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WO2025076362A1 - Système chirurgical assisté par ordinateur agnostique d'implant, appareil et procédé - Google Patents

Système chirurgical assisté par ordinateur agnostique d'implant, appareil et procédé Download PDF

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Publication number
WO2025076362A1
WO2025076362A1 PCT/US2024/049974 US2024049974W WO2025076362A1 WO 2025076362 A1 WO2025076362 A1 WO 2025076362A1 US 2024049974 W US2024049974 W US 2024049974W WO 2025076362 A1 WO2025076362 A1 WO 2025076362A1
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WIPO (PCT)
Prior art keywords
implant
posterior
bone
cut surface
spacer
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Inventor
Jonathan Gibson
Eytan M. DEBBI
Joel F. Zuhars
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Think Surgical Inc
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Think Surgical Inc
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
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    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B17/155—Cutting femur
    • 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
    • A61B17/1613—Component parts
    • A61B17/1622—Drill handpieces
    • A—HUMAN NECESSITIES
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    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/846—Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface
    • A61B17/848—Kirschner wires, i.e. thin, long nails
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
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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
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A—HUMAN NECESSITIES
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    • A61B2034/2068—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis using pointers, e.g. pointers having reference marks for determining coordinates of body points
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    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30891—Plurality of protrusions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
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    • A61F2002/4632—Special tools for implanting artificial joints using computer-controlled surgery, e.g. robotic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2002/4632—Special tools for implanting artificial joints using computer-controlled surgery, e.g. robotic surgery
    • A61F2002/4633—Special tools for implanting artificial joints using computer-controlled surgery, e.g. robotic surgery for selection of endoprosthetic joints or for pre-operative planning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4657—Measuring instruments used for implanting artificial joints
    • A61F2002/4658—Measuring instruments used for implanting artificial joints for measuring dimensions, e.g. length

Definitions

  • TKA Total Knee Arthroplasty
  • a distal femoral cut is made to form a distal cut surface on the femur.
  • a sizing guide is then mounted to the distal cut surface to assist the surgeon in determining an appropriate implant size for the implant and to determine the desired internal-external (I-E) rotation for mounting the implant on the femur.
  • the sizing guide once properly positioned according to the determined implant size and I-E rotation, includes holes for 125520-10102-6901777 10/4/2024 guiding a drill bit to form holes in the bone, where the drilled holes receive pegs of a 4-in- 1 cut block to mount a 4-in-1 cut block on the distal cut surface in the proper alignment to guide the formation of the remaining cut surfaces on the distal femur.
  • Arthritis is a leading cause of joint damage that over time leads to cartilage degradation, pain, stiffness, and bone loss. Arthritis can also cause the muscles articulating the joints to lose strength and become painful.
  • Joint arthroplasty is an orthopedic procedure in which an arthritic or dysfunctional joint surface is replaced with an orthopedic implant.
  • the accurate placement and alignment of an implant is a large factor in determining the success of joint arthroplasty.
  • TKA total knee arthroplasty
  • the articulating surfaces of the knee joint are replaced with prosthetic components, or implants, typically formed of metal or plastic, to create new articulating joint surfaces.
  • the implants include surfaces intended to contact bone.
  • TKA requires the removal of worn or damaged articular cartilage and bone on the distal femur and proximal tibia, where the removal cuts the bone to provide surfaces (“cut surfaces”) on the remaining bone to contact the contact surfaces of the implant.
  • the position and orientation (POSE) of the cut surfaces determine the final placement and POSE of the implants within the joint.
  • surgeons plan and create the cut surfaces so the final placement of the implants restores the mechanical axis or kinematics of the patient’s leg while preserving the balance of the surrounding knee ligaments. Even small implant alignment errors outside of clinically acceptable ranges correlate with worse outcomes and increased rates of revision surgery.
  • Femoral implants typically have five femoral contact surfaces and one or more stabilizing features (e.g., pegs, boxes). The five femoral contact surfaces are intended to contact five cut surfaces on the remaining femur.
  • the stabilizing features of a femoral 125520-10102-6901777 10/4/2024 implant may include pegs or a box to stabilize the femoral implant on the femur.
  • the pegs or box are intended to be inserted into stabilizing cut features (e.g., holes) cut into the bone, typically through a cut surface of the femur and are typically formed perpendicular to a cut surface.
  • Tibial implants typically have one tibial contact surface and a stabilizing feature (e.g., a keel). The one tibial contact surface is intended to contact one cut surface on the remaining tibia.
  • the stabilizing features of a tibial implant may include a keel to stabilize the tibial implant on the tibia.
  • FIGs.1A – 1C illustrate a patient’s distal femur 10 and a contour matching femoral implant 12 for a TKA procedure, where five contact surfaces on the implant are intended to contact five cut surfaces on the femur.
  • the anterior cut surface 14 is intended to contact the anterior contact surface 13
  • the anterior chamfer cut surface 16 is intended to contact the anterior chamfer contact surface 15
  • the distal cut surface 18 is intended to contact the distal contact surface 17
  • the posterior chamfer cut surface 20 is intended to contact the posterior chamfer contact surface 19
  • the posterior cut surface 22 is intended to contact the posterior contact surface 21.
  • the femoral implant 12 also includes stabilizing features in the form of pegs (23, 24) intended to be inserted into stabilizing cut features (e.g., holes, not shown) formed into the distal cut surface 18 of the femur 10.
  • the manual instrumentation is aligned and affixed to the bone to guide the formation of each cut surface.
  • a sizing guide 25 is mounted to the distal cut surface 18 as shown in FIG.2 to assist the surgeon in determining an appropriate implant size for the implant and a desired internal-external rotation for mounting the implant on the bone.
  • the sizing guide 25 includes guide holes 26 that receive and guide a drill bit to form holes in the bone (or for guiding the placement of pins in the 125520-10102-6901777 10/4/2024 bone).
  • the sizing guide 25 may further include paddles 27 that reference (or rest against) the posterior condyles ‘PC’ to assist with the alignment.
  • FIGs. 3A and 3B depict a conventional 4-in-1 cut block used in TKA procedures, where FIG. 3A is top perspective view thereof, and FIG. 3B is bottom perspective view thereof.
  • the 4-in-1 cut block 40 may include a body 42 having a top surface 44, a bottom surface 45, a pair of pegs (54a, 54b) extending from the bottom surface 45, and a plurality of guide slots.
  • the plurality of guide slots may include an anterior guide slot 52, an anterior chamfer guide slot 50, a posterior chamfer guide slot 48, and a posterior guide slot 46.
  • Each of the guide slots receive a surgical saw blade for guiding the surgical saw blade in forming the corresponding cut surfaces on the bone.
  • the pegs (54a, 54b) are configured to fit in the peg holes formed on the femoral distal cut surface 18. The peg holes may have been formed on the distal cut surface 18 by advancing a drill bit through the guide holes 26 in the manufacturer’s sizing guide 25 as previously described.
  • Computer-assisted surgery can overcome many of the obstacles associated with manual instrumentation. Computer-assisted surgery is an expanding field having applications in total joint arthroplasty (TJA), unicondylar knee arthroplasty, bone fracture repair, maxillofacial reconstruction, and spinal reconstruction.
  • CAS systems e.g., surgical robotic systems
  • CAS devices are particularly useful for surgical procedures requiring dexterity, precision, and accuracy, and generally include planning software and a computer-assisted surgical device.
  • these CAS devices are the RIO® Robotic Arm (Stryker/Mako), the TSolution One® Surgical System (THINK Surgical), the TMINI® Miniature Robotic System (THINK Surgical), and the ROSA® Surgical System (Zimmer). All of these systems generally include planning software for planning the location of an 125520-10102-6901777 10/4/2024 implant with respect to the bone.
