WO2024257100A2 - Méthodes et appareil pour opération d'ostéotomie de dérotation en varus (vdro) à l'aide d'un gabarit de guidage - Google Patents
Méthodes et appareil pour opération d'ostéotomie de dérotation en varus (vdro) à l'aide d'un gabarit de guidage Download PDFInfo
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- WO2024257100A2 WO2024257100A2 PCT/IL2024/050581 IL2024050581W WO2024257100A2 WO 2024257100 A2 WO2024257100 A2 WO 2024257100A2 IL 2024050581 W IL2024050581 W IL 2024050581W WO 2024257100 A2 WO2024257100 A2 WO 2024257100A2
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
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- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
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- 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
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- 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
- A61B17/1742—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip
- A61B17/175—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the hip for preparing the femur for hip prosthesis insertion
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3601—Femoral heads ; Femoral endoprostheses for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
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- A61F2/3603—Femoral heads ; Femoral endoprostheses for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices implanted without ablation of the whole natural femoral head
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
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Definitions
- the present invention in some embodiments thereof, relates to a surgical guiding joint integration group (JIG) and, more particularly, but not exclusively, to a surgical guiding JIG for varus de rotation osteotomy (VDRO) procedure.
- JIG surgical guiding joint integration group
- VDRO varus de rotation osteotomy
- Additional background art includes scientific publication “3D-printed navigation template in proximal femoral osteotomy for older children with developmental dysplasia of the hip”, by Pengfei Zheng et al. disclosing that “To explore the feasibility of 3D-printed navigation template in proximal femoral varus rotation and shortening osteotomy for older children with developmental dysplasia of the hip (DDH).
- DDH developmental dysplasia of the hip
- the template-guided group achieved a better outcome; however, there was no significant difference.
- Application of the navigation template for older DDH children can reduce the operation time, radiation exposure, and epiphysis damage, which also simplifies surgery and improves precision.”.
- Additional background art includes scientific publication ''Correction of complex three- dimensional deformities at the proximal femur using indirect reduction with angle blade plate and patient-specific instruments: a technical note", by Lukas Jud et al. disclosing that “Using 3D planning and PSI for complex corrective osteotomies at the proximal femur can be a useful tool in understanding the individual deformity and performing the aimed deformity reduction.
- the indirect reduction over the implant is a simple and valuable tool in achieving the desired correction, and concurrently, surgical exposure can be limited to a subvastus approach.”.
- a guiding JIG for use on a femoral bone during a VDRO procedure, having an osteotomy guide comprising: a. a first cutting slot, shaped and sized to receive a first cutting tool; b. a second cutting slot, shaped and sized to receive a second cutting tool; and c. a frame defining the first cutting slot and the second cutting slot; wherein the first cutting slot directs the first cutting tool to cut the femoral bone in a first desired path, and the second cutting slot directs the second cutting tool to cut the femoral bone in a second desired path.
- Example 2 The guiding JIG according to example 1, wherein the first cutting slot and the second cutting slot are positioned relative to each other such that cutting the bone therethrough results in a bone wedge separated from the bone.
- Example 3 The guiding JIG according to example 2, wherein the bone wedge is triangular shape.
- Example 4 The guiding JIG according to example 3, wherein said triangular shape comprises an angle equivalent to a desired correction angle.
- Example 5 The guiding JIG according to example 2, wherein the bone wedge has trapezoidal shape.
- Example 6 The guiding JIG according to example 5, wherein said trapezoidal shape is according to a desired correction angle and a level of shortening of the femur.
- Example 7 The guiding JIG according to any one of examples 1-6, wherein the first cutting tool and the second cutting tool are one and the same.
- Example 8 The guiding JIG according to any one of examples 1-7, wherein the first cutting tool and the second cutting tool are a saw.
- Example 9 The guiding JIG according to any one of examples 1-8, wherein the guiding JIG comprises a guiding conduit configured to direct a guide implement into the center of the femur head.
- Example 10 The guiding JIG according to example 9, wherein the guiding conduit comprises a slit configured to shorten said guiding conduit.
- Example 11 The guiding JIG according to example 9, wherein the guiding conduit comprises an inner lumen sufficiently large to accommodate the guide implement but sufficiently small to limit lateral movement of said guide implement therewithin.
- Example 12 The guiding JIG according to example 9, wherein the guiding conduit is a guiding conduit for a chisel; and wherein the guiding conduit comprises an inner lumen shaped as the selected chisel.
- Example 13 The guiding JIG according to any one of examples 1-12, wherein the guiding JIG further comprises a distal guiding hole deviating from a femoral longitudinal shaft-neck axis, according to a desired level of rotation correction.
- Example 14 The guiding JIG according to any one of examples 1-13, wherein the guiding JIG further comprises a proximal guiding hole shaped and sized according to fixators of a selected plate.
- Example 15 The guiding JIG according to any one of examples 1-14, wherein the guiding JIG comprises a JIG body having an inner surface with geometry which complements a geometry of the femoral bone.
- Example 16 A method for using a guiding JIG while performing a VDRO procedure on a femoral bone, comprising: a. providing a patient specific guiding JIG comprises an osteotomy guide; b. mounting the guiding JIG on the femoral bone; c. cutting a bone wedge through the osteotomy guide of the guiding JIG.
- Example 17 The method according to example 16, wherein the bone wedge is triangular shape.
- Example 18 The method according to example 17, wherein said triangular shape comprises an angle equivalent to a desired correction angle.
- Example 19 The method according to example 16, wherein the bone wedge has trapezoidal shape.
- Example 20 The method according to example 19, wherein said trapezoidal shape is according to a desired correction angle and a level of shortening of the femur.
- Example 21 A guiding JIG for use on a femoral bone during a VDRO procedure, comprising: a. a guide body, shaped and sized to be deployed on the femoral bone; b. a guide conduit, defining a path into the center of the femur head; and c. an osteotomy guide, defining at least one path for cutting the bone.
- Example 22 The guiding JIG according to example 21, wherein the guide conduit is a guiding conduit for a guide implement.
- Example 23 The guiding JIG according to example 21, wherein the guiding conduit is shaped according to a k-wire, having diameter less than 2 mm.
- Example 24 The guiding JIG according to any one of examples 21-23, wherein the guiding conduit is a guiding conduit for chisel; said guiding conduit comprising a wall and an inner lumen, wherein the inner lumen shaped and sized according to a selected chisel.
- Example 25 A method for performing VDRO procedure on a femoral bone using a single guiding JIG, said single guiding JIG comprising: a. a guiding conduit for a guide implement defining a path into the center of the femur head; and b. an osteotomy guide, comprising: i. a first cutting slot, shaped and sized to receive a first cutting tool; and ii. a second cutting slot, shaped and sized to receive a second cutting tool; where the first cutting slot and the second cutting slot positioned relative to each other such that cutting the bone therethrough results in a bone wedge; said method comprising: c. mounting the guiding JIG on the femoral bone; d.
- a guide implement into the center of the femur head through guiding conduit for a guide implement; e. cutting the femoral bone through the first cutting slot, using a first cutting tool; f. cutting the femoral bone through the second cutting slot, using a second cutting tool to create a bone wedge separating the femoral bone to distal fragment and proximal fragment.
- Example 26 The method according to example 25, wherein the guiding JIG further comprises a distal guiding hole for rotation correction; and wherein the method further comprises a rotation correction of the femur using said distal guiding hole.
- Example 27 The method according to example 26, wherein performing said rotation correction comprises: a. applying operating tool on the distal fragment through the distal guiding hole to create a distal bore on the distal fragment, according to the position of the distal guiding hole on the guiding JIG; b. removing the bone wedge; and c. rotating the distal fragment so that the distal bore is aligned with the center of the femur head.
- Example 28 The method according to example 25, wherein the single guiding JIG further comprises at least one proximal guiding hole, shaped and sized according to a fixator of a selected plate; and wherein the method further comprises drilling on the proximal fragment through the at least one proximal guiding hole.
- Example 29 The method according to example 28, wherein the method further comprises: a. applying operating tool on the proximal fragment through the at least one proximal guiding hole, to create at least one proximal bore on the proximal fragment, according to the position of the at least one proximal guiding hole on the guiding JIG; b. removing the guide implement from the bone, resulted in a bore at the center of the femur head; and c. connecting a selected plate according to the bore at the center of the femur head, the at least one proximal bore and the distal bore.
- Example 30 A method for performing a VDRO procedure on a femoral bone using a single guiding JIG, wherein the single guiding JIG comprises: a. a guiding conduit for a chisel defining a path into the center of the femur head; and b. an osteotomy guide, comprising: i. a first cutting slot, shaped and sized to receive a first cutting tool; and ii. a second cutting slot, shaped and sized to receive a second cutting tool; wherein the first cutting slot and the second cutting slot positioned relative to each other such that cutting the bone therethrough results in a bone wedge; wherein the method comprises: c. mounting the guiding JIG on the femoral bone; d.
- Example 31 The method according to example 30, wherein the guiding JIG further comprises a distal guiding hole for rotation correction, and wherein the method further comprises performing a rotation correction of the femur using said distal guiding hole.
- Example 32 The method according to example 31, wherein performing said rotation correction comprises: a. applying operating tool on the distal fragment through the distal guiding hole to create a distal bore on the distal fragment, according to the position of the distal guiding hole on the guiding JIG; b. removing the bone wedge; and c. rotating the distal fragment so that the distal bore is aligned with the center of the femur head.
- Example 33 The method according to example 32, wherein the applying operating tool on the distal fragment through the distal guiding hole is performed prior to performing osteotomy.
- Example 34 A guiding JIG for use on a femoral bone during a VDRO procedure, comprising: a. a JIG body at least partially circumferentially surrounding the femoral bone; b. guiding elements positioned on the JIG body, comprising: i. functional guiding elements, shape and sized for directing operating tools applied on the femoral bone; and ii. fixating guiding elements, shape and sized for directing the insertion of fixators into the femur.
- Example 35 The guiding JIG according to example 34, wherein said JIG body has a grip on the femoral bone.
- Example 36 The guiding JIG according to example 34 or example 35, wherein said JIG body comprises an inner surface with a geometry that complements a geometry of the femoral bone.
- Example 37 A guiding JIG for use on a femoral bone during a VDRO procedure, comprising: a. a removable guide conduit for a guide implement; b. a guide conduit for a chisel; wherein the removable guiding conduit for guide implement mounted within the inner lumen of the guiding conduit for chisel.
- Example 38 The guiding JIG according to example 37, wherein said removable guide conduit is configured for directing said guide implement into a center of the femur head.
- Example 39 The guiding JIG according to example 37 or 38, wherein said removable guide conduit comprises: a. a wall defining an inner lumen; and b. said inner lumen, shaped and sized to receive a selected guide implement; wherein the size of the inner lumen is sufficiently small to limit lateral movements of the selected guide implement therewithin.
- Example 40 The guiding JIG according to example 37, wherein said guide conduit for a chisel is configured for directing said chisel into the center of the femur head.
- Example 41 The guiding JIG according to example 37 or example 40, wherein said guide conduit for chisel comprises: a. a wall defining the inner lumen; and b. said inner lumen, shaped and sized to receive a selected chisel; wherein the size of the inner lumen is sufficiently small to limit lateral movements of the selected chisel therewithin.
- Example 42 The guiding JIG according to any one of examples 37-41, wherein the removable guiding conduit for guide implement is configured to be removed from the inner lumen of the guiding conduit for chisel while the guide implement remains inserted into the center of the femur head.
- Example 43 The guiding JIG according to any one of examples 37-42, wherein upon removing the removable guiding conduit for the inner lumen guiding conduit for chisel, the guiding conduit for chisel is free to receive a selected chisel, threaded on the guide implement inserted within the center of the femur head.
- Example 44 The guiding JIG according to any one of examples 37-43, wherein the removable guiding conduit for guide implement comprises a slit along the longitudinal axis thereof.
- Example 45 A method for inserting a guide implement and a chisel into the center of the femur head using a single guiding JIG, wherein the single guiding JIG comprises: a. a guiding conduit for chisel, shaped and sized to receive a selected chisel; and b. a removable guiding conduit for a guide implement, shaped and sized to receive a selected guide implement, mounted within the guiding conduit for chisel; the method comprises: c. mounting the guiding JIG onto the femoral bone, at the treatment site; d. inserting a selected guide implement into the center of the femur head through the removable guiding conduit for a guide implement; e.
- Example 46 A method for impacting a chisel into a femoral bone using a guiding JIG, the guiding JIG comprising a guiding conduit for chisel, comprising an inner lumen; and a wall, the inner lumen shaped and sized according to a selected chisel; the method comprising: a. mounting the guiding JIG onto the femoral bone, at the treatment site; b. placing a chisel within the guiding conduit for chisel; and c. impacting the chisel into the femoral bone through the guiding conduit for chisel.
- Example 47 A method for designing a guiding JIG for a VDRO procedure, comprising: a. receiving a scan image of a patient femur; b. receiving input; c. generating a 3D model of the femur at the treatment site; d. identifying features of the femur; e. calculating the correction angle by subtracting the fixation angle of the selected plate from the current shaft angle; f. placing a representation of a first cutting plane perpendicular to the femoral head neck axis; g. placing a representation of a second cutting plane, wherein the angle between the first and second plane is the correction angle; h. placing a vector perpendicular to the cutting planes; i. generating guiding elements representations; and j. generating a 3D JIG body based on the3D model of the femur at the treatment site.
- Example 48 The method according to example 47, wherein the input comprises one or more of: a. fixation angle of the selected plate; b. type of the selected plate; c. selected set of tools; and d. surgical approach.
- Example 49 The method according to example 47 or example 48, wherein the features of the femur comprise one or more of: a. femoral head-neck axis; b. femoral longitudinal shaft- neck axis; and c. current shaft angle between the femoral head- neck axis and the femoral longitudinal shaft-neck angle.
- Example 50 The method according to any one of examples 47-49, wherein the guiding elements representations comprises representations of functional guiding elements.
- Example 51 The method according to example 50, wherein the representations of functional guiding elements comprise a representation of a guiding conduit, based on the head neck axis, wherein the guiding conduit defining a path into the center of the femur head.
- Example 52 The method according to example 51, wherein the guiding conduit shaped and sized to receive a guide implement.
- Example 54 The method according to example 50, wherein the guiding elements representations comprises a representation of an osteotomy guide comprising a support frame and one or more cutting slots, wherein said one or more cutting slots are based on the first and the second cutting planes.
- Example 55 The method according to example 51, wherein the guiding elements representations further comprises representations of fixating guiding elements.
- Example 56 The method according to example 55, wherein the representations of fixating guiding elements comprise a representation of a fixating guides holes based on the vector perpendicular to the cutting planes.
- Example 57 The method according to any one of examples 47-56, wherein the representation of a first cutting plane perpendicular to the femoral head neck axis is placed along the femoral longitudinal shaft-neck axis according to a desired femur shortening.
- Example 58 A guiding JIG for use during hip resurfacing, comprising: a. a JIG body, shaped and sized to be mounted on the femur head; b. a guiding conduit positioned on the JIG body and defining a path into the center of the femur head; and c. at least one osteotomy guide positioned on the JIG body and defining a path for cutting the femur head.
- Example 59 The guiding JIG according to example 58, wherein the guiding conduit is sized and shaped to receive and direct a guide implement.
- Example 60 The guiding JIG according to example 58 or 59, wherein the guiding conduit comprises a slit extending along a wall of said conduit, from a proximal end of said wall, facing away from a femur neck, to a distal end of said wall, facing toward a femur neck, and ends at a portion of said wall not connected to the JIG body.
- Example 61 The guiding JIG according to any of examples 58-60 , wherein the guide osteotomy comprises a cutting slot.
- Example 62 The guiding JIG according to any of examples 58-61 , wherein the guide osteotomy comprises a supporting frame.
- Example 63 The guiding JIG according to example 62, wherein said frame comprises at least one sturdy surface, positioned therewithin.
- Example 64 The guiding JIG according to any of examples 58-63 , wherein the JIG body comprises an inner surface having a geometry which complements the geometry of the femur head of the patient, at the treatment site.
- Example 65 The guiding JIG according to any of examples 58-64 , wherein the JIG body at least partially surrounds the femur head.
- Example 66 The guiding JIG according to any of examples 58 to 8 , wherein the JIG body has a grip on the femoral head.
- Example 67 The guiding JIG according to any of examples 58-66 , wherein the JIG body at least partially covers the femur neck.
- Example 68 The guiding JIG according to any of examples 58-67 , comprising a measurable mark, designed to have a specific size and shape, configured to be measured to indicate that said guiding JIG is produced according to a desired design.
- Example 69 A guiding JIG deployable in parts on a bone, comprising: a. a JIG body comprising more than JIG parts, shaped and sized to be mounted on the bone; and b. at least one guiding element positioned on the JIG body.
