WO2021026029A1 - Guide d'alésage d'épaulement doté d'un élément de vérification - Google Patents

Guide d'alésage d'épaulement doté d'un élément de vérification Download PDF

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Publication number
WO2021026029A1
WO2021026029A1 PCT/US2020/044617 US2020044617W WO2021026029A1 WO 2021026029 A1 WO2021026029 A1 WO 2021026029A1 US 2020044617 W US2020044617 W US 2020044617W WO 2021026029 A1 WO2021026029 A1 WO 2021026029A1
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WO
WIPO (PCT)
Prior art keywords
patient
guide
reaming
central
bone
Prior art date
Application number
PCT/US2020/044617
Other languages
English (en)
Inventor
Ilke VANHAELEN
Filip JONKERGOUW
Original Assignee
Materialise N.V.
Materialise Usa, Llc
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Publication date
Application filed by Materialise N.V., Materialise Usa, Llc filed Critical Materialise N.V.
Publication of WO2021026029A1 publication Critical patent/WO2021026029A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; 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
    • A61B17/1778—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the shoulder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1684—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the shoulder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8897—Guide wires or guide pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101—Computer-aided simulation of surgical operations
    • A61B2034/105—Modelling of the patient, e.g. for ligaments or bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides
    • 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
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth
    • 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
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B2090/364—Correlation of different images or relation of image positions in respect to the body
    • A61B2090/365—Correlation of different images or relation of image positions in respect to the body augmented reality, i.e. correlating a live optical image with another image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis

Definitions

  • This application relates to patient-specific, orthopaedic devices such as guides and prostheses.
  • Joint replacement procedures are used to repair damaged joints. During a joint replacement procedure, the joint is aligned by resecting one or more bones and a prosthesis may be implanted. Joint replacement procedures may be performed on the knee, ankle, hip, shoulder, elbow, etc. Standard and patient- specific guides and implants have been used in joint replacement procedures.
  • shoulder arthroplasty involves replacement of the glenoid fossa of the scapula with a prosthetic glenoid component.
  • the conventional glenoid component provides a laterally or outwardly facing, generally concave bearing surface against a prosthetic humeral head. It may also include a medially or inwardly projecting stem for fixing the glenoid component in a cavity constructed by resecting the glenoid fossa and suitably resecting the cancellous bone from the glenoid fossa.
  • the main goals of shoulder arthroplasty are pain relief and range of motion restoration.
  • a hole is drilled to fix a guide (or central) pin (e.g., a pin element) through the glenoid fossa.
  • a cannulated reamer is then slid over the guide pin and used to shape the scapula to prepare the surface for receiving the glenoid component, typically by forming a cavity in the glenoid vault.
  • Superior and inferior holes are drilled to accommodate screws to hold the implant in place.
  • a trial glenoid component is implanted in the prepared cavity and if it fits, it is replaced by the actual glenoid component.
  • Preoperative planning may be used to create a surgical plan based on the scanned data of the patient. Scanned images are also used to determine the instruments and prosthetic components, including patient- specific guides and implants, needed for the surgical procedure. During planning, based on the scanned images, a three-dimensional model of the joint is prepared and corresponding guides and implants are designed. These components may be prepared using additive manufacturing techniques.
  • Patient- specific guides used in shoulder arthroplasty include an inner guide surface designed to mate with a joint surface of the patient. Such guides may lock or mate or clip onto the articular surface of the joint in a unique position.
  • the guides may have apertures to guide various surgical instruments at predetermined positions so as to achieve bone resection needed to fix the implant at the desired location.
  • the surgical reaming guide includes a positioning element comprising a patient- specific surface, the patient-specific surface shaped to mate with a corresponding bone surface of a patient.
  • the surgical reaming guide includes a first guiding element coupled to the positioning element, wherein the first guiding element is configured to receive and guide a reference element along a reference axis that intersects with a central axis, the reference axis and the central axis defined in the bone surface such that the intersection occurs at a desired reaming depth of the bone surface when the positioning element is mated with the corresponding bone surface of the patient.
  • the surgical reaming guide includes a first guiding element, a central guiding element, and a positioning element having a patient- specific surface corresponding to a bone surface of a patient.
  • the method includes mating the patient- specific surface of the positioning element to the corresponding bone surface of the patient, wherein the patient-specific surface of the positioning element comprises one or more surfaces complementary to the corresponding bone surface of the patient.
  • the method includes drilling, along a central axis provided by the central guiding element, a first hole into a first position of the bone surface.
  • the method includes drilling, along a reference axis provided by the first guiding element, a second hole into a second position of the bone surface. In some examples, the method includes reaming the bone surface of the first position and the second position until the first hole and the second hole at least partially overlap at a reamed surface of the bone.
  • the surgical reaming guide includes a central guiding element and a positioning element having a patient-specific surface corresponding to a bone surface of a patient.
  • the method includes mating the patient-specific surface of the positioning element to the corresponding bone surface of the patient, wherein the patient- specific surface of the positioning element comprises one or more surfaces complementary to the corresponding bone surface of the patient.
  • the method includes drilling, along a central axis provided by the central guiding element, a first hole into a first position of the bone surface.
