System and method for navigation

Abstract

Disclosed is a system for assisting in guiding and performing a procedure on a subject (30). The subject may be any appropriate subject such as inanimate object and / or an animate object. The system comprises a subject support member (204) configured to support at least a portion of a mass of the subject in a selected position; and a coil assembly (95) positioned with the support member, wherein the coil assembly is configured to at least one of emit an electromagnetic (EM) field or sense an EM field.

Description

SYSTEM AND METHOD FOR NAVIGATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 593,352, filed October 26, 2023, the entire content of which is incorporated herein by reference.FIELD

[0002] The subject disclosure is related generally to a tracking and navigation system, and particularly to tracking using an electromagnetic field generator and related sensor.BACKGROUND

[0003] This section provides background information related to the present disclosure which is not necessarily prior art.

[0004] An instrument can be navigated relative to a subject for performing various procedures. For example, the subject can include a patient on which a surgical procedure is being performed. During a surgical procedure, an instrument can be tracked in a physical space which may also be referred to as an object or subject space. In various embodiments, the subject space can be a patient space defined by a patient. The location of the instrument that is tracked can be displayed on a display device relative to an image of the patient.

[0005] The position of the patient can be determined with a tracking system. Generally, a patient is registered to the image, via tracking an instrument relative to the patient to generate a translation map between the subject or object space (e.g., patient space) and the image space. This often requires a user, such as a surgeon, to identify one or more points in the subject space and correlating, often identicalpoints, in the image space.

[0006] After registration, the position of the instrument can be appropriately displayed on the display device while tracking the instrument. The position of the instrument relative to the subject can be displayed as a graphical representation, sometimes referred to as an icon on the display device.

[0007] Moreover, various types of medical procedures may require or at least be assisted by positioning or support devices in order to position the patient properly during the medical or surgical procedure. In some instances, this positioning may also be adjustable to account for different spinal procedures or the patient’s size. Orthopedic procedures may also be assisted by patient positioning devices or supports to be used during a procedures.

[0008] With electromagnetic type navigation systems, the electromagnetic generators or transmitters and the electromagnetic receivers also must be positioned at appropriate distances apart from one another. Still further, with the electromagnetic type navigation system, it is desirable to have little or no conductive or magnetic materials near the transmitter and receiver configuration in order to eliminate as much interference as possible. Here again, in a typical OR environment there are various patient support devices that make it difficult to reduce interference.SUMMARY

[0009] This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.

[0010] It may be desirable to provide a patient positioning device having an integrated electromagnetic localizer. The localizer may generate an electromagnetic(EM) field that may be sensed by a tracking sensor. Having an integrated localizer may substantially reduce or eliminate various disadvantages and drawbacks. For example, positioning an EM localizer to have minimal interference relative to a tracking sensor and / or positioning an EM localizer adjacent a volume of a procedure may be enhanced. Therefore, the present invention may provide an integrated electromagnetic localizer for a navigation in a patient positioning device to assist in medical procedures. This may assist in solving related problems, such as and not limited to, having the localizer at a selected position of a subject and / or possible interference.

[0011] A tracking system, such as a tracking system that includes the EM localizer emits an electromagnetic field, may be used to track one or more tracking devices. The tracking devices may be positioned on instruments and tracked in a physical space also referred to as a patient space. The position of the tracking device and an instrument with which it is associated (e.g., attached to) may be displayed in an image representing the subject. For example, the determined position may be superimposed on a portion of the image.

[0012] An electromagnetic (EM) field may be emitted by an emitter or transmitter and may be sensed by an electromagnetic sensing device of the tracking device. According to various embodiments, the electromagnetic sensing device may include one or more coils of a conductive material. Various other materials, such as conductive materials, may interfere with a field being sensed by the sensor. The interference with the field that is sensed by the sensor, however, may be quantified and analyzed to determine the position of a portion that is interfering with the field.

[0013] A positioning member may be used to assist in positioning or holding asubject in a selected position. The positioning member may be used as only a single member or may be provided as a part of a system having more than one positioning member and / or a positioning member holding portion. The positioning member may have one or more localizers associated therewith. The association may include a fixation to the member, an insertion into the member, or other appropriate associations.

[0014] Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.DRAWINGS

[0015] The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.

[0016] Fig. 1 is diagrammatic view illustrating an overview of a procedure suite including a robotic system and a navigation system, according to various embodiments;

[0017] Fig. 2A is a detailed view of a patient positioning system and coil assembly, according to various embodiments;

[0018] Fig. 2B is a detail view of a coil assembly, according to various embodiments;

[0019] Fig. 3A is a detailed view of a patient positioning system and coil assembly, according to various embodiments;

[0020] Fig. 3B is a detailed view of the assembled patient positioning system andcoil assembly of Fig. 3A, according to various embodiments;

[0021] Fig. 4 is a detailed view of a patient positioning system and coil array, according to various embodiments;

[0022] Fig. 5 is a schematic view of a coil assembly and coil array, according to various embodiments;

[0023] Fig. 6 is a schematic view of a coil assembly and coil array, according to various embodiments;

[0024] Fig. 7 is a detailed view of a patient positioning system and coil assembly, according to various embodiments; and

[0025] Fig. 8 is a flowchart of a process for navigation, according to various embodiments.

[0026] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.DETAILED DESCRIPTION

[0027] Example embodiments will now be described more fully with reference to the accompanying drawings.

[0028] The subject disclosure is directed to an exemplary embodiment of a surgical procedure on a subject, such as a human patient. It is understood, however, that the system and methods described herein are merely exemplary and not intended to limit the scope of the claims included herein. In various embodiments, it is understood, that the systems and methods may be incorporated into and / or used on non-animate objects. The systems may be used to, for example, to register coordinate systems between two systems for use on manufacturing systems, maintenance systems, and the like. For example, automotive assembly may useone or more robotic systems including individual coordinate systems that may be registered together for coordinated or concerted actions. Accordingly, the exemplary illustration of a surgical procedure herein is not intended to limit the scope of the appended claims.

[0029] The EM localizer system may be provided relative to a subject to assist in generating a field adjacent to a subject. A problem may include that an EM localizer may be a distance from a selected region. A subject support, therefore, may incorporate at least a portion of an EM localizer. Further, a system may be provided to allow for the operation of two or more EM localizers and / or portions thereof to operate together or in concert.

[0030] Discussed herein, according to various embodiments, is a tracking system that may be used to track a selected tracking device. The tracking system may operate, according to various embodiments, by emitting an electromagnetic (EM) field from a localizer, also referred to as an EM localizer or EM (field) generator. The EM field may be emitted from one or more coils that may be oriented relative to an origin point. The coils may emit the field. The field may be a largely magnetic field. The field may be constant or varying in time; constant or varying in frequency; or both. A tracking device may include one or more coils of conductive material that operate as sensors to sense the field. The field may generate a voltage within the coil of the tracking device. A determination of a position and orientation (also referred to collectively as a “pose”) of the tracking device may be made based on a determination and or measurement of the induced voltage from the field. It is understood that a current may relate to a voltage and may also be measured.

[0031] Various materials are conductive, such as conductive polymers, metal ormetal alloys, or other materials. Objects or items may be formed with these materials. If an item formed with these materials is also in or near the field generated by the EM localizer, a current may be formed or induced in the object, such as Eddy currents. In this instance, the object may be referred to as an interfering or target object. When a current is induced in the interfering object, a field may also be produced. Similarly, magnetic objects may produce a field as a reaction to the field generated by the EM localizer. A field produced due to the induced current in and / or the magnetic reaction of the interfering object may also be referred to as an interfering field. These interfering fields may alter the field sensed by the tracking device such that it is not always sensing only the EM field generated by the EM localizer. The tracking device may sense both the EM field from the localizer and the EM field that is the interfering field. According to various theories, the sensed field may be a combination of both and / or the EM field from the EM localizer that is altered by the interfering field.

[0032] Various portions may be tracked relative to the subject. For example, a tracking system may be incorporated into a navigation system that includes one or more instruments that may be tracked relative to the subject. The navigation system may include one or more tracking systems that track various portions, such as tracking devices, associated with instruments. The tracking system may include a localizer that is configured to, alone or in combination with a processor, determine the pose of a tracking device in a navigation system coordinate system. Determination of the navigation system coordinate system may include those described at various references including U.S. Pat. No. 8,737,708;U.S. Pat. No. 9,737,235; U.S. Pat. No. 8,503,745; and U.S. Pat. No. 8,175,681 ; all incorporated herein by reference. In particular, a localizer may be used to allow atracking system or navigation system to track an object within a volume relative to the subject. The navigation volume, in which a device may be tracked, may be referred to as the navigation coordinate system or navigation space. A determination or correlation between two coordinate systems may allow for or also be referred to as a registration between two coordinate systems.

