Patellar clamp and patellar tracking system

Abstract

Disclosed herein is a patella clamp configured to grip a patient's patella. The patella clamp includes a clamp assembly, a ratchet arm assembly, and a handle assembly. The clamp assembly includes a first patella gripping portion and a second patella gripping portion mounted in opposing relation to one another. In use, actuation of the handle assembly drives the second patella gripping portion toward the first patella gripping portion to clamp the patient's patella. The handle assembly is configured to be movably adjustable (e.g., rotatable) relative to the clamp assembly. Additionally and / or alternatively, the patella clamp may be configured as a tracked patella clamp positioned and configured for use in orthopaedic computer-assisted surgery and / or robotic surgery, whereby a surgeon may view a virtual patella model for visualizing a patella preparation step in a computer-based environment prior to performing the patella preparation step on a patient.

Description

Technical Field

[0001] Cross-Reference to Related Applications This application claims the priority benefit of U.S. Provisional Patent Application Serial No. 63 / 287,662, filed on December 9, 2021, entitled "Patella Clamp and Patella Tracking System", the entire contents of which are hereby incorporated by reference in their entirety into the present specification.

[0002] The present disclosure is directed to orthopedic surgical instruments, and more specifically, to a patella clamp that may include a tracking member for use in computer-assisted surgical systems and / or robotic surgical systems to facilitate determination of patella characteristics for planning surgery and for preparing the patella during surgical procedures.

Background Art

[0003] Orthopedic patella clamps are known. Generally speaking, a patella clamp includes a handle assembly and an assembly for clamping or grasping or resecting (terms used interchangeably herein without the intent to limit). In use, the clamp assembly may include a first grasping portion and a second grasping portion, and engages the patient's patella positioned between the first grasping portion and the second grasping portion. In one example, the first grasping portion and the second grasping portion may engage the patient's patella in the superior / inferior direction, and the handle assembly may include, for example, a threaded shaft and a nut for driving the first grasping portion and the second grasping portion. Alternatively, the first grasping portion and the second grasping portion may engage the patient's patella in the medial / lateral direction, and the handle assembly may include, for example, a pistol grip.

[0004] In any case, one drawback of known patellar clamps is that the clamp assembly and the handle assembly remain in the same position relative to each other. In other words, the handle assembly cannot be adjusted relative to the clamp assembly. Fixing the position of the handle assembly relative to the clamp assembly limits the opportunities for use by surgeons.

[0005] Another drawback of known patellar clamps and known patellar preparation processes is that the surgeon cannot observe the excision result before performing the cut using the patellar clamp. As a result, when using existing techniques, for example, when cutting the patient's patella freehand or using an excision guide, reamer, or similar instrument, the surgeon cannot always be confident about the plane they will create.

[0006] It is beneficial to provide a lightweight, adjustable patellar clamp that can enhance visibility when resecting a patient's patella. For example, by configuring the patellar clamp so that the clamp assembly and handle assembly are adjustable to move relative to each other, the patellar clamp can accommodate variations in surgical technique regarding the degree of subluxation or abduction, variations between the left and right knees, and variations between medial and lateral approaches.

[0007] It is also beneficial to provide a patellar clamp positioned and configured for use in computer-assisted surgical systems and / or robotic surgical systems to enable modeling, visualization, and / or similar representations of the patella and the resulting patellar preparation steps (e.g., resection, reaming, cutting, and / or similar).

[0008] Therefore, an improved patellar clamp is still in demand. This disclosure is provided with the above in mind. [Overview of the project]

[0009] This summary provides a simplified version of some of the concepts described later in the detailed description of the invention. This summary is not intended to identify any important or essential features of the claimed subject matter, nor is it intended to assist in determining the scope of the claimed subject matter.

[0010] Disclosed herein is a patellar clamp comprising a clamp assembly and a handle assembly. When in use, the clamp assembly is configured to be positioned to grasp the patient's patella. According to one or more features of this disclosure, the handle assembly is configured to be movably adjustable relative to the clamp assembly. For example, in any of the above or below examples, the clamp assembly is coupled to the handle assembly via a multi-position ratchet assembly (e.g., an adjustable ratchet assembly), thereby allowing the handle assembly to rotate relative to the clamp assembly. This configuration allows the patellar clamp to be positioned when in use so that the surgeon can reposition (e.g., move, rotate, etc.) the handle assembly out of the way, for example to improve visibility and / or to accommodate other anatomical structures.

[0011] Disclosed herein is a surgical system configured to generate a virtual patellar model relating to a patient's patella. The surgical system may include, or use, a tracking patellar clamp. The surgical system may include a tracking system communicatively coupled to at least one tracker coupled to the tracking patellar clamp. The tracking patellar clamp may include a clamp assembly and a handle assembly. When in use, the clamp assembly is configured to be positioned to grasp the patient's patella. The surgical system may run a computer-assisted surgical application that operates to generate patellar information based on tracking information received from at least one tracker. The patellar information may be associated with at least one patellar characteristic, such as position, dimensions, cutting plane, and / or homogeneous. The patellar model may be presented via a display device and may be configured to be a virtual representation relating to the patient's patella. In any of the above or below examples, at least one tracker may include a tracking array of optical sensors for use with an optical tracking system.

[0012] In any of the above or below examples relating to a surgical system, the user may input a patellar preparation step. Non-limiting examples of patellar preparation steps may include cutting, excision, cutting, and / or similar actions. The computer-assisted surgical system may facilitate the user's visualization of the patellar preparation step before physically performing it on an actual patient's patella by presenting a patellar model that includes the patellar preparation step. In any of the above or below examples relating to a surgical system, the computer-assisted surgical system may present performance information related to the patellar preparation step. Non-limiting examples of performance information may include range of motion information.

[0013] In any of the above or below examples, the tracking patellar clamp may include a clamp assembly that acts to engage with a patella, a handle assembly coupled to the clamp assembly that, when driven, acts to drive the patella to be fixed inside the clamp assembly, and at least one tracking member that acts to determine tracking information of the patella.

[0014] In any of the above or below examples, the handle assembly may be operable to rotate relative to the clamp assembly. In any of the above or below examples, at least one tracking member may be coupled to the clamp assembly.

[0015] In any of the above or below examples, the tracking information may include at least one of the positional or orientational information of the patella. In any of the above or below examples, the tracking information may include a cross-sectional plane related to the patella.

[0016] In any of the above or below examples, at least one tracking member may be configured to determine instrument information of a surgical instrument associated with a tracking patellar clamp. In any of the above or below examples, the instrument information may include the position of the surgical instrument relative to the patella. In any of the above or below examples, at least one tracking member may be configured to determine instrument information via detection of the reflective surface of the surgical instrument. In any of the above or below examples, the surgical instrument may include a reamer tool.

[0017] In any of the above or below examples, the computer-assisted surgical system may include at least one computing device, the computing device including a display device, a processing circuit, and memory coupled to the processing circuit. The memory may include instructions, when executed by the processing circuit, causing the processing circuit to receive tracking information related to the patella and detected by at least one tracking member coupled to a tracking patellar clamp engaged with the patella; to determine patellar information representing at least one characteristic of the patella based on the tracking information; to generate a patellar model configured as a virtual representation of the patella and configured based on the patellar information; and to present a graphical user interface (GUI) object visually illustrating the patellar model on a GUI screen via the display device.

[0018] In any of the above or below examples, the instruction may, when executed by the processing circuit, cause the processing circuit to receive instrument tracking information that corresponds to a surgical instrument associated with a tracking patellar clamp and that can be detected by at least one tracking member.

[0019] In any of the above or below examples, when the instruction is executed by the processing circuit, the processing circuit may perform the following: determine instrument information which is instrument information of a surgical instrument and which may include at least one of the position or orientation of the surgical instrument, based on instrument tracking information.

[0020] In any of the above or below examples, the instruction may cause the processing circuit, when executed by the processing circuit, to display a GUI model of the surgical instrument on the GUI screen based on the instrument information.

[0021] In any of the above or below examples, the surgical instruments may include a reamer tool. In any of the above or below examples, the tracking information may include a cutting plane related to the patella.

[0022] The above and below examples of this disclosure offer numerous advantages. In one non-limiting example of advantages, the clamp assembly of the patellar clamp (e.g., the first and second patellar gripping portions) may be rotated relative to the handle assembly. This allows the handle assembly to be moved out of the way during the examination, evaluation, and / or resection of the patella. This configuration can improve visibility (e.g., the surgeon can see the patella more clearly). In addition, an additional working window can be formed, allowing the surgeon to utilize resection tools and / or reamer guides without being obstructed by the handle assembly. Furthermore, the patella can be gripped in a wider variety of positions.

