WO2026053212A1 - System and method for providing a guide - Google Patents

Abstract

A guidance unit is disclosed. The guidance unit may be used to assist in guiding an instrument during a procedure. The guidance unit may be formed or positioned with a robotic system.

Description

A001 1290W001

SYSTEM AND METHOD FOR PROVIDING A GUIDE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/691 ,050, filed 5 September 2024, the entire content of which is incorporated herein by reference.

FIELD

[0002] The subject disclosure is related to a guide system, and particularly a custom guide generation system.

BACKGROUND

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

[0004] For various procedures a target may be selected for the procedure. The target may be reached by moving an instrument along a trajectory. The trajectory may be selected for various purposes, such as avoiding structures or intersecting structures. The trajectory along which the instrument will pass may be achieved by holding the instrument, for example by a user.

SUMMARY

[0005] This section provides a general summary of the disclosure and is not a comprehensive disclosure of its full scope or all its features.

[0006] A procedure may include a surgical procedure. The surgical procedure may be performed on a selected subject, such as a human subject or another subject. A subject A001 1290W001 may be a non-human subject, such as an animal. Further, a procedure may be performed on a non-living subject, such as an interior of a machine or system, including an airframe, automobile, or other system.

[0007] For a procedure, a target may be selected. The target may be any appropriate portion within the subject on which a procedure made to performed. For example, the target may include a portion to be resected, a region for an implant, or position for other appropriate procedure actions. The target may be reached with a selected trajectory. The selected trajectory may be determined based upon various information obtained regarding the subject prior to the procedure. For example, image data may be selected or acquired of the subject to assist in determining a trajectory. Thus, a procedure may be planned prior to performing actions on the subject during a procedure.

[0008] Image data may be acquired of the subject. The image data may be used to determine a target, determine an entry region, determine a trajectory, and other portions of the procedure or features of the subject. The trajectory may include a path from an entry point to the target. The selection of these portions may be automatic, manual, or combinations thereof. According to various embodiments the trajectory may be selected after the entry region and the target have been selected. The trajectory may be determined substantially automatically with the execution of instructions by a processor and without further user intervention. The trajectory may be a straight line from the entry point to the target or include other geometries based upon other determined features such as structures to be avoided or structures to be intersected.

[0009] Once a trajectory is determined, a guide unit may be generated or formed to match the trajectory. For example, a system may be used to form a trajectory guide bore through a solid or semi-solid structure. As discussed herein a mass may have a guide A001 1290W001 bore formed therethrough. The guide unit may also or alternatively include a mechanical system that is adjusted to achieve a guide structure or shape to achieve the trajectory.

[0010] The trajectory in the guide system or unit may be formed with a robotic system. The robotic system may have a guide forming member that may be positioned at the selected trajectory. The robotic system may have an origin and a movable portion, such as an end effector. The end effector may move the guide forming member relative to a selected portion, such as the guide unit to allow the guide unit to be adjusted or formed.

[0011] Thus, a planning phase may be used to determine a trajectory. The trajectory may then be formed separate from the subject. The trajectory may be formed in a guide unit by a robotic system. The robotic system may operate substantially automatically, without user intervention, based on the determined trajectory.

[0012] Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

DRAWINGS

[0013] 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.

[0014] Fig. 1 is an environmental view of a procedure theater;

[0015] Fig. 2 is a flow chart of a process for forming a guidance system; A001 1290W001

[0016] Fig 3 is an exemplary screenshot of a first image based upon first image data;

[0017] Fig. 4 is a detail environmental view of a base affixed to a subject;

[0018] Fig. 5 is an exemplary screenshot of a displayed second image based upon second image data;

[0019] Fig. 6 is an exemplary screenshot of a display of a fused image;

[0020] Fig. 7 is an exemplary view of a robotic system and a guidance unit, according to various embodiments;

[0021] Fig. 7A is an exemplary view of a guidance unit, according to various embodiments;

[0022] Fig. 8 is an exemplary view of the robotic system and the guidance unit forming configuration, according to various embodiments;

[0023] Fig. 9 is an environmental view of the guidance unit affixed to a subject, according to various embodiments;

[0024] Fig. 10 is an exemplary view of a guidance unit, according to various embodiments;

[0025] Fig. 10A is a detail view of a portion of Fig. 10, according to various embodiments;

[0026] Fig. 1 1 is an exemplary view of a robotic system and the guidance unit, according to various embodiments; and

[0027] Fig. 12 is an environmental illustration of the guidance unit affixed to a subject, according to various embodiments.

[0028] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. A001 1290W001

DETAILED DESCRIPTION

[0029] Example embodiments will now be described more fully with reference to the accompanying drawings.

[0030] FIG. 1 is a diagram illustrating an overview of a procedure theater that may include an operating theater and include various systems and assemblies. An imaging system 20 may be used to acquire image data at a selected time. Further, the theater may be used for various procedures, such as positioning of an instrument, implant, or delivery system, etc. The imaging system may be used to image a subject 24 and/or other portions. One skilled will understand that during a procedure a navigation system may be used to track one or more portions, such as the imaging system 20, the subject 24, etc. to assist in placement and positioning of various members relative to one another, such as the imaging system relative to the subject 24. Imaging and navigation systems may include those disclosed in U.S. Pat. No. 1 1 ,344,268, incorporated herein by reference. According to various embodiments, no imaging system is present or used during a procedure. As discussed herein, various procedures may use a pre-taken imaging. For example, a magnetic resonance image may be acquired for planning and it may be merged with a computed tomography image taken prior to a procedure with a subject fixation (e.g., when head fixation is already mounted (as a separate process can be done even a day prior to surgery)).

[0031] In various embodiments, however, an external or separate navigation system is not used or necessary to assist in guiding and moving an instrument relative to the subject. For example, a guidance unit 30 (shown schematically in Fig. 1 ) may be positioned relative to the subject to guide and/or assist in guiding an instrument 34 relative to the subject 24. The instrument 34 may have an end effector or working end 38 that may A001 1290W001 be used to perform at least a portion of a procedure on the subject 24. A user 42 may assist in moving or holding the instrument 34, as discussed herein. If selected the navigation system may include one or more of a STEALTHSTATION® AXIEM™, STEALTHSTATION® TRIA®, TREON®, and/or S7™ Navigation Systems, sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colorado. Exemplary navigation or tracking systems are also disclosed in U.S. Pat. No. 7,751 ,865, issued July 6, 2010; U.S. Patent No. 5,913,820, issued June 22, 1999; and U.S. Patent No. 5,592,939, issued January 14, 1997; U.S. Patent No. 7,797,032, issued September 14, 2010 and U.S. Pat. No. 6,747,539, issued June 8, 2004; U.S. Pat. No. 6,474,341 , issued November 5, 2002; U.S. Pat. No. 5,983,126, issued November 9, 1999; U.S. Pat. App. No. 10/649,214, filed on January 9, 2004, published as U.S. Pat. App. Pub. No. 2004/0116803, all of which are incorporated herein by reference. Related to the navigation systems, exemplary registration techniques are disclosed in U.S. Pat. No. 9,737,235, issued August 22, 2017, incorporated herein by reference.

