TOTAL ANKLE REPLACEMENT SYSTEM
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority to (i) U.S. Provisional Application
No. 63/552,487 entitled “Total Ankle Replacement System,” filed on February 12, 2024, and (ii) U.S. Provisional Application No. 63/650,034 entitled “Total Ankle Replacement System,” filed on May 21, 2024, the contents of each of which are hereby incorporated by reference in their entirety.
BACKGROUND
[0002] Total ankle replacement requires fixation of the tibial component to the tibia of a patient, and further requires fixation of the talar component to the talus of the patient. Improving time zero fixation by the inclusion of high retention force features may aide in the long term survival of the tibial component. Accordingly, disclosed herein are total ankle replacement systems that provide a high retention force to aid in preventing loosening after initial implantation.
SUMMARY
[0003] Total ankle replacement requires a prosthesis to replace resected bone and eroded joint cartilage. The component that replaces the distal tibia historically has left room for improvement for initial fixation (time zero fixation) to bone. Some of the challenges lay within the exposure required to use instruments that would adequately prepare the bone for the final implant. Fixation that includes vertical pegs are the most difficult to prepare due to lack of exposure in the ankle joint space . Angled pegs have been used to solve the issue of exposure : however, the time zero fixation for such design leaves room for improvement. Other previous designs have used an anterior approach where the anterior cortex is breached using drills and osteotomes. These drills are large in size and create large bone voids that require back filling with autograft, allograft, or synthetic bone void fillers once the implant is seated. Accordingly, such designs have raised concerns of weakening the weight bearing anterior cortical bone.
[0004] Accordingly, the present disclosure provides a tibial tray that incorporates an anterior approach but with a minimal breach of bone tissue. The fixation would also be designed in a manner that when impacted to final position, the tibial tray provides compression with respect to the resected bone, thereby helping to improve time zero fixation.
[0005] Thus, in one aspect, a system or use in total ankle replacement procedures is described. The system includes a tibial component having a top surface and a bottom surface opposite the top surface. The tibial component includes at least one fixation component extending away from the top surface of the tibial component. The at least one fixation component includes a first end and a second end opposite the first end. The system also includes a talar component comprising having a top surface and a bottom surface opposite the top surface. The top surface of the talar component includes a groove extending from a posterior side of the talar component to an anterior side of the talar component. The system also includes an articulation component having a top surface and a bottom surface opposite the top surface. The top surface of the articulation component is configured to mate with the bottom surface of the tibial component. The bottom surface of the articulation component is configured to contact the top surface of the talar component when in use.
[0006] In another aspect, a method can include (i) forming a channel in an anterior side of a tibia, and (ii) positioning the fixation component of the tibial component of the first aspect into the channel, (iii) positioning the bottom surface of the talar component of the first aspect onto a talar of the patient, (iv) positioning the top surface of the articulation component of the first aspect in contact with the bottom surface of the tibial component to thereby secure the tibial component to the articulation component such that the articulation component is positioned between the talar component and the tibial component.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] Figures 1A-1E provide a plurality of views of an example tibial component of a total ankle replacement system.
[0008] Figures 2A-2D provide a plurality of views of another example tibial component of a total ankle replacement system.
[0009] Figure 3 provides another example tibial component of a total ankle replacement system.
[0010] Figure 4 provides a plurality of fixation components for an example tibial component of a total ankle replacement system.
[0011] Figures 5A-5D provide a plurality of views of another example tibial component of a total ankle replacement system. [0012] Figures 6A-6D provide a plurality of views of another example tibial component of a total ankle replacement system.
[0013] Figures 7A-7D provide a plurality of views of another example tibial component of a total ankle replacement system.
[0014] Figures 8A-8F provide a plurality of views of an example talar component of a total ankle replacement system.
[0015] Figures 9A-9F provide a plurality of views of another example talar component of a total ankle replacement system.
[0016] Figures 10A-10F provide a plurality of views of another example talar component of a total ankle replacement system.
[0017] Figures 11A-11E provide a plurality of views of another example talar component of a total ankle replacement system.
[0018] Figures 12A-12D provide a plurality of views of an articulation component of a total ankle replacement system configured to be coupled to a tibial component.
[0019] Figure 13 provides a gutter sword for use in a total ankle replacement procedure .
[0020] Figure 14A provides a pin targeter for use in a total ankle replacement procedure.
[0021] Figure 14B provides another pin targeter for use in a total ankle replacement procedure.
[0022] Figure 15A provides a distal targeting and alignment guide for use in a total ankle replacement procedure.
[0023] Figure 15B provides another distal targeting and alignment guide for use in a total ankle replacement procedure.
[0024] Figure 16 provides an angel wing for use in a total ankle replacement procedure. [0025] Figure 17A provides a tibia outline for use in a total ankle replacement procedure.
[0026] Figure 17B provides another tibia outline for use in a total ankle replacement procedure.
[0027] Figure 18A provides a sagittal aligner for use in a total ankle replacement procedure.
[0028] Figure 18B provides another a sagittal aligner for use in a total ankle replacement procedure.
[0029] Figure 18C provides another a sagittal aligner for use in a total ankle replacement procedure. [0030] Figure 19A provides a top view of the angle wing, tibia outline, and sagittal aligner for use in a total ankle replacement.
[0031] Figure 19B provides a perspective view of the angle wing, tibia outline, and sagittal aligner for use in a total ankle replacement.
[0032] Figure 20 provides a reaming guide for use in a total ankle replacement procedure.
[0033] Figure 21 provides another reaming guide for use in a total ankle replacement procedure.
[0034] Figures 22A-22E provides views of a saw cut guide for use in a total ankle replacement procedure.
[0035] Figures 23A-23E provides a saw cut comer pin and various cut guide components for use in a total ankle replacement procedure.
