Systems and methods of gating for active cutting

Abstract

A method to facilitate active surgical cutting includes acquiring anatomical data of a patient and determining tissue of the patient that is targeted as part of a surgical procedure and tissue of the patient that is to be protected from cutting, and creating a surgical plan for controlling autonomous execution of the cutting, including determining a cut to perform, determining a cut plane along which a cutting tool is to execute the cut, and generating a virtual gate. The virtual gate includes a first boundary at a first location on the cut plane, a second boundary at a second location on the cut plane, and an axis extending therebetween. The virtual gate defines a programmatic constraint restricting position of the cutting tool from the protected tissue. The surgical plan is provided to a controller configured to control a robotic instrument in performing the cutting in accordance with the surgical plan.

Description

SYSTEMS AND METHODS OF GATING FOR ACTIVE CUTTINGCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority benefit under 35 U.S.C. §119 of U.S. provisional application No. 63 / 650,591 filed May 22, 2024, entitled SYSTEMS AND METHODS OF GATING FOR ACTIVE CUTTING, which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] Aspects described herein relate, generally, to the field of surgery. More specifically, aspects related to the field of robotic surgery and robot-assisted surgery. Even more specifically, aspects relate to the use of robots during surgery to perform surgical cuts, such as during resection procedures, by following a predetermined cut path and / or constraining a cutting tool to a cut-specific boundary. Aspects may also have utility in other areas involving robot mounted tools, beyond those set forth above.BACKGROUND

[0003] A clinical procedure may require a surgical incision to access anatomy of interest. For example, an incision may be made in skin with a scalpel to expose bony anatomy. Generally, it is clinically preferably to minimize the extent of an exposure (i.e., to have a minimally invasive exposure), and to reduce and / or eliminate undesired contact with tissue that is unaffected or not of surgical interest. Generally, minimized damage to healthy tissue results in faster recovery times with improved outcomes.

[0004] Various tools are employed during surgeries to protect healthy tissue and / or critical anatomy that is not of surgical interest from damage, such as damage resulting from unwanted contact with surgical instruments (e.g., scalpels, saws, rotary tools, and / or other tools used for cutting and / or grinding). Despite the plethora of technology available to facilitate surgery, human error is not completely eliminated and remains a risk of damage to healthy / protected tissue, especially during the performance of surgical cuts. For example, during a Total Knee Arthroplasty (TKA), various tools may be employed to reduce, mitigate, and / or eliminate risk of damage to the medial collateral ligament (MCL), patellar tendon, popliteal artery, lateral cruciate ligament (LCL), popliteus tendon, quadriceps tendon and / orother anatomy. The instrumentality and methods utilized to reduce, mitigate, and / or eliminate risks of damage to healthy tissue often depends on the specific surgery to be performed, industry standards, surgical team preferences, idiosyncrasies in patient anatomies, cost- related factors, etc.SUMMARY

[0005] In an aspect, a method to facilitate active surgical cutting includes acquiring anatomical data of a patient and determining, based on the anatomical data of the patient, target tissue, of the patient, that is targeted for cutting as part of a surgical procedure, and protected tissue, of the patient, that is to be protected from the cutting. The method further includes creating a surgical plan for controlling autonomous execution of the cutting. Creating the surgical plan includes determining a cut to perform as part of the cutting of the target tissue, determining a cut plane along which a cutting tool is to cut in executing the cut, and generating, for the cut, a virtual gate. The virtual gate includes a first boundary point at a first location on the cut plane, the first boundary point corresponding to a first boundary for a first portion of the protected tissue, a second boundary point at a second location on the cut plane, the second boundary point corresponding to a second boundary for a second portion of the protected tissue, and an axis extending between the first boundary point and the second boundary point, the axis being coplanar with the cut plane along which the cutting tool is to cut. The virtual gate defines a programmatic constraint that restricts positioning of the cutting tool, as part of robotic execution of the cutting, from cutting the protected tissue. The method further includes providing the surgical plan to a controller that is configured to control a robotic instrument in performing the cutting, using the cutting tool, in accordance with the surgical plan.

[0006] In another aspect a system for facilitating active surgical cutting includes a memory and a processor in communication with the memory, wherein the system is configured to perform a method including acquiring anatomical data of a patient and determining, based on the anatomical data of the patient, target tissue, of the patient, that is targeted for cutting as part of a surgical procedure, and protected tissue, of the patient, that is to be protected from the cutting. The method further includes creating a surgical plan for controlling autonomous execution of the cutting. Creating the surgical plan includes determining a cut to perform as part of the cutting of the target tissue, determining a cut planealong which a cutting tool is to cut in executing the cut, and generating, for the cut, a virtual gate. The virtual gate includes a first boundary point at a first location on the cut plane, the first boundary point corresponding to a first boundary for a first portion of the protected tissue, a second boundary point at a second location on the cut plane, the second boundary point corresponding to a second boundary for a second portion of the protected tissue, and an axis extending between the first boundary point and the second boundary point, the axis being coplanar with the cut plane along which the cutting tool is to cut. The virtual gate defines a programmatic constraint that restricts positioning of the cutting tool, as part of robotic execution of the cutting, from cutting the protected tissue. The method further includes providing the surgical plan to a controller that is configured to control a robotic instrument in performing the cutting, using the cutting tool, in accordance with the surgical plan.

[0007] In yet another aspect, a computer program product for facilitating active surgical cutting includes a computer readable storage medium readable by a processing circuit and storing instructions for execution by the processing circuit for performing a method including acquiring anatomical data of a patient and determining, based on the anatomical data of the patient, target tissue, of the patient, that is targeted for cutting as part of a surgical procedure, and protected tissue, of the patient, that is to be protected from the cutting. The method further includes creating a surgical plan for controlling autonomous execution of the cutting. Creating the surgical plan includes determining a cut to perform as part of the cutting of the target tissue, determining a cut plane along which a cutting tool is to cut in executing the cut, and generating, for the cut, a virtual gate. The virtual gate includes a first boundary point at a first location on the cut plane, the first boundary point corresponding to a first boundary for a first portion of the protected tissue, a second boundary point at a second location on the cut plane, the second boundary point corresponding to a second boundary for a second portion of the protected tissue, and an axis extending between the first boundary point and the second boundary point, the axis being coplanar with the cut plane along which the cutting tool is to cut. The virtual gate defines a programmatic constraint that restricts positioning of the cutting tool, as part of robotic execution of the cutting, from cutting the protected tissue. The method further includes providing the surgical plan to a controller that is configured to control a robotic instrument in performing the cutting, using the cutting tool, in accordance with the surgical plan.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The subject matter which is regarded as the invention is particularly pointed out and distinctly claimed in the claims at the conclusion of the specification. The foregoing and other features and advantages of the invention will be readily understood from the following detailed description of the preferred embodiments taken in conjunction with the accompanying drawings in which:

[0009] FIG. 1 depicts an example of a virtual gate extending between sides of an incision in anticipation of a subsequent cut;

[0010] FIG. 2 depicts an example in-process tibial cut in which a cutting blade has passed through a virtual gate in order to reach patient anatomy to be cut but is constrained / restricted within the virtual gate;

[0011] FIG. 3 depicts an example of undesired positioning of a blade, and an example virtual gate to address this situation, in accordance with aspects described herein;

[0012] FIG. 4 illustrates principles of a conservative approach to cut boundaries;

[0013] FIGS. 5-10A illustrate example aspects described herein in the context of multiple cuts of a total knee arthroplasty;

[0014] FIGS. 11-12 depict an example use of a virtual gate in conjunction with cut paths, in accordance with aspects described herein;

[0015] FIG. 13 depicts an example surgical environment and system morphology of aspects disclosed herein; and

[0016] FIG. 14 depicts an example computer system to incorporate, use, and / or facilitate aspects described herein.DETAILED DESCRIPTION OF THE INVENTION

[0017] Aspects will be discussed hereinafter in detail in terms of various exemplary embodiments and with reference to the accompanying drawings. In following the detailed description, numerous specific details are set forth in order to provide a thoroughunderstanding of the present invention. It will be obvious, however, to those skilled in the art that the aspects may be practiced without these specific details. In other instances, well- known structures are not shown in detail in order to avoid unnecessary obscuring of aspects described.

[0018] Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary, or the following detailed description. It is also understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the inventive concepts defined in the appended claims. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting, unless the claims expressly state otherwise.

[0019] In the example of a manual surgery to perform a TKA, a surgeon may plan a resection profile, including a series of cut pathways, using various software implemented technologies in conjunction with the results of a CT scan. A set of safety boundaries may be established as part of this planning. The surgeon may also use physical tools, such as a manual jig or a cutting block which captures a cutting blade. A cutting block serves to reduce, mitigate, and / or eliminate risks of damage to healthy tissue by spatially restricting (e.g., constraining) movement of the cutting blade thereby directing the blade away from / preventing physical engagement with critical anatomy and / or other healthy tissue which is not of surgical interest. A physical or programmatically (e.g., in software) defined restriction (e.g., constraint) to movement, positioning, orientation, and / or travel of the cutting blade is referred to herein as a “gate,” “safe-zone boundary,” “patient-specific boundary,” or similar, depending on the type(s) of restriction being imposed on the blade.

