Surgical instruments equipped with display systems

Abstract

A C-arm or mobile intensifier device is an example of a medical imaging device based on X-ray technology. Because the C-arm device can display high-resolution X-ray images in real time, the physician can monitor the progress of the operation at any time and can therefore take appropriate actions based on the displayed images. However, during certain procedures, such as during procedures where attention must be paid to the patient's anatomy and the medical imaging device display, monitoring the images is often challenging. In one example, a surgical instrument assembly includes a processor, a surgical instrument configured to operate on the anatomy, and a display coupled to the processor and attached to the surgical instrument. The display can be configured to display visual information including an X-ray image generated by the medical imaging device, depth gauge information generated by a depth gauge coupled to the surgical instrument, and trajectory information associated with various intramedullary nailing operations.

Description

Technical Field

[0001] The present invention relates to systems that can be used with medical imaging. Background Art

[0002] A C-arm or mobile intensifier device is an example of a medical imaging device based on X-ray technology. The name C-arm derives from the C-shaped arm used to connect an X-ray source and an X-ray detector. Various medical imaging devices (such as C-arm devices) can perform fluoroscopy, a type of medical imaging that displays continuous X-ray images on a monitor. During a fluoroscopy procedure, an X-ray source or emitter emits X-rays that penetrate the patient's body. An X-ray detector or image intensifier converts the X-rays that pass through the body into a visible image, which is displayed on the medical imaging device's monitor. Because medical imaging devices such as C-arm devices can display high-resolution X-ray images in real time, physicians can monitor the progress of the procedure at any time and take appropriate actions based on the displayed images. However, monitoring images during certain procedures, such as those requiring attention to the patient's anatomy and the medical imaging device's display, can often be challenging. For example, if a medical professional is required to manipulate a drill while observing the medical imaging device's display, aligning the drill bit with the distal locking hole can be difficult. Summary of the Invention

[0003] In one example, a surgical instrument assembly includes a processor, a surgical instrument configured to operate on an anatomical structure, and a display coupled to the processor and attached to the surgical instrument. The display may be configured to display fluoroscopic data of the anatomical structure, such as an X-ray image or video data. The fluoroscopic data is generated by an imaging device. The surgical instrument assembly may also include a memory in communication with the processor. The memory may have instructions stored therein that, when executed by the processor, cause the surgical instrument assembly to receive fluoroscopic data from the imaging device in real time via, for example, a wireless communication channel. Additionally, the surgical instrument may include a proximal end and a working end opposite the proximal end. The working end may be configured to operate on an anatomical structure, and the display may be positioned to provide a line of sight to both the working end and the display from a position proximal to the surgical instrument. Additionally, the display may be configured to provide a visual indication of the alignment of a cutting instrument of the surgical instrument relative to the direction of travel of X-rays from an X-ray emitter of the imaging device to an X-ray receiver of the imaging device.

[0004] In another example, an accelerometer of a surgical instrument assembly is calibrated using the direction of X-ray travel from an X-ray generator to an X-ray receiver of a medical imaging device. The surgical instrument assembly may include a drill having a drill bit. The surgical instrument assembly may display an X-ray image of an anatomical structure generated by the medical imaging device. The X-ray image may include a target location. The tip of the drill bit may be positioned on the anatomical structure, and the surgical instrument assembly may display a representation of the position of the drill tip and the target location. The surgical instrument assembly may also display an orientation image including a static region and a movable indicator that indicates the orientation of the drill bit, wherein the direction of X-ray travel is used to orient the drill bit when the movable indicator has a predetermined spatial relationship with the static region. A hole may be drilled in the anatomical structure while the tip of the drill bit is aligned with the target location and while the movable indicator has the predetermined spatial relationship with the static region.

[0005] In yet another example, a surgical instrument assembly includes a surgical instrument configured to operate on an anatomical structure; a display; and a processor configured to 1) determine an axis of the anatomical structure and 2) determine, based on the axis, a representation of a trajectory defining an entry point into the anatomical structure. The display can be configured to display X-ray data of the anatomical structure generated by an imaging device. The display can be further configured to superimpose the representation of the trajectory on the X-ray data of the anatomical structure to display the representation of the trajectory. The display can also be configured to superimpose a boundary on the X-ray data of the anatomical structure to display the boundary of the anatomical structure. In one example, the anatomical structure is a bone including an intramedullary (IM) canal, the surgical instrument assembly is configured to drill a hole in the bone, and the representation of the trajectory further defines a line along which the hole can be drilled to meet the IM canal.

[0006] The foregoing summarizes some aspects of the present disclosure and is not intended to reflect the full scope of the present disclosure. Additional features and advantages of the present disclosure are mentioned in the following description, will be apparent from the description, or may be learned by practicing the present invention. In addition, the above summary of the invention and the following detailed description are exemplary and illustrative and are intended to provide further explanation of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The foregoing summary and the following detailed description of exemplary embodiments of the present disclosure are better understood when read in conjunction with the accompanying drawings. Reference is made to the accompanying drawings for purposes of illustrating exemplary embodiments of the present disclosure. However, it should be understood that this patent application is not limited to the precise arrangements and mechanisms shown. In the accompanying drawings:

[0008] Figure 1 An exemplary imaging system is shown according to an exemplary embodiment, wherein the exemplary imaging system includes an imaging device in electrical communication with a surgical instrument assembly.

[0009] Figure 2A and Figure 2B for Figure 1 A perspective view of an exemplary surgical instrument assembly including a display attached to the surgical instrument is shown.

[0010] Figure 2C is a rear elevation view of an exemplary surgical instrument assembly.

[0011] Figure 2D is a side elevation view of an exemplary surgical instrument assembly.

[0012] Figure 3 For use Figure 1 A block diagram of an exemplary computing device in an imaging system is shown.

[0013] Figure 4A Shows that the Figures 2A-2D An exemplary X-ray image of an anatomical structure displayed by a surgical instrument assembly is shown, wherein the X-ray image includes a target location.

[0014] Figure 4B Another exemplary X-ray image of an anatomical structure is shown illustrating the position of a cutting instrument of a surgical instrument assembly relative to a target location of the anatomical structure.

[0015] Figure 4C Another exemplary X-ray image of an anatomical structure is shown with the tip of a cutting instrument positioned at a target location.

[0016] Figure 5A An exemplary screenshot of a display of a surgical instrument assembly showing a visual indication of the alignment of a cutting instrument relative to a direction of travel of X-rays from an X-ray emitter to an X-ray receiver of an imaging device, wherein the cutting instrument is misaligned relative to a first direction.

[0017] Figure 5B 1 is another example screenshot of a display of a surgical instrument assembly showing a visual indication of alignment of a cutting instrument relative to a direction of x-ray travel, wherein the cutting instrument is misaligned relative to a second direction that is substantially perpendicular to the first direction.

[0018] Figure 5C is another example screenshot of a display of a surgical instrument assembly showing a visual indication of alignment of a cutting instrument relative to a direction of X-ray travel, wherein the cutting instrument is aligned with the direction of X-ray travel such that the cutting instrument and the direction of X-ray travel have the same orientation.

[0019] Figure 6A Shown Figure 1An exemplary imaging system is shown, which illustrates exemplary anatomical structures and exemplary orientations of surgical instrument assemblies.

[0020] Figure 6B Shown Figure 6A Another exemplary orientation of a surgical instrument assembly in an imaging system is shown.

[0021] Figure 7A and Figure 7B is a perspective view of a surgical instrument assembly according to another embodiment, wherein the surgical instrument assembly includes a display and a depth gauge secured to the surgical instrument.

[0022] Figure 8 for Figure 7A and Figure 7B A perspective view of the depth gauge and display shown in FIG.

[0023] Figure 9 is a cross-section of an exemplary anatomical structure in which a cutting instrument has been advanced through the anatomical structure in a drilling direction.

[0024] Figure 10A and Figure 10B is an exemplary screen shot of a display of a surgical instrument assembly showing a visual indication of the depth of the tip of a cutting instrument relative to a portion of the anatomy.

[0025] Figure 11 is an exemplary split-screen shot of a display of a surgical instrument assembly, showing both a visual indication of the alignment of the cutting instrument and a visual indication of the depth of the tip of the cutting instrument.

[0026] Figure 12 is another screen shot of a display of a surgical instrument assembly, simultaneously showing: a visual indication of the alignment of the cutting instrument; a visual indication of the depth of the tip of the cutting instrument; and the cutting instrument within an X-ray image of the anatomy.

[0027] Figure 13 for Figure 7A A perspective view of a surgical instrument assembly is shown illustrating an exemplary X-ray image displayed on a display of the surgical instrument assembly.

[0028] Figure 14A An exemplary screenshot of a display of a surgical instrument assembly showing an X-ray image of an anatomical structure from a first or anteroposterior (AP) view, wherein the X-ray image includes a cutting instrument positioned to enter the anatomical structure for a particular intramedullary (IM) nailing procedure.

[0029] Figure 14B An exemplary screen shot of a display of a surgical instrument assembly, wherein the screen shot includes Figure 14AAn X-ray image with an AP representation of the AP boundary and trajectory of a specific IM nailing procedure superimposed on the X-ray image.

[0030] Figure 15 An exemplary screen shot of a display of a surgical instrument assembly, wherein the screen shot includes Figure 14B The X-ray image is the same as above, but the position of the cutting instrument is adjusted according to the AP representation of the trajectory.

