WO2024092178A1 - Guide de coupe de navigation adapté au patient - Google Patents

Guide de coupe de navigation adapté au patient Download PDF

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Publication number
WO2024092178A1
WO2024092178A1 PCT/US2023/077990 US2023077990W WO2024092178A1 WO 2024092178 A1 WO2024092178 A1 WO 2024092178A1 US 2023077990 W US2023077990 W US 2023077990W WO 2024092178 A1 WO2024092178 A1 WO 2024092178A1
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WIPO (PCT)
Prior art keywords
patient
surgical
bone
data
guide
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2023/077990
Other languages
English (en)
Inventor
Constantinos Nikou
Branislav Jaramaz
Ryan L. Landon
Samuel C. DUMPE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smith and Nephew Orthopaedics AG
Smith and Nephew Asia Pacific Pte Ltd
Smith and Nephew Inc
Original Assignee
Smith and Nephew Orthopaedics AG
Smith and Nephew Asia Pacific Pte Ltd
Smith and Nephew Inc
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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 WO2024092178A1 publication Critical patent/WO2024092178A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/14—Surgical saws
    • A61B17/15—Guides therefor
    • A61B17/154—Guides therefor for preparing bone for knee prosthesis
    • A61B17/157—Cutting tibia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
    • A—HUMAN NECESSITIES
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    • 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
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    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00207—Electrical control of surgical instruments with hand gesture control or hand gesture recognition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2017/1602—Mills
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
    • A—HUMAN NECESSITIES
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    • 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
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    • A61B90/06—Measuring instruments not otherwise provided for
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    • 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
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    • 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
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    • 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
    • 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
    • A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders

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 and apparatuses 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 Computer assisted methods have been developed that provide a graphical image of a resected bone and design software has enabled surgeons to surgically install an implant that fits the resected portion of the bone more precisely.
  • a surgeon typically registers the patient's anatomical site by touching various landmarks around the patient's joint using a registration tool.
  • a surgical tool e.g., a cutter
  • the surgical tool may be guided by a computer-assisted system.
  • registration by this process is time-consuming and prone to errors.
  • the surgeon must hold the registration tool steady against a smooth bone surface for a period of time to accurately obtain registration. For example, while the surgeon holds the tool in place, an assistant may need to identify the specific registration point selected on an input device.
  • PSI Patient-specific instrument
  • a patient-matched surgical guide includes a first portion including an inner surface configured to align the first portion with a known location of a patient's bone and a second portion, removably interfaced to the first portion, that includes a cut guide configured to guide a resection tool along a predetermined resection geometry in reference to the known location.
  • the second portion is further configured to be pinned, with one or more second pins, to the patient's bone when positioned based on the alignment of the first portion.
  • the first portion is configured to be removed without interference to the position of the second portion.
  • the inner surface is configured to only align the first portion with the known location of the patient's bone in one spatial orientation.
  • at least one of the first portion and the second portion further includes an externally interfaced tracking element. ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ [0011]
  • at least one of the first portion and the second portion further includes an integrated tracking element.
  • the second portion includes one or more separately removable portions.
  • the first portion is further configured to be interfaced to the patient's bone at the known location with one or more first pins.
  • the first portion is further configured to be removed without removing at least one of the one or more first pins.
  • the first portion includes at least one pin interface, wherein the angle of an inserted pin in the at least one pin interface intersects the predetermined resection geometry at a predetermined cut depth.
  • at least one of the one or more first pins and the one or more second pins include integrated tracking markers.
  • the predetermined resection geometry is a planar cut and at least two of the second pins are configured to guide the planar cut.
  • the surgical guide is 3D printed.
  • a tracking element is printed directly into the surgical guide.
  • the interface between the first portion and the second portion includes a breakable feature.
  • the interface between the first portion and the second portion includes at least one of a tab, a pin, a clip, a fastener, or an adhesive.
  • the interface between the first portion and the second portion includes an irregular surface on the first portion and a conforming surface on the second portion.
  • a system for performing a computer-assisted surgical procedure on a bone of a patient includes a patient-matched surgical guide configured to couple to the bone in a single spatial orientation, a surgical tool, and a tracking device.
  • the patient-matched surgical guide includes a first portion, a second portion, and a first tracking element.
  • the first portion includes an inner surface that conforms to a patient's bone in a known location based on an alignment of the inner surface to the patient's bone.
  • the second portion is removably interfaced to the first portion and includes a cut guide configured to ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No.
  • PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ guide a resection tool along a predetermined resection geometry in reference to the known location.
  • the first portion is configured to be removed without interference to a position of the second portion.
  • the surgical tool includes a cutting tip and a second tracking element.
  • the tracking device includes one or more sensors configured to detect the location of the first and second tracking element with respect to the known location after removal of the first portion.
  • the second portion is configured to be pinned to the patient’s bone, using one or more pins, when in a position based on the alignment of the first portion.
  • the predetermined resection geometry is a planar cut and at least two of the one or more pins are configured to guide the planar cut.
  • the inner surface is configured to interface to the patient's bone in only one spatial orientation.
  • a method of resection associated with a knee joint includes affixing a first tracking element to the femur, transferring registration data from the femur to a multibody patient-specific instrument, wherein the multibody patient-specific instrument comprises a second tracking element, an articular portion, and a cut guide portion, affixing the multibody patient-specific instrument to the tibia, removing the articular portion, tensioning ligaments associated with the knee joint, and resecting the tibia using the cut guide portion.
  • the method further includes acquiring, using a processor, tensioning data based on the tensioning of the ligaments, and determining, using the processor, a position of a femoral implant using the tensioning data.
  • 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.
  • 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.
  • FIGS.3-14 illustrate a surgical system employing a patient-specific instrument as applied in a surgical procedure in accordance with an embodiment.
  • FIG.15 depicts a multibody patient-specific instrument interfaced to a patient’s anatomy in accordance with an embodiment.
  • FIG.16 depicts a multibody patient-specific instrument with an interface external tracker in accordance with an embodiment.
  • FIG.17 depicts a multibody patient-specific instrument with a removed portion in accordance with an embodiment.
  • FIG.18 depicts a multibody patient-specific instrument with an integrated tracker in accordance with an embodiment.
  • FIG.19 illustrates an example workflow for the usage of multibody patient- specific instrument in accordance with an embodiment.
