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WO2025027507A1 - Outils de résection entraînés par moteur à extrémité distale magnétisée pour le suivi électromagnétique de ceux-ci - Google Patents

Outils de résection entraînés par moteur à extrémité distale magnétisée pour le suivi électromagnétique de ceux-ci Download PDF

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Publication number
WO2025027507A1
WO2025027507A1 PCT/IB2024/057329 IB2024057329W WO2025027507A1 WO 2025027507 A1 WO2025027507 A1 WO 2025027507A1 IB 2024057329 W IB2024057329 W IB 2024057329W WO 2025027507 A1 WO2025027507 A1 WO 2025027507A1
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WO
WIPO (PCT)
Prior art keywords
tool
instrument
distal end
coils
electromagnetic
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.)
Pending
Application number
PCT/IB2024/057329
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English (en)
Inventor
Aayush Malla
Victor SNYDER
Bradley JACOBSEN
Andrew Wald
Hubert BEAMON
Michael Vu
Haoran LI
Annie EGAN
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Medtronic Navigation Inc
Original Assignee
Medtronic Navigation Inc
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Filing date
Publication date
Application filed by Medtronic Navigation Inc filed Critical Medtronic Navigation Inc
Publication of WO2025027507A1 publication Critical patent/WO2025027507A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/062—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0809—Indication of cracks or breakages
    • 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
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy

Definitions

  • the present disclosure is directed to navigated surgery, and more particularly to tracking tools used during medical and surgical procedures.
  • Image guided medical and surgical procedures utilize patient images obtained prior to or during a medical procedure to guide a physician performing the procedure.
  • Imaging technologies that produce highly-detailed, two, three, and four dimensional images, such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopic imaging (such as with a C-arm device), positron emission tomography (PET), and ultrasound imaging (US) have increased interest in navigated medical procedures.
  • CT computed tomography
  • MRI magnetic resonance imaging
  • fluoroscopic imaging such as with a C-arm device
  • PET positron emission tomography
  • US ultrasound imaging
  • a navigation system tracks the patient, instruments and other devices in the surgical field and/or patient space. These tracked devices are then displayed relative to the image data on the workstation in an image space.
  • the patient, instruments and other devices can be equipped with tracking devices.
  • a tracking device can be coupled to an exterior surface of an instrument, and can provide the surgeon, via a corresponding tracking system, an accurate depiction of the location of that instrument in the patient space.
  • An electromagnetic based tracking tool includes a proximal end and a body.
  • the proximal end is configured to attach directly to or indirectly to a motor of an instrument.
  • the body extends from the proximal end and is configured to be actuated by the motor to resect tissue of a patient.
  • the body includes: a distal end having one or more resecting elements; and a first one or more electromagnetic coils arranged on or in the body and configured to emit or receive electromagnetic signals for detection of a location of a portion of the body while the portion of the body is moving.
  • an electromagnetic tracking system includes: the electromagnetic based tracking tool; a second one or more electromagnetic coils separate from the tool and configured to emit the electromagnetic signals or receive the electromagnetic signals; and a controller configured to detect the location of the portion of the body while the portion of the body is moving based on the received electromagnetic signals.
  • an instrument in other features, includes: a housing; a motor disposed in the housing; and a tool attached to and configured to be moved by the motor to resect tissue of a patient.
  • the tool includes a distal end that is at least partially magnetized.
  • the instrument further includes a first one or more electromagnetic coils disposed in the housing and configured to generate electromagnetic signals in response to detection of a magnetic field generated by the distal end of the tool while the tool is moving for detection of a location of the distal end of the tool while the tool is moving.
  • an electromagnetic tracking system includes: the instrument; a second one or more electromagnetic coils separate from the tool and configured to receive the electromagnetic signals; and a controller configured to detect the location of the distal end of the tool based on the received electromagnetic signals.
  • an instrument in other features, includes: a housing including a motor, the motor configured to rotate a shaft; and an electromagnetic based tracking tool extending from the housing and connected to and configured to be actuated by the shaft to resect tissue of a patient.
  • the electromagnetic based tracking tool includes: a body comprising a distal end having one or more resecting elements; and a first one or more electromagnetic coils arranged on or in the body and configured to emit or receive electromagnetic signals to detect a location of the distal end of the body while the distal end of the body is moving.
  • an electromagnetic tracking system includes an instrument having a housing, a motor, a tool and first electromagnetic coils.
  • the motor is disposed in the housing.
  • the tool is attached to and configured to be moved by the motor to resect tissue of a patient.
  • the tool includes a distal end that is at least partially magnetized.
  • the first electromagnetic coils are disposed at a distal end of the housing and are configured to generate electromagnetic signals in response to detection of a magnetic field generated by a magnetized portion of the distal end of the tool while the tool is moving.
  • the second electromagnetic coils are separate from the tool and configured to receive the electromagnetic signals.
  • the controller is configured to detect a location of the distal end of the tool based on the received electromagnetic signals while the tool is moving.
  • FIG. 1 is a diagram of a navigation system including an example tracking system with an electromagnetic (EM) based tracking instrument in accordance with the present disclosure.
  • EM electromagnetic
  • FIG. 2 is a cross-sectional side view of a portion of an example EM based tracking instrument including a single coil arrangement with two pogo pin connecting assemblies in accordance with the present disclosure.
  • FIG. 3 is a cross-sectional side view of a portion of an example EM based tracking instrument including a dual coil arrangement with four pogo pin connecting assemblies and tool internally located coil terminals in accordance with the present disclosure.
  • FIG. 4 is a cross-sectional side view of a portion of an example EM based tracking instrument including a dual coil arrangement internal to a tool tip, four pogo pin connecting assemblies, and distal end located coil terminals in accordance with the present disclosure.
  • FIG. 5 is a cross-sectional side view of an example pogo pin including a plunger and a spring arrangement in accordance with the present disclosure.
  • FIG. 6 is a cross-sectional side view of an example pogo pin including a plunger, a ball and a spring arrangement in accordance with the present disclosure.
  • FIG. 7 is a cross-sectional side view of an example pogo pin including a plunger, a shell, and a spring arrangement in accordance with the present disclosure.
  • FIG. 8 is a cross-sectional side view of a portion of another example instrument including housing mounted coils and a magnetic tool tip in accordance with the present disclosure.
  • FIG. 9 is a cross-sectional side view of a portion of another example instrument including bearings with electrical terminals in accordance with the present disclosure.
  • FIG. 10 is a cross-sectional side view of a portion of another example instrument including bearing assemblies with electrical contactor coils in accordance with the present disclosure.
  • FIG. 11 is a cross-sectional perspective view of a portion of another example instrument with an oscillating (or moving) saw blade including EM coils in accordance with the present disclosure.
  • FIG. 12 is a cross-sectional perspective view of a portion of another example instrument with an oscillating (or moving) saw blade including EM coils in accordance with the present disclosure.
  • FIG. 13 is a cross-sectional perspective view of a portion of another example instrument with a magnetic oscillating (or moving) saw blade and a housing with a grip portion having EM coils in accordance with the present disclosure.
  • FIG. 14 is a perspective view of a portion of another example instrument having a radially extending and annularly moving saw blade with EM coils in accordance with the present disclosure.
  • FIG. 15 is a perspective view of another example instrument with an axially extending and moving saw blade having EM coils in accordance with the present disclosure.
  • FIG. 16 is a functional block diagram of a tracking control system in accordance with the present disclosure.
  • FIG. 17 illustrates a tracking method in accordance with the present disclosure.
  • Some existing navigation drill systems today utilize a passive navigation method of tracking a tip of a tool during use, such as a tip of a drill bit. This method has limited ability to accurately track the tip of the tool.
  • a passive navigation system can typically include an optical tracker, which can have, for example, four reflective spheres that are mounted to an instrument and used to estimate a location of a tip of a tool of the instrument.
