Triangulation of items in a patient's body

Abstract

A surgical positioning system includes a transmitter fixed to a medical implant, at least three microphones, at least one processor, and a memory. The transmitter has a speaker and a power source. The memory stores instructions for execution by the processor that, when executed, cause the processor to receive information about detected sound from each of the at least three microphones and to calculate a location of the implant based on location information corresponding to each of the at least three microphones and the received information.

Description

TECHNICAL FIELD

[0001] The present technology relates generally to surgical procedures, and more particularly to object localization and tracking during surgical procedures. BACKGROUND

[0002] X-ray imaging is used to determine the location of objects within a patient and thus not optically visible, including both anatomical features of the patient (e.g., bones or features thereof) and medical devices (e.g., implants, tools). If a reference marker is affixed to an object and extends outside the body to be visible to a navigation camera, a navigation system can be used to determine the location of such objects. SUMMARY

[0003] Aspects of the present disclosure include:

[0004] A surgical localization system comprising: a transmitter affixed to a medical implant; at least three microphones; at least one processor; and a memory. The transmitter comprises a loudspeaker and a power source. The memory stores instructions for execution by the processor that, when executed, cause the processor to: receive information about a detected sound from each of the at least three microphones; and calculate a location of the implant based on location information corresponding to each of the at least three microphones and the received information.

[0005] Any of the aspects herein, wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: receive a model of a portion of a patient anatomy; and calculate a predicted speed of sound through at least one segment of the portion of the patient anatomy based on the model.

[0006] Any of the aspects herein, wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to update the predicted speed of sound based on calibration data corresponding to a calibration sound generated by the transmitter and detected by each of the at least three microphones.

[0007] Any of the aspects herein, wherein the calculating the location of the implant is further based on the updated predicted speed of sound.

[0008] Any of the aspects herein, wherein each of the at least three microphones is mounted in a fixed position relative to any other of the at least three microphones.

[0009] Any of the aspects herein, wherein the detected sound has a frequency less than 20 kHz.

[0010] Any of the aspects herein, wherein the detected sound has a frequency less than 20 Hz.

[0011] Any of the aspects herein, wherein at least one microphone of the at least three microphones is mounted to a movable arm, and the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: receive arm position data corresponding to a position of the movable arm; and calculate a position of each microphone of the at least three microphones based at least in part on the arm position data.

[0012] Any of the aspects herein, wherein the position information for each microphone of the at least three microphones includes data regarding a position of each microphone of the at least three microphones relative to other microphones of the at least three microphones, and the calculated transmitter position is related to the position of the at least three microphones.

[0013] Any of the aspects herein, wherein the position information for each microphone of the at least three microphones is related to a common coordinate system.

[0014] Any of the aspects herein, wherein the transmitter comprises a plurality of speakers each configured to emit sound at a different frequency than other speakers of the plurality of speakers, the received information includes information regarding detected sound generated by each speaker of the plurality of speakers individually, and the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to determine an orientation of the implant based at least in part on the received information.

[0015] A method of locating an object during a surgical procedure, the method comprising: receiving a model of a portion of a patient anatomy; receiving a surgical plan comprising information regarding a planned position of an implant within the portion of the patient anatomy; calculating a predicted speed of sound along at least one path extending at least partially through the portion of the patient anatomy based on the planned position of the implant and the model; receiving detection information from at least three microphones regarding detected sound generated by a speaker fixed to the implant; and determining a position of the implant based on the predicted speed of sound and the detection information.

[0016] Any of the aspects herein, wherein the detection information includes first detection information regarding a first detected sound generated by the speaker at a first time, and further comprising: receiving, from the at least three microphones, second detection information regarding a second detected sound generated by the speaker at a second time after the first time; and determining the movement of the implant based on the first detection information and the second detection information.

[0017] Any of the aspects herein, wherein the detection information corresponds to detected sounds generated by a plurality of speakers affixed to the implant, and further comprising: determining an orientation of the implant based on the predicted speed of sound and the detection information.

[0018] Any of the aspects herein, wherein each of the detected sounds has a unique frequency relative to any other of the detected sounds.

[0019] Any of the aspects herein, wherein the determination is further based on location information corresponding to a location of each of the at least three microphones.

[0020] Any of the aspects herein, wherein the detection information includes first detection information regarding a first detected sound generated by the speaker at a first time, the method further comprising: receiving, from the at least three microphones, second detection information regarding a second detected sound generated by a second speaker affixed to an anatomical element of the patient; and determining a location of the implant relative to the anatomical element based on the first detection information and the second detection information.

[0021] A surgical triangulation system, comprising: a plurality of microphones configured to be mounted at fixed locations around an operating room; a transmitter configured to be affixed to an internal anatomical feature of a patient or implant; at least one processor; and a memory. The transmitter includes a speaker and a power source. The memory stores instructions for execution by the at least one processor that, when executed, cause the at least one processor to: receive a surgical plan including information regarding a portion of the patient anatomy; receive, from the plurality of microphones, sound information regarding sounds detected by the plurality of microphones and generated by the speaker; and calculate a location of the transmitter based on the surgical plan, the sound information, and information regarding the fixed locations of the plurality of microphones.

[0022] Any of the aspects herein, wherein the transmitter is biocompatible.

[0023] Any of the aspects herein, wherein the emitter comprises a second speaker, and the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: receive, from the plurality of microphones, second sound information regarding a second sound detected by the plurality of microphones and generated by the second speaker; and calculate an orientation of the emitter based on the surgical plan, the second sound information, and the information regarding the fixed positions of the plurality of microphones.

[0024] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the technologies described in this disclosure will be apparent from the description and drawings, and from the claims.

[0025] The phrases “at least one”, “one or more”, and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, a phrase such as “at least one of A, B, and C” or “one or more of A, B, and C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together. When each of A, B, and C in the above phrases refers to an element, such as X, Y, and Z, the phrase is intended to cover a single element selected from X, Y, and Z, a combination of elements selected from X, Y, and Z (e.g., X and Y or X and Z), and a combination of elements selected from two or more classes of elements (e.g., Y and Z, where Y is the first class and Z is the second class). n m o o

[0026] The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.

[0027] The foregoing is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. The summary is neither an extensive overview of the disclosure nor an enumeration of its various aspects, embodiments, and configurations. It is neither intended to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure, but to present selected concepts of the disclosure in a simplified form as a prelude to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure can utilize one or more of the features set forth above or described below in conjunction with the aspects and configurations set forth herein. ​​​​

[0028] Many additional features and advantages of the present application will become apparent to those of ordinary skill in the art upon consideration of the ensuing description of the embodiments. BRIEF DESCRIPTION OF DRAWINGS

[0029] The accompanying drawings, which are incorporated in and form a part of the specification, illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings merely illustrate preferred and alternative examples of how the present disclosure can be made and used and should not be

[0030] Figure 1A is a block diagram of a system in accordance with at least one embodiment of the present disclosure;

[0031] Figure 1B is a block diagram of a transmitter in accordance with at least one embodiment of the present disclosure;

[0032] Figure 2 is an illustration of an operating room;

[0033] Figure 3 is a flow diagram of a method in accordance with at least one embodiment of the present disclosure; and

[0034] Figure 4 is another flow diagram of a method in accordance with at least one embodiment of the present disclosure. DETAILED DESCRIPTION

[0035] It should be understood that various aspects disclosed herein can be combined in different combinations than the combinations specifically recited in the description and accompanying drawings. It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes described herein can be performed in a different sequence, and / or certain acts or events can be omitted, combined, and / or added (e.g., additional acts or events can be performed as part of the disclosed technology). In addition, the description of several examples of the disclosure has been presented for purposes of clarity, and it is not necessary to describe all features of the disclosure in every example. Further, the described aspects and embodiments have been presented for purposes of example, and other examples and embodiments can be employed as structural changes or equivalent.