[0031] Figure 16 is an exemplary screen shot of a display of a surgical instrument assembly showing Figure 15 An X-ray image of the anatomy and cutting instrument shown, but from a second or lateral view rather than an AP view, wherein the screenshot includes the X-ray image with a lateral representation of the lateral boundaries and trajectory of a particular IM stapling procedure superimposed on the X-ray image.

[0032] Figure 17 An exemplary screen shot of a display of a surgical instrument assembly, wherein the screen shot includes Figure 16 The X-ray image is shown, but the position of the cutting instrument is adjusted according to the lateral representation of the trajectory.

[0033] Figure 18 Another exemplary screenshot of a display of a surgical instrument assembly according to an exemplary embodiment, wherein the screenshot includes 1) an x-ray image of an anatomical structure; 2) an axis of the anatomical structure superimposed on the x-ray image; and a representation of a trajectory superimposed on the x-ray image, wherein the representation of the trajectory is offset at a certain angle relative to the axis.

[0034] Figure 19 is another exemplary screen shot of a display of a surgical instrument assembly illustrating exemplary technical information associated with an IM stapling protocol.

[0035] Figure 20 for Figure 7A A perspective view of a surgical instrument assembly is shown showing a first exemplary X-ray image and a second exemplary X-ray image displayed on a display of the surgical instrument assembly, wherein a first representation of a trajectory is superimposed on the first X-ray image and a second representation of the trajectory is superimposed on the second X-ray image.

[0036] Figure 21 is another exemplary screenshot of a display of a surgical instrument assembly, where the screenshot includes options for performing different operations. DETAILED DESCRIPTION

[0037] Medical professionals can use medical imaging devices (e.g., C-arm devices) to perform various medical procedures on patients. For example, medical professionals can use imaging devices to assess fractures, guide surgical procedures, or verify the results of surgical repairs. C-arm devices, for example, provide speckle imaging and fluoroscopic imaging, which allows for the generation of continuous, real-time moving images. These images are provided to the C-arm device's display. It has been recognized herein that in some cases, the C-arm system's display is not positioned in a manner that adequately assists the medical professional. In various embodiments described herein, images provided by the imaging device are transmitted in real time to a display that can be mounted to a surgical instrument, allowing the medical professional to observe the fluoroscopic images provided by the imaging device as the medical professional manipulates and observes the working end of the surgical instrument. The display can receive the images in real time, allowing the display to display the images as the imaging device generates them. In one example, a display is mounted to a surgical drill, allowing the fluoroscopic images provided by the imaging device to be observed during an intramedullary (IM) nailing procedure. In one embodiment, an alignment application can also be rendered on the display mounted to the surgical drill to guide the medical professional during the IM nailing procedure. The display can be interactive and can facilitate various aspects of the IM nailing procedure. For example, the display can assist in determining and achieving the correct entry point trajectory for a given IM nail, as well as determining and achieving the correct position and orientation of the distal locking screw for the IM nail.

[0038] As an initial topic, because fluoroscopy is a type of medical imaging that displays a continuous X-ray image on a monitor, the terms "fluoroscopic data," "fluoroscopic image," "video data," and "X-ray image" may be used interchangeably herein without limitation unless otherwise indicated. Thus, an X-ray image may refer to an image generated during a fluoroscopic procedure in which an X-ray beam passes through a patient's anatomy. Furthermore, it should be understood that fluoroscopic data may include X-ray images, video data, or computer-generated visual representations. Thus, fluoroscopic data may include static images or dynamic images.

[0039] See also Figure 1, the medical imaging system 102 may include a medical imaging device 104 and a surgical instrument assembly 202 in electrical communication with the imaging device 104. The medical imaging device 104, which may be a C-arm device, may include an X-ray generator or emitter 106 configured to emit X-rays through a body (e.g., bone) and an X-ray detector or receiver 108 configured to receive the X-rays from the X-ray emitter 106. Thus, the medical imaging device 104 may define an X-ray travel direction 128 from the X-ray emitter 106 to the X-ray receiver 108. The X-ray emitter 106 may define a flat surface 106a facing the X-ray receiver 108. The medical imaging device 104 may also include an arm 110 that physically connects the X-ray emitter 106 and the X-ray receiver 108. The medical imaging device 104 may also be in communication with a medical imaging device display 112 that is configured to display the X-ray image from the X-ray detector 108. In some cases, the medical imaging device display 112 may be hardwired to the X-ray detector 108 such that the display 112 may be in a fixed position relative to the arm 110 .

[0040] Medical imaging device 104 is presented as a C-arm device to facilitate description of the subject matter disclosed herein and is not intended to limit the scope of the present disclosure. Furthermore, imaging system 102 and imaging device 104 are presented as a medical imaging system and a medical imaging device, respectively, to facilitate description of the subject matter disclosed herein and are not intended to limit the scope of the present disclosure. Therefore, it should be understood that other devices, systems, and configurations may be used to implement the embodiments disclosed herein in addition to or in place of a system such as system 102, and all such embodiments are contemplated to be within the scope of the present disclosure. It is recognized herein that the location of display 112 can present challenges for medical professionals. For example, in some cases, medical professionals may need to view images or data rendered by display 112 while observing a patient positioned between X-ray generator 106 and X-ray detector 108. In one example, during an IM nailing procedure, medical professionals may face challenges placing distal locking screws due to insufficient auxiliary instruments or guidance systems (such as an aiming arm for proximal screw placement). Distal screws are typically inserted using a freehand technique under fluoroscopic guidance. This freehand technique is often referred to as the perfect circle technique. For example, once a perfect circle is established during an IM nailing procedure, it can be difficult to properly align the drill bit with the axis of the distal locking hole due to a lack of visibility while using radiographic images. Incorrect alignment can lead to fracture or splitting of the implant during drilling of the guide hole, which can result in implant breakage, poor reduction / fixation, surgical delays, etc. It is also recognized herein that the orientation of the X-ray image rendered by the display 112 may not match the orientation of the patient's anatomy, thereby presenting further challenges to medical professionals.

[0041] As another example of the technical problems solved by the embodiments described herein, before placing the distal locking screw, medical professionals may face the challenge of placing IM nails due to insufficient auxiliary instruments or guidance systems. IM nails are usually inserted using freehand techniques under fluoroscopic guidance. However, incorrect placement may cause pain to the patient. For example, different bones and different IM nails require that the IM nails be inserted into the bone at different entry points and different trajectories in order to minimize pain. In addition, current methods of determining the appropriate entry point and trajectory for a specific bone, such as by consulting technical guidelines, may result in errors or delays. In various examples described herein, the surgical instrument assembly can be configured to guide and assist medical professionals during various operations such as IM nailing procedures.

[0042] See also Figure 21 , a user can select one or more operations by actuating options on an exemplary user interface 2100 that can be displayed by the display 112. For example, a user can select the IM trajectory option 2104 to perform an IM drilling operation. A user can select the bone setting option 2103 to perform operations associated with securing a plate to a bone. A user can select the nailing option 2102 to perform operations associated with securing a nail with a distal locking screw. It should be understood that alternative or additional options can be presented by the user interface 2100 as needed. In addition, it should be understood that actuation of an option can result in the presentation of further displays to guide the user through a specific operation.

[0043] Now see Figure 3 In one embodiment, data (e.g., video or still images) provided by the medical imaging device 104 can be received by an instrument application, such as a fluoroscopic imaging application, which can be a program capable of running on any suitable computing device, such as software or hardware, or a combination of both. A user can utilize the instrument application to view images generated by the medical imaging device 104. The instrument application can receive and display fluoroscopic images at various positions (e.g., positions aligned with the patient's view).

[0044] See also Figures 2A-2D and Figure 3 Any suitable computing device 204 may be configured to host the instrument application. It should be understood that computing device 204 may include any suitable device, examples of which include portable computing devices such as laptops, tablets, or smartphones. For another example, computing device 204 may be located within surgical instrument 203.

[0045] In an exemplary configuration, computing device 204 includes a processing portion or unit 206, a power supply 208, an input portion 210, a display 212, a memory portion 214, a user interface portion 216, and an accelerometer 215. It should be emphasized that the block diagram of computing device 204 is described as exemplary and is not intended to imply a specific implementation and / or configuration. Processing portion 206, input portion 210, display 212, memory 214, user interface 216, and accelerometer 215 can be coupled together to enable communication therebetween. Accelerometer 215 can be configured to generate accelerometer information corresponding to the orientation of computing device 204. It should be understood that any of the aforementioned components can be distributed across one or more separate devices and / or locations.

[0046] In various embodiments, input portion 210 comprises a receiver of computing device 204, a transmitter of computing device 204, or a combination thereof. Input portion 210 is capable of receiving information, such as fluoroscopic data, in real time from medical imaging device 104. It should be understood that the transmitting and receiving functionality may also be provided by one or more devices external to computing device 204 and, thus, surgical instrument assembly 202.

[0047] Depending on the exact configuration and type of processor, memory portion 214 may be volatile (such as certain types of RAM), non-volatile (such as ROM, flash memory, etc.), or a combination thereof. Computing device 204 may include additional storage (e.g., removable and / or non-removable) including, but not limited to, tape, flash memory, smart cards, CD-ROMs, digital versatile disks (DVDs) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage, Universal Serial Bus (USB) compatible memory, or any other medium that can be used to store information and that can be accessed by computing device 204.

