System and method for navigation

Abstract

A system for assisting in guiding and performing a procedure on a subject is disclosed. The subject can be any suitable subject, such as an inanimate object and / or a living object. The system includes 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

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

[0002] This subject matter generally relates to a tracking and navigation system, and particularly to tracking using an electromagnetic field generator and associated sensors. Background Technology

[0003] This section provides background information in connection with this disclosure, which is not necessarily prior art.

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

[0005] Patient localization can be determined using a tracking system. Typically, the patient is registered to the image by generating a transformation mapping between the subject or object space (e.g., patient space) and the image space relative to the patient tracking device. This usually requires a user (such as a surgeon) to identify one or more points in the subject space and associate them with the same points in the image space.

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

[0007] In addition, various types of medical procedures may require positioning or support devices, or at least be assisted by positioning or support devices, to properly position the patient during medical or surgical procedures. In some cases, this positioning may also be adjustable to accommodate different spinal surgeries or patient sizes. Orthopedic surgeries may also be assisted by patient positioning devices or supports used during the procedure.

[0008] For electromagnetic navigation systems, the electromagnetic generator or transmitter and the electromagnetic receiver must also be positioned at an appropriate distance from each other. Furthermore, for electromagnetic navigation systems, it is desirable to have little or no conductive or magnetic material near the transmitter and receiver configuration in order to eliminate interference as much as possible. Similarly, in a typical OR environment, the presence of various patient support devices makes reducing interference difficult. Summary of the Invention

[0009] This section provides a general overview of this disclosure and is not a full disclosure of the complete scope or all features of this disclosure.

[0010] It may be desirable to provide a patient positioning device with an integrated electromagnetic locator. The locator can generate an electromagnetic (EM) field that can be sensed by a tracking sensor. Having an integrated locator can significantly reduce or eliminate various drawbacks and defects. For example, it can enhance the positioning of the EM locator with minimal interference relative to the tracking sensor and / or position the EM locator adjacent to the surgical volume. Therefore, the present invention can provide an integrated electromagnetic locator for navigation in a patient positioning device to assist in medical procedures. This can help solve related problems such as, but not limited to, positioning the locator in a selected location on the subject and / or potential interference.

[0011] Tracking systems (such as tracking systems that include EM locators that emit electromagnetic fields) can be used to track one or more tracking devices. The tracking devices can be positioned on an instrument and tracked in a physical space also known as the patient space. The positioning of the tracking device and the instruments associated with it (e.g., attached to it) can be displayed in an image representing the subject. For example, the determined positioning can be superimposed on a portion of the image.

[0012] Electromagnetic (EM) fields can be emitted by a transmitter or sender and can be sensed by an electromagnetic sensing device of a tracking device. Depending on the implementation, the electromagnetic sensing device may include one or more coils of conductive material. Various other materials, such as conductive materials, may interfere with the field sensed by the sensor. However, the interference with the field sensed by the sensor can be quantified and analyzed to determine the location of a portion of the interfering field.

[0013] Positioning components can be used to assist in positioning or holding a subject in a selected location. A positioning component can be used as a single component or can be provided as part of a system having more than one positioning component and / or a positioning component holding portion. A positioning component can have one or more locators associated with it. This association can include fixation to the component, insertion into the component, or other suitable association.

[0014] Further areas of applicability will become apparent from the description provided herein. The descriptions and specific examples in this overview are intended for illustrative purposes only and are not intended to limit the scope of this disclosure. Attached Figure Description

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

[0016] Figure 1This is a schematic diagram illustrating an overview of a surgical site, including robotic and navigation systems, according to various implementation schemes; Figure 2A It is a detailed view of the patient positioning system and coil assembly according to various implementation schemes; Figure 2B These are detailed views of the coil assembly according to various implementation schemes; Figure 3A It is a detailed view of the patient positioning system and coil assembly according to various implementation schemes; Figure 3B It is based on various implementation plans. Figure 3A Detailed view of the assembled patient positioning system and coil assembly; Figure 4 It is a detailed view of the patient positioning system and coil array according to various implementation schemes; Figure 5 These are schematic diagrams of coil assemblies and coil arrays according to various implementation schemes; Figure 6 These are schematic diagrams of coil assemblies and coil arrays according to various implementation schemes; Figure 7 It is a detailed view of the patient positioning system and coil assembly according to various implementation schemes; and Figure 8 It is a flowchart of the navigation process according to various implementation schemes.

[0017] In several views of all the accompanying drawings, the corresponding reference numerals indicate the corresponding components. Detailed Implementation

[0018] The example implementation will now be described in more complete form with reference to the accompanying drawings.

[0019] This subject matter disclosure relates to exemplary embodiments of surgical procedures performed on subjects such as human patients. However, it should be understood that the systems and methods described herein are merely exemplary and are not intended to limit the scope of the claims included herein. In various embodiments, it should be understood that the systems and methods can be incorporated into and / or used on non-living objects. For example, these systems can be used to register coordinate systems between two systems for use in manufacturing and maintenance systems, etc. For example, automobile assembly may use one or more robotic systems comprising separate coordinate systems that can be registered together for coordinated or joint actions. Therefore, the exemplary description of surgical procedures herein is not intended to limit the scope of the appended claims.

[0020] An EM locator system can be provided relative to the subject to assist in generating a field for the neighboring subject. Issues may include the EM locator being some distance from the selected area. Therefore, a subject support can be incorporated into at least a portion of the EM locator. Furthermore, a system can be provided to allow the operation of two or more EM locators and / or portions thereof to occur together or concurrently.

[0021] This paper discusses a tracking system that can be used to track a selected tracking device, according to various embodiments. According to various embodiments, the tracking system can operate by emitting an EM (field) from a locator (also referred to as an electromagnetic (EM) locator or an EM (field) generator). The EM field can be emitted from one or more coils, which can be oriented relative to the origin. The coils can emit a field. This field can be a dominant magnetic field. The field can be constant or time-varying; constant or frequency-varying; or both. The tracking device can include one or more coils of conductive material that operate as sensors to sense the field. The field can generate a voltage within the coils of the tracking device. The position and orientation (also collectively referred to as "pose") of the tracking device can be determined based on the determination and / or measurement of the induced voltage from the field. It should be understood that current can be related to voltage and can also be measured.

[0022] Various materials are conductive, such as conductive polymers, metals or metal alloys, or other materials. Objects or articles can be formed from these materials. If an article formed from these materials is also in or near the field generated by the EM locator, a current, such as eddy currents, can be formed or induced in the object. In this case, the object can be referred to as an interfering or target object. A field can also be generated when a current is induced in the interfering object. Similarly, a magnetic object can generate a field as a response to the field generated by the EM locator. The field generated due to induced currents and / or magnetic reactions in the interfering object can also be referred to as an interfering field. These interfering fields can alter the field sensed by the tracking device so that it does not always sense only the EM field generated by the EM locator. The tracking device can sense both the EM field from the locator and the EM field as an interfering field. According to various theories, the sensed field can be a combination of both and / or the EM field from the EM locator that has been altered by the interfering field.

[0023] Individual parts can be tracked relative to a subject. For example, the tracking system can be incorporated into a navigation system that includes one or more devices that can be tracked relative to a subject. The navigation system may include one or more tracking systems that track individual parts associated with the devices, such as tracking devices. The tracking system may include a locator configured to determine the pose of the tracking device in the navigation system coordinate system, either individually or in combination with a processor. The determination of the navigation system coordinate system may include those described in various references, including U.S. Patent No. 8,737,708. U.S. Patent Nos. 9,737,235, 8,503,745, and 8,175,681, all of which are incorporated herein by reference. Specifically, a locator can be used to allow a tracking or navigation system to track an object within a volume relative to a subject. The navigation volume in which the tracking device can be located can be referred to as a navigation coordinate system or navigation space. The determination or correlation between two coordinate systems can allow, or is also referred to as, registration between the two coordinate systems.

