System and method for navigation

Abstract

Disclosed is a system for assisting in guiding and performing a procedure on a subject. The subject may be any appropriate subject such as a living or non-living subject or inanimate object and / or an animate object.

Description

A0012143W001SYSTEM AND METHOD FOR NAVIGATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 697,348, filed 20 September 2024, the entire content of which is incorporated herein by reference.FIELD

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

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

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

[0005] The position of the patient can be determined with a tracking system. Generally, a patient is registered to the image, via tracking an instrument relative to the patient to generate a translation map between the subject or object space (e.g., patient space) and the image space. This often requires a user, such as aA0012143W001 surgeon, to identify one or more points in the subject space and correlating, often identical points, in the image space.

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

[0007] This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.

[0008] According to various embodiments, an imaging system may be used to acquire image data of a subject. The imaging system may include an ultrasound imaging system that includes an ultrasound (US) probe that generally includes an ultrasound transducer to emit and receive ultrasound frequencies. It is understood, however, that the imaging system may include separate components that emit and receive ultrasound frequencies. Other imaging modalities may also be used to acquire image data of the subject, such as magnetic resonance imaging (MRI), computed tomography (CT), fluoroscope, etc. Images generated from image data of any of these types of imaging modalities may be registered to the subject space.

[0009] A tracking system, such as a tracking system that senses an electromagnetic (EM) field or light, may be used to track one or more tracking devices. The tracking devices may be positioned on instruments (which may include procedure instruments, imagers, or other members) and tracked in a physical space also referred to as a patient space. The position of the trackingA0012143W001 device and an instrument with which it is associated (e.g., attached to) may be displayed in an image representing the subject. For example, the determined position may be superimposed on a portion of the image. To perform the tracking and illustration of a tracked object relative to an image of the subject the subject may also be tracked and registration may be necessary (e.g., registration to the patient) as discussed herein.

[0010] A navigation system may be used to register an image to a navigation space. The navigation system may also be used to determine a pose of an instrument that is tracked in the navigation space. Thus, a pose of a tracked portion or member may be displayed relative to an image. Also, systems may be used where a patient is not registered to an image but where an imaging device is tracked so that a pose of the acquired image data and related image are tracked.

[0011] According to various embodiments, a tracking system may also include or alternatively include an ultrasound tracking system. With an ultrasound tracking system, an ultrasound signal may be sent and received to determine a location or position, or together a pose, of a tracking device. A selected tracking device may include both an EM tracking device and a US tracking device. Further, according to various embodiments, a device may operate to receive and / or send both an EM field or signal and an US signal. Thus, at least two tracking systems may be registered together.

[0012] The tracking device may be associated with any selected portion of an instrument associated relative to the subject. In various embodiments, for example, the treatment device may be associated with the subject. The treatmentA0012143W001 device may provide non-invasive treatment, such as focused ultrasound. The focused ultrasound may be provided to the subject via a constructed device, including one or more ultrasound transducers. Many ultrasound transducers may each operate and / or be operated in concert to provide a focused point or region of ultrasound therapy within the subject below a surface of the subject. The device including the many ultrasound transducers may also be used to image or determine a position or depth of the individual ultrasound transducer relative to the subject. Therefore, the device including the many ultrasound transducers may determine an image or position of the subject having the device associated therewith.

[0013] A tracking device may be associated with the device. Therefore, the ultrasound transducers may have a known position relative to the tracking device. An imaged portion of the subject with the many ultrasound transducers may be coordinated or correlated with the tracking device associated with the instrument. Thus, the pose of the tracking device may be related to the subject with the many ultrasound transducers associated there with.

[0014] Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.DRAWINGSA0012143W001

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

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

[0017] Fig. 2 is a schematic detailed view of an ultrasound system having a tracking device associated therewith, according to various embodiments;

[0018] Fig. 3 is a flowchart of a process to register an image space to a navigation space, according to various embodiments; and

[0019] Fig. 4 is a flowchart of a sub-process that is optional in the process of Fig. 3.

[0020] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.DETAILED DESCRIPTION

[0021] Example embodiments will now be described more fully with reference to the accompanying drawings.

[0022] The subject disclosure is directed to an exemplary embodiment of a surgical procedure on a subject, such as a human patient. It is understood, however, that the system and methods described herein are merely exemplary and not intended to limit the scope of the claims included herein. In various embodiments, it is understood, that the systems and methods may be incorporated into and / or used on non-animate objects. The systems may be used to, for example, to register coordinate systems between two systems for use onA0012143W001 manufacturing systems, maintenance systems, and the like. For example, automotive assembly may use one or more robotic systems including individual coordinate systems that may be registered together for coordinated or concerted actions. Accordingly, the exemplary illustration of a surgical procedure herein is not intended to limit the scope of the appended claims.

[0023] Discussed herein, according to various embodiments, is a tracking system that may be used to track a selected tracking device. The tracking system may operate, according to various embodiments, by emitting an electromagnetic (EM) field from a localizer, also referred to as an EM localizer. The EM field may be emitted from one or more coils that may be oriented relative to an origin point. The coils may emit the field. The field may be a largely magnetic field. The field may be constant or varying in time. A tracking device may include one or more coils of conductive material that operate as sensors to sense the field. The field may generate a voltage or current within the coil of the tracking device. A determination of a position and orientation (also referred to collectively as a “pose”) of the tracking device may be made based on a determination of the induced voltage or current from the field. It is further understood that an EM, or any appropriate tracking system, may operate by emitting a signal (e.g., EM fields) from the tracking device and receiving signals at the localizer.

[0024] Various materials are conductive or conductive and magnetic, such as conductive polymers, metal or metal alloys, or other materials. Objects or items may be formed with these materials. If an item formed with these materials is also in or near the field generated by the EM localizer, a current may be formed orA0012143W001 induced or magnetization coerced in the object. In this instance, the object may be referred to as an interfering or target object. When a current is induced or a magnetization coerced in the interfering object, a field may also be produced. A field produced due to the induced current or coerced magnetization in the interfering object may also be referred to as an interfering field. These interfering fields may alter the field sensed by the tracking device such that it is not always sensing only the EM field generated by the EM localizer. The tracking device may sense both the EM field from the localizer and the EM field that is the interfering field. According to various theories, the sensed field may be a combination of both and / or the EM field from the EM localizer that is altered by the interfering field.

[0025] Various portions may be tracked relative to the subject. For example, a tracking system may be incorporated into a navigation system that includes one or more instruments that may be tracked relative to the subject. The navigation system may include one or more tracking systems that track various portions, such as tracking devices, associated with instruments. The tracking system may include a localizer that is configured to, alone or in combination with a processor, determine the pose of a tracking device in a navigation system coordinate system. Determination of the navigation system coordinate system may include those described at various references including U.S. Pat. No. 8,737,708; U.S. Pat. No. 9,737,235; U.S. Pat. No. 8,503,745; and U.S. Pat. No. 8,175,681 ; all of which are incorporated herein by reference. In particular, a localizer may be able to track an object within a volume relative to the subject. The navigation volume, in which a device may be tracked may include or be referred to as the navigation coordinateA0012143W001 system or navigation space. A determination or correlation between two coordinate systems may allow for or also be referred to as a registration between two coordinate systems.

[0026] Furthermore, images may be acquired of selected portions of a subject. The images may be displayed for viewing by a user, such as a surgeon. Superimposed on a portion of the image may be a graphical representation of a tracked portion or member, such as an instrument. The images may have a coordinate system and define an image space. According to various embodiments, the graphical representation may be superimposed on the image at an appropriate position due to registration of an image space (also referred to as an image coordinate system) to a subject space. A method to register a subject space defined by a subject to an image space may include those disclosed in U.S. Pat. Nos. U.S. Pat. No. 8,737,708; U.S. Pat. No. 9,737,235; U.S. Pat. No. 8,503,745; and U.S. Pat. No. 8,175,681 ; all incorporated herein by reference. In various embodiments, however, the imaging device may be tracked so its images may be tracked in a navigation space. In such a system, a display of tracked instruments relative to tracked images without a tracked or registered patient may occur, but may also be tracked and registered to a patient.

