PROTECTION SYSTEMS, ASSEMBLIES, AND DEVICES

Protection systems, assemblies, and devices are provided. A protection assembly may be configured to transition an end unit of a robot between a first state and a second state. A signal indicating a breaching state may be received. The protection assembly may transition the end unit from the first state to the second state when the signal is received.

BACKGROUND

The present disclosure is generally directed to protection systems, assemblies, and devices, and relates more particularly to protection systems, assemblies, and devices for protecting an end unit of a robot.

Surgical robots may assist a surgeon or other medical provider in carrying out a surgical procedure, or may complete one or more surgical procedures autonomously. Providing controllable linked articulating members allows a surgical robot to reach areas of a patient anatomy during various medical procedures.

BRIEF SUMMARY

Example aspects of the present disclosure include:

A protection system according to at least one embodiment of the present disclosure comprises a protection assembly configured to transition an end unit of a robot between a first state and a second state; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive a signal indicating a breaching state; and cause the protection assembly to transition the end unit from the first state to the second state when the signal is received.

Any of the aspects herein, wherein the end unit comprises a surgical tool or a surgical instrument.

Any of the aspects herein, wherein the breaching state comprises a breach of the end unit from a hard tissue to a soft tissue.

Any of the aspects herein, wherein the first state comprises a working state and the second state comprises a non-working state.

Any of the aspects herein, wherein the protection assembly comprises: a platform configured to receive the end unit; a biasing member configured to bias the end unit to the second state; and a locking mechanism configured to lock the biasing member, wherein when the locking mechanism releases the biasing member, the biasing member transitions the end unit from the first state to the second state.

Any of the aspects herein, wherein the end unit is extended when in the first state and retracted when in the second state.

Any of the aspects herein, wherein causing the protection assembly to transition the end unit from the first state to the second state comprises causing the locking mechanism to release the biasing member.

Any of the aspects herein, wherein the locking mechanism comprises an electro-mechanical device.

Any of the aspects herein, wherein the protection assembly comprises: a sleeve configured to transition between a first sleeve position and a second sleeve position, wherein the sleeve covers the end unit when in the first sleeve position and does not cover the end unit when in the second sleeve position, wherein the second sleeve position correlates to the first state of the end unit and the first sleeve position correlates to the second state of the end unit; a biasing member configured to bias the sleeve to the first sleeve position; and a locking mechanism configured to lock the biasing member in a locked state, wherein the biasing member does not bias the sleeve when in the locked state, and wherein when the locking mechanism releases the biasing member from the locked state, the biasing member transitions the sleeve from the second sleeve position to the first sleeve position.

Any of the aspects herein, wherein the protection assembly further comprises a platform, the sleeve disposed on the platform, wherein the sleeve is extended away from the platform and covers the end unit when in the first sleeve position and is positioned on the platform when in the second sleeve position.

A protection system according to at least one embodiment of the present disclosure comprises a platform configured to support an end unit, the end unit configured to transition between a first state and a second state; a biasing member configured to bias the end unit to the second state; and a locking mechanism configured to lock the biasing member in a locked state, wherein the biasing member does not bias the end unit when in the locked state, and wherein when the locking mechanism releases the biasing member from the locked state, the biasing member transitions the end unit from the first state to the second state.

Any of the aspects herein, wherein the end unit comprises a surgical tool or a surgical instrument.

Any of the aspects herein, wherein the biasing member comprises a spring and the locking mechanism is a solenoid, wherein the spring is compressed when in the locked state. Any of the aspects herein, wherein the end unit is extended when in the first state and retracted when in the second state.

Any of the aspects herein, wherein the platform comprises a first end opposite a second end.

Any of the aspects herein, wherein the end unit is extended away from the first end and past the second end when in the first state and retracted towards the first end when in the second state.

A protection system according to at least one embodiment of the present disclosure comprises a sleeve movable between a first sleeve position and a second sleeve position, wherein the sleeve covers an end unit of a robot when in the first sleeve position and does not cover the end unit when in the second sleeve position; a biasing member configured to bias the sleeve to the first sleeve position; and a locking mechanism configured to lock the biasing member in a locked state, wherein the biasing member does not bias the sleeve when in the locked state, and wherein when the locking mechanism releases the biasing member from the locked state, the biasing member transitions the sleeve from the second sleeve position to the first sleeve position.

Any of the aspects herein, wherein the end unit comprises a surgical tool or a surgical instrument.

Any of the aspects herein, wherein the biasing member comprises a spring.

