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WO2023059589A1 - Systèmes de guide de coupe - Google Patents

Systèmes de guide de coupe Download PDF

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Publication number
WO2023059589A1
WO2023059589A1 PCT/US2022/045613 US2022045613W WO2023059589A1 WO 2023059589 A1 WO2023059589 A1 WO 2023059589A1 US 2022045613 W US2022045613 W US 2022045613W WO 2023059589 A1 WO2023059589 A1 WO 2023059589A1
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WO
WIPO (PCT)
Prior art keywords
surgical
tibial
patient
data
cut
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2022/045613
Other languages
English (en)
Inventor
Branislav Jaramaz
Riddhit MITRA
Samuel C. DUMPE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smith and Nephew Orthopaedics AG
Smith and Nephew Asia Pacific Pte Ltd
Smith and Nephew Inc
Original Assignee
Smith and Nephew Orthopaedics AG
Smith and Nephew Asia Pacific Pte Ltd
Smith and Nephew Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smith and Nephew Orthopaedics AG, Smith and Nephew Asia Pacific Pte Ltd, Smith and Nephew Inc filed Critical Smith and Nephew Orthopaedics AG
Publication of WO2023059589A1 publication Critical patent/WO2023059589A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

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    • A61B17/154—Guides therefor for preparing bone for knee prosthesis
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Definitions

  • the present disclosure relates generally to methods, systems, and apparatuses related to a computer-assisted surgical system that includes various hardware and software components that work together to enhance surgical workflows.
  • the disclosed techniques may be applied to, for example, shoulder, hip, and knee arthroplasties, as well as other surgical interventions such as arthroscopic procedures, spinal procedures, maxillofacial procedures, rotator cuff procedures, ligament repair and replacement procedures.
  • the condyles of the femur may require resection of the distal, posterior, and/or anterior surfaces, and/or chamfer cuts therebetween, in order to accommodate an implant component.
  • Executing a surgical plan to provide resected surfaces at accurate locations is a significant factor in the success of the knee arthroplasty procedure and associated patient outcomes. Accordingly, great care must be taken in locating resection surfaces and accurately completing the resections.
  • resection of the femur may be completed using computer guidance, such as a computer-assisted burring tool.
  • the computer- assisted surgical system can reliably complete bone cuts in accordance with the surgical plan while the surgeon operates the burring tool.
  • burring each surface requires sufficient access to the surface in the operating environment in order to maneuver the burring tool to complete the cuts. While burring of the anterior surface, the distal surface, and the chamfer cuts is relatively straightforward using a burring tool and robotic guidance, the posterior surface resection may be difficult to complete with respect to burring tool access and orientation. One significant issue is that the posterior surface is often difficult to access because the back of the knee may be at least partially obstructed during the surgical procedure based on the positioning of the patient. Difficulty accessing the site freely to complete the cuts may make the resections unwieldy and/or present a risk for damaging the bone and/or soft tissue.
  • the computer-assisted burring tool may not be the ideal or most effective instrument for completing the posterior surface resection.
  • the precise location of each of the resection planes varies based on patient parameters and/or implant component characteristics (e.g., make, model, or size) and is thus variable for each patient.
  • Implant component characteristics e.g., make, model, or size
  • Customized cut guides may impose a significant investment that adds cost, time, and logistics to knee arthroplasty procedures.
  • a posterior femoral cut guide device includes a fixed component and an adjustable component.
  • the fixed component includes an anterior contact portion, first and second distal contact portions and a central portion disposed between the first and second distal contact portions, wherein the first and second distal contact portions and the central portion each extend from the anterior contact portion, first and second tracks disposed between the central portion and the first distal contact portion and the central portion and the second distal contact portion, respectively, and an adjustment mechanism.
  • the adjustable component includes first and second adjustable portions configured to be received by the first and second tracks, respectively, an interior portion extending from the first and second adjustable portions and coupled to an exterior portion at a central divider, wherein the interior portion is spaced from the exterior portion on first and second sides of the central divider to form first and second cut slots for facilitating femoral condyle resections, and an actuator coupled to at least the interior portion, in operable communication with the adjustment mechanism, and configured to cause the adjustable component to extend or retract relative to the fixed component.
  • the adjustment mechanism comprises a circular gear
  • the actuator comprises a linear gear configured to convert rotational motion of the circular gear into linear motion when engaged by the circular gear.
  • the anterior contact portion comprises an anterior pin hole configured to receive a pin, wherein the pin is configured to affix the anterior contact portion to a femur.
  • the central portion comprises a distal pin hole configured to receive a pin, wherein the pin is configured to affix the central portion to a femur.
  • the device further includes a peg extending from one of the first and second distal contact portions, where the peg is configured to engage a lateral groove in one of the first and second adjustable portions.
  • the device further includes sizing indicia disposed on one or more of the first adjustable portion, the second adjustable portion, and the central portion.
  • the device further includes a locking screw configured to lock a position of the adjustable component relative to the fixed component.
  • a method for facilitating a total knee arthroplasty surgical procedure includes resecting anterior, distal, and chamfer portions of a femur of a patient to generate at least anterior and distal cut planes; operating an adjustment mechanism of a fixed component of a posterior femoral cut guide device to engage an actuator of an adjustable component of the posterior femoral cut guide device to move one or more femoral cut slots of the adjustable component to a location determined based on one or more dimensions of a femoral implant component; affixing the posterior femoral cut guide device to one or more of the anterior or distal cut planes; inserting a resection tool into each of the cut slots to resect femoral condyles of the femur after; removing the posterior femoral cut guide from the femur; and attaching the femoral implant component to the femur.
  • the adjustment mechanism comprises a circular gear and the actuator comprises a linear gear, wherein the circular gear is in operable communication with the linear gear.
  • resecting anterior, distal, and chamfer portions comprises resecting the anterior, distal, and chamfer portions using a computer-assisted surgical resection tool.
  • the method further includes locking the location of the adjustable component using a locking screw.
  • affixing the posterior femoral cut guide device comprises burring one or more holes in the femur of the patient; and for each of the one or more holes, inserting a pin through a corresponding pin hole of the posterior femoral cut guide device into the corresponding hole.
  • removing the posterior femoral cut guide from the femur further comprises removing at least one pin from the corresponding hole.
  • a method for facilitating a total knee arthroplasty surgical procedure includes affixing a fixation base to a tibia of a patient at a location relative to a long axis of the tibia determined using a depth stylus or simulated resection plane inserted into the fixation base; inserting a tibia cut block assembly into the fixation base after removing the depth stylus or simulated resection plane from the fixation base; aligning a tibial cut slot of a tibial cut block component of the tibial cut block assembly with a tibial resection plane defined by a preoperative surgical plan for the patient; affixing the tibia cut block assembly to the tibia; inserting a resection tool into the tibial cut slot to resect the tibia; and attaching a tibial implant component to the tibia after removing the tibial cut block assembly and fixation base from the
  • affixing the fixation base comprises affixing the fixation base by inserting one or more tibial pins through one or more corresponding tibial pin holes.
  • the method further comprises displaying a location and orientation of the tibial resection plane on a head-mounted display.
  • aligning a tibial cut slot comprises adjusting a vertical adjustment knob configured to facilitate granular movement in the proximal-distal direction.
  • aligning a tibial cut slot comprises adjusting a flexion adjustment knob configured to facilitate tilting the tibial cut slot in a flexion-extension direction.
  • aligning a tibial cut slot comprises adjusting an angulation adjustment knob configured to facilitate tilting the tibial cut slot in a varus-valgus direction.
  • aligning a tibial cut slot comprises affixing one or more of a tracking device and a tracking array to the tibial cut slot; and aligning the tibial cut slot with the tibial resection plane based on information received from the tracking device or tracking array.
  • affixing the tibia cut block assembly comprises affixing the tibia cut block assembly by inserting one or more pins through one or more corresponding pin holes.
  • the posterior femoral cut guide device also includes an adjustable component that includes first and second adjustable portions configured to be received by the first and second tracks, respectively.
  • An interior portion extends from the first and second adjustable portions and is coupled to an exterior portion at a central divider.
  • the interior portion is spaced from the exterior portion on first and second sides of the central divider to form first and second cut slots for facilitating femoral condyle resections.
  • the adjustable portion also includes a linear gear coupled to at least the interior portion and configured to convert rotational motion of the circular gear into linear motion when engaged by the circular gear to thereby cause the adjustable component to extend or retract relative to the fixed component.
  • a method for facilitating a total knee arthroplasty surgical procedure includes resecting anterior, distal, and chamfer portions of a femur of a patient using a computer-assisted surgical resection tool to generate at least anterior and distal cut planes.
  • a circular gear of an adjustment mechanism of a fixed component of a posterior femoral cut guide device is then rotated to engage a linear gear of an adjustable component of the posterior femoral cut guide device to move one or more femoral cut slots of the adjustable component to a location determined based on one or more dimensions of a femoral implant component.
  • a resection tool is then inserted into each of the cut slots to resect femoral condyles of the femur after affixing the posterior femoral cut guide to one or more of the anterior or distal cut planes.
  • the femoral implant component is then attached to the femur after removing the posterior femoral cut guide from the femur.
  • a method for facilitating a total knee arthroplasty surgical procedure includes affixing a fixation base to a tibia of a patient at a location relative to a long axis of the tibia determined using a depth stylus or simulated resection plane inserted into the fixation base.
  • a tibia cut block assembly is inserted into the fixation base after removing the depth stylus or simulated resection plane from the fixation base.
  • the tibia cut block assembly is then affixed to the tibia after aligning a tibial cut slot of a tibial cut block component of the tibial cut block assembly with a tibial resection plane defined by a preoperative surgical plan for the patient.
  • a resection tool is inserted into the tibial cut slot to resect the tibia.
  • a tibial implant component is then attached to the tibia after removing the tibial cut block assembly and fixation base from the tibia.
  • FIG. 1 depicts an operating theatre including an illustrative computer-assisted surgical system (CASS) in accordance with an embodiment.
  • CASS computer-assisted surgical system
  • FIG. 2 depicts an example of an electromagnetic sensor device according to some embodiments.
  • FIG. 3A depicts an alternative example of an electromagnetic sensor device, with three perpendicular coils, according to some embodiments.
  • FIG. 3B depicts an alternative example of an electromagnetic sensor device, with two nonparallel, affixed coils, according to some embodiments.
  • FIG. 3C depicts an alternative example of an electromagnetic sensor device, with two nonparallel, separate coils, according to some embodiments.
  • FIG. 4 depicts an example of electromagnetic sensor devices and a patient bone according to some embodiments
  • FIG. 5A depicts illustrative control instructions that a surgical computer provides to other components of a CASS in accordance with an embodiment.
  • FIG. 5B depicts illustrative control instructions that components of a CASS provide to a surgical computer in accordance with an embodiment.
  • FIG. 5C depicts an illustrative implementation in which a surgical computer is connected to a surgical data server via a network in accordance with an embodiment.
  • FIG. 6 depicts an operative patient care system and illustrative data sources in accordance with an embodiment.
  • FIG. 7A depicts an illustrative flow diagram for determining a pre-operative surgical plan in accordance with an embodiment.
  • FIG. 7B depicts an illustrative flow diagram for determining an episode of care including pre-operative, intraoperative, and post-operative actions in accordance with an embodiment.
  • FIG. 7C depicts illustrative graphical user interfaces including images depicting an implant placement in accordance with an embodiment.
  • FIG. 8 depicts an adjustable and reusable posterior femoral cut guide in a retracted configuration for guidance of the posterior femoral condyle resections in a knee arthroplasty procedure in accordance with an embodiment.
  • FIG. 9 depicts an adjustable and reusable posterior femoral cut guide in an extended configuration for guidance of the posterior femoral condyle resections in a knee arthroplasty procedure in accordance with an embodiment.
  • FIG. 10 depicts an adjustable and reusable posterior femoral cut guide affixed to anterior and distal femoral cut planes to facilitate resection of the posterior femoral condyles in a knee arthroplasty procedure in accordance with an embodiment.
  • FIGS. 11A-B depict a fixation base of a tibial cut guide affixed to the tibia of a patient and a depth stylus and a simulated plane, respectively, inserted into the fixation base in accordance with an embodiment.
  • FIG. 12 depicts a fixation base of a tibial cut guide affixed to the tibia of a patient and coupled to a tracking device in accordance with an embodiment.
  • FIG. 13 depicts a tibial cut guide with a fixation base coupled to the tibia of a patient and a tracking device and a tibial cut block assembly inserted into the fixation base in accordance with an embodiment.
  • FIG. 14 depicts vertical, fixation, and flexion adjustment mechanisms of a tibial cutting guide in accordance with an embodiment.
  • FIG. 15 depicts a flowchart of an exemplary hybrid knee arthroplasty surgical method for resection of the femur and tibia whereby some cuts are performed robotically and the posterior femoral condyle resections are performed manually using a posterior femoral cut guide in accordance with an embodiment.
  • FIG. 16 depicts an alternate fixation base of a tibial cut guide affixed to the tibia of a patient and a depth stylus inserted into the fixation base in accordance with an embodiment.
  • FIG. 17 depicts an alternate fixation base of a tibial cut guide affixed to the tibia of a patient and coupled to a tracking device in accordance with an embodiment.
  • FIG. 18 depicts an alternate tibial cut guide with a fixation base coupled to the tibia of a patient and a tracking device and a tibial cut block assembly inserted into the fixation base in accordance with an embodiment.
  • FIG. 19 depicts vertical, fixation, and flexion adjustment mechanisms of an alternate tibial cutting guide in accordance with an embodiment.
  • the term “implant” is used to refer to a prosthetic device or structure manufactured to replace or enhance a biological structure.
  • a prosthetic acetabular cup (implant) is used to replace or enhance a patients worn or damaged acetabulum.
  • implant is generally considered to denote a man-made structure (as contrasted with a transplant), for the purposes of this specification an implant can include a biological tissue or material transplanted to replace or enhance a biological structure.
  • real-time is used to refer to calculations or operations performed on-the-fly as events occur or input is received by the operable system.
  • real-time is not intended to preclude operations that cause some latency between input and response, so long as the latency is an unintended consequence induced by the performance characteristics of the machine.
  • CORI is a registered trademark of BLUE BELT TECHNOLOGIES, INC. of Pittsburgh, PA, which is a subsidiary of SMITH & NEPHEW, INC. of Memphis, TN.