  • the planning software may include 3-D models of the patient’s bones, 3-D models of various implants, and software tools that allow the user to position the implant models relative to the bone models.
  • the CAS device then executes the plan to assist in forming the cut surfaces on the bones to mount the implants thereon in the planned POSE.
  • the planning software is used to build a 3-D bone model of the patient’s bone using pre-operative images (e.g., computed tomography (CT) scans, magnetic resonance imaging (MRI)).
  • CT computed tomography
  • MRI magnetic resonance imaging
  • the planning software includes an implant library having a plurality of implant models that may be positioned relative to the 3-D bone models to designate the best fit, fill, and/or alignment of the implants on the bones. A user may therefore select an implant model of their choice in the implant library and plan the procedure accordingly.
  • All of the implants available in the implant library are supported by the CAS system.
  • the CAS system uses the known geometry of each supported implant to accurately cut the bone in the proper shape, position, and orientation to form the cut surfaces on the bone corresponding to the implant contact surfaces to allow the implant to be mounted to the bone in the planned position and orientation.
  • surgeons have widely different preferences on the types of implants they routinely use. If the CAS system does not support a particular implant (e.g., the full geometry data of the implant is unavailable), then a surgeon cannot use that implant with the CAS system.
  • different implant lines may be more beneficial to one patient than another. A patient cannot benefit from the use of the CAS system if the implant needed for the patient is not supported by the CAS system.
  • a method for computer- assisted surgery involves using a computer-assisted surgical (CAS) device to assist in forming a distal cut surface and a posterior cut surface on a femur bone for a total knee 125520-10102-6901777 10/4/2024 arthroplasty (TKA) procedure, wherein forming the posterior cut surface removes the posterior condyles needed for sizing an implant with an implant manufacture’s sizing guide; and placing a spacer on the posterior cut surface (e.g., directly thereon, or sandwiched between the posterior cut surface and the tibia plateau or tibia cut surface) to replace the removed posterior condyles in order to use the implant manufacturer’s sizing guide.
  • CAS computer-assisted surgical
  • the user may be instructed to mount the implant manufacturer’s sizing guide on the distal cut surface with the spacer in place, and then, after mounting of the implant manufacturer’s sizing guide, the mounted implant manufacturer’s sizing guide may be used to determine an implant size from a plurality of manufacturer implant sizes. Then, holes in the mounted implant manufacturer’s sizing guide may be used to insert pins or drill holes in the bone. Then, the pins or holes may be used to align a 4-in-1 cut block in a correct POSE to form remaining cut surfaces to accommodate the determined implant size.
  • the spacer may be an adjustable thickness spacer (e.g., adjustable between at least 8 mm and 11 mm such as in 0.5 mm increments) or the spacer may be a fixed thickness spacer.
  • the thickness of the spacer may be equal to or adjustable to a posterior thickness of a femoral implant or to the thickness of the removed posterior condyles.
  • the CAS device may assist in the formation of the distal cut surface and the posterior cut surface without having implant geometry data for the implant.
  • the method also may involve insertion of the pins, wherein the pins may be tiered alignment pins having a bottom portion with a diameter greater than a top portion and/or the pins may be inserted using an alignment pin assembly having a sleeve and a pin.
  • a system for computer-assisted surgery comprises a computer-assisted surgical (CAS) device for assisting in the formation of a distal cut surface and a posterior cut surface on a femur bone during a total knee arthroplasty (TKA) procedure, wherein forming the posterior cut surface removes the posterior condyles needed for sizing an implant with an implant manufacture’s sizing guide; and a spacer for placement on the posterior cut surface to replace the removed posterior condyles in order to use the implant manufacturer’s sizing guide.
  • CAS computer-assisted surgical
  • the system may further include the implant manufacturer’s sizing guide for mounting to the distal cut surface with the spacer in place.
  • the implant manufacturer’s sizing guide may be used to determine an implant size from a plurality of manufacturer implant sizes.
  • the implant manufacturer’s sizing guide may include guide holes for guiding the placement of pins in the bone or for drilling holes in the bone, wherein the pins or holes are used to align a 4-in-1 cut block in a correct POSE to form remaining cut surfaces to accommodate the determined implant size.
  • the spacer may be an adjustable thickness spacer (e.g., adjustable between at least 8 mm and 11 mm such as in 0.5 mm increments) or the spacer may be a fixed thickness spacer.
  • the thickness of the spacer may be equal to or adjustable to a posterior thickness of a femoral implant or to the thickness of the removed posterior condyles.
  • the CAS device may assist in the formation of the distal cut surface and the posterior cut surface without having implant geometry data for the implant.
  • the pins may be inserted, wherein the pins may be tiered alignment pins having a bottom portion with a diameter greater than a top portion and/or the pins may be inserted using an alignment pin assembly having a sleeve and a pin.
  • a spacer is specifically configured for placement on a posterior cut surface to replace removed posterior condyles needed to mount an implant manufacture’s sizing guide on a distal cut surface for a total knee arthroplasty (TKA) procedure.
  • the spacer may be an adjustable thickness spacer (e.g., adjustable between at least 8 mm and 11 mm such as in 0.5 mm increments) or the spacer may be a fixed thickness spacer.
  • the thickness of the spacer may be equal to or adjustable to a posterior thickness of a femoral implant or to the thickness of the removed posterior condyles.
  • the spacer may be configured to by referenced by paddles or other posterior condyle referencing feature of the sizing guide.
  • a CAS planning system comprises at least one processor and at least one tangible, non-transitory computer-readable medium having embodied therein computer program instructions, which, when executed by the at least one processor, implement an implant agnostic graphical user interface (GUI) for defining a 125520-10102-6901777 10/4/2024 distal cut surface and a posterior cut surface for a total knee arthroplasty (TKA) procedure without having implant geometry data for a manufacturer’s implant.
  • GUI implant agnostic graphical user interface
  • a computer program product comprising at least one tangible, non-transitory computer-readable medium having embodied therein computer program instructions which, when executed by at least one processor, implement an implant agnostic graphical user interface (GUI) for defining a distal cut surface and a posterior cut surface for a total knee arthroplasty (TKA) procedure without having implant geometry data for a manufacturer’s implant.
  • GUI implant agnostic graphical user interface
  • a system for computer-assisted surgery comprises a computer-assisted surgical (CAS) device for assisting in the formation of a distal cut surface and a posterior cut surface on a femur bone during a total knee arthroplasty (TKA) procedure; and an alignment guide configured for placement on the posterior cut surface to align a posterior guide slot of a cut block with the location of the posterior cut surface.
  • the alignment guide may include one or more alignment features configured to fit inside the posterior guide slot and/or a face for placement against the posterior cut surface.
  • the alignment guide may be at least one of a surgical saw blade or a retractor.
  • the thickness of the alignment feature may be less than a size of an opening of the posterior guide slot.
  • the system may further include a computer comprising a processor configured to instruct a user to place a manufacturer’s sizing guide on the distal cut surface for sizing the implant before the posterior cut surface is formed.
  • the CAS device may assist in the formation of the distal cut surface and the posterior cut surface without having implant geometry data for the implant.
  • FIG. 1A depicts a femoral bone 10 and a femoral implant 12, where the femoral bone 10 was cut to form five cut surfaces including the anterior cut surface 14, the anterior chamfer cut surface 16, the distal cut surface 18, the posterior chamfer cut surface 20, and the posterior cut surface 22.
  • FIGs. 1B and 1C depict a femoral implant having a pair of pegs (23, 24) and five contact surfaces including the anterior contact surface 13, the anterior chamfer contact surface 15, the distal contact surface 17, the posterior chamfer contact surface 19, and the posterior contact surface 21.