[0032] In the example shown, the imaging system 20 comprises or may include portions of an O-arm® imaging system or device sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colorado, USA. In various embodiments, the imaging system 20 may have a gantry housing 44 that encloses an image data capturing portion 46. The gantry 44 may include a first portion 48 (which may include a generally fixed portion) and a second portion 50 (which may include a moveable portion relative to the first portion 48). The image capturing portion 46 may include an x-ray source or emission portion 52 and an x-ray receiving or image receiving portion (also referred to as a detector that may be operable to detect x-rays) 54 located generally or as practically possible 180 degrees from each other and mounted on a moveable rotor (not illustrated) relative to a A001 1290W001 track 56 of the image capturing portion 46. The image capturing portion 46 can be operable to rotate 360 degrees around the gantry 44 on or with the rotor during image data acquisition. The imaging capturing portion may rotate within the gantry 44 while being enclosed by the gantry 44.

[0033] The image capturing portion 46 may rotate around a central point or axis 24a, allowing image data of the patient 24 to be acquired from multiple directions or in multiple planes. The axis 24a of the imaging system 20 may be aligned or positioned relative to an axis, such as a longitudinal axis, of the patient 24. The imaging system 20 can include all or portions of the systems and methods 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. Other possible imaging systems can include C-arm fluoroscopic imaging systems which can also generate three-dimensional views of the patient 24.

[0034] The position of the image capturing portion 46 can be precisely known relative to any other portion of the imaging device 20. In addition, as discussed herein, the precise knowledge of the position of the image capturing portion 46 can be used in conjunction with the guidance unit 30 and/or a mounting portion therefore to assist in ensuring a selected trajectory relative to the subject 24.

[0035] The imaging system 20 can include a support system including a housing or cart 60. The imaging system 20 can include a separate image processing unit 64 that can be housed in the cart 60. Other processing units or modules may include a processing unit 68. The processing unit 68 may access or be in communication with a memory 72 that is a local or network accessed memory. The processing unit 68 can receive information, including image data, from the imaging system 20 and/or other data such as trajectory data or the like. As discussed herein, the processing unit 68 may communicate A001 1290W001 with a robotic assembly or other appropriate portion. Image data can be displayed as an image 76 on a display device 78 of a workstation or other computer system 80. The system 80 can include appropriate input devices, such as a keyboard 82. It will be understood that other appropriate input devices can be included, such as a mouse, a foot pedal or the like.

[0036] The image processing unit 64 may be configured, if provided, to process image data from the imaging system 20 and transmit the image data to the processor 68. It will be further understood, however, that the imaging system 20 need not perform any image processing and the image processing unit 60 can transmit the image data directly to the processing unit 68. The one or more systems discussed herein may include or operate with a single or multiple processing centers or units that can access single or multiple memory systems based upon system design. It is understood, however, that all of the processing units discussed herein may be generally processors that are executing instructions recalled form a selected memory, have onboard memory, or be application specific processors. Further, each of the processors may be provided or configured to perform all processing tasks discussed herein. Thus, although a specific process may be discussed as an imaging process, the navigation processing unit 110 may also be configured to perform the process.

[0037] The imaging system 20, as discussed herein, may move relative to the subject 24. The subject 24may be fixed to an operating table or support table 84, but is not required to be fixed to the table 84. The table 84 can include a plurality of straps 88. The straps 88 can be secured around the subject 24to fix the subject 24 relative to the table 84. Various additional or alternative apparatuses may be used to position the subject 24 in a static position on the operating table 84. Examples of such patient positioning A001 1290W001 devices are set forth in U.S. Pat. App. Pub. No. 2004/0199072, published October 7, 2004, (U.S. Pat. App. No. 10/405,068 entitled “An Integrated Electromagnetic Navigation And Patient Positioning Device”, filed April 1 , 2003), which is hereby incorporated by reference. Other known apparatuses may include a Mayfield® clamp.

[0038] Also, the position of the subject 24 relative to the imaging system 20 can be determined by the navigation system and/or precise positioning of the imaging portion 20 is further described 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.

[0039] As discussed further herein, the subject 24 may have the procedure performed thereon. As an example, the procedure may be performed on a cranial region or portion of the subject 24, such as relative to a skull or cranial portion 24c. The guidance unit 30 may be connected to the cranial portion 24c of the subject 24. In so doing, the procedure may be assisted by the guidance unit as it is executed on the subject 24. In various embodiments, therefore, the subject 24 may be prepared for the procedure via a process 100, as illustrated in Fig. 2.

[0040] The process 100 may include an initial planning phase or step in block 104. During the planning in block 104 various steps or portions may occur in any particular manner or order. For example, imaging may be performed and/or image data may be acquired of the subject 24. The imaging may be any appropriate imaging, such as magnetic resonance imaging (MRI), x-ray images, computed tomography (CT), or other appropriate imaging. Generally the imaging may be acquired to the subject to allow for performing various analysis of the subject, such as via an image analysis. Image analysis may allow for determination of the various features relative to the subject 24. For example, with continuing reference to Fig. 2 and additional reference to Fig. 3, the image data A001 1290W001 acquired may be used to generate various images that may be displayed on a selected display, such as the display 78. It is understood that the display may be any appropriate display, however.

[0041] The images displayed may include various features of the subject, such as the cranial region 24c. The images may include images of a brain 106 of the subject 24. The brain 106 may include various structures that may be identified with the image analysis. Structures may include ventricles 108, cerebellum 112, and other portions.

[0042] The images displayed with the display device may be used to identify one or more targets, such as a target 120. The target 120 may be a target for a portion of the procedure, such as a biopsy, implant, location, or the like. Thus, the target 120 may be identified (e.g., determined) or selected for any appropriate purpose.

[0043] The image data may be used to identify an entry region 124. The entry region 124 may be defined relative to portions of the image, such as within a circle, between two axes or lines 124i and 124ii, or other appropriate portion. The entry region 124 may be used to define or select where an entry for an instrument may be made to obtain access to the target 120.

[0044] Between the entry region 124 and the target 120 may be identified (e.g., determined) or selected a trajectory 130. The trajectory 130 may be a path for the instrument 34 to move from the entry region 124 to the target 120. The instrument 34 may be any appropriate instrument such as an implantation assembly, an implant, a biopsy instrument, or any other appropriate instrument that may be used for the procedure. It is understood that various procedures may be performed on the subject 24 which do not include a brain or cranium procedure, therefore the instrument may include a bone saw, spinal implant, or the like. Nevertheless, the trajectory 130 may be identified (e.g., A001 1290W001 determined) or selected to allow or be a path for the instrument between the entry region 124 and the target 120. In various embodiments, the trajectory 130 may be a path that the instrument 34 may traverse during the procedure.