[0048] The computing device 204 may also include a user interface portion 216 that allows a user to communicate with the computing device 204. The user interface 216 may include inputs that provide the ability to control the computing device 204 via, for example, buttons, soft keys, a mouse, voice-activated controls, a touch screen, movement of the computing device 204, visual cues (e.g., moving a hand in front of a camera on the computing device 204), and the like. The user interface portion 216 may provide outputs including visual information (e.g., via a display), audio information (e.g., via a speaker), mechanical forms (e.g., via a vibration mechanism), or combinations thereof. In various configurations, the user interface portion 216 may include a display, a touch screen, a keyboard, a mouse, an accelerometer, a motion detector, a speaker, a microphone, a camera, a tilt sensor, or any combination thereof. The user interface portion 216 may also include any suitable means for inputting, for example, biometric information such as fingerprint information, retinal information, voice information, and / or facial feature information. Thus, a computer system such as the computing device 204 may include a processor, a display coupled to the processor, and a memory in communication with the processor. The memory may store instructions that, when executed by the processor, cause the computer system to perform operations, such as those described herein. The display 212 may be configured to display visual information, such as a Figures 4A-4C 、 Figures 5A-5C and Figures 10A to 18 As stated.

[0049] See also Figure 1 and Figure 3 , the transmitter unit 114 can be electrically coupled to or part of the medical imaging device 104. The transmitter unit 114 can be any suitable computing device configured to receive and transmit images (e.g., video signals including fluoroscopic images). It should be understood that the transmitter unit 114 can include any suitable device, examples of which include a portable computing device such as a laptop, tablet computer, or smartphone.

[0050] See specifically Figure 3 In an exemplary configuration, transmitter unit 114 may include a processing portion or unit 116, a power supply 118, an input portion 120, and an output portion 122. It should be emphasized that the block diagram of transmitter unit 114 is described as exemplary and is not intended to imply a specific implementation and / or configuration. Processing portion 116, input portion 120, and output portion 122 may be coupled together to enable communication therebetween. It should be understood that any of the aforementioned components may be distributed across one or more separate devices and / or locations.

[0051] In various embodiments, input portion 120 comprises a receiver of transmitter unit 114, and output portion 122 comprises a transmitter of transmitter unit 114. Input portion 120 is capable of receiving information, such as fluoroscopic images or video data, from medical imaging device 104 (specifically, output interface 105 of medical imaging device 104). Output interface 105 may include a coaxial output, a USB output, a component output, a wireless output, etc. It should be understood that the transmission and reception functions may also be provided by medical imaging device 104. In one example, transmitter unit 114 is electrically coupled to output interface 105 of medical imaging device 104 to establish a wired or wireless connection between transmitter unit 114 and display 112. Output interface 105 may include one or more video output connectors using a matching input module. In one example, processing portion 116 (which may include one or more processors running an embedded operating system) may detect the presence of a signal (e.g., a video signal including a fluoroscopic image) from medical imaging device 104. Processing portion 116 may process the signal as needed for transmission to surgical instrument assembly 202. For example, processing portion 116 may compress the signal in order to reduce the bandwidth used to transmit the signal.

[0052] After processing portion 116 performs processing on the video signal, the video signal, including the fluoroscopic image, can be transmitted by output portion 122 of transmitter unit 114 to input portion 210 of computing device 204, as desired. Output portion 122 of transmitter unit 114 can be configured to transmit the fluoroscopic image according to any desired communication protocol. For example, output portion 122 can include a ZigBee module connected to processing portion 206 via a universal serial bus (USB), allowing output portion 122 to transmit data wirelessly (via a wireless communication channel) according to any ZigBee protocol. Output portion 122 can transmit the video signal, such as the fluoroscopic image, via Wi-Fi, Bluetooth, broadcast, or any other desired wireless communication channel.

[0053] Thus, the input portion 210 of the device 204 can receive data or video signals, such as fluoroscopic images, transmitted from the medical imaging device 104 via a wireless communication channel in real time. The input portion 210 can be configured to receive ZigBee messages, Wi-Fi messages, Bluetooth messages, broadcast messages, or messages formatted according to any desired wireless protocol. In one example, when the input portion 210 of the device 204 receives a fluoroscopic image from the medical imaging device 104, the processing portion 206 of the computing device 204 can retrieve and verify the image. For example, the processing portion 206 can verify that the received image is from the appropriate medical imaging device. For example, if the image is verified, the image can be forwarded to the display 212. The processing portion 206 can also ensure that valid data is displayed. For example, if there is an interruption in the wireless communication channel or connection between the computing device 204 and the medical imaging device 104, the processing portion 206 can identify the interruption and send a message to the display 212, so that the interruption is communicated to the medical professional viewing the display 212. In some instances, when the quality of the communication link between imaging device 104 and surgical instrument assembly 202 falls below a predetermined threshold, processor 206 may cause surgical instrument assembly 202 to display an error indication on display 212. Thus, a wireless point-to-point communication channel or connection between transmitter unit 114 and computing device 204 may be established, and the wireless point-to-point connection may be managed by input portion 210 and output portion 122 at the physical layer and processing portions 116 and 206 at the application layer.

[0054] Usually see Figures 2A-2D 、 Figure 7A-7B and Figure 13 , the medical imaging system 102 may include a surgical instrument assembly 202, which may include a computing device 204 mounted to a surgical instrument 203. The surgical instrument 203 may be configured to operate on an anatomical structure, such as the anatomical structure 124. The surgical instrument 203 may define a body 205, and the computing device 204 may be attached to any location of the body 205 as desired. In one example, see Figures 2A-2D , the computing device 204, and thus the display 212, can be supported by a mount 228. The mount 228 can include a support surface 230 that supports the computing device 204, and thus the display 212. The mount 228 can also include an arm 232 attached to the support surface 230 and the body 205 of the surgical instrument 203 so that the display 212 is in a fixed position relative to the body 205 of the surgical instrument 203. The arm 232 or the support surface 230 can be configured to rotate to adjust the viewing angle of the display 212. The mount 228 can be positioned so that the display does not interfere with the operation of the surgical instrument 203. It should be understood that the computing device 204 can be alternatively mounted to the surgical instrument 205 as desired.

[0055] See also Figure 7A 、 Figure 7B and Figure 8 For example, surgical instrument assembly 202 may further include a depth gauge 250. Depth gauge 250 may include one or more processors configured to measure, determine, and transmit data related to the depth of a drilling operation performed on an anatomical structure, as further described herein. In some examples, depth gauge 250 is embodied in accordance with the measurement device suitable for bone screw length determination described in International Application Publication No. WO / 2017 / 083992, the disclosure of which is incorporated herein by reference as if fully set forth. It should be understood that depth gauge 250 may be embodied in alternative ways. Depth gauge 250 may be in communication with display 212. Depth gauge 250 may be configured to measure the drilling depth of surgical instrument 203 when surgical instrument 203 is operating as a drill. Depth gauge 250 may be secured to surgical instrument 203 in a fixed position relative to surgical instrument 203. Depth gauge 250 may be releasably attached or secured to body 205 of surgical instrument 203 so as to be secured in a fixed position relative to body 205. The depth gauge 250 can be supported by an adapter 252 that can be secured to the body 205 and the depth gauge 250. The adapter 252 can be sized to be clamped to the body 205 as desired so that the adapter 252, and therefore the depth gauge 250, remains in a fixed position relative to the body 250 while the surgical instrument 203 is operating. In one example, the adapter 252 can be adjusted by moving, for example, rotating, an actuator 255. The actuator 255 can be configured as a knob or the like. For example, the actuator 255 can be rotated in a clockwise direction to tighten the adapter 252, and the actuator can be rotated in a counterclockwise direction to loosen the adapter 252.

[0056] The depth gauge 250 can define a depth gauge body 254 defining a first or front end 254a and a second or rear end 254b opposite the first end 254a along a longitudinal direction L. The depth gauge body 254 can also define a third or top end 254c and a fourth or bottom end 254d opposite the third end 254c along a transverse direction T substantially perpendicular to the longitudinal direction L. The adapter 252 can be secured to the fourth end 254d of the depth gauge 250, though it should be understood that the depth gauge 250 can alternatively be secured to the adapter 252 as desired. The adapter 252 can be press-fitted to the body 205 of the surgical instrument 203. The adapter 252 can define a clamping collar secured to the body 205 of the surgical instrument 203, though it should be understood that the adapter 252 can alternatively be secured to the surgical instrument 203. In another example, the depth gauge 250 can be secured directly to the surgical instrument 203 without the adapter 252.

[0057] Still see Figure 7A 、 Figure 7B and Figure 8 The depth gauge 250 may further include a depth gauge member 256 extending from the depth gauge body 254, for example at the second end 254b of the depth gauge body 254. The computing device 204 may further define a computing device body 204a and a computing device member 258 extending from the body 204a for attachment to the depth gauge member 256. The computing device member 258 may be monolithic or otherwise attached to the computing device body 204a such that the computing device member 258 may be in a fixed position relative to the computing device body 204a. Additionally, the display 212 may be in a fixed position relative to the computing device body 204a. Thus, the display 212 may be in a fixed position relative to the computing device member 258. The computing device member 258 may be configured to rotate relative to the depth gauge member 256. In one example, the computing device member is configured to rotate about an axis 260 that is substantially parallel to the transverse direction T. Thus, the display 212 may be configured to rotate about an axis 260 that is substantially parallel to the transverse direction T. For example, the display 212 can be configured to rotate about an axis 260 to adjust the viewing angle of the display 212 while performing operations. The axis 260 can be centered relative to the width of the display 212, which is defined along a lateral direction A that is substantially perpendicular to both the longitudinal direction L and the transverse direction T. It should be understood that the display 212 can be configured to rotate about alternative axes as desired. The one or more processors of the depth gauge 250 can be communicatively coupled to the computing device 204, and therefore coupled to the display 212. In one example, the depth gauge 250 is configured to transmit data wirelessly to the computing device 204. For example, the depth gauge 250 can provide real-time data to the computing device 204 via a Wi-Fi network.