  • the method includes inserting a central pin into the first hole along the central axis.
  • the method includes reaming the bone until a reference element inserted in the central guiding element reaches a desired depth indicated by a visual marker on one or more of the reference element or the central guiding element.
  • Certain aspects pf the present disclosure provide a method of using a surgical reaming guide comprising a central guiding element and a positioning element having a patient- specific surface corresponding to a bone surface of a patient.
  • the method includes mating the patient- specific surface of the positioning element to the corresponding bone surface of the patient, wherein the patient- specific surface of the positioning element comprises one or more surfaces complementary to the corresponding bone surface of the patient.
  • the method includes drilling, along a central axis provided by the central guiding element, a first hole into a first position of the bone surface.
  • the method includes inserting a central pin into the first hole along the central axis.
  • the method includes reaming the bone while a reference element is inserted in the bone a desired depth indicated by a visual marker on the reference element.
  • Coupled or connected may be detachably coupled or connected to one another, meaning they can be decoupled or disconnected without breaking, or can be fixedly coupled or connected to one another, meaning that to decouple or disconnect would requiring breaking them to be apart.
  • embodiments described as coupled or connected could further be defined more specifically as one of either detachably or fixedly so.
  • FIGs. 1A-1E are perspective drawings illustrating various perspectives of a reaming guide, in accordance with certain aspects of the present disclosure.
  • FIG. 2A is a diagram illustrating an optimal reaming depth from a glenoid surface, in accordance with certain aspects of the present disclosure.
  • FIG. 2B is a perspective diagram illustrating three examples of how different points of the axes of FIG. 2A appear to a surgeon during reaming, in accordance with certain aspects of the present disclosure.
  • FIG. 2C is a perspective diagram illustrating an intersection of a first reference element (on a central functional element axis) and a second reference element (on a guiding element axis), in accordance with certain aspects of the present disclosure.
  • FIG. 3A is a flowchart illustrating an example process for using the reaming guide of FIGs. 1A-1E, in accordance with certain aspects of the present disclosure.
  • FIG. 3B is a perspective diagram illustrating the reaming guide where the connecting element and guiding element form an extension of the glenoid guide, in accordance with certain aspects of the present disclosure.
  • FIG. 3C is a perspective diagram illustrating a reaming guide and a reference pin/wire, in accordance with certain aspects of the present disclosure.
  • FIG. 3D is a perspective diagram illustrating a reaming guide having a removably attached central functional element, in accordance with certain aspects of the present disclosure.
  • FIG. 4A is a perspective diagram illustrating positioning elements of a reaming guide designed to interact with features on or surrounding the glenoid, in accordance with certain aspects of the present disclosure.
  • FIG. 4B is a flowchart illustrating an example process for using the reaming guide of FIG. 4A, in accordance with certain aspects of the present disclosure.
  • FIG. 4C is a perspective diagram illustrating the reaming guide of FIG. 4A and a central guide pin that may be placed using a central functional element of the reaming guide, in accordance with certain aspects of the present disclosure.
  • FIG. 4D is a perspective diagram illustrating a slide-able reference pin arm sliding onto a reference pin, in accordance with certain aspects of the present disclosure.
  • FIG. 4E is a perspective diagram illustrating a reaming guide comprising a central functional element that is detachable from the remainder of the guide, in accordance with certain aspects of the present disclosure.
  • FIGs. 5A and 5B are perspective diagrams illustrating a two-piece reaming guide system, in accordance with certain aspects of the present disclosure.
  • Certain aspects of devices and methods discussed herein relate to customized, patient-specific, orthopaedic devices such as guides and prostheses. For example, certain aspects provide a guide suited for shoulder arthroplasty procedures which guide a reamer to desired depth and/or provide a checking mechanism for reaming depth. It is contemplated that elements and features of one embodiment or technique may be beneficially incorporated in other embodiments and techniques without further recitation.
  • One embodiment provides an orthopaedic guide, such as for a glenoid implant for facilitating implantation of the glenoid implant in the glenoid cavity, which includes a shoulder reaming guide with a checking feature.
  • an orthopaedic guide such as for a glenoid implant for facilitating implantation of the glenoid implant in the glenoid cavity, which includes a shoulder reaming guide with a checking feature.
  • the devices and methods discussed herein are intended to guide/assist a surgeon during the intraoperative reaming of a bone cavity, such as the glenoid surface.
  • Shoulder arthroplasty involves removal of a portion of the glenoid surface to accommodate a glenoid implant.
  • a bone portion is removed using a reamer (or a reaming device).
  • Reamers generally include one or more spinning blades that remove the bone from the glenoid surface.
  • Such reamers are cannulated, such that they can be inserted over a central pin/wire, referred to as a guide pin, inserted into the glenoid.
  • a glenoid implant may be placed. The depth of the surgical incision and the tension of the surrounding soft tissues makes it difficult to see landmarks accurately or to determine the depth of the reamed cavity, making glenoid preparation the most challenging step.
  • FIGs. 1A-1E are perspective drawings illustrating various perspectives of a reaming guide 100, in accordance with certain aspects of the present disclosure.
  • the reaming guide 100 may be a patient- specific device used as a surgical guide for guiding or checking a reamer onto a bone (e.g., a glenoid or hip) of a patient.