[0036] Figure 24 provides a tibial rasping guide for use in a total ankle replacement procedure.
[0037] Figure 25 provides a side cutting ridge reaming guide for use in a total ankle replacement procedure.
[0038] Figures 26A-26B provide a rasp for use in a total ankle replacement procedure.
[0039] Figure 27 provides another rasp for use in a total ankle replacement procedure.
[0040] Figures 28A-28B provide a tibia tray trial for use in a total ankle replacement procedure.
[0041] Figure 29 provides a starting broach for use in a total ankle replacement procedure.
[0042] Figure 30 provides a finishing broach for use in a total ankle replacement procedure.
[0043] Figure 31A provides an articulation component trial for use in a total ankle replacement procedure.
[0044] Figure 3 IB provides another articulation component trial for use in a total ankle replacement procedure.
[0045] Figure 32A provides an articulation component trial handle for use in a total ankle replacement procedure.
[0046] Figure 32B provides another articulation component trial handle for use in a total ankle replacement procedure.
[0047] Figure 33A provides a flat cut talus trial for use in a total ankle replacement procedure. [0048] Figure 33B provides another flat cut talus trial for use in a total ankle replacement procedure.
[0049] Figure 33C provides another flat cut talus trial for use in a total ankle replacement procedure.
[0050] Figure 33D provides a drill guide for use with the flat cut talus trial of Figure 33C for use in a total ankle replacement procedure.
[0051] Figure 33E provides the flat cut talus trial of Figure 33C with the drill guide of Figure 33D for use in a total ankle replacement procedure.
[0052] Figure 34 provides a peg drill guide for use in a total ankle replacement procedure.
[0053] Figure 35 provides a talar reaming guide for use in a total ankle replacement procedure.
[0054] Figures 36A-36D provide a plurality of views of a chamfer cutting guide for use in a total ankle replacement procedure
[0055] Figure 37 provides an upcoupled talus cut guide for use in a total ankle replacement procedure.
[0056] Figure 38 provides a recut guide for use in a total ankle replacement procedure.
[0057] Figure 39 provides a chamfer cut trial for use in a total ankle replacement procedure.
[0058] Figure 40 provides an uncoupled talus guide for use in a total ankle replacement procedure.
[0059] Figure 41 provides a recut guide for use in a total ankle replacement procedure .
[0060] Figure 42 provides a cut guide spacer for use in a total ankle replacement procedure.
[0061] Figure 43A provides a tibia inserter for use in a total ankle replacement procedure.
[0062] Figure 43B provides another tibia inserter for use in a total ankle replacement procedure.
[0063] Figure 44 provides a talus inserter for use in a total ankle replacement procedure.
[0064] Figure 45 provides a talus impactor for use in a total ankle replacement procedure.
[0065] Figure 46 provides an articulation component inserter for use in a total ankle replacement procedure. [0066] Figures 47A-47D provide a modular inserter, a tibial tray inserter tip, and an impaction handle for use in a total ankle replacement procedure.
[0067] Figure 48 provides a parallel distractor for use in a total ankle replacement procedure.
[0068] Figure 49 provides an articulation component inserter for use in a total ankle replacement procedure in a total ankle replacement procedure.
[0069] Figure 50 provides a talus distractor for use in a total ankle replacement procedure.
[0070] Figure 51 provides another articulation component inserter for use in a total ankle replacement procedure.
[0071] Figure 52 provides a capsule release tool for use in a total ankle replacement procedure.
[0072] Figure 53 provides a tibia trial removal tool for use in a total ankle replacement procedure.
[0073] Figure 54 provides a parallel distractor for use in a total ankle replacement procedure.
[0074] Figure 55 provides a driver and minimum resection height tool for use in a total ankle replacement procedure.
[0075] Figure 56 provides a tibia tray protective insert for use in a total ankle replacement procedure.
[0076] Figures 57A-57B provide a hybrid guide with reaming drill sleeve for use in a total ankle replacement procedure.
[0077] Figures 58A-58C provide tibia bone removal tools for use in a total ankle replacement procedure.
DETAILED DESCRIPTION
[0078] With reference to the Figures, Figures 1A-12D illustrate various components of a system for use in total ankle replacement procedures. In particular, the system includes a tibial component 102 having a top surface 104 and a bottom surface 106 opposite the top surface 104. The tibial component 102 includes at least one fixation component 108 extending away from the top surface 104 of the tibial component 102. The at least one fixation component 108 includes a first end 110 and a second end 112 opposite the first end 110. The system also includes a talar component 202 having a top surface 204 and a bottom surface 206 opposite the top surface 204. The top surface 204 of the talar component 202 includes a groove 208 extending from a posterior side 210 of the talar component 202 to an anterior side 212 of the talar component 202. The system also includes an articulation component 302 having a top surface 304 and a bottom surface 306 opposite the top surface 304. The top surface 304 of the articulation component 302 is configured to mate with the bottom surface 106 of the tibial component 102. The bottom surface 306 of the articulation component 302 is configured to contact the top surface 204 of the talar component 202 when in use.
[0079] Figures 1A-7D each illustrate various examples of the tibial component 102, which is configured to be positioned within a tibia of a patient when in use. Each of the tibial components 102 of Figures 1A-7D are designed for fixation to a bone (e.g., atibia) of a patient using an anterior approach.
[0080] In an example, the first end 110 of the at least one fixation component 108 has a first width, and the second end 112 of the at least one fixation component 108 has a second width that is greater than the first width. In one such example, the first end 110 of the at least one fixation component 108 comprises a cutting surface. In an example, the tibial component 102 includes a first end 114 and a second end 116 opposite the first end 114, and the first end 110 of the at least one fixation component 108 is offset from the first end 114 of the tibial component 102. In an example, the second end 112 of the at least one fixation component 108 is offset from the second end 116 of the tibial component 102.