[0058] It should also be understood that computing device 204 may alternatively be an integral part of surgical instrument 203. Furthermore, while surgical instrument 203 is shown as a surgical drill for illustrative purposes, it should be understood that computing device 204 and depth gauge 250 may be mounted to or integrally formed with any number of suitable alternative devices or instruments. For example, surgical instrument assembly 202 may include an instrument or device configured to target a bony region or other portion of an anatomical structure, remove a medical implant, perform an osteotomy, or any other procedure, such as any other procedure employing fluoroscopy as needed. Thus, while anatomical structure 124 is presented as bone, it should be understood that the structures that a surgical instrument assembly may be configured to operate on are not limited to bone.

[0059] Computing device 204, and thus surgical instrument assembly 202, may include a display 212 that may be attached to the surgical instrument. Display 212 may be configured to display a fluoroscopic image of anatomical structure 124 generated by imaging device 104. In an exemplary configuration, display 212 may display the fluoroscopic image of anatomical structure 124 in real time, such that the image of anatomical structure 124 is displayed by display 212 at the same time as imaging device 104 generates the image. In some cases, display 212, and thus surgical instrument assembly 202, may include multiple displays, e.g., a first display 212a and a second display 212b having a different orientation than first display 212a. In another exemplary configuration, e.g., Figure 7A 、 Figure 7B 、 Figure 8 and Figure 13 As shown in , display 212 , and therefore surgical instrument assembly 202 , includes only one display.

[0060] See also Figures 2A-2D 、 Figure 7A-7B and Figure 13 , the surgical instrument 203 may define a proximal end 203b and a working end 203a opposite the proximal end 203b. The working end 203a may be configured to perform operations on, for example, a structure of a medical patient, such as the anatomical structure 124, such as cutting, drilling, or otherwise aligning. The display 212 may face the proximal end 203b. The display 212 (specifically, a first display 212a and a second display 212b) may be positioned to provide a line of sight to both the working end 203a and the display 212 from a position proximal to the surgical instrument 203. Thus, in some cases, for example, a medical professional may be able to view both the display 212 and the working end 203a of the surgical instrument 203 while operating the surgical instrument 203.

[0061] In one example, the surgical instrument 203 includes a cutting instrument 226 including a proximal end 226b adjacent to the body 205 of the surgical instrument 203 and a cutting tip 226a opposite the proximal end 226b of the cutting instrument 226. The cutting tip 226a can define a terminal end of the cutting instrument opposite the proximal end 226b of the cutting instrument 226. The cutting instrument 226 can have a cutting tip 226a that can be configured to remove anatomical material from an anatomical structure, such as the anatomical structure 124. In the illustrated example, the cutting instrument 226 is a drill bit, and the cutting tip 226a is the end of the drill bit, but it should be understood that other instruments and configurations can be used in addition to or in place of instruments such as the cutting instrument 226 to implement the embodiments disclosed herein, and all such embodiments are contemplated as being within the scope of the present disclosure.

[0062] Surgical instrument assembly 202 may include an alignment tool 218, such as an axis alignment tool, mounted to body 205 of surgical instrument 203. It should be understood that alignment tool 218 may alternatively be an integral part of surgical instrument 203. Alignment tool 218 may be rigidly attached to body 205 of surgical instrument 203. In one example, cutting instrument 226 is located at working end 203a of surgical instrument 203, and alignment tool 218 is located at proximal end 203b of the surgical instrument, but it should be understood that alignment tool 218 may be positioned alternatively as desired. Alignment tool 218 may define a first surface 218a located proximal to surgical instrument 203 and a second surface 218b opposite first surface 218a. Second surface 218b may define a flat surface, and thus alignment tool 218 may define a flat surface. Thus, second surface 218b of alignment tool 218 may define a plane. Cutting instrument 226 (e.g., a drill bit) may be oriented perpendicular to the plane defined by second surface 218b of alignment tool 218. In one example, the alignment tool 218 includes a pin oriented perpendicular to a plane defined by the second surface 218b of the alignment tool. The pin can be configured to be received by a hole defined by the proximal end 203b of the surgical instrument 203. The hole defined by the proximal end 203b of the surgical instrument 203 can have an orientation parallel to the cutting instrument 226, such that when the pin of the alignment tool 218 is received by the hole defined by the proximal end 203b of the alignment tool 218, the second surface 218b of the alignment tool defines a plane perpendicular to the orientation of the cutting instrument 226.

[0063] See also Figures 4A-4C , the fluoroscopic image of the anatomical structure 124 may include one or more target locations 126. The target locations 126 may represent locations on the anatomical structure 124 at which the surgical instrument 203 may be drilled, cut, or otherwise aligned. According to the illustrated example, the target location 126 may be defined by an implant 125 (e.g., an IM nail or rod) in the bone. It should be understood that the exemplary operations performed by the surgical instrument assembly are presented as IM nailing operations to facilitate describing the subject matter disclosed herein, and the exemplary IM operations are not intended to limit the scope of the present disclosure. Therefore, it should be understood that the surgical instrument assembly 202 may be used to perform other operations in addition to or in lieu of operations such as the exemplary IM nailing operations, and all such embodiments are contemplated to be within the scope of the present disclosure.

[0064] The display 212 may display fluoroscopic images associated with IM stapling operations, etc. Additionally, the display 212 may display images or data associated with the depth gauge 250. Additionally, the display 212 may display images or data associated with the depth gauge 250 while the display 212 is presenting fluoroscopic images. The display 212 may be configured to display fluoroscopic images generated by and received from the medical imaging device 104, such as the fluoroscopic images 400a-c of the anatomical structure 124. See, in particular, Figure 4A , a display 212 (e.g., a first display 212a) may display an exemplary fluoroscopic image 400a of an implant 125 in an anatomical structure 124. The implant 125 may define one or more target locations 126 where material may be removed from the anatomical structure 124. In an exemplary IM nailing operation, by viewing the display 212 displaying the fluoroscopic image from the imaging device 104, the medical professional may manipulate the patient or the imaging device 104 while viewing the patient and the display 212 until the target locations 126 define a perfect circle, as shown. Figure 4A In the IM nailing example, when one or more target locations 126 define a perfect circle, holes can be drilled at the target locations 126 for locking screws.

[0065] Now see Figure 4B , the display 212 may display an exemplary fluoroscopic image 400b. Thus, the display 212 may be configured to display the position of the cutting tip 226a of the cutting instrument 226 relative to the target location 126 on the fluoroscopic image of the anatomical structure 124. The fluoroscopic image 400b may show, for example Figure 6B The cutting tip 226a is shown in FIG. The cutting tip 226a can be configured to remove anatomical material from one or more target locations 126 of the anatomical structure 124. Figure 4C As shown, tip 226a of cutting instrument 226 (e.g., a drill bit) can be positioned, for example, at the center of target location 126 on anatomical structure 124. Display 212 can be positioned to provide a line of sight to both tip 226a and display 212 from a position proximal to surgical instrument 203, such that a medical professional can observe fluoroscopic images 400b and 400c, and thus tip 226a and anatomical structure 124, in order to center tip 226a at target location 126. Display 212 of surgical instrument 203 can be a mirror image of display 112 of medical imaging device 104, such that display 212 of surgical instrument assembly 202 can simultaneously render the same image as that rendered by display 112 of imaging device 104, so as to display the image in real time.

[0066] In some instances, e.g., based on a user selection via user interface 216, surgical instrument assembly 202 may rotate the fluoroscopic image displayed on display 212 to a rotated orientation such that the vertical direction or the horizontal direction on display 212 corresponds to the vertical direction or the horizontal direction, respectively, of movement of surgical instrument 203 relative to anatomical structure 124. Thus, in some instances, the fluoroscopic image displayed by display 212 in the rotated orientation may have been rotated compared to a fluoroscopic image displayed on a medical imaging device display 112 that is separate from display 212 coupled to surgical instrument 203.

[0067] Now see Figures 5A-5C , the display 212 may also be configured to provide a visual indication of the alignment of the cutting tip 226a relative to the direction of travel 128 of the X-rays from the X-ray emitter 106 to the X-ray receiver 108, such as an orientation image 129. In one example, the display 212 includes a first display 212a and a second display 212b, and the first display 212a is configured to display a fluoroscopic image (e.g., fluoroscopic images 400a-c) from the imaging device 104, and the second display 212b is configured to display an orientation screen (e.g., orientation screens 500a-c) that includes a visual indication of the orientation of the cutting instrument 226. It should be understood that the first display 212a may additionally or alternatively display the orientation screen, and the second display 212b may additionally or alternatively display the fluoroscopic image. Additionally, in some cases, the display 212 may include only one display that may display both the fluoroscopic image and the orientation screen simultaneously. Additionally, see Figure 11 and Figure 12 In some cases, the display 212 may include only one display that can simultaneously display any combination of the fluoroscopic image, the orientation screen, and the depth gauge data. In one example, a user may select an option via the user interface 216 to select a corresponding one of the fluoroscopic image, the orientation screen, or the depth gauge data to be displayed by the display 212. As another example, the display 212 may be split, such as in half or in thirds, so that any combination of the fluoroscopic image, the orientation screen, and the depth gauge data may be displayed simultaneously by the display 212. It should be understood that the examples of images that may be displayed by the display 212 described herein (e.g., Figures 4A-4C 、 Figures 5A-5C 、 Figures 10A-20 ) are not intended to be exhaustive. Display 212 may provide various information to the user via a variety of arrangements or alternative visual depictions.