  • the term “implant” is used to refer to a prosthetic device or structure manufactured to replace or enhance a biological structure.
  • a prosthetic acetabular cup (implant) is used to replace or enhance a patients worn or damaged acetabulum.
  • the term “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.
  • bone or “bony anatomy” are used to refer to anatomical features of sufficient structure to support surgical blocks and/or tracking elements. Bone may refer to bone (e.g., compact and spongy) and cartilage. ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No.
  • FIG.1 provides an illustration of an example computer-assisted surgical system (CASS) 100, according to some embodiments.
  • the CASS uses computers, robotics, and imaging technology to aid surgeons in performing orthopedic surgery procedures such as total knee arthroplasty (TKA) or total hip arthroplasty (THA).
  • TKA total knee arthroplasty
  • THA total hip arthroplasty
  • surgical navigation systems can aid surgeons in locating patient anatomical structures, guiding surgical instruments, and implanting medical devices with a high degree of accuracy.
  • Surgical navigation systems such as the CASS 100 often employ various forms of computing technology to perform a wide variety of standard and minimally invasive surgical procedures and techniques. Moreover, these systems allow surgeons to more accurately plan, track and navigate the placement of instruments and implants relative to the body of a patient, as well as conduct pre-operative and intra-operative body imaging.
  • An Effector Platform 105 positions surgical tools relative to a patient during surgery. The exact components of the Effector Platform 105 will vary, depending on the embodiment employed. 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 ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ 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.
  • 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.
  • the Resection Equipment 110 is held and operated by the surgeon ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ 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.
  • the Effector Platform 105 or Robotic Arm 105A can be controlled by the CASS 100 to position a cutting guide or jig 105D adjacent to the patient’s anatomy in accordance with a pre-operatively or intraoperatively developed surgical plan such that the cutting guide or jig will produce a precise bone cut in accordance with the surgical plan.
  • the Tracking System 115 uses one or more sensors to collect real-time position data that locates the patient’s anatomy and surgical instruments.
  • the Tracking System may provide a location and orientation of the End Effector 105B during the procedure.
  • data from the Tracking System 115 also 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.
  • 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.
  • this can include stereoscopic, tri-scopic, quad-scopic, etc. imaging.
  • additional cameras can be placed ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ throughout the surgical theatre.
  • handheld tools or headsets worn by operators/surgeons can include imaging capability that communicates images back to a central processor to correlate those images with images captured by the camera array. This can give a more robust image of the environment for modeling using multiple perspectives.
  • imaging devices may be of suitable resolution or have a suitable perspective on the scene to pick up information stored in quick response (QR) codes or barcodes. This can be helpful in identifying specific objects not manually registered with the system.
  • the camera may be mounted on the Robotic Arm 105A.
  • image-based tracking systems e.g., IR tracking systems, video or image based tracking systems, etc.
  • EM electromagnetic
  • implantation of standard optical trackers requires tissue resection (e.g., down to the cortex) as well as subsequent drilling and driving of cortical pins.
  • optical trackers require a direct line of sight with a tracking system, the placement of such trackers may need to be far from the surgical site to ensure they do not restrict the movement of a surgeon or medical professional.
  • certain features of objects can be tracked by registering physical properties of the object and associating them with objects that can be tracked, such as fiducial marks fixed to a tool or bone.
  • objects that can be tracked such as fiducial marks fixed to a tool or bone.
  • a surgeon may perform a manual registration process whereby a tracked tool and a tracked bone can be manipulated relative to one another. By impinging the tip of the tool against the surface of the bone, 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.
  • 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 ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ 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.
  • 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
  • HMD Head Mounted Device
  • 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 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 ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ relationship can be used to calculate a calibration matrix that relates the CASS IR camera coordinate frame to the fixed holographic world frame. This means that if a calibration matrix has previously been calculated, the surgical tool no longer needs to be visible to the AR headset.
  • 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.
  • Powered Impaction and Acetabular Reamer Devices [0059] Part of the flexibility of the CASS design described above with respect to FIG.1 is that additional or alternative devices can be added to the CASS 100 as necessary to support particular surgical procedures.
  • the CASS 100 may include a powered impaction device. Impaction devices are designed to repeatedly apply an impaction force that the surgeon can use to perform activities such as implant alignment.
  • impaction devices can be manual in nature (e.g., operated by the surgeon striking an impactor with a mallet), powered 11 ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ impaction devices are generally easier and quicker to use in the surgical setting.
  • Powered impaction devices may be powered, for example, using a battery attached to the device.
  • Various attachment pieces may be connected to the powered impaction device to allow the impaction force to be directed in various ways as needed during surgery.
  • the CASS 100 may include a powered, robotically controlled end effector to ream the acetabulum to accommodate an acetabular cup implant.
  • the patient’s anatomy can be registered to the CASS 100 using CT or other image data, the identification of anatomical landmarks, tracker arrays attached to the patient’s bones, and one or more cameras.
  • Tracker arrays can be mounted on the iliac crest using clamps and/or bone pins and such trackers can be mounted externally through the skin or internally (either posterolaterally or anterolaterally) through the incision made to perform the THA.
  • the CASS 100 can utilize one or more femoral cortical screws inserted into the proximal femur as checkpoints to aid in the registration process.
  • the CASS 100 also can utilize one or more checkpoint screws inserted into the pelvis as additional checkpoints to aid in the registration process.
  • Femoral tracker arrays can be secured to or mounted in the femoral cortical screws.
  • the CASS 100 can employ steps where the registration is verified using a probe that the surgeon precisely places on key areas of the proximal femur and pelvis identified for the surgeon on the display 125.
  • Trackers can be located on the robotic arm 105A or end effector 105B to register the arm and/or end effector to the CASS 100.
  • the verification step also can utilize proximal and distal femoral checkpoints.
  • the CASS 100 can utilize color prompts or other prompts to inform the surgeon that the registration process for the relevant bones and the robotic arm 105A or end effector 105B has been verified to a certain degree of accuracy (e.g., within 1mm).
  • the CASS 100 can include a broach tracking option using femoral arrays to allow the surgeon to intraoperatively capture the broach position and orientation and calculate hip length and offset values for the patient. Based on information provided about the patient’s hip joint and the planned implant position and orientation after broach tracking is completed, the surgeon can make modifications or adjustments to the surgical plan.