  • FIG. 1 provides an illustration of an example computer-assisted surgical system (CASS) 100, according to some embodiments.
  • the CASS uses computers, robotics, and imaging technology to aid surgeons in performing orthopedic surgery procedures such as total knee arthroplasty (TKA) or total hip arthroplasty (THA).
  • TKA total knee arthroplasty
  • THA total hip arthroplasty
  • surgical navigation systems can aid surgeons in locating patient anatomical structures, guiding surgical instruments, and implanting medical devices with a high degree of accuracy.
  • Surgical navigation systems such as the CASS 100 often employ various forms of computing technology to perform a wide variety of standard and minimally invasive surgical procedures and techniques.
  • these systems allow surgeons to more accurately plan, track and navigate the placement of instruments and implants relative to the body of a patient, as well as conduct pre-operative and intra-operative body imaging.
  • An Effector Platform 105 positions surgical tools relative to a patient during surgery.
  • the exact components of the Effector Platform 105 will vary, depending on the embodiment employed.
  • the Effector Platform 105 may include an End Effector 105B that holds surgical tools or instruments during their use.
  • the End Effector 105B may be a handheld device or instrument used by the surgeon (e.g., a NAVIO® hand piece or a cutting guide or jig) or, alternatively, the End Effector 105B can include a device or instrument held or positioned by a Robotic Arm 105 A. While one Robotic Arm 105 A is illustrated in FIG. 1, in some embodiments there may be multiple devices.
  • the Robotic Arm 105 A may be mounted directly to the table T, be located next to the table T on a floor platform (not shown), mounted on a floor-to- ceiling pole, or mounted on a wall or ceiling of an operating room.
  • the floor platform may be fixed or moveable.
  • the robotic arm 105 A is mounted on a floor- to-ceiling pole located between the patient’s legs or feet.
  • the End Effector 105B may include a suture holder or a stapler to assist in closing wounds.
  • the surgical computer 150 can drive the robotic arms 105A to work together to suture the wound at closure.
  • the surgical computer 150 can drive one or more robotic arms 105 A to staple the wound at closure.
  • the Effector Platform 105 can include a Limb Positioner 105C for positioning the patient’s limbs during surgery.
  • a Limb Positioner 105C is the SMITH AND NEPHEW SPIDER2 system.
  • the Limb Positioner 105C may be operated manually by the surgeon or alternatively change limb positions based on instructions received from the Surgical Computer 150 (described below). While one Limb Positioner 105C is illustrated in FIG. 1, in some embodiments there may be multiple devices. As examples, there may be one Limb Positioner 105C on each side of the operating table T or two devices on one side of the table T.
  • the Limb Positioner 105C may be mounted directly to the table T, be located next to the table T on a floor platform (not shown), mounted on a pole, or mounted on a wall or ceiling of an operating room.
  • the Limb Positioner 105C can be used in non- conventional ways, such as a retractor or specific bone holder.
  • the Limb Positioner 105C may include, as examples, an ankle boot, a soft tissue clamp, a bone clamp, or a soft-tissue retractor spoon, such as a hooked, curved, or angled blade.
  • the Limb Positioner 105C may include a suture holder to assist in closing wounds.
  • the Effector Platform 105 may include tools, such as a screwdriver, light or laser, to indicate an axis or plane, bubble level, pin driver, pin puller, plane checker, pointer, finger, or some combination thereof.
  • tools such as a screwdriver, light or laser, to indicate an axis or plane, bubble level, pin driver, pin puller, plane checker, pointer, finger, or some combination thereof.
  • Resection Equipment 110 (not shown in FIG. 1) performs bone or tissue resection using, for example, mechanical, ultrasonic, or laser techniques.
  • Resection Equipment 110 include drilling devices, burring devices, oscillatory sawing devices, vibratory impaction devices, reamers, ultrasonic bone cutting devices, radio frequency ablation devices, reciprocating devices (such as a rasp or broach), and laser ablation systems.
  • the Resection Equipment 110 is held and operated by the surgeon during surgery.
  • the Effector Platform 105 may be used to hold the Resection Equipment 110 during use.
  • the Effector Platform 105 can also include a cutting guide or jig 105D that is used to guide saws or drills used to resect tissue during surgery.
  • a cutting guide or jig 105D that is used to guide saws or drills used to resect tissue during surgery.
  • Such cutting guides 105D can be formed integrally as part of the Effector Platform 105 or Robotic Arm 105 A, or cutting guides can be separate structures that can be matingly and/or removably attached to the Effector Platform 105 or Robotic Arm 105 A.
  • the Effector Platform 105 or Robotic Arm 105A can be controlled by the CASS 100 to position a cutting guide or jig 105D adjacent to the patient’s anatomy in accordance with a pre-operatively or intraoperatively developed surgical plan such that the cutting guide or jig will produce a precise bone cut in accordance with the surgical plan.
  • the Tracking System 115 uses one or more sensors to collect real-time position data that locates the patient’s anatomy and surgical instruments. For example, for TKA procedures, the Tracking System may provide a location and orientation of the End Effector 105B during the procedure. In addition to positional data, data from the Tracking System 115 can also be used to infer velocity/acceleration of anatomy/instrumentation, which can be used for tool control. In some embodiments, the Tracking System 115 may use a tracker array attached to the End Effector 105B to determine the location and orientation of the End Effector 105B.
  • the position of the End Effector 105B may be inferred based on the position and orientation of the Tracking System 115 and a known relationship in three-dimensional space between the Tracking System 115 and the End Effector 105B.
  • Various types of tracking systems may be used in various embodiments of the present invention including, without limitation, Infrared (IR) tracking systems, electromagnetic (EM) tracking systems, video or image based tracking systems, and ultrasound registration and tracking systems.
  • IR Infrared
  • EM electromagnetic
  • the surgical computer 150 can detect objects and prevent collision.
  • the surgical computer 150 can prevent the Robotic Arm 105A and/or the End Effector 105B from colliding with soft tissue.
  • Any suitable tracking system can be used for tracking surgical objects and patient anatomy in the surgical theatre.
  • a combination of IR and visible light cameras can be used in an array.
  • Various illumination sources such as an IR LED light source, can illuminate the scene allowing three-dimensional imaging to occur. In some embodiments, this can include stereoscopic, tri-scopic, quad-scopic, etc. imaging.
  • additional cameras can be placed throughout the surgical theatre.
  • handheld tools or headsets worn by operators/surgeons can include imaging capability that communicates images back to a central processor to correlate those images with images captured by the camera array. This can give a more robust image of the environment for modeling using multiple perspectives.
  • imaging devices may be of suitable resolution or have a suitable perspective on the scene to pick up information stored in quick response (QR) codes or barcodes. This can be helpful in identifying specific objects not manually registered with the system.
  • the camera may be mounted on the Robotic Arm 105A.
  • EM based tracking devices include one or more wire coils and a reference field generator.
  • the one or more wire coils may be energized (e.g., via a wired or wireless power supply). Once energized, the coil creates an electromagnetic field that can be detected and measured (e.g., by the reference field generator or an additional device) in a manner that allows for the location and orientation of the one or more wire coils to be determined.
  • a single coil such as is shown in FIG. 2, is limited to detecting five (5) total degrees-of-freedom (DOF).
  • sensor 200 may be able to track/determine movement in the X, Y, or Z direction, as well as rotation around the Y -axis 202 or Z-axis 201.
  • a three coil system such as that shown in FIG. 3A is used to enable tracking in all six degrees of freedom that are possible for a rigid body moving in a three-dimensional space (i.e., forward/backward 310, up/down 320, left/right 330, roll 340, pitch 350, and yaw 360).
  • the inclusion of two additional coils and the 90° offset angles at which they are positioned may require the tracking device to be much larger.
  • less than three full coils may be used to track all 6DOF.
  • two coils may be affixed to each other, such as is shown in FIG. 3B. Because the two coils 30 IB and 302B are rigidly affixed to each other, not perfectly parallel, and have locations that are known relative to each other, it is possible to determine the sixth degree of freedom 303B with this arrangement.
  • the sensor device is substantially larger in diameter than a single coil because of the additional coil.
  • the practical application of using an EM based tracking system in a surgical environment may require tissue resection and drilling of a portion of the patient bone to allow for insertion of a EM tracker.
  • a solution is needed for which the use of an EM tracking system can be restricted to devices small enough to be inserted/embedded using a small diameter needle or pin (i.e., without the need to create a new incision or large diameter opening in the bone).
  • a second 5DOF sensor which is not attached to the first, and thus has a small diameter, may be used to track all 6DOF.
  • two 5DOF EM sensors may be inserted into the patient (e.g., in a patient bone) at different locations and with different angular orientations (e.g., angle 303C is non-zero).
  • first 5DOF EM sensor 401 and a second 5DOF EM sensor 402 are inserted into the patient bone 403 using a standard hollow needle 405 that is typical in most OR(s).
  • first sensor 401 and the second sensor 402 may have an angle offset of “a” 404.
  • a minimum value may be based on one or more factors, such as, for example, the orientation accuracy of the tracking system, a distance between the first and second EM sensors.
  • a pin/needle e.g., a cannulated mounting needle, etc.
  • the pin/needle would be a disposable component, while the sensors themselves may be reusable.
  • the EM sensors may be affixed to the mounting needle/pin (e.g., using a luer-lock fitting or the like), which can allow for quick assembly and disassembly.
  • the EM sensors may utilize an alternative sleeve and/or anchor system that allows for minimally invasive placement of the sensors.
  • the above systems may allow for a multi-sensor navigation system that can detect and correct for field distortions that plague electromagnetic tracking systems.
  • field distortions may result from movement of any ferromagnetic materials within the reference field.
  • a typical OR has a large number of devices (e.g., an operating table, LCD displays, lighting equipment, imaging systems, surgical instruments, etc.) that may cause interference.
  • field distortions are notoriously difficult to detect.
  • the use of multiple EM sensors enables the system to detect field distortions accurately, and/or to warn a user that the current position measurements may not be accurate.
  • relative measurement of sensor positions may be used to detect field distortions.
  • the relative distance between the two sensors is known and should remain constant. Thus, any change in this distance could indicate the presence of a field distortion.
  • specific objects can be manually registered by a surgeon with the system preoperatively or intraoperatively. For example, by interacting with a user interface, a surgeon may identify the starting location for a tool or a bone structure. By tracking fiducial marks associated with that tool or bone structure, or by using other conventional image tracking modalities, a processor may track that tool or bone as it moves through the environment in a three-dimensional model.
  • certain markers such as fiducial marks that identify individuals, important tools, or bones in the theater may include passive or active identifiers that can be picked up by a camera or camera array associated with the tracking system.
  • an IR LED can flash a pattern that conveys a unique identifier to the source of that pattern, providing a dynamic identification mark.
  • one or two dimensional optical codes can be affixed to objects in the theater to provide passive identification that can occur based on image analysis. If these codes are placed asymmetrically on an object, they can also be used to determine an orientation of an object by comparing the location of the identifier with the extents of an object in an image.
  • a QR code may be placed in a comer of a tool tray, allowing the orientation and identity of that tray to be tracked.
  • Other tracking modalities are explained throughout.
  • augmented reality headsets can be worn by surgeons and other staff to provide additional camera angles and tracking capabilities.
  • certain features of objects can be tracked by registering physical properties of the object and associating them with objects that can be tracked, such as fiducial marks fixed to a tool or bone.
  • objects such as fiducial marks fixed to a tool or bone.
  • a surgeon may perform a manual registration process whereby a tracked tool and a tracked bone can be manipulated relative to one another.
  • a three- dimensional surface can be mapped for that bone that is associated with a position and orientation relative to the frame of reference of that fiducial mark.
  • a model of that surface can be tracked with an environment through extrapolation.
  • the registration process that registers the CASS 100 to the relevant anatomy of the patient can also involve the use of anatomical landmarks, such as landmarks on a bone or cartilage.
  • the CASS 100 can include a 3D model of the relevant bone or joint and the surgeon can intraoperatively collect data regarding the location of bony landmarks on the patient’s actual bone using a point probe 114 that is connected to the CASS.
  • Bony landmarks can include, for example, the medial malleolus and lateral malleolus, the ends of the proximal femur and distal tibia, and the center of the hip joint.
  • the CASS 100 can compare and register the location data of bony landmarks collected by the surgeon with the point probe 114 with the location data of the same landmarks in the 3D model.
  • the CASS 100 can construct a 3D model of the bone or joint without pre-operative image data by using location data of bony landmarks and the bone surface that are collected by the surgeon using a CASS point probe 114 or other means.
  • the registration process can also include determining various axes of a joint. For example, for a TKA the surgeon can use the CASS 100 to determine the anatomical and mechanical axes of the femur and tibia.
  • the surgeon and the CASS 100 can identify the center of the hip joint by moving the patient’s leg in a spiral direction (i.e., circumduction) so the CASS can determine where the center of the hip joint is located.
  • a Tissue Navigation System 120 (not shown in FIG. 1) provides the surgeon with intraoperative, real-time visualization for the patient’s bone, cartilage, muscle, nervous, and/or vascular tissues surrounding the surgical area.
  • Examples of systems that may be employed for tissue navigation include fluorescent imaging systems and ultrasound systems.
  • the Display 125 provides graphical user interfaces (GUIs) that display images collected by the Tissue Navigation System 120 as well other information relevant to the surgery.
  • GUIs graphical user interfaces
  • the Display 125 overlays image information collected from various modalities (e.g., CT, MRI, X-ray, fluorescent, ultrasound, etc.) collected pre-operatively or intra-operatively to give the surgeon various views of the patient’s anatomy as well as real-time conditions.
  • the Display 125 may include, for example, one or more computer monitors.
  • one or more members of the surgical staff may wear an Augmented Reality (AR) Head Mounted Device (HMD).
  • AR Augmented Reality
  • FIG. 1 the Surgeon 111 is wearing an AR HMD 155 that may, for example, overlay pre-operative image data on the patient or provide surgical planning suggestions.
  • AR HMD 155 may, for example, overlay pre-operative image data on the patient or provide surgical planning suggestions.
  • Surgical Computer 150 provides control instructions to various components of the CASS 100, collects data from those components, and provides general processing for various data needed during surgery.
  • the Surgical Computer 150 is a general purpose computer.
