System and method for navigation

Abstract

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

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 593,864, filed on October 27, 2023, the entire contents of which are incorporated herein by reference.

[0003] This application includes subject matter relating to the subject matter of application 63 / 593,864 (Agent's File No. A0009694US01 / 5074A-0000297-US-PS1). The full disclosure of each of the foregoing applications is incorporated herein by reference. Technical Field

[0004] This subject matter generally relates to a tracking and navigation system, and particularly to tracking using electromagnetic fields and related sensors. Background Technology

[0005] This section provides background information in connection with this disclosure, which is not necessarily prior art.

[0006] The instrument can be navigated relative to a subject for various surgical procedures. For example, the subject may include a patient undergoing surgery. During surgery, the instrument can be tracked in a physical space, which may also be referred to as the object or subject space. In various embodiments, the subject space may be a patient space defined by the patient. The position of the tracked instrument can be displayed on a display device relative to an image of the patient.

[0007] Patient localization can be determined using a tracking system. Typically, the patient is registered to the image by generating a transformation mapping between the subject or object space (e.g., patient space) and the image space relative to the patient tracking device. This usually requires a user (such as a surgeon) to identify one or more points in the subject space and associate them with the same points in the image space.

[0008] After registration, the instrument's position can be appropriately displayed on the display device while tracking the instrument. The instrument's position relative to the subject can be displayed graphically, sometimes referred to as an icon on the display device. Summary of the Invention

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

[0010] According to various implementations, the imaging system can be used to acquire image data of a subject. The imaging system may include an ultrasound imaging system comprising an ultrasound (US) probe, which typically includes an ultrasound transducer to transmit and receive ultrasound frequencies. However, it should be understood that the imaging system may include separate components for transmitting and receiving ultrasound frequencies.

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

[0012] Electromagnetic (EM) fields can be emitted by a transmitter or sender and sensed by an electromagnetic sensing device of a tracking device. Depending on the implementation, the electromagnetic sensing device may include one or more coils of conductive material, or may include other sensors, including but not limited to Hall effect sensors, fluxgate sensors, magnetoresistive sensors, tunnel junction sensors, optical sensors, microelectromechanical systems (MEMS) sensors, magneto-optical sensors, or combinations thereof. Various other materials, such as conductive materials, magnetic materials, or a combination of conductive and magnetic materials, may interfere with the field transmitted by the sensor. However, the interference with the field sensed by the sensor can be quantified and analyzed to determine the location or orientation of a portion of the interfering field or a subset of such degrees of freedom.

[0013] The navigation system can be used for registration or after the image has been registered to the navigation space. Therefore, the pose of the tracked portion or component can be displayed relative to the image. Furthermore, a system can be used where the patient is not registered to the image, but the imaging device is tracked so that the pose of the acquired image data and the associated image is tracked.

[0014] According to various embodiments, the sensor can be positioned relative to an object that is a disturbance. The disturbance object can move relative to the sensor, and a related distortion can be measured in the sensing field. A metric can be used to determine the amount of distortion. The metric may include geometry determination and / or phase shift determination. The positioning of the disturbance object can be characterized by a metric used to measure the distortion. The value of the metric can change based on the distortion or the positioning of the disturbance object. Therefore, even if the tracking device is not directly attached to the disturbance object, the positioning of the disturbance object can be characterized and determined in volume relative to a tracking device including an EM field sensor. Thus, the positioning of the disturbance object can be determined relative to the instrument portion including the tracking device.

[0015] 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

[0016] The accompanying drawings described herein are for illustrative purposes only, representing the selected embodiments and not all possible specific implementations, and are not intended to limit the scope of this disclosure.

[0017] Figure 1 This is a schematic diagram illustrating an overview of robot systems and navigation systems according to various implementation schemes; Figure 2 It is a schematic diagram of an apparatus having at least a first part and a second part according to various implementation schemes; Figure 3 It is located in a part of the subject Figure 2 Detailed schematic diagram of the instrument; Figure 4 This is a schematic diagram of a device in its first configuration, consisting of two parts capable of moving in one degree of freedom. Figure 5A It is in the second configuration and has two parts. Figure 4 A schematic diagram of the instrument; Figure 5B This is a schematic diagram of a tracking device and its sensing configuration according to various implementation schemes; Figure 6A It is a two-part configuration in the third configuration according to various implementation schemes. Figure 4 A schematic diagram of the instrument; Figure 6B These are schematic diagrams of tracking devices and sensing tracking devices according to various implementation schemes; Figure 7 It is a schematic diagram of a device in a first configuration according to various embodiments, having at least a first part and a second part capable of moving in two degrees of freedom; Figure 8A and Figure 8B It is in the second configuration Figure 7 A schematic diagram of the instrument; Figure 9A and Figure 9B It is in the third configuration Figure 7 A schematic diagram of the instrument; Figure 10 It is a schematic diagram of a device in a first configuration according to various embodiments, having at least three degrees of freedom of movement of a first part relative to a second part; Figure 11 It is in the second configuration Figure 10 A schematic diagram of the instrument; Figure 12 Includes schematic diagrams of various instruments in multiple configurations; and Figure 13 It is a flowchart illustrating the process of various implementation schemes.

[0018] In several views of all the accompanying drawings, the corresponding reference numerals indicate the corresponding components. Detailed Implementation

[0019] Exemplary embodiments will now be described more fully with reference to the accompanying drawings.

[0020] This subject matter disclosure relates to exemplary embodiments of surgical procedures performed on subjects such as human patients. However, it should be understood that the systems and methods described herein are merely exemplary and are not intended to limit the scope of the claims included herein. In various embodiments, it should be understood that the systems and methods can be incorporated into and / or used on non-living objects. For example, these systems can be used to register coordinate systems between two systems for use in manufacturing and maintenance systems, etc. For example, automobile assembly may use one or more robotic systems comprising separate coordinate systems that can be registered together for coordinated or joint actions. Therefore, the exemplary description of surgical procedures herein is not intended to limit the scope of the appended claims.

[0021] This paper discusses a tracking system that can be used to track a selected tracking device, according to various embodiments. According to various embodiments, the tracking system can operate by emitting an electromagnetic (EM) field from a locator (also known as an EM locator). The EM field can be emitted from one or more coils, which can be oriented relative to the origin. The coils can emit the field. The field can be a dominant magnetic field. The field can be constant or time-varying. The tracking device can include one or more coils of conductive material that operate as sensors to sense the field. The field can generate a voltage or current within the coils of the tracking device. The positioning and orientation (also collectively referred to as “pose”) of the tracking device can be determined based on the determination of the induced voltage or current from the field. It should also be understood that an EM, or any suitable tracking system, can operate by emitting a signal (e.g., an EM field) from the tracking device and receiving the signal at the locator.

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

[0023] Individual parts can be tracked relative to a subject. For example, the tracking system can be incorporated into a navigation system that includes one or more instruments that can be tracked relative to a subject. The navigation system may include one or more tracking systems that track individual parts associated with the instruments, such as tracking devices. The tracking system may include a locator configured to determine the pose of the tracking device in the navigation system coordinate system, either individually or in combination with a processor. The determination of the navigation system coordinate system may include those described in various references, including U.S. Patent Nos. 8,737,708, 9,737,235, 8,503,745, and 8,175,681, all of which are incorporated herein by reference. Specifically, the locator is capable of tracking a subject within a volume relative to the subject. The navigation volume in which the tracking device can be tracked may include, or is referred to as, a navigation coordinate system or navigation space. The determination or correlation between two coordinate systems may allow, or is also referred to as, registration between two coordinate systems.

[0024] In addition, images of selected portions of the subject can be acquired. These images can be displayed for viewing by users such as surgeons. The images may have been overlaid on a portion of an image that may include a graphical representation of the tracked portion or component (such as an instrument). The images may have a coordinate system and define an image space. According to various embodiments, the graphical representation can be overlaid on the image at an appropriate location due to registration from the image space (also referred to as the image coordinate system) to the subject space. Methods for registering the subject space defined by the subject to the image space can include those disclosed in U.S. Patent Nos. 8,737,708, 9,737,235, 8,503,745, and 8,175,681, all of which are incorporated herein by reference. However, in various embodiments, the imaging device can be tracked, and thus its images can be tracked in a navigation space. In such a system, it is possible to display the tracked instrument relative to the tracked image in the absence of a tracked or registered patient. Furthermore, the tracked instrument and images are displayed relative to the tracked and registered patient.

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

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

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

[0028] Additional or alternative imaging systems 80 may be used to acquire preoperative, intraoperative, or postoperative or real-time image data of a subject (such as subject 30). However, it should be understood that imaging can be performed on any suitable subject, and any suitable surgical procedure can be performed relative to the subject. In the example shown, imaging system 80 includes an O-arm sold by Medtronic Navigation, Inc., which has a business location in Colorado, USA. ® Imaging apparatus. Imaging system 80 may have a generally annular rack housing 82 in which an image capture portion is movably positioned and / or enclosed. Imaging system 80 may include those disclosed in: U.S. Patent Nos. 7,188,998, 7,108,421, 7,106,825, 7,001,045, and 6,940,941, all of which are incorporated herein by reference in any appropriate portion thereof. It should also be understood that imaging system 80 may additionally or alternatively include a fluoroscope C-arm. Other exemplary imaging apparatus may include fluoroscopes such as dual-plane fluoroscope systems, ceiling-mounted fluoroscope systems, catheterization lab fluoroscope systems, fixed C-arm fluoroscope systems, isocentric C-arm fluoroscope systems, 3D fluoroscope systems, etc. Other suitable imaging apparatus may also include MRI, CT, ultrasound, etc.