[0023] The above or below examples of this disclosure offer many technical advantages and features compared to conventional systems. One non-limiting example of technical advantages may include providing a tracking patellar clamp of this disclosure that may be used in conjunction with computer-assisted surgical systems and / or robotic surgical systems. Another non-limiting example of technical advantages may include providing a surgical system configured to allow a surgeon to visualize a patellar preparation step before making any adjustments to the actual patient's patella, and / or to allow a surgeon to visualize performance information related to the patellar preparation step. The surgical planning process of any of the above or below examples may facilitate planning for patellar preparation and / or implant device positioning in a manner that reduces complexity and improves efficiency and effectiveness compared to conventional systems. For example, a surgical planning process, as illustrated in any of the above or below examples, may enable healthcare professionals to avoid invalid patellar preparation steps during the planning and / or execution of a surgical procedure, and / or to avoid incorrect or ineffective patellar preparation, thereby saving time and effort and improving patient outcomes. The above or below examples are not limited to this context. Additional technical advantages and features over conventional systems will be apparent to those skilled in the art based on this disclosure.

[0024] The above or following examples described in the present disclosure may provide improvements in computing technology. For example, managing the complexity associated with planning patellar placement and / or preparation, particularly managing changes during surgical procedures, has long been a problem for medical professionals using conventional computer-aided tools. Patellar preparation involves multiple parameters (e.g., depth, angle, and / or the like), as well as interactions with other parts of the patient's anatomy. These parameters result in a multidimensional and complex configuration space that a surgeon (or other medical personnel) must navigate when attempting to achieve surgical goals, such as maintaining or restoring proper kinematics of the knee joint.

[0025] The computer-aided surgical planning process according to any of the above or following examples may improve computing technology, for example, by determining a patellar model that can facilitate easier and more efficient evaluation of patellar preparation, thereby enabling virtual visualization at a point in time prior to actual physical preparation on the patella, which is not available using existing computing systems, for example.

[0026] The surgical planning process according to any of the above or following examples may be applied to various practical applications. For example, the patellar model may be applied by a surgeon and / or a computing system to create a surgical plan. In another example, the patellar model may be applied by a surgeon and / or a computing system to perform surgery on a patient, such as performing an arthroplasty procedure. In additional examples, the surgical planning process (and its patellar model) may be incorporated into surgical system hardware used for planning and / or executing surgical procedures. The above or following examples are not limited in this context. Additional practical applications will be apparent to those skilled in the art based on the present disclosure.

[0027] Further features and advantages of at least some of the above or following examples of the present invention, as well as the structure and operation of various above or following examples of the present invention, are described in detail below with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Various examples of the disclosed device will now be described, by way of example, with reference to the accompanying drawings.

[0029] [Figure 1] Figure 1 illustrates a side view of an example of a patella clamp according to one or more features of the present disclosure, wherein the patella clamp includes a handle assembly, a clamp assembly, and a ratchet arm assembly.

[0030] [Figure 2] Figure 2 illustrates an exploded perspective view of the patella clamp shown in Figure 1.

[0031] [Figure 3] Figure 3 illustrates a plan view of the clamp assembly engaged with the patella of a patient.

[0032] [Figure 4] Figure 4 illustrates a side view of the ratchet arm assembly.

[0033] [Figure 5] Figure 5 illustrates a side view of the patella clamp shown in Figure 1, with the clamp assembly rotated by 90 degrees from the horizontal direction.

[0034] [Figure 6] Figure 6 illustrates an end view of the patella clamp shown in Figure 1, with the clamp assembly rotated by 45 degrees from the horizontal direction.

[0035] [Figure 7]Figure 7 illustrates a perspective view of an example of a tracking patellar clamp according to one or more features of the present disclosure.

[0036] [Figure 8A] Figures 8A, 8B, and 8C illustrate various diagrams of a tracking patellar clamp, as shown in Figure 7, that engages with the patella, according to one or more features of the present disclosure. [Figure 8B] Same as above. [Figure 8C] Same as above.

[0037] [Figure 9] Figure 9 illustrates an environment for operating a system for planning and performing joint replacement surgery according to one or more features of the present disclosure.

[0038] [Figure 10] Figure 10 illustrates an exemplary tracking array for use with computer-assisted surgical systems and / or robotic surgical systems, according to one or more features of the present disclosure.

[0039] [Figure 11] Figure 11 is a block diagram illustrating a system for performing a surgical planning process according to one or more features of the present disclosure.

[0040] [Figure 12] Figure 12 illustrates an exemplary graphical user interface for performing a surgical planning process according to one or more features of the present disclosure.

[0041] [Figure 13A] Figures 13A, 13B, and 13C illustrate various diagrams of an example of a tracking patellar clamp having a patellar preparation member according to one or more features of the present disclosure. [Figure 13B] Same as above. [Figure 13C] Same as above.

[0042] It should be understood that the drawings are not necessarily to scale, and that the examples disclosed are sometimes illustrated as schematic or partial representations. In certain examples, details that are not necessary for understanding the disclosed method and device, or details that would obscure other details, may be omitted. It should also be understood that this disclosure is not limited to the specific examples illustrated herein. Throughout the drawings, unless otherwise noted, similar reference numerals refer to similar components. [Modes for carrying out the invention]

[0043] In the following, various features of patellar clamps arranged and configured for use in orthopedic computer-assisted surgical systems and / or robotic surgical systems will be described in more detail with reference to the accompanying drawings, in which one or more features of such patellar clamps will be illustrated and described. It will be understood that the various features can be used independently of each other, and that the various features can be used in combination. It will also be understood that patellar clamps as disclosed herein can be embodied in many different forms and should not be construed as being limited to the examples described herein. Rather, these examples are provided so that this disclosure will convey specific features of patellar clamps to those skilled in the art.

[0044] As described herein, according to one or more features of the present disclosure, a patellar clamp includes an assembly for clamping, gripping, or excising (a term used herein interchangeably, without limitation) positioned and configured to grip a patient's patella, and a handle assembly, trigger, arm assembly, pistol grip, etc. (a term used herein interchangeably, without limitation) positioned and configured to adjust, move, etc., the clamp assembly around the patient's patella. When in use, the clamp assembly is positioned and configured to be movable and adjustable relative to the handle assembly. For example, in any of the above or below examples, the clamp assembly may be positioned and configured to rotate around a longitudinal axis, thereby providing an expanded field of view and / or expanded workspace by rotating the handle assembly when in use.

[0045] Additionally, and / or alternatively, according to one or more features of the present disclosure, the patellar clamp may include one or more tracking members that operate in such a way that the patellar clamp can be used with a computer-assisted surgical system and / or robotic surgical system to enable modeling, visualization, and / or similar, in particular, relating to the patella and the resulting patellar preparation steps.

[0046] Herein, an example of a patellar clamp 100 according to one or more features of the present disclosure will be illustrated and described with reference to Figures 1 and 2. As shown in the illustrations, the patellar clamp 100 includes a handle assembly 110 and a clamp assembly 130. As shown in the illustrations, in any of the above or below examples, the handle assembly 110 includes a first arm 112 and a second arm 114. In any of the above or below examples, the second arm 114 may be movable and the first arm 112 may be stationary, although other configurations are also conceivable, such as when both the first arm 112 and the second arm 114 are movable relative to each other. In any of the above or below examples, the second arm 114 may be coupled to the first arm 112 via a pivot pin 116. As will be readily apparent to those skilled in the art, this configuration allows the user to move, adjust, and / or clamp the clamp assembly 130 around the patient's patella by narrowing the second arm 114 toward the first arm 112 during use, as will be described in more detail below. Thus, although the handle assembly 110 may be in the form of a pistol grip as shown in the illustration, the handle assembly 110 may be provided in any other suitable mechanism, whether currently known or to be developed in the future. Thus, this disclosure should not be limited to any particular type of handle assembly unless expressly asserted.

[0047] As shown in the illustration, in any of the above or below examples, the clamp assembly 130 includes a first patellar gripping portion 132 and a second patellar gripping portion 134. In any of the above or below examples, the first patellar gripping portion 132 and the second patellar gripping portion 134 may be arranged in an opposing engagement relationship such that the second patellar gripping portion 134 is movably positioned relative to the first patellar gripping portion 132. For example, the second patellar gripping portion 134 may be arranged and configured to move toward the first patellar gripping portion 132 by driving the handle assembly 110. With such arrangement, with further reference to Figure 3, the user can capture the patient's patella P positioned between the patellar gripping portions by driving the second patellar gripping portion 134 toward the first patellar gripping portion 132. In addition, in any of the above or below examples, as most clearly shown in Figures 3 and 5, the first patellar gripping portion 132 and the second patellar gripping portion 134 may include teeth, spikes, serrations, etc. 136 (terms used herein interchangeably and without limitation) to capture or grip the patient's patella P. In any of the above or below examples, the first patellar gripping portion 132 and the second patellar gripping portion 134 may be arranged and configured to provide an opening of about 60 mm (e.g., the distance between the first patellar gripping portion 132 and the second patellar gripping portion 134) for gripping patellas of various sizes, but this is one configuration, and other dimensions may be used.