Any of the aspects herein, further comprising a platform configured to receive the sleeve, wherein the sleeve is extended away from the platform and covers the end unit when in the first sleeve position and is positioned on the platform when in the second sleeve position.

Any one or more of the features disclosed herein.

Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.

DETAILED DESCRIPTION

In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (alone or in combination with instructions). Computer-readable media may 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).

Instructions may 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), graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), 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 may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.

During a robotic surgical procedure or a robot assisted surgical procedure such as, for example, a spinal procedure, a surgical tool operated by a robot may breach hard tissue such as bone to soft tissue. When such breach is detected, stopping an inward motion of the surgical tool and reversing the motion includes decelerating the surgical tool and robotic arm and accelerating the large mass in the opposite direction. Such motion may be slow to execute. Another latency may be introduced from sending commands from a controller to each motor in the robotic arm.

At least one embodiment of the present disclosure provides for a spring-loaded rail that may be, for example, 2-3 cm in length, that is installed at an end-unit of a robotic arm. The rail may be aligned with a trajectory of the end unit. The rail may be locked in place by an electro-mechanical locking device, while the spring is compressed. When an emergency retreat is triggered, the rail lock may be released, and the spring may push the end-unit outwards on the rail, which distances a tip of the end unit from, for example, sensitive soft tissue.

In an alternative embodiment of the present disclosure, the spring may push down a protective sleeve around the end unit to protect the patient from the end unit and/or to protect the end unit from damage.

Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) preventing an end unit from undesirably contacting a patient, (2) preventing an end unit from breaching hard tissue to soft tissue, (3) providing a safety mechanism for autonomous or semi-autonomous surgical robots, and (4) increasing patient and surgical team safety.

Turning first toFIG.1, a block diagram of a system100according to at least one embodiment of the present disclosure is shown. The system100may be used to protect an end unit such as an end unit124of a robot such as a robot114using a protection assembly such as a protection assembly126and/or carry out one or more other aspects of one or more of the methods disclosed herein. The system100comprises a computing device102, one or more imaging devices112, a robot114, a navigation system118, a database130, and/or a cloud or other network134. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system100. For example, the system100may not include the imaging device112, the robot114, the navigation system118, one or more components of the computing device102, the database130, and/or the cloud134.

The computing device102comprises a processor104, a memory106, a communication interface108, and a user interface110. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device102.

The processor104of the computing device102may be any processor described herein or any similar processor. The processor104may be configured to execute instructions stored in the memory106, which instructions may cause the processor104to carry out one or more computing steps utilizing or based on data received from the imaging device112, the robot114, the navigation system118, the database130, and/or the cloud134.

The memory106may be or comprise 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 memory106may store information or data useful for completing, for example, any step of the method400described herein, or of any other methods. The memory106may store, for example, instructions and/or machine learning models that support one or more functions of the robot114. For instance, the memory106may store content (e.g., instructions and/or machine learning models) that, when executed by the processor104, enable signal processing120.

The signal processing120enables the processor104to process signal data (received from for example, a protection assembly126, the computing device102, or any component of the system100or any component outside of the system100) for the purpose of, for example, identifying one or more states of end unit124. The states may comprise, for example, a working state, a breaching state, a non-working or standby state, or any other state. The working state may correlate to whether the end unit124is in a working state and ready for use. For example, the working state may indicate that power is received by the end unit124.

The breaching state may indicate that the end unit124has breached or may breach, for example, hard tissue such as a bone. When such breaching state is triggered, in some embodiments, the end unit124is retracted away from, for example, the hard tissue. In other embodiments, when the breaching state is triggered, a sleeve such as a sleeve330is moved downward to cover the end unit124. The standby state may indicate that the end unit124is not in use. In the standby state, the end unit124may be retracted or may be covered by the sleeve330to protect the end unit124from damage and/or to prevent damage by the end unit124to, for example, a patient or a surgical team.

The content, if provided as in instruction, may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines. Alternatively or additionally, the memory106may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that can be processed by the processor104to carry out the various method and features described herein. Thus, although various contents of memory106may be described as instructions, it should be appreciated that functionality described herein can be achieved through use of instructions, algorithms, and/or machine learning models. The data, algorithms, and/or instructions may cause the processor104to manipulate data stored in the memory106and/or received from or via the imaging device112, the robot114, the database130, and/or the cloud134.