[0068] The visual indication of alignment, such as the orientation image 129, can be based on the X-ray direction of travel 128 and can also be based on accelerometer information corresponding to the orientation of the cutting instrument 226. For example, the X-ray direction of travel 128 from the X-ray generator 106 to the X-ray receiver 108 of the medical imaging device 104 can be used to calibrate the accelerometer 215 of the surgical instrument assembly 202. In an exemplary calibration, an alignment tool 218 attached to the surgical instrument 203 is configured to align with a surface of the medical imaging device 104 having a predetermined orientation so as to align the cutting instrument 226 (e.g., a drill bit) with the X-ray direction of travel 128. In one example, the alignment tool 218 is configured to align with the flat surface 106a of the X-ray emitter, although it should be understood that the alignment tool 218 can be configured to align with other surfaces of the medical imaging device 104 as desired. Specifically, the second surface 218b of the alignment tool 218 can be a flat surface that can abut the flat surface 106a of the medical imaging device 104 when the cutting instrument 226 is aligned with the direction of X-ray travel 128. Continuing with this example, when the surface 218b of the alignment tool 218 abuts the flat surface 106a of the X-ray generator 106, a zero value can be set to calibrate the accelerometer 215 with the medical imaging device 104 (specifically, the direction of the X-ray beam generated by the medical imaging device 104). In one example, to set the zero value to calibrate the accelerometer 215 with the direction of X-ray travel 128, when the surface 218b of the alignment tool is pressed flatly against the flat surface 106a of the X-ray generator 106, the user can activate the calibration option 134 on the display 212 so that the zero value is set when the cutting instrument 226 is oriented along the direction of X-ray travel 128.

[0069] As another example, the calibration instrument may be part of or attached to the medical imaging device 104. When the medical imaging device 104, and specifically the direction of X-ray travel 128, is oriented in a desired direction to perform an operation, the calibration instrument of the medical imaging device 104 may identify a zero value relative to gravity, such that the zero value corresponds to the desired direction of X-ray travel 128. The calibration instrument 128 of the medical imaging device 104 may transmit the zero value relative to gravity to the accelerometer 215. Thus, the surgical instrument assembly 202 may receive the zero value from the medical imaging device 104, representing the direction of X-ray travel 128 from the X-ray generator 106 to the X-ray receiver 108 of the medical imaging device 104, in order to calibrate the accelerometer 215 of the surgical instrument assembly 202 using the direction of X-ray travel 128 defined by the medical imaging device 104. The accelerometer 215 may set its zero value relative to gravity to the zero value it received from the calibration instrument of the medical imaging device 104, thereby calibrating the accelerometer 215 using the direction of X-ray travel 128. Thus, when the cutting instrument 226 is oriented along the X-ray direction of travel 128 , the accelerometer 215 may indicate a value of zero.

[0070] In one example, the accelerometer 215 corresponds to the orientation of the display 212. Thus, in some cases, when the orientation of the display 212 relative to the cutting instrument 226 is adjusted, the zero value is reset to recalibrate the accelerometer 215 with the direction of travel of the X-rays 128. In some examples, the display 212 has one or more preconfigured orientations (e.g., 90 degrees, 75 degrees, etc.) relative to the cutting instrument 226. Thus, in some cases, after calibrating in a first preconfigured orientation, the display 212 can be moved to a second preconfigured orientation. In one example, a user can use the user interface 216 to select a preconfigured orientation in which the display 212 is positioned. The accelerometer 215 can receive the second preconfigured orientation and adjust the zero value accordingly so that the display 212 can be adjusted without recalibrating the accelerometer. As another example, the medical imaging device 104 includes an accelerometer that can recognize changes in the orientation of the direction of travel of the X-rays. In this example, the accelerometer of the medical imaging device can transmit the orientation change of the direction of X-ray travel to surgical instrument assembly 202 so that the zero value can be reset without recalibrating accelerometer 215. Thus, the zero value can be adjusted according to the orientation change of X-ray generator 106 and X-ray receiver 108.

[0071] For example, when accelerometer 215 of surgical instrument assembly 202 is calibrated using the direction of X-ray travel, the accelerometer can generate accelerometer information indicating the orientation of cutting instrument 226 relative to X-ray direction of travel 128. The accelerometer information can be displayed by display 212 in various orientation screens, such as orientation screens 500a-c, which can include orientation image 129. Using the IM nailing example, by observing orientation image 129 while using surgical instrument assembly 202, cutting instrument 226 can be maintained in the proper orientation while drilling a hole. That is, a hole can be drilled at target location 126 that defines a perfect circle.

[0072] For example, see Figures 5A-5C, the orientation screen 500a-c may include an orientation image 129, which may include a static area 130 and a movable indicator 132. The movable indicator 132 may represent the orientation of the cutting instrument 226. In one example, the cutting instrument 226 is oriented using the X-ray direction of travel 128 when the movable indicator 132 has a predetermined spatial relationship relative to the static area 130. In one example, a hole is drilled in the anatomical structure 124 while the end 226a of the cutting instrument 226 (e.g., a drill bit) is aligned with the target location 126 and the movable indicator 132 has a predetermined spatial relationship relative to the static area 130. It should be understood that the predetermined spatial relationship can vary as needed. In some cases, for example, when the movable indicator 132 covers the static area 130, the cutting instrument 226 is oriented using the X-ray direction of travel 128. In some cases, such as Figure 5C As shown, the cutting instrument 226 is oriented using the X-ray direction of travel 128 when the movable indicator 132 is located within the boundaries defined by the static region 130 .

[0073] See above Figures 4A-4C As described above, the display 212 can display fluoroscopic images and user interfaces associated with placing locking screws to secure the IM nail. Figures 13 to 20 , the display 212 may additionally or alternatively display an X-ray or fluoroscopic image and a user interface associated with placing the implant 125 (e.g., an IM nail). The display 212 may be configured to display an X-ray image, such as X-ray data or image 602 ( Figure 13 、 Figure 14A 、 Figure 14B ), X-ray image 604( Figure 15 ), X-ray image 606( Figure 16 ), X-ray image 608( Figure 17 ), X-ray image 610( Figure 18 ) and X-ray images 630a and 630b ( Figure 20 As used herein, unless otherwise specified, X-ray data and X-ray images are used interchangeably without limitation. Figure 14A, the display 212 may display X-ray data 602 of the anatomical structure 124. According to the illustrated example, the X-ray data 602 includes a cutting instrument 226 positioned to drill a hole in the anatomical structure 224 for the implant 125. The X-ray data 602 also includes a fixture 612 positioned to move soft tissue for the drilling operation. In one example, the hole may be drilled to intersect with the IM canal of the anatomical structure or bone 124. Thus, the hole may define an entry point into the bone and a trajectory between the entry point and the IM canal, and the implant 125 (e.g., an IM nail or rod) may be inserted into the hole, which is sized to receive the implant 125. It is recognized herein that the appropriate trajectory and entry point for the drilling operation (e.g., to minimize pain) may vary depending on the type of bone and / or implant to be inserted. It is further recognized herein that the appropriate trajectory and entry point may not be readily accessible in a given operating room, such that a given medical professional may rely on personal knowledge to estimate the appropriate trajectory and entry point. Additionally, even if the appropriate trajectory and entry point are known, drilling operations are often performed freehand such that the actual trajectory and entry point may differ from the appropriate trajectory and entry point.

[0074] In one exemplary embodiment, see Figure 14B and Figure 17 , the processor of surgical instrument assembly 202 may identify or determine a boundary 614 of anatomical structure 124, such as a first or anterior-posterior (AP) boundary 615 ( Figure 14B and Figure 15 ) or second or lateral boundary 617 ( Figure 16 and Figure 17Boundary 614 may define a first outermost edge 614a of anatomical structure 124 and a second outermost edge 614b of anatomical structure 124 opposite first outermost edge 614a. In some examples, the processor may determine boundary 614 by executing the edge detection process described in U.S. Patent Application Publication No. 2007 / 0274584, the disclosure of which is incorporated herein by reference as if fully set forth. It should be understood that other edge detection algorithms may be implemented as desired, and the above-described edge detection process is presented for illustrative purposes. In some cases, the processor may identify boundary 614 based on a user selection via user interface 216. For example, display 212 may display an option, such as a manual alignment option 646. A user, such as a medical professional, may activate manual alignment option 646, such as by touch or the like. When manual alignment option 646 is activated, the user may manually overlay one or more images on the X-ray data, causing display 212 to display the one or more images on the X-ray data. An example of an image that the user may manually overlay is boundary 614. By way of example, a user may manually overlay an image on the X-ray data using a stylus, finger, etc. In one example, a user may actuate manual alignment option 646 to adjust boundary 614 determined by a processor of surgical instrument assembly 202. For example, the processor may perform an edge detection process to determine boundary 614, but in some cases, the edge detection process may produce a portion of boundary 614 that is offset from the actual outermost edge of anatomical structure 124. For example, the edge detection process may incorrectly identify a break in anatomical structure 124 as part of boundary 614. In this example, the user may adjust the portion of boundary 614 that was incorrectly identified as representing the outermost edge of anatomical structure 124 via user interface 216. Thus, surgical instrument assembly 202 may adjust at least a portion, such as all, of boundary 614 in response to the user actuating at least one option of user interface 216.