  • FIG. 2 depicts a sizing guide mounted on the distal cut surface 18 formed on the femur 10.
  • FIG. 6 depicts a 2-DoF hand-held robot 100 (referred to hereinafter as 2-DoF device) for inserting pins (106a, 106b) in a bone ‘B’ coincident with a virtual plane ‘VP’.
  • FIG. 7 depicts a cutting guide 108 coupled to the pins (106a, 106b) inserted in the femur.
  • FIG. 8 depicts the 2-DoF device 100 maintaining alignment of the axis of a pin coincident with a second virtual plane ‘VP2’ for inserting pins (107a, 107b) in the distal cut surface 18.
  • FIG.12 depicts a 4-in-1 cut block 40 mounted to the distal cut surface according to the measurement from the sizing guide.
  • FIG. 13 depicts the femoral bone having all of the bone cuts from the above procedure.
  • FIGs.14A and 14B depict an alignment guide for aligning a 4-in-1 cut block on the bone, where FIG.14a is a front view thereof, and FIG.14B is a perspective view thereof.
  • FIG. 15 depicts a distal cut surface and posterior cut surface formed on the bone and an alignment guide for placement on the posterior cut surface.
  • FIG. 16A depicts an alignment guide placed on a posterior cut surface formed on the bone and a 4-in-1 cut block for placement on a portion of the alignment guide. 125520-10102-6901777 10/4/2024
  • FIG.16B depicts a portion of an alignment guide placed inside the posterior guide slot of the 4-in-1 cut block to align the 4-in-1 cut block on the bone.
  • FIG.17 depicts a digitizer digitizing surfaces of an implant to determine geometry data about the implant.
  • FIG. 18 depicts a digitizer digitizing guide slots of a cut block to determine geometry data about the cut block or geometry data about an implant associated with the cut block.
  • FIG. 21B depicts the alignment of a cut block on a bone by placing a guide slot of the cut block onto a portion of alignment pin assemblies inserted in the bone.
  • FIG. 22 is a schematic view showing the computer-assisted surgical system 100 including a 2-DoF device 102, a computing system 104, and a tracking system 106. In other inventive embodiments, the system includes an end effector 206 extending from a robotic arm.
  • FIG.23A shows the 2-DOF device 102 in a first working POSE.
  • FIG.23B illustrates the 2-DOF device 102 in a second working POSE.
  • a recited range from 1 to 4 is intended to include 1-2, 1-3, 1-4, 2-3, 2-4, and 3-4 and also may include factional values (e.g., 1.1-2, 1.2-2, etc.).
  • the following terms are used herein as set forth below. 125520-10102-6901777 10/4/2024
  • like reference numerals described in with respect to subsequent drawings have the meaning imparted thereto with respect to the previously detailed drawings.
  • the term “bone data” refers to data related to one or more bones.
  • the bone data may be determined: (i) prior to making modifications (e.g., bone cuts, insertion of a pin or screw, etc.) to one or more bones, referred to as pre-operative bone data; and/or (ii) determined after one or more modifications have been made to a bone, referred to as post-modification bone data.
  • modifications e.g., bone cuts, insertion of a pin or screw, etc.
  • the bone data may include: the shapes of the one or more bones; the sizes of the one or more bones; angles and axes associated with the one or more bones (e.g., epicondylar axis of the femoral epicondyles, longitudinal axis of the femur, the mechanical axis of the femur); angles and axes associated with two or more bones relative to one another (e.g., the mechanical axis of the knee); anatomical landmarks associated with the one or more bones (e.g., femoral head center, knee center, ankle center, tibial tuberosity, epicondyles, most distal portion of the femoral condyles, most proximal portion of the femoral condyles); bone density data; bone microarchitecture data; and stress/loading conditions of the bone(s).
  • angles and axes associated with the one or more bones e.g., epicondylar axis of the femoral epicondyles
  • CAS device refers to devices used in surgical procedures that are at least in part assisted by one or more computers.
  • CAS devices illustratively include tracked/navigated instruments and surgical robots.
  • a surgical robot illustratively include robotic hand-held 125520-10102-6901777 10/4/2024 devices, serial-chain robots, bone mounted robots, parallel robots, or master-slave robots, as described in U.S. Patent Nos.
  • the surgical robot may be active (e.g., automatic/autonomous control), semi- active (e.g., a combination of automatic and manual control), haptic (e.g., tactile, force, and/or auditory feedback), and/or provide power control (e.g., turning a robot or a part thereof on and off).
  • active e.g., automatic/autonomous control
  • semi- active e.g., a combination of automatic and manual control
  • haptic e.g., tactile, force, and/or auditory feedback
  • power control e.g., turning a robot or a part thereof on and off.
  • CAS system refers to a system comprising at least one CAS device and may further include additional computers, software, devices, or instruments.
  • An example of a CAS system may include: i) a CAS device and software (e.g., cutting instructions, pre-operative bone data) used by the CAS device; ii) a CAS device and software (e.g., surgical planning software) used with a CAS device; iii) one or more CAS devices (e.g., a surgical robot); iv) a combination of i), ii), and iii); and iv) any of the aforementioned with additional devices or software (e.g., a tracking system, tracked/navigated instruments, tracking arrays, bone pins, rongeur, an oscillating saw, a rotary drill, manual cutting guides, manual cutting blocks, manual cutting jigs, etc.).
  • the device operating data may also be referred to as data used for operating a device.
  • the device operating data may also, or alternatively, be used to provide feedback (e.g., display instructions on a GUI) to a user for navigating one or more non-robotically controlled instruments (e.g., a tracked cutting tool, a tracked drill) relative to a bone.
  • a non-robotically controlled instruments e.g., a tracked cutting tool, a tracked drill
  • the term “digitizer” refers to a device capable of measuring, collecting, recording, and/or designating the position of physical locations (e.g., points, lines, planes, boundaries, etc.) in three-dimensional space.
  • a “digitizer” may be: a “mechanical digitizer” having passive links and joints, such as the high-resolution electro-mechanical sensor arm described in U.S. Patent No.
  • a tracking system may determine the location of a digitizer probe tip in contact with a point on the bone, where the determined location of that point is saved to computer memory.
  • registration refers to: the determination of the spatial relationship between two or more objects; the determining of a coordinate transformation between two or more coordinate systems associated with those objects; the mapping of an object onto another object; and a combination thereof.
  • Examples of objects routinely registered in an operating room illustratively include: CAS systems/devices; anatomy (e.g., bone); bone data (e.g., 3-D virtual bone models); a surgical plan (e.g., location of 125520-10102-6901777 10/4/2024 virtual planes defined relative to bone data, cutting instructions defined relative to bone data, or other device operating data defined relative to bone data); and any external landmarks (e.g., a tracking array affixed to a bone, an anatomical landmark, a designated point/feature on a bone, etc.) associated with the bone (if such landmarks exist).
  • CAS systems/devices e.g., anatomy
  • bone data e.g., 3-D virtual bone models
  • a surgical plan e.g., location of 125520-10102-6901777 10/4/2024 virtual planes defined relative to bone data, cutting instructions defined relative to bone data, or other device operating data defined relative to bone data
  • any external landmarks e.g.,
  • the registration procedure relies on the manual collection of several points (i.e., point-to-point, point-to-surface) on the bone using a tracked digitizer where the surgeon is prompted to collect several points on the bone that are readily mapped to corresponding points or surfaces on a 3-D bone model.
  • the points collected from the surface of a bone with the digitizer may be matched using iterative closest point (ICP) algorithms to generate a transformation matrix.