[0036] In one or more examples, the described methods, processes, and techniques can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions can be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media can include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0037] Instructions can be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple A11, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term "processor" as used herein can refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the

[0038] Before any embodiments of the present disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The present disclosure is capable of other embodiments and of being practiced or being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure can use examples to show one or more aspects thereof. Unless otherwise stated, the use of one or more examples (which can be indicated by "for example," "by way of example," "e.g.," "such as," or similar language) is not intended to limit the scope of the present disclosure.

[0039] Existing methods of locating an object in a patient's body, whether that object is a foreign object such as a medical device or tool (including, for example, a medical implant), or a native object such as a patient's anatomical feature (including, for example, a bone or organ in the patient's body), include x-ray imaging, which exposes the patient and operating room staff to harmful radiation, and ultrasound imaging, which requires positioning an ultrasound probe near the patient's skin and aiming at the object in question. There remains, for example, a need to locate an object in a patient's body without using a system or device that emits harmful radiation, and more conveniently than is possible using ultrasound waves.

[0040] According to some embodiments of the present disclosure, a small chip or resonant article, which can be, for example, a loudspeaker, can be attached, affixed, or otherwise secured to an object to be tracked or followed, such as a medical implant, a medical tool, a bone, or any other object in or to be placed in a patient's body. In some embodiments, the small chip can be removably secured to the object, while in other embodiments, the small chip can be permanently secured to the object, contained within the object, or otherwise configured to remain on or within the object. Also according to some embodiments of the present disclosure, a plurality of devices can be positioned outside the patient and configured to send and / or receive one or more signals from the small chip or resonant article. For example, in embodiments in which the small chip or resonant article is or includes a loudspeaker, each device of the plurality of devices can be a microphone. The plurality of devices can be positioned at known locations relative to each other, and / or at known locations within a common coordinate system. Each device of the plurality of devices can include one or more sensors for accurately measuring a distance to any other device of the plurality of devices or for determining its location within the coordinate system. Each device of the plurality of devices can be fixed in position, or one or more devices of the plurality of devices can be movable. In the latter case, the location of each device of the plurality of devices (or at least any movable devices) can be determined after the device moves, whether using one or more sensors on the device itself, using one or more sensors on an arm or other object holding the device, or using other means.

[0041] The plurality of devices can transmit a signal to the small chip or resonant article, which can return the signal (or transmit another signal in response to the first signal). Upon receipt of the returned signal or other signal from the small chip or resonant article by the plurality of devices, the location of the small chip or resonant article can be triangulated using a processor (e.g., based on the time of flight of the signal or otherwise). Errors in the system can be reduced by increasing the number of the plurality of devices, and / or by adding more small chips or resonant items to the object.

[0042] According to at least one embodiment of the present disclosure, ultrasound waves can be used for triangulation. Ultrasound waves have good angular accuracy. In embodiments using ultrasound waves, accuracy can be achieved using a truss with flexible joints and one or more encoders.

[0043] According to at least another embodiment of the present disclosure, wireless signals can be used for triangulation, including radio frequency signals, WiFi signals, ZigBee signals, Bluetooth signals, Bluetooth Low Energy signals, Bluetooth beacon signals, GSM signals, LTE signals, and signals using any other wireless communication protocol. In some embodiments, no wireless communication protocol is needed. Multiple transceivers can be located outside the patient’s body and configured to interrogate a small chip or resonant item inside the patient’s body and then receive a return signal from the small chip or resonant item. Errors can be reduced by changing which of the multiple transceivers transmits the signal and by using all of the transceivers in the array to receive the return signal. High speed processing can be utilized to facilitate triangulation using wireless signals (or any other triangulation method described herein).

[0044] According to at least another embodiment of the present disclosure, sound can be used to achieve triangulation. For example, a small ceramic “loudspeaker” can be placed on an implant or medical tool or other element to be tracked. An array of microphones can be located outside the patient’s body, each microphone configured to detect sound waves at one or more frequencies at which the loudspeaker is configured to generate such sound waves. For example, the one or more frequencies can be selected based on which frequencies best move through anatomical tissue. Multiple frequencies can be used to achieve better accuracy.

[0045] According to yet other embodiments of the present disclosure, multiple triangulation methods can be used simultaneously or together to improve accuracy. Additionally, in some embodiments, the small chip or resonant item can be passive (e.g., configured to only reflect a signal generated outside the patient’s body) or active (e.g., configured to generate a signal that can be detected outside the patient’s body). Accuracy can be improved by increasing the number of devices positioned outside the patient’s body, and / or by utilizing multiple small chips or resonant items on an implant, tool, or other item inside the patient’s body.

[0046] Embodiments of the present disclosure advantageously achieve more accurate placement of implants and tools inside a patient’s body. Embodiments of the present disclosure also advantageously achieve position determination and tracking without exposing the patient or any attending physicians or other operating room staff to harmful radiation. Embodiments of the present disclosure further advantageously achieve position determination and tracking without the need for a fiducial line to the tracked object or to a reference marker attached to the tracked object.

[0047] Turning first to Figure 1AA block diagram of a system 100 according to at least one embodiment of the present disclosure is shown. System 100 can be used for, for example: locating an object within a patient, whether the object is a foreign object (e.g., a medical instrument, implant, or other device) or a patient's anatomical feature (e.g., bone or organ); determining the orientation of an object within a patient; detecting movement or relative movement of an object within a patient; for autonomous surgery; for robot-assisted surgery; calibrating a triangulation system; verifying the operational integrity of a navigation system using an independent triangulation system and / or vice versa; performing one or more aspects of one or more of the methods disclosed herein; or for any other useful purpose. System 100 includes a computing device 102, a plurality of sensors 132, a robot 136, a transmitter 156, a navigation system 160, a database 164, and a cloud 168. Despite the foregoing description, systems according to other embodiments of the present disclosure may omit any or more of the computing device 102, the plurality of sensors 132, the robot 136, the transmitter 156, the navigation system 160, the database 164, and / or the cloud 168. Additionally, according to other embodiments of this disclosure, one or more components of system 100 may be arranged differently (e.g., one or more of the plurality of sensors 132, robot 136, and navigation system 160 may be included). Figure 1A The component shown is part of the computing device 102.

[0048] The computing device 102 includes at least one processor 104, at least one communication interface 108, at least one user interface 112, and at least one memory 116. In other embodiments of this disclosure, the computing device may omit one or both of the communication interface 108 and the user interface 112.

[0049] At least one processor 104 of computing device 102 may be any processor identified or described herein or any similar processor. At least one processor 104 may be configured to execute instructions stored in at least one memory 116, which may enable at least one processor 104 to perform one or more computational steps using or based on data received, for example, from multiple sensors 132, robot 136, transmitter 156, navigation system 160, database 164 and / or cloud 168.

[0050] The computing device 102 can also include at least one communication interface 108. The at least one communication interface 108 can be used to receive image data or other information from an external source, such as the plurality of sensors 132, the robot 136, the navigation system 160, the database 164, the cloud 168, and / or a portable storage medium (e.g., a USB drive, a DVD, a CD), and / or to transmit instructions, images, or other information from the at least one processor 104 and / or the computing device 102 more generally to an external system or device (e.g., another computing device 102, the robot 136, the navigation system 160, the database 164, the cloud 168, and / or a portable storage medium (e.g., a USB drive, a DVD, a CD)). The at least one communication interface 108 can include one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and / or one or more wireless interfaces (e.g., configured to transmit information via one or more wireless communication protocols, such as 802.11a / b / g / n, Bluetooth, Bluetooth Low Energy, NFC, ZigBee, etc.). In some embodiments, the at least one communication interface 108 can be used to enable the device 102 to communicate with one or more other processors 104 or computing devices 102, whether to reduce the time needed to complete a computationally intensive task or for any other reason.