[0020] Robots and / or other computer integrated systems and / or equipment are increasingly utilized in surgical procedures. Often, such devices include a mounted cutting tool to perform cuts / incisions that are user-initiated and controlled - that is, a human operator of the robot dynamically directs, typically via physical input devices, the movement and other actions of the cutting tool by directing the robot to perform such actions (i.e., the robot is not actively executing the cuts / incisions). Commanding a robot to execute or assist with surgical cuts may require generating a toolpath (and / or a cut path) for a robot with a mounted cutting instrument (e.g., a scalpel, sagittal saw, or other cutting tool) to follow. A toolpath representsa series of ordered coordinates through which a tool such as a cutting instrument may travel and / or is constrained to in performing a function, like cutting. A surgical toolpath is generally dictated by the user (e.g., a surgeon or other medical professional). Generally, the robot executes its intended task with the tool at or around each ordered coordinate on the toolpath while staying within the restraints set by any gates. A sequence of cuts encompassed in a toolpath may be represented as a sequence of planes.

[0021] In accordance with aspects described herein, systems and methods to facilitate active surgical cutting are provided. For instance, aspects provide programmatically-defined virtual constraints (gates) for controlling autonomous robotic execution of cuts defined as part of a surgical plan. There are currently no commercial systems or methods for navigated active robots with robot mounted cutting instruments (e.g., robot mounted scalpels, scissors, and / or sagittal saws). Executing surgical cuts actively (i.e., by a robot autonomously following a cut path) may be more efficient and safer than manual surgical procedures, allowing the surgeon to use both hands for other tasks and potentially freeing up space in the operating room. It therefore follows that there is a present need for active robotic surgical systems (including associated instrumentality) and methods for generating surgical plans, under control of which the active robotic surgical systems are to perform in actively, autonomously (including semi -autonomously), and safely executing cutting along toolpaths during various procedures, an example of which is surgery, such as a TKA, as one example.

[0022] To facilitate the performance of surgical cuts by an active robotic surgical system, systems and methods are provided for generating one or more virtual boundaries (i.e., “virtual gates”, “safe-zone boundaries”, “virtual constraints” and / or “patient specific boundaries”) as described in more detail below to constrain / restrict movement of a robot / robot mounted cutting tool to areas of surgical interest and away from, or at least to prevent physical interaction with, other (potentially critical) anatomy of a patient. The systems and methods disclosed herein may be applicable to, inter alia, surgical procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical structures (e.g., bony structures) can be identified relative to a model (e.g., a CT based model) of a patient’s anatomy.

[0023] Aspects may be used to assist a surgeon and / or surgical team preoperatively and / or intraoperatively (during an operation) by actively and / or autonomously generating,defining, and / or implementing virtual gates (e.g., virtual boundaries / constraints) to facilitate safe cutting and desired orientation and movement of a robot and / or robot mounted tool, such as a cutting tool (e.g., a scalpel or sagittal saw), along a toolpath (e.g., a cut path) during surgery. Virtual gates may be employed in isolation or in combination with various other forms of virtual boundaries (e.g., safe-zone boundaries and / or patient specific boundaries). Aspects are disclosed throughout this application with reference to a TKA, though it should be understood that this is by way of example, and not limitation, and that aspects may be helpful for any navigated surgical procedure, including those that involve use of a cutting tool (e.g., saws, scalpels, scissors, and / or other tools featuring a blade), those that utilize grinding tools (e.g., rotary tools and / or other grinding-type tools), and others.

[0024] A virtual gate may be used to constrain / restrict movement of a cutting blade / cutting tool during a surgery. With respect to physical jigs / cutting blocks used during a manual surgery, such device may be fixed in place at a location corresponding to a surgical cut to be made during the surgery (e.g., a cut to be made during a TKA, including a tibial gate cut, an anterior femur cut, an anterior chamfer cut, a distal femur cut, a posterior chamfer cut, a posterior cut, or any other cut a surgeon may decide on as part of a surgical plan) and / or areas of a patient’s anatomy that a cutting tool is to avoid during surgery. The physical jig or cutting block serves to physically constrain and / or restrain movement of a cutting blade, which includes a surgeon’s ability to move a cutting tool or the blade of a cutting tool, either away from, or to prevent physical engagement with, protected tissue of the patient (i.e., tissue not intended to be cut during surgery). In accordance with aspects described herein, a virtual gate serves to programmatically restrain a robot / robot mounted cutting tool to achieve an effect similar to the way that a surgeon is restrained by being physically unable to move the blade beyond the boundary and / or constraint set by the physical jig or cutting block, for instance. Although aspects and examples described herein are presented in the context of controlling movement of a cutting tool during an active and / or autonomous robotic surgery, aspects may also be used to prevent a robotic arm (e.g., with a cutting tool) operating semi- autonomously (e.g., that is under the physical control of a user (e.g. surgeon) during a robot- assisted but user-performed procedure) from being physical manipulated and / or moved by the user in a manner that would violate the boundary and / or constraint set by the virtual gate(s) being used.

[0025] As described herein, a virtual gate may include a plurality (e.g., at least two) of gate points and an axis. The gate points serve as virtual vertices and / or endpoints representative of virtual boundaries that correlate to respective points or locations in real space. No portion of the cutting tool may be positioned such that it makes contact with the points in real space that correspond to the gate points of the virtual gates, and therefore the points may be defined for a controller of a robot such that the controller never allows robotic movement and / or positioning that would cause the cutting tool or a blade thereof (or allow for any other undesired physical contact by any other component) to make contact with the points in real space that correspond to the gate points. In this manner, gate points may correspond to specific and protected points and / or portions of a patient’s anatomy.

[0026] The axis of the virtual gate extends between the two gate points and defines a space along which the cutting tool (e.g., the blade of the cutting tool) may move freely between the two gate points along that axis. The virtual gate, by way of the axis and gate points, may define an entry passage for a cutting tool, an exit passage for a cutting tool, and / or a general tool boundary which avoids the specific and / or protected portions of the patient’s anatomy. For example, during a TKA, a collection of virtual gates may define entry passages for a robot mounted cutting tool / blade, exit passages for the robot mounted cutting tool / blade, and general tool boundaries for the robot mounted cutting tool / blade to effect the necessary cuts involved.

[0027] In an example shown in FIG. 1, virtual gate 100 is shown within an existing incision 101 in anticipation of a subsequent cut. The virtual gate 100 includes two gate points102. 104 and an axis 103 (i.e., a line) on a cut plane (not shown). In FIG. 1, the surgical incision 101 was made in a direction substantially normal to the direction of extension of axis103. A generally planar cutting tool or blade thereof (e.g., a blade of a sagittal saw) is to enter through the incision 101 to underlying anatomy (such as bone) in order to make a planar cut. The planar cutting tool and / or blade is to pass through virtual gate 100 in an orientation matching that of axis 103, i.e., parallel and through axis 103 between the two gate points 102,104. Virtual gate 100 constrains the side-to-side (along the axis) movement of the cutting tool / blade thereof to movement between the two gate points 102, 104 (i.e., along the axis 103) while the cutting tool and / or blade passes through the virtual gate 100 and into underlying anatomy to be cut, during execution of the planar cut, and during withdrawal of the blade after the cut has been made . The positioning of the virtual gate 100 in FIG. 1 is byway of example only. The virtual gate 100 extends almost or exactly across the widest part of the incision and its gate points generally align with the periphery of the surgical incision 101, though this may not always be the case for different virtual gates, surgical incisions, and / or applications of aspects described herein. For example, two gate points may restrict a planar cutting tool to a space which extends outside some or all edges of a particular surgical incision, or to a space which does not reach some or any of the edges of a particular surgical incision.

[0028] In the perspective of FIG. 1, the cutting tool / blade would enter the gate 100 from the viewer’s vantage point and travel into and through the figure (e.g., passing through the “paper”). In the context of a surgical procedure for a patient, the cutting tool would encounter and cut into patient anatomy underlying the incision area. The two gate points 102, 104 define the outer boundaries of the virtual gate 100, and in this case correspond to the sides of the surgical incision 101. Axis 103 (i.e., line) extends between these two points and defines a space, within the cut plane, to which a cutting tool and / or a blade thereof is constrained during surgery and / or performance of one or more surgical cut(s). Therefore, when employed, the cutting tool or blade thereof will be constrained by the virtual gate 100 to movement along the axis 103 and within the cut plane, such that the cutting tool or the blade thereof cannot contact either of the two gate points 102, 104.

