WO2025160661A1 - Dual predrilling module for an osteotomy procedure and an additional orthopedic procedure - Google Patents
Dual predrilling module for an osteotomy procedure and an additional orthopedic procedureInfo
- Publication number
- WO2025160661A1 WO2025160661A1 PCT/CA2025/050114 CA2025050114W WO2025160661A1 WO 2025160661 A1 WO2025160661 A1 WO 2025160661A1 CA 2025050114 W CA2025050114 W CA 2025050114W WO 2025160661 A1 WO2025160661 A1 WO 2025160661A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- repair
- bone
- predrilling
- dual
- module
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1728—Guides or aligning means for drills, mills, pins or wires for holes for bone plates or plate screws
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
- A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- 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
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8095—Wedge osteotomy devices
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1714—Guides or aligning means for drills, mills, pins or wires for applying tendons or ligaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B2017/564—Methods for bone or joint treatment
- A61B2017/565—Methods for bone or joint treatment for surgical correction of axial deviation, e.g. hallux valgus or genu valgus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B2017/568—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor produced with shape and dimensions specific for an individual patient
Definitions
- the technical field generally relates to orthopedic tools, and more particularly, to orthopedic tools for use in orthopedic surgeries such as osteotomies.
- Knee osteotomies are orthopedic procedures aimed at correcting the alignment of the lower limb to correct a mechanical alignment.
- a high tibial osteotomy is a type of osteotomy which involves correcting the alignment of the lower limb by reconfiguring the mechanical axis of the tibia.
- the high tibial osteotomy can be an open wedge osteotomy or a closed wedge osteotomy.
- a planar cut is made in the tibia below the knee, and the tibia bone is opened along the planar cut to form a wedge-shaped opening with a specified angle.
- a wedge of bone having a specified angle is removed from the tibia bone below the knee, and the tibia bone is closed along the wedge.
- the correction can be maintained by installing a fixation plate, among other techniques.
- the opening or closing effectively corrects s the angle of the tibia relative to the femur, thereby correcting the lower limb mechanical alignment and reconfiguring the pressure distribution between the tibia and the femur.
- a dual predrilling module for drilling a fixation hole and a repair tunnel in a bone
- the dual predrilling module comprising: a body comprising: a bone interface side comprising a bone contacting surface engageable with a surface of the bone and an operative side opposite the bone interface side; an osteotomy drill guide extending outwardly from the operative side and configured for guiding a drill bit therein to create a fixation hole according to a fixation hole pathway for receiving a fixation fastener and secure an implant to the bone; and a repair drill guide extending outwardly from the operative side and configured for guiding the drill bit therein to create a repair tunnel according to a repair tunnel pathway extending across the bone to open to an articular surface of bone, the repair tunnel pathway being determined to intersect a predetermined cutting plane intended to create an osteotomy, without intersecting the fixation hole pathway.
- the bone contacting surface of the bone interface side is configured to substantially conform to surface contours of the bone at a predetermined position on the bone.
- the repair tunnel is configured for an orthopedic repair procedure.
- the orthopedic repair procedure is one of an anterior cruciate ligament repair, a posterior cruciate ligament repair and a meniscus repair.
- the repair tunnel is configured to receive a repair fastener therein to secure a graft to the bone via compression.
- the implant comprises a fixation plate.
- the repair drill guide comprises a repair guide barrel extending from the operative side at a predetermined angle according to the repair tunnel pathway.
- the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a tibial plateau.
- the repair drill guide is configured to create the repair tunnel in a medial region of the tibia, in a lateral region of the tibia, or in an anterior region of the tibia.
- the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a distal end of a femur.
- the repair guide barrel includes an internal wall defining a repair guide tunnel extending along a lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
- the internal wall of the repair guide tunnel is configured to constrain a movement of the drill bit in accordance with the repair tunnel pathway.
- the osteotomy drill guide comprises an osteotomy guide barrel extending from the operative side at a predetermined angle according to the fixation hole pathway.
- the osteotomy guide barrel has a predetermined osteotomy guide barrel length defined between the bone contacting surface and a terminal end of the osteotomy guide barrel to limit insertion of the drill bit therein and create a fixation hole having a predetermined fixation hole length terminating at a fixation hole end.
- the fixation hole pathway terminates at the fixation hole end.
- the osteotomy guide barrel includes an internal wall defining an osteotomy guide tunnel extending along the lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
- the internal wall and the terminal end of the osteotomy guide tunnel are configured to constrain a movement of the drill bit in accordance with the fixation hole pathway.
- the osteotomy drill guide further comprises a handle member connected to the body to facilitate manipulation and positioning of the body.
- the handle member is a rigid elongated member extending from the operative side of the guide body.
- the body defines fastener apertures for receiving retaining fasteners to removably secure the body to the bone.
- the body is configured to span across an osteotomy opening created along a planar cut performed according to the predetermined cutting plane, and comprises a proximal section positioned above the osteotomy opening and a distal section positioned below the osteotomy opening.
- the body further comprises an intermediate section extending between the proximal and distal sections and spanning the osteotomy opening, and an alignment mechanism extending outwardly from the bone interface side and configured for insertion into the osteotomy opening for engaging the bone and secure the body in a predetermined position relative to the bone.
- the alignment mechanism comprises a wedge.
- the wedge comprises contours configured to match inner surface contours of the osteotomy opening.
- the bone is a tibia or a femur.
- a dual predrilling module for drilling a fixation hole and a repair tunnel in a bone
- the dual predrilling module comprising: a body comprising: a bone interface side comprising a bone contacting surface engageable with a surface of the bone and an operative side opposite the bone interface side; an osteotomy drill guide extending outwardly from the operative side and configured for guiding a drill bit therein to create a fixation hole for receiving a fixation fastener to secure an implant to the bone; and a repair drill guide extending outwardly from the operative side and configured for guiding the drill bit therein to create a repair tunnel having a predetermined orientation such that the repair tunnel intersects a predetermined cutting plane intended to create an osteotomy and extends across the bone to open to an articular surface of bone, without intersecting the fixation hole.
- the bone contacting surface of the bone interface side is configured to substantially conform to surface contours of the bone at a predetermined position on the bone.
- repair tunnel is configured for an orthopedic repair procedure.
- the orthopedic repair procedure is one of an anterior cruciate ligament repair, a posterior cruciate ligament repair and a meniscus repair.
- the repair tunnel is configured to receive a repair fastener therein to secure a graft to the bone via compression.
- the implant comprises a fixation plate.
- the repair drill guide comprises a repair guide barrel extending from the operative side at a predetermined angle according to the predetermined orientation of the repair tunnel.
- the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a tibial plateau.
- the repair drill guide is configured to create the repair tunnel in a medial region of the tibia, in a lateral region of the tibia, or in an anterior region of the tibia.
- the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a distal end of a femur.
- the repair guide barrel includes an internal wall defining a repair guide tunnel extending along a lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
- the internal wall of the repair guide tunnel is configured to constrain a movement of the drill bit according to the predetermined orientation of the repair tunnel.
- the osteotomy drill guide comprises an osteotomy guide barrel extending from the operative side at a predetermined angle according to the fixation hole.
- the osteotomy guide barrel has a predetermined osteotomy guide barrel length defined between the bone contacting surface and a terminal end of the osteotomy guide barrel to limit insertion of the drill bit therein and create the fixation hole having a predetermined fixation hole length terminating at a fixation hole end.
- the osteotomy guide barrel includes an internal wall defining an osteotomy guide tunnel extending along the lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
- the internal wall and the terminal end of the osteotomy guide tunnel are configured to constrain a movement of the drill bit.
- the osteotomy drill guide comprises a plurality of osteotomy drill guides to create a plurality of fixation holes, the predetermined orientation of the repair tunnel being determined to intersect the predetermined cutting plane without intersecting each one of the corresponding fixation holes.
- the osteotomy drill guide further comprises a handle member connected to the body to facilitate manipulation and positioning of the body.
- the handle member is a rigid elongated member extending from the operative side of the guide body.
- the body defines fastener apertures for receiving retaining fasteners to removably secure the body to the bone.
- the body is configured to span across an osteotomy opening created along a planar cut performed according to the predetermined cutting plane, and comprises a proximal section positioned above the osteotomy opening and a distal section positioned below the osteotomy opening.
- the body further comprises an intermediate section extending between the proximal and distal sections and spanning the osteotomy opening, and an alignment mechanism extending outwardly from the bone interface side and configured for insertion into the osteotomy opening for engaging the bone and secure the body in a predetermined position relative to the bone.
- the alignment mechanism comprises a wedge.
- the wedge comprises contours configured to match inner surface contours of the osteotomy opening.
- the bone is a tibia or a femur.
- a dual predrilling module for drilling a fixation hole and a repair tunnel in a bone in combination with a fixation plate superposable to the bone
- the dual predrilling module comprising: a body comprising: a fixation plate engaging side removably engageable with the fixation plate; and an operative side opposite the bone interface side; and an osteotomy drill guide extending outwardly from the operative side and being configured for guiding a drill bit therein to create a fixation hole according to a fixation hole pathway for receiving a fixation fastener and secure the fixation plate to the bone; and a repair drill guide extending outwardly from the operative side and configured for guiding the drill bit therein to create a repair tunnel according to a repair tunnel pathway, the repair tunnel pathway being determined to intersect a predetermined cutting plane intended to create an osteotomy and to extend across the bone to open to an articular surface of bone, without intersecting the fixation hole pathway.
- the fixation plate engaging side of the body comprises an alignment feature to enable alignment of the body with the fixation plate.
- the bone contacting surface of the bone interface side is configured to substantially conform to surface contours of the bone at a predetermined position on the bone.
- the repair tunnel is configured for an orthopedic repair procedure.
- the orthopedic repair procedure is one of an anterior cruciate ligament repair, a posterior cruciate ligament repair and a meniscus repair.
- the repair tunnel is configured to receive a repair fastener therein to secure a graft to the bone via compression.
- the repair drill guide comprises a repair guide barrel extending from the operative side at a predetermined angle according to the repair tunnel pathway.
- the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a tibial plateau.
- the repair drill guide is configured to create the repair tunnel in a medial region of the tibia, in a lateral region of the tibia, or in an anterior region of the tibia.
- the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a distal end of a femur.
- the repair guide barrel includes an internal wall defining a repair guide tunnel extending along a lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
- the internal wall of the repair guide tunnel is configured to constrain a movement of the drill bit in accordance with the repair tunnel pathway.
- the osteotomy drill guide comprises an osteotomy guide barrel extending from the operative side at a predetermined angle according to the fixation hole pathway.
- the osteotomy guide barrel has a predetermined osteotomy guide barrel length defined between the bone contacting surface and a terminal end of the osteotomy guide barrel to limit insertion of the drill bit therein and create a fixation hole having a predetermined fixation hole length terminating at a fixation hole end.
- the fixation hole pathway terminates at the fixation hole end.
- the osteotomy guide barrel includes an internal wall defining an osteotomy guide tunnel extending along the lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
- the internal wall and the terminal end of the osteotomy guide tunnel are configured to constrain a movement of the drill bit in accordance with the fixation hole pathway.
- the osteotomy drill guide comprises a plurality of osteotomy drill guides to create a plurality of fixation holes, each fixation hole of the plurality of fixation holes having a corresponding fixation hole pathway and the repair tunnel pathway being determined to intersect the predetermined cutting plane without intersecting each one of the corresponding fixation hole pathways.
- the dual predrilling module further comprises a handle member connected to the body to facilitate manipulation and positioning of the body.
- the handle member is a rigid elongated member extending from the operative side of the guide body.
- the body defines fastener apertures for receiving retaining fasteners to removably secure the body to the bone.
- the body is configured to span across an osteotomy opening created along a planar cut performed according to the predetermined cutting plane, and comprises a proximal section positioned above the osteotomy opening and a distal section positioned below the osteotomy opening.
- the body further comprises an intermediate section extending between the proximal and distal sections and spanning the osteotomy opening, and an alignment mechanism extending outwardly from the bone interface side and configured for insertion into the osteotomy opening for engaging the bone and secure the body in a predetermined position relative to the bone.
- the alignment mechanism comprises a wedge.
- the wedge comprises contours configured to match inner surface contours of the osteotomy opening.
- the bone is a tibia or a femur.
- a method for designing a dual predrilling module for guiding a drill bit to form a fixation hole and a repair tunnel in a bone comprising the steps of: creating a digital 3D model of the bone; virtually cutting the 3D model of the bone to form a planar cut therein; virtually opening the 3D model of the bone along the planar cut to a desired correction angle; virtually positioning an implant and a fixation fastener on the 3D model of the bone to determine a fixation hole pathway of a fixation hole configured to receive the fixation fastener therein; virtually determining a repair tunnel pathway of a repair tunnel configured to receive a repair fastener therein so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathway; and designing the dual predrilling guide with an osteotomy drill guide and a repair drill guide positioned to achieve the fixation hole pathway and the repair tunnel pathway, respectively.
- a method for designing a dual predrilling module for guiding a drill bit to form a fixation hole and a repair tunnel in a bone comprising the steps of: creating a digital 3D model of the bone; virtually cutting the 3D model of the bone to form a planar cut therein; virtually opening the 3D model of the bone along the planar cut to a desired correction angle; virtually positioning an implant and a fixation fastener on the 3D model of the bone to determine a fixation hole pathway of a fixation hole configured to receive the fixation fastener therein; virtually determining a repair tunnel pathway of a repair tunnel configured to receive a repair fastener therein so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathway; virtually closing the 3D model of the bone to determine corresponding initial positions of the fixation hole pathway and the repair tunnel pathway; and designing the dual predrilling guide with an osteotomy drill guide and a repair drill guide positioned to achieve
- a method for designing a dual predrilling module for guiding a drill bit to form a fixation hole and a repair tunnel in a bone comprising the steps of: creating a digital 3D model of the bone; virtually cutting the 3D model of the bone to form a planar cut therein; virtually closing the 3D model of the bone along the planar cut to a desired correction angle; virtually positioning an implant and a fixation fastener on the 3D model of the bone to determine a fixation hole pathway of a fixation hole configured to receive the fixation fastener therein; virtually determining a repair tunnel pathway of a repair tunnel configured to receive a repair fastener therein so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathway; virtually opening the 3D model of the bone to determine corresponding initial positions of the fixation hole pathway and the repair tunnel pathway; and designing the dual predrilling guide with an osteotomy drill guide and a repair drill guide positioned to achieve
- Figures 1 to 7C illustrate various views related to aspects and implementations of the dual predrilling module described herein.
- Figure 1 is a perspective view of a dual predrilling module, in accordance with an implementation.
- Figure 2 is another perspective view of the dual predrilling module of Figure 1.
- Figure 3 is another perspective view of the dual predrilling module of Figure 1.
- Figure 4 is another perspective view of the dual predrilling module of Figure 1.
- Figure 5A is a perspective view of the dual predrilling module of Figure 1 , shown engaged with a patient’s tibia bone and spanning across an osteotomy opening.
- Figure 5B is a perspective view of the patient’s tibia bone of Figure 5A, shown with a repair tunnel intersecting the osteotomy opening and opening to an articular surface of the tibia bone.
- Figure 6 is a perspective view of a dual predrilling module in accordance with another implementation and of a fixation plate, the fixation plate being engaged with the patient’s tibia bone and spanning across an osteotomy opening and the dual predrilling module being engaged with the fixation plate.
- Figure 7A is a front perspective view of a fixation plate for securing an open wedge formed in a patient’s tibia bone, in accordance with an implementation in which the fixation plate is provided with a wedge element.
- Figure 7B is a rear perspective view of the fixation plate of Figure 7A.
- Figure 7C is a side view of the fixation plate of Figure 7A.
- Techniques described herein relate to systems, devices and methods that can be used or implemented in preparation for performing both an osteotomy procedure to correct the alignment of a patient’s knee and an additional orthopedic procedure, such as an orthopedic “repair procedure”.
- the additional orthopedic procedure can be for instance a repair or reconstruction of the anterior cruciate ligament (ACL) or the posterior cruciate ligament (PCL), or a meniscus repair (such as a meniscus root repair), among other examples.
- the osteotomy procedure and the additional orthopedic procedure can together be referred to as a concomitant case.
- the success of the overall procedure can depend on the proper positioning and alignment of osteotomy drill guides dedicated to the osteotomy procedure and of a repair drill guide dedicated to the additional orthopedic procedure, which in turn will determine the location of various screws that will be used in the procedures.
- This proper alignment can be determined so as to avoid interference between the resulting repair tunnel and the components associated with the fixation plate, and in particular between the repair tunnel and fixation fasteners and a plate wedge, if applicable, of a fixation plate used for the osteotomy procedure.
- a dual predrilling module having a predetermined spatial distribution of osteotomy guide tunnels dedicated to the osteotomy procedure and a repair guide tunnel dedicated to the additional orthopedic procedure is described herein.
- Various implementations of the dual predrilling module and associated components, as well as methods for using the dual predrilling module, will now be described in the following paragraphs.