[0029] The positioning of imaging systems 33, 80 and / or portions thereof (such as image capture portions) can be precisely known relative to any other portion of imaging devices 33, 80. According to various embodiments, imaging devices 33, 80 can know and / or recall precise coordinates relative to a fixed or selected coordinate system. For example, robotic system 20 can know or determine its positioning and position the US probe 33 in a selected pose. Image data acquired using one or more ultrasound arrays of the US probe 33 can be registered in navigation systems such as those disclosed in U.S. Patent Nos. 7,085,400 and 9,138,204, both of which are incorporated herein by reference. Similarly, imaging system 80 can also position the imaging portion in a selected pose. This allows imaging system 80 to know its positioning relative to patient 30 or other references. Additionally, as discussed herein, precise knowledge of the positioning of the image capture portion can be used in conjunction with a tracking system to determine the positioning of the image capture portion and image data relative to a tracked subject (such as patient 30). In other words, the imaging system tracking devices 62, 81 can be used and / or operated to determine the pose of the imaging systems 33, 80 at selected times (such as during image data acquisition). According to various embodiments, the localization of the imaging system can be used to register an image space or coordinate system to a patient space or coordinate space. The robotic system can also be registered to one or more spaces or coordinate systems, such as by the systems and methods disclosed in U.S. Patent No. 11,135,025, which is incorporated herein by reference.

[0030] In this document, unless otherwise stated, references to imaging system 33 may refer to any suitable imaging system. Therefore, the US probe 33 as an imaging system is merely an example disclosed in relation to this subject matter. As those skilled in the art will understand, typically the US probe 33 can emit a US wave in a plane and receive an echo relative to any portion joined by that wave. The echo received at the US probe 33, or other suitable received echo, can be used to generate image data and can be used to generate a US image, also known as a sound map.

[0031] The imaging device 80 can be tracked using the tracking device 62. Furthermore, the tracking device 81 can be directly associated with the US probe 33. Therefore, the US probe 33 can be directly tracked using the navigation system 26 as discussed herein. Alternatively, the US probe 33 can be located and tracked using the robotic system 20. In any case, according to various embodiments, image data defining the image space acquired by the patient 30 can be registered relative to the object space (e.g., manually, inherently, or automatically). The object space can be the space defined by the patient 30 in the navigation system 26.

[0032] Patient 30 may also be tracked using a patient tracking device, DRF, or tracker 58 as the patient moves. Alternatively or otherwise, patient 30 may be fixed within a navigation space defined by navigation system 26 to allow and / or maintain registration such as with image space with image 108. As discussed further herein, registration of image space with patient space or subject space allows navigation of device 68 using image data. When navigating device 68, the positioning of device 68 may be illustrated on display device 84 relative to acquired image data of patient 30, such as with graphical representations 68i, 68i'. Alternatively, patient 30 may not be tracked or fixed, and the system may track device 68 relative to imaging devices 33 and their associated images. Additional and / or alternative display devices 84' may also be present to display images. Various tracking systems, such as tracking systems including optical locator 88 or electromagnetic (EM) locator 92, may be used to track device 68.

[0033] More than one tracking system may be used to track the instrument 68 or other parts, such as using the tracking device 81 in the navigation system 26 to track the US probe 33. According to various embodiments, these may include an electromagnetic tracking (EM) system with an EM locator 94 and / or an optical tracking system with an optical locator 88. As discussed herein, either or both of the tracking systems may be used to track the selected tracking device. It should be understood that, unless otherwise discussed, the tracking device may be a part capable of being tracked using the selected tracking system. The tracking device does not necessarily refer to the entire component or structure to which the tracking device is attached or associated.

[0034] The position of patient 30 relative to imaging device 33 can be determined by navigation system 26. As discussed herein, the position of imaging system 33 can be determined. As further discussed herein, patient 30 can be tracked using dynamic reference frame 58. Therefore, the position of patient 30 relative to imaging device 33 can be determined.

[0035] Image data acquired from imaging system 33 or any suitable imaging system can be acquired at imaging device controller 96 and / or forwarded from imaging device controller to navigation computer and / or processor module (also referred to as processor) 102, which may include processor module, which may be part of controller or workstation 98 having display 84 and user interface 106. Furthermore, any suitable type of memory system or module 103 may be accessed by processor 102. It is also understood that image data does not necessarily need to be stored in controller 96 first, but may also be sent directly to workstation 98. Workstation 98 may provide facilities for displaying image data as image 108 on display 84 and for saving, digitally processing, or printing hard copies of the received image data. User interface 106, which may be a keyboard, mouse, stylus, touchscreen, or other suitable device, allows user 72 to provide input to control imaging devices 80, 33 or adjust image settings on display 84 via imaging device controller 96. Workstation 98 can also instruct image device controller 96 to adjust the image capture section of imaging device 80 to obtain various two-dimensional images along different planes, thereby generating representative two-dimensional image data and three-dimensional image data.

[0036] Continue to refer to Figure 1 The navigation system 26 may also include a tracking system comprising either or both of an electromagnetic (EM) locator 94 and / or an optical locator 88. The tracking system may include a controller and an interface portion 110. The controller 110 may be connected to a processor portion 102, which may include a processor contained within a computer. The EM tracking system may include a Stealth Station sold by Medtronic Navigation, Inc., which has a business location in Louisville, Colorado. ® AXIEM ™The navigation system may be, or may be, the EM tracking system described in the following patents: U.S. Patent Application Serial No. 10 / 941,782, filed September 15, 2004, entitled “METHOD AND APPARATUS FOR SURGICAL NAVIGATION”; U.S. Patent No. 5,913,820, published June 22, 1999, entitled “Position Location System”; and U.S. Patent No. 5,592,939, granted January 14, 1997, entitled “Method and System for Navigating a Catheter Probe”; all of which are incorporated herein by reference. It should be understood that the navigation system 26 may also be or include any suitable tracking system (including STEALTHSTATION with an optical locator). ® TREON ® S7 ™ or S8 ™ The tracking system (which can be used as an optical locator 88) is sold by Medtronic Navigation, Inc., located in Colorado. Other tracking systems include acoustic systems, radiation systems, radar systems, etc. The tracking system can be used according to techniques generally known or described in the references combined above. Details are not included herein unless the chosen operation disclosed in the subject matter is clearly explained.

[0037] Wired or physical connectors can interconnect the tracking system, imaging device 80, etc. Alternatively, instead of being directly coupled to controller 110, various components such as instrument 68 can utilize wireless communication channels, such as those disclosed in U.S. Patent No. 6,474,341, entitled "Surgical Communication Power System," published November 5, 2002, which is incorporated herein by reference. Furthermore, tracking devices 62, 66, 54 can generate fields and / or signals sensed by positioners 88, 94.

[0038] Various parts of the navigation system 26, such as the device 68, and other parts described in detail below, may be equipped with at least one and typically multiple tracking devices 66. The device may also include more than one type or form of tracking device 66, such as EM tracking devices and / or optical tracking devices. The device 68 may include a grippable or manipulable portion at its proximal end, and the tracking device may be fixed near the manipulable portion of the device 68.

[0039] Another representative or alternative positioning and tracking system is described in U.S. Patent No. 5,983,126, entitled "Catheter Location System and Method," issued November 9, 1999, which is incorporated herein by reference. Navigation system 26 may be a hybrid system including components from various tracking systems.

[0040] According to various implementations, navigation system 26 can be used to track any appropriate parts, such as US probe 33 and / or device 68, relative to each other or patient 30. As discussed above, tracking system can be used to track device 68. Image data from patient 30 or an appropriate subject can be used to assist user 72 in guiding device 68. Image data may or may not be registered to patient 30. For example, as discussed herein, US probe 33 is tracked and generates image data. Therefore, as discussed above, it is not necessary to register image data to the subject to show the pose of the tracked device 68 relative to the image data generator with the tracked US probe 33. Image data defines an image space that is registered to patient space defined by patient 30. Registration can be performed automatically, manually, or in combination thereof, as discussed herein. Registration can include procedural and final transformation (including translation and rotation) mappings. Typically, registration involves determining points in image data and subject space and determining transformation mappings between them. Once completed, image space is registered to subject space, or any two or more coordinate spaces.

[0041] Typically, registration also allows for the generation of a transformation map of the tracked physical pose of the device 68 relative to the image space of the image data. This transformation map allows the tracked position of the device 68 to be displayed on the display device 84 relative to the image data 108. A graphical representation 68i (also referred to as an icon) can be used to exemplify the position of the device 68 relative to the image data 108.

[0042] Continue to refer to Figure 1 The subject registration system or method may use tracking device 58. Tracking device 58 may include a trackable portion or component 120, but may also serve as or be operable as a reference point assembly. Reference point assembly 120 may include a clamp or other fixation portion 124 and an imageable reference point body 120. However, it should be understood that component 120 may be separate from tracking device 58. Fixation portion 124 may be provided to fix any suitable portion, such as a part of an anatomical structure. Figure 1As illustrated, the reference point assembly 120 may interconnect with a portion of the spine 126, such as the spinous process 130. The fixation portion 124 may interconnect with the spinous process 130 in any suitable manner. For example, a pin or screw may be driven into the spinous process 130. Furthermore, the tracking device 58 may be operable for tracking using one or more tracking systems or modalities, such as an EM tracking system or an optical tracking system.

[0043] like Figure 1 As illustrated, the imaging device 33 may include a US probe 33, which can be positioned relative to the subject 30, such as by means of the robotic system 20 and / or the surgeon 72. In various embodiments, the surgeon 72 may manipulate the robotic arm 20 and / or hold the US probe 33 separately from it. Thus, as discussed herein, the robotic system 20 may move the US probe 33 to a selected position relative to the subject 30. According to various embodiments, the imaging system can be positioned relative to the subject in any suitable manner.

[0044] The determination of the location of an object, such as a tracking device, can be performed in any suitable manner. Furthermore, the location of individual parts relative to other tracking devices can be determined. According to various embodiments, the pose of an interfering object (which may be conductive) can be determined relative to a tracking device within an EM navigation coordinate system, particularly when an EM field is emitted and distorted relative to an interfering object, which can generate or emit a field based on induced currents or coercive magnetization within the object.

[0045] Instrument 68 can be any suitable instrument and, as discussed herein, can include instruments that can be used in a variety of surgical procedures. Depending on various embodiments, instrument 68 may, for example, include an inserter or guiding catheter 200, such as... Figures 2 to 6B As illustrated, device 200 can be used as a supplement to and / or as the device 68. Therefore, the discussion of device 200 can include all the features identified above with respect to device 68, such as tracking and illustrating the pose of device 68 with respect to selected image data, such as using graphical representation 68i.