[0024] In addition, images of selected portions of the subject can be acquired. These images can be displayed for viewing by a user, such as a surgeon. The images may have a graphical representation of the tracked portion or component (such as an instrument) superimposed on a portion of the image. The images may have a coordinate system and define an image space. According to various embodiments, the graphical representation can be superimposed on the image at the appropriate location due to registration from the image space (also referred to as the image coordinate system) to the subject space. Methods for registering a subject-defined space to the image space can include those disclosed in U.S. Patent Nos. 8,737,708, 9,737,235, 8,503,745, and 8,175,681, all of which are incorporated herein by reference.

[0025] Tracking of instruments during surgery (such as surgical procedures or treatments) allows for surgical navigation. As discussed herein, when image data is used to define an image space, it can be correlated or registered with a physical space defined by a subject (such as a patient). Thus, according to various embodiments, the patient defines a patient space in which instruments can be tracked and navigated. The image space defined by the image data can be registered to the patient space defined by the patient. Registration can be performed using reference points that can be identified in both the image data and the patient space.

[0026] Figure 1This is a schematic diagram illustrating an overview of an operating room or surgical environment. In various embodiments, the operating room may include a surgical field in which a robotic system 20 and a navigation system 26, which can be used for various surgical procedures, may be placed. The robotic system 20 may include the Mazor X, sold by Medtronic, Inc. ™ Robotic guidance system. Robotic system 20 can be used to assist in guiding selected instruments, such as drills, screws, etc., relative to subject 30. Alternatively or additionally, robotic system 20 can hold and / or move an imaging system, such as an ultrasound (US) probe 33. Robotic system 20 may include a mount 34 that secures a portion of itself relative to subject 30, such as a robot base 38. Robotic system 20 may include one or more arms 40, such as an end effector 44, which may be movable or pivotable relative to subject 30. Robotic arms 40 may be controlled by a selected robotic control module, which may be included in a navigation system or processor as discussed herein, or by a separate robotic control module 45. Robotic control module 45 may include one or more processors or memories that can transmit, execute, or store instructions for the operation of robotic arms 40. The end effector may be any suitable component, such as a tube, guide, or channel member. An imaging system, such as the US probe 33, may be attached to and / or replace the end effector. The end effector 44 can be moved relative to the base 38 by one or more motors. The positioning of the end effector 44 can be known or determined using one or more encoders relative to the base 38, wherein the one or more encoders are located at one or more joints of the robot system 20, such as wrist joint 48 and / or elbow joint 52. One or more parts of the robot system 20 can be formed of a conductive material.

[0027] Navigation system 26 can be used to track the position of one or more tracking devices and / or determine and / or exemplify their pose. Tracking devices may include robotic tracking device 54, subject tracking device 58, imaging system tracking device 62, imaging system or second imaging system tracking device 81, and / or instrument or tool tracking device 66. Tool or movable component 68 can be any suitable tool, such as a drill, catheter, forceps, or other tool operated by user 72. Tool 68 may also include and / or be an implant, such as a spinal implant or orthopedic implant. Furthermore, tool 68 may include one or more movable portions, such as deployable portions. For example, heart valve replacement and related inserter tools that can insert instrument 68 or selected portions (such as implants) into the heart 127 of subject 30 and / or any other suitable portion (such as the spine or vertebrae) of any suitable subject. It should be further noted that navigation system 26 can be used to navigate any type of instrument, implant, or delivery system, including: guidewires, arthroscopic systems, orthopedic implants, spinal implants, deep brain stimulation (DBS) probes, etc. Furthermore, these instruments can be used for navigation or mapping of any area of ​​the body. The navigation system 26 and various instruments can be used in any appropriate surgical procedure, such as typically minimally invasive or open surgery.

[0028] Additional or alternative imaging systems 80 can be used to acquire preoperative, intraoperative, or postoperative or real-time image data of a subject (such as subject 30). However, it should be understood that imaging can be performed on any suitable subject, and any suitable surgical procedure can be performed relative to the subject. In the example shown, imaging system 80 includes an O-arm sold by Medtronic Navigation, Inc., which has a business location in Colorado, USA. ® Imaging apparatus. Imaging system 80 may have a generally annular rack housing 82 in which image capture portions are movably positioned and / or enclosed. Imaging system 80 may include those disclosed in the following patents: U.S. Patent 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 in any appropriate portion thereof. It should also be understood that imaging system 80 may additionally or alternatively include a fluoroscope C-arm. Other exemplary imaging apparatus may include fluoroscopes such as dual-plane fluoroscope systems, ceiling-mounted fluoroscope systems, catheterization lab fluoroscope systems, fixed C-arm fluoroscope systems, isocentric C-arm fluoroscope systems, 3D fluoroscope systems, etc. Other suitable imaging apparatus may also include MRI, CT, ultrasound, etc.

[0029] The positioning of imaging systems 33, 80 and / or portions thereof (such as image capture portions) can be precisely known relative to any other portion of imaging devices 33, 80. According to various embodiments, imaging devices 33, 80 can know and / or recall precise coordinates relative to a fixed or selected coordinate system. For example, robotic system 20 can know or determine its positioning and position the US probe 33 in a selected pose. Image data acquired using one or more ultrasound arrays of the US probe 33 can be registered in navigation systems such as those disclosed in U.S. Patent Nos. 7,085,400 and 9,138,204, both of which are incorporated herein by reference. Similarly, imaging system 80 can also position the imaging portion in a selected pose. This allows imaging system 80 to know its positioning relative to patient 30 or other references. Additionally, as discussed herein, precise knowledge of the positioning of the image capture portion can be used in conjunction with a tracking system to determine the positioning of the image capture portion and image data relative to a tracked subject (such as patient 30).

[0030] In other words, the imaging system tracking devices 62, 81 can be used and / or operated to determine the pose of the imaging systems 33, 80 at selected times (such as during image data acquisition). According to various embodiments, the localization of the imaging system can be used to register an image space or coordinate system to a patient space or coordinate space. The robotic system can also be registered to one or more spaces or coordinate systems, for example, by the systems and methods disclosed in U.S. Patent No. 11,135,025, which is incorporated herein by reference.

[0031] In this document, unless otherwise stated, references to imaging system 33 may refer to any suitable imaging system. Therefore, the US probe 33 as an imaging system is merely an example disclosed in relation to this subject matter. As those skilled in the art will understand, typically the US probe 33 can emit a US wave in a plane and receive an echo relative to any portion joined by that wave. The echo received at the US probe 33, or other suitable received echo, can be used to generate image data and can be used to generate a US image, also known as a sound map.

[0032] The imaging device 80 can be tracked using the tracking device 62. Furthermore, the tracking device 81 can be directly associated with the US probe 33. Therefore, the US probe 33 can be directly tracked using the navigation system 26 as discussed herein. Alternatively, the US probe 33 can be located and tracked using the robotic system 20. In any case, according to various embodiments, image data defining the image space acquired by the patient 30 can be registered relative to the object space (e.g., manually, inherently, or automatically). The object space can be the space defined by the patient 30 in the navigation system 26.

[0033] Patient 30 can also be tracked using a patient tracking device, DRF, or tracker 58 as the patient moves. Alternatively or additionally, patient 30 can be fixed within a navigation space defined by navigation system 26 to allow and / or maintain registration such as with image space with image 108. As discussed further herein, registration of image space with patient space or subject space allows the use of image data to navigate device 68. When navigating device 68, the positioning of device 68 can be illustrated on display device 84 relative to the acquired image data of patient 30, such as with graphical representations 68i, 68i'. Additional and / or additional display devices 84' may also be present to display images. Various tracking systems, such as tracking systems including optical locator 88 or electromagnetic (EM) locator 92, can be used to track device 68.

[0034] More than one tracking system can be used to track the device 68 or other parts, such as using the tracking device 81 in the navigation system 26 to track the US probe 33. According to various embodiments, these may include an EM system with an electromagnetic tracking (EM) locator 94 and / or an optical tracking system with an optical locator 88. The optical locator may have one or more cameras or optical receivers 89 and one or more associated transmitters. The EM locator 94 may have one or more conductive material coils or coil assemblies 95. In various embodiments, the coil assembly 95 includes at least three coils oriented at a single center, and each coil is wound around an axis orthogonal to two of the other axes. As discussed herein, any one or two tracking systems can be used to track a selected tracking device. It should be understood that, unless otherwise discussed, a tracking device can be a part that can be tracked using a selected tracking system. A tracking device does not necessarily refer to the entire component or structure to which the tracking device is attached or associated.