[0048] Thus, referring to Figure 3, in use, the first patellar gripping portion 132 can hold the patient's patella P using its associated teeth 136. Subsequently, by driving the handle assembly 110, the second patellar gripping portion 134 is driven toward the patient's patella P, thereby engaging the patient's patella P with the associated opposing teeth 136. As shown in the illustration, in any of the above or below examples, a saw blade 142 may be inserted from the side of the first patellar gripping portion 132. For example, the saw blade 142 may be inserted through a dedicated cutting slot or placed on the surface of the first patellar gripping portion 132. In use, the saw blade 142 may be used to cut or excise a portion of the patient's patella P (for example, the posterior surface of the patient's patella P may be cut).

[0049] As shown in the illustration, in any of the above or below examples, the handle assembly 110 may be coupled to the clamp assembly 130 by the ratchet arm assembly 150, although it is assumed that the handle assembly 110 may be coupled to the clamp assembly 130 by other suitable mechanisms, such as those currently known or to be developed in the future. When in use, the ratchet arm assembly 150 is configured to transmit the drive of the handle assembly 110 to the clamp assembly 130, so that, as will be understood by those skilled in the art, the drive of the handle assembly 110 (for example, by the user squeezing the first arm 112 and the second arm 114, thereby driving the second arm 114 toward the first arm 112) drives the second patellar gripping portion 134 toward the first patellar gripping portion 132, thereby engaging, for example, the patient's patella P positioned between the first patellar gripping portion 132 and the second patellar gripping portion 134.

[0050] In any of the above or below examples, referring to Figure 4, the ratchet arm assembly 150 includes a ratchet arm 152, which has a first end 154, a second end 156, and a plurality of teeth 158 positioned between the first end 154 and the second end 156. The ratchet arm assembly 150 may also include a lever 160 (Figures 1 and 2) and a bushing 170. When in use, the lever 160 is mounted on the ratchet arm 152 in contact with the teeth 158 formed on the ratchet arm 152. When in use, as will be easily understood by those skilled in the art, the lower part of the lever 160 is pushed toward the second end 156 of the ratchet arm 152 by the drive of the handle assembly 110. The lever 160 then engages and / or interacts with a plurality of teeth 158 on the ratchet arm 152, thereby translating the ratchet arm 152 distally toward the second end 156.

[0051] Referring to Figures 1, 2, and 4, the ratchet arm 152 includes an engaging member (e.g., a first engaging member) 180 coupled to or associated with the second end 156 of the ratchet arm 152. When in use, the engaging member 180 is non-rotatably coupled to the ratchet arm 152, so that the engaging member 180 is aligned with the longitudinal axis C of the ratchet arm 152. LIt does not rotate around. Similarly, as shown in the figure, the second patella gripping portion 134 includes an engaging member (e.g., a second engaging member) 182. When in use, the first engaging member 180 and the second engaging member 182 include engaging surfaces having engaging features. When in use, the engaging features on the engaging surface of the second engaging member 182 associated with the second patella gripping portion 134 are arranged and configured to connect with the engaging features on the engaging surface of the first engaging member 180 of the ratchet arm 152. For example, in any of the above or below examples, the engaging features may be provided as a plurality of corresponding raised and recessed features (e.g., a plurality of male engaging projections and a plurality of female engaging projections, and a plurality of recesses) arranged and configured to engage with one another. For example, the raised features may be substantially hemispherical, but since the exact shape and number of features are not important, the raised features may be provided in alternative forms such as, but not limited to, engaging teeth or similar. Additionally, the engaging features are not limited to raised and recessed features, but may be provided in any other suitable form known or to be developed in the future, including, for example, Hirth couplings, ball plungers, splined couplings, or any other type of mechanical connection or configuration that enables selective engagement and rotation between a first engaging member and a second engaging member.

[0052] For example, in any of the above or below examples, the engagement surface of the first engagement member 180 may include a series of return stoppers arranged in a radial pattern. The engagement features on the engagement surface of the second engagement member 182 may include a series of projections arranged in a radial pattern. Alternatively, the anti-rotation feature may be located on the second engagement member 182, and the projections may be located on the first engagement member 180. In use, the projections selectively engage with the series of return stoppers, thereby fixing the position of the second engagement member 182, and consequently the position of the second patella gripping portion 134, relative to the first engagement member 180, and consequently to the ratchet arm 152 and the handle assembly 110.

[0053] In any of the above or below examples, the first engaging member 180 associated with the ratchet arm 152 may include an internally threaded hole for engaging with the fastening member 194 (Figures 1 and 2). The second engaging member 182 associated with the second patella gripping portion 134 includes a through hole configured to allow the fastening member 194 to be inserted through it, so that the fastening member 194 can be screw-engaged with the threaded hole 192 of the first engaging member 180 of the ratchet arm 152.

[0054] As shown in the illustration, in any of the above or below examples, the ratchet arm assembly 150 may also include a bushing 170, as described above. When in use, the bushing 170 is mounted on the ratchet arm 152 (for example, the bushing 170 includes an opening configured to allow the ratchet arm 152 to pass through it). When in use, the bushing 170 is aligned with the longitudinal axis C of the ratchet arm 152. L It rotates freely around it. Additionally, the bushing 170 moves freely in translation relative to the ratchet arm 152. When in use, the bushing 170 is connected to, or associated with, the first patella gripping portion 132. Thus, when in use, the bushing 170 connects the first patella gripping portion 132 to the ratchet arm 152. With this configuration, when in use, the first engaging member 180 and the second engaging member 182 are driven distally toward the second end 156 of the ratchet arm 152 by the drive of the handle assembly 110. In addition, since the second patella gripping portion 134 is connected to the second engaging member 182, the second patella gripping portion 134 is driven distally. However, since the first patella gripping portion 132 is connected to the ratchet arm assembly 150 via a bushing 170 that rotates freely around the ratchet arm 152 and moves freely along the ratchet arm 152, the first patella gripping portion 132 remains stationary and does not move relative to the ratchet arm 152.

[0055] As is most clearly shown in Figure 2, the ratchet arm assembly 150 may also include a first biasing member 198, which is positioned around the fastening member 194 between the enlarged head portion of the fastening member 194 and a second engaging member 182 associated with the second patella gripping portion 134. In this particular example, the fastening member 194 holds the first biasing member 198 and the second engaging member 182 on the second end 156 of the ratchet arm 152. In this configuration, the first biasing member 198, which may be in the form of a coil spring, biases the second engaging member 182 associated with the second patella gripping portion 134 to come into contact with the first engaging member 180 associated with the ratchet arm 152. During use, the user may pull the second engaging member 182 against the biasing force of the first biasing member 198 by gripping or holding the first engaging member 180, thereby disengaging or separating the engaging features on the first engaging member 180 and the engaging features on the second engaging member 182 (for example, by driving the second engaging member 182 away from the first engaging member 180 and the handle assembly 110). Subsequently, with the second engaging member 182 separated from the first engaging member 180, the handle assembly 110 is moved along the longitudinal axis C of the ratchet arm 152. LThe first patellar gripping portion 132 and the second patellar gripping portion 134 can be rotated relative to the clamp assembly 130 (for example, relative to the clamp assembly 130). After the first patellar gripping portion 132 and the second patellar gripping portion 134 (for example, the clamp assembly 130) have reached the desired orientation, the user can release the second engaging member 182, thereby engaging the second engaging member 182 with the first engaging member 180 by the biasing force of the first biasing member 198 (for example, the second engaging member 182 and the first engaging member 180 can be biased together to return to the engaged relationship). With this configuration, referring to Figure 5, according to the features of this disclosure, the clamp assembly 130 (for example, the first patellar gripping portion 132 and the second patellar gripping portion 134) can be rotated relative to the handle assembly 110. For example, as shown in the figure, the clamp assembly 130 (e.g., the first patella gripping portion 132 and the second patella gripping portion 134) can be oriented at an angle of approximately 90 degrees from the horizontal.