[0046] The device 200 may include various portions that allow use of the device 200 relative to the subject 30. For example, the device 200 may include a handle 202, which may include various portions such as guiding or directing portions 204 that allow the catheter or extension portion 208 of the device 200 to bend or move relative to the axis 210 of the handle 202. Furthermore, the device 200 may include one or more extendable portions, such as a capsule 212 that can be axially movable relative to the distal tip 214 of the extension portion 208. The capsule portion 212 may extend or move along an axis 216 that may be extended or defined by the distal portion 214 of the catheter portion 208.

[0047] Therefore, the catheter portion 208 can be moved within the subject 30 for a selected procedure. The guide portion 204 on the handle 202 can be used to bend or move the catheter portion 208 to guide the angle or turn of the distal end 214.

[0048] The tracking device 66 may be positioned at or near the distal tip 214 of the catheter portion 208. According to various embodiments, the tracking device 66 may be attached (e.g., fixed) to the catheter portion 208, such as at the distal tip 214. Thus, the tracking device 66 can be used to track the pose of at least the distal tip 214 of the catheter portion 208. However, as discussed above, when the capsule 212 moves away from the distal tip 214, the specific pose of the capsule may not be directly known due to the tracked pose of the tracking device 66. As discussed herein, the capsule 212 may approach the distal tip 214, including contact with the distal tip. Therefore, the tracked pose of the tracking device 66 can be used to directly know the pose of the capsule 212 when approaching the distal tip 214. However, as discussed herein, the capsule 212 may move away from the distal tip 214 and / or move toward a distance from that distal tip. Therefore, the tracked pose of the tracking device may not be used to directly know the pose of the capsule 212.

[0049] To determine the pose of the capsule 212, particularly when it is oriented distally towards the distal tip 214, measurements can be taken at or using the tracking device 66. The capsule 212 may include at least a portion of and / or be entirely formed of a perturbation material (which may be conductive). Due to the EM field generated by the EM locator 94, the perturbation material of the capsule 212 may have a current induced therein. The induced current in the capsule 212 (including in its conductive material) can generate a field emitted from the capsule 212. The field emitted from the capsule 212 may affect the tracking device 66 and / or the field sensed by the tracking device 66. The field emitted by the induced current in the capsule 212 may be referred to as the induced field. Therefore, as further discussed herein, the pose of the capsule 212 relative to the subject 30 can be determined at least based on the induced field sensed at the tracking device 66 and the tracked pose of the tracking device 66.

[0050] Go to Reference Figure 3 The device 200, including the catheter portion 208, can be positioned within a selected portion of the subject 30, such as the heart 127. The device 200 can be used to position a selected implant, such as a valve replacement 224. The valve assembly 224 can be any suitable valve assembly and / or any suitable implant that can be positioned within the body of an appropriate subject (such as patient 30). In various embodiments, such as Intrepid... ™ A catheter-based mitral valve replacement system, a valve replacement device investigated by Medtronic, a company with a business site in Minneapolis, Minnesota. Device 200 may be a catheter for delivering or moving the implant to a selected location, such as at or near the mitral valve 226 within the heart 127 of a subject. Device 200, including catheter portion 208, may include a first portion 230 and a second portion 234. The two portions 230, 234 may be movable relative to each other, such as... Figure 3 As illustrated, the tracking device 66 can be positioned near the distal tip 214 of the second portion 234. Therefore, the tracking device 66 can be used to track the pose of the distal tip 214 of the instrument 200. When in such a position... Figure 2When exemplified in a proximal positioning (e.g., fully folded or retracted positioning), the pose of the tracking device 66 can be used to determine or understand the positioning of the capsule 212, since the capsule 212 is in a fixed position relative to the distal end 214. However, the capsule 212 can move distally toward the distal tip 214, such as relative to the piston 238. The piston 238 can be sealed relative to the inner wall 239 of the capsule 212. Fluid can be moved or propelled through a tube (also referred to as a moving member) 242 extending from the distal end 214. The tube 242 can be generally rigid, such that it extends along an axis 244 generally perpendicular to the plane 246 of the distal end 214 of the conduit portion 208. The capsule 212 can be sealed at the distal end, such that when fluid is propelled past the piston 238, the capsule will move along the axis 244. Thus, the capsule 212 can move axially relative to the distal end 214, such as generally moving along the axis 244 with one degree of freedom.

[0051] like Figure 3 As illustrated, the capsule 212 may be affected by a field emitted by the EM locator 94. Currents can be induced in the capsule 212 (such as in its conductive portions), and due to the induced currents in the capsule 212, one or more fields, such as those represented by field lines 250, can be generated. The induced field 250 may affect or be sensed by the tracking device 66.

[0052] refer to Figure 4 The device 200 can be provided in a first configuration (e.g., a proximity configuration), including when the capsule 212 is located at or near the mitral valve 226, such as Figure 3 As illustrated, the capsule 212 can encapsulate the implant 224, such as... Figure 4 As illustrated. Implant 224 can be positioned within capsule 212 to be released or delivered due to movement of capsule 212, such as Figure 3 As illustrated and discussed further herein, when the capsule 212 is completely removed from the implant 224 and is positioned at a selected distal location relative to the distal tip 214, the implant 224 may only be fully extended and / or positioned. Therefore, the understanding of the positioning of the capsule relative to the implant 224 can be selectively determined. When the implant 224 is completely released from the capsule 212, the positioning of the capsule 212 relative to the distal tip 214 can be predetermined, such as based on the size or anatomy of the implant 224.

[0053] like Figure 4As illustrated, the capsule 212 may include a dimension as a linear dimension 250. Dimension 250 may be predetermined or known. The initial positioning of the distal end or point 254 of the capsule 212 may be known relative to the tracking device 66. As discussed above, a piston 238 may be positioned within the capsule 212. In various embodiments, the piston 238 may be moved relative to the distal end 214 of the device 200 due to the pressure of fluid moving through the tube 242 and across the piston 238, thereby moving the capsule 212 relative to the distal end 214. In various embodiments, the piston 238 remains stationary relative to 214, and fluid pushes the capsule 212 out along the linear dimension 250 relative to the piston 238, end 214, and tracker 66. The capsule 212 is configured and is movable relative to the tracking device 66, which is fixed to the insertion portion 208 of the device 200. In the initial or collapsed configuration, as Figure 4 As illustrated, the size 250 of the capsule 212 may also be related to and / or the size of the distance between the distal point 254 of the capsule 212 and the tracking device 66.

[0054] Continue to refer to Figure 4 Referring also to FIG5, the capsule 212 is movable relative to the distal end 214. The capsule 212 can move because the piston 238 and fluid pass through the tube 242 generally in the direction of arrow 254. The volume between the piston 238 and the distal end 256 of the capsule can be filled with liquid to allow the capsule 212 to move away from the distal end 214. Therefore, the dimension of the distal end 256 relative to the distal end 214 can be changed. As illustrated in FIG5, the implant 224 can be partially released or exposed from the capsule 212. Dimension 258 can be defined between the distal end 214 and / or the tracking device 66 and the distal end 256.

[0055] As discussed above, the EM locator 94 can emit a field. The emitted field can interact with a capsule 212 that may be formed of or include a conductive material. The conductive material may be at least part of a wall 262. What is induced in the wall 262 can be an electric current, also referred to as an induced current or eddy current 264. The eddy current can also flow around the diameter of the capsule 212. The eddy current 264 can generate a field 268, which can also be referred to as an induced field. This field can supplement and / or distort the field generated by the EM locator 94. Thus, the induced field 268 can also be sensed by the locator 66, as schematically illustrated in FIG5. The field 268 generated by the induced eddy current 264 may be referred to herein as an interference field or an induced field to distinguish it from the field generated by the EM locator 94. However, those skilled in the art will understand that the field sensed by the tracking device 66 can include positively interacting (e.g., additive or subtractive) fields, such that the tracking device 66 senses a field generated due to a combination of various factors. However, based on the field generated using the EM locator 94 and the material and geometry of the capsule 212, the induced field from the capsule 212 can be known. Therefore, the induced eddy current 264 can be known and / or predetermined, making the interference field 268 sensed by the tracking device 66 also known.

[0056] Point 254, which can move with the capsule 212, can move relative to the distal end point 270, which can be located at the distal end of the piston 238. At the initial positioning, such as when the capsule 212 is in contact with the extension 208, the distal point 270 of the piston can extend substantially co-located with the distal point 254 of the capsule 212. However, as the capsule 212 moves, the distal point 254 moves away from the distal point 270 of the piston 238. Therefore, the induced current 264 of the field 268 generated in the capsule 212 may affect the tracking device 66. Distance 258 can be determined based on a measurement of a metric at the tracking device 66. This metric can be any suitable metric based on the selected tracking system. For example, the phase shift of the received signal can be determined, a change in the geometry sensed or determined by the tracking device can be determined, or other suitable metrics can be used. The phase shift can be the phase shift or phase change of the sensed EM signal of the signal sensed by the locator 94 by the tracking device 66. The change in geometry can refer to the change in the sensing geometry of the tracking portion of the tracking device 66.

[0057] For example, refer to Figure 5BThe tracking device may include multiple coils that can sense a field by inducing current therein. The coils may be positioned with a selected geometry, such as a first coil 280, a second coil 284, and a third coil 288. The coils may be placed substantially equidistant from each other (e.g., in a plane), but may also be positioned relative to each other in any three-dimensional configuration. For example, each coil may be wrapped around different (e.g., orthogonal axes) but have a common center point. Thus, the tracking device 66 is merely exemplary. However, the dimensions (such as equilateral dimensions) between each coil in the coil may be known or predetermined, such as a first dimension 290 between the first and second coils, a second dimension 292 between the first and third coils, and a third dimension 294 between the second and third coils. This geometry may be known and predetermined and stored in the navigation system, such as its memory module.

[0058] When the tracking device 66 senses a field, its geometry can be determined. In a known field, the geometry can be measured as substantially equilateral, as illustrated by the tracking device 66. However, under a selected or known distortion field or using a known secondary field, the measured or determined tracking device 66Z1 can be determined. The tracked device 66Z1 being measured may have each of the measured coils, such as a first measured coil 280', a second measured coil 284', and a third measured coil 288'. However, the measured or determined distance between each coil may not be an equilateral distance, but may be other distances, such as a first measured distance 290' between the first measured coil 280' and the second measured coil 284', a second measured distance 292' between the first measured coil 280' and the third measured coil 288', and a third measured distance 294' between the second measured coil 284' and the third measured coil 288'. Different distances may be the measures of measurement.

