System and method for navigation procedures

Abstract

A guidance or alignment system is disclosed. The system can be used to at least assist in a procedure. The system can assist in aligning an object and / or determining a physical boundary of a selected portion of the procedure.

Description

Technical Field

[0001] This disclosure generally relates to a system and method for determining and / or selecting the position (including positioning and orientation) of a component in space and / or relative to a subject. Background Technology

[0002] This section provides background information in connection with this disclosure, which is not necessarily prior art.

[0003] In navigation systems used for various procedures (such as surgical procedures, assembly procedures, etc.), instruments or objects can be tracked. Instruments can be tracked using one or more tracking systems in various operating modes, such as determining position by measuring the effect of a magnetic field on a sensor coil and / or using optical sensors. The sensor coil may contain a conductive material placed within a magnetic field, in which a current is induced. The measured induced current can be used to identify or determine the location of the instrument or object.

[0004] Electromagnetic fields can be generated using multiple coils (such as three orthogonally placed coils). Various transmitters or field generation systems are available, including the AxiEM, sold by Medtronic Navigation, Inc., which has a business location in Louisville, Colorado. TM Electromagnetic navigation system. AxiEM TM An electromagnetic navigation system may include multiple coils for generating an electromagnetic field sensed by a tracking device; these coils may be sensor coils to allow the use of, for example... Navigation systems, such as surgical navigation systems, are used to track and / or display the position of the tracked instruments.

[0005] The tracking system may also, or alternatively, include an optical tracking system. Optical tracking systems include, for example... Tracking systems include optical tracking systems, which consist of a set of cameras with a field of view to triangulate the position of the instrument. Summary of the Invention

[0006] This section provides an overall overview of this disclosure and is not a complete disclosure of its full scope or all of its features.

[0007] A system for performing and / or preparing procedures is disclosed. The procedures can be performed on a living subject (such as an animal, a human, or other selected patient). The procedures can comprise any suitable type of procedure, such as those performed on inanimate subjects (e.g., enclosed structures, fuselages, chassis, etc.). However, a navigation system can be used to perform the procedures, wherein a tracking system is capable of tracking one or more selected items.

[0008] The navigation system can be used to navigate an instrument relative to a subject to perform procedures. In various embodiments, the procedures may include procedures on the spine, such as spinal fusion, where two or more vertebrae are connected to a selected implant system or assembly. The procedures can also be used to gain or obtain access to volumes such as cranial volume. In various embodiments, for example, and the implant may be placed in the subject's brain.

[0009] The disclosed system includes an alignment guide that can be positioned relative to a subject. The alignment guide may include a component that can be fixed to the subject. Further, the alignment guide may move with selected systems, such as a mechanical or robotic system relative to the subject. Suitable robotic systems may include Stealth, sold by Medtronic, Inc., which has a business location in Louisville, Colorado. Cranial robot guidance platform.

[0010] Further areas of applicability will become apparent from the description provided herein. The descriptions and specific examples in this overview are intended for illustrative purposes only and are not intended to limit the scope of this disclosure. Attached Figure Description

[0011] The accompanying drawings described herein are for illustrative purposes only, and not for all possible embodiments, and are not intended to limit the scope of this disclosure.

[0012] Figure 1 It is the environmental view of the navigation system;

[0013] Figure 2 It is an adjustable guidance system based on the alignment system of each implementation scheme;

[0014] Figure 3 This is an assembly view of the alignment system, including guide members and an adjustable base, according to various implementation schemes;

[0015] Figure 3A It is a detailed view of the guidance system and the adjustable base;

[0016] Figure 4 This is a flowchart of the procedure for using the alignment system;

[0017] Figure 5A , Figure 5B and Figure 5C The use of the alignment system according to various embodiments is illustrated in series; and

[0018] Figure 6A and Figure 6B The use of the alignment system according to various implementation schemes is shown.

[0019] In several views of all the accompanying drawings, the corresponding reference numerals indicate the corresponding parts. Detailed Implementation

[0020] Exemplary embodiments will now be described more fully with reference to the accompanying drawings.

[0021] First refer to Figure 1 The diagram illustrates a navigation system 10. The navigation system 10 can be used by one or more users, such as user 12, for various purposes or procedures. The navigation system 10 can be used to determine or navigate the device 16 within a volume (also referred to as its posture). This position may include at least six degrees of freedom, including three-dimensional X, Y, Z positioning and one or more orientation degrees. Orientation may include one or more degrees of freedom, such as three degrees of freedom (including lateral, pitch, and roll). However, it should be understood that any appropriate degree of freedom position information (such as position information with fewer than six degrees of freedom) may be determined and / or presented to user 12.