[0027] The tracking of an instrument during a procedure, such as a surgical or operative procedure, allows for navigation of a procedure. When image data is used to define an image space it can be correlated or registered to a physical space defined by a subject, such as a patient as discussed herein. According to various embodiments, therefore, the patient defines a patient space in which anA0012143W001 instrument can be tracked and navigated. The image space defined by the image data can be registered to the patient space defined by the patient. The registration can occur with the use of fiducials that can be identified in the image data and in the patient space.

[0028] Fig. 1 is a diagrammatic view illustrating an overview of a procedure room or arena. In various embodiments, the procedure room may include a surgical suite in which may be placed a robotic system 20 and a navigation system 26 that can be used for various procedures. The robotic system 20 may include a MazorX™ robotic guidance system, sold by Medtronic, Inc. The robotic system 20 may be used to assist in guiding a selected instrument, such as drills, screws, etc. relative to a subject 30. In addition or alternatively, the robotic system 20 may hold and / or move an imaging system, such as an ultrasound (US) probe 33 or 33’. The robotic system 20 may include a mount 34 that fixes a portion, such as a robotic base 38, relative to the subject 30. The robotic system 20 may include one or more arms 40 that are moveable or pivotable relative to the subject 30, such as including an end effector 44. The robotic arm 40 may be controlled by a selected robotic control module, which may be included with the navigation system or processor, as discussed herein, or a separate robotic control module 45. The robotic control module 45 may include one or more processors or memory that may communicate, execute instructions, or store instructions for operation of the robotic arm 40. The end effector may be any appropriate portion, such as a tube, guide, or passage member. Affixed to and / or in place of the end effector may be the imaging system that may be the US probe 33. The end effector 44 may beA0012143W001 moved relative to the base 38 with one or more motors. The position of the end effector 44 may be known or determined relative to the base 38 with one or more encoders at one or more joints, such as a wrist joint 48 and / or an elbow joint 52 of the robotic system 20. One or more portions of the robotic system 20 may be formed of conductive materials.

[0029] The navigation system 26 can be used to track the location of one or more tracking devices and / or determine and / or illustrate a pose thereof. Tracking devices may include a robot tracking device 54, a subject tracking device 58, an imaging system tracking device 62, an imaging system or second imaging system tracking device 81 , and / or an instrument or tool tracking device 66. A tool or moveable member 68 may be any appropriate tool such as a drill, forceps, catheter, biopsy instrument, or other tool operated by or with a user 72. The tool 68 may also or alternatively be an implant, such as a spinal implant or orthopedic implant. Further, the tool 68 may include one or more moveable portions, such as deployable portions. For example, a heart valve replacement and related inserter tool that may insert the instrument 68 or selected portion, such as an implant, into a heart 127 of the subject 30 and / or any other appropriate portion of any appropriate subject. It should further be noted that the navigation system 26 may be used to navigate any type of instrument, implant, or delivery system, including: guide wires, arthroscopic systems, orthopedic implants, spinal implants, deep brain stimulation (DBS) probes, etc. Moreover, the instruments may be used to navigate or map any region of the body. The navigation system 26 and the variousA0012143W001 instruments may be used in any appropriate procedure, such as one that is generally minimally invasive or an open procedure.

[0030] An additional or alternative, imaging system 80 may be used to acquire pre-, intra-, or post-operative or real-time image data of a subject, such as the subject 30. It will be understood, however, that any appropriate subject can be imaged and any appropriate procedure may be performed relative to the subject. In the example shown, the imaging system 80 comprises an O-arm® imaging device sold by Medtronic, Inc. having a place of business in Minnesota, USA. The imaging system 80 may have a generally annular gantry housing 82 in which an image capturing portion is moveably placed and / or enclosed. The imaging system 80 can include those disclosed in U.S. Pat. Nos. 7,188,998; 7,108,421 ; 7,106,825; 7,001 ,045; and 6,940,941 ; all of which are incorporated herein by reference, or any appropriate portions thereof. It is further appreciated that the imaging system 80 may include in addition or alternatively a fluoroscopic C-arm. Other exemplary imaging devices may include fluoroscopes such as bi-plane fluoroscopic systems, ceiling mounted fluoroscopic systems, cath-lab fluoroscopic systems, fixed C-arm fluoroscopic systems, isocentric C-arm fluoroscopic systems, 3D fluoroscopic systems, etc. Other appropriate imaging devices can also include MRI, CT, ultrasound, etc.

[0031] The position of the imaging system 33, 80, and / or portions therein such as the image capturing portion, can be precisely known relative to any other portion of the imaging device 33, 80. The imaging device 33, 80, according to various embodiments, can know and / or recall precise coordinates relative to aA0012143W001 fixed or selected coordinate system. For example, the robotic system 20 may know or determine its position and position the US probe 33 at a selected pose. The image data acquired with one or more ultrasound arrays of the US probe 33 may be registered in the navigation system such as disclosed in the U.S. Patent No. 7,085,400 and U.S. Patent No. 9,138,204, both incorporated herein by reference. Similarly, the imaging system 80 may also position the imaging portions at a selected pose. This can allow the imaging system 80 to know its position relative to the patient 30 or other references. In addition, as discussed herein, the precise knowledge of the position of the image capturing portion can be used in conjunction with a tracking system to determine the position of the image capturing portion and the image data relative to the tracked subject, such as the patient 30. In other words, the imaging system tracking device 62, 81 may be used and / or operable to determine a pose of the imaging system 33, 80 at a selected time such as during image data acquisition. The position of the imaging system, according to various embodiments, may be used for registration of an image space or coordinate system to a patient space or coordinate space. The robotic system may also be registered to one or more spaces or coordinate systems such as by the system and method as disclosed in U.S. Pat. No. 11 ,135,025, incorporated herein by reference.

[0032] Herein, reference to the imaging system 33 may refer to any appropriate imaging system, unless stated otherwise. Thus, the US probe 33 as the imaging system is merely exemplary regarding the subject disclosure. As one skilled in the art will understand, generally the US probe 33 may emit a US waveA0012143W001 in a plane and receive an echo relative to any portions engaged by the wave. The received echo at the US probe 33 or other appropriate received may be used to generate image data and may be used to generate an US image also referred to as a sonogram.

[0033] The imaging device 80 can be tracked with the tracking device 62. Also, the tracking device 81 can be associated directly with the US probe 33. The US probe 33 may, therefore, be directly tracked with a navigation system 26 as discussed herein. In addition or alternatively, the US probe 33 may be positioned and tracked with the robotic system 20. Regardless, image data defining an image space acquired of the patient 30 can, according to various embodiments, be registered (e.g., manually, inherently, or automatically) relative to an object space. The object space can be the space defined by a patient 30 in the navigation system 26.

[0034] Additionally, a US transducer or other US receiver may receive a signal from a separate transmitter, such as the US probe 33. Further, a US tracking device may receive or emit a US signal that may be used for tracking. As discussed herein, for example, one or more US emitters and US receivers may be used to determine at least one degree of freedom of a pose of a portion associated with at least one of the US receivers or emitters.

[0035] The patient 30 can also be tracked as the patient moves with a patient tracking device, DRF, or tracker 58. Alternatively, or in addition thereto, the patient 30 may be fixed within navigation space defined by the navigation system 26 to allow for and / or maintain registration such as to the image space of the imageA0012143W001108. As discussed further herein, registration of the image space to the patient space or subject space allows for navigation of the instrument 68 with the image data. When navigating the instrument 68, a position of the instrument 68 can be illustrated relative to image data acquired of the patient 30 on a display device 84 such as with a graphical representation 68i, 68i’. Alternatively, the patient 30 may not be tracked or fixed and the system may track the instrument 68 relative to imaging device 33 and their associated images. An additional and / or alternative display device 84’ may also be present to display an image. Various tracking systems, such as one including an optical localizer 88 or an electromagnetic (EM) localizer 94 can be used to track the instrument 68.