[0081] In an example, the tibial component 102 comprises a first material, and the at least one fixation component 108 comprises a second material that is different from the first material. In one such example, the first material comprises titanium, and wherein the second material comprises a nickel-titanium alloy. In one example, the tibial component 102 comprises a single-piece design that is 3D printed with a porous structure. In another example, the tibial component 102 comprises a two or three-piece design that is supplied to user as an assembled system. In another example, tibial component 102 comprises a two or three-piece design that is supplied to user in parts and is assembled on the back table by a medical professional prior to use.
[0082] With reference to the Figures, as shown in Figure 1A, in an example the at least one fixation component 108 includes one or more through-holes 118 between the first end 110 and the second end 112. As further shown in Figure 1A, in an example the at least one fixation component 108 includes a first side 120 and a second side 122 opposite the first side 120, and the first side 120 and the second side 122 of the at least one fixation component 108 each include a plurality of indents 124 positioned between the first end 110 and the second end 112. The plurality of indents 124 may act as anti-backout features to prevent the tibial component 102 from moving in an anterior direction after insertion into the tibia of the patient. In another example as shown in Figures 1A-1C, the at least one fixation component 108 includes a first side 120 and a second side 122 opposite the first side 120, and the first side 120 and the second side 122 of the at least one fixation component 108 each include a plurality of channels 126 extending from the first end 110 to the second end 112. As further shown in Figures 1A-1C, the at least one fixation component 108 includes a first side 120 and a second side 122 opposite the first side 120, and the first side 120 and the second side 122 of the at least one fixation component 108 each include a plurality of angled surfaces 128 extending from the first end 110 to the second end 112.
[0083] In an example, if the at least one fixation component 108 is parallel to the top surface 104 of the tibial component 102, then instrumentation providing an upward/superior force may be required during impaction. In another example, the at least one fixation component 108 may be designed such that the geometry provides a slope allowing for upward pressure to be applied while the implant is being impacted. In one such example, as shown in Figures 2A-2D, a height of the first end 110 of the at least one fixation component 108 is greater than a height of the second end 112 of the at least one fixation component 108 to thereby provide dynamic compression after implantation. Further compression can be achieved by the at least one fixation component 108 bending slightly during impaction, thereby acting like a spring and therefore providing dynamic compression after impact.
[0084] In an example, the tibial component 102 includes one or more modular fixation elements configured to be coupled to the bottom surface 106 of the tibial component 102. These one or more modular fixation elements may take the form of pegs, as a non-limiting example. The one or more modular fixation elements may be inserted perpendicular to the body, in one example. The one or more modular fixation elements may be self-cutting or press fit, and may further be designed to aid in counter-acting the shear forces in the ankle.
[0085] In an example, the tibial component 102 includes a first side surface 130 and a second side surface 132 opposite the first side surface 130, and at least a portion of the first side surface 130 and the second side surface 132 include a porous structure positioned thereon. In another example, at least a portion of the top surface 104 of the tibial component 102 includes a porous structure positioned thereon. In an example, the porous structure may include separate surfaces or structures that are sintered, diffusion bonded, or additively manufactured to the various surfaces of the tibial component 102. The porous structure may advantageously promote bone ingrowth/on growth of the tibial component 102. In particular, the porous structure may act as bone cement retaining feature for the tibial component 102. [0086] Figure 3 illustrates another example of the fixation component 108 of the tibial component 102. As shown in Figure 3, the fixation component 108 includes a portion with a triangular cross-section, and a cutting surface at one end of the fixation component. Figure 4 illustrates a variety of cross-sections for the fixation component 108 of the tibial component 102.
[0087] Figures 5A-5D illustrate another example of the fixation component 108 of the tibial component 102. As shown in Figures 5A-5D, the fixation component 108 includes a curved keel with a needle point 134 to help reduce stress shielding. As shown in Figures 5C- 5D, the fixation component 108 may further include anti-backout features (e.g., idents 124).
[0088] Figures 6A-6D illustrate another example of the fixation component 108 of the tibial component 102. As shown in Figures 6A-6D, the fixation component 108 includes a curved keel for a portion of the fixation component 108 with a needle point 134 to help reduce stress shielding. As shown in Figures 6B and 6D, the fixation component 108 may further include indents 124 as well as a curved feature 136 adjacent the second end 112. The curved feature 136 prevents posterior migration of the tibial component 102. As such, a cross-section of the fixation component 108 at the second end 112 may be triangular with straight lines, while a cross-section of the fixation component 108 at the first end 110 may be triangular with curved lines. Further, as shown in Figure 6A, each of the first side surface 130 and the second side surface 132 include a groove 138 positioned along at least a portion of the length of the first side surface 130 and the second side surface 132. The groove 138 provides additional stability of the tibial component 102 within the tibia.
[0089] Further, as shown in Figure 6C, the bottom surface 106 of the tibial component 102 includes a recess 140 configured to receive the top surface 304 of the articulation component 302. The recess 140 may include a first end 142 and a second end 144 opposite the first end 142, and a width of the first end 142 may be greater than a width of the second end 144 to ease insertion of the articulation component 302 into the recess 140. The recess 140 further includes a locking component 146 that is configured to interact with a protrusion 308 of the articulation component 302 to thereby secure the articulation component 302 to the tibial component 102.