- Example 70 The guiding JIG according to example 69, wherein more than one JIG portion comprises a first JIG portion and a second JIG portion, wherein said first JIG portion comprises an inner surface having a geometry that complements the geometry of bone at the treatment site, and wherein said second JIG portion configured to be aligned with at least one JIG portion.
- Example 71 The guiding JIG according to example 70, wherein said second JIG portion comprises an an inner surface having a geometry that complements the geometry of bone at the treatment site.
- Example 72 The guiding JIG according to example 70, wherein said first portion comprises a first geometry that interacts with a second geometry of said second portion; wherein said first geometry and said second geometry are complementary to each other.
- Example 73 The guiding JIG according to any of example 72, wherein said first geometry comprises one or more protrusions and wherein said second geometry comprises one or more recesses shaped and sized to accommodate said one or more protrusions.
- Example 74 The guiding JIG according to any of examples 72-73, wherein said first geometry comprises one or more recesses and wherein said second geometry comprises one or more protrusions shaped and sized to occupy said one or more protrusions.
- Example 75 The guiding JIG according to any of examples 69-74 , at least one guiding element comprises one or more of: at least one guiding conduit shape and sized to direct a guide implement into the bone and at least one osteotomy guide, sized and shaped to direct a cutting tool into the bone.
- Example 76 The guiding JIG according to example 75, wherein said at least one guiding conduit is positioned on the JIG body, defining a path into the center of the femur head, and wherein said at least one osteotomy guide is positioned on the JIG body defining a path for cutting the femur head or neck.
- Example 77 The guiding JIG according to any of examples 69 to 19 , wherein the bone is a femur head and the JIG is designed for a hip resurfacing procedure.
- Example 78 The guiding JIG according to any of examples 69-76 , wherein the bone is a femur neck and the JIG is designed for a hip replacement procedure.
- Example 79 A guiding JIG having an adjustable osteotomy guide, comprising: a. a JIG body, shaped and sized to be mounted on a bone; and b. at least one osteotomy guide, comprising a first cutting surface and a second cutting surface, defining a cutting slot therebetween, wherein at least one of said first cutting surface or said second cutting surface is removable.
- Example 80 The guiding JIG according to example 79, wherein the JIG body comprises more than one JIG portion, wherein more than one JIG portion comprises a first JIG portion comprises said first cutting surface and a second JIG portion comprises said second cutting surface, wherein one of said first JIG portion or said second JIG portion is removable.
- Example 81 The guiding JIG according to example 80, wherein said first JIG portion is removable and comprises one or more grip holes, wherein said one or more grip holes are shaped and sized to accommodate a gripping tool.
- Example 82. The guiding JIG according to example 81, wherein said second JIG portion comprises at least one fixating guide, sized and shaped for directing a fixator therethrough into the bone.
- Example 83 The guiding JIG according to any of examples 79-82, comprising at least one detachable connection point between said first cutting surface and said second cutting surface.
- Example 84 The guiding JIG according to example 83, wherein said at least one detachable connection point is defined by a sliding pin of said first cutting surface and a groove of said second cutting surface, wherein said groove is sized and shaped to receive the sliding pin and includes an opening that allows the sliding pin to exit therefrom upon movement.
- Example 85 A guiding JIG for use during hip resurfacing or hip replacement procedure, comprising: a. a JIG body, shaped and sized to be mounted on the femur head; b. a plurality of osteotomy guides positioned on the JIG body wherein each osteotomy guide of said plurality of osteotomy guides defines a path for cutting the femur head.
- Example 86 The guiding JIG according to example 85, wherein said plurality of osteotomy guides is in the form of a plurality of cutting slots
- Example 87 The guiding JIG according to example 85, wherein said plurality of osteotomy guides are in the form of a plurality of a pair of tubular guiding conduits.
- Example 88 The guiding JIG according to any of examples 85-87, comprising a guiding conduit positioned on the JIG body and defining a path into the center of the femur head.
- Example 89 A method for performing hip resurfacing procedure on a femur head using a single guiding JIG, said single guiding JIG comprising: a. a JIG body, shaped and sized to be mounted on the femur head; b. a guiding conduit positioned on the JIG body and defining a path into the center of the femur head; and c. an osteotomy guide positioned on the JIG body and defining a path for cutting the femur head; said method comprising: d. mounting the guiding JIG on the femur head; e. inserting a guide implement into the center of the femur head through guiding conduit for a guide implement; f.
- Example 90 The method according to example 89, wherein the JIG body further comprises an inner surface having geometry which completes the geometry of the femur head; and wherein the method further comprises aligning the guiding JIG on the femur head by fitting the geometry of the inner surface of the JIG with the geometry of the femur head.
- Example 91 A method for designing a guiding JIG, comprising: a. creating a patient specific 3D simulation of the femur head; b. identifying features of the femur head; c. creating a footprint; and d. designing guiding elements.
- Example 92 The method according to example 91, wherein the patient- specific 3D simulation of the femur head is based on a scan image of the femur head.
- Example 93 The method according to example 91 or example 92, wherein said identifying comprises identifying the femur neck.
- Example 94 The method according to any of examples 91-93 , wherein said identifying comprises identifying the femoral neck-head axis.
- Example 96 The method acceding to any of examples 91-95, further comprising positioning the guiding elements on the footprint, each defining a path thereinto.
- Example 97 The method according to any of examples 91 to 39 , wherein said designing comprises designing one or more of: a. a guiding conduit for guide implement; and b. an osteotomy guide comprises a cutting slot, shaped and sized to receive a cutting tool.
- Example 98 The method according to example 96, wherein said positioning the guiding conduit for guide implant comprises positioning in-line with the femoral neck-head axis, and protruding from the bone.
- Example 99 The method according to example 96 or example 98, wherein said positioning comprises positioning a cutting slot perpendicular to the femoral neck-head axis.
- Example 100 The method according to any to example 99, wherein said positioning locating the cutting slot on the femur head, at a distance from the femur neck.
- Example 101 The method according to example 99, further comprising positioning the cutting slot on the femur neck and/or in proximity to the femur neck.
- Example 102 The method according to any of examples 91-101 , further comprising receiving an input from a physician.
- Example 104 The method according to any of examples 91-103 , further comprises positioning at least one measurable geometry on the JIG.
- Example 105 A guiding JIG, for femur head or neck surgery, obtained by a process comprising: a. creating a patient-specific 3D simulation of the femur head; b. identifying features of the femur head in the simulation; c. creating a footprint based on the identified features; and d. designing guiding elements that are integrated into the guiding jig based on the footprint; and e. producing the guiding JIG.
- Example 106 The guiding JIG according to example 105, wherein said identifying comprises identifying the femur neck and the femoral neck-head axis.
- Example 107 The guiding JIG according to example 105 or example 106, wherein said designing comprises designing one or more of at least one guiding conduit for a guide implement, and at least an osteotomy guide comprises a cutting slot, shaped and sized to receive a cutting tool.
- all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
- some embodiments of the present invention may be embodied as a system, method or computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “circuit,” “module” or “system.” Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. Implementation of the method and/or system of some embodiments of the invention can involve performing and/or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of some embodiments of the method and/or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware and/or by a combination thereof, e.g., using an operating system.
- a data processor such as a computing platform for executing a plurality of instructions.
- the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a magnetic hard-disk and/or removable media, for storing instructions and/or data.
- a network connection is provided as well.
- a display and/or a user input device such as a keyboard or mouse are optionally provided as well.
- the computer readable medium may be a computer readable signal medium or a computer readable storage medium.
- a computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing.
- a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.
- a computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof.
- a computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.
- Program code embodied on a computer readable medium and/or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.
- Computer program code for carrying out operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including an object-oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages.
- the program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server.
- the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).
- LAN local area network
- WAN wide area network
- Internet Service Provider for example, AT&T, MCI, Sprint, EarthLink, MSN, GTE, etc.
- These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or block diagram block or blocks.
- the computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.
- Some of the methods described herein are generally designed only for use by a computer, and may not be feasible or practical for performing purely manually, by a human expert.
- a human expert who wanted to manually perform similar tasks, such as designing a JIG, might be expected to use completely different methods, e.g., making use of expert knowledge and/or the pattern recognition capabilities of the human brain, which would be vastly more efficient than manually going through the steps of the methods described herein.
- Figure 1A is an illustration of hip dislocation correction by varising de -rotation osteotomy (VDRO) procedure, in accordance with some exemplary embodiments of the invention
- Figure IB is an illustration of the femur current shaft angle, in accordance with some exemplary embodiments of the invention.
- Figure 1C is an illustration of the correction angle calculation, in accordance with some exemplary embodiments of the invention.
- FIG. 2 is a flowchart describing an exemplary process of VDRO procedure using a guiding JIG, in accordance with some exemplary embodiments of the invention
- Figures 3A-D are perspective views of guiding JIG for a VDRO process, in accordance with some exemplary embodiments of the invention.
- Figure 3E is a rear view of a guiding JIG for a VDRO process, in accordance with some exemplary embodiments of the invention.
- Figure 4A is a perspective view of a guiding JIG for a VDRO process using a chisel, in accordance with some exemplary embodiments of the invention.
- Figure 4B-D are perspective views of a guiding JIG for a VDRO process using a guide implement and a chisel, in accordance with some exemplary embodiments of the invention
- Figure 5A is a perspective view of a variant of guiding JIG for a VDRO process using a chisel, in accordance with some exemplary embodiments of the invention
- Figure 5B is a perspective view of a variant of guiding JIG for a VDRO process, in accordance with some exemplary embodiments of the invention.
- Figure 6 is a flowchart describing an exemplary workflow of a surgeon using guiding JIG during VDRO procedure, in accordance with some exemplary embodiments of the invention.
- Figures 7A-C are a flow chart describing the workflow of a surgeon using guiding JIG during VDRO procedure, in accordance with some exemplary embodiments of the invention.
- Figures 8A-C are a flow chart describing the workflow of a surgeon using guiding JIG during VDRO procedure using a chisel, in accordance with some exemplary embodiments of the invention.
- Figures 9A-D are flow chart describing the workflow of a surgeon using a kit including a set of guiding JIGs, in accordance with some exemplary embodiments of the invention.
- FIG 10 is a perspective view of a locking cannulated blade plate (LCB), which required chiseling of the bone, in accordance with some exemplary embodiments of the invention.
- LLB locking cannulated blade plate
- Figures 11 and 12 illustrate the rotation correction of the femur, in accordance with some exemplary embodiments of the invention
- FIG. 13A-B is a flowchart describing an exemplary design process of a guiding JIG, in accordance with some exemplary embodiments of the invention.
- FIGS 14A-B are flowchart describing an exemplary feedback system in the design process of a guiding JIG, in accordance with some exemplary embodiments of the invention.
- Figures 15A-B are top-level flowchart of an exemplary algorithm for designing a guiding JIG, in accordance with some exemplary embodiments of the invention.
- FIGS. 16A-H and 17A-B are a detailed flowchart of an exemplary algorithm for designing a guiding JIG, in accordance with some exemplary embodiments of the invention.
- Figures 18A-Z and 19A-G illustrate steps of the algorithm described in Figures 16A-H and 17A-B, in accordance with some exemplary embodiments of the invention
- Figures 20A-B are perspective views of a disassemblable guiding JIG for a VDRO process, in accordance with some exemplary embodiments of the invention.
- Figures 21A-C are perspective views of a disassemblable guiding JIG for a, in accordance with some exemplary embodiments of the invention.
- Figures 22A-C are perspective views of a guiding JIG deployable in parts, in accordance with some exemplary embodiments of the invention.
- Figures 23A-C are perspective views of a guiding JIG having a durable guiding element, in accordance with some exemplary embodiments of the invention;
- Figure 23D is a perspective view of a durable surface(s) for a guiding JIG, in accordance with some exemplary embodiments of the invention.
- Figure 23E is a sturdy surface(s) before being folded to achieve a three-dimensional form of the sturdy surface(s), in accordance with some exemplary embodiments of the invention.
- the present invention in some embodiments thereof, relates to a surgical guide and, more particularly, but not exclusively, to a surgical guide for a VDRO (varus derotation osteotomy) procedure.
- VDRO variable derotation osteotomy
- Guiding JIG and/or “Surgical navigator” and/or “Surgical guide” and/or “patient- specific instrument (PSI) means a “Surgical JIG”.
- An aspect of some embodiments of the invention relates to a surgical navigator for a VDRO procedure, deployed on a femoral bone.
- the surgical navigator encompasses (and/or surrounds), to some extent, the femoral bone, optionally providing a grip thereon.
- the grip has the potential advantage of minimizing the requirement for an assistant holding the surgical navigator during the procedure.
- the grip limits movements of the guiding JIG after alignment and before/after fixating thereof onto the bone, having the potential advantage of minimizing deviations from the aligned placement.
- the inner surface of the surgical navigator conforms (and/or matches) to the bone geometry at the treatment site, having a potential advantage of further enhancing the grip on the bone.
- An aspect of some embodiments of the invention relates to a surgical navigator (e.g., a single surgical navigator) for a VDRO procedure having two recesses for cutting the bone therethrough.
- a bone osteotomy performed through the two recesses results in a bone segment separated from the bone, dividing the bone into two fractions.
- the bone segment is optionally shaped as triangular, with an angle equivalent to the required correction angle.
- the bone segment is shaped as trapezoidal, optionally, resulting from further shortening the femur.
- each recess defines a path into the bone, for a cutting instrument to cut therethrough.
- the relative position of the two recesses with respect to each other defines the shape and/or size of the bone wedge. In some embodiments, this relative position is based on one or more preoperative computed calculations, having the potential advantage of minimizing the requirement form a physician to estimate the location and/or angle of the cuts on the bone. In some embodiments, one recess is sized and/or shaped to receive a specific cutting instrument whereas the other recess is sized and/or shaped to receive a different cutting instrument. Alternatively, or additionally, both recesses are shaped and sized to receive the same cutting instrument.
- an aspect of some embodiments of the invention relates to a single surgical navigator for approaching a location in the femur head, for example, the center of the femur head, and for performing osteotomy on the bone.
- the surgical navigator includes a passageway for a guide tool (such as a Kirschner wire, also referred to herein as K-wire).
- the passageway for a guide directs the insertion of the guide tool into the center of the femur head.
- the surgical navigator includes a passageway for a chisel.
- the passageway for a chisel directs the insertion of a chisel into the center of the femur head.
- the single surgical navigator may direct the insertion of a guide tool into the femur head in any desired path and/or from any desired insertion location.
- the desired insertion path within the femur head is along an axis defining the central of the femur head, optionally, based on input from a surgeon.
- another path is required.
- the patient's congenital bone structure, previous treatments and/or implants, damage, and/or injuries to the bone may require an insertion path other than along said axis.
- a structure of a selected implant structure may require another insertion path than along said axis.
- the required insertion path through the bone and/or insertion point over the bone is required by the patient’s physician, alternatively or additionally, said required insertion path and/or said insertion point is recommended by a computer program (optionally, comprises a ML component) which evaluate the bone structure (e.g., the bone Image, such as a CT scan) and offers a path therewithin.
- a computer program optionally, comprises a ML component which evaluate the bone structure (e.g., the bone Image, such as a CT scan) and offers a path therewithin.
- An aspect of some embodiments of the invention relates to a surgical navigator that allows and/or simplifies the removal thereof without removing a tool (e.g., a guide tool and/or an operating tool) deposited therewithin and inserted into the bone, from the bone.
- a tool e.g., a guide tool and/or an operating tool
- the surgical navigator comprises a passageway for directing a guide tool into a bone, and a wall defining said passageway.
- a first end (e.g., first opening) of the wall is facing an operator, and a second end (e.g., second opening) is partially connected and/or partially positioned on the body of the surgical navigator. This partial positioning allows a portion of the wall and/or a portion of the wall’s second end to be free of the surgical navigator’s body.
- the wall comprises a slit and/or a cut extending from said first end to said free portion of the second end, allowing the wall to be opened and passing a guide tool inserted within the bone therethrough.
- the wall is provided with said slit. Alternatively or additionally said slit is formed after inserting the guide tool through the passageway. In some embodiments, the wall comprises a line and/or an area designated to be cut/opened. Alternatively or additionally, the wall comprises marking for directing the formation of the slit.
- the slit is relatively wide, defining an opening on the wall for a tool to pass therethrough. In some embodiments, the opening is sufficiently small to maintain the passageway defined by the wall.
- the surgical navigator is designed such that the wall is positioned near and/or at an edge of the surgical navigator’s body, allowing the formation of said free portion. This configuration has the potential advantage of facilitating the removal of the surgical navigator.
- the body comprises an opening and/or a gap, located next to said free portion, allowing the free portion to be free (e.g., unconnected) to the surgical navigator’s body.
- This configuration has the potential advantage of enabling the wall to be positioned at any desired location on the surgical navigator's body.
- the tool remaining within the bone can be further used.
- a guide tool inserted within a femur head may be used for mounting a chisel thereon, for example, as commonly performed during VDRO procedures.