[0029] A cut plane is any plane along which a cutting tool is expected to cut in performing a surgical cut. Generally, a cut plane will be defined, selected, and / or confirmed by the surgeon based on the surgery to perform. A surgeon may use patient data (e.g., the results of various scans such as CT scans, any patient-specific measurements, etc.) to define, select, and / or confirm the cut plane, and may further be guided by various factors including industry standards. A cut plane may correspond to one or more cut(s) to be made during performance of a surgery (e.g., to any cut performed during a TKA). In the example shown in FIG. 1, each of the two gate points 102, 104 represent a respective programmatically-defined “never pass” constraint and / or boundary for restricting and / or constraining orientation and / or movement of a blade (e.g., a blade of a robot mounted cutting tool) in at least one dimension to orientation and / or movement along the axis 103 (i.e., a line) between the two gate points 102, 104. To be clear, by “never pass” constraint and / or boundary in this context is meant that the cutting tool (e.g., a blade of the cutting tool) can never travel (along the axis 103 in the direction extending between the two gate points 102, 104) beyond the boundary set by thetwo gate points 102, 104. The blade can pass through the axis 103 (akin to entering and passing through the paper along axis 103 and between points 102, 104 of FIG. 1), and can move side-to-side along the axis 103, if desired, though bounded by the gate points.

[0030] In embodiments, gate points may be defined, positioned, selected, etc. to correspond to particular protected anatomy. For example, the first gate point 102 may correspond to a first protected portion of the patient’s anatomy, and the second gate point 104 may correspond to a second protected portion of the patient’s anatomy, thereby restricting a robot and / or robot mounted cutting tool (e.g., a blade of the cutting tool) to movement / orientation along the axis 103 between the two gate points 102, 104 (e.g., within the virtual gate 100) and away from areas of protected anatomy. An one or more array (s) and / or one or more visual and / or optical sensor(s) may assist a robot in placing (statically or dynamically) the virtual gate 100 (e.g., determining the location of the first gate point 102, the second gate point 104, and / or the axis 103) and / or physical stimulus such as anatomical landmarks during a procedure and / or when performing one or more cut(s).

[0031] Boundaries and / or constraints (e.g., the first gate point 102, the second gate point 104, and / or the axis 103) corresponding to protected tissue(s) may be conservatively placed (i.e., applied to the individual) based on known anatomical information. For example the exact location(s) of the first gate point 102 and the second gate point 104 may be influenced by patient-specific factors and / or other patient data which may be obtained preoperatively, as one example (e.g., from advanced imaging, such as X-rays, CT scans, MRIs, etc.), such as idiosyncrasies in the patient’s anatomy and / or other health conditions and / or ailments, evaluated in combination with other non-patient-specific factors, such as industry standards for performing a certain procedure and / or cut. The protected portions of the patient’s anatomy may include various anatomical structures and / or landmarks (e.g., tendons, organs, arteries, and / or any other anatomical structures) which a robot, robot mounted cutting tool and / or blade is to avoid when making a cut during a surgical procedure. In an example, the locations of the first gate point 102, the second gate point 104, and / or the axis 103 may be determined and / or placed automatically by a system based on information obtained preoperatively about the patient (e.g., from advanced imaging, such as X-rays, CT scans, MRIs, etc.), and a surgeon may then optionally modify this if the surgeon chooses. Alternatively, a surgeon may determine and / or place the first gate point 102, the second gate point 104, and / or the axis 103 independently or with a surgical team.

[0032] A virtual gate can correspond to physical constraints imposed by a surgical cut (e.g., various anatomical structures and / or landmarks to be avoided) such that a robot / robot mounted cutting tool is limited to movement and / or orientation within the boundary of the surgical exposure for each respective cut. In FIG. 2, an example of a cutting blade 208 constrained / restricted within a virtual gate 200 (e.g., a tibial cut gate) is shown with respect to a tibial cut. In the example, a cut plane 206 (matching the plane along which the tibial crosssection is shown) corresponds to a plane of a patient’s knee (e.g., of a patient’s tibia 214) along which at least one cut is to be made. In such an example, the planned surgical cut is a tibial cut, and the robot, robot mounted cutting tool and / or blade thereof making the tibial cut is constrained and / or restrained in terms of side-to-side movement by the virtual gate 200 to an area between the patient’s MCL 210 and patellar tendon 212. The virtual gate 200 (e.g., tibial cut gate here) may be defined by an axis 203 (e.g., a line), a first gate point 202 and a second gate point 204, all of which sit in the cut plane 206. In an example, the axis 203 may extend between the first gate point 202 and the second gate point 204, the first gate point 202 may correspond to the patient’s MCL 210, and the second gate point 204 may correspond to the patient’s patellar tendon 212.

[0033] As shown in FIG. 2 and with respect to the view depicted therein, the cutting blade 208 has passed through the virtual gate 200 traveling generally from the bottom-left to top-right portion of the figure within the cut-plane 206. Notably, the blade 208 is shown constrained such that it cannot not enter anywhere other than between the two gate points 202, 204, and is constrained and / or restricted laterally to movement (generally left-right movement in this view, indicated by B) within the virtual gate 200 (e.g., to movement along the axis 203 between the first gate point 202 and the second gate point 204). The blade 208 could in this example move deeper into the tibia 214, which would be shown by first portion 207 of the blade 208 having been moved through the axis 203 further in a direction towards the top right portion of the figure (see the direction indicated by A). The blade 308 could be extended, turned, and / or rotated as desired and as permitted by the virtual gate 200, that is, which does not result in a second portion 209 of the blade 208 located between the two gate points 202, 204 from moving laterally along axis 203 to exceed the boundaries set by the two gate points 202, 204. Additionally, a base end 230 of the blade 208 could be moved laterally (e.g., in the B direction) if desired as long as the above constraint on movement of the second portion 207 of the blade 208 remains satisfied. The first portion 207 and the base end 230could therefore be permitted to move further laterally (e.g., in opposite B directions) while the second portion 209 remains constrained laterally to movement between the two gate points 202, 204. Additionally, the blade 208 could move reciprocally in the lateral direction, for instance based on lateral movement of the base end 230, so long as portion 209 remains within the gate boundaries (e.g., between the two gate points 202, 204). In this way, the virtual gate 200 is a programmatically-defined restriction on movement and / or positioning of the blade 208 of the robot mounted cutting tool which restricts and / or prevents the blade 208 from engaging with (e.g., cutting) the MCL 210 and / or the patellar tendon 212 of the patient while also permitting sufficient movement to properly perform the tibial cut.

[0034] Aspects may be used in combination with other types of virtual boundaries, as needed. For example, a surgeon and / or surgical team may wish to protect other structures than the patient’s MCL and patellar tendon during a TKA, such as the patient’s popliteal artery, popliteus tendon, various other soft tissue(s), and / or other anatomical structures and / or landmarks a robot, robot mounted cutting tool and / or a blade thereof is to avoid. To account for other areas of protected anatomy, a virtual gate may be used in combination with one or a plurality of safe-zone boundaries and / or patient-specific boundaries, as described in more detail below. In this way, aspects may utilize multiple layers of boundaries such that protected anatomy and / or anatomical structures may receive multiple layers of protection.

[0035] FIG. 3 depicts an example of undesired positioning of a blade 308, and an example virtual gate 300 to address this situation, in accordance with aspects described herein. In this example, the blade 308 is depicted as having been positioned and / or moved sufficiently toward the lower right comer of the figure that it risks damage to the patellar tendon. Virtual gate 300 is shown as an example boundary that could be provided to prevent this. More specifically, provisional of virtual gate 300 would constrain the robot, robot mounted cutting tool and / or blade 308 thereof to movement in the direction indicated by B. FIG. 3 shows an example violation that would not occur during practical application since the movement and / or positioning of the blade 308 would violate the virtual gate 300 boundary if it were provided.

[0036] Additionally, the example of FIG. 3 provides a plurality of virtual constraints and / or boundaries. In the example, the virtual gate 300, a safe-zone boundary 320, and a patient-specific boundary 330 are shown in combination. The blade 308 in this example sitswithin safe-zone boundary 320 and within the patient-specific boundary 330 , but would violate the boundaries set by the virtual gate 300. This example demonstrates that even with constraints in place, there may still be a need for the virtual gate 300 to mitigate and / or eliminate risks of harm and / or damage to protected tissues.

[0037] In practical application, if the virtual gate 300 were to be used, the robot, robot mounted cutting tool and / or blade 308 thereof could not be positioned as shown, because the presence of the virtual gate 300 would require the blade 308 stay within the boundaries defined by the virtual gate 300. A problem in the prior art of TKA surgery is the potential for damage to be caused to protected anatomy (e.g., during cutting), such as a patient’s MCL, patellar tendon, LCL, PCL, popliteal artery, and / or other anatomy in the surgical region. As noted above this problem in the prior art also applies more generally to other anatomical features, structures, and regions related to other types of surgeries and / or procedures, which may similarly benefit from employing aspects disclosed herein. Here, the safe-zone boundary 320 and / or the patient-specific boundary 330 may be enough to protect some protected anatomy, but also may not impose conservative enough constraints on the robot, robot mounted cutting tool, and / orblade 308 thereof to prevent damage to, inter alia, a patient’s MCL, patellar tendon, LCL, PCL, popliteal artery, and / or other protected anatomy, and therefore the additional layer(s) of protection provided by the virtual gate 300 may be desired.

