Motor-driven resection tool with magnetized distal end for electromagnetic tracking of magnetized distal end

Abstract

An instrument includes a housing, a motor, a tool, and one or more electromagnetic coils. The motor is disposed in the housing. The tool is attached to the motor and is configured to be moved by the motor to resect tissue of a patient. The tool includes an at least partially magnetized distal end. The one or more first electromagnetic coils are disposed in the housing and configured to generate an electromagnetic signal to detect a position of the distal end of the tool as the tool moves in response to detecting a magnetic field generated by a magnetized portion of the distal end of the tool as the tool moves.

Description

Cross Reference to Related Applications

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 516,314, filed July 28, 2023. This application includes subject matter related to that disclosed in U.S. Patent Application No. 63 / 516,307 (Attorney Docket No. A0010225US01 / 5074A-000298-US-PS1), filed July 28, 2024. The entire disclosure of the above applications is incorporated herein by reference. TECHNICAL FIELD

[0002] The present disclosure relates to navigated surgery, and more particularly to tracking tools used during medical and surgical procedures. BACKGROUND

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

[0004] Image-guided medical and surgical procedures utilize patient images obtained prior to or during the medical procedure to guide the physician in performing the procedure. Imaging technologies that produce highly detailed two-dimensional, three-dimensional, and four-dimensional images, such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy (such as with a C-arm device), positron emission tomography (PET), and ultrasound imaging (US) have increased interest in navigated medical procedures.

[0005] During a navigated procedure, images are acquired by a suitable imaging device to be displayed on a workstation. The navigation system tracks the patient, instruments, and other devices in the patient space and / or the surgical field. These tracked devices are then displayed in the image space relative to the image data on the workstation. To track the patient, instruments, and other devices, the patient, instruments, and other devices can be equipped with tracking devices. For example, a tracking device can be coupled to an outer surface of an instrument, and can provide the surgeon with an accurate depiction of the location of the instrument in the patient space via a corresponding tracking system. SUMMARY

[0006] This section provides a summary of the present disclosure, and is not a complete disclosure of the full scope or all the features of the present disclosure.

[0007] An electromagnetic-based tracking tool is disclosed, comprising a proximal end and a body. The proximal end is configured to be directly or indirectly attached to a motor of an instrument. The body extends from the proximal end and is configured to be actuated by the motor to remove tissue from a patient. The body includes: a distal end having one or more resection elements; and one or more first electromagnetic coils disposed on or within the body and configured to transmit or receive electromagnetic signals to detect the position of a portion of the body as a portion of the body moves.

[0008] Among other features, an electromagnetic tracking system is disclosed, comprising: the electromagnetic-based tracking tool; one or more second electromagnetic coils, which are separate from the tool and configured to emit or receive the electromagnetic signals; and a controller configured to detect the position of the part of the body based on the received electromagnetic signals as the part of the body moves.

[0009] Among other features, an instrument is disclosed, comprising: a housing; a motor disposed within the housing; and a tool attached to the motor and configured to be moved by the motor to remove tissue from a patient. The tool includes a distal end that is at least partially magnetized. The instrument further includes one or more first electromagnetic coils disposed within the housing and configured to generate an electromagnetic signal in response to detecting a magnetic field generated by the distal end of the tool during movement, to detect the position of the distal end of the tool during movement.

[0010] Among other features, an electromagnetic tracking system is disclosed, comprising: the instrument; one or more second electromagnetic coils, the one or more second electromagnetic coils being separate from the tool and configured to receive the electromagnetic signals; and a controller configured to detect the position of the distal end of the tool based on the received electromagnetic signals.

[0011] Among other features, an instrument is disclosed, comprising: a housing including a motor configured to rotate an axis; and an electromagnetic-based tracking tool extending from the housing and connected to the axis and configured to be actuated by the axis to remove tissue from a patient. The electromagnetic-based tracking tool includes: a body including a distal end having one or more resection elements; and one or more first electromagnetic coils disposed on or within the body and configured to emit or receive electromagnetic signals to detect the position of the distal end of the body as it moves.

[0012] Among other features, an electromagnetic tracking system is disclosed, comprising an instrument having a housing, a motor, a tool, and first electromagnetic coils. The motor is disposed within the housing. The tool is attached to the motor and configured to be moved by the motor to remove tissue from a patient. The tool includes a distal end that is at least partially magnetized. The first electromagnetic coils are disposed at the distal end of the housing and configured to generate electromagnetic signals in response to detecting a magnetic field generated by the magnetized portion of the distal end of the tool as the tool moves. Second electromagnetic coils are separate from the tool and configured to receive these electromagnetic signals. A controller is configured to detect the position of the distal end of the tool based on the received electromagnetic signals as the tool moves.

[0013] Further applicable areas will become clear from the description provided herein. The descriptions and specific examples in this invention are intended for illustrative purposes only and are not intended to limit the scope of this disclosure. Attached Figure Description

[0014] The accompanying drawings described herein are for illustrative purposes only, and not all possible embodiments, and are not intended to limit the scope of this disclosure.

[0015] Figure 1 This is a diagram of a navigation system including an example tracking system with an electromagnetic (EM) based tracking instrument, in accordance with this disclosure.

[0016] Figure 2 This is a cross-sectional side view of a portion of an EM-based tracking instrument according to the example disclosed herein, which includes a single coil arrangement with two spring pin connection assemblies.

[0017] Figure 3 This is a cross-sectional side view of a portion of an EM-based tracking instrument according to this disclosure, which includes a dual-coil arrangement with four spring-pin connection assemblies and coil terminals located inside the tool.

[0018] Figure 4 This is a cross-sectional side view of a portion of an EM-based tracking instrument according to the example disclosed herein, the tracking instrument including a dual coil arrangement inside the tool tip, four spring-loaded pin connection assemblies, and coil terminals located at the distal end.

[0019] Figure 5 This is a cross-sectional side view of an example spring needle, including a plunger and spring arrangement, according to this disclosure.

[0020] Figure 6 This is a cross-sectional side view of an example spring needle, including the arrangement of plunger, ball, and spring, according to this disclosure.

[0021] Figure 7This is a cross-sectional side view of an example spring pin, including the plunger, housing, and spring arrangement, according to this disclosure.

[0022] Figure 8 This is a cross-sectional side view of a portion of another example instrument according to this disclosure, which includes a housing-mounted coil and a magnetic tool tip.

[0023] Figure 9 This is a cross-sectional side view of a portion of another example instrument, including bearings with electrical terminals, according to this disclosure.

[0024] Figure 10 This is a cross-sectional side view of a portion of another example instrument, including a bearing assembly with an electrical contactor coil, in accordance with this disclosure.

[0025] Figure 11 This is a cross-sectional perspective view of a portion of another example instrument having an oscillating (or moving) saw blade including an EM coil, as disclosed herein.

[0026] Figure 12 This is a cross-sectional perspective view of a portion of another example instrument having an oscillating (or moving) saw blade including an EM coil, as disclosed herein.

[0027] Figure 13 This is a cross-sectional perspective view of a portion of another example instrument according to this disclosure, which has a magnetically oscillating (or moving) saw blade and a housing with a gripping portion having an EM coil.

[0028] Figure 14 This is a perspective view of a portion of another example instrument according to this disclosure, the instrument having a radially extending and annularly moving saw blade having an EM coil.

[0029] Figure 15 This is a perspective view of another example instrument with an axially extending and movable saw blade, which has an EM coil, according to this disclosure.

[0030] Figure 16 This is a functional block diagram of the tracking and control system based on the contents of this disclosure; and

[0031] Figure 17 The tracking method described in this disclosure is demonstrated.

[0032] Throughout the various views in the accompanying drawings, corresponding reference numerals indicate the corresponding parts. Detailed Implementation

[0033] Example embodiments will now be described more fully with reference to the accompanying drawings.

[0034] Some existing navigation drilling systems today utilize passive navigation methods that track the tip of the tool (such as the drill bit tip) during use. This method has limited ability to accurately track the tool tip.