  • the reaming guide 100 may include one or more guiding elements (e.g., central functional element 105 of glenoid guide 104, and/or guiding element 102 of reference pin arm 101, collectively referred to as “guiding elements”). Illustrated throughout FIGs.
  • 1A-1E are one or more patient- specific positioning elements (e.g., patient-specific positioning element 107 of glenoid guide 104), one or more connecting elements (e.g., connecting element 109 of glenoid guide 104 and/or connecting element 103 of reference pin arm 101, collectively referred to as “connecting elements”) for connecting the one or more guiding elements to the one or more patient- specific positioning elements, and one or more reference elements (e.g., reference element 123 of glenoid guide 104 and/or reference element 121 of reference pin arm 101, collectively referred to as “reference elements”).
  • patient- specific positioning elements e.g., patient-specific positioning element 107 of glenoid guide 104
  • connecting elements e.g., connecting element 109 of glenoid guide 104 and/or connecting element 103 of reference pin arm 101, collectively referred to as “connecting elements”
  • reference elements e.g., reference element 123 of glenoid guide 104 and/or reference element 121 of
  • reference pin arm 101 is configured to accept one or more reference elements (e.g., a first reference element 121, a second reference element 123, and/or a third reference element 125) for guiding or checking the reaming depth.
  • the one or more reference elements 121-125 may be integrated into the device, removably attached thereto (e.g., detachable), or housed by a portion of the reaming guide 100 (e.g., a guiding element 102 and/or central functional element 105 may provide a housing to guide each of the one or more reference elements 121-125).
  • These one or more reference elements 121-125 may include a wire, a pin, a reference pin, a screw or gauge, a K-wire, a Hoffman pin, a drill bit, or a drilling pin (e.g., a metal wire or metal pin).
  • a reference pin arm 101 illustrated in FIGs. 1A, IB, ID, and IE includes a guiding element 102 (e.g., a cannula) for receiving a reference element 121-125.
  • the reaming guide 100 may include a glenoid guide 104 having a central functional element 105 extending through it.
  • the location and orientation of the glenoid guide 104 and/or the central functional element 105 may be predetermined and set during pre-operative planning.
  • the central functional element 105 of the glenoid guide 104 may be configured to receive the second reference element 123 (e.g., a bone guide pin or wire), while the guiding element 102 of the reference pin arm 101 is configured to receive the first reference element 121 (e.g., a drill bit or drilling pin) for reaming.
  • a third reference element 125 is received by the guiding element 102 of the reference pin arm 101 to determine/check depth after reaming.
  • the one or more guiding elements may be used as guiding reference elements for surgical instruments, such as a reamer or a drill.
  • the one or more guiding elements comprise a cylindrical shape, and are configured for guiding the placement of a pin or wire into the bone. Other shapes, such as slots, are also possible depending on the type of the surgical instrument (or reamer) to be guided.
  • one or more of the reference elements may be remove-ably or slide-ably connected or attached to the reaming guide 100 by the one or more guiding elements.
  • the one or more reference elements may be used for aligning the reamer.
  • the reaming guide 100 may be used in a method of performing an orthopaedic bone-reaming procedure on a glenoid to facilitate implantation of a prosthesis in a glenoid cavity, including positioning of one or more guide pins.
  • the surgeon may use constraint data to plan and prepare for reaming.
  • the constraint data may be patient-specific (e.g., the size, shape, and quality of the available bone stock, the size of the implant, etc.) or procedure-specific data (e.g., a preference for the amount of inclination and version for the glenoid prosthesis, the amount of bone to ream, the size of the implant, the angle for reference pin insertion, etc.).
  • the surgeon may determine the location, orientation and depth of reaming.
  • the disclosure describes techniques for providing a patient- specific surgical guide for guiding a reference element (e.g., a reamer) up to a pre-determined depth.
  • the techniques include: (a) obtaining, from a pre-operative plan, a pre-defined central axis and a pre-defined reaming depth along said pre-defined central axis of a planned reaming step; (b) identifying and selecting, based on volume information of the glenoid from a patient and the bony anatomy surrounding the glenoid, features of the bone on or surrounding the glenoid which are suitable for positioning a patient-specific reaming guide; (c) based on the information in step (a), determining a trajectory of the reference element such as to achieve the convergence of the central axis and said trajectory at the pre-defined reaming depth; and (d) based on the information in steps (b) and (c), designing the patient- specific
  • designing the patient-specific reaming guide may include: (i) designing one or more guiding elements, such as a drill-guiding cylinder or pin-guiding cylinder, for guiding the reference element along the determined trajectory; (ii) designing one or more positioning elements designed to interact with the features of the bone on or around the glenoid of the patient; (iii) designing one or more fixed or detachable connecting elements for connecting the guiding elements to the one or more positioning elements; and/or (iv) designing the central functional element 105 for guiding the placement of a guide pin or wire along the pre-determined central axis.