[0036] More than one tracking system can be used to track the instrument 68 or other portion, such as the US probe 33 with the tracking device 81 in the navigation system 26. According to various embodiments, these can include an electromagnetic tracking (EM) system having the EM localizer 94 and / or an optical tracking system having the optical localizer 88. In various embodiments, an ultrasound system may be used for tracking, such that ultrasonic signals may be used to measurement rather than or in addition to sonogram generation. Thus, a US localizer, as discussed herein, may be used with the navigation system 26 to determine at least one degree of freedom of a pose of a portion associated with a US tracking device. Either or both of the tracking systems can be used to track selected tracking devices, as discussed herein. It will be understood, unless discussed otherwise, that a tracking device can be a portion trackable with aA0012143W001 selected tracking system. A tracking device need not refer to the entire member or structure to which the tracking device is affixed or associated.

[0037] The position of the patient 30 relative to the imaging device 33 can be determined by the navigation system 26. The position of the imaging system 33 may be determined, as discussed herein. The patient 30 can be tracked with the dynamic reference frame 58, as discussed further herein. Accordingly, the position of the patient 30 relative to the imaging device 33 can be determined.

[0038] Image data acquired from the imaging system 33, or any appropriate imaging system, can be acquired at and / or forwarded from an image device controller 96, that may include a processor module, to a navigation computer and / or processor module (also referred to as a processor) 102 that can be a part of a controller or work station 98 having the display 84 and a user interface 106. Further, a memory system or module 103, of any appropriate type, may be accessed by the processor 102. It will also be understood that the image data is not necessarily first retained in the controller 96, but may also be directly transmitted to the work station 98. The work station 98 can provide facilities for displaying the image data as an image 108 on the display 84, saving, digitally manipulating, or printing a hard copy image of the received image data. The user interface 106, which may be a keyboard, mouse, touch pen, touch screen or other suitable device, allows the user 72 to provide inputs to control the imaging device 80, 33, via the image device controller 96, or adjust the display settings of the display 84. The work station 98 may also direct the image device controller 96 to adjust the image capturing portion of the imaging device 80 to obtain various two-A0012143W001 dimensional images along different planes in order to generate representative two- dimensional and three-dimensional image data.

[0039] With continuing reference to FIG. 1 , the navigation system 26 can further include the tracking system including either or both of the electromagnetic (EM) localizer 94 and / or the optical localizer 88. The tracking systems may include a controller and interface portion 110. The controller 110 can be connected to the processor portion 102, which can include a processor included within a computer. The EM tracking system may include the STEALTHSTATION® Navigation System, sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colorado; or can be the EM tracking system described in U.S. Patent No. 7,751 ,865; U.S. Patent No. 5,913,820; and U.S. Patent No. 5,592,939; all of which are herein incorporated by reference. It will be understood that the navigation system 26 may also be or include any appropriate tracking system, including a STEALTHSTATION® TREON®, S7™, S8™ tracking systems having an optical localizer, that may be used as the optical localizer 88, and sold by Medtronic Navigation, Inc. having a place of business in Colorado, USA. With the optical localizer a camera or optical sensor 89 may sense a reflected or actively emitted optical signal, such as an infrared signal or a visible light signal such as from a selected object. Other tracking systems include an acoustic, radiation, radar, etc. The tracking systems can be used according to generally known or described techniques in the above incorporated references. Details will not be included herein except when to clarify selected operation of the subject disclosure.A0012143W001

[0040] Wired or physical connections can interconnect the tracking systems, imaging device 80, etc. Alternatively, various portions, such as the instrument 68 may employ a wireless communications channel, such as that disclosed in U.S. Patent No. 6,474,341 , herein incorporated by reference, as opposed to being coupled directly to the controller 110. Also, the tracking devices 62, 66, 54 can generate a field and / or signal that is sensed by the localizer(s) 88, 94.

[0041] Various portions of the navigation system 26, such as the instrument 68, and others as will be described in detail below, can be equipped with at least one, and generally multiple, of the tracking devices 66. The instrument can also include more than one type or modality of tracking device 66, such as an EM tracking device and / or an optical tracking device. The instrument 68 can include a graspable or manipulable portion at a proximal end and the tracking devices may be fixed near the manipulable portion of the instrument 68.

[0042] Additional representative or alternative localization and tracking system is set forth in U.S. Patent No. 5,983,126, hereby incorporated by reference. The navigation system 26 may be a hybrid system that includes components from various tracking systems.

[0043] According to various embodiments, the navigation system 26 can be used to track any appropriate portion such as the US probe 33 and / or the instrument 68 relative to each other or the patient 30. The navigation system may also be used or alternatively used to track an ultrasound system 200, as discussed herein, with the tracking device 58 that may be associated (e.g., affixed) therewith.A0012143W001The instrument 68 can be tracked with the tracking system, as discussed above. Image data of the patient 30, or an appropriate subject, can be used to assist the user 72 in guiding the instrument 68. The image data may or may not be registered to the patient 30. For example, as discussed herein, the US probe 33 is tracked and generates the image data. Thus, as discussed above, the image data need not be registered to the subject to display a pose of the tracked instrument 68 relative to the image data generator with the tracked US probe 33. The image data defines the image space that is registered to the patient space defined by the patient 30. The registration can be performed as discussed herein, automatically, manually, or combinations thereof. The registration can include the process and the final transformation (including a translation and rotation) map. Registration may also or alternatively be performed with the US system 200 and the associated features thereof and / or the tracking device 58. Generally, registration includes determining points in the image data and the subject space and determining a transformation map therebetween. Once done, the image space is registered to the subject space, or any two or more coordinate spaces.

[0044] Generally, registration also allows a transformation map to be generated of a tracked physical pose of the instrument 68 relative to the image space of the image data. The transformation map allows the tracked position of the instrument 68 to be displayed on the display device 84 relative to the image data 108. The graphical representation 68i, also referred to as an icon, can be used to illustrate the location of the instrument 68 relative to the image data 108.A0012143W001

[0045] With continuing reference to Fig. 1 , a subject registration system or method can use the tracking device 58. The tracking device 58 may include portions or members 121 that may be trackable, but may also act as or be operable as a fiducial assembly. The fiducial assembly 121 can include a clamp or other fixation portion and the imageable fiducial body. It is understood, however, that the members may be separate from the tracking device 58. The fixation portion can be provided to fix any appropriate portion, such as a portion of the anatomy or a portion associated with the subject 30. As illustrated in Fig. 1 , the fiducial assembly 121 can be interconnected with a portion of a head or skull. The fixation portion can be interconnected with the skull in any appropriate manner. For example, a pin or a screw can be driven into the skull. Further, the tracking device 58 may be operable to track with one or more tracking systems or modalities, such as EM tracking system or optical tracking system.

[0046] According to various embodiments, an ultrasound probe or transducer may emit or transmit ultrasound waves in a selected pattern or plane. The plane may be a shape as is understood by one skilled in the art. The plane is generally able to acquire data in a field of view to generate images, also referred to as sonograms when images are generated based on ultrasound data. The ultrasound transducer may also receive one or more ultrasound reflections to determine information therefrom.

[0047] As discussed above, various tracking systems may be used with the navigation system 26 to allow for determination of a pose of a plurality of portions in a navigation space or volume. Various systems, such the EM tracking systemA0012143W001 including the localizer 94 may emit or generate an electromagnetic field. The field may be sensed by one or more items, such as the DRF 58 or the tracking device 66 to allow determination of the pose within the navigation space defined by the emitted field. Further, various other tracking systems may be operated, such as the optical tracking system including the localizer 88. As discussed above, various elements may be used to register the two tracking systems to one another, or coregister them to a selected portion, such as the image data 108 of the subject 30.