  • the CASS 100 can include one or more powered reamers connected or attached to a robotic arm 105A or end effector 105B that prepares the pelvic bone to receive an acetabular implant according to a surgical plan.
  • the robotic arm 105A and/or end effector 105B can inform the surgeon and/or control the power of the reamer to ensure that the acetabulum is being resected (reamed) in accordance with the ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ surgical plan.
  • the CASS 100 can power off the reamer or instruct the surgeon to power off the reamer.
  • the CASS 100 can provide the surgeon with an option to turn off or disengage the robotic control of the reamer.
  • the display 125 can depict the progress of the bone being resected (reamed) as compared to the surgical plan using different colors. The surgeon can view the display of the bone being resected (reamed) to guide the reamer to complete the reaming in accordance with the surgical plan.
  • the CASS 100 can provide visual or audible prompts to the surgeon to warn the surgeon that resections are being made that are not in accordance with the surgical plan.
  • the CASS 100 can employ a manual or powered impactor that is attached or connected to the robotic arm 105A or end effector 105B to impact trial implants and final implants into the acetabulum.
  • the robotic arm 105A and/or end effector 105B can be used to guide the impactor to impact the trial and final implants into the acetabulum in accordance with the surgical plan.
  • the CASS 100 can cause the position and orientation of the trial and final implants vis-à-vis the bone to be displayed to inform the surgeon as to how the trial and final implant’s orientation and position compare to the surgical plan, and the display 125 can show the implant’s position and orientation as the surgeon manipulates the leg and hip.
  • the CASS 100 can provide the surgeon with the option of re-planning and re-doing the reaming and implant impaction by preparing a new surgical plan if the surgeon is not satisfied with the original implant position and orientation.
  • the CASS 100 can develop a proposed surgical plan based on a three dimensional model of the hip joint and other information specific to the patient, such as the mechanical and anatomical axes of the leg bones, the epicondylar axis, the femoral neck axis, the dimensions (e.g., length) of the femur and hip, the midline axis of the hip joint, the ASIS axis of the hip joint, and the location of anatomical landmarks such as the lesser trochanter landmarks, the distal landmark, and the center of rotation of the hip joint.
  • the CASS-developed surgical plan can provide a recommended optimal implant size and implant position and orientation based on the three dimensional model of the hip joint and other information specific to the patient.
  • the CASS-developed surgical plan can include proposed details on offset values, inclination and anteversion values, center of rotation, cup size, medialization values, superior-inferior fit values, femoral stem sizing and length.
  • the CASS-developed surgical plan can be viewed preoperatively and intraoperatively, and the surgeon can modify CASS-developed surgical plan preoperatively ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ or intraoperatively.
  • the CASS-developed surgical plan can display the planned resection to the hip joint and superimpose the planned implants onto the hip joint based on the planned resections.
  • the CASS 100 can provide the surgeon with options for different surgical workflows that will be displayed to the surgeon based on a surgeon’s preference. For example, the surgeon can choose from different workflows based on the number and types of anatomical landmarks that are checked and captured and/or the location and number of tracker arrays used in the registration process.
  • a powered impaction device used with the CASS 100 may operate with a variety of different settings. In some embodiments, the surgeon adjusts settings through a manual switch or other physical mechanism on the powered impaction device. In other embodiments, a digital interface may be used that allows setting entry, for example, via a touchscreen on the powered impaction device.
  • Such a digital interface may allow the available settings to vary based, for example, on the type of attachment piece connected to the power attachment device.
  • the settings can be changed through communication with a robot or other computer system within the CASS 100.
  • Such connections may be established using, for example, a Bluetooth or Wi-Fi networking module on the powered impaction device.
  • the impaction device and end pieces may contain features that allow the impaction device to be aware of what end piece (cup impactor, broach handle, etc.) is attached with no action required by the surgeon, and adjust the settings accordingly. This may be achieved, for example, through a QR code, barcode, RFID tag, or other method.
  • the settings include cup impaction settings (e.g., single direction, specified frequency range, specified force and/or energy range); broach impaction settings (e.g., dual direction/oscillating at a specified frequency range, specified force and/or energy range); femoral head impaction settings (e.g., single direction/single blow at a specified force or energy); and stem impaction settings (e.g., single direction at specified frequency with a specified force or energy).
  • the powered impaction device includes settings related to acetabular liner impaction (e.g., single direction/single blow at a specified force or energy).
  • the powered impaction device may offer settings for different bone quality based on preoperative testing/imaging/knowledge and/or intraoperative assessment by surgeon.
  • the powered impactor device may have a dual function.
  • the powered impactor device not only could provide reciprocating motion to provide an impact force, but also could provide reciprocating motion for a broach or rasp.
  • the powered impaction device includes feedback sensors that gather data during instrument use and send data to a computing device, such as a controller within the device or the Surgical Computer 150.
  • This computing device can then record the data for later analysis and use. Examples of the data that may be collected include, without limitation, sound waves, the predetermined resonance frequency of each instrument, reaction force or rebound energy from patient bone, location of the device with respect to imaging (e.g., fluoro, CT, ultrasound, MRI, etc.) registered bony anatomy, and/or external strain gauges on bones.
  • the computing device may execute one or more algorithms in real-time or near real-time to aid the surgeon in performing the surgical procedure.
  • the computing device uses the collected data to derive information such as the proper final broach size (femur); when the stem is fully seated (femur side); or when the cup is seated (depth and/or orientation) for a THA.
  • information such as the proper final broach size (femur); when the stem is fully seated (femur side); or when the cup is seated (depth and/or orientation) for a THA.
  • the information may be displayed for the surgeon’s review, or it may be used to activate haptics or other feedback mechanisms to guide the surgical procedure.
  • the data derived from the aforementioned algorithms may be used to drive operation of the device.
  • the device may automatically extend an impaction head (e.g., an end effector) moving the implant into the proper location, or turn the power off to the device once the implant is fully seated.
  • the derived information may be used to automatically adjust settings for quality of bone where the powered impaction device should use less power to mitigate femoral/acetabular/pelvic fracture or damage to surrounding tissues.
  • Robotic Arm [0071]
  • 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 ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ freedom (like a Spider device) and possess 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.
  • 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 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.
  • 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 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.
  • ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇
  • 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 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 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.).
  • 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.
  • ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ [0083]
  • 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. Patent No.10,342,636 to Nowatschin et al., the entire contents of each of which is herein incorporated by reference.
  • 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.
  • PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ 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 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. Patent No.10,064,686 filed August 15, 2011 and entitled “Systems and Methods for Optimizing Parameters for Orthopaedic Procedures”; U.S. Patent No.10,102,309 filed July 20, 2012 and entitled “Systems and Methods for Optimizing Fit of an Implant to Anatomy”; and U.S. Patent No.8,078,440 filed September 19, 2008 and entitled “Operatively Tuning Implants for Increased Performance,” the entire contents of each of which are hereby incorporated by reference into this patent application. [0087] Furthermore, the data can be used for educational, training, or research purposes.
  • 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. In some ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No.
  • preoperative data used by the CASS 100 includes demographic, anthropometric, cultural, or other specific traits about a patient that can coincide with activity levels and specific patient activities to customize the surgical plan to the patient. For example, certain cultures or demographics may be more likely to use a toilet that requires squatting on a daily basis.
  • FIGS.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 acquired 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. Note that the example of FIG.2A assumes that the components of the Effector Platform 105 are each controlled directly by the Surgical Computer 150. In embodiments where a component is manually controlled by the Surgeon 111, instructions may be provided on the Display 125 or AR HMD 155 to direct the Surgeon 111 how to move the component. [0091] The various components included in the Effector Platform 105 are controlled by the Surgical Computer 150 providing positional commands that instruct the component where to move within a coordinate system.
  • the Surgical Computer 150 provides the Effector Platform 105 with instructions that identify how to react when a component of the Effector Platform 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 the 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.
  • Using the robotic arm 105A to assist with placing the cutting guide 105D can reduce the likelihood of error in placement.
  • a vision system and a processor utilizing that vision system to implement the surgical plan may be used to place a cutting guide 105D at a precise location and in a precise orientation relative to a tibia or femur so that a cutting slot of the cutting guide may be aligned with the cut to be ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No.
  • the cutting guide 105D may include one or more pin holes that are used by a surgeon to drill and screw or pin the cutting guide into place before performing a resection of the patient tissue using the cutting guide. This can free the robotic arm 105A or ensure that the cutting guide 105D is fully affixed without moving relative to the bone to be resected.
  • this procedure can be used to make the first distal cut of the femur during a total knee arthroplasty.
  • the cutting guide 105D can be fixed to the femoral head or the acetabulum for the respective hip arthroplasty resection. It should be understood that any arthroplasty that utilizes precise cuts can use the robotic arm 105A and/or cutting guide 105D in this manner.
  • the Resection Equipment 110 is provided with a variety of commands to perform bone or tissue operations. As with the Effector Platform 105, position information may be provided to the Resection Equipment 110 to specify where it should be located when performing resection.
  • commands provided to the Resection Equipment 110 may be dependent on the type of resection equipment.
  • the commands may specify the speed and frequency of the tool.
  • the commands may specify intensity and pulse duration.
  • Some components of the CASS 100 do not need to be directly controlled by the Surgical Computer 150; rather, the Surgical Computer only needs to activate the component, which then executes software locally specifying the manner in which to collect data and provide it to the Surgical Computer. In the example of FIG.2A, there are two components that are operated in this manner: the Tracking System 115 and the Tissue Navigation System 120.
  • the Surgical Computer 150 provides the display 125 with any visualization that is needed by the Surgeon 111 during surgery.
  • the Surgical Computer 150 may provide instructions for displaying images, GUIs, etc. using techniques known in the art.
  • the display 125 can include various portions of the workflow of a surgical plan. During the registration process, for example, the display 125 can show a preoperatively constructed 3D bone model and depict the locations of the probe as the Surgeon 111 uses the probe to collect locations of anatomical landmarks on the patient.
  • the display 125 can include information ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ about the surgical target area.
  • the display 125 can depict the mechanical and anatomical axes of the femur and tibia.
  • the display 125 can depict varus and valgus angles for the knee joint based on a surgical plan, and the CASS 100 can depict how such angles would be affected if contemplated revisions to the surgical plan were 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. [0096] As the workflow progresses to preparation of bone cuts or resections, 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 were performed. If the surgeon 111 chooses 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. [0097]
  • 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 would 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 would 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 would affect the surgical plan and preview how such implants would be positioned on the bone.
  • the CASS 100 can provide such information for ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ each of the planned bone resections in a TKA or THA. In a TKA, the CASS 100 can provide robotic control for one or more of the planned bone resections.
  • the CASS 100 can provide robotic control only for the initial distal femur cut, and the surgeon 111 can manually perform other resections (anterior, posterior and chamfer cuts) using conventional means, such as a 4-in-1 cutting guide or jig 105D.
  • the display 125 can employ different colors to inform the surgeon of the status of the surgical plan. For example, un-resected bone can be displayed in a first color, resected bone can be displayed in a second color, and planned resections can be displayed in a third color. Implants can be superimposed onto the bone in the display 125, and implant colors can change or correspond to different types or sizes of implants.
  • the information and options depicted on the display 125 can vary depending on the type of surgical procedure being performed. Further, the surgeon 111 can request or select a particular surgical workflow display that matches or is consistent with his or her surgical plan preferences. For example, for a surgeon 111 who typically performs the tibial cuts before the femoral cuts in a TKA, the display 125 and associated workflow can be adapted to take this preference into account. The surgeon 111 also can preselect that certain steps be included or deleted from the standard surgical workflow display.
  • the surgical workflow display can be organized into modules, and the surgeon can select which modules to display and the order in which the modules are provided based on the surgeon’s preferences or the circumstances of a particular surgery.
  • Modules directed to ligament and gap balancing can include pre- and 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 and/or after bone resections are performed.
  • the Surgical Computer 150 may provide images, text, etc.
  • 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.
  • 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.
  • 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 ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ to the surgeon 111.
  • the term “surgical planning model” refers to software that simulates the biomechanics performance of anatomy under various scenarios to determine the optimal way to perform cutting and other surgical activities. For example, for knee replacement surgeries, the surgical planning model can measure parameters for functional activities, such as deep knee bends, gait, etc., and select cut locations on the knee to optimize implant placement.
  • One example of a surgical planning model is the LIFEMODTM simulation software from SMITH AND NEPHEW, INC.
