Patent Description:
During some spinal procedures, pedicle screws may be implanted into a plurality of vertebrae and connected to each other via a rod. The rod may be inserted into a head or an extension of each screw and reduced onto each screw until the rod is secured in place. During the process, the rod may be adjusted to align with the pedicle screws.

<CIT> discloses a load gauge to measure the forces that must be applied to properly position a spinal fixation assembly to one or more vertebrae.

<CIT> discloses a robotic system for performing spine surgery. The robotic system comprises a robotic manipulator and a navigation system to track a surgical tool relative to a patient's spine. The robotic system may be controlled manually and/or autonomously to place implants in the patient's spine.

The invention provides a system for monitoring a rod reduction process according to claim <NUM>.

Any aspect in combination with any one or more other aspects.

Any one or more of the features disclosed herein.

Any one or more of the features as substantially disclosed herein.

Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

Any one of the aspects/features/embodiments in combination with any one or more other aspects/features/embodiments.

Use of any one or more of the aspects or features as disclosed herein.

It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.

It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and/or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the disclosed techniques according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a computing device and/or a medical device.

In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof.

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 <NUM>-series processors, Nvidia GeForce RTX <NUM>-series processors, AMD Radeon RX <NUM>-series processors, AMD Radeon RX <NUM>-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.

In spine surgery with instrumentation such as screws and rods, a surgeon will insert each screw into a corresponding vertebra and connect the screws with a rod. When fixating two or more vertebrae, the rod connecting the screws is meant to align with the geometry of the screw tulip or head. In order to achieve this, the surgeon may need to re-shape the rod and/or force the rod into place. By forcing the rod into place, the surgeon will apply forces onto the screws and may subject the screw to pullout forces and/or potentially break one or more screws (or the pedicles or other vertebral anatomy into which the screws have been placed). The surgeon will also apply forces onto the rod, which may also potentially break the rod or bend the rod into a less effective configuration. These issues are especially problematic when operating on a long construct or using the rod as a tool to achieve alignment (e.g., the surgeon may force the spine to match the geometry of the rod).

Embodiments of the present disclosure provide for a tool used to couple the rod to the tulip. The tool includes an integrated force sensor to measure the forces and/or torques applied onto the screw. The force(s) and/or torque(s) may be examined in real-time by a computerized model that will take into consideration the quality of the screw inserted, the geometry and mechanical properties of the rod, and the patient alignment plan. When inserting the screw robotically, the position of the screws and the geometry of the rod is well defined and known to the robot. Furthermore, the quality of the screw is determined by the robotic arm as the robotic arm inserts the screw via measurement of the force and/or torque when inserting the screw into the spine.

In some embodiments, the tool can be a persuader and can aid in optimizing the rod insertion for an outcome of fitting the rod to the spine (or vice versa) with minimal disruptive forces of the spine and screws. The tool may be handheld and operated by a user (e.g., a surgeon), may be handheld and operated by a user assisted by a robotic system, or may be supported and operated by a robotic system. Sensors on or integrated to the persuader can verify that the forces or torques will not exceed a maximum force or torque that can loosen a screw or break the screw, rod, or hard tissue anatomy. The persuader can instruct the robotic system or user to move from screw to screw to distribute the load and avoid "point loading" a single screw, in a way that takes into account the quality of the screw and will not damage the fixation. In some cases, a robotic system can insert the rod and close the screws. In other cases, a surgeon or user can insert the rod and the system can close the screws. In some embodiments the persuader can be a hand-held device.

As described more fully below, methods, systems, and devices for monitoring a rod reduction process may beneficially prevent breakage or loosening of pedicle screw(s) and/or the rod. By monitoring forces or torques applied during the rod reduction process, the system can detect when the applied force or torque may cause breakage or loosening of the pedicle screw(s) and/or the rod and can cause the system to pause or remove the applied force or applied torque. Further, a surgical plan may be updated to prevent such breakage or loosening of the screw(s) and/or the rod. As such, the rod reduction process may be executed without risk of breaking or loosening pedicle screw(s) and/or a rod.

Embodiments of the present disclosure provide technical solutions to the problems of (<NUM>) improving rod reduction processes; (<NUM>) monitoring forces or torques exerted on components of a rod reduction process; (<NUM>) preventing breakage or loosening of components of a rod reduction process; and/or (<NUM>) increasing patient safety during rod reduction processes.