[0033] Furthermore, images may be acquired of selected portions of a subject. The images may be displayed for viewing by a user, such as a surgeon. The images may have superimposed on a portion of the image a graphicalrepresentation of a tracked portion or member, such as an instrument. The images may have a coordinate system and define an image space. According to various embodiments, the graphical representation may be superimposed on the image at an appropriate position due to registration of an image space (also referred to as an image coordinate system) to a subject space. A method to register a subject space defined by a subject to an image space may include those disclosed in U.S. Pat. Nos. U.S. Pat. No. 8,737,708; U.S. Pat. No. 9,737,235; U.S. Pat. No. 8,503,745; and U.S. Pat. No. 8,175,681 ; all incorporated herein by reference.

[0034] The tracking of an instrument during a procedure, such as a surgical or operative procedure, allows for navigation of a procedure. When image data is used to define an image space it can be correlated or registered to a physical space defined by a subject, such as a patient as discussed herein. According to various embodiments, therefore, the patient defines a patient space in which an instrument can be tracked and navigated. The image space defined by the image data can be registered to the patient space defined by the patient. The registration can occur with the use of fiducials that can be identified in the image data and in the patientspace.

[0035] Fig. 1 is a diagrammatic view illustrating an overview of a procedure room or arena. In various embodiments, the procedure room may include a surgical suite in which may be placed a robotic system 20 and a navigation system 26 that can be used for various procedures. The robotic system 20 may include a Mazor X™ robotic guidance system, sold by Medtronic, Inc. The robotic system 20 may be used to assist in guiding a selected instrument, such as drills, screws, etc. relative to a subject 30. In addition or alternatively, the robotic system 20 may hold and / or move an imaging system, such as an ultrasound (US) probe 33. The robotic system 20 may include a mount 34 that fixes a portion, such as a robotic base 38, relative to the subject 30. The robotic system 20 may include one or more arms 40 that are moveable or pivotable relative to the subject 30, such as including an end effector 44. The robotic arm 40 may be controlled by a selected robotic control module, which may be included with the navigation system or processor, as discussed herein, or a separate robotic control module 45. The robotic control module 45 may include one or more processors or memory that may communicate, execute instructions, or store instructions for operation of the robotic arm 40. The end effector may be any appropriate portion, such as a tube, guide, or passage member. Affixed to and / or in place of the end effector may be the imaging system that may be the US probe 33. The end effector 44 may be moved relative to the base 38 with one or more motors. The position of the end effector 44 may be known or determined relative to the base 38 with one or more encoders at one or more joints, such as a wrist joint 48 and / or an elbow joint 52 of the robotic system 20. One or more portions of the robotic system 20 may be formed of conductive materials.

[0036] The navigation system 26 can be used to track the location of one or more tracking devices and / or determine and / or illustrate a pose thereof. Tracking devices may include a robot tracking device 54, a subject tracking device 58, an imaging system tracking device 62, an imaging system or second imaging system tracking device 81 , and / or an instrument or tool tracking device 66. A tool or moveable member 68 may be any appropriate tool such as a drill, forceps, catheter, or other tool operated by a user 72. The tool 68 may also be and / or an implant, such as a spinal implant or orthopedic implant. Further, the tool 68 may include one or more moveable portions, such as deployable portions. For example, a heart valve replacement and related inserter tool that may insert the instrument 68 or selected portion, such as an implant, into a heart 127 of the subject 30 and / or any other appropriate portion of any appropriate subject, such as a spine or spinal column. It should further be noted that the navigation system 26 may be used to navigate any type of instrument, implant, or delivery system, including: guide wires, arthroscopic systems, orthopedic implants, spinal implants, deep brain stimulation (DBS) probes, etc. Moreover, the instruments may be used to navigate or map any region of the body. The navigation system 26 and the various instruments may be used in any appropriate procedure, such as one that is generally minimally invasive or an open procedure.

[0037] An additional or alternative, imaging system 80 may be used to acquire pre- , intra-, or post-operative or real-time image data of a subject, such as the subject 30. It will be understood, however, that any appropriate subject can be imaged and any appropriate procedure may be performed relative to the subject. In the example shown, the imaging system 80 comprises an O-arm® imaging device sold byMedtronic Navigation, Inc. having a place of business in Colorado, USA. The imaging system 80 may have a generally annular gantry housing 82 in which an image capturing portion is moveably placed and / or enclosed. The imaging system 80 can include those disclosed in U.S. Pat. Nos. 7,188,998; 7,108,421 ; 7,106,825; 7,001 ,045; and 6,940,941 ; all of which are incorporated herein by reference, or any appropriate portions thereof. It is further appreciated that the imaging system 80 may include in addition or alternatively a fluoroscopic C-arm. Other exemplary imaging devices may include fluoroscopes such as bi- plane fluoroscopic systems, ceiling mounted fluoroscopic systems, cath-lab fluoroscopic systems, fixed C-arm fluoroscopic systems, isocentric C-arm fluoroscopic systems, 3D fluoroscopic systems, etc. Other appropriate imaging devices can also include MRI, CT, ultrasound, etc.

[0038] The position of the imaging system 33, 80, and / or portions therein such as the image capturing portion, can be precisely known relative to any other portion of the imaging device 33, 80. The imaging device 33, 80, according to various embodiments, can know and / or recall precise coordinates relative to a fixed or selected coordinate system. For example, the robotic system 20 may know or determine its position and position the US probe 33 at a selected pose. The image data acquired with one or more ultrasound arrays of the US probe 33 may be registered in the navigation system such as disclosed in the U.S. Patent No. 7,085,400 and U.S. Patent No. 9,138,204, both incorporated herein by reference. Similarly, the imaging system 80 may also position the imaging portions at a selected pose. This can allow the imaging system 80 to know its position relative to the patient 30 or other references. In addition, as discussed herein, the preciseknowledge of the position of the image capturing portion can be used in conjunction with a tracking system to determine the position of the image capturing portion and the image data relative to the tracked subject, such as the patient 30.In other words, the imaging system tracking device 62, 81 may be used and / or operable to determine a pose of the imaging system 33, 80 at a selected time such as during image data acquisition. The position of the imaging system, according to various embodiments, may be used for registration of an image space or coordinate system to a patient space or coordinate space. The robotic system may also be registered to one or more spaces or coordinate systems such as by the system and method as disclosed in U.S. Pat. No. 11 ,135,025, incorporated herein by reference.

[0039] Herein, reference to the imaging system 33 may refer to any appropriate imaging system, unless stated otherwise. Thus, the US probe 33 as the imaging system is merely exemplary regarding the subject disclosure. As one skilled in the art will understand, generally the US probe 33 may emit a US wave in a plane and receive an echo relative to any portions engaged by the wave. The received echo at the US probe 33 or other appropriate received may be used to generate image data and may be used to generate an US image also referred to as a sonogram.

[0040] The imaging device 80 can be tracked with the tracking device 62. Also, the tracking device 81 can be associated directly with the US probe 33.The US probe 33 may, therefore, be directly tracked with a navigation system 26 as discussed herein. In addition or alternatively, the US probe 33 may be positioned and tracked with the robotic system 20. Regardless, image data defining an image space acquired of the patient 30 can, according to various embodiments, be registered (e.g., manually, inherently, or automatically) relative to an object space.The object space can be the space defined by a patient 30 in the navigation system26.

[0041] The patient 30 can also be tracked as the patient moves with a patient tracking device, DRF, or tracker 58. Alternatively, or in addition thereto, the patient 30 may be fixed within navigation space defined by the navigation system 26 to allow for and / or maintain registration such as to the image space of the image 108. As discussed further herein, registration of the image space to the patient space or subject space allows for navigation of the instrument 68 with the image data. When navigating the instrument 68, a position of the instrument 68 can be illustrated relative to image data acquired of the patient 30 on a display device 84 such as with a graphical representation 68i, 68i’. An additional and / or alternative display device 84’ may also be present to display an image. Various tracking systems, such as one including an optical localizer 88 or an electromagnetic (EM) localizer 92 can be used to track the instrument 68.