[0075] like Figure 14B 、 Figure 15 、 Figure 16 and Figure 17 As shown, the display 212 may overlay the boundary 614 on the X-ray image of the anatomical structure 124 to display the boundary 614 of the anatomical structure 124. Figure 18 and Figure 20 , the processor of surgical instrument assembly 202 may determine axis 616 of anatomical structure 124. The processor of surgical instrument assembly 202 may determine a representation of trajectory 618 defining an entry point 620 into the anatomical structure. Figure 14B-Figure 18 and Figure 20, the display 212 may overlay the representation of the trajectory 618 on the X-ray image of the anatomical structure 124 to display the representation of the trajectory 618. The representation of the trajectory 618 may define a line along which a hole may be drilled to meet the IM canal of the anatomical structure 124. The representation of the trajectory 618 may be determined based on the axis 616. Figure 18 and Figure 20 , the display 212 may superimpose the axis 616 on the X-ray data of the anatomical structure to display the axis 616 of the anatomical structure 124 .

[0076] In some examples, axis 616 can define a centerline along the length of the anatomical structure. Figure 14B-Figure 17 , the trajectory may coincide with axis 616, such that the representations of trajectory 618 and axis 616 may overlap one another. For example, first outermost edge 614a may be spaced apart from second outermost edge 614b to define a width of the anatomical structure that is substantially perpendicular to the length of the anatomical structure. Thus, axis 616 may be equidistant from first outermost edge 614a and second outermost edge 614b along the length of anatomical structure 124. In some cases, the processor may identify axis 616 based on a user selection via user interface 216. For example, a user, such as a medical professional, may activate manual alignment option 646, for example, by touch. When manual alignment option 646 is activated, the user may manually overlay one or more images on the X-ray data, causing display 212 to display the one or more images on the X-ray data. An example of an image that the user may manually overlay is axis 616. As shown, axis 616 is represented as a dashed line, but it should be understood that axis 616 may alternatively be represented as a solid line, for example, as desired. By way of example, a user may manually overlay an image on the X-ray data using a stylus, finger, or the like. In one example, a user may activate manual alignment option 646 to adjust axis 616 determined by the processor of surgical instrument assembly 202 based on boundary 614, specifically first outermost edge 614a and second outermost edge 614b. Thus, surgical instrument assembly 202 may adjust or determine at least a portion, such as all, of axis 616 in response to the user actuating at least one of the options in user interface 216. Additionally, surgical instrument assembly 202 may determine axis 616 of anatomical structure 124 based on boundary 614 of anatomical structure 124 such that if boundary 614 of the anatomical structure changes, axis 616 of anatomical structure 124 changes in accordance with the change in boundary 614. For example, if second outermost edge 614b is adjusted away from first outermost edge 614a, surgical instrument assembly 202 may move axis 616 toward second outermost edge 614b such that axis 616 is displayed further away from first outermost edge 614a than before boundary 614 was adjusted.

[0077] Without being bound by theory, it is recognized herein that the embodiments described herein can reduce the number of X-ray images taken in an operating room, thereby reducing the time it takes to perform a given procedure. In one example, see Figure 14A-Figure 15 as well as Figure 20 , display 212 may display an X-ray image of anatomical structure 124 from a first or anteroposterior (AP) view. The surgical instrument assembly may determine a representation of trajectory 618 that defines an entry point 620 into anatomical structure 124. Display 212 may superimpose the representation of trajectory 618 on the X-ray image of anatomical structure 124 to display the representation of trajectory 618.

[0078] In some cases, the processor may determine a representation of trajectory 618 in response to a user selection via user interface 216. For example, display 212 may display an option, such as an auto-align option 622. A user, such as a medical professional, may activate auto-align option 622, such as by touch or the like. Upon activating auto-align option 622, the processor of surgical instrument assembly 202 may determine a representation of trajectory 618 that defines an entry point 620 into anatomical structure 124. In response to auto-align option 622 being selected or activated, the surgical instrument assembly may also determine axis 616 or boundary 614, or both axis 616 and boundary 614. Additionally, in response to auto-align option 622 being activated, display 212 may superimpose at least one, such as only one, of the representation of trajectory 618, axis 616, and boundary 614, such as any combination thereof, on the X-ray image of anatomical structure 124 to display the representation of trajectory 618, axis 616, and / or boundary 614.

[0079] In some examples, surgical instrument assembly 202 may determine a representation of trajectory 618 based on technical information, such as technical information stored in memory 214. Such technical information may include appropriate trajectories for drilling holes in various bones for placement of IM nails. Based on the technical information, surgical instrument assembly 202 may determine a representation of the trajectory. By way of example, the technical information may specify that the trajectory of a given bone viewed from an AP perspective is 5 degrees lateral to the axis measured from a point directly below the lesser trochanter. Continuing with this example, the technical information may specify that the trajectory of a given bone viewed from a lateral perspective is centered in the greater trochanter and aligned with the medullary canal. In one example, the type of bone and nail may be input into the processor via user interface 216, and the view corresponding to the X-ray image (e.g., lateral or AP) may be input into the processor via user interface 216. In response, the processor may retrieve technical information corresponding to the view of the X-ray image, the type of bone, and the nail. Based on the retrieved technical information, the trajectory may be determined. In some cases, the processor first determines boundary 614 and, based on this boundary, determines axis 616. The representation of trajectory 618 may be determined based on axis 616 and technical information. For example, the technical information may indicate that the trajectory coincides with axis 616 in a first view and is angularly offset from the axis by a specific angle in a second view that is substantially perpendicular to the first view (see FIG. Figure 19 ).

[0080] See also Figure 19 , a given user can retrieve technical information from the surgical instrument assembly that activates a user selection via the user interface 216. For example, a user selection can cause the display 212 to display technical information 650a and 650b. Technical information 650a may include a graphical depiction of an appropriate trajectory 652a from an AP view. Technical information 650b may include a graphical depiction of an appropriate trajectory 652b from a lateral view. Among other operations, the displayed technical information may include textual instructions 654 for placing an IM staple. In one example, in response to a user selection, the user interface 216 may present audible instructions associated with an IM staple operation, etc.

[0081] In some cases, a given user (e.g., a medical professional) may utilize the technical information presented by surgical instrument assembly 202 to manually overlay a representation of trajectory 618 on a given X-ray image. For example, the user may actuate manual alignment option 646, e.g., by touch, etc. Upon actuation of manual alignment option 646, the user may manually overlay a representation of trajectory 618, causing display 212 to display trajectory 618 on the X-ray data. The representation of trajectory 618 may define a solid line, a dashed line, etc. In one example, the user may actuate manual alignment option 646 to adjust axis 616 determined by the processor of surgical instrument assembly 202 after automatic alignment option 622 is selected. Surgical instrument assembly 202 may adjust or determine at least a portion, e.g., all, of the representation of the trajectory in response to the user actuating at least one of the options in user interface 216. Accordingly, the processor of surgical instrument assembly 202 may adjust the representation of the trajectory to define a new representation of the trajectory, and display 212 may overlay the new representation of the new trajectory on the X-ray image of the anatomical structure to display the new representation of the new trajectory. In one example, the processor may adjust the representation of the trajectory in response to the user actuating at least one of the options of the user interface 216 .

[0082] See also Figure 14B By observing the representation of the trajectory 618 and the cutting instrument 226 visible on the X-ray image 602, the user can move the cutting instrument 226 to align with the representation of the trajectory, as shown. Figure 15 Alternatively, in an automatic scenario, the cutting instrument 226 may be automatically moved to align with the representation of the trajectory 618. In one example, when the cutting instrument 226 is aligned with the representation of the trajectory 618, the medical imaging device 104 may be adjusted to define a new X-ray travel direction 128 from the X-ray emitter 106 to the X-ray receiver 108 to generate the X-ray images 606 and 608, which is different from the X-ray travel direction that generated the X-ray images 602 and 604. For example, the medical imaging device 104 may be adjusted to generate an image that is substantially perpendicular to the X-ray image 606. Figure 14B and Figure 15 A second or lateral view of the first or AP view is shown.

[0083] See also Figure 14B 、 Figure 15 and Figure 20 , the representation of the trajectory 618 may be referred to as a first representation 618a of the trajectory from a first perspective, such as from an AP perspective. In one example, see Figure 16 、 Figure 17 and Figure 20, surgical instrument assembly 202 may determine a second representation 618b of a trajectory defining entry point 620 into anatomical structure 124. Second representation 618b may be from a second perspective. By way of example, the second perspective may be substantially circumferential to the first perspective, such that the first perspective may define an AP view and the second perspective may define a lateral view. Second representation 618b of the trajectory may be determined and displayed according to any of the embodiments described herein for determining and displaying a representation of trajectory 618.

[0084] See also Figure 14B-Figure 18 , the display 212 can display the position of the cutting tip 226a relative to the entry point 620 of the anatomical structure. By observing the second representation 618b of the trajectory and the cutting instrument 226 visible on the X-ray images 606 and 608, the user can move the cutting instrument 226, and thereby the cutting tip 226a, to align with the second representation 618 of the trajectory. Alternatively, in an automatic scenario, the cutting instrument 226 can be automatically moved to align with the second representation 618b of the trajectory.