[0035] Passive navigation systems typically include an optical tracker, which may have, for example, four reflective spheres mounted to the instrument and used to estimate the position of the tool tip. The tool refers to a drill bit, saw blade, or other tool used during the procedure. A camera tracks the positions of the tracker's four reflective spheres in space relative to a reference frame. Based on the detected sphere positions and the known spatial relationship between the tool tip and the spheres, the position of the tool tip relative to the reference frame is determined.

[0036] Passive navigation methods are based on the assumption that the tool tip maintains a known, fixed relationship with the tracker to accurately determine the tool tip's position. While calibration procedures are typically performed to ensure the known relationship between the tool tip and tracker is correct, the tool tip can move relative to the tracker. The calibration process may include using an array separate from the tracker to check the tool tip's position relative to a reference frame. The tool and / or its tip can deflect, bend, jiggle, vibrate, and / or move at high speeds. Furthermore, the relationship between the tool tip and tracker may change or shift over time, for example, due to wear and tear (or degradation) and / or damage associated with use. Such movement may be difficult to accurately track and / or detect using existing passive navigation methods and may result in inaccurate tracking of the tool tip's instantaneous (or real-time) position.

[0037] Examples described herein include EM (electromagnetic)-based tracking tools (referred to herein as “tools”) and EM-based tracking instruments (referred to herein as “instruments”) for accurate real-time tracking of tools and instruments (including parts thereof). Examples provided include accurate positioning and orientation determination of the tool’s tip and the distal end of the instrument housing (or attachment), including detecting movement such as tip deflection, tool jitter and / or vibration, tip migration relative to the distal end of the instrument, etc. Examples include detecting said movement to detect tool instability and / or breakage, thereby replacing the tool and / or instrument. Examples also include actively monitoring tool tip positioning and actively adjusting the tool’s speed, torque, stability, damping, and / or feed rate. This can occur during procedures, such as when removing tissue and / or bone. Feed rate refers to, for example, the rate at which the tool moves relative to the patient when moved by a robot.

[0038] Figure 1 This is a diagram of a navigation system 10 (also called a tracking system) with an EM-based tracking instrument 12. About Figures 2 to 15Examples of EM-based tracking instruments are shown and described. Instrument 12 may include i) an EM-based tracking tool having a magnetized portion and / or including one or more EM tracking coils, and ii) a housing including the EM tracking coils and / or coil terminals. The EM tracking coils may operate as either an EM transmitting or receiving device and are used to detect the position of various portions of the tool and housing, including the tip of the tool and the distal end of the housing. These EM tracking coils may be located anywhere on, in, and / or embedded within the tool and / or housing. In some embodiments, the EM tracking coils are located on, in, and / or embedded in the tip of the tool or the distal end of the housing. This is done to improve the accuracy of detecting the position and orientation of the tool tip.

[0039] Any part of the tool can be magnetized. In some embodiments, the magnetic field associated with the tool is detected via an EM tracking coil located within the housing. This detection of the magnetic field via the EM tracking coil allows the tracking system to detect the tool's position and orientation. In some embodiments, the tool's tip is magnetized to improve the accuracy of detecting the tool tip's position and orientation. In other embodiments, the tool's tip is not magnetized and may include one or more EM coils. See also Figures 2 to 15 And corresponding descriptions of further examples.

[0040] Navigation system 10 can be used in various procedures and track the position of implants (such as spinal or orthopedic implants) relative to the patient 13. Furthermore, navigation system 10 can track the position and orientation of various tools and instruments (such as those disclosed herein). It should be further noted that navigation system 10 can be used to navigate any type of instrument, implant, or delivery system, including: leads, arthroscopic systems, orthopedic implants, spinal implants, deep brain stimulator (DBS) probes, etc. In addition, these instruments can be used to navigate or map any area of ​​the body. Navigation system 10 and various instruments can be used in any suitable procedure, such as procedures that are typically minimally invasive, arthroscopic, percutaneous, stereotactic, or open procedures.

[0041] The navigation system 10 may include an imaging device 14 for acquiring preoperative, intraoperative, or postoperative or real-time image data of the patient 13. Alternatively, various image-free systems may be used, or patient images may be generated using images from an atlas model, such as those disclosed in U.S. Patent Publication No. 2005-0085714, filed October 16, 2003, entitled “METHOD AND APPARATUS FOR SURGICAL NAVIGATION OF A MULTIPLE PIECE CONSTRUCT FORIMPLANTATION,” which is incorporated herein by reference. The imaging device 14 may be, for example, a fluorescence fluoroscopy X-ray imaging device, which may be configured as an O-arm having an X-ray source 18, an X-ray receiver 20, an optional calibration and tracking target 22, and an optional radiation sensor 24. TM Or C-arm 16. However, it will be understood that patient image data can also be acquired using other imaging devices, such as those discussed above and in this article.

[0042] An imaging device controller 28 that can control the C-arm 16 can capture and store X-ray images received at the X-ray receiver 20 for later use. The controller 28 can also be detached from and / or control the rotation of the C-arm 16. For example, the C-arm 16 can move in the direction of arrow A or rotate about the longitudinal axis 29 of the patient 13, thereby allowing a front or side view of the patient 13 to be imaged. Each of these movements involves rotation about the mechanical axis 32 of the C-arm 16. The movement of the imaging device 14 (such as the C-arm 16) can be tracked using a tracking device 33.

[0043] exist Figure 1 In the example, the longitudinal axis 29 of patient 13 is substantially aligned with the mechanical axis 32 of C-arm 16. This allows C-arm 16 to rotate relative to patient 13, thereby allowing images of patient 13 to be taken from multiple directions or around multiple planes. An example of a fluorescence C-arm X-ray device that can be used as an optional imaging device 14 is the “9600 Series Mobile Digital Imaging System” from GE Healthcare (formerly known as OEC Medical Systems, Inc.) of Salt Lake City, Utah. Other exemplary fluoresceins include biplane fluoroscopy systems, ceiling fluoroscopy systems, catheterization lab fluoroscopy systems, fixed C-arm fluoroscopy systems, isocentric C-arm fluoroscopy systems, 3D fluoroscopy systems, etc. Exemplary O-arm TMThe imaging equipment is available from Medtronic Navigation in Littleton, Massachusetts.

[0044] In operation, imaging device 14 generates X-rays from X-ray source 18, which propagate through patient 13 and calibration and / or tracking target 22 into X-ray receiving unit 20. This allows direct visualization of the patient 13 and the radiopaque instrument within the X-ray cone. It will be understood that tracking target 22 does not need to include a calibration section. X-ray receiving unit 20 generates image data representing the intensity of the received X-rays. Typically, X-ray receiving unit 20 includes an image intensifier that first converts the X-rays into visible light and a charge-coupled device (CCD) camera that converts the visible light into digital image data. X-ray receiving unit 20 can also be a digital device that directly converts X-rays into digital image data to form an image, potentially avoiding the distortion introduced by first converting to visible light. With this type of digital C-arm (which is typically a flat panel device), the optional calibration and / or tracking target 22 and calibration process discussed below can be eliminated. Moreover, the calibration process can be eliminated or not used at all in various procedures. Alternatively, imaging device 14 can take a single image only when calibration and tracking target 22 are in place. After that, the calibration and tracking target 22 can be removed from the line of sight of the imaging device 14.

[0045] Two-dimensional fluorescence fluoroscopic images, which can be captured by imaging device 14, are captured and stored in controller 28. Multiple two-dimensional images captured by imaging device 14 can also be captured and assembled to provide a larger view or image of the entire area of ​​the patient, rather than just a portion of the area of ​​the patient 13. For example, multiple image data of the patient's leg can be appended together to provide a complete view or complete image dataset of the leg, which can later be used to track contrast agents, such as in bolus tracking.

[0046] Patient image data 100 can be forwarded from controller 28 to navigation computer and / or processor or workstation 34. It should also be understood that the image data is not necessarily initially stored in controller 28, but can also be directly transmitted to workstation 34. Workstation 34 may include display 36, user input device 38, and controller 101. Controller 101 may include or be connected to image processor, navigation processor, and memory to store instructions and data. Workstation 34 may provide facilities for displaying patient image data 100 as an image on display 36, saving, digitally manipulating, or printing a hard copy of the received patient image data 100.