[0038] One or more virtual gate(s) may be utilized in combination with one or more safezone boundary and / or patient-specific boundary during a TKA or other procedure to define more conservative and / or protective boundaries and / or constraints to protect a wider range of anatomy than in the prior art, such as the patient’s MCL, patellar tendon, soft tissue, popliteal artery, LCL, PCL, and / or other anatomy in the case of a TKA (i.e., to restrict and / or constrain movement of the robot, robot mounted cutting tool and / or blade 308 thereof to movement within the conservative area defined by combining the virtual gate 300, the safe-zone boundary 320, and the patient-specific boundary 330). The virtual gate 300 may have a first gate point 302 which corresponds to a patient’s MCL, a second gate point 304 which corresponds to the patient’s patellar tendon, and an axis 303 extending between the first gate point 302 and the second gate point 304, as shown with respect to a cut plane 306 for cutting a portion of the patient’s femur 314. The virtual gate 300 may restrict and / or constrain movement of the cutting blade 308 (e.g., a cutting blade of a robot mounted cutting tool) inthe direction (denoted B), which is generally perpendicular to the direction of travel (denoted A) of the blade 308 to effect the cut, such that the blade 308 is able to move in the B direction along axis 303 such that the blade 308 remains between the first gate point 302 and the second gate point 304, and therefore the blade 308 avoids, inter alia, the patient’s MCL and patellar tendon.

[0039] A safe-zone boundary is a 2D boundary on a plane of a patient’s anatomy for the blade of a robot mounted cutting tool which cannot be altered, expanded, or changed by a user, intentionally or unintentionally. Unlike virtual gates described herein, safe-zone boundaries are defined by an area, rather than a line and / or an axis. The safe-zone boundary 320 may correspond generally to any protected tissue(s) of the patient, for instance the patient’s MCL, LCL, PCL, patellar tendon, popliteal artery, soft tissue, and / or any other structure to be protected during surgery / performance of the cut. The safe-zone boundary 320 may be based on and / or defined by any desired approach, for instance based on general data regarding the structure of a knee, bones in the knee, and / or surrounding tissue and / or anatomy of the knee, including the location(s) of target surgical tissue(s) and / or protected tissue(s).

[0040] A patient specific boundary is a 2D boundary on a plane of a patient’s anatomy (generally within a safe-zone boundary) for the blade of a robot mounted cutting tool which cannot be altered, expanded, or changed by a user, intentionally or unintentionally. Unlike virtual gates, and similar to safe-zone boundaries, patient-specific boundaries are defined by an area, rather than a line and / or an axis. The patient specific boundary 330 during a TKA may, like the safe-zone boundary 320, correspond generally to any protected tissue(s) of the patient, including the patient’s MCL, LCL, PCL, patellar tendon, popliteal artery, soft tissue, and / or any other structure to be protected during surgery and / or performance of a cut. However, the patient-specific boundary 330 may be directly based on and / or defined by patient-specific data, such as the results of a scan / scans (e.g., CT scans) indicating the exact location of various structures of the knee, bones in the knee, and / or surrounding tissue / anatomy of the knee, including the location(s) of target surgical tissue(s) and / or protected tissue(s). FIG. 3 illustrates multiple layers of protection corresponding to some degree to at least the patient’s MCL and patellar tendon (and perhaps also to other anatomy, e.g., the popliteal artery of the patient).

[0041] Referring now to FIG. 4, a system may be configured to default to a most conservative boundary for purposes of directing robotic cutting to affect one or more cut(s) where protected anatomy may be in close proximity to a cutting tool and / or a blade thereof. FIG. 4 shows an example bone 414 in which a first portion 432 of a patient-specific boundary 430 extends outside the boundary of a safe-zone boundary 420 (as noted above, a patientspecific boundary generally exists within a safe-zone boundary), and a second portion 434 of the patient-specific boundary is encompassed by the safe-zone boundary 420. Aspects described herein may constrain a robot, robot mounted cutting tool and / or blade thereof to movement and / or orientation within the most conservative boundary formed by considering the safe-zone boundary 420 and the patient-specific boundary 430. In the example shown in FIG. 4, the robot, robot mounted cutting tool and / or blade thereof may be constrained / restricted to movement within the second portion 434 of the patient-specific boundary and a first portion 422 of the safe-zone boundary 420, such that the robot, robot mounted cutting tool and / or blade thereof does not travel through or beyond the innermost boundary (e.g., the most conservative boundary) defined by the combined safe-zone boundary 420 and patient specific boundary 430, and thereby avoids the first portion 432 of the patient specific boundary 430.

[0042] In many surgical procedures, there are a plurality of surgical tasks and / or cuts to be made, and therefore there may be a plurality of corresponding virtual gates. For example, in a TKA procedure, there may be six cuts and at least six virtual gates, each corresponding to a different cut of the six cuts, respectively. An example of multiple cuts for a TKA is depicted by FIGS. 5-10.

[0043] In the example of FIG. 5, a tibial cut gate 500 (e.g., a virtual gate for a tibial cut) is defined by an axis 503 (e.g., a line), a first gate point 502, and a second gate point 504 on a cut plane 506 (matching the plane along which the tibial cross-section is shown). The axis503 may extend between the first gate point 502 and the second gate point 504. The first gate point 502 may correspond to an MCL (540 of FIG. 5 A) of a patient, and the second gate point504 may correspond to a patellar tendon (570 of FIG. 5 A) of the patient. When making the tibial cut, surgical approach is generally on a medial side. When utilizing the tibial cut gate 500 to constrain and / or restrict movement and / or orientation of a cutting blade 508 that has passed through the gate during the tibial cut, the tibial cut gate 500 may constrain and / or restrict the cutting blade 508 (e.g., the blade of a scalpel or a sagittal saw) to remain betweengate points 502, 504 (e.g., a space between the MCL 540 and patellar tendon 570) and side- to-side movement (if any) along axis 503. In addition to the tibial cut gate 500, a safe-zone boundary 520 corresponding to the shape of the bone (e.g., the tibia 514) to be cut may provide additional protection to the MCL 540, the patellar tendon 570, an LCL (550 of FIG. 5A), and / or other protected anatomy, especially including soft tissue. This facilitates directing, restricting, and / or constraining the cutting blade 508 from contacting the MCL, patellar tendon, LCL, and / or other protected anatomy and mitigating the risk of harm thereto.

[0044] FIG. 5 A shows an example anatomical environment and surgical region for the tibial cut to the tibia 514 and depicts an incision 545 along with the position of some protected anatomy of a patient such as the MCL 540, the LCL 550, a PCL 560 and the patellar tendon 570. The tibial cut gate 500 may be positioned such that the blade 508 would be required to pass through, and remain within the boundary of, the tibial cut gate 500 (from the perspective of side-to-side movement within the gate) to make the tibial cut. In such a scenario, the tibial cut gate 500 may help restrict and / or constrain the blade 508 from contact with, inter alia, the patellar tendon 570, the MCL 540, the LCL 550, and / or the PCL 560 during performance of the tibial cut.

[0045] In the example of FIG. 6, an anterior femur cut gate 600 (e.g., a virtual gate for an anterior femur cut to a femur 614) is defined by an axis 603 (e.g., a line), a first gate point 602, and a second gate point 604 on a cut plane 606. The axis 603 may extend between the first gate point 602 and the second gate point 604. The first gate point 602 may correspond to an LCL (560 of FIG. 6A) and / or a patellar tendon (570 of FIG. 6A) of a patient, and the second gate point 604 may correspond to an MCL (540 of FIG. 6 A) of the patient. When making the anterior femur cut, surgical approach is from a distal trajectory. When utilizing the anterior femur cut gate 600 to constrain and / or restrict movement and / or orientation of a cutting blade 608 that has passed through the gate during the anterior femur cut, the anterior femur cut gate 600 may constrain and / or restrict the cutting blade 608 (e.g., the blade of a scalpel or a sagittal saw) medially and laterally (direction B) to remain between gate points 602, 604 and side-to-side movement (if any) along axis 603. This may facilitate directing, restricting, and / or constraining the cutting blade 608 from contacting protected anatomy, mitigating the risk of harm thereto.

[0046] FIG. 6A shows an example anatomical environment and surgical region for the anterior femur cut and depicts an incision 645 along with the position of some protected anatomy of a patient such as an MCL 640, an LCL 650, and a quadriceps tendon 680. The anterior femur cut gate 600 may be positioned such that the blade 608 would be required to pass through, and remain within the boundary of, the anterior femur cut gate 600 (from the perspective of side-to-side movement within the gate) to make the anterior femur cut. In such a scenario, the anterior femur cut gate 600 may help restrict and / or constrain the blade 608 from contact with, inter alia, the MCL 640, the LCL 650, and / or the quadriceps tendon 680, during performance of the anterior femur cut.