  • the tool refers to a drill bit, a saw blade, or other tool used during a procedure.
  • a camera tracks the locations of the four reflective spheres of the tracker in space relative to a reference frame. Based on the detected locations of the spheres and a known spatial relationship between the tip of the tool and the spheres, a location of the tip of the tool is determined relative to the reference frame.
  • Passive navigation methods are based on an assumption that a tip of a tool remains in a known fixed relationship with a tracker for accurate determination of the location of the tip of the tool.
  • a calibration process is typically performed to assure that the known relationship between the tip of the tool and the tracker is correct, the tip of the tool can move relative to the tracker.
  • the calibration process can include using an array separate from the tracker to check the location of the tip of the tool relative to the reference frame.
  • a tool and/or the tip of the tool can deflect, bend, chatter, vibrate, and/or move at highspeed.
  • the relationship between the tip of the tool and a tracker can change or migrate over time, for example, due to wear and tear (or degradation) and/or damage associated with usage.
  • the stated movement may be difficult to accurately track and/or detect using existing passive navigation methods and can result in inaccurate tracking of instantaneous (or real-time) positions of tips of tools.
  • Examples set forth herein include EM (electromagnetic)_based tracking tools (referred to herein as “tools”) and EM based tracking instruments (referred to herein as “instruments”) for accurate real time tracking of the tools and instruments including portions thereof.
  • the examples provided include accurate location and orientation determination of tips of tools and distal ends of instrument housings (or attachments) including detection of movement such as tip deflection, tool chattering and/or vibrating, tip migration relative to a distal end of an instrument, etc.
  • the examples include detecting the stated movement for detection of tool instability and/or breakage for tool and/or instrument replacement.
  • the examples also include actively monitoring tool tip positioning and actively adjusting speed, torque, stability, dampening, and/or feed rate of a tool. This can occur during a procedure, such as while resecting tissue and/or bone.
  • the feed rate refers to a rate of movement of the tool relative to a patient, for example, when moved by a robot.
  • FIG. 1 is a diagram of a navigation system 10 (also referred to as a tracking system) with an EM based tracking instrument 12. Examples of the EM based tracking instrument are shown and described with respect to FIGs. 2- 15.
  • the instrument 12 may include i) an EM based tracking tool having a portion that is either magnetized and/or includes one or more EM tracking coils, and ii) a housing that includes EM tracking coils and/or coil terminals.
  • the EM tracking coils may operate as EM transmitting devices or EM receiving devices and used to detect locations of portions of the tool and housing including a tip of the tool and a distal end of the housing.
  • the EM tracking coils may be located anywhere on, in and/or embedded in the tool and/or housing. In some embodiments, the EM tracking coils are on, in and/or embedded in a tip of the tool or a distal end of the housing. This is done to improve accuracy in detecting the location and orientation of the tip of the tool.
  • any portion of a tool may be magnetized.
  • the magnetic field associated with the tool is detected via EM tracking coils located in the housing. This detection of the magnetic field via the EM tracking coils allows the tracking system to detect the location and orientation of the tool.
  • a tip of the tool is magnetized to improve accuracy in detecting the location and orientation of the tip of the tool.
  • the tip of the tool is not magnetized and may include one or more EM coils. See FIGs. 2-15 and corresponding description for further examples.
  • the navigation system 10 can be used for various procedures and to track the location of an implant, such as a spinal implant or orthopedic implant, relative to a patient 13. Also, the navigation system 10 can track the position and orientation of various tools and instruments, such as the tools and instruments disclosed herein. It should further be noted that the navigation system 10 may be used to navigate any type of instrument, implant, or delivery system, including: guide wires, arthroscopic systems, orthopedic implants, spinal implants, deep-brain stimulator (DBS) probes, etc. Moreover, these instruments may be used to navigate or map any region of the body. The navigation system 10 and the various instruments may be used in any appropriate procedure, such as one that is generally minimally invasive, arthroscopic, percutaneous, stereotactic, or an open procedure.
  • DBS deep-brain stimulator
  • the navigation system 10 may include an imaging device 14 that is used to acquire pre-, intra-, or post-operative or real-time image data of a patient 13.
  • an imaging device 14 that is used to acquire pre-, intra-, or post-operative or real-time image data of a patient 13.
  • various imageless systems can be used or images from atlas models can be used to produce patient images, such as those disclosed in U.S. Patent Pub. No. 2005-0085714, filed 10/16/2003, entitled "METHOD AND APPARATUS FOR SURGICAL NAVIGATION OF A MULTIPLE PIECE CONSTRUCT FOR IMPLANTATION,” incorporated herein by reference.
  • the imaging device 14 can be, for example, a fluoroscopic x-ray imaging device that may be configured as an O-arm TM or a C-arm 16 having an x-ray source 18, an x-ray receiving section 20, an optional calibration and tracking target 22 and optional radiation sensors 24. It will be understood, however, that patient image data can also be acquired using other imaging devices, such as those discussed above and herein.
  • An imaging device controller 28, that can control the C-arm 16 can capture the x-ray images received at the x-ray receiving section 20 and store the images for later use.
  • the controller 28 may also be separate from the C-arm 16 and/or control the rotation of the C-arm 16.
  • the C-arm 16 can move in the direction of arrow A or rotate about a longitudinal axis 29 of the patient 13, allowing anterior or lateral views of the patient 13 to be imaged. Each of these movements involves rotation about a mechanical axis 32 of the C-arm 16.
  • the movements of the imaging device 14, such as the C-arm 16 can be tracked with a tracking device 33.
  • the longitudinal axis 29 of the patient 13 is substantially in line with the mechanical axis 32 of the C-arm 16. This can enable the C-arm 16 to be rotated relative to the patient 13, allowing images of the patient 13 to be taken from multiple directions or about multiple planes.
  • An example of a fluoroscopic C-arm X-ray device that may be used as the optional imaging device 14 is the “Series 9600 Mobile Digital Imaging System,” from GE Healthcare, (formerly OEC Medical Systems, Inc.) of Salt Lake City, Utah.
  • Other exemplary fluoroscopes include bi-plane fluoroscopic systems, ceiling fluoroscopic systems, cath-lab fluoroscopic systems, fixed C-arm fluoroscopic systems, isocentric C-arm fluoroscopic systems, 3D fluoroscopic systems, etc.
  • An exemplary O-arm TM imaging device is available from Medtronic Navigation of Littleton, MA.
  • the imaging device 14 In operation, the imaging device 14 generates x-rays from the x- ray source 18 that propagate through the patient 13 and calibration and/or tracking target 22, into the x-ray receiving section 20. This allows direct visualization of the patient 13 and radio-opaque instruments in the cone of X- rays. It will be understood that the tracking target 22 need not include a calibration portion.
  • the x-ray receiving section 20 generates image data representing the intensities of the received x-rays.
  • the x-ray receiving section 20 includes an image intensifier that first converts the x-rays to visible light and a charge coupled device (CCD) video camera that converts the visible light into digital image data.
  • CCD charge coupled device
  • X-ray receiving section 20 can also be a digital device that converts x-rays directly to digital image data for forming images, thus potentially avoiding distortion introduced by first converting to visible light.
  • this type of digital C-arm which is generally a flat panel device
  • the optional calibration and/or tracking target 22 and the calibration process discussed below may be eliminated.
  • the calibration process may be eliminated or not used at all for various procedures.
  • the imaging device 14 may only take a single image with the calibration and tracking target 22 in place. Thereafter, the calibration and tracking target 22 may be removed from the line-of-sight of the imaging device 14.
  • Two dimensional fluoroscopic images that may be taken by the imaging device 14 are captured and stored in the controller 28. Multiple two- dimensional images taken by the imaging device 14 may also be captured and assembled to provide a larger view or image of a whole region of a patient, as opposed to being directed to only a portion of a region of the patient 13. For example, multiple image data of a patient’s leg may be appended together to provide a full view or complete set of image data of the leg that can be later used to follow contrast agent, such as Bolus tracking.
