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WO2024254421A1 - Ensembles marqueurs de repère pour systèmes de navigation chirurgicale - Google Patents

Ensembles marqueurs de repère pour systèmes de navigation chirurgicale Download PDF

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Publication number
WO2024254421A1
WO2024254421A1 PCT/US2024/032963 US2024032963W WO2024254421A1 WO 2024254421 A1 WO2024254421 A1 WO 2024254421A1 US 2024032963 W US2024032963 W US 2024032963W WO 2024254421 A1 WO2024254421 A1 WO 2024254421A1
Authority
WO
WIPO (PCT)
Prior art keywords
surgical
fiducial marker
fiducial
data
probe
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.)
Pending
Application number
PCT/US2024/032963
Other languages
English (en)
Inventor
Kevin Santos NUNES
Luis Carlos Fial Teixeira RIBEIRO
Rui Jorge Melo Teixeira
João Pedro de Almeida BARRETO
Michel Goncalves ALMEIDA ANTUNES
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 WO2024254421A1 publication Critical patent/WO2024254421A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/94—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/94—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
    • A61B90/96—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text using barcodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/102—Modelling of surgical devices, implants or prosthesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/105—Modelling of the patient, e.g. for ligaments or bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2055—Optical tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2063—Acoustic tracking systems, e.g. using ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2065—Tracking using image or pattern recognition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B2090/364—Correlation of different images or relation of image positions in respect to the body
    • A61B2090/365—Correlation of different images or relation of image positions in respect to the body augmented reality, i.e. correlating a live optical image with another image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/372—Details of monitor hardware
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3983—Reference marker arrangements for use with image guided surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/50—Supports for surgical instruments, e.g. articulated arms
    • A61B2090/502—Headgear, e.g. helmet, spectacles

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, neuro-surgery procedures, rotator cuff procedures, ligament repair and replacement procedures.
  • BACKGROUND [0003] Many modern orthopedic surgical procedures are performed with assistance from a surgical navigation system.
  • TKA total knee arthroplasty
  • femoral condyles and tibial plateau femoral condyles and tibial plateau
  • metal and polyethylene components for patients that generally have severe arthritis or a severe knee injury.
  • the surgeon needs to perform precise bone resections to obtain the best positioning of the implant using a complete set of standard instrumentation available for all different shapes and sizes of knees.
  • the problem is that the surgeon needs to verify which instruments best fit on each patient intraoperatively and use those standard instruments to perform the bone resections, which can lead to those cuts not being as precise as they should be.
  • TKA instrumentation is composed of instruments of multiple sizes, usually delivered in multiple instrumentation trays, which represent a significant capital equipment cost for the manufacturer and sterilization cost for the healthcare facility.
  • 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT SUMMARY [0005]
  • the present disclosure is directed to fiducial marker assemblies for surgical navigation systems.
  • the present disclosure is directed to a fiducial marker for use with a surgical navigation system, the fiducial marker comprising: a plurality of faces, each of the plurality of faces comprising a fiducial configured to be identified by the surgical navigation system; wherein at least two of the fiducials are configured to be visible to the surgical navigation system from substantially any orientation; and a connector configured to engage with a probe.
  • the present disclosure is directed to a fiducial marker for use with a surgical navigation system, the fiducial marker comprising: a plurality of faces, each of the plurality of faces comprising a fiducial configured to be identified by the surgical navigation system; wherein at least two of the fiducials are configured to be visible to the surgical navigation system from substantially any orientation; and a channel configured to receive a fastener therethrough; wherein the fiducial marker is configured to not rotate with respect to the fastener when the fastener is inserted through the channel.
  • the present disclosure is directed to a surgical equipment kit for use with a surgical navigation system, the surgical equipment kit comprising: a probe configured to be received by one or more pieces of other surgical equipment; and a fiducial marker comprising: a plurality of faces, each of the plurality of faces comprising a fiducial configured to be identified by the surgical navigation system, wherein at least two of the fiducials are configured to be visible to the surgical navigation system from substantially any orientation, and a connector configured to engage with the probe.
  • FIG.1 depicts an operating theatre including an illustrative computer-assisted surgical system (CASS) in accordance with an embodiment.
  • FIG.2A depicts illustrative control instructions that a surgical computer provides to other components of a CASS in accordance with an embodiment. 1610184997.2 Attorney Docket No.
  • FIG.2B depicts illustrative control instructions that components of a CASS provide to a surgical computer in accordance with an embodiment.
  • FIG.2C 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.3A depicts a perspective view of a fiducial marker configured to be affixed to a bone in accordance with an embodiment of the present disclosure.
  • FIG.3B depicts a reverse perspective view of the fiducial marker of FIG.3A in accordance with an embodiment of the present disclosure.
  • FIG.3C depicts an overhead view of the fiducial marker of FIG.3A in accordance with an embodiment of the present disclosure.
  • FIG.3D depicts a perspective view of a first step of securing fasteners to the fiducial marker of FIGS.3A–3C in accordance with an embodiment of the present disclosure.