[0045] The trajectory 130 may be selected based upon various inputs, such as identification of features in the images, selected by the user 42, or other appropriate parameters. For example, the processor system, such as the imaging processor 64, may automatically, with no user input, identify structures in the images such as based upon prior models, edge detection of the various structures, shape analysis, or the like. Additionally or alternatively, the user 42 may identify various seed points and the imaging processor 64 may use various region growing techniques to identify or define edges of selected structures. These structures may be used to identify or be made “go” or “no go” regions. Thus, the trajectory 130 may be selected to enter within the entry region 124 and reach the target without passing through or near any of the “no go” region and/or specifically passing through only “go” regions. The trajectory 130 may be a path that may be followed by the instrument between the entry region 124 and the target 120. The trajectory 130 may be a straight path or may have a non-straight geometry, such as a parabola, serpentine, or the like trajectory.

[0046] Once the trajectory is determined in the planning step 104, a base 152 generation and mounting step may occur in block 140. The base mounting in step 140 may include mounting a base or holder to the subject 24, such as to the cranium 24c. The base 152 may be a fixture that is fixed to the cranium in a selected region such as at or near or at a selected pose relative to the entry point 124. The base 152 may also be fixed to the cranium at a position near or adjacent to the entry region 124 such that the guidance unit 30 may allow guiding of the instrument into the entry region 124 while being guided A001 1290W001 by the guidance unit 30. The guidance unit 30 may be positioned away from the basel 52, but fixed to the subject 24 at a distance from the entry region 124. The base may form a portion of a system including the guidance unit 30. The guidance unit 30 may be later used to fixed to the subject 24 via the base 152 to assist in guiding the instrument through the entry region 124 to the target 130.

[0047] The base mounting in block 140 may also be initially planned in the planning step 104. For example, a base position 144 may be determined in the planning step 104. The base position 144 may be illustrated on the image, as illustrated in Fig 3. Thus, the planning may also plan the base position 144 at which the based is to be fixed to the subject. Thus, the position of the base mounted to the subject, the entry portion 124, the target 120, and the trajectory 130 may all be planned relative to the image data in the images, as displayed on the display 78. The mounting of the base in block 140, therefore, may be made at the mounted position in block 144.

[0048] The base 152 may also include various fiducial features or imageable portions, such as one or more fiducial points or elements 148 that may be formed with the base 152, as illustrated in Fig. 4. The fiducial elements 148 may allow for an image to be acquired of the subject 24 with the base 152 mounted thereto after step 140. The pose of the base 152 may be determined and/or known for further processes as discussed herein. The fiducials may be removed following an image acquisition and/or registration between the subject and the image. The process 100, therefore, may allow for image data acquisition of these subject 24 with the base 152 mounted to the subject 24. Image data may be acquired of the subject 24 in a manner similar to image data acquired for the planning block 104. Accordingly image data may include MRI image data, CT image data, or any appropriate image data. The image data may include the fiducials included in the A001 1290W001 base 152. The image data acquired of eh subject 24 with the base 152 may be acquired subsequent to the image data acquired for the planning. It is understood, however, that the image data with the base 152 and the planning image data may be the same image data.

[0049] An image-to-image registration or fusion between the image acquired in block 160 and the image data acquired in block 104. The image to image registration may include a fusion step or process in block 164. As discussed above, the fusion may be of images that are acquired with the same or different portions. For example, a CT image and a MR image may be fused and both may include the base 152. Herein, unless specifically indicated otherwise, fusion and image-to-image registration refer to the same process and/or fused image.

[0050] The fusion or registration of two images or image data allow for the correlation of features in one image to the other. Features may also be used to correlate or fuse the images. For example, if the base 152 is present in both images the imageable portions may be used for fusion. In various embodiments, the base may not be on both images as one (typically MRI) may serve for planning purposes from which the system will derive the guidance positioning for the base to be attached to the subject 30 and not include the base 152. Other features may also be used, such as anatomical features of the subjects 24, including the structure or shape of the cranium 24c, anatomical features such as the cheekbone shapes, forehead shape, eye socket geometry or position, or the like. The registration may include image to image registration such as that disclosed in US patent application publication 2001/0036302 published in November 1 , 2001 , US patent application 8,504,139, both included by reference herein. A001 1290W001

[0051] The image-to-image registration or image fusion allows for features (e.g., structures, identified portions, parameters related thereto, etc.) in one image to be registered or located in the second image. For example, due to the image fusion in block 164 a target identified in the first image, such as displayed on the display device 78 in Fig. 3, may be registered to images in in block 164 as illustrated in the images 170 illustrated in Fig. 5. That is the pose of the target in the second image may be determined based on the fusion of the images. Thus, any parameters relative thereto are also determined in both.

[0052] The images 170 may also be displayed on the display device at 78. The images may be registered in an appropriate manner. For example, the image data acquired in block 164 may include the CT image data which may allow for the illustration or display of a bony portion 174. The prior acquired image may include MR image, and may be displayed as a portion superimposed or displayed relative to the CT image, such as an MRI image data portion 178. It is understood, however, that the image data may also be fused substantially in totality to allow for an overlay of the MR image entirely on the CT image. Nevertheless, as illustrated in Fig. 5 the fusion and/or overlay may allow for the illustration of at least a selected portion of the image from the planning phase 104 to be displayed relative to the later acquired image, such as the image data acquired in block 160. Various features may also be determined (e.g., segmented) and displayed such as the base 152 as a base image portion 152 prime. The image portion 152’ may be a graphical representation displayed at the position of the base and/or be acquired in the image data. The fusion may allow for the confirmation of the pose of the base 152 as illustrated in the image 152’ relative to other portions. The other portions may include the cranium 24c’ in the image, the target 120, the entry region 124, and the trajectory 130. A001 1290W001

[0053] Therefore, the fusion may allow the planning features from block 104 to also be displayed relative to the image data 170. All the planning features and parameters may be displayed relative to the image data acquired once the base 152 is affixed to the subject 24. This may allow for the pose of the base 152 to be illustrated relative to the other parameters or features, as illustrated in Fig. 5. The base representation 152' is illustrated relative to the other parameters or features, including the entry region 124 and the trajectory 130.

[0054] Any portion that is later mounted to the base may also be identified or confirmed relative to the parameters in the image. For example, the base 152 may include various features such as a surface 180. The surface 180 may define a plane 184. The plane 184 may be defined relative to the subjects 24, as illustrated in Fig. 4. The base 152 may also, therefore, define a plane 184' in the image data 170. The plane 184' may be determined or known relative to the entry region 124 and the trajectory 130. The plane 184, therefore, may be used as a geometric representation or known feature relative to the trajectory 130. As the base 152 was fixed to the subject 24 the plane 184 defined by the surface 180 may be known or fixed relative to the subjects 24. Thus, once the fusion has occurred with the representation or image of the base 152', a geometry, such as the plane 184', may be known or determined relative to the trajectory 130 and other portions, such as the entry region 124.

[0055] The geometry may be determined in appropriate manners, such as by the processor unit or system 68 executing instructions to determine or calculate geometric configurations between the base image 152’ and/or the plane 184' relative to the features from the planning phase or block 104, such as the trajectory 130. Thus, the processing unit 68 may also be used to determine a position of a portion relative to the trajectory 130 A001 1290W001 to allow for a guide region to be formed to guide an instrument along with the trajectory 130 at least into the subjects 24.