[0090] Figures 7A-7B illustrate another example of the fixation component 108 of the tibial component 102. As shown in Figures 7A-7B, the fixation component 108 includes a curved keel for a portion of the fixation component 108 with a needle point 134 to help reduce stress shielding. As shown in Figures 7A-7B, the fixation component 108 may further include a triangular feature 147 adjacent the second end 112. The triangular feature 147 prevents posterior migration of the tibial component 102. As such, a cross-section of the fixation component 108 at the second end 112 may be triangular with straight lines, while a crosssection of the fixation component 108 at the first end 110 may be triangular with curved lines. [0091] Figures 8A-11E each illustrate various examples of the talar component 202, which is configured to be positioned within a talus of a patient when in use. With reference to Figures 8A-8F, in an example the bottom surface 206 of the talar component 202 is substantially flat. In an example, the bottom surface 206 of the talar component includes one or more interosseous fixation elements 214 extending away from the bottom surface 206. In one such example, the one or more interosseous fixation elements 214 comprise a pair of talar pegs, and each of the pair of talar pegs are angled between 0 and 90 degrees with respect to the bottom surface 206 of the talar component 202. In one particular example, as shown in Figures 8A-8F, each of the pair of talar pegs are perpendicular to the bottom surface 206 of the talar component 202. In an example, at least a portion of the one or more interosseous fixation elements 214 include a porous structure positioned thereon. In another example, at least a portion of the bottom surface 206 of the talar component includes a porous structure positioned thereon. As described above, the porous structure may advantageously promote bone ingrowth/on growth of the talar component 202. In particular, the porous structure may act as bone cement retaining feature for the talar component 202. In one example, as shown in Figure 6F, the talar component 202 may further include a peg extending from at least one side surface. [0092] With reference to Figures 9A-9F, in an example the bottom surface 206 of the talar component 202 is substantially flat and includes three interosseous fixation elements 214 extending away from the bottom surface 206 at a non-zero angle with respect to the bottom surface 206. In one example, as shown in Figure 9F, the talar component 202 may further include a peg extending from at least one side surface. With reference to Figures 10A-10F, in an example the bottom surface of the talar component 202 is substantially flat and includes two interosseous fixation elements 214 extending away from the bottom surface 206 at a non-zero angle with respect to the bottom surface 206 and a spike 216 extending from the bottom surface 206 of the talar component 202. The spike 216 may include a pointed tip configured to enter the talus of the patient during installation of the talar component 202 to further aid in securing the talar component 202 to the talus of the patient. In one example, as shown in Figure 10F, the talar component 202 may further include a peg extending from at least one side surface.
[0093] With reference to Figures 11A-11E, in an example the bottom surface 206 of the talar component 202 includes a first angled surface 218 adjacent the anterior side 212 of the talar component 202, a second angled surface 220 adjacent the posterior side 210 of the talar component 202, and a substantially flat surface 222 positioned between the first angled surface 218 and the second angled surface 220. In one such example, at least a portion of the first angled surface 218, the second angled surface 220, and the substantially flat surface 222 of the talar component 202 each include a porous structure positioned thereon. In an example, the talar component 202 includes one or more interosseous fixation elements 214 extending away from the first angled surface 218 of the talar component 202. In one such example, the one or more interosseous fixation elements 214 comprise a pair of talar pegs, and each of the pair of talar pegs are angled between 0 and 90 degrees with respect to the first angled surface 218 ofthe talar component 202. In one particular example, as shown in Figures 11A-11E, each of the pair of talar pegs are perpendicular to the first angled surface 218 of the talar component 202. In one such example, the one or more interosseous fixation elements 214 comprise three talar pegs, and each of the three talar pegs are angled between 0 and 90 degrees with respect to the first angled surface 218 of the talar component 202. In one particular example, each of the three talar pegs are not perpendicular to the first angled surface 218 of the talar component 202. In an example, at least a portion of the one or more interosseous fixation elements 214 include a porous structure positioned thereon.
[0094] In another example, the bottom surface 206 of the talar component 202 of Figures 11A-11E includes two interosseous fixation elements 214 extending away from the bottom surface 206 at a non-zero angle with respect to the first angled surface 218 of the talar component and a spike 216 extending from the second angled surface 220 of the talar component 202. The spike 216 may include a pointed tip configured to enter the talus of the patient during installation to further aid in securing the talar component 202 to the talus of the patient.
[0095] With reference to Figures 8A-11E, in an example the talar component 202 includes a first cutout 224 positioned on a first side surface between the posterior side 210 and the anterior side 212 of the talar component 202, and the talar component further includes a second cutout 226 positioned on a second side surface opposite the first side surface between the posterior side 210 and the anterior side of the talar component 202. In use, the first cutout 224 and the second cutout 226 are used for the talus impactor to grip the sides of the talar component 202 during installation.
[0096] Figures 12A-12D illustrate the articulation component 302 of the system. In an example, the articulation component 302 comprises ultra-high-molecular-weight polyethylene (UHMWPE). In another example, the articulation component 302 comprises Vitamin E infused UHMWPE. In an example, the bottom surface 306 of the articulation component 302 is configured to substantially match the top surface 304 of the talar component 202 such that the articulation component 302 and talar component 202 can move relative to one another and frictionally engage one another on the top surface 304 of the articulation component 302. In an example, the bottom surface 306 of the articulation component 302 is configured for at least partially constraining a mobility of the articulation component 302 relative to the tibial component 102.
[0097] In an example, as discussed above, the bottom surface 106 of the tibial component 102 includes a locking component 146, and the top surface 304 of the articulation component 302 includes a protrusion 308 configured to fit within the recess 140 to thereby secure the tibial component 102 to the articulation component 302. In one particular example, the protrusion 308 comprises a ramp surface 310, as shown in Figure 12A. In an example, the bottom surface 106 ofthe tibial component 102 includes a first dovetail 148, and the top surface 304 of the articulation component 302 includes a second dovetail 312 configured to mate with the first dovetail to thereby prevent vertical movement of the tibial component 102 with respect to the articulation component 302. Further, as shown in Figure 12A, the top surface 304 of the articulation component 302 may include a cutout 314 positioned adjacent to the protrusion 308 to allow deflection ofthe protrusion 308.