[0035] The positioning of patient 30 relative to imaging device 33 can be determined by navigation system 26. As discussed herein, the positioning of imaging system 33 can be determined. As further discussed herein, patient 30 can be tracked using dynamic reference frame 58. The DRF can be an EM tracking device, such as one or more conductive material coils that can sense voltages from EM locator 94. Therefore, the positioning of patient 30 relative to imaging device 33 can be determined.

[0036] Image data acquired from imaging system 33 or any suitable imaging system can be acquired at imaging device controller 96 and / or forwarded from imaging device controller to navigation computer and / or processor module (also referred to as processor) 102, which may include processor module, and the navigation computer and / or processor module may be part of controller or workstation 98 having display 84 and user interface 106. Furthermore, any suitable type of memory system or module 103 may be accessed by processor 102. It is also understood that image data does not necessarily need to be stored in controller 96 first, but may also be sent directly to workstation 98. Workstation 98 may provide facilities for displaying image data as image 108 on display 84 and for saving, digitally processing, or printing hard copies of the received image data. User interface 106, which may be a keyboard, mouse, stylus, touchscreen, or other suitable device, allows user 72 to provide input to control imaging devices 80, 33 or adjust image settings of display 84 via imaging device controller 96. Workstation 98 can also instruct image device controller 96 to adjust the image capture portion of imaging device 80 to obtain various two-dimensional images along different planes, thereby generating representative two-dimensional image data and three-dimensional image data.

[0037] Continue to refer to Figure 1 The navigation system 26 may further include a tracking system comprising either or both of an electromagnetic (EM) locator 94 and / or an optical locator 88. The tracking system may include a controller and an interface portion 110. The controller 110 may be connected to a processor portion 102, which may include a processor contained within a computer. The EM tracking system may include a Stealth Station sold by Medtronic Navigation, Inc., which has a business location in Louisville, Colorado. ® AXIEM ™A navigation system; or it may be an EM locator as described in the following patents: U.S. Patent No. 7,751,865, entitled “METHOD AND APPARATUS FOR SURGICAL NAVIGATION,” published July 6, 2010; U.S. Patent No. 5,913,820, entitled “PositionLocation System,” published June 22, 1999; and U.S. Patent No. 5,592,939, entitled “Method and System for Navigating a Catheter Probe,” published January 14, 1997, all of which are incorporated herein by reference. It should be understood that the navigation system 26 may also be or include any suitable tracking system (including STEALTHSTATION with an optical locator). ® TREON ® S7 ™ or S8 ™ The tracking system (which can be used as an optical locator 88) is sold by Medtronic Navigation, Inc., located in Colorado. Other tracking systems include acoustic systems, radiation systems, radar systems, etc. The tracking system can be used according to techniques generally known or described in the references combined above. Details are not included herein unless the chosen operation disclosed in the subject matter is clearly explained.

[0038] Wired or physical connectors can interconnect the tracking system, imaging device 80, etc. Alternatively, instead of being directly coupled to the controller 110, various components such as instrument 68 can utilize wireless communication channels, such as the wireless communication channel disclosed in U.S. Patent No. 6,474,341 entitled "Surgical Communication Power System," published November 5, 2002, which is incorporated herein by reference. Furthermore, tracking devices 62, 66, 54 according to various embodiments can generate fields and / or signals sensed by locators 88, 94, and vice versa.

[0039] Various parts of the navigation system 26, such as the device 68, and other parts described in detail below, may be equipped with at least one and typically multiple tracking devices 66. The device may also include more than one type or form of tracking device 66, such as EM tracking devices and / or optical tracking devices. The device 68 may include a grippable or manipulable portion at its proximal end, and the tracking device may be fixed near the manipulable portion of the device 68.

[0040] Another representative or alternative positioning and tracking system is described in U.S. Patent No. 5,983,126, entitled "Catheter Location System and Method," issued November 9, 1999, which is incorporated herein by reference. Navigation system 26 may be a hybrid system including components from various tracking systems.

[0041] According to various embodiments, navigation system 26 can be used to track any appropriate portion, such as US probe 33 and / or device 68, relative to patient 30. As discussed above, tracking system can be used to track device 68. Image data from patient 30 or an appropriate subject can be used to assist user 72 in guiding device 68. Image data may or may not be registered to patient 30. For example, as discussed herein, US probe 33 is tracked and generates image data. Therefore, it is not necessary to register the image data to the subject to show the pose of the tracked device 68 relative to the image data generator with the tracked US probe 33. The image data defines an image space that is registered to patient space defined by patient 30. Registration can be performed automatically, manually, or a combination thereof, as discussed herein. Registration may include procedural and final transformation (including translation and rotation) mappings. Typically, registration involves determining points in the image data and subject space and determining the transformation mapping between them. Once completed, image space is registered to subject space, or any two or more coordinate spaces.

[0042] Typically, registration also allows for the generation of a transformation map of the tracked physical pose of the device 68 relative to the image space of the image data. This transformation map allows the tracked position of the device 68 to be displayed on the display device 84 relative to the image data 108. A graphical representation 68i (also referred to as an icon) can be used to exemplify the position of the device 68 relative to the image data 108.

[0043] Continue to refer to Figure 1 The subject registration system or method may use tracking device 58. Tracking device 58 may include a trackable portion or component 120, but may also serve as or be operable as a reference point assembly. Reference point assembly 120 may include a clamp or other fixation portion 124 and an imageable reference point body 120. However, it should be understood that component 120 is typically separate from tracking device 58. Fixation portion 124 may be provided to fix any suitable portion, such as a part of an anatomical structure. Figure 1As illustrated, the reference point assembly 120 can interconnect with a portion of the spine, such as the spinous process of a vertebra 126. The fixing portion 124 can interconnect with the spinous process in any suitable manner. For example, a pin or screw can be driven into the spinous process. Furthermore, the tracking device 58 can be operated for tracking using one or more tracking systems or modalities, such as an EM tracking system or an optical tracking system.

[0044] like Figure 1 As illustrated, the imaging device 33 may include a US probe 33, which may be positioned relative to the subject 30, for example, via the robotic system 20 and / or the surgeon 72. In various embodiments, the surgeon 72 may manipulate the robotic arm 20 and / or keep the US probe 33 separate from it. Thus, as discussed herein, 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 suitable manner.

[0045] The determination of the location of an object, such as a tracking device, can be performed in any suitable manner. Furthermore, the location of individual parts relative to other tracking devices can be determined. According to various embodiments, the pose of a conductive object can 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 article, which can be generated or emitted based on induced currents in the conductive article.

[0046] Instrument 68 can be any suitable instrument and, as discussed herein, can include instruments that can be used in a variety of surgical procedures. Depending on various embodiments, instrument 68 may, for example, include an inserter or a guiding catheter. Inserter instrument 68 can be used to assist in procedures relative to one or more vertebrae of the heart 127 and / or vertebrae 126. However, the pose of instrument 68 can be determined by tracking device 68. As discussed above, EM locator 94 can be operated to generate a field, thereby allowing tracking device 68 to be tracked.

[0047] As illustrated in Figure 2, a subject positioning system 200 may be provided to assist in the positioning of the subject 30. The subject positioning system 200 may include one or more components to assist in the positioning of the subject 30. As discussed herein, the components may be adjustable and / or selectively positioned.

[0048] like Figure 2A and Figure 2BAs illustrated, the patient positioning system 200 (also referred to as a patient or subject support) can be positioned relative to the operating table or patient support 104. The patient positioning system 200 may include various parts, such as one or more supports 204. Any part of the patient positioning system 200 can support or position at least a portion of the mass of the subject 30. For example, the patient positioning system 200 can be raised, rotated, held at an angle, supported at a selected location, etc.

[0049] In the patient positioning system 200, the support is a rod or support tube 204 that can be connected to a plate or platform member 208. The platform member 208 may include one or more adjustable locations (such as holes 212) to receive or connect to the rod 204 using any suitable connector (such as bolts), or to be slidably received in the holes. The rod 204 can be positioned, for example, by the user 72 relative to the subject 30 at any suitable adjustable location. The rod 204 can be positioned to extend vertically from or perpendicular to the plate 208, or to extend at an adjustable angle relative to the plate 208. Furthermore, as discussed herein, more than one rod can be positioned relative to the subject 30. Additionally, the rod 204 can be positioned at any selected location on the plate 208, which may not be pre-selected or determined, but may be selected substantially randomly by the user 72 as needed.