[0056] In addition, referring to Figure 6, by disengaging the second engaging member 182 from the first engaging member 180, the clamp assembly 130 (for example, the first patella gripping portion 132 and the second patella gripping portion 134) is positioned along the longitudinal axis C of the ratchet arm 152. L It can be rotated, angularly oriented, and so on. As shown in the figure, for example, the clamp assembly 130 (for example, the first patella gripping portion 132 and the second patella gripping portion 134) is aligned with the longitudinal axis C of the ratchet arm 152. L Therefore, it can be positioned at an angle of approximately 45 degrees.

[0057] Referring to Figures 1 and 2, in any of the above or below examples, the first patellar gripping portion 132 may include a cutting slot 140. As shown, the cutting slot 140 may extend circumferentially around the first patellar gripping portion 132 (for example, the cutting slot 140 may extend around the periphery of the first patellar gripping portion 132). For example, the cutting slot 140 may extend over approximately 270 degrees, but this is just one example, and the cutting slot 140 may extend over a larger or smaller angle. When in use, the cutting slot 140 is positioned and configured to receive a saw blade 142 (Figure 4) to excise a portion of the patella.

[0058] Further descriptions and features relating to the patellar clamp 100 can be found in U.S. Patent Application Publication No. 2021 / 0378683, filed on 3 June 2021 and entitled “Patella Clamp,” the entire contents of which are incorporated herein by reference.

[0059] In any of the above or below examples, methods, systems, apparatus, devices, and / or combinations thereof may provide a surgical planning process for a computer-assisted surgical system and / or robotic surgical system (or a computer-assisted surgical system (CASS)). The surgical planning process may include creating a surgical plan for at least a portion of an implant surgery. In any of the above or below examples, the portion of the implant surgery may be a patellar preparation process and / or an implant placement procedure, or may include such a process and / or procedure. In any of the above or below examples, the patellar preparation process may include associating the patella with one or more tracking members configured to provide patellar information to a computer-assisted surgical system and / or robotic surgical system (and / or computing devices associated with a computer-assisted surgical system and / or robotic surgical system). Patellar information may include, but is not limited to, orientation, position, dimensions, and / or similar.

[0060] In any of the above or below examples, the patellar preparation process may include generating a visual representation of the patella based on patellar information. Non-limiting examples of visual representations may include a graphical model, including two-dimensional (2D) and / or three-dimensional (3D) graphical user interface (GUI) objects that can be displayed via the display of a computing device.

[0061] Generally, surgeons are unaware of the outcome of the patellar preparation steps they are currently performing (e.g., cutting planes of the patella), which are typically done freehand or with excision instruments. However, surgeons are not always confident in the planes or other preparations they are creating. Therefore, patellar preparation processes using computer-aided and / or robotic functions, along with corresponding clamps, allow surgeons to verify the outcome before performing cutting or other patellar preparations.

[0062] According to one or more features of the present disclosure, referring to Figure 7, the patellar clamp 100 may take the form of a “tracking patellar clamp” including one or more tracking frames 300. In any of the above or below examples, the tracking frame 300 may include a plurality of tracking members 301 or tracking member arrays consisting of devices, sensors, and / or similar items that are operable to provide tracking, navigation, orientation determination, position determination, and / or similar with respect to a portion of a patient (e.g., the patella) in a computer-assisted surgical system and / or robotic surgical system (see, for example, Figure 14). In any of the above or below examples, the tracking members 301 may be, or include, reference point markers, markers, trackers, sensors, and / or similar items (terms used herein interchangeably and not intended to limit). In any of the above or below examples, the tracking frame 300 and / or tracking member 301 may include, and / or be coupled to, one or more transceivers (e.g., wireless transmitting devices) configured to transmit the information detected by the tracking frame 300 and / or tracking member 301 to, for example, a computing device.

[0063] In any of the above or below examples, the tracking frame 300 and / or tracking member 301 may be coupled to the clamp assembly 130, and as a result remain stationary relative to the patella. In any of the above or below examples, the tracking frame 300 and / or tracking member 301 may be coupled to the handle assembly 110, and as a result be configured to rotate with the handle assembly 110. In such “rotating” examples, the tracking member may be associated with the clamp assembly 130 and / or the patella to provide a reference point (or “triangulation”) for the tracking frame 300 and / or tracking member 301, so that tracking information can be collected and made correct in all possible directions of rotation. In another “rotating” example, an offset (e.g., based on the position of the handle assembly 110) may be determined to format the tracking information to correspond to the actual position of the tracking frame 300 and / or tracking member 301.

[0064] A tracking patellar clamp configured according to any of the above or below examples may enable the surgeon to use reamers, saw blades, and / or other preparatory tools in combination with computer-assisted surgical techniques and / or robotic surgical techniques. For example, by attaching a tracker to the resection jaws of a tracking patellar clamp, the surgeon may be able to visualize planar cuts (and / or other patellar preparations) on the patella, as well as interactions with the femur (and / or other anatomical structures, and / or components such as implant components) before performing any cutting or other preparatory steps.

[0065] In any of the above or below examples, the marker 301 is coupled to various parts of the patellar clamp 100. For example, the marker 301 may be dimensionally coupled to the anterior jaw section (e.g., the first patellar gripping portion 132) because the anterior jaw section is fixed and the posterior jaw section (e.g., the second patellar gripping portion 134) is translationally movable. The marker 301 (and / or additional markers not shown in Figure 7) may be attached to any part of the patellar clamp, including, but not limited to, the first patellar gripping portion 132, the second patellar gripping portion 134, the handle assembly, and / or similar.

[0066] Figures 8A, 8B, and 8C illustrate various diagrams relating to an example of the tracking patellar clamp 100 shown in Figure 7, engaged with the patella P, more specifically illustrating a side view, a front view, and a top view of the patellar clamp 100, respectively. Referring to Figure 8A, a patellar preparation process and / or patellar preparation configuration associated with the patellar clamp 100 is provided, including a high-position point cutting plane 801, an initial cutting plane or saw-slot cutting plane 802, and a manually selected high-position point (e.g., for a robotic surgical system). Referring to Figure 8B, a patellar preparation process and / or patellar preparation configuration associated with the patellar clamp 100 is illustrated, including a manually selected second high-position point for the inclined plane 805, for input to the inclined plane from the high-position point, or for a second input point for the inclined plane from the high-position point 804. Referring to Figure 8C, a patellar preparation process and / or patellar preparation configuration associated with a patellar clamp 100 for a through hole 806, for example, to mark the center point of a patellar implant. In any example above or below, the patella P may be positioned / sized and its center point marked for a robotic surgical system by using a see-through template 807, for example, cutting or other preparation processes.

[0067] In any of the above or below examples, the tracking patellar clamp 100 may enable determining, tracking, monitoring, and / or similar properties of the patella. Non-limiting examples of patellar properties may include position, orientation, dimensions (e.g., thickness), preparatory members (e.g., depth of reamed holes, periphery, and / or similar), and / or similar.

[0068] In any of the above or below examples, the tracking member 301 may enable tracking, such as 3D tracking, by comparing it to markers placed on other parts of the patient, such as the femur (see, for example, Figure 10). The member 301 may be tracked by an optical tracking unit. A computing device (see, for example, Figure 9) may be capable of generating a simulated patella ("patellar model") by investigating the anatomical features of the patella (e.g., width, height, thickness, medial thickness, lateral thickness, etc.) (see, for example, Figure 12). The regions thus investigated may be linked to previously investigated regions on the patient, such as the femur. Information regarding postoperative patellofemoral tracking may be communicated to the surgeon or other users using the marker 301 and associated patient information.

[0069] Referring to Figure 9, an example of system 900 for performing surgical procedures using a computer-assisted system and / or robotic system is illustrated. In any of the above or below examples, system 900 may be, or include, an image-less (e.g., CT-less) system. In other examples, system 900 may be, or include, an image-based system based on diagnostic image data. In any of the above or below examples, system 900 may operate using a combination of image-less and image-based processes. The above or below examples are not limited to this context.

[0070] The system 900 may include a surgical cutting tool 950 having an associated tracking frame 955 (also referred to as a tracking array 955), a graphical user interface 930, a tracking system 940, and a patient tracking frame 920 (e.g., one or more trackers, tracking arrays, and / or similar). The illustration also includes an incision 910 through which, for example, reoperation of the knee may be performed.

[0071] In one example, the illustrated robotic surgical system 900 illustrates a handheld, computer-controlled surgical robot system identical or similar to the Cori® and / or Navio® surgical systems, for example, those of Smith & Nephew, Inc., Cordova, Tennessee, USA. System 900 may track and control handheld surgical instruments using a tracking system 940 or other type of tracking system coupled to the robot controller. For example, the tracking system 940 tracks the position of the instrument relative to a target bone by tracking a tracking array 955 coupled to the surgical instrument 950, and by tracking a tracking array 920 coupled to the patient (see, for example, Figure 9).

