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EP2830527A1 - Enregistrement automatique du tissu corporel mou et système de surveillance de l'emplacement chirurgical et méthode avec référence de centrage appliquée à la peau - Google Patents

Enregistrement automatique du tissu corporel mou et système de surveillance de l'emplacement chirurgical et méthode avec référence de centrage appliquée à la peau

Info

Publication number
EP2830527A1
EP2830527A1 EP13716228.5A EP13716228A EP2830527A1 EP 2830527 A1 EP2830527 A1 EP 2830527A1 EP 13716228 A EP13716228 A EP 13716228A EP 2830527 A1 EP2830527 A1 EP 2830527A1
Authority
EP
European Patent Office
Prior art keywords
surgical
surgical site
orientation
image information
pattern
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP13716228.5A
Other languages
German (de)
English (en)
Inventor
Udi DAON
Martin Gregory Beckett
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Navigate Surgical Technologies Inc
Original Assignee
Navigate Surgical Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/571,284 external-priority patent/US8938282B2/en
Priority claimed from PCT/IL2012/000363 external-priority patent/WO2013061318A1/fr
Priority claimed from US13/745,763 external-priority patent/US20130131505A1/en
Priority claimed from US13/745,762 external-priority patent/US9554763B2/en
Application filed by Navigate Surgical Technologies Inc filed Critical Navigate Surgical Technologies Inc
Publication of EP2830527A1 publication Critical patent/EP2830527A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3983—Reference marker arrangements for use with image guided surgery

Definitions

  • the invention relates to location monitoring hardware and software systems. More specifically, the field of the invention is that of surgical equipment and software for monitoring surgical conditions.
  • 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.
  • 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.
  • 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.
  • the plurality of pattern segments may have an adhesive property and is configured to be adhered directly to the skin.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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:
  • 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.
  • the step of applying the fiducial reference may comprise transferring the plurality of pattern segments from a transfer tape.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a method for determining the position and orientation of a tracker with respect to a surgical site 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;
  • 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.
  • Figure 1 is a schematic diagrammatic view of a network system in which embodiments of the present invention may be utilized.
  • Figure 2 is a block diagram of a computing system (either a server or client, or both, as appropriate), with optional input devices (e.g., keyboard, mouse, touch screen, etc.) and output devices, hardware, network connections, one or more processors, and
  • FIGS 3A-J are drawings of hardware components of the surgical monitoring system according to embodiments of the invention.
  • Figures 4A-C is a flow chart diagram illustrating one embodiment of the registering method of the present invention.
  • Figure 5 is a drawing of a dental fiducial key with a tracking pole and a dental drill according to one embodiment of the present invention.
  • Figure 6 is a drawing of an endoscopic surgical site showing the fiducial key, endoscope, and biopsy needle according to another embodiment of the invention.
  • 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.
  • 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.
  • 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.
  • 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
  • FIG. 10 represents 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.
  • a computer generally includes a processor for executing instructions and memory for storing instructions and data, including interfaces to obtain and process imaging data.
  • a general-purpose computer has a series of machine encoded instructions stored in its memory, the computer operating on such encoded instructions may become a specific type of machine, namely a computer particularly configured to perform the operations embodied by the series of instructions.
  • Data structures greatly facilitate data management by data processing systems, and are not accessible except through sophisticated software systems.
  • Data structures are not the information content of a memory, rather they represent specific electronic structural elements that impart or manifest a physical organization on the information stored in memory. More than mere abstraction, the data structures are specific electrical or magnetic structural elements in memory, which simultaneously represent complex data accurately, often data modeling physical characteristics of related items, and provide increased efficiency in computer operation.
  • the manipulations performed are often referred to in terms, such as comparing or adding, commonly associated with mental operations performed by a human operator.
  • 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.
  • 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.
  • the computer programs may communicate or relate to other programs or equipments through signals configured to particular protocols, which may or may not require specific hardware or programming to interact.
  • various general-purpose machines may be used with programs written in accordance with the teachings herein, or it may prove more convenient to construct more specialized apparatus to perform the required method steps. The required structure for a variety of these machines will appear from the description below.
  • 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.