[0042] More than one tracking system can be used to track the instrument 68 or other portion, such as the US probe 33 with the tracking device 81 in the navigation system 26. According to various embodiments, these can include an electromagnetic tracking (EM) system having the EM localizer 94 and / or an optical tracking system having the optical localizer 88. The optical localizer may have one or more cameras or optical receivers 89 and one or more related emitters. The EM localizer 94 may have one or more coils or coil assemblies 95 of conductive material. In various embodiments, the coil assembly 95 includes at least three coils that are oriented with a single center and each coil is wrapped around an axis that are orthogonal to both of the other axes. Either or both of the tracking systems can beused to track selected tracking devices, as discussed herein. It will be understood, unless discussed otherwise, that a tracking device can be a portion trackable with a selected tracking system. A tracking device need not refer to the entire member or structure to which the tracking device is affixed or associated.

[0043] The position of the patient 30 relative to the imaging device 33 can be determined by the navigation system 26. The position of the imaging system 33 may be determined, as discussed herein. The patient 30 can be tracked with the dynamic reference frame 58, as discussed further herein. The DRF may be an EM tracking device, such as one or more coils of conductive material that may have induced therein a voltage from the EM localizer 94. Accordingly, the position of the patient 30 relative to the imaging device 33 can be determined.

[0044] Image data acquired from the imaging system 33, or any appropriate imaging system, can be acquired at and / or forwarded from an image device controller 96, that may include a processor module, to a navigation computer and / or processor module (also referred to as a processor) 102 that can be a part of a controller or work station 98 having the display 84 and a user interface 106. Further, a memory system or module 103, of any appropriate type, may be accessed by the processor 102. It will also be understood that the image data is not necessarily first retained in the controller 96, but may also be directly transmitted to the work station 98. The work station 98 can provide facilities for displaying the image data as an image 108 on the display 84, saving, digitally manipulating, or printing a hard copy image of the received image data. The user interface 106, which may be a keyboard, mouse, touch pen, touch screen or other suitable device, allows the user 72 to provide inputs to control the imaging device 80, 33, via the image device controller96, or adjust the display settings of the display 84. The work station 98 may also direct the image device controller 96 to adjust the image capturing portion of the imaging device 80 to obtain various two- dimensional images along different planes in order to generate representative two- dimensional and three-dimensional image data.

[0045] With continuing reference to FIG. 1 , the navigation system 26 can further include the tracking system including either or both of the electromagnetic (EM) localizer 94 and / or the optical localizer 88. The tracking systems may include a controller and interface portion 110. The controller 1 10 can be connected to the processor portion 102, which can include a processor included within a computer. The EM tracking system may include the STEALTHSTATION® AXIEM™ Navigation System, sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colorado; or can be the EM tracking system described in U.S. Patent No. 7,751 ,865 entitled "METHOD AND APPARATUS FOR SURGICAL NAVIGATION" issued July 6, 2010; 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; all of which are herein incorporated by reference. It will be understood that the navigation system 26 may also be or include any appropriate tracking system, including a STEALTHSTATION® TREON®, S7™ , S8™ tracking systems having an optical localizer, that may be used as the optical localizer 88, and sold by Medtronic Navigation, Inc. of Colorado. Other tracking systems include an acoustic, radiation, radar, etc. The tracking systems can be used according to generally known or described techniques in the above incorporated references. Details willnot be included herein except when to clarify selected operation of the subject disclosure.

[0046] Wired or physical connections can interconnect the tracking systems, imaging device 80, etc. Alternatively, various portions, such as the instrument 68 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 controller 1 10. Also, the tracking devices 62, 66, 54, according to various embodiments, can generate a field and / or signal that is sensed by the localizer(s) 88, 94 and vice versa.

[0047] Various portions of the navigation system 26, such as the instrument 68, and others as will be described in detail below, can be equipped with at least one, and generally multiple, of the tracking devices 66. The instrument can also include more than one type or modality of tracking device 66, such as an EM tracking device and / or an optical tracking device. The instrument 68 can include a graspable or manipulable portion at a proximal end and the tracking devices may be fixed near the manipulable portion of the instrument 68.

[0048] Additional representative or 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 navigation system 26 may be a hybrid system that includes components from various tracking systems.

[0049] According to various embodiments, the navigation system 26 can be used to track any appropriate portion such as the US probe 33 and / or the instrument 68relative to the patient 30. The instrument 68 can be tracked with the tracking system, as discussed above. Image data of the patient 30, or an appropriate subject, can be used to assist the user 72 in guiding the instrument 68. The image data may or may not be registered to the patient 30. For example, as discussed herein, the US probe 33 is tracked and generates the image data. Thus, the image data need not be registered to the subject to display a pose of the tracked instrument 68 relative to the image data generator with the tracked US probe 33. The image data defines the image space that is registered to the patient space defined by the patient 30. The registration can be performed as discussed herein, automatically, manually, or combinations thereof. The registration can include the process and the final transformation (including a translation and rotation) map. Generally, registration includes determining points in the image data and the subject space and determining a transformation map therebetween. Once done, the image space are registered to the subject space, or any two or more coordinate spaces.

[0050] Generally, registration also allows a transformation map to be generated of a tracked physical pose of the instrument 68 relative to the image space of the image data. The transformation map allows the tracked position of the instrument 68 to be displayed on the display device 84 relative to the image data 108. The graphical representation 68i, also referred to as an icon, can be used to illustrate the location of the instrument 68 relative to the image data 108.

[0051] With continuing reference to Fig. 1 , a subject registration system or method can use the tracking device 58. The tracking device 58 may include portions or members 120 that may be trackable, but may also act as or be operable as a fiducial assembly. The fiducial assembly 120 can include a clamp or other fixation portion124 and the imageable fiducial body 120. It is understood, however, that the members 120 may be separate from the tracking device 58. The fixation portion 124 can be provided to fix any appropriate portion, such as a portion of the anatomy. As illustrated in Fig. 1 , the fiducial assembly 120 can be interconnected with a portion of a spine, such as a spinous process of a vertebra 126 of the spine. The fixation portion 124 can be interconnected with a spinous process in any appropriate manner. For example, a pin or a screw can be driven into the spinous process. Further, the tracking device 58 may be operable to track with one or more tracking systems or modalities, such as EM tracking system or optical tracking system.

[0052] As illustrated in Fig. 1 , the imaging device 33 may include the US probe 33 that may be positioned relative to the subject 30, such as by the robotic system 20 and / or the surgeon 72. In various embodiments, the surgeon 72 may operate the robotic arm 20 and / or hold the US probe 33 separate therefrom. As discussed herein, therefore, the robotic system 20 may move the US probe 33 to a selected position relative to the subject 30. According to various embodiments, the imaging system may be positioned relative to the subject in any appropriate manner.

[0053] Determination of a position of an object, such as a tracking device may be performed in any appropriate manner. Further, positions of various portions relative other tracking device may also be determined. According to various embodiments, a pose of a conductive object may be determined relative to a tracking device within an EM navigation coordinate system particularly when an EM field is emitted and distorted relative to a conductive item that may generate or emit fields in light of induced currents in the conductive item.

[0054] The instrument 68 may be any appropriate instrument, and as discussedherein may include an instrument that may be used in various procedures. According to various embodiments, for example, the instrument 68 may include an inserter or guided catheter. The inserter instrument 68 may be used to assist in a procedure relative the heart 127 and / or one of more of the vertebra 126. The pose of the instrument 68, however, may be determined by tracking the tracking device 68. As discussed above, the EM localizer 94 may be operable to generate a field to allow the tracking device 68 to be tracked.

[0055] As illustrated in Fig. 2, a subject positioning system 200 may be provided to assist in positioning the subject 30. The subject positioning system 200 may include one or more components to assist in positioning the subject 30. The components may be adjustable and / or selectively positioned, as discussed herein.

[0056] As illustrated in Figs. 2A and 2B, a patient positioning system 200, which may also be referred to as a patient or subject support, may be positioned relative to the operating table or patient support 104. The patient positioning system 200 may include various portions, such as one or more supports 204. Any portion of the patient positioning system 200 may support or position at least a portion of the mass of the subject 30. For example, the patient positioning system 200 may elevate, rotate, hold at an angle, support at a selected position, etc.

[0057] In the patient positioning system 200, the supports are bars or support tubes 204 that may be connected to a board or platform member 208. The platform member 208 may include one or more adjustment positions, such as holes 212 to receive or connect to the bars 204 with any appropriate connector, such as bolts orslidably received in the holes. Therefore, the bars 204 may be positioned at any appropriate adjustable position relative to the subject 30, such as by the user 72. The bars 204 may be positioned to extend vertically from or perpendicularly to the board 208 or at an adjustable angle relative to the board208. Further, as discussed herein, more than one of the bars may be positioned relative to the subject 30. Further, the bars 204 may be positioned at any selected position on the board 208 that may not be pre-selected or determined but may be generally randomly chosen by the user 72 as needed.