  • contrast agent such as Bolus tracking.
  • Patient image data 100 can be forwarded from the controller 28 to a navigation computer and/or processor or workstation 34. It will also be understood that the image data is not necessarily first retained in the controller 28, but may also be directly transmitted to the workstation 34.
  • the workstation 34 can include a display 36, a user input device 38 and a controller 101.
  • the controller 101 can include or be connected to an image processor, navigation processor, and memory to hold instruction and data.
  • the workstation 34 can provide facilities for displaying the patient image data 100 as an image on the display 36, saving, digitally manipulating, or printing a hard copy image of the received patient image data 100.
  • the user input device 38 can comprise any device, such as a user input device 38, that can enable a user to interface with the workstation 34, such as a touchpad, touch pen, touch screen, keyboard, mouse, wireless mouse, or a combination thereof.
  • the user input device 38 allows a physician or user 39 to provide inputs to control the imaging device 14, via the C-arm controller 28, or adjust the display settings of the display 36.
  • the controller 101 can determine the location of the tracking device 58 with respect to the patient space, and can output image data 102 to the display 36.
  • the image data 102 can comprise an icon 103 that provides an indication of the location of the tracking device 58 with respect to the patient space, illustrated on the patient image data 100, as will be discussed herein.
  • the patient image data 100 can comprise at least one of data from the navigation system 10, image data acquired by the imaging device 14, patient information entered by the user through the user input device 38, preoperative images, or combinations thereof.
  • the radiation sensors 24 can sense the presence of radiation, which is forwarded to the controller 28, to identify whether or not the imaging device 14 is actively imaging. This information is also transmitted to a coil array controller 48, further discussed herein.
  • the imaging device 14 is shown in FIG. 1 , any other alternative 2D, 3D or 4D imaging modality may also be used.
  • any 2D, 3D or 4D imaging device such as an O-armTM imaging device, isocentric fluoroscopy, bi-plane fluoroscopy, ultrasound, computed tomography (CT), multislice computed tomography (MSCT), magnetic resonance imaging (MRI), high frequency ultrasound (HFU), positron emission tomography (PET), optical coherence tomography (OCT), intra-vascular ultrasound (IVUS), ultrasound, intra-operative CT or MRI may also be used to acquire 2D, 3D or 4D pre- or postoperative and/or real-time images or patient image data 100 of the patient 13.
  • an intra-operative MRI system such as the PoleStar® MRI system sold by Medtronic, Inc.
  • the images of the patient 13 may also be obtained and displayed in two, three or four dimensions.
  • fourdimensional surface rendering regions of the body may also be achieved by incorporating patient data or other data from an atlas or anatomical model map or from pre-operative image data captured by MRI, CT, or echocardiography modalities.
  • OCT optical coherence tomography
  • Image datasets from hybrid modalities could also provide functional image data superimposed onto anatomical data to be used to confidently reach target sites within the patient 13.
  • PET positron emission tomography
  • SPECT single photon emission computer tomography
  • the imaging device 14 provides a virtual bi-plane image using a singlehead C-arm fluoroscope as the imaging device 14 by simply rotating the C-arm 16 about at least two planes, which could be orthogonal planes, to generate two- dimensional images that can be converted to three-dimensional volumetric images.
  • the icon 103 representing the location of an impacter, stylet, reamer driver, taps, drill, deep-brain stimulator (DBS) probes, or other instrument, introduced and advanced in the patient 13, may be superimposed in more than one view and included in the image data 102 displayed on the display 36.
  • DBS deep-brain stimulator
  • the navigation system 10 can further include the instrument 12 (e.g. drill, saw, etc., as described herein), an electromagnetic navigation and tracking system (or tracking system) 44 that includes a localizer, such as a coil array 46 and/or second coil array 47, the coil array controller 48, a navigation probe interface 50, a dynamic reference frame (DRF) 54 and one or more tracking devices 58.
  • the navigation system 10 can include the tracking system 44, the tracking devices 58, a controller 101 and the display 36.
  • the tracking system 44 may include an electromagnetic tracking system 44a and an optical tracking system 44b.
  • the optical tracking system 44b may include, for example the StealthStation® Treon® and the StealthStation® Tria® both sold by Medtronic Navigation, Inc.
  • the tracking system 44 may include acoustic, radiation, radar, infrared, and/or other componentry.
  • the tracking system 44 includes components of both electromagnetic and optical tracking.
  • the DRF 54 can include the tracking devices 58.
  • the tracking devices 58 or any appropriate tracking device as described herein, can include both a sensor, a transmitter, or combinations thereof and can be indicated by the reference numeral 58. Further, the tracking devices 58 can be wired or wireless to provide a signal or emitter or receive a signal from a system. Nevertheless, a tracking device can include an electromagnetic coil to sense a field produced by the localizing coil array 46 or 47. The tracking device can include reflectors that can reflect a signal to be received by the optical localizer or tracking system 44b. Nevertheless, one will understand that the tracking devices 58 can receive a signal, transmit a signal, or combinations thereof to provide information to the navigation system 10 to determine a location of the tracking devices 58.
  • the tracking device 33 of the C-arm 16 could comprise a suitable tracking device 58.
  • the navigation system 10 can then determine a location of the instrument 12 based on the locations of the tracking devices 58 to allow for navigation relative to the patient 13 and the patient space.
  • the optical tracking system 44b can transmit and receive an optical signal, or combinations thereof.
  • the tracking devices 58 can include an optical tracking device can be interconnected with the instrument 12, or other devices such as the DRF 54. As generally known, the optical tracking device can reflect, transmit or receive an optical signal to/from the optical localizer or tracking system 44b that can be used in the navigation system 10 to navigate or track various elements. Therefore, one skilled in the art will understand, that the tracking devices 58 can be any appropriate tracking device to work with any one or multiple tracking systems.
  • the tracking system 44 can include the EM coils of the instrument 12 and the coil arrays 46, 47.
  • the coil arrays 46, 47 may also be supplemented or replaced with a mobile localizer (not shown).
  • the mobile localizer may be one such as that described in U.S. Patent Application Serial No. 10/941 ,782, filed Sept. 15, 2004, and entitled "METHOD AND APPARATUS FOR SURGICAL NAVIGATION", herein incorporated by reference.
  • the EM coils of the instrument 12 and/or the coil arrays 46, 47 can transmit EM signals that are received by the tracking devices 58.
  • the tracking devices 58 can then transmit or receive signals based upon the EM signals transmitted from the EM coils of the instrument 12 and/or the coil arrays 46, 47.
  • the EM coils of the instrument 12 operate as receivers receiving EM signals transmitted by the coil arrays 46, 47.
  • an isolator circuit or assembly may be included in a transmission line to interrupt a line carrying a signal or a voltage to the navigation probe interface 50.
  • the isolator circuit included in the isolator box may be included in the navigation probe interface 50, the instrument 12, the DRF 54, the transmission lines coupling the instrument 12, or any other appropriate location.
  • the isolator assembly is operable to isolate any of the instruments or patient coincidence instruments or portions that are in contact with the patient 13 should an undesirable electrical surge or voltage take place.
  • the navigation system 10 can further include a gating device or an ECG or electrocardiogram (not shown), which is attached to the patient 13, via skin electrodes, and in communication with the coil array controller 48. Respiration and cardiac motion can cause movement of cardiac structures relative to the instrument 12, even when the instrument 12 has not been moved. Therefore, images can be acquired from the imaging device 14 based on a time-gated basis triggered by a physiological signal.
  • the ECG or EGM signal may be acquired from the skin electrodes or from a sensing electrode included on the instrument 12 or from a separate reference probe (not shown).
