Orthopedic implants and instruments

Abstract

An orthopedic implant including a body. The body has a top surface facing a bottom surface, a front surface facing a back surface, and a pair of side surfaces facing each other. At least a part of the bottom surface of the implant body includes a concave shape extending from one side surface to the other side surface. The concave shape is biased to be close to either the front surface or the back surface of the implant body. Also disclosed is an instrument configured to couple with an orthopedic trial. The instrument includes an engagement portion configured to attach to another instrument configured to facilitate the operation of the instrument. The engagement portion includes one or more openings configured to receive at least a part of one or more protrusions of the instrument.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 366,817, filed on June 22, 2022, entitled "Orthopedic Implants and Instruments", the disclosure of which is hereby incorporated by reference in its entirety.

[0002] This disclosure relates to implants, instruments, and corresponding methods for performing orthopedic surgery. This disclosure relates to podiatric and orthopedic implants and instruments that may be used in arthroplasty and / or other surgical procedures.

Background Art

[0003] Many currently available implants, instruments, systems, and methods do not fully meet the needs of patients. Further, many currently available implants, instruments, systems, and methods for ankle arthroplasty do not take into account the anatomical characteristics of the joint and the associated mechanical and kinematic movement patterns / abilities.

Summary of the Invention

[0004] This disclosure is directed to orthopedic implants. According to one aspect of the disclosure, an orthopedic implant includes a body. The body includes a top surface facing a bottom surface, a front surface facing a rear surface, and a pair of lateral sides facing each other on the body. At least a portion of the bottom surface of the implant body includes a concave shape extending from one lateral side to the other lateral side. The concave shape is biased to be closer to either the front surface or the rear surface of the implant body.

[0005] According to a first aspect of the present disclosure, the implant includes at least one opening disposed on the front surface of the implant body.

[0006] According to a first aspect of the present disclosure, the at least one opening includes a pair of openings disposed on opposite sides of the midline of the implant.

[0007] According to a first aspect of the present disclosure, the concave shape is biased towards the front surface of the implant body.

[0008] According to a first aspect of the present disclosure, the concave shape is biased towards the back surface of the implant body.

[0009] According to a first aspect of the present disclosure, the implant also includes a protrusion extending upward from the top surface of the body.

[0010] According to a first aspect of the present disclosure, the protrusion includes a substantially rectangular shape.

[0011] According to a first aspect of the present disclosure, the protrusion is vertically spaced from the top surface of the implant body and includes a top surface in a plane substantially parallel to the top surface of the implant body.

[0012] According to a first aspect of the present disclosure, the protrusion includes a lateral dimension that increases along the height of the protrusion from a portion adjacent to the top surface of the implant body to the top surface of the protrusion.

[0013] According to a first aspect of the present disclosure, the protrusion includes a male devetail component.

[0014] According to a first aspect of the present disclosure, the protrusion includes a notch extending upward from the top surface of the protrusion, and the notch is centrally located laterally with respect to the protrusion.

[0015] According to a first aspect of the present disclosure, an implant is connectable to another implant via a protrusion and a notch.

[0016] A second aspect of the present disclosure is directed to an implant component. The implant component includes a body, and the body further includes a top surface facing a bottom surface, a front surface facing a back surface, and a pair of side surfaces facing each other on the body. At least a part of the bottom surface of the body of the implant extends from one side surface to the other side surface and includes a concave shape located between the front surface and the back surface of the body.

[0017] According to a second aspect of the present disclosure, the concave shape is located closer to the front surface of the body than the back surface of the body.

[0018] According to a second aspect of the present disclosure, the concave shape is located closer to the back surface of the body than the front surface of the body.

[0019] According to a second aspect of the present disclosure, the implant component includes a protrusion extending upward from the top surface of the body of the implant component.

[0020] According to a second aspect of the present disclosure, the protrusion is vertically spaced from the top surface of the body of the implant and includes a top surface in a plane substantially parallel to the top surface of the body of the implant.