  • ICP iterative closest point
  • This transformation matrix and various other transformation matrices provides the mathematical locational relationship between: (i) bone data (e.g., a 3-D bone model, planned location for forming one or more cut surfaces; planned location for an implant model relative to a bone model); and/or a surgical plan (e.g., a pre-defined location for a targeted virtual plane that was defined with respect to bone data, a pre-defined location of device operating data that was defined with respect to bone data); and (ii) the coordinate system of a tracking array affixed to the bone (if present); or a CAS device (e.g., the base coordinate system of the CAS device, or a coordinate system of a tracking array affixed to the CAS device and, if needed, calibration data and/or kinematic data that define the location of an end-effector relative to the tracking array); and any other coordinate system or object required to perform the procedure.
  • bone data e.g., a 3-D bone model, planned location for forming one or more cut surfaces; planned location
  • the registration is performed using imageless registration.
  • the term “display” is intended to encompass a variety of the digital devices that during operation provide an image (including multiple images in succession to form a video feed) recognizable to human viewing.
  • Digital devices operative herein as displays illustratively include a graphical user interface (GUI), a computer or television (TV) monitor, a holographic display, a mobile display, a smartphone display, a video wall, a head-mounted display, a heads-up display, a virtual reality headset, a broadcast reference 125520-10102-6901777 10/4/2024 monitor, any of the aforementioned with a touchscreen capability, and a combination thereof.
  • GUI graphical user interface
  • TV television
  • TV television
  • holographic display a mobile display
  • smartphone display a smartphone display
  • video wall a head-mounted display
  • a heads-up display a virtual reality headset
  • broadcast reference 125520-10102-6901777 10/4/2024 monitor any of the aforementioned with a touchscreen capability,
  • One or more computers comprising a processor may be operatively coupled to the display for controlling the output of the display.
  • the term “feedback” may refer to visual feedback provided on a display. This “feedback” may also be provided in other forms, which may be in lieu of or in addition to visual feedback.
  • the “feedback” may include audio feedback, haptic/tactile feedback (e.g., a buzz or vibration when a digitizer tip is located at in an area of max deviation), or other visual feedback (e.g., a light on the surgical device may turn green or red depending on the amount of error between the surgical device and a planned cut surface).
  • Embodiments of the present invention provide a CAS system and method that allows the CAS system to be used with an unsupported implant.
  • An unsupported implant is an implant in which the system lacks information about, or is not programmed with, the full geometry data of the implant.
  • certain embodiments relate to an agnostic implant platform, which would allow the CAS device to be used for any implant line and/or implant manufacturer.
  • One hurdle with an agnostic implant platform is the lack of implant geometry data from the implant manufacturers. The user/system is not equipped with 3-D implant models or the full implant geometry data to plan the location for forming all the cut surfaces on the bone (or generate a complete set of device operating data) and therefore a CAS device is unable to assist in forming all the bone cut surfaces.
  • embodiments of the CAS system may be configured to assist a user in planning locations for forming the distal cut surface and the posterior cut surface on the femur and the proximal cut surface on the tibia using at least one of: (i) the user’s knowledge of the femoral implant distal thickness, the femoral implant posterior thickness, and the tibia implant thickness (which may include the tibia base plate thickness and may also include the various thicknesses of the tibia implant liners); (ii) publicly available information about the femoral implant distal thickness, the 125520-10102-6901777 10/4/2024 femoral implant posterior thickness, and the tibia implant thickness (which may include the tibia base plate thickness and also include the various thicknesses of the tibia implant liner); or (iii) via other means (e.g., a laser
  • a CAS device may then assist in forming the distal cut surface and posterior cut surface on the femur and the proximal cut surface on the tibia.
  • the distal cut surface and posterior cut surface on the femur define how the femoral implant will mount on the bone in five degrees-of-freedom (anterior-posterior position, proximal-distal position, varus-valgus rotation, flexion- extension rotation, and internal-external rotation), which are the most relevant degrees-of- freedom that affect clinical outcomes. Therefore, certain embodiments can still leverage the accuracy of using a CAS system to assist in forming at least these two cut surfaces on the femur to accurately align the implant on the bone in five degrees-of-freedom without the full geometry data of the implant.
  • Embodiments of the systems and methods described herein further assist the user in sizing the implant since there may not be enough implant geometry data available to the system or the user to determine an appropriately sized implant for the patient. Notching may occur if the implant is sized small and a poor implant fit may occur if the implant is sized large.
  • systems and methods are described for overcoming this lack of implant geometry data in order to use a CAS device to assist in accurately forming at least two cut surfaces on the femur while further providing a method to determine an appropriately sized femoral implant for the patient.
  • a spacer is placed on the posterior cut surface (directly thereon, or sandwiched between the posterior cut surface and the tibia plateau (or tibia cut surface)) to replace the removed posterior condyles in order to use the manufacturer’s sizing guide to: (i) determine an appropriate implant size; and (ii) determine the location for mounting the 4-in-1 block 125520-10102-6901777 10/4/2024 on the distal cut surface to align the 4-in-1 cut block in the correct POSE to guide the formation of the remaining cut surfaces to accommodate the determined implant size.
  • the thickness of the spacer replicates (or matches) the thickness of the femoral implant posterior thickness, while in other embodiments, the thickness of the spacer replicates (or matches) the thickness of the removed posterior condyles.
  • the spacer may have an adjustment mechanism to account for the posterior thickness of different implant lines, or the thickness of the removed posterior condyles.
  • the thickness of the spacer can be adjusted between 8 and 11 millimeters (mm), which are common posterior thicknesses of femoral implants.
  • multiple spacers of different thicknesses can be provided.
  • GUI 30 a graphical user interface 30 is shown for planning a TKA procedure with an implant agnostic CAS system.
  • the GUI 30 is operated by planning software for planning the location for forming cut surfaces on the bone to mount an implant in a desired POSE.
  • the planning software may include models of the femur and tibia (also referred to as a femoral bone model 32 or tibial bone model 34), which may have been generated from an image data set (e.g., CT scan data) of the patient’s bones.
  • the GUI may also display an amount of bone that will be resected for a given bone cut (e.g., 7.0 mm on the lateral distal condyle and 4.5 mm on the medial distal condyle as shown in the top left window of the GUI 30 of FIG.4).
  • the planned location for forming the cut surfaces relative to the bone data e.g., 3-D bone model
  • the planned location of any device operating data e.g., the planned location of a virtual plane or virtual boundary
  • relative to the bone data may also be saved for future use.
  • FIG. 5 depicts a GUI 31 for gap balancing the knee in the operating room.
  • a first tracking array is affixed to the femur and a second tracking array is affixed to the tibia.
  • the bone data is then registered to the femur and tibia (and more specifically to the coordinate system of the tracking arrays affixed to each bone, respectively) using techniques known in the art.
  • the 3-D bone models of the femur and tibia may be registered to the locations of each bone, respectively, by matching points digitized on the bone with corresponding points/surfaces on the 3-D bone models.
  • a tracking system may then track the location and movement of the femur and tibia by way of the tracking arrays affixed thereto and the system can determine the corresponding location and motion of the 3-D bone models using the registration data (i.e., the registered location of each 3-D bone model to the coordinate system of each tracking array, respectively).
  • the system can also determine the planned location for the bone cuts and/or the device operating data relative to the real-time location of each bone, respectively, using the registration data and the surgical plan.
  • the user applies tension to the surrounding ligaments by either placing a tensioner between the two bones or by pulling the tibia away from the femur (e.g., in varus-valgus, or proximal-distal) to 125520-10102-6901777 10/4/2024 force tension on the ligaments.
  • the user flexes and extends the knee throughout the knee’s range of motion (e.g., 0 degrees is fully extended and as much as the knee can flex >0 degrees).