  • FIG.3E depicts a perspective view of a second step of securing fasteners to the fiducial marker of FIGS.3A–3C in accordance with an embodiment of the present disclosure.
  • FIG.3F depicts a perspective view of a third step of securing fasteners to the fiducial marker of FIGS.3A–3C in accordance with an embodiment of the present disclosure.
  • FIG.3G depicts a perspective view of a fourth step of securing fasteners to the fiducial marker of FIGS.3A–3C in accordance with an embodiment of the present disclosure.
  • FIG.3H depicts a perspective view of a first step of securing the fiducial marker of FIGS.3A–3C to a bone using two fasteners in accordance with an embodiment of the present disclosure.
  • FIG.3I depicts a perspective view of a second step of securing the fiducial marker of FIGS.3A–3C to a bone using two fasteners in accordance with an embodiment of the present disclosure.
  • FIG.3J depicts a perspective view of a third step of securing the fiducial marker of FIGS.3A–3C to a bone using two fasteners in accordance with an embodiment of the present disclosure.
  • FIG.3K depicts a perspective view demonstrating that the fiducial marker is secured from both translation and rotation movement once secured using two fasteners as shown in FIGS.3H–3J in accordance with an embodiment of the present disclosure.
  • FIG.4A depicts a perspective view of a second embodiment of a fiducial marker configured to be affixed to a bone in accordance with an embodiment of the present disclosure. 1610184997.2 Attorney Docket No.
  • FIG.4B depicts an overhead view of the fiducial marker of FIG.4A in accordance with an embodiment of the present disclosure.
  • FIG.4C depicts a perspective view of a first step securing fasteners to the fiducial marker of FIGS.4A and 4B in accordance with an embodiment of the present disclosure.
  • FIG.4D depicts a perspective view of a second step securing fasteners to the fiducial marker of FIGS.4A and 4B in accordance with an embodiment of the present disclosure.
  • FIG.4E depicts a perspective view of a third step securing fasteners to the fiducial marker of FIGS.4A and 4B in accordance with an embodiment of the present disclosure.
  • FIG.5A depicts an overhead view of a third embodiment of a fiducial marker configured to be affixed to a bone in accordance with an embodiment of the present disclosure.
  • FIG.5B depicts a perspective view of the fiducial marker of FIG.5A in accordance with an embodiment of the present disclosure.
  • FIG.5C depicts a sectional view of the fiducial marker of FIG.5A along line 5— 5 in accordance with an embodiment of the present disclosure.
  • FIG.5D depicts a perspective view of a first step securing fasteners to the fiducial marker of FIGS.5A–C in accordance with an embodiment of the present disclosure.
  • FIG.5E depicts a perspective view of a second step securing fasteners to the fiducial marker of FIGS.5A–C in accordance with an embodiment of the present disclosure.
  • FIG.6A depicts a perspective view of a fiducial marker configured to be affixed to a probe in accordance with an embodiment of the present disclosure.
  • FIG.6B depicts a reverse perspective view of the fiducial marker of FIG.6A in accordance with an embodiment of the present disclosure.
  • FIG.6C depicts a sectional view of the fiducial marker of FIG.6A along line 6— 6 in accordance with an embodiment of the present disclosure.
  • FIG.7A depicts an exploded view of a fiducial marker and a probe in accordance with an embodiment of the present disclosure.
  • FIG.7B depicts an elevational view of the fiducial marker and the probe of FIG. 7A secured together in accordance with an embodiment of the present disclosure.
  • FIG.8 depicts a perspective view of a probe including a fiducial marker engaged with a cut guide in accordance with an embodiment of the present disclosure. 1610184997.2 Attorney Docket No.
  • FIG.9A depicts a perspective view of a first step of the performance of a femoral distal cut using the probe-containing cut guide in accordance with an embodiment of the present disclosure.
  • FIG.9B depicts a perspective view of a second step of the performance of a femoral distal cut using the probe-containing cut guide in accordance with an embodiment of the present disclosure.
  • FIG.9C depicts a perspective view of a third step of the performance of a femoral distal cut using the probe-containing cut guide in accordance with an embodiment of the present disclosure.
  • FIG.10A depicts a perspective view of a first step of the performance of a tibial proximal cut using the cut guide in accordance with an embodiment of the present disclosure.
  • FIG.10B depicts a perspective view of a second step of the performance of a tibial proximal cut using the cut guide in accordance with an embodiment of the present disclosure.
  • FIG.10C depicts a perspective view of a third step of the performance of a tibial proximal cut using the cut guide in accordance with an embodiment of the present disclosure.
  • FIG.11A depicts a perspective view of a first step of the use of the cut guide for verification of the femoral distal cut in accordance with an embodiment of the present disclosure.
  • FIG.11B depicts a perspective view of a second step of the use of the cut guide for verification of the femoral distal cut in accordance with an embodiment of the present disclosure.
  • FIG.12A depicts a perspective view of a first step of the use of the cut guide for verification of the tibial proximal cut in accordance with an embodiment of the present disclosure.