[0021] According to a second aspect of the present disclosure, the protrusion includes a lateral dimension that increases along the height of the protrusion from a portion adjacent to the top surface of the body of the implant to the top surface of the protrusion.

[0022] According to a second aspect of the present disclosure, the protrusion includes a male snap component. A third aspect of the present disclosure is directed to an orthopedic implant. The implant includes a body that further includes a top surface facing the bottom surface, a front surface facing the back surface, and a pair of side surfaces facing each other on the body. At least a part of the bottom surface of the body of the implant includes a concave shape extending from one side surface to the other side surface, and the concave shape is biased to be close to either the front surface or the back surface of the body of the implant. The implant also includes a protrusion that extends upward from the top surface of the body and has a top surface in a plane substantially parallel to the top surface of the body. The protrusion includes a lateral dimension that increases along the height of the protrusion from a portion adjacent to the top surface of the body to the top surface of the protrusion.

[0023] A fourth aspect of the present disclosure is directed to an instrument configured to be removably coupled to an orthopedic trial. The instrument includes an engagement portion configured to be removably coupled to one or more other instruments configured to facilitate the manipulation, placement, and / or repositioning of the instrument. The engagement portion includes one or more holes or openings configured to receive at least a portion of one or more protrusions of the instrument to facilitate a removable coupling.

[0024] The fifth aspect of the present disclosure is directed to an instrument. The instrument includes a handle and an actuator disposed adjacent to the handle. The instrument further includes an elastic member disposed adjacent to the handle and between two portions of the handle. The elastic member can urge the two portions of the handle away from each other. The actuator can be actuated to hold the two portions of the handle in a desired position. The instrument also includes a four-bar mechanism coupled to the handle and a punch removably coupled to a part of the four-bar mechanism. The punch includes an upper portion configured to receive at least a part of the four-bar mechanism therein to facilitate a removable coupling, and a platform located on the opposite side of the upper portion from the four-bar mechanism, and the platform is integral with the upper portion. The punch further includes a pair of projections disposed at the end of the platform. The pair of projections extends upward and substantially vertically from the platform.

[0025] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the detailed description of the invention, serve to explain the principles of the invention. It is to be emphasized that, depending upon the standard practice in the industry, various features may or may not be drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or reduced for clarity of discussion. The drawings are provided for purposes of exemplifying embodiments of the invention of the present disclosure and are not to be construed as limiting the invention.

Brief Description of the Drawings

[0026]

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MODE FOR CARRYING OUT THE INVENTION

[0027] In this detailed description and the following claims, the terms proximal, distal, anterior, or plantar, posterior, or dorsal, medial, lateral, superior, and inferior are defined by standard usage to indicate a particular part or site of a bone or implant according to reference terms indicating the relative placement or orientation of natural bones. For example, "proximal" means the part of the device or implant closest to the torso, and "distal" indicates the part of the device or implant farthest from the torso. As terms regarding direction, "anterior" is the direction toward the front side of the body, "posterior" means the direction toward the back side of the body, "medial" means the direction toward the midline of the body, "lateral" is the direction toward the side of the body or the direction away from the midline of the body, "superior" means the direction toward above another object or structure, and "inferior" means the direction toward below another object or structure. Further, particularly regarding the foot, the term "dorsal" refers to the top of the foot, and the term "plantar" refers to the sole of the foot.

[0028] Similarly, in this specification, positions or directions may be used with reference to anatomical structures or surfaces. For example, as the current implants, devices, instruments, and methods are described herein with reference to use with the bones of the foot, the bones of the foot, ankle, and lower leg can be used to describe the surfaces, positions, directions, or orientations of the implants, devices, instruments, and methods. Further, the implants, devices, instruments, and methods disclosed herein, and their aspects, components, features, etc., are described with respect to one side of the body for the sake of brevity. However, since the human body is relatively symmetric or mirror-image about a line of symmetry (midline), the implants, devices, instruments, and methods described and / or illustrated herein, and their aspects, components, features, etc., can be changed, varied, modified, reconfigured, or otherwise altered without departing from the spirit and scope of the invention for use or association with the other side of the body for the same or similar purposes. It is expressly contemplated herein, for example, that the implants, devices, instruments, and methods, and their aspects, components, features, etc., described herein with respect to the right foot can be mirrored to function similarly on the left foot. Further, although the implants, devices, instruments, and methods disclosed herein, and their aspects, components, features, etc., are described with respect to the foot for the sake of brevity, it should be understood that the implants, devices, instruments, and methods can be used with other bones of the body having a similar structure.