- a guide tool inserted within a femur head may be used for directing a second surgical navigator, for example, a surgical navigator for directing a chisel.
- a guide tool inserted within a femur head may be used for loading a cylindrical cutter thereon, for example, as commonly performed during hip resurfacing procedures.
- the surgical navigator’s body is configured to be cut and/or torn around the inserted tool.
- the body comprises lines and/or areas of thin material and/or spaced holes for directing and/or facilitating said cut and/or teat. In some embodiments, such lines and/or areas are marked for directing an operator while cutting the surgical navigator.
- the surgical navigator is comprised of segments, such that the connection of the segments forms the wall.
- each segment includes a part of the wall, and when the segments interface, the wall is assembled. After introducing a tool via the wall into the bone, the segments can be disconnected, disassembling the wall and freeing the tool from the surgical navigator (e.g., during the removal of the surgical navigator) while the tool remains inserted within the bone.
- An aspect of some embodiments of the invention relates to a method for inserting a chisel into the center of the femur head without requiring previous insertion of a guide into the center of the femur head, and/or loading the chisel over the guide, using a surgical navigator.
- the surgical navigator comprises a passageway shaped as the chisel.
- the passageway defines the progression of the chisel along the longitudinal axis thereof, having the potential advantage of minimizing lateral and/or rotational movements therewithin, during chiseling.
- the passageway directs the chisel, carving the bone, into the center of the femur head, optionally in a single possible configuration. In some embodiments, this has the potential advantage of minimizing performance errors. In some embodiments, a prior insertion of a guide into the center of the femur head for directing the chiseling is less and/or not required, having the potential advantage of simplifying the procedure and/or reducing the duration of the surgery.
- An aspect of some embodiments of the invention relates to a single surgical navigator for inserting a guide into the center of the femur head and subsequently impacting a chisel threaded on the inserted guide.
- the surgical navigator comprises a passageway for a guide, placed within a passageway for a chisel.
- the passageway for a guide is separable and can be withdrawn out of the passageway for a chisel after the insertion of a selected guide into the center of the femur.
- the wall of the passageway for a guide comprises at least one notch thereon, having the potential advantage of easing the removal of the passageway wall while the guide is left within the center of the femur head, and optionally, protruding therefrom.
- a chisel is loaded on the guide, and placed within the passageway for chisel. Then, in some embodiments, the chisel carves the bone through the passageway for a chisel, directing the carving along the head-neck axis of the femur head.
- the passageway for a chisel is shaped and/or sized according to the shape and/or size of the chisel, having the potential advantage of minimizing the rotation of the chisel around the guide.
- the insertion of the guide device is at least partially visualized, having the potential advantage of indicating the progress of the guide along a desired path, optionally into the center of the femur head.
- carving with a chisel loaded on a guide, through a passageway for the chisel has the potential advantage of further minimizing performance errors.
- the separable passageway for a guide allows to perform the insertion of a guide into the center of the femur head and/or the bone carving with a chisel, using a single JIG, having the potential advantage of simplifying the procedure and/or reducing the duration of surgery
- An aspect of some embodiments of the invention relates to a pre-operative method of designing a surgical navigator, optionally comprising a feedback system.
- the feedback system performs a feasibility examination of a pre-operative input, optionally received from a physician.
- the feasibility examination further considers the patient- specific femur anatomy.
- the input from the physician comprises a surgical approach, and/or a selected plate type, and/or a fixation angle of the plate, and/or a selected set of tools.
- the feedback system if the pre-operative input cannot be applied to the specific femur of the patient, then the feedback system notifies the physician.
- the feedback system presents alternatives to the selected plate type, and/or fixation angle of the plate and/or selected set of tools, or any combination thereof.
- the preoperative input is a range of options for the feedback system to suggest preferred options, alternatively or optionally the pre-operative input lacks at least one parameter for defining the surgical guide design, then the feedback system offers completion for the missing information.
- An aspect of some embodiments of the invention relates to a method for designing a surgical navigator with two recesses.
- the two recesses are configured for performing osteotomy therethrough.
- the method comprises customizing the surgical navigator to match a bone geometry of the patient’s femur.
- the method comprises identifying the femoral head-neck axis and determining a representation of a first recess vertical thereto.
- the method comprises determining the location of a representation of a first recess according to the age of a child patient, and/or according to a desired level of femoral shortening.
- the method comprises placing a representation of a second recess according to a desired correction angle. In some embodiments, the method comprises thickening the representation of the two recesses according to the geometry of a selected cutting instrument, optionally a single cutting instrument, alternatively or additionally, two different cutting instruments. In some embodiments, the method is performed automatically by a computer program.
- an aspect of some embodiments of the invention relates to a surgical navigator sturdy upon contact with sharp objects, such as sharp tools (guide tools and/or working tools), and/or sharp bone residues.
- the surgical navigator comprises a passageway for directing a guide tool and/or a fixator (such as a screw and/or a k-wire) and/or a recess for directing a cutting tool, defined by a wall.
- the wall is sturdy when contacted by a sharp object, optionally introduced thereinto.
- the term “sturdy” does not limit the material, properties and/or structure of the wall.
- the wall can comprise and/or be formed from a rigid material, alternatively or additionally, the wall can comprise and/or be formed from a resilient material, optionally soft material.
- the wall comprises a sturdy element, such as one or more sturdy surfaces deployed therewithin.
- the one or more sturdy surfaces conform to the shape of the wall’s inner surface.
- the one or more sturdy surfaces comprises and/or formed of a metal, such as stainless steel.
- one or more surfaces are flat, to potentially fit within a wall defining a recess for a cutting tool.
- one or more surfaces are tubular, to potentially fit within a wall defining a passageway for a guide tool
- an aspect of some embodiments of the invention relates to a surgical navigator mountable on a bone in parts and/or steps.
- the surgical navigator is comprised of more than one segment where at least one segment is configured to be positioned on the bone, and at least one additional segment is configured to be positioned on the bone by connecting and/or interfacing with the at least one segment.
- the at least one segment comprises an inner surface that fits steady on the bone surface, optionally, by having a geometry that complements the surface geometry of the bone.
- the at least one additional segment comprises one or more geometry that can interact with (e.g., connect to) a corresponding geometry on the at least one segment.
- the at least one additional segment potentially simplifies the deployment of the surgical navigator, having a particular use for relatively large surgical navigators.
- the at least one additional segment comprises an inner surface having a geometry that complements the surface geometry as well. Mounting the segments in steps has the potential advantage of simplifying the match between the surgical navigator and the bone, having a particular use for relatively large surgical navigators.
- an aspect of some embodiments of the invention relates to an adjustable osteotomy guide, for directing bone osteotomy.
- the osteotomy guide comprises two cutting surfaces defining a recess therebetween for introducing a cutting tool therethrough.
- the two surfaces are connected, optionally to form a frame.
- the recess is located and/or oriented on the surgical navigator for directing a cutting tool in a desired path into the bone, optionally, a single path.
- the distance between the two surfaces is sufficient to enable the entrance of a cutting tool but small enough to avoid lateral movements thereof. During surgery, the need to increase the degrees of freedom of the operator and/or to improve its access to the bone may arise.
- one of the cutting surfaces can be removed, such that osteotomy can performed using a single cutting slot, thereby potentially increasing the operator degrees of freedom.
- a cutting surface can be removed by disconnecting the two surfaces.
- the first surface comprises one or more sliding pins and the second surface comprises one or more grooves shaped and/or sized to accommodate the one or more sliding pins.
- one or more sliding pins slide out of the grooves and disconnect the two surfaces.
- the surgical navigator is comprised of at least two segments, optionally, two segments, each including one of the cutting slots. Removing one of the segments results in a single remaining cutting surface. Removing said segment potentially reveals the bone underneath, thereby potentially further increasing the operator's degrees of freedom.
- the removed segment is selected according to an area of the bone that needs to be reviled.
- removing a segment of the surgical navigator has the potential advantage of simplifying the removal of a cutting surface.
- one or both of the segments comprise one or more grip holes, optionally, shaped and/or sized according to a gripping tool.
- a surgical guide comprises more than one osteotomy guide (optionally, two osteotomy guides), such as a surgical JIG for a VDRO procedure, where at least one of the osteotomy guides is adjustable.
- an aspect of some embodiments of the invention relates to a disassemblable surgical navigator for a VDRO procedure.
- the surgical navigator comprises a detachable segment (e.g., a portion and/or a part), optionally located between two or more recesses directing bone osteotomy, optionally, defined by the two or more recesses.
- the detachable segment is shaped and/or sized according to the surface of a bone wedge intended to be cut and/or separated from the bone, covered by the surgical navigator’s body.
- the detachable segment enables the removal thereof from the disassemblable surgical navigator (after and/or during bone osteotomy) while maintaining the rest of the surgical navigator deployed on the bone fragments formed as a result of the osteotomy.
- the detachable segment can be removed before the osteotomy to potentially increase the operator’ s degrees of freedom.
- removing the detachable segment forms a proximal segment of the surgical navigator, located on a proximal bone fragment and a distal segment of the surgical navigator, located on a distal bone fragment.
- the proximal and distal segments of the surgical navigator direct the positioning and/or attachment of the bone fragments.
- the proximal and/or distal fragments of the surgical navigator direct a plate to be deployed theron. Upon plate placement above the surgical navigator’s fragments, the fragments are removed, optionally, by tearing thereof, alternatively, or additionally, by disassembling thereof, and optionally, the plate is then fastened on the bone.
- the surgical navigator is comprised of the proximal segment, the detachable segment, and the distal fragments, optionally anchored to each other for being deployed as a single unit.
- at least one of the segments is independent and the segments are deployed separately on the bone, optionally in parts, optionally aligned with respect to each other.
- the proximal and distal segments are formed upon the removal of the detachable segment.
- An aspect of some embodiments of the invention relates to a surgical navigator having at least one verification component for evaluating the reliability of a produced surgical navigator.
- at least one verification component is designed to have a specific size and/or shape.
- a produced surgical navigator having a verification component sized and/or shaped according to the design thereof indicates that the produced surgical navigation is reliable (e.g., shaped and/or sized according to a desired design).
- at least one verification component comprises a geometry design to have measurable shape and/or size.
- the verification component is a coin, designed to have a specific diameter.
- the surgical navigator is provided with a designated measurement tool, for example, which comprises a recess shape and/or sized to receive a verification coin.
- the surgical navigator comprises more than one verification component, optionally, located distance from each other, optionally, on different portions of the surgical navigator, optionally, next to guiding elements of the surgical navigator. The more than one verification component has the potential advantage of improving the probability of detecting a faulty surgical navigator.
- An aspect of some embodiments of the invention relates to a surgical navigator for performing osteotomy on a bone, defining a plurality (e.g., more than one) cutting paths within the bone, optionally, for an operator to select from.
- the surgical navigator comprises one or more osteotomy guides, wherein each osteotomy guide comprises a plurality of recesses (e.g., cutting slots) for directing a cutting tool therethrough.
- each recess defines a different path into the bone, optionally, a single pathway.
- the surgical navigator comprises a plurality of passageways, each defining a different location on the bone and guiding a tool into the bone that is used as a mark for performing osteotomy, optionally by using an additional surgical navigator that defines a cutting angle at the marked location.
- a surgical navigator comprising a plurality of passageways has the potential advantage or reducing and/or avoiding impairment of the mechanical strength of the surgical navigator while enabling path selection.
- FIG. 1A-C illustrating femur deformities correction by varising de-rotation osteotomy (VDRO) procedure, in accordance with some exemplary embodiments of the invention.
- VDRO varising de-rotation osteotomy
- the head of the femur 104 (ball) is misaligned with the acetabulum (socket), and there is an abnormality in the current shaft angle 110 (shown in figure IB) between the longitudinal femoral shaft-neck axis 106 (shown in figure IB) and the femoral head-neck axis 108 (shown in figure IB), and may also be referred to herein as the center of the femur head axis.
- the VDRO procedure is employed to restore the ball into the socket, by the correction of the current neck shaft angle 110.
- a desired neck shaft angle 112 (shown in figure 1C) is achieved by cutting and removing a bone wedge from the femur. This bone osteotomy is preformed according to correction angle 114 (shown in figure 1C), calculated by subtracting the desired neck shaft angle 112 from the current neck shaft angle 110.
- correction angle 114 shown in figure 1C
- the removal of the bone wedge separates the femoral bone into two fragments. This separation allows the femur head to be tilted back into the acetabulum. Additionally, the femur can be rotated to address rotational deformities that may be present.
- the two fragments are held together with metal plate 116 fixed by screws.
- the plate is selected according to the fixation angle thereof, which defines the desired neck-shaft angle.
- the plate is usually removed after the bones have healed and strengthened.
- a patient is selected for a VDRO procedure.
- the patient suffers from anatomic changes on the femoral side (e.g., femoral anteversion, coxa valga).
- the patient is an individual older than 2 years old with residual hip dysplasia.
- a guiding JIG is computer-designed and/or partially computer-designed.
- the design is fully-automated. In some embodiments of the invention, the design is semi-automated.
- a scanned image of the patient is used for the design of the guiding JIG, having the potential advantage of not requiring measurements of the exposed femoral bone.
- the guiding JIG can be designed prior to surgery, having the potential advantage of saving time during operation and/or minimizing the period of time in which the bone is exposed.
- the guiding JIG can be designed and produced at any stage prior and/or during the VDRO procedure.
- the computer-based and/or semi computer-based guiding JIG has the potential advantage of being designed and/or produced in a relatively quick manner if a need arises after exposing the bone and/or during performing the procedure.
- the design is based on a 3D model of the femoral bone anatomy, generated from the scan image and on required preoperative input, optionally, from a physician.
- the design is performed by a design software/system, optionally, based on the patient’s 3D model of the femoral bone.
- the design is based on input from a surgeon optionally, according to an operative plan of the surgery.
- the design software/system comprises a feedback system configured for alerting if and when the preoperative input results in an unfeasible design.
- a feedback system configured for alerting if and when the preoperative input results in an unfeasible design.
- feasible alternatives are suggested by the system.
- improved alternatives are suggested for a feasible design as well.
- the guiding JIG is designed to limit the degree of freedom of an operator, human surgeon, and/or robotic operator, performing the VRDO procedure. This limitation allows directing operating tools applied on the femoral bone in a desired path.
- the guiding JIG is designed to direct operating tools in a single possible path into the bone. This design has the potential advantage of minimizing the risk of performance errors during surgery. In some embodiments of the invention, the guiding JIG is designed to allow more operation freedom to the operator, defining a range of possible paths into the bone. This design has the potential advantage of limiting performance error together with allowing the surgeon freedom to operate in unforeseen situations. In some embodiments, the design of the guiding JIG is customized according to one or more of: the patient’ s anatomy, a selected plate, and/or a set of tools for performing the VDRO procedure.
- the guiding JIG is produced according to the customized design of step 204.
- the design is implemented by 3D printing, as further described in step 1320 of figure 13B.
- a VDRO procedure is performed by using the guiding JIG.
- the guiding JIG is placed on the femur and is configured to act as a guide for an operator, optionally, a human surgeon, alternatively or additionally, a robotic operator.
- the operator applies one or more operating tools on the femoral bone through the guiding JIG, which directs the progress of the operating tools to and/or within the bone.
- performing VDRO using a guiding JIG has the potential advantage of minimizing performance errors. An additional potential advantage is that VDRO procedures can potentially be performed by operators having less and/or no training.
- the guiding JIG directs the operating tools into the femoral bone, optionally, in a single possible path, alternatively, in a limited range of possible paths.
- a potential advantage of this direction is that less visualization and/or no visualization is required.
- a potential advantage of minimizing visualization is the reduction of exposure to x-ray radiation.
- the guiding JIG defines the place and/or angle of operations (such as drills and/or cuts) on the bone, an additional potential advantage is the evaluation and/or discretion of a physician on how to position the operating tools is less and/or not required.
- an additional potential advantage is that a time required for the design and production while the patient is cut-opened and under full anesthesia is reduced.
- FIG. 3A-E showing perspective views of a guiding JIG 300 for a VDRO process, in accordance with some exemplary embodiments of the invention.
- guiding JIG 300 comprises a JIG body 302 and guiding elements positioned thereon.
- JIG body 302 comprises a proximal end 304 facing the femur head and a distal end 306, facing away from the femur head.
- JIG body 302 further comprises an inner surface 301 (shown in figure 3E) and an outer surface 313.
- the inner surface 301 is configured to face the femoral bone, and the outer surface 313 is configured to face the operator.
- the geometry of inner surface 301 complements the geometry of the bone at the treatment site, so that guiding JIG 300 can be positioned steadily thereon optionally in a single possible configuration.
- outer surface 303 comprises at least one mark designed to indicate (e.g., sign and/or point to) familiar anatomical landmarks upon properly placing guiding JIG 300 on the bone.