  • the Surgical Computer 150 may be a parallel computing platform that uses multiple central processing units (CPUs) or graphics processing units (GPU) to perform processing.
  • the Surgical Computer 150 is connected to a remote server over one or more computer networks (e.g., the Internet).
  • the remote server can be used, for example, for storage of data or execution of computationally intensive processing tasks.
  • Surgical Computer 150 can connect to the other components of the CASS 100.
  • the computers can connect to the Surgical Computer 150 using a mix of technologies.
  • the End Effector 105B may connect to the Surgical Computer 150 over a wired (i.e., serial) connection.
  • the Tracking System 115, Tissue Navigation System 120, and Display 125 can similarly be connected to the Surgical Computer 150 using wired connections.
  • the Tracking System 115, Tissue Navigation System 120, and Display 125 may connect to the Surgical Computer 150 using wireless technologies such as, without limitation, Wi-Fi, Bluetooth, Near Field Communication (NFC), or ZigBee.
  • the CASS 100 includes a robotic arm 105 A that serves as an interface to stabilize and hold a variety of instruments used during the surgical procedure.
  • these instruments may include, without limitation, retractors, a sagittal or reciprocating saw, the reamer handle, the cup impactor, the broach handle, and the stem inserter.
  • the robotic arm 105 A may have multiple degrees of freedom (like a Spider device) and have the ability to be locked in place (e.g., by a press of a button, voice activation, a surgeon removing a hand from the robotic arm, or other method).
  • movement of the robotic arm 105 A may be effectuated by use of a control panel built into the robotic arm system.
  • a display screen may include one or more input sources, such as physical buttons or a user interface having one or more icons, that direct movement of the robotic arm 105 A.
  • the surgeon or other healthcare professional may engage with the one or more input sources to position the robotic arm 105 A when performing a surgical procedure.
  • a tool or an end effector 105B attached or integrated into a robotic arm 105A may include, without limitation, a burring device, a scalpel, a cutting device, a retractor, a joint tensioning device, or the like.
  • the end effector may be positioned at the end of the robotic arm 105A such that any motor control operations are performed within the robotic arm system.
  • the tool may be secured at a distal end of the robotic arm 105 A, but motor control operation may reside within the tool itself.
  • the robotic arm 105 A may be motorized internally to both stabilize the robotic arm, thereby preventing it from falling and hitting the patient, surgical table, surgical staff, etc., and to allow the surgeon to move the robotic arm without having to fully support its weight. While the surgeon is moving the robotic arm 105 A, the robotic arm may provide some resistance to prevent the robotic arm from moving too fast or having too many degrees of freedom active at once. The position and the lock status of the robotic arm 105 A may be tracked, for example, by a controller or the Surgical Computer 150.
  • the robotic arm 105A can be moved by hand (e.g., by the surgeon) or with internal motors into its ideal position and orientation for the task being performed.
  • the robotic arm 105 A may be enabled to operate in a “free” mode that allows the surgeon to position the arm into a desired position without being restricted. While in the free mode, the position and orientation of the robotic arm 105 A may still be tracked as described above. In one embodiment, certain degrees of freedom can be selectively released upon input from user (e.g., surgeon) during specified portions of the surgical plan tracked by the Surgical Computer 150.
  • a robotic arm 105 A or end effector 105B can include a trigger or other means to control the power of a saw or drill. Engagement of the trigger or other means by the surgeon can cause the robotic arm 105 A or end effector 105B to transition from a motorized alignment mode to a mode where the saw or drill is engaged and powered on.
  • the CASS 100 can include a foot pedal (not shown) that causes the system to perform certain functions when activated. For example, the surgeon can activate the foot pedal to instruct the CASS 100 to place the robotic arm 105 A or end effector 105B in an automatic mode that brings the robotic arm or end effector into the proper position with respect to the patient’s anatomy in order to perform the necessary resections.
  • the CASS 100 can also place the robotic arm 105A or end effector 105B in a collaborative mode that allows the surgeon to manually manipulate and position the robotic arm or end effector into a particular location.
  • the collaborative mode can be configured to allow the surgeon to move the robotic arm 105 A or end effector 105B medially or laterally, while restricting movement in other directions.
  • the robotic arm 105 A or end effector 105B can include a cutting device (saw, drill, and burr) or a cutting guide or jig 105D that will guide a cutting device.
  • movement of the robotic arm 105 A or robotically controlled end effector 105B can be controlled entirely by the CASS 100 without any, or with only minimal, assistance or input from a surgeon or other medical professional.
  • the movement of the robotic arm 105A or robotically controlled end effector 105B can be controlled remotely by a surgeon or other medical professional using a control mechanism separate from the robotic arm or robotically controlled end effector device, for example using a joystick or interactive monitor or display control device.
  • a robotic arm 105 A may be used for holding the retractor.
  • the robotic arm 105 A may be moved into the desired position by the surgeon. At that point, the robotic arm 105 A may lock into place.
  • the robotic arm 105A is provided with data regarding the patient’s position, such that if the patient moves, the robotic arm can adjust the retractor position accordingly.
  • multiple robotic arms may be used, thereby allowing multiple retractors to be held or for more than one activity to be performed simultaneously (e.g., retractor holding & reaming).
  • the robotic arm 105A may also be used to help stabilize the surgeon’s hand while making a femoral neck cut.
  • control of the robotic arm 105 A may impose certain restrictions to prevent soft tissue damage from occurring.
  • the Surgical Computer 150 tracks the position of the robotic arm 105A as it operates. If the tracked location approaches an area where tissue damage is predicted, a command may be sent to the robotic arm 105 A causing it to stop.
  • the robotic arm 105A is automatically controlled by the Surgical Computer 150, the Surgical Computer may ensure that the robotic arm is not provided with any instructions that cause it to enter areas where soft tissue damage is likely to occur.
  • the Surgical Computer 150 may impose certain restrictions on the surgeon to prevent the surgeon from reaming too far into the medial wall of the acetabulum or reaming at an incorrect angle or orientation.
  • the robotic arm 105 A may be used to hold a cup impactor at a desired angle or orientation during cup impaction. When the final position has been achieved, the robotic arm 105 A may prevent any further seating to prevent damage to the pelvis.
  • the surgeon may use the robotic arm 105 A to position the broach handle at the desired position and allow the surgeon to impact the broach into the femoral canal at the desired orientation.
  • the robotic arm 105 A may restrict the handle to prevent further advancement of the broach.
  • the robotic arm 105 A may also be used for resurfacing applications.
  • the robotic arm 105 A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.).
  • implant components e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.
  • the robotic arm 105A may stabilize the surgeon’s handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.
  • the robotic arm 105 A may be a passive arm.
  • the robotic arm 105 A may be a CIRQ robot arm available from Brainlab AG.
  • CIRQ is a registered trademark of Brainlab AG, Olof-Palme-Str. 9 81829, Miinchen, FED REP of GERMANY.
  • the robotic arm 105A is an intelligent holding arm as disclosed in U. S. Patent No. 10,426,571 to Krinninger et al., U.S. Patent No. 10,993,777 to Nowatschin et al., U.S. Patent Application No. 15/561,048 to Nowatschin et al., and U.S. Patent No. 10,342,636 to Nowatschin et al., the entire contents of each of which is herein incorporated by reference.
  • the episode of care can include three phases: pre-operative, intra-operative, and post-operative. During each phase, data is collected or generated that can be used to analyze the episode of care in order to understand various aspects of the procedure and identify patterns that may be used, for example, in training models to make decisions with minimal human intervention.
  • the data collected over the episode of care may be stored at the Surgical Computer 150 or the Surgical Data Server 180 as a complete dataset.
  • a dataset exists that comprises all of the data collectively pre- operatively about the patient, all of the data collected or stored by the CASS 100 intra-operatively, and any postoperative data provided by the patient or by a healthcare professional monitoring the patient.
  • the data collected during the episode of care may be used to enhance performance of the surgical procedure or to provide a holistic understanding of the surgical procedure and the patient outcomes.
  • the data collected over the episode of care may be used to generate a surgical plan.
  • a high-level, pre-operative plan is refined intra-operatively as data is collected during surgery.
  • the surgical plan can be viewed as dynamically changing in realtime or near real-time as new data is collected by the components of the CASS 100.
  • pre-operative images or other input data may be used to develop a robust plan preoperatively that is simply executed during surgery.
  • the data collected by the CASS 100 during surgery may be used to make recommendations that ensure that the surgeon stays within the pre-operative surgical plan. For example, if the surgeon is unsure how to achieve a certain prescribed cut or implant alignment, the Surgical Computer 150 can be queried for a recommendation.
  • the pre-operative and intraoperative planning approaches can be combined such that a robust pre-operative plan can be dynamically modified, as necessary or desired, during the surgical procedure.
  • a biomechanics-based model of patient anatomy contributes simulation data to be considered by the CASS 100 in developing preoperative, intraoperative, and post- operative/rehabilitation procedures to optimize implant performance outcomes for the patient.
  • implants can be designed using episode of care data.
  • Example data-driven techniques for designing, sizing, and fitting implants are described in U.S. Patent No. 10,064,686 filed August 15, 2011 and entitled “Systems and Methods for Optimizing Parameters for Orthopaedic Procedures”; U.S. Patent No. 9,371,286 filed July 20, 2012 and entitled “Systems and Methods for Optimizing Fit of an Implant to Anatomy”; and U.S. Patent No. 8,078,440 filed September 19, 2008 and entitled “Operatively Tuning Implants for Increased Performance,” the entire contents of each of which are hereby incorporated by reference into this patent application.
  • the data can be used for educational, training, or research purposes.
  • other doctors or students can remotely view surgeries in interfaces that allow them to selectively view data as it is collected from the various components of the CASS 100.
  • similar interfaces may be used to “playback” a surgery for training or other educational purposes, or to identify the source of any issues or complications with the procedure.
  • Data acquired during the pre-operative phase generally includes all information collected or generated prior to the surgery.
  • information about the patient may be acquired from a patient intake form or electronic medical record (EMR).
  • patient information that may be collected include, without limitation, patient demographics, diagnoses, medical histories, progress notes, vital signs, medical history information, allergies, and lab results.
  • EMR electronic medical record
  • patient information that may be collected include, without limitation, patient demographics, diagnoses, medical histories, progress notes, vital signs, medical history information, allergies, and lab results.
  • the pre-operative data may also include images related to the anatomical area of interest. These images may be captured, for example, using Magnetic Resonance Imaging (MRI), Computed Tomography (CT), X-ray, ultrasound, or any other modality known in the art.
  • the pre-operative data may also comprise quality of life data captured from the patient.
  • pre-surgery patients use a mobile application (“app”) to answer questionnaires regarding their current quality of life.
  • preoperative data used by the CASS 100 includes demographic, anthropometric, cultural, or other specific traits about a patient that can coincide with activity levels and specific patient activities to customize the surgical plan to the patient. For example, certain cultures or demographics may be more likely to use a toilet that requires squatting on a daily basis.
  • FIGS. 5A and 5B provide examples of data that may be acquired during the intraoperative phase of an episode of care. These examples are based on the various components of the CASS 100 described above with reference to FIG. 1; however, it should be understood that other types of data may be used based on the types of equipment used during surgery and their use.
  • FIG. 5A shows examples of some of the control instructions that the Surgical Computer 150 provides to other components of the CASS 100, according to some embodiments. Note that the example of FIG. 5 A assumes that the components of the Effector Platform 105 are each controlled directly by the Surgical Computer 150. In embodiments where a component is manually controlled by the Surgeon 111, instructions may be provided on the Display 125 or AR HMD 155 instructing the Surgeon 111 how to move the component. [0106] The various components included in the Effector Platform 105 are controlled by the Surgical Computer 150 providing position commands that instruct the component where to move within a coordinate system.
  • the Surgical Computer 150 provides the Effector Platform 105 with instructions defining how to react when a component of the Effector Platform 105 deviates from a surgical plan. These commands are referenced in FIG. 5A as “haptic” commands.
  • the End Effector 105B may provide a force to resist movement outside of an area where resection is planned.
  • Other commands that may be used by the Effector Platform 105 include vibration and audio cues.
  • the end effectors 105B of the robotic arm 105 A are operatively coupled with cutting guide 105D.
  • the robotic arm 105 A can move the end effectors 105B and the cutting guide 105D into position to match the location of the femoral or tibial cut to be performed in accordance with the surgical plan. This can reduce the likelihood of error, allowing the vision system and a processor utilizing that vision system to implement the surgical plan to place a cutting guide 105D at the precise location and orientation relative to the tibia or femur to align a cutting slot of the cutting guide with the cut to be performed according to the surgical plan.
  • the cutting guide 105D may include one or more pin holes that are used by a surgeon to drill and screw or pin the cutting guide into place before performing a resection of the patient tissue using the cutting guide. This can free the robotic arm 105 A or ensure that the cutting guide 105D is fully affixed without moving relative to the bone to be resected. For example, this procedure can be used to make the first distal cut of the femur during a total knee arthroplasty.
  • cutting guide 105D can be fixed to the femoral head or the acetabulum for the respective hip arthroplasty resection. It should be understood that any arthroplasty that utilizes precise cuts can use the robotic arm 105A and/or cutting guide 105D in this manner.
  • the Resection Equipment 110 is provided with a variety of commands to perform bone or tissue operations. As with the Effector Platform 105, position information may be provided to the Resection Equipment 110 to specify where it should be located when performing resection. Other commands provided to the Resection Equipment 110 may be dependent on the type of resection equipment. For example, for a mechanical or ultrasonic resection tool, the commands may specify the speed and frequency of the tool. For Radiofrequency Ablation (RFA) and other laser ablation tools, the commands may specify intensity and pulse duration.
  • RFA Radiofrequency Ablation
  • the commands may specify intensity and pulse duration.
  • Some components of the CASS 100 do not need to be directly controlled by the Surgical Computer 150; rather, the Surgical Computer 150 only needs to activate the component, which then executes software locally specifying the manner in which to collect data and provide it to the Surgical Computer 150.
  • the Tracking System 115 and the Tissue Navigation System 120.
  • the Surgical Computer 150 provides the Display 125 with any visualization that is needed by the Surgeon 111 during surgery.
  • the Surgical Computer 150 may provide instructions for displaying images, GUIs, etc. using techniques known in the art.