[0050] The patient positioning system 200 may also include a movable support member 216. The movable support member 216 may be a head support or a partial support. Thus, the movable support member 216 may be moved to support the head 30h of the subject 30 in a selected position. In addition, a pad or cushion 220 may be placed between the subject 30 and any part of the patient positioning system 200, such as the support plate 208.

[0051] In various embodiments, the patient support or positioning system 200 may be mounted to the operating table 104 or other suitable portion, for example, using one or more clamping components 224. The patient support or positioning system 200 may be movably positioned relative to any suitable support or area. Thus, the patient positioning system 200 can be used to position the patient or subject 30 in a selected orientation and location.

[0052] Positioner 94 may include one or more of coils or coil assemblies 95. Additionally, one or more 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 a first rod 204a. A second coil assembly 95b may be positioned with a second rod 204b. A third coil assembly 95c may be positioned with or included in a pad 220, and a fourth coil assembly 95d may be positioned with a movable support 216. Thus, according to various embodiments, coil assemblies 95 may be positioned with or included in one or more support portions that are adjustable and movable relative to the subject 30.

[0053] In short, the coil or coil assembly 95 may include, for example: Figure 2B The illustrated components. 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 coils 230, 234, and 238 may be formed or positioned on the support 240. Therefore, the coil assembly 95 can be efficiently positioned relative to the various portions of the patient support 200. Furthermore, the coil assembly 95 may include each of coils 230, 234, and 238 wound around an axis orthogonal to each axis of the other coils, but all coils have a single common origin or intersection, such as within the support 240.

[0054] According to various embodiments, for example, the coil assembly 95a may be formed together with and / or fixed to the rod 204a. According to various embodiments and configurations discussed herein, the coil assembly 95a may operate as an EM locator 94. This allows the coil array 95a of the rod 204a to emit a field that can be sensed by a tracking device connected to the subject 30, positioned relative to the subject, and / or moving relative to the subject. Figure 2AAs illustrated, rod 95a can be positioned near the spine 244 of subject 30, which includes at least vertebrae, such as vertebra 126 discussed above. Vertebra 126 may include a DRF 58 associated therewith. Therefore, coil 95a can operate as locator 94 because it emits a field that can be sensed by DRF 58. Thus, the pose of vertebra 126, such as within the field of coil 95a, can be determined. However, as those skilled in the art will understand, the field permitted by coil 95b of second rod 204b can also be sensed by DRF 58. Therefore, DRF 58 can sense one or both fields from one or both of the coil assemblies 95a, 95b. Additionally, according to various embodiments and operations, other portions of the coil assembly (such as coil assemblies 95c and 95d) may also emit fields sensed by locator 58. Furthermore, as noted above, instrument 68 with tracking device 66 can also sense fields emitted by any of the coil assemblies. As discussed herein, the field sensed by the tracking device 66 associated with the apparatus 68 may depend on and / or vary based on the pose or proximity of the tracking device 68 relative to one or more of the coils 95a to 95d. Furthermore, the field emitted by any of the coil assemblies may be an EM field, and any of the coil assemblies may emit multiple fields. Therefore, the pose of any tracked portion or tracking device may be based on the emission and / or sensing of one or more emission fields.

[0055] However, various parts of the patient positioning assembly 200 may include coils 95 integrated therewith. This integration may also be fixed to it. For example, coil assembly 95a may be fixed to rod 204a such that movement of rod 204a necessarily requires coil assembly 95a to move with it. Thus, movement of one or more rods of rod 204 (such as the first rod 204a) may cause coil array 95a to move with it. This allows rod 204a to move at any appropriate location relative to subject 30, and coil assembly 95a associated with or connected to it moves with rod 204a. Thus, when positioned relative to subject 30, coil assembly 95a is immediately positioned with rod 204a to create or adjust navigation space. This eliminates the need to position any additional coils or coil assemblies relative to subject 30 to allow tracking of selected parts (such as device 66 or DRF 58) relative to subject 30. Furthermore, as noted above, more than one coil assembly may be positioned relative to subject, such as coil assembly 95b including a second rod 204b.

[0056] According to various implementation schemes, each support member may include a selected geometry to be positioned relative to the subject 30. For example... Figure 2AAs illustrated, each of the rods 204 may extend substantially vertically or orthogonally to the plane defined by the plate support 208. Thus, the first rod 204a may extend along axis 204l, which is perpendicular to or orthogonal to the plane defined by the upper surface 209 of the support plate 208.

[0057] Given the orientation of rod 204 and its orientation relative to surface 209, the configuration or orientation of coil 95a relative to support 208 can be known. Therefore, the known configuration of coil assembly 95 relative to patient positioning assembly 200 can be known. This allows for the identification of interfering objects to allow for predetermined interference (if any). For example, if rod 204a includes an interfering portion mounted to plate 208, then once rod 204a is assembled to plate 208, the known position of coil assembly 95a relative to that plate is known.

[0058] In various embodiments, various parts of the patient support or positioning system 200 may include or have a coil assembly 95 coupled thereto. However, in various embodiments, reference is made to... Figure 3A and Figure 3B Patient positioning component 260 is illustrated. A patient positioning system may be used in place of or as a supplement to patient positioning system 200. Patient positioning system 260 may include one or more components movable relative to subject 30. For example, patient positioning system 260 may include head support 264. Head support 264 may be similar to or the same as patient positioning system 200 discussed above. Head support 264 may be positioned to support at least a portion of the head 30h of subject 30 to help ensure that head 30h is held in a selected position. Patient positioning system 260 may also include additional components, such as arm or shoulder supports 268. Head support 264 and arm support 268 may be movable relative to subject 30. Each of the support components 264, 268 may be individually movable relative to subject 30 to any appropriate or selected position. These components may be positioned relative to subject 30 in a non-attached manner, such as not directly or physically connected to support members such as support plate 208.

[0059] However, the support components of the patient positioning system 260 can assist in holding or supporting the subject 30, or at least its parts, in a selected positioning posture. The patient positioning system 260 can also support or maintain at least a certain mass of the subject 30.

[0060] 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 for receiving a selected component. This volume may be accessible through a selected panel or opening, such as through an end 274 of the support 268.

[0061] The size and shape of volume 272 can be designed to retain (e.g., accommodate) and guide locator components, such as locators or coil assemblies 95e within housings or placement members 278. Housing 278 can include any suitable housing that houses and assembles the coil assembly 95e within volume 272. The coil assembly 95e retained within housing 278 can be placed within volume 272 of positioning member 268. Housing 278 can also be keyed or directed to specific portions of volume 272, and thus to member 268, such as by means of protrusions.

[0062] Go to Reference Figure 3B A user (such as user 72) can place the housing 278 within the support member 268. The housing member 278 can be positioned within the volume 272 in any suitable manner. According to various embodiments, for example, the housing 278 may be assembled within the volume 272 in only a single orientation or positioning. Thus, the coil assembly 95e may have a known configuration and orientation relative to the positioning member 268. The positioning member 268 can then be positioned relative to the subject 30 to assist in supporting or positioning a portion of the subject 30, such as a limb 30l of the subject 30.

[0063] Therefore, according to various implementation schemes, the support portion of, for example, the arm support 268 can be positioned relative to the subject 30 at any suitable location. The placement position relative to the subject 30 can be substantially random and selected by the user 72 based on various parameters that may be unique to the subject 30, the user 72, or the surgery.

[0064] Support member 268 can be any suitable support member and may include a volume 272 for receiving housing 278. It should be understood that the kit may include multiple support members 268. Each of the multiple support members may have various shapes, geometries, or sizes, etc. Therefore, during surgery, user 72 can select an appropriate positioning or support member for a chosen procedure. User 72 can position the support member for use during surgery. If navigation is selected, user 72 can place housing 278 with coil assembly 95e within the volume 272 of support member 268. Therefore, coil assembly 95e can be positioned relative to subject 30 for surgery. Thus, coil assembly 95e can be positioned substantially close to or adjacent to a portion of the procedure, such as orthopedic surgery including shoulder replacement or plate insertion.