- a bone is initially cut into according to a predetermined cutting plane to form a planar cut that is subsequently opened to form a wedge-shaped opening having a specified angle.
- a bone is also initially cut into according to a predetermined cutting plane to remove a wedge of bone having a specified angle.
- the bone can be for instance a tibia or a femur. When the bone is a tibia, the planar cut is made below the knee, whereas when the bone is a femur, the planar cut is made above the knee.
- the bone is thus initially cut according to a predetermined cutting plane, which is typically performed using a surgical guide configured to be mounted to a patient’s bone and that includes a plurality of modules to guide various surgical tools used throughout the osteotomy procedure.
- the surgical guide can be a patient-specific instrumentation (PSI).
- PSI patient-specific instrumentation
- the surgical guide can include a plurality of canals for securing the surgical guide to the patient’s bone via a plurality of screws at strategic locations.
- the surgical guide can include a drilling module comprising a plurality of drill guides to assist in creating drill holes in the patient’s bone in preparation for forming the planar cut therein.
- the surgical guide can further include a cutting module to assist in cutting the patient's bone.
- the cutting guide can include an osteotome guide for guiding a corresponding osteotome to cut the patient’s bone at a predetermined position, orientation and depth.
- the osteotome guide is thus configured to guide an osteotome to create a planar cut in the patient’s bone, for instance in the area weakened by the drill holes formed using the drilling module.
- a dual predrilling module can be used for predrilling holes in the patient’s bone via osteotomy guide tunnels dedicated to the osteotomy procedure and a repair guide tunnel dedicated to an orthopedic repair procedure. It is to be noted that an orthopedic repair procedure includes orthopedic reconstruction procedures.
- the dual predrilling module will now be described in more detail.
- a dual predrilling module 100 configured to drill at least two types of holes in a patient’s bone 1 is shown.
- the bone is exemplified as a tibia. It is to be understood that in other implementations, the bone can be a femur or any other bone that can benefit from an orthopedic procedure using the dual predrilling module described herein.
- the dual predrilling module 100 is configured to drill two types of holes in the patient’s bone, namely one or more fixation holes and a repair tunnel 140 (shown in Fig 5B), such as a repair tunnel that extends across the bone to open at the level of the articular surface of bone, /.e., at the level of the tibial plateau when the bone is a tibia (as exemplified in Fig 5B), or a distal end of a femur when the bone is a femur.
- the fixation holes are created to eventually receive fixation fasteners therein for securing a fixation plate or another implant to the patient’s bone 1.
- the repair tunnel 140 can be created to receive a repair fastener therein, the repair fastener being used in the context of an orthopedic repair procedure such as a repair or reconstruction of the ACL or the PCL, or a meniscus repair, for instance.
- the dual predrilling module 100 can be patientspecific in that it can be custom-made according to the anatomy of the patient’s bone 1 and according to a preoperative plan. Accordingly and as shown in Figures 1 to 5A, the dual predrilling module 100 can be configured to precisely fit in a predetermined position onto the patient’s bone 1 to ensure proper alignment therewith, and to assist in drilling holes in the patient’s bone 1 in predetermined positions, orientations and depths.
- the dual predrilling module 100 can be configured to fit onto a fixation plate used in the osteotomy procedure, also to assist in drilling holes in the patient’s bone 1 in predetermined positions, orientations and depths. This aspect will be discussed in further detail hereinbelow.
- the dual predrilling module 100 comprises a body 102 having a bone interface side 104 and an operative side 106.
- the bone interface side 104 comprises a bone-contacting surface 108 having contours complementary in shape to the surface contours of the patient’s bone 1.
- the operative side 106 comprises an outer surface 109.
- the bone interface side 104 can abut against the patient’s bone 1 , and key into a specific position thereon.
- the bone-contacting surface 108 of the bone interface side 104 is represented as a solid surface.
- the bone-contacting surface 108 can be defined by an open lattice, and can comprise edges conforming to the contours of the patient’s bone 1.
- the body 102 of the dual predrilling module 100 can define fastener apertures (now shown) for receiving retaining fasteners to removably secure the body 102 to the patient’s bone.
- the operative side 106 is provided opposite the bone interface side 104 and comprises a plurality of osteotomy drill guides 110 extending outwardly therefrom for guiding corresponding drill bits.
- the expression “drill bit” is intended to refer to any drilling instrument suitable for drilling into a bone.
- each of the osteotomy drill guides 110 includes an osteotomy guide barrel 112 extending outwardly from the body 102 of the dual predrilling module 100 at a predetermined angle along a lengthwise axis and terminating at a terminal end 114.
- the osteotomy guide barrel 112 is exemplified as being substantially annular and thus comprises an internal wall defining a hollow interior in the form of an osteotomy guide tunnel 116 extending through the osteotomy guide barrel 112 along the lengthwise axis thereof and across an entire thickness of the body 102, the osteotomy guide barrel 112 opening on the bone interface side 104 and on the operative side 106 of the body 102 of the dual predrilling module 100.
- the osteotomy guide tunnels 116 are sized and shaped to receive a corresponding drill bit therein, enabling the drill bit to slide in and out of the osteotomy guide barrel 112, while the internal wall and the terminal end 114 of the osteotomy guide barrel 112 together can contribute to constraining movement of the drill bit to a predetermined depth, position, and orientation relative to the patient’s bone 1.
- An abutting member on the drill bit can be provided to limit an insertion depth of an operative end of the drill bit into the osteotomy guide barrel 112 as it abuts onto the terminal end 114 of the osteotomy guide barrel 112.
- the length of the osteotomy guide barrel 112 can limit the insertion depth of a drill bit and can ensure that the depth of drill holes formed therewith is as desired.
- the plurality of osteotomy drill guides 110 is configured to cooperate with a calibrated drill bit having a fixed operative length.
- the osteotomy guide barrels 112 of the osteotomy drill guides 110 are sized, positioned and oriented to create fixation holes (not shown) in a predetermined pattern, i.e., according to a predetermined spatial distribution, for receiving corresponding fixation fasteners therein to secure an implant, such as the fixation plate 200 shown in Figures 7 A to 7C, to the patient’s bone 1.
- the fixation plate 200 to be secured to the patient’s bone 1 can be patient-specific and can be designed to be affixed using different types of fixation fasteners.
- a preoperative plan can define a configuration of the fixation fasteners, including their size, depth, orientation, and position, that will be chosen to ensure that the implant can be affixed properly to the patient’s bone.
- the osteotomy drill guides 110 can be configured to guide drill bits to create the fixation holes in preparation for receiving the fixation fasteners configured according to the preoperative plan, each of the fixation holes extending along a fixation hole pathway that is also predetermined according to the preoperative plan.
- the length of each osteotomy guide barrel 112 can be adjusted to limit the insertion depth of the drill bit, creating fixation holes with selected predetermined depths which can be the same or different.
- the position and orientation of the osteotomy guide barrels 112 can be adjusted to define fixation holes extending at selected angles and positions to achieve the desired corresponding fixation hole pathways.
- the diameters of the osteotomy guide tunnels 116 can be adjusted to accommodate drill bits of different diameters to create fixation holes of different sized for accommodating different sizes of fasteners.
- the operative side 106 of the body 102 of the dual predrilling module 100 further includes a repair drill guide 130 extending outwardly therefrom for guiding a corresponding drill bit.
- the repair drill guide 130 comprises a repair guide barrel 132 extending outwardly from the body 102 of the dual predrilling module 100 at a predetermined angle along a lengthwise axis and terminating at a terminal end 134.
- the repair guide barrel 132 is exemplified as being substantially annular and thus comprises an internal wall defining a hollow interior in the form of a repair guide tunnel 136 extending through the repair guide barrel 132 along the lengthwise axis thereof and opening on the bone interface side 104 and operative side 106 of the dual predrilling module 100.
- the repair guide tunnel 136 is sized and shaped to receive a corresponding drill bit therein, enabling the drill bit to slide in and out of the repair guide barrel 132, while the internal wall and the terminal end 134 of the repair guide barrel 132 together can contribute to constraining movement of the drill bit to a predetermined depth, position, and orientation relative to the patient’s bone 1.
- An abutting member on the drill bit can limit an insertion depth of an operative end of the drill bit into the repair guide barrel 132 as it abuts with the terminal end 134 of the repair guide barrel 132.
- the length of the repair guide barrel 132 can limit insertion depth of a drill bit and assure the depth of drill holes formed therewith.
- the repair guide barrel 132 can be configured so that the drill bit creates a repair tunnel across the bone, for instance to reach the tibial plateau.
- the diameter of the repair guide tunnel 136 can be adjusted to accommodate a drill bit selected to create a repair tunnel suitable for the type of orthopedic repair procedure that needs to be performed.
- the repair drill guide 130 can be located at various locations on the dual predrilling module 100, such that the repair tunnel can be created in a medial region of the bone, in a lateral region of the bone, or in an anterior region of the bone.
- the repair drill guide 130 is configured such that the repair tunnel can extend along a repair tunnel pathway 144 (shown in Figure 5B) that is predetermined according to the preoperative plan.
- the repair tunnel pathway 144 can be selected so that it intersects the predetermined cutting plane and thus the subsequent planar cut that will be created in the patient’s bone 1 , and that it does not intersect the fixation hole pathways.
- the preoperative plan can thus include the determination of both the fixation hole pathways and the repair tunnel pathway so that the above criteria can be met, /.e., so that the repair tunnel pathway intersects the predetermined cutting plane and that the repair tunnel pathway is free of interference with the fixation hole pathways, /.e., without intersecting the fixation hole pathways, or with other components of the fixation plate. It is to be understood that when referring to the repair tunnel pathway intersecting the predetermined cutting plane, it is intended to include implementations where the planar cut is modified to become an osteotomy opening. The repair tunnel pathway can thus be selected such that it intersects the predetermined cutting plane, the planar cut and the subsequent resulting osteotomy opening.
- the fixation hole pathway when referring to the fixation hole pathway, can be considered to end where the fixation fastener received in the fixation hole would also end. Accordingly, in some implementations, the repair tunnel pathway can be posterior to the fixation holes, which is considered as also being free of interference with the fixation hole pathways, i.e., as not intersecting the fixation holes for the fixation fasteners. In other implementations, the repair tunnel pathway can also be anterior to the fixation holes.
- Providing the osteotomy drill guides 110 and the repair drill guide 130 on a common body 102 of the dual predrilling module 100 can enable obtaining coherence between the fixation holes and the repair tunnel to meet selected criteria such as those mentioned above to enable a healthcare provider to perform both an osteotomy procedure and an orthopedic repair procedure in a combined orthopedic procedure.
- challenges associated with the determination of a repair tunnel pathway that would have to be done independently of already determined fixation hole pathways and potentially after fasteners would be received in corresponding fixation holes following an osteotomy procedure can be avoided.
- a successful overall procedure that includes concomitant cases can be achieved using the dual predrilling module as described herein given the proper positioning and alignment of osteotomy guide tunnels dedicated to the osteotomy procedure and of a repair guide tunnel dedicated to the additional orthopedic procedure.
- examples of orthopedic repair procedures can include a repair or reconstruction of the ACL or the PCL.
- the ACL is one of the major ligaments of the knee, and is located in the middle of the knee and runs from the femur to the tibia.
- the ACL prevents the tibia from sliding out in front of the femur.
- the ACL provides rotational stability to the knee.
- the reconstruction of the ligament can involve using a tendon or ligament autograft, i.e., taken from the patient’s own body, or an allograft, i.e., a tissue taken from a donor.
- a first end of the graft can be inserted into a repair tunnel in the tibia and a repair fastener can be inserted into the repair tunnel to secure the graft between the bone surface and the outer surface of the repair fastener by compression, among other techniques.
- a similar approach can be taken to secure a second end of the graft to the femur.
- the dual predrilling module 100 described herein can be used to determine a proper alignment of the repair tunnel pathway relative to the fixation hole pathways and other components of the fixation plate.
- FIG. 1 Another example of an orthopedic repair procedure is a meniscus repair.
- Medial and lateral menisci are crescent-shaped fibrocartilage structures that provide joint congruity, stabilization and lubrication and act as “shock absorbers” for joint preservation. Tears to the medial meniscal root can modify the biomechanics and kinematics of the knee, which can cause early degeneration of the knee joint. Absence of the medial meniscus (entire medial meniscal root tear) can place large stresses on the ACL.
- a meniscus repair is similar to a repair or reconstruction of the ACL or the PCL in that it also involves securing a portion of the meniscus, typically the meniscal root, to the bone, such as the tibia, using a repair fastener inserted into a repair tunnel.
- the repair tunnel can also be referred to as a transtibial channel.
- the dual predrilling module 100 can be configured to drill one or more fixation holes and a repair tunnel in the patient’s bone 1 after the geometry of the patient’s bone 1 has been surgically altered.
- the dual predrilling module 100 is configured to span across an osteotomy opening 3 formed in the patient’s bone 1 , such that the osteotomy drill guides 110 and the repair drill guide 130 can be positioned to define one or more fixation holes and a repair tunnel directly in their final position.
- the dual predrilling module 100 can have a body 102 substantially similar to a fixation plate that will ultimately be secured to the patient’s bone 1 to span across the osteotomy opening 3.
- the patient’s bone 1 can thus be opened along a planar cut to form the osteotomy opening 3, and once the osteotomy opening 3 is formed, the dual predrilling module 100 can be secured to the patient’s bone 1 at the same position where the fixation plate will eventually be located and secured to the patient’s bone 1.
- k-wires can be used to validate the positioning of the dual predrilling module 100 onto the patient’s bone 1.
- the dual predrilling module 100 thus includes osteotomy drill guides 110 positioned at the exact locations where the fastener apertures of the fixation plate will subsequently be positioned to create one or more fixation holes each having a corresponding fixation hole pathway, and a repair drill guide 130 positioned at the exact location where a repair fastener would be inserted and to obtain the desired repair tunnel pathway, so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathways. Therefore, after the one or more fixation holes and the repair tunnel are formed, the dual predrilling module 100 can be removed and replaced by a fixation plate. The fixation plate can then be positioned to align with the one or more fixation holes and then secured in place via fixation fasteners. Alternatively, the fixation plate can be placed on the patient’s bone before the repair tunnel is created. The orthopedic repair procedure can also be conducted either prior to or after the fixation of the fixation plate onto the patient’s bone.
- the dual predrilling module 100 can be configured to drill one or more fixation holes and a repair tunnel in the patient’s bone 1 prior to a surgical alteration of the bone’s geometry, such as a high-tibial open-wedge osteotomy or a high-tibial closed-wedge osteotomy.
- the dual predrilling module 100 can thus be configured to account for the one or more fixation holes and repair tunnels moving as the geometry of the bone is altered during surgery, such that the one or more fixation holes can be in alignment with the fixation fasteners of an implant and that the repair tunnel has a desired trajectory once the bone alterations are complete.
- the dual predrilling module 100 can be configured to predrill one or more fixation holes while the patient’s bone 1 is in a closed configuration (/.e., before the patient’s bone 1 is opened along the planar cut formed using the drilling and cutting modules).
- the osteotomy drill guides 110 can be positioned to form one or more fixation holes that will eventually align with the location of fixation fasteners for affixing an implant and the repair drill guide 130 can be positioned to form the repair tunnel necessary for the orthopedic repair procedure once the patient’s bone 1 is opened along the planar cut to an opened configuration.
- the position of the one or more fixation holes and the repair tunnel can be determined by modelling the patient’s bone 1 , virtually opening the bone model to a desired opening angle, virtually positioning an implant and determine fixation hole pathways of corresponding fixation fasteners on the bone model to set final positions of the one or more fixation holes, and virtually determining a repair tunnel pathway of a repair tunnel configured to receive a repair fastener therein so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathways.
- the sentence “without intersecting the fixation hole pathways” is intended to mean that the repair tunnel pathway of the repair tunnel is free of interference with the fixation hole pathway(s), i.e., that the repair tunnel pathway of the repair tunnel and the fixation hole pathway(s), together form non-intersecting pathways.
- a fixation hole necessarily extends along a corresponding fixation hole pathway and a repair tunnel necessarily extends along a corresponding repair tunnel pathway
- a repair tunnel created according to a repair tunnel pathway extending across the bone opening to an articular surface of bone and intersecting a predetermined cutting plane intended to create an osteotomy, without intersecting a fixation hole pathway should be considered equivalent to a repair tunnel extending across the bone, opening to an articular surface of bone and intersecting a predetermined cutting plane intended to create an osteotomy without intersecting a fixation hole, once the fixation hole and the repair tunnel are created.
- the bone model can then be subsequently closed virtually to determine initial positions of the one or more fixation holes and the repair tunnel.
- the dual predrilling module 100 can then be designed according to the initial positions of the fixation and repair tunnels.
- the dual predrilling module 100 can include an attachment/alignment mechanism for securing the dual predrilling module 100 to the patient’s bone 1 and/or for assuring proper alignment of the dual predrilling module 100 relative to the patient’s bone 1.
- a single mechanism can provide both the functions of securing and aligning the dual predrilling module 100 relative to the patient’s bone 1.