  • the display 125 can include various aspects of the workflow of a surgical plan. During the registration process, for example, the display 125 can show a preoperatively constructed 3D bone model and depict the locations of the point probe 114 as the surgeon uses the probe to collect locations of anatomical landmarks on the patient.
  • the display 125 can include information about the surgical target area. For example, in connection with a TKA, the display 125 can depict the mechanical and anatomical axes of the femur and tibia.
  • the display 125 can depict varus and valgus angles for the knee joint based on a surgical plan, and the CASS 100 can depict how such angles will be affected if contemplated revisions to the surgical plan are made. Accordingly, the display 125 is an interactive interface that can dynamically update and display how changes to the surgical plan would impact the procedure and the final position and orientation of implants installed on bone.
  • the display 125 can depict the planned or recommended bone cuts before any cuts are performed.
  • the surgeon 111 can manipulate the image display to provide different anatomical perspectives of the target area and can have the option to alter or revise the planned bone cuts based on intraoperative evaluation of the patient.
  • the display 125 can depict how the chosen implants would be installed on the bone if the planned bone cuts are performed. If the surgeon 111 choses to change the previously planned bone cuts, the display 125 can depict how the revised bone cuts would change the position and orientation of the implant when installed on the bone.
  • the display 125 can provide the surgeon 111 with a variety of data and information about the patient, the planned surgical intervention, and the implants.
  • the display 125 can also include information about the anatomy of the surgical target region including the location of landmarks, the current state of the anatomy (e.g., whether any resections have been made, the depth and angles of planned and executed bone cuts), and future states of the anatomy as the surgical plan progresses.
  • the display 125 can also provide or depict additional information about the surgical target region.
  • the display 125 can provide information about the gaps (e.g., gap balancing) between the femur and tibia and how such gaps will change if the planned surgical plan is carried out.
  • the display 125 can provide additional relevant information about the knee joint such as data about the joint’s tension (e.g., ligament laxity) and information concerning rotation and alignment of the joint.
  • the display 125 can depict how the planned implants’ locations and positions will affect the patient as the knee joint is flexed.
  • the display 125 can depict how the use of different implants or the use of different sizes of the same implant will affect the surgical plan and preview how such implants will be positioned on the bone.
  • the CASS 100 can provide such information for each of the planned bone resections in a TKA or THA.
  • the CASS 100 can provide robotic control for one or more of the planned bone resections.
  • the CASS 100 can provide robotic control only for the initial distal femur cut, and the surgeon 111 can manually perform other resections (anterior, posterior and chamfer cuts) using conventional means, such as a 4-in-l cutting guide or jig 105D.
  • the display 125 can employ different colors to inform the surgeon of the status of the surgical plan. For example, un-resected bone can be displayed in a first color, resected bone can be displayed in a second color, and planned resections can be displayed in a third color. Implants can be superimposed onto the bone in the display 125, and implant colors can change or correspond to different types or sizes of implants.
  • the information and options depicted on the display 125 can vary depending on the type of surgical procedure being performed. Further, the surgeon 111 can request or select a particular surgical workflow display that matches or is consistent with his or her surgical plan preferences. For example, for a surgeon 111 who typically performs the tibial cuts before the femoral cuts in a TKA, the display 125 and associated workflow can be adapted to take this preference into account. The surgeon 111 can also preselect that certain steps be included or deleted from the standard surgical workflow display.
  • the surgical workflow display can be organized into modules, and the surgeon can select which modules to display and the order in which the modules are provided based on the surgeon’s preferences or the circumstances of a particular surgery.
  • Modules directed to ligament and gap balancing can include pre- and postresection ligament/gap balancing, and the surgeon 111 can select which modules to include in their default surgical plan workflow depending on whether they perform such ligament and gap balancing before or after (or both) bone resections are performed.
  • the Surgical Computer 150 may provide images, text, etc. using the data format supported by the equipment.
  • the Display 125 is a holography device such as the Microsoft HoloLensTM or Magic Leap OneTM
  • the Surgical Computer 150 may use the HoloLens Application Program Interface (API) to send commands specifying the position and content of holograms displayed in the field of view of the Surgeon 111.
  • API HoloLens Application Program Interface
  • one or more surgical planning models may be incorporated into the CASS 100 and used in the development of the surgical plans provided to the surgeon 111.
  • the term “surgical planning model” refers to software that simulates the biomechanics performance of anatomy under various scenarios to determine the optimal way to perform cutting and other surgical activities. For example, for knee replacement surgeries, the surgical planning model can measure parameters for functional activities, such as deep knee bends, gait, etc., and select cut locations on the knee to optimize implant placement.
  • One example of a surgical planning model is the LIFEMODTM simulation software from SMITH AND NEPHEW, INC.
  • the Surgical Computer 150 includes computing architecture that allows full execution of the surgical planning model during surgery (e.g., a GPU-based parallel processing environment).
  • the Surgical Computer 150 may be connected over a network to a remote computer that allows such execution, such as a Surgical Data Server 180 (see FIG. 5C).
  • a set of transfer functions are derived that simplify the mathematical operations captured by the model into one or more predictor equations. Then, rather than execute the full simulation during surgery, the predictor equations are used. Further details on the use of transfer functions are described in U.S. Patent Application No. 17/269,091, filed February 17, 2021 and entitled “Patient Specific Surgical Method and System,” the entirety of which is incorporated herein by reference.
  • FIG. 5B shows examples of some of the types of data that can be provided to the Surgical Computer 150 from the various components of the CASS 100.
  • the components may stream data to the Surgical Computer 150 in real-time or near real-time during surgery.
  • the components may queue data and send it to the Surgical Computer 150 at set intervals (e.g., every second). Data may be communicated using any format known in the art.
  • the components all transmit data to the Surgical Computer 150 in a common format.
  • each component may use a different data format, and the Surgical Computer 150 is configured with one or more software applications that enable translation of the data.
  • the Surgical Computer 150 may serve as the central point where CASS data is collected. The exact content of the data will vary depending on the source. For example, each component of the Effector Platform 105 provides a measured position to the Surgical Computer 150. Thus, by comparing the measured position to a position originally specified by the Surgical Computer 150 (see FIG. 5B), the Surgical Computer can identify deviations that take place during surgery.
  • the Resection Equipment 110 can send various types of data to the Surgical Computer 150 depending on the type of equipment used.
  • Example data types that may be sent include the measured torque, audio signatures, and measured displacement values.
  • the Tracking Technology 115 can provide different types of data depending on the tracking methodology employed.
  • Example tracking data types include position values for tracked items (e.g., anatomy, tools, etc.), ultrasound images, and surface or landmark collection points or axes.
  • the Tissue Navigation System 120 provides the Surgical Computer 150 with anatomic locations, shapes, etc. as the system operates.
  • the Display 125 generally is used for outputting data for presentation to the user, it may also provide data to the Surgical Computer 150.
  • the Surgeon 111 may interact with a GUI to provide inputs which are sent to the Surgical Computer 150 for further processing.
  • the measured position and displacement of the HMD may be sent to the Surgical Computer 150 so that it can update the presented view as needed.
  • the data can take the form of, for example, self-reported information reported by patients via questionnaires.
  • functional status can be measured with an Oxford Knee Score questionnaire
  • post-operative quality of life can be measured with a EQ5D-5L questionnaire.
  • Other examples in the context of a hip replacement surgery may include the Oxford Hip Score, Harris Hip Score, and WOMAC (Western Ontario and McMaster Universities Osteoarthritis index).
  • Such questionnaires can be administered, for example, by a healthcare professional directly in a clinical setting or using a mobile app that allows the patient to respond to questions directly.
  • the patient may be outfitted with one or more wearable devices that collect data relevant to the surgery. For example, following a knee surgery, the patient may be outfitted with a knee brace that includes sensors that monitor knee positioning, flexibility, etc. This information can be collected and transferred to the patient’s mobile device for review by the surgeon to evaluate the outcome of the surgery and address any issues.
  • one or more cameras can capture and record the motion of a patient’s body segments during specified activities postoperatively. This motion capture can be compared to a biomechanics model to better understand the functionality of the patient’s joints and better predict progress in recovery and identify any possible revisions that may be needed.
  • the post-operative stage of the episode of care can continue over the entire life of apatient.
  • the Surgical Computer 150 or other components comprising the CASS 100 can continue to receive and collect data relevant to a surgical procedure after the procedure has been performed.
  • This data may include, for example, images, answers to questions, “normal” patient data (e.g., blood type, blood pressure, conditions, medications, etc.), biometric data (e.g., gait, etc.), and objective and subjective data about specific issues (e.g., knee or hip joint pain).
  • This data may be explicitly provided to the Surgical Computer 150 or other CASS component by the patient or the patient’s physician(s).
  • the Surgical Computer 150 or other CASS component can monitor the patient’s EMR and retrieve relevant information as it becomes available.
  • This longitudinal view of the patient’s recovery allows the Surgical Computer 150 or other CASS component to provide a more objective analysis of the patient’s outcome to measure and track success or lack of success for a given procedure. For example, a condition experienced by a patient long after the surgical procedure can be linked back to the surgery through a regression analysis of various data items collected during the episode of care. This analysis can be further enhanced by performing the analysis on groups of patients that had similar procedures and/or have similar anatomies.
  • data is collected at a central location to provide for easier analysis and use.
  • Data can be manually collected from various CASS components in some instances.
  • a portable storage device e.g., USB stick
  • the data can then be transferred, for example, via a desktop computer to the centralized storage.
  • the Surgical Computer 150 is connected directly to the centralized storage via a Network 175 as shown in FIG. 5C.
  • FIG. 5C illustrates a “cloud-based” implementation in which the Surgical Computer 150 is connected to a Surgical Data Server 180 via a Network 175.
  • This Network 175 may be, for example, a private intranet or the Internet.
  • other sources can transfer relevant data to the Surgical Data Server 180.
  • the example of FIG. 5C shows 3 additional data sources: the Patient 160, Healthcare Professional(s) 165, and an EMR Database 170.
  • the Patient 160 can send pre-operative and post-operative data to the Surgical Data Server 180, for example, using a mobile app.
  • the Healthcare Professional(s) 165 includes the surgeon and his or her staff as well as any other professionals working with Patient 160 (e.g., a personal physician, a rehabilitation specialist, etc.). It should also be noted that the EMR Database 170 may be used for both pre-operative and post-operative data. For example, assuming that the Patient 160 has given adequate permissions, the Surgical Data Server 180 may collect the EMR of the Patient pre-surgery. Then, the Surgical Data Server 180 may continue to monitor the EMR for any updates postsurgery. [0125] At the Surgical Data Server 180, an Episode of Care Database 185 is used to store the various data collected over a patient’s episode of care. The Episode of Care Database 185 may be implemented using any technique known in the art.
  • a SQL-based database may be used where all of the various data items are structured in a manner that allows them to be readily incorporated in two SQL’s collection of rows and columns.
  • a No-SQL database may be employed to allow for unstructured data, while providing the ability to rapidly process and respond to queries.
  • the term “No-SQL” is used to define a class of data stores that are non-relational in their design.
  • Various types of No-SQL databases may generally be grouped according to their underlying data model.
  • These groupings may include databases that use column-based data models (e.g., Cassandra), document-based data models (e.g., MongoDB), key-value based data models (e.g., Redis), and/or graph-based data models (e.g., Allego).
  • column-based data models e.g., Cassandra
  • document-based data models e.g., MongoDB
  • key-value based data models e.g., Redis
  • graph-based data models e.g., Allego
  • Data can be transferred between the various data sources and the Surgical Data Server 180 using any data format and transfer technique known in the art. It should be noted that the architecture shown in FIG. 5C allows transmission from the data source to the Surgical Data Server 180, as well as retrieval of data from the Surgical Data Server 180 by the data sources. For example, as explained in detail below, in some embodiments, the Surgical Computer 150 may use data from past surgeries, machine learning models, etc. to help guide the surgical procedure.
  • the Surgical Computer 150 or the Surgical Data Server 180 may execute a de-identification process to ensure that data stored in the Episode of Care Database 185 meets Health Insurance Portability and Accountability Act (HIPAA) standards or other requirements mandated by law.
  • HIPAA Health Insurance Portability and Accountability Act
  • HIPAA provides a list of certain identifiers that must be removed from data during de-identification.
  • the aforementioned de-identification process can scan for these identifiers in data that is transferred to the Episode of Care Database 185 for storage.
  • the Surgical Computer 150 executes the de- identification process just prior to initiating transfer of a particular data item or set of data items to the Surgical Data Server 180.
  • a unique identifier is assigned to data from a particular episode of care to allow for re-identification of the data if necessary.
  • FIGS. 5A - 5C discuss data collection in the context of a single episode of care, it should be understood that the general concept can be extended to data collection from multiple episodes of care.
  • surgical data may be collected over an entire episode of care each time a surgery is performed with the CASS 100 and stored at the Surgical Computer 150 or at the Surgical Data Server 180.
  • a robust database of episode of care data allows the generation of optimized values, measurements, distances, or other parameters and other recommendations related to the surgical procedure.
  • the various datasets are indexed in the database or other storage medium in a manner that allows for rapid retrieval of relevant information during the surgical procedure.
  • a patient-centric set of indices may be used so that data pertaining to a particular patient or a set of patients similar to a particular patient can be readily extracted. This concept can be similarly applied to surgeons, implant characteristics, CASS component versions, etc.
  • the CASS 100 is designed to operate as a self-contained or “closed” digital ecosystem.
  • Each component of the CASS 100 is specifically designed to be used in the closed ecosystem, and data is generally not accessible to devices outside of the digital ecosystem.
  • each component includes software or firmware that implements proprietary protocols for activities such as communication, storage, security, etc.
  • the concept of a closed digital ecosystem may be desirable for a company that wants to control all components of the CASS 100 to ensure that certain compatibility, security, and reliability standards are met.
  • the CASS 100 can be designed such that a new component cannot be used with the CASS unless it is certified by the company.
  • the CASS 100 is designed to operate as an “open” digital ecosystem.
  • components may be produced by a variety of different companies according to standards for activities, such as communication, storage, and security. Thus, by using these standards, any company can freely build an independent, compliant component of the CASS platform. Data may be transferred between components using publicly available application programming interfaces (APIs) and open, shareable data formats.