[0022] The positioning of the device 16 can be accomplished using a first or device tracking device 56, and can help the user 12 understand and / or comprehend the position of the device 16 relative to a selected reference frame, such as an image reference frame, and therefore relative to the subject 20, even if the user 12 cannot directly see the device 16. Various procedures may obstruct the user 12's view, such as performing repairs or assembling inanimate systems (e.g., robotic systems), assembling parts of a machine body or automobile, etc. Various other procedures may include surgical procedures performed on a living subject, such as performing spinal procedures, neurological procedures, locating deep brain stimulation probes, or other surgical procedures. In various embodiments, for example, the subject 20 may be a human subject 20, and the procedure may be performed on a human subject 20. However, it should be understood that for any suitable procedure, the device 16 can be tracked and / or navigated relative to any subject. Tracking or navigating a device on a human or living subject for procedures such as surgical procedures is merely exemplary.

[0023] In various embodiments, as further discussed herein, the surgical navigation system 10 may incorporate various components or systems, such as those disclosed in U.S. Patent Nos. RE44,305; 7,697,972; 8,644,907; and 8,842,893; and U.S. Patent Application Publication No. 2004 / 0199072, all of which are incorporated herein by reference. Various components that may be used with or as part of the surgical navigation system 10 may include an imaging system 24 operable to image the object 20, such as… Imaging systems, magnetic resonance imaging (MRI) systems, computed tomography (CT) systems, etc. The object support 26 can be used to support or hold the object 20 during imaging and / or during the procedure. The same or different supports can be used for different parts of the procedure.

[0024] In various embodiments, the imaging system 24 may include a source 24s. The source may emit and / or generate X-rays. The X-rays may form cones 24c that impact the subject 20, such as in a cone beam. Some of the X-rays pass through the subject 20, and some X-rays are attenuated by the subject. The imaging system 24 may also include a detector 24d to detect X-rays that are not completely attenuated or blocked by the subject 20. Therefore, the image data may include X-ray image data. Further, the image data may be two-dimensional (2D) image data.

[0025] Image data may be acquired during a surgical procedure, such as by one or more imaging systems discussed above, or prior to the surgical procedure for displaying image 30 on display device 32. In various embodiments, even if the image data is 2D image data, the acquired image data may be used to form or reconstruct selected types of image data, such as three-dimensional volume. Instrument 16 may be tracked by one or more tracking systems in a trackable volume or navigation volume (also referred to as the subject space defined relative to subject 20). Tracking systems may include one or more tracking systems operating in the same or multiple and / or different ways or modes. For example, a tracking system may include an electromagnetic (EM) locator 40, such as... Figure 1 As shown in the various embodiments, those skilled in the art will understand that other suitable tracking systems can be used, including optical tracking systems, which may include optical tracking system locator 82, radar, ultrasound, etc. The EM locator 40 and tracking system discussed herein are merely exemplary tracking systems capable of operating in conjunction with navigation system 10.

[0026] The location of the tracking device 16 relative to the subject 20 can be tracked within the tracking volume and then displayed as a graphical representation, also referred to as icon 16i, using display device 32. In various embodiments, icon 16i may be overlaid on and / or adjacent to image 30. As discussed herein, navigation system 10 may be incorporated into display device 30 and operated to render image 30 from selected image data, display image 30, determine the position of device 16, determine the position of icon 16i, etc.

[0027] EM locator 40 (and / or alternative locator 40') is operable to generate an electromagnetic field using a transmitting coil array (TCA) 42 incorporated into locator 40. TCA 42 may include one or more coil groups or arrays. In various embodiments, more than one group is included, and each group may include three coils, also referred to as a trios or triplets. A coil drive current can be used to power the coils in the coil group to generate or form an electromagnetic field. When current is driven through the coils, the generated electromagnetic field will extend away from coil 42 and form a navigation domain or volume 50, such as surrounding all or part of the head 20h, spinal vertebrae 20v, or other suitable portion. The coils can be powered via a TCA controller and / or a power supply 52. ​​However, it should be understood that more than one EM locator in EM locator 40 may be provided, and each EM locator may be placed in a different and selected location.

[0028] The navigation domain or volume 50 typically defines a navigation space or patient space. As commonly understood in the art, the device tracking device 56 can be used to track the device 16, such as a drill, wire, guide tube, guide member, etc., relative to the patient or subject 20 within the navigation space defined by the navigation domain. For example, the device 16 may be freely movable by the user 12 relative to a dynamic reference frame (DRF) or a patient reference frame tracker 60, which is fixed relative to the subject 20. Both tracking devices 56 and 60 may include a tracking portion for tracking using a suitable tracking system, such as a sensing coil (e.g., a conductive material formed in or placed in the coil) for sensing and measuring magnetic field strength, an optical reflector and / or transmitter, an ultrasonic transmitter, etc. Because the tracking device 56 is connected or associated with the device 16 relative to the DRF 60, the navigation system 10 can be used to determine the position of the device 16 relative to the DRF 60.