[0048] Turning to reference Fig. 2, according to various embodiments, an instrument or tool may include an instrument 200 that may be associated with the subject 30, such as a head or skull 30h thereof, and may be used to assist in performing or allowing a registration. The instrument 200 may also be referred to as an ultrasound system, as discussed further herein. The instrument 200 may be provided in any appropriate configuration, but may include a substantially rigid external shell or member 204 that may be positioned relative to the subject 30, such as fit over a head 30h or portion thereof of the subject 30. The rigid shell 204 may be rigid enough or substantially rigid so as to not change shape or configuration during a selected period, such as during a procedure.

[0049] The tracking device 58, which may be the subject tracking device, may be fixed to the shell member 204 in the selected pose, as illustrated in Fig. 2. The tracking device 58, therefore, may have a fixed and known pose relative to the shell 204 and the portions thereof. For example, the instrument 200 may further include one or more ultrasound transducers 210. Any appropriate number of the ultrasound transducers 210 may be provided, exemplary discussed herein may beA0012143W001 a first ultrasound transducer 210a, a second ultrasound transducer 210b, and a third ultrasound transducer 210c. Any appropriate number of the ultrasound transducers, 210, however, may be provided with the device 200. Generally, for example, the ultrasound transducers 210 may be provided on the device 200 to substantially cover a surface, such as the surface generally near or facing the subject 30 or on an interior of shell 204.

[0050] The ultrasound transducers 210 may be provided to emit and / or will receive ultrasound signals to and from the subject 30. For example, the ultrasound transducer 210a may emit an ultrasound signal that travels generally the direction of arrow 214 toward the subject 30. After contacting a selected portion of the subject, such as a skull bone 30b the signal, or at least a portion thereof, may be reflected and generally travel in the direction of the arrow 216. The ultrasound transducer 210a may receive the reflected signal. It is understood, however, that other ultrasound transducers may also receive the reflected signal such as the ultrasound transducer 210b. The signal delay or delta, the time between the emission and the receiving, may be used to determine a distance, such as a distance 220 of the ultrasound transducer 210a from the bone 30b. The process discussed further detail herein generally may include the execution of instructions such as with the processor system 102, or any appropriate processor system. Generally, the ultrasound transducer 210 may operate as generally understood by one skilled in the art who may be positioned in a substantially fixed manner relative to the member 204 of the US system 200.A0012143W001

[0051] The US system 200 may further include a subject contacting member 224. The subject contacting member 224 may be any appropriate member such as including an ultrasound transducing coupling medium. The patient or subject contacting member 224 may be substantially conformable such that the US system 200 may be fitted tightly and securely to the subject 30. For example, a mounting band or member 228 may be used to mount the US system 200 to the subject 30, such that the deformable member 224 may or is substantially deformed to be in contact with the subject 30 over all or substantially all (e.g., at least 80%) of the surface of the contacting member 224. The mounting member 228 may also be referred to as a subject holding member or system to engage the subject and assist in holding or fixing the US system 200 relative to the subject. The deformable member 224 may be a subject contacting member that may also assist in holding or fixing the US system 200 relative to the subject 30. For example, the deformable member 224 may deform to engage surface contours of the subject 30 (e.g., skin surface over a bone (e.g., skull, spine, or femur) to assist in holding the US system 200 relative to the subject 30. Moreover, the deformable member 224 may deform to engage any contour of the subject to assist in ensure no air gap between the US system 200 (including the deformable member 224) and the subject 30 (or at least an external surface of the subject 30).

[0052] The contacting member 224 may further include a material or coupling medium that has generally the same speed of ultrasound transmission as skin of the subject 30. Thus, when the contacting member 224 engages a skin 30s of the subject 30, the transmission speed of the ultrasound does not change whenA0012143W001 going from the contacting member 224 to the skin 30s. The US wave or emitted signal will generally have a speed of transmission (e.g., speed) through a material. The speed may be different for different materials. The speed of the transmission may be known and recalled and / or determined with the US system.

[0053] The ultrasound transducers 210 may be provided and positioned to be in contact with the subject contacting member 224. It is understood, however, that a complete contact may not be possible, but is generally selected. Thus, the ultrasound signal may be emitted by the transducers 210 and travel at a substantially constant speed until the ultrasound signal passes through the skin 30s of the subject 30. Thus, the speed of the ultrasound will substantially not change until the ultrasound signal reaches a substance other than skin 30s of the subject 30.

[0054] The subject contacting member 224, as noted above, may contact the subject 30 in a generally fixed manner. Thus, the US system 20 may be held generally fixed relative to the subject 30. Further, the subject contacting member 224, at least in so doing, may maintain the ultrasound transducers 210 at a fixed pose relative to the subject 30. The ultrasound transducers 210 are generally fixed relative to one another, such as via the shell 204, and further relative to the subject 30 as the subject contacting member 224 is held fixed relative to the subject 30.

[0055] The geometric pose of the tracking device 58 relative to the ultrasound transducers 210 may be known, such as predetermined or determined during a procedure. The pose may be predetermined and stored in the memoryA0012143W001103, such as during a manufacturing of the US system 200. The pose may also be known by determination during a procedure such as by tracking a tracking instrument relative to the subject 30. In various embodiments, for example, a second (e.g., subject or patient) tracking device 232 may be fixed to the subject separate from the instrument or system 200. Thus, the tracking device 58 may be tracked relative to the second tracking device 232. Additionally or alternatively, a probe, such as the instrument 68, may be tracked within the navigation system 26 to track a pose of the tracking device 58 relative to the subject 30. This may allow the pose of the tracking device 58 relative to the ultrasound transducers, such as an arc length and orientation 240 and / or 244, may be determined and known. The exemplary geometric configuration 240 relative to the ultrasound transducer 210a and the geometric configuration 244 relative to the ultrasound transducer 210c may be known to determine the pose of the various ultrasound transducers relative to the tracking device 58. It is understood that the pose of all of the ultrasound transducers 210 may be known, either predetermined or determined during a procedure. The exemplary and illustrative configuration 240, 244 is merely for the clarity of the subject disclosure.

[0056] The distance between one or more of the ultrasound transducers 210 may be determined when the US system 200 is fit to the subject 30. As discussed above, the distance 220 may be determined between the ultrasound transducer 210a and the subject 30 and a distant 250 may be determined between the subject 30 and the ultrasound transducer 210c. Not only may the distances 220, 250 be determined, but the information based on the ultrasound transducers 210 may alsoA0012143W001 be used to determine a configuration of the subject, such as the head 30h. As discussed above, image data may be generated or collected of the subject 30 at any appropriate time, such as with the imaging system 80. The image 108 may be displayed with the display device 84. The US system 200 may, therefore, be used to register the subject to the image 108. As the distances between one or more of the ultrasound transducers 210 may be determined, these distances may be used to identify features of the subject 30 and these may be compared or found in the image 108. The information from the ultrasound transducers 210 may be used to determine the configuration of the head 30h. The data acquired with the ultrasound transducers 210, such as one or more distances, may be used to determine a surface geometry, subject features (e.g., ridges or low points) and the geometry may be compared to the image 108 or otherwise acquired with the subject 30. Thus, the image 108 may be registered to the subject 30 by the collection of the configuration of the subject 30 based upon the many distances and other information collected with the ultrasound transducers 210 once the US system 200 is positioned relative to the subject 30.

[0057] As the pose of the tracking device 58 is known relative to one or more of the ultrasound transducers 210, the configuration of the subject 30 determined with the ultrasound transducers 210 thus allows for a registration of the subject space, determined with the US system 200 and related to ultrasound transducers 210, to the image 108 of the subject 30. Further the registration may be substantially maintained and / or updated as the ultrasound transducers 210 may be used to continuously measure and / or receive signals from the subject 30. AsA0012143W001 noted herein, the US system 200 may be tracked relative to the subject, thus, the US system 200 need not be rigidly fixed to the subject 30 to maintain a known pose of a treatment therewith, such as a focused ultrasound (FUS)treatment.