  • FIG.12B depicts a perspective view of a second step of the use of the cut guide for verification of the tibial proximal cut in accordance with an embodiment of the present disclosure.
  • FIG.13A depicts an exploded view of the probe, cut guide, and internal rotation guide in accordance with an embodiment of the present disclosure.
  • FIG.13B depicts a perspective view of the probe, cut guide, and internal rotation guide of FIG.13A secured together in accordance with an embodiment of the present disclosure. 1610184997.2 Attorney Docket No.
  • FIG.14A depicts a perspective view of a first step of the use of the internal rotation guide for placement of the pins for the finishing block on the femoral distal cut in accordance with an embodiment of the present disclosure.
  • FIG.14B depicts a perspective view of a second step of the use of the internal rotation guide for placement of the pins for the finishing block on the femoral distal cut in accordance with an embodiment of the present disclosure.
  • FIG.14C depicts a perspective view of a third step of the use of the internal rotation guide for placement of the pins for the finishing block on the femoral distal cut in accordance with an embodiment of the present disclosure.
  • FIG.15A depicts a perspective view of a plane tool configured to engage with a probe in accordance with an embodiment of the present disclosure.
  • FIG.15B depicts a reverse perspective view of the plane tool of FIG.15A in accordance with an embodiment of the present disclosure.
  • FIG.15C depicts a side elevational view of the plane tool of FIG.15A in accordance with an embodiment of the present disclosure.
  • FIG.16A depicts an exploded view of the plane tool of FIG.15A and a probe in accordance with an embodiment of the present disclosure.
  • FIG.16B depicts a perspective view of the plane tool of FIG.15A and the probe secured together in accordance with an embodiment of the present disclosure.
  • FIG.17A depicts a perspective view of the first step of the use of the plane tool for guiding the femoral distal cut in accordance with an embodiment of the present disclosure.
  • FIG.17B depicts a perspective view of the second step of the use of the plane tool for guiding the femoral distal cut in accordance with an embodiment of the present disclosure.
  • FIG.18A depicts a perspective view of the first step of the use of the plane tool for guiding the tibial proximal cut in accordance with an embodiment of the present disclosure.
  • FIG.18B depicts a perspective view of the second step of the use of the plane tool for guiding the tibial proximal cut in accordance with an embodiment of the present disclosure.
  • FIG.19A depicts a perspective view of a first step of using the plane tool for verifying the femoral distal cut in accordance with an embodiment of the present disclosure. 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT [0066]
  • FIG.19B depicts a perspective view of a second step of using the plane tool for verifying the femoral distal cut in accordance with an embodiment of the present disclosure.
  • FIG.20A depicts a perspective view of a first step of using the plane tool for verifying the tibial proximal cut in accordance with an embodiment of the present disclosure.
  • FIG.20B depicts a perspective view of a second step of using the plane tool for verifying the tibial proximal cut in accordance with an embodiment of the present disclosure.
  • FIG.21A depicts an exploded view of the probe-containing plane tool and the internal rotation guide in accordance with an embodiment of the present disclosure.
  • FIG.21B depicts a perspective view of the probe-containing plane tool and the internal rotation guide of FIG.21A secured together in accordance with an embodiment of the present disclosure.
  • FIG.22A depicts an exploded view of a probe holder and a probe in accordance with an embodiment of the present disclosure.
  • FIG.22B depicts a perspective view of the probe holder and the probe of FIG.
  • 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.
  • the term “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.
  • the use of the term “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.
  • surgeons or other medical professionals can include any doctor, nurse, medical professional, or technician.
  • 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 THA.
  • TKA total knee 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.
  • 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. For example, for a knee surgery, 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 CORI® 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 105A. While one robotic arm 105A is illustrated in FIG.1, in some embodiments there may be multiple devices. As examples, there may be one robotic arm 105A on each side of an operating table T or two devices on one side of the table T. The robotic arm 105A 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.
  • 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 105A 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 105A 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.
  • Resection Equipment 110 (not shown in FIG.1) performs bone or tissue resection using, for example, mechanical, ultrasonic, or laser techniques. Examples of 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. In some embodiments, 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 also can include 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 105A or cutting guides can be separate structures that can be matingly and/or removably attached to the Effector Platform 105 or robotic arm 105A.
  • PT-5962-WO-PCT/D030102 PATENT 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.
  • data from the Tracking System 115 can be used to infer velocity/acceleration of anatomy/instrumentation, which can be used for tool control.
  • 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.
  • imaging capability can give a more robust image of the environment for modeling using multiple perspectives.
  • some 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 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT 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.
  • specific objects can be manually registered by a surgeon with the system preoperatively or intraoperatively.
  • a surgeon may identify the starting location for a tool or a bone structure.
  • 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 also can 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. For example, a QR code may be placed in a corner of a tool tray, allowing the orientation and identity of that tray to be tracked. Other tracking modalities are explained throughout. For example, in some embodiments, augmented reality (AR) headsets can be worn by surgeons and other staff to provide additional camera angles and tracking capabilities.