[0047] User input device 38 may include any device that allows a user to interface with workstation 34, such as a touchpad, stylus, touchscreen, keyboard, mouse, wireless mouse, or a combination thereof. User input device 38 allows physicians or users 39 to provide input to control imaging equipment 14 via C-arm controller 28 or to adjust display settings on monitor 36.

[0048] The controller 101 can determine the position of the tracking device 58 relative to the patient space and can output image data 102 to the display 36. The image data 102 may include an icon 103 that provides an indication of the position of the tracking device 58 relative to the patient space, as shown on the patient image data 100, as will be discussed herein. It should be noted that the patient image data 100 may include at least one of the following: data from the navigation system 10, image data acquired by the imaging device 14, patient information input by the user via the user input device 38, preoperative images, or combinations thereof.

[0049] When the X-ray source 18 generates X-rays that propagate to the X-ray receiver 20, the radiation sensor 24 can detect the presence of radiation, which is then relayed to the controller 28 to identify whether the imaging device 14 is actively imaging. This information is also transmitted to the coil array controller 48, which will be discussed further herein.

[0050] Although Figure 1 Imaging device 14 is shown, but any other alternative 2D, 3D, or 4D imaging modality can also be used. For example, any 2D, 3D, or 4D imaging device, such as O-arm. TMImaging equipment, isocentric fluoroscopy, biplane fluoroscopy, ultrasound, computed tomography (CT), multi-slice computed tomography (MSCT), magnetic resonance imaging (MRI), high-frequency ultrasound (HFU), positron emission tomography (PET), optical coherence tomography (OCT), intravascular ultrasound (IVUS), ultrasound, intraoperative CT, or MRI can also be used to acquire 2D, 3D, or 4D preoperative or postoperative and / or real-time images or patient image data 100 of patient 13. For example, an intraoperative MRI system, such as the PoleStar® MRI system sold by Medtronic, Inc. Images of patient 13 can also be acquired and displayed in two, three, or four dimensions. In more advanced forms, four-dimensional surface rendering areas of the body can also be achieved by combining patient data or other data from atlases or anatomical models or from preoperative image data captured from MRI, CT, or echocardiographic modalities. A more detailed discussion of optical coherence tomography (OCT) is set forth in U.S. Patent No. 5,740,808, issued April 21, 1998, entitled “Systems and Methods for Guiding Diagnostic or Therapeutic Devices in Interior Tissue Regions,” which is incorporated herein by reference.

[0051] Image datasets from mixed modalities (such as positron emission tomography (PET) combined with CT or single-photon emission computed tomography (SPECT) combined with CT) can also provide functional image data overlaid on anatomical data for reliable access to target sites within the patient13. It should be further noted that, as Figure 1 The imaging device 14 shown provides virtual biplane images by simply rotating the C-arm 16 around at least two planes (which may be orthogonal planes) using a single-headed C-arm fluorescein as the imaging device 14, to generate two-dimensional images that can be converted into three-dimensional volumetric images. By acquiring images in more than one plane, icon 103 indicates that impactors, core needles, reamer drivers, taps, drills, deep brain stimulator (DBS) probes, or other instruments introduced and advanced in the patient 13 can be superimposed in more than one view and included in the image data 102 displayed on the display 36.

[0052] Continue to refer to Figure 1The navigation system 10 may further include instrument 12 (e.g., a drill, saw, etc. as described herein), an electromagnetic navigation and tracking system (or tracking system) 44, which includes a locator (e.g., coil array 46 and / or a second coil array 47), a coil array controller 48, a navigation probe interface 50, a dynamic reference frame (DRF) 54, and one or more tracking devices 58. The navigation system 10 may include the tracking system 44, the tracking devices 58, a controller 101, and a display 36. The tracking system 44 may include an electromagnetic tracking system 44a and an optical tracking system 44b. The optical tracking system 44b may include, for example, StealthStation® Treon® and StealthStation® Tria®, both sold by Medtronic Navigation, Inc. The tracking system 44 may include acoustic, radiation, radar, infrared, and / or other components. In an embodiment, the tracking system 44 includes components of both electromagnetic and optical tracking. The DRF 54 may include the tracking device 58.

[0053] Tracking device 58, as described herein, or any suitable tracking device, may include sensors, transmitters, or combinations thereof, and may be indicated by reference numeral 58. Further, tracking device 58 may be a wired or wireless transmitter or receiver of signals from a system. However, tracking device may include electromagnetic coils to sense fields generated by positioning coil arrays 46 or 47. Tracking device may include reflectors that can reflect signals to be received by the optical locator or tracking system 44b. However, it will be understood that tracking device 58 may receive signals, transmit signals, or combinations thereof to provide information to navigation system 10 to determine the position of tracking device 58. Additionally, it will be understood that tracking device 33 of C-arm 16 may include suitable tracking device 58. Navigation system 10 can then determine the position of instrument 12 based on the position of tracking device 58 to allow navigation relative to patient 13 and patient space.

[0054] Regarding the optical locator or tracking system 44b, the optical tracking system 44b can transmit and receive optical signals or combinations thereof. Tracking device 58 may include an optical tracking device that can interconnect with instrument 12 or other devices (such as DRF 54). As is generally known, an optical tracking device can reflect, transmit, or receive optical signals from the optical locator or tracking system 44b, which can be used in navigation system 10 for navigating or tracking various elements. Therefore, those skilled in the art will understand that tracking device 58 can be any suitable tracking device for working with any one or more tracking systems.

[0055] Tracking system 44 may include the EM coil and coil arrays 46, 47 of instrument 12. Coil arrays 46, 47 may also be supplemented or replaced by a motion locator (not shown). The motion locator may be as described in U.S. Patent Application Serial No. 10 / 941,782, filed September 15, 2004, entitled “METHOD AND APPARATUS FOR SURGICAL NAVIGATION,” which is incorporated herein by reference. In an embodiment, the EM coil and / or coil arrays 46, 47 of instrument 12 may transmit EM signals received by tracking device 58. Tracking device 58 may then transmit or receive signals based on the EM signals transmitted from the EM coil and / or coil arrays 46, 47 of instrument 12. In an embodiment, the EM coil of instrument 12 operates as a receiver to receive the EM signals transmitted by coil arrays 46, 47.

[0056] The navigation system 10 may further include isolator circuitry or components (not specifically shown). Isolator circuitry or components may be included in transmission lines to interrupt the line carrying signals or voltages to the navigation probe interface 50. Alternatively, isolator circuitry included in an isolator housing may be included in the navigation probe interface 50, instrument 12, DRF 54, transmission lines coupled to instrument 12, or any other suitable location. The isolator component is operable to isolate any instrument or patient-compatible instrument or portion in contact with patient 13 in the event of an unwanted surge or voltage.

[0057] Additionally, the navigation system 10 may further include a gating device or ECG or electrocardiogram (not shown) attached to the patient 13 via skin electrodes and communicating with a coil array controller 48. Respiration and cardiac movement can cause movement of cardiac structures relative to the instrument 12, even when the instrument 12 is not yet moving. Therefore, images can be acquired from the imaging device 14 based on a time-gated basis triggered by physiological signals. For example, ECG or EGM signals can be acquired from skin electrodes, from sensing electrodes included on the instrument 12, or from a separate reference probe (not shown). Characteristics of this signal (such as R-wave peaks or P-wave peaks associated with ventricular or atrial depolarization, respectively) can be used as trigger events for the coils in the coil array controller 48 to drive the coils in the coil arrays 46, 47. This trigger event can also be used to gate or trigger image acquisition during the imaging phase using the imaging device 14. By time-gating the image data 102 and / or navigation data, an icon 103 showing the position of the instrument 12's tool in image space relative to the patient space at the same point in the cardiac cycle can be displayed on the display 36. Further details regarding the time gating of image data and / or navigation data can be found in U.S. Publication No. 2004-00978906, entitled “Navigation System for Cardiac Therapies,” filed November 19, 2002, which is incorporated herein by reference.