[0029] Due to the registration of the subject space relative to the image space, navigation of the movable portion relative to the subject 20 can be performed (which may include determining and displaying the position of the tracked portion). The navigation volume or patient space can be registered to the image space defined by the image 30 of the subject 20, and an icon 16i representing the device 16 can be displayed at the navigated (e.g., determined) and tracked positions using a display device 32, such as overlaid on the image 30. Patient space-to-image space registration and determination of the position of a tracking device (e.g., tracking device 56) relative to a DRF (e.g., DRF 60) can be performed as is commonly known in the art, including as disclosed in U.S. Patent Nos. RE44,305; 7,697,972; 8,644,907; and 8,842,893; and U.S. Patent Application Publication No. 2004 / 0199072, all of which are incorporated herein by reference. Typically, registration involves translation between the subject space and the image space. This can be accomplished by identifying points in the subject space (i.e., the reference portion) and identifying the same points in the image (i.e., the image reference). Then, a translation map from the image space to the subject space can be created, as can be done using the navigation system 10.

[0030] The navigation system 10 may further include a navigation processor system 66. The navigation processor system 66 may include a display device 32, a TCA 40, a TCA controller 52, and other components and / or connections thereto. For example, a wired connection may be provided between the TCA controller 52 and the navigation processing unit or module 70. Further, the navigation processor system 66 may have one or more user control inputs (such as a keyboard 72), and / or additional inputs, such as from communication with one or more memory systems 74, which are integrated or via a communication system. According to various embodiments, the navigation processor system 66 may include navigation processor systems disclosed in U.S. Patent Nos. RE44,305; 7,697,972; 8,644,907; and 8,842,893; and U.S. Patent Application Publication No. 2004 / 0199072, all of which are incorporated herein by reference, or may also include commercially available systems sold by Medtronic Navigation Inc., which has a place of business in Louisville, Colorado. or Fusion TM Surgical navigation system.

[0031] Tracking information (including information related to the magnetic fields sensed by the tracking devices 56, 60) can be transmitted via a communication system (such as a TCA controller, or possibly a tracking device controller 52) to a navigation processor system 66, which includes a navigation processor 70. Thus, the position of the tracked device 16 can be displayed as icon 16i relative to image 30. Various other memory and processing systems may also be provided with and / or communicate with the processor system 66, including a memory system 72 that communicates with the navigation processor 70 and / or the imaging processing unit 76 (including imaging or image memory 112). Imaging memory 112 can store or be used to retrieve images or image data of the subject 20, such as those acquired through imaging system 24 or other suitable imaging systems.

[0032] As discussed above, the image processing unit 76 can be incorporated into the imaging system 24, such as O- Imaging system 24. Therefore, imaging system 24 may include various components capable of movement within gantry 78, such as the source and X-ray detector. Imaging system 24 may also be tracked by imaging tracking device 80. However, it should be understood that imaging system 24 is not required when tracking a tracking device including instrument tracking device 56. Furthermore, imaging system 24 may be any suitable imaging system including MRI, CT, etc.

[0033] In various embodiments, the tracking system may include an optical locator 82. The optical locator 82 may include one or more cameras that observe or have a field of view defining or surrounding the navigation volume 50. The optical locator 82 may receive input light (e.g., infrared or ultraviolet light) to determine position or track a tracking device, such as an instrument tracking device 56. It should be understood that the optical locator 82 may be combined with and / or alternatively used to track the instrument 16 in conjunction with the EM locator 40.

[0034] Information from all tracking devices can be transmitted to the navigation processor 70 for determining the position of the tracked parts relative to each other and / or for positioning the instrument 16 relative to the image 30. The imaging system 24 can be used to acquire image data to generate or produce an image 30 of the subject 20. However, it should be understood that other suitable imaging systems may also be used. As discussed above, the TCA controller 52 can be used to operate and power the EM locator 40.

[0035] The image 30 displayed using the display device 32 may be based on image data acquired from the subject 20 in various ways. For example, the imaging system 24 may be used to acquire image data for generating the image 30. However, it should be understood that other suitable imaging systems may be used to generate the image 30 using image data acquired using the selected imaging system. The imaging system may include a magnetic resonance imaging (MRI) scanner, a computational tomography (CT) scanner, and other suitable imaging systems. Furthermore, the acquired image data may be two-dimensional or three-dimensional data and may have a time-varying component, such as imaging the patient during heart rhythm and / or respiratory cycles.

[0036] In various implementations, the image data is 2D image data generated using a cone-beam imaging system. The cone-beam used to generate the 2D image data can be an imaging system (such as...). This is part of an imaging system. The 2D image data can then be used to reconstruct a 3D image or model of the imaging object (such as patient 20). The reconstructed 3D image and / or an image based on the 2D image data can be displayed. Therefore, those skilled in the art will understand that selected image data can be used to generate image 30.

[0037] Furthermore, an icon 16i, indicating the location of the tracked device 16, may be displayed on the display device 32 relative to the image 30. Additionally, the image 30 may be segmented for various purposes, including those further discussed herein. Segmentation of the image 30 may be used to identify and / or define objects or portions within the image. In various embodiments, the image may include segments of the brain used to assist in or perform selected procedures relative to the brain, such as placement of deep brain stimulation (DBS) leads.

[0038] As discussed above, navigation system 10 can be used for navigation, such as via tracking devices, various components, or locator 40. The components can be navigated for purposes such as identifying the position of the tracked portion relative to subject 20, registering image data to subject 20, and other appropriate purposes. In various embodiments, guidance components or system 200 can be used relative to subject 20 for selected portions of the procedure.