  • gap balancing may occur before any bone cuts are made, or in some case, the user may choose to make the tibia bone cut first and then perform gap balancing.
  • the tracking system records the movement of the bones, via the tracking arrays, and determines the corresponding motion of the registered bone models throughout this motion.
  • the GUI 31 may display the 3-D bone models and movement of the 3-D bone models corresponding to the real-time movement of the bones.
  • a computer operatively coupled to the tracking system determines the medial and lateral gaps between the bones at two or more flexion-extension locations (one with the knee fully extended and another with the knee fully flexed).
  • the computer may determine the gaps by measuring the distance between the distal portion of the femoral bone model (e.g., a point on the outer surface of the femoral bone model that is closest to the tibia bone model) and the proximal portion of the tibial bone model (e.g., a point on the outer surface of the tibia bone model) for each angle throughout this flexion- extension motion.
  • the graph on the right shows the gaps at six different flexion-extension locations (or angles), where the pattern filled bars are the medial gap measurements and the un-filled bars represent the lateral gap measurements.
  • the user may choose to adjust the planned location for a bone cut. For example, the user may rotate the implant internally or externally to obtain an equal medial- lateral gap in flexion, and varus or valgus to obtain an equal medial-lateral gap in extension. The user may also move the implant distally or proximally to decrease or increase the size of the gap in extension, or posterior or anterior to decrease or increase the size of the gap in flexion, to make sure there is enough room for the implants to fit in the knee and that the ligaments will be properly tensioned when the implants are positioned in the knee.
  • the bone models shown on the left of the GUI 31 shows equal gaps in extension and the bone models shown in the middle of the GUI 31 shows equal gaps in flexion.
  • FIG.5 shows the gaps being measured from the distal portion of the femoral bone model to the proximal portion of the tibia bone model
  • embodiments of the present invention may also include different points for measuring the gap distances.
  • the gaps may be measured between: (i) one or more points on a surface of a femoral implant at a planned location on the femoral bone model and one or more points on a planned location for forming a cut surface on the tibia bone model; (ii) one or more points on the surface of the tibial implant model and one or more points on the surface of the femoral implant model; (iii) one or more points on a planned location for any other cut surface on a bone model and one or more points on an implant model; or (iv) any other combination of measurements between points on an implant model, a bone model, or a planned location of a cut surface.
  • the points for measuring the gap distances may also include points located on cut surfaces formed on the bone (e.g., a point on the femoral distal cut surface 18 formed on the femur ‘F’, or a point on the proximal tibia cut surface formed on the tibia ‘T’).
  • FIGs. 6 – 9 depict an implant agnostic system and method for forming the distal femoral cut surface and the posterior femoral cut surface at the planned (or pre-determined) locations using a 2-DoF hand-held surgical robot as further described below with reference to FIGs.13 – 14B.
  • the distal cut surface and posterior cut surface may be formed with other CAS devices, including the system and method described in PCT Publication No.
  • a cutting guide 108 is then coupled to the pins (106a, 106b) inserted in the femur ‘F’ as shown in FIG.7.
  • the cutting guide 108 includes a body 110 having a guide slot 112 and a coupling portion 114.
  • the guide slot 112 is configured to receive a cutting tool (e.g., surgical saw blade) therethrough, where a user advances the cutting tool through the guide slot 112 to form the distal cut surface on the femur ‘F’.
  • the coupling portion 114 couples the body 110 to the pins (106a, 106b).
  • FIG. 8 depicts the 2-DoF device 100 maintaining alignment of the axis of a pin coincident with a second virtual plane ‘VP2’ for inserting pins (107a, 107b) in the distal cut surface 18.
  • the location for the second virtual plane “VP2” is defined such that when the cutting guide 108 is coupled to the pins (107a, 107b) (as shown in FIG. 9), the guide slot 112 is aligned with the pre-determined location to form the posterior cut surface 22 as shown in FIG. 9.
  • the location for the second virtual plane ‘VP2’ is defined as 125520-10102-6901777 10/4/2024 a plane offset from the pre-determined location for the posterior cut surface by the known distance between the guide slot 112 and the bottom surface of the body 101 plus a half- width (or radius) of a pin.
  • a user may advance a surgical saw blade through the guide slot 112 to form the posterior cut surface 22.
  • FIG.10A depicts a spacer 120 for placement on the posterior cut surface to replace the removed posterior condyles in order to use a manufacturer’s sizing guide in a conventional manner.
  • the thickness of the spacer 120 may be adjustable or selectable to match the thickness of the bone that was resected from the posterior condyles, or to match the posterior thickness of the implant.
  • the spacer 120 may include a top platform 122, a bottom platform 124, and an adjustment mechanism 126.
  • the thickness of the spacer 120 may be adjustable via the adjustment mechanism 126, which when operated (e.g., rotate a knob or wheel, push a button, etc.) moves the top platform 122 and bottom platform 124 either towards or away from one another thereby changing the thickness of the spacer 120.
  • the adjustment mechanism 126 may allow the spacer to be adjusted in 0.5mm increments with an adjustable range between 8 mm and 11 mm.
  • multiple spacers of different thicknesses may be provided in the operating room (OR) and the surgeon can select which spacer to use, or the spacers may be configured to be stackable in order to provide spacers of different thicknesses.
  • FIG.10B depicts a spacer 120’ having a non-adjustable thickness or fixed thickness, where 125520-10102-6901777 10/4/2024 multiple spacers 120’ of different thicknesses may be provided in the OR for selection by the user.
  • FIG.10C depicts the spacer 120 placed on the posterior cut surface 22 to replace the posterior condyles that were removed when forming the posterior cut surface.
  • the system may instruct the user to place the spacer (120, 120’) on the posterior cut surface via a graphical user interface GUI located in the OR, or via other feedback mechanisms (e.g., an instruction manual).
  • FIG. 11 depicts a sizing guide 25 mounted to the distal cut surface with the spacer 120 replacing the posterior condyles that were previously removed.
  • the sizing guide 25 is generally provided by the implant manufacturer and is specific to the manufacturer’s implant line.
  • These sizing guides 25 include paddles 27 (shown in FIG.2) or other posterior condyle referencing features that reference (e.g., abut against) the uncut posterior condyles in order for the sizing guide to be used according to the manufacturer’s specifications. Since the posterior condyles have been cut with the accuracy of a CAS device, the spacer 120 may be placed on the posterior cut surface to replace the removed posterior condyles to use the sizing guide 25 as manufactured (e.g., the paddles 27 or other posterior condyle referencing feature of the sizing guide 25 may now reference the bottom surface of the spacer 25).
  • the system may then instruct the user to mount the sizing guide 25 on the distal cut surface via a graphical user interface GUI located in the OR, or via other feedback mechanisms (e.g., an instruction manual).
  • the sizing guide 25 mounted to the distal cut surface 18, the sizing guide 25 may be set to 0 degrees of rotation from the posterior condyle axis and the user may then determine an appropriately sized implant with the sizing guide 25. Once the implant size is determined, the guide holes 26 in the sizing guide 25 are aligned for a surgeon to insert pins or drill peg holes in the bone, where the inserted pins or drilled peg holes are used to align a 4-in-1 cut block in the correct POSE for forming the remaining bone cuts on the bone.
  • FIG. 13 depicts the femoral bone having all of the bone cuts from the above procedure.
  • the thickness of the spacer 120, 120’ is configured to replicate (or match) the posterior thickness of the femoral implant as previously described. This provides the surgeon with more flexibility when planning the location for the posterior cut surface that will still allow the use of the manufacturer’s sizing guide. In certain situations, the user may choose to resect the posterior femur (e.g., the posterior condyles) by more or less than the posterior thickness of the implant.