- different mechanisms can be provided to align and/or to secure the dual predrilling module 100, and thus separate mechanisms can be provided to respectively perform the alignment and attachment functions.
- the dual predrilling module 100 can be secured to the patient’s bone directly via fasteners.
- the bone interface side 104 of the dual predrilling module 100 can be shaped to have contours complementary in shape to the contours of a specific area of the patient’s bone 1 to provide a proper alignment of the dual predrilling module 100 relative to the patient’s bone 1.
- the attachment/alignment mechanism can comprise a member configured to interface and/or insert into a hole or other feature formed in the patient’s bone 1 , for example in the osteotomy opening formed along the planar cut.
- the bone interface side 104 of the body 102 of the dual predrilling module 100 has a bone-contacting surface 108 substantially conforming to a surface contour of the patient’s bone 1 at a predetermined position.
- the body 102 of the dual predrilling module 100 is configured with a proximal section 102a for positioning adjacent a surface of the patient’s bone 1 above the osteotomy opening 3, a distal section 102b for positioning adjacent a surface of the patient’s bone 1 below the osteotomy opening 3, and an intermediate section 102c for spanning the osteotomy opening 3.
- the attachment/alignment mechanism comprises a wedge 122 extending outwardly from the bone-contacting surface 108 of the bone interface side 104 at the location of the intermediate section 102c of the body 102, the wedge 122 being configured for insertion into the osteotomy opening 3.
- the wedge 122 can be sized and shaped according to the expected dimensions of the desired osteotomy opening 3 as determined by the preoperative plan.
- the wedge 122 can further comprise contours matching inner surface contours of the osteotomy opening 3. The wedge 122 can thus enable the dual predrilling module 100 to be secured at a predetermined position relative to osteotomy opening 3, while also validating that the bone 3 has been opened to the correct angle.
- the dual predrilling module 100 can be secured in place relative to the patient’s bone 1 before drilling is performed through the osteotomy drill guides 110 and the repair drill guide 130.
- the body 102 can include fastener apertures in the proximal 102a and distal 102b sections to enable securing the body 102 of the dual predrilling module 100 directly to the patient’s bone 1 via fixation fasteners.
- the dual predrilling module 100 can be secured to an anchor module already attached to the patient’s bone 1 at the correct position.
- the dual predrilling module 100 further comprises a handle member 120 configured to enable the dual predrilling module 100 to be more easily manipulated by a healthcare provider and positioned at a desired location on the patient’s bone 1.
- the handle member 120 is a rigid elongated member extending outwardly from the body 102 of the dual predrilling module 100 along a lengthwise axis and facilitates manipulation of the dual predrilling module 100 by hand.
- different types of handle members can be provided.
- the handle member 120 can be removable and/or can comprise an interface for a positioning tool or guide.
- the handle member 120 can include inscriptions provided thereon to identify the dual predrilling module 100 and/or to indicate the type of drill bits with which the dual predrilling module 100 is designed to cooperate.
- the repair guide barrel 132 of the dual predrilling module 100 can be adapted to be coupled to an auxiliary diameter adaptor (not shown).
- the auxiliary diameter adaptor can be configured to modify a diameter of the repair guide barrel 132. Modifying the diameter of the repair guide barrel 132 can facilitate cooperation with selected orthopedic instruments such a Kirschner wire (also referred to as a k-wire).
- the diameter of the auxiliary diameter adaptor coupled to the repair guide barrel 132 can be selected to accommodate a specific orthopedic instrument according to its diameter.
- the k-wire can be used for temporary fixation of the dual predrilling module to the patient’s bone.
- the fixation plate 200 includes a body 202 that can be made from a rigid, biocompatible and degradation-resistant material, such as stainless steel or titanium, although other materials are possible, including different metals and/or plastics and/or a combination thereof.
- the fixation plate 200 is exemplified as an osteotomy plate configured to be secured to an antero-medial side of the patient’s bone 1 and to retain the osteotomy opening 3 created therein during an open-wedge osteotomy procedure.
- the fixation plate 200 can be configured to be secured to another side of the patient’s bone 1 , for instance depending on surgical requirements.
- the body 202 of the fixation plate 200 includes a proximal section for securing to the patient’s bone 1 above the osteotomy opening 3, a distal section for securing to the patient’s bone 1 below the osteotomy opening 3, and an intermediate section for spanning the osteotomy opening 3.
- the fixation plate 200 is patient-specific in that the fixation plate 200 is designed based on the specific anatomy of the patient’s bone 1 and based on the specific needs of the patient determined during the preoperative plan. The shape and configuration of the fixation plate 200 can therefore vary from one procedure to another based upon the bone anatomy of different patients and based on the fixation requirements.
- the body 202 of the fixation plate 200 can be sized, shaped, and configured to fit snugly against the patient’s bone 1 while also providing the required support and being minimally noticeable under the patient’s skin.
- the body 202 is thin and substantially flat, and is configured to follow the contours of the patient’s bone 1. In this configuration, for example, when the fixation plate 200 is secured to the patient’s bone 1 , it can protrude from the surface of the patient’s bone 1 at a uniform height along the entire body 202.
- the body 202 can be designed to have a thickness that varies in depending on the location, enabling the body 202 to have an increased or a reduced strength or rigidity where required and/or enable the body 202 to protrude less noticeably from the patient’s bone in selected areas.
- the body 202 of the fixation plate 200 comprises a bone interface side 204 and an outward-facing side 206.
- the bone interface side 204 comprises an inner surface 208 for positioning against the patient’s bone 1.
- the contours of the inner surface 208 of the bone interface side 204 are complementary in shape to the surface contours of a predetermined location on the patient’s bone 1 where the fixation plate 200 is intended to be positioned. Accordingly, the fixation plate 200 can fit snugly onto the patient’s bone 1 at a position determined preoperatively.
- the outward-facing side 206 includes an outward surface 209 that is substantially smooth and/or flat to make it minimally noticeable under the patient’s skin. In the illustrated implementation, the outward-facing side 206 comprises sloped and/or chamfered edges 210 which provide a smoother transition between the body 202 of fixation plate 200 and the patient’s bone 1.
- the fixation plate 200 can be secured to the patient’s bone 1 via fixation plate fasteners (not shown).
- the fixation fasteners can include surgical screws configured to be drilled into the patient’s bone 1 , although other types of fasteners are possible.
- the fixation fasteners are configured to engage with the fixation plate 200 via apertures or canals 222 opening on the bone interface side 204 and the outward-facing side 206 of the fixation plate 200.
- the canals 222 can be sized and shaped to receive different sizes of fixation fasteners therein.
- the canals 222 can be configured to guide corresponding fixation fasteners at a predetermined angle or orientation as the fixation fasteners are inserted into the patient’s bone 1.
- the canal 222 includes a peripheral wall extending through the thickness of the body 202 of the fixation plate 200 at a predetermined angle to guide the fixation fasteners as they are drilled through the canals 222.
- the peripheral wall of the canal 222 can be threaded, for example to engage with corresponding threads of fixation fasteners as the fixation fasteners are drilled through canals 222, and/or to engage or lock with a head of the fixation fasteners once fully inserted.
- the peripheral wall of the canal 222 can further be configured to abut against a head of a fixation fastener to block the fixation fastener from being inserted too deep into the patient’s bone 1.
- the fixation plate 200 can be designed with a different number and configuration of canals 222 for receiving a different number and/or different configurations of fixation fasteners based on the fixation requirements to promote optimal securing of the fixation plate 200.
- the fixation plate 200 can be configured such that it can accommodate combinations of different sizes of fixation fasteners (both diameter and length) and different orientations of fixation fasteners, for example based on the position of the patient’s bone 1 to which a particular fixation fastener is to be secured.
- the fixation plate 200 is configured to accommodate two large laterally-spaced fixation fasteners in the proximal section 202a of the body 202, and two smaller vertically-spaced fixation fasteners in the distal section 202b of the body 202. It is to be understood that other configurations of that fixation plate 200 are possible and within the scope of the present description.
- additional support members can be provided to further assist the fixation plate 200 in retaining the osteotomy opening 3 formed in the patient’s bone 1 and/or to assist in correctly positioning the fixation plate 200 relative to the osteotomy opening 3.
- a wedge element 212 can be provided to abut against internal surfaces on opposite sides of the osteotomy opening 3 when the fixation plate 200 is positioned on the patient’s bone 1.
- the wedge element 212 can have contours and/or surfaces that conform to the specific shape of the patient’s bone 1 . As a load is applied across osteotomy opening 3, the wedge element 212 can exert an opposing force on the patient’s bone 1 via the internal surfaces.
- the wedge element 212 is formed as an integral part of body 202 of fixation plate 200, and is made from the same rigid, biocompatible material, /.e., stainless steel or titanium.
- the wedge element 212 can be a separate piece which can be fastened or secured to the fixation plate 200 and/or directly to the patient’s bone 1 .
- the wedge element 212 can be made of a different material, such as a rigid plastic or the like, depending on the required structural properties.
- the wedge element 212 extends outwardly from the bone interface side 204 of the fixation plate 200, and is positioned on an intermediate section of the fixation plate body 202. In this configuration, the wedge element 212 extends inside the osteotomy opening 3 when the fixation plate 200 is secured to the patient’s bone 1.
- the wedge element 212 comprises a proximal abutment 214 for abutting against a proximal internal surface of the bone of the osteotomy opening 3, and a distal abutment 216 for abutting against a distal internal surface of bone of the osteotomy opening 3.
- the proximal 214 and distal 216 abutments are spaced apart from one another via a concave canal 218. In this configuration, a certain amount of flexure is permitted in the rigid body 202 of fixation plate 200 as a load is applied across abutments 214, 216.
- the wedge element 212 can be a solid block having abutments 214, 216 defined on opposite sides thereof. [00126] As mentioned above, the wedge element 212 can be configured to provide different levels of support based on patient-specific needs.
- the abutments 214 and 216 can also be designed with different shapes and configurations which can further affect the rigidity and/or the distribution of ferees in the wedge element 212.
- the wedge element 212 can be further configured with bearing surfaces that conform to a shape of the patient’s cortical bone to ensure better contact therewith, and avoid contact with the trabecular bone
- the fixation plate 200 is provided with a single wedge element 212 configured to be engaged with the osteotomy opening 3 along an antero-medial side of the patient’s bone 1 . It is appreciated, however, that in other implementations, other wedge element configurations are possible.
- the fixation plate 200 can include a double wedge element comprising a first anterior wedge element 212a, and a second posterior wedge element spaced apart from one another in the intermediate section 202 of the plate body 202.
- the wedge element 212 is configured to engage in, and provide support to, the osteotomy opening 3 on an antero-medial side of the patient’s bone 1. It is appreciated, however, that in some implementations, further support may be desired towards the anterior and/or posterior of the patient’s bone 1. Accordingly, in some implementations, the wedge element 212 can be configured as an extended wedge with a section which extends away from the plate body 202 in the anterior and/or posterior direction.
- the wedge element 212 is provided with the proximal 214 and distal 216 abutments that are spaced apart from one another via the concave canal 218. It is appreciated, however, that in other implementations, the wedge element 112 can be free of concave canal.
- the dual predrilling module 100 can be configured for placement over a fixation plate 200, such as the fixation plate 200 exemplified in Figures 7A to 7C.
- the dual predrilling module 100 can also be configured to drill fixation holes and a repair tunnel in the patient’s bone 1 after the geometry of the patient’s bone 1 has been surgically altered, but with the fixation plate 200 being provided between the patient’s bone 1 and the dual predrilling module 100.
- the fixation plate 200 can be considered as being “sandwiched” between the patient’s bone 1 and the dual predrilling module 100.
- the dual predrilling module 100 is configured to span across the osteotomy opening 3 formed in the patient’s bone 1 as described above, such that osteotomy drill guides 110 can be positioned to define fixation holes directly in their final position and a repair drill guide 130 can be positioned to define a repair directly in its final position.
- the body of the dual predrilling module 100 can have a fixation plate engaging side 146 configured to engage with the outward-facing side 206 of the fixation plate 200, in an “over-the-plate configuration”.
- the dual predrilling module 100 is thus removably engageable with the fixation plate 200, in the over-the-plate configuration, and optionally removably secured thereto using a fastener such as pin screw or by using a drill bit that is momentarily left in place during the creation of the fixation holes and the repair tunnel.
- a fastener such as pin screw
- a drill bit that is momentarily left in place during the creation of the fixation holes and the repair tunnel.
- the fixation plate engaging side 146 of the body 102 of the dual predrilling module 100 can include an alignment feature enabling a proper alignment and subsequent removable engagement with the fixation plate 200 that will be secured to the patient’s bone 1 via fixation fasteners.
- the fixation plate engaging side 146 of the body 102 can include an outwardly protruding element configured to be received into a corresponding recess defined on the outward-facing side 206 of the fixation plate 200, or vice versa.
- the alignment feature provided or defined on the outward-facing side 206 of the fixation plate 200 can be configured to be present for a limited period of time to avoid the outward-facing side 206 of the fixation plate 200 having an irregular surface, and subsequently ensure that the outward-facing side 206 is substantially smooth and/or flat to make it minimally noticeable under the patient’s skin.
- the alignment feature provided or defined on the outward-facing side 206 of the fixation plate 200 can be removable therefrom once the dual predrilling module 100 is ready to be disengaged and removed from the fixation plate 200.
- the alignment feature provided or defined on the outward-facing side 206 of the fixation plate 200 can be made of a material that is bioresorbable, and that is thus configured to be resorbed or dissolved naturally under physiological conditions after a given period of time.
- the fixation plate 200 can also define apertures or canals 222 as described above, and can further include a canal rim 224 extending around a corresponding canal 222.
- the fixation plate engaging side 146 of the dual predrilling module 100 can include a canal rim recess configured to receive therein a corresponding canal rim 224. This type of engagement can contribute to facilitating the stable engagement of the dual predrilling module 100 over the fixation plate 200.
- the dual predrilling module 100 can be configured to drill fixation holes and a repair tunnel in the patient’s bone 1 after the geometry of the patient’s bone 1 has been surgically altered, given that the coupling with the fixation plate 200 is performed once the fixation plate 200 is already placed against the patient’s bone 1 with the osteotomy opening 3 already being present.
- the dual predrilling module 100 is configured to span across the osteotomy opening 3 formed in the patient’s bone 1 , such that osteotomy drill guides 110 can be positioned over corresponding canals 222 defines on the fixation plate 200 to create fixation holes and a repair tunnel directly in their final positions.
- the repair drill guide can be oriented at a predetermined angle with respect to the outer surface 109 of the body 102 of the dual predrilling module 100, the shape and size of the canal 222 associated with the repair drill guide 130 can be adapted to take into account the angled entry of a drill bit that will be used to create the repair tunnel via the repair drill guide 130.
- the patient’s bone 1 can thus be opened along a planar cut to form the osteotomy opening 3, and once the osteotomy opening 3 is formed, the fixation plate 200 can be placed according to the preoperative plan, for instance as shown in Figure 6.
- k-wires can be used to validate the positioning of the fixation plate 200 onto the patient’s bone.
- the dual predrilling module 100 can be engaged with the fixation plate 200 as described above, with the fixation plate 200 remaining in place once the fixation holes and the repair tunnel are created.
- the dual predrilling module 100 thus includes osteotomy drill guides 110 positioned at the exact locations where the fastener apertures of the fixation plate will subsequently be positioned to create fixation holes each having a corresponding fixation hole pathway, and a repair drill guide 130 positioned at the exact location where a repair fastener would be inserted and to obtain the desired repair tunnel pathway. Therefore, after the fixation holes and the repair tunnel are formed, the dual predrilling module 100 can be removed and subsequent steps of the osteotomy procedure and the additional orthopedic procedure can be performed as determined by the healthcare provider.
- a method for designing a dual predrilling guide configured for guiding a drill bit into an osteotomy drill guide to form a fixation hole and a repair drill guide to form a repair tunnel in a bone will now be described in further detail.
- the method can include creating a digital 3D model of a patient’s bone.
- the 3D model can be constructed, for example, by using different types of medical imaging techniques, such as a CT scan, to acquire images of the patient’s bones, and assembling the images to form a 3D model representing the structure of the patient’s bones, including their shapes, surfaces, and/or volumes, among other parameters.
- the 3D model can subsequently be used to preoperatively simulate the effect of surgical interventions on selected ones of the patient’s bones.
- the method can include selecting a desired correction angle to apply to the patient’s bone via surgical intervention.
- a computer program can calculate the mechanical axis of the patient’s knee and/or the distribution of stresses within the patient’s knee, using the 3D model.
- the computer program can enable modifying the 3D model to adjust the orientation of the patient’s tibia bone relative to the patient’s femur, or vice versa.
- the mechanical axis and/or distribution of stresses in the knee can be recalculated following the adjustment, and a correction angle can be selected once a desired knee alignment has been attained.
- the method can include designing a patient-specific fixation plate to retain the patient’s bone at the selected correction angle.