[0059] Three distances or orientations of the coil can be measured and compared with predetermined measurements based on predetermined distances to the capsule 212. Measurements of the capsule 212 and associated predetermined measurements of the columns (such as distances from the tracking device 66) can be stored in a memory module. Thus, for example, as... Figure 5B The geometry of the illustrated measurement tracking device 66Z1 can be compared with, for example... Figure 5AThe illustrated distance 258 is relevant. Therefore, if the geometry of the measurement by the tracking device 66Z1 is measured during surgery, the distance 258 can be determined, for example, via a lookup table. The determined distance 258 can be based on a pre-determined distance 258 and a pre-determined lookup table of the measured geometry 66Z1. Therefore, the icon or graphical representation displayed by the device 68i can illustrate the size 258 of the capsule 212.

[0060] Go to Reference Figure 6A and Figure 6B The capsule 212 can continue to move relative to the piston 238 in the direction of arrow 253. Similarly, the distal end or distal point 254 of the capsule can move relative to the distal point 270 of the piston 238. Figure 6A As illustrated, implant 224 can be completely released from capsule 212. Therefore, capsule 212 can be in a second positioning such that the distal end 256 is 300 units away from the distal end 214 of catheter portion 208. Similarly, tracking device 66 can be positioned or fixed to the distal end 214. However, as discussed above, capsule 212 may still be affected by the emission field from EM locator 94, inducing a current 264 therein, which further generates a sensing field 268. Sensing field 268 may still affect tracking device 66. However, when there is a distance 300 units between capsule 212 and tracking device 66, sensing field 268 may have different intensities or orientations, etc. Therefore, the sensing field can be as follows: Figure 6A The example illustrates a slightly modified field 268'. Similarly, the tracking device 66 can have various known and fixed geometries of the tracking coils or portions 280 to 288, such as... Figure 6B As illustrated. However, due to a slight alteration in the field 268', the sensed or measured tracking device 66Z2 can be measured. The measuring coils 280'', 284'', and 288'' can be used to measure the measurement relative to the quantities defined therein. The distances between these coils can include a first distance 290'', a second distance 292'', and a third distance 294''. These three distances 290'' to 294'' can also be predetermined based on the distance 300 of the capsule 212 in the field emitted by the EM locator 94. Therefore, similarly, when the measured tracking device 66Z2 is measured, a lookup table can be used to determine the size or location of the capsule 212, which can be determined to have a size 300 relative to the distal end 214. The determined location of the capsule 212 can then be illustrated on the display device 84, such as using a graphical representation 68i.

[0061] Therefore, in light of the foregoing, the tracking device 66 and the fields sensed therewith can be used to determine the pose of a portion of the instrument 68 that is not directly tracked by a tracking device (such as tracking device 66) to which it is attached. This portion, moving relative to tracking device 66, may affect the fields emitted by EM locator 94 and / or generate secondary fields, such as field 268, that can be sensed by tracking device 66. Metrics measured by the navigation system can be used to determine the pose of a movable portion (such as capsule 212) relative to tracking device 66. This metric can be used to determine the precise pose of the portion that has moved relative to tracking device 66, particularly when movement is restricted in various dimensions. For example, capsule 212 typically moves only along an axis in the direction of arrow 253. Therefore, the dimensions of capsule 212 relative to distal end 214 can be determined based on metrics measured by tracking device 66. In various embodiments, a measured and determined geometric metric can be used to determine a distance or a degree of freedom. According to various implementations, various techniques (such as those disclosed in U.S. Patent No. 11,439,317, U.S. Patent No. 11,571,261, U.S. Patent Application No. 2021 / 0330390, or U.S. Patent Application Publication No. 2021 / 0330391, all of which are incorporated herein by reference) can be used to measure the distortion field and determine the non-distortion field, and determine both the distortion geometry and the non-distortion geometry, and then determine the constant tracker positioning and orientation, as well as the capsule extension.

[0062] In various implementations, the average tracking position and orientation of the coil can remain substantially constant from configuration 66 to 66z1 to 66z2. As an example, the triangular plane and centroid can remain substantially constant from configuration 66 to 66z1 to 66z2, such that the determined position and orientation of the tracker 66 remain substantially constant as the capsule 212 moves away from the tracker 66.

[0063] By understanding the dimensions of the capsule 212, it can be determined that the implant 224 will be fully released from the device 68. It should be understood that any suitable implant to be released can be determined, and the positioning of various parts can be displayed on the display device.

[0064] also, Figure 5A and Figure 6A The illustrations can be displayed as graphic representations on display device 84 to illustrate the defined poses and navigation poses of various parts such as capsule 212, extension 208, or implant 224. It should also be understood that the representations can be related to the actual or patient spatial poses of the various parts, such as... Figure 3 As illustrated. Therefore, Figure 5A and Figure 6A The details and diagrams in the illustrations are exemplary representations of the actual or defined poses of the apparatus 68 and its parts.

[0065] The capsule 212 can be formed of a selected conductive material. For example, various steels or steel alloys can be used. Other conductive materials can also be disposed in the capsule 212. Furthermore, the capsule 212 may not be made entirely of a conductive material, but may have conductive portions formed therewith. For example, the capsule 212 may be formed of a polymer material having one or more conductive members or features, such as metal sheets, included therein. However, the conductive portions may have current induced therein, such as current 264, which can then emit or generate a field 268. This can allow the pose of a capsule or movable portion without a tracking device relative to a tracking device, such as tracking device 66, to be determined.

[0066] Continue to refer to Figure 1 In conjunction with the discussion above, and also refer to other resources. Figure 7 The device 320 is illustrated herein. Apart from the parts discussed herein, device 320 may be similar to device 68 as discussed above. Therefore, the discussion of device 320 may be related to and / or incorporated into the discussion of device 68 described above, and may include similar features. For example, device 320 may include an extendable or catheter member 324 and a relatively movable member or capsule 326. Capsule 326 may be similar to capsule 220 discussed above. Device 320 may also include a tracking device 66 disposed near the distal end 328 of the extendable portion 324. Capsule 326 may be formed of or comprise a conductive material, such as the conductive materials discussed above.

[0067] For further reference Figure 8A and Figure 8B The capsule 326 can be moved away from the distal end 328 of the catheter member 324. However, the tracking device 66 can be maintained at or near the distal end 328. The catheter member 324 can extend along axis 332. Axis 332 can be defined or known relative to the tracking device 66. Axis 332 can be referred to or understood as the long axis of the extendable device portion 324 and / or the tracking device 66. The capsule 326 can be moved away from the distal end 328 by an extension or actuating portion or drive portion 334. According to various embodiments, the extension or actuating portion 334 can move or actuate the capsule 326 away from the distal end 328, and / or the drive portion 334 can be a tube to apply or move fluid, thereby moving the capsule 326 away from the distal end or the end of the drive member 334, as discussed above. In any case, the capsule 326 can be moved a distance 338 from the distal end 328. Distance 338 can be measured from the distal end 340 of the capsule 336 to the distal end 328 of the extendable portion 324. Distance 338 can be measured along axis 332.

[0068] Additionally, the capsule 326 can move away from the axis 332. For example... Figure 8A As illustrated, for example, the capsule 326 may define or have an axis 344, and the capsule axis 344 may extend at an angle 348 to the axis 332. Therefore, the capsule 326 can move relative to the central axis 332 along an arc 352. The arc 352 can be defined by rotation of the capsule 326 relative to the central axis 332 (such as the direction of arrow 356). Thus, the pose of the capsule 326 may include at least two degrees of freedom, including distance 338 and angle 380, which can allow the capsule 326 to move in an arc with a pose relative to the tracking device 66. Therefore, in this example, the angle 348 can be considered fixed, such that the two determinable degrees of freedom may include the extended distance 338 and the rotation angle 380 about the arc 352. This can allow the navigation system to directly track the tracking device 66, whose pose may not be directly known by tracking the tracking device 66.

[0069] However, as discussed above, a current can be induced in the capsule or a portion of the capsule 326. The current can be represented by a current line or circle 360. Similar to the discussion above, a current can be induced in the conductive portion of the capsule 326. The induced current can generate a field 364 emitted or generated by the induced current 360. As discussed above, the field 364 can be sensed by the tracking device 66. A metric can be measured or determined at the tracking device 66 to aid in determining the pose of the capsule 326 relative to the tracking device 66. Again, this metric can be any suitable metric, such as those discussed above, including geometric change measurements. Other metrics may include one or more phase shifts, residuals, or other suitable metrics. However, the pose of the capsule 326 can be determined by measuring the metric at the tracking device 66. In other words, in this example, two or more measured and determined metric components or metrics can be used to determine various measurements, such as a distance and a rotation in one instance, or two degrees of freedom in another.

[0070] Similarly, the pose of the capsule 326 can be predetermined based on measurements. The determined pose may include both distance 338 and angle 380. Furthermore, when the capsule 326 rotates about axis 332 but the tracking device 66 remains in a single position, the angle 380 may be defined relative to the tracking device 66.

[0071] For example, referring to Figure 9, the capsule 326 can rotate relative to axis 332 in the direction of arrow 368. Therefore, axis 344 of capsule 326 can form an angle 384 about axis 332. Although angle 370 can be similar to or the same as angle 348, the arc positioning relative to tracking device 66 can be different, such as... Figure 9A and Figure 9B As illustrated, relative to Figure 8A and Figure 8B The arc positioning is illustrated. Therefore, due to the induction of current 360 and the field 364' generated by the inducing current 360, the arc positioning of the sac 326 can be determined again. Therefore, the pose of the sac 326 can be determined in at least two degrees of freedom, including the arc positioning and the distance from the tracking device 66. Similarly, the determined pose of the sac 326 can be determined in patient space and / or illustrated using graphical representations and images (such as the supply device 84). Therefore, the determined pose of the untracked or indirectly tracked portion can be determined in at least two degrees of freedom relative to the tracking device.