  • the surgeon while assessing the soft tissues of the knee (e.g., using the gap balancing technique as described above) may determine that the posterior cut surface should be formed more anteriorly or posteriorly on the bone at a location that results in a resection amount that does not equate to the posterior thickness of the implant.
  • the posterior cut surface is typically formed at a location that results in a resection amount corresponding to the posterior thickness of the implant. For example, if the posterior thickness of the implant is 8 mm, then the posterior resection amount is also 8 mm. This is to maintain the joint line when the implant components are installed in the knee.
  • computer-assisted surgery gives the surgeon more tools to position the implant components according to their surgical philosophies and/or preferences.
  • One such tool is the planning software that allows the surgeon to assess the bones and then position the implant models relative to the bone models to designate the best fit and alignment.
  • CAS systems may also allow the surgeon to assess the soft tissues surrounding the knee, such as the gap balancing technique described above, and then make adjustments to the planned locations for forming the cut surfaces to ensure, among other things, that the ligaments are properly tensioned when the implants are installed in the knee.
  • the location for forming 125520-10102-6901777 10/4/2024 the posterior cut surface on the bone may result in a resection amount that does not match the posterior thickness of the femoral implant.
  • the guide holes 26 of the manufacturer’s sizing guide 25 are used to guide a drill bit in forming the peg holes in the distal cut surface.
  • the sizing guide is specifically dimensioned, such that when the pegs of the 4-in-1 cut block are then placed in those formed peg holes, the posterior guide slot 46 of the 4-in-1 block 40 is aligned on the bone at a location that will always result in a posterior resection amount equal to the posterior thickness of the implant. This is to preserve the joint line of the knee when using manual instrumentation.
  • the surgeon has more discretion on where to plan the formation of the posterior cut surface, which may not result in a posterior resection amount equal to the posterior thickness of the femoral implant.
  • a spacer 120, 120’ having a thickness that replicates (or matches) the posterior thickness of the femoral implant is used. This will place the guide holes 26 of the manufacturer’s sizing guide 25 in the correct location for forming the peg holes and sizing the implant as if the posterior resection amount was equal to the posterior thickness of the implant regardless of the actual resection amount.
  • the surgeon then mistakenly places a spacer having a thickness equal to the thickness of the removed condyles (i.e., a spacer having a thickness of 6 mm) on the posterior cut surface to size the implant.
  • the surgeon advances a drill bit through the guide holes 26 to form the peg holes.
  • the posterior guide slot 46 of the 4-in-1 cut block 40 is aligned relative to the bone at a location that would result in an 8 mm posterior resection amount, which would be a 2 mm “over-resection” from the actual posterior cut surface formed at 6 mm.
  • a spacer having a thickness of the implant (8 mm) may be placed on the posterior cut surface to size the implant with the sizing guide 25 (instead of a using a spacer of 6 mm). After sizing, the surgeon advances a drill bit through the guide holes 26 to form the peg holes.
  • the posterior guide slot 46 of the 4-in-1 cut block 40 is aligned relative to the bone at a location that would result in a 6 mm posterior resection amount, which aligns with the actual posterior cut surface formed at 6 mm. All the guide slots now align in the correct POSE for forming the remaining cut surfaces on the bone. In another example, using the same implant, the surgeon may decide to form the posterior cut surface with a posterior resection amount of 10 mm.
  • the surgeon then mistakenly places a spacer having a thickness equal to the thickness of the removed condyles (i.e., a spacer having a thickness of 10 mm) on the posterior cut surface to size the implant.
  • the surgeon advances a drill bit through the guide holes 26 to form the peg holes.
  • the posterior guide slot 46 of the 4-in-1 cut block 40 is aligned relative to the bone at a location that would result in an 8 mm posterior resection amount, which would be a 2 mm “under-resection” from the actual posterior cut surface formed at 10 mm.
  • the user has more options to determine or plan the location for the posterior cut surface, which ultimately defines the I-E rotation for the femoral implant. Therefore, when the user is using the manufacturer sizing guide with the spacer (120, 120’) having a thickness equal to the posterior thickness of the implant, the user can set the I-E adjustment mechanism on the sizing guide to 0 ⁇ of rotation from the posterior condylar axis, which will maintain the I-E rotation as defined by the posterior cut surface.
  • the manufacturer sizing guide with the spacer (120, 120’) having a thickness equal to the posterior thickness of the implant the user can set the I-E adjustment mechanism on the sizing guide to 0 ⁇ of rotation from the posterior condylar axis, which will maintain the I-E rotation as defined by the posterior cut surface.
  • the anterior cut surface also defines the I-E rotation for the femoral implant, so the I-E adjustment setting on the sizing guide is set to 0 ⁇ of rotation from the posterior condylar axis to maintain the desired I-E rotation of the femoral implant as defined by the anterior cut surface. It’s possible that this may be applied to the distal cut surface and any other cut surface on the femur.
  • a user may use a CAS system to plan and form the distal cut surface and at least one other cut surface on the femur then use a spacer and the manufacturer’s sizing guide in the same manner as previously described for that at least one other cut surface on the femur.
  • a specific embodiment for using a CAS device to assist in forming at least two cut surfaces on the femur while further providing a method to determine an appropriately sized femoral implant for the patient is shown.
  • the same system and method may be used to plan the locations and form the femoral distal cut surface and the femoral posterior cut surface as described above with reference to FIGs. 4 to 7.
  • the manufacturer’s sizing guide 25 is placed on the distal cut surface 18 and used to size the implant, where the paddles 27 of the sizing guide 25 can reference the posterior condyles as shown in FIG. 2.
  • the sizing guide 25 is used before the posterior cut surface is formed on the femur for sizing the implant. After the user determines an appropriately sized implant for the patient, the sizing guide 25 is removed and the posterior cut surface 22 is formed in the same manner as described with reference to FIGs. 8 and 9. Briefly, a 2-DoF device 100 125520-10102-6901777 10/4/2024 maintains alignment of a pin 107 coincident with a second virtual plane “VP2” for inserting pins (107a, 107b) in the distal cut surface 18 coincident with the second virtual plane “VP2”. A cut guide 108 is then coupled to the pins, and a user advances a surgical saw blade through the guide slot 112 to form the posterior cut surface 22.
  • FIGs. 14A and 14B depict an alignment guide 60 for aligning a 4-in-1 cut block 40 in the correct POSE relative to the bone to guide the formation of the remaining cut surfaces on the femur.
  • the alignment guide 60 includes a body 62 and one or more alignment features (62a, 62b).
  • the one or more alignment features (62a, 62b) are configured to fit inside the posterior guide slot 46 of the 4-in-1 cut block 40 to align the posterior guide slot 46 with the posterior cut surface 22 formed on the bone. In doing so, the other guide slots of the 4- in-1 cut block 40 will align on the bone in the correct POSE to guide the formation of the remaining cut surfaces.
  • the thickness of the one or more alignment features (62a, 62b) may therefore be less than the size of the opening of the posterior guide slot 46. In some embodiments, the thickness of the alignment features (62a, 62b) ranges from 0.5 mm to 1.5 mm in order to fit inside (or slide into) the opening of the posterior guide slot 46.
  • the body 62 of the alignment guide 60 has the same thickness as the alignment features (62a, 62b), while in other embodiments, the body 62 may have a different thickness than the alignment features (62a, 62b).
  • the alignment features (64a, 64b) may be prongs, projections, or extensions, that extend from the body 62 of the alignment guide 60, while in other embodiments, the alignment features (64a, 64b) are part of the body 62 that does not necessarily extend from any portion of the body 62 (e.g., a portion or area of the body 62 may fit inside the posterior guide slot 46).