- the 3D model can be used to determine the expected shape and form of the patient’s bone caused by surgical intervention. More specifically, the steps of the surgical procedure can be simulated using the 3D model, enabling the 3D model to describe the expected shape and form of the patient’s bone during and after the surgical procedure.
- the 3D model of the patient’s bone can be virtually cut according to a predetermined cutting plane to form a planar cut therein and opened or closed along the planar cut to attain the selected correction angle.
- a patient-specific fixation plate can then be designed to conform to the final expected shape and contours of the patient’s bone and the open or closed wedge formed therein, based on the shape and form described by the 3D model.
- Designing the fixation plate can include selecting the type of fixation fasteners, their position and orientation on the fixation plate, their shape, their depth, and modelling corresponding canals in the fixation plate to accommodate the chosen fixation fasteners.
- the designed fixation plate and selected fixation fasteners can then be virtually positioned on the 3D model the patient’s bone, and a fixation hole pathway along which a corresponding one of the fixation fasteners is planned to extend once the fixation fastener is drilled into the patient’s bone can also be determined. If a plurality of fixation fasteners is intended to be used, a fixation hole pathway can be selected for each fixation fastener of the plurality of fixation fasteners.
- the method further includes selecting the type of repair fastener that is intended to be used to perform the orthopedic repair procedure. Selecting the type of repair fastener also include determining a repair tunnel pathway along which the repair fastener is planned to extend once the repair fastener is placed into the patient’s bone and the orthopedic repair procedure is performed.
- Determining a fixation hole pathway (or the fixation hole pathways) and determining the repair tunnel pathway can be done virtually according to the 3D model of the patient’s bone by performing various iterations of placement of the fixation hole pathway (or the fixation hole pathways) and the repair tunnel pathway until a desired configuration is achieved.
- the determination of the fixation hole pathway(s) and the repair pathway can be done so that the repair tunnel pathway intersects the predetermined cutting plane and thus the subsequent planar cut modelled in the patient’s bone without intersecting the fixation hole pathway, or without intersecting each one of the fixation hole pathways if a plurality of fixation fasteners is intended to be used.
- a dual predrilling module configured to cooperate with a drill bit to predrill holes in the patient’s bone can be designed accordingly.
- the dual predrilling module is designed to include an osteotomy drill guide to predrill a fixation hole having the selected fixation hole pathway and a repair drill guide to predrill a repair tunnel having the selected repair tunnel pathway.
- the dual predrilling module can be configured to drill fixation hole(s) and a repair tunnel in the patient’s bone after the osteotomy opening has been formed in the patient’s bone.
- the predrilling module can be designed to conform to the patient’s bone after the osteotomy opening has been formed in the patient’s bone, and can include a positioning element, such as a wedge, configured for insertion in the osteotomy opening.
- the dual predrilling module can be configured to drill fixation hole(s) and a repair tunnel before the patient’s bone has been altered.
- the computer program can use the 3D model of the patient’s bone with the osteotomy opening, the fixation hole(s) and the repair tunnel defined therein so that the repair tunnel pathway intersects the predetermined cutting plane and thus the subsequent planar cut without intersecting the fixation hole pathway, or without intersecting each one of the fixation hole pathways if a plurality of fixation fasteners is intended to be used.
- the computer program can then be used to virtually close or open the patient’s bone using the 3D model to determine the corresponding positions, i.e., the initial positions, of the fixation hole(s) and the repair tunnel on the unaltered bone.
- the computer program can subsequently design a dual predrilling module configured to drill the fixation Hole(s) and the repair tunnel at the initial positions and orientations in the patient’s unaltered bone that will correspond to the final positions and orientations of the fixation hole(s) and the repair tunnel after the bone is altered, i.e., opened at the selected opening angle.
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Abstract
A dual predrilling module for drilling a fixation hole and a repair tunnel in a bone is provided. The dual predrilling module includes a body comprising a bone interface side comprising a bone contacting surface engageable with a surface of the bone or a fixation plate engaging side removably engageable with a fixation plate, and an operative side opposite the bone interface side or the fixation plate engaging side. The dual predrilling module further includes an osteotomy drill guide to create a fixation hole according to a fixation hole pathway, and a repair drill guide extending outwardly to create a repair tunnel according to a repair tunnel pathway, the repair tunnel pathway being determined to intersect a predetermined cutting plane intended to create an osteotomy and to extend across the bone to open to an articular surface of bone, without intersecting the fixation hole pathway.
Description
DUAL PREDRILLING MODULE FOR AN OSTEOTOMY PROCEDURE AND AN ADDITIONAL ORTHOPEDIC PROCEDURE
TECHNICAL FIELD
[001] The technical field generally relates to orthopedic tools, and more particularly, to orthopedic tools for use in orthopedic surgeries such as osteotomies.
BACKGROUND
[002] Knee osteotomies are orthopedic procedures aimed at correcting the alignment of the lower limb to correct a mechanical alignment. For instance, a high tibial osteotomy is a type of osteotomy which involves correcting the alignment of the lower limb by reconfiguring the mechanical axis of the tibia. Depending on the required correction, the high tibial osteotomy can be an open wedge osteotomy or a closed wedge osteotomy. In an open wedge osteotomy for a high tibial osteotomy, a planar cut is made in the tibia below the knee, and the tibia bone is opened along the planar cut to form a wedge-shaped opening with a specified angle. In a closed wedge osteotomy for a high tibial osteotomy, a wedge of bone having a specified angle is removed from the tibia bone below the knee, and the tibia bone is closed along the wedge. After the bone is opened or closed, the correction can be maintained by installing a fixation plate, among other techniques. The opening or closing effectively corrects s the angle of the tibia relative to the femur, thereby correcting the lower limb mechanical alignment and reconfiguring the pressure distribution between the tibia and the femur.
[003] When the condition of the patient requires that an additional orthopedic procedure be performed in proximity of the location of the fixation plate installed in the context of the knee osteotomy, it may be challenging to coordinate the knee osteotomy with the additional orthopedic procedure, given that the screws used to secure the fixation plate to the bone already occupy various regions of the bone. It can thus become difficult for the healthcare provider to perform the additional orthopedic procedure a posteriori without the risk of running into the screws of the fixation plate and/or without crossing a region of the bone weakened by the presence of the screws.
[004] Accordingly, there remain a number of challenges with respect to orthopedic
procedures, and particularly with respect to existing tools for performing such orthopedic procedures.
SUMMARY
[005] In accordance with an aspect, there is provided a dual predrilling module for drilling a fixation hole and a repair tunnel in a bone, the dual predrilling module comprising: a body comprising: a bone interface side comprising a bone contacting surface engageable with a surface of the bone and an operative side opposite the bone interface side; an osteotomy drill guide extending outwardly from the operative side and configured for guiding a drill bit therein to create a fixation hole according to a fixation hole pathway for receiving a fixation fastener and secure an implant to the bone; and a repair drill guide extending outwardly from the operative side and configured for guiding the drill bit therein to create a repair tunnel according to a repair tunnel pathway extending across the bone to open to an articular surface of bone, the repair tunnel pathway being determined to intersect a predetermined cutting plane intended to create an osteotomy, without intersecting the fixation hole pathway.
[006] In some implementations, the bone contacting surface of the bone interface side is configured to substantially conform to surface contours of the bone at a predetermined position on the bone.
[007] In some implementations, the repair tunnel is configured for an orthopedic repair procedure.
[008] In some implementations, the orthopedic repair procedure is one of an anterior cruciate ligament repair, a posterior cruciate ligament repair and a meniscus repair.
[009] In some implementations, the repair tunnel is configured to receive a repair fastener therein to secure a graft to the bone via compression.
[0010] In some implementations, the implant comprises a fixation plate.
[0011] In some implementations, the repair drill guide comprises a repair guide barrel extending from the operative side at a predetermined angle according to the repair tunnel pathway.
[0012] In some implementations, the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a tibial plateau.
[0013] In some implementations, the repair drill guide is configured to create the repair tunnel in a medial region of the tibia, in a lateral region of the tibia, or in an anterior region of the tibia.
[0014] In some implementations, the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a distal end of a femur.
[0015] In some implementations, the repair guide barrel includes an internal wall defining a repair guide tunnel extending along a lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
[0016] In some implementations, the internal wall of the repair guide tunnel is configured to constrain a movement of the drill bit in accordance with the repair tunnel pathway.
[0017] In some implementations, the osteotomy drill guide comprises an osteotomy guide barrel extending from the operative side at a predetermined angle according to the fixation hole pathway.
[0018] In some implementations, the osteotomy guide barrel has a predetermined osteotomy guide barrel length defined between the bone contacting surface and a terminal end of the osteotomy guide barrel to limit insertion of the drill bit therein and create a fixation hole having a predetermined fixation hole length terminating at a fixation hole end.
[0019] In some implementations, the fixation hole pathway terminates at the fixation hole end.
[0020] In some implementations, the osteotomy guide barrel includes an internal wall defining an osteotomy guide tunnel extending along the lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
[0021] In some implementations, the internal wall and the terminal end of the osteotomy guide tunnel are configured to constrain a movement of the drill bit in accordance with the fixation hole pathway.
[0022] In some implementations, the osteotomy drill guide comprises a plurality of osteotomy drill guides to create a plurality of fixation holes, each fixation hole of the plurality of fixation holes having a corresponding fixation hole pathway and the repair tunnel pathway being determined to intersect the predetermined cutting plane without intersecting each one of the corresponding fixation hole pathways.
[0023] In some implementations, the osteotomy drill guide further comprises a handle member connected to the body to facilitate manipulation and positioning of the body.
[0024] In some implementations, the handle member is a rigid elongated member extending from the operative side of the guide body.
[0025] In some implementations, the body defines fastener apertures for receiving retaining fasteners to removably secure the body to the bone.
[0026] In some implementations, the body is configured to span across an osteotomy opening created along a planar cut performed according to the predetermined cutting plane, and comprises a proximal section positioned above the osteotomy opening and a distal section positioned below the osteotomy opening.
[0027] In some implementations, the body further comprises an intermediate section extending between the proximal and distal sections and spanning the osteotomy opening, and an alignment mechanism extending outwardly from the bone interface side and configured for insertion into the osteotomy opening for engaging the bone and secure the body in a predetermined position relative to the bone.
[0028] In some implementations, the alignment mechanism comprises a wedge.
[0029] In some implementations, the wedge comprises contours configured to match inner surface contours of the osteotomy opening.
[0030] In some implementations, the bone is a tibia or a femur.
[0031] In accordance with another aspect, there is provided a dual predrilling module for drilling a fixation hole and a repair tunnel in a bone, the dual predrilling module comprising: a body comprising: a bone interface side comprising a bone contacting surface engageable with a surface of the bone and an operative side opposite the bone interface side; an osteotomy drill guide extending outwardly from the operative side and configured for guiding a drill bit therein to create a fixation hole for receiving a fixation fastener to secure an implant to the bone; and a repair drill guide extending outwardly from the operative side and configured for guiding the drill bit therein to create a repair tunnel having a predetermined orientation such that the repair tunnel intersects a predetermined cutting plane intended to create an osteotomy and extends across the bone to open to an articular surface of bone, without intersecting the fixation hole.
[0032] In some implementations, the bone contacting surface of the bone interface side is configured to substantially conform to surface contours of the bone at a predetermined position on the bone.
[0033] In some implementations, wherein the repair tunnel is configured for an orthopedic repair procedure.
[0034] In some implementations, the orthopedic repair procedure is one of an anterior cruciate ligament repair, a posterior cruciate ligament repair and a meniscus repair.
[0035] In some implementations, the repair tunnel is configured to receive a repair fastener therein to secure a graft to the bone via compression.
[0036] In some implementations, the implant comprises a fixation plate.
[0037] In some implementations, the repair drill guide comprises a repair guide barrel extending from the operative side at a predetermined angle according to the predetermined orientation of the repair tunnel.
[0038] In some implementations, the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a tibial plateau.
[0039] In some implementations, the repair drill guide is configured to create the repair tunnel in a medial region of the tibia, in a lateral region of the tibia, or in an anterior region of the tibia.
[0040] In some implementations, the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a distal end of a femur.
[0041] In some implementations, the repair guide barrel includes an internal wall defining a repair guide tunnel extending along a lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
[0042] In some implementations, the internal wall of the repair guide tunnel is configured to constrain a movement of the drill bit according to the predetermined orientation of the repair tunnel.
[0043] In some implementations, the osteotomy drill guide comprises an osteotomy guide barrel extending from the operative side at a predetermined angle according to the fixation hole.
[0044] In some implementations, the osteotomy guide barrel has a predetermined osteotomy guide barrel length defined between the bone contacting surface and a terminal end of the osteotomy guide barrel to limit insertion of the drill bit therein and create the fixation hole having a predetermined fixation hole length terminating at a fixation hole end.
[0045] In some implementations, the osteotomy guide barrel includes an internal wall defining an osteotomy guide tunnel extending along the lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
[0046] In some implementations, the internal wall and the terminal end of the osteotomy guide tunnel are configured to constrain a movement of the drill bit.
[0047] In some implementations, the osteotomy drill guide comprises a plurality of osteotomy drill guides to create a plurality of fixation holes, the predetermined orientation of the repair tunnel being determined to intersect the predetermined cutting plane without intersecting each one of the corresponding fixation holes.
[0048] In some implementations, the osteotomy drill guide further comprises a handle member connected to the body to facilitate manipulation and positioning of the body.
[0049] In some implementations, the handle member is a rigid elongated member extending from the operative side of the guide body.
[0050] In some implementations, the body defines fastener apertures for receiving retaining fasteners to removably secure the body to the bone.
[0051] In some implementations, the body is configured to span across an osteotomy opening created along a planar cut performed according to the predetermined cutting plane, and comprises a proximal section positioned above the osteotomy opening and a distal section positioned below the osteotomy opening.
[0052] In some implementations, the body further comprises an intermediate section extending between the proximal and distal sections and spanning the osteotomy opening, and an alignment mechanism extending outwardly from the bone interface side and configured for insertion into the osteotomy opening for engaging the bone and secure the body in a predetermined position relative to the bone.
[0053] In some implementations, the alignment mechanism comprises a wedge.
[0054] In some implementations, the wedge comprises contours configured to match inner surface contours of the osteotomy opening.
[0055] In some implementations, the bone is a tibia or a femur.
[0056] In accordance with another aspect, there is provided a dual predrilling module for drilling a fixation hole and a repair tunnel in a bone in combination with a fixation plate superposable to the bone, the dual predrilling module comprising: a body comprising: a fixation plate engaging side removably engageable with the fixation plate; and an operative side opposite the bone interface side; and an osteotomy drill guide extending outwardly from the operative side and being configured for guiding a drill bit therein to create a fixation hole according to a fixation hole pathway for receiving a fixation fastener and secure the fixation plate to the bone; and a repair drill guide extending outwardly from the operative side and configured for guiding the drill bit therein to create a repair tunnel according to a repair tunnel pathway, the repair tunnel pathway being determined to intersect a predetermined cutting plane intended to create an osteotomy and to extend across the bone to open to an articular surface of bone, without intersecting the fixation hole pathway.
[0057] In some implementations, the fixation plate engaging side of the body comprises an alignment feature to enable alignment of the body with the fixation plate.
[0058] In some implementations, the bone contacting surface of the bone interface side is configured to substantially conform to surface contours of the bone at a predetermined position on the bone.
[0059] In some implementations, the repair tunnel is configured for an orthopedic repair procedure.
[0060] In some implementations, the orthopedic repair procedure is one of an anterior cruciate ligament repair, a posterior cruciate ligament repair and a meniscus repair.
[0061] In some implementations, the repair tunnel is configured to receive a repair fastener therein to secure a graft to the bone via compression.
[0062] In some implementations, the repair drill guide comprises a repair guide barrel extending from the operative side at a predetermined angle according to the repair tunnel pathway.
[0063] In some implementations, the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a tibial plateau.
[0064] In some implementations, the repair drill guide is configured to create the repair tunnel in a medial region of the tibia, in a lateral region of the tibia, or in an anterior region of the tibia.
[0065] In some implementations, the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a distal end of a femur.
[0066] In some implementations, the repair guide barrel includes an internal wall defining a repair guide tunnel extending along a lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
[0067] In some implementations, the internal wall of the repair guide tunnel is configured to constrain a movement of the drill bit in accordance with the repair tunnel pathway.
[0068] In some implementations, the osteotomy drill guide comprises an osteotomy guide barrel extending from the operative side at a predetermined angle according to the fixation hole pathway.
[0069] In some implementations, the osteotomy guide barrel has a predetermined osteotomy guide barrel length defined between the bone contacting surface and a terminal end of the osteotomy guide barrel to limit insertion of the drill bit therein and create a fixation hole having a predetermined fixation hole length terminating at a fixation hole end.
[0070] In some implementations, the fixation hole pathway terminates at the fixation hole end.
[0071] In some implementations, the osteotomy guide barrel includes an internal wall defining an osteotomy guide tunnel extending along the lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
[0072] In some implementations, the internal wall and the terminal end of the osteotomy guide tunnel are configured to constrain a movement of the drill bit in accordance with the fixation hole pathway.