Turning first to <FIG>, a block diagram of a system <NUM> according to at least one embodiment of the present disclosure is shown. The system <NUM> may be used to process image data; execute a threshold algorithm <NUM>; and/or carry out other aspects of one or more of the methods disclosed herein. The system <NUM> comprises a computing device <NUM>, one or more imaging devices <NUM>, a navigation system <NUM>, a robot <NUM>, a robotic arm <NUM>, one or more robotic sensors <NUM>, one or more tools <NUM>, and/or one or more sensors <NUM>. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system <NUM>. For example, the system <NUM> may not include the navigation system <NUM>, the robot <NUM>, the robotic arm <NUM>, the robotic sensor <NUM>, and/or the sensor <NUM>. Systems according to other embodiments of the present disclosure may also be arranged differently than as shown in <FIG>. For example, the such systems may comprise a tool <NUM>, a sensor <NUM>, and a computing device <NUM> all enclosed within a common housing.

The computing device <NUM> comprises a processor <NUM>, a memory <NUM>, a communication interface <NUM>, and a user interface <NUM>. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device <NUM>.

The processor <NUM> of the computing device <NUM> may be any processor described herein or any similar processor. The processor <NUM> may be configured to execute instructions stored in the memory <NUM>, which instructions may cause the processor <NUM> to carry out one or more computing steps utilizing or based on data received from the imaging device <NUM>, the robot <NUM>, the navigation system <NUM>, the robotic sensor <NUM>, the tool <NUM>, and/or the sensor <NUM>.

The memory <NUM> may 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 memory <NUM> may store information or data useful for completing, for example, any step of the method <NUM> described herein. The memory <NUM> may store, for example, one or more threshold algorithms <NUM> and/or one or more surgical plans <NUM>. Such algorithms may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines. The algorithms may cause the processor <NUM> to manipulate data stored in the memory <NUM> and/or received from the imaging device <NUM>, the robot <NUM>, the navigation system <NUM>, the robotic sensor <NUM>, the tool <NUM>, and/or the sensors <NUM>.

The computing device <NUM> may also comprise a communication interface <NUM>. The communication interface <NUM> may be used for receiving image data or other information from an external source (such as the imaging device <NUM>, the navigation system <NUM>, the robot <NUM>, the robotic sensor <NUM>, the tool <NUM>, and/or the sensors <NUM>), and/or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device <NUM>, the navigation system <NUM>, the imaging device <NUM>, the robot <NUM>, the robotic sensor <NUM>, the tool <NUM>, and/or the sensors <NUM>). The communication interface <NUM> may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and/or one or more wireless interfaces (configured, for example, to transmit information via one or more wireless communication protocols such as <NUM>. 11a/b/g/n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface <NUM> may be useful for enabling the device <NUM> to communicate with one or more other processors <NUM> or computing devices <NUM>, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.

The computing device <NUM> may also comprise one or more user interfaces <NUM>. The user interface <NUM> may be or comprise a keyboard, mouse, trackball, monitor, television, touchscreen, headset, and/or any other device for receiving information from a user and/or for providing information to a user. In some embodiments, the user interface <NUM> may receive information and/or commands from a user via voice activation. In other embodiments, the user interface <NUM> may incorporate augmented reality or virtual reality. The user interface <NUM> may be used, for example, to receive a user selection or other user input regarding receiving a surgical plan <NUM> for reducing a rod; to receive a user selection or other user input regarding determining, based on at least one parameter, a threshold for forces or torques exerted by a tool <NUM> on the rod or a pedicle screw; to receive a user selection or other user input regarding causing at least one sensor <NUM> to monitor a magnitude of the forces or torques exerted by the tool <NUM> on the pedicle screw or the rod during reduction of the rod into the head; to receive a user selection or other user input regarding updating the plan <NUM> when the monitored magnitude meets the threshold; to receive a user selection or other user input regarding causing a robotic arm <NUM> to insert the rod into the patient; to receive a user selection or other user input regarding causing the robotic arm <NUM> to operate the tool <NUM> to reduce the rod onto a plurality of pedicle screws in stages, the plurality of pedicle screws including the pedicle screw; to receive a user selection or other user input regarding receiving, from at least one robotic sensor <NUM>, sensor data corresponding to a force or torque exerted by the robotic arm <NUM> onto the pedicle screw during implantation of the pedicle screw in the patient; to receive a user selection or other user input regarding determining a screw quality of the pedicle screw based on the sensor data; and/or to display images and/or a surgical plan <NUM>. In some embodiments, the user interface <NUM> may be useful to allow a surgeon or other user to modify a plan <NUM>, or other information displayed, though it will be appreciated that each of the preceding inputs may be generated automatically by the system <NUM> (e.g., by the processor <NUM> or another component of the system <NUM>) or received by the system <NUM> from a source external to the system <NUM>. In some embodiments, user input such as that described above may be optional or not needed for operation of the systems, devices, and methods described herein.

Although the user interface <NUM> is shown as part of the computing device <NUM>, in some embodiments, the computing device <NUM> may utilize a user interface <NUM> that is housed separately from one or more remaining components of the computing device <NUM>. In some embodiments, the user interface <NUM> may be located proximate one or more other components of the computing device <NUM>, while in other embodiments, the user interface <NUM> may be located remotely from one or more other components of the computer device <NUM>.