  • a characteristic of this signal such as an R-wave peak or P- wave peak associated with ventricular or atrial depolarization, respectively, may be used as a triggering event for the coil array controller 48 to drive the coils in the coil arrays 46, 47.
  • This triggering event may also be used to gate or trigger image acquisition during the imaging phase with the imaging device 14.
  • the icon 103 of the location of the tool of the instrument 12 in image space relative to the patient space at the same point in the cardiac cycle may be displayed on the display 36. Further detail regarding the time-gating of the image data and/or navigation data can be found in U.S. Pub. Application No.
  • portions of electromagnetic tracking system 44 may be incorporated into the imaging device 14, including the radiation sensors 24, the workstation 34 and the controller 101. Incorporating portions of the electromagnetic tracking system 44 can provide an integrated imaging and tracking system. Any combination of these components can also be incorporated into the imaging device 14, which again can include a fluoroscopic C-arm imaging device or any other appropriate imaging device.
  • the coil arrays 46, 47 are shown attached to the operating table 49. It should be noted, however, that the coil arrays 46, 47 can also be positioned at any other location as well and can also be positioned in the items being navigated.
  • the EM coils of the instrument 12 and the coils of the coil arrays 46, 47 are each operable to generate distinct electromagnetic fields into the navigation region of the patient 13, which is sometimes referred to as patient space.
  • Representative electromagnetic systems are set forth in U.S. Patent No. 5,913,820, entitled “Position Location System,” issued June 22, 1999 and U.S. Patent No. 5,592,939, entitled “Method and System for Navigating a Catheter Probe,” issued January 14, 1997, each of which are hereby incorporated by reference.
  • the EM coils of the instrument 12 and the coil arrays 46, 47 can be controlled or driven by the coil array controller 48.
  • the coil array controller 48 can drive each of the EM coils of the instrument 12 and each coil in the coil arrays 46, 47 in a time division multiplex or a frequency division multiplex manner. In this regard, each coil can be driven separately at a distinct time or all of the coils can be driven simultaneously with each being driven by a different frequency.
  • electromagnetic fields are generated in areas near and/or within the patient 13 where the medical procedure is being performed. These areas are sometimes referred to as the patient space.
  • the electromagnetic fields generated in the patient space induce currents in the tracking device 58 positioned on or in the instrument 12. These induced signals from the instrument 12 are delivered to the navigation probe interface 50 and can be subsequently forwarded to the coil array controller 48.
  • the navigation probe interface 50 may provide all the necessary electrical isolation for the navigation system 10.
  • the navigation probe interface 50 can also include amplifiers, filters and buffers to directly interface with the tracking devices 58 in the instrument 12.
  • the tracking devices 58 or any other appropriate portion, may employ a wireless communications channel, such as that disclosed in U.S. Patent No. 6,474,341 , entitled “Surgical Communication Power System,” issued November 5, 2002, herein incorporated by reference, as opposed to being coupled directly to the navigation probe interface 50.
  • the tracking devices 58 may also be referred to as localization sensors.
  • the electromagnetic sources or generators may be located within the instrument 12, DRF 54, and one or more receiver coils may be provided externally to the patient 13 forming a receiver coil array similar to the coil arrays 46, 47.
  • An additional representative alternative localization and tracking system is set forth in U.S. Patent No. 5,983,126, entitled “Catheter Location System and Method,” issued November 9, 1999, which is hereby incorporated by reference.
  • the localization system may be a hybrid system that includes components from various systems.
  • the DRF 54 of the tracking system 44 can also be coupled to the navigation probe interface 50 to forward the information to the coil array controller 48.
  • the DRF 54 can include a small magnetic field detector.
  • the DRF 54 may be fixed to the patient 13 adjacent to the region being navigated so that any movement of the patient 13 is detected as relative motion between the coil arrays 46, 47 and the DRF 54. This relative motion can be forwarded to the coil array controller 48, which can update the registration correlation and maintain accurate navigation, as further discussed herein.
  • the DRF 54 may include any appropriate tracking device(s) 58 used by the navigation system 10. Therefore, the DRF 54 can include an optical tracking device or acoustic tracking device. If the DRF 54 is used with an electromagnetic tracking device it can be configured as a pair of orthogonally oriented coils, each having the same center or may be configured in any other non-coaxial or co-axial coil configurations (not specifically shown).
  • the navigation system 10 operates as follows.
  • the navigation system 10 creates a translation map between all points in the radiological image generated from the imaging device 14 and the corresponding points in the patient’s anatomy in patient space. After this map is established, whenever a tracked instrument, such as the instrument 12 is used, the workstation 34 in combination with the coil array controller 48 and the controller 28 uses the translation map to identify the corresponding point on the preacquired image or atlas model, which is displayed on display 36. This identification is known as navigation or localization.
  • the icon 103 representing the localized point or instrument 12 can be shown as image data 102 on the display 36, as will be discussed herein.
  • the navigation system 10 To enable navigation, the navigation system 10 must be able to detect both the position of the patient’s anatomy and the position of the instrument 12 or tool attached to the instrument 12. Knowing the location of these two items allows the navigation system 10 to compute and display the position of the instrument 12 in relation to the patient 13 on the display 36.
  • the tracking system 44 can be employed to track the instrument 12 and the anatomy simultaneously.
  • the tracking system 44 if using an electromagnetic tracking assembly, has the coil arrays 46, 47 located adjacent to the patient space and configured to generate a low-energy magnetic field referred to as a navigation field. Because every point in the navigation field or patient space is associated with a unique field strength, the tracking system 44 can determine the position of the instrument 12 by measuring the field strength at the tracking device 58 location.
  • the DRF 54 is fixed to the patient 13 to identify the location of the patient 13 in the navigation field.
  • the tracking system 44 continuously recomputes the relative position of the DRF 54 and the instrument 12 during localization and relates this spatial information to patient registration data to enable image guidance of the instrument 12 within and/or relative to the patient 13.
  • Patient registration is the process of determining how to correlate the position of the instrument 12 relative to the patient 13 to the position on the diagnostic or pre-acquired images.
  • a physician or user 39 may use point registration by selecting and storing particular points from the pre-acquired images and then touching the corresponding points on the patient’s anatomy with a pointer probe (not shown).
  • the navigation system 10 analyzes the relationship between the two sets of points that are selected and computes a match, which correlates every point in the image data 102 with its corresponding point on the patient’s anatomy or the patient space, as discussed herein.
  • the points that are selected to perform registration are the fiducial markers 60, such as anatomical landmarks.
  • the landmarks or fiducial markers 60 are identifiable on the images and identifiable and accessible on the patient 13.
  • the fiducial markers 60 can be artificial markers that are positioned on the patient 13 or anatomical landmarks that can be easily identified in the image data 102.
  • the artificial landmarks, such as the fiducial markers 60 can also form part of the DRF 54, such as those disclosed in U.S. Patent No. 6,381 ,485, entitled “Registration of Human Anatomy Integrated for Electromagnetic Localization,” issued April 30, 2002, herein incorporated by reference.
  • the navigation system 10 may also perform registration using anatomic surface information or path information as is known in the art.
  • the navigation system 10 may also perform 2D to 3D registration by utilizing the acquired 2D images to register 3D volume images by use of contour algorithms, point algorithms or density comparison algorithms, as is known in the art.
  • An exemplary 2D to 3D registration procedure is set forth in U.S. Serial No. 60/465,615, entitled “Method and Apparatus for Performing 2D to 3D Registration” filed on April 25, 2003, hereby incorporated by reference.
  • a substantially fiducial-less registration system can be provided, particularly if the imaging device 14 and the tracking system 44 are substantially integrated. Therefore, the tracking system 44 would generally know the position of the imaging device 14 relative to the patient 13 and fiducial markers 60 may not be required for registration. Nevertheless, it will be understood that any appropriate type of registration system can be provided for the navigation system 10.