[0072] When extending from the distal end 328, the pose of the capsule 326 may include: Figure 8A and Figure 9A The distance between the two arcs shown is 338. However, as... Figure 8A and Figure 8B As illustrated, arc positioning along circle 352 can be illustrated as arc positioning 380 above tracking device 66. However, in Figure 9A and Figure 9B In the illustrated arc positioning, the capsule 326 can be positioned at arc positioning 384, which is illustrated as being below the tracking device 66. Relative arc positioning 380, 384 can be understood as the right, left, upper, or lower side of the tracking device 66, but can be predetermined or measured relative to the tracking device 66. Therefore, the corresponding fields 364, 364' can be based on both distance 338 and arc positioning. Furthermore, distance 338 can vary, similar to the various positioning of the capsule 212 discussed above.

[0073] Go to Reference Figure 10 and Figure 11 And continue to refer to Figures 7 to 9B An example is illustrated by device 390. Device 390 may include portions similar to those discussed above, such as an extendable portion 394 movable in a selected area, or a tracking device 66 that may extend along or define an axis 398. Furthermore, device 390 may include a movable or capsule member 402. Capsule 402 may extend along axis 404. Capsule 402 may have a distal end or portion 408. Distal end 408 may be movable relative to the distal end 412 of extendable portion 394. Axis 404 may define an angle 418 relative to axis 398. As discussed above, distal end 408 may also be movable a distance away from the distal end 412 of extendable member 394.

[0074] The capsule 402 may have a current 422 induced therein, which can generate a field 426 that can be sensed by the tracking device 66. Similar to what has been discussed above, sensing of the field 426 at the tracking device 66 can be used to determine a distance 430 and an arc length or position relative to the tracking device 66. Furthermore, according to various embodiments, the pushing or moving member 434 may be flexible and allow the capsule 402 to be positioned at different angles relative to the axis 398. Thus, the angle 418 can also be specifically determined. Therefore, the navigation system can determine three degrees of freedom of the pose of the capsule 402 relative to the tracking device 66. Thus, as discussed above, the capsule 402 can be positioned relative to the distal end 412 and in three degrees of freedom, including a distance 430, an angle 418, and an arc length or position, such as arc 352.

[0075] Therefore, refer to Figure 11 Angle 438 can be different from angle 418 between axis 404 and axis 398 of device 390. Distance and arc displacement can be the same, but angles can be different. Therefore, when the moving or propelling member 434 is flexible, the capsule 402 can also be at different angles.

[0076] Therefore, according to various embodiments, the device 390 may have three degrees of freedom of movement of the capsule 402 relative to the tracking device 66, which can be determined relative to the tracking device 66. In other words, three or more measured and determined metric components or measures can be determined to define the three degrees of freedom (e.g., angles or dimensions). Similarly, the device 390 may include features similar to those of the device 68 discussed above, and Figure 10 and Figure 11 The schematic diagram can represent the physical or patient spatial positioning of various parts of the device 390 and / or its graphical representation. Therefore, the pose or positioning of the capsule 402 can be determined relative to the tracking device.

[0077] The navigation system 20 can be used to track the tracking device to represent and determine the pose of the capsule 402. Similarly, the pose of the capsule 402 can be determined based on the fields 426, 426' generated by the induced current 422. Metrics can be measured or determined at the tracking device 66 based on the fields 426, 426' generated by the capsule portion 402. This allows the pose of the capsule portion 402 relative to the tracking device 66 to be determined, even though the capsule portion 402 is not directly tracked by the tracking device to which it is directly attached.

[0078] Go to Reference Figure 12As discussed above, device 68 can be configured in a variety of ways. For example, the device may include the steerable catheter assembly 200, the steerable catheter 220, and / or the steerable catheter 390 discussed above. In each of the various exemplary embodiments, device 68 may be provided with at least a first portion having a tracking device attached thereto and a second portion without the tracking device attached thereto, the second portion being movable relative to the first portion including the tracking device. According to various embodiments, the device can be substantially inserted into the patient's body, such as inserting a steerable catheter into the heart 127 in various embodiments; however, the device does not need to be fully inserted into the subject's internal organs. For example, various suture, stitch, and fixation systems can be used. For example, Signia, sold by Medtronic, can be used. ™ or Endo GIA ™ Suturing system.

[0079] Depending on the implementation, the suture device can have various configurations or parts, such as Figure 12 As exemplified. According to Figure 12 Various embodiments of the device 460 are illustrated in the diagram. The stapler 460 may include a first stapler 464 comprising a handle or gripping area 468 and a movable or suturing area 472. The movable area 472 may typically be movable and / or have a portion capable of moving relative to the tracking device 66, which may be connected to a shaft 474 extending from the handle. The stapler assembly 464 may include a first portion 478 that is substantially immovable relative to the shaft 474 and typically remains aligned with the axis 480 of the shaft. Thus, the distal tip point 484 (also referred to as the principal point) may typically be known at a fixed pose relative to the tracking device 66. However, a second portion or jaw 486 may be movable relative to the first jaw portion 478 at a pivot point 488. Therefore, an angle 490 may be formed between the first jaw 478 and the second jaw 486. The angle 490 may vary as the device 464 is manipulated during use.

[0080] The measurement point or metric point 494 can be determined relative to any other part of the tracking device 66 and / or the instrument 464 in a manner similar to that discussed above. For example, the EM positioner 94 can generate a field that induces a current in at least the second jaw portion 486. When the jaw portion moves to form an angle 490, causing point 494 to move along arc 496, the induced current 498 can generate a field 500 similar to the field discussed above. Field 500 can be sensed by the tracking device 66. Therefore, the metric measured at the tracking device 66 can include the metrics discussed above. The pose of the metric point or metric point 494 can then be determined based on the measurement of the metric at the tracking device 66. This can allow the pose of at least the second jaw 486 relative to a portion of the instrument 464, such as the first jaw 478.

[0081] Tracking the measurement point 494 allows for determination of the pose of the two distal portions of the instrument 464. This tracking also helps ensure appropriate tissue is captured for suturing or manipulation using the instrument 464. Furthermore, this tracking can be used to confirm that a selected distance or pose has been achieved between the various portions of the instrument 464, such as ensuring that the second jaw 486 moves sufficiently close to the first jaw 478 to suture selected tissue. Similarly, the pose of the various jaws of the instrument 464 allows for confirmation or execution of the procedure.

[0082] To assist in surgery (such as confirming surgery), various outputs can be made. Position can be illustrated on the display device 84. Additionally, other outputs can be provided, such as confirmation signals (including visual or audio signals), indicating that the selected gap has closed or has traversed an angle or arc length to confirm a specific operation of the instrument 464.

[0083] According to various embodiments, instrument 68 may include an instrument operable at a handle having a distal portion that includes a movable portion movable relative to tracking device 66. The various movable portions may include a single movable portion or multiple movable portions. Furthermore, the movable portion may be fixed in place relative to the spindle and / or may be capable of movement relative to the spindle. However, even if the tracking device is not directly connected to the movable portion, measurements taken at tracking device 66 can be used to determine the pose of the movable portion relative to tracking device 66. Therefore, the pose of the movable portion can be navigated during surgery, and the pose can be output, such as by displaying it graphically on display device 84.

[0084] Therefore, continue to refer to Figure 12Various other instruments similar to instrument 464 may be provided. For example, instrument 520 may also include a handle portion 524 similar to handle portion 468 and a shaft portion 526 similar to shaft portion 474 to which tracking device 66 is connected. The shaft may extend along an axis 528 that is substantially immovable relative to handle portion 524. However, instrument 520 may include two jaws or movable members, including a first movable member 532 and a second movable member 534. The two movable members may be movable relative to pivot portion 536 of instrument 520.

[0085] like Figure 12 As illustrated, each of the jaws 532, 524 can move relative to axis 528 along a corresponding arc or arc length. The first jaw 532 can move along arc 540 or be variably positioned along an arc, and the second jaw 534 can move along a second arc 544. The principal point 548 relative to the tracking device 66 can be known or predetermined. Since axis 526 is substantially stationary relative to the tracking device 66, the principal point 548 can generally be known and fixed relative to the tracking device 66. However, one or more measurement points or measurement points 552 and 554, respectively measured relative to the two movable jaws 532, 534, can be determined based on or using measurements of the metrics at the tracking device 66. The two jaws 532, 534 can have currents induced therein, which can generate fields that can be measured at the tracking device 66, similar to the discussion above. Therefore, the pose of the two jaws 532, 534 can be determined based on measurements of the metrics at the tracking device 66. Therefore, similarly, the poses of the two jaws 532, 534 can be known or determined based on measurements of metrics, and allow for navigation during surgery.

[0086] Continue to refer to Figure 12The instrument 460 may include an instrument 570. Instrument 570 may also include a handle 574 similar to the handle 524 discussed above, a shaft 576 similar to the shaft 526 discussed above, and a tracking device 66 connected to the shaft 576. As discussed above, the shaft 576 may extend relative to the tracking device 66 along an axis 578. The instrument 570 may include two jaws or components, including a first jaw 580 and a second jaw 584. Each of these jaws may be movable relative to each other and / or the axis at a pivot point or joint 588. Thus, for example, the first jaw 580 may be movable relative to the axis 578 along an arc 590, and the second jaw 584 may be movable relative to the axis 578 along an arc 594. Each of the jaws 580, 584 may be movable independently and separately relative to the axis 578 along a corresponding arc 590, 594. However, in various configurations, the two jaws can move together relative to axis 578 along any arc (such as arc 594'). Therefore, the pose of the two jaws can be determined individually or together based on measurements of the metric.

[0087] Similarly, when the tracking device is connected to a typically non-flexible or immovable axis 576, the principal point or initial point 600 can be defined as a fixed point relative to the tracking device 66. The pose of the jaws 580, 584 can be determined together or separately based on the measurement points 604, 606 of the respective jaws 580, 584 or a single measurement point 610 of both jaws 580, 584 together. The pose of the jaws 580, 584 at the respective measurement points 604, 606, 610 can also be determined based on the field generated by the induced current in the jaws, which can be sensed at the tracking device 66. Similarly, the EM positioner 94 can generate a field of induced current in the jaw portions 580, 584. Therefore, due to the field generated by the induced current in the jaws 580, 584, the pose of the jaws changing relative to the tracking device 66 can be measured.