[0098] In some examples, one or more components of the system can be made via an additive manufacturing process using an additive -manufacturing machine, such as stereolithography, multi-jet modeling, inkjet printing, selective laser sintering/melting (or DMLS, EBM), and fused filament fabrication, among other possibilities. Additive manufacturing enables one or more components of the system and other physical objects to be created as intraconnected single-piece structure through the use of a layer-upon-layer generation process. Additive manufacturing involves depositing a physical object in one or more selected materials based on a design of the object. For example, additive manufacturing can generate one or more components of the system using a Computer Aided Design (CAD) of the system as instructions. As a result, changes to the design of the system can be immediately carried out in subsequent physical creations of the system. This enables the components of the system to be easily adjusted or scaled to fit different types of applications (e.g., for use with various types and sizes of patient anatomy). In one particular example, the tibial component is additively-manufactured with titanium and the talar component is additively-manufactured with cobalt-chromium (CoCr).
[0099] The layer-upon-layer process utilized in additive manufacturing can deposit one or more components of the system with complex designs that might not be possible for devices assembled with subtractive manufacturing. In turn, the design of the system can include aspects that aim to improve overall operation. For example, the design can incorporate physical elements that help redirect stresses in a desired manner that traditionally manufactured devices might not be able to replicate.
[00100] Additive manufacturing also enables depositing one or more components of the system in a variety of materials using a multi-material additive -manufacturing process. In another example, each component of the system is made from the same material. Other example material combinations are possible as well. Further, one or more components of the system can have some layers that are created using a first type of material and other layers that are created using a second type of material.
[00101] In an example, an interior of one or more components the system is hollow. In one such example, the interior of the system includes a lattice structure. In an example, an entirety of the interior of one or more components of the system comprises the lattice structure. In another example, the interior of one or more components of the system includes alternating solid layers and lattice structure layers. The solid and lattice layers can be manufactured from the same material (such as CoCr or titanium) or a variation of mixed material layers. This same material may also comprise the shell of one or more components of the system as well. The lattice structure positioned in the hollow interior of one or more components of the system that adds strength to the implant can be either be a uniform beam design or a formula driven gyroid shape.
[00102] The present disclosure also provides a variety of instrumentation for use in a total ankle replacement procedure. The variety of instrumentation are illustrated in Figures 13- 58B and will be discussed in additional detail below.
[00103] Figure 13 provides a gutter sword 402 for use in a total ankle replacement procedure. The gutter sword 402 provides medial-lateral adjust to the center pin. The gutter sword further places pins within ±10mm of the distal targeting alignment guide. Figure 14A provides a first embodiment of a pin targeter 404 for use in placing alignment pins in a total ankle replacement procedure. In an alternative example, the pin targeter 404 includes one arm instead of the pictured two. Figure 14B provides a second embodiment of a pin targeter 404 for use in placing alignment pins in a total ankle replacement procedure. The second embodiment shown in Figure 14B includes a single linkage between the joint line, distal pin, and proximal pin. Further, the second embodiment includes a screw drive for medial-lateral translation, and a proximal pin guide that can retract for stab incision. [00104] Figures 15A-15B provide varying designs on a distal targeting and alignment guide 406 for use in a total ankle replacement procedure. The distal targeting and alignment guide may include dovetail features for quick connecting the cut blocks. The distal targeting and alignment guide 406 further includes click feedback tool-less adjustments, which are color coded for ease of use. The distal targeting and alignment guide 406 may include “gun sights” for precise adjustments. In an alternative example, the “gun sights” may be present on the cut blocks instead of the distal targeting and alignment guide 406. The distal targeting and alignment guide 406 enables ± 10mm adjustment in superior-inferior and medial -lateral directions. The distal targeting and alignment guide 406 may include a varus-valgus adjustment knob and separate lock. The distal targeting and alignment guide 406 enables a user to lock and unlock without affecting translations. Further, the distal targeting and alignment guide 406 may include an attachment mechanism at the bottom for ancillary instruments. The distal targeting and alignment guide 406 provides ease of set-up without the need for external positioning features. Additionally, the distal targeting and alignment guide 406 provides six degrees of freedom positioning plus audible and tactile location feedback for the surgeon during the procedure. The distal targeting and alignment guide 406 allows for tool-less adjustment and locking, and includes sidelocks for varus-valgus, superior-inferior, and medial-lateral directions. The distal targeting and alignment guide 406 further includes a set screw as a backup in case of extreme vibration dislodges the cut block attachment during the bone preparation process.
[00105] Figure 16 provides an angel wing 408 for use in a total ankle replacement procedure. The angel wing 408 is able to be reversed for use on either side of the ankle, and includes a retainer slot for receiving the sagittal aligner. The angel wing 408 is able to slide in the medial-lateral direction all the way down to the skin, and further allows the sagittal aligner to be placed as close to bone as possible to reduce magnification error.
[00106] Figures 17A-17B provide various examples of a tibia outline 410 for use in a total ankle replacement procedure. The tibia outline 410 provides an outer profile of the tibial component. The tibia outline 410 is reversible for use with the angel wing. The tibia outline 410 includes 10mm indicators, and may be used to provide a tibia cut extension, and may include a gunsight for alignment purposes.
[00107] Figures 18A-18C provide various examples of a sagittal aligner 412 for use in a total ankle replacement procedure. The sagittal aligner 412 provides a perfect circle configured to match to a tibial plafond of a patient. The sagittal aligner 412 includes a flat/chamber cut indication, and a spring clip-on to the angel wing. The sagittal aligner 412 further includes a hole for a tibial alignment rod. Figures 19A-19B provides a top view of the angel wing 408, tibia outline 410, and sagittal aligner 412 for use in a total ankle replacement procedure.