  • designing one or more guiding elements such as a drill-guiding cylinder or pin-guiding cylinder, for guiding the reference element along the determined trajectory
  • designing one or more positioning elements designed to interact with the features of the bone on or around the glenoid of the patient
  • designing one or more fixed or detachable connecting elements for connecting the guiding elements to the one or more positioning elements
  • designing the central functional element 105 for guiding the placement of
  • the volume information of the glenoid may be based on medical images or the patient, such as computer tomography (CT) or magnetic resonance imaging (MRI) images.
  • CT computer tomography
  • MRI magnetic resonance imaging
  • the volume information may comprise voxel data.
  • the volume information may comprise one or more virtual 3D models, for example created based on medical images through segmentation (e.g., by using Mimics, or any other image-based engineering software).
  • the devices may include: one or more guiding elements, such as a drill-guiding cylinder or a pin-guiding cylinder, for guiding a reference element along a pre-determined trajectory; one or more positioning elements designed to interact with features on or around the glenoid of the patient; one or more fixed or detachable connecting elements for connecting the guiding elements to the one or more positioning elements; and/or one or more reference pin arms, slide- ably connectable to the one or more guiding elements of the positioning elements, whereby a reference pin arm interacts with the reference element such that the trajectory of the reference element axis intersects a pre-determined central axis of a reaming step at a pre-determined reaming depth.
  • guiding elements such as a drill-guiding cylinder or a pin-guiding cylinder, for guiding a reference element along a pre-determined trajectory
  • one or more positioning elements designed to interact with features on or around the glenoid of the patient
  • one or more fixed or detachable connecting elements for connecting the guiding
  • the central functional element (e.g., the central function element 105 of FIGs. 1A-1E) is designed for guiding the placement of a guide pin or wire along the pre-determined central axis.
  • the guide may include one or more moveable parts which, in some examples, may be moveable with respect to each other (e.g., the reference pin arm 101 may be configured to rotate about the functional element 105 of the glenoid guide 104).
  • one or more patient-specific positioning elements 107 may be configured to interact with features on or surrounding the glenoid.
  • the patient- specific positioning elements 107 may include elements of the reaming guide 100 having one or more surfaces that have been designed based on the volume information of the glenoid and the bony anatomy surrounding the glenoid.
  • one or more surfaces of the reaming guide 100 may be designed and manufactured such that the one or more surfaces are complementary to the three-dimensional shape of the features of the bone identified in step (b) above. Accordingly, the one or more surfaces of the reaming guide 100 can mate with the identified bone.
  • one or more of the positioning elements 107 ensure clamping of the guide over at least part of a glenoid rim or a coracoid (e.g., via a coracoid clip, as supplied by Materialise NV).
  • one or more elements of the reaming guide 100 may be manufactured via molding or additive manufacturing processes.
  • the reaming guide 100 is designed with an optimal trajectory for reference element 121 based on the quality of the bone, an expected incision size, and/or an expected visibility of reference element 121.
  • the trajectory is pre-operatively planned, preferably based on volume information of the glenoid.
  • the guiding elements include a guiding means designed to provide accurate insertion of the reference elements along the pre-operatively planned trajectory.
  • the guiding means may include a simple hole, flange, a tunnel, or a cylindrical aperture.
  • the one or more guiding elements may provide support for surgical intervention procedures (e.g., cutting, drilling, screwing, reshaping, reaming, etc.).
  • FIG. 2A is a diagram illustrating an optimal reaming depth 201 from the glenoid surface 207, in accordance with certain aspects of the present disclosure.
  • an axes of a guiding element 200 e.g., guiding element 102 and/or central functional element 105 of FIGs. 1A-1E
  • an optimal reaming depth may include a predetermined reaming depth.
  • a central functional element axis 205 e.g., an axis about which the central functional element 105 is formed as a cylinder
  • guiding element axis 202 e.g., an axis about which the guiding element 102 is formed as a cylinder
  • the convergence point 203 is indicative of where the depth of a central functional element axis 205b and an optimal depth of a guiding element axis 202b fully overlap. Though illustrated as such, the optimal depth of the central functional element axis 205b and the optimal depth of the guiding element axis 202b do not have to be exactly at the same point or fully overlap. For example, the optimal depth of the central functional element axis 205b and the optimal depth of the guiding element axis 202b may partially overlap, touch, or be separated by a relatively small, pre-determined distance.
  • points for a shallow depth of the central functional element axis 205a and a shallow depth of the guiding element axis 202a may be separated by a relatively larger distance.
  • Points for a deep depth of the central functional element axis 205c and a deep depth of the guiding element axis 202c may be separated by a distance relatively larger than the optimal depth points (e.g., the optimal depth of the guiding element axis 202b and the optimal depth of the central functional element axis 205b) and the shallow depth points (e.g., the shallow depth of the guiding element axis 202a and the shallow depth of the central functional element axis 205a).
  • FIG. 2B is a perspective diagram illustrating three examples of how different points of the axes of FIG. 2A appear to a surgeon during reaming, in accordance with certain aspects of the present disclosure.
  • FIG. 2C is a diagram illustrating an intersection of reference element 123 (on the central functional element axis 205) and reference element 121 (on the guiding element axis 202).
  • FIG. 3A is a flowchart illustrating an example process 300 for using the reaming guide lOO ofFIGs. 1A-1E.