[0056] As discussed above, the image fusion allows for the determination of the pose of the base 152 relative to various portions of the subject, such as the trajectory 130 as illustrated in Fig. 5. The base 152 may be identified in the image such as by automatic segmentation, identification by the user, or combinations of both. For example, the base 152 may be substantially automatically identified without user intervention such as through shape detection due to edge detection or segmentation in the image or image data. Therefore, the pose of the base 152 may be determined relative to the trajectory 130 that has been determined in the planning phase or block 104. A determination of a base pose relative to planned parameters may be made in block 190. At least one planned parameter may include a pose of the base, such as the plane 184’, relative to the trajectory 130. Other planned parameters, however, may also include the target, structures in the subject, or the like.

[0057] The determination of the base pose relative to the planned parameters may allow for the generation of the guidance unit 30. The determined base pose relative to the planned parameters may allow for an evaluation and determination of a configuration of the guidance unit to guide the instrument 34 to the target 120 along at least a portion of the trajectory 130. The determination of the base pose relative to the planned parameters allows for an execution 200. The execution 200 may be a subprocess of the process 100 to plan or provide a guidance unit to assist for guiding the instrument 34 along to the trajectory. The execution may include various subprocesses or processes as discussed further herein to provide a mechanism or system to form a physical guiding portion to guide the instrument 34. In various embodiments, including those discussed herein, the A001 1290W001 physical guidance unit may include at least a bore through which at least a portion of the instrument 34 may pass such that the instrument 34 is moved along the trajectory 130 at least externally to the subject as the instrument 34 is positioned or moved into the subject.

[0058] With continuing reference to Fig. 2, and additional reference to Fig. 6 as discussed above the base 152 may be identified or determined within the image such as an image 210 as illustrated in Fig. 6. The image 210 may be any appropriate image and may be the fusion image, a generated graphic based upon the fusion image, or any other appropriate image. Regardless, the base 152 may be illustrated as the graphical representation 152'. Further in the execution phase or block 200, a recall of the determined base may be made in block 214. In recalling the determined base a configuration of the base, a geometry of the base, and the like may be determined or recalled, such as from a model thereof that is stored and recalled from a memory.

[0059] Further, in the execution phase a recall of the determined pose of the base relative to the plan parameters may be made in block 216. Recalling the pose of the base and the parameters may include various features, such as recalling the determined pose of the base 152 relative to the trajectory 130. As discussed above the fused image may allow for the identification or determination of the base 152 in the image and the planning image or data includes the trajectory 130. Accordingly, as illustrated in Fig. 6, the base representation 152' is able to be illustrated relative to the trajectory 130. Further, as discussed above, one or more features such as the plane 184 may be determined and/or illustrated as the plane or line 184’. Thus, various geometric configurations of the base relative to the trajectory 130 may be known based upon the acquired image data, the planning data, and other inputs. As discussed above the determination of the base and various other features, such as the geometry thereof, may be substantially automatic due A001 1290W001 to evaluation of the image data and/or recall of a model of the various features, such as of the base, or input by the user. User intervention is not required, however, to determine the geometry of the base 152 in the image, but rather may be performed substantially automatically by image analysis.

[0060] As illustrated in Fig. 6, the trajectory 130 may extend from the target 120 through and/or relative to the base 152’. Therefore, various geometric configurations or positions may also be determined such as an angle 220 between the trajectory 130 and the plane 184'. Various positions or configurations may also be determined, such as a distance 224 from the trajectory 130 to an edge 228 of the graphical representation of 152’ of the base. Therefore, a geometry of the base relative to the trajectory may be determined in the image in Fig. 6 as noted in block 232 of the execution phase 200. Determining the geometry of the base relative to the trajectory, or any other appropriate plan parameter, may be useful for determining a guidance unit to geometry, or at least a guide to portion geometry relative to the trajectory 130.

[0061 ] The determination of the geometry of the base (or a parameter thereof such as the plane 184’, edge, etc.) relative to plan parameters in block 232 may be understood to be optional. Nevertheless, the determination of various guidance unit configurations in block 240 may be based upon the recalled determined base and the recalled determine pose of the base relative to the plan parameters.

[0062] A determination of guidance unit configuration in block 240 may include a determination of various positioning and/or settings for a guidance unit. Included in the guidance unit configuration and/or relative thereto may be a determination of guide portion parameters. As discussed above, the guidance unit may include at least one guide portion and the guide portion may be used to directly (e.g., via contact) guide the instrument A001 1290W001 relative to the subject. Therefore, determining guide portion parameters in block 240 may be used to determine a pose of the guide portion relative to the subject. The guide portion parameters may include a geometry thereof, as discussed herein.

[0063] Given the determined or selected guidance unit configurations made in block 240, the configuration may be a plurality of measurements, positions, data for manufacturing, or the like. The determined or selected guidance unit configuration in block 240 may be output in block 250. The output of the guidance unit configuration in block 250 may be in any appropriate manner, such as transmitted wirelessly, transmitted over a wired connection, transmitted via a physical medium, or the like. Generally, the output may include a digital or signal output then be transmitted to other systems.

[0064] The guidance unit configuration includes a core that is a mathematical transformation from a base axes system to a trajectory axes system of the guidance unit. Further, according to selection of the type of guidance unit and procedure, another set of instructions for user or system can be derived in form of pre-sets to any adjustable mechanism included in the guidance system of the guidance unit. For example the guidance unit can engage a rotating carousel that is rotatable relative to the base with accurate and/or predetermined or known positions. The user or system may then need to select a particular position (e.g., position #3) to generate the correct guidance in space.

[0065] In various embodiments, the output configurations may be saved for later use in block 254. Various memory systems, such as the memory system 72 may be used to store the output configurations. The output configurations may then be transmitted from the memory, for various purposes.

[0066] In various embodiments, the output guidance unit configuration from block 250 may be transferred to a robotic system, also referred to as a robot, 320 in block 260. A001 1290W001

The guidance unit configuration output may be transferred to the robotic system 320 (Fig. 7) to operate to the robotic system 320 to achieve a guide member pose in block 264. A guide member may be any appropriate member, such as a guide member 268 (Fig. 7). Operating the robot to achieve guide member pose may include determining movements of the robotic system to move the guide member to a selected pose, as discussed further herein. The output guidance unit the configuration may be transformed by any appropriate processing system, such as a processing system of the robotic system 334 or the processing unit 68 to determine a movement or a number of movements of the robotic system to achieve the guide member 268 to a selected pose.