  • AR augmented reality
  • the infrared/time of flight sensor data which is predominantly used for hand/gesture detection, can build correspondence between the AR headset and the tracking system of the robotic system using sensor fusion techniques. This can be used to calculate a calibration matrix that relates the optical camera coordinate frame to the fixed holographic world frame.
  • 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. For example, 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 also can 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 probe 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 probe 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 probe or other means.
  • the registration process also can include determining various axes of a joint.
  • 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. For example, in one embodiment, 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.
  • GUIs graphical user interfaces
  • 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.
  • a tracker array-mounted surgical tool could be 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT detected by both the IR camera and an AR headset (HMD) using sensor fusion techniques without the need for any “intermediate” calibration rigs.
  • This near-depth, time-of-flight sensing camera located in the HMD could be used for hand/gesture detection.
  • the headset’s sensor API can be used to expose IR and depth image data and carryout image processing using, for example, C++ with OpenCV. This approach allows the relationship between the CASS and the virtual coordinate frame to be determined and the headset sensor data (i.e., IR in combination with depth images) to isolate the CASS tracker arrays.
  • the image processing system on the HMD can locate the surgical tool in a fixed holographic world frame and the CASS IR camera can locate the surgical tool relative to its camera coordinate frame. This relationship can be used to calculate a calibration matrix that relates the CASS IR camera coordinate frame to the fixed holographic world frame.
  • 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.
  • Various techniques generally known in the art can be used for connecting the Surgical Computer 150 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. 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT Robotic Arm [0093]
  • the CASS 100 includes a robotic arm 105A 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 105A 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 105A 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 105A. The surgeon or other healthcare professional may engage with the one or more input sources to position the robotic arm 105A 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 105A, but motor control operation may reside within the tool itself.
  • the robotic arm 105A 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 105A, 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 105A may be tracked, for example, by a controller or the Surgical Computer 150. [0097] In some embodiments, 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 105A 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 105A may 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT 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 105A 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 105A 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.
  • the surgeon can activate the foot pedal to instruct the CASS 100 to place the robotic arm 105A 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 also can 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 105A or end effector 105B medially or laterally, while restricting movement in other directions.
  • the robotic arm 105A 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 105A 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 105A may be used for holding the retractor.
  • the robotic arm 105A may be moved into the desired position by the surgeon. At that point, the robotic arm 105A may lock into place.
  • the robotic arm 105A is provided with data regarding the patient’s position, such that if the patient 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT 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 105A 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 105A 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 105A 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 105A may prevent any further seating to prevent damage to the pelvis.
  • the surgeon may use the robotic arm 105A 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 105A may restrict the handle to prevent further advancement of the broach.
  • the robotic arm 105A may also be used for resurfacing applications. For example, the robotic arm 105A 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.). Where only a burr is employed, 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 105A may be a passive arm.
  • the robotic arm 105A may be a CIRQ robot arm available from Brainlab AG.
  • CIRQ is a registered trademark of Brainlab AG, Olof-Palme-Str.981829, Ober, FED REP of GERMANY.
  • the robotic arm 105A is an intelligent holding arm as disclosed in U.S. Patent Application No.15/525,585 to Krinninger et al., U.S. Patent Application No. 15/561,042 to Nowatschin et al., U.S. Patent Application No.15/561,048 to Nowatschin et al., and U.S.
  • Surgical Procedure Data Generation and Collection The various services that are provided by medical professionals to treat a clinical condition are collectively referred to as an “episode of care.”
  • the episode of care can include three phases: pre-operative, intra-operative, and post-operative.
  • data is collected or generated that can be used to analyze the episode of care in order to understand various features 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 post- operative 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 real-time 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 intra-operative 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 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT 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.
  • the data gathered during the episode of care may be used as an input to other procedures ancillary to the surgery.
  • implants can be designed using episode of care data. Example data-driven techniques for designing, sizing, and fitting implants are described in U.S.
  • 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).
  • EMR electronic medical record
  • patient information 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. For example, in one embodiment, 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 1610184997.2 Attorney Docket No.
  • FIGS.2A and 2B provide examples of data that may be acquired during the intra- operative 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.2A 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.
  • FIG.2A assumes that the components of the Effector Platform 105 are each controlled directly by the Surgical Computer 150.
  • instructions may be provided on the Display 125 or AR HMD 155 instructing the Surgeon 111 how to move the component.
  • 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.2A 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 105A are operatively coupled with cutting guide 105D.
  • the robotic arm 105A 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.
  • 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.
  • a surgeon can use any suitable tool, such as an oscillating or rotating saw or drill to perform the cut (or drill a hole) with perfect placement and orientation because the tool is mechanically limited by the features of the cutting guide 105D.
  • the 1610184997.2 Attorney Docket No.
  • PATENT 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 105A 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. In some embodiments, where the arthroplasty is a hip arthroplasty, cutting guide 105D can be fixed to the femoral head or the acetabulum for the respective hip arthroplasty resection.
  • 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.
  • the Surgical Computer 150 provides the Display 125 with any visualization that is needed by the Surgeon 111 during surgery. For monitors, the Surgical Computer 150 may provide instructions for displaying images, GUIs, etc. using techniques known in the art.
