Attachments and systems for tracking surgical instruments

Abstract

The tracker attachment for the high speed drilling device may include an attachment comprising an attachment body engageable with a surgical handpiece and a tracker operable with a surgical navigation system to track a position of the attachment. The attachment may further comprise a cantilever arm extending proximally of the attachment body to an accessory mount. The tracker may comprise an accessory socket configured to removably engage with the accessory mount. The system may further comprise a sterile packaging system for storing and transporting the tracker.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This patent application claims the priority and all benefits of U.S. Provisional Patent Application No. 63 / 257,066, filed on October 18, 2021, Provisional Patent Application No. 63 / 318,436, filed on March 10, 2022, and Provisional Patent Application No. 63 / 413,014, filed on October 4, 2022, the entire contents of which are incorporated herein by reference.

Background Art

[0002] In one non - limiting example, certain accessories such as tracking markers are permanently fixed to the associated surgical instrument and can also form part of the associated surgical instrument. There is a need for an accessory mount for use with a surgical instrument that allows for easy installation and removal of such accessories and provides consistent alignment of the accessories with the surgical instrument.

Summary of the Invention

[0003] In one embodiment, an attachment for a surgical instrument is disclosed. The surgical instrument may include a surgical handpiece. The attachment may comprise an attachment body extending from a proximal end to a distal end. The proximal end may be configured to engage with a surgical handpiece. The attachment body may comprise a bushing portion located at the proximal end of the attachment body and engaged with the distal end of the surgical handpiece. The bushing portion has a first diameter. The attachment body may further comprise a mounting flange located distal to the bushing portion. The mounting flange has a second diameter greater than the first diameter of the bushing portion. The attachment may further comprise a tool chuck coupled to the attachment body and configured to receive a material removal tool located at the working end of the surgical instrument. The attachment may further comprise a drive shaft supported within the attachment body and operably coupled to the tool chuck. The drive shaft may be rotatable around the instrument axis to transmit power from the surgical handpiece to the material removal tool. The attachment may further include a cantilever arm coupled to the attachment body adjacent to the mounting flange. The cantilever arm extends proximal to the accessory mount. The accessory mount can be positioned proximal to the bushing portion.

[0004] In a second embodiment, a system for tracking the position of a rotary cutting tool is disclosed. The system may comprise a rotary cutting tool, a surgical handpiece equipped with a motor, and a surgical instrument attachment. The surgical instrument attachment may comprise an attachment body extending from a proximal end to a distal end. The proximal end may be configured to engage with the surgical handpiece. The surgical instrument attachment may further comprise a cantilever arm coupled to the attachment body and extending proximal to an accessory mount. The accessory mount may be positioned proximal to the proximal end of the attachment body and spaced apart from the surgical handpiece. The system may further comprise a tracker. The tracker may comprise a tracker frame and at least three optical markers coupled to the tracker frame. The tracker may further comprise an accessory socket coupled to the tracker frame. The accessory socket may be configured to engage with an accessory mount. The tracker may be positioned proximal to the attachment body when the accessory socket is coupled to the accessory mount.

[0005] In a third embodiment, a coupling structure for coupling a surgical instrument tracker to a surgical instrument is disclosed. This coupling structure may comprise an accessory mount and an accessory socket. The accessory mount can be coupled to the surgical instrument, and the accessory socket can be coupled to a surgical instrument tracker. The accessory mount may comprise a body portion having an upper surface and defining a clamp hole on the upper surface. The accessory mount may further comprise a first lateral wing portion and a second lateral wing portion projecting from opposing sides of the body portion in a transverse direction relative to the upper surface. The first lateral wing portion may have a first lateral surface, and the second lateral wing portion may have a second lateral surface. The first and second lateral surfaces may be at angles symmetrical with respect to the longitudinal plane of the surgical instrument. The accessory mount may further comprise a plurality of alignment pegs projecting from the upper surface. The accessory socket may comprise a clamp surface defining a fastener hole and a plurality of alignment channels recessed in the clamp surface and configured to engage complementarily with a plurality of alignment pegs. The accessory socket may further comprise a first socket wall hanging down from the clamp surface, having a first rail surface spaced apart from the clamp surface and a first inclined surface extending between the first rail surface and the clamp surface. The accessory socket may further comprise a second socket wall hanging down from the clamp surface, having a second rail surface spaced apart from the clamp surface and a second inclined surface extending between the second rail surface and the clamp surface. The system may further comprise a clamp fastener disposed in the fastener hole and engageable with the clamp hole. The clamp fastener may be configured to bias the upper surface of its body portion toward the clamp surface of the accessory socket so that the alignment pegs engage with the alignment channels.

[0006] In a fourth embodiment, a sterile packaging system for a surgical navigation tracker is disclosed. The sterile packaging system may comprise a sterile tracker and a blister pack. The sterile tracker may comprise a tracker frame defining a battery container. The sterile tracker may further comprise an electrical circuit comprising a positive terminal and a negative terminal disposed in the battery container, and a plurality of tracking markers electrically connected to the positive terminal and the negative terminal. The sterile tracker may further comprise a battery disposed in the battery container between the positive terminal and the negative terminal, and insulating members disposed between the battery and the positive terminal and the negative terminal, respectively. The blister pack may comprise a shell portion defining a sterile interior shaped to receive the sterile tracker. The blister pack may further comprise a sealing film disposed on the sterile interior in cooperation with the shell portion to seal the sterile tracker within the blister pack.

[0007] Any of the above embodiments can be combined in whole or in part. Any of the above features can be combined in whole or in part. Any of the above embodiments for any of the embodiments can be combined with any other embodiment. Any of the above embodiments can be combined with any other embodiment, whether in the same embodiment or a different embodiment. The summary of this invention is a simplified introduction to some of the concepts that will be further described below in the "Detailed Description". The summary of this invention is not intended to limit the scope of the claimed subject matter, nor is it intended to identify any important or essential features of the claimed subject matter.

[0008] The merits of this disclosure will be readily apparent as the disclosure is better understood by referring to the following detailed description, in conjunction with the accompanying drawings. [Brief explanation of the drawing]

[0009] [Figure 1] This is an example of surgical equipment demonstrating a surgical navigation system. [Figure 2] This is a perspective view showing a user holding a surgical instrument having an attachment and a tracker connected to it. [Figure 3] Figure 2 is another perspective view of the surgical instruments and tracker. [Figure 4] This is a perspective view of a surgical instrument with the tracker removed, virtually showing the partially removed tracker. [Figure 5] This is a perspective view of the tracker and the coupling structure having an accessory mount and accessory socket. [Figure 6] Figure 5 shows the bonding structure and a bottom perspective view of the tracker. [Figure 7] This is a cross-sectional view of the bond structure. [Figure 8] These are cross-sectional views of the tracker, bonding structure, and attachment. [Figure 9] This is a magnified cross-sectional view of a tracker showing the accessory socket of the coupling structure. [Figure 10] This is a perspective cross-sectional view of the tracker and bonding structure. [Figure 11] This is a cross-sectional perspective view of the tracker and insulating strip. [Figure 12] This is a cross-sectional view of the tracker and accessory socket. [Figure 13] This is a bottom view perspective of the tracker and accessory socket. [Figure 14] This is a perspective view of an attachment and accessory mount for surgical instruments. [Figure 15] This is a diagram of the proximal end of the attachment and accessory mount. [Figure 16] Another perspective view of the accessory mount. [Figure 17] Another perspective view of the accessory mount. [Figure 18] This is a perspective view of a surgical instrument having an attachment and a tracker connected thereto. [Figure 19] Figure 18 is an enlarged side view of the surgical instrument and tracker, showing the tracker partially detached from the surgical instrument. [Figure 20] It is a bottom perspective view of a coupling structure having a tracker, an accessory mount, and an accessory socket. [Figure 21] It is another perspective view of the tracker and the coupling structure of FIG. 20. [Figure 22] It is an enlarged cross-sectional view of the tracker showing the accessory mount of the coupling structure. [Figure 23] It is a perspective cross-sectional view of the tracker and the coupling structure. [Figure 24] It is another cross-sectional view of the tracker and the coupling structure. [Figure 25] It is a bottom perspective view of the tracker and the accessory socket. [Figure 26] It is a bottom view of the tracker and the accessory socket. [Figure 27] It is a bottom perspective view of the tracker and the accessory socket. [Figure 28] It is a partially cut-away perspective view of the sterilized tracker of FIGS. 2 to 12, disposed and supported inside a sterilization packaging system. [Figure 29] It is another partially cut-away perspective view of the sterilization packaging system of FIG. 28, showing the shell portion and the insertion portion. [Figure 30] It is an environmental view of the sterilization packaging system showing the user removing the sterilized tracker and the insertion portion from the shell portion. [Figure 31] It is an environmental view of the sterilization packaging system showing the user assembling the sterilized tracker to a surgical instrument without direct contact with the sterilized tracker.

Mode for Carrying Out the Invention

[0010] Referring to figures in which similar figures indicate similar parts, the present disclosure includes two exemplary embodiments (discussed in further detail below) of a navigation tracker 300, 1300 and an instrument attachment 240 for use with a handheld surgical instrument 200 in conjunction with a surgical navigation system 102, and a method for operating the tracker 300. Figure 1 shows an exemplary surgical system 100 which may include a surgical navigation system 102 for tracking one or more surgical instruments 200, including the surgical instrument 200, and a tracker 300, to assist a medical professional such as a surgeon in performing a medical procedure.