The imaging device <NUM> may be capable of taking a 2D image or a 3D image to yield an image and/or image data. The imaging device <NUM> may be used to verify or monitor placement of the tool <NUM> and/or a surgical instrument (e.g., pedicle screw(s) and/or rod). "Image data" as used herein refers to the data generated or captured by an imaging device, including in a machine-readable form, a graphical form, and in any other form. The imaging device <NUM> may be or comprise, for example, a camera, a CT scanner, a fluoroscope, an ultrasound probe, an O-arm, a C-arm, a G-arm, any other device utilizing X-ray-based imaging, a magnetic resonance imaging (MRI) scanner, an optical coherence tomography scanner, an endoscope, a microscope, a thermographic camera (e.g., an infrared camera), or any other imaging device suitable for obtaining images or image data corresponding to an anatomical feature of a patient or an object.

The navigation system <NUM> may provide navigation for a surgeon and/or a surgical robot during an operation. The navigation system <NUM> may be any now-known or future-developed navigation system, including, for example, the Medtronic StealthStation™ S8 surgical navigation system. The navigation system <NUM> may include a camera or other sensor(s) for tracking one or more reference markers or other objects within the operating room or other room where a surgery takes place. In various embodiments, the navigation system <NUM> may be used to track a position of the imaging device <NUM> (or, more particularly, of a navigated reference marker attached, directly or indirectly, in fixed relation to the imaging device <NUM>) and/or of the robot <NUM> (or, more particularly, of a navigated reference marker attached, directly or indirectly, in fixed relation to the robot <NUM>). The navigation system <NUM> may include a display for displaying one or more images from an external source (e.g., the computing device <NUM>, imaging device <NUM>, or other source) or a video stream from the camera or other sensor of the navigation system <NUM>. In some embodiments, the system <NUM> can operate without the use of navigation system <NUM>.

The robot <NUM> may be any surgical robot or surgical robotic system. The robot <NUM> may be or comprise, for example, the Mazor X™ Stealth Edition robotic guidance system. The robot <NUM> may comprise one or more robotic arms <NUM>. In some embodiments, the robotic arm <NUM> may comprise a plurality of robotic arms, though the robot <NUM> may comprise one robotic arm, two robotic arms, or more than two robotic arms. The robotic arm <NUM> may be used to selectively hold and/or operate one or more imaging devices <NUM>, the tool <NUM>, and/or any instrument (e.g., pedicle screws, set screws, and/or rods). In some embodiments, the robotic arm <NUM> has at least five degrees of freedom. In other embodiments, the robotic arm <NUM> has at least six degrees of freedom. In yet other embodiments, the robotic arm <NUM> has fewer than five or greater than six degrees of freedom. The robotic arm <NUM> (and/or a base of the robot <NUM>) may also have three dimensions of orientation. The combination of multiple degrees of freedom and multiple dimensions of orientation allows for the robotic arm <NUM> to move to any pose. In other words, the robotic arm <NUM> is not limited to a fixed area and can move in any direction. Further, in some embodiments, the robot <NUM> can move during a surgical procedure to position the robotic arm <NUM> (and thus, the tool <NUM>).

Reference markers (e.g., navigation markers) may be placed on the robot <NUM>, the robotic arm <NUM>, the imaging device <NUM>, the tool <NUM>, and/or any other object in the surgical space. The markers may be tracked by the navigation system <NUM>, and the results of the tracking may be used by the robot <NUM> and/or by an operator of the system <NUM> or any component thereof. As described above, in some embodiments, the navigation system <NUM> can be used to track other components of the system <NUM> (e.g., the imaging device <NUM>) and the system <NUM> can operate without the use of the robot <NUM> (e.g., with the surgeon manually manipulating the imaging device <NUM>).

In some embodiments, the robot <NUM> comprises the one or more robotic sensors <NUM> operable to yield sensor data of the robot <NUM> or the robotic arm <NUM>. In alternative embodiments, the robot <NUM> does not comprise the robotic sensors <NUM>. The sensor data may include, but is not limited to, a force or torque experienced by the robotic arm <NUM> and/or the robot <NUM>. In some examples, the force or torque corresponds to a force or torque received by a surgical instrument (e.g., a pedicle screw) from the robotic arm <NUM>. In such examples, the sensor data may be used to determine a change in a mechanical property of the surgical instrument.

Each robotic sensor <NUM> may be any kind of robotic sensor <NUM> for measuring the force or torque. The robotic sensor <NUM> may include one or more or any combination of components that are electrical, mechanical, electro-mechanical, magnetic, electromagnetic, or the like. The robotic sensor <NUM> may include, but is not limited to, one or more of a torque sensor, a force sensor, a linear encoder, a rotary encoder, a capacitor, and/or an accelerometer. In some embodiments, the robotic sensor <NUM> may include a memory for storing sensor data. In still other examples, the robotic sensor <NUM> may output signals (e.g., sensor data) to one or more sources (e.g., the computing device <NUM>, the navigation system <NUM>, and/or the robot <NUM>).