  • the body 60 may include at least one face configured for placement against the posterior cut surface 62. For example, FIG.
  • the alignment guide 50 may be made of any suitable material 125520-10102-6901777 10/4/2024 (e.g., metals, plastics, etc.), and may be single use or sterilizable for multiple uses.
  • the alignment guide 60 may further include a handle (not shown) for easy handling by the user.
  • the alignment guide 60 is a separate device as part of a surgical kit for use during the procedure.
  • the alignment guide 60 is a device commonly used during a TKA procedure or any other surgical procedure for that matter.
  • the alignment guide 60 may be a surgical saw blade readily available in the operating room (OR), where a face of the surgical saw blade is placed against the posterior cut surface 22 and then the posterior guide slot 46 slides down onto a tip of the saw blade.
  • OR operating room
  • Other devices readily available in the OR that may be used as an alignment guide 60 include a retractor, pins, clamps, and other surgical hardware.
  • the alignment guide 60 may be used as many devices and/or configurations of devices as the alignment guide 60 as long as the device is capable of referencing the location of the posterior cut surface 22 (e.g., placing a face of the device against the posterior cut surface) and include some portion that can reference (e.g., fits inside) the posterior guide slot 46 in order to align the posterior guide slot 46 with the location of the posterior cut surface 22.
  • the alignment guide 60 is shown placed against the posterior cut surfaces (22a, 22b).
  • the alignment guide 60 may be held in place by the user, while in other embodiments, a clamp or other fixation device may be used to hold the alignment guide 60 against the posterior cut surface 22.
  • the alignment guide 60 includes one or more spikes, prongs, or other bone interacting elements (not shown) extending from a face of the body 62 to interact with the bone to hold the alignment guide 60 to the posterior cut surface 22.
  • the posterior guide slot 46 of the 4- in-1 cut block 40 is then placed on the alignment features (62a, 62b) as shown in FIG.16B.
  • FIG.16B depicts the 4-in-1 cut block 40 positioned on the distal cut surface 18, where the alignment features (62a, 62b) are positioned inside the posterior guide slot 46 to align the posterior guide slot 46 with the posterior cut surface 22.
  • the user may hammer the 4-in-1 cut block 40 into the distal cut surface 18 to secure the pegs (54a, 54b) of the cut block 40 in the bone.
  • the use may in addition, or alternatively, place pins or screws through 125520-10102-6901777 10/4/2024 designated areas in the cut block 40 and into the bone to secure the 4-in-1 cut block at the aligned location.
  • the user may advance a surgical saw blade through the other guide slots to form the remaining cut surfaces on the bone.
  • the femoral implant is then installed on the cut surfaces to complete the femoral side of the TKA procedure.
  • Embodiments of the present invention also provides a system and method for determining geometry data about an implant and/or cut block in order to use an unsupported implant with a CAS system.
  • a signal is sent to the tracking system via the active LED signaling that the button was pushed.
  • the user input mechanism 76 allows the user to provide a signal to the system to digitize or collect the real-time location of the probe tip 72 and thereby digitize or collect one or more points on the surface of an implant that is in contact with the probe tip 72.
  • the digitizer probe 70 and a tracking system may be used to determine certain geometry data about an unsupported implant, or geometry data for a plurality of unsupported implants where each implant has a different implant size (e.g., an implant line manufactured by company ‘X’, with implants ranging from size 0 to 10).
  • a user wielding the digitizer probe may digitize several points on certain surfaces of the implant to determine geometry data of those surfaces, given that the physical implants are available prior to the procedure.
  • the user may “paint” (e.g., digitize or collect a plurality of points) the contact surfaces (13, 15, 17, 19, 21) of the femoral implant 12 to obtain geometry data about the location of each contact surface relative to the other contact surfaces.
  • a user wielding the digitizer probe 70 may digitize a plurality of points on the anterior contact surface 13, a plurality of points on the anterior chamfer contact surface 15, a plurality of points on the distal contact surface 17, a plurality of points on the posterior chamfer contact surface 19, and a plurality of points on the posterior contact surface 21.
  • the points may be digitized in the manner described above, where the user activates a user-input mechanism when the probe tip 72 is in contact with a contact surface, and the tracking system (or computing system operatively coupled to the tracking system) then records the location of the probe tip 72 at those locations to digitize the contact surfaces.
  • the implant may be tracked by a tracking system (e.g., via a tracking array affixed to the implant) or securely fixed in position while the user digitizes the implant.
  • the plurality of points digitized on each contact surface may be stored in the memory of the computing system. The above procedure may be repeated on different 125520-10102-6901777 10/4/2024 implants of different implant sizes to build a library of geometry data for an entire implant line if so desired.
  • the user may further digitize a plurality of points on the outer surface (e.g., 27) of the implant (sometimes referred to as the articulating surface of the implant). Digitizing the outer surface of the implant provides geometry data that allows the user to assess how the outer surfaces of the implant (e.g., femoral implant) will contact, move, or articulate relative to the opposing TKA implant (e.g., tibial liner) during pre-operative or intra- operative planning. Digitizing the outer surface may also provide geometry data that allows the user to assess how the patella might track in the anterior groove of the femoral implant 12 during pre-operative or intra-operative planning.
  • TKA implant e.g., tibial liner
  • Digitizing the outer surface may further provide geometry data regarding the thickness of the implant (e.g., the posterior thickness of the femoral implant 12).
  • the plurality of digitized points that represent geometry data about the implant(s) may now be used to assist a user in planning and/or executing a TKA procedure.
  • the computing system includes planning software for planning the surgical procedure.
  • the planning software may utilize the plurality of digitized points as raw data to assist a user with planning the procedure (e.g., displaying the digitized points as a point cloud showing the relationship of each contact surface relative to the other contact surface, or showing a point cloud of the outer surface of the implant).
  • the planning software may fit a plane to the plurality of points digitized on each contact surface.
  • the software may fit a total of five planes corresponding to the five contact surfaces, where each plane is fitted to a contact surface. The intersection of those planes marks the boundary between one contact surface relative to its neighboring contact surface.
  • the planning software uses the fitted planes (in their fixed relationship) to assist a user with planning the procedure.
  • the planning software may utilize statistical shape modeling, morphing, or other 3-D modeling software to generate a 3-D model of the implant from the plurality of digitized points (e.g., fitting the plurality of digitized points to a generic 3-D implant 125520-10102-6901777 10/4/2024 model).
  • the planning software may then use the generated 3-D model to assist a user with planning the procedure.
  • the planning software may include various software tools that allow the user to position any of the aforementioned (e.g., point cloud, fitted planes, generated 3-D model, hereinafter referred to as digitized implant data) relative to bone data (e.g., 3-D bone model) of the patient’s bone to designate the best fit and alignment for the implant on the bone.
  • digitized implant data e.g., point cloud, fitted planes, generated 3-D model, hereinafter referred to as digitized implant data
  • bone data e.g., 3-D bone model
  • the planning software can now display the digitized implant data to assist the user in planning the location for the implant relative to the bone data 32.
  • the surgical plan may be saved for future use (e.g., used to execute the TKA procedure with the assistance of a CAS device).
  • the planned location for the digitized implant data relative to the bone data defines the planned location for forming the cut surfaces as described above.
  • the user wielding the digitizer digitizes the guide slots of the cut block 40 to determine the locations of the guide slots relative to one another.
  • the user may place the probe tip 72 in a guide slot (e.g., anterior guide slot 520) and slide the digitizer across the guide slot while the tracking system (or a computing system operatively coupled to the tracking system) records the location of the probe tip 72.
  • the user may digitize points in the guide slot on both the top side 44 of the cut block 40 and on the bottom side 45 of the cut block 40 to provide enough digitized points to define both the location and orientation of each guide slot.