  • the processes 300 includes securing the reaming guide 100 to the glenoid by placing the reaming guide 100 onto a glenoid and/or a bony anatomy surrounding the glenoid, such that the guide’s positioning elements are mated to the surface of the bone.
  • the processes 300 includes drilling holes using the central functional element 105 and reference element.
  • a hole may be drilled into the bony anatomy using the central functional element 105 by inserting a drill bit (or other reference element) through the central functional element 105, and subsequently removing the drill bit.
  • a central guide tunnel is created in the bony anatomy.
  • a hole may be drilled into the bony anatomy using the guiding element 102 by inserting a drill bit (or other reference element) through guiding element 102 and subsequently removing the drill bit.
  • a reference tunnel is created in the bony anatomy.
  • the process 300 includes inserting a central guide pin through the central functional element.
  • a central guide pin may be inserted into the reference tunnel using the reaming guide’s central functional element.
  • the process 300 includes removing the reaming guide from the bone. [0057] At block 309, the process 300 includes sliding a cannulated reamer onto the central guide pin for reaming.
  • the process 300 includes reaming the bone until the convergence point of the reference tunnel and the central pin is reached.
  • the reaming process may be paused or stopped at regular intervals until a depth such that on the reamed surface of the bone (e.g., a plane corresponding to the reamed surface of the bone), the central guide tunnel/central guide pin intersects with the reference tunnel intersection with the surface/plane.
  • the intersection may substantially coincide, or overlap in location/position with the reference tunnel intersection with the surface/plane.
  • the process 300 may optionally include inserting the reference element into the reference tunnel to determine the depth.
  • the reference tunnel may be drilled after placing the central guide pin.
  • the reference element may be drilled into the bone until it collides with the central guide pin.
  • the central guide pin is not placed using the reaming guide, but is instead placed freehand, or using another means of guidance.
  • the reamer is placed before and removed after drilling the reference tunnel.
  • the guide is configured and used to secure a central pin to the glenoid in a pre-determined location and orientation, corresponding to predetermined angles of inclination and version for the prosthesis.
  • the guiding elements connected to the remainder of the guide by means of the connection elements, may be configured and used to position the reference element into the glenoid at the desired angle and depth.
  • the central guide pin may be used to determine the reaming location and orientation, and the combination of the central guide pin and the reference tunnel may be used to determine the reaming depth.
  • the reaming guide 100 may be configured for multiple use cases, including as a depth checking device and as a guide.
  • FIG. 3B is a perspective diagram illustrating the reaming guide 100 where the connecting element 103 and guiding element 102 form an extension of the glenoid guide 104, in accordance with certain aspects of the present disclosure.
  • the guiding element 102 is used to guide a drill bit 333 for drilling of a reference hole or tunnel intersecting the pre-determined central functional element axis 205 at the pre-determined reaming depth 201.
  • a central guide pin 331 is inserted into the bone using the central functional element 105 as guide.
  • the reaming guide 100 may then be removed by lifting it from the bony anatomy and sliding it along the central guide pin 331.
  • a cannulated reamer may be slid onto the central guide pin 331, using the central guide pin 331 as an orientation and location guide in combination with the reference tunnel (e.g., the void left by drilling using drill bit 333) as a depth guide for reaming.
  • the bone surface may be reamed until the reference tunnel is observed as merging/overlapping with the central pin.
  • the observation of the merge may indicate an optimal, predetermined depth 201, and cue an end to reaming.
  • the reference tunnel may be filled with a liquid of a colour contrasting with the bone to provide better visual aid.
  • the reference pin is constructed from a bio- safe, preferably bioresorbable material of a colour contrasting with the bone and left inside the reference tunnel, or a stick of such material may be inserted into the reference tunnel.
  • the bio-safe material should be soft enough to be easily reamed away and should be harmless to the health of the patient in case any debris is left in the incision.
  • FIG. 3C is a perspective diagram illustrating the reaming guide 100 and a reference pin/wire 341, in accordance with certain aspects of the present disclosure.
  • the connecting element 103 and guiding element 102 form an extension of the glenoid guide 104.
  • the central guide pin 331 is inserted using the central functional element 105 as guide.
  • the reaming guide 100 is removed by sliding it over the central guide pin 331.
  • the cannulated reamer is then slid onto the central guide pin 331 using the central guide pin 331 as an orientation and location guide for reaming.
  • a user may, at regular intervals, lift the reamer to check the depth using a reference pin/wire 341.
  • the reference pin/wire 341 is inserted in the reference tunnel to check if the bone surface has been reamed to the pre-determined depth 201.
  • an indication that the reaming has been performed to the pre-determined depth 201 is when the reference pin 341 touches the central pin (not shown) due to convergence of the trajectories.
  • the guiding element 102 may be formed as an extension of the glenoid guide 104. In such an example, the guiding element 102 is used as a guide for drilling the reference element tunnel (e.g., using the drill bit 333).
  • the surgeon drills using the central functional element 105 and subsequently inserts the central guide pin 331.
  • the reaming guide 100 is removed by sliding it over the central guide pin 331.
  • the surgeon reams using a cannulated reamer that slides over the central guide pin. While reaming, the surgeon periodically stops and lifts the reamer to check the depth of reaming.
