-element fiducial pattern 710 to the coordinate system of the surgical site. The resulting virtual construct may then 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.

[00084] Multi-element fiducial pattern 710 changes its shape as the body moves during surgery. The relative locations and relative orientations of pattern segments 720 change in the process (see Figure 7A relative to Figure 7B). In this process the integrity of individual pattern segments 720 is maintained and they may be tracked by tracker 730, including but not limited to a stereo video camera. The changed multi-element fiducial pattern 710' may be compared with initial multi-element fiducial pattern 710' to create a transformation matrix. The relocating and reorienting of pattem segments 720 may therefore be mapped on a continuous basis within the coordinate system of the surgical site. In the exemplary embodiment of Figures 7A and 7B, a total of seven pattern segments 720 are shown. In other embodiments multi-element fiducial pattem 710 may comprise larger or smaller numbers of pattern segments 720. During operation of the surgical monitoring system of this embodiment a selection of pattern segments 720 may be employed and there is no limitation that all pattern segments 720 of multi-element fiducial pattern 710 have to be employed. The decision as to how many pattern segments 720 to employ may, by way of example, be based on the resolution required for the surgery to be done or on the processing speed of the controller, which may be, for example, computer 210 of Figure 2. [00085] For the sake of clarity, Figure 7A employs a dissociable multi-element fiducial pattern. In other embodiments the multi-element fiducial pattern may have a dissociated fiducial pattern, such as that of Figure 7B, as default. The individual pattern segments 720 then change position as the body of the patient changes shape near the surgical site during the surgery. In yet other embodiments, for example Figures 7C and 7D, multi- element fiducial patterns 752 and 752' do not include tracking markers 740 and the tracking system, including tracker 758, may rely on tracking pattem segments 754 purely on the basis of their unique shapes, which lend themselves to determining orientation due to a lack of a center of symmetry. As already pointed out, in other embodiments pattern segments 720 may not be in general limited to being capable of being joined topologically at their perimeters to form a contiguous surface. Nor is there a particular limitation on the general shape of the multi-element fiducial pattern.

[00086] In a further embodiment, for example in Figures 7E and 7F, multi-element fiducial pattern 762 and 762' may comprise of individual pattem segments 764 composed of a marking of a contrast material that produces suitable contrast in a scan of the surgical site and which may be applied to surgical incise film material 766. This embodiment does not require tracking markers 740 of Figures 7 A and 7B. The contrast material may, in one embodiment, be an ink or paint having radio-opaque properties to produce the suitable contrast for scans, and be visible to tracker 768. The surgical incise film may be, for example without limitation, Ioban™ 2 Antimicrobial Incise Film from 3M Incorporated of St. Paul, MN, or a similar surgical incise film capable of bearing an scan-locatable ink pattern. The ink or paint marking may be applied in the shape of the individual pattern segments 764 using a suitable stencil or may be pre -manufactured on the surgical incise film. The application of the fiducial reference to the fiducial location on the skin proximate the surgical site may comprise applying surgical incise film 766 to the skin over the surgical site and then transferring the marking of a multi-element scan locatable ink fiducial pattern to the surgical incise film proximate the surgical site. This implementation employing a surgical incise film holds the benefit of placing fiducial pattern 762 in the closest possible proximity to the surgical site, as the first surgical incision during the surgery is made through the surgical incise film.

[00087] In yet a further embodiment, the radio-opaque ink or paint marking may be applied directly to the skin of the patient proximate the surgical site in order to create multielement fiducial pattern 710 comprising individual pattern segments 720. The suitable ink or paint may have suitable radio-opaque properties to produce the suitable contrast to render it scan-locatable and conforms to regulatory requirements. The ink or paint may be applied directly to the skin in the shape of the individual pattern segments 720 using a suitable stencil.

[00088] In a further embodiment the ink or paint marking may be applied as a transfer pattern from an inked transfer tape applied to the skin, as described in United States Patent. No. 5,743,899 to Zinreich et al or Patent Cooperation Treaty application WO

2011/094833A1 by Aeos Biomedical Inc. of Vancouver, British Columbia, the disclosures of which are explicitly incorporated by reference herein.