[0051] The at least one user interface 112 can be or include a keyboard, a mouse, a trackball, a monitor, a television, a touchscreen, a button, a joystick, a switch, a lever, and / or any other device for receiving information from a user and / or for providing information to a user of the computing device 102. The at least one user interface 112 can be used, for example, to receive a user selection or other user input in connection with any step of any method described herein; to receive a user selection or other user input regarding one or more configurable settings of the computing device 102 and / or another component of the system 100; to receive a user selection or other user input regarding how data received, modified, and / or generated by the computing device 102 is to be stored and / or communicated and / or to where the data is to be stored and / or communicated; and / or to display information (e.g., text, images) and / or play sounds to a user based on data received, modified, and / or generated by the computing device 102. Although the at least one user interface 112 is included in the system 100, the system 100 can automatically (e.g., without any input via the at least one user interface 112 or otherwise) perform one or more or all of the steps of any method described herein.

[0052] While the at least one user interface 112 is shown as part of the computing device 102, in some embodiments, the computing device 102 can utilize a user interface 112 housed separately from one or more remaining components of the computing device 102. In some embodiments, the user interface 112 can be positioned proximate to one or more other components of the computing device 102, while in other embodiments, the user interface 112 can be positioned remotely from one or more other components of the computing device 102.

[0053] The at least one memory 116 can be or include RAM, DRAM, SDRAM, other solid state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer-readable data and / or instructions. The at least one memory 116 can store information or data suitable for completing any steps of, for example, the method 300 and / or the method 400 described herein. The at least one memory 116 can store, for example, information about one or more predetermined coordinate systems 120 (e.g., information about a robot coordinate system or space, information about a navigation coordinate system or space, information about a patient coordinate system or space); instructions 124 for execution by the at least one processor 104, for example, to cause the at least one processor 104 to perform one or more of the steps of the method 300 and / or the method 400; and / or one or more algorithms 128 for use by the processor to perform any calculations needed to complete one or more of the steps of the method 300 and / or the method 400 or for any other calculations. In some embodiments, such predetermined coordinate systems 120, instructions 124, and / or algorithms 128 can be organized into one or more applications, modules, packages, layers, or engines, and can cause the at least one processor 104 to manipulate data stored in the at least one memory 116 and / or received from or through another component of the system 100.

[0054] The plurality of sensors 132 are configured to detect one or more signals generated by or reflected by the emitter 156. The plurality of sensors can be positioned at fixed and known locations on or around an operating table, within an operating room, on one or more stands or other objects within an operating room, and / or at any other location suitable for receiving and / or detecting one or more signals generated by or reflected by the emitter 156. In some embodiments, the plurality of sensors 132 includes at least one sensor 132 configured to generate a signal that can then be reflected by the emitter 156 and detected or otherwise received by the plurality of sensors 132. In some embodiments, the plurality of sensors can include three sensors. In other embodiments, the plurality of sensors can include more than three sensors. The sensors can be interspersed around an operating room or other surgical environment to increase the likelihood that at least three of the plurality of sensors 132 will detect or receive a signal from the emitter 156. In some embodiments, one or more of the plurality of sensors 132 can be positioned on or proximate to a patient's skin, while in other embodiments none of the plurality of sensors 132 can be positioned on or proximate to a patient's skin. The plurality of sensors 132 can be or can include microphones, wireless receivers or transceivers (e.g., configured to receive radio frequency signals generated by any sort or using any protocol or no protocol), ultrasound probes, radar probes, sonar probes, any other device capable of receiving a signal, and / or any combination of two or more of the foregoing.

[0055] The plurality of sensors 132 can be or can include directional sensors configured to determine a direction from which a signal was detected.

[0056] Although not shown in the figures, in some embodiments, the system 100 can include a plurality of emitters 156 and a single sensor 132, and the single sensor 132 can be configured to be placed within a patient's body to detect signals generated by or reflected by the plurality of emitters 156 and to be in communication with the computing device 102 (whether via the sensor 132, the communication interface 108, or otherwise).

[0057] In embodiments in which the plurality of sensors 132 are located at fixed locations (e.g., mounted to a wall, ceiling, and / or floor of an operating room, and / or mounted to a fixed operating table, or mounted to one or more immovable stands or structures), information about the fixed locations at which the plurality of sensors 132 are located can be stored, for example, in the memory 116. Such information can be related to one or more predetermined coordinate systems 120 stored in the memory 116.

[0058] In some embodiments, one or more of the plurality of sensors 132 may be movable, whether by means of being fixed to or held by a movable support, fixed to or held by a robot arm or articulated arm, or otherwise. In embodiments where one or more of the plurality of sensors 132 are fixed to or held by a robot arm, the robot arm may be precisely movable (e.g., such that the precise position of a given point on the robot arm is known at any given time during its operation), such that the position of one or more sensors 132 is known regardless of the pose of the robot arm. In embodiments of this disclosure that include one or more movable sensors 132, once the sensor 132 is positioned (and subsequently, at any time the movable sensor 132 is repositioned), the position of any such movable sensor 132 can be determined, whether using one or more sensors on a movable support, robot arm, or articulated arm, or otherwise; using manual measurement techniques; using a calibration process (which may or may not utilize triangulation methods); or otherwise.

[0059] The more sensors included in the multiple sensors 132, the higher the accuracy of any triangulation calculation. Furthermore, the wider the distribution of the sensors included in the multiple sensors 132, the higher the accuracy of any triangulation calculation. The multiple sensors 132 may include at least three sensors, at least four sensors, at least five sensors, or at least ten sensors.

[0060] Despite Figure 1A The diagram shows communication only with computing device 102, but in some embodiments, multiple sensors 132 may communicate with any or more of computing device 102, robot 136, navigation system 160, database 164 and / or cloud 168.

[0061] Multiple sensors 132 can be configured to receive and / or detect only signals generated or reflected by transmitter 156. For example, in the case where multiple sensors 132 include one or more microphones and transmitter 156 includes one or more speakers, the one or more microphones can be configured to receive or detect only sounds at one or more specific frequencies. This configuration of multiple sensors 132 can advantageously reduce the amount of noise detected by multiple sensors 132, reduce the amount of processing power required to interpret any received or detected signals, and / or improve the accuracy of the results of any triangulation process. Multiple sensors 132 can be configured to continuously receive and / or detect signals from transmitter 156, or can be configured to receive and / or detect such signals only when activated (whether manually or autonomously, or according to a predetermined schedule), or otherwise.

[0062] The robot 136 can be any surgical robot or surgical robotic system. The robot 136 can be or can include, for example, a Mazor X TM Robotic Stealth Edition. The robot 136 can include a base 140 that supports a single robotic arm 144. The robot 136 can include one or more robotic arms 144. In some embodiments, the robotic arm 144 can include a first robotic arm and a second robotic arm. In other embodiments, the robot 136 can include more than two robotic arms 144. In some embodiments, the robotic arm 144 can assist in a surgical procedure (e.g., by holding a tool in a desired trajectory or pose and / or supporting the weight of the tool as a surgeon or other user operates the tool, or otherwise) and / or perform a surgical procedure automatically.

[0063] The robotic arm 144 can have three, four, five, six, seven, or more degrees of freedom. The robotic arm 144 can include one or more segments 152. Each segment 152 can be secured to at least one adjacent member by a joint such that the robotic arm articulates. The joint can be any type of joint that enables selective movement of a member relative to the structure to which the joint is attached (e.g., another segment of the robotic arm, or the base 140). For example, the joint can be a pivot joint, a hinged joint, a saddle joint, or a ball-and-socket joint. The joint can allow movement of the member in one or more dimensions and / or along one axis or along multiple axes.

[0064] While the proximal end of the robotic arm 144 can be secured to the base 140 (whether via a joint or otherwise), the distal end of the robotic arm 144 can support an end effector. The end effector can be, for example, a tool (e.g., a drill, a saw, an imaging device) or a tool guide (e.g., for guiding a biopsy needle, an ablation probe, or other tool along a desired trajectory).