  • APIs application programming interfaces
  • optimization can refer to selecting optimal parameter(s) based on data from the entire episode of care, including any pre-operative data, the state of CASS data at a given point in time, and post-operative goals. Moreover, optimization may be performed using historical data, such as data generated during past surgeries involving, for example, the same surgeon, past patients with physical characteristics similar to the current patient, or the like.
  • the optimized parameters may depend on the portion of the patient’s anatomy to be operated on.
  • the surgical parameters may include positioning information for the femoral and tibial component including, without limitation, rotational alignment (e.g., varus/valgus rotation, external rotation, flexion rotation for the femoral component, posterior slope of the tibial component), resection depths (e.g., varus knee, valgus knee), and implant type, size and position.
  • the positioning information may further include surgical parameters for the combined implant, such as overall limb alignment, combined tibiofemoral hyperextension, and combined tibiofemoral resection. Additional examples of parameters that could be optimized for a given TKA femoral implant by the CASS 100 include the following:
  • the surgical parameters may comprise femoral neck resection location and angle, cup inclination angle, cup anteversion angle, cup depth, femoral stem design, femoral stem size, fit of the femoral stem within the canal, femoral offset, leg length, and femoral version of the implant.
  • Shoulder parameters may include, without limitation, humeral resection depth/angle, humeral stem version, humeral offset, glenoid version and inclination, as well as reverse shoulder parameters such as humeral resection depth/angle, humeral stem version, Glenoid tilt/version, glenosphere orientation, glenosphere offset and offset direction.
  • This existing knowledge base and execution is limited with respect to the outcomes optimization offered to patients needing care. For example, limits exist with respect to accurately diagnosing a patient to the proper, least-invasive prescribed care; aligning dynamic patient, healthcare economic, and surgeon preferences with patient-desired outcomes; executing a surgical plan resulting in proper bone alignment and balance, etc.; and receiving data from disconnected sources having different biases that are difficult to reconcile into a holistic patient framework. Accordingly, a data-driven tool that more accurately models anatomical response and guides the surgical plan can improve the existing approach.
  • the Operative Patient Care System 620 is designed to utilize patient specific data, surgeon data, healthcare facility data, and historical outcome data to develop an algorithm that suggests or recommends an optimal overall treatment plan for the patient’s entire episode of care (preoperative, operative, and postoperative) based on a desired clinical outcome. For example, in one embodiment, the Operative Patient Care System 620 tracks adherence to the suggested or recommended plan, and adapts the plan based on patient/care provider performance. Once the surgical treatment plan is complete, collected data is logged by the Operative Patient Care System 620 in a historical database. This database is accessible for future patients and the development of future treatment plans.
  • simulation tools e.g., LIFEMOD®
  • LIFEMOD® can be used to simulate outcomes, alignment, kinematics, etc. based on a preliminary or proposed surgical plan, and reconfigure the preliminary or proposed plan to achieve desired or optimal results according to a patient’s profile or a surgeon’s preferences.
  • the Operative Patient Care System 620 ensures that each patient is receiving personalized surgical and rehabilitative care, thereby improving the chance of successful clinical outcomes and lessening the economic burden on the facility associated with near-term revision.
  • the Operative Patient Care System 620 employs a data collecting and management method to provide a detailed surgical case plan with distinct steps that are monitored and/or executed using a CASS 100.
  • the performance of the user(s) is calculated at the completion of each step and can be used to suggest changes to the subsequent steps of the case plan.
  • Case plan generation relies on a series of input data that is stored on a local or cloud-storage database. Input data can be related to both the current patient undergoing treatment and historical data from patients who have received similar treatment(s).
  • a Patient 605 provides inputs such as Current Patient Data 610 and Historical Patient Data 615 to the Operative Patient Care System 620.
  • Various methods generally known in the art may be used to gather such inputs from the Patient 605.
  • the Patient 605 fills out a paper or digital survey that is parsed by the Operative Patient Care System 620 to extract patient data.
  • the Operative Patient Care System 620 may extract patient data from existing information sources, such as electronic medical records (EMRs), health history files, and payer/provider historical files.
  • EMRs electronic medical records
  • the Operative Patient Care System 620 may provide an application program interface (API) that allows the external data source to push data to the Operative Patient Care System.
  • API application program interface
  • the Patient 605 may have a mobile phone, wearable device, or other mobile device that collects data (e.g., heart rate, pain or discomfort levels, exercise or activity levels, or patient-submitted responses to the patient’s adherence with any number of preoperative plan criteria or conditions) and provides that data to the Operative Patient Care System 620.
  • the Patient 605 may have a digital application on his or her mobile or wearable device that enables data to be collected and transmitted to the Operative Patient Care System 620.
  • Current Patient Data 610 can include, but is not limited to, activity level, preexisting conditions, comorbidities, prehab performance, health and fitness level, pre-operative expectation level (relating to hospital, surgery, and recovery), a Metropolitan Statistical Area (MSA) driven score, genetic background, prior injuries (sports, trauma, etc.), previous joint arthroplasty, previous trauma procedures, previous sports medicine procedures, treatment of the contralateral joint or limb, gait or biomechanical information (back and ankle issues), levels of pain or discomfort, care infrastructure information (payer coverage type, home health care infrastructure level, etc.), and an indication of the expected ideal outcome of the procedure.
  • MSA Metropolitan Statistical Area
  • Historical Patient Data 615 can include, but is not limited to, activity level, preexisting conditions, comorbidities, prehab performance, health and fitness level, preoperative expectation level (relating to hospital, surgery, and recovery), a MSA driven score, genetic background, prior injuries (sports, trauma, etc.), previous joint arthroplasty, previous trauma procedures, previous sports medicine procedures, treatment of the contralateral joint or limb, gait or biomechanical information (back and ankle issues), levels or pain or discomfort, care infrastructure information (payer coverage type, home health care infrastructure level, etc.), expected ideal outcome of the procedure, actual outcome of the procedure (patient reported outcomes [PROs], survivorship of implants, pain levels, activity levels, etc.), sizes of implants used, position/orientation/alignment of implants used, soft-tissue balance achieved, etc.
  • Healthcare Professional(s) 630 conducting the procedure or treatment may provide various types of data 625 to the Operative Patient Care System 620.
  • This Healthcare Professional Data 625 may include, for example, a description of a known or preferred surgical technique (e.g., Cruciate Retaining (CR) vs Posterior Stabilized (PS), up- vs down-sizing, tourniquet vs toumiquet-less, femoral stem style, preferred approach for THA, etc.), the level of training of the Healthcare Professional(s) 630 (e.g., years in practice, fellowship trained, where they trained, whose techniques they emulate), previous success level including historical data (outcomes, patient satisfaction), and the expected ideal outcome with respect to range of motion, days of recovery, and survivorship of the device.
  • a known or preferred surgical technique e.g., Cruciate Retaining (CR) vs Posterior Stabilized (PS), up- vs down-sizing, tourniquet vs toumique
  • the Healthcare Professional Data 625 can be captured, for example, with paper or digital surveys provided to the Healthcare Professional 630, via inputs to a mobile application by the Healthcare Professional, or by extracting relevant data from EMRs.
  • the CASS 100 may provide data such as profile data (e.g., a Patient Specific Knee Instrument Profile) or historical logs describing use of the CASS during surgery.
  • Information pertaining to the facility where the procedure or treatment will be conducted may be included in the input data.
  • This data can include, without limitation, the following: Ambulatory Surgery Center (ASC) vs hospital, facility trauma level, Comprehensive Care for Joint Replacement Program (CJR) or bundle candidacy, a MSA driven score, community vs metro, academic vs non-academic, postoperative network access (Skilled Nursing Facility [SNF] only, Home Health, etc.), availability of medical professionals, implant availability, and availability of surgical equipment.
  • ASC Ambulatory Surgery Center
  • CJR Comprehensive Care for Joint Replacement Program
  • MSA driven score a MSA driven score
  • community vs metro community vs metro
  • academic vs non-academic academic vs non-academic
  • postoperative network access Skilled Nursing Facility [SNF] only, Home Health, etc.
  • These facility inputs can be captured by, for example and without limitation, Surveys (Paper/Digital), Surgery Scheduling Tools (e.g., apps, Websites, Electronic Medical Records [EMRs], etc.), Databases of Hospital Information (on the Internet), etc.
  • Input data relating to the associated healthcare economy including, but not limited to, the socioeconomic profile of the patient, the expected level of reimbursement the patient will receive, and if the treatment is patient specific may also be captured.
  • the Patient Data 610, 615 and Healthcare Professional Data 625 may be captured and stored in a cloud-based or online database (e.g., the Surgical Data Server 180 shown in FIG. 5C).
  • Information relevant to the procedure is supplied to a computing system via wireless data transfer or manually with the use of portable media storage.
  • the computing system is configured to generate a case plan for use with a CASS 100. Case plan generation will be described hereinafter. It is noted that the system has access to historical data from previous patients undergoing treatment, including implant size, placement, and orientation as generated by a computer-assisted, patient-specific knee instrument (PSKI) selection system, or automatically by the CASS 100 itself. To achieve this, case log data is uploaded to the historical database by a surgical sales rep or case engineer using an online portal. In some embodiments, data transfer to the online database is wireless and automated.
  • PSKI patient-specific knee instrument
  • Historical data sets from the online database are used as inputs to a machine learning model such as, for example, a recurrent neural network (RNN) or other form of artificial neural network.
  • a machine learning model such as, for example, a recurrent neural network (RNN) or other form of artificial neural network.
  • RNN recurrent neural network
  • an artificial neural network functions similar to a biologic neural network and is comprised of a series of nodes and connections.
  • the machine learning model is trained to predict one or more values based on the input data.
  • predictor equations may be optimized to determine the optimal size, position, and orientation of the implants to achieve the best outcome or satisfaction level.
  • the predictor equation and associated optimization can be used to generate the resection planes for use with a PSKI system.
  • the predictor equation computation and optimization are completed prior to surgery.
  • Patient anatomy is estimated using medical image data (x-ray, CT, MRI).
  • Global optimization of the predictor equation can provide an ideal size and position of the implant components.
  • Boolean intersection of the implant components and patient anatomy is defined as the resection volume.
  • PSKI can be produced to remove the optimized resection envelope. In this embodiment, the surgeon cannot alter the surgical plan intraoperatively.
  • the surgeon may choose to alter the surgical case plan at any time prior to or during the procedure. If the surgeon elects to deviate from the surgical case plan, the altered size, position, and/or orientation of the component(s) is locked, and the global optimization is refreshed based on the new size, position, and/or orientation of the component(s) (using the techniques previously described) to find the new ideal position of the other component(s) and the corresponding resections needed to be performed to achieve the newly optimized size, position and/or orientation of the component(s).
  • the femoral implant position is locked relative to the anatomy, and the new optimal position of the tibia will be calculated (via global optimization) considering the surgeon’s changes to the femoral implant size, position and/or orientation.
  • the surgical system used to implement the case plan is robotically assisted (e.g., as with NAVIO® or the MAKO Rio)
  • bone removal and bone morphology during the surgery can be monitored in real time. If the resections made during the procedure deviate from the surgical plan, the subsequent placement of additional components may be optimized by the processor taking into account the actual resections that have already been made.
  • FIG. 7A illustrates how the Operative Patient Care System 620 may be adapted for performing case plan matching services.
  • data is captured relating to the current patient 610 and is compared to all or portions of a historical database of patient data and associated outcomes 615.
  • the surgeon may elect to compare the plan for the current patient against a subset of the historical database.
  • Data in the historical database can be filtered to include, for example, only data sets with favorable outcomes, data sets corresponding to historical surgeries of patients with profiles that are the same or similar to the current patient profile, data sets corresponding to a particular surgeon, data sets corresponding to a particular aspect of the surgical plan (e.g., only surgeries where a particular ligament is retained), or any other criteria selected by the surgeon or medical professional.
  • the case plan from the previous patient can be accessed and adapted or adopted for use with the current patient.
  • the predictor equation may be used in conjunction with an intra-operative algorithm that identifies or determines the actions associated with the case plan. Based on the relevant and/or preselected information from the historical database, the intraoperative algorithm determines a series of recommended actions for the surgeon to perform. Each execution of the algorithm produces the next action in the case plan. If the surgeon performs the action, the results are evaluated. The results of the surgeon’s performing the action are used to refine and update inputs to the intra-operative algorithm for generating the next step in the case plan.
  • the system utilizes preoperative, intraoperative, or postoperative modules in a piecewise fashion, as opposed to the entire continuum of care.
  • caregivers can prescribe any permutation or combination of treatment modules including the use of a single module.
  • the various components of the CASS 100 generate detailed data records during surgery.
  • the CASS 100 can track and record various actions and activities of the surgeon during each step of the surgery and compare actual activity to the pre-operative or intraoperative surgical plan.
  • a software tool may be employed to process this data into a format where the surgery can be effectively “played-back.”
  • one or more GUIs may be used that depict all of the information presented on the Display 125 during surgery. This can be supplemented with graphs and images that depict the data collected by different tools.
  • a GUI that provides a visual depiction of the knee during tissue resection may provide the measured torque and displacement of the resection equipment adjacent to the visual depiction to better provide an understanding of any deviations that occurred from the planned resection area.
  • the ability to review a playback of the surgical plan or toggle between different aspects of the actual surgery vs. the surgical plan could provide benefits to the surgeon and/or surgical staff, allowing such persons to identify any deficiencies or challenging aspects of a surgery so that they can be modified in future surgeries.
  • the aforementioned GUIs can be used as a teaching tool for training future surgeons and/or surgical staff.
  • the data set effectively records many aspects of the surgeon’s activity, it may also be used for other reasons (e.g., legal or compliance reasons) as evidence of correct or incorrect performance of a particular surgical procedure.
  • a rich library of data may be acquired that describes surgical procedures performed for various types of anatomy (knee, shoulder, hip, etc.) by different surgeons for different patients.
  • aspects such as implant type and dimension, patient demographics, etc. can further be used to enhance the overall dataset.
  • the dataset Once the dataset has been established, it may be used to train a machine learning model (e.g., RNN) to make predictions of how surgery will proceed based on the current state of the CASS 100.
  • a machine learning model e.g., RNN
  • Training of the machine learning model can be performed as follows.
  • the overall state of the CASS 100 can be sampled over a plurality of time periods for the duration of the surgery.