[0058] The US system 200 may include various features to assist in a procedure on the subject 30. For example, the ultrasound transducers 210 may be used to provide a therapy to the subject 30. The ultrasound transducers 210 may be used to produce a focused ultrasound signal within the subject 30. Such ultrasound treatments are known to one skilled in the art. Such ultrasound treatments may be provided for a plurality of reasons such as tumor ablation, nontumor tissue ablation, or other appropriate procedures.

[0059] While the US system 200 illustrated in Fig. 2 is exemplary positioned relative to the head of 30h of the subject 30, it is understood that the US system 200 may be oriented relative to any appropriate portion of the subject. For example, the substantially rigid member 204 may be shaped and configured to be positioned relative to an alternative portion of the subject such as a spinal column, leg bone, or the like. The rigid shell 204 may be any appropriate shape and be positioned relative to the appropriate portion of the subject and the ultrasound transducers 210 and the configurable member 224 may be positioned relative to the subject 30 to allow for the determination of the various distances and registration with the track device 58. As discussed herein, the compliant portion may allow for a maintained contact between the shell 204 and any appropriate portion of the subject 30.A0012143W001

[0060] In further or alternative embodiments, the US system 200 may allow for access, such as through a bore 260 through the US system 200. The bore 260 may allow for access through the device 200 to the subject 30. The bore 260 may be pre-formed in the device 200. In various embodiments, however, the bore 260 may be formed once the subject 30 is registered with the image 108. Thus, the US system 200 may be positioned on the patient 30 and the registration may occur to allow for a determination of a pose to form the bore 260. The bore may be formed at a position on the US system 200 to allow access to a selected portion of the subject 30, such as for insertion of a probe, ablation, or biopsy instrument, stimulator device (e.g. brain stimulation instrument), or other instruments. The bore 260 may be formed in any appropriate pose on the US system 200 to allow for access to a selected portion of the subject 30 and based upon the registration with the image 108.

[0061] According to various embodiments, the tracking device 58 may be integrated into the system 200. For example, the tracking device 58 may be formed with the rigid member 204, such as formed with the rigid member as a tracking device or portion 58a. The tracking device 58a, for example, may include one or more conductive coils that generate an EM field to allow for tracking of the rigid member 204 and, therefore, the system 200. The coil may be placed in a mold or in a bore formed in the rigid member 204. Additionally or alternatively, one or more reflective numbers, such as a reflective member 58b and 58c may be formed on or with the rigid member 204. For example, one or more reflective stickers may be placed on an exterior surface of the rigid member 204. It is understood that theA0012143W001 tracking device 58 need not be provided separately or attached separately to the system 200. The tracking device 58 may be formed integrally with at least the rigid member 204. Further, in various embodiments, one or more of the ultrasound transducers 210 may be provided as the tracking device 58, such as with a US tracking system and / or it may include a tracking member that may be tracked with one or more tracking system. Within an ultrasound tracking system, according to various embodiments, the US transducer or system may operate as an ultrasound measuring system rather than an imaging or sonogram system.

[0062] Various portions of the system 200 may allow for reduction or elimination of some error in registration. For example, the deformable member 224 may be deformed and held substantially fixedly against the subject 30. That being that the deformable member 224 may be placed in a configuration relative to the subject that will not change greater than a selected amount for a period of time, such as during a procedure. The amount of change may have a maximum that would induce an error (e.g., undetected or undesired error) into the navigation. Also, the skin 30s of the subject 30 would not generally move relative to the subject 30 and / or the system 200.

[0063] Further, the encapsulation of at least a portion of the head 30h of the subject 30 may assist in maintaining the pose of the US system 200, including the tracking device 58, relative to the subject 30. Once attached, the US system 200 may be held substantially fixed relative to the subject 30. Substantially fixed ensures that the US system 200 is held relative to the subject 30 with movement below a threshold to ensure maintaining a registration and / or allowing for aA0012143W001 generation of registration with the navigation system 26. Therefore, movement of the US system 200 may generally be less than about 1 mm in any direction after being positioned on the subject 30 for use. Thus, varying deformability or thickness of the skin may be accounted for by the substantially removable configuration of the US system 200 relative to the subject 30.

[0064] The distance, such as the distance 220, the distance 250, or any other appropriate distance relative to the ultrasound transducers 210 may be determined based upon generally known calculations for the transmission of ultrasound waves. Generally, the distance is determined as one half the velocity of the ultrasound wave multiplied by the travel time. Therefore, a calculation of the distance may be efficiently calculated with an appropriate processor system, such as the processor system 102. Known techniques for performing calculation may be performed.

[0065] A measurement of the thickness of a skull in one or more locations may also be made as a change in the speed of ultrasound from the skin to the bone and again from the bone to internal tissue, such as dura or brain matter, may be determined. The thickness of the skull at many different positions, such as at each of the ultrasound transducers 210 may, therefore, be determined. The determination may be made by an appropriate process, such as there should be two reflections which may be at different times that may be sensed or determined in the measured ultrasound voltage. Also, the speed of the US wave in the skull may be known or predetermined and / or recalled. Thus, to make the thickness determinations the two measured voltages may be first determined. The first timeA0012143W001 or reflection is when the US wave encounters the outer or external skull surface (t(out)). The second time or reflection is when the US wave encounters the interface between the skull and the cerebral spinal fluid (t(inner)). The thickness of the skull may then be determined from a formula where the time difference (i.e., t(inner)-t(out)) is multiplied by the velocity of the US wave in the skull divided by two.

[0066] By determining the thickness of the skull at many positions, such as at one or more of the ultrasound transducers 210, a map of thicknesses of the skull 30b may be determined. This map of thicknesses may assist in the registration, as discussed above and further herein by identifying many specific points of measured specific thickness. Similarly, may points of specific thickness may be determined in the image data acquired with alternative imaging modalities, such as CT or other imaging modalities, discussed above. The thicknesses at the many points may be used to assist in performing a registration, such as by matching and correlating measure points and points in the image with the same thickness. Additionally or alternatively, a geometry of a surface of the skull bone 30b may also be determined based upon the many distances calculated with the ultrasound transducers 210. The surface geometry or contour may also be used to match image data of the subject, as discussed above. These or other features or configurations of the bone 30b determined with the ultrasound system may be correlated to features of the image data for registration, as discussed herein. Accordingly, various mapping or measuring information may be used to allow for registration to the image 108.A0012143W001

[0067] In various embodiments, the US system 200 may be held or moved by the robotic system 20 or any appropriate robotic system. For example, as illustrated in Fig. 2 the end effector 44 of the robotic system may engage or be connected to the shell 204. The end effector 44 may be rigidly or removably rigidly connected to the shell 204. Thus, the robotic system20 may move the US system 200 in a selected manner. The movement of the US system 200 by the robotic system may be automatic, manual, or combinations thereof, as discussed herein. According to various embodiments, the robotic system 20 may move the US system 200 to ensure and / or maintain a selected registration or pose of the US system 200 relative to the subject 30, such as the subject head 30h. The movement may be based on the imaging of the US system 200 of the subject 30, tacking of the subject via the subject tracker 232, combinations thereof, or selected tracking of the subject 30.

[0068] A process 300 may be used to allow for registration of the subject 30, including a navigation space relative to the subject 30, to the image 108 and its image space. The process 300, as illustrated in Fig. 3, may assist in registering the image data for performing a procedure and may use the information acquired with the ultrasound transducers 210. Briefly, the registration may be substantially automatic. The automatic registration may include the collection of the distances, determination of a configuration of the subject (e.g., the mapping of a surface or other features of the subject 30), and the comparison or matching to the image 108 to perform the registration. It is understood that a selected system, such as a user 72 or the robotic system 20, may position the US system 200 on the subjectA0012143W00130. Nevertheless, the registration may occur substantially automatically without further user input once the US system 200 is positioned.