  • a physical object has a corresponding software object that may collect and transmit observed data from the physical device to the software system.
  • Such observed data may be accessed from the physical object and/or the software object merely as an item of convenience; therefore where "actual data” is used in the following description, such "actual data” may be from the instrument itself or from the corresponding software object or module.
  • Messages are sent and received between objects having certain functions and knowledge to carry out processes. Messages are generated in response to user instructions, for example, by a user activating an icon with a "mouse" pointer generating an event. Also, messages may be generated by an object in response to the receipt of a message. When one of the objects receives a message, the object carries out an operation (a message procedure) corresponding to the message and, if necessary, returns a result of the operation.
  • an operation a message procedure
  • Each object has a region where internal states (instance variables) of the object itself are stored and where the other objects are not allowed to access.
  • One feature of the object-oriented system is inheritance. For example, an object for drawing a "circle" on a display may inherit functions and knowledge from another object for drawing a "shape" on a display.
  • a programmer "programs" in an object-oriented programming language by writing individual blocks of code each of which creates an object by defining its methods.
  • a collection of such objects adapted to communicate with one another by means of messages comprises an object-oriented program.
  • Object-oriented computer programming facilitates the modeling of interactive systems in that each component of the system may be modeled with an object, the behavior of each component being simulated by the methods of its corresponding object, and the interactions between components being simulated by messages transmitted between objects.
  • An operator may stimulate a collection of interrelated objects comprising an object-oriented program by sending a message to one of the objects.
  • the receipt of the message may cause the object to respond by carrying out predetermined functions, which may include sending additional messages to one or more other objects.
  • the other objects may in turn carry out additional functions in response to the messages they receive, including sending still more messages.
  • sequences of message and response may continue indefinitely or may come to an end when all messages have been responded to and no new messages are being sent.
  • the term "object” relates to a set of computer instructions and associated data, which may be activated directly or indirectly by the user.
  • the terms "windowing environment”, “running in windows”, and “object oriented operating system” are used to denote a computer user interface in which information is manipulated and displayed on a video display such as within bounded regions on a raster scanned video display.
  • the terms "network”, “local area network”, “LAN”, “wide area network”, or “WAN” mean two or more computers that are connected in such a manner that messages may be transmitted between the computers.
  • typically one or more computers operate as a “server”, a computer with large storage devices such as hard disk drives and communication hardware to operate peripheral devices such as printers or modems.
  • workstations provide a user interface so that users of computer networks may access the network resources, such as shared data files, common peripheral devices, and inter-workstation communication.
  • Users activate computer programs or network resources to create “processes” which include both the general operation of the computer program along with specific operating characteristics determined by input variables and its environment.
  • an agent sometimes called an intelligent agent
  • an agent uses parameters typically provided by the user, searches locations either on the host machine or at some other point on a network, gathers the information relevant to the purpose of the agent, and presents it to the user on a periodic basis.
  • the term "desktop” means a specific user interface which presents a menu or display of objects with associated settings for the user associated with the desktop.
  • the desktop accesses a network resource, which typically requires an application program to execute on the remote server, the desktop calls an Application Program Interface, or "API", to allow the user to provide commands to the network resource and observe any output.
  • API Application Program Interface
  • the term “Browser” refers to a program which is not necessarily apparent to the user, but which is responsible for transmitting messages between the desktop and the network server and for displaying and interacting with the network user. Browsers are designed to utilize a communications protocol for transmission of text and graphic information over a worldwide network of computers, namely the "World Wide Web" or simply the "Web”. Examples of Browsers compatible with embodiments of the present invention include the Internet
  • SGML Markup Language
  • HTML HyperText Markup Language
  • Browsers may also be programmed to display
  • XML extensible Markup Language
  • DTD Document Type Definitions
  • the XML file may be analogized to an object, as the data and the stylesheet formatting are separately contained (formatting may be thought of as methods of displaying information, thus an XML file has data and an associated method).
  • PDA personal digital assistant
  • WW AN wireless wide area network
  • synchronization means the exchanging of information between a first device, e.g. a handheld device, and a second device, e.g. a desktop computer, either via wires or wirelessly. Synchronization ensures that the data on both devices are identical (at least at the time of synchronization).