[0088] According to various embodiments of the device discussed above, the field can be generated by a portion of the tracking device that is not directly connected to it. Thus, a portion such as a jaw or capsule can move relative to the tracking device, while the tracking device remains stationary in the subject or navigation space. The moving portion can have an induced current therein, which generates the field. According to the various embodiments discussed above, the field generated by the induced current in the moving portion may affect the measurement of a metric at tracking device 66. This effect at tracking device 66 may be a metric, or may include a metric of the measurement. The measurement of the metric can be used to determine the pose of the moving portion at appropriate times, such as during movement or after it has stopped. The determined pose of the moving portion can be based on a predetermined pose and the measurement of the metric, which may be predetermined and stored in a lookup table or other suitable memory system. Thus, when the metric is measured, the metric value can be compared with the lookup table to determine the pose of the moving portion. Therefore, the moving portion does not need to have a tracking device directly connected to it to allow the pose of the moving portion to be determined.

[0089] In various implementations, the lookup table may include a selected number of specific poses (e.g., position and orientation) of the movable part relative to the tracking device 66. Each pose in the lookup table can be associated with a measurement of a metric. Thus, a measurement of a metric is associated with a pose of the movable part. However, a measurement of a metric may not perfectly match only one predetermined measurement of the metric. For example, the stored measurement values ​​may include 1, 2, and other values, but the measurement value could be 1.6. Therefore, a system (such as a processor module executing instructions) can interpolate between at least two values ​​to determine the possible pose of the movable part during navigation. For example, the system may determine that the movable part lies between poses associated with measurement values ​​1 and 2, but is 60% closer to the pose of measurement value 2.

[0090] Depending on the implementation, one or more metric parameters can be stored in discrete lookup tables for one or more pose degrees of freedom. Interpolation can be performed between or within these tables using single or multiple variables, linear or nonlinear, global or local functions, splines, or other interpolations.

[0091] Depending on the implementation, a model (e.g., the interpolation described above) can be generated. This model can describe one or more relationships between single or multiple metric parameters and single or multiple pose degrees of freedom.

[0092] Go to Reference Figure 13The illustration illustrates a method or process 700. Method 700 can be used to assist in the performance of surgery to determine the pose of an instrument or a portion of an instrument without a tracking device connected to or attached thereto. As discussed above, the tracking device can be attached to at least a portion of the instrument, and the second portion can be movable relative to the tracking device. The second portion can be a capsule, a movable jaw, or any suitable part. Navigation can be performed on the second or movable portion when no tracking device is directly connected to it. Therefore, the discussion of a capsule herein is merely an example of a movable portion that may have a current in which a generated field is induced.

[0093] Method or process 700 may begin in start box 704. Method 700 may then include loading an implant into the device as an optional step. As discussed above, the device may include an implant delivery system, so loading the implant box 708 may be an optional step. Method 700 may then include positioning the capsule relative to the tracking device at a first location in box 710. Positioning the capsule at the first location may include attaching or holding the capsule relative to a device (such as device 200) at the first location. This may include the time when the capsule is being moved or before the capsule is being moved to the selected implant location. Then, in box 712, the device may be moved to the selected location. Moving the device to the selected location may include moving the device, such as device 200, relative to the heart 127. Movement of the device may include moving the entire device, including the capsule at the first location relative to the tracking device.

[0094] At a selected point, within box 714, the capsule can be moved relative to the tracking device, such as to a second positioning. Moving the capsule relative to the tracking device can include moving the capsule relative to itself or pumping fluid, as discussed above. This can allow the capsule to move relative to another part of the device, such as a portion including the tracking device, as discussed above. Movement of the capsule can include moving the capsule from a proximal positioning near the tracking device to a distal positioning away from the tracking device. Thus, the capsule can include at least two poses relative to the tracking device. However, the movable portion can include multiple distal poses, as discussed above.

[0095] Process 700 may include, generally, moving parts of an instrument for various purposes, such as moving an instrument with an implant relative to a human subject. Thus, process 700 may include at least one subroutine or portion 720 comprising steps or elements as discussed above, including optionally loading the implant in block 708, positioning the capsule relative to the tracking device at a first location in block 710, moving the instrument to a selected location in block 712, and moving the capsule relative to the tracking device to a second location in block 714. A navigation system including tracking device 66 can be used to substantially directly track the instrument while it has a capsule in the first location relative to the tracking device. As discussed above, moving the capsule relative to the tracking device to (or at least one) a second location allows the navigation system to measure metric. Thus, once the capsule has moved from the first location discussed above, the navigation system can execute various instructions to determine the capsule's pose, and execute various instructions at least according to portions of subroutine 730. In subroutine 730, in block 734, a signal can be received from the tracking device based on sensing by the tracking device. In block 736, a measurement of the metric can be determined. The metric can be any suitable metric, such as those discussed above. The determination of the metric can be based on the measurement or received sensing measurement and / or calculations based on that sensing measurement. For example, as discussed above, a field can be measured using the tracking device 66. The metric can be based on a field measurement, such as based on an induced current in the capsule or a field generated due to an induced current in the capsule.

[0096] Based on the determined metrics, the cyst's invocation pose can be made in box 740. Similarly, as discussed above, the cyst's pose can be predetermined based on various measured or determined metrics. Therefore, once the metrics are determined in box 736, the pose can be invoked. Invocation may include using a lookup table that compares the determined measurements of the metrics with the predetermined metric measurements and associated poses.

[0097] Once a pose is invoked in box 740, it can be output in box 744. Similarly, an output pose can be invoked and / or determined. For example, the pose can be based on interpolation between at least two predetermined measurements of a metric and the associated pose. Outputs can include a variety of outputs, such as visual indications of the pose of the capsule, or graphical representations on display device 84. Other outputs can include audio or visual confirmations of predetermined poses, such as the proximity of the instrument's jaws.

[0098] Regardless, after outputting the pose based on the measured metric in block 736, it can be determined in block 748 whether the capsule has been moved. Determining whether the capsule has been moved in block 748 can be based on various processes. For example, a user can input that the capsule has been moved, such as by using appropriate input. Alternatively, the system can sense that the capsule has been moved, such as by using a metric or signal change received from the tracking device, such as by using continuous or constant measurements. In any case, if it is determined that the capsule has been moved, a "yes" path 750 can be followed to receive a signal from the tracking device's sensing in block 734. Therefore, process 730 can be iterated to allow continuous updates to the capsule's pose. The updates can be substantially real-time and can allow continuous iteration until the user has provided input that the capsule has stopped moving or is not moving.

[0099] If it is determined that the capsule has not been moved, a "No" path 752 can be followed. The "No" path 752 can include optional confirmation of the capsule's pose relative to the plan in box 758. For example, as discussed above, the capsule can be used to assist in positioning implant 224. Thus, the user can confirm that the capsule is in a selected pose relative to the tracking device, such as a pre-planned and / or determined pose, before ending the procedure. In other words, navigation of a movable portion (e.g., the capsule) can allow confirmation of a selected portion of the procedure (e.g., implant placement) without further analysis, such as image data capture. However, after determining that the capsule will no longer move by following path 752, process 700 can end in end box 760. However, if the capsule is not in the confirmed pose, the process can be iterated again to receive additional signals in box 734 if selected.

[0100] Therefore, as discussed above, the system can be used to track a portion of an instrument that is not directly connected to a tracking device. The system can execute instructions similar to or including instructions for at least a portion of forming method 700, such as the positioning determination subroutine 730. The navigation system may include a processor that executes instructions to perform the steps discussed above to allow determination (such as substantially automatic determination) of the pose of a portion of the instrument (such as a capsule). Therefore, the system discussed above can allow substantially automatic determination by executing instructions similar to those discussed above.

[0101] Depending on the implementation, the ultrasound probe can emit or transmit ultrasound waves in a selected mode or plane. The plane can be a shape understood by those skilled in the art. The plane is typically capable of acquiring data in the field of view to generate an image (also referred to as an acoustic map when an image is generated based on ultrasound data).

[0102] Example

[0103] 1. A system for navigating an instrument relative to a subject for surgical purposes, the system comprising: an instrument having a first instrument portion and a second instrument portion, the second instrument portion having an interference portion; a tracking device connected to the first instrument portion, wherein the tracking device includes at least one field sensor, and wherein the second instrument portion is movable relative to the tracking device; wherein at least the interference portion of the second instrument portion is configured to generate an interference field based on the interference portion; a navigation processor configured to execute instructions to: receive a field signal from the tracking device based at least in part on sensing the interference field at the at least one field sensor; determine a pose of the second instrument portion relative to the tracking device based on the received interference field signal; evaluate the determined pose relative to a planned final pose; and output the evaluation result of the determined pose relative to the planned final pose.

[0104] 2. The system of claim 1, further comprising: an electromagnetic (EM) locator configured to generate a locator field; wherein the locator field induces an interference field in the interference portion of the second instrument portion.

[0105] 3. The system of claim 2, wherein the second instrument portion is configured to move from a proximity location to a distance location; wherein the interference field sensed by the tracking device varies between the proximity location and the distance location.

[0106] 4. The system of claim 2, wherein the interference field signal changes with the change of the interference field sensed by the tracking device; wherein a measurement of the metric performed using the tracking device is determined based on the interference field signal.

[0107] 5. The system of claim 2, further comprising: an implant configured to be carried by the device; wherein the planned final pose allows the implant to be positioned within the subject; wherein the measurement of the metric is operable to confirm the planned final pose.

[0108] 6. The system of claim 2, further comprising: wherein the first portion of the instrument and the second portion of the instrument are hingedly movable relative to each other.

[0109] 7. The system of claim 1, further comprising: a display device configured to display a graphical representation based on an output evaluation result of the determined pose relative to the planned final pose.

[0110] 8. The system of claim 1, further comprising: an audio output system configured to emit audible sound based on an output evaluation result of the determined pose relative to the planned final pose.