[00089] The radio-opaque marking may be, for example without limitation, the heavy metal based ink described in general by United States Patent Application U.S.

2004/0127824A1 by Falahee et al. ("Falahee" hereinafter), the disclosure of which is hereby explicitly incorporated by reference herein. A suitable ink may, without limitation, include barium heavy metal. A suitable ink composition for both x-ray tomography and nuclear magnetic resonance imaging diagnostic purposes is disclosed in U.S. Pat. No. 4,916,170 issued to Nambu et al. ("Nambu" hereinafter), the disclosure of which is hereby explicitly incorporated by reference herein. As disclosed in Nambu, the skin marker composition that may be employed in the present disclosed embodiments may be comprised of a radioopaque material for x-ray diagnostic purposes and/or a non-magnetic hydrogel for magnetic resonance imaging purposes.

[00090] In the cases of the transfer pattern and the surgical incise film, pattern segments 720, 754 and 764 may be incorporated on the transfer material or tape and on the incise film, respectively, during their manufacture. In these two distinct implementations, pattern segments 720, 754, and 764 are predetermined, but sufficient pattern segments 720, 754, and 764 may be prepared during manufacture to allow the surgeon or system operator a choice of which pattern segments 720, 754, and 764 to employ during surgery, as already explained with regard to Figure 7.

[00091] Another aspect of embodiments of the present invention involve an automatic registration method for tracking surgical activity using multi-element fiducial pattern 710, as shown in the flow chart diagram of Figure 8, encompassing Figures 8A, 8B and 8C. Figure 8 A and Figure 8B together present, without limitation, a flowchart representation of one method for determining the three-dimensional location and orientation of one segment of multi-element fiducial pattern 710 from scan data. Figure 8C presents a flow chart representation of a method for determining the spatial distortion of the surgical site based on the changed orientations and locations of pattern segments 720 of multi-element fiducial pattern 710, using as input the result of applying the method shown in Figure 8A and Figure 8B to every one of pattern segments 720 that is to be employed in determining the spatial distortion of the surgical site. In principle, not all pattern segments 720 need to be employed.

[00092] Once the process starts [802], as described in Figures 8 A and 8B, the system obtains scan data set [404] from, for example, a CT scanner and checks for default CT scan Hounsfield unit (HU) value [806] 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. If such a default value is not present, then a generalized predetermined system default value is employed [808]. Next the data is processed by removing scan slices or segments with Hounsfield data values outside the expected values associated with the fiducial key [810], followed by the collecting of the remaining points [812]. If the data is empty [814], the CT value threshold is adjusted [816], the original data restored [818], and the processing of scan slices continues [810]. Otherwise, with the existing data a center of mass is calculated [820], as are the X, Y, and Z axes [822]. If the center of mass is not at the X, Y, Z cross point

[824], then the user is notified [826] and the process ended [828]. If the center of mass is at the X, Y, Z cross point [824], then the pattern of the fiducial is compared to the data [836], and if the cumulative error is larger than the maximum allowed error [838] the user is notified [840] and the process is ended [842]. If the cumulative error is not larger than the maximum allowed error [838], then the coordinate system is defined at the XYZ cross-point

[844] and the CT profile is updated for HU units [846]. This process of Figure 8 A and Figure 8B is repeated for each of pattern segments 720 that is to be employed in determining the spatial distortion of the surgical site. The information on the location and orientation of each of pattern segments 720 is then used as input to the method described relating to Figure 8C.

[00093] Turning now to Figure 8C, image information is obtained from camera [848] and it is determined whether any particular segment 720 of multi-element fiducial pattern 710 on the patient body is present in image information [850]. If no particular pattern segment 720 is present in the image information, then the user is queried as to whether the process should continue [852]. If not, then the process is ended [854]. If the process is to continue, the user is notified that no particular pattern segment 720 was found in the image information [856] and the process returns to obtaining image information from camera [848]. If one of particular segments 720 is present in the image information at step [850], then, other ones of pattern segments 720 employed are identified and the three-dimensional location and orientation of all segments 720 employed are determined based on image information [858]. The three-dimensional location and orientation of pattern segments 720 employed based on the image information is compared with the three dimensional location and orientation of the same pattern segment as based on scan data [860]. Based on this comparison the spatial distortion of the surgical site is determined [862] . In order to monitor such distortions in real time, the process may be looped back to obtain image information from camera [848]. A suitable query point [864] may be included to allow the user to terminate at [866]. 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.