[0011] The surgical navigation system 102 may include a navigation interface comprising one or more display units 104 and one or more user input units 106. The display unit 104 of the surgical navigation system 102 may be configured to display various prompts or data input boxes. For example, the display unit 104 may be configured to display a text box or prompt that allows the surgeon to manually fill in or select the type of surgical procedure to be performed. The display unit 104 may also be configured to display patient data such as preoperative images or scans. As described above, preoperative images may be based on MRI scans, radiographic scans, or computed tomography (CT) scans of the patient's anatomical structures. Preoperative images can be uploaded to the surgical navigation system 102 and displayed on the display unit 104. The display unit 104 may further be configured to display a surgical plan for the medical procedure overlaid on the patient data or images. The surgical plan may include a surgical route for performing the medical procedure, or a planned trajectory or orientation of medical instruments during the medical procedure. The surgical plan may also include overlaying the position and / or orientation of an implant or medical device to be inserted during the medical procedure onto patient data or images. It is conceivable that the surgical navigation system 102 may include a display unit 104 configured to display and / or project a holographic image of a planned trajectory or orientation for a surgical route to perform a medical procedure, or for a medical device during the medical procedure. This may include projecting the surgical route onto the patient or other surface in the operating room. It may also include projecting the surgical route onto a head unit worn by the surgeon, such as a lens, shield, or glasses of a head unit. An exemplary configuration of the surgical navigation system 102, including a display unit worn by the surgeon to display a target trajectory and / or target position, is disclosed in U.S. Patent Application Publication 2020 / 0085511, which is incorporated herein by reference in its entirety.

[0012] The user input unit 106 can be configured to allow a surgeon to input or fill in patient data or modify the surgical plan. Patient data may include patient images, such as preoperative images of the patient's anatomical structure. These images may be based on MRI, radiographic, or computed tomography (CT) scans of the patient's anatomical structure. Patient data may also include additional information regarding the type of medical procedure being performed, the patient's anatomical characteristics, the patient's specific medical condition, and / or operational settings for surgical navigation settings. For example, when performing spinal surgery, the surgeon may input information about the specific vertebra being operated on via the user input unit 106. The surgeon may also input various anatomical dimensions of the vertebra, and / or the size and shape of any medical devices or implants to be inserted during the procedure. The user input unit 106 can also be configured to allow a surgeon to select, edit, or manipulate patient data. For example, the surgeon may identify and / or select anatomical features from the patient data. This may include selecting the surgical site, such as selecting the vertebra and / or a specific area on the vertebra where the medical procedure should be performed.

[0013] The surgical navigation system 102 may further include a navigation processor 108. The navigation processor 108 may be located on a personal computer or laptop computer. The navigation processor 108 can communicate with a user input unit 106, a display unit 104, a central processing unit (CPU) and / or other processors, memory (not shown), and storage devices (not shown). The navigation processor 108 may further include software and / or operation commands for implementing various routines and / or methods disclosed herein relating to the operation of the surgical navigation system 102. The software and / or operation commands may include a planning system configured to find the precise position and / or angular alignment of the surgical instruments 200 relative to the patient 120. The navigation processor 108 can communicate with the surgical instruments 200 directly or indirectly, either wired or wirelessly.

[0014] The surgical navigation system 102 may also include a tracking unit or localizer 122 comprising one or more sensors 124. The sensors may include cameras such as CCD cameras, CMOS cameras, and / or optical imaging cameras, magnetic sensors, radio frequency sensors, or any other sensors adapted to detect and / or sense the position of a tracker 300 of a surgical instrument 200. One exemplary localizer 122 may be capable of detecting radiation or light from multiple markers and generating a localizer signal representing the detected radiation or light. The exemplary surgical navigation system 102 may be configured to utilize a tracker 300 with fixed spatial relationships between tracking markers. A description of various suitable localizers that may be available can be found in U.S. Patent No. 10,531,926, which is incorporated herein by reference in its entirety.

[0015] The navigation processor 108 can be enabled to receive localizer signals. The navigation processor 108 can further enable the registration and tracking of the tracker 300 based on the received sensor signals. Based on the localizer signals, the processor can also calculate the orientation and / or position of the tracker 300 relative to the localizer 122. The navigation processor 108 can access information about spatial relationships. In such cases, three-dimensional images captured by a stereo camera are not required, and the camera may include only a single two-dimensional image sensor.

[0016] The navigation processor 108 can further be configured to receive and / or store patient information / data (e.g., computed tomography scans and / or tracking signals of the patient's body). The navigation processor 108 can then calculate the position and / or orientation of the surgical instrument 200 relative to the patient 120. The navigation processor 108 can be configured to generate visual or acoustic signals indicating the tracking of the surgical instrument 200. Visual signals can be displayed on the display unit 104. The navigation processor 108 can be part of a separate computing device from the localizer. Alternatively, the localizer may include the navigation processor.

[0017] Figure 2 shows a perspective view of a first configuration of the tracker 300 and surgical instrument 200. The surgical instrument 200 has a proximal end 202 and a distal end 204 spaced apart along the instrument axis A1. In many cases, such as that shown in Figure 2, the surgical instrument 200 transmits mechanical energy along the instrument axis A1 from a power source (e.g., a motor or ultrasonic transducer) to a cutting tool 208 coupled to the surgical instrument 200. One example of this configuration is shown in Figure 2, where the surgical instrument 200 is illustrated together with a rotary cutting tool such as a high-speed drill attachment.

[0018] The surgical instrument 200 may include an attachment 240, a surgical handpiece 206 (or handpiece), and a cutting tool 208. The attachment 240 is configured to engage with the surgical handpiece 206 and receive the cutting tool 208. The attachment 240 transmits rotational motion from the handpiece 206 to the cutting tool 208. Thus, the handpiece 206 is powered and receives electrical control signals from a control system coupled to the handpiece 206, for example, via a flexible supply cable 212.

[0019] The handpiece 206 may include a housing 210, a motor (not shown) disposed within the housing 210, a flexible supply cable 212 protruding proximally from the housing 210, and a handpiece interface 214 at the distal end 216 of the surgical handpiece 206. The housing 210 has a handpiece diameter 218. Exemplary surgical instruments can be found in U.S. Patents 8,597,316 and 10,537,339, which are incorporated herein by reference in their entirety.

[0020] Power from the handpiece 206 is transmitted to the attachment 240 to drive the cutting tool 208. As shown in Figures 3 and 14, the attachment 240 may include an attachment body 242 extending from a proximal end 244 to a distal end 246. As used herein, “distal” generally refers to the part closer to the patient during use (e.g., the material removal tool closest to the surgical site), and “proximal” generally refers to the part further away from the patient during use (e.g., the power cord). The proximal end 244 of the attachment 240 is configured to engage with the distal end 216 of the surgical handpiece 206. The attachment body 242 includes a bushing portion 248 located at the proximal end 244 of the attachment body 242, the bushing portion being engageable with the handpiece interface 214 of the handpiece 206. The bushing portion 248 is received by the handpiece interface 214 and is roughly aligned with the instrument axis A1. The bushing portion 248 has a first diameter 250, which is sized to fit within the handpiece interface 214 at the distal end 216 of the handpiece 206.

[0021] The attachment body 242 further includes a mounting flange 252 positioned distal to the bushing portion 248, the mounting flange having a second diameter 254. The second diameter 254 of the mounting flange 252 is larger than the first diameter 250 of the bushing portion 248. The second diameter 254 is sized to limit the insertion of the bushing portion 248 into the handpiece 206. The second diameter 254 can be less than or equal to the housing diameter 218 of the handpiece 206. The mounting flange 252 abuts against the distal end of the handpiece 206 when the attachment 240 is fully coupled to the handpiece 206.

[0022] The drive shaft 256 is disposed within the attachment body 242 and is supported for rotation around the instrument axis A1, and in some examples, further around the tool axis A2. The drive shaft 256 is rotatable around the instrument axis A1 to transmit power from the surgical handpiece 206 to the cutting tool 208. In some embodiments of the attachment 240, the drive shaft 256 may include two or more drive shaft segments engaged in a torque conversion relationship such that the rotation of one drive shaft segment is transmitted to other drive shaft segments(s). The drive shaft segments can be operably coupled using, for example, a universal joint, a constant velocity joint, a gear, etc. For this purpose, some embodiments of the attachment 240 can be angled with respect to the instrument axis A1. The attachment 240 illustrated herein is such that the distal end 246 is angled with respect to the proximal end 244. Here, one of the drive shaft segments 256A is positioned at the proximal end of the attachment 240 and aligned with the instrument axis A1, while the other drive shaft segment 256B is positioned at the distal end of the attachment 240 and aligned with the tool axis A2. Angling the attachment 240 can facilitate favorable control and / or visibility by the surgeon during use. For example, a surgeon may prefer the working end to be angled when performing a procedure with one type of cutting tool, and a straight working end when performing a procedure with another type of cutting tool. The attachment 240 may be straight or angled at 15 degrees, 45 degrees, etc. In addition, the attachment may be of various lengths, such as 30 mm, 50 mm, etc.