  • the display 125 can include various portions of the workflow of a surgical plan.
  • the display 125 can show a preoperatively constructed 3D bone model and depict the locations of the probe 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.
  • the display 125 in connection with a TKA, 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 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT depict how such angles will be affected if contemplated revisions to the surgical plan are made.
  • 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. Various patient-specific information can be displayed, including real-time data concerning the patient’s health such as heart rate, blood pressure, etc.
  • the display 125 also can 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 also can 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 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT manually perform other resections (anterior, posterior and chamfer cuts) using conventional means, such as a 4-in-1 cutting guide or jig 105D.
  • the display 125 can employ different colors to inform the surgeon of the status of the surgical plan.
  • un-resected bone can be displayed in a first color
  • resected bone can be displayed in a second color
  • 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 also can preselect that certain steps be included or deleted from the standard surgical workflow display. For example, if a surgeon 111 uses resection measurements to finalize an implant plan but does not analyze ligament gap balancing when finalizing the implant plan, 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, for example, can include pre- and post-resection 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.
  • 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 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT to perform cutting and other surgical activities.
  • 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.2C).
  • 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 WIPO Publication No.2020/037308, filed August 19, 2019, entitled “Patient Specific Surgical Method and System,” the entirety of which is incorporated herein by reference.
  • FIG.2B 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.2B), the Surgical Computer can identify deviations that take place during surgery. [0125]
  • 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. Similarly, 1610184997.2 Attorney Docket No.
  • 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.
  • various types of data can be collected to quantify the overall improvement or deterioration in the patient’s condition as a result of the surgery.
  • 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
  • the post-operative quality of life can be measured with a EQ5D-5L questionnaire.
  • 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.
  • 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 a patient.
  • the Surgical Computer 150 or other 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT 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). Alternatively, or additionally, 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.
  • 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. For example, a portable storage device (e.g., USB stick) can be attached to the Surgical Computer 150 into order to retrieve data collected during surgery. The data can then be transferred, for example, via a desktop computer to the centralized storage.
  • a portable storage device e.g., USB stick
  • FIG.2C 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.2C shows three 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.).
  • 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 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT 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 post- surgery.
  • 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.
  • 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). Any type of No-SQL database may be used to implement the various embodiments described herein and, in some embodiments, the different types of databases may support the Episode of Care Database 185. [0132] 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.
  • 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
  • the architecture shown in FIG.2C 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.
  • 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
  • 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 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT 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.2A–C 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.
  • Fiducial Marker Assemblies for Navigated Surgical Procedures [0136] Described herein are fiducial marker assemblies for use in conjunction with a surgical navigation system or CASS, such as are described above, for the performance of a navigated surgical procedure, such as a TKA.
  • fiducial markers can have blind spots in particular orientations, i.e., there can be orientations relative to the navigation system where the fiducials may not be identifiable thereby. This can be an issue in surgical procedures because it can be time-consuming to properly place fiducial markers and ensure that they are all individually identifiable by the navigation system. Further, the operating room is a dynamic environment, and a fiducial marker that is initially properly oriented with respect to the navigation system may become moved or mis-oriented during the course of the procedure. In contrast, the fiducial markers described herein are designed to be identifiable by a surgical navigation system from substantially any angle.
  • fiducial markers are more efficient to set up and more robustly account for movements during the surgical procedure, which reduces the potential for intraoperative 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT navigation errors and minimizes the need to periodically adjust and re-register the fiducial markers with the navigation system.
  • the fiducial marker assemblies described herein could be used for image-free orthopedic navigated surgery (e.g., a TKA).
  • the fiducial markers are designed to assist the surgeon in controlling surgical variables for obtaining optimal implant alignment by increasing the operational efficiency and preventing navigation errors due to mis-identified fiducials.
  • the fiducial marker assemblies could also be used in image-based orthopedic procedures, wherein a patient-specific 3D bone model is used to match the patient’s anatomy, as opposed to using bony landmarks.
  • some or all of the instrumentation described herein can be disposable, which could represent a commercial and/or clinical advantage over conventional systems that rely on equipment that is expensive to clean and/or store.
  • the instrumentation described herein could be implant-agnostic, which could represent a commercial and/or clinical advantage over conventional systems that have limited or no interoperability (i.e., are manufacturer-specific).
  • the surgical equipment kit described herein can include fiducial markers that can be attached to the femur and tibia of the patient using conventional fasteners (e.g., 3.2 mm Steinmann pins).
  • the probe (which could be pre- calibrated from the factory) could be used to sample anatomical landmarks.
  • the probe could thereafter be inserted into the cut guide (which, once again, could be pre-calibrated from the factory) to provide guidance to the surgeon on where to perform the desired cuts.
  • the internal rotation guide could be secured to the cut guide and the probe to guide the drilling of the holes for the femoral finishing block.
  • the surgical equipment kit described herein can utilize the same fiducial markers to perform a complete surgical procedure (e.g., a TKA) without the need to individually register and calibrate each component of the surgical equipment kit with the surgical navigation system.