[0058] It should be further noted that the components of the electromagnetic tracking system 44 can be integrated into the imaging device 14, which includes the radiation sensor 24, the workstation 34, and the controller 101. Integrating the components of the electromagnetic tracking system 44 can provide an integrated imaging and tracking system. Any combination of these components can also be integrated into the imaging device 14, which may also include a fluorescence C-arm imaging device or any other suitable imaging device.

[0059] Coil arrays 46 and 47 are shown attached to the operating table 49. However, it should be noted that coil arrays 46 and 47 can also be positioned in any other location and can also be positioned within the object being navigated. The EM coil of instrument 12 and the coils of coil arrays 46 and 47 are each operable to generate different electromagnetic fields into the navigation area of ​​patient 13, which is sometimes referred to as the patient space. Representative electromagnetic systems are described in U.S. Patent No. 5,913,820, issued June 22, 1999, entitled “Position Location System,” and U.S. Patent No. 5,592,939, issued January 14, 1997, entitled “Method and System for Navigating a Catheter Probe,” each of which is incorporated herein by reference.

[0060] The EM coils and coil arrays 46, 47 of instrument 12 can be controlled or driven by a coil array controller 48. The coil array controller 48 can drive each EM coil and each coil in coil arrays 46, 47 of instrument 12 in a time-division multiplexing or frequency-division multiplexing manner. In this respect, each coil can be driven individually at different times, or all coils can be driven simultaneously, with each coil driven by a different frequency. When the EM coils and coil arrays 46, 47 of instrument 12 are driven with the coil array controller 48, an electromagnetic field is generated in the area near and / or within the patient 13 where the medical procedure is being performed. These areas are sometimes referred to as the patient space.

[0061] The electromagnetic field generated in the patient space induces a current in the tracking device 58 positioned above or within instrument 12. These induced signals from instrument 12 are delivered to the navigation probe interface 50 and can then be forwarded to the coil array controller 48.

[0062] The navigation probe interface 50 provides all necessary electrical isolation for the navigation system 10. The navigation probe interface 50 may also include amplifiers, filters, and buffers for direct interface connection to the tracking device 58 in the instrument 12. Alternatively, instead of direct coupling to the navigation probe interface 50, the tracking device 58 or any other suitable component may employ a wireless communication channel, such as the wireless communication channel disclosed in U.S. Patent No. 6,474,341, entitled “Surgical Communication PowerSystem,” issued November 5, 2002, which is incorporated herein by reference. The tracking device 58 may also be referred to as a positioning sensor.

[0063] In an alternative embodiment, the electromagnetic source or generator may be located within instrument 12, DRF 54, and one or more receiver coils may be positioned externally to patient 13, thereby forming a receiver coil array similar to coil arrays 46, 47. Further representative or alternative positioning and tracking systems are described in U.S. Patent No. 5,983,126, issued November 9, 1999, entitled "Catheter Location System and Method," which is incorporated herein by reference. Alternatively, the positioning system may be a hybrid system comprising components from various systems.

[0064] The DRF 54 of the tracking system 44 can also be coupled to the navigation probe interface 50 to forward information to the coil array controller 48. According to various embodiments, the DRF 54 may include a small magnetic field detector. The DRF 54 may be fixed to the patient 13 and adjacent to the area of ​​positive navigation, such that any movement of the patient 13 is detected as relative motion between the coil arrays 46, 47 and the DRF 54. This relative motion can be forwarded to the coil array controller 48, which can update the registration correlation and maintain accurate navigation, as discussed further herein. The DRF 54 may include any suitable tracking device(s) 58 used by the navigation system 10. Thus, the DRF 54 may include an optical tracking device or an acoustic tracking device. If the DRF 54 is used with an electromagnetic tracking device, it may be configured as a pair of orthogonally oriented coils, each coil having the same center; or it may be configured to employ any other non-coaxial or coaxial coil configuration (not specifically shown).

[0065] In short, the navigation system 10 operates as follows: The navigation system 10 creates a transformation map between all points in the radiographic images generated from the imaging device 14 and their corresponding points in the patient's anatomical structures in patient space. After this mapping is established, whenever the tracked instrument (such as instrument 12) is used, the workstation 34, in conjunction with the coil array controller 48 and controller 28, uses the transformation map to identify the corresponding points on the pre-acquired image or atlas model displayed on the display 36. This identification is referred to as navigation or localization. The icon 103 representing the localization point or instrument 12 can be shown as image data 102 on the display 36, as will be discussed herein.

[0066] To enable navigation, the navigation system 10 must be able to detect both the position of the patient's anatomical structures and the position of the instrument 12 or tools attached to the instrument 12. Knowing the positions of these two items allows the navigation system 10 to calculate the position of the instrument 12 relative to the patient 13 and display it on the display 36. The tracking system 44 can be used to track both the instrument 12 and the anatomical structures simultaneously.

[0067] If an electromagnetic tracking component is used, the tracking system 44 has coil arrays 46, 47 positioned near the patient space and is configured to generate a low-energy magnetic field known as the navigation field. Because each point in the navigation field or patient space is associated with a unique field strength, the tracking system 44 can determine the position of the instrument 12 by measuring the field strength at the location of the tracking device 58. The DRF 54 is fixed to the patient 13 to identify the position of the patient 13 in the navigation field. The tracking system 44 continuously recalculates the relative position of the DRF 54 and the instrument 12 during positioning and correlates this spatial information with patient registration data to enable the guidance of the instrument 12 within and / or relative to the patient 13.

[0068] Patient registration is the process of determining how to associate the position of instrument 12 relative to patient 13 with a position on a diagnostic image or pre-acquired image. To register patient 13, a physician or user 39 may use point registration by selecting and storing specific points from the pre-acquired image, and then touching the corresponding points on the patient's anatomy with a pointer probe (not shown). Navigation system 10 analyzes the relationship between the two selected sets of points and calculates a match that associates each point in image data 102 with its corresponding point on the patient's anatomy or in patient space, as discussed herein. The points selected for performing registration are reference markers 60, such as anatomical landmarks. Similarly, the landmarks or reference markers 60 are identifiable on the image and are identifiable and accessible on patient 13. Reference markers 60 may be artificial markers located on patient 13 or anatomical landmarks that can be easily identified in image data 102. Artificial landmarks (such as reference marker 60) can also form part of DRF 54, such as those disclosed in U.S. Patent No. 6,381,485, issued April 30, 2002, entitled "Registration of Human Anatomy Integrated for Electromagnetic Localization," which is incorporated herein by reference.

[0069] The navigation system 10 can also perform registration using anatomical surface information or path information known in the art. The navigation system 10 can also perform 2D-to-3D registration by utilizing the acquired 2D image to register a 3D volumetric image using contour algorithms, point algorithms, or density comparison algorithms, as known in the art. An exemplary 2D-to-3D registration procedure is described in U.S. Serial No. 60 / 465,615, filed April 25, 2003, entitled “Method and Apparatus for Performing 2D to 3D Registration,” which is incorporated herein by reference.

[0070] As also discussed herein, a registration system that is essentially referenceless can be provided, particularly where the imaging device 14 and the tracking system 44 are substantially integrated. Therefore, the tracking system 44 generally knows the position of the imaging device 14 relative to the patient 13, and registration may not require a reference marker 60. However, it will be understood that any suitable type of registration system can be provided for the navigation system 10.

[0071] To maintain registration accuracy, navigation system 10 continuously tracks the position of patient 13 during registration and navigation. This is because patient 13, DRF 54, and coil arrays 46, 47 can all move during the procedure, even when such movement is not expected. Alternatively, once registration occurs, patient 13 can remain stationary, for example, using a head frame (not shown). Therefore, if navigation system 10 does not track the position of patient 13 or areas of anatomical structures, any patient movement after image acquisition will result in inaccurate navigation within that image. DRF 54 allows tracking system 44 to register and track anatomical structures. Because DRF 54 is rigidly attached to patient 13, any movement of anatomical structures or coil arrays 46, 47 is detected as relative motion between coil arrays 46, 47 and DRF 54. This relative motion is transmitted via navigation probe interface 50 to coil array controller 48, which updates registration correlations to maintain accurate navigation.