[0023] The attachment 240 may further include a tool chuck 258 supported within the attachment body 242 and configured to engage with a cutting tool 208. The cutting tool 208 is positioned at the working end of a surgical instrument 200, where the working end generally refers to the distal end of the surgical instrument 200 intended to perform a procedure (e.g., material removal) on a patient. The tool chuck 258 is operably coupled to a drive shaft 256 to receive power from the handpiece 206. More specifically, the tool chuck 258 can be coupled to a distal drive shaft segment 256B and aligned with the tool axis A2. The tool chuck 258 advantageously allows the cutting tool 208 to be removed from the attachment 240 without first removing other parts of the surgical instrument 200 (e.g., a tracker 300).

[0024] Referring to Figure 13, in addition to the above, the attachment 240 may further include a cantilever arm 260. The cantilever arm 260 can be coupled to the attachment body 242 adjacent to or distal to the mounting flange 252. The cantilever arm 260 extends proximal from the attachment body 242 to an accessory mount 262. The cantilever arm 260 is configured such that the accessory mount 262 is positioned proximal to the bushing portion 248. More specifically, the accessory mount 262 is separated from the mounting flange 252 by an arm distance 264. An arm socket 266 is located at the distal end of the cantilever arm 260 and engages with the attachment body 242 to couple the cantilever arm 260 to the attachment 240. Here, the arm socket 266 is ring-shaped and couples to the attachment body 242 using an interference fit. In other words, the inner diameter of the arm socket 266 is approximately the same as the second diameter 254 of the bushing portion 248, thereby allowing the arm socket 266 to be pressed against the attachment body 242 and held without additional fasteners. In other embodiments of the attachment body 242 or the cantilever arm 260, the arm socket 266 may be welded to the attachment body 242 during manufacturing. It is also conceivable that other joining methods may be utilized, such as brazing, adhesive, soldering, one or more screw components, crimping, and swaging. The arm socket 266 may be removably coupled to both the attachment body 242 and the cantilever arm 260. Alternatively, the arm socket 266 may be integrally formed with the attachment body 242 and the cantilever arm 260.

[0025] The cantilever arm 260 extends in a direction approximately parallel to the instrument axis A1. The cantilever arm 260 is shaped to minimize the contour of the surgical instrument 200. In other words, the cantilever arm 260 is shaped to minimize the outer surface of the cantilever arm 260 relative to the instrument axis A1. To this end, the cantilever arm 260 may have a curved contour 268 that is separated from the handpiece 206 and follows the cylindrical shape of the handpiece 206. More specifically, the cantilever arm has an arm radius distance 270 from the curved contour 268 to the instrument axis A1. The ratio of the handpiece diameter 218 to the arm radius distance 270 is greater than 1.25:1, which significantly reduces the footprint of the surgical instrument 200 and improves balance in the surgeon's hand. Similarly, the ratio of the arm distance 260 to the arm radius distance 270 is greater than 5:1.

[0026] Figures 13–16 show an accessory mount 262 coupled to the proximal end of a cantilever arm 260. The accessory mount 262 is configured to engage with an accessory socket 340 (see Figure 4). As discussed below, the accessory socket 340 is coupled to the tracker frame 302 of the tracker 300 to removably couple the tracker 300 to the attachment 240. The accessory mount 262 may include a body portion 272, a first lateral wing portion and a second lateral wing portion 274, and one or more alignment pegs 276. The body portion 272 has an upper surface 278 which may define a clamp hole 280. The upper surface 278 is generally oriented away from the instrument axis A1. The clamp hole 280 is configured to receive a corresponding clamp fastener 282, which will be discussed below. Here, the clamp hole 280 is threaded in the form of a female thread to receive the clamp fastener 282, and the clamp fastener 282 is threaded in the form of a male thread of the corresponding shape.

[0027] The first and second lateral wing portions 274 can be further defined as the first lateral wing portion 274A and the second lateral wing portion 274B. The first and second lateral wing portions 274A and 274B project from opposing sides of the fuselage portion 272 in a direction that can be roughly transverse to the upper surface 278. Each of the lateral wing portions 274 has a corresponding lateral surface 284. More specifically, the first lateral wing portion 274A has a first lateral surface 284A, and the second lateral wing portion 274B has a second lateral surface 284B. As illustrated in the example in Figure 14, the lateral surfaces 284 are generally at an angle of approximately 90 degrees to the upper surface 278. However, some variation is expected due to the nature of certain manufacturing processes. In other embodiments, the angle between the lateral surface 284 and the upper surface 278 can be any value between 0 and 180 degrees. However, the lateral surface 284 is not parallel to the fixture axis A1. A mounting width 286 can be defined between the first lateral surface 284A and the second lateral surface 284B.

[0028] A longitudinal plane P1 (see Figure 11), aligned with the instrument axis A1 and positioned vertically, is defined by the surgical instrument 200. The longitudinal plane P1, exemplary, defines the left and right sides of the surgical instrument 200. The first and second lateral surfaces 284 can be at angles symmetrical with respect to the longitudinal plane P1 of the surgical instrument 200. In other words, the first lateral surface 284A can form a first angle with respect to the longitudinal plane P1, and the second lateral surface 284B can form a second angle with respect to the longitudinal plane P1. The first angle of the first lateral surface 284A and the second angle of the second lateral surface 284B can be equal and opposite to each other, i.e., they can be mirror images with respect to the longitudinal plane P1. The exemplary accessory mount 262 shown herein includes, exemplary, a lateral surface 284 that may intersect at a point distal to the accessory mount 262.

[0029] The accessory mount 262 may further include one or more alignment pegs 276 protruding from the upper surface 278. The alignment pegs 276 are configured to engage with corresponding alignment channels 346 defined in the accessory socket 340. The accessory mount 262 may include any preferred number of alignment pegs 276 to ensure secure engagement with the accessory socket 340. More specifically, the alignment pegs 276 prevent relative movement of the tracker 300 relative to the attachment 240 during use, which can reduce tracking accuracy. The one or more alignment pegs 276 may further be defined as eight alignment pegs, such as those illustrated herein. Other numbers of alignment pegs may also be conceived.

[0030] Here, the alignment pegs 276 may be used to restrict the relative movement between the tracker 300 and the accessory mount 262. The alignment pegs 276 can be arranged radially around the clamp hole 280 in a circular or semicircular pattern to restrict movement. Here, the alignment pegs 276 are shaped like elongated, truncated pyramidal shapes. A mount height 288 can be defined between the lowest surface of the lateral wing 274 and the highest point of the alignment peg 276.

[0031] As described above, the tracker 300 can be detachably coupled to the surgical instrument 200 to track the position and orientation of the attachment 240 and the cutting tool 208. The tracker 300 is operable with the surgical navigation system 102 to determine the position and orientation of the tracker 300 in space. The tracker 300 is operable with the surgical instrument 200 and the surgical navigation system 102 to determine the position and / or orientation of the surgical instrument 200 or its components within the operating room. To accurately determine the position of the surgical instrument 200, the tracker 300 is coupled to the surgical instrument 200 and configured to prevent relative movement between the tracker and the surgical instrument during surgical procedures. In addition, the tracker 300 should be coupled to the surgical instrument 200 to maximize its visibility to the surgical navigation system 102. It should also be understood that certain features of the described tracker can be used to track patients, other devices in the operating room, or even medical professionals.

[0032] Although surgical instrument 200 is shown as a high-speed drill throughout the figure, the tracker 300 can also be used with surgical instruments other than high-speed drills. For example, the tracker 300 may be coupled to a handheld ultrasound ablation tool, a biopsy needle, or part of a robotic device such as a robot end effector, robotic arm, or other equipment in the operating room. Similarly, the tracker 300 may be adapted to be coupled to other surgical instruments (not shown), such as a handheld drill, saw, or crowbar. As described above, the attachment 240 coupled to the working end of surgical instrument 200 is shown in Figure 2 as an angled attachment that drives a rotary tool on a tool axis A2 different from the instrument axis A1. For example, the attachment may be straight or angled at 15 degrees, 45 degrees, etc., and the attachment may be of various lengths, such as 30 mm, 50 mm, etc.

[0033] In some cases, certain surgical procedures may require the surgeon to perform precise movements using surgical instruments. These and other surgical procedures may last for several hours. When a heavy tracker is attached to a handheld surgical instrument, the tracker may shift the center of gravity of the assembly, which can be cumbersome for the surgeon (e.g., due to the torque applied to the holding hand). The tracker 300 shown throughout the figure can offer reduced weight through material selection and design features that minimize the amount of material required to maintain the shape and desired properties of the tracking device. The handheld surgical instrument 200 can be made less cumbersome to hold.

[0034] Referring here to Figures 2 to 12, a first embodiment of the tracker 300 is shown. To facilitate the detachable coupling of the tracker 300 to the surgical instrument 200, the tracker 300 includes a tracker frame 302 having a proximal end 304 and a distal end 306, as shown in Figure 4. The tracker frame 302 includes a mounting portion 308 defining an instrument opening 310 through which the attachment 240 is inserted and coupled to the tracker 300. As will be discussed in more detail below, the surgical instrument 200 engages with the tracker 300 from the proximal end 304 of the tracker frame 302. As shown in Figure 3, the tracker 300 is illustrated detached and assembled with the attachment 240. The first tracker 300 is virtually shown in a partially assembled state with the attachment 240 positioned in the instrument opening 310, while the second tracker 300 is shown separated from the attachment 240. The tracker 300 is assembled to the attachment 240 by inserting the distal end of the attachment 240 through the instrument opening 310 from the proximal end 304 of the tracker 300. The instrument opening 310 is shaped and sized such that it stops the tracker 300 when it reaches the assembly position and prevents it from falling off the proximal end of the surgical instrument 200.