The robotic sensor <NUM> may be integrated internally into the robotic arm <NUM> or otherwise positioned inside of the robotic arm <NUM>. In some embodiments, the robotic sensor <NUM> is positioned inside a joint (shown in <FIG>) of the robotic arm <NUM>. The robotic sensor <NUM> may include a plurality of sensors and each sensor may be positioned at the same location or a different location as any other sensor. For example, a robotic sensor <NUM> may be positioned in one or more joints of the robotic arm <NUM>. It will be appreciated that in some embodiments the sensor(s) <NUM> can be positioned at or on any component of the system <NUM> or surrounding environment (e.g., on any portion of the navigation system <NUM>, the robot <NUM>, the robotic arm <NUM>, and/or any other component at the surgical site).

In some embodiments, the robotic sensor <NUM> may send data to the computing device <NUM> to display on the user interface <NUM> or otherwise notify the surgeon or operator of the sensor data received from the robotic sensor <NUM>. In other embodiments, the robotic sensor <NUM> may alert the surgeon or operator of a change in a mechanical property of the surgical instrument (e.g., a pedicle screw) by an alert such as a sound or a light display.

The tool <NUM> may enable execution of a surgical procedure such as a rod reduction. The tool <NUM> can be hand-held or adapted to be held by the robotic arm <NUM>. In some embodiments, the tool <NUM> is used manually by a user (e.g., a surgeon). For example, the tool <NUM> may be used by a user to persuade a rod into place while also gauging forces applied to a pedicle screw to which the rod is being persuaded. In other words, a physical connection between the tool <NUM> and the screw may not be robotically controlled. In other embodiments, the robot <NUM> may aid the surgeon in using the tool <NUM>. In further embodiments, the tool <NUM> may be held by the robotic arm <NUM> and automatically controlled by the robot <NUM>. Instructions for using the tool <NUM> may either be machine readable or human readable. In examples where the instructions are machine readable, the instructions may be transmitted to the robot <NUM> to execute. In examples where the instructions are human readable, the instructions may be displayed on the user interface <NUM> or audibly communicated to the surgeon.

In some embodiments, the tool <NUM> is a persuader for reducing a rod onto one or more heads of one or more pedicle screws. In other embodiments, the tool <NUM> may be any tool used during a rod reducing process. For example, the tool <NUM> may be either a screwdriver for driving a pedicle screw into a vertebra, a pedicle screw extender for gripping the pedicle screw at an extended distance, and/or a nut driver for tightening a set screw into a head of a pedicle screw.

Sensor(s) <NUM> may be used to track and/or sense a force or torque exerted by the tool <NUM> on a surgical instrument (e.g., a rod and/or pedicle screw(s)). In some embodiments, the sensor <NUM> is disposed on the tool <NUM>. In other embodiments, the sensor <NUM> is disposed on a head of a pedicle screw. In further embodiments, the sensor <NUM> may be positioned on any component of the system <NUM>. The sensor <NUM> may be any kind of sensor <NUM> for measuring the force or torque exerted by the tool <NUM>. The sensor <NUM> may include one or more or any combination of components that are electrical, mechanical, electro-mechanical, magnetic, electromagnetic, or the like. The sensor <NUM> may include, but is not limited to, one or more of a torque sensor, a force sensor, a linear encoder, a rotary encoder, a capacitor, and/or an accelerometer. In some embodiments, the sensor <NUM> may include a memory for storing sensor data. In still other examples, the sensor <NUM> may output signals (e.g., sensor data) to one or more sources (e.g., the computing device <NUM>, the navigation system <NUM>, and/or the robot <NUM>). The sensor <NUM> may be either positioned adjacent to or integrated with the tool <NUM>. The sensor <NUM> may include a plurality of sensors and each sensor may be positioned at the same location or a different location as any other sensor.

In some embodiments, the sensor <NUM> may send the data to the computing device <NUM> when the sensor <NUM> detects that a magnitude of the forces or torques exerted by the tool <NUM> exceeds a threshold. In other embodiments, the sensor <NUM> may continuously send the data to the computing device <NUM>. Further, in some embodiments, the sensor <NUM> may send data to the computing device <NUM> to display on the user interface <NUM> or otherwise notify the surgeon or operator of the magnitude exceeding the threshold. In other embodiments, the sensor <NUM> may alert the surgeon or operator of the magnitude exceeding the threshold by an alert such as a sound or a light display. The sensor <NUM> may advantageously provide a safety function by monitoring and alerting the surgeon or operator of the magnitude exceeding the threshold.