  • the Surgical Computer 150 includes computing architecture that allows full execution of the surgical planning model during surgery (e.g., a GPU-based parallel processing environment).
  • the Surgical Computer 150 may be connected over a network to a remote computer that allows such execution, such as a Surgical Data Server 180 (see FIG.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 each 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. ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ [0104] The Resection Equipment 110 can send various types of data to the Surgical Computer 150 depending on the type of equipment used.
  • Example data types that may be sent include the measured torque, audio signatures, and measured displacement values.
  • the Tracking Technology 115 can provide different types of data depending on the tracking methodology employed.
  • Example tracking data types include position values for tracked items (e.g., anatomy, tools, etc.), ultrasound images, and surface or landmark collection points or axes.
  • the Tissue Navigation System 120 provides the Surgical Computer 150 with anatomic locations, shapes, etc. as the system operates.
  • the Display 125 generally is used for outputting data for presentation to the user, it may also provide data to the Surgical Computer 150.
  • the Surgeon 111 may interact with a GUI to provide inputs which are sent to the Surgical Computer 150 for further processing.
  • the measured position and displacement of the HMD may be sent to the Surgical Computer 150 so that it can update the presented view as needed.
  • 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
  • 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 ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ 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 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 in 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 3 additional data sources: the Patient 160, Healthcare Professional(s) 165, and an EMR Database 170.
  • the Patient 160 can send pre-operative and post-operative data to the Surgical Data Server 180, for example, using a mobile app.
  • the ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ 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 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 into 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. [0111] 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 provides a list of certain identifiers that must ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No.
  • PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ be removed from data during de-identification.
  • the aforementioned de-identification process can scan for these identifiers in data that is transferred to the Episode of Care Database 185 for storage.
  • the Surgical Computer 150 executes the de- identification process just prior to initiating transfer of a particular data item or set of data items to the Surgical Data Server 180.
  • a unique identifier is assigned to data from a particular episode of care to allow for re-identification of the data if necessary.
  • FIGS.2A – 2C 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.
  • Further details of the management of episode of care data are described in International Patent Application No. PCT/US19/67845, filed December 20, 2019 and entitled “METHODS AND SYSTEMS FOR PROVIDING AN EPISODE OF CARE,” the entirety of which is incorporated herein by reference.
  • Open Versus Closed Digital Ecosystems [0115]
  • the CASS 100 is designed to operate as a self-contained or “closed” digital ecosystem.
  • Each component of the CASS 100 is specifically designed to be used in the closed ecosystem, and data is generally not accessible to devices outside of the digital ecosystem.
  • each component includes software or firmware that implements proprietary protocols for activities such as communication, storage, security, etc.
  • the concept of a closed digital ecosystem may be desirable for a company that wants to control all components of the CASS 100 to ensure that certain compatibility, security, and reliability standards are met.
  • the CASS 100 can be designed such that a new component cannot be used with the CASS unless it is certified by the company. ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No.
  • the CASS 100 is designed to operate as an “open” digital ecosystem.
  • components may be produced by a variety of different companies according to standards for activities, such as communication, storage, and security. Thus, by using these standards, any company can freely build an independent, compliant component of the CASS platform. Data may be transferred between components using publicly available application programming interfaces (APIs) and open, shareable data formats.
  • APIs application programming interfaces
  • optimization can refer to selecting optimal parameter(s) based on data from the entire episode of care, including any pre-operative data, the state of CASS data at a given point in time, and post-operative goals. Moreover, optimization may be performed using historical data, such as data generated during past surgeries involving, for example, the same surgeon, past patients with physical characteristics similar to the current patient, or the like. [0118] The optimized parameters may depend on the portion of the patient’s anatomy to be operated on.
  • the surgical parameters may include positioning information for the femoral and tibial component including, without limitation, rotational alignment (e.g., varus/valgus rotation, external rotation, flexion rotation for the femoral component, posterior slope of the tibial component), resection depths (e.g., varus knee, valgus knee), and implant type, size and position.
  • the positioning information may further include surgical parameters for the combined implant, such as overall limb alignment, combined tibiofemoral hyperextension, and combined tibiofemoral resection. Additional examples of parameters that could be optimized for a given TKA femoral implant by the CASS 100 include the following: ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No.
  • the surgical parameters may comprise femoral neck resection location and angle, cup inclination angle, cup anteversion angle, cup depth, femoral stem design, femoral stem size, fit of the femoral stem within the canal, femoral offset, leg length, and femoral version of the implant.
  • Shoulder parameters may include, without limitation, humeral resection depth/angle, humeral stem version, humeral offset, glenoid version and inclination, as well as reverse shoulder parameters such as humeral resection depth/angle, humeral stem version, Glenoid tilt/version, glenosphere orientation, glenosphere offset and offset direction.
  • Various conventional techniques exist for optimizing surgical parameters are typically computationally intensive and, thus, parameters often need to be determined pre-operatively. As a result, the surgeon is limited in his or her ability to make modifications to optimized parameters based on issues that may arise during ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No.
  • FIGS.3-14 illustrate a patient-specific instrument that is designed to conform at least in part to a contour of a patient's unique anatomy.
  • a patient-specific instrument is provided as a distal femoral block 400 comprising one or more mounting devices such as holes 402, 404, 406 for receiving one or more surgical fasteners 502, 504, 506.
  • the block 400 has an anatomy-facing portion 1200 that includes a surface contact, line contact, or point contact with the patient's anatomy 300 (e.g., distal femoral articular cartilage and bone).
  • the block 400 mates with the anatomy 300 in only one spatial orientation within six degrees-of-freedom.
  • Block 400 includes an alignment site in the form of an adapter portion 450 that mates with a complementary adapter portion 760 of a mount 700.
  • the housing receives an array or other tracking element and thus the housing 700 functions as a mount.
  • the block 400 may be held to the patient's native anatomy, or secured thereto using surgical fasteners 502, 504, 506 as shown in FIGS.5 and 6.
  • Mount 700 may then be secured to the block 400 via adapter portions 760, 450 as shown in FIGS.7 and 8.
  • the mount is then secured to the patient's anatomy as shown in FIGS.9 and 10.
  • the mount 700 may have one or more bosses 730, 780 having apertures 732, 782 therein that are suitable for receiving surgical fasteners 903, 905.