[0073] In some implementations, the osteotomy drill guide comprises a plurality of osteotomy drill guides to create a plurality of fixation holes, each fixation hole of the plurality of fixation holes having a corresponding fixation hole pathway and the repair tunnel pathway being determined to intersect the predetermined cutting plane without intersecting each one of the corresponding fixation hole pathways.
[0074] In some implementations, the dual predrilling module further comprises a handle member connected to the body to facilitate manipulation and positioning of the body.
[0075] In some implementations, the handle member is a rigid elongated member extending from the operative side of the guide body.
[0076] In some implementations, the body defines fastener apertures for receiving retaining fasteners to removably secure the body to the bone.
[0077] In some implementations, the body is configured to span across an osteotomy opening created along a planar cut performed according to the predetermined cutting plane, and comprises a proximal section positioned above the osteotomy opening and a distal section positioned below the osteotomy opening.
[0078] In some implementations, the body further comprises an intermediate section extending between the proximal and distal sections and spanning the osteotomy opening, and an alignment mechanism extending outwardly from the bone interface side and configured for insertion into the osteotomy opening for engaging the bone and secure the body in a predetermined position relative to the bone.
[0079] In some implementations, the alignment mechanism comprises a wedge.
[0080] In some implementations, the wedge comprises contours configured to match inner surface contours of the osteotomy opening.
[0081] In some implementations, the bone is a tibia or a femur.
[0082] In accordance with another aspect, there is provided a method for designing a dual predrilling module for guiding a drill bit to form a fixation hole and a repair tunnel in a bone, the method comprising the steps of: creating a digital 3D model of the bone; virtually cutting the 3D model of the bone to form a planar cut therein; virtually opening the 3D model of the bone along the planar cut to a desired correction angle; virtually positioning an implant and a fixation fastener on the 3D model of the bone to determine a fixation hole pathway of a fixation hole configured to receive the fixation fastener therein; virtually determining a repair tunnel pathway of a repair tunnel configured to receive a repair fastener therein so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathway; and designing the dual predrilling guide with an osteotomy drill guide and a repair drill guide positioned to achieve the fixation hole pathway and the repair tunnel pathway, respectively.
[0083] In accordance with another aspect, there is provided a method for designing a dual predrilling module for guiding a drill bit to form a fixation hole and a repair tunnel in a bone, the method comprising the steps of: creating a digital 3D model of the bone; virtually cutting the 3D model of the bone to form a planar cut therein; virtually opening the 3D model of the bone along the planar cut to a desired correction angle; virtually positioning an implant and a fixation fastener on the 3D model of the bone to determine a fixation hole pathway of a fixation hole configured to receive the fixation fastener therein; virtually determining a repair tunnel pathway of a repair tunnel configured to receive a repair fastener therein so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathway; virtually closing the 3D model of the bone to determine corresponding initial positions of the fixation hole pathway and the repair tunnel pathway; and designing the dual predrilling guide with an osteotomy drill guide and a repair drill guide positioned to achieve the corresponding initial positions of the fixation hole pathway and the repair tunnel pathway, respectively.
[0084] In accordance with another aspect, there is provided a method for designing a dual predrilling module for guiding a drill bit to form a fixation hole and a repair tunnel in a bone, the method comprising the steps of: creating a digital 3D model of the bone; virtually cutting the 3D model of the bone to form a planar cut therein; virtually closing the 3D model of the bone along the planar cut to a desired correction angle;
virtually positioning an implant and a fixation fastener on the 3D model of the bone to determine a fixation hole pathway of a fixation hole configured to receive the fixation fastener therein; virtually determining a repair tunnel pathway of a repair tunnel configured to receive a repair fastener therein so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathway; virtually opening the 3D model of the bone to determine corresponding initial positions of the fixation hole pathway and the repair tunnel pathway; and designing the dual predrilling guide with an osteotomy drill guide and a repair drill guide positioned to achieve the corresponding initial positions of the fixation hole pathway and the repair tunnel pathway, respectively.
BRIEF DESCRIPTION OF THE DRAWINGS
[0085] Figures 1 to 7C illustrate various views related to aspects and implementations of the dual predrilling module described herein.
[0086] Figure 1 is a perspective view of a dual predrilling module, in accordance with an implementation.
[0087] Figure 2 is another perspective view of the dual predrilling module of Figure 1.
[0088] Figure 3 is another perspective view of the dual predrilling module of Figure 1.
[0089] Figure 4 is another perspective view of the dual predrilling module of Figure 1.
[0090] Figure 5A is a perspective view of the dual predrilling module of Figure 1 , shown engaged with a patient’s tibia bone and spanning across an osteotomy opening.
[0091] Figure 5B is a perspective view of the patient’s tibia bone of Figure 5A, shown with a repair tunnel intersecting the osteotomy opening and opening to an articular surface of the tibia bone.
[0092] Figure 6 is a perspective view of a dual predrilling module in accordance with another implementation and of a fixation plate, the fixation plate being engaged with the
patient’s tibia bone and spanning across an osteotomy opening and the dual predrilling module being engaged with the fixation plate.
[0093] Figure 7A is a front perspective view of a fixation plate for securing an open wedge formed in a patient’s tibia bone, in accordance with an implementation in which the fixation plate is provided with a wedge element.
[0094] Figure 7B is a rear perspective view of the fixation plate of Figure 7A.
[0095] Figure 7C is a side view of the fixation plate of Figure 7A.
DETAILED DESCRIPTION
[0096] Techniques described herein relate to systems, devices and methods that can be used or implemented in preparation for performing both an osteotomy procedure to correct the alignment of a patient’s knee and an additional orthopedic procedure, such as an orthopedic “repair procedure”. The additional orthopedic procedure can be for instance a repair or reconstruction of the anterior cruciate ligament (ACL) or the posterior cruciate ligament (PCL), or a meniscus repair (such as a meniscus root repair), among other examples. The osteotomy procedure and the additional orthopedic procedure can together be referred to as a concomitant case. In this type of concomitant cases, the success of the overall procedure can depend on the proper positioning and alignment of osteotomy drill guides dedicated to the osteotomy procedure and of a repair drill guide dedicated to the additional orthopedic procedure, which in turn will determine the location of various screws that will be used in the procedures. This proper alignment can be determined so as to avoid interference between the resulting repair tunnel and the components associated with the fixation plate, and in particular between the repair tunnel and fixation fasteners and a plate wedge, if applicable, of a fixation plate used for the osteotomy procedure.
[0097] In order to do so, a dual predrilling module having a predetermined spatial distribution of osteotomy guide tunnels dedicated to the osteotomy procedure and a repair guide tunnel dedicated to the additional orthopedic procedure is described herein.
[0098] Various implementations of the dual predrilling module and associated components, as well as methods for using the dual predrilling module, will now be described in the following paragraphs.
Dual Predrilling Module
[0099] In an open wedge osteotomy procedure, a bone is initially cut into according to a predetermined cutting plane to form a planar cut that is subsequently opened to form a wedge-shaped opening having a specified angle. In a closed wedge osteotomy procedure, a bone is also initially cut into according to a predetermined cutting plane to remove a wedge of bone having a specified angle. The bone can be for instance a tibia or a femur. When the bone is a tibia, the planar cut is made below the knee, whereas when the bone is a femur, the planar cut is made above the knee. In both types of procedures, /.e., the open wedge osteotomy procedure and the closed wedge osteotomy procedure, the bone is thus initially cut according to a predetermined cutting plane, which is typically performed using a surgical guide configured to be mounted to a patient’s bone and that includes a plurality of modules to guide various surgical tools used throughout the osteotomy procedure. In some implementations, the surgical guide can be a patient-specific instrumentation (PSI). The surgical guide can include a plurality of canals for securing the surgical guide to the patient’s bone via a plurality of screws at strategic locations. The surgical guide can include a drilling module comprising a plurality of drill guides to assist in creating drill holes in the patient’s bone in preparation for forming the planar cut therein. The surgical guide can further include a cutting module to assist in cutting the patient's bone. The cutting guide can include an osteotome guide for guiding a corresponding osteotome to cut the patient’s bone at a predetermined position, orientation and depth. The osteotome guide is thus configured to guide an osteotome to create a planar cut in the patient’s bone, for instance in the area weakened by the drill holes formed using the drilling module.
[00100] Once the planar cut according to the predetermined cutting plane is created or prior to the planar cut according to the predetermined cutting plane being created, a dual predrilling module can be used for predrilling holes in the patient’s bone via osteotomy guide tunnels dedicated to the osteotomy procedure and a repair guide tunnel dedicated to an orthopedic repair procedure. It is to be noted that an orthopedic repair procedure
includes orthopedic reconstruction procedures. The dual predrilling module will now be described in more detail.
[00101] With reference to Figures 1 to 6, an example of a dual predrilling module 100 configured to drill at least two types of holes in a patient’s bone 1 is shown. In the implementation shown, the bone is exemplified as a tibia. It is to be understood that in other implementations, the bone can be a femur or any other bone that can benefit from an orthopedic procedure using the dual predrilling module described herein. In the illustrated implementation, the dual predrilling module 100 is configured to drill two types of holes in the patient’s bone, namely one or more fixation holes and a repair tunnel 140 (shown in Fig 5B), such as a repair tunnel that extends across the bone to open at the level of the articular surface of bone, /.e., at the level of the tibial plateau when the bone is a tibia (as exemplified in Fig 5B), or a distal end of a femur when the bone is a femur. The fixation holes are created to eventually receive fixation fasteners therein for securing a fixation plate or another implant to the patient’s bone 1. The repair tunnel 140 can be created to receive a repair fastener therein, the repair fastener being used in the context of an orthopedic repair procedure such as a repair or reconstruction of the ACL or the PCL, or a meniscus repair, for instance. The dual predrilling module 100 can be patientspecific in that it can be custom-made according to the anatomy of the patient’s bone 1 and according to a preoperative plan. Accordingly and as shown in Figures 1 to 5A, the dual predrilling module 100 can be configured to precisely fit in a predetermined position onto the patient’s bone 1 to ensure proper alignment therewith, and to assist in drilling holes in the patient’s bone 1 in predetermined positions, orientations and depths. Alternatively and as shown in Figure 6, the dual predrilling module 100 can be configured to fit onto a fixation plate used in the osteotomy procedure, also to assist in drilling holes in the patient’s bone 1 in predetermined positions, orientations and depths. This aspect will be discussed in further detail hereinbelow.
[00102] In the implementation shown in Figures 1 to 5A, the dual predrilling module 100 comprises a body 102 having a bone interface side 104 and an operative side 106. The bone interface side 104 comprises a bone-contacting surface 108 having contours complementary in shape to the surface contours of the patient’s bone 1. The operative side 106 comprises an outer surface 109. In this configuration, the bone interface side 104 can abut against the patient’s bone 1 , and key into a specific position thereon. In the
illustrated implementation, the bone-contacting surface 108 of the bone interface side 104 is represented as a solid surface. However, in other implementations, other configurations are possible. For example, the bone-contacting surface 108 can be defined by an open lattice, and can comprise edges conforming to the contours of the patient’s bone 1.
[00103] In some implementations, the body 102 of the dual predrilling module 100 can define fastener apertures (now shown) for receiving retaining fasteners to removably secure the body 102 to the patient’s bone.
Osteotomy drill guides
[00104] The operative side 106 is provided opposite the bone interface side 104 and comprises a plurality of osteotomy drill guides 110 extending outwardly therefrom for guiding corresponding drill bits. As used herein, the expression “drill bit” is intended to refer to any drilling instrument suitable for drilling into a bone. In the illustrated implementation, each of the osteotomy drill guides 110 includes an osteotomy guide barrel 112 extending outwardly from the body 102 of the dual predrilling module 100 at a predetermined angle along a lengthwise axis and terminating at a terminal end 114. The osteotomy guide barrel 112 is exemplified as being substantially annular and thus comprises an internal wall defining a hollow interior in the form of an osteotomy guide tunnel 116 extending through the osteotomy guide barrel 112 along the lengthwise axis thereof and across an entire thickness of the body 102, the osteotomy guide barrel 112 opening on the bone interface side 104 and on the operative side 106 of the body 102 of the dual predrilling module 100. The osteotomy guide tunnels 116 are sized and shaped to receive a corresponding drill bit therein, enabling the drill bit to slide in and out of the osteotomy guide barrel 112, while the internal wall and the terminal end 114 of the osteotomy guide barrel 112 together can contribute to constraining movement of the drill bit to a predetermined depth, position, and orientation relative to the patient’s bone 1. An abutting member on the drill bit can be provided to limit an insertion depth of an operative end of the drill bit into the osteotomy guide barrel 112 as it abuts onto the terminal end 114 of the osteotomy guide barrel 112. In this configuration, the length of the osteotomy guide barrel 112 can limit the insertion depth of a drill bit and can ensure that the depth of drill holes formed therewith is as desired.
[00105] The plurality of osteotomy drill guides 110 is configured to cooperate with a calibrated drill bit having a fixed operative length. The osteotomy guide barrels 112 of the osteotomy drill guides 110 are sized, positioned and oriented to create fixation holes (not shown) in a predetermined pattern, i.e., according to a predetermined spatial distribution, for receiving corresponding fixation fasteners therein to secure an implant, such as the fixation plate 200 shown in Figures 7 A to 7C, to the patient’s bone 1. As will be described in more detail hereinafter, the fixation plate 200 to be secured to the patient’s bone 1 can be patient-specific and can be designed to be affixed using different types of fixation fasteners.
[00106] Based on the anatomy of the patient’s bone 1 , a preoperative plan can define a configuration of the fixation fasteners, including their size, depth, orientation, and position, that will be chosen to ensure that the implant can be affixed properly to the patient’s bone. The osteotomy drill guides 110 can be configured to guide drill bits to create the fixation holes in preparation for receiving the fixation fasteners configured according to the preoperative plan, each of the fixation holes extending along a fixation hole pathway that is also predetermined according to the preoperative plan. For example, the length of each osteotomy guide barrel 112 can be adjusted to limit the insertion depth of the drill bit, creating fixation holes with selected predetermined depths which can be the same or different. Similarly, the position and orientation of the osteotomy guide barrels 112 can be adjusted to define fixation holes extending at selected angles and positions to achieve the desired corresponding fixation hole pathways. Finally, the diameters of the osteotomy guide tunnels 116 can be adjusted to accommodate drill bits of different diameters to create fixation holes of different sized for accommodating different sizes of fasteners.
Repair drill guide
[00107] Still referring to Figures 1 to 6, the operative side 106 of the body 102 of the dual predrilling module 100 further includes a repair drill guide 130 extending outwardly therefrom for guiding a corresponding drill bit. In the illustrated implementation, the repair drill guide 130 comprises a repair guide barrel 132 extending outwardly from the body 102 of the dual predrilling module 100 at a predetermined angle along a lengthwise axis and terminating at a terminal end 134. The repair guide barrel 132 is exemplified as being substantially annular and thus comprises an internal wall defining a hollow interior in the
form of a repair guide tunnel 136 extending through the repair guide barrel 132 along the lengthwise axis thereof and opening on the bone interface side 104 and operative side 106 of the dual predrilling module 100. The repair guide tunnel 136 is sized and shaped to receive a corresponding drill bit therein, enabling the drill bit to slide in and out of the repair guide barrel 132, while the internal wall and the terminal end 134 of the repair guide barrel 132 together can contribute to constraining movement of the drill bit to a predetermined depth, position, and orientation relative to the patient’s bone 1. An abutting member on the drill bit can limit an insertion depth of an operative end of the drill bit into the repair guide barrel 132 as it abuts with the terminal end 134 of the repair guide barrel 132. In this configuration, the length of the repair guide barrel 132 can limit insertion depth of a drill bit and assure the depth of drill holes formed therewith. In other implementations, the repair guide barrel 132 can be configured so that the drill bit creates a repair tunnel across the bone, for instance to reach the tibial plateau. The diameter of the repair guide tunnel 136 can be adjusted to accommodate a drill bit selected to create a repair tunnel suitable for the type of orthopedic repair procedure that needs to be performed. The repair drill guide 130 can be located at various locations on the dual predrilling module 100, such that the repair tunnel can be created in a medial region of the bone, in a lateral region of the bone, or in an anterior region of the bone.
[00108] The repair drill guide 130 is configured such that the repair tunnel can extend along a repair tunnel pathway 144 (shown in Figure 5B) that is predetermined according to the preoperative plan. In particular, in the case of the repair tunnel, the repair tunnel pathway 144 can be selected so that it intersects the predetermined cutting plane and thus the subsequent planar cut that will be created in the patient’s bone 1 , and that it does not intersect the fixation hole pathways. The preoperative plan can thus include the determination of both the fixation hole pathways and the repair tunnel pathway so that the above criteria can be met, /.e., so that the repair tunnel pathway intersects the predetermined cutting plane and that the repair tunnel pathway is free of interference with the fixation hole pathways, /.e., without intersecting the fixation hole pathways, or with other components of the fixation plate. It is to be understood that when referring to the repair tunnel pathway intersecting the predetermined cutting plane, it is intended to include implementations where the planar cut is modified to become an osteotomy opening. The repair tunnel pathway can thus be selected such that it intersects the predetermined cutting plane, the planar cut and the subsequent resulting osteotomy opening. It is also to
be understood that in some implementations, when referring to the fixation hole pathway, the fixation hole pathway can be considered to end where the fixation fastener received in the fixation hole would also end. Accordingly, in some implementations, the repair tunnel pathway can be posterior to the fixation holes, which is considered as also being free of interference with the fixation hole pathways, i.e., as not intersecting the fixation holes for the fixation fasteners. In other implementations, the repair tunnel pathway can also be anterior to the fixation holes.