[0065] A single housing 278 having coil assembly 95e may be provided in a kit or separately for use with one or more support portions used relative to subject 30. Thus, if the kit includes multiple support portions and only a few support portions are needed for the procedure, coil assembly 95e may be positioned only at a selected or necessary location relative to subject 30. Therefore, only an optimal (e.g., minimum) number of coil assemblies may be used to assist navigation or track selected procedures.

[0066] Furthermore, the locator 94 discussed above is not required. Instead, the coil assembly 95e within the housing 278 can be positioned relative to the subject 30. This allows for efficient placement of the coil assembly 95e. Efficient placement may include positioning the coil assembly 95e substantially adjacent to or close to the surgical location, such as within 5 cm, within 10 cm, or any suitable location.

[0067] Similarly, the configuration of the housing 278, coil assembly 95e, or other components within a specific configuration of the support portion may be known to aid in understanding the geometry and / or interference portions relative to the coil assembly 95e. As noted above, a positioner including the coil assembly 95e can be used for tracking the device 68. According to various embodiments, such as Figure 3B As illustrated, instrument 68 can be a reaming or cutting tool, which can be a power tool. The power tool can operate a tool tip 68t, which can be a reamer, to ream a portion of the subject 30. Tracking device 66 can be used to track instrument 68 during the procedure. Coil assembly 95e can be used to generate the field sensed by tracking device 66. Therefore, modular housing 278 can be inserted into support 268 at an appropriate location to assist in generating or emitting the field sensed by tracking device 66 near the operated part (such as limb 30l of subject 30).

[0068] According to various implementation plans, such as Figure 4 As illustrated, the patient support or positioning system 300 may include selected constructions or geometries, such as a recessed receiving area 304 surrounded by raised walls or ridges 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 selected materials, such as compliant or flexible materials. It should be understood that the patient positioning system according to various embodiments may include compliant or non-compliant portions or materials to achieve selected support or positioning of the subject 30.

[0069] The patient positioning system 300 may include a specific or general recess or recess 312, which 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 a third coil assembly 95h. Each of the three coil assemblies 95f to 95h may be arranged in the coil array 320 in a manner similar to that of the locator 94 discussed above. The coil array 320 may include at least three of the coil assemblies 95f, 95g, and 95h to emit or generate a selected field in a selected manner, such as by time variation, by frequency variation, or by any suitable manner.

[0070] The coil array 320 can be disposed within an assembly or housing 324 that can be placed within a recess 312. The coil array assembly 320 (such as within the housing 324) may include a guide or keying portion 328 that can engage or be engaged relative to a keying portion 332 of the recess 312. Therefore, the coil array assembly 324 can be positioned substantially singly (e.g., only one) or oriented within the recess 312. Thus, the coil array assembly 320 can be positioned within a patient support or positioning system 300 at appropriate times.

[0071] As discussed above, the patient support assembly 260 may include a recess or retaining region 272 for receiving the coil assembly 95e within the housing 278. The housing 278 may house a single coil assembly 95e, as discussed above. However, the coil array assembly 320 may include an array of more than one coil assembly, such as coil assemblies 95f, 95g, and 95h. As will be understood by those skilled in the art, the coil array 320 of coil assemblies 95f, 95g, and 95h may emit a field having at least one selected parameter. Furthermore, each coil assembly may emit a varying field that can be sensed by one or more instruments or tracking devices, such as the tracking device 66 associated with instrument 68.

[0072] The subject can be positioned relative to the patient positioning component 300, such as positioning the subject's head 30h within the recess 304 to provide access to the coil array 320 adjacent to selected portions of the subject 30. The device 68 can then be moved relative to the subject and the coil array 320. The tracking device 66 can sense the field emitted by the coil array 320, which includes each of the coil components 95f, 95g, and 95h.

[0073] The patient positioning component 300 allows the array of coil assemblies to be positioned substantially simultaneously with the patient positioning system 300. Therefore, multiple coil assemblies can be positioned relative to the patient positioning portion 300 in a generally known configuration. Furthermore, the coil array 320 can be positioned relative to selective portions of the patient or subject 30 for surgical purposes.

[0074] Therefore, according to various embodiments, the locator 94 or its components (such as one or more coil assemblies in the coil assembly 95) can be positioned relative to the subject in a selected manner. In other words, one or more coil assemblies in the coil assembly can be provided to operate as a locator, whether or not they are in a housing or portion separate from one or more patient positioning components. Figure 2A As illustrated, the patient positioning assembly 200 may have coil assemblies integrated into selected portions that can be positioned relative to the subject 30, such as in the rod 204. The coil assemblies may be permanently attached to the rod in substantially known manners. According to various embodiments, individual coil assemblies within the coil assembly may be positioned relative to the subject 30 having a patient support, such as in… Figure 3A and Figure 3B The illustrated patient positioning or support assembly 260. Therefore, a selected number of coil assemblies can be positioned relative to the subject 30 for performing or assisting in navigation surgery. Additionally, multiple coil assemblies can be provided in a fixed array with a known configuration relative to a patient support (such as patient support assembly 300). Thus, multiple coil assemblies 95f, 95g, 95h can be arranged in array 320 and patient support 300 with known geometry.

[0075] Therefore, according to various embodiments, the patient support assembly may include one or more coil assemblies for generating a field to assist surgical navigation. This allows the field generated by the locator to be positioned at a selected area or volume relative to the subject 30 and within the patient support. Therefore, a separate locator (such as locator 94) may not be necessary and does not need to be provided relative to the subject 30 to allow the generation or emission of a field to be sensed relative to the subject 30 using a tracking device.

[0076] As discussed above, depending on the various implementations, different parts of the patient support or positioning system can be permanently or selectively integrated with it for use in surgery. At least one tracking coil assembly (e.g., 95a, 95e). The tracking coil assembly can operate as a locator 94, even if not positioned as a separate unit remote from the patient, such as... Figure 1 Instead of being exemplified, it is included in the patient support or positioning system or positioned adjacent to the patient along with the patient support or positioning system.

[0077] One or more coil assemblies from various coil assemblies can operate together as a tracking array (such as a tracking array including two or more coil assemblies from the coil assemblies). For example, as Figure 5 As illustrated, the transmitter and receiver array 334 may include a coil assembly 340 configured to transmit signals and one or more coils serving as the receiver assembly 344. According to various embodiments, the coil assembly 340 may be understood as a coil assembly as discussed above, such as coil assembly 95a, and the receiver assembly 344 may be a system such as a tracking assembly or device similar to DRF 58. The system may also include a second coil and transmitter assembly 350, which may include coil assembly 354 and receiver assembly 358.

[0078] The first coil and receiver assembly 334, together with the second coil and array receiver assembly 350, can operate as a coil array 362. Assuming the transmitter assembly including coil assembly 340 and the second coil assembly 354 are in known positions relative to each other, the coil array can operate as a coil array. Therefore, linked or connected receivers (such as a first receiver 344 connected to the first coil array 340 and a second receiver 358 connected to the second coil assembly 354) can be used to determine their poses relative to each other. According to various embodiments, the first coil assembly 340 can transmit or emit a field sensed by the receiver 358. Therefore, the pose of the receiver relative to the coil array 340 can be known, and thus, the pose of coil assembly 354 relative to coil assembly 354 can be known. Similarly, the second coil assembly 354 can emit a field sensed by the receiver 344. Therefore, the pose of the receiver 344 relative to the coil assembly 354 can be known, thereby allowing the pose of coil assembly 340 relative to coil assembly 344 to be known.

[0079] Each of the receivers 344, 358 can be fixed relative to the corresponding coil assembly 340, 354 and in any suitable manner, such as to the rod 204 or any other suitable assembly. In any case, the two assemblies 334, 358 can operate as an array 362 based on the determination or knowledge of the pose of the coil assemblies 340, 354 relative to each other. Therefore, the tracking device 66 of the instrument 68 can track in a field emitted by any one of the assemblies 334, 350 and / or a combination of both as array 362. Thereafter, the pose of the tracking device 66 and the associated or related instrument 68 can be determined in a manner similar to the tracking and navigation discussed above (such as using the locator assembly 94).