Turning to <FIG>, a block diagram of another system <NUM> according to at least one embodiment of the present disclosure is shown. The system <NUM> includes a computing device <NUM> (which may be the same as or similar to the computing device <NUM> described above), a navigation system <NUM> (which may be the same as or similar to the navigation system <NUM> described above), and a robot <NUM> (which may be the same as or similar to the robot <NUM> described above). Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system <NUM>. For example, the system <NUM> may not include the navigation system <NUM>.

As illustrated, the robot <NUM> includes a robotic arm <NUM> (which may comprise one or more members 218A connected by one or more joints 218B) extending from a base <NUM>. In other embodiments, the robot <NUM> may include two or more robotic arms. The base <NUM> may be stationary or movable. The robotic arm <NUM> is operable to execute one or more planned movements and/or procedures autonomously and/or based on input from a surgeon or operator. In the illustrated embodiment, a tool <NUM> (which may be the same as or similar to the tool <NUM> described above), may be disposed at an end of the robotic arm <NUM>, though the tool <NUM> (or any other tool(s) or instrument(s)) may be disposed on any portion of the robotic arm <NUM>. In other embodiments, the tool <NUM> may be handheld and operated by a user or by a user assisted by the robot <NUM>. The tool <NUM> may be used to perform a procedure on a vertebra <NUM> of a spinal region <NUM>. Further, different tools <NUM> may be attached to the robotic arm <NUM> at difference stages of a surgical procedure. For example, a drill may be attached to the robotic arm <NUM> to drill a hole for a pedicle screw, and a screwdriver may then be attached to the robotic arm <NUM> to drive the pedicle screw in the hole. In the same example, a driver may be attached to the robotic arm <NUM> to drive a set screw in a head of each pedicle screw.

A robotic sensor <NUM> (which may be the same as or similar to the robotic sensor <NUM> described above, and of which more than one may be included in the robotic arm <NUM>) may be integrated into a joint 218B of the robotic arm <NUM>. Though the sensor <NUM> is shown integrated into the joint 218B nearest the base <NUM>, the sensor <NUM> may be integrated into any joint 218B, any member 218A, or any portion of the robotic arm <NUM> and/or the robot <NUM>. Furthermore, more than one robotic sensor <NUM> may be integrated into the robotic arm <NUM> and/or the robot <NUM>. As similarly described above, the robotic sensor <NUM> may be one or more of a torque sensor, a force sensor, or an encoder integrated into the joint 218B. The robotic sensor <NUM> is configured to sense at least one of an applied force or an applied torque exerted on the robotic arm <NUM>. As will be described below with respect to <FIG>, such sensor data may be used to determine a screw quality of each of one or more pedicle screws.

A sensor <NUM> (which may either be the same as or similar to the sensor <NUM> described above) may also be integrated into the tool <NUM>. As described above, the sensor <NUM> may be disposed on the tool <NUM>, and may be used to track and/or sense a force or torque exerted by the tool <NUM> on a surgical instrument (e.g., a rod and/or pedicle screw(s)), or vice versa. The sensor <NUM> may also be integrated into the tool <NUM>. The sensor <NUM> may be any kind of sensor <NUM> for measuring the force or the torque exerted by the tool <NUM> on a pedicle screw or other surgical instrument or device, or vice versa.

Turning now to <FIG>, a method <NUM> for monitoring a rod reduction process 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) <NUM> of the computing device <NUM> or <NUM> described above. The at least one processor may be part of a robot (such as a robot <NUM> or <NUM>) or part of a navigation system (such as a navigation system <NUM> or <NUM>). A processor other than any processor described herein may also be used to execute the method <NUM>. The at least one processor may perform the method <NUM> by executing instructions stored in a memory (such as the memory <NUM>). The instructions may correspond to one or more steps of the method <NUM> described below. One or more aspects of the method <NUM> may be performed by or with a surgical robot and/or a surgeon.

The method <NUM> comprises receiving a surgical plan such as the surgical plan <NUM> for reducing a rod (step <NUM>). The surgical plan may be received via a user interface (e.g., the user interface <NUM>) and/or a communication interface (e.g., the communication interface <NUM>) of a computing device such as the computing device <NUM> or <NUM>, and may be stored in a memory such as the memory <NUM> of the computing device. The surgical plan may include information about a rod reduction process. The information may include a pedicle screw placement, a rod shape, a rod insertion point, an order in which a rod will be reduced onto a plurality of pedicle screws, and/or an amount of force or torque exerted for each rod reduction step. The surgical plan may also include information about one or more planned movements of a robotic arm such as the robotic arm <NUM> or <NUM>. In some embodiments, the surgical plan includes a planned trajectory or path for the robotic arm.

