System for rod insertion planning and rod insertion

Abstract

The present disclosure provides systems and methods for insertion of a rod. At least one tower extending from a head of a corresponding implanted pedicle screw can be tracked to identify tower movement. An insertion point and a path from the insertion point to the at least one tower can be calculated. A rod can be inserted at the insertion point and along the rod, and the path can be adjusted based on the identified tower movement during insertion of the rod.

Description

Technical Field

[0001] This technology generally relates to robotic surgery, and more specifically to planning rod insertion and using robot-assisted or robotic surgery to perform rod insertion. Background Technology

[0002] Minimally invasive surgery advantageously reduces patient trauma by minimizing the size of the required incision. Surgical robots are useful during surgical procedures and can operate autonomously (e.g., without any human input during the procedure), semi-autonomously (e.g., with some human input during the procedure), or non-autonomously (e.g., only under the guidance of human input). In some cases, using multiple robotic arms during surgery allows more procedures to be completed in a shorter time compared to using only one robotic arm. Summary of the Invention

[0003] Exemplary aspects of this disclosure include: A robotic system for inserting a rod according to at least one embodiment of the present disclosure includes a robotic arm including a proximal end portion; and a distal end portion movable relative to the proximal end portion, the distal end portion being configured to position the rod; at least one processor; and a memory storing instructions for execution by the at least one processor, the instructions, when executed, causing the at least one processor to: track at least one tower to identify tower movement, the tower extending from the head of a corresponding implanted pedicle screw; calculate an insertion point and a path from the insertion point to the at least one tower; insert the rod at the insertion point and along the path by the robotic arm; and adjust the path by the robotic arm based on the tower movement during the rod insertion.

[0004] In any aspect of this document, the system further includes: at least one sensor, wherein the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: use the at least one sensor to monitor the magnitude of the force received by the robotic arm.

[0005] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: suspend the movement of the bar by the robotic arm when the magnitude of the force meets a threshold.

[0006] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: tighten the fixing screw of the corresponding pedicle screw in the robotic arm.

[0007] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: cause the robotic arm to remove the at least one tower from the head of the corresponding pedicle screw.

[0008] In any aspect of this document, the tracking of at least one tower uses at least one of a navigation system, markers, or sensors.

[0009] In any aspect of this document, adjusting the path by the robotic arm includes adjusting at least one of the orientation or position of the rod.

[0010] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further instruct the at least one processor to: verify the placement of the rod in the at least one tower.

[0011] In any aspect of this document, the placement of the rod in at least one tower is verified using at least one of a laser pointer and reflector, a navigation system, a sensor, or a marker.

[0012] A robotic system for inserting a rod according to at least one embodiment of the present disclosure includes a first robotic arm and a second robotic arm, each robotic arm including: a proximal end portion; and a distal end portion movable relative to the proximal end portion, wherein the distal end portion of the first robotic arm is configured to position the rod, and the distal end portion of the second robotic arm is configured to hold at least one tower in a known position, the at least one tower extending from the head of a corresponding pedicle screw in one of a plurality of vertebrae; at least one processor; and a memory storing instructions for execution by the at least one processor, the instructions, when executed, causing the at least one processor to: receive position information about the current position of the at least one tower; calculate an insertion point and a path from the insertion point to the at least one tower based on the current position; and cause the first robotic arm to insert the rod at the insertion point and along the calculated path.

[0013] In any aspect of this document, the position information is received from at least one sensor of the second robotic arm.

[0014] In any aspect of this document, the system also includes: a tracking marker positioned on the second robotic arm; and a navigation system configured to generate the location information based on detected movement of the tracking marker.

[0015] In any aspect of this document, the system also includes at least one sensor, and wherein the memory stores additional instructions for execution by the at least one processor, which, when executed, further instruct the at least one processor to: verify the placement of the rod in the at least one tower via the at least one sensor.

[0016] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: cause the first robotic arm to tighten the fixing screw of the corresponding pedicle screw.

[0017] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: cause the first robotic arm to remove the tower from the head of the corresponding pedicle screw.

[0018] In any aspect of this document, wherein the current position is different from the known position, and the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: when the difference between the current position and the known position meets a predetermined threshold, cause the first robotic arm to adjust the path during the insertion of the rod.

[0019] In any aspect thereof, wherein the current position is different from the known position, and the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: adjust the position of the at least one tower by the second robotic arm based on the difference between the current position and the known position satisfying a predetermined threshold.

[0020] A method for inserting a rod according to at least one embodiment of the present disclosure includes: tracking at least one tower extending from a corresponding implanted pedicle screw to detect movement of the at least one tower; calculating an insertion point and a path from the insertion point to the at least one tower; inserting the rod at the insertion point and along the path with a robotic arm; and adjusting the path based on the detected movement during the insertion of the rod.

[0021] In any aspect of this document, the method also includes: removing the tower from the corresponding pedicle screw by the robotic arm.

[0022] In any aspect of this document, the method further includes: tightening the fixing screw of the corresponding pedicle screw with the robotic arm.

[0023] In any aspect of this document, the tracking of at least one tower uses at least one of a navigation system, markers, or sensors.

[0024] In any aspect of this document, the method also includes: verifying the placement of the rod in the at least one tower.

[0025] A robotic system for inserting a rod according to at least one embodiment of the present disclosure includes a robotic arm including a proximal end portion; and a distal end portion movable relative to the proximal end portion, the distal end portion being configured to hold at least one tower in a known position; at least one processor; and a memory storing instructions for execution by the at least one processor, the instructions, when executed, causing the at least one processor to: calculate an insertion point and a path from the insertion point to the at least one tower; generate instructions for inserting the rod along the path; and update the path during the insertion of the rod based on information about the position of the rod or the movement of the tower.

[0026] In any aspect of this document, the system further includes: at least one sensor, wherein the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: use the at least one sensor to monitor the magnitude of the force received by the robotic arm.

[0027] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: release the tower by the robotic arm when the magnitude of the force meets a threshold.

[0028] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: cause the robotic arm to tighten the fixing screw corresponding to the pedicle screw of the tower.

[0029] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: cause the robotic arm to remove the at least one tower from the head of the pedicle screw corresponding to the tower.

[0030] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to move the tower from the known position to a newer position based on at least one of the force applied to the robotic arm or information about the position of the bar.

[0031] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further instruct the at least one processor to: verify the placement of the rod in the at least one tower.

[0032] In any aspect of this document, the placement of the rod in at least one tower is verified using at least one of a laser pointer and reflector, a navigation system, a sensor, or a marker.

[0033] A method for calculating the insertion point and path of a rod according to at least one embodiment of the present disclosure includes: receiving a surgical plan having at least one image and information about the location of at least one tower, the at least one image depicting a surgical area; identifying a soft tissue portion and at least one anatomical element in the at least one image; calculating an insertion point and a path from the insertion point to the at least one tower based on the identified soft tissue portion and at least one anatomical element; and inserting the rod at the insertion point and along the path using a robotic arm.

[0034] In any aspect of this document, the at least one image is obtained from at least one of an MRI scanner, an ultrasound scanner, or a CT scanner.

[0035] In any aspect of this document, the at least one image includes a first image and a second image of the surgical area, the first image including hard tissue information and the second image including soft tissue information.

[0036] In any aspect thereof, the first image is generated using a first imaging modality and the second image is generated using a second imaging modality.

[0037] In any aspect of this document, the first image is a CT image and the second image is an ultrasound image.

[0038] In any aspect of this document, one of the first image and the second image is a preoperative image, and the other of the first image and the second image is an intraoperative image.

[0039] Any aspect of this document in which the insertion point and the path are calculated based on one or more inputs.

[0040] In any aspect of this document, the identification of the at least one anatomical element is performed using at least one of feature recognition, machine learning, artificial intelligence, or neural networks.

[0041] In any aspect of this article, segmentation is used to identify the soft tissue portion.

[0042] Any aspect of this document in which the insertion point and the path are calculated based on information about the geometry of the rod.

[0043] In any aspect of this document, the method further includes updating the path based on detected movement of the soft tissue portion during insertion of the rod along the path.

[0044] In any aspect of this document, the method also includes updating the path based on the detected movement of the at least one tower.

[0045] A method for inserting a rod according to at least one embodiment of the present disclosure includes: receiving a surgical plan having information about an insertion point and a path from the rod to at least one tower; causing a robotic arm to insert the rod at the insertion point using the path; tracking the rod during insertion using the path; determining a difference between the pose of the rod and the path; and updating the path when the difference meets a threshold.