[0029] This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 661,945, filed on April 24, 2019, which is a national stage application based on International Application No. PCT / US2019 / 029009, filed on April 24, 2019, and published as International Publication No. WO 2020 / 013901, and which claims the benefit of priority to U.S. Patent Application No. 16 / 949,310, filed on October 24, 2020, which is a continuation of U.S. Patent Application No. 17 / 647,646, filed on January 11, 2022, and issued as U.S. Patent No. 11,219,530 on January 11, 2022. The disclosures of these applications are hereby incorporated by reference in their entireties.

[0030] Next, referring to FIGS. 1-7, an orthopedic trial 100 according to one aspect of the present disclosure is shown. In some aspects, the trial 100 may be a component of a kit or system (e.g., an implant kit or implant system), and the kit or system may include, for example, one or more trials 100 of various shapes and / or sizes. Further, in some aspects, the trial 100 may correspond to one or more implant or instrument components of a kit or system as described above. The trial 100 may include one or more shapes and / or features configured to interface with one or more components of such a kit or system (e.g., features corresponding to detachable couplings with instruments, contours configured to interface with implant components, etc.).

[0031] The trial 100 is shown to include a body 110 having an upper surface 112 facing a lower surface 136, a pair of outer surfaces 126 facing each other, and a front surface 122 facing a back surface 132. As shown, the body 110 has a substantially rectangular prism-based configuration. The upper surface 112 and the lower surface 136, the outer surfaces 126, and the front surface 122 and the back surface 132 are each substantially perpendicular to each other. The body 110 is shown to include a protrusion 116 extending upwardly from the upper surface 112. The protrusion includes a ledge 118 that at least partially extends around the outer periphery of the protrusion 116 between the upper surface 112 of the body 110 and the top surface of the protrusion 116 that is substantially parallel to the upper surface 112. In some embodiments, the protrusion 116 may be configured to include a substantially octagonal or rectangular prism-based shape, or other similar and / or alternative shapes. In some embodiments, the protrusion 116 and its ledge 118 may collectively form coupling means for facilitating a detachable coupling with, for example, one or more other instruments and / or implant components. In some embodiments, the trial 100 may be configured to be detachably coupled in a dovetail configuration with an instrument and / or implant via the protrusion 116 and the ledge 118. The protrusion 116 and the ledge 118 form a male dovetail component that is received by a female dovetail component in an instrument and / or implant. As shown, the protrusion 116 includes a notch 120 located between the protrusion 116 and the front surface 122 of the trial 100. The notch 120 is centrally located with respect to the protrusion 116 (the protrusion 116 is also centrally located with respect to the top surface 112 of the trial 100). In some embodiments, the top surface 112 may also include one or more openings 114 disposed around the top surface 112 and at least partially extending into the body 110 of the trial 100 in a direction toward the lower surface 136).In some embodiments, the opening 114 may be configured to removably couple the trial 100 to an instrument, such as an insertion instrument configured to facilitate placement of the trial 100 in a desired position as part of an implant trial / sizing process, or other components of an implant / instrument kit / system. As shown, the trial 100 includes four openings. Two openings are disposed between the protrusion 116 and the front surface 122, and two openings are disposed between the protrusion 116 and the back surface 132 (although one or more of the openings may be arranged in various configurations in some embodiments).