[0047] In the example of FIG. 7, an anterior chamfer cut gate 700 (e.g., a virtual gate for an anterior chamfer cut to a femur 714) is defined by an axis 703 (e.g., a line), a first gate point 702 and a second gate point 704 on a cut plane 706. The axis 703 may extend between the first gate point 702 and the second gate point 704. The first gate point 702 may corresponds to an MCL (740 of FIG. 7A) of a patient, and the second gate point 704 corresponds to an LCL (750 of FIG. 7A) of the patient. When making the anterior chamfer cut to the femur, surgical approach is from a distal trajectory. When utilizing the anterior chamfer cut gate 700 to constrain and / or restrict movement and / or orientation of a cutting blade 708 that has passed through the gate during the anterior chamfer cut, the anterior chamfer cut gate 700 may constrain and / or restrict the cutting blade 708 (e.g., the blade of a scalpel or a sagittal saw) medially and laterally (direction B) to remain between gat points 702, 704 and side-to-side movement (if any) along axis 703. This may facilitate directing, restricting, and / or constraining the cutting blade 708 from contacting protected anatomy, mitigating the risk of harm thereto.

[0048] FIG. 7A shows an example anatomical environment and surgical region for the anterior chamfer cut and depicts an incision 745 along with the position of some protected anatomy such as the MCL 740, the LCL 750, and a quadriceps tendon 780 of the patient. The anterior chamfer cut gate 700 may be positioned such that the blade 708 would be required to pass through, and remain within the boundary of, the anterior chamfer cut gate 700 (from the perspective of side-to-side movement within the gate) to make the anterior chamfer cut. In such a scenario, the anterior chamfer cut gate 700 may help restrict and / or constrain the blade 708 from contact with, inter alia, the MCL 740, the LCL 750, and / or the quadriceps tendon 780 during performance of the anterior chamfer cut.

[0049] In example of FIG. 8, a distal femur cut gate 800 (e.g., a virtual gate for a distal femur cut to a femur 814) is defined by an axis 803 (e.g., a line), a first gate point 802 and a second gate point 804 on a cut plane 806. The axis 803 may extend between the first gate point 802 and the second gate point 804. The first gate point 802 may correspond to a patellar tendon (870 of FIG. 8 A) and / or an extensor mechanism (not shown) of the patient, and the second gate point 804 may correspond to a medial side of the patient’s knee (not shown). When making the distal femur cut, surgical approach is generally from an anterior medially biased trajectory. When utilizing the distal femur cut gate 800 to constrain and / or restrict movement and / or orientation of a cutting blade 808 that has passed through the cut gate 800 during the distal femur cut, the distal femur cut gate 800 may constrain and / or restrict the cutting blade 808 (e.g., the blade of a scalpel or a sagittal saw) to a space between the patellar tendon (and knee extensor mechanism) and the medial side of the knee (e.g., to remain between gate points 802, 804 and side-to-side (direction B) movement (if any)) along axis 803. This may facilitate directing, restricting, and / or constraining the cutting blade 808 from contacting the protected anatomy, mitigating the risk of harm thereto.

[0050] FIG. 8A shows an example anatomical environment and surgical region for the distal femur cut and depicts an incision 845 along with the position of some protected anatomy such as an MCL 840, and LCL 850, and a quadriceps tendon 880 of the patient. The distal femur cut gate 800 may be positioned such that the blade 808 would be required to pass through, and remain within the boundary of, the distal femur cut gate 800 (from the perspective of side-to-side movement within the gate) to make the distal femur cut. In such a scenario, the distal femur cut gate 800 may help restrict and / or constrain the blade 808 from contact with, inter alia, the MCL 840, the LCL 850, and / or the quadriceps tendon 880 during performance of the distal femur cut.

[0051] In the example of FIG. 9, a posterior chamfer cut gate 900 (e.g., a virtual gate for a posterior chamfer cut to a femur 914) is defined by an axis 903 (e.g., a line), a first gate point 902 and a second gate point 904 on a cut plane 906. The axis 903 may extend between the first gate point 902 and the second gate point 904. The first gate point 902 may correspond to an LCL (950 in FIG. 9A) and / or a patellar tendon (970 of FIG. 9A) of a patient, and the second gate point 904 may correspond to an MCL 940 of the patient. When making the posterior chamfer cut to the femur, surgical approach is from an anterior trajectory. When utilizing the posterior chamfer cut gate 900 to constrain and / or restrictmovement and / or orientation of a cutting blade 908 that has passed through the gate during the posterior chamfer cut, the posterior chamfer cut gate 900 may constrain and / or restrict the cutting blade 908 (e.g., the blade of a scalpel or a sagittal saw) medially and laterally (direction B) to remain between gate points 902, 904 and side-to-side movement (if any) along the axis 903. This may facilitates directing, restricting, and / or constraining the cutting blade 908 away from the protected anatomy, mitigating the risk of harm thereto.

[0052] FIG. 9A shows an example anatomical environment and surgical region for the posterior chamfer cut and depicts an incision 945 along with the position of some protected anatomy such as the MCL 940, the LCL 950, and the quadriceps tendon 980 of the patient. The posterior chamfer cut gate 900 may be positioned such that the blade 908 would be required to pass through, and remain within the boundary of, the posterior chamfer cut gate 900 (from the perspective of side-to-side movement within the gate) to make the posterior chamfer cut. In such a scenario, the posterior chamfer cut gate 900 may help restrict and / or constrain the blade 908 from contact with, inter alia, the MCL 940, the LCL 950, and / or the quadriceps tendon 980 during performance of the posterior chamfer cut.

[0053] In the example of FIG. 10, a posterior femur cut gate 1000 (e.g., a virtual gate for a posterior femur cut to a femur 1014) is defined by an axis 1003 (e.g., a line), a first gate point 1002 and a second gate point 1004 on a cut plane 1006. The axis 1003 may extend between the first gate point 1002 and the second gate point 1004. The first gate point 1002 may correspond to a an LCL (1050 of FIG. 10A) and / or a patellar tendon (1070 of FIG. 10A), and the second gate point 1004 may correspond to an MCL (1040 of FIG. 10 A) of the patient. When making the posterior femur cut, surgical approach is from an anterior trajectory. When utilizing the posterior cut gate 1000 to constrain and / or restrict movement and / or orientation of a cutting blade 1008 that has passed through the gate during the posterior femur cut, the posterior femur cut gate 1000 may constrain and / or restrict the cutting blade 1008 (e.g., the blade of a scalpel or a sagittal saw) medially and laterally (direction B) to remain between gate points 1002, 1004 and side-to-side movement (if any) along axis 1003. This may facilitate directing, restricting, and / or constraining the cutting blade 1008 away from protected anatomy, mitigating the risk of harm thereto.

[0054] FIG. 10A shows an example anatomical environment and surgical region for the posterior femur cut and depicts an incision 1045 along with the position of some protectedanatomy such as the MCL 1040, the LCL 1050 the quadriceps tendon 1080, and a popliteal tendon 1090 of the patient. The posterior femur cut gate 1000 may be positioned such that the blade 1008 would be required to pass through, and remain within the boundary of, the posterior femur cut gate 1000 (from the perspective of side-to-side movement within the gate) to make the posterior femur cut. In such a scenario, the posterior femur cut gate 1000 may help restrict and / or constrain the blade 1008 from contact with, inter alia, the MCL 1040, the LCL 1050, the quadriceps tendon 1080, and / or the popliteal tendon 1090 during performance of the posterior femur cut.

[0055] FIG. 11 depicts an example virtual gate 1100 shown with respect to a surgical plan that includes a plurality of cut paths 1150 to perform a cut and / or resection of bone 1114 during a TKA. Surgeons may be trained on cut paths, and cut paths may be displayed on a monitor for the surgeon to follow and / or monitor during surgery (described in more detail below). Generally, a cut path will constrain a robot, robot mounted cutting tool and / or blade thereof to the most conservative available boundary with respect to a surgical directive. For example, the cut paths 1150 may be configured to avoid ligaments, vessels, and other protected anatomy. Further the cut paths 1150 may correspond to a particular implant shape (e.g., a knee implant) and may direct that no more of the bone 1114 be cut than is required for an implant to fit. The length and trajectory of the cuts, and the movement of the blade to affect such cuts, made along each such cut path of the cut paths 1150, may be determined and / or constrained by, for example, any virtual gates, patient-specific boundaries, safe-zone boundaries, and / or other factors. A control system of a robot may be configured to maintain a cutting blade 1108 on each cut path (e.g., prevent the cutting blade 1108 from deviating from those cut paths). In the example shown in FIG. 11, the virtual gate 1100 includes an axis 1103 that extends between first gate point 1102 and second gate point 1104 on a cut plane 1106.