  • the navigation system 10 continuously tracks the position of the patient 13 during registration and navigation. This is because the patient 13, DRF 54, and coil arrays 46, 47 may all move during the procedure, even when this movement is not desired. Alternatively the patient 13 may be held immobile once the registration has occurred, such as with a head frame (not shown). Therefore, if the navigation system 10 did not track the position of the patient 13 or area of the anatomy, any patient movement after image acquisition would result in inaccurate navigation within that image.
  • the DRF 54 allows the tracking system 44 to register and track the anatomy. Because the DRF 54 is rigidly fixed to the patient 13, any movement of the anatomy or the coil arrays 46, 47 is detected as the relative motion between the coil arrays 46, 47 and the DRF 54. This relative motion is communicated to the coil array controller 48, via the navigation probe interface 50, which updates the registration correlation to thereby maintain accurate navigation.
  • the navigation system 10 can be used according to any appropriate method or system. For example, pre-acquired images, atlas or 3D models may be registered relative to the patient 13 and the patient space.
  • the navigation system 10 allows the images on the display 36 to be registered and to accurately display the real time location of the various instruments, such as the instrument 12, and other appropriate items, such as DRF 54.
  • the DRF 54 may be used to ensure that any planned or unplanned movement of the patient 13 or the coil arrays 46, 47 can be determined and used to correct the image data 102 on the display 36.
  • FIG. 2 shows a portion 200 of an EM based tracking instrument including a single coil arrangement 202 with two pogo pin connecting assemblies 204, 206.
  • Pogo pin connecting assemblies are referred to herein as “pogo pins”. Examples of pogo pin connecting assemblies are shown in FIGs. 5-7 and may replace any other pogo pins referred to herein.
  • the EM based tracking instrument includes a housing (or attachment) 210, a shaft 211 that is rotated about a longitudinal axis 212, and a tool 214 that is connected to and rotates with the shaft 211.
  • the tool 214 may be a drill bit as shown or other tool. Flutes and cutting edges of the drill bit are not shown.
  • the tool 214 may include cutting edges and/or other resecting elements.
  • a motor having coils 216 rotates the shaft 211.
  • the tool 214 includes conductive layers 218, 220.
  • An insulative layer 221 is disposed between the conductive layers 218, 220.
  • the conductive layers 218, 220 may extend from terminals 222 in a proximal portion (or end) of the tool 214 to a distal portion (or end) of the tool 214, where, in one embodiment, terminals 224 are located.
  • the conductive layers 218, 220 may be cylindrically-shaped and line an interior surface of a cavity 232 within the tool 214.
  • the terminals 222 connect conductive elements (e.g., plungers, springs, balls, shells, etc.) of the pogo pins 204, 206 to the conductive layers 218, 220.
  • the terminals 224 connect the conductive layers 218, 220 to ends of a coil 230, which may be located at the distal end of the cavity 232 within the tool 214.
  • the terminals 222 may be annular-shaped. Plungers 240 of the pogo pins 204, 206 contact and apply pressure on the terminals 222, but are not attached to the terminals 222. This allows the tool 214 to spin and connection with the coil 230 to be maintained.
  • the ends of the coil 230 are represented by wires 242.
  • a single coil 230 is shown in in the cavity 232, one or more coils may be included.
  • the coils may be in different arrangements and, have the same or different numbers of windings.
  • the coils may be wound about X, Y, and Z axes and/or other axes.
  • the longitudinal axis 212 may refer to an X axis.
  • the coils may be located at or near a distal end of the cavity 232.
  • Wires 244 may be connected to the pogo pins 204, 206 and conduct current to and from the coil 230. Although the wires 244 are shown external to the housing 210, the wires 244 may be routed within the housing 210. Also, although portions of the pogo pins 204, 206 are shown as extending outward from the housing 210, the pogo pins 204, 206 may reside entirely within the housing 210.
  • the shaft 211 and the tool 214 rotate relative to the housing 210, which is stationary.
  • Annular-shaped bearings 250 are disposed between the housing 210 and the tool 214.
  • insulated wires may be included instead of the conductive layers 218, 220.
  • the insulated wires may extend within the cavity 232 and from the terminals 222 to the wires 242.
  • FIG. 3 shows a portion 300 of an EM based tracking instrument including a dual coil arrangement 302 with four pogo pins 304. Examples of the pogo pins 304 are shown in FIGs. 5-7.
  • the EM based tracking instrument includes a housing (or attachment) 310, a shaft 311 that is rotated about a longitudinal axis 312, and a tool 314 that is connected to and rotates with the shaft 311 .
  • the tool 314 may be a drill bit as shown or other tool. Flutes and cutting edges of the drill bit are not shown.
  • a motor rotates the shaft 311 .
  • the tool 314 includes conductive layers 317, 318, 319, 320.
  • Insulative layers are disposed between adjacent pairs of the conductive layers 317, 318, 319, 320.
  • the conductive layers 317, 318, 319, 320 may extend from terminals 322 in proximal portions of the tool 314 to a distal portion of the tool 314, where, in one embodiment, terminals 324 are located.
  • the conductive layers 317, 318, 319, 320 may be cylindrically-shaped and line an interior surface of a cavity 332 within the tool 314.
  • the terminals 322 connect conductive elements (e.g., plungers, springs, balls, shells, etc.) of the pogo pins 304 to the conductive layers 317, 318, 319, 320.
  • the terminals 324 connect the conductive layers 317, 318, 319, 320 to ends of coils 330, 331 , which may be located at the distal end of the cavity 332 within the tip 333 of the tool 314.
  • the coils 330, 331 may be concentric coils, as shown, or may be located separate from each other and/or in different orientations and arrangements.
  • the terminals 322 may be annular-shaped. Plungers 340 of the pogo pins 304 contact and apply pressure on the terminals 322 but are not attached to the terminals 322. This allows the tool 314 to spin and connection with the coils 330, 331 to be maintained.
  • the ends of the coils 330, 331 are represented by wires 342.
  • the coils 330, 331 are shown in in the cavity 332, additional coils may be included.
  • the coils may be in different arrangements, and have the same or different numbers of windings.
  • the coils may be wound about X, Y, and Z axes and/or other axes.
  • the longitudinal axis 312 may refer to the X axis.
  • the coils may be located at or near a distal end of the cavity 332.
  • Wires may be connected to the pogo pins 304 and conduct current to and from the coils 330, 331. Although portions of the pogo pins 304 are shown as extending outward from the housing 310, the pogo pins 304 and corresponding wires may reside entirely within the housing 310.
  • insulated wires may be included instead of the conductive layers 317, 318, 319, 320.
  • the insulated wires may extend within the cavity 332 and from the terminals 322 to the wires 342.
  • the insulated wires have an outer jacket and an inner conductive core.
  • ends of the coils 330, 331 extend along the cavity 332 and connect to the terminals 322.
  • FIG. 4 shows a portion 400 of an EM based tracking instrument including a dual coil arrangement 402 internal to a tool tip 403, four pogo pins 404, and distal end coil terminals 405.
  • the instrument is configured to the instrument of FIG. 3, except includes the distal end coil terminals 405 instead of terminals 324 that are internal to the cavity 332.
  • the instrument includes a tool 414 that has conductive layers 420, 422, 424, 426.
  • the tip 403 may be a drill bit having flutes and cutting edges as shown.
  • the terminals 405 connect the conductive layers 420, 422, 424, 426 to ends of coils 430, 431 , which may be located at the distal end of the tool 414 within the tip 403.
  • the coils 430, 431 may be concentric coils, as shown, or may be located separate from each other and/or in different orientations.
  • coils 430, 431 are shown in in the cavity 332, additional coils may be included.
  • the coils may be in different arrangements, having the same or different numbers of windings.
  • the coils may be wound about X, Y, and Z axes and/or other axes.