[0058] The patient positioning system 200 may further include a movable support member 216. The movable support member 216 may be a head or portion support. The moveable support 216, therefore, may be moved to support a head 30h of the subject 30 in a selected position. Further, a cushion or pad 220 may be placed between the subject 30 and any portion of the patient positioning system 200, such as the support board 208.

[0059] In various embodiments, the patient support or positioning system 200 may be mounted to the operating table 104 or other appropriate portion, such as with one or more clamp members 224. The patient support or positioning system 200 may be moveably positioned relative to any appropriate support or region. Therefore, the patient positioning system 200 may be used to position the patient or subject 30 in a selected orientation and position.

[0060] The localizer 94 may include one or more of the coils or coil assemblies 95. Further or in addition thereto, one or more of the coil assemblies may be positioned relative to or with the patient support assembly 200. For example, a first coil assembly 95a may be positioned with the first bar 204a. A second coil assembly95b may be positioned with the second bar 204b. A third coil assembly 95c may be positioned or included with the padding 220 and a fourth coil assembly 95d may be positioned with the movable support 216. Therefore, the coil assemblies 95, according to various embodiments, may be positioned or included with one or more of the support portions that may be adjusted and moved relative to the subject 30.

[0061] Briefly, the coils or coil assemblies 95 may include various portions as illustrated in Fig. 2B. According to various embodiments, for example, the coil assembly 95 may include an outer coil 230, an intermediate coil 234, and an inner coil 238. Each of the coils 230, 234, 238 may be formed or positioned on a support 240. Therefore, the coil assembly 95 may be efficiently positioned relative to various portions of the patient support 200. Further, the coil assembly 95 may include each of the coils 230, 234, 238 wound around an axis that is orthogonal to each axis of the other coils but all have a single common origin or intersection point, such as within the support 240.

[0062] According to various embodiments, for example, the coil assembly 95a may be formed with and / or fixed to the bar 204a. The coil assembly 95a may operate as the EM localizer 94, according to various embodiments and configurations as discussed herein. This allows the coil array 95a of the bar 204a to emit a field that may be sensed by a tracking device connected to, positioned relative to, and / or moved relative to the subject 30. As illustrated in Fig. 2A, the bar 95a may be positioned near a spine 244 of the subject 30 including at least a vertebra, such as the vertebra 126 discussed above. The vertebra 126 may include the DRF 58 associated therewith. Therefore, the coil 95a may operate as a localizer 94 as it emits a field that may be sensed by the DRF 58. Therefore, the pose of the vertebra126 may be determined such as within the field of the coil 95a. Nevertheless, as understood by one skilled in the art, a field admitted by the coil 95b of the second bar 204b may also be sensed by the DRF 58. Thus, the DRF 58 may sense one or both of the fields from one or both of the coil assemblies 95a, 95b. Additionally, according to various embodiments and operations, the coil assemblies of the other portions, such as the coil assemblies 95c and 95d may also emit fields that are sensed by the localizer 58. Further, as noted above, the instrument 68 having the tracking device 66 may also sense fields emitted by any of the coil assemblies. As discussed herein, the field sensed by the tracking device 66 associated with the instrument 68 may depend and / or vary based upon a pose or proximity of the tracking device 68 relative to one or more of the coils 95a-95d. Further, the field emitted by any of the coil assemblies may be an EM field, and any of the coil assemblies may emit multiple fields. Thus, the pose of any tracked portions or tracking device may be based on emitting and / or sensing one or a plurality of emitted fields.

[0063] Nevertheless, the various portions of the patient positioning assembly 200 may include the coils 95 integrated therewith. The integration may be fixation thereto. For example, the coil assembly 95a may be fixed to the bar 204a such that movement of the bar 204a necessarily requires movement of the coil assembly 95a therewith. Therefore, movements of one or more of the bars 204, such as the first bar 204a, may move the coil array 95a therewith. This allows the bar 204a to be moved at any appropriate position relative to the subject 30 and the coil assembly 95a is associated or connected therewith is moved with the bar 204a. Thus, the coil assembly 95a is immediately positioned with the bar 204a when positioned relativeto the subject 30 to create or adjust the navigation space. This may, therefore, eliminate the need for any additional coils or coil assemblies to be positioned relative to the subject 30 for emitting a field relative to the subject 30 to allow for tracking of a selected portion, such as the instrument 66 or the DRF 58. Further, as noted above, more than one of the coil assemblies may be positioned relative to the subject, such as including the coil assembly 95b with the second bar 204b.

[0064] According to various embodiments, various supports may include selected geometries to be positioned relative to the subject 30. As is illustrated in Fig. 2A, each of the bars 204 may extend substantially vertically or normal to a plane defined by the board support 208. Therefore, the first bar 204a may extend along an axis 2041 that is perpendicular or normal to a plane defined by an upper surface 209 of the support board 208.

[0065] Given the orientation of the bar 204, and relative to the surface 209, a configuration or orientation of the coil 95a may be known relative to the support 208. Thus, the known configuration of the coil assembly 95 may be known relative to the patient positioning assembly 200. This may allow for determination of interfering objects to allow for a predetermined interference, if present. For example, if the bar 204a includes an interfering portion that is mounted to the board 208, a known position of the coil assembly 95a relative to the board 208 is known once the bar 204a is assembled thereto.

[0066] In various embodiments, various portions of the patient support or positioning system 200 may include or have incorporated therewith coil assemblies 95. In various embodiments, however, with reference to Fig. 3A and Fig. 3B, a patient positioning assembly 260 is illustrated. The patient positioning system maybe used in place of or in addition to the patient positioning system 200. The patient positioning system 260 may include one or more components that may be moved relative to the subject 30. For example, the patient positioning system 260 may include a head support 264. The head support 264 may be similar or identical to the patient positioning system 200, discussed above. The head support 264 may be positioned to support at least a portion of the head 30h of the subject 30 to assist in ensuring that the head 30h is held in the selected position. The patient positioning system 260 may further include additional components, such as an arm or shoulder support 268. The head support 264 and the arm support 268 may be separately movable relative to the subject 30. Each of the support components 264, 268 may be individually movable to any appropriate or selected pose relative to the subject 30. The components may be placed relative to the subject 30 in a non-attached manner, such as not being directly or physically connected to a support member such as the support board 208.

[0067] Nevertheless, the support members of the patient positioning system 260 may assist holding or supporting the subject 30, or at least portions thereof, in the selected pose. The patient positioning system 260 may further support or hold at least a mass of the subject 30.

[0068] Each of the portions of the patient positioning system 260 may include a holding area, such as a holding area 272 of the arm support 268. The holding area 272 may be a volume or region within at least a portion of the support 268 to receive a select component. The volume may be accessible through a selected panel or opening, such as through and end 274 of the support 268.

[0069] The volume 272 may be sized and shaped to hold, such as contain andindex a localizer component such as a localizer or coil assembly 95e within a housing or placement member 278. The housing 278 may include any appropriate housing that houses the coil assembly 95e and fits within the volume 272. The coil assembly 95e held within the housing 278 may be placed in the volume 272 of the positioning member 268. The housing 278 may further be keyed or indexed to a specific portion of the volume 272 and, therefore, the member 268, such as with a protuberance.

[0070] Turning to reference Fig. 3B, the user, such as the user 72 may place the housing 278 within the support member 268. The housing member 278 may be positioned within the volume 272 in any appropriate manner. According to various embodiments, for example, the housing 278 may be fit within the volume 272 in only a single orientation or position. Thus, the coil assembly 95e may have a known configuration and orientation relative to the positioning member 268. The positioning member 268 may then be placed relative to the subject 30 to assist in supporting or positioning a portion of the subject 30, such as a limb 301 of the subject 30.

[0071] According to various embodiments, therefore, the support portion, such as the arm support 268, may be positioned in any appropriate position relative to the subject 30. The placed position may be substantially random relative to the subject 30 and selected by the user 72 based on various parameters that may be unique to the subject 30, the user 72, or the procedure.

[0072] The support member 268 may be any appropriate support member and may include the volume 272 to receive the housing 278. It is understood that a kit may include a plurality of the support members 268. Each support member of the plurality of the support members may have various shapes, geometries, sizes, or thelike. Therefore, during a procedure, the user 72 may select an appropriate positioning or support member for the selected procedure. The user 72 may position the support member for use during the procedure. If navigation is selected, the user 72 may place the housing 278 with the coil assembly 95e within the volume 272 of the support member 268. Therefore, the coil assembly 95e may be positioned relative to the subject 30 for a procedure. Thus the coil assembly 95e may be positioned substantially near or adjacent to a portion of a procedure, such as an orthopedic procedure including a shoulder replacement, plate insertion, or the like.