[0069] Further, the US system 200 may move relative to the subject and registration may be maintained and / or reregistered substantially automatically. The system 200 including the several ultrasound transducers 210 and the tracking device 58 may continuously determine information relative to the subject 30, such as the distances as discussed above. Therefore, if these distances change the determination of an orientation of the tracking device 58 relative to the subject 30 may be determined based upon updating the distances of one or more of the transducers 210 and allowing for a re-registration or an augmentation of the registration to the image 108. Therefore, even if movement of the system 200 occurred, registration may be automatically updated and / or reregistered. In other words, the US system 200 may be operated to provide the focused US signal based on a determined movement of the US system 200 relative to the subject 30. Additionally or alternatively, for example if the US system 200 is connected to the robotic system 20, the US system may be moved relative to the subject if the subject 30 and / or the US system 200 are determined to move relative to one another.

[0070] With continuing reference to Fig. 3, the process 300 may begin in start block 310. Starting in start block 310 can include initiating the process 300, such as the user 72 initiating use of the system, including the US system 200. A possible input may include positioning the subject in the US system 200 in block 314. As discussed above, this may include the user 72 positioning the subject 30A0012143W001 relative to the US system 200. Alternatively or additionally, the robotic system 20 may assist in positioning the US system 200 relative to the subject. It is understood, however, that the process 300 does not require the block 314, but the input may be understood to be performed relative to the subject 30 according to various embodiments.

[0071] The process 300 may include acquisition of the ultrasound data in block 320. Acquiring the ultrasound data in block 320 may include activating one or more of the US transducers 210 to acquire data relative to the subject 30 in the US system 200. For example, the various distances or signals related thereto, such as the distance 220 and the distance 250, may be acquired. The ultrasound distance may include additional or alternative information or data, such as the change of speed at different positions, the transmission and receipt of US signals at different US transducers 210 than emitted them, or other data. Regardless, the various ultrasound data may be acquired with one or more of the transducers 210, as discussed above. A signal related to the data may be transmitted from the US transducers to a selected system, such as the processor 102.

[0072] The data may then be used to evaluate the subject in block 324. Evaluation in block 324 may include measuring or determining (e.g., by execution of instructions with the processor 102) distances or points at various poses relative to the subject 30. For example, the two distances 220, 250 may be determined. Additionally or alternatively, as discussed above, thicknesses of the skull bone 30b may also be determined at different positions. The information may be used to mapA0012143W001 the subject or determine a configuration of the subject in the evaluation of the subject block 324.

[0073] As discussed above, the various distances may be used to generate a surface configuration or map of the subject 30. Additionally, the thickness of the skull bone 30b may be determined at the different positions to determine a subject configuration, such as generate a map of the subject 30. Regardless, the evaluation of the subject data in block 324 may allow for the determination and / or output of information regarding the subject 30 that may assist in the registration, as discussed further herein. The evaluation of the data may include the generation of one or more of the features, such as the map or the configuration outline as discussed above.

[0074] The process 300 may access or acquire subject image data in block 328. The image data may be acquired with any appropriate imaging system. The image data may be acquired prior to a procedure, such as preoperative planning images or image data and / or acquired during a procedure. For example, as illustrated in Fig. 1 , the imaging system 80 may be provided in the surgical theater to acquire image data of the subject. Therefore, images or image data may be acquired once a procedure is started, but prior to registration, such as with the US system 200. Further, as discussed above, the process 300 may be incorporated into an algorithm or instructions that are executed with the processor 102. Therefore, acquiring or accessing the subject data image data or images may include recalling them from memory or operating an imaging system to acquire the image data.A0012143W001

[0075] The acquired image data may be used to determine various parameters or features of the subject that may be compared to the evaluation of the subject in block 324. The features from the image data may be segmented from images. The segmented features may include anatomical structures, fiducial members, etc. For example, the skull bone may be segmented from the image. As another example, various brain structures may be segmented from the image. The segmentation may be performed with generally known techniques, such as edge detection and may be fully automatic, manual, or combinations thereof (e.g., a user identifies a seed portion).

[0076] Once the image data is acquired in the process 300, a correlation or registration between the accessed image data and the subject evaluation may be made in block 332. The correlation or registration may include image matching or feature matching and a correlation of the space determined with the US system 200 and the image data. For example, as discussed above, a surface contour of the skull bone 30b may be determined with the US system 200 by measuring the one or more distances. A contour of a surface of the subject may be determined by evaluation of the image or image data acquired or accessed in block 328. Therefore, the two surface contours may be overlaid on one another for a registration of the image data acquired in block 328 and the evaluation of the subject from block 324. Based upon the correlation (e.g., the overlay), a registration of the image or image data acquired in block 328 and the evaluation for block 324 may be made. Thus, the correlation or registration of block 332 may be similar to image registration save that the evaluation of the subject in block 324A0012143W001 and the US system data acquiring block 320 may not be image data, but rather may be data based upon and evaluation of a surface measured with the one or more ultrasound transducers 210 of the US system 200. In various embodiments, registration may also and / or alternatively include a mutual information based algorithm or process where a measurement of how much information one image contains about another. In the image registration, a mutual information based process may find correspondences between different modalities, such as magnetic resonance imaging (MRI) and computed tomography (CT). The process assume that mutual information is maximized when the images are correctly aligned.

[0077] The system 300 may also determine, recall, or access a pose of the tracking device 58 on the US system in block 336. As discussed above, the geometry of the tracking device 58 relative to the one or more US transducers 210 may be measured or determined, such as with tracking a probe, predetermined based upon a configuration of the US system 200, or other appropriate means. The geometry may include the various geometric configurations of the US system 200 relative to the tracking device 58, such as the angles 240, 244. The geometry or pose of the tracking device 58 of the US system 200 may be recalled or accessed in block 336. The tracking device 58 may also be tracked in block 340. As the tracking device 58 may be tracked with any appropriate tracking system in the navigation system 26, as discussed above, the pose of the tracking device 58 on the US system 200 may be recalled or determined in block 340.A0012143W001

[0078] Based upon the correlation or registration of block 332, the recalled geometry or pose of the tracking device of the US system of block 336, and the recalled or accessed tracked pose of the tracking device 58 of block 340, a registration of the subject or navigation space to the image space may be made in block 350. The tracking device 58 may be tracked in the subject or navigation space, as discussed above. The known geometry or pose of the tracking device 58 relative to the US system 200 that is acquiring the data regarding the subject 30 may allow for the correlation of the pose of the tracking device relative to the US system 200 and the data collected therewith. Therefore, the navigation space may be registered to the image space with the US system 200 and the related tracking device 58.

[0079] The registration of the image space to the navigation or subject space may allow for navigation of other tracked instruments relative to the subject 30. The tracking device 58 may be used to register the subject to the image data, thus the displayed image 108 may be registered to the subject or navigation space. Other tracked instruments may be tracked in the navigation system and their pose may be displayed relative to the image 108, such as with the graphical representation 68i superimposed on the image 108. The tracking device 58 of the US system 200 allows for the registration of the image data to the navigation space.

[0080] The US system 200 may generally be maintained on the subject 30, as discussed above. However, the process 300 may have an optional process or subroutine 354 to determine if motion has occurred or when motion does occur.A0012143W001The process 300 may determine whether the tracking device is moved in block 358. According to various embodiments, the US system 200 may substantially continuously monitor the data between the US transducers 210 and the subject 30. Therefore, a change in distance or change in the determined configuration of the subject 30 may provide indication that the US system 200 has moved relative to the subject. Further, a tracked movement of the tracking device 58 may also be used to determine that the device has moved. If any movement or change in configuration is determined, a YES path 362 may be followed to loop or iterate the registration process 300. Accordingly, the YES path 362 may allow for the collection and determination of various data, as discussed above. This may allow for the registration in block 350 to be performed again, substantially automatically without intervention, based upon a determination of a change in configuration or tracked pose of the tracking device 58. Thus, the process 300 may allow for a maintaining of the registration and / or for reregistration substantially automatically without input from the user 72. The system may, however, provide an indication that the YES path 362 is performed to provide an indication or warning to the user 72, such as on the display 84.