[0072] Referring to Figure 10, an exemplary tracking array 920 for use with the computer-assisted and / or robotic system 900 of Figure 9 is illustrated. As shown in Figure 10, the tracking array 920 may include a tracking array 400 bonded to the patient's bone via a post or mount 405 to track the position of an instrument or surgical device relative to a target bone, such as the femur F and / or tibia T, in a knee procedure. Additionally, the tracking array 300 may be associated with the patella P via a patellar clamp 100.

[0073] The trackers 301 and / or 401 may include any type of device, sensor, communication component, and / or equivalent that, by interacting with the tracking system of a computer-assisted surgical system and / or robotic surgical system (such as the tracking system 940 in Figure 9), can provide the computer-assisted surgical system and / or robotic surgical system with position, orientation, and / or equivalent information related to the patient's anatomical structure. Exemplary and non-limiting examples of the trackers 301 and / or 401 may include infrared sources, radio frequency (RF) sources, ultrasonic sources, radio transmitters, and / or equivalents. In any of the above or below examples, the tracker 301 may include an infrared tracker configured for use with an optical tracking system. The above or below examples are not limited to this context.

[0074] Figure 11 is a block diagram illustrating an operating environment 1100 for planning and / or performing an example surgical procedure. Non-limiting examples of surgical procedures may include orthopedic procedures or arthroplasty.

[0075] As shown in Figure 11, the operating environment 1100 may include a surgical system 1130. In any of the above or below examples, the surgical system 1130 may include a computing device 1110 that is operably coupled to a network 1190 via a communication interface (e.g., a transceiver) 1160. The computing device 1110 may be, or include, one or more logic devices, including, but not limited to, server computers, client computing devices, personal computers (PCs), workstations, laptops, notebook computers, smartphones, tablet computing devices, and / or similar devices. Although Figure 11 illustrates a single computing device 1110, the above or below examples are not limited in this respect because the surgical system 1130 may include multiple computing devices 1110 and / or be operably communicative to multiple computing devices 1110, and because the surgical planning process in any of the above or below examples may be performed using multiple computing devices 1110. In addition, the components of the computing device 1110 shown in Figure 11 may be located inside multiple different computing devices. In any of the above or below examples, the surgical system 1130 may be the system 900 in Figure 9, or a part thereof. The above or below examples are not limited to this context.

[0076] In any of the above or below examples, the surgical system 1130 may include a computing device 1110 that acts as or as part of a control system (e.g., system 900), as or as part of a tracking system 940, as or as part of a surgical instrument 950, and / or as or as part of a similar instrument. Optionally, in any of the above or below examples, the surgical system 1130 may also include a display device 1172 and / or one or more data sources (e.g., databases) 1130a-1130n, or be operablely coupled to them. In any of the above or below examples, the display device 1172 and / or databases 1130a-1130n may be used to provide navigation and control of surgical instruments 1150, in which case the navigation and control may include navigation and control of cutting tools, punctate probes, cutting members, bone saws, reamers, or other tools / instruments, such as those used during arthroplasty procedures, such as orthopedic (or similar) artificial implant surgery.

[0077] The control system 1110 may include one or more computing devices configured to coordinate information received from the tracking system 930 and to provide control to the surgical instruments 950. In any of the above or below examples, the control system 1110 may include a planning module 1112, a navigation module 1114, a control module 1116, and a communication interface 1170. In any of the above or below examples, the planning module 1112 may provide a preoperative planning service that allows a surgeon or other medical professional to virtually plan the procedure before reshaping the patella (and other parts of the knee joint) during the implant procedure on the patient.

[0078] For example, in a total knee arthroplasty (TKA) procedure, planning module 1112 may be used to generate and / or present a virtual model of the patella ("patellar model"). The patellar model may be manipulated by referencing a virtual implant host model (e.g., "knee joint model") and / or a virtual implant device ("implant model") (see, for example, Figure 12).

[0079] In any of the above or below examples, a virtual model of the implant host (e.g., the patella and / or its components, including the joint to be modified) may be fabricated by using a point-like probe or similar instrument tracked by an optical tracking system 940. The control system 1110 may be used to fabricate a patellar model in the form of a virtual model of the patient's actual anatomical structure by collecting data (patellar information) from the patellar surface, for example, via a planning module 1112. This method can, among other things, improve the accuracy of the planning process by using data collected from the patient's actual patella, thereby ensuring proper fit of the new artificial implant and optimization of anatomical alignment, among other things, by enabling accurate and / or iterative reshaping of the patella. The patellar model may be generated based on patellar information including, but not limited to, width, height, maximum thickness, medial surface thickness, lateral surface thickness, bone quality, highest position point, lowest position point, and / or similar information.

[0080] In one example, the navigation module 1114 may coordinate the tracking of the position and orientation of implants, implant hosts (e.g., the patient's patella, femur, tibia, and / or similar bones), and / or surgical instruments 950. In a specific example, the navigation module 1114 may also coordinate the tracking of a virtual model (e.g., a patellar model) used in preoperative or intraoperative planning within the planning module 1112. Tracking the virtual model may include operations such as aligning the virtual model to the implant host and generating predictive performance information using data obtained via the tracking system 940. In these examples, the navigation module 1114 receives input from the tracking system 940 regarding the physical position and orientation of the surgical instruments 150 and the patient's patella. Tracking the implant host may include tracking multiple individual bone structures using tracking arrays 300 and / or 400, etc. For example, during a total knee arthroplasty (TKA) procedure, the tracking system 940 may track the patella using a tracking device 300 engaged with the patella (as shown, for example, in Figure 10).

[0081] In one example, the control module 1116 may process information provided by the navigation module 1114 to generate control signals for displaying patellar information on the display 1172 and / or for controlling the surgical instruments 950. In a particular example, the control module 1116 may also work with the navigation module 1114 to generate visual animations to assist the surgeon during the surgical procedure. The visual animations may be displayed via a display device such as the display device 1172 (see, for example, Figure 12). In one example, the visual animations may include real-time or substantially real-time 3D representations of, among other things, the implant, patella, femur, tibia, and / or the surgical instruments 950.

[0082] Figure 12 illustrates an exemplary graphical user interface for performing a surgical planning process according to one or more features of the present disclosure. As shown in Figure 12, a patellar model 1250 configured as a graphical user interface (GUI) object, such as a virtual (e.g., virtual 3D) representation of the patella P in the patient's anatomical structure 1260, may be presented on a GUI interface (window or screen) 1205 (e.g., via a display 1172). Virtual representations of knee implant components, such as the femoral component 1230 and the tibial component 1231, may be presented in various illustrations, such as a front view 1220 and a lateral view 1221. In any example above or below, performance information 1210 may be displayed on the GUI interface 1205. Generally, the performance information 1210 may include metrics configured to provide indicators of implant performance based on the configuration of the implant components and / or the preparation of the patient's anatomical structure. For example, a surgeon may perform cutting or other preparation of the patellar model 1250, and the predicted performance information 1210 may be presented.

[0083] Referring to Figures 8A and 8B, additional markers located outside the array 300 may be used to track the patella. In any of the above or below examples, markers, sensors, tracking members, and / or similar devices may be placed on various regions of the patient's patella, femur, and / or other parts. For example, an internal marker 850 may be attached to a portion of the patella to obtain information about the position of the patella, for example, within the femoral groove. In this way, the interaction between the patella and the femur may be tracked and determined by the surgical system 1130 for visualization using the patellar model 1250 on the GUI interface 1205. In another example, an anterior marker or tracking member may be placed, for example, on the anterior side of the patella to provide information for patellofemoral simulation.

[0084] In any of the above or below examples, markers (such as reflective markers), sensors, tracking members ("patellar tracking members"), and / or similar devices may be positioned on or around the patella for use by the tracking member 301 to determine tracking information. The tracking information may be used by a computer-assisted surgical system (see, for example, Figure 9) to determine patellar information. The patellar tracking members may have known positions, locations, orientations, and / or similar properties.

[0085] In any of the above or below examples, other anatomical regions such as the femur and tibia may also be investigated and modeled to enable performance information 1210 in the form of range of motion simulations, for example, to provide a surgeon with a current assessment to determine whether correction is necessary.

[0086] In any of the above or below examples, the patella model 1250 may be generated to visualize the amputation and / or other patellar preparation steps. For example, the surgeon may input the type of amputation into the surgical system 1130 (e.g., via data entry or selection by a computer-assisted surgery application), and the result of the amputation may be presented on the patellar model 1250. Thus, the surgeon may visualize the result of the patellar preparation step via the GUI interface 1205 before actually performing the patellar preparation step on the patient.