[0073] A single housing 278 with the coil assembly 95e may be provided with a kit or separate from a kit to be used in one or more of the support portions used relative to the subject 30. Therefore, if a kit includes a plurality of support portions and only a sub-plurality are needed for a procedure, the coil assembly 95e may be positioned only at the selected or necessary position relative to the subject 30. Thus, only an optimal (e.g., minimal) number of the coil assemblies may be used to assist in navigating or tracking a selected procedure.

[0074] Further, the localizer 94, discussed above, need not be used. Rather, the coil assembly 95e within the housing 278 may be positioned relative to the subject 30. This may allow for an efficient placement of the coil assembly 95e. An efficient placement may include positioning of the coil assembly 95e substantially adjacent or near a procedure position, such as within 5 centimeters, within 10 centimeters, or any appropriate position.

[0075] Again, the configuration of the housing 278, the coil assembly 95e, or other portions may be known within the specific configuration of the support portions to assist in understanding the geometry and / or interfering portions relative to the coilassembly 95e. As noted above, the localizer including the coil assembly 95e may be used to track the instrument 68. According to various embodiments, as illustrated in Fig. 3B, the instrument 68 may be a reaming or cutting tool that may be a power tool. The power tool may operate a tool tip 68t that may be a reamer to ream a portion of the subject 30. The tracking device 66 may be used to track the instrument 68 during a procedure. The coil assembly 95e may be used to generate a field that is sensed by the tracking device 66. The modular housing 278, therefore, may be inserted into the support 268 at an appropriate position to assist in generating or emitting a field that sensed by the tracking device 66 near the operational portion, such as the limb 301 of the subject 30.

[0076] According to various embodiments, as illustrated in Fig. 4, a patient support or positioning system 300 may include a selected construction or geometry, such as a depressed receiving area 304 surrounded by a raised wall or ridge 308. For example, the patient positioning system 300 may be used to assist in holding or supporting the head 30h of the subject 30. The patient positioning system 300 may be formed of a selected material, such as a compliant or flexible material. It is understood that the patient positioning system according to various embodiments may include compliant or non-compliant portions or materials to achieve a selected support or position of the subject 30.

[0077] The patient positioning system 300 may include therein a specific or general depression or recess 312 that may be provided to receive a coil array assembly 320. The coil array assembly 320 may include a plurality of coil assemblies including a first coil assembly 95f, a second coil assembly 95g, and the third coil assembly 95h. Each of the three coil assemblies 95f-h may be provided in the coil array 320in a manner similar to that of the localizer 94, discussed above. The coil array 320 may include at least three of the coil assemblies 95f, g, h to emit or generate a selected field in a selected manner, such as in a time varying, frequency varying, or in any appropriate manner.

[0078] The coil array 320 may be provided in an assembly or housing 324 that may be placed in the recess 312. The coil array assembly 320, such as within the housing 324, may include an index or key portion 328 that may engage a key portion 332 of or relative to the recess 312. Therefore, the coil array assembly 324 may be positioned within the recess 312 in a substantially single, such as only one, manner or orientation. Thus, the coil array assembly 320 may be positioned within the patient support or positioning system 300 at an appropriate time.

[0079] As discussed above, the patient support assembly 260 may include the recess or holding regions 272 to receive the coil assembly 95e in the housing 278. The housing 278 may house a single coil assembly 95e as discussed above.The coil array assembly 320, however, may include more than one such as an array of the coil assemblies 95f, g, h. As is understood by one skilled in the art, the coil array 320 of the coil assemblies 95f, g, h may emit a field with at least one selected parameter. Further, each of the coil assemblies may emit varying fields that may be sensed by one or more instruments or tracking devices, such as the tracking device 66 associated with the instrument 68.

[0080] The subject may be positioned relative to the patient positioning assembly 300, such as having the head 30h of the subject positioned within the depression 304 to provide the coil array 320 adjacent to a selected portion of the subject 30. The instrument 68 may then be moved relative to the subject and the coil array 320.The tracking device 66 may sense a field emitted by the coil array 320 including each of the coil assemblies 95f, g, h.

[0081] The patient positioning assembly 300 may allow for an array of the coil assemblies to be positioned substantially simultaneously with the patient positioning system 300. Therefore, the plurality of the coil assemblies may be positioned at a generally known configuration relative to the patient positioning portion 300. Further, the coil array 320 may be positioned relative to a selective portion of the patient or subject 30 for a procedure.

[0082] According to various embodiments, therefore, the localizer 94, or portions thereof such as one or more of the coil assemblies 95, may be positioned relative to the subject in the selected manners. In other words, one or more of the coil assemblies may be provided to operate as the localizer whether it is in a housing or portion separate from one or more patient positioning portions or not. As illustrated in Fig. 2A, the patient positioning assembly 200 may have coil assemblies that are integrated into selected portions that may be positioned relative to the subject 30, such as in the bars 204. The coil assemblies may be permanently attached to the bars in a substantially known manner. According to various embodiments, a single one of the coil assemblies may be provided relative to the subject 30 with a patient support, such as in the patient positioning or support assembly 260 as illustrated in Figs. 3A and 3B. Thus, a selected number of the coil assemblies may be positioned relative to the subject 30 for performing or assisting in navigating a procedure. Additionally, a plurality of the coil assemblies may be provided in a fixed array of a known configuration relative to a patient support, such as the patient support assembly 300. Therefore, the plurality of coil assemblies 95f, g, h, may be providedin the known geometry in the array of 320 and in the patient support 300.

[0083] According to various embodiments, therefore, a patient support assembly may include one or more coil assemblies to generate a field to assist in navigation of a procedure. This may allow, therefore, the field generated by a localizer to be positioned at selected areas or volumes relative to the subject 30 and within patient supports. Therefore, a separate localizer, such as the localizer 94, may not be necessary and need not be provided relative to the subject 30 to allow for generation or emitting of a field to be sensed with a tracking device relative to the subject 30.

[0084] As discussed above, the various portions of the patient support or positioning system, according to various embodiments, may have incorporated therewith either permanently or selectively for a procedure. At least one tracking coil assembly (e.g. 95a, 95e). The tracking coil assembly may be operated as the localizer 94 even if not positioned as a separate unit away from the patient, is illustrated Fig. 1 , but rather included or positioned adjacent to the patient with the patient support or positioning system.

[0085] One or more of the various coil assemblies may operate together as a tracking array, such as the tracking array of the localizer 94 including two or more of the coil assemblies. For example, as illustrated in Fig. 5, a transmitter and receiver array 334 may include a coil assembly 340 that is configured to transmit a signal and one or more coils as a receiver assembly 344. According to various embodiments, the coil assembly 340 may be understood to be the coil assembly as discussed above, such as the coil assembly 95a, and the receiver assembly 344 may be a system such as a tracking assembly or device similar to the DRF58. The system may further include a second coil and transmitter assembly 350 thatmay include a coil assembly 354 and a receiver assembly 358.

[0086] Together the first coil and receiver assembly 334 and the second coil and array receiver assembly 350 may operate as a coil array 362. The coil array may be operated as a coil array given that the transmitter assemblies, including the coil assembly 340 and the second coil assembly 354 are at known positions relative to one another. Therefore the linked or connected receiver, such as the first receiver 344 connected with the first coil array 340 and the second receiver 358 connected with the second coil assembly 354 may be used to determine a pose relative to one another. According to various embodiments, the first coil assembly 340 may transmit or emit a field that is sensed by the receiver 358. Therefore, the pose of the receiver relative to the coil array 340 may be known and, therefore, the pose of the coil assembly 354 relative to the coil assembly 354 may be known. Similarly, the second coil assembly 354 may emit a field that is sensed by the receiver 344. Therefore, the pose of the receiver 344 may be known relative to the coil assembly 354, thus allowing the pose of the coil assembly 340 to be known relative to the coil assembly 344.

[0087] Each of the receivers 344, 358 may be fixed relative to the respective coil assemblies 340, 354 and in any appropriate manner, such as being fixed into the rods 204 or any other appropriate assembly. Regardless, the two assemblies, 334, 358 may operate as the array 362 based upon a determination or knowledge of the pose of the coil assemblies 340, 354 relative to one another. Therefore the tracking device 66 of the instrument 68 may be tracked in a field emitted by either of the assemblies 334, 350 and / or in a combination of both as the array 362. The determination of the pose of the tracking device 66 and the related or associatedinstrument 68 may thereafter be determined in a manner similar to the tracking and navigation as discussed above, such as with the localizer assembly 94.