[00094] By the above method the software of the controller, for example computer 210 of Figure 2, is capable of recognizing multi-element fiducial pattern 710 and calculating a model of the surgical site based on the identity of multi-element fiducial pattern 710 and its changes in shape based on observation data received from multi-element fiducial pattern 710. This allows the calculation in real time of the locations and orientations of anatomical features in the proximity of multi-element fiducial pattern 710.

[00095] In a further embodiment shown in Figures 9A and 9B, multi-element fiducial pattern 910 is deposited in a radio opaque ink in a spatially arbitrary arrangement of elements 920 on the patient proximate patient skin at a surgical site. Figure 9A shows pattern 910 as- deposited and Figure 9B shows that pattern now changed to pattern 910' due to variation of the surgical site. The deposition of pattern 910 may be directly on the skin or on a suitable surgical incise film applied over the surgical site. Individual element 920 may be a single point, or alternatively a small formless or defined shape. More generally, individual element 920 may be a larger area, but having a locatable two-dimensional center-of-mass. Individual elements 920 of pattern 910 are not required to be individually directly identifiable or unique and may be placed in a non-predetermined spatial arrangement. The position of each individual element 920 may be determined directly from the three-dimensional scan data of the surgical site and this may be done in the coordinate system of the scan data. The surgical site and at least a portion of multi-element fiducial pattern 910 may be imaged by tracker 930. The resulting image information may be supplied to a suitable controller, for example processor 214 and memory 217 of computer 210 of Figure 2. Such controller is suitably configured to determine a correspondence between the arrangement of a small number of the individual elements in the image information and the corresponding individual elements in the scan data. In the present specification we refer to such a small number of elements as a "constellation of elements". Figures 9A and 9B show two constellations 940 and 950 of individual elements. A constellation of elements with a minimum of three points uniquely identifies the particular constellation with the corresponding points in the scan data.

Although it is possible that some constellations of points may become arranged such that they cannot be uniquely identified, for example if lying in a substantially straight line, a large number of points produced in a suitably random pattern should always allow a suitable choice of constellations to provide a sufficient number of correspondences, thereby allowing the identification of the position of any of elements 920. As the surgical site changes, constellations 940 and 950 may be repositioned and reoriented with repect to each other, but the local changes in their close vicinities are small. This allows individual constellations 940 and 950 to remain uniquely identifiable.

[00096] Figures 9C and 9D illustrate a similar use of constellations, wherein skin 912 of the surgical site receives transfer member 902, for example incise film or transfer tape, which bear elements 922. Elements 922, in addition to having radio-opaque qualities, also are visible to tracker 932 so that the location of elements 922, and their corresponding constellations 942 and 952, may be apparent on scans and image data. Certain ones of elements 922 form constellation 942, while other form constellation 952, which during the course of surgery may alter position as shown in Figure 9D with regards to skin 912'.

[00097] Once a correspondence has been determined between constellations of elements in the image and the three dimensional element positions from the scan data, then the position and orientation of the tracker with respect to the surgical site may be calculated in the same way as with an arrangement of fiducial markers as described in the previous embodiments. The position and orientation of areas of the surgical site and any other implements with any other type of tracking markers may also be determined and displayed in the same way as in the earlier embodiments. [00098] As described with respect to another ink-based embodiments above, the radio- opaque ink may be, for example without limitation, the heavy metal based ink described in Falahee. A suitable ink may, without limitation, include barium heavy metal. A suitable ink composition for both x-ray tomography and nuclear magnetic resonance imaging diagnostic purposes is disclosed in Nambu. As disclosed in Nambu, the skin marker composition that may be employed in the disclosed embodiments may be comprised of a radioopaque material for x-ray diagnostic purposes and/or a non-magnetic hydrogel for magnetic resonance imaging purposes.