[0035] Referring to Figure 6, the tracker frame 302 may further include an elongated portion 312 supported on the mounting portion 308 and extending proximal and in a direction substantially parallel to the instrument axis A1. The elongated portion 312 may have an upper surface 314. The upper surface 314 may have a substantially triangular shape when viewed from above, and the elongated portion 312 may taper from the distal end 306 to the proximal end 304. The tracker frame 302 may define a battery container 316 positioned adjacent to the upper surface 314 of the tracker frame 302. The battery container 316 may be configured to receive a battery 318 in order to electrically connect the battery 318 to the electrical circuit 374 of the tracker 300. The battery container 316 may be configured to prevent the flow of current from the battery 318 until the battery 318 is fully inserted into the battery container 316. One exemplary embodiment of an LED tracking marker is shown in U.S. Patent Application Publication No. 2019 / 0321108, which is incorporated herein by reference. Other embodiments may also be conceived.

[0036] To track the position and orientation of the surgical instrument 200, the tracker 300 may further include a tracker array 320 having a plurality of tracking markers 322, which are optionally positioned on one or more tracked surfaces 324A, 324B, 324C and coupled to a tracker frame 302, as shown in Figure 11. The first tracked surface 324A is positioned on the upper surface 314 of the elongated portion 312, the second tracked surface 324B is positioned laterally to the elongated portion 312 and the mounting portion 308 on the first side of the longitudinal plane P1, and the third tracked surface 324C is positioned laterally to the elongated portion 312 and the mounting portion 308 on the second side of the longitudinal plane P1. The tracker array 320 may further include a tracker contour defined perpendicular to the instrument axis A1, which includes three radial segments. The tracked surfaces 324A, 324B, and 324C can be aligned with their respective radial segments 326A, 326B, and 326C, with each side being non-parallel to the others, for example, at approximately 120 degrees. Multiple tracked surfaces 324A, 324B, and 324C are positioned such that each tracked surface 324A, 324B, and 324C is oriented in a different direction from the others. The first tracked surface 324A can be aligned with the first radial segment 326A, the second tracked surface 324B can be aligned with the second radial segment 326B, and the third tracked surface 324C can be aligned with the third radial segment 326C. Other numbers of arrays and / or other numbers of sides can also be conceived. A tracker utilizing a similar configuration of the tracked surface is disclosed in U.S. Patent Application Publication No. 2021 / 0236212, which is incorporated herein by reference in its entirety.

[0037] As shown in Figures 4 and 11, at least one of the tracking markers 322 can be positioned distal to the mounting portion 308 on the elongated portion 312, and at least another of the tracking markers 322 can be positioned proximal to the mounting portion 308. In some embodiments, such as those illustrated herein, the tracker array 320 may include at least three tracking markers 322, in which case at least three tracking markers 322 define a marker plane on one of the tracked surfaces 324A, 324B, and 324C. At least one of the tracking markers 322 may be positioned on each of the radial segments 326A, 326B, and 326C to improve easy visibility by the navigation system.

[0038] As described above, the tracker 300 can be clamped to the surgical instrument 200 in a secure and reliable manner. For this purpose, the tracker 300 may further include an accessory socket 340 that is operable to attach the tracker 300 to the surgical instrument 200, as shown in Figure 12. The accessory socket 340 can be detachably coupled to the accessory mount 262 by the surgeon or another user or other medical professional. The accessory mount 262 coupled to the surgical instrument 200 and the accessory socket 340 coupled to the tracker 300 can together be called a coupling structure.

[0039] Referring to Figures 10 to 12, the accessory socket 340 may include a clamp surface 342 defining a fastener hole 344 and one or more alignment channels 346 recessed in the clamp surface 342. The alignment channels 346 are configured to engage complementarily with one or more alignment pegs 276 of the accessory mount 262. The accessory socket 340 may further define a socket opening 348 sized and shaped to receive the accessory mount 262. The socket opening 348 is generally located at the proximal end of the accessory socket 340.

[0040] The accessory socket 340 further includes a distal wall 350 adjacent to the clamp surface 342. The distal wall 350 is located at the distal end 306 of the tracker frame 302 opposite the socket opening 348. The distal wall 350 protrudes away from the clamp surface toward the surgical instrument 200. When the accessory mount 262 is received in the accessory socket 340, the distal wall 350 restricts the movement of the accessory mount 262 from proximal to distal. In other words, the accessory socket 340 receives the accessory mount 262 within the socket opening 348 at its proximal end. As the accessory mount 262 moves from proximal to distal, the distal wall 350 restricts the movement and holds the accessory mount 262 in the accessory socket 340, and when the accessory mount 262 engages with the distal wall 350, the accessory mount 262 is in a fully inserted position. The distal wall 350 prevents the tracker frame 302 from detaching from the accessory mount 262 before the clamp fastener 282 is tightened.

[0041] The accessory socket 340 may further include a first socket wall and a second socket wall extending from the clamp surface 342. More specifically, as shown in Figure 9, the first socket wall 352 and the second socket wall 358 each extend from the clamp surface 342. The first socket wall 352 may have a corresponding first rail surface 354 spaced apart from the clamp surface 342. The first socket wall 352 may further have a first inclined surface 356 extending between the first rail surface 354 and the clamp surface 342. The second socket wall 358 may have a corresponding second rail surface 360 ​​spaced apart from the clamp surface 342. The second socket wall 358 may further have a second inclined surface 362 extending between the second rail surface 360 ​​and the clamp surface 342. The first socket wall 352, the first rail surface 354, and the first inclined surface 356 are positioned on one side of the longitudinal plane P1 to partially define the accessory socket 340. The second socket wall 358, the second socket rail surface 360, and the second inclined surface 362 are positioned on the opposite side of the longitudinal plane P1 to partially define the accessory socket 340. The first socket wall 352, the second socket wall 358, and the distal wall 350 work together to define the accessory socket 340.

[0042] The accessory socket 340 defines a socket width 364 and a socket height 366. The socket width 364 can be defined as the distance between the first inclined surface 356 of the first socket wall 352 and the second inclined surface 362 of the second socket wall 358. The socket height 366 can be defined as the distance between the clamp surface 342 and the first rail surface 354. The distance between the clamp surface 342 and the second rail surface 360 ​​is generally equal to the distance between the clamp surface 342 and the first rail surface 354. In other embodiments where the distance between the clamp surface 342 and the second rail surface 360 ​​is different from the distance between the clamp surface 342 and the first rail surface 354, the socket height may be defined by the distance between the clamp surface 342 and the second rail surface 360 ​​instead.

[0043] Similar to the lateral surface 284, the first inclined surface 356 and the second inclined surface 362 generally form an angle of approximately 90 degrees with respect to the clamp surface 342. However, some variation is expected due to the nature of certain manufacturing processes. However, the inclined surfaces are not parallel to the instrument axis A1. The first inclined surface 356 and the second inclined surface 362 can be at symmetrical angles with respect to the longitudinal plane P1 of the surgical instrument 200. In other words, the first inclined surface 356 can form a first angle with respect to the longitudinal plane P1, and the second inclined surface 362 can form a second angle with respect to the longitudinal plane P1. The first angle of the first inclined surface 356 and the second angle of the second inclined surface 362 can be equal and opposite to each other. Furthermore, the angle of the first socket wall 352 is the same as the angle of the first lateral surface 284A of the first lateral wing portion 274A with respect to the longitudinal plane P1 of the surgical instrument 200, and the angle of the second socket wall 358 is the same as the angle of the second lateral surface 284B of the second lateral wing portion 274B with respect to the longitudinal plane P1 of the surgical instrument 200. In this way, engagement between the first inclined surface 356 and the first lateral surface 284A is facilitated. Similarly, engagement between the second inclined surface 362 and the second lateral surface 284B is also facilitated. The mounting width 286 of the accessory mount 262 between the first lateral surface 284A and the second lateral surface 284B is greater than the socket width 364 of the accessory socket 340, thereby preventing the tracker 300 from sliding off the accessory mount 262 and the back of the surgical instrument 200. Similarly, the mounting height 288 of the accessory mount 262 between the lowest surface of the lateral wing 274 and the highest point of the alignment peg 276 is less than the socket height 366. In other words, the socket height 366 can be greater than the mounting height 288.

[0044] Referring here to Figures 9 and 10, a channel opening 368 can be defined on at least one of the first rail surface 354 and the second rail surface 360. The channel opening 368 can be a hole or notch defined on at least one of the first rail surface 354 and the second rail surface 360 ​​and aligned with one or more of the alignment channels 346 defined on the clamp surface 342 of the accessory socket 340. The channel opening 368 can be further defined as one or more channel openings 368, in which case each channel opening 368 is aligned with one or more of the alignment channels 346. When the channel opening 368 is aligned with the alignment channels 346 on the first rail surface 354 and the second rail surface 360, the user is given improved access to the alignment channels 346, which can facilitate inspection (e.g., for identifying damage), cleaning, and also during the manufacture of the tracker 300.