[0065] The robotic arm 144 can include one or more pose sensors 148. The pose sensors 148 can be configured to detect the pose of the robotic arm and can be or can include one or more rotary encoders, linear encoders, incremental encoders, or other sensors. Data from the pose sensors 148 can be provided to a processor of the robot 136, the processor 104 of the computing device 102, and / or the navigation system 160. This data can be used to calculate the spatial position of the robotic arm 144 relative to a predetermined coordinate system. Such calculated positions can be used, for example, to determine the spatial position of one or more of the plurality of sensors 132 attached to the robotic arm 144.

[0066] Still referring to Figure 1A Also referring to Figure 1Btransmitter 156 can be passive and / or unpowered, and can be made of a material that will enhance its reflectivity and / or shaped into a shape that will enhance its reflectivity. For example, the transmitter 156 can be configured to reflect ultrasound waves, or to reflect radio frequency waves, or to be a radar target or a sonar target. In such embodiments, the transmitter 156 can be unpowered.

[0067] In embodiments in which the transmitter 156 is configured to generate one or more waves or other signals, the transmitter 156 can be powered. In such embodiments, the transmitter 156 can include a power source 172. The power source 172 can be, for example, a lithium iodide battery or any other battery or fuel cell suitable for use and / or implantation in a patient (whether within a protective housing or otherwise).

[0068] The transmitter 156 can also include a signal or wave generator 176, which can be a speaker (where sound waves will be used for triangulation), a radio emitter (where RF signals will be used for triangulation), or any other emitter or generator. In cases where the signal generator 176 is a speaker, the speaker can be configured to generate sound waves at a single frequency, or selectively at one of a plurality of predetermined frequencies. The speaker can be configured to generate sound waves at any frequency within the sound spectrum. In some embodiments, the speaker can be configured to generate sound waves only at or below the sound spectrum (e.g., at frequencies less than 20 kHz). In other embodiments, the speaker can be configured to generate sound waves only within the infrasound spectrum (e.g., below 20 Hz). In other embodiments, the speaker can be configured to generate sound waves within the ultrasonic spectrum (e.g., above 20 kHz). In other embodiments, the speaker can be configured to generate sound waves only outside of the sound spectrum (e.g., both below and above 20 kHz). The use of sound waves outside of the sound spectrum can advantageously enable the system 100 to avoid generating sounds that are audible to operating room staff and / or to avoid sounds generated by the operating room staff being picked up by the plurality of sensors 132 and confusing (e.g., by the processor 102) the sounds generated by the transmitter 156.

[0069] In cases where the signal generator 176 is a speaker, the speaker can be a ceramic speaker. The speaker can be a piezoelectric speaker. The maximum dimension (e.g., length or width or height) of the speaker can be less than one-quarter of an inch, or less than one-half of an inch, or less than one inch, or less than one and one-half inches.

[0070] The signal generator 176 can be configured to generate the signal at periodic intervals (e.g., every second, every five seconds, every ten seconds, every twenty seconds, every thirty seconds, every minute, every five minutes, every thirty minutes, or any other interval). The signal generator 176 can also be configured to generate the signal only in response to an external stimulus (which can be, for example, a signal received by the emitter 156 from an external source). In such embodiments, the emitter 156 can include a receiver configured to receive and / or detect such a signal, and / or a processor or other logic (implemented in software and / or hardware) configured to cause the signal generator 176 to generate the signal in response to receipt of the signal. The emitter 156 can also include one or more sensors (e.g., an accelerometer or other sensor) configured to detect movement of the emitter 156 and / or any other environmental characteristic related to the emitter 156, and can include a processor or other logic (implemented in software and / or hardware) configured to cause the signal generator to generate the signal in response to one or more predetermined environmental conditions.

[0071] In some embodiments, the emitter 156 can include multiple signal generators 176. In such embodiments, the signal generators 176 can be positioned as far apart from each other as possible on or within the emitter 156, and can be configured to generate signals having slightly different characteristics. For example, in cases where the signal generator 176 is a speaker, each speaker can be configured to generate a sound wave having a slightly different frequency (e.g., one speaker can be configured to generate a 100 Hz sound wave, and another speaker can be configured to generate a 102 Hz sound wave). Of course, greater variations are also possible; one speaker can be configured to generate a 20 Hz sound wave, and another speaker can be configured to generate a 20 kHz sound wave. In such embodiments, triangulation can be used to calculate the position of each of the multiple signal generators 176, and then the calculated positions can be used to determine the orientation of the emitter 156. As can be appreciated, the orientation of the emitter 156 determined based on the calculated positions of two separate signal generators 176 will not be as accurate as the orientation of the emitter 156 determined based on the calculated positions of three or more separate signal generators 176.

[0072] The transmitter 156 can include a housing in which the power source 172 and the signal generator 176 are stored. The housing can protect the power source 172 and the signal generator 176 from bodily fluids and other environmental conditions within the patient’s body in which the transmitter 156 is placed, whether temporarily or permanently. The housing can also protect the patient from the power source 172 and / or the signal generator 176. In some embodiments, the transmitter 156 can be biocompatible by virtue of such a housing, while in other embodiments, the components of the transmitter 156 themselves can be biocompatible and can not require a housing.

[0073] The transmitter 156 can be or can include a device or mechanism for securing the transmitter 156 to a medical implant, a surgical tool, an anatomical feature, or other object within or to be inserted into the patient’s body. The transmitter 156 can be configured to attach to such an object using one or more screws or other mechanical fasteners, or using an adhesive, or using sutures, or using staples, or using any other fastening or securing mechanism. In some embodiments, an implant or surgical tool can be manufactured with the transmitter 156 (or one or more components of the transmitter 156) contained within the implant, such that the implant serves as a housing for the transmitter 156 or one or more components thereof. In some embodiments, the transmitter 156 can be configured to be secured within a hole drilled or otherwise shaped in the implant, tool, anatomical feature, or other object, whether by friction fit or otherwise. The transmitter 156 is configured to be securely fixed to the object such that determination of the position of the transmitter enables determination of the position of the object. The transmitter 156 can be permanently fixed to the object, or can be removably fixed to the object. In some embodiments, the transmitter 156 can be left safely within the patient’s body.

[0074] Some embodiments of the system 100 can include more than one transmitter 156. In such embodiments, multiple transmitters 156 can be fixed to a single object (e.g., to better determine the orientation of the object), and / or one or more transmitters 156 can be fixed to more than one object (e.g., in order to determine the positions of more than one object within the patient’s body, and / or to determine relative movement between more than one object).

[0075] Referring again to Figure 1A , the navigation system 160 can provide navigation for the surgeon and / or the robot 136 during a surgical or surgical procedure. The navigation system 160 can be any now known or hereafter developed navigation system, including, for example, the Medtronic StealthStation®. The navigation system 160 can be configured to determine the position of the transmitter 156 within the patient’s body, and to determine the position of the transmitter 156 relative to the patient’s body. The navigation system 160 can be configured to determine the position of the transmitter 156 within the patient’s body based on the signals received from the transmitter 156, and to determine the position of the transmitter 156 relative to the patient’s body based on the signals received from the transmitter 156 and the position of the transmitter 156 within the patient’s body. TMS8 Surgical Navigation System. The navigation system 160 can include a camera or other sensor for detecting and / or tracking one or more reference markers, navigation trackers, or other objects within the operating room or other room in which a surgical procedure is being performed. In some embodiments, the navigation system 160 can include a plurality of sensors 132. In various embodiments, the navigation system 160 can be used to track the position of the robotic arm 144 and / or one or more other objects for which the navigation system 160 has line of sight (where the navigation system is an optical system) or which the navigation system 160 can otherwise detect. The navigation system 160 can be used to track the position of one or more reference markers or arrays or other structures that can be used for detection by the camera or other sensor of the navigation system 160. The navigation system 160 can include a display for displaying one or more images from an external source (e.g., the computing device 102, the plurality of sensors 132, or other source), or a video stream from the camera or other sensor of the navigation system 160. In some embodiments, the system 100 can operate without use of the navigation system 160.