- guiding JIG 300 comprises at least one mark on outer surface 303 that points to the greater trochanter and/or lesser trochanter. This at least one mark potentially directs an operator to place the JIG over the bone and/or indicates improper positioning.
- JIG body 302 is sized and/or shaped to be deployed on a portion of the target bone (e.g., femur head) at a site intended for treatment.
- the guiding JIG body 302 partially circumferentially surrounds the femur, relative to the longitudinal shaft-neck of the femur.
- the geometry of the JIG (surrounding the femur) provides a natural grip of the JIG on the bone. This grip may potentially reduce the need to fix the jig onto the bone using bone-penetrating fixator(s).
- JIG body 302 (e.g., the contact surface with the bone) is sufficiently large to enable a steady positioning of JIG 300 on the bone surface. In some embodiments, This steady positioning is achieved by the match between the geometry of the contact surface and the geometry of the bone surface, optionally, a single steady positioning. In some embodiments, the JIG body 302 is as small as possible (e.g., minimized) to potentially reduce the extent of required bone exposure, while still enabling steady positioning. In some embodiments, JIG body 302 is designed such that inner surface 305 includes a relatively complex 'topographic' area of the bone for potentially improving and/or facilitating the steady positioning of JIG 300.
- JIG 300 designed to include a complex 'topographic' area of the bone potentially enables to decrease the size of JIG body 302 required for achieving said steady positioning, having the potential advantage of further reducing the extent of required bone exposure.
- JIG body 102 is designed to cover at least a portion of the femur neck and/or other are showing topographical change, optionally patient-specific areas.
- JIG body 302 encompasses and/or surrounds a portion of the femur head together with a portion of the femur neck (as shown for example in the figures, having the potential advantage of improving the match to the bone and/or facilitating achieving a steady positioning. In other embodiments, JIG body 302 encompasses and/or surrounds a portion of the femur head, potentially reducing and/or avoiding exposure of the femur neck. In some embodiments, the guiding elements of guiding JIG 300 comprise functional guiding elements and/or fixating guiding elements.
- the functional guiding elements are positioned on JIG body 302 according to a desired path into the femoral bone. In some embodiments, the location and/or orientation of a functional guiding element on JIG body 302 defines said desired path into the femoral bone. In some embodiments, the shape and/or size of the functional guiding elements corresponds to the shape and/or size of the selected operating tools.
- the functional guiding elements of guiding JIG 300 comprise a guiding conduit for a guide implement 310, such as a k-wire, directing the insertion of the guide implement into the center of the femur head.
- a guide implement 310 such as a k-wire
- the guiding conduit for a guide implement 310 comprises an inner lumen 312, and a wall 314.
- the inner lumen 312 is shaped according to the shape of a selected guide implement. In some embodiments, the size of inner lumen 312 is large enough to accommodate the selected guide implement but limited to prevent lateral movement and/or rotation therewithin.
- the guiding conduit has a diameter of about 2 mm (for example, 1.5 mm, 2.5mm, 3.1mm, 3.5mm), optionally, between about 2 mm and about 3mm. Optionally between about 1.5mm and about 3.5mm, optionally between about 0.5mm and about 5mm.
- the location and/or the orientation of guiding conduit 310 into the center of the femur head direct the progress of the guide implement into the center of the femur head, optionally in a single possible path, alternatively, in a range of possible paths.
- the location and/or orientation of guiding conduit for a guide implement 310 is defined by the head-neck axis of the femur head, so that an inserted guide implement will be in line with the head-neck axis of the femur head (e.g., guiding conduit for a guide implement 310 is inline with the head-neck axis).
- guiding conduit for a guide implement 310 can be located and/or oriented on JIG body 302 to direct a guide implement in any desired path within the bone (e.g., other than the head-neck axis), for example, if requested by a surgeon.
- the functional guiding elements of guiding JIG 300 comprise an osteotomy guide 316 including at least two cutting slots (318 and 320), and a support frame 322, optionally, a single support frame for both cutting slots (318 and 320), alternatively or additionally, a support frame for one and/or each cutting slot.
- the osteotomy guide 316 is configured to direct a cutting tool during the femoral bone osteotomy.
- the cutting slot 318 is sized and/or shaped to receive a first cutting implement, such as a cutting saw, according to the size and/or shape of the first selected cutting implement.
- cutting slot 320 is sized and/or shaped to receive a second cutting implement, according to a size and/or shape of the second selected cutting implement.
- the first cutting implement and the second cutting implement are one.
- the cutting slots (318 and 320) are wide enough to accommodate the selected cutting implement, but sufficiently narrow to limit lateral movement therewithin.
- the cutting slots are 1 mm wide (for example, 0.5mm, 0.7mm, 1.1mm, 1,5mm), optionally, between about 2 mm and about 0.1mm.
- the cutting slots 318 and 320 are conically shaped with a wider opening at the entrance of the slot, gradually narrowing towards the bone, having the potential advantage of easing the entrance of the cutting tool.
- the location of cutting slots 318 and 320 defines the osteotomy site. In some embodiments, the cutting slots 318 and 320 are positioned relative to each other such that cutting the bone therethrough results in a bone wedge, cut from the femur, separating the bone into a distal and proximal fragment. In some embodiments of the invention the location and/or orientation of cutting slots 318 and 320 define a triangular bone wedge, according to the desired correction angle.
- the location and/or orientation of cutting slots 318 and 320 define a trapezoidal bone wedge, In some embodiments, optionally, by increasing the distance between the cutting slots 318 and 320, which defined by the desired shortening of the femur.
- one cutting slot is perpendicular to the head-neck axis and the second cutting slot is positioned relative thereto according to the desired correct angle and/or shortening distance.
- one cutting slot is parallel to the head-neck axis of the femur head, and the second cutting slot is positioned relative thereto according to the desired correct angle, and/or shortening distance.
- the support frame 322 defines cutting slots 318 and 320.
- the depth of support frame 322 with relative to the radial direction of the longitudinal axis of the femur defines the depth of cutting slots 318 and 320.
- deeper cutting slots enhance the stabilization of the cutting tool thereinto, having the potential advantage of minimizing operation errors during osteotomy.
- support frame 322 further stabilizes the structure of JIG body 302.
- cutting slot 318 and/or 320 is defined by a recess on JIG body 302 which exposes the bone, for example, cutting slot 1622 as shown for example in figure 16A.
- the functional guiding elements of guiding JIG 300 further comprise a distal guiding hole 324 (shown in Figure 3C) for the alignment of the distal fragment with the proximal fragment of the femoral bone and/or for rotation correction of the femur.
- distal guiding hole 324 is located between osteotomy guide 316 and distal end 306 of JIG body 302, directing an operating tool to be applied onto the distal fragment of the femoral bone. In some embodiments of the invention, distal guiding hole 324 directs drilling for a locking screw of a selected plate, shaped and sized according to the dimensions and/or shape of the selected locking screws.
- a distal bore, on the distal bone fragment, resulting from penetrating the bone through distal guiding hole 324, and a bore at the center of the femur, on the proximal bone fragment, resulting from penetrating the bone through guiding conduit for a guide implement 310 define a single configuration relative to the longitudinal axis of the femur, for placing the selected plate (as shown in figures 11-12).
- the functional guiding elements of guiding JIG 300 further comprise at least one proximal guiding hole 326 (shown in figure 3D).
- Proximal guide hole 326 is positioned to direct drilling onto the proximal fragment of the femur (optionally, before cutting the bone).
- the location and number of the at least one proximal guiding hole 326 on JIG body 302 are defined according to the shape of the selected plate, for example locking proximal femur plate (LPF).
- the size of the proximal drilling guiding hole 326 is defined by the fixators of the selected plate, such as a k-wire and/or a locking screw.
- the bore resulting from penetrating the bone through proximal drilling hole 326 is used for the alignment of the distal fragment relative to the femoral head-neck axis and minimizes the risk for translation deviation along the femoral head-neck axis when fixing the plate.
- the distal bore on the distal fragment resulted from penetrating the bone through distal guiding hole 324 and the at least one proximal bore at the proximal fragment of the femur, resulted from the penetrating the bone through at least one proximal drilling hole 326 define a single configuration, for placing the plate.
- a guiding sleeve is mounted (not shown) on distal guiding hole 324 and/or on at least one proximal guiding hole 326, having the potential advantage of enhancing the stability of an operating tool inserted therethrough.
- the length of the sleeve defines the depth and/or potential depth of insertion therethrough, having the potential advantage of minimizing the risk for over drilling into the bone.
- the fixating guiding elements direct the insertion of fixators and are positioned (e.g., located and/or originated) on the guiding JIG so that the path of a fixator will not collide with the path dictated by the functional guiding elements.
- guiding JIG 300 comprises at least one fixation guiding hole 328 for guiding the insertion of at least one fixator, such as but not limited to a k-wire.
- the size of the at least one fixating guiding hole 328 is determined according to the fixator selected by the physician.
- the at least one guiding hole is sized to accommodate the selected fixator, and to limit lateral movement therewithin.
- the location of the at least one fixating guiding hole 328 on guiding JIG 300 determines the location of the at least one fixator.
- the at least one fixating guiding hole 328 is located adjacent to the distal end of JIG body 302, alternatively, or additionally, the at least one fixation guiding hole 310 is located at a side portion of JIG body 302.
- a guiding sleeve 330 is mounted on fixating guiding hole 306 for directing the insertion angle of the fixator.
- guiding JIG 300 comprises one or more structure supports, such as structure support 308, to maintain the shape thereof.
- structure support 308 is attached to guiding conduit 310, for mechanical support.
- structure support 308 maintains the orientation of guiding conduit 310, by fixating the angle between the guiding conduit 310 and the longitudinal axis of the guiding JIG.
- structural support 308 is further attached to osteotomy guide 308, maintaining the relative location of osteotomy site 316 and guiding conduit 310.
- JIG body 302 is formed from an elastic material which maintains the structure thereof upon appliance and/or alignment on the femoral bone. In some embodiments, this material has sufficient flexibility to be mounted over the femoral bone, and some degree of rigidity to be fixed thereon.
- JIG body 302 comprises regions of relatively higher rigidity and regions of relatively higher flexibility.
- the relatively higher rigidity regions are used for structural support, optionally the regions of higher flexibility allow the JIG body to be mounted on the bone.
- regions of higher rigidity are thicker portions of JIG body 302, whereas regions of higher flexibility are thinner portions of JIG body 302.
- the different regions can be achieved by adding supplements such as plasticizers for enhancing flexibility and/or stiffeners for enhancing rigidity
- the different regions can be formed from different materials and/or composites distinguished by their rigidity and/or flexibility.
- structural support such as structural support 308 is formed from the same material as JIG body 302, alternatively or additionally, structural support 308 is formed from a substantially rigid material than the material of JIG body 302, having the potential advantage of enhanced support with minimizing the size and/or required amount of material for structural support 308.
- guiding JIG 300 is used as a single guiding JIG, optionally or additionally, guiding JIG 300 is a part of a kit including a set of at least two guiding JIGs. In some embodiments of the invention guiding JIG 300 is used for insertion of a guiding implement into the center of the femur head, optionally, not comprising guiding osteotomy 316.
- FIG 4A showing a perspective view of a guiding JIG 400 for a VDRO process using a chisel, in accordance with some exemplary embodiments of the invention.
- Guiding JIG 400 is identical to guiding JIG 300, with the exception of the following variances:
- guiding JIG 400 does not include guiding conduit for guide implement 310.
- guiding JIG 400 is designed for a chisel-based plate and does not include at least one proximal guiding hole 326 for locking screws of the plate.
- guiding JIG 400 comprises a guiding conduit for a chisel 410 having an inner lumen 412, and a wall 414.
- inner lumen 412 possesses the shape of the selected chisel. A potential advantage of inner lumen 412 having the shape of the selected chisel is that there is no requirement for prior insertion of a K-wire for the chisel to be threaded on.
- the size of inner lumen 412 is large enough to accommodate the selected chisel but small enough to limit lateral movement and/or rotation of the chisel therewithin, having the potential advantage of minimizing undesired rotation and/or lateral deviation of the chisel upon impacting the bone.
- guiding conduit for a chisel 410 directs a chisel impacting the femur into the center of the femur head.
- the length of wall 414 is sufficiently long to stabilize the chisel placed within inner lumen 412, while leaving an exposed portion of the inserted chisel to be impacted.
- the length of wall 414 defines the initial length of the exposed chisel portion which defines the depth of the chiseling into bone.
- the combination of the location of guiding conduit for chisel 410 together with the orientation thereof directs a chisel impacting the bone into the center of the femur head in only a single possible path.
- guiding conduit for a chisel 410 is orientated on JIG body 402 according to a desired orientation of the chisel when chiseling the bone, for potentially forming a cavity within the bone shape, size, and/or orientated according to accommodate a corresponding portion of the chisel-based plate (e.g., a portion shaped and/or sized as the chisel).
- he location and/or orientation of guiding conduit for chisel 410 is defined by the femoral neck-head axis such that the guiding conduit for chisel 410 is in line with the head-neck axis.
- the location and/or orientation of guiding conduit for chisel 410 defined a path into the bone other than inline by the femoral neck-head axis, optionally, any desired path, optionally, defined by a structure a selected chisel-based plate and/or by input of the surgeon.
- structure support 408 is attached to guiding conduit for chisel 410, for mechanical support.
- structure support 308 maintains the orientation of guiding conduit for chisel 410.
- the cavity at the center of the femur head created by chiseling through guiding conduit for chisel 410, and the distal bore formed by drilling through proximal guiding hole 424, define a single configuration for placing the plate.
- guiding JIG 400 comprises a removable guiding conduit for a guide implement 440, that can be mounted within guiding conduit for a chisel 410 (as shown for example in figures 4B-C.
- the removable guiding conduit for a guide implement is configured to direct a guide implement (e.g., a K-wire) into the center of the femur head (shown for example in Figure 4C), as described for guiding conduit for a guide implement 310 of guiding JIG 300.
- the removable guiding conduit for a guide implement is attached and/or anchored to guiding conduit for a chisel 410, optionally positioned within guiding conduit for a chisel 410.
- This attachment (and/or anchoring) allows removable guiding conduit for a guide implement 440 to be positioned steady within guiding conduit for a chisel 410, maintaining a desired position thereof for directing the insertion of a guide implement into the center of the femur head (and/or any other path into the bone, dictated by guiding conduit for a chisel 410).
- At least a portion 442 of removable guiding conduit for a guide implement 440 is shaped and/or sized to fit within wall 414 and occupy inner lumen 412.
- the outer surface of at least a portion 442 of removable guiding conduit for a guide implement is at least partially shaped and/or sized to complement the geometry of inner lumen 412 of guiding conduit for chisel 410.
- the friction between said outer surface and the inner surface of guiding conduit for chisel 410 e.g., the inner surface of well 414) maintains removable guiding conduit for a guide implement 440 at a steady position within lumen 412.
- removable guiding conduit for a guide implement 440 comprises a protruding portion 444 configured to protrude from guiding conduit for a chisel 410 when removable guiding conduit for a guide implement 440 is mounted therewithin.
- Protruding portion 444 potentially facilitates the insertion of a guide implement into removable guiding conduit for a guide implement 440 and/or facilitates the removal thereof.
- the removable guiding conduit for a guide implement is configured to be withdrawn from guiding JIG 400, subsequent to the insertion of a guiding implement into the center of the femur head.
- the removable guiding conduit for a guide implement is withdrawn by cutting thereof, optionally or additionally, by puling thereof.
- the removable guiding conduit for a guide implement comprises a slit along the longitudinal axis thereof, having the potential advents of easing the removal thereof while the guiding implement remains within the center of the femur head.
- guiding conduit for chisel 410 is free to receive a chisel threaded on the guide implement, inserted into the center of the femur head.
- the removable guiding conduit for a guide implement allows both the insertion of a guide implement and/or the insertion of a chisel into the center of the femur head, using a single JIG, having a potential advantage of reducing the procedure duration.
- the insertion of the guide implement is visualized to minimize deviations from the path into the center of the femur head.
- the chisel is threaded on the guide implement, having the potential advantage of minimizing deviations of the chiseling from the path into the center of the femur head.
- An additional potential advantage is minimizing the rotation of the chisel around the guide implement by impacting the chisel through the guiding conduit for a chisel.
- FIG 5A showing a perspective view of a guiding JIG 500 for a VDRO process, in accordance with some exemplary embodiments of the invention.
- Guiding JIG 500 is a variant of guiding JIG 400, having the same general functional elements.
- guiding JIG 500 comprises JIG body 502 having a larger surface area, compared to JIG body 402.
- JIG body 502 partially circumferentially surrounds the femur, to a greater extent than the JIG body of guiding JIG 400. This enhanced partial surrounding eases the alignment of JIG body 502 on the femur, compared to guiding JIG 400.
- guiding JIG 500 has an enhanced grip on the bone so less invasive fixating thereto is required.
- guiding guide 500 comprises at least one extension 530.