[00099] A further aspect of the present invention involves an embodiment having an automatic registration method for tracking surgical activity using a multi-element fiducial pattern 910, as shown in the flow chart diagram of Fig. 10. The method comprises depositing [1010] multi-element fiducial pattern 910 in a radio opaque ink in an arbitrary arrangement of elements 920 on the patient skin proximate surgical site 900; obtaining

[1020] scan data about surgcal site 900; transferring [1030] image information about surgical site 900 from tracker 930; identifying [1040] within the image information constellations 940, 950 of elements 920; identifying [1050] constellations 940, 950 of elements 920 in the scan data; deriving [1060] a three-dimensional transformation matrix to relate multi-element fiducial pattern 910 to a coordinate system of surgical site 900 based on the position and orientation of the constellation of elements 940, 950 in the scan data and the position and orientation of the constellation of elements 940, 950 in the image information; and determining [1070] the position and orientation of tracker 930 with respect to surgical site 900. The depositing of the radio-opaque ink may comprise, in one embodiment directly applying such ink with or without the aid of a stencil (no shown), or in alternative embodiments applying a surgical incise film to the skin over surgical site 900 and then depositing the radio-opaque ink on the surgical incise film.

[000100] If the surgical site is comparatively rigid, one constellation of elements should suffice for the disclosed method. If the surgical site is comparatively less rigid, more than one constellation of elements may be employed for enhancing the disclosed method. [000101 ] With the position and orientation of the tracker now known in the coordinate system of the surgical site, the resulting virtual construct may then be used by surgical procedure planning software for virtual modeling of the contemplated procedure. It may alternatively be used to track changes in the surgical site as described in one of foregoing embodiments relating to real time tracking. It may also be used to track surgical

instrumentation suitably marked with tracking markers or other three-dimensionally trackable markings that may be identified by the controller based on the image information of the surgical site obtained from tracker 930.

[000102] An advantage of these radio opaque ink embodiments involves avoiding any pre-manufactured markers to employ the apparatus and methods of the disclosed invention, as long as the instruments to be tracked are suitable marked for determining their three- dimensional position and orientation.

Claims

WHAT IS CLAIMED IS:

1. A surgical monitoring system comprising a tracker (508, 610, 730, 758, 768, 930, 932) arranged for obtaining image information and characterized by a fiducial reference (710, 754, 764, 910, 910', 912, 912') including a radio -opaque marking having skin adhesion property such that the radio-opaque marking adheres to a location on skin proximate a surgical site (600); and a computer system having scan data of the patient with the fiducial reference fixed to the skin of surgical patient, said computer system in communication with said tracker and including a processor (214) with memory (217) and a software program having a series of instructions that when executed by the processor determines the relative position and orientation of the fiducial reference based on the image information from said tracker and the scan data.

2. A surgical monitoring system comprising a tracker for obtaining image information, a controller in communication with a memory storing previously obtained scan data, a fiducial reference configured for attaching to a portion of the body proximate a surgical site, the fiducial reference being observable by the tracker, characterized by the controller having a processor with software that when executed by the processor determines a three-dimensional location and orientation of the fiducial reference based on scan data and image information of the surgical site, and spatially relates the image information to the scan data to determine the three-dimensional location and the orientation of the fiducial reference.

3. The surgical monitoring system of Claim 1 or 2 characterized in that the fiducial reference is configured in at least one of marked and shaped for having at least one of its location determined from the scan data, and its orientation determined from the scan data.

4. The surgical monitoring system of any of the previous Claims characterized in that the fiducial reference is configured in at least one of marked and shaped for being uniquely identified from the scan data.

5. The surgical monitoring system of any of the previous Claims characterized in that the fiducial reference comprises a plurality of markings disposed in a pattern, and the memory also stores software that when executed by said processor enables said processor to recognize a pattern of the markings and calculate a model of the surgical site based on the identity of the pattern and changes in shape of the pattern based on the scan data and the image information.