[0046] Any aspect of this document in which the updated path is communicated to the user.

[0047] In any aspect of this document, tracing the rod includes tracing the soft tissue portion surrounding the rod.

[0048] In any aspect of this document, the surgical plan includes at least one image depicting the surgical area, and the method further includes: identifying a soft tissue portion and at least one anatomical element in the at least one image; and calculating the insertion point and the path from the insertion point to the at least one tower based on the identified soft tissue portion and at least one anatomical element.

[0049] In any aspect of this article, the at least one image is obtained from an MRI scanner.

[0050] Any aspect of this document in which the insertion point and the path are calculated based on one or more inputs.

[0051] In any aspect of this document, the identification of the at least one anatomical element is performed using at least one of feature recognition, machine learning, artificial intelligence, or neural networks.

[0052] In any aspect of this article, segmentation is used to identify the soft tissue portion.

[0053] Any aspect of this document in which the insertion point and the path are calculated based on information about the geometry of the rod.

[0054] In any aspect of this document, the tracking of the stick uses at least one of a navigation system, markers, or sensors.

[0055] A system for calculating the insertion point and path of a rod according to at least one embodiment of the present disclosure, the system comprising at least one processor; and at least one memory storing instructions for execution by the at least one processor, the instructions, when executed, causing the at least one processor to: receive a surgical plan having at least one image and information about the location of at least one tower, the at least one image depicting a surgical area; identify soft tissue portions and at least one anatomical element; calculate an insertion point and a path from the insertion point to the at least one tower based on the identified soft tissue portions and at least one anatomical element, the at least one tower extending from an implanted pedicle screw; and insert a robotic arm at the insertion point and along the path to insert the rod.

[0056] In any aspect of this document, the at least one image is obtained from at least one of an MRI scanner, an ultrasound scanner, or a CT scanner.

[0057] In any aspect of this document, the at least one image includes a first image and a second image of the surgical area, the first image including hard tissue information and the second image including soft tissue information.

[0058] In any aspect thereof, the first image is generated using a first imaging modality and the second image is generated using a second imaging modality.

[0059] In any aspect of this document, the first image is a CT image and the second image is an ultrasound image.

[0060] In any aspect of this document, one of the first image and the second image is a preoperative image, and the other of the first image and the second image is an intraoperative image.

[0061] Any aspect combined with one or more other aspects.

[0062] Any one or more of the features disclosed in this article.

[0063] This article generally discloses one or more of the features.

[0064] Any one or more of the features generally disclosed in this article are combined with any one or more other features generally disclosed in this article.

[0065] Any one of the aspects / features / implementations may be combined with any one or more other aspects / features / implementations.

[0066] Use any one or more of the aspects or features disclosed herein.

[0067] It should be understood that any feature described herein may be combined with any other feature described herein to claim protection, regardless of whether the feature comes from the same described implementation.

[0068] Details of one or more aspects of this disclosure are set forth in the following drawings and description. Other features, objects, and advantages of the technology described in this disclosure will be apparent from the specification and drawings.

[0069] The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that possess both connective and disjoint qualities in operation. For example, the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and / or C” all mean only A, only B, only C, A and B together, A and C together, B and C together, or A, B, and C together. When each of A, B, and C in the above expressions refers to an element such as X, Y, and Z, or such as X1-X… n Y1-Y m and Z1-Z o When referring to a class of elements, the phrase is intended to mean a single element selected from X, Y, and Z; a combination of elements selected from the same class (e.g., X1 and X2); and elements selected from two or more classes (e.g., Y1 and Z). o () combination.

[0070] The term "a / an" refers to one or more of the same entity. Therefore, the terms "a / an," "one or more," and "at least one" are used interchangeably herein. It should also be noted that the terms "comprising / including" and "having" are used interchangeably.

[0071] The foregoing is a simplified overview of this disclosure to provide an understanding of some aspects thereof. This summary is neither a broad nor an exhaustive overview of this disclosure and its various aspects, embodiments, and configurations. It is not intended to identify key or essential elements of this disclosure, nor to define its scope, but rather to present selected concepts in a simplified form as an introduction to the more detailed description presented below. It should be understood that other aspects, embodiments, and configurations of this disclosure may utilize one or more of the features set forth above or described in detail below, individually or in combination.

[0072] Many additional features and advantages of the invention will become apparent to those skilled in the art upon consideration of the embodiments described below. Attached Figure Description

[0073] The accompanying drawings are incorporated in and form part of this specification to illustrate several examples of this disclosure. These drawings, together with the description, explain the principles of this disclosure. The drawings illustrate only preferred and alternative examples of how to implement and use this disclosure, and these examples should not be construed as limiting this disclosure solely to the examples shown and described. Further features and advantages will become apparent from the following more detailed description of various aspects, embodiments, and configurations of this disclosure, as illustrated by the accompanying drawings referenced below.

[0074] Figure 1 It is a block diagram of a system according to at least one embodiment of the present disclosure; Figure 2 A flowchart of a method according to at least one embodiment of this disclosure; and Figure 3 Another flowchart of a method according to at least one embodiment of this disclosure. Detailed Implementation

[0075] It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example or embodiment, certain actions or events of any process or method described herein may be performed in a different order, and / or may be added, combined, or omitted entirely (e.g., implementing the disclosed technology may not require all described actions or events depending on the different embodiments of this disclosure). Furthermore, although some aspects of this disclosure are described for clarity as being performed by a single module or unit, it should be understood that the technology of this disclosure can be performed by a combination of units or modules associated with, for example, computing devices and / or medical devices.

[0076] 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 functionality may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. A computer-readable medium may include a non-transitory computer-readable medium, which corresponds to a tangible medium, such as a data storage medium (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 is accessible by a computer).

[0077] 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 microprocessor), 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 circuits. Therefore, the term "processor" as used herein may refer to any of the foregoing structures or any other physical structures suitable for implementing the described techniques. Furthermore, this technology may be fully implemented in one or more circuit or logic elements.

[0078] Before explaining any embodiment of this disclosure in detail, it should be understood that this disclosure is not limited in its application to the construction details and component arrangements set forth in the following description or shown in the accompanying drawings. This disclosure can have other embodiments and can be practiced or implemented in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of “including / comprising” or “having” and variations thereof herein is intended to cover items listed thereafter and their equivalents, as well as additional items. In addition, this disclosure may use examples to illustrate one or more aspects thereof. Unless otherwise expressly stated, the use or listing of one or more examples (which may be indicated by “for example,” “by means of an example,” “e.g.,” “such as,” or similar language) is not intended to, and does not limit, the scope of this disclosure.

[0079] Minimally invasive surgical (MIS) techniques are increasingly being used in spinal procedures. Surgeons performing MIS may encounter challenges in rod fusion cases when inserting a rod into a patient's back. The procedure involves using towers attached to the inserted pedicle screws; these towers act as screw expanders and allow the rod (inserted through a small incision) to slide sequentially into each tower. After the rod is inside all the towers, it is locked in place using a fixation screw in each tower. This procedure is time-consuming and not robust throughout its duration. The complexity of the procedure also increases with the additional screws required. Typical spinal surgeons attempt to avoid performing this procedure on more than 3-4 spinal segments.

[0080] According to embodiments of this disclosure, a surgeon can plan a surgical procedure on a robotic platform (or use any computer with a user interface and provide the plan to the robotic platform). Preoperative images can be used for surgical procedure planning. Preoperative images can be obtained from MRI or other imaging devices. Anatomical elements can be identified in the preoperative images using, for example, machine learning-based tissue algorithms (e.g., U-net). Soft tissue can be identified using tissue segmentation to identify major blood vessels, nerves, nerve roots, muscle tissue, bones, ligaments, and / or large organs. Preoperative planning may also include identifying the desired implant (including a rod) and determining the desired location of the implant. The implant can then be inserted. An insertion point and a path from the rod to at least one tower can be calculated based on the location of the soft tissue and anatomical elements identified in at least one image and / or the inserted implant. The rod can be inserted at the insertion point and along the path to place the rod in at least one tower. At least one tower can be tracked to identify tower movement during rod insertion. The path can be updated when tower movement is identified or when movement of the rod deviates from the path is identified. Embodiments of this disclosure also provide a method for inserting a bar at an insertion point and moving the bar along a path using a robotic arm. In some embodiments, a first robotic arm can insert the bar, and a second robotic arm can support at least one tower.