  • the machine learning model can then be trained to translate a current state at a first time period to a future state at a different time period.
  • a plurality of machine learning models may be used rather than a single model.
  • the machine learning model may be trained not only with the state of the CASS 100, but also with patient data (e.g., captured from an EMR) and an identification of members of the surgical staff. This allows the model to make predictions with even greater specificity. Moreover, it allows surgeons to selectively make predictions based only on their own surgical experiences if desired.
  • predictions or recommendations made by the aforementioned machine learning models can be directly integrated into the surgical workflow.
  • the Surgical Computer 150 may execute the machine learning model in the background making predictions or recommendations for upcoming actions or surgical conditions.
  • a plurality of states can thus be predicted or recommended for each period.
  • the Surgical Computer 150 may predict or recommend the state for the next 5 minutes in 30 second increments.
  • the surgeon can utilize a “process display” view of the surgery that allows visualization of the future state.
  • FIG. 7C depicts a series of images that may be displayed to the surgeon depicting the implant placement interface.
  • the surgeon can cycle through these images, for example, by entering a particular time into the display 125 of the CASS 100 or instructing the system to advance or rewind the display in a specific time increment using a tactile, oral, or other instruction.
  • the process display can be presented in the upper portion of the surgeon’s field of view in the AR HMD.
  • the process display can be updated in realtime. For example, as the surgeon moves resection tools around the planned resection area, the process display can be updated so that the surgeon can see how his or her actions are affecting the other aspects of the surgery.
  • the inputs to the model may include a planned future state.
  • the surgeon may indicate that he or she is planning to make a particular bone resection of the knee joint. This indication may be entered manually into the Surgical Computer 150 or the surgeon may verbally provide the indication.
  • the Surgical Computer 150 can then produce a film strip showing the predicted effect of the cut on the surgery.
  • Such a film strip can depict over specific time increments how the surgery will be affected, including, for example, changes in the patient’s anatomy, changes to implant position and orientation, and changes regarding surgical intervention and instrumentation, if the contemplated course of action were to be performed.
  • a surgeon or medical professional can invoke or request this type of film strip at any point in the surgery to preview how a contemplated course of action would affect the surgical plan if the contemplated action were to be carried out.
  • various aspects of the surgery can be automated such that the surgeon only needs to be minimally involved, for example, by only providing approval for various steps of the surgery.
  • robotic control using arms or other means can be gradually integrated into the surgical workflow over time with the surgeon slowly becoming less and less involved with manual interaction versus robot operation.
  • the machine learning model in this case can learn what robotic commands are required to achieve certain states of the CASS- implemented plan.
  • the machine learning model may be used to produce a film strip or similar view or display that predicts and can preview the entire surgery from an initial state.
  • an initial state may be defined that includes the patient information, the surgical plan, implant characteristics, and surgeon preferences.
  • the surgeon could preview an entire surgery to confirm that the CASS-recommended plan meets the surgeon’s expectations and/or requirements.
  • the output of the machine learning model is the state of the CASS 100 itself, commands can be derived to control the components of the CASS to achieve each predicted state. In the extreme case, the entire surgery could thus be automated based on just the initial state information.
  • an optically tracked point probe 114 may be used to map the actual surface of the target bone that needs a new implant. Mapping is performed after removal of the defective or worn-out implant, as well as after removal of any diseased or otherwise unwanted bone. A plurality of points is collected on the bone surfaces by brushing or scraping the entirety of the remaining bone with the tip of the point probe 114. This is referred to as tracing or “painting” the bone.
  • the collected points are used to create a three-dimensional model or surface map of the bone surfaces in the computerized planning system.
  • the created 3D model of the remaining bone is then used as the basis for planning the procedure and necessary implant sizes.
  • An alternative technique that uses X-rays to determine a 3D model is described in U.S. Patent No. 11,386,990, filed April 17, 2019 and entitled “Three Dimensional Guide with Selective Bone Matching,” the entirety of which is incorporated herein by reference.
  • the point probe 114 painting can be used to acquire high resolution data in key areas such as the acetabular rim and acetabular fossa. This can allow a surgeon to obtain a detailed view before beginning to ream.
  • the point probe 114 may be used to identify the floor (fossa) of the acetabulum.
  • the information from the point probe 114 can be used to provide operating guidelines to the acetabular reamer during surgical procedures.
  • the acetabular reamer may be configured to provide haptic feedback to the surgeon when he or she reaches the floor or otherwise deviates from the surgical plan.
  • the CASS 100 may automatically stop the reamer when the floor is reached or when the reamer is within a threshold distance.
  • the thickness of the area between the acetabulum and the medial wall could be estimated. For example, once the acetabular rim and acetabular fossa has been painted and registered to the pre-operative 3D model, the thickness can readily be estimated by comparing the location of the surface of the acetabulum to the location of the medial wall. Using this knowledge, the CASS 100 may provide alerts or other responses in the event that any surgical activity is predicted to protrude through the acetabular wall while reaming.
  • the point probe 114 may also be used to collect high resolution data of common reference points used in orienting the 3D model to the patient. For example, for pelvic plane landmarks like the ASIS and the pubic symphysis, the surgeon may use the point probe 114 to paint the bone to represent a true pelvic plane. Given a more complete view of these landmarks, the registration software has more information to orient the 3D model.
  • the point probe 114 may also be used to collect high-resolution data describing the proximal femoral reference point that could be used to increase the accuracy of implant placement.
  • GT Greater Trochanter
  • the alignment is highly dependent on proper location of the GT; thus, in some embodiments, the point probe 114 is used to paint the GT to provide a high resolution view of the area.
  • it may be useful to have a high-resolution view of the Lesser Trochanter (LT).
  • LT Lesser Trochanter
  • the Dorr Classification helps to select a stem that will maximize the ability of achieving a press-fit during surgery to prevent micromotion of femoral components post-surgery and ensure optimal bony ingrowth.
  • the Dorr Classification measures the ratio between the canal width at the LT and the canal width 10 cm below the LT. The accuracy of the classification is highly dependent on the correct location of the relevant anatomy. Thus, it may be advantageous to paint the LT to provide a high-resolution view of the area.
  • the point probe 114 is used to paint the femoral neck to provide high-resolution data that allows the surgeon to better understand where to make the neck cut.
  • the navigation system can then guide the surgeon as they perform the neck cut.
  • the femoral neck angle is measured by placing one line down the center of the femoral shaft and a second line down the center of the femoral neck.
  • a high-resolution view of the femoral neck (and possibly the femoral shaft as well) would provide a more accurate calculation of the femoral neck angle.
  • High-resolution femoral head neck data could also be used for a navigated resurfacing procedure where the software/hardware aids the surgeon in preparing the proximal femur and placing the femoral component.
  • the femoral head and neck are not removed; rather, the head is trimmed and capped with a smooth metal covering.
  • a 3D model is developed during the preoperative stage based on 2D or 3D images of the anatomical area of interest.
  • registration between the 3D model and the surgical site is performed prior to the surgical procedure.
  • the registered 3D model may be used to track and measure the patient’s anatomy and surgical tools intraoperatively.
  • landmarks are acquired to facilitate registration of this pre-operative 3D model to the patient’s anatomy.
  • these points could comprise the femoral head center, distal femoral axis point, medial and lateral epicondyles, medial and lateral malleolus, proximal tibial mechanical axis point, and tibial A/P direction.
  • these points could comprise the anterior superior iliac spine (ASIS), the pubic symphysis, points along the acetabular rim and within the hemisphere, the greater trochanter (GT), and the lesser trochanter (LT).
  • ASIS anterior superior iliac spine
  • GT greater trochanter
  • LT lesser trochanter
  • each pre-operative image is compared to a library of images showing “healthy” anatomy (i.e., without defects). Any significant deviations between the patient’s images and the healthy images can be flagged as a potential defect. Then, during surgery, the surgeon can be warned of the possible defect via a visual alert on the display 125 of the CASS 100. The surgeon can then paint the area to provide further detail regarding the potential defect to the Surgical Computer 150.
  • the surgeon may use a non-contact method for registration of bony anatomy intra-incision.
  • laser scanning is employed for registration.
  • a laser stripe is projected over the anatomical area of interest and the height variations of the area are detected as changes in the line.
  • Other non-contact optical methods such as white light inferometry or ultrasound, may alternatively be used for surface height measurement or to register the anatomy.
  • ultrasound technology may be beneficial where there is soft tissue between the registration point and the bone being registered (e.g., ASIS, pubic symphysis in hip surgeries), thereby providing for a more accurate definition of anatomic planes.
  • the CASS 100 uses computers, robotics, and imaging technology to aid surgeons in performing surgical procedures.
  • the CASS 100 can aid surgeons in locating patient anatomical structures, guiding surgical instruments, and implanting medical devices with a high degree of accuracy.
  • Surgical navigation systems such as the CASS 100 often employ various forms of computing technology to perform a wide variety of standard and minimally invasive surgical procedures and techniques.
  • these systems allow surgeons to more accurately plan, track, and navigate the placement of instruments and implants relative to the body of a patient, as well as conduct pre-operative and intra-operative body imaging.
  • the optical tracking system 115 of the CASS 100 uses sensor(s) to collect real-time position data that locates the anatomy of the patient 120 and surgical instruments such as a resection tool 105B in the surgical environment.
  • the optical tracking system 115 described herein utilizes red-green-blue (RGB) sensor(s), although grayscale image sensors can also be used.
  • the optical tracking system 115 removes the NIR passband filter used in conventional systems to capture color information.
  • the RGB sensors acquire visible data using an additive color model where red, green, and blue light are combined in various ways to reproduce a broad array of colors.
  • NIR is beyond human visual perception and covers wavelengths of the electromagnetic spectrum from about 750 nm to about 2500 nm.
  • the optical tracking system 115 acquires color images and tracking images in an interleaved manner.
  • an acquisition frame may be dedicated to capturing a conventional RGB image followed by an NIR image that is used for tracking.
  • the color images acquired by the RGB sensor of the optical tracking system 115 provide a visual perception of the surgical area, while the tracking images can be used for tracking the 3D positions of fiducial markers in the surgical environment.
  • the term fiducial marker refers generally to any object placed in the field of view of the optical tracking system 115 for use as a point of reference.
  • the optical tracking system 115 can track fiducial markers using any technique known in the art including, without limitation, triangulation-based techniques and pose estimation methods.
  • the 3D position of the fiducial markers may be used to derive the 6D pose (orientation and position) of each respective fiducial marker using techniques generally known in the art.
  • Fiducial markers may be used to identify individuals, tools, or bones in the surgical operating theater and may include passive or active identifiers that can be picked up by a camera or camera array associated with the optical tracking system 115.
  • an IR light-emitting diode LED
  • one or two dimensional optical codes e.g., barcode, quick response (QR) code, etc.
  • QR quick response
  • codes are placed on an object, they can also be used to determine an orientation of an object by comparing the location of the identifier within the extent of an object in an image.
  • a QR code may be placed in a comer of a tool tray, allowing the orientation and identity of that tray to be tracked.
  • Other tracking modalities may also be employed.
  • the surgical computer 150 may use the detected fiducial locations to register surgical data to the color images.
  • the CASS 100 may guide the surgeon 111 based on pre-operative or intra-operative data using either the monitor 125 or the HMD 155.
  • Pre-operative information such as trajectories, cutting planes, scanner images, or 3D anatomical reconstructions may be registered on the patient’s anatomy directly on the color images to create augmented reality (AR) images of the surgical environment.
  • AR augmented reality
  • the color images may be used to perform depth map computations to sense more information within the volume seen by the optical tracking system 115.
  • the task of converting multiple 2D images into a 3D model involves the generation of multiple depth maps that comprise information relating to the distance of the surfaces of scene objects from a viewpoint. Once the depth maps are generated, they are combined to create a final mesh.
  • the images acquired by the optical tracking system 115 could add 3D sense points during the registration process. Adding the 3D sense points may shorten the process and/or make it more robust and accurate.
  • An advantage of the optical tracking system 115 is that both the tracking information and the color image are in the same, or substantially similar, referential space, thereby allowing for the combination of a 2D image with 3D information without having to change the referential. While an exemplary configuration of the optical tracking system 115 is shown in FIG. 1, in some embodiments of this technology, the optical tracking system is advantageously mounted and/or controlled to reduce obfuscation and optimize imaging data collection, as will now be described with reference to various exemplary embodiments of this technology.
  • an adjustable and reusable posterior femoral cut guide 800 in a retracted configuration for guidance of the posterior femoral condyle resections in a knee arthroplasty procedure is illustrated in accordance with an embodiment.
  • the posterior femoral cut guide 800 includes a fixed component 802 and an adjustable component 804 that is configured to move relative to the fixed component, such as prior to fixation of the fixed component to the femur of a patient, for example.
  • the fixed component 802 includes an anterior contact portion 806 that includes anterior pin holes 808A-B for affixing the posterior femoral cut guide 800 to the anterior portion of the femur, although fewer or more pin holes can be used in other examples, and a different fixation mechanism can also be used.
  • the fixed component 802 further includes a first distal contact portion 810, a second distal contact portion 812, and a central portion 814 that extend from the anterior contact portion 806. While the first and second distal contact portions 810 and 812, respectively, are illustrated in this particular example, any number of distal contact portions can be used as long as at least one distal contacting portion or face is provided.
  • the central portion includes optional distal pin holes 815A-B for affixing the posterior femoral cut guide 800 to the distal portion of the femur.
  • the adjustable component 804 of the posterior femoral cut guide 800 is movable relative to the fixed portion 802 using an adjustment mechanism, which in this example includes an actuator that translates rotational motion into linear motion via a pinion 900 that engages a rack 816.
  • the rack 816 may include a linear gear that, when engaged by a circular gear (i.e., the pinion 900), causes the adjustable component 804 to extend away from the fixed component 802 to a location determined based on any number of parameters including the make, model, and/or size of the femoral implant component selected for the arthroplasty procedure.
  • the pinion 900 is coupled to an adjustment screw 818 that extends through the first distal contact portion 810 in this example.
  • Other types of adjustment mechanisms can also be used in other examples.
  • a medial adjustable portion 820 and a lateral adjustable portion 822 of the adjustable component move within a medial track 824 and a lateral track 826 of the fixed component, respectively.