[0076] The database 164 can store information about a given surgery or surgical procedure, such as one or more surgical plans, one or more digital models of a portion of a patient anatomy, one or more digital models of implants, tools, or other objects (anatomic features or foreign objects) that can be located or positioned within a patient, one or more images of a patient anatomy, and / or any other useful information. Any data described above as being stored within the memory 116 can also or alternatively be stored within the database 164, and vice versa. The database 164 can be configured to provide any information stored therein to the computing device 102 or any other device of the system 100 or any other device external to the system 100, whether directly or via the cloud 168. In some embodiments, the database 164 can be or can include part of a hospital image storage system and / or an electronic health record system, such as a picture archiving and communication system (PACS), a health information system (HIS), and / or another system for collecting, storing, managing, and / or transmitting electronic medical records including image data.

[0077] The cloud 168 can be or can represent the Internet or any other wide area network. The computing device 102 can connect to the cloud 168 via the communication interface 108 using a wired connection, a wireless connection, or both. In some embodiments, the computing device 102 can communicate with the database 164 and / or external devices (e.g., computing devices) via the cloud 168.

[0078] Turning now to Figure 2A plurality of sensors 212, which can be the same as or similar to the plurality of sensors 132, can be installed in any number of fixed locations around the operating room 200, including, for example, the surgical table 202 (on which a patient can lie during a surgical procedure), one or more legs 204 of the surgical table 202, a wall 206 or 208 of the operating room, the floor 210 of the operating room, and / or the ceiling (not shown) of the operating room. The plurality of sensors 212 can be spread around the operating room to improve the accuracy of any triangulation calculations. The plurality of sensors 212 can be positioned to increase the likelihood that at least a minimum number of sensors 212 (e.g., three sensors 212) will receive and / or detect signals generated or reflected by the emitter 156.

[0079] In some embodiments, an array of sensors 212 can be installed to a fixed frame that is configured to be mounted to a wall 206 or 208, mounted to or suspended from the ceiling of the operating room, or otherwise positioned within the operating room. The array of sensors 212 can advantageously include at least three sensors having known positions relative to one another, and thus can facilitate use of the systems and methods described herein in situations where the plurality of sensors have not yet been installed in the operating room or are not permanently installed in the operating room.

[0080] Turning now to Figure 3 A method 300 for navigating with a robotic reference frame, for example, can be performed by at least one processor. The at least one processor can be the same as or similar to the processor 104 of the computing device 102 described above. The at least one processor can be part of a robot, such as the robot 136, or part of a navigation system, such as the navigation system 160. Processors other than any processors described herein can also be used to perform the method 300. The at least one processor can perform the method 300 by executing instructions stored in a memory, such as the instructions 124 of the memory 116. The instructions can correspond to one or more steps of the method 300 described below. The instructions can cause the processor to perform one or more algorithms, such as the algorithm 128.

[0081] The method 300 includes receiving a model of a portion of a patient's anatomy (step 304). The model can be a digital 3D model of the portion of the patient's anatomy that is relevant to the planned surgical procedure. For example, if a surgical procedure is planned for a portion of a patient's spine, the model can be a digital 3D model of the patient's spine or a portion thereof, and can include details about anatomical features surrounding the patient's spine. As another example, if a surgical procedure is planned for a patient's abdomen, the model can be a digital 3D model of the patient's abdomen, including patient organs located in the abdomen. The model can be generated based on one or more pre-operative images, which can be, for example, CT scans, MRI images, X-ray images, or other images. The model can have been generated from multiple two-dimensional images. The model can be received from a database, such as the database 164, via the cloud 168, or from another external source. The model can also be received from a memory, such as the memory 116. The model can be received via the communication interface 108 and / or via the user interface 112. In some embodiments, the model can be received directly from an imaging device.

[0082] The method 300 also includes calculating a predicted speed of sound through at least one segment of the portion of the patient's anatomy (step 308). Where sound is to be used for triangulation purposes, the speed of sound through a segment of the patient's anatomy (e.g., a segment extending from a transmitter located somewhere within a portion of the patient's anatomy to the outer surface of the patient's anatomy, corresponding to the model received in step 304) can be calculated. The calculation can include determining which materials are along the segment (e.g., bone tissue, soft tissue, blood, gastric fluid), measuring or otherwise determining the depth thickness of each material along the segment, looking up (e.g., in a lookup table or other database) the speed of sound through each material, and then calculating the speed of sound along the entire segment based on the foregoing information. Thus, as a simple example, if the segment under consideration is determined to extend through two inches of bone tissue, half an inch of fat tissue, and a sixteenth of an inch of skin tissue, the calculation can include determining the speed of sound through each of the bone tissue, fat tissue, and skin tissue, and then calculating how long it would take for a sound wave to travel through the two inches of bone tissue at the speed of sound through bone tissue, through the half an inch of fat tissue at the speed of sound through fat tissue, and through the sixteenth of an inch of skin tissue at the speed of sound through skin tissue. In some embodiments, an average speed of sound through the anatomical tissue can be calculated, and the distance that a sound wave must travel from a transmitter located within the patient's anatomy to the patient's body surface divided by the average speed of sound through the anatomical tissue to determine the amount of time it will take for the sound wave to reach the patient's body surface.

[0083] In some embodiments, a predicted speed of sound through a plurality of segments of the patient’s anatomy can be calculated. Also in some embodiments, the calculation can be based on the general or precise location of one or more of the plurality of sensors positioned to detect or receive the sound waves. Thus, for example, if one microphone is positioned directly above the surgical table and another microphone is positioned directly to the side of the surgical table, a first predicted speed of sound can be calculated for a segment of the patient’s anatomy extending from a planned location of a transmitter within the patient’s anatomy to a surface of the patient’s anatomy located above the planned location (e.g., in the direction of the microphone positioned directly above the surgical table), and a second predicted speed of sound can be calculated for a segment of the patient’s anatomy extending from the planned location of the transmitter to a surface of the patient’s anatomy located to the side of the transmitter (e.g., in the direction of the microphone positioned directly to the side of the surgical table). In other embodiments, an average speed of sound can be used for the calculation of step 308, and this model can be used to determine the precise or approximate distance that a sound wave must travel through the patient’s anatomical tissue before reaching a surface of the patient’s anatomical tissue and propagating through the air in the operating room.

[0084] Method 300 also includes updating the predicted speed of sound based on calibration data (step 312). For example, a transmitter (such as transmitter 156) can be placed on one side of the patient’s body, and a sensor (such as sensor 212) can be placed on the opposite side of the patient’s body, the positional relationship between the transmitter and the sensor being known. The transmitter can generate a sound at a first known time, which can be detected by the sensor at a second known time. Based on the first known time, the second known time, and the known distance between the transmitter and the sensor, a speed of sound through the patient’s body can be calculated, and this calculated speed of sound can be used as calibration data for updating the predicted speed of sound calculated in step 308.

[0085] Method 300 also includes receiving position data corresponding to the position of each of the plurality of microphones (step 316). The position data can be relative to a single coordinate system, and can include information about the position of each of the plurality of microphones within the single coordinate system. In other embodiments, the position data can be relative to one or more of the other microphones in the plurality of microphones, such that even if the positions of the microphones relative to the operating room or relative to a more global coordinate system are unknown, the position of each microphone is known relative to the positions of the other microphones in the plurality of microphones. The position data can include information about the actual position of each of the plurality of microphones, or from which the actual position of each of the plurality of microphones can be calculated. In some embodiments, the position data can include information about the pose of a robot or other articulated arm to which one or more of the plurality of microphones is attached.

[0086] The method 300 also includes calculating a position of each of the plurality of microphones (step 320). The position data received in step 316 includes information from which the actual position of each of the plurality of microphones can be calculated (including, for example, information about the pose of the movable arm from which the position of a microphone attached to the movable arm can be calculated) in which case the step 320 of calculating a position of each of the plurality of microphones can be accomplished. The calculation can use one or more algorithms such as the algorithm 128 (which can be or include, for example, one or more algebraic, geometric, trigonometric, or other algorithms) to calculate the position of each of the plurality of microphones, either relative to the other microphones of the plurality of microphones or relative to a single common coordinate system such as the predetermined coordinate system 120.