The method <NUM> may also comprise receiving sensor data corresponding to a force or torque exerted onto the pedicle screw during implantation of the pedicle screw in the patient (step <NUM>). The force or torque exerted may be force or torque exerted by a robotic arm or by a user operating a tool such as the tool <NUM> or <NUM>. The sensor data may be obtained from at least one sensor such as the sensor <NUM> or <NUM> disposed on or integrated with a tool such as the tool <NUM> or <NUM> or from at least one robotic sensor such as the robotic sensor <NUM> or <NUM> on a robotic arm such as the robotic arm <NUM> or <NUM>. The at least one robotic sensor may either be positioned on the robotic arm or integrated with the robotic arm. The robotic sensor may send data to the computing device to display on the user interface. A processor such as the processor <NUM> or any other component of the system such as the system <NUM> or <NUM> may receive the sensor data and generate a notification to notify the surgeon or operator of the sensor data received from the robotic sensor. In other embodiments, the processor or other component of the system may alert the surgeon or operator of a change in a mechanical property (described below in step <NUM>) of the surgical instrument (e.g., a pedicle screw) by an alert such as a sound or a light display.

The method <NUM> also comprises determining a screw quality of the pedicle screw (step <NUM>). The determining may be based on sensor data received in step <NUM>. The sensor data may be a force and/or a torque exerted by the robotic arm onto the pedicle screw (and thus, corresponding to the force and/or torque received by the pedicle screw) when the screw is inserted into a vertebra. Determining the screw quality may include calculating a change in one or more mechanical properties of each screw as a result of the force or torque received by each screw. For example, a screw may experience a change in stress due to a force or torque received from the robotic arm. In the same example, if the change in stress is greater than a maximum stress of the screw, then the screw may subsequently no longer be able to withstand the same amount of force or torque initially received. Thus, the threshold may be decreased to avoid applying a force or torque equal to or near the force or torque initially received. The screw quality may also be determined based on sensed sound and/or vibration(s) data corresponding to the screw during insertion of the screw. The sound and/or vibration data may provide further information about a change in one or more mechanical properties of the screw.

The method <NUM> also comprises determining, based on at least one parameter, a threshold for forces or torques exerted by a tool such as the tool <NUM> or <NUM> on the rod or a pedicle screw (step <NUM>). The determining may comprise executing a threshold algorithm such as the threshold algorithm <NUM>. The threshold may be set at a level that will prevent (at some level of statistical certainty, for example) the tool from exerting a force or torque that will break the rod, the pedicle screw, and/or corresponding vertebrae during the rod reduction. Determining this threshold may include determining and analyzing bone quality of corresponding vertebrae to avoid breaking any of the corresponding vertebrae. Further, the threshold may be set at a level that will prevent (again, for example, at some level of statistical certainty) the tool from exerting a force or torque that will pull the pedicle screw out of a vertebra.

The at least one parameter may be received by the computing device, and more particularly, by the processor of the computing device, and may be stored in the memory. In some embodiments, the at least one parameter may be indirectly received via any other component of the system or a node of a network to which the system is connected. The at least one parameter may also be received from a surgical plan such as the surgical plan <NUM>. The at least one parameter may also be, but is not limited to, a screw quality, a geometry of the rod, a mechanical property of the rod, a rod strength analysis, an updated spine position, a bone quality, one or more dimensions of the bone into which the screw has been screwed, a patient age, and/or a patient range of motion.

Where the at least one parameter includes screw quality, the screw quality may be determined from sensor data (such as force data or torque data) as detected by a robotic sensor (such as the robotic sensor <NUM> or <NUM>) as described with respect to step <NUM>. The sensor data may be obtained as described with respect to step <NUM>, described above. For example, a strength of the screw may be reduced if the screw receives a force or torque greater than an anticipated force or torque during insertion of the screw. Where the at least one parameter includes bone quality, the bone quality may be obtained from preoperative image(s) and/or patient input.

Any one or more of the geometry, mechanical property, and/or rod strength of the rod, when included in the at least one parameter, may be received from a surgical plan (e.g., a surgical plan <NUM>) that includes dimensions and the geometry of the rod. The geometry, mechanical property, and/or rod strength of the rod may also be received from a surgeon. Such information may be received, for example, via a user interface such as the user interface <NUM> and/or a communication interface such as the communication interface <NUM> of the computing device. The mechanical property of the rod may include, but is not limited to, at least one of hardness, brittleness, ductility, toughness, and/or strength.

The updated spine position of a patient may be received from the surgical plan or input received from a surgeon. The input may be received, for example, via the user interface and/or the communication interface of the computing device. The updated spine position may also be depicted in or otherwise determinable from an image of the patient prior to or during a surgical procedure received from an imaging device, such as the imaging device <NUM>.