- extension 530 is an area having complement geometry to the bone anatomy, exceeding the boundaries of JIG body 502.
- extension 530 potentially provides an additional landmark for the alignment of JIG body 502 onto the femur.
- extension 530 enhanced the fixating of JIG body 502 onto the bone, having the potential advantage of further reducing and/or avoiding the need for invasive fixating.
- guiding JIG 500 comprises guiding conduit for chisel 510 having longer wall 514 compared to guiding JIG 400.
- structure support is attached to guiding conduit for chisel 510 to maintain the orientation thereof, optionally along the longitudinal axis of wall 514.
- longer wall 514 defines deeper inner lumen 512 which has the potential advantage of enhancing the chisel stability.
- guiding conduit for chisel 510 can be shortened, for example, if a need arises during surgery. The shortening of the guiding conduit for chisel 510 increases the range of operating and/or the potential depth of chiseling.
- guiding conduit for chisel 510 comprises at least one slit to ease the shortening thereof during surgery, and/or for indicating the modified depth of chiseling.
- guiding IIG 500 comprises an osteotomy guide 516 having support frame 522 for guiding slots 518 and 520.
- support frame 522 extends beyond guiding slots 518 and 520, partially surrounding circumferentially JIG body 502. This extension has the potential advantage of enhancing the structural support of JIG body 502.
- support frame 522 has reduced depth, relative to the radial axis of JIG body 502, compared to support frame 322 of guiding JIG 300.
- a less deep support frame defines less deep cutting slots 518 and 520 compared to cutting slots 318 and 320 of guiding JIG 300.
- the reduced depth of cutting slots 518 and 520 defines a less stable osteotomy guide, having the potential advantage of allowing some degree of freedom when cutting the bone.
- the degree of freedom can be beneficial when unexpected situations arise during surgery.
- support frame 522 is relatively deep but comprises at least one slit to ease the shortening thereof during surgery.
- FIG 5B showing a perspective view of a guiding JIG 550 for a VDRO process, in accordance with some exemplary embodiments of the invention.
- Guiding JIG 550 is a variant of guiding JIG 300.
- guiding JIG 550 differs from guiding JIG 300 by having at least one extension 530, as described for guiding JIG 500.
- guiding JIG 550 comprises JIG body 502 having a larger surface, compared to JIG body 300, as described for guiding JIG 500.
- guiding JIG 550 is a part of a kit including a set of guiding JIGs, so an osteotomy guide is not included, alternatively or additionally, guiding JIG 550 comprises an osteotomy guide, optionally, as described for guiding JIG 500.
- guiding JIG 550 differs from guiding JIG 300 by having longer wall 554 of guiding conduit for a guide implement 522, relative to the longitudinal axis thereof, compared to guiding conduit for a guide implement 310 of guiding JIG 300.
- longer wall 554 defines deeper inner lumen 556 which has the potential advantage of enhancing the guide implement stability during insertion into the center of the femur head. Enhancing the stability of the guide implement within the guide conduit for guide implement 552 has the potential advantage of directing the progress of the guide implement in a single possible path.
- guiding conduit for a guide implement 552 can be shortened, for example, if a need arises during surgery.
- the shortening of the guiding conduit for guide implement 522 increases the range of operating therethrough.
- structure support is attached to guiding conduit for chisel 552 to maintain the orientation thereof, optionally along the longitudinal axis of wall 554 (not shown).
- kits including a set of at least two guiding JIGs is provided.
- the kit includes at least one of guiding JIGs 300 and/or 550, and at least one of guiding JIG 400 and/or 500.
- guiding JIGs 300 and/or 550 are used for directing a guide, such as k-wire into the center of the femur head.
- Guiding JIG 400 and/or 500 are used for directing a chisel impacting the bone, into the center of the femur head and/or for performing osteotomy.
- Guiding JIGs 300 and/or 550 do not comprise at least one proximal guiding hole 326, optionally or additionally JIGs 300 and/or 550 do not comprise an osteotomy guide.
- a distal guiding hole is located at least on one of the guiding JIGs of the set, and/or on each guiding JIG of the set, having the potential advantage of allowing to applied operating tool therethrough in various situations throughout the procedure.
- the fixating guiding holes of the first JIG are at the same location with respect to the femur anatomy such as the fixating guiding holes of the second JIG.
- the bores on the bone resulted from inserting fixators through the fixating guiding holes of the first JIG used as additional alignment indication for fixating the second JIG.
- the guiding JIG is configured to be used by a robotic arm.
- the guiding JIG comprises a camera for directing the robotic arm, optionally, the JIG body comprises a designated site for mounting the camera, optionally, shaped and/or sized according to the selected camera.
- the JIG body comprises at least one label, detectable by a camera of the robotic arm.
- labels on the JIG body direct the progression of the robotic arm.
- the at least one label is attached to the JIG body after production thereof, alternatively or additionally, the at least one label is inherently printed into the JIG body, optionally, during production thereof.
- the insertion of the guiding JIG through the incision in the thigh, and/or placement of the guiding JIG onto the femur is performed by a human operator. Alternatively, or additionally, the insertion and/or placement of the guiding JIG onto the femur is performed by the robotic arm.
- the JIG body comprises a marker, such as a metal screw, for evaluating the alignment of the guiding JIG onto the bone by visualization.
- the location of the robotic arm is calibrated prior to operation, optionally by determining a desired distance between the robotic arm and the guiding JIG.
- the progress of the robotic arm is monitored using a visualization device, such as an X-ray device.
- the robotic arm is updated with a preoperative plane, including the desired path and/or paths into the femur.
- the robotic arm compares the progress thereof with the preoperative plane and alerts for deviations from the desired path and/or paths into the bone.
- the guiding elements of the guiding JIG have a conical shape, which widens towards the entrance thereof. This conical shape has the potential advantage of enhancing tolerance for the insertion of operating tools by the robotic arm.
- the guiding elements are elongated, optionally, emerging out of the body. This has the potential advantage of allowing the robotic arm space for movement, external to the body. An additional potential advantage is minimizing the risk of the robotic arm injuring the bone and/or tissues.
- the elongated guiding elements are supported with sufficient structural support to maintain the stability thereof.
- the guiding elements comprise signs for the detection thereof by the robotic arm and/or for directing the entrance thereinto.
- the wall of a guiding element comprises a colored sign, such as a red sign, detectable by a camera of the robotic arm.
- the robotic arm comprises an X-ray device, and the wall of a guiding element comprises a metal sign detectable by X-ray.
- the wall of the guiding elements comprises a plurality of marks, for example, parallel lines and/or rings, along the longitudinal axis thereof.
- the marks are configured to be bent and/or deformed if the guiding elements are bent and/or deformed. This has the potential advantage of indicating if the robotic arm enters into a guiding element improperly.
- the guiding JIG comprises a barcode for updating the robotic arm with the preoperative plane, such as the selected plate type, the selected fixation angle of the plate, the selected set of tools, the selected surgical approach, specific surgical instructions, the location of the guiding elements on the guide body, the distance between the guiding elements, the order of guiding elements to access, which guiding elements to access, depth limitation for insertion, optionally different limitation for each guiding element and/or any combination thereof.
- the barcode refers the robotic arm to an external database including the preoperative plane.
- the barcode comprises an RFID element including the preoperative plate.
- the fixating guiding elements are configured to receive a fixator of the robotic arm, shaped and/or sized according to a fixed pin of the robotic arm.
- the guiding JIG is configured to direct the placement of the plate.
- the plat is first connected onto the guiding JIG, which comprises dedicated guiding elements for the insertion of the plate’s blade and/or locking screws and/or guide implement such as a k-wire.
- the guiding JIG is configured to be removed after to the placement of the plate thereon.
- the JIG body is tearable, having the potential advantage of easing the removal thereof after the placement of the plate thereon.
- the JIG body comprises at least one slit thereon, having the potential advantage of easing the tearing of the JIG body.
- JIG body comprises a plurality of slits, allowing the guiding JIG to be removed in parts.
- the removal of the guiding JIG is performed by the robotic arm, alternatively or additionally, the removal is performed by a human operator.
- FIG 6 showing a flowchart describing an exemplary workflow of an operator using guiding JIG, during a VDRO procedure, in accordance with some exemplary embodiments of the invention.
- a patient is selected, optionally, a child patient, as described in step 202, of Figure 2.
- the guiding JIG is placed on the femoral bone, optionally, subsequently to bone exposure.
- the guiding JIG partially circumferentially surrounds the femur, relative to the longitudinal shaft-neck of the femur. In some embodiments of the invention, the guiding JIG grips the bone, having the potential advantage of minimizing the requirement of an assistant, holding and placing the guiding JIG prior to fixing thereof on the femoral bone.
- the guiding JIG is aligned onto the femur by reaching a match between the inner surface of the JIG body and the femoral bone geometry, at the treatment site. Since the guiding JIG is customized according to the bone anatomy of the patient, the inner surface of the JIG body has a geometry that complements the anatomy of the femoral bone at the treatment site, having the potential advantage that the guiding JIG is positioned steady on the bone in a single possible configuration.
- operating tools are applied on the femoral bone according to the guiding JIG.
- the guiding JIG directs operating tools into the femoral bone, through guiding elements positioned thereof.
- the guiding elements have depth limitations defining a maximum depth for the insertion of operating tools therethrough.
- a single guiding JIG is used.
- a kit including at least two guiding JIGs is used.
- the guiding JIG is first fixed onto the femur, optionally to maintain the aligned position described in step 602.
- the fixating is done by inserting at least one fixator, for example, a k-wire, through fixating guiding elements, into the femur.
- VDRO procedure is employed using functional guiding elements of the guiding JIG.
- the guiding JIG is being removed from the bone. Optionally in one piece.
- the bone position is corrected according to the marks and/or bores resulting from applying operating tools through the guiding JIG.
- the distal fragment and the proximal fragment of the bone are being joined together.
- the femur head is tilted back into the acetabulum.
- the distal fragment is rotated for rotation correction of the femur.
- the plate is connected to fix the corrected position of the bone.
- the guiding JIG dictates bores on the bone which defines a single configuration for connecting the plate.
- the correction of the bone position can be done together with the connection of the plate.
- the plate can be connected first to the head of the femur, then the distal fragment is rotated and joined with the proximal fragment, such that the distal bore fits to the plate.
- FIG. 7A-C showing a flowchart of an exemplary workflow for performing a VDRO procedure using guiding JIG 300, in accordance with some exemplary embodiments of the invention.
- a patient is selected, as described in step 202 of Figure 2.
- the femoral bone is exposed, according to the selected surgical approach, optionally, selected by the physician, alternatively or additionally, suggested by the feedback system.
- the size of the incision is sufficient for introducing the guiding JIG.
- the guiding JIG design does not require measurements of the exposed bone, having the potential advantage of minimizing the required incision size and/or level of bone exposure.
- the incision size corresponds to the size of the guiding JIG inserted therethrough.
- the JIG body is bendable and/or compressible, configured to be inserted in a bent and/or compressed form, optionally held by the operator.
- the guiding JIG expands upon reaching the bone. This bent and/or compressed form has the potential advantage of minimizing the required incision size.
- the surgical approach defines the location and/or the size of the required incision.
- the guiding JIG is placed onto the femoral bone, at the treatment site.
- the guiding JIG is aligned by fitting the inner surface thereof to the surface of the bone.
- the geometry of the inner surface of the JIG body completes the geometry of the femoral bone, so that the guiding JIG fits onto the bone surface in one possible steady configuration.
- the guiding JIG is fixed onto the femoral bone, optionally, by at least one fixator, such as a k-wire.
- This fixating maintains the aligned position of the guiding JIG onto the bone.
- the JIG body at least partially circumferentially surrounding the femur, optionally having a grip and/or some level of grip on the femoral bone. This grip has the potential advantage of minimizing the requirement of an assistant, holding the guiding JIG until the fixating thereof onto the bone, and/or allowing a single operator to perform the procedure.
- the at least one fixator is inserted through at least one fixating guiding hole of the guiding JIG.
- Each fixating guiding hole defines a path for a fixator, designed not to collide with the path of other fixators, and/or the path of other operating tools that will further be inserted through functional guiding elements.
- a guide implement such as a k-wire, is inserted through the guiding conduit for a guide implement 310.
- the guiding conduit for a guide implement directs the guide implement into the center of the femur head, optionally in a single possible path, alternatively or additionally, in a limited range of possible paths.
- the guiding conduit for a guide implement 310 can be shortened, optionally by the operator, having the potential advantage of increasing the range of operation, if a need arises.
- cutting the guiding conduit for a guide implement 310 optionally, according to slits thereon.
- an operating tool such as a driller, is applied through the distal guiding hole of the guiding JIG.
- the distal guiding hole directs a drilling for alignment of the distal proximal fragment to the proximal fragment of the bone (optionally, prior to osteotomy), and/or for rotation correction of rotational deformities.
- this step can be performed in a prior and/or subsequent stage.
- an operating tool such as a driller, is applied through the proximal guiding hole of the guiding JIG.
- a first cutting tool such as a saw, is applied through the first cutting slot of the osteotomy guide on the guiding JIG.
- a second cutting tool such as a saw, is applied through the second cutting slot of the osteotomy guide on the guiding JIG.
- the first and the second cutting tools are one.
- the bone wedge has a triangular shape, according to the correction angle.
- the bone wedge has a trapezoidal shape, optionally, when femur shortening is required.
- the trapezoidal bone wedge is shaped according to the correction angle and the level of the shortening.
- one and/or both of the cutting slots direct the cutting tools cutting the bone, optionally in a single possible path. Alternatively, or additionally, in a limited range of possible paths.
- the osteotomy guide can be shortened, optionally by the operator, having the potential advantage of increasing the range of operation through one and/or both of the cutting slots, if a need arises.
- fixators are removed.
- the at least one fixator inserted through the at least one fixing guiding hole of the guiding JIG is extracted from the bone.
- the guide implement is removed from the center of the femur head.
- this step can be performed in a prior and/or subsequent stage.
- the guiding JIG is removed from the bone and from the incision site.
- the bone wedge is removed, resulting in the separation of the femur into a distal fragment and a proximal fragment.
- the femur head is tilted to be directed toward the acetabulum.
- the femur head is passively tilted subsequent to the bone wedge removal, alternatively or additionally, the femur head is actively tilted, optionally by the physician, until alignment of the femur head toward the acetabulum
- the guide implement inserted into the center of the femur head is removed subsequently to this tilting.
- the tilting is performed by tilting the guide implement.
- the distal fragment of the bone is aligned with the proximal fragment thereof.
- the bore on the bone distal fragment, resulted from the distal guiding hole, and the bore resulted from the guiding conduit for a guide implement, placed on the proximal bone fragment, are aligned.
- the distal fragment is rotated to achieve this alignment (as shown in figures 11-12).
- the distal fragment and the proximal fragment of the bone are joined together.
- the selected plate is placed on the bone.
- the plate is positioned so that the holes of the plate are aligned with: a. the bore at the center of the femur head, resulted from the insertion of a guide implement through the guiding conduit for a guide implement; b. the distal bore, on the distal fragment, resulted from applying an operating tool through the distal guiding hole; and c. the at least one proximal bore, on the proximal fragment, resulted from applying an operating tool through the at least one proximal hole.
- the placement of the plate according to the bore at the center of the femur head and the distal bore on the distal fragment defines a single configuration for placing the plate, according to the longitudinal neck- shaft axis of the femur.
- the placement of the plate according to the bore at the center of the femur head, the distal bore on the distal fragment and the at least one proximal bore on the proximal fragment define a single configuration for placing the plate.
- the plate is fixed to the femoral bone, optionally, by the insertion of fixators such as k-wires and/or locking screws.
- steps 732-738 are concurrently performed and/or performed in a different order.
- the plate can be first aligned and/or fixed into the center of the femur head, then the distal fragment of the bone is aligned and/or rotated and/or joined with the proximal fragment according to the semi-placed plate.
- FIG. 8A-C showing a flowchart describing an exemplary workflow for performing a VDRO procedure using guiding JIG 400, in accordance with some exemplary embodiments of the invention.
- Steps 802-810 are as described in steps 702-710 of figures 7A-C, respectively.
- a selected chisel is inserted through the guiding conduit for a chisel on the guiding JIG.
- the guiding conduit for a chisel directs the chisel impacting the bone into the center of the femur head without requited prior insertion of a guide implement into the center of the femur head and/or threading the chisel thereon.
- the guiding conduit for a chisel limits rotational and/or lateral movements of the chisel therewithin.
- the guiding conduit for a chisel directs the path of the chisel impacting the bone within the bone, optionally, in a single possible path, optionally or additionally in a limited range of possible paths.
- the difference between the lengths of the chisel and the guiding conduit for a chisel defines the depth of chiseling, having the potential advantage of minimizing over-chiseling.
- the guiding conduit for a chisel can be shortened, optionally by the operator, having the potential advantage of increasing the range of operation and/or increasing the depth of chiseling, if a need arises.