[0087] The method 300 also includes receiving information about a detected signal generated by the emitter (step 324). As shown herein, in cases where the emitter is or includes a loudspeaker and the plurality of sensors being utilized is a plurality of microphones, the detected signal is a sound signal. The detected signal can have a frequency corresponding to a frequency to which the plurality of microphones is tuned or otherwise configured to detect. The detected signal can have a frequency corresponding to a unique frequency at which the emitter is configured to generate sound waves, or a frequency selected from a limited set of frequencies at which the emitter is configured to selectively generate sound waves. The detected signal can have one or more characteristics intended to distinguish the detected signal from one or more other sounds in the operating room environment. In some embodiments, for example, the detected signal can include a single pulse, while in other embodiments the detected signal can include a series of pulses that can or can not be equal in length and time interval to the preceding and / or following pulse(s). The detected signal may, for example, have a frequency in the infrasound range or the ultrasonic range so as to be inaudible to the operating room staff. The detected signal can have a frequency in the acoustic range (between the infrasound range and the ultrasonic range), but near the boundary of the range so as to reduce the likelihood that the signal will be heard by a person in the operating room. The detected signal can have a frequency selected to avoid interfering with one or more instruments, tools, or other devices or systems in the operating room environment.

[0088] The information about the detected signal can be received at one time (e.g., as a collection of data generated by each of the plurality of microphones), or the information about the detected signal can be received over time (e.g., data generated by each of the plurality of sensors can be received based on the time at which the signal is detected by each of the plurality of microphones). In the former case, the information can include data corresponding to the time at which the signal is detected by each of the plurality of microphones. In the latter case, the information can not include data corresponding to the time at which the signal is detected by each of the plurality of microphones.

[0089] In instances in which the plurality of microphones are directional microphones (e.g., microphones configured to determine a direction from which a signal is received), the information regarding the detected signal can include information regarding a direction from which the signal is received from each of the plurality of microphones.

[0090] The transmitter can be the same as or substantially similar to, for example, the transmitter 156. Information regarding the detected signal can be received from the plurality of microphones, whether directly or via one or more communication interfaces, such as the communication interface 108. The information can be raw data corresponding to the detected signal generated by the transmitter, or the information can be processed data corresponding to the detected signal generated by the transmitter. For example, the information can simply be an electrical signal generated by each of the plurality of microphones as the detected signal reaches each of the plurality of microphones. Alternatively, the information can be or can include a result of amplifying, filtering, conditioning, and / or otherwise processing one or more such electrical signals.

[0091] The method 300 also includes calculating a location of the transmitter (step 328). The calculation can be based on the information received in step 324. In instances in which the information does not include data corresponding to a time at which the signal is detected by each of the plurality of microphones, the calculation can also be based on a time at which the data is received from each of the plurality of microphones. The calculation can also be based on the predicted speed of sound calculated in step 308, the updated predicted speed of sound from step 312, and / or the model received in step 304. The calculation can be further based on a location of each of the plurality of microphones, as received in step 316 or as calculated in step 320. The calculation can utilize one or more algorithms 128, including, for example, one or more trigonometric, geometric, or other mathematical equations or functions. The calculation includes determining a location of the transmitter (and thus a location of an implant, tool, anatomical feature, or other object to which the transmitter is attached or otherwise fixed) using a triangulation method based on known distances between or among the microphones and information regarding a speed of sound through one or more mediums.

[0092] Method 300 also includes determining an orientation of the implant (step 332). Where the emitter includes multiple speakers, each speaker can generate a signal (e.g., a sound wave), and each signal can be detected by multiple microphones. The signals can differ from one another in at least one characteristic, such that each signal can be distinguished from the others. The location of each speaker can then be calculated according to step 328, and the calculated speaker locations can be used, along with information about the location of each speaker within or on the emitter, for example, to determine an orientation of the emitter. Where the relative positioning of the emitter and the object to which the emitter is attached or otherwise fixed (here, the implant) is known, the orientation of the object can also be determined as a result. In other words, this determination can be based on information about the multiple detected signals, information about the location of each speaker within the emitter, and / or information about the relative location of the emitter and the object to which the emitter is attached or otherwise fixed.

[0093] The present disclosure encompasses multiple variations on method 300. For example, in embodiments of the present disclosure, one or more of the steps of method 300 can be omitted. More specifically, a method according to embodiments of the present disclosure can omit one or more of steps 304, 308, 312, 316, 320, 324, and / or 332, while including the remaining steps of method 300. The present disclosure also encompasses methods that include additional steps beyond those described herein with respect to method 300. In other words, the methods encompassed by the present disclosure include more or fewer steps than method 300 (including steps that are different than those described herein). Additionally, while method 300 is described in connection with an emitter that includes speakers and multiple microphones configured to detect sound emitted by the speakers, other embodiments of the present disclosure can utilize non-sound signals for triangulation to determine the location of the emitter (or the location of one or more speakers of the emitter, or the location of an object to which the emitter is attached). For example, embodiments of the present disclosure can utilize RF or other electromagnetic signals in place of sound signals, with corresponding emitters and multiple sensors. Additionally, while method 300 is described based on the use of active emitters and multiple sensors configured to receive only signals generated by separate emitters, other embodiments of the present disclosure utilize multiple sensors that include at least one transceiver capable of generating a signal, and a passive emitter configured to reflect a signal so generated, or an active emitter configured to receive and respond to the signal. Thus, embodiments of the present disclosure can utilize radar, sonar, ultrasound, or other technologies that utilize signal reflection or bounce-back to determine distance or other information from which the location of an object can be calculated or otherwise determined.

[0094] Additionally, although the various steps of method 300 are described in connection with information about a single detected sound, in embodiments of the present disclosure, multiple sounds can be detected, whether all sounds are from the same loudspeaker or from multiple loudspeakers (each of which can generate one or more detected sounds). For example, where the emitter includes three loudspeakers, each loudspeaker can detect a sound, and information about each of the detected sounds can be used for any purpose described herein (e.g., to determine a position, orientation, movement, relative position, etc.). Each detected sound can be the same or different (e.g., different frequencies, different amplitudes, different pulse patterns). As another example, each of multiple objects within a patient can have an emitter attached thereto, and one or more sounds can be generated by one or more loudspeakers corresponding to each emitter. Again, information about these detected sounds can be used for any purpose described herein, and each detected sound can be the same or different.

[0095] Method 300 advantageously enables determination of the position and even the orientation of the emitter and the object to which the emitter is attached or otherwise fixed. The object can be a medical device, tool, or implant, or other foreign object (relative to the patient), or the object can be an anatomical feature of the patient. Moreover, method 300 advantageously does not require the use of harmful radiation, nor does method 300 require line-of-sight between each of multiple sensors and the emitter. Method 300 can be accomplished automatically during a surgical procedure, without the need for manual intervention and without consuming valuable time of the operating room staff. Method 300 advantageously enables the operating room staff to determine and / or track the position, orientation, and / or movement of one or more objects within a patient, thereby enabling improved accuracy and safety during a surgical procedure.

[0096] Reference is now made to Figure 4 Method 400, which uses triangulation to determine the position, movement, and / or orientation of an object, includes receiving a model of a portion of a patient anatomy (step 404). Step 404 can be the same as or substantially similar to step 304 described above.

[0097] The method 400 also includes receiving a surgical plan including information about a planned implant location (step 408). The surgical plan can be received via a communication interface, such as the communication interface 108, and can be received from or via a memory, such as the memory 116, a database, such as the database 164, and / or a cloud, such as the cloud 168. The surgical plan can include information about one or more steps of a surgical procedure, including one or more planned locations of an implant during the surgical procedure. The one or more planned locations can correspond to planned locations of the implant relative to one or more anatomical features in a model of a portion of the patient’s anatomy or relative to a coordinate system, such as the predetermined coordinate system 120. The surgical plan can be combined with or separate from the model of the patient’s anatomy received in step 404.