  • a first device e.g. a handheld device
  • a second device e.g. a desktop computer
  • Synchronization ensures that the data on both devices are identical (at least at the time of synchronization).
  • PCS personal communications service
  • CDMA code-division multiple access
  • TDMA time division multiple access
  • GSM Global System for Mobile Communications
  • 3G Third Generation
  • 4G fourth Generation
  • PDC personal digital cellular
  • CDPD cellular digital packet data
  • AMPS Advance Mobile Phone Service
  • Mobile Software refers to the software operating system, which allows for application programs to be implemented on a mobile device such as a mobile telephone or PDA.
  • Examples of Mobile Software are Java and Java ME (Java and JavaME are trademarks of Sun Microsystems, Inc. of Santa Clara, California), BREW (BREW is a registered trademark of Qualcomm Incorporated of San Diego,
  • 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.
  • MRI magnetic resonance imaging
  • CT computerized tomography
  • CBCT cone beam computerized tomography
  • 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.
  • fiducial location refers to a useful location to which a fiducial reference is attached. A “fiducial location” will typically be proximate a surgical site.
  • the term “marker” or “tracking marker” refers to an object or reference that may be perceived by a sensor proximate to the location of the surgical or dental procedure, where the sensor may be an optical sensor, a radio frequency identifier (RFID), a sonic motion detector, an ultra-violet or infrared sensor.
  • RFID radio frequency identifier
  • 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.
  • image information is used in the present specification to describe information obtained by the tracker, whether optical or otherwise, and usable for determining the location of the markers and their orientation and movement continually in 'real time' during a procedure.
  • Figure 1 is a high-level block diagram of a computing environment 100 according to one embodiment.
  • Figure 1 illustrates server 110 and three clients 112 connected by network 114. Only three clients 112 are shown in Figure 1 in order to simplify and clarify the description.
  • Embodiments of the computing environment 100 may have thousands or millions of clients 112 connected to network 114, for example the Internet. Users (not shown) may operate software 116 on one of clients 112 to both send and receive messages network 114 via server 110 and its associated communications equipment and software (not shown).
  • FIG. 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
  • Bus 212 allows data communication between central processor 214 and system memory 217, which may include read-only memory (ROM) or flash memory (neither shown), and random access memory (RAM) (not shown), as previously noted.
  • RAM is generally the main memory into which operating system and application programs are loaded.
  • ROM or flash memory may contain, among other software code, Basic Input-Output system (BIOS), which controls basic hardware operation such as interaction with peripheral components.
  • BIOS Basic Input-Output system
  • Applications resident with computer system 210 are generally stored on and accessed via computer readable media, such as hard disk drives (e.g., fixed disk 244), optical drives (e.g., optical drive 240), floppy disk unit 237, or other storage medium.
  • applications may be in the form of electronic signals modulated in accordance with the application and data communication technology when accessed via network modem 247 or interface 248 or other telecommunications equipment (not shown).
  • Storage interface 234 as with other storage interfaces of computer system
  • Modem 247 may provide direct connection to remote servers via telephone link or the Internet via an Internet service provider (ISP) (not shown).
  • ISP Internet service provider
  • Network interface 248 may provide direct connection to remote servers via direct network link to the Internet via a POP (point of presence).
  • Network interface 248 may provide such connection using wireless techniques, including digital cellular telephone connection, Cellular Digital Packet Data (CDPD) connection, digital satellite data connection or the like.
  • CDPD Cellular Digital Packet Data
  • Software source and/or object codes to implement the present disclosure may be stored in computer-readable storage media such as one or more of system memory 217, fixed disk 244, optical disk 242, or floppy disk 238.
  • the operating system provided on computer system 210 may be a variety or version of either MS-DOS® (MS-DOS is a registered trademark of Microsoft Corporation of Redmond, Washington), WINDOWS® (WINDOWS is a registered trademark of Microsoft Corporation of Redmond, Washington), OS/2® (OS/2 is a registered trademark of International Business Machines Corporation of Armonk, New York), UNIX® (UNIX is a registered trademark of X/Open Company Limited of Reading, United Kingdom), Linux® (Linux is a registered trademark of Linus Torvalds of Portland, Oregon), or other known or developed operating system.