[0067] The robotic system 320 that may move the guide member to the selected pose in block 264. Therefrom a formation or a setting of a guidance unit configuration that may be made in block 272. The forming or the setting of the guidance unit configuration may be made in any appropriate manner, as also discussed herein. In various embodiments, a mechanical system may be operated to achieve a selected guidance unit configuration including a positioning of a guide bore for guiding the instrument 34. The guidance unit may then be fixed in block 280. In fixing the guidance unit in block 280 the guidance unit may be set for use. For example, the mechanical system may be fixed such that the guide bore configuration or pose is maintained during a selected portion of a procedure. The fixed guidance unit may then be fixed to the base in block 290. As discussed above the base 152 may be positioned on the subject 24 in an appropriate manner, such as prior to the fusion of the images for planning and the acquired image data in block 160. Thus, the guidance unit once fixed into a selected configuration may be fixed to the base in block 290. The fixation of the guidance unit to the base may be an A001 1290W001 appropriate manner such as with a quick connect (e.g., quarter twist), threaded, separate fasteners, or the like.

[0068] Further, the procedure may then be performed in block 294. Performing the procedure is optional for the process 100, as discussed above, but may be performed with the guidance unit in place in the guidance unit having the guide portion to guide the instrument 34. Performing the procedure with the guidance unit, however, is not required for the configuration of the guidance unit. Further, the fixation of the guidance to the base is not required. For example, the process 100 may be used to generate the output of the guidance unit configuration and the process 100 may end there. In various embodiments, the guidance unit configuration may be used to form or set the guidance unit in block 272 and fixing in the block 280. After fixing the guidance unit, however, the guidance unit may be stored for various purposes such as a later procedure.

[0069] At a selected time the process 100 may end in End block 300. Ending the process 100 in block 300 may include various steps, such as completing a selected portion or a procedure. It is understood that the process 100, however, may be used to form a plurality of guidance unit configurations and/or different guidance units including the configurations. All may be made and/or used during a single procedure on the single subject 24 or in a plurality of procedures on a plurality of subjects, or combinations thereof. Thus, the process 100 may be performed one or many times for selected purpose.

[0070] Further, the process 100 may be performed in substantially real time. That is the process 100 may be used to generate one or more configurations and/or related guidance units during a single procedure on the subject 24. For example, a guidance unit may be formed, as discussed herein, to be used during a procedure. A second guidance unit may also then be made during the procedure. In various embodiment, however, the A001 1290W001 process 100 may be used to generate the configuration and/or the guidance unit that is then stored for a selected procedure.

[0071] The process 100 may be performed such that guidance unit configurations may be determined and/or output without a tracking system or navigation relative to the subject 24 or other portions. In other words, only using the imaging and image data and the fusion of selected images, the guidance unit configuration is determined and output. The guidance unit configuration may be, in various embodiments, determined with no tracking or one or more portions and with only the image data. The base 152 may be affixed to the subject prior to a selected image data collection or allow for the determination and identification of the pose of the base 152 relative to the subject 24. Thus, the guidance unit configuration may be based only thereon along with the planned trajectory 130 and/or other planned parameters.

[0072] According to various embodiments, as discussed above, the guidance unit configuration may be output and transferred to the robotic system 320. The robotic system 320 may include any appropriate robotic system, such as one schematically or exemplary illustrated in Fig. 7. The robotic system 320 is illustrated to include various portions such as a segmented arm assembly 324 having one or more movable joints 326. The robotic system 320 may be a mobile system that is mounted to a base 328 with one or more wheels 330. It is understood, however, that the robotic system may be provided in any appropriate manner and the robotic system illustrated in Fig. 7 is merely exemplary.

[0073] The robotic system 320 may further include a processing unit or assembling 334. The processing unit 334 may be used to operate and control movement of the robotic system 320 including the trajectory tool or guide member 268. The guide member 268 may be moved substantially precisely relative to any portion of the robotic assembly 320 A001 1290W001 as it is connected to the robotic arm 324. The robotic arm 324 may be moved in various degrees of freedom, including 6° of freedom. In addition, the robotic assembly 320 may include a substantially precise end effector 340 to which may be mounted the guide member 268. The robotic assembly, therefore, may move in substantially infinite positions relative to other portions of the robotic system, such as the base 328, including in an x dimension 344, y dimension 346 and z dimension 348.

[0074] The robotic system 320 may be used to transfer the trajectory 130 into a selected member or assembly of the guidance unit, according to various embodiments. For example, a guidance unit 30i may be the guidance unit 30 as discussed above. The guidance unit 30i may include a cylinder 350 that may be of a selected geometry or size, such as to ensure that the trajectory 130 may be achieved relative to the subject 24. The cylinder 350 may include a substantially rigid wall 354. The wall 354 may be container or guidance unit wall. The walls 354 may be rigid enough for assist in the guiding the instrument 34, connection to the base, etc., as discussed herein. The cylinder may have at least one open end including a first or top open end 356 and a second or bottom open end 358. It is understood that any appropriate passages may be formed in the cylinder 350 and having the first of second ends 356, 358 be open or only one be open is merely exemplary.

[0075] To form the guidance unit 30i a selected material 362 may be placed in the cylinder 350. The selected material may be a hardenable material, such as a monomer that may be polymerized, a material that may be dried, or other appropriate materials. For example, the material 362 may be a bone cement such as a polymethylmethacrylate (PMMA) material. The material 362 may include, however, any polymerizable material and/or hardenable material that may achieve a selected hardness at a selected time or A001 1290W001 rate period. The hardenable material is generally or substantially able to harden to a degree that is able to maintain a guide bore to guide the instrument 34, as discussed herein. The hardenable material being appropriate selection with a goal to provide a stable physical guiding channel to work through which can be used to derive the actual hardness parameters to be achieved.

[0076] The cylinder 350 may include a dimension, such as a diameter 366, that may generally be similar to at least a dimension 154 of the base 152. Thus, the cylinder 350 may be mounted to the base 152 in a substantially known configuration or position. The guidance unit 30i may be fixed to the base 152 for the procedure, as discussed above. Thus, the guidance unit 30i may be removably fixed to the base 152 to guide the instrument 34. The base 152 may include various features according to various embodiments. For example, via mechanical configurable items (such as a rotating carousel) that allows to expand reach and working volume of the guidance unit.

[0077] Portions of the robotic assembly 320 may be correlated or known relative to the base 152 fixed to the subject 24. For example, the robotic assembly 320 may include a forming or work area or region 370 that includes a surface 372 that may be related or equal to the base 152. Therefore, a plane 184” may be related to the plane 184' of the base 152. Similarly, the other geometry may be transferred to the work region 370 including the angle 220 which may be the angle 222', the dimension 224 which may be the dimension 224', and the dimension 225 that may be the dimension 225' in the robotic assembly 320.

[0078] Accordingly, as illustrated in Fig. 7A, the various geometric configurations that are the guidance unit configurations may be transferred to the robotic assembly 320 A001 1290W001 and the relevant portions of the work region 370. Thus, the trajectory 130 may also be transferred to the work region 370 as the trajectory 130’.