[0088] In various embodiments, as illustrated in Fig. 6, an assembly or array assembly 370 may include a first coil assembly 374 and a second coil assembly 378. The two coil assemblies 374, 378 may be operated as both a transmitter and a receiver. Therefore, the determined pose of the second coil assembly 378 relative to the first coil assembly 374 may be determined substantially directly based upon sensing the field emitted by the first coil assembly 374. Similarly, a reciprocal may be used to determine a pose of the first coil assembly 374 relative to the second coil assembly 378.

[0089] In various embodiments, the coil assemblies may be operated as transmitters and receivers in an appropriate multiplex manner. For example, the selected coils of the first coil assembly 374 may be operated as a transmitter at a first time and as a receiver at a second time to allow for time multiplexing of the transmission and receiving of a signal. Similarly, the coils of the second coil assembly 378 may be operated in a time multiplexed manner. Therefore, the respective coil assemblies 374, 378 may emit and sense a field to generate a signal regarding a pose relative to each other.

[0090] In an alternative or additional manner, frequency multiplexing may also be used to allow for operation of the respective coil assemblies 374, 378 is both a transmitter and the receiver. For example, each of the coil portions of the respective coil assemblies 374, 378 may be operated at different or alternating frequencies to allow for a substantially simultaneous transmission and receiving or sensing of a field or a signal therein to allow for determination of oppose of the coil assembly 378, 374relative to one another.

[0091] Regardless, again, the coil array 370 may be operated as the localizer 94 even if the two coil assembly 374, 378 are positioned relative to each other in a substantially unfixed or initially unknown manner once the determined pose of the coil assemblies 374, 378 relative to one another is determined. Therefore, the pose of the tracking device 66 and the related or determined pose of the instrument 68 may be determined based upon the field emitted by the two coil assemblies 374, 378 that may be operated as the coil array 370.

[0092] Therefore, a plurality of the coil assemblies, such as the coil assemblies as is illustrated in Figs. 5 and 6, may be positioned at substantially random positions or poses relative to the subject 30. As discussed above, and for example as illustrated in Fig. 2a, the rods 204a, 204b may be positioned at any pose or level relative to the spine 244 that is most conducive for a surgical procedure. The pose of the two rods 204, 204b may not be known prior to the initiation of the procedure and may be based upon a specific procedure, surgeon preference, or other parameters. Nevertheless, the two rods 204a, 204b may include the respective coil assemblies 95a, 95b that may be used to emit a field to allow for tracking of the tracking device 66 of the instrument 68, or any other appropriate tracking device. The two or more coil assemblies may be operated as a coil array, such as the coil array 370 based upon an intra-procedure determination of the pose relative to one another. Thus, a plurality of coil assemblies may be used in a non-fixed manner to allow for tracking of one or more tracking devices during a procedure.

[0093] In addition, with reference to Fig. 7, a system may be used to determine an optimal or best coil assembling for navigation or tracking with selected instruments.As illustrated in Fig. 7, the patient 30, or any appropriate subject, may be positioned relative to the patient positioning system 200. The patient positioning system 200 may include the two rods 204a, 204b positioned relative to the subject 30. The respective rods may include the respective coil assemblies 95a, 95b. As discussed above, the two coil assemblies may be operated as a coil or localizer array to assist in performing a procedure, including tracking instruments or navigating instruments relative to the subject 30.

[0094] According to various embodiments, however, the procedure relative to the subject 30 may be performed at multiple positions in / or at differing distances from one or more of the coil assemblies. For example, as illustrated in Fig. 7, the instrument 68 may be operated at a first position 68p’ and at a second position 68p” relative to the first coil array 95a and the second coil assembly 95b.

[0095] It is illustrated in Fig. 7, the instrument in the first position 68p’ may be a first distance 400 from the first coil assembly 95a and a second distance 404 from the second coil assembly 95b. At the second position of the instrument 68p” the instrument may be a first distance 408 from the second coil assembly 95b and a second distance 412 from the first coil assembly 95a. Accordingly, at either of the position 68p’ or the second position 68p”, the instrument 68 may be nearer to one of the coil assemblies than the other.

[0096] Accordingly, as discussed herein, the navigation system, including the processor assembly 103 may execute instructions to evaluate and / or determine which signal to use for navigation of the instrument of the various positions 68p’, 68p” and / or selected weighting thereof. It is further understood, however, that a plurality of coil assemblies may be used with the patient support assembly 200 andthe illustrates and the discussion of two is merely exemplary.

[0097] Turning reference to Fig. 8, the system as discussed above, including the navigation system 26 may be used to track one or more instruments, such as the instrument 68 relative to the subject 30, which may be any appropriate subject. As also discussed above, the localizer may include one or more coil assembly in patient support or positioning system, according to various embodiments.

[0098] A method or process 450 may be used to assist in the navigation and / or determination of a pose of one or more of the instruments. The process 450 may begin in START block 454. Thereafter a sub-block or sub-portion may include a positioning phase of sub-portion of 456. The positioning phase 456 is optional and may be a physical positioning and / or determination (e.g., receiving an input) of the pose of the one or more coil array assemblies. Accordingly, the sub-process 456 may include positioning the first coil assembly in block 458 and positioning a second coil assembly in block 460. As discussed herein, positioning the second coil assembly is optional and positioning the first coil assembly may be the only requirement and / or having a first coil assembly may be the only requirement for allowing for navigation or tracking of an instrument. Nevertheless, the sub-process 456 may include positioning and / or having one or more coil assemblies in an operating theater relative to the subject 30.

[0099] After the sub-process 456, an optional determination of the pose of a first coil assembly relative to a second coil assembly and vice versa may be made in block 464. The determination of the pose of the first coil may be relative to the second coil assembly and vice versa in block 464. The determination may be in any appropriate manner, such as those discussed above. Accordingly, the respectivecoil assemblies may have receivers associated therewith and / or may be operated as receivers. Therefore, a pose of the first coil assembly relative to the second coil assembly and vice versa may be determined.

[0100] As discussed above, the operation or determination of the two coil assemblies relative to one another may allow for operation of the two coil assemblies as a single coil array, similar to the localizer 94. During operation of the coil assembly as an array, the two coil assemblies may be used to determine a single pose of the instrument. Therefore, either as the array or as a single one of the coil assemblies, a first field EM field 1 may be emitted in block 470.

[0101] The emitted EM field 1 may be sensed by the tracking device in block474. Once sensed, a signal may be transmitted to a selected system, such as the navigation system as discussed above. The signal from the tracking device may be evaluated, such as by executing instructions by the processor to determine the pose of the tracking device and / or with the related or associated instrument in block 480. Again, the determination of the pose of the tracking device may be based upon a signal generated after sensing the EM field in block 474. The signal may be transmitted to the navigation system or within the navigation system in any appropriate manner, such as wirelessly and / or wired.

[0102] After determining a pose of the tracking device based upon the sensed EM field 1 , a determination of whether a second EM field, EM field 2, is sensed from the second coil array in block 484.

[0103] If no second field, EM field 2, is sensed in block 484, a NO path 488 may be followed to output that determined pose in block 490. The determined pose may be based upon the EM field 1 alone if no second field is emitted or sensed or usedto make a determination. The sensed field may be emitted by a single coil assembly and / or with the coil array, if determined in block 464. The output determined pose may be saved for various purposes, or otherwise utilized such as optionally displaying the output in block 494. The displayed output may include a display of an icon or graphical representation, such as the graphical representation 68i of the instrument 68 relative to an image, or reconstruction of an image of the subject 30. The graphical representation may be displayed in any appropriate manner, such as superimposed on an image, displayed relative to a coordinate system, in a virtual reality or mixed reality system, or in any appropriate manner.

[0104] After outputting the determined pose in block 490, a determination of whether tracking is complete may be made in block 498. If tracking is complete, a YES pathway 500 may be followed to end the process in block 504. Ending the process in block 504 may include moving the instrument to a different position relative to the subject 30, ending the procedure (e.g., closing the subject), or other appropriate operations.

[0105] If tracking is determined to not be completed, a NO path 508 may be followed to emit or sense EM field 1 in either blocks 470 or 474. Therefore, the process 450 may iterate to allow for selected tracking and / or navigation of the instrument 66, according to various embodiments.

[0106] If a determination is made in block 484 that a second EM field 2 is sensed, a YES path 520 may be followed. After following the YES path 520, the EM field 2 may be sensed or a signal based thereon may be generated and sent in block 524.