[00108] Figure 20 provides a first reaming guide 414 foruse in atotal ankle replacement procedure. The first reaming guide 414 is used to ream out bone in the tibia by repeated drill plunges. The first reaming guide 414 is paired with chamfer and flat talus cut slots. Figure 21 provides a second reaming guide 416 for use in a total ankle replacement procedure . The second reaming guide 416 to ream out additional bone in the tibia by repeated drill plunges. The order of usage for the first reaming guide 414 and second reaming guide 416 is interchangeable.
[00109] Figures 22A-22E provides views of a saw cut guide 418 for use in a total ankle replacement procedure. The saw cut guide 418 is used cut out bone via saw slots. The saw cut guide 418 is paired with chamfer and flat talus cut slots. The saw cut guide 418 includes connection features for coupling to the distal targeting and alignment guide 406, which allows the cut guide 418 to slide off the way down to the bone. The saw cut guide 418 further includes a recessed central pin hole allows for 3 ,2mm threaded headed pin for additional fixation, which also generates pilot hole for tibial resection extractor instrument. The saw cut guide 418 further includes features to allow sawblade excursion pins to attach to the saw cut guide 418.
[00110] Figures 23A-23D provides a saw cut comer pin 420 for use in a total ankle replacement procedure. The saw cut comer pin 420 shown in Figures 21A and 21C slide into comer holes and clip into saw cut guide 418 shown in Figures 22A-22E to prevent pin rotation and vibration out of guide, and further allows extra space for saw excursion while protecting the bone in the superior medial-lateral comers. The saw cut comer pin 420 shown in Figures 23B and 23D further can slide into comer holes of the hybrid guide with reaming drill sleeve of Figures 57A-57B discussed below to prevent pin rotation and vibration out of guide, and further allows extra space for saw excursion while protecting the bone in the superior medial- lateral comers. The reaming drill sleeve 422 shown in Figure 23E allows the reamer to spin without contacting the saw cut guide 418, thereby creating accurate perpendicular drill holes.
[00111] Figure 24 provides atibial rasping guide 424 foruse in atotal ankle replacement procedure. The tibial rasping guide 424 is used to contain the rasp and prevent over-rasping of the tibial bone.
[00112] Figure 25 provides a side cutting ridge reaming guide 426 foruse in atotal ankle replacement procedure. The side cutting ridge reaming guide 426 is used by drilling through the washer, and reaming along the guided path. [00113] Figures 26A-26B provide a rasp 428 for use in a total ankle replacement procedure. Figure 27 provides another rasp 430 for use in a total ankle replacement procedure. The rasps 428, 430 of Figures 24A-25 are used to remove remaining “peaks” in the tibial bone after reaming.
[00114] Figures 28A-28B provide a tibia tray trial 432 for use in a total ankle replacement procedure. The tibia tray trial 432 includes a slot to guide the starting and finishing broaches. The tibia tray trial 432 also includes dovetail to hold the articulation component trial 438. The tibia tray trial 432 also includes grooves to indicate implant length and keel position. The tibia tray trial 432 also includes holes allowing it to slide over tibial pins.
[00115] Figure 29 provides a starting broach 434 for use in a total ankle replacement procedure. The starting broach 434 includes a serrated edge to break through anterior cortex. Figure 30 provides a finishing broach 436 for use in a total ankle replacement procedure. The finishing broach 436 includes an implant keel matching resection. In another example, a single broach may be used for both starting and finishing.
[00116] Figures 31A-31B provide examples of an articulation component trial 438 for use in a total ankle replacement procedure. The articulation component trial 438 includes a dovetail track and a lock detail similar to the articulation component 302 discussed above. The articulation component trial 438 is compatible with both tibial component 102 and tibia tray trial 432. In one example, as shown in Figure 3 IB, the articulation component trial 438 includes a spring loaded locking feature/tab.
[00117] Figures 32A-32B provide examples of an articulation component trial handle 440 for use in a total ankle replacement procedure. The articulation component trial handle 440 attaches to the articulation component trial 438 and releases the spring -loaded feature in the articulation component trial 438 when inserted, and can be disengaged by pressing the button. [00118] Figures 33A-33B provides a flat cut talus trial 442 for use in a total ankle replacement procedure. The flat cut talus trial 442 includes a lollipop handle, guidewires or shouldered pin holes and peg prep guide holes. The flat cut talus trial 442 has fully or semi constrained geometry with the articulation component trial 438. Figures 33C-33E show an alternative embodiment of the flat cut talus trial 442 including a drill guide 444 that slides into the flat cut talus trial 442 and can be used to drill peg holes.
[00119] Figure 34 provides a peg drill guide 446 for use in a total ankle replacement procedure. Figure 35 provides a reaming guide 448 for use in a total ankle replacement procedure. The reamer insert hole pattern varies with size for anterior chamfer. [00120] Figures 36A-36D provide a plurality of views of a chamfer cutting guide 450 for use in a total ankle replacement procedure . The chamfer cutting guide 450 includes a spacer 451 that attaches to tibial component 102/tibia tray trial 432 and to the chamfer cut trial 456. The chamfer cutting guide 450 allows the tibia to drive the location of the talus. The chamfer cutting guide 450 is pinned and all other components are removed. The posterior chamfer cut is performed with a sawblade.
[00121] Figure 37 provides an uncoupled talus guide 452 for use in a total ankle replacement procedure. The uncoupled talus guide 452 generates tension in the ligaments prior to cutting the talus.