The patient range of motion may be input received from a surgeon or patient. The input may be received, for example, via the user interface and/or the communication interface of the computing device. The patient range of motion may include, but is not limited to, a range of motion of a spinal region of the patient. The range of motion may be determined, in some embodiments, by a computing device such as the computing device <NUM> or <NUM>, based on a plurality of images showing the patient in positions of maximum bending (e.g., positions of flexion or extension).

The method <NUM> further comprises inserting the rod into a patient (step <NUM>). The rod may be inserted by a robotic arm such as the robotic arm <NUM> or <NUM>, in which case the step <NUM> comprises causing the robotic arm to insert the rod into the patient. Alternatively, the rod may be inserted by a user (based, for example, on instructions provided via a user interface), or may be inserted by a user assisted by a robot such as the robot <NUM> or <NUM>. In some embodiments, the robotic arm may insert the rod based on an insertion point and/or trajectory defined by the surgical plan. In other embodiments, the robotic arm may insert the rod based on inputs received from a surgeon or user. The input may be received, for example, via a user interface such as the user interface <NUM> and/or a communication interface such as the communication interface <NUM> of a computing device such as the computing device <NUM> or <NUM>.

The method <NUM> also comprises operating the tool to reduce the rod onto a plurality of pedicle screws in stages (step <NUM>). The tool may be operated by a robotic arm such as the robotic arm <NUM> or <NUM>, in which case the step <NUM> comprises causing the robotic arm to operate the tool to reduce the rod onto the plurality of screws in stages. Alternatively, the tool may be operated by a user (e.g., based on instructions provided via a user interface), or may be operated by a user assisted by a robot such as the robot <NUM> or <NUM>. Reducing the rod in stages is based on the surgical plan and comprises causing the robotic arm or surgeon to incrementally tighten, in sequence, a set screw in a head of each pedicle screw of the plurality of pedicle screws to avoid point loading any single pedicle screw. Reducing the rod in stages may include generating instructions to reduce the rod in stages. In some embodiments, the instructions may be machine readable and transmitted to the robotic arm. In other embodiments, the instructions may be displayed on the user interface or audibly communicated to the surgeon.

The method <NUM> also comprises receiving sensor data corresponding a magnitude of a force or torque exerted by the tool on the pedicle screw or the rod during reduction of the rod into a head (step <NUM>). The sensor data may be obtained from at least one sensor, which may be or comprise, for example, a sensor <NUM> or <NUM>. As previously described, the sensor may be used to track and/or sense a force or torque exerted by the tool on a surgical instrument (e.g., a rod and/or pedicle screw(s)). The sensor may be disposed on the tool, on a head of a screw, or on any component of the system. In some embodiments, the sensor is integrated into the tool. The sensor may be any kind of sensor for measuring the force or torque exerted by the tool on the pedicle screw or the rod. The sensor may include one or more or any combination of components that are electrical, mechanical, electro-mechanical, magnetic, electromagnetic, or the like. The sensor may include, but is not limited to, one or more of a torque sensor, a force sensor, a linear encoder, a rotary encoder, a capacitor, and/or an accelerometer. In some embodiments, the sensor may include a memory for storing sensor data. In still other examples, the sensor may output signals to one or more sources (e.g., a computing device such as the computing device <NUM> or <NUM>, a navigation system such as the navigation system <NUM> or <NUM>, and/or the robot). The sensor may include a plurality of sensors (which may or may not all be the same as each other) and each sensor may be positioned at the same location or a different location as any other sensor.

In some embodiments, the sensor may send sensed data to the computing device when the sensor detects that a magnitude of the forces or torques exerted by the tool exceeds a threshold, as described further below. In other embodiments, the sensor may continuously send sensed data to the computing device. Further, in some embodiments, the sensor may send data to the computing device to display on the user interface or to otherwise notify the surgeon or operator of the monitored magnitude and/or that the magnitude exceeds the threshold. In other embodiments, based on sensor data, the processor or other component of the system may alert the surgeon or operator of the magnitude exceeding the threshold by an alert such as a sound or a light display. The sensor may advantageously provide a safety function by monitoring and alerting the surgeon or operator of the magnitude exceeding the threshold.

In some embodiments, the sensor may be used to monitor a pose of the robotic arm. In the same embodiments, the sensor may be used to monitor a position of each pedicle screw and a position of the rod via the robotic arm (e.g., one or more robotic arms may be holding or otherwise contacting a pedicle screw or rod). For example, the robotic arm may hold the rod during rod insertion or may hold the pedicle screw during insertion of the pedicle screw. The position of each pedicle screw and the position of the rod may be monitored in real-time. In other embodiments, the position of each pedicle screw and/or the position of the rod is monitoring by the navigation system. In further embodiments, the rod and/or each pedicle screw may be monitored by a robotic sensor such as the robotic sensor <NUM> or <NUM>.