[0087] For example, by performing patellar tracking using a tracking patellar clamp as described above or any of the following examples, the surgeon may be able to track the interaction between the femur and the patella. For instance, the surgical system 1130 may be able to display the direct placement of the patella into the patellar-femoral groove via a GUI interface 1205, and enable the surgeon to visualize the kinematics (performance information 1210) through the patient's range of motion.

[0088] In another example, the surgeon may be able to determine the properties of the patella (e.g., thickness) after a preparation step (e.g., cutting a predetermined amount from a portion of the patella).

[0089] In additional examples, the surgical system 1130 may facilitate the use of a cutting instrument instead of a saw and saw guide. For example, the surgical system 1130 may continuously monitor how much bone is being removed and / or how much bone is being retained. The surgeon may investigate the height position of the patella and instruct the surgical system 1130 on how much bone to leave or how much bone to remove. In one example, after a planar resection, a peg hole in the patella can be formed with a cutting instrument and / or a reamer, and the result can be visualized on the GUI interface 1205 via a patellar model 1250.

[0090] In a further example, the surgical system 1130 may indicate to the surgeon the resulting plane, for example, via a collet attached to the resection guide. In this example, the depth may be controlled by using an appropriate depth locking member. If a tracker is attached to the reamer or other preparation tool (see, for example, Figures 13B and 13C), depth control can be controlled via a computer-assisted surgical application 1160. For example, the depth of reaming can be determined by the difference between the marker on the resection guide and the reamer.

[0091] In another example, if a surgeon specifies a biconvex patellar implant, both convex surfaces and the peg hole in the patella can be automatically cut via a computer-assisted surgical system and / or robotic surgical system.

[0092] Referring back to Figure 11, in any of the above or below examples, the communication interface 1170 may facilitate communication between the control system 1110 and external systems and devices. The communication interface 1170 may include both wired and wireless communication interfaces, and may include, among other things, Ethernet, IEEE 802.11 wireless, or Bluetooth. As shown in Figure 11, in this example, the primary external systems connected via the communication interface 1170 may include the tracking system 940 (which may be, or include, a patellar tracking function as in any of the above or below examples) and the surgical instrument 950. Although not shown, other devices such as the databases 1130a-1130n and the display device 130 may also be connected to the control system 1110 via the communication interface 1170. In one example, the communication interface 1170 communicates with other modules within the control system 1110 and with hardware systems over an internal bus.

[0093] In any of the above or below examples, the tracking system 940 may provide positional and orientational information relating to the surgical device and to a portion of the anatomical structure of the implant host, including the patella registered within the surgical system 1130 in any of the above or below examples, in order to assist in the navigation and control of the semi-active robotic surgical device. While one exemplary and non-limiting example of the tracking system 940 may be an OPTOTRAK® 3-D motion-measuring and position-measuring tracking system as described herein, it will be understood by those skilled in the art that other tracking systems with other accuracies and / or other resolutions may be used.

[0094] In one example, the surgeon may use surgical instrument 950 to shape the patella to fit an artificial implant. For example, the controlled surgical system 1130 may track and control a surgical cutting instrument to perform precise cutting, cutting, reaming, or other preparations with respect to the patella. In any example above or below, the surgeon may input preparation instructions (e.g., cut or cut over X mm from the top of the patella, ream over a distance of Y mm within position Z of the patella, and / or perform similar preparations) via a GUI interface, and the surgical system 1130 may implement the preparation instructions on the patient's patella by providing control signals to the corresponding robotic surgical tools.

[0095] In any of the above or below examples, the control system 1110 may operate to generate a virtual or anatomical model of the patient and / or to access such a model. For example, the control system 1110 may operate to generate an anatomical model of the patient via an anatomical model generation process identical or similar to the method described in U.S. Patent Application Publication No. 2019 / 0365474 entitled “Systems and Methods for Planning and Performing Image Free Implant Revision Surgery” and / or PCT International Application No. PCT / US2020 / 054231 entitled “Registration of Intramedullary Canal During Revision Total Knee Arthroplasty,” both of which are incorporated herein by reference as if they were contained in their entirety. The above or below examples are not limited to this context. For example, a surgical planning process according to any example above or below may generate an anatomical model produced through various other processes (e.g., image-based processes) that may be operated by any example above or below described in this disclosure, and / or access such an anatomical model.

[0096] The anatomical model may be a virtual representation of a part of the patient, such as the patella, or may include such a virtual representation, for example, that is identical or similar to the computer models of the patient's anatomical structures provided in the Cori® surgical system and / or the Navio® surgical system. The anatomical model may be graphically depicted via the display device 1172 and may be visually manipulated (e.g., it may be rotated, moved, observed as entirely or partially transparent or semi-transparent, observed as a wireframe or similar image, and / or subjected to similar processing).

[0097] In one non-limiting example, the anatomical model generation process may include an image-free process, such as mapping the actual surface of the target bone(s) where a new implant is needed, using a punctate probe (e.g., an optically tracked punctate probe). The mapping may be performed after removing a defective or worn implant, or after removing diseased or other undesirable bone. Points may be collected on the bone surface via "painting," by brushing or scraping the entire bone residue using the tip of the punctate probe. The collected points may be used to create a three-dimensional model or surface map of the bone surface within a computerized planning system. In another non-limiting example, the anatomical model may be achieved mathematically, for example, by incorporating a set of Cartesian coordinates representing the tissue surface to generate a model file (e.g., in file formats such as, but not limited to, *.stl, *.obj, *.fea, *.stp, *.sur, *.igs, *.wrl, *.xyz, and / or similar). In additional, non-limiting examples, the anatomical model generation process may include image-based processes, such as those based on diagnostic images of the patient's subject anatomy, including X-ray images, CT images, and / or analogous images. Image analysis software may be used to analyze the diagnostic images and generate anatomical models, such as 3D models. In any of the above or below examples, the anatomical model generation process may use a combination of image-free and image-based processes. In any of the above or below examples, at least some of the information used to generate the patellar model may include information manually entered by the surgeon (e.g., dimensions). In general, anatomical models in any of the above or below examples may be generated using a variety of processes, but are not limited to, conventional probe painting, reference-mapped 3D imaging, visual edge detection, combinations thereof, and / or analogous images.

[0098] For certain surgical procedures, such as total knee arthroplasty (TKA), the procedure, or care episode, may include three stages: preoperative, intraoperative, and postoperative. At each stage, data may be collected or generated that can be used to analyze the care episode. Thus, the display device 1172 may function as an interactive interface that can dynamically update and display how changes in the surgical plan (e.g., visualizations regarding amputation or other patellar preparation) will affect the procedure and how they will affect the final performance of the implant and / or the final performance of the patella.

[0099] The computing device (or control system) 1110 may include a processor circuit 1120 that may include and / or be able to access various logics for performing processes according to any of the above or below examples, such as a surgical planning process. For example, the processor circuit 1120 may include computer-assisted surgical logic 1122 and / or anatomical model logic 1124, and / or be able to access such logic. The processing circuit 1120 and / or computer-assisted surgical logic 1122, and / or parts thereof, may be implemented by hardware, by software, or by a combination thereof. As used in this application, the terms “logic,” “component,” “layer,” “system,” “circuit,” “decoder,” “encoder,” “control loop,” and / or “module” are intended to refer to a computer-related entity which is either hardware, a combination of hardware and software, software, or running software, and these examples may be provided by exemplary computing architectures.For example, logic, circuits, or modules may include, but are not limited to, processes operating on a processor, processors, hard disk drives, multiple storage drives (consisting of optical and / or magnetic storage media), objects, executable files, execution threads, programs, computers, hardware circuits, integrated circuits, application-specific integrated circuits (ASICs), programmable logic devices (PLDs), digital signal processors (DSPs), systems on a chip (SoC), memory units, logic gates, registers, semiconductor devices, chips, microchips, chipsets, software components, programs, applications, firmware, software modules, computer code, control loops, computational models or computational applications, AI models or AI applications, ML models or ML applications, proportional-integral-derivative (PID) controllers, FG circuits, variations thereof, any combination thereof, and / or similar things.

[0100] Although the computer-assisted surgical logic 1122 is illustrated in Figure 1 as being located inside the processor circuit 1120, any examples above or below are not limited thereto. For example, the computer-assisted surgical logic 1122, the anatomical model logic 1124, and / or any of these components may be located inside an accelerator, inside a processor core, inside an interface, inside an individual processor die, inside memory, inside a storage device, inside a data store, inside a database, inside something implemented as a whole or in part as a software application (e.g., computer-assisted surgical application 1160), and / or something of the same kind.