[0085] In some cases, when the cutting instrument 226, and therefore the cutting tip 226a, is aligned with the first representation of the trajectory 618a and the second representation of the trajectory 618b, the drilling operation can begin because the cutting instrument 226 is aligned with the appropriate entry point and trajectory, which can be determined by the technical information described herein. The display 212 can be positioned to provide a line of sight to both the tip 226a and the display 212 from a position proximal to the surgical instrument 203 so that the medical professional can observe the X-ray image and therefore the tip 226a and the anatomical structure 124 in order to center the tip 226a at the entry point 620.

[0086] Now see Figure 18 , the display 212 can also be configured to provide a visual indication of the alignment of the cutting instrument 226 relative to the first representation 618a and the second representation 618b of the trajectory, such as an orientation image 629. The visual indication of alignment, such as the orientation image 629, can be based on the X-ray direction of travel 128 and can also be based on accelerometer information corresponding to the orientation of the cutting instrument 226. For example, when the X-ray image 604 is taken from a first perspective, the accelerometer 215 of the surgical instrument assembly 202 can be calibrated with the X-ray direction of travel 128 from the X-ray generator 106 to the X-ray receiver 108 of the medical imaging device 104, and when the X-ray image 608 is taken from a second perspective that is substantially perpendicular to the first perspective, the accelerometer can be calibrated with the X-ray direction of travel 128.

[0087] For example, see Figure 18, the orientation image 629 may include a static region 130 and a movable indicator 132. The movable indicator 132 may indicate the orientation of the cutting instrument 226. In one example, when the movable indicator 132 has a predetermined spatial relationship relative to the static region 130, the cutting instrument 226 is oriented using the first representation 618a and the second representation 618b of the trajectory. In one example, a hole is drilled in the anatomical structure 124 while the cutting instrument 226 (e.g., a drill bit) is aligned with the first and second representations of the trajectory and the movable indicator 132 has a predetermined spatial relationship relative to the static region 130. It should be understood that the predetermined spatial relationship may vary as desired. In some cases, for example, when the movable indicator 132 covers the static region 130, the cutting instrument 226 is oriented using the first and second representations of the trajectory. In some cases, when the movable indicator 132 is within the boundaries defined by the static region 130, the cutting instrument 226 is oriented using the first and second representations of the trajectory.

[0088] Now see Figures 10A-12 , the display 212 may also be configured to provide a visual indication of the depth of the cutting tip 226a relative to one or more portions of the anatomical structure 124, such as a depth gauge image 262. In one example, see Figure 9 , the anatomical structure 124 defines a first or proximal cortex 123 and a second or distal cortex 127 that is opposite the first cortex 123 along a first direction D1, or X-ray travel direction 128 (which may be in the drilling direction). The first cortex 123 may define a first or proximal surface 123a and a second or distal surface 123b that is opposite the first surface 123a along the first direction D1. Similarly, the second cortex 127 may define a first or proximal surface 127a and a second or distal surface 127b that is opposite the first surface 127a along the first direction D1, which may also be along the X-ray travel direction 128. The anatomical structure 124 may define a hollow portion 131. For example, the hollow portion 131 may be defined between the second surface 123b of the first cortex 123 and the first surface 127b of the second cortex 127. The visual indication of depth (e.g., the depth gauge image 262) may change as the cutting instrument 226 (specifically, the cutting tip 226a) is advanced into the anatomical structure 124. Specifically, the depth gauge image 262 may include data that may change when the cutting instrument tip 226 a contacts the respective first and second surfaces of the first and second cortices 123 and 127 .

[0089] In the exemplary operation, first see Figure 10A and Figure 12, which respectively illustrate an exemplary depth gauge screen 1000a and an exemplary split screen 1200, the depth gauge image 262 is configured to measure a first distance of a reference position relative to a portion of the anatomical structure 124, and the display 212 is configured to indicate a second distance of the cutting tip 226a relative to the portion of the anatomical structure 124. The depth gauge 250 can be configured to measure the first distance as the surgical instrument 203 drills a hole. The display 212 can be configured to indicate the second distance as the surgical instrument drills the hole so as to indicate the second distance in real time. The first cortex 123 can define a portion of the anatomical structure 124. In one example, the first cortex 123 (specifically, the first surface 123a of the first cortex 123) defines a reference position from which the distance to the reference position is measured by the depth gauge 250. In one example, the cutting tip 226a defines the reference position such that the first distance is equal to the second distance.

[0090] In an alternative example, the surgical instrument 203 may include a drill sleeve that defines a reference position from which the distance to the portion of the anatomical structure 124 is measured by the depth gauge 250, such that the first distance is greater than the second distance. Among other reasons, the cutting instrument 226 may be placed in the sleeve to protect the soft tissue surrounding the bone. During drilling, the depth gauge 250 may determine the distance from the terminal end of the drill sleeve to the first surface 123a of the first cortex 123. The distance from the terminal end of the drill sleeve to the first surface 123a of the first cortex may be greater than the distance from the cutting tip 226a to the first surface 123a of the first cortex 123. Therefore, the depth gauge 250 can measure a real-time drilling depth distance that is greater than the real-time drilling depth distance displayed by the display 212. The difference between the first distance and the second distance can be determined by calibrating the display 212 to account for the distance between the cutting tip 226a and the terminal end of the drill sleeve (which can be referred to as the offset distance) so that the display 212 provides a total drilling depth indication 264 that indicates the distance from the cutting instrument tip to the first surface 123a of the first cortex 123. In one example, the user can enter the offset distance by selecting a calibration option on the user interface 216. In another example, the depth gauge 250 can determine the offset distance during calibration mode.

[0091] The display 212 can display a depth gauge screen 1000a and an exemplary split screen 1000. In the illustrated example, when the cutting instrument tip 226a abuts the first surface 123a of the first cortex 123, the total drilling depth indication 264 indicates zero (0). Alternatively, the depth gauge can be calibrated so that when the drill sleeve abuts the first surface 123a of the first cortex 123, the total drilling depth indication 264 can indicate zero (0). The surgical instrument 203 can be configured to drill a hole in a first direction D1 from the first cortex 123 toward the second cortex 127. Thus, the total drilling depth indication 264 can indicate zero (0) prior to the drilling operation, whereby the cutting instrument tip 226a enters the anatomical structure 124 during the drilling operation. See also Figure 10B and Figure 11 , which illustrate an exemplary depth gauge screen 1000b and an exemplary split screen 1100, respectively, as the drilling operation progresses and the cutting instrument tip 226a advances through the first cortex 123, the total drilling depth indication 264 may increase to indicate the real-time distance that the cutting instrument tip 226a has traveled relative to the first surface 123a of the first cortex 123. As shown, the indication of the depth gauge image 262 is presented in millimeters, although it should be understood that the indication may be presented in any alternative units.

[0092] The depth gauge image 262 may also include a nearest cortex exit point indication 266 that indicates the distance from the cutting instrument tip 226a to the distal surface of the cortex nearest the borehole. Thus, the display 212 may be configured to indicate a third distance when the cutting instrument tip 226a exits the first cortex 123, wherein the third distance may represent the width of the first cortex 123 along the first direction D1. For example, when the cutting instrument tip 226a travels along the first direction D1 (which may be the X-ray travel 128) so as to exit the second surface 123b of the first cortex 123, the nearest cortex exit point indication 266 indicates the distance from the first surface 123a of the first cortex 123 to the second surface 123b of the first cortex 123. Thus, in one example, at the moment when the cutting instrument tip 226a passes through the second surface 123b of the first cortex 123, the nearest cortex exit point indication 266 may indicate the same value as the total borehole depth indication 264.

[0093] Continuing with the drilling operation example, when the cutting instrument tip 226a advances along the first direction D1 to exit the second surface 127b of the second cortex 127, the nearest cortex exit point indicator 266 displays the distance from the first surface 123a of the first cortex 123 to the second surface 127b of the second cortex 127. Therefore, the display 212 can be configured to display a fourth distance when the cutting instrument tip 226a exits the second cortex 127, and the fourth distance can represent the bone width along the first direction D1. The display 212 can be configured to simultaneously display the second, third, and fourth distances. Furthermore, at the moment the cutting instrument tip 226a passes through the second surface 127b of the second cortex 127, the nearest cortex exit point indicator 266 can display the same value as the total drilling depth indicator 264. The depth gauge image 262 can also include a previous cortex exit point indicator 268, which displays an indication or value associated with the previous, but not the nearest, cortex exit point. Thus, continuing with this example, when the cutting instrument tip 226a leaves the second surface 127b of the second cortex 127, the previous cortex departure point 268 displays the distance from the first surface 123a of the first cortex 123 to the second surface 123b of the first cortex 123. Thus, the value displayed in the most recent cortex departure point indication 266 is moved to the previous cortex departure point indication 268. As the cutting instrument tip 226a travels away from the second surface 127b of the second cortex 127, the total drilling depth indication 264 may increase to indicate the real-time distance that the cutting instrument tip 226a has traveled relative to the first surface 123a of the first cortex 123, as shown in FIG. Figure 10B and Figure 11 exemplified in .