  • MS-DOS MS-DOS is a registered trademark of Microsoft Corporation of Redmond, Washington
  • WINDOWS® WINDOWS is a registered trademark of Microsoft Corporation of Redmond, Washington
  • OS/2® OS/2 is a registered
  • a signal may be directly transmitted from a first block to a second block, or a signal may be modified (e.g., amplified, attenuated, delayed, latched, buffered, inverted, filtered, or otherwise modified) between blocks.
  • a signal 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).
  • 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.
  • 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.
  • 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.
  • a tracking marker may be attached directly to the fiducial reference.
  • 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.
  • 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.
  • 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.
  • 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.
  • fiducial key 10 allows computer software stored in memory and executed in a suitable controller, for example processor 214 and memory 217 of computer 210 of Figure 2, to recognize its relative position within the surgical site from the scan data, so that further observations may be made with reference to both the location and orientation of fiducial key 10.
  • the fiducial reference includes a marking that is apparent as a recognizable identifying symbol when scanned.
  • the fiducial reference includes a shape that is distinct in the sense that the body apparent on the scan has an asymmetrical form allowing the front, rear, upper, and lower, and left/right defined surfaces that may be unambiguously determined from the analysis of the scan, thereby to allow the determination not only of the location of the fiducial reference, but also of its orientation.
  • the computer software may create a coordinate system for organizing objects in the scan, such as teeth, jaw bone, skin and gum tissue, other surgical instruments, etc.
  • the coordinate system relates the images on the scan to the space around the fiducial and locates the instruments bearing markers both by orientation and position.
  • the model generated by the monitoring system may then be used to check boundary conditions, and in conjunction with the tracker display the arrangement in real time on a suitable display, for example display 224 of Figure 2.
  • the computer system has a predetermined knowledge of the physical configuration of fiducial key 10 and examines slices/sections of the scan to locate fiducial key 10. Locating of fiducial key 10 may be on its distinct shape, or on the basis of distinctive identifying and orienting markings upon the fiducial key or on attachments to the fiducial key 10 as tracking marker 12. Fiducial key 10 may be rendered distinctly visible in the scans through higher imaging contrast by the employ of radio -opaque materials or high-density materials in the construction of the fiducial key 10. In other embodiments the material of the distinctive identifying and orienting markings may be created using suitable high density or radio-opaque inks or materials.
  • fiducial key 10 Once fiducial key 10 is identified, the location and orientation of the fiducial key 10 is determined from the scan segments, and a point within fiducial key 10 is assigned as the center of the coordinate system. The point so chosen may be chosen arbitrarily, or the choice may be based on some useful criterion.
  • a model is then derived in the form of a transformation matrix to relate the fiducial system, being fiducial key 10 in one particular embodiment, to the coordinate system of the surgical site.
  • the resulting virtual construct may be used by surgical procedure planning software for virtual modeling of the contemplated procedure, and may alternatively be used by instrumentation software for the configuration of the instrument, for providing imaging assistance for surgical software, and/or for plotting trajectories for the conduct of the surgical procedure.
  • the monitoring hardware includes a tracking attachment to the fiducial reference.
  • the tracking attachment to fiducial key 10 is tracking marker 12, which is attached to fiducial key 10 via tracking pole 11.
  • Tracking marker 12 may have a particular identifying pattern.
  • the trackable attachment, for example tracking marker 12, and even associated tracking pole 11 may have known configurations so that observational data from tracking pole 11 and/or tracking marker 12 may be precisely mapped to the coordinate system, and thus progress of the surgical procedure may be monitored and recorded.
  • fiducial key 10 may have hole 15 in a predetermined location specially adapted for engagement with insert 17 of tracking pole 11.
  • tracking poles 11 may be attached with a low force push into hole 15 of fiducial key 10, and an audible haptic notification may thus be given upon successful completion of the attachment.
  • reorient the tracking pole during a surgical procedure may be in order to change the location of the procedure, for example where a dental surgery deals with teeth on the opposite side of the mouth, where a surgeon switches hands, and/or where a second surgeon performs a portion of the procedure.