  • the fiducial markers described herein can be configured to be viewable from substantially any orientation. Stated differently, the fiducial markers can lack any “blind spots” that prevent less than two fiducials from being visible from a particular orientation.
  • the fiducial markers 200 include multiple faces 202 and each of the faces 202 include a fiducial 204. In one embodiment shown in FIGS.
  • the fiducial marker 200 can include a combination of a hexagonal prism body portion and a triangular prism top portion.
  • the fiducial marker 200 includes nine faces 202 (six faces for the hexagonal prism body portion and three faces from the triangular 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT prism top portion) that each bear a fiducial 204.
  • the illustrated embodiments for the fiducial marker 200 are provided simply for illustrative purposes and other embodiments could be arranged in a variety of other shapes and configurations.
  • the fiducial marker 200 is configured such that at least two of the faces 202 (and, thus, the corresponding fiducials 204) are visible from substantially any orientation, except from a straight-on bottom view (where none of the faces 202 would be visible). Because at least two faces 202 of the fiducial markers 200 are visible from substantially any orientation, the various embodiments of the fiducial marker 200 are more efficient to utilize intraoperatively because they do not need to be placed and oriented in precise manner to ensure that they are properly registered by the tracking system 115 and, further, more robustly account for movement within the operating room (e.g., movement of the patient by the surgical team or movement of the tracking system 115 during the procedure).
  • the various configurations of the fiducial markers 200 maximize the visibility of more than one face 202, minimize the occurrences of particular orientations that increase the chance for errors due to homography estimation of the planar faces, and minimize of the presence of over-slanted faces 202 in particular orientations.
  • the fiducials 204 can include, for example, passive fiducials that are identifiable by the tracking system 115 (FIGS.2A and 2B) of a surgical navigation system. Passive fiducials could include reflective fiducials (e.g., infrared- reflective fiducials), QR-code based fiducials, and any other type of fiducials that are identifiable by a surgical navigation system.
  • the fiducials 204 could include active fiducials.
  • the fiducial markers 200 can be constructed from a biocompatible material (e.g., a biocompatible plastic).
  • the fiducials 204 can further be utilized in an augmented reality (AR) system.
  • AR augmented reality
  • the fiducials 204 could be individually identifiable, allowing for information to be rendered over the anatomy in real-time via an AR-enabled display device (e.g., a head-mounted display, a smartphone, or a tablet).
  • the fiducials 204 could be utilized in an endoscopic surgical system.
  • fiducial markers 200 can include a variety of different configurations that allow them to be attached to different devices and utilized for different purposes. For 1610184997.2 Attorney Docket No.
  • FIGS.3A–5E illustrate embodiments of fiducial markers 200 that are designed to be affixed to patients’ bones (e.g., the tibia and/or femur) and FIGS.6A–7B illustrate an embodiment of a fiducial marker 200 that is designed to be affixed to a probe 250 (which can in turn be used in combination with a number of other devices, as shown in FIGS.8–22B and described below).
  • the various embodiments of bone and probe-affixed fiducial markers 200 are described below.
  • Conventional fiducial markers are generally intraoperatively affixed to a patient’s bone via a single fastener.
  • this single-pin attachment technique creates issues because the fiducial marker could be moved or reoriented if torsional forces are applied to the fiducial marker, which in turn can cause the fiducial marker to no longer be properly oriented with respect to the tracking system 115 and can force the surgical team to re-register the fiducial marker(s) with the surgical navigation system.
  • This process is inefficient and delays the surgical procedure. Therefore, the embodiments of the fiducial markers 200 that are designed to be affixed to a patient’s bone 224 are configured such that they will not rotate or otherwise reorient intraoperatively in response to torsional forces applied thereto.
  • a fiducial marker 200 configured to be affixed to a bone 224 via fasteners 222 can include two or more channels 220 that are arranged at angles with respect to each other.
  • the channels 220 can be configured to receive a fastener 222 therethrough, such as a Steinman pin.
  • the channels 220 extend through the body of the fiducial marker 200 and are angled with respect to each so that the fasteners 222 inserted therethrough are oriented at corresponding angles with respect to each other.
  • the fiducial marker 200 can be affixed to the patient’s bone 224 via fasteners 222 inserted through each of the channels 220.
  • the fiducial marker 200 is affixed in place in a manner that prevents both translational and rotational movement of the fiducial marker 200 relative to the bone 224, as shown in FIG.3K.
  • the fasteners 222 could be attached backwards into the fiducial marker 200 to avoid causing debris from the sharp tip of the fastener 222 drilling into the fiducial marker 200. Due to the stiffness of the fasteners 222, friction, and the fact that the orientations of the fasteners 222 are not on the same plane, the fasteners 222 stabilize the fiducial marker 200 and accordingly secure the fiducial marker 200 in position relative to the bone 224.
  • a fiducial marker 200 configured to be affixed to a bone 224 via fasteners 222 can include a threaded aperture 210 that is 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT configured to receive a set screw 211 therethrough.