  • the second coil 431 may be included for redundancy, verification of the signal from the first coil 430, and/or for improving accuracy of location estimations of the tip 403. As an example, if two coils are concentric, the signals provided using the coils should indicate a same center location for the coils.
  • FIG. 5 shows a pogo pin 500 including a plunger 502, spring 504, a conductive base element (or barrel) 506 and a housing 508.
  • the spring 504 provides radially inward pressure on the plunger 502 to bias the plunger 502 distally outward, such that the plunger remains in contacts with, for example, a rotating terminal (e.g., the terminals 222, 322 of FIGs. 2-3).
  • FIG. 6 shows a pogo pin 600 including a plunger 602, a ball 603, a spring 604, a conductive base element 606 (or barrel) and a housing 608.
  • FIG. 7 shows a pogo pin 700 including a plunger 702, a shell 703, a spring 704, a conductive base element (or barrel) 706 and a housing 708.
  • FIG. 8 shows a portion 800 of an instrument including housing mounted coils 802, 804, 806 and a magnetic tool tip 808.
  • the coils 802, 804, 806 are integrated into a housing (or attachment) 810 of the instrument.
  • the instrument also includes a movable and/or rotatable tool 812 that is connected to a shaft 814, which rotates within the housing 810 about a longitudinal axis 816.
  • the tool 812 rotates with the shaft 814 on the bearings 820.
  • the coils 802, 804, 806 are wound about respective axes (e.g., X, Y, Z axes) and are in perpendicular or orthogonal orientations relative to each other. Although three coils are shown, one or more coils may be included.
  • the axes about which the coils 802, 804, 806 are wound (referred to as the wound axes) are perpendicular to each other. In one embodiment, none of the coils are offset and are oriented such that the wound axes intersect each other. In another embodiment, not all three wound axes cross each other at the same point in space. For example, the point at which two of the intersect axes intersect may be different than a point through with two other ones of the axes intersect.
  • the coils 802, 804, 806 can occur when one of the coils is offset in position relative to the other coils. Two or more of the wound axes may not intersect each other, depending on the locations and orientations of the coils.
  • the coils may be internal to, embedded in the material, and/or outer wall of the housing 810, or may be external to and on the housing 810.
  • the tip 808 may be connected to or brazed on a cylindrically shaped body 830 of the tool 812.
  • the tip 808 and the body 830 include threads such that the tip 808 is screwed onto the body 830. If brazed, brazing material may exist between a distal end of the body 830 and the tip 808.
  • a portion of the body 830 is disposed within and brazed to an inner cavity of the tip 808.
  • Wires may extend from the coils 802, 804, 806 and within and along the body 830. Each coil having a respective pair of wires. The wires may receive signals from the coils 802, 804, 806 or provide signals to the coils 802, 804, 806.
  • the coils 802, 804, 806 are at the distal end of the housing 810 and detect a signal or magnetic field emitted from the magnetized tip 808. In an embodiment, the signals and/or magnetic fields of the coils are detected and triangulation is performed to determine the location of the tip 808. In an embodiment, the tool 812 does not include an EM coil and is configured to be cleaned and autoclaved.
  • FIG. 9 shows a portion 900 of an instrument including bearings 902 with electrical terminals 904.
  • the electrical terminals 904 connect the bearings 902 to wires 906 extending to a coil 908.
  • the coil 908 is disposed at a distal end of a cavity 910 of a tool 912.
  • Wires 914 may extend from the bearings 902 and through the housing 920.
  • the wires 914 may receive signals from the coil 908 or provide signals to the coil 908.
  • FIG. 10 shows a portion 1000 of an instrument including bearing assemblies 1002 with electrical contactor coils 1004 electrically connecting inner portions 1006 to outer portions 1008 of the assemblies 1002.
  • the inner portions 1006 may include bearings on which a shaft 1010 and tool 1012 of the instrument rotate.
  • Electrical terminals 1014 electrically connect the electrical contactor coils 1004 to coil 1020 located at a distal end of a cavity 1022 of the tool 1012.
  • Wires 1030 may extend from the outer portions 1008 through a housing (or attachment) 1032.
  • the example of FIG. 10 utilizes bearing and seal contact surfaces to complete electrical connections to one or more coils at a distal end of the tool 1012.
  • Wires 1034 may extend from the terminals 1014 to the coil 1020.
  • wires may be included if additional coils are included.
  • FIG. 11 shows a portion 1100 of an instrument with an oscillating (or moving) saw blade 1102 including EM coils 1104.
  • the instrument is an oscillating instrument, where a distal end of the saw blade 1102 moves back-and-forth at high speed, as represented by arrow 1106.
  • the saw blade 1102 is connected to an actuator block 1120, which is oscillated by a motor and eccentric gear drive assembly 1122 that converts rotational movement of a shaft of a motor to oscillating movement.
  • the actuator block 1120 may be referred to as an oscillating element.
  • Supply wires 1124 extend from the coils 1104 and although shown as extending away from the instrument, may extend within a housing 1130 of the instrument.
  • Return ends of the coils 1104 may be connected to return wires 1126 as shown or to the saw blade 1102.
  • the saw blade 1102 may serve as a return electrode.
  • the return wires 1126 may extend through the housing 1130.
  • the return wires 1 126 may extend along an opposite side of the saw blade 1102 than the supply wires 1124.
  • the supply wires 1124 may be connected to surface contacts on the housing 1130, which are supplied power to energize the coils 1104. Although two EM coils 1 104 are shown, one or more may be included on the saw blade 1102.
  • the wires 1124, 1126, as with other wires referred to herein, may have conductive cores contained within insulated jackets.
  • FIG. 12 shows a portion 1200 of an instrument with an oscillating (or moving) saw blade 1202 including EM coils 1204.
  • the instrument is an oscillating instrument, where a distal end of the saw blade 1202 moves back-and-forth at high speed.
  • the saw blade 1202 is connected to an actuator block 1220, which is oscillated by a motor and eccentric gear drive assembly 1222 that converts rotational movement of a shaft of a motor to oscillating movement.
  • the actuator block 1220 may be referred to as an oscillating element.
  • Supply wires 1222 extend from the coils 1204 and although shown as extending away from the instrument, may extend within a housing 1230 of the instrument.
  • EM coils 1204 may be included on the saw blade 1202. Return ends of the EM coils 1204 may be connected to return wires 1224 or to the saw blade 1202, which may serve as a return electrode.
  • the return wires 1224 may extend through the housing 1230.
  • the supply wires 1222 may be connected to surface contacts on the housing 1230, which are supplied power to energize the coils 1204.
  • FIG. 13 shows a portion 1300 of an instrument with a magnetic oscillating (or moving) saw blade 1302 and a housing 1304 with a grip portion 1306 having EM coils 1308.
  • the instrument is an oscillating instrument, where a distal end of the saw blade 1302 moves back-and-forth at high speed.
  • the saw blade 1302 is connected to an actuator block 1320, which is oscillated by a motor and eccentric gear drive assembly 1322 that converts rotational movement of a shaft of a motor to oscillating movement.
  • the actuator block 1320 may be referred to as an oscillating element.
  • the saw blade is a magnetic blade having a corresponding magnetic field.
  • the EM coils 1308 detect the magnetic field and generate EM signals which are sent to a control module via wires 1310. Although shown as being external to the housing 1304, the wires 1310 may extend within the housing 1304. The ends of each of the EM coils 1308 that are not connected to the wires 1310 may be connected to respective wires and/or to contacts (not shown) in the housing 1304.
  • FIG. 14 shows a portion 1400 of an example instrument having a radially extending and annularly moving saw blade 1402 with EM coils 1404, which may be connected and used as other EM coils described herein.
  • the instrument includes a body 1406 and an end attachment 1408 for fastening the saw blade 1402 to the body 1406.