[0072] Navigation system 10 can be used according to any suitable method or system. For example, it can be used to register pre-acquired images, atlases, or 3D models relative to patient 13 and patient space. Navigation system 10 allows for the registration of images on display 36 and accurately displays the real-time positions of various instruments (such as instrument 12) and other appropriate items (such as DRF 54). Additionally, DRF 54 can be used to ensure that any planned or unplanned movement of patient 13 or coil arrays 46, 47 can be determined and used to correct image data 102 on display 36.

[0073] Figure 2 A portion 200 of an EM-based tracking instrument is shown, comprising a single-coil arrangement 202 with two spring-pin connection assemblies 204, 206. The spring-pin connection assembly is referred to herein as a "spring pin". Figures 5 to 7 An example of a spring pin connection assembly is shown, and it can replace any other spring pin mentioned herein. The EM-based tracking instrument includes a housing (or attachment) 210, a shaft 211 that rotates about a longitudinal axis 212, and a tool 214 connected to and rotating with the shaft 211. As an example, the tool 214 can be a drill bit or other tool as shown. The grooves and cutting edges of the drill bit are not shown. The tool 214 may include cutting edges and / or other cutting elements.

[0074] A motor with coil 216 rotates shaft 211. Tool 214 includes conductive layers 218, 220. Insulating layer 221 is disposed between conductive layers 218, 220. Conductive layers 218, 220 can extend from a terminal 222 in a proximal portion (or proximal end) of tool 214 to a distal portion (or distal end) of tool 214, in one embodiment, a terminal 224 is located at the distal portion. Conductive layers 218, 220 may be cylindrical and line the inner surface of cavity 232 within tool 214. Terminal 222 connects conductive elements of spring pins 204, 206 (e.g., plungers, springs, balls, housings, etc.) to conductive layers 218, 220. Terminal 224 connects conductive layers 218, 220 to an end of coil 230, which may be located at the distal end of cavity 232 within tool 214. Terminal 222 may be annular. The plunger 240 of the spring pins 204 and 206 contacts and applies pressure to terminal 222, but is not attached to terminal 222. This allows tool 214 to rotate and remain connected to coil 230. The end of coil 230 is indicated by wire 242.

[0075] Although a single coil 230 is shown in cavity 232, one or more coils may be included. The coils may be arranged differently and have the same or different numbers of windings. The coils may be wound around the X-axis, Y-axis, Z-axis, and / or other axes. As an example, the longitudinal axis 212 may refer to the X-axis. The coils may be located at or near the distal end of cavity 232.

[0076] The wire 244 can be connected to the spring pins 204 and 206 and conduct current to and from the coil 230. Although the wire 244 is shown outside the housing 210, it can be wired inside the housing 210. Furthermore, although portions of the spring pins 204 and 206 are shown extending outward from the housing 210, they can reside entirely within the housing 210.

[0077] Shaft 211 and tool 214 rotate relative to housing 210, which is stationary. Annular bearing 250 is disposed between housing 210 and tool 214.

[0078] Although tool 214 is shown as having conductive layers 218, 220, it may include insulated wires instead of conductive layers 218, 220. The insulated wires may extend within cavity 232 and from terminal 222 to wire 242.

[0079] Figure 3 A portion 300 of an EM-based tracking instrument is shown, which includes a dual-coil arrangement 302 with four spring pins 304. Figures 5 to 7 An example of spring needle 304 is shown. The EM-based tracking instrument includes a housing (or attachment) 310, a shaft 311 that rotates about a longitudinal axis 312, and a tool 314 connected to and rotating with the shaft 311. As an example, tool 314 may be a drill bit or other tool as shown. The grooves and cutting edges of the drill bit are not shown.

[0080] A motor rotates shaft 311. Tool 314 includes conductive layers 317, 318, 319, and 320. Insulating layers are disposed between adjacent pairs of conductive layers 317, 318, 319, and 320. Conductive layers 317, 318, 319, and 320 can extend from a terminal 322 in a proximal portion of tool 314 to a distal portion of tool 314, in one embodiment, where a terminal 324 is located in the distal portion. Conductive layers 317, 318, 319, and 320 may be cylindrical and line the inner surface of a cavity 332 within tool 314. Terminal 322 connects conductive elements of spring pin 304 (e.g., plunger, spring, ball, housing, etc.) to conductive layers 317, 318, 319, and 320.

[0081] Terminal 324 connects conductive layers 317, 318, 319, and 320 to the ends of coils 330 and 331, which may be located at the distal end of cavity 332 within tip 333 of tool 314. Coils 330 and 331 may be concentric coils, as shown, or may be positioned separately from each other and / or positioned with different orientations and arrangements. Terminal 322 may be annular. The plunger 340 of spring needle 304 contacts terminal 322 and applies pressure thereon, but is not attached to terminal 322. This allows tool 314 to rotate while maintaining connection with coils 330 and 331. The ends of coils 330 and 331 are indicated by wire 342.

[0082] Although two coils 330 and 331 are shown in cavity 332, additional coils may be included. The coils may be arranged differently and have the same or different numbers of windings. The coils may be wound around the X-axis, Y-axis, Z-axis, and / or other axes. As an example, the longitudinal axis 312 may refer to the X-axis. The coils may be located at or near the distal end of cavity 332.

[0083] A wire (not shown) can be connected to the spring pin 304 and conduct current to and from the coils 330, 331. Although the portions of the spring pin 304 are shown as extending outward from the housing 310, the spring pin 304 and the corresponding wire can reside entirely within the housing 310.

[0084] Shaft 311 and tool 314 rotate relative to housing 310, which is stationary. Annular bearing 350 is disposed between housing 310 and tool 314.

[0085] Although tool 314 is shown as having conductive layers 317, 318, 319, 320, it may include insulated wires instead of conductive layers 317, 318, 319, 320. The insulated wires may extend within cavity 332 and from terminal 322 to wire 342. The insulated wires have an outer sheath and an inner conductive core. In an embodiment, the ends of coils 330, 331 extend along cavity 332 and connect to terminal 322.

[0086] Figure 4 A portion 400 of an EM-based tracking instrument is shown, which includes a dual-coil arrangement 402 within a tool tip 403, four spring pins 404, and a distal coil terminal 405. The instrument is configured for use with... Figure 3 The instrument, except for the distal coil terminal 405 which is not the terminal 324 inside the cavity 332, includes a tool 414 having conductive layers 420, 422, 424, and 426. As an example, the tip 403 may be a drill bit with grooves and cutting edges as shown.

[0087] Terminal 405 connects conductive layers 420, 422, 424, 426 to the ends of coils 430, 431, which may be located at the distal end of tool 414 within tip 403. Coils 430, 431 may be concentric coils, as shown, or may be positioned separately from each other and / or positioned in different orientations.

[0088] Although two coils 430 and 431 are shown in cavity 332, additional coils may be included. The coils may be arranged differently, having the same or different numbers of windings. The coils may be wound around the X, Y, and Z axes and / or other axes. A second coil 431 may be included for redundancy, to verify signals from the first coil 430, and / or to improve the accuracy of the position estimation of the tip 403. As an example, if the two coils are concentric, the signals provided by the coils should indicate the same center position of the coils.

[0089] Figure 5 A spring-loaded pin 500 is shown, comprising a plunger 502, a spring 504, a conductive base element (or cylinder) 506, and a housing 508. The spring 504 provides radially inward pressure on the plunger 502 to bias the plunger 502 distally outward, such that the plunger remains with, for example, a rotating terminal (e.g., ...). Figures 2 to 3 The terminals 222 and 322 in the middle are in contact. Figure 6 A spring needle 600 is shown, which includes a plunger 602, a ball 603, a spring 604, a conductive base element 606 (or a cylinder), and a housing 608. Figure 7 A spring needle 700 is shown, which includes a plunger 702, a housing 703, a spring 704, a conductive base element (or cylinder) 706, and a casing 708.