[0098] The method 400 also includes calculating a predicted speed of sound along at least one path extending at least partially through a portion of the patient’s anatomy (step 412). Calculating the predicted speed of sound can be the same as or substantially similar to step 308 described above in connection with the method 300. The calculation can be based at least in part on the information about the planned implant location, and can include calculating a predicted speed of sound along one or more paths extending from the planned implant location or proximate to the planned implant location to a surface of the patient’s body. The calculated predicted speed of sound can be updated based on calibration data, which can be generated and / or received prior to or during a surgical procedure corresponding to the surgical plan received in step 408.

[0099] The method 400 also includes receiving first detection information corresponding to a first detected sound generated by a speaker connected to an implant (step 416). The first detection information can be the same as or substantially similar to the information about a detected sound described above in connection with step 324. The first detection information can include data received directly or indirectly from a plurality of sensors, such as the plurality of sensors 132, which in this embodiment are a plurality of microphones.

[0100] The method 400 also includes determining a location of the implant (step 420). Determining the location of the implant can be based on a computed or otherwise determined location of the speaker (which can be computed or otherwise determined in the same manner or in a substantially similar manner as described above in connection with step 328 computing the location of the emitter), and on information about the location of the speaker relative to the location of the implant (which can be stored, for example, in a memory such as the memory 116, or received via a communication interface such as the communication interface 108, whether from or via a database such as the database 164, a cloud such as the cloud 168, or from or via elsewhere). Computing or otherwise determining the location of the speaker can be accomplished using triangulation, and the first detection information, a predicted speed of sound, information about the location of or distance between each of a plurality of microphones configured to detect sound generated by the speaker, and / or any other useful information.

[0101] The method 400 also includes receiving second detection information about a second detected sound (step 424). Receiving the second detection information about the second detected sound can be the same as or similar to receiving the first detection information about the first detected sound, as described above in connection with step 416. However, in step 424, the second detected sound can be generated by: the same speaker that generated the first detected sound; a different speaker that includes the same emitter as the speaker that generated the first sound; a different speaker attached to the same implant (and not including part of the same emitter as the speaker that generated the first sound); or a different speaker attached to a different object (e.g., a medical device, a tool, an implant or other foreign implant, or an anatomical feature of the patient) than the speaker that generated the first sound.

[0102] The method 400 also includes determining a movement or orientation of the implant, or a location of the implant relative to another object (step 428). The determination can include first determining a location of the speaker that generated the second detected sound. The location of the speaker that generated the second detected sound can be determined in the same manner or in a substantially similar manner as described above in connection with step 328. The determination (of step 428) can also include determining a location of the object to which the speaker that generated the second detected sound is attached, which can be accomplished based on the determined location of the speaker that generated the second detected sound and based on information about the relative location of the speaker and the object to which the speaker is attached.

[0103] In the case that the second detected sound is generated by the same speaker as the first detected sound, step 428 can include determining a movement of the implant. If the location determined from step 420 is different than the location determined in step 428, the difference in the determined locations corresponds to a movement of the speaker (and thus of the implant to which the speaker is attached).

[0104] In cases where the second detected sound is generated by a different speaker of the same emitter that includes the speaker that generated the first sound, the location determined from step 420 can be used, along with the determined location of step 428, to determine the orientation of the emitter, and also to determine the orientation of the object to which the emitter is attached (e.g., using information about the location of the emitter on the object to which the emitter is attached). Determining the orientation can be the same as or substantially similar to determining the orientation of the implant as described above in connection with step 332.

[0105] In cases where the second detected sound is generated by a different speaker attached to the same implant (and does not include part of the same emitter as the speaker that generated the first sound), the orientation of the implant can be determined directly, without first determining the orientation of the emitter. The orientation of the implant can be determined in the same manner or substantially similar manner as described above in connection with step 332.

[0106] In cases where the second detected sound is generated by a different speaker attached to a different object (e.g., a medical device, a tool, an implant, or other extraneous implant or an anatomical feature of the patient) than the speaker that generated the first sound, then the location of the implant relative to the location of the object to which the different speaker is attached can be determined. Such information can be used, for example, to determine the location of the implant relative to the location of an anatomical feature of the patient (e.g., where the implant needs to be positioned adjacent to or otherwise relative to an anatomical feature of the patient), or to determine the location of the tool relative to the location of the implant (e.g., where the tool needs to be connected to the implant, or where the tool needs to avoid contact with the implant).

[0107] Each of the detected sounds of method 400 can have a unique frequency. In some embodiments, such as embodiments in which a single speaker generates more than one detected sound, each speaker can be configured to generate sound at a different frequency than each other speaker is configured to generate sound at.

[0108] The present disclosure encompasses a number of variations with respect to the method 400. For example, although the method 400 is described above with respect to the use of a speaker and a number of microphones configured to detect one or more sounds generated by the speaker, in other embodiments, the method 400 can utilize, for example, RF or other electromagnetic waves instead of sound waves, and a corresponding signal generator (instead of a speaker) and sensor (instead of a microphone). The method 400 can also be implemented with a passive emitter instead of a speaker, which can be simply configured to reflect a signal generated outside the patient (whether by one or more of the number of sensors or by a separate emitter, the location of which is known). Such embodiments can utilize ultrasound, radar, sonar, or other techniques for determining the location and / or orientation of an emitter.

[0109] Additionally, although the method 400 only explicitly describes the use of information with respect to a first detected sound and information with respect to a second detected sound, in embodiments of the present disclosure, a number of sounds can be detected, whether all sounds are from the same speaker or from a number of speakers (each of the number of speakers can generate one or more detected sounds). For example, where an emitter attached to an implant includes three speakers, and additional emitters including three speakers are each attached to a number of anatomical features to be inserted into the area of the implant, as well as to one or more tools to be used during a surgical procedure involving the implant (or involving a portion of the patient anatomy in which the implant is positioned), then the location and / or orientation of each of the emitters (and thus of each of the objects to which the emitters are attached) can be determined, as well as any movement of such emitters (and thus of the objects to which the emitters are attached), as well as the location of one emitter relative to any other emitters (and thus of one object to which the emitters are attached relative to any other objects to which the other emitters are attached).

[0110] Similar to the method 300, the method 400 advantageously is able to determine the location and even the orientation of emitters and objects to which the emitters are attached or otherwise secured. The method 400 is also able to detect movement of the emitters (and the objects to which the emitters are attached) and the location of one emitter relative to the location of another emitter (and the objects to which the emitters are attached). Furthermore, the method 400 advantageously does not require the use of harmful radiation, nor does the method 400 require a line of sight between each of the number of sensors and the emitters. The method 400 can be accomplished automatically during a surgical procedure, without the need for manual intervention and without consuming valuable time of the operating room staff. The method 400 advantageously enables the operating room staff to determine and / or track the location, orientation, and / or movement of one or more objects within a patient, thereby enabling improved accuracy and safety during a surgical procedure.

[0111] Any signal generator described herein, such as signal generator 176, can be used in place of any loudspeaker described herein, and any sensor described herein, such as sensor 212, can be used in place of any microphone described herein, so long as the sensor is configured to receive or detect a signal generated by the signal generator, and the signal generator is configured to generate a signal that can be detected and received by the sensor.

[0112] Although both method 300 and method 400 are described as including a step of receiving a model of a portion of a patient’s anatomy, and are also described as including a step of calculating a predicted speed of sound through at least one segment of the portion of the patient’s anatomy (method 300) or a predicted speed of sound along at least one path extending at least partially through the portion of the patient’s anatomy (method 400), embodiments of the present disclosure do not require either or both of these limitations. For example, when a surgical procedure is an open procedure (rather than, for example, a minimally invasive procedure), there can be a line of sight between a transmitter (whether a loudspeaker or otherwise) and a sensor (whether a microphone or otherwise) such that a signal generated by the transmitter need not propagate through the patient’s anatomy to reach the sensor, nor need adjustments be made to the speed of the signal based on interference from the patient’s anatomy. Also, although method 300 and method 400 are described as including steps related to calculating a predicted speed of sound to account for interference from the patient’s anatomy, embodiments using other types of signals can include corresponding steps related to calculating a predicted speed at which a considered type of signal would propagate through the patient’s anatomy.