[0081] The iterative path discussed above, after determining that the tracking device has moved and following the YES path 362, may include a selected alternative path including a sub-process 370 illustrated in Fig. 4. The sub-process 370 may be performed either with or prior to returning to block 320, as illustrated in Fig. 3. Alternatively, the sub-process 370 may be performed and then followed directly again to the determination block of whether the tracking device is movedA0012143W001 in block 358. Thus, the process 300 may include an alternative process after determination of movement of the tracking device that may affect the treatment of the subject.

[0082] With continuing reference to Fig. 3 and additional reference to Fig. 4, the sub-process 370 may allow or direct movement of the US system 200 with the robotic system 20. The robotic system 20 may move the US system 200 relative to the subject 30 to assist in maintaining the US system 200 relative to the subject 30 in a selected manner, such as a focused pose of the US system relative to the subject 30. The focused pose may be the pose that is providing a focused ultrasound treatment to the subject. Thus, the sub-process 370 may include a recall of a pose of treatment in block 374. The pose of the treatment may be a determined pose relative to the subject 30 for treatment, such as for a focused ultrasound treatment from the US system 200. The recalled pose may be a specific pose within the subject 30 for the treatment. The pose within the subject may be determined relative to the subject tracking device, such as the tracking device 232. The pose of treatment may be the position within the subject for treatment and / or may include a pose of the US system 200 to provide the treatment to the position within the subject.

[0083] In block 378 a recall of the current focused pose of the US system may be determined, which may be determined relative to the recalled pose of treatment. The focused pose of the US system may be determined based upon tracking the US system 200 with the tracking device 58, a known determination based upon a movement of the robotic system 20 holding the US system 200, orA0012143W001 other appropriate mechanisms. The current focused pose may be the current or real time focused point relative to the US system 200 that is the region or volume of the focused ultrasound production.

[0084] The robotic system 20 may then move the US system 200 to align the focused pose to the treatment pose in block 380. The movement of the US system may be based upon the determined movement of the tracking device in block 358. Further, the robotic system 20 may move the US system in any appropriate manner to achieve the realignment of the focus pose to the treatment pose. The movement of the robotic system may be substantially automatic based upon the determined difference of the focused pose and the treatment pose. The robotic system 20 may move the US system 200 to achieve the alignment. The movement may be based on provided specific movement instructions or a pose for the treatment based on the recalled treatment pose and the robotic system 20 may control movement of the robotic system 20 to achieve the pose with the US system 200 by its included control scheme.

[0085] Thus, the process 300 may ensure a maintaining of a pose of treatment, which may also be referred to as the treatment focus pose, relative to the subject 30. The process 300 may include the various portions as illustrated in Fig. 3 and / or the sub-process 370 illustrated in Fig. 4.

[0086] If no change is determined to have occurred, a NO path 390 may be followed and the process may end in block394. The process 300, therefore, may also determine that a change has not occurred and a reregistration is not required.A0012143W001

[0087] The ending of the process in block 394may be understood to include various procedures such as performing a procedure on the subject 30, or the like after the registration has occurred. Accordingly, it is understood that ending the process 300 in block 394does not mean a complete cessation of any actions. Further, it is understood that ending the process of block 394may allow the user 72 to reinitiate the process 300 at an appropriate time.

[0088] Thus, the US system 200 may allow for a registration of the subject space or navigation space to the image space in an appropriate manner. The US system 200 may acquire data with one or more US transducers 210 to allow for a determination of the configuration of the subject 30. Based thereon, a correlation or registration may be made of the subject or navigation space to an image space to allow for navigating instruments relative to an image, as discussed above. The process 300 may be substantially automatic and be included in the instructions or algorithm that may be executed by the processor 102 or any other appropriate processing system. The instructions for the process 300 may be stored in an appropriate memory, such as the memory 103, and recall that an appropriate time such as by access or initiation by the user 72.

[0089] The techniques of this disclosure may also be described in the following examples:

[0090] Example 1 - A system for navigating a procedure, comprising: a navigation system having a tracking system; an ultrasound system comprising an ultrasound transducer, a rigid shell, and a tracking device; wherein the tracking system is configured to track the tracking device; wherein the tracking device isA0012143W001 fixed relative to the ultrasound transducer; wherein the tracking system is configured to track the tracking device in a navigation space; wherein the ultrasound transducer is configured to generate a position signal based on a reflected ultrasound signal from a subject; a processor system configured to execute instructions to: receive the position signal, determine a configuration of the subject, register the configuration of the subject to an image of the subject, output the registration as an image registration.

[0091] Example 2 - The system of Example 1 , wherein the processor system is configured to execute further instructions to: correlate the configuration of the subject to a pose of the tracking device; and register the image registration to the navigation space.

[0092] Example 3 - The system of Example 2, wherein the configuration of the subject is based on the position signal that includes a distance of the ultrasound transducer from the subject.

[0093] Example 4 - The system of Example 2, further comprising: an instrument; an instrument tracking device; and a display device configured to display the image; wherein a pose of the instrument is operable to be determined by tracking the tracking device with the tracking system in the navigation space; wherein a graphical illustration of the instrument is operable to be displayed superimposed on the image with the display device.

[0094] Example 5 - The system of Example 1 , wherein the ultrasound transducer comprises a plurality of ultrasound transducers; wherein eachA0012143W001 transducer of the plurality of ultrasound transducers is at an individual fixed positioned relative to the rigid shell.

[0095] Example 6 - The system of Example 5, wherein the ultrasound system further comprises a subject contacting member; wherein the subject contacting member is configured to maintain the plurality of the ultrasound transducers at a fixed pose relative to the subject.

[0096] Example 7 - The system of Example 6, wherein the subject contacting member includes a medium having a speed to of transmission of ultrasound waves therein equal to that of at least a portion of the subject.

[0097] Example 8 - The system of Example 5, wherein the processor system configured to execute instructions to determine the configuration of the subject includes determining an external surface contour of a portion of the subject based on the position signal from at least a sub-plurality of the ultrasound transducers of the plurality of ultrasound transducers.

[0098] Example 9 - The system of Example 8, wherein the processor system is configured to execute further instructions to determine an image surface contour; wherein register the configuration of the subject to the image of the subject includes correlating the determined external surface contour of a portion of the subject and the determined image surface contour.

[0099] Example 10 - The system of Example 1 , wherein the ultrasound system further comprises a subject contacting member; wherein the subject contacting member is configured to maintain the ultrasound transducer at a fixed pose relative to the subject.A0012143W001

[0100] Example 11 - The system of Example 10, wherein the ultrasound system is configured to engage a head of the subject that is a human.

[0101] Example 12 - The system of Example 1 , wherein the ultrasound system further comprises a subject holding member configured to engage the subject to maintain the ultrasound system in a pose relative to the subject.

[0102] Example 13 - A method for navigating a procedure, comprising: providing an ultrasound system comprising an ultrasound transducer, a rigid shell, and a tracking device; providing the tracking device fixed relative to the ultrasound transducer; tracking the tracking device with a tracking system in a navigation space; generating a position signal based on a reflected ultrasound signal from a subject to the ultrasound transducer; operating a processor system to execute instructions to: receive the position signal, determine a configuration of the subject, register the configuration of the subject to an image of the subject, output the registration as an image registration.

[0103] Example 14 - The method of Example 13, further comprising: operating the processor system to execute further instructions to: correlate the configuration of the subject to a pose of the tracking device; and register the image registration to the navigation space.

[0104] Example 15 - The method of Example 14, further comprising: tracking an instrument tracking device associated with an instrument; displaying the image with a display device; determining a pose of the instrument by the tracking of the tracking device with the tracking system; displaying a graphical illustration of the instrument superimposed on the image with the display device.A0012143W001

[0105] Example 16 - The method of Example 13, further comprising: providing the ultrasound transducer as a plurality of ultrasound transducers; providing each transducer of the plurality of ultrasound transducers at a fixed position relative to the rigid shell.

[0106] Example 17 - The method of Example 16, further comprising: providing the ultrasound system with a subject contacting member; maintain the plurality of the ultrasound transducers at a fixed pose relative to the subject with the subject contacting member.