[0081] Some embodiments of this disclosure provide for calculating a path for rod insertion (for robotic or non-robotic insertion in the absence of rod tracking). The patient may undergo preoperative MRI, and the software may use algorithms (e.g., such as U-net) to perform machine-based tissue identification of anatomical features of a specified spinal segment of the patient as shown in the MRI. Tissue segmentation is then performed to segment major blood vessels, nerves and nerve roots, muscle tissue, bone, ligaments, and other large organs. Preoperative and / or intraoperative planning is completed based on the MRI, including determining the desired implant and rod. This procedure is then performed to implant the desired implant. The location for rod insertion is calculated, including optimizing the insertion point (based on the geometry of the rod and tissue). Different inputs are used to calculate the path, such as avoiding major blood vessels, avoiding identified nerves and nerve roots, aligning the rod to travel as parallel to muscle structures as possible, minimizing ligament transfer, minimizing rod rotation required in the motion path, avoiding insertion into unrelated organs, avoiding rod collisions with skeletal anatomy, and / or data presented to the surgeon.

[0082] Some embodiments of this disclosure provide for calculating a path for rod insertion (for robotic or non-robotic insertion in the presence of rod tracking). The patient may undergo preoperative MRI, and the software may use algorithms (e.g., such as U-net) to perform machine-based tissue identification of anatomical features of a specified spinal segment of the patient as shown in the MRI. Tissue segmentation is then performed to segment major blood vessels, nerves and nerve roots, muscle tissue, bone, ligaments, and other large organs. Preoperative and / or intraoperative planning is completed based on the MRI, including determining the desired implant and rod. This procedure is then performed to implant the desired implant. The location for rod insertion is calculated, including optimizing the insertion point (based on the geometry of the rod and tissue). Various inputs are used to calculate the path, such as avoiding major blood vessels, avoiding identified nerves and nerve roots, aligning the rod to travel as parallel to muscle structures as possible, minimizing ligament transfer, minimizing rod rotation required in the motion path, avoiding insertion into unrelated organs, avoiding collisions between the rod and skeletal anatomy, and / or data presented to the surgeon. Furthermore, the rod may be tracked using, for example, an inertial measurement unit, navigation and / or electromagnetic sensors at the distal end of the rod. The software can also display the desired rod direction and orientation to the user. It can also update the rod path and orientation as the rod moves.

[0083] Embodiments of this disclosure also provide for tracking towers during rod insertion using a robotic arm. A single arm can insert the rod while simultaneously tracking the tower position. Surgical procedures can be planned and performed to the extent that the tower is positioned or implanted into the patient's anatomy (with or without the robot). Each tower in the relevant array can be tracked using navigation, reflectors, inertial measurement units, or other methods. The rod shape is known or measured (e.g., by a navigation probe running on the rod), and the rod can be attached to the robot at a known location and orientation. The path to the insertion point and the path to the tower can be calculated. The robot can perform rod insertion based on the calculated path. When the tower is in the tracked position, the robot path can adjust as the tower moves (the tower can move when it is flexible and the rod is moving and deviating from the patient's body).

[0084] Embodiments of this disclosure also provide for tracking a tower using multiple robots acting as rod inserters during rod insertion. Surgical procedures can be planned and performed to the extent that the tower is positioned or implanted into the patient's anatomy (with or without robots). During the procedure, one of the robotic arms can hold the tower in a known, continuously measured position (the robot may have a tower with end effectors and a safety mechanism to avoid injury). The rod shape is known or measured (e.g., by a navigation probe running on the rod), and the rod can be attached to the robot in a known position and orientation. The path to the insertion point and the path to the tower can be calculated. The robot can perform rod insertion based on the calculated path. Because the tower is held in the tracking position by the first robotic arm, and because the robot is aware of the position of the first robotic arm, the robotic arm inserting the rod can adjust the path of the rod as the tower moves (the tower can move when it is flexible and the rod moves and deviates from the patient's body). Alternatively, the path of the rod insertion robot may not change when the robot holding the tower moves the tower (within its calculated limits) to align with the rod path. In other implementations, the robotic arm that inserts the rod can adjust its path as the tower moves, and the robotic arm that holds the tower can move the tower. If the rod is inside the designated tower, the robotic arm holding the tower can communicate, which can be done using algorithms or rod marker identification: (i) circuit closure (e.g., between two robots), (ii) laser pointers and reflectors, and (iii) visible light. The path can be updated if the desired path changes. The rotational orientation of the rod can be changed according to the desired fixation (i.e., multiple surgeons insert the rod in one orientation for easy insertion, then rotate the rod to the correct orientation). The rod-holding robot can screw in a fixing screw that holds the rod in place. The rod-holding robot can also disconnect the tower extender.

[0085] The embodiments disclosed herein provide technical solutions to the following problems: (1) improving the success rate of rod insertion in spinal procedures, and especially in MIS spinal procedures; (2) improving rod insertion planning; (3) reducing the duration of spinal procedures by taking into account and adjusting the movement of pedicle screw towers; (4) increasing the number of segments that can be successfully reached in MIS spinal surgery; and / or (5) improving patient safety during robot-assisted or robotic minimally invasive surgery.

[0086] First turn Figure 1 The diagram illustrates a block diagram of a system 100 according to at least one embodiment of the present disclosure. The system 100 can be used, for example: calculating the insertion point and the path from the rod to the tower; adjusting the path when movement of the tower or the rod deviates from the path; performing one or more aspects of one or more of the methods disclosed herein; for navigation purposes; performing fully autonomous and / or robot-assisted surgery using multiple robots; or for any other useful purpose.

[0087] System 100 includes a computing device 102, an imaging device 132, a robot 136, a navigation system 156, a database 160, and a cloud 164. Notwithstanding the foregoing, systems according to other embodiments of this disclosure may omit any or more of the computing device 102, imaging device 132, robot 136, navigation system 156, database 160, and / or cloud 164. Furthermore, systems according to other embodiments of this disclosure may arrange one or more components of system 100 differently (e.g., one or more of the imaging device 132, robot 136, and / or navigation system 156 may be included in...). Figure 1 (One or more components shown are part of computing device 102). Furthermore, systems according to other embodiments of this disclosure may include two or more of the components described herein, including, for example, imaging device 132, robot 136, and / or database 160.

[0088] The computing device 102 includes at least one processor 104, at least one communication interface 108, at least one user interface 112, and at least one memory 116. In other embodiments of this disclosure, the computing device may omit one or both of the communication interface 108 and the user interface 112.

[0089] At least one processor 104 of computing device 102 may be any processor identified or described herein or any similar processor. At least one processor 104 may be configured to execute instructions 124 stored in at least one memory 116, which may enable at least one processor 104 to perform one or more computational steps using or based on data received, for example, from imaging device 132, robot 136, navigation system 156, database 160 and / or cloud 164.

[0090] The computing device 102 may also include at least one communication interface 108. The at least one communication interface 108 may be used to receive image data or other information from external sources (such as imaging device 132, robot 136, navigation system 156, database 160, cloud 164, and / or portable storage media (e.g., USB drive, DVD, CD)), and / or to transmit instructions, images, or other information from at least one processor 104 and / or the computing device 102 more generally to external systems or devices (e.g., another computing device 102, imaging device 132, robot 136, navigation system 156, database 160, cloud 164, and / or portable storage media (e.g., USB drive, DVD, CD)). The at least one communication interface 108 may include one or more wired interfaces (e.g., USB port, Ethernet port, FireWire port) and / or one or more wireless interfaces (e.g., configured to transmit information via one or more wireless communication protocols, such as 802.11a / b / g / n, Bluetooth, Bluetooth Low Energy, NFC, Bee, etc.). In some implementations, at least one communication interface 108 may be used to enable computing device 102 to communicate with one or more other processors 104 or computing device 102, whether to reduce the time required to complete computationally intensive tasks or for any other reason.

[0091] At least one user interface 112 may be or include a keyboard, mouse, trackball, monitor, television, touchscreen, button, joystick, switch, lever, headset, glasses, or wearable device and / or any other means for receiving information from a user and / or providing information to a user of computing device 102. At least one user interface 112 may be used, for example, to: receive user selections or other user input relating to any step of any of the methods described herein; receive user selections or other user input regarding one or more configurable settings of computing device 102, imaging device 132, robot 136, and / or another component of system 100; receive user selections or other user input regarding how to store and / or transmit data received, modified, and / or generated by computing device 102 and / or where to store and / or transmit such data; and / or display information (e.g., text, images) and / or play sound to a user based on data received, modified, and / or generated by computing device 102. Although system 100 includes at least one user interface 112, system 100 may automatically (e.g., without any input through at least one user interface 112 or otherwise) perform one or more or all of the steps of any of the methods described herein.