  • the threaded aperture 210 can be oriented generally transversely with respect to the channels 220. Further, the threaded aperture 210 intersects with one or more of the fastener channels 220 such that the set screw 211 inserted through the threaded aperture 210 can frictionally engage with a fastener 222 inserted therethrough, as shown in FIG.4E.
  • the set screw 211 can fix the fiducial marker 200 at the desired height and prevent the fiducial marker 200 from rotating with respect to the fasteners 222. Accordingly, the set screw 211 can be used as an alternative or additional mechanism for securing the fiducial marker 200 in place along the fasteners 222 and, thereby, relative to the bone 224.
  • the channels 220 can be angled, as in the embodiment shown in FIGS.3A–3K, or oriented parallel with respect to each other, as shown in FIGS.4C–4E.
  • a fiducial marker 200 configured to be affixed to a bone 224 via fasteners 222 can include a threaded channel 212 that is configured to engage with a corresponding threaded fastener 223.
  • the threaded channel 212 can replace one or more of the channels 220 described above with respect to the embodiments shown in FIGS.3A–4E.
  • the threaded channel 212 can be configured to engage with a corresponding threaded portion of a fastener 222.
  • the fiducial marker 200 can be fixed at the desired height and prevented from rotating with respect to the fasteners 222, as shown in FIG.5E.
  • different embodiments of the fiducial markers 200 can be intended for different intraoperative purposes.
  • the embodiments of the fiducial markers 200 described above with respect to FIGS.3A–5E can be intended to be intraoperatively affixed to a patient’s bone 224.
  • alternative embodiments of the fiducial markers 200 can be intended to be intraoperatively affixed to other devices.
  • FIGS.6A–6C illustrate an embodiment of a fiducial marker that is designed to be affixed to a probe 250, as shown in FIGS.7A and 7B.
  • the fiducial markers 200 can further include a recessed interior 206 and a connector 208 that is configured to engage with the probe 250.
  • the probe 250 could include, for example, a point probe as described above.
  • the connector 208 could include threading that is configured to engage with a 1610184997.2 Attorney Docket No. PT-5962-WO-PCT/D030102 PATENT corresponding threaded portion 252 on the probe 250.
  • the connector 208 could include a friction fit connector, snap fit connectors, and so on.
  • the probe 250 can further be configured to engage with a variety of other components of the surgical system, thereby allowing the probe 250 with the fiducial marker 200 affixed thereto to be used throughout the surgical procedure without the need to separately register each individual piece of surgical equipment. Therefore, the surgical team would only need to register a single piece of equipment, i.e., the probe 250, and could reuse the registered probe 250 for all of the other pieces of surgical equipment. Not having to separately register each individual piece of surgical equipment greatly increases the efficiency of performing the surgical procedure.
  • the ability to reuse a single fiducial marker 200 by alternatively attaching the probe 250 to different pieces of equipment obviates the need for separate fiducial markers 200 to be affixed to each piece of surgical equipment, which greatly decreases the overall cost of the surgical equipment kit because the fiducials 204 are generally one of, if not the most, expensive components of the surgical equipment kit.
  • the probe 250 could be configured to engage with, for example, a cut guide 300 (FIGS.8–12B), an internal rotation guide 350 (FIGS.13A–14C), a plane tool 400 (15A–21B), and/or a probe holder 450 (FIGS.22A and 22B).
  • FIGS.8–12B illustrate a cut guide 300 including a slot 302 or recess that is configured to receive the length of body portion of the probe 250 therein.
  • the slot 302 can include threading that is configured to engage with corresponding threading on the probe 250.
  • Other embodiments can utilize other mechanisms for securing the probe 250 to the cut guide 300.
  • the cut guide 300 can be utilized for both femoral and tibial bone resections, as well as being used to guide the positioning of the finishing block for the anterior, posterior, and oblique femoral resections. Furthermore, it can be used to record the performed cuts, allowing the operator to rectify an execution error or to tweak the following cuts.
  • FIGS.9A–9C illustrate the performance of a femoral distal cut using the probe-containing cut guide 300
  • FIGS.10A–10C illustrate the performance of a tibial proximal cut using the cut guide 300
  • FIGS.11A and 11B illustrate the use of the cut guide 1610184997.2 Attorney Docket No.
  • FIGS.13A–14C illustrate an internal rotation guide 350 that is configured to engage with the probe 250.
  • the internal rotation guide 350 could include a 352 or recess that is configured to receive the length of body portion of the probe 250 therein.
  • the internal rotation guide 350 is configured to engage with the body portion of the cut guide 300.
  • a finishing block is used to perform the anterior, posterior, and oblique cuts.
  • the placement of the finishing block is crucial to achieve the desired ligament gap and internal rotation.
  • the internal rotation guide 350 is utilized to guide the placement of the finishing block pins in the distal cut. Using the internal rotation guide 350 is critical to guide the placement of the finishing block pins because the pins are spaced at a distance that is not constant across manufacturers; therefore, the internal rotation guide 350 must precisely guide the placement of the finishing block pins.