  • FIG. 15 shows a portion 1500 of an instrument with an axially extending and moving saw blade 1502 having EM coils 1504, which may be connected and used as other EM coils described herein.
  • the instrument may be a linear actuator reciprocating instrument.
  • the instrument includes a body 1506 and an engagement handle 1508, which when pressed activates a motor of the instrument to move the saw blade 1502 in a reciprocating manner.
  • the saw blade 1502 is attached to a reciprocating element (or shaft) 1510 that is moved by the motor.
  • one of the tools and/or housings of the instruments includes one or more transmit EM coils and one or more other
  • EM coils within an imaging space are used to detect the EM signals transmitted by the one or more transmit EM coils.
  • 12 magnetic fields are generated by 12 transmit EM coils.
  • 6 transmit EM coils are generated.
  • for each transmit EM coil there are two or more receive EM coils to determine location and orientation of the transmit EM coil.
  • 6 magnetic fields are generated to track movement of a single receive EM coil.
  • 2-3 receive EM coils are used to detect location and orientation of a distal end of an instrument and/or tool.
  • the receive EM coils may be located on the instrument or off of the instrument. When off the instrument, then at least one transmit EM coil is located on the instrument. When on the instrument, then at least one transmit EM coil is located off the instrument.
  • FIG. 16 shows a tracking control system 1600 that may be used as part of the navigation system 10 of FIG. 1.
  • the tracking control system 1600 includes the controller 101 , which may include a processor 1602 implementing a gantry control module 1604, a source module 1606, a detector module 1608, an image capture module 1610, an EM transmission module 1612, and a tracking module 1614, a navigation control module 1616 and a degradation module 1618.
  • the gantry control module 1604 may control positioning and determine positions of the gantry of the imaging and/or navigation system 10.
  • the gantry control module 1604 may control a gantry motor 1620.
  • the source module 1606 may control an X-ray source and/or positioning thereof including controlling one or more source motors 1622 of a source actuator and motor assembly 1624.
  • the detector module 1608 may control operation of an X-ray detector and/or positioning thereof including controlling one or more detector motors 1626 of a detector actuator and motor assembly 1628.
  • the image capture module 1610 may control capturing of images of a patient and/or space surrounding the patient.
  • the EM transmission module 1612 may control generation and emission of electromagnetic signals via EM coils such as the EM coils referred to herein.
  • the EM transmission module 1612 may supply current at selected frequencies and/or having respective signatures to EM coils via wires, terminals, tool layers, pogo pins, bearing assemblies, and/or other conductive elements referred to herein.
  • the tracking module 1614 may determine locations of tools and/or instruments and/or portions thereof based on received EM signals detected by EM coils on tools, instruments, localizers and/or tracking devices referred to herein.
  • the localizers and the tracking devices may each include EM coils.
  • the EM coils of the tools, instruments, localizers and tracking devices may each operate as an emitter or as a receiver of EM signals.
  • the EM signals are received and processed via the tracking module 1614. Tracking data associated with the EM signals may be stored in memory of the processor 1602 or in other memory separate from the processor 1602.
  • the tracking data can include data indicating and/or indicative of the locations of a tip of a tool, a distal end of the tool, and/or a distal end of the corresponding instrument housing (or attachment).
  • the controller 101 can receive EM signals and/or sensor data, via a cable (e.g., the cable 130 of FIG. 1 ), indicative of the EM signals generated by or received by the EM coils.
  • the tracking system 44 and/or the navigation control module 1616 of the navigation system 10 can display locations of the tip of the tool, the distal end of the tool and/or the distal end of the instrument housing.
  • the navigation control module 1616 can receive the tracking data from the tracking system 44 as input.
  • the navigation control module 1616 can also receive patient image data as input.
  • the patient image data can comprise images of the anatomy of a patient obtained from a pre- or intraoperative imaging device, such as the images obtained by the imaging device 14 of FIG. 1.
  • the navigation control module 1616 can generate image data for display on the display 36.
  • the image data can comprise the patient image data superimposed with an icon 103 of the tool and/or instrument, as shown in FIG. 1.
  • the icon 103 can provide a graphical representation of the position, orientation and trajectory of the tip of the tool, a distal end of the tool, and/or a distal end of the instrument housing relative to the anatomy of the patient.
  • the icon 103 can illustrate a starting point of the tool, (i.e., an "X" adjacent to a bone in the anatomy) and can illustrate the trajectory of the tool through the anatomy, (i.e., dashes from the "X").
  • a current location of the tool can also be displayed by the icon 103 (i.e., an "O" at the end of the dashes). It should be understood, however, that any suitable symbol, indicia or the like could be employed to graphically represent the location and/or trajectory of the tip of the tool relative to the anatomy.
  • the tracking module 1614 can receive as an input start-up data from the navigation control module 1616 and sensor data from EM coils of tools, instruments, localizers, and/or tracking devices.
  • the navigation control module 1616 can receive as input tracking data and patient image data.
  • the tracking data can be indicative of locations of portions of the tools, instruments, localizers, and/or tracking devices in patient space. Based on the tracking data, the navigation control module 1616 determines the appropriate patient image data for display on the display 36, and outputs both the tracking data and the patient image data together as image data.
  • the degradation module 1618 in response to the tracking module 1614 detecting the movement of a distal end of an instrument (e.g., a distal end of instrument 1630, a distal end of a tool of the instrument, or distal end of other instrument or tool referred to herein), can detect tool instability and/or breakage for tool and/or instrument replacement.
  • the degradation module 1618 actively monitors locations of tool tips (or distal ends of tools) and based thereon actively adjusts speed, torque, stability, dampening, and/or feed rate of the tool via a corresponding motor (e.g., motor 1632 or other motor referred to herein) and/or one or more actuators (e.g., actuators 1634 or other actuators disclosed herein).
  • FIG. 17 shows a tracking method that may be executed by the processor 1602 of the controller 101 of FIG. 16. The following operations may be iteratively performed.
  • the tracking module 1614 may determine whether start-up data has been received from the navigation control module 1616. If startup data has been received, then the tracking module 1614 performs operation 1702.
  • the tracking system 44 is activated and EM signals are generated and emitted from selected EM coils. This may include one or more coils of a first one or more of the tool(s), instrument(s), localizer(s) and/or tracking device(s) involved.
  • the tracking module 1614 determines whether EM signals have been received at a second one or more of the tool(s), instrument(s), localizer(s) and/or tracking device(s). If EM signals have been received, then operation 1706 is performed.
  • the tracking module 1614 determines the locations and orientations of the distal ends of the instruments (e.g., distal end of tools and/or distal end of housings of the instruments) in patient space based on the EM signals received.
  • the tracking module 1614 also tracks movement of the distal ends of the instruments. This includes movement relative to a patient, oscillating movement, reciprocating movement, bending movement, deflection, flexing movement, etc.
  • the tracking module 1614 or other module may display icons and/or images of the tools and/or instruments relative to the patient in the corresponding imaging volume based on the determined locations of the tools and/or instruments.
  • the degradation module 1618 monitors the stated movement for detection of tool instability and/or breakage for tool and/or instrument replacement.
  • the degradation module 1618 may display on the display 36 of FIG. 1 an indication when the tool and/or instrument is experiencing instability and/or breakage and should be replaced or repaired.
  • Degraded operation of the instrument may also be detected based on locations, orientations and movement of the tool. Degraded operation includes when the tool loosens and/or becomes loose and/or when the tool bends and/or flexes more than expected for normal operation.
  • the degradation module 1618 determines a tip location of the tool relative to the housing and/or a proximal portion of the tool and determines deviations from “normal”. For example, it may be expected that the tip of a rotating tool is to remain located within spherical range (e.g., a sphere having a diameter of a 0.5-2 mm) defined relative to a proximal portion of the tool.
  • the degradation module 1618 may determine this expectation from i) the design of the tool, ii) a characterization procedure during manufacturing, and/or iii) an intraoperative characterization procedure.