[0090] Figure 8 A portion 800 of an instrument is shown, comprising housing-mounted coils 802, 804, 806 and a magnetic tool tip 808. Coils 802, 804, 806 are integrated into the instrument's housing (or attachment) 810. The instrument also includes a movable and / or rotatable tool 812 connected to a shaft 814 that rotates within the housing 810 about a longitudinal axis 816. Tool 812 rotates with shaft 814 on bearing 820.

[0091] Coils 802, 804, and 806 are wound around respective axes (e.g., X-axis, Y-axis, Z-axis) and are oriented perpendicularly or orthogonally to each other. Although three coils are shown, one or more coils may be included. The axes around which coils 802, 804, and 806 are wound (referred to as winding axes) are perpendicular to each other. In one embodiment, no coils are offset and are oriented such that the winding axes intersect each other. In another embodiment, not all three winding axes intersect each other at the same point in space. For example, the point where two intersecting axes intersect may be different from the point where two of the other axes intersect. This depends on the position of coils 802, 804, and 806 and can occur when one of the coils is offset relative to the other coils. Depending on the position and orientation of the coils, two or more of the winding axes may not intersect each other. The coils may be inside the housing 810, embedded in the material, and / or the outer wall, or they may be outside the housing 810 and on the housing itself.

[0092] Tip 808 may be attached to or brazed to the cylindrical body 830 of tool 812. In another embodiment, tip 808 and body 830 include threads such that tip 808 is screwed onto body 830. If brazed, brazing material may be present between the distal end of body 830 and tip 808. In an embodiment, a portion of body 830 is disposed within and brazed to the internal cavity of tip 808. Wires may extend from coils 802, 804, 806 and within and along body 830. Each coil has a corresponding pair of wires. Wires may receive or supply signals to coils 802, 804, 806. Coils 802, 804, 806 are located at the distal end of housing 810 and detect signals or magnetic fields emitted from magnetized tip 808. In an embodiment, the signals and / or magnetic fields of the coils are detected and triangulation is performed to determine the position of tip 808. In an embodiment, tool 812 does not include an EM coil and is configured to be cleaned and autoclaved.

[0093] Figure 9 A portion 900 of an instrument is shown, which includes a bearing 902 having an electrical terminal 904. The electrical terminal 904 connects the bearing 902 to a wire 906 extending to a coil 908. The coil 908 is located at the distal end of a cavity 910 of a tool 912. A wire 914 extends from the bearing 902 and passes through a housing 920. The wire 914 can receive signals from or supply signals to the coil 908.

[0094] Figure 10A portion 1000 of an instrument including bearing assemblies 1002 having an electrical contactor coil 1004 electrically connecting an internal portion 1006 of assembly 1002 to an external portion 1008. The internal portion 1006 may include bearings on which the instrument's shaft 1010 and tool 1012 rotate. An electrical terminal 1014 electrically connects the electrical contactor coil 1004 to a coil 1020 located at a distal end of a cavity 1022 of the tool 1012. A wire 1030 may extend from the external portion 1008 through a housing (or attachment) 1032.

[0095] Figure 10 The example utilizes bearings and sealed contact surfaces to achieve an electrical connection to one or more coils at the distal end of tool 1012. A wire 1034 can extend from terminal 1014 to coil 1020. Additional wires may be included if additional coils are included.

[0096] The examples disclosed in this article apply to mobile tools, and more examples of these mobile tools can be found in [link to article]. Figures 11 to 15 As shown in the image.

[0097] Figure 11 A portion 1100 of an instrument with an oscillating (or moving) saw blade 1102 is shown, the saw blade including an EM coil 1104. The instrument is an oscillating instrument in which the distal end of the saw blade 1102 moves back and forth at high speed, as indicated by arrow 1106. The saw blade 1102 is connected to an actuator block 1120, which is oscillated by a motor and an eccentric gear drive assembly 1122 that converts the rotational movement of the motor shaft into oscillating movement. The actuator block 1120 may be referred to as an oscillating element. A supply wire 1124 extends from the coil 1104 and, although shown extending away from the instrument, may extend within the instrument housing 1130. The return end of the coil 1104 may be connected to a return wire 1126 as shown or to the saw blade 1102. The saw blade 1102 may serve as a return electrode. The return wire 1126 may extend through the housing 1130. The return conductor 1126 may extend along the side of the saw blade 1102 opposite to the supply conductor 1124. The supply conductor 1124 may be connected to surface contacts on the housing 1130, which are supplied with power to energize the coil 1104. Although two EM coils 1104 are shown, the saw blade 1102 may include one or more EM coils. The conductors 1124, 1126 (like other conductors mentioned herein) may have conductive cores contained within an insulating sheath.

[0098] Figure 12A portion 1200 of an instrument is shown with an oscillating (or moving) saw blade 1202, which includes an EM coil 1204. The instrument is an oscillating instrument in which the distal end of the saw blade 1202 moves back and forth at high speed. The saw blade 1202 is connected to an actuator block 1220, which is oscillated by a motor and an eccentric gear drive assembly 1222 that converts the rotational movement of the motor shaft into oscillating movement. The actuator block 1220 may be referred to as an oscillating element. A supply wire 1222 extends from the coil 1204 and, although shown extending away from the instrument, may extend within the instrument housing 1230. Although two EM coils 1204 are shown, one or more EM coils may be included on the saw blade 1202. The return end of the EM coil 1204 may be connected to a return wire 1224 or the saw blade 1202, which may serve as a return electrode. The return wire 1224 may extend through the housing 1230. The supply wire 1222 can be connected to surface contacts on the housing 1230, which are supplied with power to energize the coil 1204.

[0099] Figure 13 A portion 1300 of an instrument is shown, comprising a magnetically oscillating (or moving) saw blade 1302 and a housing 1304 having a gripping portion 1306 with EM coils 1308. The instrument is an oscillating instrument in which the distal end of the saw blade 1302 moves back and forth at high speed. The saw blade 1302 is connected to an actuator block 1320, which is oscillated by a motor and an eccentric gear drive assembly 1322 that converts the rotational movement of the motor shaft into oscillating movement. The actuator block 1320 may be referred to as an oscillating element. The saw blade is a magnetic saw blade with a corresponding magnetic field. The EM coils 1308 detect this magnetic field and generate EM signals, which are transmitted to a control module via wires 1310. Although shown externally to the housing 1304, the wires 1310 may extend within the housing 1304. The end of each EM coil 1308 that is not connected to the wire 1310 may be connected to a corresponding wire and / or contact (not shown) in the housing 1304.

[0100] Figure 14 A portion 1400 of an example instrument is shown, having a radially extending and annularly moving saw blade 1402, which has EM coils 1404 that can be connected and used as other EM coils described herein. The instrument includes a body 1406 and an end attachment 1408 for securing the saw blade 1402 to the body 1406.

[0101] Figure 15A portion 1500 of an instrument is shown, having an axially extending and movable saw blade 1502 with EM coils 1504, which can be connected and used as other EM coils described herein. The instrument may be a linear actuator reciprocating motion instrument. The instrument includes a body 1506 and an engagement handle 1508, which, when pressed, activates the instrument's motor to move the saw blade 1502 in a reciprocating manner. The saw blade 1502 is attached to a reciprocating motion element (or shaft) 1510 moved by the motor.

[0102] In the examples above, various EM coils are disclosed and described. In embodiments, one of the instrument's tools and / or housings includes one or more transmitting EM coils, and one or more other EM coils within the imaging space (or volume) are used to detect EM signals emitted by the one or more transmitting EM coils. In one embodiment, 12 transmitting EM coils generate 12 magnetic fields. In another embodiment, 6 transmitting EM coils are generated. In one embodiment, for each transmitting EM coil, there are two or more receiving EM coils to determine the position and orientation of the transmitting EM coil. In one embodiment, 6 magnetic fields are generated to track the movement of a single receiving EM coil. In another embodiment, 2 to 3 receiving EM coils are used to detect the position and orientation of the distal end of the instrument and / or tool. The receiving EM coils may be located on or outside the instrument. When the receiving coils are located outside the instrument, at least one transmitting EM coil is located on the instrument. When the receiving coils are located on the instrument, at least one transmitting EM coil is located outside the instrument.