[00109] Providing the osteotomy drill guides 110 and the repair drill guide 130 on a common body 102 of the dual predrilling module 100 can enable obtaining coherence between the fixation holes and the repair tunnel to meet selected criteria such as those mentioned above to enable a healthcare provider to perform both an osteotomy procedure and an orthopedic repair procedure in a combined orthopedic procedure. With this approach, challenges associated with the determination of a repair tunnel pathway that would have to be done independently of already determined fixation hole pathways and potentially after fasteners would be received in corresponding fixation holes following an osteotomy procedure, can be avoided. Indeed, when a repair tunnel pathway is determined while fixation holes are already created, it can become difficult and/or challenging for the healthcare provider to avoid intersecting the fixation holes or other components of the fixation plate while ensuring that the repair tunnel pathway intersects the osteotomy opening for performing a satisfactory orthopedic repair procedure. Thus, as mentioned above, a successful overall procedure that includes concomitant cases can be achieved using the dual predrilling module as described herein given the proper positioning and alignment of osteotomy guide tunnels dedicated to the osteotomy procedure and of a repair guide tunnel dedicated to the additional orthopedic procedure.
[00110] As mentioned above, examples of orthopedic repair procedures can include a repair or reconstruction of the ACL or the PCL. The ACL is one of the major ligaments of the knee, and is located in the middle of the knee and runs from the femur to the tibia. The ACL prevents the tibia from sliding out in front of the femur. Together with the PCL, the ACL provides rotational stability to the knee. In the case of a repair or reconstruction of the ACL or the PCL following a tear, the reconstruction of the ligament can involve using a tendon or ligament autograft, i.e., taken from the patient’s own body, or an allograft, i.e., a tissue taken from a donor. In order to fix the graft to the tibia and the femur, a first end
of the graft can be inserted into a repair tunnel in the tibia and a repair fastener can be inserted into the repair tunnel to secure the graft between the bone surface and the outer surface of the repair fastener by compression, among other techniques. A similar approach can be taken to secure a second end of the graft to the femur. When the first and second ends of the graft are secured to the tibia and the femur respectively, the graft extends across the knee, from the tibia to the femur. When the repair or reconstruction of the ACL or the PCL is to be performed concomitantly with an osteotomy procedure, the dual predrilling module 100 described herein can be used to determine a proper alignment of the repair tunnel pathway relative to the fixation hole pathways and other components of the fixation plate.
[00111] Another example of an orthopedic repair procedure is a meniscus repair. Medial and lateral menisci are crescent-shaped fibrocartilage structures that provide joint congruity, stabilization and lubrication and act as “shock absorbers” for joint preservation. Tears to the medial meniscal root can modify the biomechanics and kinematics of the knee, which can cause early degeneration of the knee joint. Absence of the medial meniscus (entire medial meniscal root tear) can place large stresses on the ACL. A meniscus repair is similar to a repair or reconstruction of the ACL or the PCL in that it also involves securing a portion of the meniscus, typically the meniscal root, to the bone, such as the tibia, using a repair fastener inserted into a repair tunnel. In this type of procedure, the repair tunnel can also be referred to as a transtibial channel.
[00112] It is to be noted that other types of orthopedic repair procedures involving the creation of a repair tunnel in the tibia or the femur can also be within the scope of the present description as one of the procedures resulting in concomitant cases.
Positioning of the dual predrilling module
[00113] In some implementations, and as shown in Figure 5A, the dual predrilling module 100 can be configured to drill one or more fixation holes and a repair tunnel in the patient’s bone 1 after the geometry of the patient’s bone 1 has been surgically altered. In the illustrated implementation, the dual predrilling module 100 is configured to span across an osteotomy opening 3 formed in the patient’s bone 1 , such that the osteotomy drill guides 110 and the repair drill guide 130 can be positioned to define one or more fixation holes and a repair tunnel directly in their final position. More specifically, the dual predrilling
module 100 can have a body 102 substantially similar to a fixation plate that will ultimately be secured to the patient’s bone 1 to span across the osteotomy opening 3. The patient’s bone 1 can thus be opened along a planar cut to form the osteotomy opening 3, and once the osteotomy opening 3 is formed, the dual predrilling module 100 can be secured to the patient’s bone 1 at the same position where the fixation plate will eventually be located and secured to the patient’s bone 1. In some implementations, when the orthopedic procedure involves a planar cut across the bone and a rotation of the portion of the bone thus severed from the remaining of the bone, k-wires can be used to validate the positioning of the dual predrilling module 100 onto the patient’s bone 1. In such implementations, the dual predrilling module 100 thus includes osteotomy drill guides 110 positioned at the exact locations where the fastener apertures of the fixation plate will subsequently be positioned to create one or more fixation holes each having a corresponding fixation hole pathway, and a repair drill guide 130 positioned at the exact location where a repair fastener would be inserted and to obtain the desired repair tunnel pathway, so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathways. Therefore, after the one or more fixation holes and the repair tunnel are formed, the dual predrilling module 100 can be removed and replaced by a fixation plate. The fixation plate can then be positioned to align with the one or more fixation holes and then secured in place via fixation fasteners. Alternatively, the fixation plate can be placed on the patient’s bone before the repair tunnel is created. The orthopedic repair procedure can also be conducted either prior to or after the fixation of the fixation plate onto the patient’s bone.
[00114] In alternative implementations, the dual predrilling module 100 can be configured to drill one or more fixation holes and a repair tunnel in the patient’s bone 1 prior to a surgical alteration of the bone’s geometry, such as a high-tibial open-wedge osteotomy or a high-tibial closed-wedge osteotomy. The dual predrilling module 100 can thus be configured to account for the one or more fixation holes and repair tunnels moving as the geometry of the bone is altered during surgery, such that the one or more fixation holes can be in alignment with the fixation fasteners of an implant and that the repair tunnel has a desired trajectory once the bone alterations are complete. For example, in the context of a high-tibial open-wedge osteotomy procedure, the dual predrilling module 100 can be configured to predrill one or more fixation holes while the patient’s bone 1 is in a closed configuration (/.e., before the patient’s bone 1 is opened along the planar cut formed using
the drilling and cutting modules). In this configuration, the osteotomy drill guides 110 can be positioned to form one or more fixation holes that will eventually align with the location of fixation fasteners for affixing an implant and the repair drill guide 130 can be positioned to form the repair tunnel necessary for the orthopedic repair procedure once the patient’s bone 1 is opened along the planar cut to an opened configuration. The position of the one or more fixation holes and the repair tunnel can be determined by modelling the patient’s bone 1 , virtually opening the bone model to a desired opening angle, virtually positioning an implant and determine fixation hole pathways of corresponding fixation fasteners on the bone model to set final positions of the one or more fixation holes, and virtually determining a repair tunnel pathway of a repair tunnel configured to receive a repair fastener therein so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathways. In the context of the present description, the sentence “without intersecting the fixation hole pathways” is intended to mean that the repair tunnel pathway of the repair tunnel is free of interference with the fixation hole pathway(s), i.e., that the repair tunnel pathway of the repair tunnel and the fixation hole pathway(s), together form non-intersecting pathways. Given that a fixation hole necessarily extends along a corresponding fixation hole pathway and a repair tunnel necessarily extends along a corresponding repair tunnel pathway, it is to be understood that a repair tunnel created according to a repair tunnel pathway extending across the bone opening to an articular surface of bone and intersecting a predetermined cutting plane intended to create an osteotomy, without intersecting a fixation hole pathway should be considered equivalent to a repair tunnel extending across the bone, opening to an articular surface of bone and intersecting a predetermined cutting plane intended to create an osteotomy without intersecting a fixation hole, once the fixation hole and the repair tunnel are created. The bone model can then be subsequently closed virtually to determine initial positions of the one or more fixation holes and the repair tunnel. The dual predrilling module 100 can then be designed according to the initial positions of the fixation and repair tunnels.
[00115] The dual predrilling module 100 can include an attachment/alignment mechanism for securing the dual predrilling module 100 to the patient’s bone 1 and/or for assuring proper alignment of the dual predrilling module 100 relative to the patient’s bone 1. In some implementations, a single mechanism can provide both the functions of securing and aligning the dual predrilling module 100 relative to the patient’s bone 1. In other implementations, different mechanisms can be provided to align and/or to secure the dual
predrilling module 100, and thus separate mechanisms can be provided to respectively perform the alignment and attachment functions. For example, in some implementations, the dual predrilling module 100 can be secured to the patient’s bone directly via fasteners. In some implementations, the bone interface side 104 of the dual predrilling module 100 can be shaped to have contours complementary in shape to the contours of a specific area of the patient’s bone 1 to provide a proper alignment of the dual predrilling module 100 relative to the patient’s bone 1. In some implementations, the attachment/alignment mechanism can comprise a member configured to interface and/or insert into a hole or other feature formed in the patient’s bone 1 , for example in the osteotomy opening formed along the planar cut.
[00116] In Figures 1 to 5, the bone interface side 104 of the body 102 of the dual predrilling module 100 has a bone-contacting surface 108 substantially conforming to a surface contour of the patient’s bone 1 at a predetermined position. The body 102 of the dual predrilling module 100 is configured with a proximal section 102a for positioning adjacent a surface of the patient’s bone 1 above the osteotomy opening 3, a distal section 102b for positioning adjacent a surface of the patient’s bone 1 below the osteotomy opening 3, and an intermediate section 102c for spanning the osteotomy opening 3. The attachment/alignment mechanism comprises a wedge 122 extending outwardly from the bone-contacting surface 108 of the bone interface side 104 at the location of the intermediate section 102c of the body 102, the wedge 122 being configured for insertion into the osteotomy opening 3. The wedge 122 can be sized and shaped according to the expected dimensions of the desired osteotomy opening 3 as determined by the preoperative plan. The wedge 122 can further comprise contours matching inner surface contours of the osteotomy opening 3. The wedge 122 can thus enable the dual predrilling module 100 to be secured at a predetermined position relative to osteotomy opening 3, while also validating that the bone 3 has been opened to the correct angle. Once the dual predrilling module 100 has been correctly positioned, it can be secured in place relative to the patient’s bone 1 before drilling is performed through the osteotomy drill guides 110 and the repair drill guide 130. In some implementations, the body 102 can include fastener apertures in the proximal 102a and distal 102b sections to enable securing the body 102 of the dual predrilling module 100 directly to the patient’s bone 1 via fixation fasteners. However, other attachment mechanisms are possible. For example, the dual predrilling module 100 can be secured to an anchor module already attached to the patient’s bone 1
at the correct position.
Additional components of the dual predrilling module
[00117] In the implementations illustrated in Figures 1 to 6, the dual predrilling module 100 further comprises a handle member 120 configured to enable the dual predrilling module 100 to be more easily manipulated by a healthcare provider and positioned at a desired location on the patient’s bone 1. In the illustrated implementation, the handle member 120 is a rigid elongated member extending outwardly from the body 102 of the dual predrilling module 100 along a lengthwise axis and facilitates manipulation of the dual predrilling module 100 by hand. In other implementations, different types of handle members can be provided. For example, the handle member 120 can be removable and/or can comprise an interface for a positioning tool or guide. In some implementations, the handle member 120 can include inscriptions provided thereon to identify the dual predrilling module 100 and/or to indicate the type of drill bits with which the dual predrilling module 100 is designed to cooperate.
[00118] In some implementations, the repair guide barrel 132 of the dual predrilling module 100 can be adapted to be coupled to an auxiliary diameter adaptor (not shown). The auxiliary diameter adaptor can be configured to modify a diameter of the repair guide barrel 132. Modifying the diameter of the repair guide barrel 132 can facilitate cooperation with selected orthopedic instruments such a Kirschner wire (also referred to as a k-wire). In such implementations, the diameter of the auxiliary diameter adaptor coupled to the repair guide barrel 132 can be selected to accommodate a specific orthopedic instrument according to its diameter. The k-wire can be used for temporary fixation of the dual predrilling module to the patient’s bone. Once the healthcare provider is satisfied with the position of the repair tunnel, the auxiliary diameter adaptor can be removed, and the drilling of the repair tunnel can be performed while the repair guide barrel 132 is still in place.
Fixation Plate
[00119] With reference now to Figures 6 and 7A to 7C, a fixation plate 200 is shown. The fixation plate 200 includes a body 202 that can be made from a rigid, biocompatible and degradation-resistant material, such as stainless steel or titanium, although other
materials are possible, including different metals and/or plastics and/or a combination thereof. In the illustrated implementation, the fixation plate 200 is exemplified as an osteotomy plate configured to be secured to an antero-medial side of the patient’s bone 1 and to retain the osteotomy opening 3 created therein during an open-wedge osteotomy procedure. In other implementations, the fixation plate 200 can be configured to be secured to another side of the patient’s bone 1 , for instance depending on surgical requirements. In the illustrated implementation, the body 202 of the fixation plate 200 includes a proximal section for securing to the patient’s bone 1 above the osteotomy opening 3, a distal section for securing to the patient’s bone 1 below the osteotomy opening 3, and an intermediate section for spanning the osteotomy opening 3. The fixation plate 200 is patient-specific in that the fixation plate 200 is designed based on the specific anatomy of the patient’s bone 1 and based on the specific needs of the patient determined during the preoperative plan. The shape and configuration of the fixation plate 200 can therefore vary from one procedure to another based upon the bone anatomy of different patients and based on the fixation requirements.
[00120] The body 202 of the fixation plate 200 can be sized, shaped, and configured to fit snugly against the patient’s bone 1 while also providing the required support and being minimally noticeable under the patient’s skin. In the illustrated implementation, the body 202 is thin and substantially flat, and is configured to follow the contours of the patient’s bone 1. In this configuration, for example, when the fixation plate 200 is secured to the patient’s bone 1 , it can protrude from the surface of the patient’s bone 1 at a uniform height along the entire body 202. Moreover, in some implementations, the body 202 can be designed to have a thickness that varies in depending on the location, enabling the body 202 to have an increased or a reduced strength or rigidity where required and/or enable the body 202 to protrude less noticeably from the patient’s bone in selected areas.
[00121] The body 202 of the fixation plate 200 comprises a bone interface side 204 and an outward-facing side 206. The bone interface side 204 comprises an inner surface 208 for positioning against the patient’s bone 1. The contours of the inner surface 208 of the bone interface side 204 are complementary in shape to the surface contours of a predetermined location on the patient’s bone 1 where the fixation plate 200 is intended to be positioned. Accordingly, the fixation plate 200 can fit snugly onto the patient’s bone 1 at a position determined preoperatively. The outward-facing side 206 includes an outward
surface 209 that is substantially smooth and/or flat to make it minimally noticeable under the patient’s skin. In the illustrated implementation, the outward-facing side 206 comprises sloped and/or chamfered edges 210 which provide a smoother transition between the body 202 of fixation plate 200 and the patient’s bone 1.
[00122] The fixation plate 200 can be secured to the patient’s bone 1 via fixation plate fasteners (not shown). The fixation fasteners can include surgical screws configured to be drilled into the patient’s bone 1 , although other types of fasteners are possible. The fixation fasteners are configured to engage with the fixation plate 200 via apertures or canals 222 opening on the bone interface side 204 and the outward-facing side 206 of the fixation plate 200. The canals 222 can be sized and shaped to receive different sizes of fixation fasteners therein. Moreover, the canals 222 can be configured to guide corresponding fixation fasteners at a predetermined angle or orientation as the fixation fasteners are inserted into the patient’s bone 1. For example, in the illustrated implementation, the canal 222 includes a peripheral wall extending through the thickness of the body 202 of the fixation plate 200 at a predetermined angle to guide the fixation fasteners as they are drilled through the canals 222. In some implementations, the peripheral wall of the canal 222 can be threaded, for example to engage with corresponding threads of fixation fasteners as the fixation fasteners are drilled through canals 222, and/or to engage or lock with a head of the fixation fasteners once fully inserted. The peripheral wall of the canal 222 can further be configured to abut against a head of a fixation fastener to block the fixation fastener from being inserted too deep into the patient’s bone 1.