[0079] The guidance member 268 may be moved by the robotic arm 324 to align with the trajectory 130' through the guidance unit 30i, as illustrated in Fig. 8. The guide member 268 may be maintained in the guidance unit 30i until the material 362 has hardened to a selected hardness. The guidance member 268 may be prepared in any appropriate manner prior to insertion to the guidance unit 30i, such as applying a lubricant thereto, to allow and/or ease removal of the guide member 268 from the guidance unit 30i. Following the hardening of the material in the guidance unit 30i, the guidance unit 30i may have the guide member 268 removed therefrom such that a guide bore 380 is formed through the hardened material 362 within the guidance unit 30i. The hardened material 362 is held within the cylinder wall 354 such that the bore 380 is substantially fixedly defined within the cylinder 350 formed or defined by the cylindrical wall 354. The bore 380 may related to the trajectory 130 when the guidance unit 30i is fixed to the base 152.

[0080] The guidance unit 30i may then be removed from the robotic assembly 320 and attached to the base 152, as illustrated in Fig. 9. The fixation of the guidance unit 30i to the base 152 may be performed in any appropriate manner. As discussed above, the cylindrical wall 354 may include internal or external threads to allow it to be threaded to the base 152. Additionally, or alternatively, the guidance unit through 30i may be affixed to the base 152 with external fasteners, such as clips, bolts, or the like.

[0081] The bore 380 may define or be formed along the trajectory 130 to allow for guidance of the instrument 34 along the trajectory 130 to a selected portion of the subject, such as the target 120. The guidance unit 30i therefore, can be substantially unique to the subject 24 and even unique to a particular portion of the procedure. In various A001 1290W001 embodiments, the guidance unit 30i may be used for a portion of the procedure, such as a first portion of a procedure. A second or additional guidance unit may then be formed in a manner similar to that discussed above and also affixed to the base 152 to assist in guiding a second or additional portion of her procedure. Therefore, any number of the guidance units 30i may be formed to assist in forming an appropriate bore 380 that that may be formed along the path within the guidance unit 30i to allow the bore 380 to be aligned with the trajectory 130 relative to the subject 24.

[0082] In various embodiments a guidance unit 30ii, as illustrated in Fig. 10, may be a mechanical system rather than a hardenable system, as discussed above. The guidance unit 30ii may be formed in any appropriate manner, and as illustrated in Fig. 10 and Fig. 10A is merely exemplary. According to various embodiments, the guidance unit 30ii may include an aligning member or portion 398 that may include a base member 400 and a transverse or extending member 404. The extending member 404 may be substantially fixed or formed as a single member with the base unit of 400.

[0083] The guidance unit 30ii may further include a first guide fixator 410 and a second guide fixator 414. Each of the guide fixators 410, 414 may be movable relative to the aligning member or portion 398, including the base 400 and/or the extending member 404. According to various embodiments, the guide fixator 410 may include a guiding apportion 420 connected to an arm 424. The guiding portion may include one or more moveable members, such as a ball member 421 captured with a capture member, such as a ring 422. Thus, the guiding portion 420 may resemble or include a ball joint such that the ball 421 may rotate and move in many degrees of freedom (e.g., double headed arrows A1 and A2) relative to the arm 424. A001 1290W001

[0084] The ring 422 may capture the ball 421 in any appropriate manner. For example, the ball 422 may be pressure fit into the ring. Additionally or alternatively the ring may be closed for fixed with a fixation member (e.g., screw) 423. Thus, the ball 421 may be moved to a selected trajectory and then held in place for the procedure. A bore 421 b through the ball 421 may then provide a guide passage for the instrument along the path or axis 130’.

[0085] The arm 424 may include external threads 426 that may engage one or more locking members, such as a first locking member 428 and a second locking member 430. The arm 424 may extend through a bore 434 formed in the extending member 404. The arm 424 may slide through the bore 434 until a selected position of the guide region 420 is achieved relative to the extending member 404. The arm 424 may pass through or engage a ring 425 on the support 404. Thus, the arm 424 may also rotate around the support 404 or an axis 404x (e.g., long axis) thereof, such as in the direction of the double headed arrow A3.

[0086] The two locking members 428, 430 can then be fixed between the arm 424 and the extending member 404, such as by threading them against the extending 404. This allows the guide portion 420 to be at a fixed pose in space relative to other portions of the guidance unit 30ii such as the base and the extending member 400, 404.

[0087] The second guide fixator 414 may be substantially similar to the first guide fixator 410. Therefore, the second guide fixator 414 may include a guidance region or portion 440 and an arm 444 that may be threaded 446. The guidance portion may include a ball 441 withing a ring or holding poirton 442 engaeable with a fixator 443 and a bore 441 b through the ball 441. Locking members 450, 454 may also engage the arm 444 A001 1290W001 relative to the extending member 404. The fixator guide fixator 414 may also pass through a bore 460 formed in the extending member 404.

[0088] The two guide fixators 410, 414 having the respective guide regions 420, 440 may, therefore, be moved in any appropriate geometry to achieve relative positions. The relative position may allow the two guidance members to be positioned along a trajectory 130' that is identical to the trajectory 130, as discussed above. It is understood by one skilled in the art that the two guide fixators 410, 414 may be included in any apporpriate number. Further, two guide fixators 410, 414 may include various other manipulatable portions, such as other ball joints or moveable portions relative to each of the two guide fixators 410, 414 and/or the support 404 to allow for any selected movement. The Fig. 10 and Fig. 10A is merely exemplary.

[0089] According to various embodiments, it is generally selected or desired to achieve at least two principles or parameters by the guidance unit. Each guide fixator can be moved freely and locked within its two-dimensional (2D) plane (i.e., two separated planes distanced from each other). Also, each guide fixator can rotate about its own axis (e.g., as a ball joint) to achieve any rotational angulation needed to align a tool through the one or more guide fixators 410, 414. One skilled in the art will understand, however, that the interactions of the guide fixators 410, 414 with a base or support may be achieved in any appropriate manner. The illustrate example may, however, provide a stability for the selected guide pose.

[0090] The guidance unit 30ii may be positioned in the work region 370 of the robotic system 320, similar to the guidance assembler unit 30i. The guide member 268 may then be moved relative to the guidance unit 30ii to allow for movements of the guidance fixator as 410, 414 relative to the guide member 268. The guide unit 268 may A001 1290W001 be positioned to pass through the guidance regions 420, 440. Accordingly, in various embodiments, the guidance regions 420, 440 may be through bores to allow passage of the guidance member 268.

[0091] The guidance member is positioned along the trajectory 130' that is equivalent to or identical to the trajectory 130 due to the same calculations discussed above. The guidance unit 30ii may be locked in the selected trajectory, such as wit the locking members discussed above. In various embodiments, the guide member or a portion of the guide member may also be fixed to the fixators 410, 414 to provide the guide bore for guiding the instrument 34. Therefore, the guide member 268 may include an external cylinder or cannula that may be fixed to the fixators 410, 414. The cannula may be fixed to the guidance regions 420, 440 to form a bore for the guidance unit 30ii. The fixation may be in any appropriate manner, such as set screws or adhesive.