[0039] Continue to refer to Figure 1 And refer to other sources Figure 2 The alignment system 200 can be positioned relative to the subject 20, such as using a mounting system or construct 204 that can be fixed to a bed or support 26. The guidance system 200 can be positioned and / or fixed relative to the subject 20. The support structure 20 can be a rigid structure and / or a movable and fixed support structure, such as those sold by Medtronic Navigation, Inc., which has a business location in Louisville, Colorado. Flexible support arm system. After being moved to a selected position, the flexible or movable support 204 can also be fixed relative to the subject 20 at the selected position. Therefore, the guide system 200 can be fixed and / or movable relative to the subject 20.

[0040] In its proper location, the guide system 200 may have a first or fixed portion 220 that can be directly connected to the support 204. The guide system 200 may further include a second or movable portion 224 movable relative to the base or the first portion 220. The movable portion 224 may move or translate relative to the fixed portion 220 in a plane at any suitable position or amount of translation. Thus, the movable portion 224 is generally movable relative to the base portion 220 in a plane or axis system 230. The guide system 200 may include Stealth, sold by Medtronic Corporation, which has a business location in Louisville, Colorado. A cranial robotic guidance platform. Therefore, the guidance system can be controlled by the user 12 and / or other appropriate components to move relative to the subject 20.

[0041] The guiding system 200 may further include guiding members. The guiding member may be a guide tube 234, which may have a hole or through-hole, as discussed herein. The guide tube 234 may be held relative to the base portion 220 by a first holding or fixing portion 238. The guide tube 234 may also be held or fixed relative to the second portion 224 by a second holding or fixing portion 242. The corresponding holding portions 238, 242 may securely hold two portions of the guide tube 234, such as near the first end or inlet portion 244 and near the second end 248. The fixing portions 238, 242 may have a fixed length relative to the corresponding members 220, 224 and the tube 234. Thus, the corresponding ends of the tubes 244, 248 are fixed at corresponding distances from the corresponding members 220, 224.

[0042] However, the fixing members 238, 242 may include joints to allow the second member 224 to move relative to the first member 220, and thereby also allow the tube 234 to move. Figure 2 As shown, tube 234 can extend along axis 252. Guide tube 234 can be in a first position 252a. Second member 224 can translate relative to first member 220 (in any direction of direction 230), and this can cause tube 234 and the corresponding axis 252 to move from the first position 252a to a second position 252b. Therefore, the movement between second member 224 and first member 220 allows tube 234 to move relative to subject 20 along its long axis 252. Thus, the alignment or trajectory of tube 234 can be adjusted relative to subject 20.

[0043] The position of tube 234 can be determined. As discussed above, the determined position can also be displayed on display device 32. In various embodiments, the tube 234 is attached to and / or associated with it by a tube or an alignment guide tracking device 270. The tracking device can be used to determine the position of tube 234.

[0044] Tracking device 270 can be any suitable tracking device, such as an EM tracking device and / or an optical tracking device. In various embodiments, tracking device 270 may include an optically trackable portion, such as a reflector ball 272, and / or may include one or more coils capable of operating with EM locator 40. As discussed above, tracking device 270 can be tracked by navigation system 10 to navigate or determine the position of guide 234 relative to subject 20. Similarly, tracking device 270 can be tracked, and the position of tube 234 associated with guide tracking device 270 can be displayed using display device 32, such as icon 234' relative to image 30. Therefore, alignment system 200 can move the long axis 252 of tube relative to subject 20 within a selected cone. The apex of the cone can be moved by moving support 204 and / or subject 20.

[0045] In various embodiments, the position of guide 234 may be tracked or determined by other tracking components. For example, the alignment system may include internal or selected sensors, such as an encoder, to determine the movement and position of guide 234. Therefore, tracking device 270 may not be required to track guide 234. The determined movement or position of alignment system 200 can be used to navigate guide 234.

[0046] Continue to refer to Figure 2 And refer to other sources Figure 3 The alignment system 200 may include a movable or adjustable portion and a guide 234 movable therefrom, the movable or adjustable portion including a first member 220 and a second member 224, as discussed above. In addition to the movable portion, as discussed above, the alignment system 200 may include a base assembly 280. The base assembly may include a selected number of portions, such as a base portion or member 284, that can be fixed to the skull 20h of the subject 20. In various embodiments, the base portion 284 may be fixed to the skull 20h or selected fixation members such as bone screws 288. An appropriate number of screws 288 or other suitable fixation members may be used to fix the base 284 to the skull 20h.

[0047] An adjustable member 292 may extend or be associated with the base portion 284. The adjustable member 292 may extend along a long axis 298, which may be fixed and / or selectively fixed relative to the base portion 284. Thus, the adjustable member 292 may be positioned relative to the base surface 302 of the base portion 284. A fixing system or member may selectively fix the adjustable member 292 relative to the base portion 284. For example, a locking member or fixing screw 293 may engage the adjustable member 292 relative to the base portion 284. Thus, the locking member 293 may be selected between an engaged or locked position and an unengaged or unlocked position. In the unlocked position, the adjustable member 292 may move relative to the base portion 284. In the locked position, the adjustable member 292 may be fixed relative to the base portion 284.