The method <NUM> also comprises updating the surgical plan when the monitored magnitude meets the threshold (step <NUM>). The updating may include updating one or more surgical steps of the surgical plan. For example, an order of pedicle screws to reduce may be adjusted. In another example, the threshold may be adjusted. In a further example, one or more surgical steps may be introduced to and/or removed from the plan. For example, the plan may be modified to include more surgical steps to move from pedicle screw to pedicle screw to distribute the force or torque loads and to avoid "point loading" onto a single pedicle screw.

The updating may include updating a position and/or orientation of one or more pedicle screws. For example, the position of one of the pedicle screws may be adjusted to reduce the force or torque on a pedicle screw. In another example, the position of one of the pedicle screws may be adjusted to account for a new rod shape (which the new rod shape may be calculated or otherwise generated to reduce the forces or torques required to reduce the rod to the pedicle screws or vice versa). In yet another example, the position of one of the pedicle screws may be adjusted based on the screw quality as determined in step <NUM>, as previously described.

The updating may also include updating a rod shape, a rod trajectory, and/or a rod insertion point. The rod shape, trajectory and/or insertion point may be updated to reduce the force or torque received by the rod and/or the pedicle screw(s). The rod shape, trajectory and/or insertion point may also be updated to account for a new position and/or a new orientation of one or more pedicle screws.

In some embodiments, the procedure may pause during the updating. For example, the robotic arm may automatically pause or may release a force or torque applied to a pedicle screw and/or rod when the magnitude meets the threshold. In another example, a notification may be audibly or visually communicated to the surgeon to alert the surgeon that the magnitude has met the threshold. In other examples, the robot may not allow the surgeon to complete a surgical step when the threshold has been met.

The methods and systems described herein provide a system, method, and device for monitoring a rod reduction process based on determining a threshold for forces or torques exerted by a tool on a pedicle screw or a rod and monitoring a magnitude of the forces or torques exerted by the tool on the pedicle screw or the rod during the rod reduction process. The monitoring beneficially reduces a likelihood of breakage or loosening of pedicle screw(s), the rod, and/or the patient's vertebrae and/or other bony anatomy. By monitoring forces or torques applied during the rod reduction process, the system detects when the applied force or torque may cause breakage or loosening of the pedicle screw(s), the rod, and/or the patient's bony anatomy, and prevents the tool from applying such force or torque. Further, a surgical plan may be updated during the process to prevent such breakage or loosening of the screw(s) and/or the rod. As such, the rod reduction process may be executed and updated to prevent breaking or loosening pedicle screw(s) and/or a rod.

As may be appreciated based on the foregoing disclosure, the present disclosure encompasses methods with fewer than all of the steps identified in <FIG> (and the corresponding description of the method <NUM>), as well as methods that include other and/or additional steps beyond those identified in <FIG> (and the corresponding description of the method <NUM>). For example, the method <NUM> may comprise only one, or only two, of the steps <NUM> to <NUM>. Methods of the present disclosure explicitly include methods with one or more steps described above as part of the method <NUM>.

The foregoing discussion has been presented for purposes of illustration and description. 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.

Claim 1:
A system (<NUM>) for monitoring a rod reduction process comprising:
a tool (<NUM>, <NUM>) configured to reduce a rod into a head of a pedicle screw;
at least one sensor (<NUM>, <NUM>) configured to measure forces or torques exerted on the pedicle screw;
at least one processor (<NUM>); and
at least one memory (<NUM>) storing instructions for execution by the at least one processor (<NUM>) that, when executed, cause the at least one processor (<NUM>) to:
determine, based on at least one parameter, a threshold for forces or torques exerted by the tool (<NUM>, <NUM>) on the pedicle screw; and
receive, from the at least one sensor, data corresponding to a magnitude of the forces or torques exerted by the tool (<NUM>, <NUM>) on the pedicle screw during reduction of the rod into the head by the tool (<NUM>, <NUM>),
characterized in that the system (<NUM>) further comprises:
at least one robotic arm (<NUM>, <NUM>) configured to selectively implant the pedicle screw in a patient and hold the tool (<NUM>, <NUM>); and
at least one robotic sensor (<NUM>, <NUM>) disposed on the robotic arm (<NUM>, <NUM>),
wherein the memory (<NUM>) stores additional instructions for execution by the at least one processor (<NUM>) that, when executed, further cause the at least one processor (<NUM>) to:
receive, from the at least one robotic sensor (<NUM>, <NUM>), sensor data corresponding to a force or torque exerted by the robotic arm (<NUM>, <NUM>) onto the pedicle screw during implantation of the pedicle screw in the patient; and
determine a screw quality of the pedicle screw based on the sensor data and calculate a change in one or more mechanical properties of the pedicle screw as a result of a force or torque received by the pedicle screw.