[0056] The virtual gate 1100 restricts movement and / or orientation of a robot, robot mounted cutting tool and / or blade 1108 thereof to a certain extent. That is, the blade can pass through the virtual gate 1100 between gate points 1102, 1104, but cannot move side-to-side within the virtual gate 1100 and along the axis 1103 any further than the gate points 1102, 1104 allow, thereby directing, restricting, and / or constraining the cutting blade 1108 from contacting protected anatomy of the patient, such as the patient’s MCL, patellar tendon, etc., as the robot, robot mounted cutting tool and / or blade 1108 thereof travels along any of the plurality of cut paths 1150, as shown in FIG. 12. FIGS. 11 and 12 illustrate that aspectspermit the robot, robot mounted cutting tool and / or blade 1108 thereof to enter and exit the virtual gate 1100 in order to travel along any of the cut paths (including any cut path of the linear cut paths 1150), during which the robot, robot mounted cutting tool and / or blade 1108 thereof is constrained and / or restricted in terms of side-to-side movement (along the axis) to movement within a space defined by the two gate points 1102, 1104 of the virtual gate 1100. This, in conjunction with movement along the defined cut paths 1150, may facilitate safe performance of one or more desired cut(s).

[0057] A limitation to the current state of the art is that, during manual surgery, user- initiated cutting is more demanding on surgeons and may limit a surgeon’s ability to perform other tasks. The surgeon may lose, or have reduced, use of their arm(s), hand(s), focus, and / or ability to communicate with a surgical team, among others. Aspects disclosed herein may lessen the demand on a surgeon during surgery, thus allowing the surgeon to balance and / or perform more and / or other tasks. For example, and referring to FIGS. 13-15, example surgical environments and system morphologies of aspects disclosed herein are shown. In an operating room, a variety of physical aspects may be employed, including, inter alia, one or multiple robot(s), rigid external fixation device(s) for fixation of a femur and / or tibia to an operating table, tracking camera(s), rigid robot tracking array(s) (e.g., array(s) of fiducials) for real time robot position tracking with cameras, foot pedal(s), monitor(s), Deadman switch (es), and more.

[0058] In an example surgical environment 1301 and system morphology shown in FIG. 13, aspects disclosed herein are utilized with respect to a TKA. A surgeon 1300 may be located at (e.g., next to) an operating table 1302 similar to the positioning of a surgeon during a manual TKA, such that the surgeon 1300 may have an unobstructed view of the operating table 1302, a patient’s knee 1304, a robot 1306, a robot mounted cutting tool 1308 and / or blade thereof to perform one or more cut(s) during surgery, and any other instrumentality which may be found near the operating table 1302. One or a plurality of rigid external fixation devices 1310 may be utilized to fix the patient’s knee 1304 or a portion thereof (e.g., the patient’s femur and / or tibia) to and / or with respect to the operating table 1302. The use of the robot 1306, the robot mounted cutting tool 1308 and / or the blade thereof may free up the surgeon 1300 to perform other tasks, including those which involve use of the surgeon’s hands, such as by holding and / or moving retractors, the rigid external fixation devices 1310, and / or other tools, instruments and / or equipment.

[0059] The robot 1306 may be positioned opposite (e.g., across from) the surgeon 1300 and oriented such that the cutting tool 1308 and / or blade thereof may be extended to and / or into the patient’s knee 1304 when making one or more cut(s) during surgery. To facilitate cutting by the robot 1306, the robot mounted cutting tool 1308 and / or the blade thereof, a tracking camera 1312 may be employed, sometimes in combination with a rigid robot tracking array 1314 (e.g., array of fiducials) and / or a rigid bone tracking array 1315 (e.g., array of fiducials).

[0060] During surgery, the tracking camera 1312 may be coupled to, in one embodiment, the robot 1306, the robot mounted cutting tool 1308 and / or the blade thereof, the rigid robot tracking array 1314 (e.g., array of fiducials), and / or a rigid bone tracking array 1315 (e.g., array of fiducials) to enable the robot 1306 (e.g., using and / or moving the robot mounted cutting tool 1308 and / or blade thereof) to identify and / or follow (e.g., proceed along) any programmatically set toolpath(s) (e.g., moving along any cut path while staying within any virtual boundaries, e.g., one or more virtual gate(s)) during performance of the surgery. The tracking camera 1312 may further track and / or record movements of the robot 1306 and / or the robot mounted cutting tool 1308 (including the blade thereof), such as when performing one or more cut(s) during surgery. In some embodiments, a control and / or computer system that is part of and / or in communication with any of the foregoing could, optionally with assistance from a user (e.g., a surgeon), make adjustments in real-time to toolpaths (e.g., cut paths) or other aspects of a surgical plan. Such real-time adjustments may be desired for any number of reasons.

[0061] Tracking of the robot 1306 and / or the robot mounted cutting tool 1308 (or the blade thereof) by the tracking camera 1312 may be assisted and / or directed by using the rigid robot tracking array 1314 and / or the rigid bone tracking array 1315 to identify points of reference, such as anatomical landmarks and / or positioning of the robot 1306, the robot mounted cutting tool 1308 and / or the blade thereof to, inter alia, constrain and / or restrict the robot 1306, the robot mounted cutting tool 1308 and / or the blade thereof to movement within preset programmatic boundaries (e.g., virtual gates, safe-zone boundaries, and / or patientspecific boundaries). The rigid robot tracking array 1314 and / or rigid bone tracking array 1315 may be positioned between the tracking camera 1312 and either the patient’s knee 1304 and / or the robot 1306, the robot mounted cutting tool 1308 and / or the blade thereof such that the fiducials of the rigid robot tracking array 1314 and / or the rigid bone tracking array 1315correspond to the one or more cut(s) to be made and / or corresponding cut paths (e.g., toolpaths) during the procedure and / or to anatomical landmarks, such as protected anatomy and / or target surgical tissue.

[0062] A display and / or monitor 1316 may also be employed, preferably facing the surgeon 1300, to permit monitoring and / or regulating of the robot 1306, the robot mounted cutting tool 1308 and / or the blade thereof by the surgeon 1300 during surgery (e.g., during performance of one or more cut(s)) if necessary or desired. The monitor 1316 may allow the surgeon 1300 to visualize programmatic restraints (e.g., virtual gates, safe-zone boundaries, and / or patient-specific boundaries) and / or movement, positioning and / or orientation of the robot 1306, robot mounted cutting tool 1308 and / or the blade thereof in real-time by displaying such information as graphical elements, potentially overlaying actual or modeled patient anatomy, on a screen of the monitor 1316. The monitor 1316 thereby permits the surgeon 1300 to ensure the robot 1306, the robot mounted cutting tool 1308 and / or the blade thereof is appropriately constrained to a cut path which coordinates with a surgical plan for the procedure. The monitor 1316 may also serve generally as another view for the surgeon. In some embodiments, a plurality of monitors may be employed.

[0063] A foot pedal 1320 may also be employed to allow the surgeon 1300 to advance the robot 1306, robot mounted cutting tool 1308 and / or blade thereof along one or more cut path(s) to perform a cut. In some embodiments, the robot 1306, robot mounted cutting tool 1308 and / or blade thereof may only be capable of advancing with direct surgeon 1300 control via the foot pedal 1320 (e.g., the robot 1306, robot mounted cutting tool 1308 and / or blade thereof remains stationary unless the foot pedal 1320 is engaged). The foot pedal 1320 may provide variable forward and / or backward speed control and may further offer extremely fast response times between the foot pedal 1320 and the robot 1306, the robot mounted cutting tool 1308 and / or the blade thereof. Response times may be relatively fast, for instance about 10ms in some embodiments. The foot pedal 1320 may allow the surgeon 1300 to remain in close proximity to a patient during a procedure, while also freeing one or both hands of the surgeon 1300 to, inter alia, move retractors and / or other instrumentality and / or equipment as needed (e.g., to protect protected tissue). The surgeon 1300 may use the foot pedal 1320 while viewing the robot 1306, the robot mounted cutting tool 1308 and / or the blade thereof in front of them on the operating table 1302 and / or by viewing the positioning and / or movement thereof and / or of the cut path(s) on the monitor 1316, as described above. The foot pedal1320 may also include a Deadman switch foot sensor (not shown) which, when triggered, functions as a protective stop and defaults to a safe state.

[0064] In some embodiments one or more surgical assistant(s) 1350 may also be present in the operating room to provide support to the surgeon 1300 during surgery.

[0065] In an aspect, a method to facilitate and / or for facilitating active surgical cutting may include acquiring anatomical data of a patient and determining, based on the anatomical data of the patient, (1) target tissue, of the patient, that is targeted for cutting as part of a surgical procedure, and (2) protected tissue, of the patient, that is to be protected from the cutting. The method may further include creating a surgical plan for controlling autonomous execution of the cutting. Creating the surgical plan may include (a) determining a cut to perform as part of the cutting of the target tissue, (b) determining a cut plane along which a cutting tool is to cut in executing the cut, and (c) generating, for the cut, a virtual gate. The virtual gate may include (i) a first boundary point at a first location on the cut plane, the first boundary point corresponding to a first boundary for a first portion of the protected tissue, (ii) a second boundary point at a second location on the cut plane, the second boundary point corresponding to a second boundary for a second portion of the protected tissue, and (iii) an axis extending between the first boundary point and the second boundary point, the axis being coplanar with the cut plane along which the cutting tool is to cut. The virtual gate may define a programmatic constraint that restricts / prevents movement / positioning of the cutting tool, as part of robotic execution of the cutting, from cutting the protected tissue. The method may further include providing the surgical plan to a controller that is configured to control a robotic instrument in performing the cutting, using the cutting tool, in accordance with the surgical plan.