  • the internal rotation guide 350 can thereafter be utilized to perform a number of different surgical cuts or other surgical steps.
  • FIGS.14A–14C illustrate the use of the internal rotation guide 350 for placement of the pins for the finishing block on the femoral distal cut.
  • FIGS.15A–21B illustrate a plane tool 400 that is configured to engage with the probe 250.
  • the plane tool 400 can include a slot 402 or recess that is configured to receive the length of body portion of the probe 250 therein, as shown in FIGS. 16A and 16B.
  • the slot 402 can include threading that is configured to engage with corresponding threading on the probe 250.
  • Other embodiments can utilize other mechanisms for securing the probe 250 to the plane tool 400.
  • the plane tool 400 similarly to the cut guide 300, is designed to guide the distal and/or proximal cuts, perform bone resection verifications, and guide the placement of the finishing block pins in the distal cut.
  • FIG. 17A–18B illustrate the use of the plane tool 400 with the probe 250 secured thereto for guiding the femoral distal cut (FIGS.17A and 17B) and the tibial proximal cut (FIGS.18A and 18B).
  • the plane tool 400 is used in conjunction with standard cutting guides. After inserting the plane tool 400 into the cutting guide slots, the operator can adjust the positioning of the cutting guide. When the desired positioning is reached, the operator can secure the cutting guide and the plane tool 400 in place by hand and drill two pins to secure the cutting guide against the bone surface. With the fiducial marker 200 and the probe 250 affixed thereto, these steps can accordingly be done under proper 1610184997.2 Attorney Docket No.
  • FIGS.19A–20B illustrate the user of the plane tool 400 with the probe 250 secured thereto for verifying the femoral distal cut (FIGS.19A and 19B) and the tibial proximal cut (FIGS.20A and 20B).
  • the planar face of the plane tool 400 can be positioned against the resected surfaces of the bones (i.e., the tibia and femur). Because the planar face of the plane tool 400 is pre- calibrated prior to use, any deviation between the actual cut made intraoperatively and the planned cut can be measured.
  • FIGS.21A and 21B illustrate a probe holder 450 that is configured to receive the probe 250.
  • the probe holder 450 can include a slot 452 or recess that is configured to receive the length of body portion of the probe 250 therein.
  • the slot 452 can include threading that is configured to engage with corresponding threading on the probe 250.
  • the probe holder 450 could include a clamp or other mechanism that allows the probe holder 450 to be secured to an operating table, for example.
  • the probe holder 450 can be utilized to hold the probe 250 at a specific height, in a static position. This configuration allows a surgical navigation system to obtain specific landmarks, such as the hip center of the patient. To calculate the hip center, the surgical team only needs to rotate the patient’s leg around the hip in proximity to the probe holder 450 (with the probe 250 secured thereto) and ensure that the surgical navigation system is detecting both the fiducial marker 200 attached to the probe 250 and any additional fiducials affixed to the patient’s femur.
  • the fiducial marker assemblies are highly beneficial because at least two of their faces can be identified by a surgical navigation system from nearly any possible orientation, thereby making it more efficient for surgical teams to perform the procedures by reducing the specificity with which the fiducial markers need to be registered with the navigation system. Further, the fiducial marker assemblies described herein can be utilized in combination with a probe and other surgical equipment that is designed to engage with the probe, thereby obviating the need for separate fiducials to be affixed to each piece of surgical 1610184997.2 Attorney Docket No.
  • 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. [0159] In addition, even if a specific number is explicitly recited, those skilled in the art will recognize that such recitation should be interpreted to mean at least the recited number (for example, the bare recitation of "two recitations," without other modifiers, means at least two recitations, or two or more recitations).
  • PT-5962-WO-PCT/D030102 PATENT into at least equal halves, thirds, quarters, fifths, tenths, et cetera.
  • each range discussed herein can be readily broken down into a lower third, middle third and upper third, et cetera.
  • all language such as “up to,” “at least,” and the like include the number recited and refer to ranges that can be subsequently broken down into subranges as discussed above.
  • a range includes each individual member.
  • a group having 1–3 cells refers to groups having 1, 2, or 3 cells.
  • a group having 1–5 cells refers to groups having 1, 2, 3, 4, or 5 cells, 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. Typically, 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.

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Abstract

L'invention concerne un marqueur de repère destiné à être utilisé avec un système de navigation chirurgicale. Le marqueur de repère comprend une pluralité de faces, chacune de la pluralité de faces comprenant un repère configuré pour être identifié par le système de navigation chirurgicale. Au moins deux des repères sont configurés pour être visibles par le système de navigation chirurgicale à partir de sensiblement n'importe quelle orientation. Certains modes de réalisation du marqueur de repère sont configurés pour venir en prise avec une sonde. Certains modes de réalisation du marqueur de repère sont configurés pour être fixés à un os d'une manière qui empêche la rotation du marqueur de repère de manière peropératoire.
PCT/US2024/032963 2023-06-08 2024-06-07 Ensembles marqueurs de repère pour systèmes de navigation chirurgicale Pending WO2024254421A1 (fr)

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