[0103] Figure 16 It shows what can be used as Figure 1 The tracking control system 1600 is a part of the navigation system 10. The tracking control system 1600 includes a controller 101, which may include a processor 1602 implementing the rack control module 1604, a source module 1606, a detector module 1608, an image capture module 1610, an EM transmission module 1612, a tracking module 1614, a navigation control module 1616, and a degradation module 1618.

[0104] The gantry control module 1604 can control the positioning of the gantry of the imaging and / or navigation system 10 and determine its location. The gantry control module 1604 can control the gantry motor 1620. The source module 1606 can control the X-ray source and / or its positioning, including controlling one or more source motors 1622 of the source actuator and motor assembly 1624. The detector module 1608 can control the operation of the X-ray detector and / or its positioning, including controlling one or more detector motors 1626 of the detector actuator and motor assembly 1628. The image capture module 1610 can control the capture of images of the patient and / or the space surrounding the patient. The EM transmission module 1612 can control the generation and emission of electromagnetic signals via an EM coil (such as an EM coil as referred to herein). The EM transmission module 1612 can supply current at a selected frequency and / or with a corresponding signature to the EM coil via wires, terminals, tool layers, spring pins, bearing assemblies, and / or other conductive elements referred to herein.

[0105] Tracking module 1614 can determine the position of a tool and / or instrument and / or parts thereof based on received EM signals detected by EM coils on the tools, instruments, locators, and / or tracking devices mentioned herein. These locators and tracking devices may each include an EM coil. The EM coils of the tools, instruments, locators, and tracking devices may each operate as transmitters or receivers of EM signals. These EM signals are received and processed via tracking module 1614. Tracking data associated with the EM signals may be stored in the memory of processor 1602 or in other memory separate from processor 1602. The tracking data may include data representing and / or indicating the position of the tool tip, the distal end of the tool, and / or the distal end of the corresponding instrument housing (or attachment).

[0106] When the EM coil of the tool or instrument is activated (i.e., emits an EM signal), the controller 101 can communicate via a cable (e.g., Figure 1 The cable 130 receives EM signals and / or sensor data indicating EM signals generated or received by the EM coil. Based on the sensor data, the tracking system 44 and / or navigation control module 1616 of the navigation system 10 can display the position of the tool tip, the distal end of the tool, and / or the distal end of the instrument housing.

[0107] The navigation control module 1616 can receive tracking data as input from the tracking system 44. The navigation control module 1616 can also receive patient image data as input. The patient image data may include images of the patient's anatomical structures obtained from preoperative or intraoperative imaging equipment, such as those obtained by... Figure 1The imaging device 14 acquires images. Based on tracking data and patient image data, the navigation control module 1616 can generate image data for display on the display 36. The image data may include patient image data overlaid with icons 103 of tools and / or instruments, such as... Figure 1 As shown. Icon 103 can provide a graphical representation of the position, orientation, and trajectory of the tool's tip, distal end, and / or the distal end of the instrument housing relative to the patient's anatomical structures. Additionally, icon 103 can show the tool's origin (i.e., an "X" adjacent to a bone in the anatomical structure) and the trajectory of the tool across the anatomical structure (i.e., a dashed line starting from the "X"). The tool's current position can also be shown by icon 103 (i.e., an "O" at the end of the dashed line). However, it should be understood that any suitable symbols, markings, etc., can be used to graphically represent the position and / or trajectory of the tool's tip relative to the anatomical structures.

[0108] The tracking module 1614 can receive start-up data from the navigation control module 1616 and sensor data from the EM coil of the tool, instrument, locator, and / or tracking device as input. The navigation control module 1616 can receive tracking data and patient image data as input. The tracking data can indicate the position of parts of the tool, instrument, locator, and / or tracking device in the patient space. Based on the tracking data, the navigation control module 1616 determines appropriate patient image data to display on the display 36 and outputs both the tracking data and the patient image data together as image data.

[0109] In response to the tracking module 1614 detecting movement of the distal end of the instrument (e.g., the distal end of instrument 1630, the distal end of the instrument's tool, or the distal end of any other instrument or tool mentioned herein), the degradation module 1618 may detect tool instability and / or breakage for tool and / or instrument replacement. The degradation module 1618 actively monitors the position of the tool tip (or the distal end of the tool) and, based on this, actively adjusts the tool's speed, torque, stability, damping, and / or feed rate via a corresponding motor (e.g., motor 1632 or other motors mentioned herein) and / or one or more actuators (e.g., actuator 1634 or other actuators disclosed herein). Actuator 1634 may include an attachment block, shaft, linkage, etc. This can occur during procedures, such as when removing tissue and / or bone.

[0110] Figure 17 It shows that it can be made by Figure 16 The tracking method is executed by the processor 1602 of the controller 101. The following operations can be performed iteratively. At 1700, the tracking module 1614 can determine whether startup data has been received from the navigation control module 1616. If startup data has been received, the tracking module 1614 performs operation 1702.

[0111] At 1702, the tracking system 44 is activated, and an EM signal is generated and transmitted from the selected EM coil. This may include one or more coils of one or more of the tools, instruments, locators and / or tracking devices involved.

[0112] At 1704, tracking module 1614 determines whether an EM signal has been received at one or more of the tools, instruments, locators, and / or tracking devices. If an EM signal has been received, operation 1706 is performed.

[0113] At 1706, the tracking module 1614 determines the position and orientation of the distal end of the instrument (e.g., the distal end of the tool and / or the distal end of the instrument housing) in the patient space based on the received EM signal. The tracking module 1614 also tracks the movement of the distal end of the instrument. This includes movement relative to the patient, oscillating movement, reciprocating movement, bending movement, deflection, flexing movement, etc.

[0114] At 1708, the tracking module 1614 or other modules can display icons and / or images of the tool and / or instrument relative to the patient in the corresponding imaging volume based on the determined position of the tool and / or instrument. At 1710, the degradation module 1618 monitors the movement to detect tool instability and / or breakage, thereby replacing the tool and / or instrument. When the tool and / or instrument is unstable and / or broken and should be replaced or repaired, the degradation module 1618 can... Figure 1 Indicators are displayed on the monitor 36. Degradation of the instrument can also be detected based on the tool's position, orientation, and movement. Degradation includes when the tool becomes loose and / or becomes loose and / or when the tool bends and / or deflects beyond what is expected during normal operation.

[0115] In an embodiment, the degradation module 1618 determines the tip position of the tool relative to the housing and / or the proximal portion of the tool, and determines the deviation from "normal". For example, it can be expected that the tip of the rotating tool will remain within a spherical range (e.g., a sphere with a diameter of 0.5-2 mm) defined relative to the proximal portion of the tool. The degradation module 1618 can determine this expectation based on i) the tool design, ii) characterization procedures during manufacturing, and / or iii) intraoperative characterization procedures. During use, when the degradation module 1618 detects that the tip of the tool (or instrument) has left the sphere, the degradation module detects a degradation operation of the instrument.

[0116] When the tool's speed makes constant positioning impractical (e.g., the tool rotates faster than the angular frequency of the transmitted EM signal), the degradation module 1618 monitors the scale of change in the induced voltage at the tip. For example, it can monitor the voltage induced in the coil of a proximal portion of the tool due to movement of the magnetized or emitting tip. If the voltage measured over many cycles of the transmitted signal (and therefore many revolutions of the tool) has a larger range than expected, the degradation module 1618 indicates suspected degradation. The expected degradation can be determined based on controlled design and / or characterization.