- the chisel is removed, by the extraction thereof from the bone through the guiding conduit for a chisel. In some embodiments of the invention, this step can be performed in a later stage.
- Steps 816-826 are as described in steps 714,718-722,726-728 of figures 7A-C, respectively.
- the femur head is tilted to be directed toward the acetabulum.
- the chisel is removed subsequently to the tilting.
- the tilting is performed by tilting the chisel inserted through the center of the femur head.
- the distal fragment of the bone is aligned with the proximal fragment thereof.
- the bore on the bone distal fragment, resulted from the distal guiding hole, and the cavity into the center of the femur head, which resulted from the chiseling, placed on the proximal bone fragment, are aligned.
- the distal fragment is rotated to achieve this alignment (as shown in figures 11-12).
- Steps 832 is as described in step 734 of figures 7A-C.
- the selected plate is placed on the bone. a.
- the plate is positioned so that the blade of the plate 1004 (shown in Figure 10) fits within the cavity into the center of the femur head, and a distal hole on the plate 1005 on the plate (shown in Figure 10) is aligned with the distal bore (shown in figure 12), on the distal fragment, resulted from applying operating tool through the distal guiding hole.
- this alignment defines a single configuration for placing the plate, according to the longitudinal neck- shaft axis of the femur, and the head-neck axis thereof.
- the plate is fixed to the femoral bone, optionally, by the insertion of locking screws.
- steps 730-836 concurrently performed and/or performed in a different order.
- the blade of the plate can be first inserted and fixed into the center of the femur head, then the distal fragment of the bone is aligned and/or rotated and/or joined with the proximal fragment according to the semi-placed plate.
- Step 838 is as described in step 734 of Figure 7C.
- FIG. 9A-D showing a flow chart describing the workflow of a surgeon using a kit including a set of guiding JIGs, in accordance with some exemplary embodiments of the invention.
- Steps 902-904 are as described in steps 702-704 of Figure 8A, respectively.
- a first guiding JIG is placed on the femoral bone at the treatment site.
- Steps 908-914 are as described in steps 708-714 of Figure 8A, respectively.
- the distal guiding hole is alternatively or additionally positioned on the second guiding JIG, so that this step is performed after placing the second guiding JIG, optionally, before performing osteotomy.
- the fixators on the first guiding JIG are removed, by extracting thereof through the guiding fixing holes.
- the first guiding JIG is removed from the bone, and extracted (e.g., removed) from the incision site.
- the guide implement is left within the center of the femur head
- a second guiding JIG is placed on the femoral bone at the treatment site.
- the second guiding has a JIG body equal and/or smaller than the first guiding JIG, which can be inserted through the incision to the bone.
- the second guiding JIG is aligned onto the femoral bone as describes in step 708 in Figure 7A.
- the fixing guiding holes of the second guiding JIG are aligned with the fixing guiding holes of the first guiding JIG.
- the alignment of the second guiding JIG on the femur is further based on the fixing guiding holes of the second JIG aligned over the bores resulting from inserting fixators through the fixing guiding holes of the first guiding JIG.
- the second guiding JIG is aligned onto the femoral bone as describes in step 710 in Figure 7A.
- the fixating guiding holes of the second guiding JIG direct the insertions of the fixators into the same path as the fixating guiding holes of the first guiding JIG, having the potential advantage of minimizing the invasive fixation bores on the bone.
- a selected chisel is threaded onto the guide implement.
- the chisel is passed over the guide implement to be placed within the guiding conduit for a chisel.
- the bone is impacted by the chisel, threaded on the guide implement.
- the guiding conduit for a chisel directs the chiseling into the center of the femur head, having the potential advantage of minimizing the rotational movements of the chisel around the longitudinal axis of the guide implement.
- Impacting a chisel threaded on a guide implement inserted into the center of the femur head has the potential advantage that the guide implement further directing the chiseling toward the center of the femur head.
- the path of the guide implement within the femur head is first visualized, to minimize the risk of errors.
- Steps 932-934 are as described in steps 718-720 of Figure 7B, respectively.
- the chisel is removed. Extracted from the bone and/or form the guiding conduit for a chisel. The chisel is threaded over the guiding implement away from the femur head.
- the guide implement is removed from the center of the femur head.
- the removal of the guiding implement is performed in a later stage.
- the fixators of the second guiding JIG are removed from the bone and/or Extracted from the guiding holes (e.g., guiding holes for fixators) of the guiding JIG.
- the guiding JIG is removed.
- Step 946 as described in step 728 of figures 7A-C.
- Step 948 as described in step 730 of figures 7A-C.
- Step 950 as described in step 830 of figures 8A-C.
- Step 952 is as described in step 734 of figures 7A-C.
- Step 954-956 as described in 834-836 of figures 8A-C.
- Step 956 is as described in step 734 of figures 7A-C. Referring to Figures 13A-B, showing a concise flowchart, describing an exemplary design process of a guiding JIG, in accordance with some exemplary embodiments of the invention.
- a scan image of the femoral bone of the patient is received, for example, a CT scan, alternatively or additionally, an image from X-ray visualization.
- the scan image is imaged prior to the design process so the design does not require the presence of the patient.
- the process design is done by a computer conjugated to an imaging device, having the potential advantage of scanning the femur of the patient and promptly designing the guiding JIG.
- a 3D printer is further conjugated so that the guiding JIG can be produced on-site, subsequent to the computer-design.
- a computed 3D model of the femur is created, according to the scan image of the patient.
- the 3D model simulates the femoral bone anatomy of the patient.
- a preoperative input is received, optionally, by the user.
- the combination of the preoperative input and the bone anatomy defines the design of the guiding JIG.
- the preoperative input includes: a. the selected fixation angle of the plate, which defines the correction angle; b. the type of the selected plate; c. the selected set of tools; and e. the surgical approach.
- a feasibility test is performed, optionally, by a feedback system of the program. For example, the feasibility test considering the requested preoperative input, in light of the femoral bone anatomy.
- feedback regarding the feasibility of the requested guiding JIG is outputted. If the selected preoperative input gives a guiding JIG design that is not feasible the feedback system informs the user and optionally offers feasible alternatives.
- the feedback system offers advantageous alternatives to a feasible guiding JIG design, as well.
- functional guiding elements ar placed on the 3D model.
- the location and orientation of the functional guiding elements are defined by the bone anatomy and/or the preoperative input.
- the size and shape of the functional guiding elements are defined by the type of the selected plate and/or the selected set of tools.
- fixation guiding elements are placed on the 3D model.
- the size and/or shape of the fixation guiding elements are defined by the selected fixators and/or selected set of tools.
- the location and orientation of the fixation guiding elements are defined according to the functional guiding elements and the femoral bone anatomy, so that the path of a fixator inserted therethrough does not collide with the path of other operating tools inserted through the functional guiding elements and/or other fixation guiding elements.
- a JIG body is created.
- the JIG body comprises the functional guiding elements and the fixation guiding elements.
- the JIG body is customized according to the bone anatomy, having an inner surface configured to come in contact with the bone.
- the inner surface has a geometry which completes the geometry of the femur at the site of deployment.
- structural support elements are placed on the JIG body, optionally, for strengthening the three-dimensional structure of the guiding JIG, alternatively or additionally, for supporting the guiding elements on the JIG body, alternatively or additionally, for maintaining the relative distance between the guiding elements of the guiding JIG.
- a quality test of the guiding JIG design is performed.
- the quality test is digitized and performed prior to guiding JIG production, alternatively or additionally, the guiding JIG is produced and placed on a printed model of the femoral bone.
- the alignment and/or stability of the JIG body on the bone model is evaluated.
- the guiding elements are measured to detect deformation results from printing errors.
- the size of the inner of the guiding conduit for a guide implement and/or the size of the lumen of the guiding conduit for a chisel and/or the cutting slots of the osteotomy guide are measured.
- the guiding JIG design is produced, optionally, by 3D printing.
- the 3D printing is based on SLS (Selective Laser Sintering) technology, which uses powder as the source material for printing.
- SLS Selective Laser Sintering
- SLA Stepolithography
- the guiding JIG is printed from biocompatible materials, approved for subcutaneous contact.
- the material used is PA12 (Nylon 12 or Polyamide 12), optionally, used in SLS technology.
- biocompatible materials are used, optionally in SLS technology, alternatively or additionally, in other technologies, such as SLA technology.
- using additional and/or different materials requires adjustment of the thicknesses of the guiding JIG body and/or structural support elements and/or walls of guiding elements thereof, optionally, to obtain a stable guiding JIG structure and/or desired level of flexibility and/or rigidity thereof.
- the materials are durable for a sterilization process and/or relatively easy to disinfect.
- the material(s) are selected according to an input from a surgeon, for example, input regarding the sterilization process.
- the production is fully automated, alternatively or additionally, the production is semiautomated.
- the production is subsequent to the design process.
- the guiding JIG produced in a time interval form the design process based on a digitized file of the design.
- the method for designing a guiding JIG is similar and/or as described in Provisional Patent Application No. 63/472,602 filed on June 13, 2023, and/or in the PCT application derived therefrom, having a docket number of 100411, and the contents of which are hereby incorporated by reference.
- said designing a guiding JIG is performed using a user interface (UI) and/or a graphical user interface (GUI) as described in Provisional Patent Application No. 63/472,602 filed on June 13, 2023, and/or in the PCT application derived therefrom, having a docket number of 100411, and the contents of which are hereby incorporated by reference.
- UI user interface
- GUI graphical user interface
- the 3D representation of the JIG is automatically designed without necessarily requiring manual input.
- the features of the femur and/or foot print and/or guiding elements and/or other parameters described herein may be automatically selected according to a surgical plan defining a surgical indication.
- a 3D representation of the JIG may be automatically generated to comply with the surgical plan and/or features of the femur and/or foot print and/or guiding elements and/or other parameters described herein.
- a user may manually adapt the surgical plan and/or features of the femur and/or foot print and/or guiding elements and/or other parameters described herein, which may trigger an automatic adaption of the 3D representation of the JIG, rather than adapting the 3D representation of the JIG directly.
- the user may adapt the location and/or shape of the footprint for automatically generating the adapted JIG, rather than adapting the JIG to fit the adapted footprint.
- the JIG may be 3D printed by a 3D printed according to the 3D representation.
- FIG. 14A-B showing a flowchart describing an exemplary input-output system of the program for designing a guiding JIG, in accordance with some exemplary embodiments of the invention.
- This flow chart is an elaboration of steps 1306-1308 described in figures 13A-B.
- a scan image of the femoral bone of the patient is received, as described in step 1302 of Figure 13 A.
- a computed 3D model of the femur is created, simulating the bone anatomy of the patient, as described in step 1304 of Figure 13A.
- a preoperative input is received, by a user of the program, optionally a physician.
- the combination of the preoperative input and the bone anatomy defines the design of the guiding JIG and/or set of at least two guiding JIGs.
- the preoperative input includes: a. the selected fixation angle of the plate, which defines the correction angle. b. the type of the selected plate; c. the selected set of tools; and d. the surgical approach.
- a range of options can be inputted, for receiving an optional design suggested by the feedback system of the program, considering the patient's anatomy. For example, a range of fixation angles and/or several plate types and/or several possible sets of operation tools, and/or any combination thereof and of additional possible input.
- partial preoperative input can be received, optionally, the feedback system alerts for missing information, alternatively or additionally the feedback system suggests an optimal guiding JIG, including suggestions for the missing perioperative input.
- the program conveys confirmation notice.
- the program conveys a confirmation notice if at least one guiding JIG is feasible.
- the program displays the feasible guiding JIG designs, optionally sorted in descending order according to recommendation, alternatively or additionally the program indicates the advantages and/or disadvantages of each design.
- the program conveys an error notice.
- the program lists the reasons for the unfeasibility, for unbinding example, if the selected plate type and/or selected correction angle does not correspond to the size of the bone, and/or if the selected set of tools doesn’t correspond to the selected plate type and/or surgical approach.
- the program suggests feasible alternatives.
- the alternative suggestions may include alteration of the fixation angle and/or type of plate and/or set of tools and/or surgery approach or any combination thereof.
- the program indicates the benefits of each suggestion.
- the program may suggest beneficial alternatives.
- the program indicates the benefits of each suggestion over the guiding JIG is defined by the preoperative input.
- the alternative suggestions may include alteration of the fixation angle and/or type of plate and/or set of tools and/or surgery approach or any combination thereof.
- the program will display the optimal feasible design, alternatively, the program will display several feasible guiding JIG designs, optionally the program further displays alternative suggestions that may include alteration of the fixation angle and/or type of plate and/or set of tools and/or surgery approach or any combination thereof.
- the program essays if a two stages surgery is preferable, for example in cases of relatively enhanced current shaft angle.
- the program suggests a fixation angle for the first surgery and optionally a fixation angle for the future second surgery.
- the program receives feedback from the user.
- the user may confirm a suggested guiding JIG design or deny the guiding system suggestions.
- the feedback system requests a new and/or modified preoperative input.
- the feedback system proceeds to this stage.
- the feasibility of the new and/or modified preoperative input is re-tested.
- the user confirms at least one of the guiding JIG designs offered by the feedback system.
- the selected design is computer designed, optionally, a single guiding JIG, alternatively or additionally, a kit including a set of at least two guiding JIGs.
- the selected guiding JIG and/or set of guiding JIGs are produced, as described in figure 13B, step 1320.
- FIGS 15A-B showing a top top-level flowchart of an exemplary algorithm for designing a guiding JIG, in accordance with some exemplary embodiments of the invention.
- a 3D model of the formal bone is created, which simulates the bone anatomy of the patient.
- the femur neck is identified
- the neck-head axis, at the center of the femur head, is identified.
- the longitudinal femoral shaft-neck axis at the center of the femur is identified.
- the correction angle is calculated. First, the current shaft angle between the neckhead axis and the longitudinal femoral shaft-neck axis is identified. Then, the selected desired shaft angle is selected and subtracted from the current shaft angle, the subtraction result is the correction angle.
- a first cutting plane is created, vertical to the femoral head- neck axis.
- a second cutting plane is created, a plane relative to the first cutting plane, according to the calculated correct angle.
- a vector for fixating is created.
- representations of guiding elements into the center of the femur head are created. These guiding elements are in line with the femoral head-neck axis.
- a representation of a guiding conduit for guide implement is created, alternatively or additionally, a guiding conduit for chisel is created.
- guiding elements for cutting the bone are created. These guiding elements are positioned according to the first and second cutting planes. In some embodiments of the invention at al least one cutting slot, optionally two cutting slots and/or an osteotomy guide are created.
- a representation of at least one fixating guiding element is created.
- the at least one representation of the fixating guiding element is in line with the vector for fixating.
- the vector for fixating defines a path which does not collide with the path of the representation of the functional guiding elements.
- a representation of the JIG body is created, based on the simulation of the bone geometry.
- representations of structural support elements are created.
- the guiding JIG design is tested, as mentioned above.
- the guiding JIG is produced, as described in step 1320, figures 13A-B.
- FIGS 16A-G, and 17A-B showing a detailed flowchart of an exemplary method for designing a guiding JIG, in accordance with some exemplary embodiments of the invention.
- a scan image of the patient's femur is received, as described in Figure 13A step 1302.
- a digitized scan image is inputted, alternatively of additionally, a scan image is obtained on site and uploaded using a scanning device conjugated to a computer.
- a 3D model of the femur is created, based on the scan image of the patient.
- the 3D model of the femur is represented by a mesh file simulating the anatomy of the patient's femur, resulting from a segmentation of the scan image.
- the 3D model simulates the femoral bone anatomy at the treatment site, alternatively or additionally, the 3D model simulates the femoral bone anatomy extending distally to include an enhanced area of the femur to allow the calculation of the rotation correction of the femur.
- the 3D model which represents the anatomy of the femur is deconstructed to naked lines and naked points, as shown in Figure 18A.
- the naked vertices are compiled into a list, optionally including all the naked vertices, alternatively, including the majority of the naked vertices.
- the list of naked vertices is sorted according to Z-values which represent height, with respect to the longitudinal shaft-head axis of the femur, optionally, in descending order. Alternatively, or additionally, the list of naked vertices is filtered by height, with respect to the longitudinal shaft-head axis of the femur, to include the highest values.
- the points from the naked vertices list, having the highest Z-value are compiled into a sup list.
- the sup list represents the proximal portion of the femur head 1802, shown in Figure 18B.
- the sup list includes about 500 points of the highest Z-values from the naked vertices list.
- a fit sphere 1804 (shown in figure 18C), which represents the femur head is created by using a maximum number of naked points from the sup list, possible to represent the femur head.
- a second sphere 1806 (shown in Figure 18D), is created based on the fit sphere 1804.
- the second sphere is co-centered with the fit sphere.
- the size of the second sphere is expended relative to the fit sphere, optionally, one and a half times larger than the fit sphere.