[0092] Thereafter, similar to the guidance unit 30i as discussed above, the guidance unit 30ii may be fixed to the base 152 that is fixed to the subject 24. Thus, the guidance unit 30ii may be used to guide the instrument 34 along the trajectory 130. Further, the guidance unit 30ii may be adjusted in any appropriate number of times in a manner similar to that discussed above to achieve a plurality of trajectories for various or different portions of the procedure. Thus, the guidance unit 30ii may be used to perform a plurality of trajectories relative to the subject 24. The guidance unit 30ii need simply be disconnected from the base 152 and repositioned relative to the robotic assembly 320 to allow the robotic assembly 320 to move the guide member 268 to the new pose to fix the guidance unit 30ii into the new position.

[0093] Therefore, a guidance unit may be formed or generated for guiding at least a portion or for procedure using a robotic assembly, as discussed above, and an A001 1290W001 adjustable guidance unit. The adjustable guidance unit may be adjusted or formed for a specific portion or for procedure and a plurality of guidance units may be formed for various or different portions of a procedure. Thus, the guidance unit may be substantially precisely formed for a particular subject, a particular portion of a procedure, and may be quickly or efficiently changed or altered for additional portions of a procedure and/or different procedure or subjects.

[0094] Examples. The following examples provide various embodiments disclosed herein.

[0095] Example 1 - A system to generate a procedure assistance system for a procedure on a subject, comprising: a robotic assembly having (i) a work region that relates to a region of the subject, (ii) an end effector configured to be moved in space relative to the work region, and (iii) a guide member moved with the end effector; a base configured to be connected to the subject; a guidance unit configured to be connected to the base; and a processor module configured to execute instructions to: (i) fuse a first image and a second image, (ii) correlate a plan parameter between the first image and the second image based on the fusion of the first image and the second image, (iii) determine a guidance unit configuration to achieve the plan parameter, and (iv) output the guidance unit configuration.

[0096] Example 2 - The system of Example 1 , further comprising: an imaging system configured to acquire image data to generate at least one of the first image or the second image.

[0097] Example 3 - The system of Example 2, wherein the image data includes a first image data acquired prior to a second image data; wherein the second image is generated from the second image data. A001 1290W001

[0098] Example 4 - The system of Example 3, wherein the second image data includes both the subject and the base.

[0099] Example 5 - The system of Example 4, further comprising: an input system to input a plan parameter including a trajectory of an instrument; wherein the trajectory is based on the first image data.

[0100] Example 6 - The system of Example 1 , wherein the robotic assembly further includes a mobile base configured to be moved from a first location to a second location.

[0101] Example 7 - The system of Example 1 , wherein the guidance unit includes a hardenable material; wherein the hardenable material is configured to harden while the guide member is within a volume of the hardenable material; wherein the guide member is configured to be removed from the volume of hardenable material to form a bore related to the plan parameter within the hardenable material.

[0102] Example 8 - The system of Example 7 , wherein the guidance unit includes a container wall, wherein the hardenable material is placed within the container wall; wherein the container wall is configured to be moved from the work region to the base in the same pose.

[0103] Example 9 - The system of Example 7, wherein the container wall is configured to be removably fixed to the base.

[0104] Example 10 - The system of Example 1 , wherein the guidance using includes a first trajectory fixator and a second trajectory fixator; wherein the guide member is configured to be positioned between the first trajectory fixator and the second trajectory fixator; wherein the first trajectory fixator is configured to be fixed relative to the second trajectory fixator related to the plan parameter. A001 1290W001

[0105] Example 11 - The system of Example 10, wherein the guidance unit includes an alignment member; wherein the alignment member is configured to be moved from the work region to the base in the same pose.

[0106] Example 12 - The system of Example 10, wherein the alignment member is configured to be removably fixed to the base.

[0107] Example 13 - A method to generate a procedure assistance system for a procedure on a subject, comprising: providing a robotic assembly having (i) a work region that relates to a region of the subject, (ii) an end effector configured to be moved in space relative to the work region, and (iii) a guide member moved with the end effector; providing a base configured to be connected to the subject; providing a guidance unit configured to be removably connected to the base and the work region; and operating a processor module to execute instructions to: (i) fuse a first image and a second image, (ii) correlate a plan parameter between the first image and the second image based on the fusion of the first image and the second image, (iii) determine a guidance unit configuration to achieve the plan parameter, and (iv) output the guidance unit configuration.

[0108] Example 14 -The method of Example 1 , further comprising: operating an imaging system to acquire image data to generate at least one of the first image or the second image.

[0109] Example 15 -The method of Example 14, wherein operating the processor module to execute instructions to fuse a first image and a second image includes registering the first image to the second image; and further operating the processor module to execute instructions to determine a pose of the base relative to the subject in the second image data.

[0110] Example 16 -The method of Example 13, further comprising: A001 1290W001 providing a hardenable material with the guidance unit; hardening the hardenable material while the guide member is within a volume of the hardenable material; removing the guide member from the volume of hardenable material to form a bore within the hardenable material that is related to a planned trajectory that is at least one plan parameter.

[0111] Example 17 - The method of Example 16, further comprising: providing the guidance unit with a container wall, wherein the hardenable material is placed within the container wall; providing the container wall to be moved from the work region to the base in the same pose.

[0112] Example 18 - The method of Example 13, further comprising: providing the guidance unit with a first trajectory fixator and a second trajectory fixator; positioning the guide member between the first trajectory fixator and the second trajectory fixator; fixing the first trajectory fixator relative to the second trajectory fixator related to the plan parameter and the positioned guide member.

[0113] Example 19 - The method of Example 18, further comprising: providing the guidance unit with an alignment member; providing the alignment member to be moved from the work region to the base in the same pose.

[0114] Example 20 -The method of Example 18, further comprising: providing the alignment member to be removably fixed to the base.

[0115] Example 1 A - A system to generate a procedure assistance system for a procedure on a subject, comprising: a robotic assembly having (i) a work region that relates to a region of the subject, (ii) an end effector configured to be moved in space relative to the work region, and (iii) a guide member moved with the end effector; a base configured to be connected to the subject; a guidance unit configured to be connected to A001 1290W001 the base; and a processor module configured to execute instructions to: (i) fuse a first image and a second image, (ii) correlate a plan parameter between the first image and the second image based on the fusion of the first image and the second image, (iii) determine a guidance unit configuration to achieve the plan parameter, and (iv) output the guidance unit configuration.

[0116] Example 2A - The system of Example 1 A, further comprising: an imaging system configured to acquire image data to generate at least one of the first image or the second image.

[0117] Example 3A - The system of Example 2A, wherein the image data includes a first image data acquired prior to a second image data; wherein the second image is generated from the second image data.

[0118] Example 4A - The system of either of Examples 2A or 3A, further comprising: an input system to input a plan parameter including a trajectory of an instrument; wherein the trajectory is based on the first image data; wherein the second image data includes both the subject and the base.

[0119] Example 5A - The system of Example 1 A, 2A, or 3A, wherein the guidance unit includes a hardenable material; wherein the hardenable material is configured to harden while the guide member is within a volume of the hardenable material; wherein the guide member is configured to be removed from the volume of hardenable material to form a bore related to the plan parameter within the hardenable material.