[0092] Although at least one user interface 112 is shown as part of computing device 102, in some embodiments, computing device 102 may utilize a user interface 112 that is separately housed from one or more other components of computing device 102. In some embodiments, user interface 112 may be located near one or more other components of computing device 102, while in other embodiments, user interface 112 may be located away from one or more other components of computing device 102.

[0093] At least one memory 116 may be or include RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory used to store computer-readable data and / or instructions. At least one memory 116 may store information or data suitable for performing any step of, for example, method 200 or 300 as described herein. At least one memory 116 may store, for example: instructions 124 for execution by at least one processor 104, for example, to cause at least one processor 104 to implement one or more steps of method 200 and / or method 300; and / or one or more algorithms 128 for any computation (e.g., calculating insertion points and paths, etc.) required by the processor to perform one or more steps of method 200 and / or method 300, or for any other computation. In some embodiments, such instructions 124 and / or algorithms 128 may be organized into one or more applications, modules, packages, layers, or engines, and may cause at least one processor 104 to manipulate data stored in at least one memory 116 and / or received from or via another component of system 100. At least one memory 116 may also store one or more surgical plans 120.

[0094] Imaging device 132 may be operable to image anatomical features (e.g., bones, veins, tissues, etc.) and / or other aspects of the patient's anatomy, and / or any surgical instruments or tools within the field of view of imaging device 132 to generate image data (e.g., image data depicting or corresponding to bones, veins, tissues, implants, tools, etc.). Imaging device 132 may be capable of capturing 2D or 3D images to generate image data. As used herein, "image data" means data generated or captured by imaging device 132, including data in machine-readable form, graphical / visual form, and any other form. In various examples, image data may include data corresponding to anatomical features of the patient or a portion thereof. The imaging device 132 may be or include, for example, an ultrasound scanner (which may include, for example, physically separate transducers and receivers, or a single ultrasound transceiver), a radar system (which may include, for example, a transmitter, receiver, processor, and one or more antennas), an O-arm, a C-arm, a G-arm, or any other device that utilizes X-ray-based imaging (e.g., a fluorescence microscope, a CT scanner, or other X-ray machine), a magnetic resonance imaging (MRI) scanner, an optical coherence tomography scanner, an endoscope, a microscope, a thermal imaging camera (e.g., an infrared camera), or any other imaging device 132 adapted to obtain images of a patient's anatomical features.

[0095] In some embodiments, imaging device 132 may include more than one imaging device 132. 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 other embodiments, the same imaging device may be used to provide both first image data and second image data and / or any other image data described herein. Imaging device 132 may be operable to generate an image data stream. For example, imaging device 132 may be configured to operate with the shutter open, or with the shutter continuously alternating between opening and closing, to capture successive images.

[0096] Robot 136 may be any surgical robot or surgical robot system. Robot 136 may be, for example, a Mazor X™ Stealth Robot Guidance System. Robot 136 may include a base 140 supporting robotic arms 148. Robot 136 may include one or more robotic arms 148 (e.g., some robots 136 may include two, three, four, or another number of robotic arms 148). In some embodiments, each robotic arm 148 may assist in surgical procedures (e.g., by holding and inserting a rod at the insertion point and along the path, by holding at least one tower) and / or automate the surgical procedure.

[0097] Each robotic arm 148 can have three, four, five, six or more degrees of freedom.

[0098] Robot 136 also includes one or more sensors 144. Sensor 144 may be a force sensor configured to detect forces applied to robot arm 148, whether via an end effector of robot arm 148, a tool held by the end effector of robot arm 148, or otherwise. Sensor 144 may be an inertial measurement unit sensor, a position sensor, a proximity sensor, a magnetometer, or an accelerometer. In some embodiments, sensor 144 may be a linear encoder, a rotary encoder, or an incremental encoder. In other embodiments, sensor 144 may be an imaging sensor. Other types of sensors may also be used as sensor 144. One or more sensors 144 may be located, for example, on robot arm 148 or at other locations.

[0099] Data from one or more sensors 144 may be provided to the processor of robot 136, the processor 104 of computing device 102, and / or the navigation system 156. This data can be used to calculate the pose of robot arm 148, the end effector of robot arm 148, and / or tools or other devices attached to robot arm 148 (whether via end effector or otherwise). The calculations may be based not only on data received from sensors 144, but also on data or information (such as, for example, physical dimensions) about, for example, robot 136 or a portion thereof, or any other related object, which may be stored in, for example, memory 116 of computing device 102 or any other memory. This data can also be used to detect whether the force received by robot arm 148 (which may be the force received by a tool supported by robot arm 148) exceeds a predetermined threshold.

[0100] One or more tracking markers 152 may be securely attached or positioned on the robot 136, whether on the base 140, the robot arm 148, and / or elsewhere. In some embodiments, one or more tracking markers 152 may be additionally or alternatively attached to one or more other components of the system 100. The tracking markers 152 may be used to enable the navigation system 156 to determine and / or track the position of the robot 136 (or any other component to which one or more tracking markers 152 are attached). In some embodiments, one or more tracking markers 152 (or similar tracking markers) may be attached to a patient undergoing a surgical procedure to enable the imaging device 132, the navigation system 156, or another system or device to track the patient's position.

[0101] The navigation system 156 of system 100 can provide navigation for the surgeon and / or robot 136 during operation. Navigation system 156 can be any navigation system now known or developed in the future, including, for example, the Medtronic StealthStation™ S8 surgical navigation system. Navigation system 156 may include cameras or other sensors for detecting and / or tracking one or more reference markers, navigation tracking markers, or other objects in the operating room or other rooms where surgical procedures are performed. In various embodiments, navigation system 156 can be used to track the position of the robotic arm 148 of each robot 136 (or more specifically, one or more tracking markers 152 attached to the robotic arm 148). Navigation system 156 can be used to track the position of one or more reference frames, markers, arrays, or other structures for detection by cameras or other sensors of navigation system 156. Navigation system 156 can be used, for example, to detect the position of a reference frame mounted to the patient and / or the position of one or more robotic arms 148. The navigation system 156 may include a display for showing one or more images from an external source (e.g., computing device 102, imaging device 132, database 160, cloud 164, or another source), or video streams from a camera or other sensor of the navigation system 156. In some embodiments, the system 100 may operate without using the navigation system 156.

[0102] Database 160 may store information relating one coordinate system to another (e.g., information relating one or more robot coordinate systems to a patient coordinate system and / or a navigation coordinate system). Database 160 may additionally or alternatively store: for example, information about or corresponding to one or more characteristics of tracking marker 152; one or more surgical plans 120 (including, for example, image information about patient anatomy at and / or near the surgical site, for use by the user of robot 136, navigation system 156, and / or computing device 102 or system 100); one or more useful images of a surgical procedure performed by or with the assistance of one or more other components of system 100; and / or any other useful information. Database 160 may be configured to provide any such information to computing device 102 or to any other device of system 100 or any other device outside system 100, whether directly or via cloud 164. In some implementations, database 160 may be part of or include 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.

[0103] Cloud 164 may be or represent the Internet or any other wide area network. Computing device 102 may connect to cloud 164 via communication interface 108 using a wired connection, a wireless connection, or both. In some embodiments, computing device 102 may communicate with database 160 and / or external devices (e.g., computing devices) via cloud 164.

[0104] Figure 2 A method 200 is described for planning rod insertion and, more specifically, for calculating the insertion point and path of the rod. Method 200 (and / or one or more steps thereof) may be implemented, for example, by at least one processor or otherwise performed. The at least one processor may be the same as or similar to processor 104 of the computing device 102 described above. The at least one processor may be part of a robot (such as robot 136) or a navigation system (such as navigation system 156). Processors other than any processor described herein may also be used to perform method 200. The at least one processor may perform method 200 by executing instructions stored in memory (such as instruction 124 in memory 116). The instructions may correspond to one or more steps of the method 200 described below. These instructions may cause the processor to execute one or more algorithms, such as algorithm 128. For example, one or more such algorithms 128 may be used to identify soft tissue and at least one anatomical element in at least one image, calculate the insertion point and the path from the insertion point to at least one tower, and / or determine the difference between the rod's position and / or orientation and the path.