[0107] An evaluation of the sensed EM field 1 relative to the sensed EM field 2 may be made in block 528 following the sensing of EM field 2. An evaluation of thesensed EM field 1 relative to the sensed EM field 2 may be made for various purposes. For example, as discussed above, the instrument may be at different relative positions relative to the various coil assemblies that may be operated, such as the first and second coil assembly positioned in blocks 458, 460. The evaluation may be used to determine an optimal or best signal or sensing of the one or more fields to determine the best or optimal pose of the tracking device. For example, a strength of the EM field 1 and the EM field 2 may be determined relative to one another. Further, an amount of distortion based upon EM field 1 and / or EM field 2 may be determined. Thus, the evaluation of the sensed EM field 1 or EM field 2 may be made in measurements of a field strength, distortion, or other parameter may be made in block 528.

[0108] After evaluating the sensing EM field 1 and sensing EM field 2 in block 528, a determination of an optimal or best tracking or navigation based upon the evaluation may be made in block 532. The optimal tracking may include selecting only one of the EM field 1 or EM field 2 to make a determination of a pose of the tracking device. Additionally or alternatively, a determination of an optimal or best tracking or navigation may also be based upon a weighting of the sensed pose based upon the EM field 1 or EM field 2. For example, a pose based upon the determination of sensing EM field 1 may be weighted twice as high or more likely to be correct than the determined pose based upon sensed EM field 2 and therefore the determined position may weigh or use the sensing field 1 pose twice as much relative to the sensed or determined pose based upon the sensed EM field 2. Regardless of the process, a determination of an optimal tracking with navigation may be made in block 532.

[0109] Based upon the optimal tracking and navigation based upon the evaluation of block 532, a determination of a pose of tracking device or instrument may be made in block 538. The determined pose of the tracking device may be based upon or after sensing both the EM field 1 and EM field 2 and the related evaluation of block 528 and the determined optimal tracking or navigation of block 532. Therefore, the determined pose in block 538 may be the same determined pose in block 480 and / or may be different based upon sensing two or more fields. Nevertheless, the determined pose may then be output in block 490 and the process 450 may continue as discussed above.

[0110] Therefore, the process 450 may be used to evaluate or determine the pose of tracking device based upon coil assemblies that are positioned relative to the subject 30 in a substantially non-predetermined or prefixed manner. Thus the use of the tracking system may be substantially seamless and / or not require additional steps other than positioning the patient support assembly, such as the patient supported positioning assembly 200 relative to the subject 30. The process 450 may allow for navigation of an instrument, according to various embodiments.

[0111] Examples

[0112] Example 1. A procedure navigation system, comprising: a subject support member assembly configured to support at least a portion of a mass of the subject in a selected position, wherein the subject support member assembly includes: a first subject support member, and a second subject support member, wherein the first subject support member is moveable relative to the second subject support member; wherein the first subject support member is configured to extend vertically from the second subject support member and contact at least a portion of thesubject in a selected position; a coil assembly positioned with the support member, wherein the coil assembly is configured to at least one of emit an electromagnetic (EM) field or sense an EM field in a navigation space; a tracking device configured to sense the EM field and generate a signal based on the sensed EM field; and a navigation processor module configured to execute instructions to determine a pose of the tracking device in a navigation space based on the received signal from the tracking device.

[0113] Example 2. The system of Example 1 , wherein the first subject support member is configured to extend vertically from the second subject support member.

[0114] Example s. The system of Example 1 , wherein the coil assembly is removably fixed to the support member or fixed to the support member.

[0115] Example 4. The system of Example 3, further comprising: a coil assembly housing; wherein the coil assembly housing is configured to house the coil assembly; wherein the coil assembly housing while housing the coil assembly is configured to be removable placed in at least one of the first subject support member or the second subject support member.

[0116] Example 5. The system of Example 1 , wherein the coil assembly includes at least a first coil assembly and a second coil assembly; wherein the navigation processor module is configured to execute further instructions to determine an optimal navigation configuration regarding a first EM field sensed from the first coil assembly and a second EM field sensed from the second coil assembly.

[0117] Example 6. The system of Example 1 , wherein the coil assembly includes at least a first coil assembly and a second coil assembly; wherein the navigation processor module is configured to execute further instructions to determine arelative pose of the first coil assembly to the second coil assembly.

[0118] Example 7. A procedure navigation system, comprising: a subject support member configured to support at least a portion of a mass of the subject in a selected position; and a coil assembly positioned with the support member, wherein the coil assembly is configured to at least one of emit an electromagnetic (EM) field or sense an EM field.

[0119] Example s. The system of Example 7, wherein the coil assembly is fixed to the support member.

[0120] Example 9. The system of Example 7, further comprising: wherein the subject support member includes at least a first subject support member and a second subject support member; wherein the first subject support member is moveable relative to the second subject support member; wherein the first subject support member is configured to extend vertically from the second subject support member.

[0121] Example 10. The system of Example 7, further comprising: wherein the coil assembly includes a first coil assembly and a second coil assembly; wherein the subject support member includes at least a first subject support member and a second subject support member; wherein the first coil assembly is associated with the first subject support member and the second coil assembly is associated with the second subject support member.

[0122] Example 1 1. The system of Example 10, wherein the first coil assembly and associated the first subject support member are configured to be positioned at a first position relative to the subject and the second coil assembly and associated second subject support member are configured to be positioned at a secondposition relative to the subject; wherein the first position is spaced apart from the second position.

[0123] Example 12. The system of Example 7, wherein the coil assembly is removably fixed to the support member.

[0124] Example 13. The system of Example 7, further comprising: a coil array, wherein the coil assembly includes a plurality of coil assemblies fixed relative to one another as the coil array; wherein the coil array is configured to be positioned with the subject support member.

[0125] Example 14. The system of Example 7, further comprising: wherein the coil assembly includes at least a first coil assembly and a second coil assembly; a navigation processor module configured to execute instructions to determine an optimal navigation configuration regarding a first EM field emitted from the first coil assembly and a second EM field emitted from the second coil assembly.

[0126] Example 15. The system of Example 7, further comprising: wherein the coil assembly includes at least a first coil assembly and a second coil assembly; a navigation processor module configured to execute instructions to determine a relative pose of the first coil assembly to the second coil assembly.

[0127] Example 16. A method for providing a procedure navigation system, comprising: providing a subject support member assembly configured to support at least a portion of a mass of the subject in a selected position, wherein providing the subject support member assembly includes: providing a first subject support member, and providing a second subject support member, configuring the first subject support member to be moveable relative to the second subject support member; configuring the first subject support member to extend vertically from thesecond subject support member and contact at least a portion of the subject in a selected position; providing a coil assembly positioned with the support member; providing the coil assembly at least one of emit an electromagnetic (EM) field or sense an EM field in a navigation space; tracking a tracking device in the navigation space; and providing a navigation processor module configured to execute instructions to determine a pose of the tracking device in a navigation space.

[0128] Example 17. The method of Example 16, further comprising: configuring the tracking device to sense the EM field and generate a signal based on the sensed EM field; and receiving the signal at the navigation procedures module to determine the pose of the tracking device based on the received signal from the tracking device.

[0129] Example 18. The method of Example 16, further comprising: at least one of (1 ) fixing the coil assembly to at least one of the first subject support member or the second subject support member, (2) removably connecting the coil assembly to at least one of the first subject support member or the second subject support member, or (3) combinations thereof.

[0130] Example 19. The method of Example 16, further comprising : providing the coil assembly at least as a first coil assembly and a second coil assembly; and providing the navigation processor module to execute further instructions to determine a relative pose of the first coil assembly to the second coil assembly.

[0131] Example 20. The method of Example 16, further comprising : providing the coil assembly at least as a first coil assembly and a second coil assembly; and providing the navigation processor module to execute further instructions to determine an optimal navigation configuration regarding a first EM field emitted fromthe first coil assembly and a second EM field emitted from the second coil assembly.

[0132] Example 21 . A procedure navigation system, comprising: a subject support member configured to support at least a portion of a mass of the subject in a selected position; and a coil assembly positioned with the support member, wherein the coil assembly is configured to at least one of emit an electromagnetic (EM) field or sense an EM field.

[0133] Example 22. The system of Example 21 , wherein the coil assembly is fixed to the support member.

[0134] Example 23. The system of Example 21 , further comprising: wherein the subject support member includes at least a first subject support member and a second subject support member; wherein the first subject support member is moveable relative to the second subject support member; wherein the first subject support member is configured to extend vertically from the second subject support member.

[0135] Example 24. The system of Example 21 , further comprising: wherein the coil assembly includes a first coil assembly and a second coil assembly; wherein the subject support member includes at least a first subject support member and a second subject support member; wherein the first coil assembly is associated with the first subject support member and the second coil assembly is associated with the second subject support member.