[0113] As can be appreciated based on the foregoing disclosure, the present disclosure encompasses methods having fewer steps than all of the steps identified in Figure 3 and Figure 4 methods 300 and 400, and methods including more steps than those identified in Figure 3 and Figure 4 methods 300 and 400. The present disclosure also encompasses methods that combine one or more steps of method 300 with one or more steps of method 400, or vice versa.

[0114] Embodiments of the present disclosure can also be used to locate items that are not located within a patient. For example, a transmitter can be attached to each of one or more robots, instruments, tools, imaging devices, and / or other systems or devices within a surgical theater, and the systems and methods described herein can be used to track the location or position of each such object during a surgical procedure. In such embodiments, the tracked location or position can be used to: ensure that no unwanted objects are placed within or left within a patient; enable a robot to operate autonomously or semi-autonomously to avoid collisions with another tracked object; facilitate proper positioning of a robot, imaging device, medical instrument or tool, or any other object relative to another object; or for any other useful purpose. In cases where the transmitter is placed on one or more anatomical features of a patient, embodiments of the present disclosure can be used for segmented tracking.

[0115] The foregoing is not intended to limit the disclosure to one or more forms disclosed herein. In the foregoing DETAILED DESCRIPTION, for purposes of simplicity, the disclosure of various features of the disclosure, for example, in one or more aspects, embodiments, and / or configurations, is focused on in the context of simplicity. Features of aspects, embodiments, and / or configurations of the disclosure can be combined across any alternative or

[0116] Moreover, while descriptions have included one or more aspects, embodiments, and / or configurations and certain variations thereof, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as can be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and / or configurations to the extent permitted, including alternate, unrecited, or equivalent structures, functions, means, or steps to those claimed, without limitation to the precise descriptions and examples given herein above. The claims are not intended to be limited to the disclosed aspects, embodiments, and / or configurations.

Claims

1. A surgical positioning system, the surgical positioning system comprising: A transmitter fixed to a medical implant, the transmitter comprising: loudspeakers; and Power source; At least three microphones; At least one processor; and A memory that stores instructions for execution by the processor, which, when executed, cause the processor to: Receive information about the detected sound from each of the at least three microphones; A model that receives a portion of the patient's anatomical structure; Based on the model, the predicted velocity of sound through at least one segment of the portion of the patient's anatomy is calculated using the following operations: Use the model to determine which material runs along the segment; The thickness of each material along the segment is measured within the model; Determine the speed of sound along each material of the segment; and The predicted sound velocity is calculated based on the thickness of each material along the segment and the sound velocity of each material; and The position of the implant is calculated based on the position information corresponding to each of the at least three microphones, the predicted sound velocity, and the received information.

2. The surgical positioning system of claim 1, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: The predicted speed of sound is updated based on calibration data corresponding to the calibration sound generated by the transmitter and detected by each of the at least three microphones.

3. The surgical positioning system of claim 2, wherein the calculation of the position of the implant is further based on the updated predicted speed of sound.

4. The surgical positioning system of claim 1, wherein each of the at least three microphones is mounted in a fixed position relative to any other microphone among the at least three microphones.

5. The surgical positioning system of claim 1, wherein the detected sound has a frequency of less than 20 kHz.

6. The surgical positioning system of claim 1, wherein the detected sound has a frequency of less than 20 Hz.

7. The surgical positioning system of claim 1, wherein at least one of the at least three microphones is mounted to a movable arm, and the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: Receive arm position data corresponding to the position of the movable arm; and The position of each of the at least three microphones is calculated based at least in part on the arm position data.

8. The surgical positioning system of claim 1, wherein the position information of each of the at least three microphones includes data about the position of each of the at least three microphones relative to the other microphones of the at least three microphones, and the calculated transmitter position is related to the position of the at least three microphones.

9. The surgical positioning system of claim 1, wherein the position information of each of the at least three microphones is related to a common coordinate system.

10. The surgical positioning system of claim 1, wherein the transmitter comprises a plurality of loudspeakers, each loudspeaker configured to emit sound at a frequency different from the other loudspeakers of the plurality of loudspeakers, the received information including information about detected sounds generated respectively by each of the plurality of loudspeakers, and the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: The orientation of the implant is determined at least in part based on the information received.

11. A non-transitory computer-readable medium comprising one or more instructions stored thereon, said one or more instructions, when executed by a processor, causing the processor to perform a method for locating an object during surgical procedures, said method comprising: A model that receives a portion of the patient's anatomical structure; Receive a surgical plan that includes information about the planned location of the implant within the portion of the patient's anatomy; Based on the planned location of the implant and the model, a predicted sound velocity is calculated along at least one path extending at least partially through a portion of the patient's anatomy, the predicted sound velocity being calculated by: The model is used to determine which materials follow the at least one path; The thickness of each material along at least one path is measured within the model; Determine the speed of sound for each material along the at least one path; as well as The predicted sound velocity is calculated based on the thickness of each material along the at least one path and the sound velocity of each material; Detection information about detected sounds generated by a speaker fixed to the implant is received from at least three microphones; as well as The location of the implant is determined based on the predicted sound velocity and the detection information.

12. The non-transitory computer-readable medium of claim 11, wherein the detection information includes first detection information regarding a first detected sound generated by the speaker at a first moment, the method further comprising: Second detection information is received from the at least three microphones regarding a second detected sound generated by the speaker, the second detected sound being generated at a second time after the first time. as well as The movement of the implant is determined based on the first detection information and the second detection information.

13. The non-transitory computer-readable medium of claim 11, wherein the detection information corresponds to detected sound generated by a plurality of speakers fixed to the implant, the method further comprising: The orientation of the implant is determined based on the predicted sound velocity and the detection information.

14. The non-transitory computer-readable medium of claim 13, wherein each of the detected sounds has a unique frequency relative to any other detected sound.

15. The non-transitory computer-readable medium of claim 11, wherein the determination is further based on location information corresponding to the position of each of the at least three microphones.

16. The non-transitory computer-readable medium of claim 11, wherein the detection information includes first detection information regarding a first detected sound generated by the speaker at a first moment, the method further comprising: Receive second detection information from the at least three microphones regarding a second detected sound generated by a second speaker from a second anatomical element attached to the patient; as well as The position of the implant relative to the anatomical element is determined based on the first detection information and the second detection information.

17. A surgical triangulation system, the surgical triangulation system comprising: Multiple microphones, which are configured to be installed in fixed locations around the operating room; A transmitter configured to be fixed to an internal anatomical feature of a patient or implant, the transmitter comprising: loudspeakers; and Power source; At least one processor; and A memory storing instructions for execution by the at least one processor, the instructions causing the at least one processor, when executed, to: Receive a surgical plan that includes information about a portion of the patient's anatomy; A model that receives a portion of the patient's anatomical structure; Based on the model, the predicted velocity of sound through at least one segment of the portion of the patient's anatomy is calculated using the following operations: Use the model to determine which material runs along the segment; The thickness of each material along the segment is measured within the model; Determine the speed of sound along each material of the segment; and The predicted sound velocity is calculated based on the thickness of each material along the segment and the sound velocity of each material; Receive sound information about sounds detected by the multiple microphones and generated by the speaker from the multiple microphones; and The position of the transmitter is calculated based on the surgical plan, the audio information, and the information about the fixed positions of the plurality of microphones.

18. The surgical triangulation system of claim 17, wherein the transmitter is biocompatible.

19. The surgical triangulation system of claim 17, wherein the transmitter includes a second speaker, and the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: Receive second sound information from the plurality of microphones regarding a second sound detected by the plurality of microphones and generated by the second speaker; and The orientation of the transmitter is calculated based on the surgical plan, the second audio information, and the information regarding the fixed positions of the plurality of microphones.

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