[0120] Example 6A - The system of Example 5A, wherein the guidance unit includes a container wall, wherein the hardenable material is placed within the container wall; wherein the container wall is configured to be moved from the work region to the base in the same pose. A001 1290W001

[0121] Example 7A - The system of Examples 1 A, 2A, or 3A, wherein the guidance using includes a first trajectory fixator and a second trajectory fixator; wherein the guide member is configured to be positioned between the first trajectory fixator and the second trajectory fixator; wherein the first trajectory fixator is configured to be fixed relative to the second trajectory fixator related to the plan parameter.

[0122] Example 8A - The system of Example 7A, wherein the guidance unit includes an alignment member; wherein the alignment member is configured to be moved from the work region to the base in the same pose.

[0123] Example 9A - The system of Example 7A, wherein the alignment member is configured to be removably fixed to the base.

[0124] Example 10A - A method to generate a procedure assistance system for a procedure on a subject, comprising: providing a robotic assembly having (i) a work region that relates to a region of the subject, (ii) an end effector configured to be moved in space relative to the work region, and (iii) a guide member moved with the end effector; providing a base configured to be connected to the subject; providing a guidance unit configured to be removably connected to the base and the work region; and operating a processor module to execute instructions to: (i) fuse a first image and a second image, (ii) correlate a plan parameter between the first image and the second image based on the fusion of the first image and the second image, (iii) determine a guidance unit configuration to achieve the plan parameter, and (iv) output the guidance unit configuration.

[0125] Example 11 A - The method of Example 10A, further comprising: operating an imaging system to acquire image data to generate at least one of the first image or the second image; wherein operating the processor module to execute instructions to fuse a first image and a second image includes registering the first image to the second image; A001 1290W001 and further operating the processor module to execute instructions to determine a pose of the base relative to the subject in the second image data.

[0126] Example 12A - The method of Example 11 A, further comprising: providing a hardenable material with the guidance unit; hardening the hardenable material while the guide member is within a volume of the hardenable material; removing the guide member from the volume of hardenable material to form a bore within the hardenable material that is related to a planned trajectory that is at least one plan parameter.

[0127] Example 13A - The method of Example 12A, further comprising: providing the guidance unit with a container wall, wherein the hardenable material is placed within the container wall; providing the container wall to be moved from the work region to the base in the same pose.

[0128] Example 14A - The method of Example 13A, further comprising: providing the guidance unit with a first trajectory fixator and a second trajectory fixator; positioning the guide member between the first trajectory fixator and the second trajectory fixator; fixing the first trajectory fixator relative to the second trajectory fixator related to the plan parameter and the positioned guide member.

[0129] Example 15A - The method of Example 14A, further comprising: providing the guidance unit with an alignment member; providing the alignment member to be moved from the work region to the base in the same pose.

[0130] 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 A001 1290W001 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.

[0131] 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.

[0132] 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 A001 1290W001 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.

[0133] 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®.

[0134] Communications may include wireless communications described in the present disclosure can be conducted in full or partial compliance with one or more IEEE standard 802, including IEEE standard 802.1 1-2012, IEEE standard 802.16-2009, and/or IEEE standard 802.20-2008. 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.

[0135] 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) A001 1290W001 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.

[0136] 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 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

A001 1290W001 CLAIMS What is claimed is:

1 . A system to generate a procedure assistance system for a procedure on a subject, comprising: a robotic assembly having (i) a work region that relates to a region of the subject,

(ii) an end effector configured to be moved in space relative to the work region, and (iii) a guide member moved with the end effector; a base configured to be connected to the subject; a guidance unit configured to be connected to the base; and a processor module configured to execute instructions to:

(i) fuse a first image and a second image,

(ii) correlate a plan parameter between the first image and the second image based on the fusion of the first image and the second image,

(iii) determine a guidance unit configuration to achieve the plan parameter, and

(iv) output the guidance unit configuration.

2. The system of Claim 1 , further comprising: an imaging system configured to acquire image data to generate at least one of the first image or the second image.

3. The system of Claim 2, wherein the image data includes a first image data acquired prior to a second image data; wherein the second image is generated from the second image data. A001 1290W001

4. The system of either of Claims 2 or 3, further comprising: an input system to input a plan parameter including a trajectory of an instrument; wherein the trajectory is based on the first image data; wherein the second image data includes both the subject and the base..

5. The system of Claims 1 , 2, or 3, wherein the guidance unit includes a hardenable material; wherein the hardenable material is configured to harden while the guide member is within a volume of the hardenable material; wherein the guide member is configured to be removed from the volume of hardenable material to form a bore related to the plan parameter within the hardenable material.

6. The system of Claim 5, wherein the guidance unit includes a container wall, wherein the hardenable material is placed within the container wall; wherein the container wall is configured to be moved from the work region to the base in the same pose.

7. The system of Claims 1 , 2, or 3, wherein the guidance using includes a first trajectory fixator and a second trajectory fixator; wherein the guide member is configured to be positioned between the first trajectory fixator and the second trajectory fixator; A001 1290W001 wherein the first trajectory fixator is configured to be fixed relative to the second trajectory fixator related to the plan parameter.

8. The system of Claim 7 , wherein the guidance unit includes an alignment member; wherein the alignment member is configured to be moved from the work region to the base in the same pose.

9. The system of Claim 7 , wherein the alignment member is configured to be removably fixed to the based.

10. A method to generate a procedure assistance system for a procedure on a subject, comprising: providing a robotic assembly having (i) a work region that relates to a region of the subject, (ii) an end effector configured to be moved in space relative to the work region, and (iii) a guide member moved with the end effector; providing a base configured to be connected to the subject; providing a guidance unit configured to be removably connected to the base and the work region; and operating a processor module to execute instructions to:

(i) fuse a first image and a second image,

(ii) correlate a plan parameter between the first image and the second image based on the fusion of the first image and the second image, A001 1290W001

(iii) determine a guidance unit configuration to achieve the plan parameter, and

(iv) output the guidance unit configuration.

11 . The method of Claim 10, further comprising: operating an imaging system to acquire image data to generate at least one of the first image or the second image; wherein operating the processor module to execute instructions to fuse a first image and a second image includes registering the first image to the second image; and further operating the processor module to execute instructions to determine a pose of the base relative to the subject in the second image data.

12. The method of Claim 1 1 , further comprising: providing a hardenable material with the guidance unit; hardening the hardenable material while the guide member is within a volume of the hardenable material; removing the guide member from the volume of hardenable material to form a bore within the hardenable material that is related to a planned trajectory that is at least one plan parameter.

13. The method of Claim 12, further comprising: providing the guidance unit with a container wall, wherein the hardenable material is placed within the container wall; A001 1290W001 providing the container wall to be moved from the work region to the base in the same pose.

14. The method of Claim 13, further comprising: providing the guidance unit with a first trajectory fixator and a second trajectory fixator; positioning the guide member between the first trajectory fixator and the second trajectory fixator; fixing the first trajectory fixator relative to the second trajectory fixator related to the plan parameter and the positioned guide member.

15. The method of Claim 14, further comprising: providing the guidance unit with an alignment member; providing the alignment member to be moved from the work region to the base in the same pose.