  • the block 400 may be removed as shown in FIGS.11 and 12. Small voids 1322, 1324, 1326 may exist where surgical fasteners 502, 504, 506 are removed.
  • the mount 700 may comprise an extension portion 750 and a mounting adapter for receiving an array 1300 having a complimentary mounting adapter 1310.
  • the mounting adapters 710, 1310 preferably rigidly secure the array 1300 to the mount 700 in only one relative spatial orientation within six degrees-of-freedom.
  • the mount 700 may allow for placement in multiple known spatial locations.
  • the mount 700 may be a marked pin allowing for the rotation and or movement of the array along an axis in a detectable manner. Further details on movable tracking arrays are described in International Patent Application No. PCT/US2016/059595, filed October 28, 2016 and entitled ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No.
  • the array 1300 may comprise three or more fiducial markers 1302, 1304, 1306 visible to a receiver 115 of a computer assisted surgical system.
  • the receiver may be mounted to a platform 1318 integral to the array 1300 or block 400.
  • Mounting adapters may comprise portions of tracks, threaded connections, dovetail joints, ball detents, snap-fit releasable connections, quarter-turn fasteners, or magnetized male/female connections.
  • the housing adaptor 710 receives the array 1300 as shown in FIG.13.
  • a location of the surgical tool 1400, as shown in FIG.14, can be tracked with respect to the patient's bone by detecting the position of the surgical tool with respect to the reference array 1300. In this case, the reference array 1300 is directly engaged to the housing 700.
  • Such implementation can eliminate the need to touch the site with the cutter for registration.
  • the surgical tool 1400 may be used to make one or more anatomical changes to the patient's anatomy 300.
  • tool 1400 includes a body 1420, a tracking element 1470, and a cutter 1410.
  • the cutter 1410 is rotatable (e.g., a burr or end mill device) and is computer-controlled to assist the surgeon in making anatomical changes that closely match a preoperatively defined surgical plan.
  • the tracking member 1470 may be provided, for example, as an array.
  • the array may have at least three fiducial markers 1472, 1474, 1476 that may be tracked in space by a receiver 115.
  • a controller sends an input to the tool 1400.
  • the input may comprise, for example, removing current to the tool 1400 or instructing the tool 1400 to retract the cutter 1410, and the response from the tool 1400 may be, for instance, terminating further anatomical changes (e.g., stop cutting).
  • additional components may need to be affixed to the bone that cause additional difficulties. For example, it may be necessary to affix a cutting block to the bone for guided resection.
  • a reference array 700/1300 may interfere or obstruct the surgical site.
  • ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇
  • FIG. 11,253,323 filed November 8, 2017 and entitled “SYSTEMS AND METHODS FOR PATIENT-BASED COMPUTER ASSISTED SURGICAL PROCEDURES,” the entirety of which is incorporated herein by reference.
  • Multibody Patient-Matched Surgical Guides [0131] Patient-matched surgical guides benefit from maximizing the contact area with the bone to ensure the planned fit is achieved.
  • FIG.15 depicts a multibody PSI block 1500 interfaced to a patient’s bone 1510 in accordance with an embodiment.
  • the articular surface, as well as the anterior surface of the femur/tibia may provide a surface with suitable area and shape such that the PSI block 1500 can only be orientated in a single spatial orientation with respect to the anatomy. Due to the resulting coverage of the anatomy, portions of the PSI block 1500 may interfere with some navigated procedures.
  • the PSI block 1500 may comprise an articular portion 1501 and a cut guide portion 1502.
  • the articular portion 1501 may include an inner surface that conforms to a patient’s bone 1510 in a known location based on an alignment of the inner surface to the patient’s bone 1510.
  • a preoperative scan may be used to create a model of at least a portion of the patient’s bone 1510.
  • the model may be used to generate the articular portion 1501 of the PSI block 1500 such that it conforms to the surface of the patient’s bone 1510.
  • the PSI block 1500 may only conform to the surface in one spatial orientation to avoid misplacement of the PSI block 1500.
  • the cut guide portion 1502 may also be configured to conform to the surface of the patient’s bone.
  • the cut guide portion 1502 may not be patient-specific but may instead be malleable to adjust to the surface of the bone 1510.
  • the conformity of the articular potion 1501 may allow for the alignment of the cut guide portion 1502.
  • the articular portion 1501 may provide a reference for registering an external tracking element to the bone.
  • the articular portion 1501, cut guide portion 1502, and tracking element may be removeable from the patient anatomy as separable components.
  • the navigated PSI block 1500 may include integrated tracking markers and no portion of the PSI block may be designed to be removeable.
  • the patient specific attributes of the articular portion 1501 may allow for the proper alignment of the PSI block 1500. Once aligned, one or more vertical pins 1503 may interface the articular portion 1501 to the bone 1510. In some embodiments, the placement of ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No.
  • the pins 1503 may interfere with the resection of the bone. As such, the pins 1503 may be removed prior to resection. In other embodiments, the placement of the pins 1503 may be configured such that the pins intersect the cutting plane, defined by the cutting slot 1506 in the cut guide portion 1502, at a planned depth for the cut. In this configuration, the pin 1503 may be used to guide the surgeon in achieving a specific depth in a cut.
  • the cut guide portion 1502 may be attached, via one or more anterior-posterior pins 1504, relative to the articular portion 1501.
  • both the articular portion 1501 and the cut guide portion 1502 may be interfaced to the patient anatomy as a single unit.
  • the articular portion 1501 may be individually interfaced to the bone 1510, and the cut guide 1502 portion may interface to the articular portion 1501.
  • the cut guide portion 1502 may be attached to the bone 1510 through one or more pin interfaces 1504 when properly aligned.
  • the PSI block may be 3D printed as a joined unit comprising both the articular portion 1501 and the cut guide portion 1502.
  • the two portions 1501/1502 may be joined by a series of 3D-printed posts configured to be snapped apart after installation.
  • the two portions 1501/1502 may be joined after the articular portion 1501 is attached to the bone 1510.
  • the interface between the two portions 1501/1502 may be configured to aid in the alignment of the two portions 1502 with respect to each other.
  • the edges of each portion 1501/1502 may be notched or grooved such that the portions 1501/1502 interlock only in the proper orientation.
  • the PSI block 1500 may comprise one or more interfaces for an external tracker 1600.
  • the interface may be on either portion or between the two portions (i.e., removably interfacing to both portions).