[0107] Example 18 - The method of Example 17, further comprising: providing the subject contacting member with a medium having a speed to transmission of ultrasound waves therein equal to that of at least a portion of the subject.

[0108] Example 19 - The method of Example 16, further comprising: operating the processor system to execute instructions to determine the configuration of the subject including to determine an external surface contour of a portion of the subject based on the position signal from at least a sub-plurality of the ultrasound transducers of the plurality of ultrasound transducers.

[0109] Example 20 - The method of Example 19, further comprising: operating the processor system to execute instructions to determine an image surface contour; wherein the register the configuration of the subject to the image of the subject includes correlating the determined external surface contour of a portion of the subject and the determined image surface contour.A0012143W001

[0110] Example embodiments are provided so that this disclosure will be thorough and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0111] Instructions may be executed by a processor and may include software, firmware, and / or microcode, and may refer to programs, routines, functions, classes, data structures, and / or objects. The term shared processor circuit encompasses a single processor circuit that executes some or all code from multiple modules. The term group processor circuit encompasses a processor circuit that, in combination with additional processor circuits, executes some or all code from one or more modules. References to multiple processor circuits encompass multiple processor circuits on discrete dies, multiple processor circuits on a single die, multiple cores of a single processor circuit, multiple threads of a single processor circuit, or a combination of the above. The term shared memory circuit encompasses a single memory circuit that stores some or all code from multiple modules. The term group memory circuit encompasses a memory circuit that, in combination with additional memories, stores some or all code from one or more modules.A0012143W001

[0112] The apparatuses and methods described in this application may be partially or fully implemented by a processor (also referred to as a processor module) that may include a special purpose computer (i.e. , created by configuring a processor) and / or a general purpose computer to execute one or more particular functions embodied in computer programs. The computer programs include processor-executable instructions that are stored on at least one non-transitory, tangible computer-readable medium. The computer programs may also include or rely on stored data. The computer programs may include a basic input / output system (BIOS) that interacts with hardware of the special purpose computer, device drivers that interact with particular devices of the special purpose computer, one or more operating systems, user applications, background services and applications, etc.

[0113] The computer programs may include: (i) assembly code; (ii) object code generated from source code by a compiler; (iii) source code for execution by an interpreter; (iv) source code for compilation and execution by a just-in-time compiler, (v) descriptive text for parsing, such as HTML (hypertext markup language) or XML (extensible markup language), etc. As examples only, source code may be written in C, C++, C#, Objective-C, Haskell, Go, SQL, Lisp, Java®, ASP, Perl, Javascript®, HTML5, Ada, ASP (active server pages), Perl, Scala, Erlang, Ruby, Flash®, Visual Basic®, Lua, or Python®.

[0114] Communications may include wireless communications described in the present disclosure can be conducted in full or partial compliance with IEEE standard 802.11 -2012, IEEE standard 802.16-2009, and / or IEEE standard 802.20-A0012143W0012008. In various implementations, IEEE 802.11 -2012 may be supplemented by draft IEEE standard 802.11ac, draft IEEE standard 802.11 ad, and / or draft IEEE standard 802.11 ah.

[0115] A processor, processor module, module or ‘controller’ may be used interchangeably herein (unless specifically noted otherwise) and each may be replaced with the term ‘circuit.’ Any of these terms may refer to, be part of, or include: an Application Specific Integrated Circuit (ASIC); a digital, analog, or mixed analog / digital discrete circuit; a digital, analog, or mixed analog / digital integrated circuit; a combinational logic circuit; a field programmable gate array (FPGA); a processor circuit (shared, dedicated, or group) that executes code; a memory circuit (shared, dedicated, or group) that stores code executed by the processor circuit; other suitable hardware components that provide the described functionality; or a combination of some or all of the above, such as in a system-on- chip.

[0116] Instructions may be executed by one or more processors or processor modules, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” or “processor module” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements. The processor or processors may operate entirely automatically and / or substantiallyA0012143W001 automatically. In automatic operation the processor may execute instructions based on received input and execute instructions in light thereof. Thus, various outputs may be made without further or any manual (e.g., user) input.

[0117] The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the invention, and all such modifications are intended to be included within the scope of the invention.

Claims

A0012143W001CLAIMSWhat is claimed is:1 . A system for navigating a procedure, comprising: a navigation system having a tracking system; an ultrasound system comprising an ultrasound transducer, a rigid shell, and a tracking device; wherein the tracking system is configured to track the tracking device; wherein the tracking device is fixed relative to the ultrasound transducer; wherein the tracking system is configured to track the tracking device in a navigation space; wherein the ultrasound transducer is configured to generate a position signal based on a reflected ultrasound signal from a subject; a processor system configured to execute instructions to: receive the position signal, determine a configuration of the subject, register the configuration of the subject to an image of the subject, output the registration as an image registration.

2. The system of Claim 1 , wherein the processor system is configured to execute further instructions to: correlate the configuration of the subject to a pose of the tracking device; and register the image registration to the navigation space.

3. The system of any preceding Claim, wherein the configuration of the subject is based on the position signal that includes a distance of the ultrasound transducer from the subject.

4. The system of any preceding Claim, further comprising:A0012143W001 an instrument; an instrument tracking device; and a display device configured to display the image; wherein a pose of the instrument is operable to be determined by tracking the tracking device with the tracking system in the navigation space; wherein a graphical illustration of the instrument is operable to be displayed superimposed on the image with the display device.

5. The system of any preceding Claim, wherein the ultrasound transducer comprises a plurality of ultrasound transducers;wherein each transducer of the plurality of ultrasound transducers is at an individual fixed positioned relative to the rigid shell.

6. The system of Claim 5, wherein the ultrasound system further comprises a subject contacting member; wherein the subject contacting member is configured to maintain the plurality of the ultrasound transducers at a fixed pose relative to the subject.

7. The system of Claim 5, wherein the processor system configured to execute instructions to determine the configuration of the subject includes determining an external surface contour of a portion of the subject based on the position signal from at least a sub-plurality of the ultrasound transducers of the plurality of ultrasound transducers.

8. The system of Claim 7, wherein the processor system is configured to execute further instructions to determine an image surface contour; wherein register the configuration of the subject to the image of the subject includes correlating the determined external surface contour of a portion of the subject and the determined image surface contour.A0012143W0019. The system of Claim 1 wherein the ultrasound system further comprises a subject contacting member; wherein the subject contacting member is configured to maintain the ultrasound transducer at a fixed pose relative to the subject.

10. A method for navigating a procedure, comprising: providing an ultrasound system comprising an ultrasound transducer, a rigid shell, and a tracking device providing the tracking device fixed relative to the ultrasound transducer; tracking the tracking device with a tracking system in a navigation space; generating a position signal based on a reflected ultrasound signal from a subject to the ultrasound transducer; operating a processor system to execute instructions to: receive the position signal, determine a configuration of the subject, register the configuration of the subject to an image of the subject, output the registration as an image registration.

11. The method of Claim 13, further comprising: operating the processor system to execute further instructions to: correlate the configuration of the subject to a pose of the tracking device; and register the image registration to the navigation space.

12. The method of Claim 13, further comprising: providing the ultrasound transducer as a plurality of ultrasound transducers; providing each transducer of the plurality of ultrasound transducers at a fixed position relative to the rigid shell.

13. The method of Claim 12, further comprising: providing the ultrasound system with a subject contacting member; maintain the plurality of the ultrasound transducers at a fixed pose relative to the subject with the subject contacting member.A0012143W00114. The method of Claim 12, further comprising: operating the processor system to execute instructions to determine the configuration of the subject including to determine an external surface contour of a portion of the subject based on the position signal from at least a sub-plurality of the ultrasound transducers of the plurality of ultrasound transducers.

15. The method of Claim 14, further comprising: operating the processor system to execute instructions to determine an image surface contour; wherein the register the configuration of the subject to the image of the subject includes correlating the determined external surface contour of a portion of the subject and the determined image surface contour.

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