[0066] In an aspect, creating the surgical plan may further include generating a trajectory for the cutting tool based on the virtual gate, wherein the virtual gate provides a constraint on the trajectory and on movement of the cutting tool that avoids / is away from the protected tissue.

[0067] In an aspect, the protected tissue may include at least one selected from the group including ligament(s), tendon(s), and joint extensor mechanism(s). In an aspect, the protected tissue may include a medial collateral ligament, a patellar tendon, and a knee extensormechanism of a patient. In another aspect, the protected tissue may include at least one selected from the group including various soft tissue, at least one artery (such as the popliteal artery) and blood vessels.

[0068] In an aspect, determining the target tissue may include determining a portion of the knee for a resection based on a computed tomography (CT) scan of the patient, the anatomical data being generated from the CT scan. In an aspect, the cutting tool includes scissors, a scalpel and / or a sagittal saw.

[0069] In another aspect, a system for facilitating active surgical cutting may include a memory and a processor in communication with the memory. In such an aspect, the computer system is configured to perform a method including acquiring anatomical data of a patient and determining, based on the anatomical data of the patient, (1) target tissue, of the patient, that is targeted for cutting as part of a surgical procedure, and (2) protected tissue, of the patient, that is to be protected from the cutting. The method may further include creating a surgical plan for controlling autonomous execution of the cutting. Creating the surgical plan may include (a) determining a cut to perform as part of the cutting of the target tissue, (b) determining a cut plane along which a cutting tool is to cut in executing the cut, and (c) generating, for the cut, a virtual gate. The virtual gate may include (i) a first boundary point at a first location on the cut plane, the first boundary point corresponding to a first boundary for a first portion of the protected tissue, (ii) a second boundary point at a second location on the cut plane, the second boundary point corresponding to a second boundary for a second portion of the protected tissue, and (iii) an axis extending between the first boundary point and the second boundary point, the axis being coplanar with the cut plane along which the cutting tool is to cut. The virtual gay may define a programmatic constraint that restricts / prevents movement / positioning of the cutting tool, as part of robotic execution of the cutting, from cutting the protected tissue. The method may further include providing the surgical plan to a controller that is configured to control a robotic instrument in performing the cutting, using the cutting tool, in accordance with the surgical plan.

[0070] In another aspect, a computer program product for facilitating active surgical cutting may include a computer readable storage medium readable by a processing circuit and storing instructions for execution by the processing circuit for performing a method including acquiring anatomical data of a patient and determining, based on the anatomical data of thepatient, (1) target tissue, of the patient, that is targeted for cutting as part of a surgical procedure, and (2) protected tissue, of the patient, that is to be protected from the cutting. The method may further include creating a surgical plan for controlling autonomous execution of the cutting. Creating the surgical plan may include (a) determining a cut to perform as part of the cutting of the target tissue, (b) determining a cut plane along which a cutting tool is to cut in executing the cut, and (c) generating, for the cut, a virtual gate. The virtual gate may include (i) a first boundary point at a first location on the cut plane, the first boundary point corresponding to a first boundary for a first portion of the protected tissue, (ii) a second boundary point at a second location on the cut plane, the second boundary point corresponding to a second boundary for a second portion of the protected tissue, and (iii) an axis extending between the first boundary point and the second boundary point, the axis being coplanar with the cut plane along which the cutting tool is to cut. The virtual gay may define a programmatic constraint that restricts / prevents movement / positioning of the cutting tool, as part of robotic execution of the cutting, from cutting the protected tissue. The method may further include providing the surgical plan to a controller that is configured to control a robotic instrument in performing the cutting, using the cutting tool, in accordance with the surgical plan.

[0071] FIG. 14 depicts an example computer system to incorporate, use, and / or facilitate aspects described herein. Computer system 1400 may be provided as part of a robot control system, for example. Computer system 1400 is in communication with one or more external device(s) 1402 (such as one or multiple robot(s), tracking camera(s), rigid robot tracking array(s), foot pedal(s), monitor(s), Deadman switch(es), etc.). Computer system 1400 includes one or more processor(s) 1402, for instance central processing unit(s) (CPUs). A processor can include functional components used in the execution of instructions, such as functional components to fetch program instructions from locations such as cache or main memory, decode program instructions, and execute program instructions, access memory for instruction execution, and write results of the executed instructions. A processor of processor(s) 1402 can also include register(s) to be used by one or more of the functional components. Computer system 1400 also includes memory 1404, input / output (I / O) devices 1408, and I / O interfaces 1410, which may be coupled to the processor(s) 1402 and each other via one or more buses and / or other connections. Bus connections represent one or more of any of several types of bus structures, including a memory bus or memory controller, aperipheral bus, an accelerated graphics port, and a processor or local bus using any of a variety of bus architectures. By way of example, and not limitation, such architectures include the Industry Standard Architecture (ISA), the Micro Channel Architecture (MCA), the Enhances ISA (EISA), the Video Electronics Standards Association (VESA) local bus, and the Peripheral Component Interconnect (PCI).

[0072] Memory 1404 can be or include main or system memory (e.g., Random Access Memory) used in the execution of program instructions, storage device(s) such as hard drive(s), flash media, or optical media as examples, and / or cache memory, as examples. Memory 1404 can include, for instance, a cache, such as a shared cache, which may be coupled to local caches (examples include LI cache, L2 cache, etc.) of processor(s) 1402. Additionally, memory 1404 may be or include at least one computer program product having a set (e.g., at least one) of program modules, instructions, code or the like that is / are configured to carry out functions of embodiments described herein when executed by one or more processors.

[0073] Memory 1404 can store an operating system 1405 and other computer programs 1406, such as one or more computer programs / applications that execute to perform aspects described herein. Specifically, programs / applications can include computer readable program instructions that may be configured to carry out functions of embodiments of aspects described herein.

[0074] Examples of EO devices 1408 include but are not limited to microphones, speakers, Global Positioning System (GPS) devices, RGB, IR, and / or spectral cameras, lights, accelerometers, gyroscopes, magnetometers, sensor devices configured to sense light, proximity, heart rate, body and / or ambient temperature, blood pressure, and / or skin resistance, registration probes and activity monitors. An I / O device may be incorporated into the computer system as shown, though in some embodiments an EO device may be regarded as an external device (1412) coupled to the computer system through one or more EO interfaces 1410.

[0075] Computer system 1400 may communicate with one or more external devices 1412 via one or more EO interfaces 1410. Example external devices include a keyboard, a pointing device, a display, and / or any other devices that enable a user to interact with computer system1400. Other example external devices include any device that enables computer system 1400 to communicate with one or more other computing systems or peripheral devices such as a printer. A network interface / adapter is an example I / O interface that enables computer system 1400 to communicate with one or more networks, such as a local area network (LAN), a general wide area network (WAN), and / or a public network (e.g., the Internet), providing communication with other computing devices or systems, storage devices, or the like. Ethernet-based (such as Wi-Fi) interfaces and Bluetooth® adapters are just examples of the currently available types of network adapters used in computer systems (BLUETOOTH is a registered trademark of Bluetooth SIG, Inc., Kirkland, Washington, U.S.A.).

[0076] The communication between I / O interfaces 1410 and external devices 1412 can occur across wired and / or wireless communications link(s) 1411, such as Ethernet-based wired or wireless connections. Example wireless connections include cellular, Wi-Fi, Bluetooth®, proximity-based, near-field, or other types of wireless connections. More generally, communications link(s) 1411 may be any appropriate wireless and / or wired communication link(s) for communicating data.

[0077] Particular external device(s) 1412 may include one or more data storage devices, which may store one or more programs, one or more computer readable program instructions, and / or data, etc. Computer system 1400 may include and / or be coupled to and in communication with (e.g., as an external device of the computer system) removable / non- removable, volatile / non- volatile computer system storage media. For example, it may include and / or be coupled to a non-removable, non-volatile magnetic media (typically called a “hard drive”), a magnetic disk drive for reading from and writing to a removable, non-volatile magnetic disk (e.g., a “floppy disk”), and / or an optical disk drive for reading from or writing to a removable, non-volatile optical disk, such as a CD-ROM, DVD-ROM or other optical media.

[0078] Aspects of the present invention may be a system, a method, and / or a computer program product, any of which may be configured to perform or facilitate aspects described herein. Computer system configured to perform these and other methods, and computer program products that include a computer readable storage medium storing instructions for execution to perform these and other methods are also provided.