[0080] In various implementation schemes, such as Figure 6As illustrated, component or array component 370 may include a first coil component 374 and a second coil component 378. The two coil components 374 and 378 can operate as both a transmitter and a receiver. Therefore, the determined pose of the second coil component 378 relative to the first coil component 374 can be determined substantially directly based on sensing the field emitted by the first coil component 374. Similarly, a reciprocal can be used to determine the pose of the first coil component 374 relative to the second coil component 378.

[0081] In various implementations, the coil assemblies can operate as both transmitters and receivers in a suitable multiplexing manner. For example, a selected coil of the first coil assembly 374 can operate as a transmitter at a first time and as a receiver at a second time, allowing time-division multiplexing of signal transmission and reception. Similarly, the coil of the second coil assembly 378 can operate in a time-division multiplexing manner. Thus, the respective coil assemblies 374 and 378 can transmit and sense fields to generate signals about their pose relative to each other.

[0082] Alternatively or in another manner, frequency division multiplexing can also be used to allow the respective coil assemblies 374, 378 to operate as both transmitters and receivers. For example, each coil portion of the coil portion of the respective coil assemblies 374, 378 can operate at different or alternating frequencies to allow substantially simultaneous transmission and reception or sensing of fields or signals therein, thereby allowing determination of the relative positions of the coil assemblies 378, 374 with respect to each other.

[0083] In any case, once the determined poses of the coil assemblies 374, 378 relative to each other are determined, the coil array 370 can operate as a positioner 94 even if the two coil assemblies 374, 378 are positioned relative to each other in a substantially non-fixed or initially unknown manner. Therefore, the pose of the tracking device 66 and the associated or determined pose of the instrument 68 can be determined based on the field emitted by the two coil assemblies 374, 378, which can operate as the coil array 370.

[0084] Therefore, multiple coil components (such as...) Figure 5 and Figure 6The illustrated coil assemblies can be positioned relative to the subject 30 at substantially random locations or poses. As discussed above, and illustrated, for example, as shown in Figure 2a, rods 204a, 204b can be positioned relative to the spine 244 in any pose or level most favorable for the surgical procedure. The poses of the two rods 204, 204b may be unknown prior to the start of the surgery and may be based on specific surgical procedures, surgeon preferences, or other parameters. However, the two rods 204a, 204b may include corresponding coil assemblies 95a, 95b, which can be used as a launch field to allow tracking of the tracking device 66 of the instrument 68 or any other suitable tracking device. Two or more coil assemblies can operate as coil arrays (such as coil array 370) based on their poses relative to each other during the surgery. Thus, multiple coil assemblies can be used in a non-fixed manner to allow tracking of one or more tracking devices during the surgery.

[0085] Additionally, refer to Figure 7 A system can be used to determine the optimal or best coil assembly for navigation or tracking using selected instruments. For example... Figure 7 As illustrated, patient 30 or any suitable subject can be positioned relative to patient positioning system 200. Patient positioning system 200 may include two rods 204a, 204b positioned relative to subject 30. The respective rods may include corresponding coil assemblies 95a, 95b. As discussed above, the two coil assemblies may operate as a coil or locator array to assist in performing surgery, including tracking or navigating instruments relative to subject 30.

[0086] However, according to various implementation schemes, the surgery relative to subject 30 can be performed at multiple locations within one or more coil assemblies and / or at different distances from one or more coil assemblies. For example, as Figure 7 As illustrated, the device 68 can operate at a first position 68p' and a second position 68p'' relative to the first coil array 95a and the second coil assembly 95b.

[0087] like Figure 7 As illustrated, the instrument at the first position 68p' can 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 68p'', the instrument can be a first distance 408 from the second coil assembly 95b and a second distance 412 from the first coil assembly 95a. Therefore, at either position 68p' or the second position 68p'', the instrument 68 can be closer to one coil assembly than the other.

[0088] Therefore, as discussed herein, the navigation system including processor component 103 can execute instructions to evaluate and / or determine which signal will be used for navigation of various positioning devices 68p', 68p'' and / or their selected weighting. However, it should also be understood that multiple coil assemblies can be used with patient support assembly 200, and the illustration and discussion of two coil assemblies are merely exemplary.

[0089] Go to Reference Figure 8 The system discussed above (including navigation system 26) can be used to track one or more devices, such as device 68 relative to subject 30, which can be any suitable subject. Also as discussed above, depending on the various embodiments, the locator may include a patient support or one or more coil assemblies in the positioning system.

[0090] Method or process 450 can be used to assist navigation and / or determine the pose of one or more devices in an instrument. Process 450 may begin in start box 454. Thereafter, sub-boxes or sub-sections may include a positioning phase of a sub-section of 456. Positioning phase 456 is optional and may be the physical positioning and / or determination (e.g., receiving input) of the pose of one or more coil array assemblies. Thus, sub-process 456 may include positioning a first coil assembly in box 458 and positioning a second coil assembly in box 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 the first coil assembly may be the only requirement allowing navigation or tracking of the instrument. However, sub-process 456 may include positioning and / or having one or more coil assemblies relative to subject 30 in an operating room.

[0091] Following subprocess 456, an optional determination of the pose of the first coil assembly relative to the second coil assembly, and vice versa, can be made in block 464. In block 464, the pose of the first coil can be determined relative to the second coil assembly, and vice versa. This determination can be in any suitable manner, such as those discussed above. Therefore, the corresponding coil assembly can have an associated receiver and / or can operate as a receiver. Thus, the pose of the first coil assembly relative to the second coil assembly can be determined, and vice versa.

[0092] As discussed above, the operation or determination of the two coil assemblies relative to each other can allow the two coil assemblies to operate as a single coil array, similar to positioner 94. During operation as an array, the two coil assemblies can be used to determine a single pose of the instrument. Thus, as an array or as a single coil assembly, a first field EM field 1 can be emitted in box 470.

[0093] In block 474, the tracking device can sense the emitted EM field 1. Once sensed, the signal can be transmitted to a selected system, such as a navigation system as discussed above. In block 480, the signal from the tracking device can be evaluated, such as by executing instructions by a processor to determine the pose of the tracking device and / or by utilizing relevant or associated instruments. Similarly, the determination of the pose of the tracking device can be based on the signal generated after sensing the EM field in block 474. This signal can be transmitted to the navigation system or transmitted within the navigation system in any suitable manner (such as wirelessly and / or via wired connection).

[0094] After determining the pose of the tracking device based on the sensed EM field 1, it is determined in box 484 whether a second EM field (EM field 2) is sensed from the second coil array.

[0095] If the second field (EM field 2) is not sensed in box 484, the determined pose can be output in box 490 by following the "No" path 488. If no second field is emitted or sensed or used for determination, the determined pose can be based solely on EM field 1. If determined in box 464, the sensed field can be emitted by a single coil assembly and / or using a coil array. The output determined pose can be saved for various purposes or otherwise utilized, such as optionally displaying the output in box 494. The displayed output can include a display of icons or graphical representations (such as a graphical representation 68i of the device 68 relative to an image), or a reconstruction of an image of the subject 30. The graphical representation can be displayed in any suitable manner, such as overlaid on an image, displayed relative to a coordinate system, displayed in a virtual reality or mixed reality system, or any suitable manner.

[0096] After the determined pose is output in box 490, it can be determined in box 498 whether tracking is complete. If tracking is complete, the “Yes” path 500 can be followed to end the procedure in box 504. Ending the procedure in box 504 may include moving the instrument to a different position relative to the subject 30, ending the procedure (e.g., suturing the subject), or other appropriate actions.

[0097] If tracking is determined to be incomplete, a "No" path 508 can be followed to transmit or sense the EM field 1 in boxes 470 or 474. Thus, depending on the various embodiments, process 450 can be iterated to allow selected tracking and / or navigation of instrument 66.

[0098] If it is determined in box 484 that the second EM field 2 has been sensed, then the "yes" path 520 can be followed. After following the "yes" path 520, in box 524, the EM field 2 can be sensed, or a signal based on the EM field can be generated and transmitted.