[00122] Figure 38 provides a recut guide 454 for use in a total ankle replacement procedure. The recut guide 454 allows for additional 2mm to be removed from the talus.
[00123] Figure 39 provides a chamfer cut trial 456 for use in a total ankle replacement procedure. The chamfer cut trial 456 includes pegs to sit in peg holes, and is used to test articulation with the articulation component trial 438.
[00124] Figure 40 provides another example uncoupled talus guide 452 for use in a total ankle replacement procedure. The talus guide 452 is configured to be used with the talus distractor 478. The talus guide 452 may include removable spacers to combat bony defects. The talus guide 452 includes chamber and flat cut saw slots. The talus guide 452 may include a short and a long version for various patient sizes.
[00125] Figure 41 provides another example recut guide 454 for use in a total ankle replacement procedure. The recut guide 454 allows for additional 2mm to be removed from the talus. The talus guide 452 is configured to be used with the talus distractor 478.
[00126] Figure 42 provides a cut guide spacer 458 for use in a total ankle replacement procedure. The cut guide spacer 458 provides a spacer for boney defects, and may be provided in 1 mm, 2 mm, and 3 mm thicknesses as non-limiting examples. The cut guide spacer 458 is universal (e.g., can be used on the left or right ankle).
[00127] Figures 43 A-43B provide examples of a tibia inserter 460 for use in a total ankle replacement procedure. The tibia inserter 460 includes actuated detents to hold tibial component 102 implant in place. In one example, actuation of the tibia inserter 460 is done by knob rotation. In another example, actuation of the tibia inserter 460 is done by a lever. In one example, as shown in Figure 43B, the tibia inserter 460 includes a metal inserter with size specification polymer impaction spacers.
[00128] Figure 44 provides a talus inserter 462 for use in a total ankle replacement procedure. The talus inserter 462 includes a handle with interchangeable angled tips, for flat/chamfer implants. The talus inserter 462 includes tips with grip features to hold talar component 202 implants. In an example, the grip features of the talus inserter 462 are positioned in the first cutout 224 and the second cutout 226 of the talar component 202 during installation. Figure 45 provides a talus impactor 464 for use in a total ankle replacement procedure.
[00129] Figure 46 provides an articulation component inserter 466 for use in a total ankle replacement procedure. The articulation component inserter 466 mates with the tibial component 102, and includes a screw driven with a ratchet. The articulation component inserter 466 may also be a shaft attached to a standard handle.
[00130] Figures 47A-47D provide a modular inserter 468, a tibial tray inserter tip 470, and an impaction handle 472 for use in a total ankle replacement procedure. The modular inserter 468 of Figure 47A connects to the tibial component 102, provides a positive stop, and remains attached for insertion of the tibial component 102 and insertion of the articulation component 302. The tibial tray inserter tip 470 of Figure 47B attaches to the modular inserter 468 and supports and protects the tibial component 102. The impaction handle 472 of Figure 47C is designed to impact onto the tibial tray inserter tip 470, but is not connected so that there is no cantilever pulling on the tibial component 102. The complete assembly of the modular inserter 468, the tibial tray inserter tip 470, and the impaction handle 472 is shown in Figure 47D.
[00131] Figure 48 provides a parallel distractor 474 for use in a total ankle replacement procedure. The parallel distractor 474 shown in Figure 48 is used to aid in insertion of the tibial component 102 by providing an upward pressure during broaching/insertion of the tibial component 102.
[00132] Figure 49 provides an articulation component inserter 476 for use in a total ankle replacement procedure. The articulation component 302 is initially inserted by hand, and the threaded rod connects to the modular inserter 468. The articulation component 302 inserter of Figure 49 then slides over the threaded rod via quick threads, and then the handle can be threaded to drive the articulation component 302 into the tibial component 102.
[00133] Figure 50 provides a talus distractor 478 for use in a total ankle replacement procedure. The talus distractor 478 distracts the flat cut talus trial 442 to hold it in place for pin placement. The talus distractor 478 also distracts the ankle j oint when using the uncoupled talus guide 452 or recut guide 454.
[00134] Figure 51 provides another articulation component inserter 466 for use in a total ankle replacement procedure. The articulation component inserter 466 of Figure 51 includes a threaded rod that locks the articulation component inserter 466 into the tibial component 102. The handle of the articulation component inserter 466 then pushes the articulation component 302 into the tibial component 102.
[00135] Figure 52 provides a capsule release tool 480 for use in a total ankle replacement procedure. The capsule release tool 480 includes a blade to cut posterior capsule from resected tibia bone.
[00136] Figure 53 provides a tibial trial removal tool 482 for use in a total ankle replacement procedure. The tibial trial removal tool 482 includes a threaded tip to insert into tibia trial.
[00137] Figure 54 provides a parallel distractor 484 for use in a total ankle replacement procedure. The parallel distractor can be used to distracts two edges parallel. In particular, the parallel distractor can be used to place tibial trials or final tibial component implant.
[00138] Figure 55 provides a driver and minimum resection height tool 486 for use in a total ankle replacement procedure. Parallel edges of the handle driver and minimum resection height tool 486 can be inserted into final resection to determine if it meets the minimum resection height. The driver and minimum resection height tool 486 may include a hexalobe or a hex style tip.
[00139] Figure 56 provides a tibia tray protective insert 488 for use in a total ankle replacement procedure. The tibia tray protective insert 488 protects the talar component 202 from contact with the tibial component 102 implant during insertion.