  • the cut block 40 may be tracked by a tracking system (e.g., via a tracking array affixed to the cut block 40) or securely fixed in position while the user digitizes the cut block 40.
  • Planning software may use the digitized points to fit a plane to each guide slot, where the intersection of one plane with another plane defines the 125520-10102-6901777 10/4/2024 boundary of one guide slot (e.g., posterior guide slot) to its neighboring guide slot (e.g., posterior chamfer guide slot).
  • the cut block is dimensioned to correspond to the shape of the femoral implant, such that the cut surfaces formed with the aid of the guide slots correspond to the shape of the contact surfaces of the femoral implant.
  • the user may also digitize the location of the pegs (54a, 54b) of the cut block 40 to determine the offset between the pegs (54a, 54b) and one or more of the guide slots.
  • the CAS system may be used in a conventional manner.
  • the system may be a 2-DoF CAS system as described in 11,457,980, where the location of the pegs (54a, 54b) relative to the planned location for the posterior or anterior cut surface may be used to assist in drilling peg holes in the bone to receive the pegs of the cut block in the planned position and orientation. Aligning a Cut Block on a Bone using Pins Inserted in the Bone [00102] In particular embodiments, with reference to FIGs.
  • a system and method for aligning a cut block on a bone in a planned POSE is shown, where the cut block is aligned on the bone using alignment pins inserted in the bone.
  • the alignment pins are inserted in the bone coincident with the second virtual plane ‘VP2’ corresponding the location for forming the posterior cut surface.
  • the alignment pins are aligned with the use of a CAS device (e.g., 2-DoF device 100) for inserting the alignment pins in the bone.
  • FIGs.19A and 19B depicts a first embodiment of an alignment pin assembly 80, where FIG.19A depicts the alignment pin assembly 80 in an assembled state, and FIG. 19B depicts the alignment pin assembly 80 in an exploded state.
  • the alignment pin assembly 80 includes a sleeve 82 and an alignment pin 84.
  • the coupling member 86 is dimensioned to match the dimensions of a coupling member of a typical tool drive by the CAS device.
  • a tool may be coupled to a CAS device by way of a socket and bit connection, where the tool includes a bit (e.g., coupling member 86) located at its proximal end that fits inside a socket associated with the driving mechanism of the CAS device. Therefore, the dimensions of the socket associated with the CAS device does not need to be modified or changed in order to receive the sleeve 82 and then drive the alignment pin assembly 80 into the bone.
  • the diameter (or width) of the alignment pin 84 is dimensioned such that a guide slot of the cut block can slide over/onto the alignment pin 84 without much play therebetween.
  • the alignment pin 84 has a diameter (or width) between 0.5 millimeters and 1.5 millimeters, and the sleeve 82 has an outer diameter (or width) between 2.5 millimeters and 3.5 millimeters with the diameter of the inner bore or opening greater than the diameter of the alignment pin 84.
  • FIGs. 20A and 20B depict a second embodiment of an alignment pin assembly 80’, where FIG. 20A depicts the alignment pin assembly 80’ in an assembled state, and FIG. 20B depicts the alignment pin assembly 80’ in an exploded state.
  • the alignment pin assembly 80’ may include a sleeve 82 and a tiered alignment pin 84’.
  • the sleeve 82 is configured to slide over a top tier 90 of the tiered alignment pin 84’.
  • the sleeve 82 may be cylindrical having an inner bore or opening for receiving the top tier 90 of the alignment pin 84’ therein.
  • the sleeve 82 may further include a coupling member 86 (e.g., a square or hexagonal peg/nut) located at a proximal end of the sleeve 82.
  • the coupling member 86 is configured to couple the alignment pin assembly 80’ to a CAS device (e.g., 2-DoF device 100) by way of a coupling mechanism (e.g., a chuck, collet, interaction fit).
  • the tiered alignment pin 84’ includes a top tier 90 (or top portion) and bottom tier 92 (or 125520-10102-6901777 10/4/2024 bottom portion), where the bottom tier 92 further includes a pin tip 88 located at a distal end of the bottom tier 82 to easily pierce the bone when inserting the alignment pin assembly 80’ into the bone.
  • the inner bore or opening of the sleeve 82 has a diameter (or width) greater than the diameter (or width) of the top tier 90 of the tiered alignment pin 84’, but less than the diameter (or width) of the bottom tier 92, such that the sleeve 82 cannot slide over the bottom tier 92.
  • the outer diameter (or outer width) of the sleeve 82 is dimensioned to match the outer diameter (or outer width) of a typical tool (e.g., pin 107, a drill bit, etc.) driven by the CAS device.
  • the coupling member 86 is dimensioned to match the dimensions of a coupling member of a typical tool drive by the CAS device.
  • a tool may be coupled to a CAS device by way of a socket and bit connection, where the tool includes a bit (e.g., coupling member 86) located at its proximal end that fits inside a socket associated with the driving mechanism of the CAS device.

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Abstract

En TKA, après la formation de la surface de coupe postérieure, un espaceur est placé sur la surface de coupe postérieure (par exemple, directement sur celle-ci, ou prise en sandwich entre la surface de coupe postérieure et la surface de coupe du tibia, du plateau ou du tibia) pour remplacer les condyles postérieurs retirés afin d'utiliser le guide de dimensionnement du fabricant pour : (i) déterminer une taille d'implant appropriée ; et/ou (ii) déterminer l'emplacement pour monter le bloc 4-en-1 sur la surface de coupe distale pour aligner le bloc de coupe 4-en-1 dans la pose correcte pour guider la formation des surfaces de coupe restantes pour s'adapter à la taille d'implant déterminée. L'épaisseur de l'espaceur peut répliquer (ou correspondre) l'épaisseur de l'épaisseur postérieure d'implant fémoral ou l'épaisseur des condyles postérieurs retirés. L'espaceur peut avoir un ajustement, un mécanisme pour tenir compte de l'épaisseur postérieure de différentes lignes d'implant ou de l'épaisseur des condyles postérieurs retirés.
PCT/US2024/049974 2023-10-05 2024-10-04 Système chirurgical assisté par ordinateur agnostique d'implant, appareil et procédé Pending WO2025076362A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050149041A1 (en) * 2003-11-14 2005-07-07 Mcginley Brian J. Adjustable surgical cutting systems
US20150173774A1 (en) * 2011-11-11 2015-06-25 Depuy (Ireland) Bone sizing guide
US20150289883A1 (en) * 2010-05-21 2015-10-15 Howmedica Osteonics Corp. Natural alignment knee instruments
US20220151640A1 (en) * 2017-09-29 2022-05-19 Smith & Nephew, Inc. Robotically assisted bone preparation for positioning of cutting block
WO2023059931A1 (fr) * 2021-10-08 2023-04-13 Think Surgical, Inc. Système chirurgical et procédé de formation de surfaces de découpe sur moins de la totalité de la surface de l'os pour la mise en place d'un implant

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050149041A1 (en) * 2003-11-14 2005-07-07 Mcginley Brian J. Adjustable surgical cutting systems
US20150289883A1 (en) * 2010-05-21 2015-10-15 Howmedica Osteonics Corp. Natural alignment knee instruments
US20150173774A1 (en) * 2011-11-11 2015-06-25 Depuy (Ireland) Bone sizing guide
US20220151640A1 (en) * 2017-09-29 2022-05-19 Smith & Nephew, Inc. Robotically assisted bone preparation for positioning of cutting block
WO2023059931A1 (fr) * 2021-10-08 2023-04-13 Think Surgical, Inc. Système chirurgical et procédé de formation de surfaces de découpe sur moins de la totalité de la surface de l'os pour la mise en place d'un implant

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