  • the external tracker 1600 may comprise an optical tracker, a magnetic tracker, or a tracker tracked by any other tracking method.
  • the external tracker 1600 may be registered in a navigation system in reference to the known location of the articular portion 1501.
  • the external tracker 1600 is configured to interface to the cut guide portion 1502, either solely or partially.
  • the articular portion 1501 may ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ be removed, by unfastening or breaking tabs and removing the pins 1503 associated with the articular portion 1501, thereby leaving the cut guide portion 1502, such as is depicted in FIG. 17.
  • the bone is tracked, via the external tracker, while the joint is exposed for navigated techniques.
  • the interface to one or more of the pins 1503 may be removed (e.g., snapped off) from the articular portion 1501, allowing the articular portion 1501 to be removed without removal of said pins 1503.
  • the pins 1503 may be used to limit the depth of a cut without the visual occlusion of the articular portion 1501.
  • a cut guide portion may serve other uses than simply being a cut guide.
  • a cut guide portion may include a shaped void for limiting a resection.
  • a cut guide portion may include a small form factor interface for a tracking element.
  • the PSI block 1500 may be designed in different manners to leave a different extent of the bone covered by the cut guide portion 1502 after separation and removal of the articular portion 1502.
  • the proximal end of the femoral guide extends over a ridge/shelf on the lateral knee. In some embodiments, this point can be the extreme extent for the removed articular portion 1501.
  • Bone contacting portions of one or more parts of a PSI block 1500 may be adjustable such that the PSI block 1500 forms a multi-use device that is temporarily configurable to interact with specific portions of more than one of the patient’s bones.
  • a multi-use PSI block 1500 can be sterilizable and can be either adjusted by a manual adjustment process or automatically configured by communication with pre-planning systems that may include software and an automated multi-use PSI block 1500 interface.
  • a multi-use PSI block 1500 may include one or more joints that can be actuated using either an internal or external source.
  • a multi-use PSI block 1500 may be inserted into a device that warps the block into a desired shape using heat and/or pressure.
  • the multi-use PSI block 1500 may be malleable, thereby allowing the block to contour to the bone through the application of one or more pins.
  • At least one of the one or more external trackers may be replaced by an integrated tracking marker disposed on or within the PSI block 1500.
  • FIG.18 depicts a PSI block 1500 with an integrated marker 1802 printed directly on the surface of the block.
  • the tracking markers can be included on any portion of the PSI block 1500.
  • the ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ integrated tracking marker may be 3D printed, laser etched, or ink printed on the PSI block.
  • the integrated tracking marker 1802 may be formed like a QR code.
  • the integrated tracking marker 1802 may be a separately identifiable object such as an oblong cube with markings. Such tracking markers may be printed or integrated into a reasonably flat portion of a PSI block 1500.
  • integrated tracking marker(s) could include reflective material or and assembly of reflective markers or material.
  • the integrated tracking marker may be on the articular portion 1501 or the cut guide portion 1502. Placing an integrated tracking marker on the cut guide portion 1502 may offer benefits throughout more phases of a procedure because the articular portion 1501 may be removed intraoperatively as described herein. An integrated tracking marker could be produced that bridges the articular portion 1501 and the cut guide portion 1502.
  • the bridging integrated tracking marker may be configured to be functional as a marker for at least one of the portions after the articular portion 1501 and the cut guide portion 1502 are separated.
  • a knob with the correct size and shape for either an RBG-D or a stereogrammetric camera to view can be included on an anterior face of the PSI block 1500 in order to establish the position of a tracker or tracker portion.
  • one or more tracking markers are placed on the direct anterior surface. Further, one or more tracking markers may be placed out of plane from the direct anterior surface. In some embodiments, there may be one tracking marker on the medial condyle, one tracking marker on the lateral condyle, and one tracking marker on the direct anterior surface.
  • the navigation system may detect a status of which portions of the multi-body PSI block 1500 are attached, either through computer vision techniques or through an association of trackers with each portion. For example, navigation may simply detect if an articular portion 1501 marker is visible, or detect the relative distance between an articular portion 1501 associated tracking marker and a cut guide portion 1502 associated tracking marker. Based on this information, transitions in the surgical plan may be automatically performed.
  • restrictions such as safe zones associated with the ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ movement of a robotic arm and/or navigated surgical tool may change as portions are removed to signal an advancement to a subsequent step in the surgical plan to the CASS 100.
  • the articular portion 1501 and the cut guide portion 1502 are further separable into one or more pieces. These separate pieces may allow for varying access to the bone 1510. Alternatively, having separate pieces may allow for the removal of a piece without removal of an associated pin.
  • one or more pins may be positioned to act as a guide.
  • two or more pins may be aligned to a cut plane, thereby allowing the surgeon to resect along the pins.
  • two or more pins may be aligned to visually define a cut plane for the surgeon.
  • three or more pins may be aligned to form a cut guide.
  • two pins can guide a cut along a plane, and a third pin can limit the height of the cut.
  • one or more pins may be installed along another axis to limit the resection depth.
  • the tracking system 115 or CASS 100 can be implemented using an augmented reality system or a virtual reality system.
  • the CASS 100 can capture the functional center of a joint by observing the centrode of a tracked bone when part of the joint is immobilized. Joint centers can also be approximated from surface points captured on externally palpable anatomic references. The observed and/or approximated joint centers can be used to establish primary reference axes and planes that aid the data acquisition process. For example, if points are probed on the joint surface or the metaphysis, a distal or proximal joint center can provide an axial check of improbable points collected or improbable instrument placement.
  • pre-operative data about the patient’s deformity can be compared to the guide’s placement relative to an initial axis drawn between the guide’s proximal/distal joint center and its adjacent joint center. If the angular measurement between the provisional axis and the planned axis exceeds an expected variance, an internal quality assurance process can be triggered and/or the user can be encouraged to verify the guide’s placement (e.g., visually comparing it to the pre-operative plan).
  • the CASS 100 can use the data to extend the user’s awareness of the quality of their input.
  • the apposition of the joint surface and the tip of a registration tool that is being tracked by a tracker can help establish a point cloud of surface points.
  • Their center can act as a proximal/distal point in the joint to terminate the axis.