[0079] Computer system 1400 may be operational with numerous other general purpose or special purpose computing system environments or configurations. Computer system 1400 may take any of various forms, well-known examples of which include, but are not limited to, personal computer (PC) system(s), server computer system(s), such as messaging server(s), thin client(s), thick client(s), workstation(s), laptop(s), handheld device(s), mobile device(s) / computer(s) such as smartphone(s), tablet(s), and wearable device(s), multiprocessor system(s), microprocessor-based system(s), telephony device(s), network appliance(s) (such as edge appliance(s)), virtualization device(s), storage controller(s), set top box(es), programmable consumer electronic(s), network PC(s), minicomputer system(s), mainframe computer system(s), and distributed cloud computing environment(s) that include any of the above systems or devices, and the like.

[0080] In some embodiments, aspects of the present invention may take the form of a computer program product, which may be embodied as computer readable medium(s). A computer readable medium may be a tangible storage device / medium having computer readable program code / instructions stored thereon. Example computer readable medium(s) include, but are not limited to, electronic, magnetic, optical, or semiconductor storage devices or systems, or any combination of the foregoing. Example embodiments of a computer readable medium include a hard drive or other mass-storage device, an electrical connection having wires, random access memory (RAM), read-only memory (ROM), erasable- programmable read-only memory such as EPROM or flash memory, an optical fiber, a portable computer disk / diskette, such as a compact disc read-only memory (CD-ROM) or Digital Versatile Disc (DVD), an optical storage device, a magnetic storage device, or any combination of the foregoing. The computer readable medium may be readable by a processor, processing unit, or the like, to obtain data (e.g., instructions) from the medium for execution. In a particular example, a computer program product is or includes one or more computer readable media that includes / stores computer readable program code to provide and facilitate one or more aspects described herein.

[0081] As noted, program instruction contained or stored in / on a computer readable medium can be obtained and executed by any of various suitable components such as a processor of a computer system to cause the computer system to behave and function in a particular manner. Such program instructions for carrying out operations to perform, achieve,or facilitate aspects described herein may be written in, or compiled from code written in, any desired programming language. In some embodiments, such programming language includes object-oriented and / or procedural programming languages such as C, C++, C#, Java, etc.

[0082] Program code can include one or more program instructions obtained for execution by one or more processors. Computer program instructions may be provided to one or more processors of, e.g., one or more computer systems, to produce a machine, such that the program instructions, when executed by the one or more processors, perform, achieve, or facilitate aspects of the present invention, such as actions or functions described in flowcharts and / or block diagrams described herein. Thus, each block, or combinations of blocks, of the flowchart illustrations and / or block diagrams depicted and described herein can be implemented, in some embodiments, by computer program instructions.

[0083] While several aspects of the present invention have been described and depicted herein, these are only examples, and alternative aspects may be affected by those skilled in the art to accomplish the same objectives. Accordingly, it is intended by the appended claims to cover all such alternative aspects as fall within the true spirit and scope of the invention.

[0084] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising”, when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or groups thereof.

[0085] The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below, if any, are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The description of one or more embodiments has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art. The embodiment was chosen and described in order to best explain variousaspects and the practical application, and to enable others of ordinary skill in the art to understand various embodiments with various modifications as are suited to the particular use contemplated.

Claims

CLAIMS:

1. A method to facilitate active surgical cutting, the method comprising: acquiring anatomical data of a patient; determining, based on the anatomical data of the patient: target tissue, of the patient, that is targeted for cutting as part of a surgical procedure; and protected tissue, of the patient, that is to be protected from the cutting; creating a surgical plan for controlling autonomous robotic execution of the cutting, the creating the surgical plan comprising: determining a cut to perform as part of the cutting of the target tissue, and a cut plane along which a cutting tool is to cut in executing the cut; and generating, for the cut, a virtual gate that comprises: a first boundary point at a first location on the cut plane, the first boundary point corresponding to a first boundary for a first portion of the protected tissue; a second boundary point at a second location on the cut plane, the second boundary point corresponding to a second boundary for a second portion of the protected tissue; and an axis extending between the first boundary point and the second boundary point, the axis being coplanar with the cut plane along which the cutting tool is to cut; wherein the virtual gate defines a programmatic constraint that restricts positioning of the cutting tool, as part of robotic execution of the cutting, from cutting the protected tissue; andproviding the surgical plan to a controller, the controller configured to control a robotic instrument in performing the cutting, using the cutting tool, in accordance with the surgical plan.

2. The method of claim 1, wherein the creating the surgical plan further comprises generating a trajectory for the cutting tool based on the virtual gate, wherein the virtual gate provides a constraint on the trajectory and on movement of the cutting tool that avoids the protected tissue.

3. The method of claim 1, wherein the protected tissue comprises at least one selected from the group consisting of at least one ligament, at least one tendon, and at least one joint extensor mechanism.

4. The method of claim 3, wherein the protected tissue comprises a medial collateral ligament, a patellar tendon, and / or a knee extensor mechanism of a patient.5 The method of claim 1, wherein the protected tissue comprises at least one selected from the group consisting of soft tissue, at least one artery, and blood vessels.

6. The method of claim 1, wherein the determining the target tissue comprises determining a portion of a knee for a resection based on a computed tomography (CT) scan of the patient, the anatomical data being generated from the CT scan.

7. The method of claim 1, wherein the cutting tool comprises scissors, a scalpel, and / or a sagittal saw.

8. A system for facilitating active surgical cutting, the system comprising: a memory; and a processor in communication with the memory, wherein the system is configured to perform a method comprising: acquiring anatomical data of a patient; determining, based on the anatomical data of the patient:target tissue of the patient, which is targeted for cutting as part of a surgical procedure; and protected tissue of the patient, which is to be protected from the cutting; creating a surgical plan for controlling autonomous robotic execution of the cutting, the creating the surgical plan comprising: determining a cut to perform as part of the cutting of the target tissue, and a cut plane along which a cutting tool is to cut in executing the cut; and generating, for the cut, a virtual gate that comprises: a first boundary point at a first location on the cut plane, the first boundary point corresponding to a first boundary for a first portion of the protected tissue; a second boundary point at a second location on the cut plane, the second boundary point corresponding to a second boundary for a second portion of the protected tissue; and an axis extending between the first boundary point and the second boundary point, the axis being coplanar with the cut plane along which the cutting tool is to cut; wherein the virtual gate defines a programmatic constraint that restricts positioning of the cutting tool, as part of robotic execution of the cutting, from cutting the protected tissue; and providing the surgical plan to a controller, the controller configured to control a robotic instrument in performing the cutting, using the cutting tool, in accordance with the surgical plan.

9. The system of claim 8, wherein the creating the surgical plan further comprises generating a trajectory for the cutting tool based on the virtual gate, wherein the virtual gate provides a constraint on the trajectory and on movement of the cutting tool that avoids the protected tissue.

10. The system of claim 8, wherein the protected tissue comprises at least one selected from the group consisting of: at least one ligament, at least one tendon, and at least one joint extensor mechanism.

11. The system of claim 8, wherein the determining the target tissue comprises determining a portion of a knee for resection based on a computed tomography (CT) scan of the patient, the anatomical data being generated from the CT scan.

12. A computer program product for facilitating active surgical cutting, the computer program product comprising: a computer readable storage medium readable by a processing circuit and storing instructions for execution by the processing circuit for performing a method comprising: acquiring anatomical data of a patient; determining, based on the anatomical data of the patient: target tissue of the patient, which is targeted for cutting as part of a surgical procedure; and protected tissue of the patient, which is to be protected from the cutting; creating a surgical plan for controlling autonomous robotic execution of the cutting, the creating the surgical plan comprising: determining a cut to perform as part of the cutting of the target tissue, and a cut plane along which a cutting tool is to cut in executing the cut; andgenerating, for the cut, a virtual gate that comprises: a first boundary point at a first location on the cut plane, the first boundary point corresponding to a first boundary for a first portion of the protected tissue; a second boundary point at a second location on the cut plane, the second boundary point corresponding to a second boundary for a second portion of the protected tissue; and an axis extending between the first boundary point and the second boundary point, the axis being coplanar with the cut plane along which the cutting tool is to cut; wherein the virtual gate defines a programmatic constraint that restricts positioning of the cutting tool, as part of robotic execution of the cutting, from cutting the protected tissue; and providing the surgical plan to a controller, the controller configured to control a robotic instrument in performing the cutting, using the cutting tool, in accordance with the surgical plan.

13. The computer program product of claim 12, wherein the creating the surgical plan further comprises generating a trajectory for the cutting tool based on the virtual gate, wherein the virtual gate provides a constraint on the trajectory and on movement of the cutting tool that avoids the protected tissue.

14. The computer program product of claim 12, wherein the protected tissue comprises at least one selected from the group consisting of at least one ligament, at least one tendon, and at least one joint extensor mechanism.

15. The computer program product of claim 12, wherein the determining the target tissue comprises determining a portion of a knee for resection based on a computed tomography (CT) scan of the patient, the anatomical data being generated from the CT scan.

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