6. The surgical monitoring system of any of the previous Claims characterized in that the fiducial reference includes a plurality of pattern segments, each segment being configured for having a segmental three-dimensional location and orientation determinable based on scan data of the surgical site, and for having the segmental three- dimensional location and orientation determinable based on image information about the surgical site.

7. The surgical monitoring system of any of the previous Claims characterized in that the plurality of markings comprise one of radio-opaque ink and radio-opaque paint borne on surgical incise film configured for application to the skin.

8. The surgical monitoring system of any of the previous Claims characterized in that the plurality of pattern segments is configured to be transferable directly to the skin.

9. The surgical monitoring system of any of the previous Claims characterized in that the plurality of pattern segments is configured to be transferable from a transfer film (766, 902) to the skin.

10. The surgical monitoring system of any of the previous Claims characterized in that at least one of the plurality of pattern segments has a unique differentiable shape that allows the controller to identify them uniquely from at least one of the scan data and the image information.

1 1. The surgical monitoring system of any of the previous Claims characterized in that the controller is configured for determining the locations and orientations of at least a selection of the pattern segments based on the image information and the scan data, and for calculating the locations of anatomical features in the proximity of the plurality of pattern segments.

12. The surgical monitoring system of any of the previous Claims characterized by at least one tracking marker (604) attached to an implement (506, 606, 608) proximate the surgery site, wherein the controller is configured for determining location and orientation of the implement based on the image information and information about the tracking marker.

13. The surgical monitoring system of any of the previous Claims characterized by a plurality of tracking markers attached to a plurality of implements proximate the surgery site, and wherein the controller is configured for determining locations and orientations of the implements based on the image information and information about the further tracking markers.

14. The surgical monitoring system of any of the previous Claims characterized in that the fiducial reference comprises a plurality of elements (910) configured in a spatially arbitrary arrangement.

15. The surgical monitoring system of any of the previous Claims characterized in that the plurality of elements includes one of a plurality radio-opaque ink dots and a plurality of radio-opaque paint dots.

16. The surgical monitoring system of any of the previous Claims characterized in that the software further includes instructions that when executed by the processor calculates the location and orientation of at least one anatomical feature of the surgical site proximate to the fiducial reference.

17. The surgical monitoring system of any of the previous Claims characterized by tracking markers attached to at least a selection of the pattern segments (710, 754, 7645), the tracking markers having at least one of identifying marks and orientation marks that allow their three-dimensional orientations to be determined by the controller from the image information.

18. The surgical monitoring system of any of the previous Claims characterized in that the controller is configured for determining the locations and orientations of at least a selection of the pattern segments based on image information and scan data.

19. The surgical monitoring system of any of the previous Claims characterized in that the software comprises further instructions that when executed by the processor further calculates the locations and three-dimensional orientations of anatomical features in the proximity of the multi-element fiducial pattern.

20. The surgical monitoring system of any of the previous Claims characterized in that the multi-element fiducial pattern comprises a plurality of pattern segments and at least one of said plurality of segments is individually configured for having a segmental three- dimensional location and orientation determinable based on scan data of the surgical site, and for having the segmental three-dimensional location and orientation determinable based on image information about the surgical site.

21. A method for relating, in real time, three-dimensional location and orientation of a surgical site to a location and orientation of the surgical site in a scan of the surgical site, the method characterized by:

applying a fiducial reference (710, 754, 764, 910, 910', 912, 912') in the form of a radio-opaque marker on skin proximate the surgical site;

performing the scan to obtain scan data (404);

determining three-dimensional location and orientation of the fiducial reference from the scan data (430);

obtaining real time image information of the surgical site (442); determining in real time three-dimensional location and orientation information of the fiducial reference from the image information (452); and

deriving a spatial transformation matrix for expressing in real time the three- dimensional location and orientation of the fiducial reference as determined from the image information in terms of the three-dimensional location and orientation of the fiducial reference as determined from the scan data (454).