[0101] The memory unit 1140 may include various types of computer-readable storage media, as well as / or read-only memory (ROM), random access memory (RAM), dynamic RAM (DRAM), double data rate DRAM (DDRAM), synchronous DRAM (SDRAM), static RAM (SRAM), programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory, polymer memory such as ferroelectric polymer memory, ovonic memory, phase change memory or ferroelectric memory, silicon oxide-nitride-oxide-silicon (SONOS) memory, magnetic cards or optical cards, device arrays such as RAID drives, solid-state memory. The memory unit 1140 may include various types of systems in the form of one or more faster memory units, such as a memory device (e.g., a USB memory stick, a solid-state drive (SSD), and any other type of storage medium suitable for storing information). In addition, the memory unit 1140 may include various types of computer-readable storage media in the form of one or more slower memory units, including an optical disc drive for reading from or writing to an internal (or external) hard disk drive (HDD), a magnetic floppy disk drive (FDD), a removable optical disc (e.g., a CD-ROM or DVD), a solid-state drive (SSD), and / or similar.

[0102] The memory unit 1140 may store various types of information and / or applications for performing the features and processes described above or below, such as the surgical planning process described above or below. For example, the memory unit 1140 may store patient information 1142, implant information 1144, anatomical models 1146, surgical plans 1150, and / or computer-assisted surgical applications 1160. In the above or below examples, all or part of the information illustrated as being stored in the memory unit 1140 may be stored in whole or in part in data sources 1130a to 1130n and made accessible to the computing device 1110.

[0103] In any of the above or below examples, patient information 1142 may include information about a patient who will undergo a surgical procedure performed through the surgical system. Patient information 1142 may include personal information (e.g., name, address, and / or similar), physical characteristics (e.g., height, weight, and / or similar), medical information (e.g., health history, health record identifiers, procedure information, and / or similar), and / or any other type of information that may be associated with the patient. In any of the above or below examples, patient information 1142 may include anatomical information of the patient, such as dimensions, bone hardness, and / or other characteristics relating to the patient's patella.

[0104] In any of the above or below examples, patient information 1142 may include information relating to a population of patients. For example, a population of patients may include individuals such that they can be used as a comparison to patients undergoing a procedure in order to generate anatomical models, surgical plans, performance information, and / or analogues, according to any of the above or below examples. In any of the above or below examples, the computer-assisted surgical application 1160 may operate to suggest preparation steps (e.g., cutting, planarization, cutting, reaming, and / or analogues) to achieve specific performance metrics (e.g., kinematics) based on population patient information 1142. For example, examples, algorithms, computational models (e.g., machine learning (ML) and / or artificial intelligence (AI) models), and / or analogues may be trained using population patient information 1142 to provide preparation recommendations based on anatomical structures and outcomes for similar patients.

[0105] In any of the above or below examples, implant information 1144 may include information about the implant related to a surgical procedure performed via the surgical system 1130. Generally, implant information 1144 may include information necessary for modeling the implant and / or information necessary for determining the configuration of the implant on or within the patient's anatomical structure. Implant information 1144 may also include information that may relate to the interaction between the patient's patella and the implant in order to determine, for example, patellar preparation, performance information, and / or similar information.

[0106] In any of the above or below examples, the anatomical model 1146 may include a virtual model relating to the patient's anatomical structure in relation to a surgical procedure performed via the surgical system 1130. In any of the above or below examples, the virtual model may include a mathematical model, a graphical model, a feature map, a combination thereof, and / or similar, such as one configured to virtually represent the patient's anatomical structure within a computing system (see, for example, Figure 4). In any of the above or below examples, the anatomical model 1146 may be configured to represent the patient's patella in accordance with this disclosure.

[0107] In any of the above or below examples, the surgical plan 1150 may include instructions, methods, steps, workflows, and / or equivalents for performing the surgical procedure. In any of the above or below examples, the surgical system 1130 may develop the surgical plan 1150 based on the anatomical model 1146 and other patient-specific information (e.g., patient information 1142), and / or implant information 1144. The surgical plan 1150 may provide recommended patellar preparation steps and preparation configurations (e.g., cutting information (location, angle, and / or equivalents), cutting information, and / or equivalents).

[0108] The surgical plan 1150 may be observed preoperatively and intraoperatively, and the surgeon may modify the surgical plan 1150 preoperatively or intraoperatively. For example, the surgeon may perform a “virtual” preparation of the patella, which may be done by virtually implementing a cut on the patella via the GUI interface 1205 in Figure 12. The computer-aided surgical logic 1122 may, for example, be via the computer-aided surgical application 1160, predict, evaluate, or otherwise determine the results of the virtual preparation, such as performance metrics, conformity, and / or similar. The surgeon may be presented with the results of the virtual preparation and may proceed accordingly (for example, by modifying or removing the virtual preparation, performing a second virtual preparation, and / or similar actions).

[0109] The surgical plan 1150 may be performed entirely or partially manually by the surgeon, and / or automatically (e.g., computer-assisted or robot-assisted) via a computer-controlled surgical instrument 150, and / or in combination thereof. The above or below examples are not limiting in this context.

[0110] In any of the above or below examples, the computer-assisted surgical logic 1122 may operate to perform, implement, or otherwise provide a computer-assisted surgical process relating to the surgical system 1130 according to any of the above or below examples. For example, in any of the above or below examples, the computer-assisted surgical logic 1122 may operate to manage or control operational features in the planning module 1112, the navigation module 1114, the control module 1116, the tracking system 940, and / or the surgical instruments 950, as described herein. In another example, the computer-assisted surgical logic 1122 may perform, implement, or otherwise provide a surgical planning process according to any of the above or below examples.

[0111] In any of the above or below examples, the computer-assisted surgical application 1160 may be a software application that includes and / or operates in conjunction with the computer-assisted surgical logic 1122 in order to perform the features of the surgical system 1130 described herein. For example, the computer-assisted surgical application 1160 may operate to present a user interface (see, for example, Figure 12) via a display device 1172.

[0112] In any of the above or below examples, some or all of the patient information 1142, implant information 1144, anatomical model 1146, surgical plan 1150, computer-aided surgical logic 1122, anatomical model logic 1124, and / or computer-aided surgical application 1160 may be stored in one or more data sources 1130a-1130n that are accessible to the computing device 1110 via the network 1190.

[0113] Figures 13A, 13B, and 13C illustrate various diagrams of an example of a tracking patellar clamp having a patellar preparation member according to one or more features of the present disclosure. As shown in Figure 13A, the patellar tracking clamp 100 may be coupled to one or more patellar preparation members 860, or may be associated with one or more patellar preparation members 860 in other embodiments. In any of the above or below examples, the patellar preparation member 860 may include a tool or other device, such as a cutting tool, reaming tool, cutting tool, or other tool, configured to prepare the patella.

[0114] In the examples of Figures 13A, 13B, and 13C, the patella preparation member 860 is a reamer tool. In any of the above or below examples, the reamer tool 860 may be detected by the surgical system 950, for example, via a tracking system 940. For example, the reamer tool 860 may have a component or property that can be detected by the tracking system 940. Referring to Figure 13B, the reamer tool 860 may include a reflective surface 861 that can be detected by the tracking system 940, for example, by the reflection of light (e.g., IR light) via the optical tracking system 940. Referring to Figure 13B, the reamer tool 860 may include a tracker 862 on the surface 861, for example. The operating characteristics of the reamer tool 860 may be determined by using the reflective surface 861 and / or the tracker 862. For example, the tracking system 940 may be configured to detect the position of the reamer tool 860 (e.g., position relative to the patella) in order to determine the reaming depth of the patella during the surgical procedure.

[0115] In any of the above or below examples, the characteristics of the reamer tool 860 (e.g., position, depth within the patella, orientation, and / or similar), as well as / or a visual representation of the reamer tool 860 (e.g., "tool model"), may be presented to the observer, for example, via the GUI interface 1205. In this way, the surgeon or other operator may be able to visualize, in real time or substantially real time, the operation of the reamer tool 860, including from various angles and orientations, etc., through the modeling in any of the above or below examples, which is not available in the prior art. Therefore, by using the devices in any of the above or below examples, the surgeon may be able to visualize the results of reaming the patella using a computer-assisted surgical system and / or a robotic surgical system, and thus be able to improve the reliability of such results.

[0116] In any of the above or below examples, a patellar tracking clamp, such as clamp 100, may enable a surgeon or other user to determine and / or define planes (e.g., planes 801, 802), and enable the surgeon to properly position a cutting tool (e.g., reamer tool 860) with precision and reliability. For example, the surgeon may be able to determine, via the tracking member of clamp 100 and the GUI interface 1205, whether the reamer tool 860 is sufficiently perpendicular to the cutting plane in question, thereby ensuring proper reaming by determining, for example, where on the patella the reamer tool 860 is about to engage or "land".