[0045] As described above, the clamp fastener 282 is positioned in the fastener hole 344 and is engageable with the clamp hole 280 of the accessory mount 262. The clamp fastener 282 is configured to bias the upper surface 278 of the body portion 272 toward the clamp surface 342 of the accessory socket 340. When the clamp fastener 282 is received in the clamp hole 280 and tightened, the clamp fastener 282 applies a compressive force to the accessory mount 262 relative to the accessory socket 340 that biases the alignment peg 276 to engage with the alignment channel 346. In other words, the clamp fastener 282 pulls the upper surface 278 toward the clamp surface 342 so that the alignment peg 276 is biased into the alignment channel 346. Generally, the alignment peg 276 is wider than the alignment channel 346 to facilitate repeatable alignment when engaged. Furthermore, if the alignment peg 276 is wider than the alignment channel 346, the alignment peg 276 will reach full insertion into the alignment channel 346 before the upper surface 278 engages with the clamp surface 342. The clamp fastener 282 is positioned near the distal end of the tracker 300 to position the tracker frame 302 proximal to the accessory mount 262. Thus, the tracking marker 322 is positioned proximal to the clamp fastener 282 and proximal to the accessory mount 262 when the accessory socket 340 is engaged with the accessory mount 262.

[0046] Reducing the radial gap between the clamp fastener 282 and the fastener hole 344 and shortening the length of the clamp fastener 282 improves the ease of assembling the tracker 300 to the attachment 240. Reducing the radial gap reduces the wobble of the clamp fastener 282 in the fastener hole 344, which allows the clamp fastener 282 to slide easily within the fastener hole 344 when the tracker 300 is assembled to the accessory mount 262. In addition, the clamp fastener 282 can be constrained within the fastener hole 344. The constraining fastener prevents the clamp fastener 282 from being easily removed from the fastener hole 344 and can further reduce the wobble of the clamp fastener 282. In one exemplary embodiment illustrated herein, the accessory socket may further include a constrained washer 370 positioned around a groove in the clamp fastener 282 at a height positioned within the fastener hole 344. The restraining washer 370 holds the clamp fastener 282 in the fastener hole 344 to assist the caregiver in assembling the tracker 300 to the accessory mount 262. The restraining washer 370 can be formed from a polymer material such as polyetheretherketone (PEEK). Other materials may also be conceived. Other embodiments such as springs, wave washers, and rubber O-rings may also be conceived. For example, an O-ring can be positioned around the clamp fastener 282 and inside the fastener hole 344 to restrain the clamp fastener 282 in the fastener hole 344. The O-ring can be formed from a rubber material (e.g., Buna-N, Viton® fluoroelastomer, silicone, and EPDM, etc.) that grips the inner surface of the fastener hole 344 and the clamp fastener 282, increasing the force required to move the clamp fastener 282. The O-ring can further hold the clamp fastener 282 in a recessed position with the threaded end recessed into the clamp surface 342.

[0047] Once the tracker 300 is assembled to the attachment 240 and the clamp fastener 282 is tightened, the coupling structure may be subjected to strong vibrations and / or high-frequency vibrations during use. To prevent these vibrations from loosening the clamp fastener 282, a second washer 372 can be positioned adjacent to the fastener hole 344 to receive the clamp fastener 282. The second washer 372 can be positioned between the head portion of the clamp fastener 282 and the tracker 300. Similar to the captured washer 370, the second washer 372 can be formed from a polymer material such as polyetheretherketone (PEEK) to grip the head portion of the clamp fastener 282, increasing the force required to loosen the clamp fastener 282 and thus preventing relative movement between the clamp fastener 282 and the fastener hole 344. Other materials may also be conceived. Other materials such as Buna-N, Viton® fluoroelastomer, silicone, EPDM, neoprene, and other rubber materials are also conceivable. Other embodiments such as springs and wave washers are also conceivable.

[0048] Similar to the alignment peg 276 described above, the accessory socket 340 may include any preferred number of alignment channels 346 to ensure secure engagement with the accessory mount 262. One or more alignment channels 346 can be further defined as eight alignment channels, such as those illustrated herein. Other numbers of alignment channels are also conceivable. The alignment channels 346 may be arranged radially around the fastener hole 344 in a circular pattern that restricts rotational movement between the accessory socket 340 and the accessory mount 262. Here, the alignment channels 346 are shaped to have an elongated pyramidal shape.

[0049] In addition to the longitudinal plane P1 described above, a tracker plane P2 is defined by the tracker 300. More specifically, the tracker plane P2 is defined by at least three of the markers 322. For this purpose, the tracker frame 302 can be positioned between the accessory socket 340 and the tracker plane P2, that is, in other words, the tracker frame 302 can be positioned between the accessory socket 340 and the markers 322. In addition, the tracker 300 can be coupled and positioned such that the tracker plane P2 is parallel to the instrument axis A1.

[0050] Various embodiments of the Tracker 300 described herein may include a Tracker Frame 302 formed from a material that may include a metal such as titanium, a polymer such as nylon, or an epoxy resin such as an aromatic epoxyamine resin. The Tracker Frame 302 may include any other suitable material that provides the rigid structure required for the Tracker 300 for use in a medical environment. The Tracker Frame 302 may be formed using injection molding or additive manufacturing processes that form the Tracker Frame 302 as a single, integrated unit. By forming the Tracker Frame 302 as a single, integrated unit, certain manufacturing processes can be eliminated. Furthermore, the dimensional accuracy of the Tracker Frame 302 can be improved by reducing the accumulation of tolerances. In addition, the rigidity of the Tracker Frame 302 can be increased by eliminating any joints between parts. By eliminating geometric shapes that are formed for the purpose of joining multiple parts together, the need to control the weight of the Tracker Frame 302 and the accuracy of the mating surfaces can be further reduced. In another exemplary embodiment of the Tracker, the Tracker Frame 302 is formed using a stereolithography process and an epoxy resin. Alternatively, the tracker frame 302 can be assembled using two or more independent parts formed through injection molding, blow molding, rotational molding, etc. The parts of the tracker frame 302 can be assembled using adhesives such as epoxy, fasteners, connecting assemblies, heat riveting, and combinations thereof.

[0051] As described above, the tracker 300 may further include a tracker array 320 having a plurality of tracking markers 322. The tracking markers 322 may also be implemented as LED light emitters, as similarly described above. Thus, the tracking markers 322 may be configured to receive power from the battery 318. The tracker 300 may include an electrical circuit 374 for electrically connecting the tracking markers 322 and the battery 318. The electrical circuit 374 may include one or more printed circuit boards, wires, connectors, and / or other conductors. The electrical circuit 374 may further include a positive terminal 376 and a negative terminal 378, respectively, located in the battery container 316, as shown in Figure 6. The electrical circuit 374 facilitates the electrical connection between the positive terminal 376 and the negative terminal 378 and the tracking markers 322.

[0052] Each of the positive terminals 376 and negative terminals 378 is positioned to engage with the corresponding positive and negative terminals (not shown) of the battery 318. Prior to the procedure in which the tracker 300 will be used, the tracker 300 may undergo one or more sterilization steps to remove all contaminants from the tracker 300. In some examples, the tracker 300 may be sterilized in a fully assembled state, including the battery 318 housed in the battery container 316. Following the sterilization step, the tracker 300 may be stored for an unknown period prior to use. To prevent the battery 318 from discharging during this storage period, the tracker 300 may further include an insulating strip 3820, which is placed between the battery 318 and each of the positive terminals 376 and negative terminals 378 of the electrical circuit to prevent the flow of electricity to the tracking marker 322. The insulating strip 3820 is lightweight and inexpensive, allowing the electrical circuit 374 to be switchless, further reducing the cost of the tracker 300.

[0053] At the start of a tracked surgical procedure, the surgeon or other medical professional activates the tracker 300 by removing the insulating strip 380 from the tracker 300, thereby enabling an electrical connection between the tracking marker 322 and the battery 318. In other words, removing the insulating strip 380 from the tracker 300 allows electricity to flow between the positive terminal 376 and the negative terminal 378, respectively, and the corresponding terminals on the battery 318.

[0054] In the embodiment illustrated herein, the insulating strip 380 includes a first insulating member 382A and a second insulating member 382B joined together to form a single insulating strip 380 extending between the positive terminal 376 and the negative terminal 378. Joining insulating members 382A and 382B together to form a single insulating strip 380 allows the user to remove both insulating members 382A and 382B simultaneously. It is also conceivable that the first insulating member 382A and the second insulating member 382B may be separate insulating strips. The first insulating member 382A and the second insulating member 382B may be formed using a non-conductive polymer, Mylar®, or Kapton® material. Other materials may also be conceivable.

[0055] To maintain the sterility of the tracker 300 during the aforementioned storage period, the tracker 300 is packaged in a sterile packaging system 450 shown in Figures 28 to 31. The sterile packaging system 450 allows the tracker 300 to be transported and stored in a non-sterile environment while maintaining its sterility. The sterile packaging system 450 may include a shell portion 452, an insertion portion 454, and a sealing film 456. The shell portion 452, the insertion portion 454, and the sealing film 456 can form a blister pack.