  • the movement of the tracking pole may trigger a re -registration of the tracking pole with relation to the coordinate system, so that the locations may be accordingly adjusted.
  • Such a re-registration may be automatically initiated when, for example in the case of the dental surgery embodiment, tracking pole 11 with its attached tracking marker 12 are removed from hole 15 of fiducial key 10 and another tracking marker with its associated tracking pole is connected to an alternative hole on fiducial key 10.
  • boundary conditions may be implemented in the software so that the user is notified when
  • observational data approaches and /or enters the boundary areas.
  • a surgical instrument or implement herein termed a
  • hand piece may also have a particular configuration that may be located and tracked in the coordinate system and may have suitable tracking markers as described herein.
  • a boundary condition may be set up to indicate a potential collision with virtual material, so that when the hand piece is sensed to approach the boundary condition an indication may appear on a screen, or an alarm sound.
  • target boundary conditions may be set up to indicate the desired surgical area, so that when the trajectory of the hand piece is trending outside the target area an indication may appear on screen or an alarm sound indicating that the hand piece is deviating from its desired path.
  • Fiducial key 10' has connection elements with suitable connecting portions to allow a tracking pole 11' to position a tracking marker 12' relative to the surgical site.
  • fiducial key 10' serves as an anchor for pole 11' and tracking marker 12' in much the same way as the earlier embodiment, although it has a distinct shape.
  • the software of the monitoring system is pre-programmed with the configuration of each particularly identified fiducial key, tracking pole, and tracking marker, so that the location calculations are only changed according to the changed configuration parameters.
  • the materials of the hardware components may vary according to regulatory requirements and practical considerations.
  • the key or fiducial component is made of generally radio opaque material such that it does not produce noise for the scan, yet creates recognizable contrast on the scanned image so that any identifying pattern associated with it may be recognized.
  • the material should be lightweight and suitable for connection to an apparatus on the patient.
  • the materials of the fiducial key must be suitable for connection to a plastic splint and suitable for connection to a tracking pole.
  • the materials of the fiducial key may be suitable for attachment to the skin or other particular tissue of a patient.
  • the tracking markers are clearly identified by employing, for example without limitation, high contrast pattern engraving.
  • the materials of the tracking markers are chosen to be capable of resisting damage in autoclave processes and are compatible with rigid, repeatable, and quick connection to a connector structure.
  • the tracking markers and associated tracking poles have the ability to be accommodated at different locations for different surgery locations, and, like the fiducial keys, they should also be relatively lightweight as they will often be resting on or against the patient.
  • the tracking poles must similarly be compatible with autoclave processes and have connectors of a form shared among tracking poles.
  • the tracker employed in tracking the fiducial keys, tracking poles and tracking markers should be capable of tracking with suitable accuracy objects of a size of the order of 1.5 square centimeters.
  • the tracker may be, by way of example without limitation, a stereo camera or stereo camera pair. While the tracker is generally connected by wire to a computing device to read the sensory input, it may optionally have wireless connectivity to transmit the sensory data to a computing device.
  • tracking markers attached to such a trackable piece of instrumentation may also be light-weight; capable of operating in a 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.
  • 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.
  • the system obtains a scan data set [404] from, for example, a CT scanner and checks for a default CT scan Hounsfield unit (HU) value [at 406] for the fiducial which may or may not have been provided with the scan based on a knowledge of the fiducial and the particular scanner model, and if such a threshold value is not present, then a generalized predetermined default value is employed [408].
  • HU Hounsfield unit
  • the CT value threshold is adjusted [at 416], the original value restored [at 418], and the segmenting processing scan segments continues [at 410]. Otherwise, with the existing data a center of mass is calculated [at 420], along with calculating the X, Y, and Z axes [at 422]. If the center of mass is not at the cross point of the XYZ axes [at 424], then the user is notified [at 426] and the process stopped [at 428]. If the center of mass is at the XYZ cross point then the data points are compared with the designed fiducial data [430].
  • the 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].
  • 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
  • the offset and relative orientation of the tracking marker to the fiducial reference is obtained from a suitable database [452].