[00123] Based on a preoperative plan, the fixation plate 200 can be designed with a different number and configuration of canals 222 for receiving a different number and/or different configurations of fixation fasteners based on the fixation requirements to promote optimal securing of the fixation plate 200. Moreover, the fixation plate 200 can be configured such that it can accommodate combinations of different sizes of fixation fasteners (both diameter and length) and different orientations of fixation fasteners, for example based on the position of the patient’s bone 1 to which a particular fixation fastener is to be secured. In the illustrated implementation, the fixation plate 200 is configured to accommodate two large laterally-spaced fixation fasteners in the proximal section 202a of the body 202, and two smaller vertically-spaced fixation fasteners in the distal section
202b of the body 202. it is to be understood that other configurations of that fixation plate 200 are possible and within the scope of the present description.
[00124] In some implementations, additional support members can be provided to further assist the fixation plate 200 in retaining the osteotomy opening 3 formed in the patient’s bone 1 and/or to assist in correctly positioning the fixation plate 200 relative to the osteotomy opening 3. For instance, a wedge element 212 can be provided to abut against internal surfaces on opposite sides of the osteotomy opening 3 when the fixation plate 200 is positioned on the patient’s bone 1. In some implementations, the wedge element 212 can have contours and/or surfaces that conform to the specific shape of the patient’s bone 1 . As a load is applied across osteotomy opening 3, the wedge element 212 can exert an opposing force on the patient’s bone 1 via the internal surfaces. In this configuration, a load across the osteotomy opening 3 can be borne by the wedge element 212 and dissipated through the patient’s bone 1 , rather than being borne by the fixation fasteners holding the fixation plate 200 in place. In the illustrated implementation, the wedge element 212 is formed as an integral part of body 202 of fixation plate 200, and is made from the same rigid, biocompatible material, /.e., stainless steel or titanium. In other implementations, the wedge element 212 can be a separate piece which can be fastened or secured to the fixation plate 200 and/or directly to the patient’s bone 1 . It is further appreciated that the wedge element 212 can be made of a different material, such as a rigid plastic or the like, depending on the required structural properties.
[00125] In the illustrated implementation shown in Figures 7A to 7C, the wedge element 212 extends outwardly from the bone interface side 204 of the fixation plate 200, and is positioned on an intermediate section of the fixation plate body 202. In this configuration, the wedge element 212 extends inside the osteotomy opening 3 when the fixation plate 200 is secured to the patient’s bone 1. The wedge element 212 comprises a proximal abutment 214 for abutting against a proximal internal surface of the bone of the osteotomy opening 3, and a distal abutment 216 for abutting against a distal internal surface of bone of the osteotomy opening 3. The proximal 214 and distal 216 abutments are spaced apart from one another via a concave canal 218. In this configuration, a certain amount of flexure is permitted in the rigid body 202 of fixation plate 200 as a load is applied across abutments 214, 216. In other implementations, the wedge element 212 can be a solid block having abutments 214, 216 defined on opposite sides thereof.
[00126] As mentioned above, the wedge element 212 can be configured to provide different levels of support based on patient-specific needs. The abutments 214 and 216 can also be designed with different shapes and configurations which can further affect the rigidity and/or the distribution of ferees in the wedge element 212. The wedge element 212 can be further configured with bearing surfaces that conform to a shape of the patient’s cortical bone to ensure better contact therewith, and avoid contact with the trabecular bone
[00127] In the implementations described above, the fixation plate 200 is provided with a single wedge element 212 configured to be engaged with the osteotomy opening 3 along an antero-medial side of the patient’s bone 1 . It is appreciated, however, that in other implementations, other wedge element configurations are possible. For example, the fixation plate 200 can include a double wedge element comprising a first anterior wedge element 212a, and a second posterior wedge element spaced apart from one another in the intermediate section 202 of the plate body 202.
[00128] In the implementations described above, the wedge element 212 is configured to engage in, and provide support to, the osteotomy opening 3 on an antero-medial side of the patient’s bone 1. It is appreciated, however, that in some implementations, further support may be desired towards the anterior and/or posterior of the patient’s bone 1. Accordingly, in some implementations, the wedge element 212 can be configured as an extended wedge with a section which extends away from the plate body 202 in the anterior and/or posterior direction.
[00129] In the implementations described above, the wedge element 212 is provided with the proximal 214 and distal 216 abutments that are spaced apart from one another via the concave canal 218. It is appreciated, however, that in other implementations, the wedge element 112 can be free of concave canal.
Alternative implementation of a dual predrilling module
[00130] In some implementations, and as shown in Figure 6, the dual predrilling module 100 can be configured for placement over a fixation plate 200, such as the fixation plate 200 exemplified in Figures 7A to 7C. In such implementations, the dual predrilling module 100 can also be configured to drill fixation holes and a repair tunnel in the patient’s bone
1 after the geometry of the patient’s bone 1 has been surgically altered, but with the fixation plate 200 being provided between the patient’s bone 1 and the dual predrilling module 100. In other words, in this implementation, the fixation plate 200 can be considered as being “sandwiched” between the patient’s bone 1 and the dual predrilling module 100. In the illustrated implementation, the dual predrilling module 100 is configured to span across the osteotomy opening 3 formed in the patient’s bone 1 as described above, such that osteotomy drill guides 110 can be positioned to define fixation holes directly in their final position and a repair drill guide 130 can be positioned to define a repair directly in its final position.
[00131] In such implementation, instead of having a bone interface side 104, the body of the dual predrilling module 100 can have a fixation plate engaging side 146 configured to engage with the outward-facing side 206 of the fixation plate 200, in an “over-the-plate configuration”. The dual predrilling module 100 is thus removably engageable with the fixation plate 200, in the over-the-plate configuration, and optionally removably secured thereto using a fastener such as pin screw or by using a drill bit that is momentarily left in place during the creation of the fixation holes and the repair tunnel. Once the fixation holes and the repair tunnel are created, the dual predrilling module 100 can be disengaged and removed from the fixation plate 200. The fixation plate 200 can subsequently be affixed to the patient’s bone 1 as described above, and the repair tunnel can be used to perform a desired orthopedic repair procedure.
[00132] In such implementations, the fixation plate engaging side 146 of the body 102 of the dual predrilling module 100 can include an alignment feature enabling a proper alignment and subsequent removable engagement with the fixation plate 200 that will be secured to the patient’s bone 1 via fixation fasteners. For instance, the fixation plate engaging side 146 of the body 102 can include an outwardly protruding element configured to be received into a corresponding recess defined on the outward-facing side 206 of the fixation plate 200, or vice versa. In some implementations, the alignment feature provided or defined on the outward-facing side 206 of the fixation plate 200 can be configured to be present for a limited period of time to avoid the outward-facing side 206 of the fixation plate 200 having an irregular surface, and subsequently ensure that the outward-facing side 206 is substantially smooth and/or flat to make it minimally noticeable under the patient’s skin. In order to do so, the alignment feature provided or defined on the outward-facing
side 206 of the fixation plate 200 can be removable therefrom once the dual predrilling module 100 is ready to be disengaged and removed from the fixation plate 200. Alternatively, the alignment feature provided or defined on the outward-facing side 206 of the fixation plate 200 can be made of a material that is bioresorbable, and that is thus configured to be resorbed or dissolved naturally under physiological conditions after a given period of time. In some implementations, the fixation plate 200 can also define apertures or canals 222 as described above, and can further include a canal rim 224 extending around a corresponding canal 222. In turn, the fixation plate engaging side 146 of the dual predrilling module 100 can include a canal rim recess configured to receive therein a corresponding canal rim 224. This type of engagement can contribute to facilitating the stable engagement of the dual predrilling module 100 over the fixation plate 200.
[00133] In implementations where the dual predrilling module 100 is configured for placement over the fixation plate 200, the dual predrilling module 100 can be configured to drill fixation holes and a repair tunnel in the patient’s bone 1 after the geometry of the patient’s bone 1 has been surgically altered, given that the coupling with the fixation plate 200 is performed once the fixation plate 200 is already placed against the patient’s bone 1 with the osteotomy opening 3 already being present. Accordingly, and as shown in Figure 6, the dual predrilling module 100 is configured to span across the osteotomy opening 3 formed in the patient’s bone 1 , such that osteotomy drill guides 110 can be positioned over corresponding canals 222 defines on the fixation plate 200 to create fixation holes and a repair tunnel directly in their final positions. In that respect, given that the repair drill guide can be oriented at a predetermined angle with respect to the outer surface 109 of the body 102 of the dual predrilling module 100, the shape and size of the canal 222 associated with the repair drill guide 130 can be adapted to take into account the angled entry of a drill bit that will be used to create the repair tunnel via the repair drill guide 130. The patient’s bone 1 can thus be opened along a planar cut to form the osteotomy opening 3, and once the osteotomy opening 3 is formed, the fixation plate 200 can be placed according to the preoperative plan, for instance as shown in Figure 6. In some implementations, when the orthopedic procedure involves a planar cut across the bone and a rotation of the portion of the bone thus severed from the remaining of the bone, k-wires can be used to validate the positioning of the fixation plate 200 onto the patient’s bone. Then, the dual predrilling module 100 can be engaged with the fixation plate 200 as
described above, with the fixation plate 200 remaining in place once the fixation holes and the repair tunnel are created. In such implementations, the dual predrilling module 100 thus includes osteotomy drill guides 110 positioned at the exact locations where the fastener apertures of the fixation plate will subsequently be positioned to create fixation holes each having a corresponding fixation hole pathway, and a repair drill guide 130 positioned at the exact location where a repair fastener would be inserted and to obtain the desired repair tunnel pathway. Therefore, after the fixation holes and the repair tunnel are formed, the dual predrilling module 100 can be removed and subsequent steps of the osteotomy procedure and the additional orthopedic procedure can be performed as determined by the healthcare provider.
Method of designing a dual predrilling guide
[00134] A method for designing a dual predrilling guide configured for guiding a drill bit into an osteotomy drill guide to form a fixation hole and a repair drill guide to form a repair tunnel in a bone will now be described in further detail.
[00135] The method can include creating a digital 3D model of a patient’s bone. The 3D model can be constructed, for example, by using different types of medical imaging techniques, such as a CT scan, to acquire images of the patient’s bones, and assembling the images to form a 3D model representing the structure of the patient’s bones, including their shapes, surfaces, and/or volumes, among other parameters. The 3D model can subsequently be used to preoperatively simulate the effect of surgical interventions on selected ones of the patient’s bones.
[00136] The method can include selecting a desired correction angle to apply to the patient’s bone via surgical intervention. In some implementations, a computer program can calculate the mechanical axis of the patient’s knee and/or the distribution of stresses within the patient’s knee, using the 3D model. The computer program can enable modifying the 3D model to adjust the orientation of the patient’s tibia bone relative to the patient’s femur, or vice versa. The mechanical axis and/or distribution of stresses in the knee can be recalculated following the adjustment, and a correction angle can be selected once a desired knee alignment has been attained.
[00137] Once the correction angle is selected, the method can include designing a
patient-specific fixation plate to retain the patient’s bone at the selected correction angle. The 3D model can be used to determine the expected shape and form of the patient’s bone caused by surgical intervention. More specifically, the steps of the surgical procedure can be simulated using the 3D model, enabling the 3D model to describe the expected shape and form of the patient’s bone during and after the surgical procedure. For example, the 3D model of the patient’s bone can be virtually cut according to a predetermined cutting plane to form a planar cut therein and opened or closed along the planar cut to attain the selected correction angle. A patient-specific fixation plate can then be designed to conform to the final expected shape and contours of the patient’s bone and the open or closed wedge formed therein, based on the shape and form described by the 3D model.
[00138] Designing the fixation plate can include selecting the type of fixation fasteners, their position and orientation on the fixation plate, their shape, their depth, and modelling corresponding canals in the fixation plate to accommodate the chosen fixation fasteners. The designed fixation plate and selected fixation fasteners can then be virtually positioned on the 3D model the patient’s bone, and a fixation hole pathway along which a corresponding one of the fixation fasteners is planned to extend once the fixation fastener is drilled into the patient’s bone can also be determined. If a plurality of fixation fasteners is intended to be used, a fixation hole pathway can be selected for each fixation fastener of the plurality of fixation fasteners.
[00139] The method further includes selecting the type of repair fastener that is intended to be used to perform the orthopedic repair procedure. Selecting the type of repair fastener also include determining a repair tunnel pathway along which the repair fastener is planned to extend once the repair fastener is placed into the patient’s bone and the orthopedic repair procedure is performed.
[00140] Determining a fixation hole pathway (or the fixation hole pathways) and determining the repair tunnel pathway can be done virtually according to the 3D model of the patient’s bone by performing various iterations of placement of the fixation hole pathway (or the fixation hole pathways) and the repair tunnel pathway until a desired configuration is achieved. Alternatively, in some implementations, it may be desired to, in a first step, determine a fixation hole pathway (or the fixation hole pathways), and then, in a second step, determine the repair tunnel pathway according to the chosen fixation hole
pathway. In yet other implementations, it may be desired to, in a first step, determine a repair tunnel pathway, and then, in a second step, determine the fixation hole pathway (or the fixation hole pathways) according to the chosen repair tunnel pathway. In each of these scenarios, the determination of the fixation hole pathway(s) and the repair pathway can be done so that the repair tunnel pathway intersects the predetermined cutting plane and thus the subsequent planar cut modelled in the patient’s bone without intersecting the fixation hole pathway, or without intersecting each one of the fixation hole pathways if a plurality of fixation fasteners is intended to be used.
[00141] Once the fixation hole pathway(s) and the repair tunnel pathway are determined, a dual predrilling module configured to cooperate with a drill bit to predrill holes in the patient’s bone can be designed accordingly. The dual predrilling module is designed to include an osteotomy drill guide to predrill a fixation hole having the selected fixation hole pathway and a repair drill guide to predrill a repair tunnel having the selected repair tunnel pathway.
[00142] As described above, in some implementations, the dual predrilling module can be configured to drill fixation hole(s) and a repair tunnel in the patient’s bone after the osteotomy opening has been formed in the patient’s bone. Accordingly, the predrilling module can be designed to conform to the patient’s bone after the osteotomy opening has been formed in the patient’s bone, and can include a positioning element, such as a wedge, configured for insertion in the osteotomy opening.
[00143] In other implementations, the dual predrilling module can be configured to drill fixation hole(s) and a repair tunnel before the patient’s bone has been altered. In such implementations, the computer program can use the 3D model of the patient’s bone with the osteotomy opening, the fixation hole(s) and the repair tunnel defined therein so that the repair tunnel pathway intersects the predetermined cutting plane and thus the subsequent planar cut without intersecting the fixation hole pathway, or without intersecting each one of the fixation hole pathways if a plurality of fixation fasteners is intended to be used. The computer program can then be used to virtually close or open the patient’s bone using the 3D model to determine the corresponding positions, i.e., the initial positions, of the fixation hole(s) and the repair tunnel on the unaltered bone. The computer program can subsequently design a dual predrilling module configured to drill
the fixation Hole(s) and the repair tunnel at the initial positions and orientations in the patient’s unaltered bone that will correspond to the final positions and orientations of the fixation hole(s) and the repair tunnel after the bone is altered, i.e., opened at the selected opening angle.
[00144] Several alternative implementations and examples have been described and illustrated herein. The implementations of the technology described above are intended to be exemplary only. A person of ordinary skill in the art would appreciate the features of the individual implementations, and the possible combinations and variations of the components. A person of ordinary skill in the art would further appreciate that any of the implementations could be provided in any combination with the other implementations disclosed herein. It is understood that the technology may be embodied in other specific forms without departing from the central characteristics thereof. The present implementations and examples, therefore, are to be considered in all respects as illustrative and not restrictive, and the technology is not to be limited to the details given herein. Accordingly, while the specific implementations have been illustrated and described, numerous modifications come to mind.
Claims
1 . A dual predrilling module for drilling a fixation hole and a repair tunnel in a bone, the dual predrilling module comprising: a body comprising: a bone interface side comprising a bone contacting surface engageable with a surface of the bone and an operative side opposite the bone interface side; an osteotomy drill guide extending outwardly from the operative side and configured for guiding a drill bit therein to create a fixation hole according to a fixation hole pathway for receiving a fixation fastener and secure an implant to the bone; and a repair drill guide extending outwardly from the operative side and configured for guiding the drill bit therein to create a repair tunnel according to a repair tunnel pathway extending across the bone to open to an articular surface of bone, the repair tunnel pathway being determined to intersect a predetermined cutting plane intended to create an osteotomy, without intersecting the fixation hole pathway.
2. The dual predrilling module of claim 1 , wherein the bone contacting surface of the bone interface side is configured to substantially conform to surface contours of the bone at a predetermined position on the bone.
3. The dual predrilling module of claim 1 or 2, wherein the repair tunnel is configured for an orthopedic repair procedure.
4. The dual predrilling module of claim 3, wherein the orthopedic repair procedure is one of an anterior cruciate ligament repair, a posterior cruciate ligament repair and a meniscus repair.
5. The dual predrilling module of any one of claims 1 to 4, wherein the repair tunnel is configured to receive a repair fastener therein to secure a graft to the bone via compression.
6. The dual predrilling module of any one of claims 1 to 5, wherein the implant comprises a fixation plate.
7. The dual predrilling module of any one of claims 1 to 6, wherein the repair drill guide comprises a repair guide barrel extending from the operative side at a predetermined angle according to the repair tunnel pathway.