[0094] Without being bound by theory, while the surgical instrument 203 is being operated under user control or autonomously, the user can view the depth gauge image 262 to better execute the drilling operation. For example, the user can view the total drill depth indication 264 while performing the drilling operation to control the surgical instrument based on the total drill depth indication 264. The surgical instrument 203 can be controlled based on the information in the depth gauge image 262 so that the cutting instrument 203 does not enter unwanted portions of the anatomical structure, such as soft tissue or distal cortex that is not fully or partially intended to be drilled. In some cases, the user can observe the depth gauge image 262, specifically the total drill depth indication 264 or the nearest cortex exit point indication 266, to match the length of the screw to the corresponding hole being drilled, rather than having to measure the hole after performing the drilling operation. In one example, the computing device 204 stores an inventory of available screws so that the screw is automatically matched to the drilled hole based on the depth of the hole in the anatomical structure 124. In one example, the user may actuate a select screw option on the user interface 216 such that a screw corresponding to one of the indications on the depth gauge image 262 , such as the nearest cortical exit point indication 266 or the total drill depth indication 262 , is selected.

[0095] Thus, in operation, the display 212 can receive and display multiple X-ray images in real time, and the display 212 can display the orientation image 129 and the depth gauge image 262, specifically the total drilling depth indication 262, as the surgical instrument 203 is being operated. Specifically, the depth gauge image 262 can indicate the distance as the cutting instrument 203 is moved. The fluoroscopic image, the orientation image, and the depth gauge image can be displayed simultaneously by the display 212. As the cutting instrument 203 moves in the drilling direction, the distance displayed by the display 212 can change so that the distance is updated in real time.

[0096] In one example, see Figure 6A , the surgical instrument 203 can be operated in a first direction D1 parallel to the direction of X-ray travel 128 to drill a hole in the first direction D1. During drilling, for example, when the orientation of the cutting instrument 226 moves away from the zero value, the movable indicator 132 can be moved away from the static region 130. The movable indicator 132 can be moved relative to the static region 130 while the orientation of the cutting instrument 226 moves relative to the zero value, so that the movable indicator 132 provides a real-time representation of the orientation of the cutting instrument 226. For example, when the proximal end 226b of the cutting instrument 226 moves in the second direction D2 relative to the cutting tip 226a of the cutting instrument 226, the movable indicator 132 can be moved in the second direction D2 (see, for example, FIG. Figure 5A ). The second direction D2 can be perpendicular to the first direction D1. Similarly, when the proximal end 226b of the cutting instrument 226 moves along the third direction D3 relative to the cutting tip 226a of the cutting instrument 226, the movable indicator 132 can move along the third direction D3 (for example, see Figure 5B ). The third direction D3 can be perpendicular to the first direction D1 and the second direction D2, respectively. Furthermore, it should be understood that when the proximal end 226b of the cutting instrument 226 moves relative to the cutting tip 226a of the cutting instrument 226 in both the second and third directions, the movable indicator 132 can move in both the second and third directions D3. Furthermore, the orientation screens 500a-c can include a digital representation 136 of the orientation of the cutting instrument 226 in the second and third directions D2 and D3.

[0097] See specifically Figure 5C , when the cutting instrument 226 is oriented according to the zero value, the movable indicator 132 can be positioned within the boundaries defined by the static region 130. Additionally, in some cases, when the cutting instrument 226 is precisely aligned with the direction of X-ray travel 128, the digital representation 136 can indicate a zero value associated with both the second direction and the third direction. Using the IM nailing example, the medical professional can maintain a constant value while drilling. Figure 5CAn orientation image 129 is shown so that a hole with the proper orientation is drilled at the target location 126 .

[0098] Although exemplary embodiments of devices for performing disclosed techniques are described herein, the basic concepts can be applied to any computing device, processor, or system capable of conveying and presenting information as described herein. The various techniques described herein can be implemented in combination with hardware or software, or in combination with both where appropriate. Therefore, the methods and devices described herein can be implemented, or some aspects or portions thereof can be in the form of program code (i.e., instructions) embodied in a tangible, non-transitory storage medium, such as a floppy disk, CD-ROM, hard drive, or any other machine-readable storage medium (computer-readable storage medium), wherein, when the program code is loaded into a machine such as a computer and executed by the machine, the machine becomes a device for performing the techniques described herein. In the case of executing program code on a programmable computer, the computing device will generally include a processor, a storage medium (including volatile and non-volatile memory and / or storage elements) readable by the processor, at least one input device, and at least one output device, such as a display. The display can be configured to display visual information. For example, the displayed visual information can include fluoroscopic data, such as an X-ray image, a fluoroscopic image, an orientation screen, or a computer-generated visual representation.

[0099] One or more programs may be implemented in component or machine language as desired. The language may be compiled or interpreted, and combined with hardware implementations.

[0100] The techniques described herein may also be practiced via communication embodied in the form of program code, which is transmitted over some transmission medium, such as by electrical wiring or cabling, by optical fiber, or by any other form of transmission. When implemented on a general-purpose processor, the program code combines with the processor to provide a unique means for invoking the functionality described herein. Additionally, any storage technology used in conjunction with the techniques described herein may always be a combination of hardware and software.

[0101] While the techniques described herein may be implemented and described in conjunction with the various embodiments of the various figures, it will be understood that other similar embodiments may be used, or that modifications or additions may be made to the embodiments without departing from the embodiments described. For example, it will be understood that the steps disclosed above can be performed in the order described above or in any other order as desired. Additionally, those skilled in the art will recognize that the techniques described in this patent application may be applied to any environment, whether wired or wireless, and to any number of such devices connected via a communications network that interact across the network. Accordingly, the techniques described herein should not be limited to any single embodiment, but should be understood in terms of breadth and scope in accordance with the appended claims.

Claims

1. A surgical instrument assembly comprising: processor; a surgical instrument configured to operate on a bone including an intramedullary canal; a display coupled to the processor and attached to the surgical instrument, the display configured to display X-ray data of the bone, the X-ray data generated by an imaging device; as well as a memory in communication with the processor, the memory having instructions stored therein that, when executed by the processor, cause the processor to 1) determine an axis of the bone, and 2) determine, based on the axis, a representation of a trajectory defining an entry point into the bone, wherein the display is further configured to superimpose the representation of the trajectory on the X-ray data of the bone so as to display the representation of the trajectory, wherein The surgical instrument is configured to drill a hole in the bone; and The representation of the trajectory also defines a line along which the hole can be drilled to meet the intramedullary canal.

2. The surgical instrument assembly of claim 1, wherein the display is further configured to superimpose the axis on the X-ray data of the bone so as to display the axis of the bone.

3. The surgical instrument assembly of claim 1 , the memory further having stored therein a predetermined trajectory specific to the intramedullary nailing procedure for the bone, and further instructions that, when executed by the processor, cause the processor to also determine the representation of the trajectory of the entry point based on the predetermined trajectory.

4. The surgical instrument assembly of claim 3, wherein the predetermined trajectory is specific to a particular implant.

5. The surgical instrument assembly of claim 1 , the memory having further instructions stored therein that, when executed by the processor, cause the processor to identify a boundary of the bone, Wherein the display is further configured to superimpose the boundary on the X-ray data of the bone so as to display the boundary of the bone.

6. The surgical instrument assembly of claim 5 , the memory having additional instructions stored therein that, when executed by the processor, cause the processor to determine the axis of the bone based on the boundary of the bone such that if the boundary of the bone changes, the axis of the bone changes.

7. The surgical instrument assembly of claim 1 , the memory having further instructions stored therein that, when executed by the processor, cause the processor to adjust the representation of the trajectory so as to define a new representation of a new trajectory, Wherein the display is further configured to superimpose the new representation of the new trajectory on the X-ray data of the bone so as to display the new representation of the new trajectory.

8. The surgical instrument assembly of claim 7 , wherein the display defines a user interface configured to display options for a user of the surgical instrument assembly, and wherein the memory has additional instructions stored therein that, when executed by the processor, cause the processor to adjust the representation of the trajectory in response to the user actuating at least one of the options of the user interface.

9. The surgical instrument assembly of claim 1 , wherein the representation of the trajectory is a first representation of the trajectory from a first perspective, the memory having further instructions stored therein that, when executed by the processor, cause the processor to: A second representation of the trajectory defining the entry point into the bone is determined, the second representation being from a second perspective.

10. The surgical instrument assembly of claim 9, wherein the first viewing angle is substantially perpendicular to the second viewing angle.

11. The surgical instrument assembly of claim 9, wherein the surgical instrument comprises a cutting instrument having a cutting tip configured to remove anatomical material from the entry point of the bone, and the display is further configured to display a position of the cutting tip relative to the entry point of the bone.

12. The surgical instrument assembly of claim 11, wherein the display is further configured to provide a visual indication of alignment of the cutting instrument relative to the first representation of the trajectory and the second representation of the trajectory.

13. A medical imaging method comprising the following steps: receiving, via a wireless communication channel, a first X-ray image of a bone including an intramedullary canal, the first X-ray image being generated by a medical imaging device; displaying the first X-ray image via a display attached to a surgical instrument having a cutting instrument; determining an axis of the bone; determining a first representation of a trajectory defining an entry point into the bone based on the axis; as well as displaying the first representation of the trajectory on the first X-ray image of the bone; in The surgical instrument is configured to drill a hole in the bone; and The first representation of the trajectory also defines a line along which the hole can be drilled to meet the intramedullary canal.

14. The method according to claim 13, further comprising: receiving a second X-ray image of the bone via the wireless communication channel, the second X-ray image generated by the medical imaging device to provide a viewing angle of the bone that is substantially perpendicular to a viewing angle provided by the first X-ray image; displaying the second X-ray image of the bone on the display; determining a second representation of the trajectory defining the entry point in the bone; as well as The second representation of the trajectory is displayed on the second X-ray image of the bone by the display.

15. The method according to claim 14, further comprising: A position of the cutting instrument relative to the first representation of the trajectory and the second representation of the trajectory is displayed.

Images