- the size of the second sphere can be adjusted to obtain an area where the geometry (boundary) thereof intersects in the femur neck, as shown in Figure 18D.
- a contour 1808) which represents the center of the femur head, is identified.
- the contour is at the intersection between the second sphere and the bone geometry is, as shown in figure 18E.
- a midpoint 1810 located at the center of the area defined by contour 1808, is identified, as shown in Figure 18F.
- the femur head axis 1812 is represented by a line between the center of the fit sphere 1814, and the midpoint representing the center of the femur neck 1810, as shown in figure 18G.
- a representation of a guide implement (not shown) is positioned at the center of the femur head and protruding therefrom.
- the guide implement is aligned with the femur head axis.
- the representation of the guide implement is thickened to create a representation of a guide conduit into the center of the femur head.
- the list of naked vertices is sorted according to Z-values which represent height, relative to the longitudinal shaft-neck axis, optionally, in ascending order. Alternatively, or additionally, the list of naked vertices is filtered by height to include the lowest values.
- the points from the naked vertices list having the lowest Z-value are compiled into a sup list.
- the sup list represents a distal portion of the femur 1818, shown in Figure 18H.
- the sup list includes about 500 points of the lowest Z-values from the naked vertices list.
- a fit plane 1820 is created by using the points of the sup list compiled at step 1726, as shown in Figure 181.
- Second plane 1822 is proximally to fit plane 1820, optionally, offsets in about 50 mm from fit plane 1820, as shown in figure 18J. In some embodiments, the second plane is created proximally to ensure that the measurement is performed in an area that is not too distal.
- the Intersection curve between the fit plane and the femur anatomy is represented by a contour 1824, as shown in figure 18K.
- the Intersection curve between the second plane and the femur anatomy is represented by a contour 1826, as shown in figure 18K.
- the midpoint 1828 at the center of the area defined by contour 1824, and the midpoint 1830 at the center of the area defined by contour 1826, are identified, as shown in Figure 18L.
- the longitudinal femur shaft- neck axis 1832 (shown in figure 18M) is represented by a line between midpoint 1828 and midpoint 1830.
- the current neck shaft angle 1834 (shown in figure 18N) between the femur headneck axis 1810 and the longitudinal femur shaft-neck axis is identified.
- the selected plate 1836 is represented, as shown in figure 180.
- the fixation angle of the selected plate defines a desired neck shaft angle 1838 as shown in Figure 18Q.
- the selection is based on the angles of the plates available in a kit, for example, 100, 110, 115 degrees.
- the representation of the selected plate 1836 is placed on the 3D model of the femur, and the representation of the blade of the plate 1837 is aligned with the femur head-neck axis 1810, as shown in Figure 18P.
- the correction angle 1840 is calculated, by subtracting the fixation angle 1838 from the current shaft- neck angle 1834, as shown in figure 18Q.
- a plane along curve 1840 is created, perpendicular to the femur head-neck axis, as shown in Figure 18R.
- the plane along curve represents a first cutting plane.
- the plane along curve is placed distally to the intersection between the neck-head axis of the femur and the representation of the bone anatomy 1841, relative to the head-neck axis. In some of the inventions the distance from intersection 1841 is 14 mm for a child and/or 10 mm for an infant.
- an axis 1842 at the intersection between the plane along curve 1840 and the femoral bone anatomy, is created, as shown in figure 18S.
- an angled plane 1844 is created, based on the axis 1840 at the intersection between the plane along curve 1842 and the femoral bone anatomy, and at the correction angle 1840, relative to the plane along curve, as shown in figure 18T.
- the angled plane 1844 represents a second cutting plane.
- the representation of a bone wedge defined by the intersection of the plane along curve and the angled plane is subtracted from the 3D model of the bone anatomy, as shown in Figure 18U.
- the subtraction of the bone wedge creates a representation of the distal fragment of the bone 1846 and the proximal fragment of the bone 1848.
- a rotation axis is created, at the center of the femur neck, based on the intersection of the plane along curve and angled plane, as shown in figure 18V.
- a representation of the distal fragment of the femur 1846 is rotated, based on the rotation axis to achieve post position.
- the position of the plate representation 1836 is aligned and/or corrected by translation, as shown in Figure 18X.
- a representation of the selected chisel 1850 is placed, according to the representation of the plate, as shown in Figure 18Y.
- the representation of the chisel 1850 is thickened, to create a representation for chisel guide 1852, as shown in figure 18Z.
- the representation of the chisel 1850 is thickened to create a representation for chisel guide 1852 with 0.2 tolerance for 2.5 mm thick chisel.
- the first cutting plane is thickened, according to a selected first cutting tool geometry, to create a representation for a first cutting slot 1854, as shown in Figure 19A.
- the second cutting plane is thickened, according to a selected second cutting tool geometry, to create a representation for a second cutting slot 1856, as shown in Figure 19 A.
- the first cutting tool and the second cutting tool has the same geometry.
- the cutting tool geometry requires that the first cutting plane and the second cutting plane are thickened to 1 mm.
- the cutting slots 1854 and 1856 are thickened to create a frame therefor, which defines a representation for an osteotomy guide for cutting tools 1858, shown in figure 19B.
- At 1672 at least one vector 1860 perpendicular to the cutting slots 1854 and 1856, is created, as a basis for generating a fixation guiding element, as shown in figure 19C.
- fixation cylinder 1862 based on the vector 1860 perpendicular to the cutting slots, is created, as shown in figure 19D.
- the fixation cylinder 1862 has a diameter of 1.6 mm.
- a fit geometry box 1864 is created, surrounding the representation of the osteotomy guide 1858 and the cylinder 1862, as shown in figure 19E.
- a footprint 1866 is created, defined by the overlap of the fit geometry box with the femoral bone anatomy.
- the footprint is thickened, to create a representation of the JIG body 1868.
- the footprint is thickened to 2.5 mm.
- guiding JIG 300 and/or 550 optionally, for used standalone, alternatively or additionally, as a part of a kit including at least two guiding JIG.
- the representation of the JIG body is combined with the representation of the guide conduit into the center of the femur head.
- the representation of the JIG body is further combined with the representation of the osteotomy guide.
- the designed guiding JIG is part of a set, including additional guiding JIG with osteotomy guide, so that the osteotomy guide representation is not combined.
- the representation of the JIG body is further combined with the at least one fixation cylinder.
- the representation of the bone geometry is subtracted from the 3D model.
- the representation of the guide implement geometry is further subtracted from the 3D model.
- the representation of the cutting slots is further subtracted from the 3D model. If the guiding JIG design does not include an osteotomy guide this step is not performed.
- the representation of the at least one fixation cylinder geometry is further subtracted from the 3D model.
- fit box geometry extends from the center of the representation of the guide conduit into the center of the femur head, relative to the longitudinal axis thereof, to the representation of the osteotomy guide.
- the guiding JIG is produced, as described in step 1530 of figures 15A-B.
- guiding JIG 400 and/or 500 optionally, for used standalone, alternatively or additionally, as a part of a kit including at least two guiding JIGs.
- the representation of the JIG body is combined with the representation of the chisel guide into the center of the femur head.
- the representation of the JIG body is further combined with the representation of the osteotomy guide.
- the representation of the JIG body is further combined with the at least one fixation cylinder.
- the representation of the bone geometry is subtracted from the 3D model.
- the representation of the cutting slots is further subtracted from the 3D model
- the representation of the chisel geometry is further subtracted from the 3D model.
- the representation of the at least one fixation cylinder geometry is further subtracted from the 3D model.
- structural support is added.
- a fit box geometry optionally, 3 mm thick.
- the fit box geometry extends from the center of the representation of the chisel guide into the center of the femur head, relative to the longitudinal axis thereof, to the representation of the osteotomy guide.
- the guiding JIG is produced, as described in step 1530 of figures 15A-B.
- FIG. 20A-B showing perspective views of a disassemblable guiding JIG 2000 for a VDRO process, in accordance with some exemplary embodiments of the invention.
- Guiding JIG 2000 is similar to other guiding JIG described herein, the same reference numerals have been used to denote parts that are similar to those described for other guiding JIG, with the prefix 20.
- guiding JIG 2000 comprises a removable portion 2050 (e.g., a removable part and/or a removable segment), optionally located between cutting slot 2018 and cutting slot 2020.
- removable portion 2050 corresponds to the bone wedge separated and/or intended to be cut from the bone (e.g., shaped, sized, and/or positioned as the bone wedge).
- removable portion can be removed remaining a proximal portion 2052 (e.g., a proximal part and/or a proximal segment), and a distal portion 2054 (e.g., a distal part and/or a distal segment), of guiding JIG 2000 mounted on the bone.
- Proximal portion 2052 remains on a proximal fragment of the bone and distal portion 2054 remains on a distal portion of the bone. Then the distal bone fragment and the proximal bone fragment can be positioned relative to each other while the portions 2052 remain on the bone fragments.
- proximal portion 2052 and distal portion 2054 are used to guide said positioning, optionally, by aligning proximal portion 2052 and distal portion 2054.
- each cutting slot 2018 and 2020 is defined by two surfaces (also referred to herein as cutting surfaces, as described for example for guide osteotomy 1920 of guiding JIG 1900.
- removable portion 2050 comprises a proximal cutting surface 2058 of cutting slot 2018 (e.g., the distal cutting slot) and a distal cutting surface 2056 of cutting slot 2020 (e.g., the proximal cutting slot) so that upon removal of removable portion 2050, proximal portion 2052 remains with proximal cutting surface 2060 and distal portion 2054 remains with distal cutting surface 2062.
- surfaces 2060 and 2062 are used to guide the attachment of the proximal bone fragment to the distal bone fragment by joining the two surfaces together.
- distal portion 2054 comprises at least one mark (not shown) configured to be joined with a complementary mark of proximal portion 2052, thereby positioning the distal bone fragment in a desired positioning with respect to the proximal bone fragment.
- the at least one mark is positioned circumferentially on the distal portion 2054 according to a desired rotation correction.
- distal portion 2054 can be aligned with proximal portion 2052 by aligning a distal guiding element (such as distal guiding hole 324) with a proximal guiding element (such as conduit 312 and/or proximal guide hole 326).
- each distal portion 2054 and proximal portion 2052 comprises at least fixating guide 2024 for directing a fixator therethrough for anchoring each JIG portion to the bone (upon the removal of portion 2050).
- removable portion 2050 can be disassembled from JIG body 2002 (e.g., guiding JIG 2000). Alternatively or additionally, removable portion 2050 can be cut out of JIG body 2000, optionally, after and/or during performing osteotomy. In some embodiments, removable portion 2050 comprises guiding lines for directing cutting thereof.
- portions 2052 and/or 2054 comprises at least one guide hole and/or conduit for directing the deployment of a plate (such as proximal drilling hole 326).
- a plate can be mounted on top of portions 2052 and/or 2054, then the portions 2052 and/or 2054 can be removed from therebeneath and further fastening the plate to the bone.
- portions 2052 and/or 2054 are comprised of sup-portions allowing the disassembly and removal thereof, alternatively or additionally, portions 2052 and/or 2054 are cuttable and/or tearable allowing to be removed by cutting and/or tearing thereof.
- portions 2052 and/or 2054 comprise line(s) and/or area(s) on JIG body 2002 having a thin material and/or spaced holes, for potentially facilitating and/or directing the JIG cutting and/or tearing.
- removable portion 2050 can be removed from guiding JIG 2000 (and/or from the bone) prior to the osteotomy.
- the osteotomy can then be performed using proximal cutting surface 2060 and/or proximal cutting surface 2062, optionally by cutting the bone along and adjacent to the surfaces.
- Performing osteotomy using the cutting surfaces potentially increases the operator's degrees of freedom, for example, if needed during surgery.
- removing removable portion 2050 potentially allows lateral movements and/or angle adjustment of the cutting tool.
- a guiding JIG (e.g., guiding JIG 2000) comprises one or more grip holes for gripping thereof and/or a portion thereof.
- the one or more gripping holes are located on removable portion 2050 for potentially simplifying the removal thereof when and/or if needed.
- FIGS 21A-C showing perspective views of a disassemblable guiding JIG 2100 for a, in accordance with some exemplary embodiments of the invention. It should be understood that the feature of grip holes is demonstrated on guiding JIG 2100 (designed for a hip replacement procedure) to allow a person having skills in the art to understand the invention and is not intended to limit the invention in any way.
- the feature of grip holes can be employed on various other guiding JIGs, including guiding JIGs for VDRO described herein.
- guiding JIG 2100 (and/or any other guiding JIG described herein) comprises one or more grip holes 2040 for holding guiding JIG 2100, optionally using a gripping tool.
- guiding JIG 2100 may be gripped at one or more grip holes during a positioning, repositioning, alignment, and/or removal of guiding JIG 2100 and/or a portion thereof.
- one or more grip holes 2040 are shaped and/or sized according to a selected gripping tool.
- guiding JIG 2000 comprises a portion 2132 intended for removal before and/or after osteotomy and a portion 2130 intended to remain on the bone after said removal.
- portion 2132 comprises one or more grip holes 2040, having a potential advantage or simplifying the removal thereof.
- guiding JIG 2100 comprises at least one connection point 2142 for connecting between portion 2132 and portion 2130.
- This connection potentially enables deploying guiding JIG 2100 as a single unit, optionally, having a sufficient contact surface for aligning the JIG body 2102 on the bone surface.
- at least one connection point 2142 is defined by a geometry on portion 2132 (e.g., on surface 2125) and a complementary geometry on portion 2130 (e.g., on surface 2124).
- portion 2132 comprises one or more protrusions
- portion 2030 comprises one or more recesses shaped and/or sized to accommodate these protrusions, and/or vice versa.
- these protrusions are in the form of sliding pins, shaped and/or sized to be moved along channel- shaped recesses with an open end to allow disconnection.
- said geometries are located at a center portion of osteotomy guide 2120, as shown for example in the figures. In other embodiments, said geometries are located at one and/or both sides of osteotomy guide 2020, for potentially allowing to cut through cutting slot 2122.
- cutting surfaces 2124, 2125 are produced (e.g., 3D printed) connected at at least one connecting point 2140, optionally, intended to be cut and/or tom, thereby separating portion 2132 from portion 2030.
- osteotomy guide 2120 is produced as a frame that can be cut to form separated cutting surfaces 2124, 2125.
- at least one connecting point 2140 is marked for directing cutting thereof.
- at least one connecting point 2140 comprises spaced holes over JIG body 2102 and/or a thin layer of JIG body 2102 for potentially directing and/or facilitating the cut.
- a guiding JIG deployable in parts.
- guiding JIG 2000 (shown for example in Figures 20A-B) is comprised of three separated portions proximal portion 2052, removable portion 2050 and distal portion 2054. In some embodiments, said portions are attached to form a single unit upon JIG deployment that can be separated upon JIG removal, allowing removal in parts and/or steps.
- guiding JIG 2000 can be mounted on the bone in parts, defined by the portions thereof.
- FIG. 22A-C showing perspective views of guiding JIG 2200 deployable in parts, in accordance with some exemplary embodiments of the invention.
- guiding JIG 2200 (e.g., JIG body 2202) is comprised of more than one JIG portion (e.g., JIG parts) allowing thereof to be deployed on a target site in parts.
- JIG portion e.g., JIG parts
- This deployment has a potential advantage of facilitating mounting JIG 2200 on the bone, potentially, while not comprising a match, optionally a singular steady match, between the guiding JIG and the bone surface at the treatment site. It is to be noted that said deployment in parts may have a particular use in guiding JIGs having relatively large and/or complex JIG body 2202.
- guiding JIG 2200 comprises at least one portion 2230 (e.g., at least one part and/or segment), configured to be aligned with the bone geometry and at least one additional portion 2232 (e.g., at least one additional part and/or segment configured to be aligned with at least one portion 2230.
- at least one additional portion 2232 is configured to be aligned with the bone geometry as well.
- At least one portion 2230 comprises an inner surface configured to face the bone (e.g., femur head) having a geometry that complements the geometry of the bone at the treatment site. This complementation allows guiding JIG 1800 to be positioned steadily on the bone, optionally, in a single possible configuration.
- at least one portion 2230 is selected and/or defined according to the bone surface and/or structure. For example, at least one portion 2230 is configured to be deployed on a bone portion having protrusions and/or depression, potentially simplifying the alignment of at least one portion 2230 over the bone.
- At least one portion 2230 comprises at least one engagement point 2234 for aligning at least one additional portion 2232 thereto, optionally or additionally, at least one engagement point 2234 enables additional portion 2232 to connect to at least one portion 2230.
- This connection has the potential advantage of reducing and/or avoiding the insertion of fixator(s) for fixing additional portion 2232.
- At least one engagement point 2234 comprises a geometry that interacts with a complementary geometry 2236 of at least one additional portion 2232.
- the interaction geometrically interferes with relative movements between the geometry of engagement point 2234 and complementary geometry 2236, thereby fixing and/or anchoring at least one portion 2232 to at least one portion 2230 and/or to the bone.