[0048] The adjustable member 292 may include an outer surface or wall 306 and an inner surface 308. An alignment guide 234 may be positioned within the adjustable member 292 and selectively engage the inner wall 308. Thus, the guide tube 234 may be aligned with the adjustment system 200 and may engage the inner surface or portion 308 of the base tube 292 to assist in fixing or holding the guide tube 234 at least relative to the skull 20h. As discussed above, the adjustable member 292 may be fixed relative to the base portion 280, and the base portion 280 may be fixed relative to the skull 20h. Therefore, the alignment tube 234 may be held relative to the skull 20h in a selected position using the adjustable or robotic portions 220, 224 and / or the lockable base 280.

[0049] In various embodiments, the inner surface 308 of the adjustable tube 292 may include a dimension 312, which may be an internal dimension of the adjusting tube 292. The guide tube 234 may include an outer dimension 316 smaller than the internal dimension 312. Therefore, the alignment tube 234 can be adjusted relative to the adjusting base 280.

[0050] In various embodiments, the alignment tube 234 can be moved to a pre-planned or predetermined selected position. A tracking device 270 can be used to track the alignment tube or device 234 to the predetermined position. An adjustable base 280 can be moved to a position and engage the guide tube 234 in a selected manner, such as by friction or contact engagement. Thus, the alignment guide 234 can be held relative to the adjustable base 280. The adjustable base 280 can then be fixed relative to the skull 20h, such as using a fixing member 288 and / or a selected adjustable locking feature. In various embodiments, the adjustable tube portion 292 can utilize suitable locking features or portions 293 such as finger screws, similar to those sold by Medtronic, a company with a business location in Minnesota. The track guide includes components that lock relative to the base portion 284. Therefore, the adjustable component 292 can be selectively engaged to the guide tube 234 and then fixed in an appropriate or selected position relative to the base 284, which is in turn fixed to the skull 20h. Thus, the adjustable base 280 can assist in fixing the guide tube 234 relative to the skull 20h for a selected time period, such as during the procedure.

[0051] Continue to refer to Figure 2 and Figure 3 And refer to other sources Figure 4 and Figures 5A to 5C An alignment system 200, which may include a guide tube 234 and a base 280, can be used to assist or guide procedures on the subject 20. Figure 4 The flowchart 360 shown includes or describes procedures or processes. A process may begin in block 364, which may include various features or procedures such as diagnosing the subject, identifying a possible diagnosis, determining a possible treatment plan, or other appropriate procedures. Therefore, a procedure may begin in block 264. After the procedure begins in block 364, procedure 360 ​​may include multiple paths, including a first path in block 368 for acquiring and / or accessing image data. Image data of subject 20 may be acquired to assist in performing procedures on subject 20 and / or diagnosing the subject, planning procedures for the subject, etc. Image data may include image data of selected portions of the subject, such as the head 20h. Image data may include image data acquired using imaging system 24 or any suitable imaging system, such as a magnetic resonance imaging (MRI) system. In various embodiments, the image data may be used to generate images that can be displayed on display device 32. Image data of subject 20 may be acquired at any appropriate time, such as before relative to subject positioning alignment system 200. For example, procedures may be planned relative to subject 20, including the posture or position / positioning guided in block 372. For example, entry points and trajectories can be determined to perform procedures such as tumor resection, DBS placement, etc. Therefore, procedures can be planned, such as using image data acquired and / or accessed from subject 20.

[0052] In addition to executing the planning procedure in block 368, or alternatively, the plan can be recalled in block 378 for the guided posture. Therefore, procedure 360 ​​does not need to include a planning procedure. Instead, the procedure can be planned at any appropriate time, and the user 12 can recall the plan for the procedure when preparation is made for the procedure subject 20, such as in an operating room with navigation system 10. Thus, a plan can be developed and saved for later use, and then recalled. The plan can be stored in a suitable memory such as navigation memory 74 and can be recalled by processor module 70.

[0053] In box 382, ​​the guidance system 200 can be positioned relative to the subject. The guidance system 200 can be used to move the guide tube 234 to a planned posture. The guide can be positioned relative to the subject 26, as in the initial position, and subsequently moved further. Reference Figure 5A For example, the alignment system 200 can be fixed using a bracket 204, which can be fixed to the patient support 26 relative to the subject's head 20h. The second portion 224 can be moved relative to the first portion 220 to move the guide tube 234 relative to the subject's head 20h. A tracking device 270 can be used to track the guide tube 234. The tracking system can track the position of the guide member 234, as with the tracking device 270. As discussed above, due to the subject space, such as the registration of the subject's head 20h with the image 30 in box 386, the position of the guide tube 234 can be displayed on the display device using icon 234'.