The memory106may also store a surgical plan122. The surgical plan122may comprise, for example, one or more steps for performing a surgical procedure. For example, the surgical plan122may include steps for activating the end unit124to put the end unit124in the working condition and steps for deactivating the end unit124to put the end unit124in the standby condition. The surgical plan122may also comprise one or more thresholds to be monitored during a surgical procedure. In some embodiments, the surgical procedure may be a spinal procedure (e.g., a spinal alignment, installing implants, osteotomy, fusion, and/or any other spinal procedure). The surgical plan122may also be stored in the database130.

The computing device102may also comprise a communication interface108. The communication interface108may be used for receiving image data or other information from an external source (such as the imaging device112, the robot114, the navigation system118, the database130, the cloud134, and/or any other system or component not part of the system100), and/or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device102, the imaging device112, the robot114, the navigation system118, the database130, the cloud134, and/or any other system or component not part of the system100). The communication interface108may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and/or one or more wireless transceivers or interfaces (configured, for example, to transmit and/or receive information via one or more wireless communication protocols such as 802.11a/b/g/n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface108may be useful for enabling the device102to communicate with one or more other processors104or computing devices102, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.

The computing device102may also comprise one or more user interfaces110. The user interface110may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and/or any other device for receiving information from a user and/or for providing information to a user. The user interface110may be used, for example, to receive a user selection or other user input regarding any step of any method described herein. Notwithstanding the foregoing, any required input for any step of any method described herein may be generated automatically by the system100(e.g., by the processor104or another component of the system100) or received by the system100from a source external to the system100. In some embodiments, the user interface110may be useful to allow a surgeon or other user to modify instructions to be executed by the processor104according to one or more embodiments of the present disclosure, and/or to modify or adjust a setting of other information displayed on the user interface110or corresponding thereto.

Although the user interface110is shown as part of the computing device102, in some embodiments, the computing device102may utilize a user interface110that is housed separately from one or more remaining components of the computing device102. In some embodiments, the user interface110may be located proximate one or more other components of the computing device102, while in other embodiments, the user interface110may be located remotely from one or more other components of the computer device102.

The imaging device112may be operable to image anatomical feature(s) (e.g., a bone, veins, tissue, etc.) and/or other aspects of patient anatomy to yield image data (e.g., image data depicting or corresponding to a bone, veins, tissue, etc.). “Image data” as used herein refers to the data generated or captured by an imaging device112, including in a machine-readable form, a graphical/visual form, and in any other form. In various examples, the image data may comprise data corresponding to an anatomical feature of a patient, or to a portion thereof. The image data may be or comprise a preoperative image, an intraoperative image, a postoperative image, or an image taken independently of any surgical procedure. In some embodiments, a first imaging device112may be used to obtain first image data (e.g., a first image) at a first time, and a second imaging device112may be used to obtain second image data (e.g., a second image) at a second time after the first time. The imaging device112may be capable of taking a 2D image or a 3D image to yield the image data. The imaging device112may be or comprise, for example, an ultrasound scanner (which may comprise, for example, a physically separate transducer and receiver, or a single ultrasound transceiver), an O-arm, a C-arm, a G-arm, or any other device utilizing X-ray-based imaging (e.g., a fluoroscope, a CT scanner, or other X-ray machine), a magnetic resonance imaging (MM) scanner, an optical coherence tomography (OCT) scanner, an endoscope, a microscope, an optical camera, a thermographic camera (e.g., an infrared camera), a radar system (which may comprise, for example, a transmitter, a receiver, a processor, and one or more antennae), or any other imaging device112suitable for obtaining images of an anatomical feature of a patient. The imaging device112may be contained entirely within a single housing, or may comprise a transmitter/emitter and a receiver/detector that are in separate housings or are otherwise physically separated.

In some embodiments, the imaging device112may comprise more than one imaging device112. For example, a first imaging device may provide first image data and/or a first image, and a second imaging device may provide second image data and/or a second image. In still other embodiments, the same imaging device may be used to provide both the first image data and the second image data, and/or any other image data described herein. The imaging device112may be operable to generate a stream of image data. For example, the imaging device112may be configured to operate with an open shutter, or with a shutter that continuously alternates between open and shut so as to capture successive images. For purposes of the present disclosure, unless specified otherwise, image data may be considered to be continuous and/or provided as an image data stream if the image data represents two or more frames per second.