[0056] The shell portion 452 can define a sterile interior 458 shaped to receive the tracker 300 for sterilization. The sterile interior 458 may include one or more projections 460 that support the tracker 300 in a specific orientation. For example, the tracker 300 is shown in an upright position with its elongated portion 312 and upper surface 314 facing generally away from the shell portion 452 (or toward the opening of the shell portion 452). The opening of the shell portion 452 is partially defined by an opening surface 462, which is a generally planar surface surrounding the sterile interior 458. A sealing film 456 is placed on the sterile interior 458 and, in cooperation with the opening surface 462, seals the tracker 300 within the sterile packaging system 450. The sealing film 456 engages with the opening surface 462 to prevent foreign matter from entering the sterile interior 458.

[0057] The sealing film 456 can be a gas-permeable film, such as the type used for ethylene oxide sterilization. The sealing film 456 can be formed from a high-density polyethylene material such as Tyvek (a trademark of DuPont). The sealing film 456 can be sealed to the opening surface 462 of the shell portion 452 using adhesive, fusion sealing, ultrasonic sealing, etc.

[0058] As best shown in Figures 29 and 30, the insertion portion 454 of the sterilization packaging system 450 may include one or more undercuts 464 configured to engage with the tracker 300. The insertion portion 454 is positioned within the sterilization interior 458 with the tracker 300 positioned between the insertion portion 454 and the shell portion 452. The undercuts 464 are regions of the insertion portion 454 defined by a contour shape that captures the manufacturing mold and prevents demolition. The undercuts 464 define a cavity 466 positioned within the insertion portion 454 and shaped to receive a portion of the tracker 300, where the cavity 466 is configured to receive the elongated portion 312 of the tracker 300. The undercuts 464 roughly match the angled shape of the tracker 300 such that when the elongated portion 312 is inserted into the cavity 466, the width of the tracker 300 is greater than the width between the opposing undercuts 464. Since the width between the opposing undercuts 464 is smaller than the corresponding width of the tracker, the elongated portion 312 is held in the cavity 466 and the insertion portion 454 is releasably coupled to the tracker 300.

[0059] The insertion portion 454 may further include a handle 468 on the opposite side of the undercut 464, facilitating the user to grasp the tracker 300 through the insertion portion 454. The user can grasp the handle 468 of the insertion portion 454 and simultaneously remove both the insertion portion 454 and the tracker 300 from the shell portion 452 without direct contact with the tracker 300, thereby assisting sterilization. The handle 468 is further positioned so that the flexing of the insertion portion 454 due to the pressure of the user gripping the handle 468 reduces the width between the opposing undercuts 464. In other words, the pressure from the user's grip is partially transmitted from the handle 468 to the undercuts 464, which prevents the tracker 300 from being inadvertently detached from the insertion portion 454. The insertion portion 454 also prevents the tracker 300 from moving within the sterile interior 458. Both the insertion portion 454 and the tracker 300 are sealed within the sterile interior 458 by a sealing film 456.

[0060] Figures 30 and 31 show how a user removes the tracker 300 from the sterile interior 458 by gripping the handle 468 and lifting both the tracker 300 and the insertion portion 454. While still gripping the handle 468, the user can manipulate the tracker 300 to assemble it onto the surgical instrument 200. Since the user does not handle the tracker 300 directly with their hands, the possibility of contaminating the tracker 300 prior to the medical procedure is reduced.

[0061] Referring here to Figures 18–27, a second exemplary embodiment of the navigation tracker 1300 is shown. As will be understood from the following description, the second tracker 1300 is similar to the tracker 300 described above in relation to Figures 2–13. Therefore, components and structural features of the second embodiment of the tracker 1300 that are the same as, or otherwise corresponding to, the tracker 300 of the first embodiment are given similar reference numerals (e.g., 300 and 1300) incremented by 1000. The differences between these versions will be described in detail, but for the purposes of clarity, consistency, and brevity, only certain structural features and components common to these versions will be discussed and depicted in the drawings of the second embodiment of the tracker 1300. Herein, unless otherwise indicated, the above description of the tracker 300 of the first embodiment may be incorporated by reference without limitation with respect to the tracker 1300 of the second embodiment.

[0062] Figures 20 and 21 show enlarged perspective views of the surgical instrument 200 and the tracker 1300 of a second embodiment. Here, the tracker 1300 may include a tracker frame 1302 for supporting a plurality of tracking markers 1322 and an accessory socket 1340 for securing the tracker frame 1302 to the surgical instrument 200. As shown in Figure 19, the tracker 1300 is illustrated disassembled and assembled to the attachment 240. The tracker 1300 is illustrated in a partially assembled state with the accessory socket 1340 detached from the accessory mount 262. Arrows indicate the steps of the disassembly process, in which the tracker 1300 is first lifted to detach the alignment channel 1346 from the alignment peg 276 and then moved distally to the accessory mount 262 (i.e., toward the attachment 240). The tracker 1300 is assembled to the attachment 240 in reverse order by inserting the accessory mount 262 through the socket opening 348 and moving the tracker 1300 in the proximal direction (i.e., away from the attachment 240).

[0063] When the navigation system determines the position and orientation of the tracker 1300, it is advantageous for the tracker 1300 to remain in the same position relative to the surgical instrument 200 in order to maximize accuracy. Therefore, in order to maximize accuracy, it is advantageous for the tracker frame 1302 and the accessory socket 340 to be sufficiently rigid to prevent deformation or movement of the markers of the tracker frame 1302 relative to the surgical instrument 200. The desire to minimize bending or deformation of the tracker frame 1302 is limited by the desire to minimize the weight of the tracker frame 1302. Furthermore, all of the aforementioned desires may be limited by the desire to improve accuracy by having a large array of tracking markers 1322, and the desire to eliminate obstacles for the surgeon operating the surgical instrument 200 by having a small tracker 1300.

[0064] Referring to Figures 20 to 24, in an exemplary configuration, the tracker 1300 may include a tracker frame 1302 having at least one protruding arm 1400, 1402, 1404, 1406. The tracker plane P2 can be defined as being parallel to and spaced away from the instrument axis A1 of the handheld surgical instrument 200, as shown in Figure 24. The tracker 1300 can be positioned above the surgical instrument 200 and roughly aligned with the tracker plane P2.

[0065] In Figure 21, at least one arm 1400, 1402, 1404, 1406 can be further defined as a first arm 1400, 1404 and a second arm 1402, 1406, or alternatively as a pair of distal arms 1400, 1402 and a pair of proximal arms 1404, 1406. Each arm 1400, 1402, 1404, 1406 protrudes from the main body portion 1408 of the tracker frame 1302 to an end spaced away from the main body portion 1408 and includes a marker support portion 1410 located at the end spaced away from the tracker frame 1302. Each marker support portion 1410 can define a post bore 1412 that can be configured to receive a marker post 1414, which can be configured to engage with a tracking marker 1322. In an exemplary embodiment of the illustrated tracker 1300, the tracking marker 1322 may be a reflective sphere or retroreflector that reflects light (typically infrared) that is visible (recognizable) to the localizer. It is also conceivable that an LED tracking marker may be used instead of a spherical tracking marker. When configured as an LED light emitter, the marker post 1414 can be omitted, and the tracking marker can be directly attached to the marker support portion 1410. Other configurations are also conceivable.

[0066] Each arm 1400, 1402, 1404, and 1406 further has a length and a width. The ratio of length to width can exceed 4. In other words, each of arms 1400, 1402, 1404, and 1406 can have a length that is at least 4 times greater than its width. It should be understood that each of the arms 1400, 1402, 1404, and 1406 can have different lengths and widths from one another, such that the ratio of length to width can exceed 4.

[0067] One way to minimize the hindrance to the surgeon is to position the arms 1400, 1402, 1404, and 1406 of the tracker 1300 away from the working end of the surgical instrument 200. These arms can be configured with different lengths so that the marker support portion 1410 is positioned proximal. More specifically, a pair of proximal arms 1404, 1406 extend a first distance from the main body 1408, and a pair of distal arms 1400, 1402 extend a second distance from the main body 1408, with the first distance being greater than the second. In other words, the marker support portion 1410 positioned proximal to the main body 1408 is further away from the main body 1408 than the marker support portion 1410 positioned distal to the main body 1408.

[0068] For this purpose, the tracker 1300 can be configured at different angles with respect to the insertion axis A2 such that the marker support portion 1410 is positioned off-center in the axial direction. In other words, the marker support portion 1410 is separated from the insertion axis A2 by a distance greater than the transverse distance in the proximal-to-distal direction. As best shown in Figure 26, the tracker 1300 has a length 1416 and a width 1418 defined by arms 1400, 1402, 1404, and 1406, where the ratio of length 1416 to width 1418 is greater than 1.5. More specifically, the length 1416 by which the marker support portions 1410 on a pair of proximal arms 1404, 1406 are separated from the corresponding marker support portions on the distal arms 1400, 1402 is at least 1.5 times greater than the width 1418 by which the marker support portions on the first arms 1400, 1404 are separated from the corresponding marker support portions on the second arms 1402, 1406.

[0069] The tracker 1300 may further include a bridge portion 1420 that is separated proximally from the main body portion 1408 and extends between the first arm 1404 and the second arm 1406. In this way, the bridge portion 1420, the first arm 1404, the second arm 1406, and the tracker frame 1302 cooperate to define an opening 1422 in the tracker 1300. Markers 1322 are generally positioned around the opening 1422 and separated from the opening 1422.