  • the reference element tunnel serves as a guide. The surgeon reams till he or she notices the central guide pin 331 overlapping/converging/meeting the reference pin. This serves as a visual depth check for the surgeon.
  • FIG. 3D is a perspective diagram illustrating the reaming guide 350 having a removably attached central functional element 355, in accordance with certain aspects of the present disclosure.
  • the reaming guide 350 is a guide that, when positioned onto the bone and, as the case may be, with the central functional element 355 detached, does not obstruct the path of the reamer. Accordingly, the reaming guide 350 may be left in situ while reaming.
  • the positioning elements may be designed to mate with features surrounding the glenoid, such as glenoid neck, the coracoid base, coracoid tip, the glenoid surface, the lateral border or ‘margo lateralis’ of the scapula, or the acromion such that the reaming guide can remain in place while reaming.
  • the reamer guide 350 comprises a positioning element 357 configured to mate with the base of the coracoid, a guiding element 352, and connecting element 353. The entire guide 350 is designed to be outside the path of the reamer.
  • the reference tunnel of predetermined depth maybe overlaid using mixed reality (such as augmented reality) onto the glenoid surface such that it can be used in combination with the reaming guide.
  • the reference tunnel maybe shown in green, with the end of the tunnel shown in red such that it is visually clear to the surgeon when he or she must stop reaming.
  • the reamer, the positioning and/or guiding elements maybe tracked using a marker, making it readable and usable with a computer navigation system. The reamer, the guide and/or the implant along with the markers or other recognition features would be compatible with computer navigation systems, including navigations systems involving mixed reality components such as augmented reality glasses.
  • the description of the methods herein are not limiting. For example, the steps may be performed in any order as deemed necessary, and steps may be added or removed.
  • the method includes: (a) obtaining, from a pre-operative plan, a pre-defined reamed surface of a planned reaming step; (b) identifying and selecting, based on volume information of the glenoid from a patient and the bony anatomy surrounding the glenoid, features of the bone on or surrounding the glenoid which are suitable for positioning a patient- specific reaming guide; (c) based on the information obtained in step (a), determining a trajectory of a reference element intersecting the pre-defined reamed surface; and (d) based on the information used and obtained in steps (b) and (c), designing the patient- specific reaming guide.
  • designing the patient-specific reaming guide includes: (i) designing one or more guiding elements, such as a drill-guiding cylinder or pin-guiding cylinder, for guiding the reference element along the determined trajectory.
  • One or both of the guiding elements and the reference element may include a visual mark to indicate when the distal end of the reference element touches the pre-determined reamed surface; (ii) designing one or more positioning elements designed to interact with the features of the bone on or around the glenoid of the patient; and (iii) designing one or more fixed or detachable connecting elements for connecting the guiding elements to the one or more positioning elements.
  • designing the patient- specific reaming guide may include designing a central functional element for guiding the placement of a guide pin or wire along the pre-determined central axis.
  • the devices may include: one or more guiding elements, such as a drill- guiding cylinder or a pin-guiding cylinder, for guiding a reference element along a pre determined trajectory; one or more positioning elements designed to interact with features on or around the glenoid of the patient; one or more fixed or detachable connecting elements for connecting the guiding elements (e.g., reference pin arm) to the one or more positioning elements; and/or a reference element slide-ably attachable to the one or more guiding elements.
  • one or both of the guiding elements and the reference element bear a visual mark (e.g., a laser marking/etching made during manufacture) to indicate when the distal end of the reference element touches the pre-determined reamed surface.
  • the devices may include a central functional element for guiding the placement of a guide pin or wire along the pre-determined central axis.
  • FIG. 4A is a perspective diagram illustrating positioning elements 407 of a reaming guide 400 designed to interact with features on or surrounding the glenoid, in accordance with certain aspects of the present disclosure.
  • the position elements 407 may be elements of the reaming guide 400 that comprise one or more surfaces that have been designed, based on the volume information of the glenoid and the bony anatomy surrounding the glenoid, to be complementary to the three-dimensional shape of the features of the bone identified in step (b) above.
  • one or more of the positioning elements 407 ensure clamping of the guide over at least part of the glenoid rim or the coracoid (e.g. using a coracoid clip, as supplied by Materialise NV).
  • a reference element 401 may be configured to slide into a guiding element 402.
  • the reference element 401 may include a visual mark 406, such as a stripe, notch, indentation or surface, to indicate when the distal end 411 of the reference element 401 touches the pre determined reamed surface.
  • a visual mark 406 such as a stripe, notch, indentation or surface.
  • the reference element 401 may be a metal pin comprising an elongated shaft, a tip at its distal end and a stripe at a certain distance from the distal end.
  • the reference element 401, the guiding element 402, and/or the connecting element 403 connecting the guiding element 402 to the remainder of the guide 400 may then be designed such that the stripe coincides with the top of the guiding element 402 upon reaching the pre determined reaming depth.
  • the pin is slid into the guiding element 402 until its tip touches the reamed surface. As long as the stripe is visible above the guiding element, the pre-determined reaming depth has not been reached and more reaming is necessary. As soon as the stripe coincides with the top of the guiding element 402, the pre-determined reaming depth has been reached.