- At least one engagement point 2234 comprises at least one protrusion shaped and/or sized to fit within at least one recess of complementary geometry 2236.
- at least one engagement point 2234 comprises at least one recess shaped and/or sized to accommodate at least one protrusion of complementary geometry 2236.
- At least one additional portion 2232 is configured to partially cover at least one portion 2230.
- at least one engagement point 2234 is positioned on an outer surface of portion 2230 configured to be covered by at least one portion 2232 whereas complementary geometry 2236 is positioned on an inner surface of portion 2232 configured to cover at least one portion 2232.
- at least one additional portion 2232 is configured to be adjacent to at least one portion 2230, optionally, not covering at least one portion 2130.
- at least one engagement point 2234 and complementary geometry 2236 are located at the contact interface between at least one additional portion 2232 and to at least one portion 2230.
- guiding JIG 2200 enables a removal thereof in parts, having the potential advantage of facilitating the JIG removal procedure.
- a guiding JIG for VDRO procedure comprises a guiding conduit into the femur head, optionally the center of the femur head, comprising a slit thereon which enables the removal of the guiding JIG while a tool deposited therewithin and inserted into the bone, remains within the bone.
- such a slit can be used in a first guiding JIG designed for inserting a guide implement (e.g., K-wire) into the center of the femur head, and be removed from the bone without removing the guide implement, then, a second guiding JIG can be mounted thereon, optionally, a guiding JIG having a guide conduit shaped and/or sized to receive a chisel.
- the guide conduit for a chisel may comprise a slit as well for potentially simplifying introducing the guide implement thereinto.
- FIG. 22A-C showing, inter alia, a guiding JIG having a guide conduit 2212 with a slit 2218.
- guiding conduit with a slit is demonstrated on guiding JIG 2200 (designed for a hip replacement procedure) to allow a person having skills in the art to understand the invention and is not intended to limit the invention in any way.
- the feature of guiding conduit with a slit can be employed on various other guiding JIGs, including guiding JIGs for VDRO described herein.
- guiding conduit 2212 comprises a slit 2218 extending from proximal end 2218 of guiding JIG 2200, (defined by the proximal end of conduit 1612), to the distal end of the conduit, at a circumferential location thereon where there is no connection to JIG body 2202.
- Slit 2218 potentially enables inserting a guide implement (e.g., a K-wire and/or a sleeve) therethrough and then removing guiding JIG 1600 while said guide implement remains inserted within the femur head.
- a guiding conduit is sized and/or shaped to receive a guide implement (such as a K wire), such as guiding conduit 310 shown in Figure 3A.
- the diameter of inner lumen 312 is about 3.5 mm for accommodating a guide implement having a diameter of about 3 mm.
- guiding conduit 2212 is sized and/or shaped according to a reducer, optionally shaped as a removable sleeve (not shown), the reducer, comprises an inner lumen for inserting the selected guide implement therethrough.
- the sleeve defines a cylindrical shape to inner lumen 2215.
- the reducer is placed within guiding conduit 2212 and reduces the effective diameter thereof.
- the reducer comprises an inner lumen for inserting a K-wire thereto and into the bone, directed according to the position and/or orientation of guiding conduit 2212. After inserting the K-wire into the bone, the reducer can be removed from the proximal opening of guiding conduit 2212.
- slit 2218 is relatively wide, defining an opening in wall 2214 (e.g., a distance between circumferential ends 2213, 2215 of wall 2214), as shown for example in figures 16A-B. This opening potentially enables and/or facilitates the removal of a guiding JIG while a guide implement is inserted through conduit 2212.
- slit 2218 is sufficiently narrow for a reducer, optionally shaped as a cylindrical sleeve, to occupy lume 2214 without passing through slit 2218.
- slit 2218 is sufficiently wide for allowing a guide implement (such as a K-wire), inserted into the reducer, to pass through slit 2218, after the reducer is removed.
- the diameter of inner lumen 2218 is about 12.5 mm for accommodating a reducer (e.g., a sleeve) having a diameter of 12 mm.
- a reducer e.g., a sleeve
- the arc length of slit 2218 is about 3 mm potentially allowing a K-wire having a diameter of about 2 mm to pass therethrough.
- slit 2218 is relatively thin, allowing wall 2214 to maintain a tubular shape (e.g., allowing the circumferential ends 2213, 2215 of wall 2214 to contact each other) during the insertion of a guide conduit 2212 and to be opened when removing guiding JIG 2200.
- slit 2218 is defined by a line on wall 2214, intended to be cut/torn while and/or before removing JIG 2200.
- slit 2218 and/or a portion thereof comprises a thin layer of material, and/or spaced holes that define said line.
- said line is in the form of a straight, alternatively or additionally, the line can have any other shape, such as curved and/or jagged.
- slit 2218 extends parallel to the longitudinal axis of guiding conduit 2212, alternatively or additionally, slit 2218 at least partially surrounds conduit 2212.
- FIG. 23A-C showing perspective views of a guiding JIG 2300 having a sturdy guiding element, in accordance with some exemplary embodiments of the invention.
- FIG. 23D showing a perspective view of a sturdy surface(s) for a guiding JIG, in accordance with some exemplary embodiments of the invention.
- FIG. 23E showing a sturdy surface(s) before being folded to achieve a three-dimensional form of the sturdy surface(s), in accordance with some exemplary embodiments of the invention.
- guiding JIG 2300 (designed for a hip replacement procedure) to allow a person having skills in the art to understand the invention and is not intended to limit the invention in any way.
- the feature of a sturdy guiding element can be employed on various other guiding JIGs, including guiding JIGs for VDRO described herein.
- guiding JIG 2300 (e.g., and/or any other guiding JIG described herein) comprises one or more guiding elements, resistant to contact with a sharp operating tool and/or sharp bone residues formed during surgery. This resistance has the potential advantage of reducing and/or avoiding damaging the JIG during surgical procedures which might impair the function thereof.
- An additional potential advantage is reducing and/or avoiding the creation of JIG residues (segments and/or crumbles from the JIG) that may undesirably remain within the patient’ s body.
- guiding JIG 2300 comprises a sturdy osteotomy guide 2320.
- the inner lumen of supporting frame 2324 and/or a portion thereof is covered by one or more sturdy surface(s) 2344, defining a sturdy contact surface(s). Said sturdy contact surface(s), potentially having resistance to scratches and cuts when operating tools and/or sharp bone residues contacting thereof.
- one or more sturdy surface(s) 2344 are, shaped and/or sized to be mounted within supporting frame 2324, optionally, according to the shape of supporting frame 2324.
- osteotomy guide 2320 comprises a cutting surface (e.g., a single cutting surface) (for example cutting surface 2124 and/or 2125) so one or more sturdy surface(s) 2344 are, shaped and/or sized to be mounted on said cutting surface, optionally, shaped as a surface.
- one or more sturdy surface(s) 2344 comprises two sturdy surface(s), optionally parallel to each other, as shown for example in Figure 21D.
- the two sturdy surface(s) are connected at a connection area and/or line 2349.
- one or more sturdy surface(s) 2344 comprises and/or is made of metal, such as stainless steel and/or titanium alloys.
- a guiding JIG may comprise a sturdy guiding conduit (e.g., guiding conduit 112).
- sturdy guiding conduit e comprises a sturdy surface therewithin, optionally, shaped as a tube and or a tube segment.
- a sturdy guiding conduit may have a particular use upon drilling therethrough and/or upon introducing sharp and/or rough implements, such as screws.
- one or more sturdy surface(s) 2344 are customized (e.g., shaped and/or sized) according to a selected operating tool and/or according to a guiding JIG design.
- the guiding JIG is designed (e.g., shaped and/or sized) to fit onto one or more sturdy surface(s) 2344, optionally, customized sturdy surface(s) 2344, alternatively or additionally, a shelf sturdy surface(s) 2344.
- supporting frame 2324 is shaped and/or sized to accommodate one or more sturdy surface(s) 2344, such that one or more sturdy surface(s) 2344 are positioned adjacent to the inner walls of supporting frame 2324.
- one or more sturdy surface(s) 2344 comprises at least one anchor for connecting to a guiding element (e.g., support frame 2324 and/or cutting surfaces).
- at least one anchor is in the form of at least one folded end 2346 of one or more sturdy surface(s) 2344, optionally two folded ends, shaped and/or sized to grip the edges of the guiding element (e.g., the edges of support frame 2344).
- one or more sturdy surface(s) 2344 comprises additional anchor 2348 optionally in the form of a plate and/or an arm which presses the outer surface of the support frame 2344 against the one or more sturdy surface(s) 2344. This press potentially allows sturdy surface(s) 2344 to cling to the inner surface of support frame 2344 and/or grip a wall of the support frame 2344 (and/or a cutting surface) by pressing it between additional anchor 2348 and the support frame 2324.
- one or more sturdy surface(s) 2344 is produced in a flat form, as shown for example in Figure 2 IE.
- one or more sturdy surface(s) 2344 is manufactured and/or cut to have a flat foldable form.
- the flat form is folded, for example at the center thereof (e.g., at connection area/line 2349) to obtain a desired three-dimensional shape.
- FIG. 23C showing, inter alia, a perspective view of guiding IIG having a verification element 2350, in accordance with some exemplary embodiments of the invention.
- guiding JIG 2300 designed for a hip replacement procedure
- the feature of a verification element can be employed on various other guiding JIGs, including guiding JIGs for VDRO described herein.
- a guiding JIG (e.g., each of the guiding JIGs described herein, such as guiding JIG 100 and/or 200) comprises a verification element 2350 for potentially evaluating that a produced JIG is shaped and/or sized according to a desired design (also referred to herein as a proper production of JIG and/or a JIG properly produced).
- verification element 2350 (e.g., a measurable mark) comprises dimensional elements, designed to have a specific size and/or shape.
- a produced guiding JIG having a verification element that presents deviation from the pre-designed shape and/or size thereof may indicate improper production on the JIG and/or undesired deformation thereof. This deviation can be detected for example by measuring and/or observing the verification element 2350. This detection potentially indicates to that a produced guiding JIG may be defective, having the potential advantage of reducing and/or avoiding the risk of performing surgery and/or any other medical procedures using a defective JIG.
- the verification element may be in the form of a round coin designed to have a specific diameter, a ring with a specific outer and inner diameter, a triangle any quadrilateral with defined side lengths, and/or any other shape having defined dimensions.
- the JIG is provided with a dedicated measuring device that comprises a recess, shaped and/or sized according to the pre-designed shape and/or size of the verification element.
- a verification element of a produced JIG that fits within said recess and complements the shape and/or size thereof potentially indicates proper production of the JIG (e.g., a production achieving a desired design).
- distortion of the shape and/or size of the verification element and/or of a shape printed thereon can be evaluated using image processing of the JIG.
- the guiding JIG comprises more than one verification element, optionally, distance for each other, optionally on different portions of the guiding JIG body. Identification of the proper production of more than one verification element potentially improves the induction reliability of a proper JIG production.
- a verification element is positioned on and/or next to each guiding element of the JIG.
- the verification element comprises resolution elements, optionally in the form of fine details such as small features, thin walls, and intricate patterns.
- the resolution elements can be visually inspected (by the human eye and/or by image processing) optionally under magnification, to evaluate the production resolution.
- the resolution elements are designed to indicate the reliability of relatively fine features such as the details of inner surface 105 (e.g., that should match the topography of the bone).
- compositions, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
- a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
- range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
- method refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.
- the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition. It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.
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Abstract
La présente invention, dans certains modes de réalisation de celle-ci, concerne un groupe d'intégration d'articulaire de guidage chirurgical (GABARIT) et, plus particulièrement, mais pas exclusivement, un gabarit de guidage chirurgical pour une procédure ostéotomie de dérotation en varus (VDRO).
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202363472392P | 2023-06-12 | 2023-06-12 | |
| US202363472397P | 2023-06-12 | 2023-06-12 | |
| US63/472,397 | 2023-06-12 | ||
| US63/472,392 | 2023-06-12 | ||
| US202363472602P | 2023-06-13 | 2023-06-13 | |
| US63/472,602 | 2023-06-13 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2024257100A2 true WO2024257100A2 (fr) | 2024-12-19 |
| WO2024257100A3 WO2024257100A3 (fr) | 2025-01-23 |
Family
ID=93851598
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IL2024/050584 Ceased WO2024257102A1 (fr) | 2023-06-12 | 2024-06-11 | Plateforme d'automatisation pour instruments spécifiques à un patient |
| PCT/IL2024/050582 Ceased WO2024257101A1 (fr) | 2023-06-12 | 2024-06-11 | Procédés et appareil pour une procédure de resurfaçage de hanche et de remplacement de hanche à l'aide d'un gabarit de guidage |
| PCT/IL2024/050581 Ceased WO2024257100A2 (fr) | 2023-06-12 | 2024-06-11 | Méthodes et appareil pour opération d'ostéotomie de dérotation en varus (vdro) à l'aide d'un gabarit de guidage |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IL2024/050584 Ceased WO2024257102A1 (fr) | 2023-06-12 | 2024-06-11 | Plateforme d'automatisation pour instruments spécifiques à un patient |
| PCT/IL2024/050582 Ceased WO2024257101A1 (fr) | 2023-06-12 | 2024-06-11 | Procédés et appareil pour une procédure de resurfaçage de hanche et de remplacement de hanche à l'aide d'un gabarit de guidage |
Country Status (2)
| Country | Link |
|---|---|
| EP (1) | EP4723999A1 (fr) |
| WO (3) | WO2024257102A1 (fr) |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6676706B1 (en) * | 2000-04-26 | 2004-01-13 | Zimmer Technology, Inc. | Method and apparatus for performing a minimally invasive total hip arthroplasty |
| US8858561B2 (en) * | 2006-06-09 | 2014-10-14 | Blomet Manufacturing, LLC | Patient-specific alignment guide |
| US9113971B2 (en) * | 2006-02-27 | 2015-08-25 | Biomet Manufacturing, Llc | Femoral acetabular impingement guide |
| EP2157926B1 (fr) * | 2007-05-14 | 2015-04-22 | Queen's University At Kingston | Outil de guidage chirurgical adapté au patient |
| US8123753B2 (en) * | 2008-04-28 | 2012-02-28 | Depuy (Ireland) Ltd. | Cutting guide assembly |
| EP2434991B1 (fr) * | 2009-05-29 | 2018-01-24 | Smith&Nephew, Inc. | Appareil de réalisation d'une arthroplastie du genou |
| WO2012058355A1 (fr) * | 2010-10-29 | 2012-05-03 | The Cleveland Clinic Foundation | Système de planification préopératoire et de fourniture d'aides chirurgicales spécifiques du patient |
| WO2012176077A1 (fr) * | 2011-06-24 | 2012-12-27 | Stryker Global Technology Center | Blocs d'alignement de patient appariés de manière anatomique |
| US10098761B2 (en) * | 2012-03-31 | 2018-10-16 | DePuy Synthes Products, Inc. | System and method for validating an orthopaedic surgical plan |
| US10022130B2 (en) * | 2013-03-05 | 2018-07-17 | Depuy Ireland Unlimited Company | Polymer 4-in-1 femoral cutting block |
| WO2019005708A2 (fr) * | 2017-06-25 | 2019-01-03 | Strong Force Intellectual Capital, Llc | Procédés et systèmes pour permettre et planifier une fabrication basée sur une impression 3d |
| US11259874B1 (en) * | 2018-04-17 | 2022-03-01 | Smith & Nephew, Inc. | Three-dimensional selective bone matching |
| US11717359B2 (en) * | 2019-11-11 | 2023-08-08 | Unik Orthopedics, Inc. | Methods and systems for robotic-assisted surgery using customized bone registration guides |
| CN111067587B (zh) * | 2019-12-20 | 2023-08-01 | 哈尔滨医科大学 | 儿童ddh股骨近端截骨导板及其使用方法 |
| US10902944B1 (en) * | 2020-01-06 | 2021-01-26 | Carlsmed, Inc. | Patient-specific medical procedures and devices, and associated systems and methods |
| CN114052823A (zh) * | 2021-10-25 | 2022-02-18 | 哈尔滨医科大学 | 儿童ddh股骨近端截骨导航模板及使用方法 |
-
2024
- 2024-06-11 WO PCT/IL2024/050584 patent/WO2024257102A1/fr not_active Ceased
- 2024-06-11 WO PCT/IL2024/050582 patent/WO2024257101A1/fr not_active Ceased
- 2024-06-11 WO PCT/IL2024/050581 patent/WO2024257100A2/fr not_active Ceased
- 2024-06-11 EP EP24822980.9A patent/EP4723999A1/fr active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP4723999A1 (fr) | 2026-04-15 |
| WO2024257100A3 (fr) | 2025-01-23 |
| WO2024257102A1 (fr) | 2024-12-19 |
| WO2024257101A1 (fr) | 2024-12-19 |
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