[0136] Example 25. The system of Example 24, wherein the first coil assembly and associated the first subject support member are configured to be positioned at a first position relative to the subject and the second coil assembly and associated second subject support member are configured to be positioned at a secondposition relative to the subject; wherein the first position is spaced apart from the second position.

[0137] Example 26. The system of Example 21 , wherein the coil assembly is removably fixed to the support member.

[0138] Example 27. The system of Example 21 , further comprising: a coil array, wherein the coil assembly includes a plurality of coil assemblies fixed relative to one another as the coil array; wherein the coil array is configured to be positioned with the subject support member.

[0139] Example 28. The system of Example 21 , further comprising: wherein the coil assembly includes at least a first coil assembly and a second coil assembly; a navigation processor module configured to execute instructions to determine an optimal navigation configuration regarding a first EM field emitted from the first coil assembly and a second EM field emitted from the second coil assembly.

[0140] Example 29. The system of Example 21 , further comprising: wherein the coil assembly includes at least a first coil assembly and a second coil assembly; a navigation processor module configured to execute instructions to determine a relative pose of the first coil assembly to the second coil assembly.

[0141] Example 30. The system of Example 21 , further comprising: wherein the subject support member assembly includes: a first subject support member, and a second subject support member, wherein the first subject support member is moveable relative to the second subject support member; wherein the first subject support member is configured to extend vertically from the second subject support member and contact at least a portion of the subject in a selected position; wherein the coil assembly is positioned with the support member, wherein the coilassembly is configured to at least one of emit an electromagnetic (EM) field or sense an EM field in a navigation space; a tracking device configured to sense the EM field and generate a signal based on the sensed EM field; and a navigation processor module configured to execute instructions to determine a pose of the tracking device in a navigation space based on the received signal from the tracking device.

[0142] Example 31. The system of Example 30, wherein the coil assembly is removably fixed to the support member or fixed to the support member.

[0143] Example 32. A method for providing a procedure navigation system, comprising: providing a subject support member assembly configured to support at least a portion of a mass of the subject in a selected position, wherein providing the subject support member assembly includes: providing a first subject support member, and providing a second subject support member, configuring the first subject support member to be moveable relative to the second subject support member; configuring the first subject support member to extend vertically from the second subject support member and contact at least a portion of the subject in a selected position; providing a coil assembly positioned with the support member; providing the coil assembly at least one of emit an electromagnetic (EM) field or sense an EM field in a navigation space; tracking a tracking device in the navigation space; and providing a navigation processor module configured to execute instructions to determine a pose of the tracking device in a navigation space.

[0144] Example 33. The method of Example 32, further comprising: configuringthe tracking device to sense the EM field and generate a signal based on the sensed EM field; and receiving the signal at the navigation procedures module to determine the pose of the tracking device based on the received signal from the tracking device.

[0145] Example 34. The method of Example 32, further comprising: at least one of (1 ) fixing the coil assembly to at least one of the first subject support member or the second subject support member, (2) removably connecting the coil assembly to at least one of the first subject support member or the second subject support member, or (3) combinations thereof.

[0146] Example 35. The method of Example 32, further comprising: providing the coil assembly at least as a first coil assembly and a second coil assembly; and providing the navigation processor module to execute further instructions to (1 ) determine a relative pose of the first coil assembly to the second coil assembly or (2) determine an optimal navigation configuration regarding a first EM field emitted from the first coil assembly and a second EM field emitted from the second coil assembly.

[0147] Example embodiments are provided so that this disclosure will be thorough and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough 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, andwell-known technologies are not described in detail.

[0148] 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.

[0149] The apparatuses and methods described in this application may be partially or fully implemented by a processor (also referred to as a processor module) that may include a special purpose computer (i.e., created by configuring a processor) and / or a general purpose computer to execute one or more particular functions embodied in computer programs. The computer programs include processorexecutable 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 driversthat interact with particular devices of the special purpose computer, one or more operating systems, user applications, background services and applications, etc.

[0150] 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. As examples only, 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®.

[0151] 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. In various implementations, IEEE 802.1 1 -2012 may be supplemented by draft IEEE standard 802.11 ac, draft IEEE standard 802.1 1ad, and / or draft IEEE standard 802.11 ah.

[0152] 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.

[0153] Instructions may be executed by one or more 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. Accordingly, the term “processor” or “processor module” as used herein 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. The processor or processors may operate entirely automatically and / or substantially automatically. In automatic operation the processor may execute instructions based on received input and execute instructions in light thereof. Thus, various outputs may be made without further or any manual (e.g., user) input.

[0154] The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the invention, and all such modifications are intended to be included within the scope of the invention.

Claims

WHAT IS CLAIMED:1 . A procedure navigation system, comprising: a subject support member configured to support at least a portion of a mass of the subject in a selected position; and a coil assembly positioned with the support member, wherein the coil assembly is configured to at least one of emit an electromagnetic (EM) field or sense an EM field.

2. The system of Claim 1 , wherein the coil assembly is fixed to the support member.

3. The system of Claim 1 , further comprising: wherein the subject support member includes at least a first subject support member and a second subject support member; wherein the first subject support member is moveable relative to the second subject support member; wherein the first subject support member is configured to extend vertically from the second subject support member.

4. The system of Claim 1 , further comprising: wherein the coil assembly includes a first coil assembly and a second coil assembly; wherein the subject support member includes at least a first subject support member and a second subject support member; wherein the first coil assembly is associated with the first subject supportmember and the second coil assembly is associated with the second subject support member.

5. The system of Claim 4, wherein the first coil assembly and associated the first subject support member are configured to be positioned at a first position relative to the subject and the second coil assembly and associated second subject support member are configured to be positioned at a second position relative to the subject; wherein the first position is spaced apart from the second position.

6. The system of Claim 1 , wherein the coil assembly is removably fixed to the support member.

7. The system of Claim 1 , further comprising: a coil array, wherein the coil assembly includes a plurality of coil assemblies fixed relative to one another as the coil array; wherein the coil array is configured to be positioned with the subject support member.

8. The system of Claim 1 , further comprising: wherein the coil assembly includes at least a first coil assembly and a second coil assembly; a navigation processor module configured to execute instructions to determine an optimal navigation configuration regarding a first EM field emittedfrom the first coil assembly and a second EM field emitted from the second coil assembly.

9. The system of Claim 1 , further comprising: wherein the coil assembly includes at least a first coil assembly and a second coil assembly; a navigation processor module configured to execute instructions to determine a relative pose of the first coil assembly to the second coil assembly.

10. The system of Claim 1 , further comprising: wherein the subject support member assembly includes: a first subject support member, and a second subject support member, wherein the first subject support member is moveable relative to the second subject support member; wherein the first subject support member is configured to extend vertically from the second subject support member and contact at least a portion of the subject in a selected position; wherein the coil assembly is positioned with the support member, wherein the coil assembly is configured to at least one of emit an electromagnetic (EM) field or sense an EM field in a navigation space; a tracking device configured to sense the EM field and generate a signal based on the sensed EM field; and a navigation processor module configured to execute instructions todetermine a pose of the tracking device in a navigation space based on the received signal from the tracking device.11 . The system of Claim 10, wherein the coil assembly is removably fixed to the support member or fixed to the support member.

12. A method for providing a procedure navigation system, comprising: providing a subject support member assembly configured to support at least a portion of a mass of the subject in a selected position, wherein providing the subject support member assembly includes: providing a first subject support member, and providing a second subject support member, configuring the first subject support member to be moveable relative to the second subject support member; configuring the first subject support member to extend vertically from the second subject support member and contact at least a portion of the subject in a selected position; providing a coil assembly positioned with the support member; providing the coil assembly at least one of emit an electromagnetic (EM) field or sense an EM field in a navigation space; tracking a tracking device in the navigation space; and providing a navigation processor module configured to execute instructions to determine a pose of the tracking device in a navigation space.

13. The method of Claim 12, further comprising: configuring the tracking device to sense the EM field and generate a signal based on the sensed EM field; and receiving the signal at the navigation procedures module to determine the pose of the tracking device based on the received signal from the tracking device.

14. The method of Claim 12, further comprising: at least one of (1 ) fixing the coil assembly to at least one of the first subject support member or the second subject support member, (2) removably connecting the coil assembly to at least one of the first subject support member or the second subject support member, or (3) combinations thereof.

15. The method of Claim 12, further comprising: providing the coil assembly at least as a first coil assembly and a second coil assembly; and providing the navigation processor module to execute further instructions to (1 ) determine a relative pose of the first coil assembly to the second coil assembly or (2) determine an optimal navigation configuration regarding a first EM field emitted from the first coil assembly and a second EM field emitted from the second coil assembly.

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