  • the reference element 401 may include a standard, off-the-shelf component (e.g. a metal pin with a visual mark, such as a stripe or an indentation, on the shaft at a fixed distance from the distal end of the pin).
  • the reference element 401 may include a blunt tip.
  • the guiding element 402 and/or its connecting element 403 may be designed according to patient specific data (e.g., such that upon placement of the reaming guide onto the bone, the distance between the top surface of the guiding element 402 and the pre-determined reamed surface equals the distance between the pin’s distal end and the visual mark).
  • the guiding element 402 and/or its connecting element 403 may be standard or off-the shelf components.
  • the reference element 401 may bear a visual mark at a correct distance from the tip.
  • FIG. 4B is a flowchart illustrating an example process 450 for using the reaming guide 400 of FIG. 4A, in accordance with certain aspects of the present disclosure.
  • the process 450 begins by securing the reaming guide 400 to the glenoid.
  • the reaming guide 400 may be placed onto the glenoid and/or the bony anatomy surrounding the glenoid, such that the reaming guide’s 400 positioning elements contact the surface of the bone in a mating way.
  • the process 450 includes drilling holes into the bony anatomy using the central functional element to guide the reference element.
  • the process 450 includes inserting a central guide pin through the central functional element.
  • the process 450 includes removing the reaming guide.
  • the process 450 includes sliding the cannulated reamer onto the central guide pin for reaming. [0086] At block 462, the process 450 includes sliding the reference element with has the markings (e.g., the laser markings).
  • the process 450 includes sliding the single reference pin arm over the reference element to check if the markings on the reference element coincide with the markings on the reference pin arm.
  • the process 450 includes reaming the bone and removing bone using the reamer.
  • the bone reaming is periodically stopped to insert the reference element into the guiding element until it touches the reamed surface to determine whether a visual mark on the guiding element and/or the reference element indicates that the pre-determined reaming depth has been reached.
  • the reaming may be restarted and stopped repeatedly until a visual mark on the guiding element and/or reference element indicates that the pre-determined reaming depth has been reached.
  • FIG. 4C is a perspective diagram illustrating the reaming guide 400 of FIG. 4A and a central guide pin 431 that may be placed using a central functional element 405 of the reaming guide 400, in accordance with certain aspects of the present disclosure.
  • the central guide pin 431 may be placed using a central functional element 405 of the reaming guide 400.
  • the guide is configured and used to secure a central guide pin 431 to the glenoid in a pre-determined location and orientation, corresponding to pre-determined angles of inclination and version for the prosthesis.
  • the guiding elements 402, connected to the remainder of the guide 400 by means of the connection elements 403, are configured and used to position the reference element which may be configured to sit in the guiding element 402 (not shown) until it makes contact with the reamed surface of the glenoid at the desired angle and depth.
  • the central guide pin 431 may be used to determine the reaming location and orientation, while the reference element 401 provides a means for checking the reaming depth.
  • the reaming guide 400 includes one or more windows allowing passage of the inserted reference element from the guiding element to the reamed surface, such that the reamer can stay in situ while checking the reaming depth.
  • FIG. 4D is a perspective diagram illustrating a slide-able reference pin arm 440 sliding onto a reference pin 442.
  • the user drills a reference tunnel.
  • the user inserts the central guide pin/guide wire, e.g. using a separate patient-specific guide.
  • the cannulated reamer uses the central pin as a guide.
  • the surgeon periodically stops reaming and places the reference pin 442 in the drilled reference tunnel.
  • the reference pin 442 has a visual mark to indicate reaming depth.
  • the surgeon next slides the reference pin arm 440 over the reference pin to verify reaming depth. When the upper end of the reference pin arm 440 coincides with the marking on the reference pin 442, pre-determined reaming depth is achieved.
  • the user may insert a central guide pin/guide wire, e.g. using a separate patient- specific or non-patient specific guide into the bone or using a detachable central functional element of the reaming guide 400.
  • the cannulated reamer uses the central pin as a guide and the user begins reaming the bone.
  • the reference pin arm 440 and visually marked reference element the user can determine the depth of the reamed surface. When the upper end of the reference pin arm 440 coincides with the marking on the reference pin 442, the pre-determined reaming depth is achieved.
  • the reaming guide 400 is configured for the reference element to touch the top of the reamer instead of the reamed surface.
  • the reamer may be left in situ.
  • the reference element may then be slid into the guiding element until its distal end touches the reamer.
  • the reference element and/or the guiding element may include a visual mark confirming whether the reamer has reached the pre-determined reaming depth.
  • FIG. 4E is a perspective diagram illustrating a reaming guide 470 comprising a central functional element 475 that is detachable from the remainder of the guide 470 (similar to what is shown in FIG. 4D), in accordance with certain aspects of the present disclosure.
  • the reaming guide 470 is a guide that, when positioned onto the bone and, as the case may be, with the central functional element detached, does not obstruct the path of the reamer.
  • the reaming guide may be left in situ while reaming.
  • the positioning elements may be designed to mate with features surrounding the glenoid, such as glenoid neck, the coracoid base, coracoid tip, the glenoid surface, the lateral border or ‘margo lateralis’ of the scapula, or the acromion such that the reaming guide can remain in place while reaming.