[0070] Several examples have been discussed in the above description. However, the embodiments discussed herein are not intended to be exhaustive or to limit this disclosure to any particular form. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other embodiments without departing from the scope of this disclosure. The terms used herein are intended to be descriptive, not restrictive. Many modifications and variations are possible in light of the above teachings, and this disclosure can be implemented in ways other than those specifically described.

[0071] item I. A tracker attachment for a high-speed drilling device, the tracker attachment comprising: an attachment body extending from a proximal end to a distal end, the proximal end of which is configured to engage with the distal end of the motor body of the high-speed drilling device; a tool chuck supported by the attachment body and configured to receive a material removal tool positioned at the working end of the high-speed drilling device; a drive shaft supported in the attachment body and operably coupled to the tool chuck; and a cantilever arm coupled to the attachment body and extending in the proximal direction, the proximal end of which is positioned proximal to the proximal end of the attachment body.

[0072] II. The cantilever arm is connected to the attachment body using interference fit, as described in item I, for the tracker attachment.

[0073] III. The cantilever arm is welded to the attachment body, as described in item I, for the tracker attachment.

[0074] IV. The cantilever arm is a tracker attachment as described in item I, having an arched contour.

[0075] V. The tracker attachment according to item I, comprising a cantilever arm, an accessory mount, the accessory mount having an upper surface, a body portion defining a clamp hole on the upper surface, and a first lateral wing portion and a second lateral wing portion projecting transversely from opposing sides of the body portion relative to the upper surface, wherein the first lateral wing portion has a first lateral surface, and the second lateral wing portion has a second lateral surface, and the first lateral surface and the second lateral surface are at angles symmetrical with respect to the longitudinal plane of the high-speed drilling device.

[0076] VI. The accessory mount is the tracker attachment described in item V, further comprising one or more alignment pegs protruding from the upper surface.

[0077] VII. The cantilever arm and accessory mount are integrally formed with the tracker attachment described in item V.

[0078] VIII. The tracker attachment described in item I, further comprising a coupling portion located at the proximal end of the attachment body and capable of engaging with the motor body of a high-speed drilling device, and a mounting flange.

[0079] IX. A system for tracking the position of a rotary cutting tool, the system comprising: a rotary cutting tool; a surgical handpiece having a motor body; a surgical instrument attachment comprising an attachment body extending from a proximal end to a distal end, the proximal end of which is configured to engage with the distal end of the motor body; a cantilever arm coupled to the attachment body and extending proximal to an accessory mount, the accessory mount being located proximal to the proximal end of the attachment body and separated from the surgical handpiece; and a tracker comprising a tracker frame configured to engage with the accessory mount, and at least three optical markers coupled to the tracker frame, the tracker being located proximal to the attachment body when the tracker frame is engaged with the accessory mount.

[0080] X. The tracker is the system described in item IX, in which the tracker frame is separated from the surgical handpiece when it is engaged with the accessory mount.

[0081] XI. The tracker frame is the system described in item IX, which radially surrounds the surgical handpiece when the tracker frame is engaged with the accessory mount.

[0082] XII. The tracker frame defines the instrument opening, and the surgical handpiece is positioned within the instrument opening when the tracker frame is engaged with the accessory mount, as described in item IX.

[0083] XIII. The surgical instrument attachment system according to item IX, further comprising a tool chuck supported within the attachment body and configured to receive a rotary cutting tool, and a drive shaft supported within the attachment body and operably coupled to the tool chuck.

[0084] XIV. The system described in item IX, wherein the attachment body is located at the proximal end of the attachment body and has a coupling portion that can engage with the motor body, and the cantilever arm is coupled to the attachment body distal to the coupling portion.

[0085] XV. The accessory mount is located proximal to the proximal end of the attachment body at a first distance and radially separated from the surgical handpiece at a second distance, the first distance being greater than the second distance, as described in item IX of the system.

[0086] XVI. The system described in item XV, where the first distance is at least 1.5 times the second distance.

[0087] XVII. The system described in item XV, where the first distance is at least twice the second distance.

[0088] XVIII. A coupling structure for connecting a surgical instrument tracker to a surgical instrument, the coupling structure comprising an accessory mount coupled to the surgical instrument, the accessory mount comprising a body portion having an upper surface and defining a clamp hole on the upper surface, a first lateral wing portion and a second lateral wing portion projecting from opposing sides of the body portion in a transverse direction relative to the upper surface, the first lateral wing portion having a first lateral surface, the second lateral wing portion having a second lateral surface, the first lateral surface and the second lateral surface being at angles symmetrical with respect to the longitudinal plane of the accessory mount, the accessory mount comprising a first lateral wing portion and a second lateral wing portion, and one or more alignment pegs projecting from the upper surface, and an accessory socket coupled to a surgical instrument tracker, the accessory socket comprising a clamp surface defining a fastener hole, and one or more alignment pegs recessed in the clamp surface A coupling structure comprising: an accessory socket comprising one or more alignment channels configured to engage complementarily with a peg; a first socket wall extending from the clamp surface, having a first rail surface spaced apart from the clamp surface and a first inclined surface extending between the first rail surface and the clamp surface; a second socket wall extending from the clamp surface, having a second rail surface spaced apart from the clamp surface and a second inclined surface extending between the second rail surface and the clamp surface; and a clamp fastener disposed in a fastener hole and engageable with the clamp hole, wherein the clamp fastener is configured to bias the upper surface of its body portion toward the clamp surface of the accessory socket so that one or more alignment pegs engage with one or more alignment channels.

[0089] XIX. The joint structure described in item XVIII, wherein the first socket wall and the second socket wall are at symmetrical angles with respect to the longitudinal plane of the surgical instrument.

[0090] XX. The coupling structure described in item XIX, wherein the angle of the first socket wall is the same as the angle of the first lateral surface of the first lateral wing portion with respect to the longitudinal plane of the surgical instrument, and the angle of the second socket wall is the same as the angle of the second lateral surface of the second lateral wing portion with respect to the longitudinal plane of the surgical instrument.

[0091] XXI. One or more alignment pegs are further defined as eight alignment pegs, as described in item XVIII.

[0092] XXII. The eight alignment pegs are arranged radially around the clamp hole, as described in item XXI.

[0093] XXIII. The clamp fastener is a coupling structure as described in item XXII, which is constrainedly held within the fastener hole.

[0094] XXIV. The coupling structure described in item XVIII, wherein the accessory socket is positioned in the fastener hole around the clamp fastener and further comprises an O-ring that constrains the clamp fastener in the fastener hole.

[0095] The coupling structure described in item XVIII, further comprising a rubber washer positioned around the clamp fastener adjacent to the fastener hole to prevent relative movement between the clamp fastener and the fastener hole.

[0096] XXVI. The joint structure described in item XVIII, wherein the first socket wall is located opposite the second socket wall in the longitudinal plane of the surgical instrument.

[0097] XXVII. A sterile packaging system for a surgical navigation tracker, comprising: a sterile tracker comprising: a sterile tracker comprising: a tracker frame defining a battery container; an electrical circuit comprising: a positive terminal and a negative terminal disposed in the battery container; a plurality of tracking markers electrically connected to the positive terminal and the negative terminal; a battery disposed in the battery container between the positive terminal and the negative terminal; and insulating members disposed between the battery and the positive terminal and the negative terminal, respectively; and a blister pack comprising: a shell portion defining a sterile interior shaped to receive the sterile tracker; and a sealing film disposed on the sterile interior in cooperation with the shell portion to seal the sterile tracker within the blister pack.

[0098] XXVIII. Multiple tracking markers are further defined as multiple LED light emitters in the sterile packaging system described in item XXVII.

[0099] XXIX. The electrical circuit does not include switches and is part of the sterile packaging system as described in item XXVII.

[0100] The XXX. Blister pack further comprises an insertion portion having a projection configured to engage with a sterile tracker, wherein the insertion portion is positioned inside the sterile environment with the sterile tracker positioned between the insertion portion and the shell portion, as described in item XXVII.

[0101] XXXI. The sterilization tracker further comprises a clamp surface defining a fastener hole, and a clamp fastener disposed in a fastener hole recessed from the clamp surface, The sterile packaging system described in item XXX, wherein the insertion portion includes a shelf portion adjacent to the fastener hole to prevent the clamp fastener from protruding from the clamp surface when the sterile tracker is placed inside the sterile environment.

[0102] XXXII. A coupling structure for connecting a surgical instrument tracker to a surgical instrument, wherein the coupling structure is an accessory mount coupled to the surgical instrument, the accessory mount comprising: a body portion having an upper surface and defining a clamp hole on the upper surface; a first lateral wing portion and a second lateral wing portion projecting from opposing sides of the body portion in a transverse direction relative to the upper surface, the first lateral wing portion having a first lateral surface, the second lateral wing portion having a second lateral surface, and the first lateral surface and the second lateral surface being at angles symmetrical with respect to the longitudinal plane of the accessory mount; and one or more alignment pegs projecting from the upper surface; and an accessory socket coupled to a surgical instrument tracker and defining a socket opening. A coupling structure comprising: an accessory socket having a clamp surface defining a fastener hole; one or more alignment channels recessed in the clamp surface and configured to engage complementarily with one or more alignment pegs; a distal wall located at the distal end of the accessory socket opposite the socket opening; and a first socket wall and a second socket wall, respectively, bonded to the clamp surface and extending proximal from the distal wall to the socket opening; and a clamp fastener disposed in the fastener hole and engaged with the clamp hole, wherein the clamp fastener is configured to bias the upper surface of its body portion toward the clamp surface of the accessory socket so that one or more alignment pegs engage with one or more alignment channels.