22. The method of Claim 21 characterized in that the fiducial reference includes a plurality of pattern segments individually locatable based on the scan data; the step of determining the three-dimensional location and orientation of the fiducial reference from the scan data comprises determining the three-dimensional location and orientation of at least one of the plurality of pattern segments from the scan data; and the step of determining in real time the three-dimensional location and orientation of the fiducial reference from the image information comprises determining the three- dimensional location and orientation of the at least one of the plurality of pattern segments from the image information.

23. The method of Claim 21 or 22 characterized in that the step of applying the fiducial reference to the skin proximate the surgical site comprises applying a plurality of markings comprising one of radio-opaque ink and radio- opaque paint borne on a surgical incise film.

24. The method of any of the previous Claims 21 -23 characterized in that the step of applying the fiducial reference on the skin proximate the surgical site comprises: applying a surgical incise film to the skin over the surgical site; and applying the fiducial reference pattern to the surgical incise film proximate the surgical site before surgery.

25. The method of any of the previous Claims 21 -24 characterized in that the step of applying the fiducial reference comprises transferring the plurality of pattern segments from a transfer tape.

26. The method of any of the previous Claims 21 -25 characterized in that the step of applying the fiducial reference comprises applying one of radio-opaque ink and radio-opaque paint directly to the skin using one of a mask and a stencil bearing the plurality of pattern segments.

27. A method for tracking in real time changes in a surgical site, the method

characterized by:

applying a multi-element fiducial reference to skin proximate the surgical site, the multi-element fiducial reference comprising a plurality of pattern segments individually locatable based on scan data;

performing a scan of the surgical site to obtain the scan data;

determining three-dimensional locations and orientations of at least a selection of the pattern segments based on the scan data;

obtaining real time image information of the surgical site;

determining in real time three-dimensional locations and orientations of the at least one of the pattern segments from the image information; and

deriving in real time the spatial distortion of the surgical site by comparing in real time the three-dimensional locations and orientations of the at least one of the pattern segments as determined from the image information with the three- dimensional locations and orientations of the at least one of the pattern segments as determined from the scan data.

28. The method of Claim 27 characterized in that the step of applying the fiducial reference on the skin proximate the surgical site comprises applying a surgical incise film bearing the plurality of pattern segments.

29. The method of Claim 27 or 28 characterized in that the step of applying the

fiducial reference on the skin proximate the surgical site comprises: applying a surgical incise film to the skin over the surgical site; and transferring the plurality of pattern segments to the surgical incise film proximate the surgical site before surgery.

30. The method of any of the previous Claims 27-29 characterized in that the step of applying the fiducial reference on the skin proximate the surgical site comprises applying the plurality of pattern segments in the form of one of radio-opaque ink and radio-opaque paint directly to the skin proximate the surgical site.

31. The method of any of the previous Claims 27-30 characterized in that the step of applying the fiducial reference comprises transferring a plurality of pattern segments from a transfer tape.

32. The method of any of the previous Claims 27-31 characterized in that the step of applying the plurality of pattern segments comprises applying one of radio-opaque ink and radio-opaque paint directly to the skin using one of a mask and a stencil defining the plurality of pattern segments.

33. A method for determining the position and orientation of a tracker relative to a surgical site, the method characterized by the steps of: applying (1010) proximate the surgical site an arbirtrarily arranged a plurality of non-unique elements (920), each element including one of radio-opaque ink and radio-opaque paint, at least a portion of said plurality of elements defining a constellation (940, 950);

obtaining scan data of the surgical site (1020);

obtaining image information about the surgical site from a tracker (1030); determining a position and orientation of at least one of the plurality of elements in the scan data (1040); and

determining a position and orientation of a constellation in the image information (1050);

deriving a three-dimensional transformation matrix to relate the multi-element fiducial pattern to a coordl inate system of the surgical site based on the position and orientation of the constellation in the scan data and the position and orientation of the constellation in the image information (1060); and

determining the position and orientation of the tracker relative to the surgical site (1070).

34. The method of Claim 27 characterized in that the step of applying includes

depositing one of a radio-opaque ink and a radio-opaque paint in an arbitrary arrangement of elements.