  • database is used in this specification to describe any source, amount or arrangement of such information, whether organized into a formal multi-element or multi-dimensional database or not.
  • a single data set comprising offset value and relative orientation may suffice in a simple implementation of this embodiment and may be provided, for example, by the user or may be within a memory unit of the controller or in a separate database or memory.
  • the offset and relative orientation of the tracking marker is used to define the origin of a coordinate system at the fiducial reference and to determine the three-dimensional orientation of the fiducial reference based on the image information [454] and the registration process ends [458].
  • the process may be looped back from step [454] to obtain new image information from the camera [442].
  • a suitable query point may be included to allow the user to terminate the process.
  • Detailed methods for determining orientations and locations of predetermined shapes or marked tracking markers from image data are known to
  • 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.
  • 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.
  • FIG. 6 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.
  • the fiducial key may comprise a multi-element fiducial pattern 710.
  • the multi-element fiducial pattern 710 may be a dissociable pattern.
  • 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.
  • breakable pattern is used as an alternative term to describe such a dissociable pattern.
  • 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.
  • 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.
  • 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.
  • the material should be lightweight. The materials should also be capable of resisting damage in autoclave processes.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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).
  • 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.
  • multi-element fiducial pattem 710 may comprise larger or smaller numbers of pattern segments 720.
  • 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]
  • Figure 7A employs a dissociable multi-element fiducial pattern.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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, IobanTM 2 Antimicrobial Incise Film from 3M Incorporated of St.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • pattern segments 720, 754 and 764 may be incorporated on the transfer material or tape and on the incise film, respectively, during their manufacture.
  • 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.
  • FIG. 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.
  • 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].
  • HU Hounsfield unit
  • 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
  • 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].
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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'.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.

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Abstract

Les modes de réalisation de la présente invention impliquent des systèmes de surveillance chirurgicaux et des méthodes de modélisation des interventions chirurgicales. Un motif de référence de centrage multiéléments (710, 754, 764, 910, 910 ', 912, 912') observable par un dispositif suiveur (508, 610, 730, 758, 768, 930, 932) peut être transféré directement sur la peau à proximité du site chirurgical ( ), soit à travers un pochoir comme un motif d'encre radio-opaque soit par l'intermédiaire de bande de transfert, ou peut être appliqué dans une forme préparée sur un film pour incision chirurgicale. En variante, le film pour incision chirurgicale peut être appliqué sur le site chirurgical et le motif d'encre de référence appliqué sur le film avant l'intervention chirurgicale. Un contrôleur détermine la localisation en trois dimensions et l'orientation du site chirurgical en comparant la position et l'orientation du motif de référence dans un balayage préalable avec la position et l'orientation du motif de référence dans les informations d'image concernant le site chirurgical obtenues à partir du dispositif suiveur. Le système peut suivre le mouvement des instruments par rapport au site chirurgical, ou peut être utilisé pour suivre les changements dans le site chirurgical lui-même.
EP13716228.5A 2012-03-28 2013-03-27 Enregistrement automatique du tissu corporel mou et système de surveillance de l'emplacement chirurgical et méthode avec référence de centrage appliquée à la peau Withdrawn EP2830527A1 (fr)

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US201261616718P 2012-03-28 2012-03-28
US201261616673P 2012-03-28 2012-03-28
US13/571,284 US8938282B2 (en) 2011-10-28 2012-08-09 Surgical location monitoring system and method with automatic registration
PCT/IL2012/000363 WO2013061318A1 (fr) 2011-10-28 2012-10-21 Système et procédé de surveillance de champ opératoire
US13/745,763 US20130131505A1 (en) 2011-10-28 2013-01-19 Surgical location monitoring system and method using skin applied fiducial reference
US13/745,762 US9554763B2 (en) 2011-10-28 2013-01-19 Soft body automatic registration and surgical monitoring system
PCT/EP2013/056525 WO2013144208A1 (fr) 2012-03-28 2013-03-27 Enregistrement automatique du tissu corporel mou et système de surveillance de l'emplacement chirurgical et méthode avec référence de centrage appliquée à la peau

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