[0099] After sensing EM field 2, the sensed EM field 1 relative to the sensed EM field 2 can be evaluated in box 528. The evaluation of the sensed EM field 1 relative to the sensed EM field 2 can be performed for various purposes. For example, as discussed above, the device can be in different relative positions with respect to various operable coil assemblies (such as the first and second coil assemblies positioned in boxes 458, 460). This evaluation can be used to determine the optimal or best signal or sensing for one or more fields to determine the optimal or best pose of the tracking device. For example, the intensity of EM field 1 and EM field 2 can be determined relative to each other. Furthermore, the amount of distortion based on EM field 1 and / or EM field 2 can be determined. Therefore, the evaluation of the sensed EM field 1 or EM field 2 can be performed in the measurement of field strength, distortion, or other parameters, and can be performed in box 528.

[0100] After evaluating sensed EM field 1 and sensed EM field 2 in block 528, optimal or best tracking or navigation can be determined based on the evaluation in block 532. Optimal tracking may include selecting only one of EM field 1 or EM field 2 to determine the pose of the tracking device. Alternatively, the determination of optimal or best tracking or navigation may also be based on a weighting of the sensed pose according to EM field 1 or EM field 2. For example, a pose determined based on sensed EM field 1 may be weighted twice as high or more likely to be correct compared to a pose determined based on sensed EM field 2, and therefore the determined positioning may be weighted twice or use the pose of sensed field 1 relative to a sensed or determined pose based on sensed EM field 2. Regardless of the process, optimal tracking with navigation can be determined in block 532.

[0101] Based on optimal tracking and navigation, and the evaluation based on box 532, the pose of the tracking device or apparatus can be determined in box 538. The determined pose of the tracking device can be based on or after sensing both EM field 1 and EM field 2, as well as the relevant evaluation in box 528 and the optimal tracking or navigation determined in box 532. Therefore, the pose determined in box 538 can be the same as the pose determined in box 480 and / or can be different based on sensing two or more fields. However, the determined pose can then be output in box 490, and process 450 can continue as discussed above.

[0102] Therefore, process 450 can be used to evaluate or determine the pose of a tracking device based on a coil assembly positioned relative to subject 30 in a substantially non-predetermined or pre-fixed manner. Thus, the use of the tracking system can be substantially seamless and / or require no additional steps other than positioning a patient support assembly (such as the positioning assembly 200 of the patient support) relative to subject 30. Depending on various embodiments, process 450 can allow for device navigation.

[0103] Example

[0104] Example 1. A surgical navigation system comprising: a subject support component assembly configured to support at least a portion of the mass of a subject in a selected location, wherein the subject support component assembly includes: a first subject support component and a second subject support component, wherein the first subject support component is movable relative to the second subject support component; wherein the first subject support component is configured to extend vertically from the second subject support component and contact at least a portion of the subject in the selected location; a coil assembly positioned together with the support component, wherein the coil assembly is configured to perform at least one of emitting an electromagnetic (EM) field or sensing 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 the pose of the tracking device in the navigation space based on the signal received from the tracking device.

[0105] Example 2. The system according to Example 1, wherein the first subject support member is configured to extend vertically from the second subject support member.

[0106] Example 3. The system according to Example 1, wherein the coil assembly is removably fixed to the support member or fixed to the support member.

[0107] Example 4. The system according to Example 3, the system further includes: a coil assembly housing; wherein the coil assembly housing is configured to store the coil assembly; wherein the coil assembly housing is configured to be removably placed in at least one of the first subject support member or the second subject support member when storing the coil assembly.

[0108] Example 5. The system according to 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 additional instructions to determine an optimal navigation configuration with respect to a first EM field sensed from the first coil assembly and a second EM field sensed from the second coil assembly.

[0109] Example 6. The system according to 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 additional instructions to determine the relative pose of the first coil assembly with respect to the second coil assembly.

[0110] Example 7. A surgical navigation system comprising: a subject support member configured to support at least a portion of the mass of the subject in a selected location; and a coil assembly positioned together with the support member, wherein the coil assembly is configured to emit an electromagnetic (EM) field or sense an EM field.

[0111] Example 8. The system according to Example 7, wherein the coil assembly is fixed to the support member.

[0112] Example 9. The system according to Example 7, the system 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 movable relative to the second subject support member; wherein the first subject support member is configured to extend vertically from the second subject support member.

[0113] Example 10. The system according to Example 7, the system 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.

[0114] Example 11. The system according to Example 10, wherein the first coil assembly and the associated first subject support member are configured to be positioned at a first location relative to the subject, and the second coil assembly and the associated second subject support member are configured to be positioned at a second location relative to the subject; wherein the first location and the second location are spaced apart.

[0115] Example 12. The system according to Example 7, wherein the coil assembly is removably fixed to the support member.

[0116] Example 13. The system according to Example 7, the system further comprising: a coil array, wherein the coil assembly includes a plurality of coil assemblies fixed relative to each other as the coil array; wherein the coil array is configured to be positioned together with the subject support member.

[0117] Example 14. The system according to Example 7, the system 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 with respect to a first EM field emitted from the first coil assembly and a second EM field emitted from the second coil assembly.

[0118] Example 15. The system according to Example 7, the system further includes: 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 the relative pose of the first coil assembly relative to the second coil assembly.

[0119] Example 16. A method for providing a surgical navigation system, the method comprising: providing a subject support component assembly configured to support at least a portion of the mass of the subject in a selected location, wherein providing the subject support component assembly comprises: providing a first subject support component and providing a second subject support component, configuring the first subject support component to be movable relative to the second subject support component; configuring the first subject support component to extend vertically from the second subject support component and contact at least a portion of the subject in the selected location; providing a coil assembly positioned together with the support component; providing the coil assembly to perform at least one of emitting an electromagnetic (EM) field or sensing 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 the pose of the tracking device in the navigation space.

[0120] Example 17. The method according to Example 16, the method 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 a navigation program module to determine the pose of the tracking device based on the signal received from the tracking device.

[0121] Example 18. The method according to Example 16, the method further comprising at least one of the following: (1) securing 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) a combination thereof.

[0122] Example 19. The method according to Example 16, the method further comprising: providing the coil assembly as at least a first coil assembly and a second coil assembly; and providing the navigation processor module to execute additional instructions to determine the relative pose of the first coil assembly relative to the second coil assembly.

[0123] Example 20. The method according to Example 16, the method further comprising: providing the coil assembly as at least a first coil assembly and a second coil assembly; and providing the navigation processor module to execute additional instructions to determine an optimal navigation configuration with respect to a first EM field emitted from the first coil assembly and a second EM field emitted from the second coil assembly.

[0124] Example 21. A surgical navigation system comprising: a subject support member configured to support at least a portion of the mass of the subject in a selected location; and a coil assembly positioned together with the support member, wherein the coil assembly is configured to emit an electromagnetic (EM) field or sense an EM field.

[0125] Example 22. The system according to Example 21, wherein the coil assembly is fixed to the support member.

[0126] Example 23. The system according to Example 21, the system 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 movable relative to the second subject support member; wherein the first subject support member is configured to extend vertically from the second subject support member.

[0127] Example 24. The system according to Example 21, the system 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.

[0128] Example 25. The system according to Example 24, wherein the first coil assembly and the associated first subject support member are configured to be positioned at a first location relative to the subject, and the second coil assembly and the associated second subject support member are configured to be positioned at a second location relative to the subject; wherein the first location and the second location are spaced apart.

[0129] Example 26. The system according to Example 21, wherein the coil assembly is removably fixed to the support member.

[0130] Example 27. The system according to Example 21, the system further includes: a coil array, wherein the coil assembly includes a plurality of coil assemblies fixed relative to each other as the coil array; wherein the coil array is configured to be positioned together with the subject support member.

[0131] Example 28. The system according to Example 21, the system 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 with respect to a first EM field emitted from the first coil assembly and a second EM field emitted from the second coil assembly.

[0132] Example 29. The system according to Example 21, the system further comprising: wherein the coil assembly includes at least a first coil assembly and a second coil assembly; and a navigation processor module configured to execute instructions to determine the relative pose of the first coil assembly relative to the second coil assembly.