  • the degradation module 1618 detects that the tip of the tool (or instrument) leaves that sphere, the degradation module detects degraded operation of the instrument.
  • the degradation module 1618 monitors a scale of variation of the induced voltage at the tip. For example, a voltage induced in coils of a proximal portion of the tool due to motion of a magnetized or transmitting tip may be monitored. If that voltage, measured over the course of many periods of the transmitted signal (and thus many revolutions of the tool) has a larger range than expected, then the degradation module 1618 indicates that degradation is suspected. What is expected can be determined from a controlled design and/or characterization.
  • a real-time location of the tip of the tool is not displayed due to the high-speed motion of the tip. Instead, an average location or a “bubble” representing the full range of motion is displayed.
  • Signal processing is less complex when a wind axis of a coil of the tip of the tool coincides with the rotation axis of the tool than when the wind axis is not the rotation axis.
  • the tip of the tool includes a permanent magnet that is used to localize the tip, then the magnet is arranged such that a line between the north and south poles of the magnet does not lie on and along (or extending parallel to) the rotation axis.
  • the magnet is arranged such that the line extending between the north and south poles is orthogonal to the rotation axis.
  • the tracking module 1614, the degradation module 1618 and/or the navigation control module 1616 may monitor tool tip positioning (location and orientation) and movement and actively adjusting speed, torque, stability, dampening, and/or feed rate of the tool. This can occur during the procedure being performed. This may include adjusting speed, power, current, voltage, etc. to the motor of the instrument of the tool.
  • a determined speed e.g., greater than a determined number of revolutions-per-minute (RPM)
  • the processor 1602 and/or controller 101 prevents the tool from running a speeds greater than the determined speed.
  • the processor 1602 and/or controller 101 permits actuation of the tool at speeds less than or equal to the determined speed.
  • Operation 1700, 1702 and/or 1704 may be performed subsequent to operation 1708.
  • the examples disclosed herein reduces stack up errors associated with tolerance variations of instrument parts.
  • the examples provide EM coil arrangements that allow for accurate determination of distal ends of tools and instruments. This detection occurs in real time and during movement of the distal ends of the tools.
  • the examples are applicable to robotic applications where a robot is moving and controlling use of an instrument, such as any of the instruments disclosed herein.
  • a tool may flex, deflect and/or bend a considerable amount.
  • the examples disclosed herein are able to detect movement of the tip of the tool due to the stated flexing, deflecting, and bending.
  • Example embodiments are provided. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide an understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well- known technologies are not described in detail.
  • Instructions may be executed by a processor and may include software, firmware, and/or microcode, and may refer to programs, routines, functions, classes, data structures, and/or objects.
  • the term shared processor circuit encompasses a single processor circuit that executes some or all code from multiple modules.
  • the term group processor circuit encompasses a processor circuit that, in combination with additional processor circuits, executes some or all code from one or more modules. References to multiple processor circuits encompass multiple processor circuits on discrete dies, multiple processor circuits on a single die, multiple cores of a single processor circuit, multiple threads of a single processor circuit, or a combination of the above.
  • the term shared memory circuit encompasses a single memory circuit that stores some or all code from multiple modules.
  • the term group memory circuit encompasses a memory circuit that, in combination with additional memories, stores some or all code from one or more modules.
  • the apparatuses and methods described in this application may be partially or fully implemented by one or more processors (also referred to as processor modules) that may include a special purpose computer (i.e., created by configuring one or more processors) to execute one or more particular functions embodied in computer programs.
  • the computer programs include processor-executable instructions that are stored on at least one non-transitory, tangible computer-readable medium.
  • the computer programs may also include or rely on stored data.
  • the computer programs may include a basic input/output system (BIOS) that interacts with hardware of the special purpose computer, device drivers that interact with particular devices of the special purpose computer, one or more operating systems, user applications, background services and applications, etc.
  • BIOS basic input/output system
  • the computer programs may include: (i) assembly code; (ii) object code generated from source code by a compiler; (iii) source code for execution by an interpreter; (iv) source code for compilation and execution by a just-in-time compiler, (v) descriptive text for parsing, such as HTML (hypertext markup language) or XML (extensible markup language), etc.
  • source code may be written in C, C++, C#, Objective-C, Haskell, Go, SQL, Lisp, Java®, ASP, Perl, Javascript®, HTML5, Ada, ASP (active server pages), Perl, Scala, Erlang, Ruby, Flash®, Visual Basic®, Lua, or Python®.
  • Communications may include wireless communications described in the present disclosure can be conducted in full or partial compliance with IEEE standard 802.11 -2012, IEEE standard 802.16-2009, and/or IEEE standard 802.20-2008.
  • IEEE 802.11 -2012 may be supplemented by draft IEEE standard 802.11 ac, draft IEEE standard 802.11 ad, and/or draft IEEE standard 802.11 ah.
  • a processor, processor module, module or ‘controller’ may be used interchangeably herein (unless specifically noted otherwise) and each may be replaced with the term ‘circuit.’ Any of these terms may refer to, be part of, or include: an Application Specific Integrated Circuit (ASIC); a digital, analog, or mixed analog/digital discrete circuit; a digital, analog, or mixed analog/digital integrated circuit; a combinational logic circuit; a field programmable gate array (FPGA); a processor circuit (shared, dedicated, or group) that executes code; a memory circuit (shared, dedicated, or group) that stores code executed by the processor circuit; other suitable hardware components that provide the described functionality; or a combination of some or all of the above, such as in a system- on-chip.
  • ASIC Application Specific Integrated Circuit
  • FPGA field programmable gate array
  • processors or processor modules such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry.
  • DSPs digital signal processors
  • ASICs application specific integrated circuits
  • FPGAs field programmable logic arrays
  • processors or processor modules may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

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  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Human Computer Interaction (AREA)
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  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Robotics (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)

Abstract

Un instrument comprend un boîtier, un moteur, un outil et une ou plusieurs bobines électromagnétiques. Le moteur est disposé dans le boîtier. L'outil est fixé au moteur et conçu pour être déplacé par le moteur pour réséquer un tissu d'un patient. L'outil comprend une extrémité distale qui est au moins partiellement magnétisée. La ou les bobines électromagnétiques sont disposées dans le boîtier et configurées pour générer des signaux électromagnétiques en réponse à la détection d'un champ magnétique généré par une partie magnétisée de l'extrémité distale de l'outil tandis que l'outil se déplace pour la détection d'un emplacement de l'extrémité distale de l'outil pendant que l'outil se déplace.
PCT/IB2024/057329 2023-07-28 2024-07-29 Outils de résection entraînés par moteur à extrémité distale magnétisée pour le suivi électromagnétique de ceux-ci Pending WO2025027507A1 (fr)

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US202363516314P 2023-07-28 2023-07-28
US202363516307P 2023-07-28 2023-07-28
US63/516,314 2023-07-28
US63/516,307 2023-07-28

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PCT/IB2024/057321 Pending WO2025027501A1 (fr) 2023-07-28 2024-07-29 Outils de résection mobiles à bobine(s) intégrée(s) pour leur suivi électromagnétique
PCT/IB2024/057329 Pending WO2025027507A1 (fr) 2023-07-28 2024-07-29 Outils de résection entraînés par moteur à extrémité distale magnétisée pour le suivi électromagnétique de ceux-ci

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US5913820A (en) 1992-08-14 1999-06-22 British Telecommunications Public Limited Company Position location system
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EP3277194B1 (fr) * 2015-03-31 2022-08-31 Medtronic Navigation, Inc. Système avec des composants alimentés par générateur thermo-électrique
WO2020210621A1 (fr) * 2019-04-12 2020-10-15 Mako Surgical Corp. Systèmes robotiques et procédés de manipulation d'un guide de coupe pour un instrument chirurgical

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