  • a peg 828 extending from or through the second distal contact portion 812 can engage a lateral groove 830 in the lateral adjustable portion 822 to retain the attachment of the adjustable component 804 to the fixed component 802 and define a maximum extension of the adjustable component.
  • sizing indicia 832 can be disposed on the medial adjustable portion 820 and/or central portion 814, for example, to facilitate the appropriate adjustment and extension of the adjustable component 804, although the sizing indicia can be located elsewhere.
  • the sizing indicia 832 includes a scale on the medial adjustable portion 820 and an opposing marker on the central portion 814, although other mechanisms for facilitating the appropriate extension can also be used.
  • the sizing indicia 832 may be a size of the implant component to be installed or a “raw value” of the depth from the anterior resected surface, which is not specific to any particular sizing convention, for example.
  • the sizing indicia 832 is laser marked onto the medial adjustable portion 820, although other deposition methods can also be used.
  • the adjustable component 804 also includes an interior portion 834 that extends from the medial and lateral adjustable portions 820 and 822, respectively.
  • An exterior portion 836 is coupled to the interior portion 834 via a fastener 838 in this example, although the interior and exterior portions can be formed as a monolithic structure along with one or more other portions of the adjustable component 804 in other examples.
  • the fastener can be disposed proximate a central divider 904.
  • the interior and exterior portions 834 and 836 each have opposing planar surfaces spaced from each other which, together with the central divider 904, define a medial cut slot 840 and a lateral cut slot 842, respectively, corresponding to the medial and lateral femoral condyles of the patient, respectively.
  • the posterior femoral cut guide 800 is illustrated in an extended configuration in accordance with an embodiment.
  • the posterior femoral cut guide 800 may be placed in any intermediate configuration between the configurations depicted in FIGS. 8-9.
  • a user may interface with the adjustment screw 818 to rotate the pinion 900 contained within the central portion 814, which engages the rack 816 to extend the adjustable component 804.
  • the adjustable component 804 may be locked with respect to the fixed component 802 using a locking mechanism.
  • the locking mechanism is a lock screw 902 that extends through the second distal contact portion 812 and engages the lateral adjustable portion (e.g., at an aperture) to thereby restrict movement of the adjustable component 804 relative to the fixed component 802.
  • Other types of locking mechanisms can also be used in other examples.
  • the posterior femoral cut guide 800 is illustrated affixed to anterior and distal femoral cut surfaces to facilitate resection of the posterior femoral condyles in a knee arthroplasty procedure in accordance with an embodiment.
  • the rack 816 is configured to move within a central groove 1000 in the central portion 814 when engaged by the pinion 900.
  • the configuration can be locked via the lock screw 902.
  • the first and second distal contact portions 810 and 812, respectively are separated by the central groove 1000 in this particular example, the first and second distal contact portions can also be connected to form only one distal contact portion or face.
  • the first and second distal contact portions 810 and 812, respectively could be connected at an anterior portion of the groove 1000, which may limit the travel of the rack in the groove.
  • the posterior femoral cut guide 800 is configured to rest against the resected anterior and distal surfaces of the femur 1002.
  • the posterior femoral cut guide 800 may be placed with the anterior contact portion 806 pressed against the anterior resected surface of the femur 1002 and the medial and second distal contact portion 810 and 812, respectively, pressed against the distal resected surface of the femur.
  • Anterior pins 1004A-B may then be inserted into the bone through anterior pin holes 808A-B to affix the fixed component 802 to an anterior portion of the femur 1002.
  • a distal pin 1006 can also be inserted into one or more of the distal pin holes 815 A-B to affix the fixed component to a distal portion of the femur 1002.
  • a saw may then be inserted into each of the medial and lateral cut slots 840 and 842, respectively, to cut the posterior surface of each of the medial and lateral femoral condyles, respectively, in separate cuts.
  • the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) are optionally preserved and not severed by cutting across the entire femur 1002.
  • the central divider 904 serves as a guard to prevent severing the ACL.
  • the cutting plane defined by the medial and lateral cut slots 840 and 842, respectively, can correspond with a predefined cutting plane of a preoperative surgical plan for the patient.
  • the posterior femoral cut guide 800 may be further configured to enable resection of the posterior condyle using a saw. In some embodiments, the posterior femoral cut guide 800 may be further configured to enable performance of the posterior chamfer cut using a saw. Each of such saw cuts may be supported via a cut slot in the posterior femoral cut guide 800. The positions of the cut slots for performing the posterior condyle and the posterior chamfer resections will be apparent to those of ordinary skill in the art based on the teachings of this disclosure.
  • the anterior pins 1004A-B, distal pin 1006, and the posterior femoral cut guide 800 may be removed from the bone. Any final adjustments and/or fine-tuning of the resection may be completed with the robotic or CASS-assisted burring tool, for example.
  • a method for knee arthroplasty using the posterior femoral cut guide 800 is described and illustrated in more detail below with reference to FIG. 15.
  • FIG. 11A a fixation base 1100 of a tibial cut guide affixed to the tibia 1102 of a patient and a depth stylus 1104 inserted into the fixation base are illustrated in accordance with an embodiment.
  • the fixation base 1100 includes a proximal aperture 1106 in which a depth stylus post 1108 is inserted in this example.
  • the depth stylus 1104 can be set or configured for the appropriate approximate distance from the distal tibia for placement of the fixation base 1100. The approximate distance can be determined based on a preoperative surgical plan for a location of a tibial resection plane, implant procedure recommended cut depths, and/or surgeon preferences, for example.
  • the fixation base 1100 includes a vertical adjustment mechanism to facilitate relatively granular movement of the depth stylus 1104 in the proximal-distal direction.
  • the vertical adjustment mechanism includes a vertical adjustment knob 1110 with a circular gear 1400 (shown in FIG. 14) configured to, when rotated, engage a plurality of teeth of a linear gear 1402 located at a proximal end of the depth stylus post 1108 that is inserted into the proximal aperture 1106.
  • the fixation base 1100 also includes a distal aperture 1112 configured to receive a portion of a connection mechanism, such as a quick connect clamp 1114 coupled to a handle 1116, although other types of connection mechanisms can be used to couple the handle to the fixation base.
  • the handle 1116 facilitates more effective manipulation and alignment relative to a long axis of the tibia of the fixation base 1100.
  • the fixation base 1100 and a simulated resection plane 1120 inserted into the proximal aperture 1106 are illustrated in accordance with an embodiment.
  • the simulated resection plane 1120 is used to determine the appropriate approximate location, at least in the proximal-distal or vertical direction, for fixation of the fixation base to the tibia 1102.
  • the appropriate approximate location for the simulated resection plane 1120 can be based on the planned location of the tibial cutting plane determined based on preoperative imaging and characteristics of the selected tibial implant component, for example.
  • the tibial cutting plane or other guidance indicia can be projected (e.g., into a field of view of a head-mounted display) to facilitate the placement of the simulated resection plane 1120.
  • the simulated resection plane 1120 can include a post (not shown) corresponding to the depth stylus post 1108 that, along with the vertical adjustment mechanism, facilitates granular vertical or proximal-distal adjustment.
  • the fixation base 1100 does not need to be affixed to the tibia 1102 in an exact location, but instead only needs to be located within particular tolerances, as explained in more detail below with reference to FIGS. 13-14.
  • the fixation base 1100 is affixed to the tibia 1102 and coupled to a tracking device 1200 as illustrated in accordance with an embodiment.
  • the fixation base 1100 is affixed to the tibia 1102 in this example via tibial pins 1202A-B inserted into the distal tibial pin holes 1118A-B, respectively. Subsequent to affixing the fixation base 1100, the depth stylus 1104 or simulated resection plane 1120 is removed from the proximal aperture 1106, the handle 1116 is disconnected from the distal aperture 1112 using the quick connect clamp 1114, and the tracking device 1200 is coupled to the fixation base at the distal aperture using the quick connect clamp.
  • the tracking device 1200 in this particular example is an optical tracking device with a plurality of markers 1204A-D (e.g., infrared (IR) markers) attached to a frame 1206, although other types of markers and/or tracking devices can also be used in other examples.
  • the markers 1204A-D are disposed at a known distance from each other and from the fixation base 1100 and, by extension, the tibia 1102.
  • a surgeon can use a robotic or CASS-assisted surgical resection tool (e.g., a burr) to resect the proximal tibia according to the tibial cutting plane defined in a surgical plan.
  • the surgical resection tool can be tracked by a surgical tracking system, which can facilitate automated movement of the surgical resection tool or guided movement (e.g., via haptic feedback), for example, based on a location of the tibia 1102 tracked via the tracking device 1200.
  • the surgical tracking system uses the tracking device 1200 to track the location of the tibia 1102 as well as to facilitate placement of a cut block assembly 1300 at an appropriate location for resection of the tibia 1102, as will now be described and illustrated in more detail.
  • a tibial cut guide with the fixation base 1100 coupled to the tibia 1102, the tracking device 1200, and a tibial cut block assembly 1300 inserted into the fixation base is illustrated in accordance with an embodiment.
  • the fixation base 1100 also is configured to receive the tibial cut block assembly 1300 at the proximal aperture 1106 via a cut block assembly post 1404.
  • the cut block assembly post 1404 can include a linear gear 1402 towards a distal end and can be of the same or similar configuration as the depth stylus post 1108 and/or simulated plane post, as described in more detail below. Accordingly, the vertical adjustment knob 1110 can be used to move the tibial cut block assembly 1300 in the proximal or distal direction.
  • the tibial cut block assembly 1300 also includes flexion and angulation adjustment mechanisms in this example, including a flexion adjustment knob 1302 and an angulation adjustment knob 1304, although other types of adjustment mechanisms can also be used in other examples.
  • the adjustment mechanisms are coupled to a tibial cut block component 1306 of the tibial cut block assembly 1300, which includes a tibial cut slot 1308. Accordingly, rotation of the flexion adjustment knob 1302 rotates the tibial cut block component 1306 and tibial cut slot 1308 in a flexion-extension direction and rotation of the angulation adjustment knob 1304 rotates the tibial cut block component and tibial cut slot in a varus-valgus direction.
  • the operation of the flexion and angulation mechanisms will be described and illustrated in more detail below with reference to FIG. 14.
  • a tibial cutting plane can be projected into a field of view of a head-mounted display worn by a surgeon.
  • the surgeon can then manipulate the vertical adjustment knob 1110, flexion adjustment knob 1302, and/or angulation adjustment knob 1304 to align the projected tibial cutting plane with the tibial cut slot 1308 of the tibial cut block component 1306.
  • the tibial cut slot 1308 can be aligned by affixing a separate tracking device or array referencing the tibial cut slot and manipulating the tibia cutting plane to correspond with the preoperative surgical plan. Other methods for aligning the tibial cut slot 1308 can also be used in other examples.
  • the tibial cut block component 1306 can be affixed to the tibia 1102 via insertion of a pin (not shown) into the proximal tibial pin hole 1310, for example. In other examples, the tibial cut block component 1306 can be aligned and/or affixed in other ways. Subsequent to fixation of the tibial cut block component 1306, the tibia 1102 can be resected via insertion of a saw into the tibial cut slot 1308, for example.
  • the vertical adjustment knob 1110 is coupled to the circular gear 1400, which engages the linear gear 1402 of the cut block assembly post 1404 (or the post of any other inserted component in another example (e.g., the depth stylus post 1108)). Accordingly, rotation of the vertical adjustment knob 1110 rotates the coupled circular gear 1400, which rotates and engages the linear gear 1402 to thereby convert the rotational motion into linear motion and extend the tibial cut block assembly 1300 vertically or in a proximal-distal direction.
  • the flexion adjustment knob 1302 is coupled to a flexion post 1406, which is configured to engage a flexion track 1408 of the tibial cut block component 1306.
  • the flexion track 1408 is shaped such that rotation of the flexion adjustment knob 1302 extends and retracts the flexion post 1406 to contact the flexion track at different depths, which is translated to tilt or rotation in the flexion-extension direction of the tibial cut block component 1306.
  • the flexion track 1408 can be helix-shaped having a range of depths.
  • the angulation adjustment knob 1304 is coupled to an angulation post 1410, which is configured to engage an angulation track 1412 of the tibial cut block component 1306.
  • the angulation track 1412 is also shaped such that rotation of the angulation adjustment knob 1304 extends and retracts the angulation post 1410 to contact the angulation track at different depths, which is translated to tilt or rotate in the varus-valgus direction of the tibial cut block component 1306.
  • Other types of flexion and angulation adjustment mechanisms can also be used in other examples, and the tibial cutting block 1306 can also be adjusted in other directions.
  • FIG. 15 a flowchart of an exemplary hybrid knee arthroplasty surgical method for resection of the femur 1002 and tibia 1102 whereby some cuts are performed robotically and the posterior femoral condyle resections are performed manually using the posterior femoral cut guide 800 is illustrated in accordance with an embodiment.
  • a surgeon resects the anterior, distal, and chamfer portions of the femur 1002 using robotic or computer-assisted surgical resection device(s).
  • One or more of the anterior, distal, and chamfer resections can be performed manually using a saw or other cutting tool, or automatically using a robotic burr or any other computer-assisted surgical resection tool, for example, that is controlled by the CASS 100 according to a preoperative surgical plan and associated patient and femoral implant component characteristics.
  • the anterior, distal, and chamfer resections can be performed relatively efficiently using robotic or computer-assisted surgical resection devices and access to perform those resections is generally greater than the access for such devices with respect to the posterior portion of the femur 1002.
  • the surgeon can adjust the posterior femoral cut guide 800 anterior- posterior size based on the surgical plan and femoral implant component dimensions.
  • the anterior-posterior size can be adjusted via the adjustment screw 818, as explained in more detail above.
  • the adjustable component 804 of the posterior femoral cut guide 800 can be locked via the lock screw 902, also as described above.
  • the surgeon can affix the posterior femoral cut guide 800 to the femur 1002 referenced to anterior and distal cut planes resulting from the resections performed in step 1500.
  • the posterior femoral cut guide can be affixed via the anterior pins 1004A-B and distal pin 1006, for example, as described in more detail above, although other fixation methods can also be used.
  • step 1506 the surgeon can manually resect the posterior femoral condyles using a saw and the posterior femoral cut guide 800. More specifically, the saw can be inserted into the medial cut slot 840 and the lateral cut slot 842 to make two separate cuts, one of each of the femoral condyles.