[0111] 9. A method for navigating an instrument relative to a subject for surgical purposes, the method comprising: providing an instrument having a first instrument portion and a second instrument portion; providing the second instrument portion having an interference portion and being movable relative to the first instrument portion, wherein at least the interference portion of the second instrument portion is configured to generate an interference field based on the interference portion; providing a tracking device having at least one field sensor connected to the first instrument portion, wherein the tracking device includes: configuring a navigation processor to execute instructions for: receiving a field signal from the tracking device based at least in part on sensing an interference field at the at least one field sensor; determining a pose of the second instrument portion relative to the tracking device based on the received interference field signal; evaluating the determined pose relative to a planned final pose; and outputting an evaluation result of the determined pose relative to the planned final pose.

[0112] 10. The method of claim 9, further comprising: providing an EM locator configured to generate a locator field; and configuring the locator field to generate an interference field from an interference portion of the second instrument portion.

[0113] 11. The method of claim 10, further comprising: configuring the second instrument portion to move from a proximity location to a distance location; wherein the interference field sensed by the tracking device varies between the proximity location and the distance location.

[0114] 12. The method of claim 11, further comprising: measuring and determining a metric based at least on a signal from the tracking device; wherein the measurement and determination of the metric are included in the interference field signal, and the interference field signal varies with changes in the interference field sensed by the tracking device.

[0115] 13. The method of claim 12, further comprising: selecting the metric from at least one of a geometry determination of the tracking device or one or more phase shift determinations at the tracking device.

[0116] 14. The method of claim 12, further comprising: providing an implant to be carried by the device; configuring the implant such that the planned final pose allows the implant to be positioned within the subject; and confirming the planned final pose by means of the measurement of the metric.

[0117] 15. The method of claim 12, further comprising: providing a pin to be carried by the instrument; configuring the pin such that the planned final pose allows the pin to be positioned within the subject; and confirming the planned final pose by means of the measurement of the metric.

[0118] 16. The method of claim 9, further comprising: providing a display device for displaying a graphical representation based on an output evaluation result of the determined pose relative to the planned final pose.

[0119] 17. The method of claim 9, further comprising: providing an audio output system configured to emit audible sound based on an output evaluation result of the determined pose relative to the planned final pose.

[0120] 18. A method for navigating an instrument having a first instrument portion and a second instrument portion relative to a subject for surgical purposes, the method comprising: receiving a field signal from the tracking device based at least in part on sensing an interfering field in at least one field sensor of the tracking device; determining a measurement of a metric based on the interfering field signal; determining a current pose of the second instrument portion relative to the tracking device based on the determined measurement; evaluating the determined current pose relative to a planned final pose; and outputting the evaluation result of the determined current pose relative to the planned final pose.

[0121] 19. The method of claim 18, further comprising: providing the instrument having a first instrument portion and a second instrument portion, the second instrument portion having an interference portion; providing the tracking device connected to the first instrument portion; and providing a navigation processor configured to execute instructions.

[0122] 20. The method of claim 19, further comprising: providing an implant configured to be carried by the device; wherein the planned final pose allows the implant to be positioned within the subject; wherein the measurement of the metric is operable to confirm the planned final pose.

[0123] 1. A system for navigating an instrument relative to a subject for surgical purposes, the system comprising: an instrument having a first instrument portion and a second instrument portion, the second instrument portion having an interference portion; a tracking device connected to the first instrument portion, wherein the tracking device includes at least one field sensor, and wherein the second instrument portion is movable relative to the tracking device; wherein at least the interference portion of the second instrument portion is configured to generate an interference field based on the interference portion; a navigation processor configured to execute instructions to: receive a field signal from the tracking device based at least in part on sensing the interference field at the at least one field sensor; determine a pose of the second instrument portion relative to the tracking device based on the received interference field signal; evaluate the determined pose relative to a planned final pose; and output the evaluation result of the determined pose relative to the planned final pose.

[0124] 2. The system of claim 1, further comprising: an electromagnetic (EM) locator configured to generate a locator field; wherein the locator field induces an interference field in the interference portion of the second instrument portion.

[0125] 3. The system of claim 2, wherein the second instrument portion is configured to move from a proximity location to a distance location; wherein the interference field sensed by the tracking device varies between the proximity location and the distance location.

[0126] 4. The system of claim 2, wherein the interference field signal changes with the change of the interference field sensed by the tracking device; wherein a measurement of the metric performed using the tracking device is determined based on the interference field signal.

[0127] 5. The system of claim 2, further comprising: an implant configured to be carried by the device; wherein the planned final pose allows the implant to be positioned within the subject; wherein the measurement of the metric is operable to confirm the planned final pose.

[0128] 6. The system of claim 2, further comprising: wherein the first portion of the instrument and the second portion of the instrument are hingedly movable relative to each other.

[0129] 7. The system of claim 1, further comprising: a display device configured to display a graphical representation based on an output evaluation result of the determined pose relative to the planned final pose.

[0130] 8. The system of claim 1, further comprising: an audio output system configured to emit audible sound based on an output evaluation result of the determined pose relative to the planned final pose.

[0131] 9. A method for navigating an instrument relative to a subject for surgical purposes, the method comprising: providing an instrument having a first instrument portion and a second instrument portion; providing the second instrument portion having an interference portion and being movable relative to the first instrument portion, wherein at least the interference portion of the second instrument portion is configured to generate an interference field based on the interference portion; providing a tracking device having at least one field sensor connected to the first instrument portion, wherein the tracking device includes: configuring a navigation processor to execute instructions for: receiving a field signal from the tracking device based at least in part on sensing an interference field at the at least one field sensor; determining a pose of the second instrument portion relative to the tracking device based on the received interference field signal; evaluating the determined pose relative to a planned final pose; and outputting an evaluation result of the determined pose relative to the planned final pose.

[0132] 10. The method of claim 9, further comprising: providing an EM locator configured to generate a locator field; and configuring the locator field to generate an interference field from an interference portion of the second instrument portion.

[0133] 11. The method of claim 10, further comprising: configuring the second instrument portion to move from a proximity location to a distance location; wherein the interference field sensed by the tracking device varies between the proximity location and the distance location.

[0134] 12. The method of claim 11, further comprising: measuring and determining a metric based at least on a signal from the tracking device; wherein the measurement and determination of the metric are included in the interference field signal, and the interference field signal varies with changes in the interference field sensed by the tracking device.

[0135] 13. The method of claim 12, further comprising: selecting the metric from at least one of a geometry determination of the tracking device or one or more phase shift determinations at the tracking device.

[0136] 14. The method of claim 12, further comprising: providing an implant to be carried by the device; configuring the implant such that the planned final pose allows the implant to be positioned within the subject; and confirming the planned final pose by means of the measurement of the metric.

[0137] 15. The method of claim 9, further comprising: receiving a field signal from the tracking device based at least in part on sensing an interfering field in at least one field sensor of the tracking device; determining a measurement of a metric based on the interfering field signal; determining a current pose of the second instrument portion relative to the tracking device based on the determined measurement; evaluating the determined current pose relative to a planned final pose; and outputting the evaluation result of the determined current pose relative to the planned final pose.

[0138] Example embodiments are provided to make this disclosure thorough and to fully communicate the scope of this disclosure to those skilled in the art. Numerous specific details, such as examples of particular components, apparatus, and methods, are set forth to provide a thorough understanding of embodiments of this disclosure. It will be apparent to those skilled in the art that specific details are not required, 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.

[0139] Instructions can be executed by a processor and can include software, firmware, and / or microcode, and can refer to programs, routines, functions, classes, data structures, and / or objects. The term "shared processor circuitry" covers a single processor circuitry that executes some or all of the code from multiple modules. The term "group processor circuitry" covers processor circuitry that, in conjunction with additional processor circuitry, executes some or all of the code from one or more modules. References to multiple processor circuitry cover multiple processor circuitry on a discrete die, multiple processor circuitry on a single die, multiple cores of a single processor circuitry, multiple threads of a single processor circuitry, or a combination thereof. The term "shared memory circuitry" covers a single memory circuitry that stores some or all of the code from multiple modules. The term "group memory circuitry" covers memory circuitry that, in conjunction with additional memory, stores some or all of the code from one or more modules.

[0140] The apparatus and methods described in this application may be implemented, in part or in whole, by a processor (also referred to as a processor module), which may include a special-purpose computer (e.g., created by configuring a processor) and / or a general-purpose computer for performing one or more specific functions embodied in a computer program. The computer program includes processor-executable instructions stored on at least one non-transitory, tangible computer-readable medium. The computer program may also include or depend on stored data. The computer program may include a basic input / output system (BIOS) that interacts with the hardware of the special-purpose computer, a device driver that interacts with a specific device of the special-purpose computer, one or more operating systems, user applications, background services, background applications, etc.

[0141] Computer programs may include: (i) assembly code; (ii) object code generated from source code by a compiler; (iii) source code for execution by an interpreter; (iv) source code for compilation and execution by a just-in-time (JIT) compiler; and (v) descriptive text for parsing, such as HTML (Hypertext Markup Language) or XML (Extensible Markup Language). As an example only, source code may be in C, C++, C#, Objective-C, Haskell, Go, SQL, Lisp, or Java. ® ASP, Perl, Javascript ® HTML5, Ada, Active Server Pages (ASP), Perl, Scala, Erlang, Ruby, Flash ® Visual Basic ® Lua or Python ® To write it.

[0142] Communication may include the wireless communications described in this disclosure, which may be wholly or partially compliant with IEEE Standard 802.11-2012, IEEE Standard 802.16-2009, and / or IEEE Standard 802.20-2008. In various specific implementations, IEEE 802.11-2012 may be supplemented by draft IEEE Standard 802.11ac, draft IEEE Standard 802.11ad, and / or draft IEEE Standard 802.11ah.

[0143] The terms processor, processor module, module, or “controller” are used interchangeably herein (unless otherwise specifically indicated), and each may be replaced by the term “circuit”. Any of these terms may refer to, be part of, or include the following: application-specific integrated circuit (ASIC); digital, analog, or mixed-signal analog / digital discrete circuit; digital, analog, or mixed-signal analog / digital integrated circuit; combinational logic circuit; field-programmable gate array (FPGA); processor circuitry (shared, dedicated, or grouped) that executes code; memory circuitry (shared, dedicated, or grouped) that stores code executed by the processor circuitry; other suitable hardware components that provide the described functionality; or some or all of the foregoing, such as in a system-on-a-chip.