The robot114may be any surgical robot or surgical robotic system. The robot114may be or comprise, for example, the Mazor X™ Stealth Edition robotic guidance system. The robot114may be configured to position, for example, the protection assembly126and the end unit124at one or more precise position(s) and orientation(s), and/or to return the protection assembly126and the end unit124to the same position(s) and orientation(s) at a later point in time. The robot114may additionally or alternatively be configured to manipulate a surgical tool (whether based on guidance from the navigation system118or not) to accomplish or to assist with a surgical task. In some embodiments, the robot114may be configured to hold and/or manipulate an anatomical element during or in connection with a surgical procedure. The robot114may comprise one or more robotic arms116. In some embodiments, the robotic arm116may comprise a first robotic arm and a second robotic arm, though the robot114may comprise more than two robotic arms. In some embodiments, one or more of the robotic arms116may be used to hold and/or maneuver the protection assembly126and the end unit124. In embodiments where two protection assemblies126and end units124are used, one robotic arm116may hold one set, and another robotic arm116may hold another set. Each robotic arm116may be positionable independently of the other robotic arm. The robotic arms116may be controlled in a single, shared coordinate space, or in separate coordinate spaces.

The robot114, together with the robotic arm116, may have, for example, one, two, three, four, five, six, seven, or more degrees of freedom. Further, the robotic arm116may be positioned or positionable in any pose, plane, and/or focal point. The pose includes a position and an orientation. As a result, the protection assembly126, the end unit124, a surgical tool, or other object held by the robot114(or, more specifically, by the robotic arm116) may be precisely positionable in one or more needed and specific positions and orientations.

The robotic arm(s)116may comprise one or more sensors that enable the processor104(or a processor of the robot114) to determine a precise pose in space of the robotic arm (as well as any object or element held by or secured to the robotic arm).

In some embodiments, reference markers (e.g., navigation markers) may be placed on the robot114(including, e.g., on the robotic arm116), the imaging device112, the protection assembly126, the end unit124or any other object in the surgical space. The reference markers may be tracked by the navigation system118, and the results of the tracking may be used by the robot114and/or by an operator of the system100or any component thereof. In some embodiments, the navigation system118can be used to track other components of the system (e.g., the protection assembly126and the end unit124) and the system can operate without the use of the robot114(e.g., with the surgeon manually manipulating the protection assembly126and the end unit124and/or one or more surgical tools, based on information and/or instructions generated by the navigation system118, for example).

The robot114may also comprise one or more protection assemblies126for transitioning an end unit124between a first state and a second state. It will be appreciated that the protection assembly126may move the end unit124to any number of states. The end unit124may comprise, for example, a surgical instrument and/or a surgical tool. In some embodiments the end unit124is extended from a platform204,304when in the first state and retracted to the platform204,304when in the second state. In other embodiments, the end unit124is uncovered when in the first state and covered by, for example, a sleeve such as the sleeve330, when in the second state. The protection assembly126may be oriented by, for example, the robotic arm116. The protection assembly126(and thus the end unit124) may be positioned at an end of the robotic arm116or on any portion of the robot114and/or the robotic arm116.

The navigation system118may provide navigation for a surgeon and/or a surgical robot during an operation. The navigation system118may be any now-known or future-developed navigation system, including, for example, the Medtronic StealthStation™ S8 surgical navigation system or any successor thereof. The navigation system118may include one or more cameras or other sensor(s) for tracking one or more reference markers, navigated trackers, or other objects within the operating room or other room in which some or all of the system100is located. The one or more cameras may be optical cameras, infrared cameras, or other cameras. In some embodiments, the navigation system118may comprise one or more electromagnetic sensors. In various embodiments, the navigation system118may be used to track a position and orientation (e.g., a pose) of the imaging device112, the protection assembly126, the end unit124, the robot114and/or robotic arm116, and/or one or more surgical tools (or, more particularly, to track a pose of a navigated tracker attached, directly or indirectly, in fixed relation to the one or more of the foregoing). The navigation system118may include a display for displaying one or more images from an external source (e.g., the computing device102, imaging device112, or other source) or for displaying an image and/or video stream from the one or more cameras or other sensors of the navigation system118. In some embodiments, the system100can operate without the use of the navigation system118. The navigation system118may be configured to provide guidance to a surgeon or other user of the system100or a component thereof, to the robot114, or to any other element of the system100regarding, for example, a pose of one or more anatomical elements, whether or not a tool is in the proper trajectory, and/or how to move a tool into the proper trajectory to carry out a surgical task according to a preoperative or other surgical plan.