[0105] Method 200 includes receiving a surgical plan (step 202). The surgical plan may be the same as or similar to surgical plan 120. The surgical plan may be received via a user interface (e.g., user interface 112) and / or a communication interface (e.g., communication interface 108) of a computing device (such as computing device 102), and may be stored in the memory of the computing device (such as memory 116). The surgical plan may include information about at least one tower of at least one pedicle screw. This information may include information about the placement and / or location and / or orientation of at least one pedicle screw. This information may also include at least one dimension of at least one tower. The surgical plan may also include information about at least one anatomical element. For example, this information may identify the vertebrae into which the pedicle screw can be implanted.

[0106] The surgical plan may also include at least one image depicting the surgical area. At least one image may be obtained from an imaging device (such as imaging device 132). In some embodiments, at least one image is obtained from MRI or other methods corresponding to MRI. In other embodiments, at least one image includes an ultrasound image, a CT image, or an image generated using an imaging modality other than MRI and / or ultrasound. The image may be obtained before the surgical procedure (e.g., preoperatively) or during the surgical procedure (e.g., intraoperatively). For example, at least one image may be obtained after the implantation of at least one pedicle screw.

[0107] In some embodiments, at least one image may include a first image and a second image of the surgical area. In some cases, the first or second image may be a preoperative image or an intraoperative image. The first image may include hard tissue information and the second image may include soft tissue information. For example, a first imaging modality (such as a CT scanner) may be used to generate the first image. For example, a second imaging modality (such as an ultrasound image) may be used to generate the second image. In some embodiments, the first and second images may be combined. For example, the soft tissue information of the second image may be combined with or added to the hard tissue information of the first image.

[0108] Method 200 further includes identifying at least a soft tissue portion and at least one anatomical element in at least one image (step 204). In some embodiments, the identification may be performed automatically by an algorithm (such as algorithm 128). In other embodiments, the identification may be performed by a surgeon or other user. Identifying the soft tissue portion and / or at least one anatomical element may include annotation or otherwise labeling each anatomical element and / or soft tissue element in the image. In some embodiments, identifying the soft tissue portion includes segmenting at least one image using one or more image processing algorithms. Anatomical elements may be or include one or more of, for example, bones, organs, arteries, muscles, ligaments, nerves, and / or any other anatomical elements. Soft tissue portions may be or include, for example, blood vessels, nerves, nerve roots, muscle tissue, ligaments, and / or organs. At least one anatomical element and soft tissue portion may or may not be mutually exclusive (e.g., an organ in an image may be identified as both a soft tissue portion and an anatomical element).

[0109] In some embodiments, feature recognition (using, for example, edge detection or other feature recognition algorithms) is used to identify at least one anatomical element. For example, the outline of a vertebra, femur, or other bone can be identified in an image. In other embodiments, machine learning, artificial intelligence, and / or neural networks can be used to identify at least one anatomical element. In such embodiments, multiple training images (each depicting one or more anatomical elements) can be provided to a processor (such as processor 104), and each training image can be annotated to include identification information about the anatomical element in the image. A processor executing instructions stored in memory (such as memory 116) or another memory can use machine learning algorithms to analyze the image and, based on the analysis, generate one or more image processing algorithms for identifying anatomical elements in the image. Such image processing algorithms can then be applied to at least one image.

[0110] Method 200 also includes calculating the insertion point and path of the rod (step 206). In some embodiments, the calculation may be performed automatically by an algorithm (such as algorithm 128). In other embodiments, the calculation may be performed by a surgeon or other user. The path from the insertion point to at least one tower is calculated to position the rod within at least one tower. The path may be calculated based on identified soft tissue portions and at least one identified anatomical element. For example, the path may be based on avoiding specific soft tissue features or anatomical elements.

[0111] The calculation of the insertion point and / or path may be based on one or more inputs. Inputs may include, for example, the geometry of the rod, the location of one or more towers through which the rod will be inserted, and / or (e.g., via pedicle screws) the target pose of the vertebrae to which the rod will be attached. Inputs may also include inputs required to accomplish one or more objectives related to the calculation of the insertion point and / or path. Such objectives may include, for example, avoiding major blood vessels, avoiding identified nerves and nerve roots, aligning the rod to travel as parallel to muscular structures as possible, minimizing ligament transfer, minimizing rod rotation required in the movement path, avoiding insertion of the rod into or through organs, and / or avoiding collisions between the rod and skeletal anatomy. One or more inputs may be received via a user interface and / or a communication interface and may be stored in memory. In some embodiments, one or more inputs may be provided in or via the surgical plan. One or more inputs may also be determined based on at least one image obtained in step 202 and processed in step 204.

[0112] Step 206 may include generating instructions for orienting the rod at the insertion point and moving the rod along a path. The instructions may be in machine-readable form (such as instruction 124) and / or human-readable form. The instructions may be communicated to the surgeon or user via a user interface (such as user interface 112) and / or via a communication interface (such as communication interface 108). The instructions may also be communicated to a robot (such as robot 136) to cause a robotic arm (such as robotic arm 148) to execute the instructions.

[0113] Method 200 also includes inserting a rod at the insertion point and along the path (step 208). In some embodiments, the insertion of the rod may be performed by a surgeon. In at least some of these embodiments, the instructions generated in step 206 may be communicated to the surgeon or user to insert the rod and move it along the path. In other embodiments, the surgeon may be assisted by a robot. For example, the robot may hold the rod, but the robot may move based on input from the surgeon.

[0114] In other embodiments, a robotic arm (such as robotic arm 148) may insert the rod. The robotic arm may hold or otherwise support the rod to orient and / or move it. The instructions generated in step 206 may be transmitted to the robot to orient the robotic arm at the insertion point and move the rod along the path.

[0115] Method 200 also includes a tracking rod (step 210). The tracking rod may include the use of a navigation system (such as navigation system 156), tracking markers (such as tracking marker 152), and / or sensors (such as sensor 144) to enable the determination of the rod's pose (e.g., position and orientation) at any given time. For example, a marker may be attached to the rod (e.g., attached to the proximal end of the rod so that it is visible when the distal end of the rod is inserted into the patient) and the marker may be tracked by a navigation camera. In another example, the rod may be supported and manipulated by an exact robotic arm, such as robotic arm 148 (e.g., a robotic arm whose pose relative to at least a robot coordinate system is always known), and information about the pose of the robotic arm and therefore the rod may be obtained from the robot. In yet another example, a sensor may be disposed on or integrated with the rod and / or the robotic arm, and the sensor may transmit or otherwise provide information about the position of the rod. The sensor may be, for example, an inertial measurement unit.

[0116] Step 210 may also include tracking at least a soft tissue portion surrounding the rod. The soft tissue portion may be tracked in real time by an imaging device (such as imaging device 132) or otherwise monitored. The soft tissue portion may be tracked to monitor for or prevent damage to the soft tissue. The location of the soft tissue portion may also be tracked or otherwise monitored, whether to ensure the calculated path remains available or for any other purpose. The soft tissue portion may be tracked, for example, using an imaging device capable of detecting soft tissue or in any other way. Warnings or notifications may be generated and communicated to the surgeon or user to indicate when undesirable damage to the soft tissue has occurred or may occur. Warnings or notifications may be communicated via a user interface (such as user interface 112).

[0117] Method 200 further includes determining the difference between the position and / or orientation of the rod and the path (step 212). The position and / or orientation of the rod can be obtained from step 210 described above. In some embodiments, the determination can be performed automatically by an algorithm (such as algorithm 128). In other embodiments, the determination can be performed by a surgeon or other user. The position and orientation or pose of the rod can be determined in a robot coordinate system, or in another coordinate system in which the path was initially determined or which has been translated, such that the pose and path of the rod can be compared in a single coordinate system.

[0118] In some implementations, the difference can be determined continuously during rod insertion. In other implementations, the difference can be determined in predetermined increments. Predetermined increments may be based on time (e.g., every 5 seconds), distance (e.g., every quarter inch), and / or path completion percentage (e.g., every 5% of path completion). This difference can be displayed or otherwise communicated to the surgeon or user.

[0119] The actual orientation of the rod may differ from the path for various reasons. In some implementations, the patient's orientation may cause soft tissues of the patient's anatomy to obstruct the initially calculated path, apply unintended forces to the rod during insertion, or otherwise deviate in a way that prevents the initially calculated path from being implemented. In some cases, the rod may be defective and unexpectedly bend or otherwise deform. In other cases, previously undetected obstacles may be identified during rod insertion, potentially requiring a change in the calculated path. In other implementations, one or more pedicle screws to which the rod is attached may dislodge from the vertebra to which they are implanted, or the vertebra may fracture, or the placement of the rod in a pedicle screw attached to one vertebra may cause the vertebra with another pedicle screw attached to it to move out of the calculated path. Any or more of these reasons and / or any other reason may cause the rod's orientation to differ from the path.