[0117] In this embodiment, due to the high-speed movement of the tip, the real-time position of the tool tip is not displayed. Instead, an average position or "bubble" representing the entire range of motion is displayed. Signal processing is less complex when the wind axis of the coil at the tool tip coincides with the axis of rotation of the tool. In cases where the tool tip includes a permanent magnet for positioning the tip, the magnet is arranged such that the line between the north and south poles of the magnet is not on the axis of rotation and does not extend along (or parallel to) the axis of rotation. In this embodiment, the magnet is arranged such that the line extending between the north and south poles is orthogonal to the axis of rotation.

[0118] At 1712, the tracking module 1614, degradation module 1618, and / or navigation control module 1616 can monitor the tool tip positioning (position and orientation) and movement, and actively adjust the tool's speed, torque, stability, damping, and / or feed rate. This may occur during the execution of a program. This can include adjusting the speed, power, current, voltage, etc., of the motor of the tool's instrument. As an example, if the degradation module 1618 detects degradation when the tool's speed is greater than a determined speed (e.g., greater than a determined number of revolutions per minute (RPM)), the processor 1602 and / or controller 101 prevent the tool from operating at a speed greater than the determined speed. The processor 1602 and / or controller 101 allow the tool to be actuated at a speed less than or equal to the determined speed.

[0119] Operations 1700, 1702, and / or 1704 can be executed after operation 1708.

[0120] The examples disclosed herein reduce stacking errors associated with tolerance variations in instrument parts. These examples provide EM coil arrangements that allow for accurate determination of the distal end of tools and instruments. This detection occurs in real time and during movement of the distal end of the tool. These examples are applicable to robotic applications where robots are moving and controlling instruments, such as any of the instruments disclosed herein. In robotic applications, tools can flex, deflect, and / or bend by considerable amounts. The examples disclosed herein are capable of detecting movement of the tool tip due to said flex, deflection, and bending.

[0121] Example embodiments are provided. Numerous specific details, such as examples of specific components, devices, and methods, are set forth to provide an understanding of embodiments of this disclosure. It will be apparent to those skilled in the art that the example embodiments can be implemented in many different forms without requiring the specific details, and that neither these specific details nor the example embodiments should be construed as limiting the scope of this disclosure. In some example embodiments, well-known processes, well-known device structures, and well-known techniques are not described in detail.

[0122] 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 circuit" includes a single processor circuit that executes some or all of the code from multiple modules. The term "group processor circuit" includes processor circuitry combined with additional processor circuitry to execute some or all of the code from one or more modules. References to multiple processor circuitry include multiple processor circuitry on a discrete die, multiple processor circuitry on a single die, multiple cores of a single processor circuit, multiple threads of a single processor circuit, or a combination of the above. The term "shared memory circuit" includes a single memory circuitry that stores some or all of the code from multiple modules. The term "group memory circuit" includes memory circuitry combined with additional memory to store some or all of the code from one or more modules.

[0123] The apparatus and methods described in this application can be implemented, in part or in whole, by one or more processors (also referred to as processor modules) to perform one or more specific functions embodied in a computer program, which may include a special-purpose computer (i.e., created by configuring one or more processors). These computer programs include 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. These computer programs may include a basic input / output system (BIOS) that interacts with the hardware of the special-purpose computer, device drivers that interact with specific devices of the special-purpose computer, one or more operating systems, user applications, background services, and applications, etc.

[0124] These 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, Java®, ASP, Perl, Javascript®, HTML5, Ada, ASP (Dynamic Server Pages), Perl, Scala, Erlang, Ruby, Flash®, Visual Basic®, Lua, or Python®.

[0125] The communications 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 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.

[0126] The terms processor, processor module, module, or “controller” are used interchangeably herein (unless explicitly stated otherwise), and each may be replaced by the term “circuit”. Any of these terms may refer to, be a part of, or include: application-specific integrated circuit (ASIC); digital, analog, or mixed-signal analog / digital discrete circuit; digital, analog, or mixed-signal analog / digital integrated circuit; combinational logic circuit; field-programmable gate array (FPGA); processor circuitry (shared, dedicated, or grouped) that executes code; memory circuitry (shared, dedicated, or grouped) that stores code executed by the processor circuitry; other suitable hardware components that provide the described functionality; or some or all of the foregoing, such as in a system-on-a-chip.

[0127] 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 circuit systems. Therefore, the terms "processor" or "processor module" as used herein can refer to any of the foregoing structures or any other physical structures suitable for implementing the described techniques. Furthermore, these techniques can be fully implemented in one or more circuit or logic elements.

[0128] For illustrative and descriptive purposes, the foregoing description of embodiments has been provided. This 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 where applicable and can be used in selected embodiments, even if not specifically shown or described. It can also be varied in many ways. Such variations should not be considered as departing from the invention, and all such modifications are intended to be included within the scope of the invention.

Claims

1. An instrument comprising: a housing; a motor disposed in the housing; a tool attached to the motor and configured to be moved by the motor to resect patient tissue, the tool comprising a distal end that is at least partially magnetized; and one or more first electromagnetic coils disposed in the housing and configured to generate an electromagnetic signal in response to detecting a magnetic field generated by the magnetized portion of the distal end of the tool as the tool moves to detect a position of the distal end of the tool as the tool moves. The one or more first electromagnetic coils comprise three coils.

2. The apparatus of claim 1, wherein, The three coils have winding axes that are perpendicular to each other.

3. The apparatus of claim 2, wherein, The one or more first electromagnetic coils are located distal to the housing.

4. The apparatus of claim 1, wherein, The tool is a drill bit.

5. The apparatus of claim 1, wherein, The tool is a saw blade.

6. The apparatus of claim 1, wherein, The motor is an oscillating motor, a rotary motor, or a reciprocating motor.

7. The apparatus of claim 1, wherein, A tip of the distal end of the tool is magnetized.

8. The apparatus of claim 1, wherein, The entire distal end of the tool is magnetized.

9. The apparatus of claim 1, wherein, 10. The instrument of claim 1, further comprising a shaft rotated by the motor, directly or indirectly connected to the tool, and configured to move the tool. The shaft extends through one of the one or more first electromagnetic coils and is adjacent to other ones of the one or more first electromagnetic coils.

11. The apparatus of claim 10, wherein, The distal end of the tool comprises a permanent magnet.

12. The apparatus of claim 1, wherein, A line extending between a north pole and a south pole of the permanent magnet does not extend parallel to an axis of rotation of the tool.

13. The apparatus of claim 12, wherein, A line extending between a north pole and a south pole of the permanent magnet is orthogonal to an axis of rotation of the tool.

14. The apparatus of claim 12, wherein, 15. An electromagnetic tracking system comprising: the instrument of claim 1; one or more second electromagnetic coils separate from the tool and configured to receive the electromagnetic signal; and a controller configured to detect a position of the distal end of the tool based on the received electromagnetic signal as the tool moves. The controller is configured to display a bubble representing a range of motion of the distal end of the tool based on the position. The controller is configured to detect at least one of i) instability and breakage of the tool, and ii) degraded operation of the instrument based on the position and detected movement of the distal end of the tool, and to indicate the detected instability, breakage, or degraded operation based on the detection.

16. The electromagnetic tracking system of claim 15, wherein, The controller is configured to adjust at least one of a speed, a torque, a stability, a damping, and / or a feed rate of the tool based on the position and detected movement of the distal end of the tool.

17. The electromagnetic tracking system of claim 15, wherein, The controller is configured to degrade above a determined speed and prevent the tool from operating above the determined speed based on the position and detected movement of the distal end of the tool.

18. The electromagnetic tracking system of claim 15, wherein, 20. An electromagnetic tracking system comprising:

19. The electromagnetic tracking system of claim 15, wherein, an instrument comprising a housing, a motor disposed in the housing, a tool attached to the motor and configured to be moved by the motor to resect patient tissue, the tool comprising a distal end that is at least partially magnetized, and ​ ​ a plurality of first electromagnetic coils disposed at a distal end of the housing and configured to generate an electromagnetic signal in response to detecting a magnetic field generated by a magnetized portion of a distal end of the tool as the tool moves; a plurality of second electromagnetic coils separate from the tool and configured to receive the electromagnetic signal; and a controller configured to detect a position of the distal end of the tool based on the received electromagnetic signal as the tool moves. ​

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