The database130may store information that correlates one coordinate system to another (e.g., one or more robotic coordinate systems to a patient coordinate system and/or to a navigation coordinate system). The database130may additionally or alternatively store, for example, one or more surgical plans122(including, for example, pose information about a target and/or image information about a patient's anatomy at and/or proximate the surgical site, for use by the robot114, the navigation system118, and/or a user of the computing device102or of the system100); one or more images useful in connection with a surgery to be completed by or with the assistance of one or more other components of the system100; and/or any other useful information. The database130may be configured to provide any such information to the computing device102or to any other device of the system100or external to the system100, whether directly or via the cloud134. In some embodiments, the database130may be or comprise part of a hospital image storage 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.

The cloud134may be or represent the Internet or any other wide area network. The computing device102may be connected to the cloud134via the communication interface108, using a wired connection, a wireless connection, or both. In some embodiments, the computing device102may communicate with the database130and/or an external device (e.g., a computing device) via the cloud134.

The system100or similar systems may be used, for example, to carry out one or more aspects of any of the method400described herein. The system100or similar systems may also be used for other purposes.

Turning toFIGS.2A and2B, a diagram of a system200comprising an end unit224in a first state and a diagram of the system200comprising the end unit224in a second state are respectively illustrated. The system200comprises a protection assembly226, which may be the same as or similar to the protection assembly126described above. The system200also comprises a robot214, which may be the same as or similar to the robot114described above. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system200. For example, the system200may comprise a navigation system, a computing device, etc.

As illustrated, the robot214comprises a robotic arm216(which may comprise one or more members216A connected by one or more joints216B) extending from a base202. In other embodiments, the robot214may comprise one robotic arm or two or more robotic arms. The base202may be stationary or movable. In the illustrated embodiment, the protection assembly226is disposed at an end of the robotic arm216. It will be appreciated that in other embodiments, an imaging device such as the imaging device112, one or more surgical tools, one or more surgical instruments, or any other component may be disposed at the end of the robotic arm216or on any portion of the robotic arm216or the robot214. The robotic arm216is operable to execute one or more planned movements and/or procedures autonomously and/or based on input from a surgeon or user. The robotic arm216may also orient and/or operate the protection assembly226.

In at least one embodiment, the protection assembly226comprises a platform204configured to support an end unit224. The platform204comprises a first end206opposite the second end208. The end unit224may be the same as or similar to the end unit124. As previously described, the end unit224may be transitioned between a first state in which the end unit224is extended from the platform204—as shown inFIG.2A—and a second state in which the end unit224is retracted to the platform204—as shown inFIG.2B. When the end unit224is in the first state, the end unit224may be operable to perform a surgical step. For example, the end unit224may comprise a surgical drill and the surgical step may comprise drilling an anatomical element such as bone.

The protection assembly226may also comprise a biasing member210configured to bias the end unit224to the second state and a locking mechanism212configured to lock the biasing member210. The locking mechanism212may lock the biasing member210so that the end unit224is operable in the first state. When the locking mechanism212releases the biasing member210, the biasing member210may transition the end unit224from the first state to the second state. In some embodiments, the biasing member210may be, for example, a spring coupled to the end unit224. It will be appreciated that in other embodiments, the biasing member210may be, for example, a motor configured to move the end unit224between the first state and the second state. In some embodiments, the locking mechanism212may be an electro-mechanical locking mechanism such as, for example, a solenoid and a lever. The solenoid may hold the lever to lock the biasing member210(when the biasing member210comprises, for example, a spring) in a locked stated.

In some embodiments, the platform204may comprise a rail to which the end unit224is coupled to. The end unit224may be movable between the first state and the second state on the rail. The rail, in some embodiments, may be, for example 2-3 cm in length. In other embodiments, the rail may be less than 2 cm or greater than 3 cm in length. The rail may also be aligned with a trajectory of the end unit224such that when the end unit224is retracted the end unit224reverses direction and moves in an opposite direction from an initial direction along the trajectory. In some embodiments, the platform may comprise a housing and the end unit224may be retracted from and into the housing.

In embodiments where the biasing member210is a spring, the spring may be locked in a compressed state by the locking mechanism212so that the end unit224is operable in the first state. When the locking mechanism212releases the spring, the spring expands and moves the end unit224along the rail to retract the end unit224towards the platform204. It will be appreciated that in other embodiments, the spring may be locked in an expanded state by the locking mechanism212so that the end unit224is operable in the first state. In such embodiments, when the locking mechanism212releases the spring, the spring may compress and move the end unit224towards the platform204.