[0120] Method 200 also includes updating the path (step 214). In some embodiments, the path may be updated based on detected movement of the soft tissue portion. Movement may be detected when, for example, a difference determined in step 212 meets a threshold. In other embodiments where at least one tower can be tracked (as described below with respect to method 300), the path may be updated based on detected movement of at least one tower. In some embodiments, the update may be performed automatically by an algorithm (such as algorithm 128). In other embodiments, the update may be performed by a surgeon or other user. Updating the path may include updating the insertion point (e.g., calculating a new insertion point), the entire path, or a portion of the path. For example, the path may be updated from the current position of the rod (in other words, the remainder of the path may be updated). In another example, the rod may be removed and the entire path and / or the insertion point may be updated. Updating the path may also include adjusting the orientation and / or position of the rod at one or more points in the path. The updated path may be provided to a robot being used to insert the rod, or the updated path may be communicated to a surgeon or user and may be communicated via a user interface (such as user interface 112). In some implementations, the new rod orientation and / or rod direction can be shown or communicated to the surgeon.

[0121] Step 214 may also include updating one or more steps of the surgical plan. The updated path may require the removal, addition, or adjustment of one or more steps based on the new path. For example, the updated path may require new commands for tightening the fixation screws of the corresponding pedicle screws.

[0122] Step 214 may also include generating updated instructions based on the updated path. In some embodiments, the updated instructions may be human-readable and communicated to the surgeon. In other embodiments, the updated instructions may be machine-readable and communicated to the robot to move the bar along the new path. The updated instructions may also cause the robot arm to remove the bar from the current path and reorient the bar to move it along the updated path.

[0123] Step 214 may also include triggering a warning or alarm to notify the surgeon that the difference has met a threshold. The warning or alarm may also notify the surgeon that the path has been updated and may prompt the surgeon to accept the updated path. In some embodiments, the threshold may be received via a user interface and / or communication interface and may be stored in memory. In other embodiments, the threshold may be provided in or via the surgical plan. In at least one embodiment, the threshold may be 1 mm. In other embodiments, the threshold may be less than or greater than 1 mm. In some embodiments, the difference may be calculated based on the maximum displacement of any point on the rod relative to a corresponding point on the path. In other embodiments, the difference may be calculated based on the displacement of the tip of the rod relative to the path. In other embodiments, the difference may be calculated as the angle of rotation between the actual orientation of the rod and the orientation of the matching path. Thus, for example, if the rod is fully inserted in the orientation that produces least resistance and then must be rotated to the final position, the difference may be the angle of rotation the rod needs to rotate to reach the final position.

[0124] Turn now Figure 3 For example, the method 300 for inserting a rod may be implemented or otherwise executed by at least one processor. The at least one processor may be the same as or similar to processor 104 of the computing device 102 described above. The at least one processor may be part of a robot (such as robot 136) or a navigation system (such as navigation system 156). Processors other than any of the processors described herein may also be used to execute method 300. At least one processor may execute method 300 by executing instructions stored in memory (such as instruction 124 in memory 116). The instructions may correspond to one or more steps of the method 300 described below. These instructions may cause the processor to execute one or more algorithms, such as algorithm 128. For example, one or more such algorithms 128 may be used to map one coordinate system to another once each coordinate system has been located, and / or calculate the insertion point and path, and / or generate rod insertion instructions.

[0125] Method 300 includes receiving information about the current position of at least one tower (step 302). In some embodiments, the information is sensor data obtained from a sensor (such as sensor 144). In some embodiments, the sensor is mounted on or integrated with the at least one tower. In other embodiments, the sensor may be mounted on or integrated with a robotic arm (such as robotic arm 148). The sensor may be, for example, an inertial measurement unit.

[0126] In some embodiments, a first robotic arm can support and move a bar, and a second robotic arm can support at least one tower in a known position and / or orientation. The first and / or second robotic arms may be the same as or similar to robotic arm 148. In such embodiments, information about the current position and / or orientation of the second robotic arm and therefore the at least one tower can be obtained (e.g., from one or more sensors 144 disposed on the second robotic arm).

[0127] In yet another example, sensors may be mounted on or integrated with at least one tower, and redundant sensors may be mounted on or integrated with a second robotic arm, and each sensor may be tracked or may transmit information about the current position of at least one tower.

[0128] In other embodiments, information may be received from a navigation system (such as navigation system 156). In such embodiments, at least one tower, a first robotic arm, and / or a second robotic arm may include tracking markers, such as tracking marker 152 (which may be a navigation LED in some embodiments), and / or another device detectable by navigation system 156, which may use the other device to determine the pose of at least one tower. The tracking marker may be positioned on or integrated with at least one tower and / or the first robotic arm. In these and other embodiments, information may include image data obtained via a camera or other imaging sensor.

[0129] Method 300 also includes tracking at least one tower to identify tower movement (step 304). Tracking at least one tower may be performed using a navigation system (such as navigation system 156), tracking markers (such as tracking marker 152), and / or sensors (such as sensor 144). For example, a marker may be attached to at least one tower and the marker may be tracked by a navigation camera. The marker may also be attached or fixed to a robotic arm, such as a robotic arm 148 that holds at least one tower, and the marker may be tracked by a navigation camera.

[0130] Tracking at least one tower may include comparing the current position and / or orientation of at least one tower with the expected or known position and / or orientation of at least one tower to identify tower movement. The current position and / or orientation of at least one tower may be obtained in step 302. The current position and / or orientation of at least one tower may then be compared with a known position and / or orientation (e.g., as determined based on previously obtained sensor data or otherwise) to determine if a difference exists. If a difference exists between the current and known position and / or orientation, the difference indicates that at least one tower has moved. The difference may then be quantified to determine the magnitude of the movement.

[0131] The identified tower movement may indicate that the rod insertion has deviated from the calculated path (described below relative to step 306) or is no longer on the calculated path. The identified tower movement may also indicate that the calculated path is no longer a feasible path for inserting the rod into the tower (because the tower is no longer on the calculated path). In some embodiments, the identified tower movement may trigger one or more additional actions, such as recalculating the path or causing the robotic arm to move the tower back to a position on the previously calculated path.

[0132] Method 300 further includes calculating the insertion point and path (step 306). Step 306 is the same as or similar to step 206 of method 200 described above.

[0133] Furthermore, the calculation of the insertion point and path may be based on the current position and / or orientation of at least one tower identified in step 302. For example, the current position and / or orientation of at least one tower may differ from the expected or known position and / or orientation of that tower (as reflected, for example, in preoperative imaging, surgical planning, or even sensor data received in step 302). Instead of moving at least one tower to a known position and / or orientation, the insertion point and path may be calculated or recalculated based on the current position and / or orientation (e.g., using a robotic arm).

[0134] Method 300 further includes inserting the bar at the insertion point and along the path using a robotic arm (step 308). Step 308 is the same as or similar to step 208 of method 200 described above with respect to the insertion of the bar by the robotic arm.

[0135] Method 300 also includes adjusting the path of the robotic arm based on tower movement during bar insertion (step 310). In some embodiments, the adjustment may be based on the use of an algorithm (such as algorithm 128) executed by a processor (such as processor 104) or the processor of the robotic arm. The adjustment may be performed automatically. Adjusting the path may include adjusting the insertion point (e.g., calculating a new insertion point), the entire path, or a portion of the path. For example, the path may be adjusted from the current position of the bar (in other words, the remainder of the path may be adjusted). In another example, the bar may be removed and the entire path and / or the insertion point may be adjusted. Adjusting the path may also include adjusting the orientation and / or position of the bar at multiple points in the path.

[0136] In some implementations, such as when each of at least one tower has moved by an equal increment, the remaining portion or the entire path may be offset by that increment. For example, if each of a plurality of towers has moved 1 cm in a particular direction, the path may be offset by 1 cm in the same direction.

[0137] Step 310 may further include generating updated instructions based on the adjusted path and transmitting the updated instructions to the robotic arm to move the bar along the adjusted path. The updated instructions may also cause the robotic arm to remove the bar from the current path and reorient the bar to move it along the adjusted path.