  • such a reamer guide comprises a positioning element 477 configured to mate with the base of the coracoid, and guiding element and connecting element.
  • the entire guide 470 is designed to be outside the path of the reamer, and the guiding element 472 is inclined such that the reference element (not shown but sits in guiding element 472), when slid through the guiding element 472 and connecting element 473, still touches the reamed surface.
  • the reference element may be at an angle such that the path of the reference element is not in the path of the reamer at any depth that is less than the desired depth (e.g., a wide angle between the reference element and the central guide pin. The surgeon may continue reaming until the visual marker on the reference element is visible, meaning reaming has reached the desired depth.
  • the surgical devices disclosed herein are further provided with a patient-specific visual aid which matches exactly with the glenoid contour. More particularly, the shape of the guide and the markings on the reference pin.
  • the visual aid is typically used for checking the optimum reaming depth after drilling of the central and reference pin holes during the reaming procedure.
  • FIGs. 5A and 5B are perspective diagrams illustrating a two-piece reaming guide system 500, in accordance with certain aspects of the present disclosure.
  • the two-piece reaming guide system 500 may include a first reaming guide 501 that is a patient specific guide with guiding element, and a second reaming guide 502 being a non-patient specific guide with a central functional element.
  • the two-piece reaming guide system 500 may be used instead of a reaming guide with a central functional element, a guiding element, and a patient- specific positioning element.
  • the first reaming guide 501 includes the guiding element coupled to the patient- specific positioning element.
  • Such a first reaming guide 501 can be used for any of the embodiments, including drilling a reference tunnel, guiding a reference element into a reference tunnel, guiding a reference element with a depth gauge, etc.
  • the second reaming guide 502 includes the central functional element and may or may not include a patient-specific positioning element.
  • the second guide 502 may be used to position a central guide pin, drill a central tunnel, etc.
  • the central guide pin may alternatively be inserted by hand instead of the second guide 502 (e.g., as illustrated in FIG. 5B).

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Abstract

L'invention concerne un système et un procédé d'alésage d'une surface osseuse. Dans certains exemples, un guide d'alésage chirurgical comprend un élément de positionnement comprenant une surface spécifique au patient, la surface spécifique au patient étant conçue pour s'accoupler avec une surface osseuse correspondante d'un patient. Dans certains exemples, le guide d'alésage chirurgical comprend un premier élément de guidage couplé à l'élément de positionnement, le premier élément de guidage étant conçu pour recevoir et guider un élément de référence le long d'un axe de référence qui croise un axe central, l'axe de référence et l'axe central définis dans la surface osseuse de telle sorte que l'intersection se produit à une profondeur d'alésage souhaitée de la surface osseuse lorsque l'élément de positionnement est accouplé à la surface osseuse correspondante du patient.
PCT/US2020/044617 2019-08-02 2020-07-31 Guide d'alésage d'épaulement doté d'un élément de vérification WO2021026029A1 (fr)

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3981079A (en) * 1973-08-23 1976-09-21 Lenczycki Joseph J Dental implant and method of mounting the same in the jaw bone
US5741266A (en) * 1996-09-19 1998-04-21 Biomet, Inc. Pin placement guide and method of making a bone entry hole for implantation of an intramedullary nail
WO2013060851A1 (fr) 2011-10-28 2013-05-02 Materialise N.V. Guides scapulaires
US20130110116A1 (en) * 2011-10-27 2013-05-02 Biomet Manufacturing Corporation Patient-specific glenoid guides
WO2014154266A1 (fr) 2013-03-27 2014-10-02 Mobelife N.V. Guide chirurgical personnalisé
US20140343403A1 (en) * 2007-05-14 2014-11-20 Queen's University At Kingston Patient-Specific Surgical Guidance Tool and Method of Use
US20170333102A1 (en) * 2016-01-05 2017-11-23 Conventus Orthopaedics, Inc. Bone fracture repair apparatus and methods
US20190209186A1 (en) * 2015-05-28 2019-07-11 Zimmer, Inc. Patient-specific bone grafting system and method

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3981079A (en) * 1973-08-23 1976-09-21 Lenczycki Joseph J Dental implant and method of mounting the same in the jaw bone
US5741266A (en) * 1996-09-19 1998-04-21 Biomet, Inc. Pin placement guide and method of making a bone entry hole for implantation of an intramedullary nail
US20140343403A1 (en) * 2007-05-14 2014-11-20 Queen's University At Kingston Patient-Specific Surgical Guidance Tool and Method of Use
US20130110116A1 (en) * 2011-10-27 2013-05-02 Biomet Manufacturing Corporation Patient-specific glenoid guides
WO2013060851A1 (fr) 2011-10-28 2013-05-02 Materialise N.V. Guides scapulaires
WO2014154266A1 (fr) 2013-03-27 2014-10-02 Mobelife N.V. Guide chirurgical personnalisé
US20190209186A1 (en) * 2015-05-28 2019-07-11 Zimmer, Inc. Patient-specific bone grafting system and method
US20170333102A1 (en) * 2016-01-05 2017-11-23 Conventus Orthopaedics, Inc. Bone fracture repair apparatus and methods

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