As shown inFIG.2A, the end unit224may be in the first state and extended towards a surgical site. The biasing member210may be locked by the locking mechanism212in a locked and/or compressed state such that the end unit224. In the illustrated embodiment, the surgical site comprises an incision218formed on a patient222to access hard tissue220such as bone. The end unit224may comprise, for example, a surgical drill to drill the hard tissue220. During a surgical procedure (such as, for example, drilling the hard tissue220), the surgical drill may be monitored to ensure that the surgical drill does not breach the hard tissue. Breaching the hard tissue by the surgical drill may harm surrounding soft tissue, and thus, it is desirable to remove the surgical drill from the surgical site if a breach occurs or is imminent. The surgical drill may be monitored by, for example, an imaging device such as the imaging device112.

As shown inFIG.2B, the locking mechanism212may release the biasing member210, thereby transitioning the end unit224from the first state to the second state when a breach is detected and/or when a threshold is met or exceeded. The threshold may be, for example, a thickness threshold. The thickness threshold may be, for example, a distance threshold measured from a tip of the surgical drill to a boundary of soft tissue, which may correlate to a thickness of the hard tissue. In other words, the thickness of the hard tissue may be monitored (using, for example, imaging such as ultrasound imaging) and when the thickness of the hard tissue meets or exceeds a minimum thickness threshold, the locking mechanism212may release the biasing member210to transition the end unit224from the first state to the second state. Such minimum thickness threshold may prevent breaching of the hard tissue to the soft tissue by the end unit224. In some embodiments, the end unit224may be transitioned from the first state to the second state when the surgical procedure is completed to protect a surgical site from the end unit224and/or the protect the end unit224from damage. After the end unit224is transitioned to the second state, the end unit224may be transitioned to the first state based on, for example, input from a surgeon, the measured distance no longer meeting or exceeding the distance threshold, and/or based on a surgical step received from a surgical plan such as the surgical plan122.

Turning toFIGS.3A and3B, a diagram of a system300comprising an end unit324in a first state and a diagram of the system300comprising the end unit324in a second state are respectively illustrated. The system300comprises a protection assembly326, which may be the same as or similar to the protection assembly126,226described above. The system300also comprises a robot314, which may be the same as or similar to the robot114,214described above. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system300. For example, the system300may comprise a navigation system, a computing device, etc.

As illustrated and similarly described above, the robot314comprises a robotic arm316(which may comprise one or more members316A connected by one or more joints316B) extending from a base302. In other embodiments, the robot314may include one robotic arm or two or more robotic arms. The base302may be stationary or movable. In the illustrated embodiment, the protection assembly326is disposed at an end of the robotic arm316. It will be appreciated that in other embodiments, an imaging device such as the imaging device112, one or more surgical tools, one or more surgical instruments, or any other component may be disposed at the end of the robotic arm316or on any portion of the robotic arm316or the robot314. The robotic arm316is operable to execute one or more planned movements and/or procedures autonomously and/or based on input from a surgeon or user.

In at least one embodiment, the protection assembly326comprises a platform304configured to support an end unit324and a sleeve330. The end unit324may be the same as or similar to the end unit124,224. In some embodiments, the end unit324may be fixed to the platform304. In other embodiments, the end unit324may be moveable. For example, the end unit324may be extended from the platform304or retracted to the platform304. The protection assembly326may also comprise the sleeve330configured to transition between a first sleeve position and a second sleeve position. The sleeve330covers the end unit324when in the first sleeve position and does not cover the end unit324when in the second sleeve position. The first sleeve position also correlates to the second state of the end unit324(e.g., when the end unit324is in a non-working or standby state) and the second sleeve position correlates to the first state of the end unit324(e.g., when the end unit324is in a working state).

The protection assembly326may also comprise a biasing member310configured to bias the sleeve330to the first sleeve position and a locking mechanism312configured to lock the biasing member310. The locking mechanism312may lock the biasing member310so that the sleeve330is in the second sleeve position and the end unit324is operable in the first state. When the locking mechanism312releases the biasing member310, the biasing member310may transition the sleeve330from the second sleeve position to the first sleeve position. In some embodiments, the biasing member310may be, for example, a spring coupled to the sleeve330. It will be appreciated that in other embodiments, the biasing member310may be, for example, a motor configured to move the sleeve330between the first sleeve position and the second sleeve position. In some embodiments, the locking mechanism312may be an electro-mechanical locking mechanism such as, for example, a solenoid and a lever. The solenoid may hold the lever to lock the biasing member310(when the biasing member310comprises, for example, a spring) in a locked stated.