[0054] Therefore, the guide tube 234 can be navigated relative to the subject's head 20h. The posture of the guide tube can be displayed using a graphical representation 234' relative to an image 30 on the display device 32. Due to the navigation of the guide tube 234, the planned position can be determined or identified, such as using the output on the display 32 at a selected time. Therefore, in box 390, the guide tube can be moved and navigated to the planned posture.

[0055] Once the guide tube 234 is in a predetermined or planned position, an indication or alarm 396 may be given to the user 12, such as through an alarm on the display device 32, an audible alarm, or other appropriate alarm. Therefore, the user 12 can move or operate the alignment system 200 to move the guide tube 234 to the planned position. It should be further understood that the alignment system can be substantially automatic and operated by the processor module 70 to move the guide tube 234 due to a plan. When the plan is recallable and / or determined and the navigation system can navigate the guide tube 234, the alignment system 200 can move due to the automatic movement of the robot system, so that the guide tube 234 moves substantially automatically to the planned position. Therefore, the guide tube 234 can be moved manually, such as by the user 12 operating the alignment system 200 and / or automatically by operating the alignment system 200 using an appropriate system such as the navigation system 10.

[0056] Once the alignment tube 234 is in the pre-planned position, in box 404, the marking device 396 can be used to mark the position 400 on the subject's head 20h. Marking the position on the subject's head 20h can be optional, but an adjustable base 280 relative to the positioning of the subject's head 20h can be useful.

[0057] Therefore, continue to refer to Figure 4 And refer to Figure 5BThe adjustable base 280 within box 410 can be positioned relative to the subject's head 20h. The adjustable base 280 can be moved to the head 20h and secured relative to the head using a suitable fixing device 288. As discussed above, the base 280 is positioned at the location marked 400 on the head 20h, or approximately at the location determined by the alignment tube 234.

[0058] During the positioning of the base 280, the alignment system 200 may be moved relative to the subject 20. As discussed above, the support portion 204 may be movable or adjustable, and thus, the movable components 220, 224 may be moved to a second positioning to allow for efficient and rapid application and fixation of the adjustable base 280 relative to the subject 20. Therefore, if the alignment system 200 is moved relative to the subject, a realignment of the guided and planned posture may occur in block 420.

[0059] Therefore, in box 420, the guide is realigned, wherein the base 280 is secured to the subject 20h with the guide tube 234 in place, and the guide tube 234 can engage the base guide tube 292. When the guide tube 234 is in the planned position and the base guide tube 292 is engaged, the alignment of the guide tube 234 and the base guide 292 is understood as along the planned posture or trajectory. Therefore, engaging the guide tube 234 into the base guide tube 292 in box 424 aligns the guide tube 234 relative to the subject 20h. Further, engaging the base system 280 in a substantially fixed position, such as securing the base 284 to the head and fixing the base tube 292 relative to the base 284, provides mechanical fixation of the guide tube 234 relative to the subject's head 20h. Therefore, for the selected procedure, the guide tube 234 can be auxiliaryly and / or mechanically fixed relative to the subject 20h.

[0060] Furthermore, the display device 32 can display an indication such as indicator 396, indicating that the alignment is in the appropriate position. Therefore, the display device 32 can display an icon of the guide tube 234'.

[0061] Once aligned in the appropriate or pre-planned position, the device 16 can be positioned relative to the guide tube 234 to assist in the execution of the procedure. In block 430, the device 16 can be moved and / or tracked relative to the subject 20h. The display device 32 can display a graphical representation 16' of the device during navigation and use, even within the guide tube 234. However, it should be understood that an illustration of the device icon 16' is not required when within the guide tube 234.

[0062] Then, in block 434, the procedure can be performed using instrument 16. Performing the procedure may include locating the appropriate portion, such as a DBS lead or a resection instrument, via guide 234. It should be understood that any appropriate procedure can be performed using instrument 16, and instrument 16 can be any appropriate instrument. Then, in block 438, method 360 may end. Ending the procedure in block 438 may include any appropriate steps, such as completing navigation, performing resection, performing implantation, etc.

[0063] Therefore, procedure 360 ​​may use alignment system 200 to assist in performing the procedure relative to subject 20. In various parts of procedure 360, a navigation system or any suitable processor module may be used to navigate guide tube 234, determine and identify the guide tube in the planned position, and cause guide tube 234 or other suitable parts to move automatically. It should also be understood that user 12 may use or operate parts of alignment system 200 and / or move the instrument relative to guide tube 234.

[0064] Those skilled in the art will understand that procedure 360 ​​does not require all of the parts identified therein. Typically, the procedure may include moving the guide to the planned posture in block 390 and engaging the guide to the base in block 424. The guide tube 234 may be moved to the planned posture in an appropriate manner and may be tracked, as discussed above. The base system 280 may then be used to assist in holding the guide tube 234 relative to the subject (e.g., mechanically securing it).