8. The dual predrilling module of claim 7, wherein the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a tibial plateau.
9. The dual predrilling module of claim 8, wherein the repair drill guide is configured to create the repair tunnel in a medial region of the tibia, in a lateral region of the tibia, or in an anterior region of the tibia.
10. The dual predrilling module of claim 7, wherein the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a distal end of a femur.
11 . The dual predrilling module of any one of claims 7 to 10, wherein the repair guide barrel includes an internal wall defining a repair guide tunnel extending along a lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
12. The dual predrilling module of claim 11 , wherein the internal wall of the repair guide tunnel is configured to constrain a movement of the drill bit in accordance with the repair tunnel pathway.
13. The dual predrilling module of any one of claims 1 to 12, wherein the osteotomy drill guide comprises an osteotomy guide barrel extending from the operative side at a predetermined angle according to the fixation hole pathway.
14. The dual predrilling module of claim 13, wherein the osteotomy guide barrel has a predetermined osteotomy guide barrel length defined between the bone contacting surface and a terminal end of the osteotomy guide barrel to limit insertion of the drill bit therein and create a fixation hole having a predetermined fixation hole length terminating at a fixation hole end.
15. The dual predrilling module of claim 14, wherein the fixation hole pathway terminates at the fixation hole end.
16. The dual predrilling module of any one of claims 13 to 15, wherein the osteotomy guide barrel includes an internal wall defining an osteotomy guide tunnel extending along the lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
17. The dual predrilling module of claim 16, wherein the internal wall and the terminal end of the osteotomy guide tunnel are configured to constrain a movement of the drill bit in accordance with the fixation hole pathway.
18. The dual predrilling module of any one of claims 1 to 17, wherein the osteotomy drill guide comprises a plurality of osteotomy drill guides to create a plurality of fixation holes, each fixation hole of the plurality of fixation holes having a corresponding fixation hole pathway and the repair tunnel pathway being determined to intersect the predetermined cutting plane without intersecting each one of the corresponding fixation hole pathways.
19. The dual predrilling module of any one of claims 1 to 18, further comprising a handle member connected to the body to facilitate manipulation and positioning of the body.
20. The dual predrilling module of claim 19, wherein the handle member is a rigid elongated member extending from the operative side of the guide body.
21. The dual predrilling module of any one of claims 1 to 20, wherein the body defines fastener apertures for receiving retaining fasteners to removably secure the body to the bone.
22. The dual predrilling module of any one of claims 1 to 21 , wherein the body is configured to span across an osteotomy opening created along a planar cut performed according to the predetermined cutting plane, and comprises a proximal section positioned above the osteotomy opening and a distal section positioned below the osteotomy opening.
23. The dual predrilling module of claim 22, wherein the body further comprises an intermediate section extending between the proximal and distal sections and spanning the osteotomy opening, and an alignment mechanism extending outwardly from the bone interface side and configured for insertion into the osteotomy opening for engaging the bone and secure the body in a predetermined position relative to the bone.
24. The dual predrilling module of claim 23, wherein the alignment mechanism comprises a wedge.
25. The dual predrilling module of claim 24, wherein the wedge comprises contours configured to match inner surface contours of the osteotomy opening.
26. The dual predrilling module of any one of claims 1 to 25, wherein the bone is a tibia or a femur.
27. A dual predrilling module for drilling a fixation hole and a repair tunnel in a bone, the dual predrilling module comprising: a body comprising: a bone interface side comprising a bone contacting surface engageable with a surface of the bone and an operative side opposite the bone interface side;
an osteotomy drill guide extending outwardly from the operative side and configured for guiding a drill bit therein to create a fixation hole for receiving a fixation fastener to secure an implant to the bone; and a repair drill guide extending outwardly from the operative side and configured for guiding the drill bit therein to create a repair tunnel having a predetermined orientation such that the repair tunnel intersects a predetermined cutting plane intended to create an osteotomy and extends across the bone to open to an articular surface of bone, without intersecting the fixation hole.
28. The dual predrilling module of claim 27, wherein the bone contacting surface of the bone interface side is configured to substantially conform to surface contours of the bone at a predetermined position on the bone.
29. The dual predrilling module of claim 27 or 28, wherein the repair tunnel is configured for an orthopedic repair procedure.
30. The dual predrilling module of claim 29, wherein the orthopedic repair procedure is one of an anterior cruciate ligament repair, a posterior cruciate ligament repair and a meniscus repair.
31 . The dual predrilling module of any one of claims 27 to 30, wherein the repair tunnel is configured to receive a repair fastener therein to secure a graft to the bone via compression.
32. The dual predrilling module of any one of claims 27 to 31 , wherein the implant comprises a fixation plate.
33. The dual predrilling module of any one of claims 27 to 32, wherein the repair drill guide comprises a repair guide barrel extending from the operative side at a predetermined angle according to the predetermined orientation of the repair tunnel.
34. The dual predrilling module of claim 33, wherein the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a tibial plateau.
35. The dual predrilling module of claim 34, wherein the repair drill guide is configured to create the repair tunnel in a medial region of the tibia, in a lateral region of the tibia, or in an anterior region of the tibia.
36. The dual predrilling module of claim 33, wherein the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a distal end of a femur.
37. The dual predrilling module of any one of claims 33 to 36, wherein the repair guide barrel includes an internal wall defining a repair guide tunnel extending along a lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
38. The dual predrilling module of claim 37, wherein the internal wall of the repair guide tunnel is configured to constrain a movement of the drill bit according to the predetermined orientation of the repair tunnel.
39. The dual predrilling module of any one of claims 27 to 38, wherein the osteotomy drill guide comprises an osteotomy guide barrel extending from the operative side at a predetermined angle according to the fixation hole.
40. The dual predrilling module of claim 39, wherein the osteotomy guide barrel has a predetermined osteotomy guide barrel length defined between the bone contacting surface and a terminal end of the osteotomy guide barrel to limit insertion of the drill bit therein and create the fixation hole having a predetermined fixation hole length terminating at a fixation hole end.
41. The dual predrilling module of claim 39 or 40, wherein the osteotomy guide barrel includes an internal wall defining an osteotomy guide tunnel extending along the lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
42. The dual predrilling module of claim 41 , wherein the internal wall and the terminal end of the osteotomy guide tunnel are configured to constrain a movement of the drill bit.
43. The dual predrilling module of any one of claims 27 to 42, wherein the osteotomy drill guide comprises a plurality of osteotomy drill guides to create a plurality of fixation holes, the predetermined orientation of the repair tunnel being determined to intersect the predetermined cutting plane without intersecting each one of the corresponding fixation holes.
44. The dual predrilling module of any one of claims 27 to 43, further comprising a handle member connected to the body to facilitate manipulation and positioning of the body.
45. The dual predrilling module of claim 44, wherein the handle member is a rigid elongated member extending from the operative side of the guide body.
46. The dual predrilling module of any one of claims 27 to 45, wherein the body defines fastener apertures for receiving retaining fasteners to removably secure the body to the bone.
47. The dual predrilling module of any one of claims 27 to 46, wherein the body is configured to span across an osteotomy opening created along a planar cut performed according to the predetermined cutting plane, and comprises a proximal section positioned above the osteotomy opening and a distal section positioned below the osteotomy opening.
48. The dual predrilling module of claim 47, wherein the body further comprises an intermediate section extending between the proximal and distal sections and spanning the osteotomy opening, and an alignment mechanism extending outwardly from the bone interface side and configured for insertion into the osteotomy opening for engaging the bone and secure the body in a predetermined position relative to the bone.
49. The dual predrilling module of claim 48, wherein the alignment mechanism comprises a wedge.
50. The dual predrilling module of claim 49, wherein the wedge comprises contours configured to match inner surface contours of the osteotomy opening.
51 . The dual predrilling module of any one of claims 27 to 50, wherein the bone is a tibia or a femur.
52. A dual predrilling module for drilling a fixation hole and a repair tunnel in a bone in combination with a fixation plate superposable to the bone, the dual predrilling module comprising: a body comprising: a fixation plate engaging side removably engageable with the fixation plate; and an operative side opposite the bone interface side; and an osteotomy drill guide extending outwardly from the operative side and being configured for guiding a drill bit therein to create a fixation hole according to a fixation hole pathway for receiving a fixation fastener and secure the fixation plate to the bone; and a repair drill guide extending outwardly from the operative side and configured for guiding the drill bit therein to create a repair tunnel according to a repair tunnel pathway, the repair tunnel pathway being determined to intersect a predetermined cutting plane intended to create an osteotomy and to extend across the bone to open to an articular surface of bone, without intersecting the fixation hole pathway.
53. The dual predrilling module of claim 52, wherein the fixation plate engaging side of the body comprises an alignment feature to enable alignment of the body with the fixation plate.
54. The dual predrilling module of claim 52 or 53, wherein the bone contacting surface of the bone interface side is configured to substantially conform to surface contours of the bone at a predetermined position on the bone.
55. The dual predrilling module of any one of claims 52 to 54, wherein the repair tunnel is configured for an orthopedic repair procedure.
56. The dual predrilling module of claim 55, wherein the orthopedic repair procedure is one of an anterior cruciate ligament repair, a posterior cruciate ligament repair and a meniscus repair.
57. The dual predrilling module of any one of claims 52 to 56, wherein the repair tunnel is configured to receive a repair fastener therein to secure a graft to the bone via compression.
58. The dual predrilling module of any one of claims 52 to 57, wherein the repair drill guide comprises a repair guide barrel extending from the operative side at a predetermined angle according to the repair tunnel pathway.
59. The dual predrilling module of claim 58, wherein the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a tibial plateau.
60. The dual predrilling module of claim 59, wherein the repair drill guide is configured to create the repair tunnel in a medial region of the tibia, in a lateral region of the tibia, or in an anterior region of the tibia.
61. The dual predrilling module of claim 58, wherein the repair guide barrel has a predetermined repair guide barrel length defined between the bone contacting surface and a terminal end of the repair guide barrel to enable insertion of the drill bit therein across the bone to reach a distal end of a femur.
62. The dual predrilling module of any one of claims 59 to 61 , wherein the repair guide barrel includes an internal wall defining a repair guide tunnel extending along a lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
63. The dual predrilling module of claim 62, wherein the internal wall of the repair guide tunnel is configured to constrain a movement of the drill bit in accordance with the repair tunnel pathway.
64. The dual predrilling module of any one of claims 52 to 63, wherein the osteotomy drill guide comprises an osteotomy guide barrel extending from the operative side at a predetermined angle according to the fixation hole pathway.
65. The dual predrilling module of claim 64, wherein the osteotomy guide barrel has a predetermined osteotomy guide barrel length defined between the bone contacting surface and a terminal end of the osteotomy guide barrel to limit insertion of the drill bit therein and create a fixation hole having a predetermined fixation hole length terminating at a fixation hole end.
66. The dual predrilling module of claim 65, wherein the fixation hole pathway terminates at the fixation hole end.
67. The dual predrilling module of any one of claims 64 to 66, wherein the osteotomy guide barrel includes an internal wall defining an osteotomy guide tunnel extending along the lengthwise axis thereof and across an entire thickness of the body to open on the bone interface side and the operative side.
68. The dual predrilling module of claim 67, wherein the internal wall and the terminal end of the osteotomy guide tunnel are configured to constrain a movement of the drill bit in accordance with the fixation hole pathway.
69. The dual predrilling module of any one of claims 52 to 68, wherein the osteotomy drill guide comprises a plurality of osteotomy drill guides to create a plurality of fixation holes, each fixation hole of the plurality of fixation holes having a corresponding fixation hole pathway and the repair tunnel pathway being determined to intersect the predetermined cutting plane without intersecting each one of the corresponding fixation hole pathways.
70. The dual predrilling module of any one of claims 52 to 69, further comprising a handle member connected to the body to facilitate manipulation and positioning of the body.
71. The dual predrilling module of claim 70, wherein the handle member is a rigid elongated member extending from the operative side of the guide body.
72. The dual predrilling module of any one of claims 52 to 71 , wherein the body defines fastener apertures for receiving retaining fasteners to removably secure the body to the bone.
73. The dual predrilling module of any one of claims 52 to 72, wherein the body is configured to span across an osteotomy opening created along a planar cut performed according to the predetermined cutting plane, and comprises a proximal section positioned above the osteotomy opening and a distal section positioned below the osteotomy opening.
74. The dual predrilling module of claim 73, wherein the body further comprises an intermediate section extending between the proximal and distal sections and spanning the osteotomy opening, and an alignment mechanism extending outwardly from the bone interface side and configured for insertion into the osteotomy opening for engaging the bone and secure the body in a predetermined position relative to the bone.
75. The dual predrilling module of claim 74, wherein the alignment mechanism comprises a wedge.
76. The dual predrilling module of claim 75, wherein the wedge comprises contours configured to match inner surface contours of the osteotomy opening.
77. The dual predrilling module of any one of claims 52 to 76, wherein the bone is a tibia or a femur.
78. A method for designing a dual predrilling module for guiding a drill bit to form a fixation hole and a repair tunnel in a bone, the method comprising the steps of: creating a digital 3D model of the bone; virtually cutting the 3D model of the bone to form a planar cut therein; virtually opening the 3D model of the bone along the planar cut to a desired correction angle;
virtually positioning an implant and a fixation fastener on the 3D model of the bone to determine a fixation hole pathway of a fixation hole configured to receive the fixation fastener therein; virtually determining a repair tunnel pathway of a repair tunnel configured to receive a repair fastener therein so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathway; and designing the dual predrilling guide with an osteotomy drill guide and a repair drill guide positioned to achieve the fixation hole pathway and the repair tunnel pathway, respectively.
79. A method for designing a dual predrilling module for guiding a drill bit to form a fixation hole and a repair tunnel in a bone, the method comprising the steps of: creating a digital 3D model of the bone; virtually cutting the 3D model of the bone to form a planar cut therein; virtually opening the 3D model of the bone along the planar cut to a desired correction angle; virtually positioning an implant and a fixation fastener on the 3D model of the bone to determine a fixation hole pathway of a fixation hole configured to receive the fixation fastener therein; virtually determining a repair tunnel pathway of a repair tunnel configured to receive a repair fastener therein so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathway; virtually closing the 3D model of the bone to determine corresponding initial positions of the fixation hole pathway and the repair tunnel pathway; and designing the dual predrilling guide with an osteotomy drill guide and a repair drill guide positioned to achieve the corresponding initial positions of the fixation hole pathway and the repair tunnel pathway, respectively.
0. A method for designing a dual predrilling module for guiding a drill bit to form a fixation hole and a repair tunnel in a bone, the method comprising the steps of: creating a digital 3D model of the bone; virtually cutting the 3D model of the bone to form a planar cut therein; virtually closing the 3D model of the bone along the planar cut to a desired correction angle; virtually positioning an implant and a fixation fastener on the 3D model of the bone to determine a fixation hole pathway of a fixation hole configured to receive the fixation fastener therein; virtually determining a repair tunnel pathway of a repair tunnel configured to receive a repair fastener therein so the repair tunnel pathway intersects the planar cut without intersecting the fixation hole pathway; virtually opening the 3D model of the bone to determine corresponding initial positions of the fixation hole pathway and the repair tunnel pathway; and designing the dual predrilling guide with an osteotomy drill guide and a repair drill guide positioned to achieve the corresponding initial positions of the fixation hole pathway and the repair tunnel pathway, respectively.
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| US202463626240P | 2024-01-29 | 2024-01-29 | |
| US63/626,240 | 2024-01-29 |
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| WO2025160661A1 true WO2025160661A1 (en) | 2025-08-07 |
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| PCT/CA2025/050114 Pending WO2025160661A1 (en) | 2024-01-29 | 2025-01-29 | Dual predrilling module for an osteotomy procedure and an additional orthopedic procedure |
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| US10282488B2 (en) * | 2014-04-25 | 2019-05-07 | Biomet Manufacturing, Llc | HTO guide with optional guided ACL/PCL tunnels |
| WO2020037420A1 (en) * | 2018-08-24 | 2020-02-27 | Laboratoires Bodycad Inc. | Surgical kit for knee osteotomies and corresponding preoperative planning method |
| US11399849B2 (en) * | 2017-08-22 | 2022-08-02 | Newclip International | Surgical guide device for assisting an open wedge osteotomy |
| US11602354B2 (en) * | 2016-06-21 | 2023-03-14 | 3D Metal Printing Limited | Surgical assembly, stabilisation plate and methods |
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| JP2012165977A (en) * | 2011-02-16 | 2012-09-06 | Olympus Terumo Biomaterials Corp | Drill guide apparatus for tibia |
| US10282488B2 (en) * | 2014-04-25 | 2019-05-07 | Biomet Manufacturing, Llc | HTO guide with optional guided ACL/PCL tunnels |
| US11602354B2 (en) * | 2016-06-21 | 2023-03-14 | 3D Metal Printing Limited | Surgical assembly, stabilisation plate and methods |
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