In some embodiments, the platform304may comprise a rail to which the sleeve330is coupled to and is movable between the first sleeve position and the second sleeve position on the rail. In embodiments where the biasing member is a spring, the spring may be locked in a compressed state by the locking mechanism312so that the end unit324is operable in the first state. When the locking mechanism312releases the spring, the spring expands and transitions the sleeve330from the second sleeve position to the first sleeve position.

As shown inFIG.3A, the sleeve330is in the second sleeve position and does not cover the end unit324. The biasing member310may be locked by the locking mechanism312in a locked and/or compressed state such that the end unit324may be uncovered operable in the first state. In the illustrated embodiment, the surgical site comprises an incision318formed on a patient322to access hard tissue320such as bone. The end unit324may comprise, for example, a surgical drill to drill the hard tissue320. During a surgical procedure (such as, for example, drilling the hard tissue320), the surgical drill may be monitored to ensure that the surgical drill does not breach the hard tissue. As previously described, breaching the hard tissue by the surgical drill may harm surrounding soft tissue, and thus, it is desirable to remove the surgical drill from the surgical site if a breach occurs or is imminent. The surgical drill may be monitored by, for example, an imaging device such as the imaging device112.

As shown inFIG.3B, the locking mechanism312may release the biasing member310, thereby transitioning the sleeve330from the second sleeve position to the first sleeve position when a breach is detected and/or when a threshold is met or exceeded. As shown, the end unit324is shown in dashed line for clarity, as the end unit324may be covered by the sleeve330when the sleeve330is in the first sleeve position (and the end unit324is in the second state). The threshold may be, for example, a distance threshold measured from a tip of the surgical drill to soft tissue, which may correlate to a thickness of the hard tissue. In some embodiments, the sleeve330may be transitioned from the second sleeve position to the first sleeve position when the surgical procedure is completed to protect a surgical site from the end unit324and/or the protect the end unit324from damage. After the sleeve330is transitioned to the first sleeve position, the sleeve330may be transitioned to the second sleeve position based on, for example, input from a surgeon, the measured distance no longer meeting or exceeding the distance threshold, and/or based on a surgical step received from a surgical plan such as the surgical plan122.

FIG.4depicts a method400that may be used, for example, for transitioning an end unit between a first state and a second state using a protection assembly, system, and/or device.

The method400(and/or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s)104of the computing device102described above. The at least one processor may be part of a robot (such as a robot114) or part of a navigation system (such as a navigation system118). A processor other than any processor described herein may also be used to execute the method400. The at least one processor may perform the method400by executing elements stored in a memory such as the memory106. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method400. One or more portions of a method400may be performed by the processor executing any of the contents of memory, such as a signal processing120.

The method400comprises receiving a first signal (step404). The first signal may be received from a protection assembly such as the protection assembly126,226,326, a computing device such as the computing device102, a navigation system such as the navigation system118, any component of a system such as the system100, or any component outside of the system. The protection assembly may be configured to transition an end unit such as the end unit124,224,324between a first state and a second state. In some embodiments, the end unit is extended from a platform such as the platform204,304when in the first state and the end unit is retracted towards the platform when in the second state. More specifically, in some embodiments, the protection assembly may comprise a biasing member such as the biasing member210configured to bias the end unit to the second state and a locking mechanism such as the locking mechanism212configured to lock the biasing member in a locked state in which the end unit is held in the first state. When the locking mechanism releases the biasing member from the locked state, the biasing member transitions the end unit from the first state to the second state.

In other embodiments, the protection assembly may comprise a sleeve such as the sleeve330, a biasing member such as the biasing member310configured to bias the sleeve to a first sleeve position, and a locking mechanism such as the locking mechanism312configured to lock the biasing member in a locked state in which the sleeve is held in the second sleeve position. In such embodiments, the first sleeve position also correlates to the second state of the end unit (e.g., when the end unit is in a non-working or standby state) and the second sleeve position correlates to the first state of the end unit (e.g., when the end unit is in a working state).

The first signal may be received by a processor such as the processor104. The processor may use, for example, a signal processing such as the signal processing120to process the signal data received for the purpose of identifying one or more states of the end unit. In some embodiments, the first signal may indicate a working state. In other embodiments, the first signal may indicate any one or more states such as, for example, a retracting state or a standby state. The working condition may indicate that the end unit is in condition for use. For example, the working condition may indicate that power is received by the end unit of the protection assembly.