[0065] Furthermore, while the procedure is shown relative to the head 20h of the subject 20, it should be understood that the alignment system 200 can be used for other suitable procedures. In various embodiments, the guidance system 200 can be used to guide or align the guide tube 234 relative to spinal procedures, biopsy procedures in any suitable organ (e.g., heart, lung, liver, etc.). Furthermore, the procedure 360 ​​and the alignment system 200 can be used for suitable procedures on non-living or inanimate objects, such as moving or driving instruments into inanimate objects. Therefore, the alignment system 200 can be used to perform procedures on any suitable subject.

[0066] As discussed above, refer to the references. Figure 6A and Figure 6B Alignment system 200 may include an adjustable base 500. Alignment system 200' may be substantially similar to or include, alternative to or different from those discussed above, or include the same or similar parts as further discussed herein. Similar parts will be identified by similar reference numerals with apostrophe (').

[0067] First refer to Figure 6AThe subject may have an alignment system 200' positioned relative to the head 20h. The alignment system 200' may include a first portion 224' movable relative to a base or a second portion 220'. Similarly, as discussed above, a support 204' may be fixed relative to a patient support 26 and assist in holding the alignment system 200' in position relative to the subject's head 20h. The alignment system 200' may include a guide member 504. The guide member may be a guide tube with holes. The guide tube 504 may include a tracking device or a tracking device 270'. The tracking device 270' may be used to track the posture of the guide tube 504 relative to the subject 20h and may be displayed on a display device 32, similar to the guide tube 234 discussed above.

[0068] The adjustable base 500 may include a base portion 510 that can be secured to the subject's head 20h using a fixing device 288', as discussed above. The adjustable base 500 may further include an adjustable portion 514 that can be moved relative to the base 510 and / or fixed relative to the base 510, as discussed above. Therefore, the adjustable portion 514 can be moved relative to the base 510 to achieve a selected alignment of the guide tube 504 relative to the subject 20h.

[0069] However, the adjustable base 500 may be movably fixed relative to the guide tube 504. For example, the guide tube 504 may include external threads, and the adjustable portion 514 may include internal threads. By rotating the base tube 514 and / or the guide tube 504, the adjustable base 500 may be axially moved along axis 520 relative to the guide tube 504, typically in the direction of the double-headed arrow 524. In various embodiments, axis 520 may be the longitudinal axis of the guide tube 504.

[0070] During the approximate or initial alignment of the guide tube 504 with respect to the head 20h, the adjustable base 500 can be in a first position, such as... Figure 6A As shown, this first position is not in contact with the head 20h. Once alignment is determined to be in the proper position, the adjustable base 500 can be moved relative to the head 20h, such as using the output 530 on the display device 32. Therefore, initial alignment or alignment of the guide tube 504 can be performed using the adjustable base 500, which is attached to the guide tube but not in contact with the head 20h.

[0071] refer to Figure 6BOnce the guide tube 504 is in the proper or pre-planned position, the adjustable base can be moved toward the head 20h, as in the direction of arrow 524a. The movement of the base 500 relative to or toward the head 20h may be due to rotation of the base tube 514 and / or rotation of the guide tube 504. Therefore, the adjustable base 500 can then be moved relative to the head 20h, as within contact, and fixed relative to the head, as using the patient fixation portion 288.

[0072] It should be understood that the adjustable base 500 can be moved relative to the guide tube 504 using any suitable mechanism, such as a steering mechanism, as discussed above, a ratchet and pawl, a claw, or other suitable mechanism. It should also be understood that a suitable connection or movement mechanism may include a retaining screw that can engage and disengage between the two guide tubes 504, 514 to allow the adjustable base 500 to move relative to the head 20h.

[0073] Therefore, as discussed above, the guide tubes 234, 504 according to the various embodiments can be moved relative to the subject 20 into a planned or selected posture. Then, the adjustable bases 280, 500 according to the various embodiments can be fixed relative to the head 20h and engage the guide tubes 234, 504 to provide mechanical and / or auxiliary fixation relative to the subject 20. The corresponding guide tubes 234, 504 can be used to assist the guiding device 16 relative to the subject 20 for performing procedures.

[0074] The provision of exemplary embodiments makes this disclosure comprehensive and fully conveys the scope to those skilled in the art. Numerous specific details, such as examples of particular components, apparatus, and methods, are set forth to provide a thorough understanding of embodiments of this disclosure. It will be apparent to those skilled in the art that specific details are not required, exemplary embodiments may be embodied in many different forms, and should not be construed as limiting the scope of this disclosure. In some exemplary embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0075] The foregoing description of embodiments has been provided for illustrative and descriptive purposes. The foregoing description is not intended to be exhaustive or limiting of this disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable and may also be used in selected embodiments where applicable, even if not specifically shown or described. The same element or feature may be varied in many ways. Such variations should not be considered as departing from this disclosure, and all such modifications are intended to be included within the scope of this disclosure.

[0076] It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically given in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any process or method described herein may be performed in a different order, or may be completely added, combined, or omitted (e.g., performing the described technique may not require all the described actions or events). Furthermore, although for clarity some aspects of this disclosure are described as being performed by a single module or unit, it should be understood that the techniques of this disclosure can be performed by combinations of units or modules associated with, for example, a medical device.