[0133] Example 30. The system according to 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 movable 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 together with the support member, wherein the coil assembly is configured to perform at least one of emitting an electromagnetic (EM) field or sensing an EM field in 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 the pose of the tracking device in navigation space based on the signal received from the tracking device.

[0134] Example 31. The system according to Example 30, wherein the coil assembly is removably fixed to the support member or fixed to the support member.

[0135] Example 32. A method for providing a surgical navigation system, the method comprising: providing a subject support component assembly configured to support at least a portion of the mass of the subject in a selected location, wherein providing the subject support component assembly comprises: providing a first subject support component and providing a second subject support component, configuring the first subject support component to be movable relative to the second subject support component; configuring the first subject support component to extend vertically from the second subject support component and contact at least a portion of the subject in the selected location; providing a coil assembly positioned together with the support component; providing the coil assembly to perform at least one of emitting an electromagnetic (EM) field or sensing 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 the pose of the tracking device in the navigation space.

[0136] Example 33. The method according to Example 32, the method 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 a navigation program module to determine the pose of the tracking device based on the signal received from the tracking device.

[0137] Example 34. The method according to Example 32, the method further comprising at least one of the following: (1) securing 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) a combination thereof.

[0138] Example 35. The method according to Example 32, the method further comprising: providing the coil assembly as at least a first coil assembly and a second coil assembly; and providing the navigation processor module to execute additional instructions to: (1) determine the relative pose of the first coil assembly relative to the second coil assembly, or (2) determine an optimal navigation configuration with respect to a first EM field emitted from the first coil assembly and a second EM field emitted from the second coil assembly.

[0139] Example embodiments are provided to make this disclosure thorough and to fully communicate the scope of this disclosure to those skilled in the art. Numerous specific details, such as examples of particular components, apparatus, and methods, are set forth to provide a thorough understanding of embodiments of this disclosure. It will be apparent to those skilled in the art that specific details are not required, example embodiments may be embodied in many different forms, and should not be construed as limiting the scope of this disclosure. In some example embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0140] Instructions can 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 circuitry" covers a single processor circuitry that executes some or all of the code from multiple modules. The term "group processor circuitry" covers processor circuitry that, in conjunction with additional processor circuitry, executes some or all of the code from one or more modules. References to multiple processor circuitry cover multiple processor circuitry on a discrete die, multiple processor circuitry on a single die, multiple cores of a single processor circuitry, multiple threads of a single processor circuitry, or a combination thereof. The term "shared memory circuitry" covers a single memory circuitry that stores some or all of the code from multiple modules. The term "group memory circuitry" covers memory circuitry that, in conjunction with additional memory, stores some or all of the code from one or more modules.

[0141] The apparatus and methods described in this application may be implemented, in part or in whole, by a processor (also referred to as a processor module), which may include a special-purpose computer (e.g., created by configuring a processor) and / or a general-purpose computer for performing one or more specific functions embodied in a computer program. The computer program includes processor-executable instructions stored on at least one non-transitory, tangible computer-readable medium. The computer program may also include or depend on stored data. The computer program may include a basic input / output system (BIOS) that interacts with the hardware of the special-purpose computer, a device driver that interacts with a specific device of the special-purpose computer, one or more operating systems, user applications, background services, background applications, etc.

[0142] 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 (JIT) compiler; and (v) descriptive text for parsing, such as HTML (Hypertext Markup Language) or XML (Extensible Markup Language). As an example only, source code may be in C, C++, C#, Objective-C, Haskell, Go, SQL, Lisp, or Java. ®ASP, Perl, Javascript ® HTML5, Ada, Active Server Pages (ASP), Perl, Scala, Erlang, Ruby, Flash ® Visual Basic ® Lua or Python ® To write it.

[0143] Communication may include the wireless communications described in this disclosure, which may be wholly or partially compliant with IEEE Standard 802.11-2012, IEEE Standard 802.16-2009, and / or IEEE Standard 802.20-2008. In various specific implementations, IEEE 802.11-2012 may be supplemented by draft IEEE Standard 802.11ac, draft IEEE Standard 802.11ad, and / or draft IEEE Standard 802.11ah.

[0144] The terms processor, processor module, module, or “controller” are used interchangeably herein (unless otherwise specifically indicated), and each may be replaced by the term “circuit”. Any of these terms may refer to, be part of, or include: application-specific integrated circuit (ASIC); digital, analog, or mixed-signal analog / digital discrete circuit; digital, analog, or mixed-signal analog / digital integrated circuit; combinational logic circuit; field-programmable gate array (FPGA); processor circuitry (shared, dedicated, or grouped) that executes code; memory circuitry (shared, dedicated, or grouped) that stores code executed by the processor circuitry; other suitable hardware components that provide the described functionality; or combinations of some or all of the foregoing, such as in a system-on-a-chip.

[0145] Instructions can 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 arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Therefore, the terms "processor" or "processor module" as used herein can refer to any of the foregoing structures or any other physical structure suitable for implementing the described techniques. Furthermore, these techniques can be fully implemented in one or more circuit or logic elements. The one or more processors can operate fully automatically and / or substantially automatically. In automatic operation, the processor can execute instructions based on received inputs and in accordance with received inputs. Therefore, various outputs can be made without additional or any manual (e.g., user) input.

[0146] The foregoing description of embodiments has been provided for illustrative and descriptive purposes. The foregoing description is not intended to be exhaustive or limiting of the invention. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable and may also be used in chosen embodiments where applicable, even if not specifically shown or described. The same element or feature may be varied in many ways. Such variations are not considered to depart from the invention, and all such modifications are intended to be included within the scope of the invention.

Claims

1. A surgical navigation system, the surgical navigation system comprising: A subject support member configured to support at least a portion of the subject's mass in a selected location; and A coil assembly positioned together with the support member, wherein the coil assembly is configured to 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 according to claim 1, further comprising: The subject support component includes at least a first subject support component and a second subject support component; The first subject support member is movable relative to the second subject support member; The first subject support member is configured to extend vertically from the second subject support member.

4. The system according to claim 1, further comprising: The coil assembly includes a first coil assembly and a second coil assembly; The subject support component includes at least a first subject support component and a second subject support component; 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.

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

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

7. The system according to claim 1, further comprising: A coil array, wherein the coil assembly comprises a plurality of coil assemblies fixed relative to each other as part of the coil array; The coil array is configured to be positioned together with the subject support member.

8. The system according to claim 1, further comprising: 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 the optimal navigation configuration with respect to a first EM field emitted from the first coil assembly and a second EM field emitted from the second coil assembly.

9. The system according to claim 1, further comprising: 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 the relative pose of the first coil assembly relative to the second coil assembly.

10. The system according to claim 1, further comprising: The subject support component assembly includes: First subject support components, and Second subject support component, The first subject support member is movable relative to the second subject support member; 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; The coil assembly is positioned together with the support member, and the coil assembly is configured to perform at least one of emitting an electromagnetic (EM) field or sensing an EM field in the 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 the pose of the tracking device in navigation space based on the signals received 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 surgical navigation system, the method comprising: A subject support component assembly is provided, the subject support component assembly being configured to support at least a portion of the subject's mass in a selected location, wherein providing the subject support component assembly includes: Provide support components for the first subject, and Provide a second subject support component. The first subject support member is configured to be movable relative to the second subject support member; 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; Provide a coil assembly that is positioned together with the support member; The coil assembly is provided to perform at least one of emitting an electromagnetic (EM) field or sensing an EM field in navigation space; Tracking device in the navigation space; and A navigation processor module is provided, which is configured to execute instructions to determine the pose of the tracking device in navigation space.

13. The method according to claim 12, further comprising: The tracking device is configured to sense the EM field and generate a signal based on the sensed EM field; as well as The signal is received at the navigation module to determine the pose of the tracking device based on the signal received from the tracking device.

14. The method according to claim 12, further comprising: At least one of the following: (1) securing 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) a combination thereof.

15. The method according to claim 12, further comprising: The coil assembly is provided as at least a first coil assembly and a second coil assembly; as well as The navigation processor module is provided to execute additional instructions such as: (1) determining the relative pose of the first coil assembly with respect to the second coil assembly, or (2) determining the optimal navigation configuration with respect to the first EM field emitted from the first coil assembly and the second EM field emitted from the second coil assembly.

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