[0103] XXXIII. The coupling structure described in item XXXII, wherein the first socket wall comprises a first rail surface separated from the clamp surface and a first inclined surface extending between the first rail surface and the clamp surface, and the second socket wall comprises a second rail surface separated from the clamp surface and a second inclined surface extending between the second rail surface and the clamp surface.

[0104] XXXIV. The coupling structure described in item XXXIII, wherein a channel opening is defined on each of the first and second rail surfaces, extending over their entire length.

[0105] XXXV. The coupling structure described in item XXXIV, wherein the channel opening is aligned with one or more alignment channels.

[0106] XXXVI. A coupling structure as described in item XXXIII, wherein a mount width is defined between the first lateral surface and the second lateral surface, and a socket width is defined between the first inclined surface and the second inclined surface, and the socket width is greater than the mount width.

[0107] XXXVII. The coupling structure described in item XXXIII, wherein the mounting height is defined between the lowest point of the first lateral wing portion and the highest point of one or more alignment pegs, and the socket opening height is defined between the clamp surface and the first rail surface, and the socket opening height is greater than the mounting height.

[0108] XXXVIII. The joint structure described in item XXXVII, wherein the first socket wall and the second socket wall are at symmetrical angles with respect to the longitudinal plane of the surgical instrument.

[0109] XXXIX. The coupling structure described in item XXXVIII, wherein the angle of the first socket wall is the same as the angle of the first lateral surface of the first lateral wing portion with respect to the longitudinal plane of the surgical instrument, and the angle of the second socket wall is the same as the angle of the second lateral surface of the second lateral wing portion with respect to the longitudinal plane of the surgical instrument.

[0110] XL. One or more alignment pegs are arranged radially around the clamp hole, as described in item XXXII.

[0111] XLI. One or more alignment pegs are further defined as eight alignment pegs, as described in item XXXII.

[0112] XLII. The clamp fastener is a coupling structure described in item XLI, which is constrainedly held within the fastener hole.

[0113] XLIII. The coupling structure described in item XXXII, further comprising an accessory socket positioned around the clamp fastener and within the fastener hole, and a washer that constrains the clamp fastener within the fastener hole.

[0114] XLIV. The coupling structure described in item XXXII, further comprising washers positioned around the clamp fastener adjacent to the fastener hole to reduce relative movement between the clamp fastener and the fastener hole.

[0115] XLV. The joint structure described in item XXXII, wherein the first socket wall is located opposite the second socket wall in the longitudinal plane of the surgical instrument.

[0116] XLVI. A system for tracking the position of a rotary cutting tool, the system comprising: a rotary cutting tool; a surgical handpiece having a motor body; a surgical instrument attachment comprising: an attachment body extending from a proximal end to a distal end, the proximal end of which is configured to engage with the motor body; a cantilever arm coupled to the attachment body and extending proximal to an accessory mount, the accessory mount being located proximal to the proximal end of the attachment body and separated from the surgical handpiece; and a tracker comprising: a tracker frame; an accessory socket coupled to the tracker frame and configured to engage with the accessory mount; and at least three optical markers coupled to the tracker frame, the at least three optical markers being located proximal to the attachment body when the accessory socket engages with the accessory mount.

[0117] XLVII. The tracker is separated from the surgical handpiece when the tracker frame is engaged with the accessory mount, as described in item XLVI of the system.

[0118] XLVIII. The surgical instrument system described in item XLVI, wherein the instrument axis is defined and the plane defined by at least three optical markers is parallel to the instrument axis.

[0119] XLIX. The surgical instrument attachment system described in item XLVI further comprises a tool chuck supported within the attachment body and configured to receive a rotary cutting tool, and a drive shaft supported within the attachment body and operably coupled to the tool chuck.

[0120] The system described in item XLVI, wherein the attachment body is located at the proximal end of the attachment body and has a coupling portion that can engage with the motor body, and the cantilever arm is coupled to the attachment body distal to the coupling portion.

[0121] The LI. Tracker frame is positioned between the accessory socket and at least three optical markers in the system described in item XLVI.

Claims

1. A tracker attachment for a high-speed drilling device, wherein the tracker attachment is An attachment body extending from a proximal end to a distal end, wherein the proximal end is configured to engage with the distal end of the motor body of the high-speed drilling device, A tool chuck, supported by the attachment body and configured to receive a material removal tool positioned at the working end of the high-speed drilling device, A drive shaft is supported within the attachment body and operably coupled to the tool chuck, A cantilever arm is connected to the attachment body and extends in the proximal direction, wherein the proximal end of the cantilever arm is positioned proximal to the proximal end of the attachment body. A tracker attachment equipped with [feature].

2. The tracker attachment according to claim 1, wherein the cantilever arm is connected to the attachment body using an interference fit.

3. The tracker attachment according to claim 1, wherein the cantilever arm is welded to the attachment body.

4. The tracker attachment according to claim 1, wherein the cantilevered arm has an arched contour.

5. The cantilevered arm is equipped with an accessory mount, and the accessory mount is A body portion having an upper surface, on which a clamp hole is defined, A first lateral wing portion and a second lateral wing portion project from opposing sides of the fuselage portion in a transverse direction relative to the upper surface, wherein the first lateral wing portion has a first lateral surface, and the second lateral wing portion has a second lateral surface, and the first lateral surface and the second lateral surface are at angles symmetrical with respect to the longitudinal plane of the high-speed drilling device. A tracker attachment according to claim 1, comprising:

6. The tracker attachment according to claim 5, wherein the accessory mount further comprises one or more alignment pegs protruding from the upper surface.

7. The tracker attachment according to claim 5, wherein the cantilever arm and the accessory mount are integrally formed.

8. The tracker attachment according to claim 1, wherein the attachment body further comprises a coupling portion disposed at the proximal end of the attachment body and capable of engaging with the motor body of the high-speed drilling device, and a mounting flange.

9. A system for tracking the position of a rotary cutting tool, wherein the system is Rotary cutting tools and A surgical handpiece equipped with a motor body, A surgical instrument attachment, An attachment body extending from a proximal end to a distal end, wherein the proximal end is configured to engage with the distal end of the motor body, A cantilever arm is coupled to the attachment body and extends proximal to an accessory mount, wherein the accessory mount is positioned proximal to the proximal end of the attachment body and separated from the surgical handpiece, and A surgical instrument attachment equipped with, It is a truck, A tracker frame configured to engage with the aforementioned accessory mount, The tracker frame is coupled to at least three optical markers, The tracker is positioned near the attachment body when the tracker frame is engaged with the accessory mount. A system equipped with these features.

10. The system according to claim 9, wherein the tracker is separated from the surgical handpiece when the tracker frame is engaged with the accessory mount.

11. The system according to claim 9, wherein the tracker frame radially surrounds the surgical handpiece when the tracker frame is engaged with the accessory mount.

12. The system according to claim 9, wherein the tracker frame defines an instrument opening, and the surgical handpiece is positioned within the instrument opening when the tracker frame is engaged with the accessory mount.

13. The system according to claim 9, wherein the surgical instrument attachment further comprises a tool chuck supported in the attachment body and configured to receive the rotary cutting tool, and a drive shaft supported in the attachment body and operably coupled to the tool chuck.

14. The system according to claim 9, wherein the attachment body is provided with a coupling portion located at the proximal end of the attachment body that can engage with the motor body, and the cantilever arm is coupled to the attachment body distal to the coupling portion.

15. The system according to claim 9, wherein the accessory mount is located proximal to the proximal end of the attachment body at a first distance and radially separated from the surgical handpiece at a second distance, the first distance being greater than the second distance.

16. A system for tracking the position of a rotary cutting tool, wherein the system is Rotary cutting tools and A surgical handpiece equipped with a motor body, A surgical instrument attachment, An attachment body extending from a proximal end to a distal end, wherein the proximal end is configured to engage with the motor body, A cantilever arm is coupled to the attachment body and extends proximal to an accessory mount, wherein the accessory mount is positioned proximal to the proximal end of the attachment body and separated from the surgical handpiece, and A surgical instrument attachment equipped with, It is a truck, Tracker frame and An accessory socket, configured to be coupled to the tracker frame and engage with the accessory mount, The tracker frame is coupled to at least three optical markers, The at least three optical markers are positioned near the attachment body when the accessory socket is engaged with the accessory mount, and the tracker and A system equipped with these features.

17. The system according to claim 16, wherein the tracker is separated from the surgical handpiece when the tracker frame is engaged with the accessory mount.

18. The system according to claim 16, wherein the surgical instrument attachment further comprises a tool chuck supported in the attachment body and configured to receive the rotary cutting tool, and a drive shaft supported in the attachment body and operably coupled to the tool chuck.

19. The system according to claim 16, wherein the attachment body is provided with a coupling portion located at the proximal end of the attachment body and engaging with the motor body, and the cantilever arm is coupled to the attachment body distal to the coupling portion.

20. The system according to claim 16, wherein the tracker frame is positioned between the accessory socket and the at least three optical markers.

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