[00140] Figures 57A-57B provide a hybrid guide 490 with reaming drill sleeve for use in a total ankle replacement procedure in a total ankle replacement procedure . The hybrid guide 490 contains reamed superior comers and medial-lateral walls. The top two holes on each side are vertical, and the bottom two holes on each side are angled. The hybrid guide 490 further contains a superior saw blade cut, coupled with chamfer and flat cut talus saw slots. The hybrid guide 490 further includes central holes for 3.2 mm and 2.4 mm threaded headed pin placement to hold guide to bone. The hybrid guide 490 is configured to be paired with drill sleeve to guide reamers, which allows the reamer to spin without contacting the cut guide to prevent broken reamer. This design further creates accurate perpendicular drill holes, with the intent to leave ridge behind for: (i) press-fit on straight wall tray, or (ii) keyed-fit on ridged wall tray.
[00141] Figures 58A-58C provide tibia bone removal tools for use in a total ankle replacement procedure. In particular, Figure 58A provides a drill bit 492 including a variety of thread geometries. In one example, the drill bit 492 includes two thread geometries. In another example, the drill bit 492 includes three thread geometries. The tip of the drill bit 492 may include a stop so the user can feel when contacting the posterior cortex. Figure 58B provides a threaded driver 494, which can be threaded over the drill bit 492 and presses on the bone remover base 496 to remove bone. Figure 58C provides a bone remover base 496 which provides a counter force against the bone to allow the drill bit 492 to pull cut bone out of the wound space.
[00142] Methods disclosed herein can be used with any of the embodiments of the system as described herein.
[00143] A method can include drilling a channel in an anterior side of a tibia. In an example, the channel does not extend entirely through the tibia. The method can also include positioning the fixation component of the tibial component of the system of any one of the embodiments described above into the channel. The method can also include positioning the bottom surface of the talar component of the system of any one of the embodiments described above onto a talar of the patient. The method can also include positioning the top surface of the articulation component of the system of any one of the embodiments described above in contact with the bottom surface of the tibial component to thereby secure the tibial component to the articulation component such that the articulation component is positioned between the talar component and the tibial component.
[00144] In an example, positioning the fixation component of the tibial component into the channel comprises using one or more impaction instruments. In another example, the channel is formed using a sharp broach.
[00145] It should be understood that arrangements described herein are for purposes of example only. As such, those skilled in the art will appreciate that other arrangements and other elements (e.g. machines, interfaces, functions, orders, and groupings of functions, etc.) can be used instead, and some elements may be omitted altogether according to the desired results. Further, many of the elements that are described are functional entities that may be implemented as discrete or distributed components or in conjunction with other components, in any suitable combination and location, or other structural elements described as independent structures may be combined.
[00146] While various aspects and examples have been disclosed herein, other aspects and examples will be apparent to those skilled in the art. The various aspects and examples disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope being indicated by the following claims, along with the full scope of equivalents to which such claims are entitled. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting. [00147] Example methods and systems are described herein. It should be understood that the words “example,” “exemplary,” and “illustrative” are used herein to mean “serving as an example, instance, or illustration.” Any example or feature described herein as being an “example,” being “exemplary,” or being “illustrative” is not necessarily to be construed as preferred or advantageous over other examples or features. The examples described herein are not meant to be limiting. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.
[00148] Furthermore, the particular arrangements shown in the Figures should not be viewed as limiting. It should be understood that other examples may include more or less of each element shown in a given Figure. Further, some of the illustrated elements may be combined or omitted. Yet further, an example may include elements that are not illustrated in the Figures.
[00149] In the following description, numerous specific details are set forth to provide a thorough understanding of the disclosed concepts, which may be practiced without some or all of these particulars. In other instances, details of known devices and/or processes have been omitted to avoid unnecessarily obscuring the disclosure. While some concepts will be described in conjunction with specific examples, it will be understood that these examples are not intended to be limiting.
[00150] As used herein, “coupled” means associated directly as well as indirectly. For example, a member A may be directly associated with a member B, or may be indirectly associated therewith, e.g., via another member C. It will be understood that not all relationships among the various disclosed elements are necessarily represented.
[00151] Unless otherwise indicated, the terms “first,” “second,” etc. are used herein merely as labels, and are not intended to impose ordinal, positional, or hierarchical requirements on the items to which these terms refer. Moreover, reference to, e.g., a “second” item does not require or preclude the existence of, e.g., a “first” or lower-numbered item, and/or, e.g., a “third” or higher-numbered item.
[00152] Reference herein to “one embodiment” or “one example” means that one or more feature, structure, or characteristic described in connection with the example is included in at least one implementation. The phrases “one embodiment” or “one example” in various places in the specification may or may not be referring to the same example. [00153] As used herein, a system, apparatus, structure, article, element, component, or hardware “configured to” perform a specified function is indeed capable of performing the specified function without any alteration, rather than merely having potential to perform the specified function after further modification. In other words, the system, apparatus, structure, article, element, component, or hardware “configured to” perform a specified function is specifically selected, created, implemented, utilized, programmed, and/or designed for the purpose of performing the specified function. As used herein, “configured to” denotes existing characteristics of a system, apparatus, structure, article, element, component, or hardware which enable the system, apparatus, structure, article, element, component, or hardware to perform the specified function without further modification. For purposes of this disclosure, a system, apparatus, structure, article, element, component, or hardware described as being “configured to” perform a particular function may additionally or alternatively be described as being “adapted to” and/or as being “operative to” perform that function.
[00154] The limitations of the following claims are not written in means-plus-fiinction format and are not intended to be interpreted based on 35 U. S. C. § 112(f), unless and until such claim limitations expressly use the phrase “means for” followed by a statement of function void of further structure.
[00155] By the term “about,” “approximately,” or “substantially” with reference to amounts or measurement values described herein, it is meant that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide. For example, in one embodiment, the term “about” can refer to ± 5% of a given value.
[00156] Illustrative, non-exhaustive examples, which may or may not be claimed, of the subject matter according the present disclosure are provided below.