[0077] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which correspond to tangible media such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and is accessible by a computer).

[0078] The instructions can be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, graphics processing units (GPUs), application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), or other equivalent integrated or discrete logic circuit systems. Therefore, the term "processor" as used herein can refer to any of the foregoing structures or any other physical structures suitable for implementing the described techniques. Furthermore, this technique can be fully implemented in one or more circuit or logic elements.

Claims

1. A system for positioning a guide member relative to a subject for a selected procedure, the system comprising: A mobility system for moving the guide member relative to the subject during navigation, wherein the mobility system is configured to fix the guide member relative to the subject when the guide member is in a selected guiding posture; as well as A base system for cooperating with the guide member and for being secured to the subject to assist in holding the guide member at least relative to the subject. The moving system is configured to move the guide member to a selected posture. The base system includes a cooperating member configured to cooperate with the guide member to assist in securing the guide member in the selected posture; and the base system includes a fixing member configured to secure to the subject. The cooperating component is movable relative to the fixed component, and When the guide member is fixed in the selected posture, the base system is axially movable relative to the guide member between a first position and a second position.

2. The system of claim 1, wherein the movement system for moving the guide member relative to the subject further comprises: A robotic system configured to be positioned close to the subject, the robotic system having at least one component for engaging the guide member and moving the guide member; The robotic system is further configured to be operated to move the guide member relative to the subject.

3. The system according to any one of claims 1 or 2, wherein the system further comprises: A tracking system for tracking the guide member relative to the subject.

4. The system according to claim 3, wherein the system further comprises: A display for showing the position of the guide member relative to an image defining an image space.

5. The system of claim 1, wherein the cooperating member is selectively fixed at one of a plurality of locations relative to the fixing member.

6. The system of claim 5, wherein the cooperating member is releasably fixed relative to the fixing member.

7. The system of claim 6, wherein the fixation member is releasably fixed relative to the subject.

8. The system according to claim 7, further comprising: An instrument, used in conjunction with the guide member, passes through at least a portion of the base system to the subject.

9. The system according to any one of claims 1 to 8, wherein the base system is movably coupled to the guide member.

10. The system of claim 9, wherein the moving system moves the guide member and the base system to a first posture in which the base system is in the first position; and The moving system causes the base system to move axially relative to the guide member to the second position after the guide member is in the first position.

11. The system of claim 10, wherein the base is moved to the second position by rotating at least a portion of the base system relative to the guide member to move the base system relative to the subject and axially relative to the guide member.

12. The system of claim 9, wherein one of the first position or the second position is closer to the subject.

13. A non-transitory computer-readable medium comprising one or more instructions stored thereon, said one or more instructions, when executed by a processor, causing the processor to perform a method for positioning a guiding member, said method comprising: Operate the moving system to move the guide member; Image registration; Navigate the movement of the guide member to the selected posture; The guide member is fixed relative to the support structure in the selected posture; A fixed base system, wherein the base system includes a cooperating part that is movable relative to a base portion; By positioning the guide member within the cooperating portion, the guide member engages with the cooperating portion; as well as The cooperating part is fixed relative to the base portion; When the guide member is fixed relative to the support structure in the selected posture, the base system is axially moved relative to the guide member from a first position to a second position; The guide member engages with the cooperating portion and the cooperating portion is fixed relative to the base portion to assist in holding the guide member in the selected posture.

14. The non-transitory computer-readable medium of claim 13, wherein axial movement of the base system relative to the guide member occurs after the guide member has been navigated to the selected posture.

15. The non-transitory computer-readable medium according to any one of claims 13 or 14, the method further comprising: The selected posture is predetermined.

16. A system for locating a guide member for a selected procedure, the system comprising: A mobility system for moving the guide member relative to the subject; A support member for securing the motion system and the guide member relative to the subject; A base system configured to be selectively fixed relative to the subject, wherein the base system includes a cooperating portion movably attached to a base portion; as well as A fixing system configured to selectively fix the cooperating part relative to the base portion; The moving system is configured to move the guide member to a selected posture; The cooperating portion is configured to cooperate with the guide member; The cooperating portion is movable relative to the base portion; The base portion is configured to be selectively fixed to the subject; and When the guide member is fixed in the selected posture, the base system is axially movable relative to the guide member between a first position and a second position.

17. The system of claim 16, further comprising: A navigation system, the navigation system including a tracking system for tracking the posture of the guide member.

18. The system according to any one of claims 16 or 17, wherein the system further comprises: The guide component; The cooperating portion includes a hole configured to selectively engage the guide member to assist in holding the guide member in a selected posture.

19. The system according to any one of claims 16 to 18, wherein the fixing system includes at least one fixing member configured to be positioned in an unengaged position and an engaged position, wherein the engaged position selectively fixes the cooperating portion relative to the base portion; The cooperating portion is configured to move relative to the base portion when the fixing member is in the unengaged position.

20. The system according to any one of claims 16 to 19, the system further comprising: The guide component; An axial positioning portion is configured to selectively position the base system relative to the guide member between a first axial position and a second axial position.

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