  • a surface model can be fit to those points to estimate outlier points collected when the tip is not in contact with the joint surface. As more points are collected at the periphery, the axis terminus can be updated, and further outlier detection would occur.
  • the surface point collection process can be flagged by an internal quality assurance process, and the user can be encouraged to recapture or refine the surface point collection.
  • no axis is generated in the CASS 100. Rather, the axis measured pre-operatively can be compared to the hip or ankle center. If the distance between the point and the axis is too large, the CASS 100 can trigger a quality system encouraging the user to collect better data or position the PSI block 1500 more carefully.
  • Quality checks and feedback instill confidence in the user and improve accuracy, which correlates with better patient outcomes.
  • FIG.19 illustrates a workflow of an illustrative use case for a multi-body PSI block.
  • a tracking element is attached to the femur 1902.
  • the femur registration data can be transferred using a PSI block 1904.
  • a PSI block, and an associated tracker, is affixed to the tibia 1906.
  • the articular portion of the PSI block is removed to allow for tensioning ligaments using navigation while the cut guide portion is still affixed 1908.
  • the cutting guide portion may be used with or without navigation to resect the tibia 1910.
  • the PSI block is configured to allow for quick material removal. By removing a portion of the PSI block, the surgeon may then have greater access to the anatomy for enhanced accuracy using a navigated tool.
  • a femoral implant may be positioned based on ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ the tensioning data 1912.
  • the femur may be resected using navigation 1914.
  • the workflow can be applied to procedures involving other joints in a similar manner.
  • the PSI block 1500 could have integrated trackers thereon, it is also possible to include trackers on the pins that affix the PSI block 1500.
  • the pins could have clear lens tracking spheres, or beads, along their length. Because the pins are affixed through specific openings in the PSI block 1500, the positions with respect to the PSI block 1500 are known. The position of the beads along the pins may be configured to ensure stability and visibility because, when used to interface the PSI block, the pins are inserted through openings in the PSI block 1500 and into the bone 1510. The beads may be positioned sufficiently high on the pins to be viewable by the tracking system 115. In current procedures, 40 mm pins are utilized. Longer pins may be required in order to provide the tracking features at the correct height for visibility by the tracking system 115. [0151] In some embodiments, each pin may include one tracker.
  • a pin may include two or more trackers in order to assist in determining more degrees of orientation.
  • the assembly of multiple components to form the PSI block can be prone to error, especially when using 3D printing. Providing the tracking features on the pins eliminates a component that needs to be mated with either portion 1501/1502, thereby simplifying manufacture and improving accuracy and tolerances.
  • tracking beads can be integrated on the surface of the PSI block 1500 itself. The tracking beads may function independently or in conjunction with other integrated tracking features described herein.
  • the tracker array is affixed to the PSI block 1500 or integrated thereon, it is also contemplated that a tracker array may be slid over the pins affixing the PSI block 1500 rather than affixing to the bone 1510 or to the PSI block 1500. In some embodiments with trackers integrated with the PSI block 1500, the use of pins may be eliminated altogether.
  • the PSI block 1500 may be configured to guide other resections (e.g., spherical). Varying shapes of the guide and pin placement may be configured for patient-specific and/or irregularly shaped resections.
  • 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. [0161] 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).
  • each range discussed herein can be readily broken down into a lower third, middle third and ⁇ ACTIVE ⁇ 1604359529.1 ⁇ Attorney Docket No. PT-5950-WO-PCT/D029902 PATENT ⁇ ⁇ 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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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dentistry (AREA)
  • Robotics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Transplantation (AREA)
  • Pathology (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un bloc d'instrument de navigation adapté au patient (PSI) (1500) qui peut être fixé à un endroit précis de l'anatomie d'un patient (1510). Un élément de suivi peut être connecté ou intégré au bloc d'instrument adapté au patient et enregistré en relation avec le bloc d'instrument adapté au patient. Une première partie (1501) du bloc d'instrument adapté au patient peut être retirée de l'anatomie du patient pour permettre l'accès à d'autres systèmes de navigation et à d'autres outils chirurgicaux. La résection guidée peut être réalisée par rapport à une seconde partie (1502) du bloc d'instrument adapté au patient qui est séparée de la première partie (1501) du bloc d'instrument adapté au patient.
PCT/US2023/077990 2022-10-27 2023-10-27 Guide de coupe de navigation adapté au patient Ceased WO2024092178A1 (fr)

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US202263419923P 2022-10-27 2022-10-27
US63/419,923 2022-10-27
US202263433811P 2022-12-20 2022-12-20
US63/433,811 2022-12-20

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US20040172044A1 (en) * 2002-12-20 2004-09-02 Grimm James E. Surgical instrument and method of positioning same
US8078440B2 (en) 2008-09-19 2011-12-13 Smith & Nephew, Inc. Operatively tuning implants for increased performance
US11253323B2 (en) 2010-04-14 2022-02-22 Smith & Nephew, Inc. Systems and methods for patient-based computer assisted surgical procedures
US10064686B2 (en) 2010-08-13 2018-09-04 Smith & Nephew, Inc. Systems and methods for optimizing parameters of orthopaedic procedures
US10102309B2 (en) 2011-07-20 2018-10-16 Smith & Nephew, Inc. Systems and methods for optimizing fit of an implant to anatomy
US10265081B2 (en) * 2012-08-09 2019-04-23 Smith & Nephew, Inc. Intra-operatively adjustable cutting guide
US20180036018A1 (en) * 2012-10-11 2018-02-08 Howmedica Osteonics Corporation Customized arthroplasty cutting guides and surgical methods using the same
US10342636B2 (en) 2015-08-12 2019-07-09 Medineering Gmbh Medical holding arm having annular LED display means
WO2020037308A1 (fr) 2018-08-17 2020-02-20 Smith & Nephew, Inc. Procédé et système chirurgicaux spécifiques d'un patient
WO2020047051A1 (fr) 2018-08-28 2020-03-05 Smith & Nephew, Inc. Mise en place et tension de greffe de ligament assisté par robot
US20210369292A1 (en) * 2018-10-01 2021-12-02 Smith & Nephew, Inc. Auxiliary marking plate for rapid-manufactured parts

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Publication number Priority date Publication date Assignee Title
CN119279780A (zh) * 2024-12-11 2025-01-10 北京维卓致远医疗科技股份有限公司 一种用于骨科手术参考架的防旋转组件

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