[0117] In the configurations illustrated in Figures 13A, 13B, and 13C, a reamer tool is used as an example of a patellar preparation member; however, any examples above or below are not limited thereto. For example, cutting tools, saws, cutting tools, excision guides, and / or other tools may be used alone or in combination with the reflective surface 861 and / or tracker 862 in accordance with the features of this disclosure, thereby determining the operational characteristics of such tools. For example, a cutting tool may be associated with the tracker 862 so that a patellar model is generated, and a cutting position and cutting depth may be provided for use by the tracking system 940, and ultimately for use by the surgical system 950.

[0118] While features comprising one or more navigation members and corresponding uses thereof are illustrated and described in relation to the patellar clamp 100, this disclosure should not be limited in that respect, and it should be understood that the inclusion of navigation members and corresponding uses thereof may be used in relation to any other patellar clamps known or to be developed in the future.

[0119] The above description has broad applications. Although this disclosure refers to specific examples, numerous modifications, changes, and variations are possible to the examples described without departing from the scope and domain of this disclosure as set forth in the appended claims (one or more). Therefore, it is intended that this disclosure is not limited to the examples described. Rather, these examples should be considered illustrative and not limiting. All modifications and variations that fall within the spirit of the invention should be considered within the scope of this disclosure. This disclosure is given the entire scope as set forth by the language of the following claims, and its equivalents. The consideration of all examples is for illustrative purposes only and does not imply that the scope of this disclosure, including the claims, is limited to these examples. In other words, although exemplary examples of this disclosure have been described in detail herein, it will be understood that, except as limited by the prior art, the concepts of the invention may be embodied and adopted in a variety of other forms, and that the appended claims are intended to be interpreted to include such modifications. Unless otherwise defined, all technical terms used herein have the same meaning as those generally understood by those skilled in the art in which this disclosure pertains.

[0120] In this specification, terms relating to orientation may be used, such as top, bottom, up, down, inside, outside, front, back, proximal, distal, upper side, lower side, upward, downward, left, right, longitudinal, front, back, upward, downward, vertical, horizontal, radial, axial, clockwise, counterclockwise, and similar. Such references to orientation are used solely for identification purposes to aid the reader's understanding of this disclosure. For example, the term “distal” may refer to the end furthest from the healthcare worker / operator when the device is introduced into the patient, while the term “proximal” may refer to the end closest to the healthcare worker when the device is introduced into the patient. Such references to orientation do not necessarily impose limitations, particularly with respect to the position, orientation, or use of this disclosure. Thus, references to orientation should not be limited to the orientation, distance, or size of specific coordinates, but are used to describe relative position by referring to specific examples. Such terms do not generally limit the scope of the claims in this specification. Any example or feature relating to any section, part, or any other component illustrated or described in relation to various examples relating to similar sections, parts, or components herein may be applied interchangeably to any other similar example or feature illustrated or described herein.

[0121] As described herein, it will be understood that “examples” or “embodiments” (such as those illustrated in the accompanying drawings) may refer to illustrative representations of environments, articles, or components in which the disclosed concepts or features may be provided or embodied, or they may refer to representations of the manner in which the concepts or features may be provided or embodied. However, such illustrated examples should be understood as examples, configurations, specimens, embodiments, illustrations, models, examples, and / or similars (unless otherwise stated), and other manners of embodying the described concepts or features, such as those that can be understood by a person skilled in the art who has learned the concepts or features from this disclosure, are within the scope of this disclosure. Furthermore, references to “one embodiment,” “one example,” or “the above or below examples” in this disclosure are not intended to be construed as excluding the existence of additional embodiments or examples in which the referred features also incorporate.

[0122] In addition, while the drawings may show one or more examples of such concepts or features together in a single example of an environment, article, or component into which such concepts or features are incorporated, it should be understood that such concepts or features are to be understood as independent and separate from one another (unless otherwise specified) and are shown together for convenience without any intention to limit them to existing together or being used together. For example, features illustrated or described as part of an example can be used separately, or used together with another example to obtain yet another example. Thus, the subject matter of the present invention is intended to encompass modifications and variations that fall within the scope of the appended claims and their equivalents.

[0123] As used herein, a member or step described in the singular form and beginning with the word "a" or "an" should be understood not to exclude multiple members or steps unless explicitly stated otherwise. Furthermore, as used herein, the terms “equipped with” and / or “equipped with,” or “contains” and / or “contains,” specify the presence of a described feature, area, step, member, and / or component, but do not exclude the presence or addition of one or more other features, areas, integers, steps, operations, members, components, and / or groups thereof.

[0124] As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are both conjunctive and disjunctive in relation to their action. The terms “one (a)” (or “one (an)”), “one or more,” and “at least one” are interchangeable herein.

[0125] References to connections (e.g., engaged, attached, joined, connected, and joined) should be interpreted broadly and may include intermediate members between sets of multiple members, and intermediate members related to movement between members, unless otherwise indicated. Thus, references to connections do not necessarily imply that two members are directly connected and have a fixed relationship with one another. Identifying references (primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another. Drawings are for illustrative purposes only, and dimensions, locations, order, and relative sizes reflected in the accompanying drawings may differ.

[0126] The above considerations are presented for illustrative and explanatory purposes only and are not intended to limit the disclosure to the forms disclosed herein. For example, various features of the disclosure are grouped into one or more examples or configurations for the purpose of streamlining the disclosure. However, it will be understood that various features in particular examples or configurations of the disclosure may be combined in alternative examples or configurations. Furthermore, the following claims are incorporated into this detailed description by this reference, and each claim exists independently as a separate example of the disclosure.

Claims

1. A tracking patellar clamp, A clamp assembly that operates to engage with the patella, A handle assembly coupled to the clamp assembly, the handle assembly which, when driven, operates to fix the patella inside the clamp assembly, The system includes at least one tracking member that operates to determine the tracking information of the patella, A tracking patellar clamp, wherein at least one tracking member is configured to determine instrument information of a surgical instrument associated with the tracking patellar clamp.

2. The tracking patellar clamp according to claim 1, wherein the handle assembly is operable to rotate relative to the clamp assembly.

3. The tracking patellar clamp according to claim 1 or 2, wherein the at least one tracking member is coupled to the clamp assembly.

4. The tracking information includes at least one of the positional information or orientation information of the patella, according to claim 1.

5. The tracking information includes a cross-sectional plane related to the patella, as described in claim 1.

6. The tracking patellar clamp according to claim 1, wherein the instrument information includes the position of the surgical instrument relative to the patella.

7. The tracking patellar clamp according to claim 1, wherein the at least one tracking member is configured to determine the instrument information by detecting the reflective surface of the surgical instrument.

8. The surgical instrument is a tracking patellar clamp according to claim 6, wherein the surgical instrument includes a reamer tool.

9. It is a computer-assisted surgical system, It includes at least one computing device, and the computing device is Display devices and, Processing circuit and The memory is coupled to the processing circuit, and when executed by the processing circuit, the memory provides the processing circuit with respect to the processing circuit. Receiving tracking information related to the patella and detected by at least one tracking member of the tracking patella clamp according to claim 1 that is engaged with the patella, Based on the aforementioned tracking information, determine patellar information that exhibits at least one characteristic of the patella, The patellar model is configured as a virtual representation of the patella and generates a patellar model configured based on the patellar information, A computer-assisted surgical system that includes instructions to perform the following actions: presenting a graphical user interface (GUI) object visually illustrating the patella model on a GUI screen via the display device; and presenting a GUI object on a GUI screen via the display device.

10. The computer-assisted surgical system according to claim 9, wherein when the command is executed by the processing circuit, the processing circuit is instructed to receive instrument tracking information corresponding to the surgical instrument associated with the tracking patellar clamp and instrument tracking information detected by at least one tracking member.

11. The computer-assisted surgical system according to claim 10, wherein when the instruction is executed by the processing circuit, the processing circuit is instructed to determine instrument information which is instrument information of the surgical instrument and includes at least one of the position or orientation of the surgical instrument, based on the instrument tracking information.

12. The computer-assisted surgical system according to claim 11, wherein when the instruction is executed by the processing circuit, the processing circuit is instructed to display a GUI model of the surgical instrument on the GUI screen based on the instrument information.

13. The computer-assisted surgical system according to claim 10, wherein the surgical instruments include a reamer tool.

14. The computer-assisted surgical system according to claim 9, wherein the tracking information includes a cutting plane related to the patella.

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