  • the medial cut slot 840 and the lateral cut slot 842 are separated by the central divider 904 to restrict usage of the saw in the area of the ACL of the patient to thereby prevent unintended engaged of the saw with the ACL and associated ACL damage.
  • step 1508 the surgeon removes the posterior femoral cut guide 800 from the femur 1002, such as by removing the anterior pins 1004A-B and the distal pin 1006, for example. Subsequent to the removal of the posterior femoral cut guide 800, the distal femur 1002 is prepared for attachment of the femoral implant component. Because access to the posterior portion of the femur 1002 is difficult, this technology facilitates robotic or computer- assisted resection of all but the posterior femoral cuts during a knee arthroplasty procedure, which is instead performed manually using, for example, a saw and the posterior femoral cut guide 800.
  • the posterior femoral cut guide 800 is adjustable and can be reused after each knee arthroplasty procedure, thereby reducing the expense and time required to produce individualized femoral cutting guides.
  • the posterior femoral cut guide 800 Prior to reuse, can be sterilized or an autoclaving procedure can be performed to ensure patient safety.
  • step 1510 in this example the surgeon then attaches the fixation base 1100 to the tibia 1102 at a location determined using a depth stylus 1104 or simulated resection plane 1120 coupled to the fixation base, for example.
  • the location can be approximate as long as it is within the tolerances of the vertical, flexion, and angulation adjustment mechanisms 1110, 1302, and 1304, respectively.
  • the fixation base 1100 can be affixed via tibial pins 1202A-B, for example.
  • step 1512 the surgeon replaces the handle 1116 coupled to the fixation base 1100 with the tracking device 1200.
  • the handle 1116 can be removed by opening the quick connect clamp 1114 and removing the handle from the distal aperture 1112.
  • the tracking device 1200 can then be inserted into the distal aperture 1112, and the quick connect clamp 1114 can be closed to fix the position of the tracking device, although other attachment mechanisms can also be used.
  • step 1514 in this example the surgeon inserts the tibial cut block assembly 1300 into the fixation base 1100 and adjusts the tibial cut block component 1306 to align the tibial cut slot 1308 with a planned tibial resection plane.
  • the planned tibial resection plane can be projected into the environment or a field of view of a head-mounted display, for example, to facilitate alignment of the tibial cut slot 1308 with the tibial resection plane, although other methods for aligning the tibial cut slot can also be used in other examples.
  • the position and orientation of the projection can be determined based on tracking data determined by a surgical tracking system using the tracking device 1200. To achieve the alignment, the surgeon can adjust the vertical, flexion, and angulation adjustment knobs 1110, 1302, and 1304, respectively, to manipulate the tibial cut slot 1308 of the tibial cut block component 1306.
  • step 1516 the surgeon affixes the tibial cut block assembly 1300 to the tibia 1102 and performs a tibial resection using, for example, a saw inserted via the tibial cut slot 1308. Accordingly, once the alignment of the tibial cut slot 1308 is achieved, the tibial cut block assembly 1300 can be affixed to the tibia 1102 via a pin inserted into the proximal tibial pin hole 1310 of the tibial cut block component 1306, for example.
  • step 1518 the surgeon removes the tibial cut block assembly 1300 and the fixation base 1100 from the tibia 1102, such as by removing the tibial pins 1202A-B and the pin inserted via the proximal tibial pin hole 1310, for example.
  • the tibia 1102 has a resected surface prepared for attachment of a tibial implant component.
  • one or more of the fixation base 1100 or tibial cut block assembly can be reused in subsequent knee arthroplasty procedures.
  • a surgeon can use a tracked robotic or computer- assisted surgical resection tool (e.g., a burr) to resect the tibia 1102 according to the tibial cutting plane instead of performing steps 1514-1518. Additionally, one or more of steps 1500- 1518 can be performed in parallel and/or in a different order in other examples.
  • a tracked robotic or computer- assisted surgical resection tool e.g., a burr
  • FIGS. 16-19 depict an alternate fixation base of a tibial cut guide affixed to the tibia of a patient in accordance with an embodiment.
  • a fixation base 1600 of affixed to the tibia 1602 of a patient, a tibial cut guide 1603, and a depth stylus 1604 inserted into the tibial cut guide are illustrated in accordance with an embodiment.
  • the tibial cut guide 1603 includes a tibial cut slot 1606 in which a base 1608 of the depth stylus 1604 is inserted in this example.
  • the depth stylus 1604 can be set or configured for the appropriate approximate distance from the distal tibia for placement of the fixation base 1600. The approximate distance can be determined based on a preoperative surgical plan for a location of a tibial resection plane, implant procedure recommended cut depths, and/or surgeon preferences, for example.
  • the fixation base 1600 also includes a distal aperture 1612 configured to receive a portion of a connection mechanism, such as a quick connect clamp 1614 coupled to a handle 1616, although other types of connection mechanisms can be used to couple the handle to the fixation base.
  • a connection mechanism such as a quick connect clamp 1614 coupled to a handle 1616
  • the handle 1616 facilitates more effective manipulation and alignment relative to a long axis of the tibia of the fixation base 1600.
  • the fixation base 1600 is affixed to the tibia 1602 and coupled to a tracking device 1700 as illustrated in accordance with an embodiment.
  • the fixation base 1600 is affixed to the tibia 1602 in this example via tibial pins 1702A-B inserted into the distal tibial pin holes 1618A-B, respectively.
  • the depth stylus 1604 is removed from the tibial cut slot 1606, the handle 1616 is disconnected from the distal aperture 1612 using the quick connect clamp 1614, and the tracking device 1700 (similar in operation to the tracking device 1200 described above in reference to FIG. 12) is coupled to the fixation base at the distal aperture using the quick connect clamp.
  • FIG. 18 an alternate tibial cut guide with a fixation base 1600 coupled to the tibia 1602 of a patient, a tracking device 1700, and a tibial cut block assembly 1603 inserted into the fixation base is illustrated in accordance with an embodiment.
  • the tibial cut block assembly 1603 also includes flexion and angulation adjustment mechanisms in this example, including a flexion adjustment knob 1802 and an angulation adjustment knob 1804, although other types of adjustment mechanisms can also be used in other examples.
  • the adjustment mechanisms are coupled to a tibial cut block component 1806 of the tibial cut block assembly 1603, which includes a tibial cut slot 1606.
  • rotation of the flexion adjustment knob 1802 rotates the tibial cut block component 1806 and tibial cut slot 1606 in a flexion-extension direction and rotation of the angulation adjustment knob 1804 rotates the tibial cut block component and tibial cut slot in a varus-valgus direction.
  • the operation of the flexion and angulation mechanisms will be described and illustrated in more detail below with reference to FIG. 19.
  • a tibial cutting plane can be projected into a field of view of a head-mounted display worn by a surgeon.
  • the surgeon can then manipulate the vertical adjustment knob 1610, flexion adjustment knob 1802, and/or angulation adjustment knob 1804 to align the projected tibial cutting plane with the tibial cut slot 1606 of the tibial cut block component 1806.
  • the tibial cut slot 1606 can be aligned by affixing a separate tracking device or array referencing the tibial cut slot and manipulating the tibia cutting plane to correspond with the preoperative surgical plan. Other methods for aligning the tibial cut slot 1606 can also be used in other examples.
  • the tibial cut block component 1806 can be affixed to the tibia 1602 via insertion of a pin (not shown) into the proximal tibial pin hole 1810, for example. In other examples, the tibial cut block component 1806 can be aligned and/or affixed in other ways. Subsequent to fixation of the tibial cut block component 1806, the tibia 1602 can be resected via insertion of a saw into the tibial cut slot 1606, for example.
  • the vertical adjustment knob 1610 is coupled to, for example, a circular gear (not shown), which engages a linear gear (not shown) of a cut block assembly post (not shown) (or the post of any other inserted component in another example). Accordingly, rotation of the vertical adjustment knob 1610 rotates the coupled circular gear, which rotates and engages the linear gear to thereby convert the rotational motion into linear motion and extend the tibial cut block assembly 1800 vertically or in a proximal-distal direction.
  • the operation of the vertical adjustment knob may be similar to that shown in FIG. 14.
  • the flexion adjustment knob 1802 is coupled to a flexion post (not shown), which is configured to engage a flexion track (not shown) of the tibial cut block component 1806.
  • the flexion track is shaped such that rotation of the flexion adjustment knob 1802 extends and retracts the flexion post to contact the flexion track at different depths, which is translated to tilt or rotation in the flexion-extension direction of the tibial cut block component 1806.
  • the flexion track can be helix-shaped having a range of depths.
  • the operation of the flexion adjustment knob may be similar to that shown in FIG. 14.
  • the angulation adjustment knob 1804 is coupled to an angulation post (not shown), which is configured to engage an angulation track (not shown) of the tibial cut block component 1806.
  • the angulation track is also shaped such that rotation of the angulation adjustment knob 1804 extends and retracts the angulation post to contact the angulation track at different depths, which is translated to tilt or rotate in the varus-valgus direction of the tibial cut block component 1806.
  • the operation of the flexion adjustment knob may be similar to that shown in FIG. 14.
  • Other types of flexion and angulation adjustment mechanisms can also be used in other examples, and the tibial cut block component 1806 can also be adjusted in other directions.
  • This technology advantageously provides a reusable tool for easily accessing the posterior femoral surface during a knee arthroplasty procedure and completing resection of the posterior femoral condyles in a manner that avoids the difficulties associated with using computer-assisted burring tools for the posterior surface resection.
  • the cutting guide systems and methods disclosed herein combine the advantages of computer-assisted resections (e.g., with respect to accuracy and speed) for cutting the majority of the femoral surfaces with the advantage of a dedicated, adjustable, and reusable cutting guide device for facilitating manual cutting (e.g., with a saw) of the posterior femoral condyles to complete the femoral resection.
  • compositions, methods, and devices are described in terms of “comprising” various components or steps (interpreted as meaning “including, but not limited to”), the compositions, methods, and devices can also “consist essentially of’ or “consist of’ the various components and steps, and such terminology should be interpreted as defining essentially closed-member groups.
  • a range includes each individual member.
  • a group having 1-3 components refers to groups having 1, 2, or 3 components.
  • a group having 1-5 components refers to groups having 1, 2, 3, 4, or 5 components, and so forth.
  • the term “about,” as used herein, refers to variations in a numerical quantity that can occur, for example, through measuring or handling procedures in the real world; through inadvertent error in these procedures; through differences in the manufacture, source, or purity of compositions or reagents; and the like.
  • the term “about” as used herein means greater or lesser than the value or range of values stated by 1/10 of the stated values, e.g., ⁇ 10%.
  • the term “about” also refers to variations that would be recognized by one skilled in the art as being equivalent so long as such variations do not encompass known values practiced by the prior art.
  • Each value or range of values preceded by the term “about” is also intended to encompass the embodiment of the stated absolute value or range of values.

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Abstract

L'invention concerne des systèmes pour une arthroplastie de genou hybride comprenant une résection fémorale postérieure manuelle à l'aide d'un guide de coupe réutilisable et d'une résection assistée par ordinateur d'autres découpes. Le guide de coupe comprend un composant fixe comprenant un mécanisme de réglage, une partie antérieure et une partie centrale entre des parties de contact distales. Des pistes sont disposées entre la partie centrale et chacune des parties de contact distales. Le guide de coupe comprend également un composant réglable qui comprend des parties ajustables configurées pour être reçues par les pistes. Une partie intérieure s'étend à partir des parties réglables et est couplée à une partie extérieure au niveau d'un diviseur central. La partie intérieure est espacée de la partie extérieure sur les côtés du diviseur central pour former des fentes de coupe. Un actionneur est couplé à la partie intérieure, en communication fonctionnelle avec le mécanisme de réglage, et configuré pour déplacer le composant réglable par rapport au composant fixe.
PCT/US2022/045613 2021-10-05 2022-10-04 Systèmes de guide de coupe Ceased WO2023059589A1 (fr)

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WO2021146540A1 (fr) * 2020-01-15 2021-07-22 Smith & Nephew, Inc. Dispositif de mesure pour essai préalable, destiné à être utilisé pendant une révision d'arthroplastie totale du genou
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Publication number Priority date Publication date Assignee Title
US5417694A (en) * 1993-11-08 1995-05-23 Smith & Nephew Richards Inc. Distal femoral cutting guide apparatus with anterior or posterior referencing for use in knee joint replacement surgery
US6013081A (en) * 1998-09-09 2000-01-11 Sulzer Orthopedics Inc. Apparatus and method for anterior and posterior referenced sizing and distal femur resection
US20120130385A1 (en) * 2003-06-19 2012-05-24 Lionberger David R Cutting guide apparatus and surgical method for use in knee arthroplasty
US8078440B2 (en) 2008-09-19 2011-12-13 Smith & Nephew, Inc. Operatively tuning implants for increased performance
US10064686B2 (en) 2010-08-13 2018-09-04 Smith & Nephew, Inc. Systems and methods for optimizing parameters of orthopaedic procedures
US9371286B2 (en) 2011-03-16 2016-06-21 Industry-Academic Cooperation Foundation, Yonsei University Pharmaceutical composition with enhanced efficacy for inhibiting angiogenesis
US10426571B2 (en) 2014-11-14 2019-10-01 Medineering Gmbh Intelligent holding arm for head surgery, with touch-sensitive operation
US10537388B2 (en) 2014-12-01 2020-01-21 Blue Belt Technologies, Inc. Systems and methods for planning and performing image free implant revision surgery
US10993777B2 (en) 2015-03-27 2021-05-04 Brainlab Robotics Gmbh Method and apparatus for controlling a surgical mechatronic assistance system by means of a holding arm for medical purposes
US10342636B2 (en) 2015-08-12 2019-07-09 Medineering Gmbh Medical holding arm having annular LED display means
US11386990B1 (en) 2018-04-17 2022-07-12 Smith & Nephew, Inc. Three-dimensional selective bone matching
WO2021146540A1 (fr) * 2020-01-15 2021-07-22 Smith & Nephew, Inc. Dispositif de mesure pour essai préalable, destiné à être utilisé pendant une révision d'arthroplastie totale du genou

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025195657A1 (fr) * 2024-03-21 2025-09-25 Smith & Nephew, Inc. Systèmes, dispositifs et procédés de résection osseuse naviguée

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