[0138] Step 310 may also include triggering a warning or alarm to notify the surgeon that tower movement has been identified. The warning or alarm may also notify the surgeon that the path has been adjusted and may prompt the surgeon to accept the adjusted path, after which the robotic arm moves the bar along the adjusted path. In some implementations, the surgeon or other user may provide input to modify the adjusted path.

[0139] In an embodiment where a first robotic arm moves a bar and a second robotic arm supports at least one tower, method 300 further includes causing the second robotic arm to adjust the position and / or orientation of at least one tower (step 312). In some embodiments, the position and / or orientation of at least one tower may be adjusted to move at least one tower back to a known position and / or orientation. In other embodiments, at least one tower may be adjusted to fit the bar path. In yet another embodiment, if tower movement is detected and the current position and / or orientation of the bar does not match the path, at least one tower may be adjusted to fit the current position and / or orientation of the bar.

[0140] In some embodiments, step 312 may occur only if the force exerted by the second robotic arm on at least one tower does not exceed a predetermined threshold. The threshold may be an absolute or relative value. The predetermined threshold may be automatically generated based on information, such as the pedicle screw to which the tower is attached (e.g., the length and width of the pedicle screw) and / or information about the vertebra to which the tower is attached via the pedicle screw (e.g., the size and bone mass of the vertebra). Alternatively, the predetermined threshold may be input by a surgeon or other user. In another embodiment, a recommended predetermined threshold may be automatically generated, and the surgeon or other user may modify and / or approve the recommended predetermined threshold. The force exerted by the second robotic arm on at least one tower may be measured, for example, by one or more sensors (e.g., sensor 144) on the second robotic arm.

[0141] It should be understood that steps 310 and 312 can occur sequentially or simultaneously. For example, when tower movement is detected, the path of the rod and the position of at least one tower can be adjusted. In another example, the path of the rod can be adjusted first, and then the position of at least one tower can be adjusted, or vice versa. Furthermore, steps 310 and 312 can optimize the placement of the rod in at least one tower based on the current position and / or orientation of at least one tower and / or rod. In some embodiments, the pose of at least one tower can be adjusted until a predetermined threshold is reached, and then the path can be calculated based on the obtained position of at least one tower.

[0142] Method 300 further includes monitoring the magnitude of a force received by the robotic arm (step 314). The robotic arm receiving the force may be a robotic arm attached to at least one tower (as described above in conjunction with step 312), or alternatively, a robotic arm with a manipulator. The force may be detected using a sensor (such as sensor 144). The detected force may be or include linear forces, rotational forces (e.g., torque), and / or any other type of force. The sensor may be positioned on the robotic arm or elsewhere. The sensor may be configured to detect motion of the robotic arm and calculate the force based on information about the stiffness of the robotic arm and the detected motion. Alternatively, the sensor may be configured to directly measure the force. Any type of sensor capable of directly measuring the force or calculating the force based on some other measurement can be used to detect the force for the purpose of step 314. In some embodiments, the detected force may include one or more individual force components (e.g., force components on each of the X, Y, and Z axes, and / or torque components around the X, Y, and Z axes).

[0143] Method 300 further includes pausing the movement of the manipulator's robotic arm when the magnitude of the force meets a predetermined threshold (step 316). The predetermined threshold may be determined in any manner described herein or in any other way. Step 316 may include generating, transmitting, and / or executing instructions (such as instruction 124) to pause the movement of the robotic arm when the magnitude of the force meets the predetermined threshold. The instruction may also cause the robotic arm to remove the manipulator from the path and / or insertion point when the magnitude of the force meets the predetermined threshold.

[0144] Step 316 may include comparing the detected force with a predetermined threshold. The comparison may include comparing a single combined force vector with the predetermined threshold, and / or comparing individual force components with individual force thresholds. The detected force may be considered below the predetermined threshold if the magnitude of the overall force vector is below the predetermined threshold, or if any individual force component exceeds its corresponding predetermined threshold component (and / or regardless of whether the magnitude of the overall force vector is below the predetermined threshold).

[0145] Additionally, in some embodiments, the predetermined threshold may include a threshold magnitude that depends on the direction of the detected force vector. Thus, for example, the predetermined threshold may include a first threshold magnitude for a force applied in a first direction, and a second threshold magnitude for a force applied in a second direction different from the first direction, which is different from the first threshold magnitude. As mentioned above, the predetermined threshold may include individual components (e.g., in the X, Y, and Z axes, and / or around the X, Y, and Z axes) or may include only the overall threshold magnitude and direction. In other embodiments, the predetermined threshold may include only the threshold magnitude.

[0146] Method 300 also includes verifying the placement of the rod in at least one tower (step 318). The placement of the rod can be verified using laser pointers and reflectors disposed on or integrated with the following: the rod, a navigation system (such as navigation system 156), a tracking marker (such as tracking marker 152), and / or a sensor (such as sensor 144).

[0147] In an embodiment where a first robotic arm moves a bar and a second robotic arm supports at least one tower, the placement of the bar can be verified by the second robotic arm. Sensors mounted on or integrated with the second robotic arm can sense the bar placed in at least one tower. For example, an accelerometer may be configured to sense vibrations and / or other movements of at least one tower (and / or associated pedicle screws) caused by the movement of the bar through the tower.

[0148] In other embodiments, circuitry can be used to verify the placement of the rod in at least one tower. The circuitry can be located between a first robotic arm supporting the rod and a second robotic arm supporting at least one tower. More specifically, where both the rod and the tower are metallic or otherwise conductive, an electrical signal can be transmitted through the rod, and a sensor on the second robotic arm can be used to detect whether a signal has been transmitted through at least one tower (which would indicate that the rod and at least one tower are in contact). The reverse operation can also be performed (e.g., an electrical signal can be introduced into the tower and detected at the rod). Alternatively, an electrical signal can be introduced into a first side of the tower and detected on an opposing second side of the tower, insulated from the first side. If a signal is detected, it can be inferred that the rod has been properly placed between the two sides of the tower and that the two sides have been positioned electrically connected to each other. Circuitry created as described above or in any other manner can therefore be used to determine whether the rod has been properly placed in each of the at least one tower.

[0149] Method 300 further includes tightening the fixing screws with a robotic arm (step 320). The robotic arm may be the same robotic arm that is (or was) attached to at least one tower and may support a tool such as a screwdriver to tighten the fixing screws in the heads of the towers and / or pedicle screws. In embodiments where multiple fixing screws are tightened for multiple corresponding pedicle screws, each fixing screw may be tightened incrementally in a certain sequence to avoid point loads on any single pedicle screw. For example, a first fixing screw may be tightened, then a second fixing screw may be tightened, and then the first fixing screw may be tightened further, etc.

[0150] In some embodiments, the robotic arm that inserts the rod can also tighten the fixing screw. In other embodiments, different robotic arms can tighten the fixing screw.

[0151] Method 300 further includes removing at least one tower from the head of the pedicle screw using a robotic arm (step 322). The robotic arm may support and manipulate tools to grasp at least one tower and apply force to disassemble, separate, disconnect, or otherwise remove at least one tower from the head. The robotic arm may also apply force to at least one tower using any kind of tool or by simply pressing the end of the robotic arm against the tower to cause at least one tower to disconnect.

[0152] At least one tower may include a score to facilitate the detachment of at least one tower from the head. In some embodiments, a robotic arm with an insert bar may also remove at least one tower. In other embodiments, different robotic arms may remove at least one tower.

[0153] As can be understood based on the foregoing disclosure, this disclosure covers those with a greater than Figure 2 and Figure 3 Methods with fewer steps than those identified in (and the corresponding descriptions of methods 200 and 300), and methods including those with fewer steps than Figure 2 and Figure 3 (And the corresponding descriptions of methods 200 and 300) are methods with more steps than those identified herein. One or more steps of the methods described herein may be performed in an order other than that described herein.

[0154] To avoid ambiguity, aspects of this disclosure can be used to automatically or with robot assistance calculate the path for inserting a rod through one, two, three, four, five, six, seven, eight, nine, ten, or more towers extending from an implanted pedicle screw. The methods described herein can be implemented using two robotic arms (one robotic arm manipulating the rod and a second robotic arm holding or manipulating one tower at a time), or using more than two robotic arms (where each additional robotic arm is configured to hold or manipulate another tower). As will be understood, the greater the number of robotic arms, the greater the number of towers that can be held or manipulated simultaneously. Therefore, in situations where a rod is about to be inserted through multiple pedicle screw towers and multiple robotic arms are available to hold and / or manipulate each of the multiple pedicle screw towers, the multiple robotic arms can be aligned (or otherwise arranged) with the multiple pedicle screw towers to facilitate rod insertion. Of course, any such manipulation of the pedicle screw towers may be limited by the magnitude of the force that can be safely applied to each pedicle screw tower by the corresponding robotic arm, and therefore perfect alignment or other arrangement of the pedicle screw towers (e.g., according to the surgical plan) may not be feasible.