The method400also comprises transitioning the end unit from a first state to a second state (step408). The protection assembly may transition the end unit from the second state to the first state based on receiving the first signal indicating that the end unit is in a working state.

In some embodiments, transitioning the end unit from the first state to the second state comprises causing the locking mechanism to release the biasing member such that the biasing member moves the end unit from the first state to the second state. For example, in some embodiments, the biasing member may comprise a spring coupled to the end unit and the locking mechanism may lock the spring in a compressed state. When the locking mechanism releases the spring, the spring may expand and move the end unit away from a surgical site and towards the platform.

In other embodiments, wherein the protection assembly comprises a sleeve, transitioning the end unit from the first state to the second state comprises causing the locking mechanism to release the biasing member such that the biasing member moves the sleeve from the second sleeve position to the first sleeve position, thereby covering the end unit. For example, in some embodiments, the biasing member may be a spring coupled to the sleeve and the locking mechanism may lock the spring in a compressed state. When the locking mechanism releases the spring, the spring may expand and move the sleeve to the end unit, thereby covering the end unit.

The method400also comprises receiving a second signal (step412). The step412may be the same as or similar to the step404described above. The second signal may indicate that the end unit is in a breaching state or a non-working or standby state The breaching state may indicate that the end unit has breached or may breach, for example, a hard tissue such as a bone. When such breaching state is triggered, in some embodiments, the end unit is retracted away from, for example, a surgical site. In other embodiments, when the breaching state is triggered, the sleeve is transitioned downward to cover the end unit. The standby state may indicate that the end unit is not in use, for example, at the end of a surgical procedure and/or operation. The standby condition may be activated by, for example, a user such as a surgeon or other medical provider. The standby condition may also be automatically activated by, for example, the processor executing a step of a surgical plan such as the surgical plan122. In the standby state, the end unit may be retracted or may be covered by the sleeve to protect the end unit from damage and/or to prevent damage from the end unit to, for example, a patient or a surgical team.

The breaching state may be triggered by, for example, when a breach is detected and/or when a threshold is met or exceeded. The threshold may be, for example, a distance threshold measured from a tip of the end unit to soft tissue, which may correlate to a thickness of hard tissue extending between the end unit and the soft tissue. The distance threshold may be determined automatically using artificial intelligence and training data (e.g., historical cases) in some embodiments. In other embodiments, the distance threshold may be or comprise, or be based on, surgeon input received via the user interface. In further embodiments, the distance threshold may be determined automatically using artificial intelligence, and may thereafter be reviewed and approved (or modified) by a surgeon or other user.

The method400also comprises transitioning the end unit from the first state to the second state (step416). The step416may be the same as or similar to the step408described above with respect to moving the end unit from the first state to the second state. Moving the end unit from the first state to the second state may be based on receiving the second signal indicating the breaching state and/or the non-working or standby state.

In some embodiments, when a distance measured between an end of the end unit and soft tissue meets or exceeds a distance threshold, the protection assembly may move the end unit from the first state to the second state and may also generate a notification to a user such as a surgeon or other medical provide. The notification may alert the user that the measured distance has met or exceeded the distance threshold. The notification may be, for example, an audible sound and/or displayed on a user interface such as the user interface110.

It will be appreciated that the steps404-408and the steps412-416may be performed in any order and may be repeated. For example, the steps412-416may occur when a measured distance between an end of an end unit and soft tissue meets or exceeds a distance threshold and the steps404-408may then occur when the distance does not meet or exceed the distance threshold. The steps412-416may repeat when the measured distance meets or exceeds the distance threshold.

In some embodiments, it will be appreciated that the end unit may be held in the first state when the first signal is being received and the end unit may transition from the first state to the second state when the first signal is not received. In other words, in some instances, the end unit may be held in the first state so long as the first signal is continuously received. When the first signal is not received (whether due to, for example, power loss or otherwise), the end unit may automatically transition to the second state.

The present disclosure encompasses embodiments of the method400that comprise more or fewer steps than those described above, and/or one or more steps that are different than the steps described above.

As noted above, the present disclosure encompasses methods with fewer than all of the steps identified inFIG.4(and the corresponding description of the method400), as well as methods that include additional steps beyond those identified inFIG.4(and the corresponding description of the method400). The present disclosure also encompasses methods that comprise one or more steps from one method described herein, and one or more steps from another method described herein. Any correlation described herein may be or comprise a registration or any other correlation.

The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and/or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and/or configurations of the disclosure may be combined in alternate aspects, embodiments, and/or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and/or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.