[0144] Instructions can be executed by one or more processors or processor modules, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Therefore, the terms "processor" or "processor module" as used herein can refer to any of the foregoing structures or any other physical structure suitable for implementing the described techniques. Furthermore, these techniques can be fully implemented in one or more circuit or logic elements. The one or more processors can operate fully automatically and / or substantially automatically. In automatic operation, the processor can execute instructions based on received inputs and in accordance with received inputs. Therefore, various outputs can be made without additional or any manual (e.g., user) input.

[0145] The foregoing description of embodiments has been provided for illustrative and descriptive purposes. The foregoing description is not intended to be exhaustive or limiting of the invention. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable and may also be used in chosen embodiments where applicable, even if not specifically shown or described. The same element or feature may be varied in many ways. Such variations are not considered to depart from the invention, and all such modifications are intended to be included within the scope of the invention.

[0146] Example 1. A system for navigating an instrument relative to a subject to perform surgery, the system comprising: An instrument having a first instrument portion and a second instrument portion, the second instrument portion having an interference portion; A tracking device connected to a first instrument portion, wherein the tracking device includes at least one field sensor, and wherein the second instrument portion is movable relative to the tracking device; wherein at least the interference portion of the second instrument portion is configured to generate an interference field based on the interference portion; Navigation processor, the navigation processor being configured to execute instructions to: The field signal is received from the tracking device based at least in part on the sensing of the interference field at the at least one field sensor. The pose of the second instrument portion relative to the tracking device is determined based on the received interference field signal. The determined pose is evaluated relative to the planned final pose, and Output the evaluation result of the determined pose relative to the final pose of the plan.

[0147] Example 2. The system according to Example 1, the system further includes: An electromagnetic (EM) locator configured to generate a locator field; The locator field induces an interference field in the interference portion of the second instrument part.

[0148] Example 3. The system according to Example 2, wherein the second instrument portion is configured to move from a proximity positioning to a distance positioning; The interference field sensed by the tracking device varies between the near location and the far location.

[0149] Example 4. The system according to Example 2, wherein the interference field signal changes with the change of the interference field sensed by the tracking device; The measurement of the metric is determined using the tracking device based on the interference field signal.

[0150] Example 5. The system according to Example 2, the system further includes: An implant, the implant being configured to be carried by the device; The final orientation of the plan allows the implant to be positioned within the subject's body; The measurement of the metric is operable to confirm the final pose of the plan.

[0151] Example 6. The system according to Example 2, the system further includes: The first part and the second part of the device are hinged relative to each other.

[0152] Example 7. The system according to Example 1, the system further includes: A display device configured to display a graphical representation based on an output evaluation result of the determined pose relative to the planned final pose.

[0153] Example 8. The system according to Example 1, the system further includes: An audio output system configured to emit audible sound based on an evaluation result output from the determined pose relative to the planned final pose.

[0154] Example 9. A method for navigating an instrument relative to a subject to perform surgery, the method comprising: An apparatus is provided, the apparatus having a first apparatus portion and a second apparatus portion; A second instrument portion is provided, the second instrument portion having an interference portion and being movable relative to the first instrument portion, wherein at least the interference portion of the second instrument portion is configured to generate an interference field based on the interference portion; A tracking device is provided, the tracking device having at least one field sensor connected to the first instrument portion, wherein the tracking device includes; Configure the navigation processor to execute instructions for: The field signal is received from the tracking device based at least in part on the sensing of an interference field in the at least one field sensor. The pose of the second instrument portion relative to the tracking device is determined based on the received interference field signal. The determined pose is evaluated relative to the planned final pose, and Output the evaluation result of the determined pose relative to the final pose of the plan.

[0155] Example 10. The method according to Example 9, the method further includes: An EM locator is provided, the EM locator being configured to generate a locator field; The locator field is configured to generate an interference field from the interference portion of the second instrument part.

[0156] Example 11. The method according to Example 10, the method further includes: The second instrument portion is configured to move from a nearby positioning location to a distant positioning location; The interference field sensed by the tracking device varies between the near location and the far location.

[0157] Example 12. The method according to Example 11, the method further includes: Metrics are measured and determined at least based on signals from the tracking device; The measurement and determination of the metric are included in the interference field signal, and the interference field signal changes as the interference field sensed by the tracking device changes.

[0158] Example 13. The method according to Example 12, the method further includes: The metric is selected from at least one of the following: determination of the geometry of the tracking device or determination of one or more phase shifts at the tracking device.

[0159] Example 14. The method according to Example 12, the method further includes: Provide an implant to be carried by the device; The implant is configured such that the planned final orientation allows the implant to be positioned within the subject's body; The final pose of the plan is confirmed by measuring the metric.

[0160] Example 15. The method according to Example 12, the method further includes: Provide the nail to be carried by the instrument; The pin is configured such that the planned final pose allows the pin to be positioned within the subject's body; The final pose of the plan is confirmed by measuring the metric.

[0161] Example 16. The method according to Example 9, the method further includes: A display device is provided for displaying a graphical representation based on an output evaluation result of the determined pose relative to the planned final pose.

[0162] Example 17. The method according to Example 9, the method further includes: An audio output system is provided, the audio output system being configured to emit audible sound based on an evaluation result output from the determined pose relative to the final pose of the plan.

[0163] Example 18. A method for navigating an instrument having a first instrument portion and a second instrument portion relative to a subject to perform surgery, the method comprising: The field signal is received from the tracking device based at least in part on sensing an interference field in at least one field sensor of the tracking device. The measurement of the metric is determined based on the interference field signal; The current pose of the second instrument portion relative to the tracking device is determined based on the determined measurements. The determined current pose is evaluated relative to the planned final pose, and Output the evaluation result of the determined current pose relative to the planned final pose.

[0164] Example 19. The method according to Example 18, the method further includes: The device is provided, the device having a first device portion and a second device portion, the second device portion having an interference portion; Provides the tracking device connected to the first instrument section; and A navigation processor is provided, which is configured to execute instructions.

[0165] Example 20. The method according to Example 19, the method further includes: An implant is provided, the implant being configured to be carried by the device; The final orientation of the plan allows the implant to be positioned within the subject's body; The measurement of the metric is operable to confirm the final pose of the plan.

Claims

1. A system for navigating instruments relative to a subject to perform surgery, the system comprising: An instrument having a first instrument portion and a second instrument portion, the second instrument portion having an interference portion; A tracking device connected to the first instrument part, wherein the tracking device includes at least one field sensor, and wherein the second instrument part is movable relative to the tracking device; At least the interference portion of the second instrument part is configured to generate an interference field based on the interference portion; Navigation processor, the navigation processor being configured to execute instructions to: The field signal is received from the tracking device based at least in part on the sensing of the interference field at the at least one field sensor. The pose of the second instrument portion relative to the tracking device is determined based on the received interference field signal. The determined pose is evaluated relative to the planned final pose, and Output the evaluation result of the determined pose relative to the final pose of the plan.

2. The system according to claim 1, further comprising: An electromagnetic (EM) locator configured to generate a locator field; The locator field induces an interference field in the interference portion of the second instrument part.

3. The system of claim 2, wherein the second instrument portion is configured to move from a proximity positioning to a distance positioning; The interference field sensed by the tracking device varies between the near location and the far location.

4. The system of claim 2, wherein the interference field signal changes with the change of the interference field sensed by the tracking device; The measurement of the metric is determined using the tracking device based on the interference field signal.

5. The system according to claim 2, further comprising: An implant, the implant being configured to be carried by the device; The final orientation of the plan allows the implant to be positioned within the subject's body; The measurement of the metric is operable to confirm the final pose of the plan.

6. The system according to claim 2, further comprising: The first part and the second part of the device are hinged relative to each other.

7. The system according to claim 1, further comprising: A display device configured to display a graphical representation based on an output evaluation result of the determined pose relative to the planned final pose.

8. The system according to claim 1, further comprising: An audio output system configured to emit audible sound based on an evaluation result output from the determined pose relative to the planned final pose.

9. A method for navigating an instrument relative to a subject to perform surgery, the method comprising: An apparatus is provided, the apparatus having a first apparatus portion and a second apparatus portion; A second instrument portion is provided, the second instrument portion having an interference portion and being movable relative to the first instrument portion, wherein at least the interference portion of the second instrument portion is configured to generate an interference field based on the interference portion; A tracking device is provided, the tracking device having at least one field sensor connected to the first instrument portion, wherein the tracking device includes; Configure the navigation processor to execute instructions for: The field signal is received from the tracking device based at least in part on the sensing of an interference field in the at least one field sensor. The pose of the second instrument portion relative to the tracking device is determined based on the received interference field signal. The determined pose is evaluated relative to the planned final pose, and Output the evaluation result of the determined pose relative to the final pose of the plan.

10. The method according to claim 9, further comprising: An EM locator is provided, the EM locator being configured to generate a locator field; The locator field is configured to generate an interference field from the interference portion of the second instrument part.

11. The method according to claim 10, further comprising: The second instrument portion is configured to move from a nearby positioning location to a distant positioning location; The interference field sensed by the tracking device varies between the near location and the far location.

12. The method according to claim 11, further comprising: Metrics are measured and determined at least based on signals from the tracking device; The measurement and determination of the metric are included in the interference field signal, and the interference field signal changes as the interference field sensed by the tracking device changes.

13. The method according to claim 12, further comprising: The metric is selected from at least one of the following: determination of the geometry of the tracking device or determination of one or more phase shifts at the tracking device.

14. The method according to claim 12, further comprising: Provide an implant to be carried by the device; The implant is configured such that the planned final orientation allows the implant to be positioned within the subject's body; The final pose of the plan is confirmed by measuring the metric.

15. The method according to claim 9, further comprising: The field signal is received from the tracking device based at least in part on sensing an interference field in at least one field sensor of the tracking device. The measurement of the metric is determined based on the interference field signal; The current pose of the second instrument portion relative to the tracking device is determined based on the determined measurements. The determined current pose is evaluated relative to the planned final pose, and Output the evaluation result of the determined current pose relative to the planned final pose.

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