[0155] Similarly, in some embodiments, a single robotic arm may be provided (or otherwise configured) with end effectors capable of simultaneously connecting to and / or manipulating multiple pedicle screw towers. In such embodiments, multiple pedicle screw towers can be held or otherwise manipulated using a single robotic arm, while another robotic arm manipulates a rod.

[0156] In other embodiments of this disclosure, only a single robotic arm may be available, which may be used to insert rods or retain and / or manipulate one or more pedicle screw towers. Regardless of whether the instructions are based on the user interface or otherwise displayed, the task not performed by any of the robotic arms may be carried out by the surgeon or other user.

[0157] The embodiments of this disclosure advantageously provide for planning rod insertion and for rod insertion that takes into account tower movement. By adjusting the rod's path and / or the tower's position, the placement of the rod within the tower can be optimized in real time during the procedure, thereby preventing unforeseen problems that might arise from inaccurate rod placement. Furthermore, the planning of rod insertion and path can be optimized to reduce trauma to soft tissues or other anatomical elements along the path. Therefore, patient safety can be improved, and trauma to soft tissues and / or anatomical elements can be reduced.

[0158] The foregoing is not intended to limit this disclosure to the one or more forms disclosed herein. In the foregoing specific embodiments, for example, for the purpose of simplifying this disclosure, various features of this disclosure are grouped together in one or more aspects, embodiments, and / or configurations. Features of aspects, embodiments, and / or configurations of this disclosure may be combined in alternative aspects, embodiments, and / or configurations other than those discussed above. The approach of this disclosure should not be construed as reflecting an intention that this application requires more features than those expressly stated in this application. Rather, as reflected in this application, aspects of the invention lie in fewer than all the features of a single foregoing aspect, embodiment, and / or configuration.

[0159] Furthermore, although the description has included descriptions of one or more aspects, embodiments, and / or configurations, as well as certain variations and modifications, other variations, combinations, and modifications are also within the scope of this disclosure upon understanding it, for example, as may be within the skill and knowledge of those skilled in the art. It is intended to obtain, to the permissible extent, rights including alternative aspects, embodiments, and / or configurations, including alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps of those claimed, regardless of whether such alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and is not intended for use with any patentable subject matter.

Claims

1. A robotic system for inserting a rod, comprising: Robotic arm, the robotic arm comprising: Proximal end; and A distal end that is movable relative to the proximal end, the distal end being configured as a positioning rod; At least one processor; and A memory storing instructions for execution by the at least one processor, the instructions causing the at least one processor, when executed, to: - Track at least one tower to identify tower movement, the tower extending from the head of the corresponding implanted pedicle screw; - Calculate the insertion point and the path from the insertion point to the at least one tower; - Insert the robotic arm into the rod at the insertion point and along the path; and - The robotic arm adjusts the path based on the tower movement during the insertion of the rod, wherein adjusting the path based on the tower movement during the insertion of the rod includes: adjusting the insertion point, adjusting the entire path, or adjusting a portion of the path.

2. The system according to claim 1, further comprising: At least one sensor, The memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: The at least one sensor is used to monitor the magnitude of the force received by the robotic arm.

3. The system of claim 2, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: When the magnitude of the force meets the threshold, the robot arm pauses the movement of the rod.

4. The system of claim 1, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: The robotic arm tightens the fixing screw of the corresponding pedicle screw.

5. The system of claim 1, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions, when executed, further causing the at least one processor to: The robotic arm removes the at least one tower from the head of the corresponding pedicle screw.

6. The system of claim 1, wherein a navigation system is used to track the at least one tower.

7. The system of claim 1, wherein tracking of the at least one tower uses a marker.

8. The system of claim 1, wherein a sensor is used to track the at least one tower.

9. The system of claim 1, wherein adjusting the path by the robotic arm includes adjusting at least one of the orientation of the rod or the position of the rod.

10. The system of claim 1, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: Verify the placement of the rod in at least one tower.

11. The system of claim 10, wherein a laser pointer and a reflector are used to verify the placement of the rod in the at least one tower.

12. The system of claim 10, wherein a navigation system is used to verify the placement of the rod in the at least one tower.

13. The system of claim 10, wherein a sensor is used to verify the placement of the rod in the at least one tower.

14. The system of claim 10, wherein a marker is used to verify the placement of the rod in the at least one tower.

15. A robotic system for inserting a rod, comprising: A first robotic arm and a second robotic arm, each robotic arm comprising: Proximal end; and The distal end that is movable relative to the proximal end. The distal end of the first robotic arm is configured as a positioning rod, and the distal end of the second robotic arm is configured to hold at least one tower in a known position, the at least one tower extending from the head of a corresponding pedicle screw in one of a plurality of vertebrae. At least one processor; and A memory storing instructions for execution by the at least one processor, the instructions causing the at least one processor, when executed, to: - Receive location information regarding the current location of the at least one tower; - Calculate the insertion point and the path from the insertion point to the at least one tower based on the current location; - To insert the first robotic arm into the rod at the insertion point and along the calculated path; and • The first robotic arm adjusts the path based on the tower movement during the insertion of the rod, wherein adjusting the path based on the tower movement during the insertion of the rod includes: adjusting the insertion point, adjusting the entire path, or adjusting a portion of the path.

16. The system of claim 15, wherein the position information is received from at least one sensor of the second robotic arm.

17. The system of claim 15, further comprising: A tracking marker, which is positioned on the second robotic arm; and A navigation system configured to generate the location information based on detected movement of the tracking marker.

18. The system of claim 15, further comprising at least one sensor, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: The placement of the rod in the at least one tower is verified by the at least one sensor.

19. The system of claim 15, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: The first robotic arm tightens the fixing screw of the corresponding pedicle screw.

20. The system of claim 15, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: The first robotic arm removes the tower from the head of the corresponding pedicle screw.

21. The system of claim 15, wherein the current position is different from the known position, and the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: When the difference between the current position and the known position meets a predetermined threshold, the first robotic arm adjusts the path during the rod insertion.

22. The system of claim 15, wherein the current position is different from the known position, and the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: The second robotic arm adjusts the position of at least one tower based on the fact that the difference between the current position and the known position meets a predetermined threshold.

23. A robotic system for inserting a rod, comprising: Robotic arm, the robotic arm comprising: Proximal end; and A distal end that is movable relative to the proximal end, the distal end being configured to hold at least one tower in a known position; At least one processor; and A memory storing instructions for execution by the at least one processor, the instructions causing the at least one processor, when executed, to: - Calculate the insertion point and the path from the insertion point to the at least one tower; - Generate instructions for inserting a bar along the said path; and - Updating the path during rod insertion based on information about the position of the rod or the movement of the tower, wherein updating the path during rod insertion based on information about the position of the rod or the movement of the tower includes: adjusting the insertion point, adjusting the entire path, or adjusting a portion of the path.

24. The system of claim 23, further comprising: At least one sensor, The memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: The at least one sensor is used to monitor the magnitude of the force received by the robotic arm.

25. The system of claim 24, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: When the magnitude of the force meets the threshold, the robotic arm releases the tower.

26. The system of claim 23, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions, when executed, further causing the at least one processor to: The robotic arm tightens the fixing screws corresponding to the pedicle screws of the tower.

27. The system of claim 23, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: The robotic arm removes at least one tower from the head of the pedicle screw corresponding to the tower.

28. The system of claim 23, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions, when executed, further causing the at least one processor to: The robotic arm moves the tower from the known position to the updated position based on at least one of the force applied to the robotic arm or information about the position of the rod.

29. The system of claim 23, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions, when executed, further causing the at least one processor to: Verify the placement of the rod in at least one tower.

30. The system of claim 29, wherein a laser pointer and a reflector are used to verify the placement of the rod in the at least one tower.

31. The system of claim 29, wherein a navigation system is used to verify the placement of the rod in the at least one tower.

32. The system of claim 29, wherein a sensor is used to verify the placement of the rod in the at least one tower.

33. The system of claim 29, wherein markings are used to verify the placement of the rod in the at least one tower.

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