[0032] The front surface 122 and the back surface 132 (each labeled with "A" and "P" to indicate "anterior" and "posterior", respectively, where the front surface 122 may be referred to as the anterior surface 122 and the back surface 132 may be referred to as the posterior surface 122) are each shown to include a pair of openings 124, 134 that extend into the body 110 of the trial 100 in a direction substantially perpendicular to the plane in which the front surface 122 and the back surface 132 are disposed. In some embodiments, the openings 124, 134 are configured to facilitate positioning the trial 100 in a desired location, for example, as part of an implant trial / sizing process, with an insertion instrument or other component of an implant / instrument kit / system, and may be configured to removably couple the trial 100 to such an instrument. For example, one or more of the openings 124, 134 may be configured to receive a protrusion of the instrument and hold at least a portion of the protrusion therein while the trial 100 is being manipulated, positioned, and / or repositioned. The side surfaces 126 of the trial 100 are also shown to each include a pair of openings 128. The openings 128 are symmetrically disposed with respect to the midline of the trial 100 when viewed from a top view such as in FIG. 6. In some embodiments, the openings 128 may be configured to provide fluid communication between the pair of side surfaces 126 (e.g., extending through the trial). Further, in some embodiments, the openings 128 may include one or more radiopaque elements disposed therein. The radiopaque elements are readily visible by fluoroscopy in contrast to the radiolucent body 110. In some embodiments, each pair of the openings 128 (e.g., the pair of openings 128 on a single side surface 126) may be staggered with respect to each other in a plurality of directions.For example, as shown in FIG. 5, one opening 128 may be closer to the upper surface 112 and / or the lower surface 132 (and accordingly closer to the front surface 122 and the lower surface 136) than the other opening 128.

[0033] The trial 100 is further shown to include a concavity 138 disposed on / within at least a portion of the lower surface 136. In some embodiments, the concavity 138 may include a ridge that separates two smaller sub - concavities along its central portion. Further, in some embodiments, the concavity 138 may correspond to the shape of one or more implants and / or a portion thereof configured to interface with the trial 100 in a trial / sizing process. For example, the concavity 138 may correspond to the convexity / curvature of the upper surface of a talus implant configured to interface with the trial 100. As shown in FIG. 4, the concavity 138 is offset towards the front surface 122 of the trial 100 (e.g., forward, “left - biased” in FIG. 4). However, when the trial 100 is inverted (e.g., FIG. 5), the concavity 138 is offset in the opposite direction (e.g., “right - biased”). Thus, the trial 100 can be inserted such that the front surface 122 faces the user to facilitate the trial for an anteriorly - biased implant and, conversely, can be inserted such that the rear surface 132 faces the user to facilitate the trial for a posteriorly - biased implant. That is, the trial 110 can be used reversibly. Thus, the trial 110 is compatible with the trial / sizing process for both anteriorly - biased and posteriorly - biased implants. Thus, the trial 100 (and / or its components / features) has (at least as shown in FIGS. 1 - 7) at least one line of symmetry, for example, a line of symmetry that runs vertically through the trial as oriented in FIGS. 6 and 7.

[0034] Next, referring to FIGS. 8 - 12, the trial 100 is shown in combination with an implant system including a tibial component 200 and a talar component 210. The tibial component 200 and the talar component 210 may be the same as and / or similar to other similar tibial and talar components of an ankle arthroplasty system, including but not limited to those incorporated herein by reference. As shown, the tibial component 200 includes a top surface 202 opposite a bottom surface 204. The bottom surface includes a recess 206 that extends from the bottom surface 204 toward the top surface 202. The top surface 202 is shown to include at least one protrusion (two in FIGS. 8 - 12) configured to facilitate fixation to the patient's distal tibia. The recess 206 is configured to receive an engagement feature 208 including a female dovetail configuration configured to interface and removably couple with the protrusion 116, ledge 118, and / or notch 120 of the trial 100, as shown at least in FIGS. 8 - 12, such that the trial 100 is removably coupled to the tibial component 200. In some aspects, the trial 100 may be configured to engage / removably couple with the talar component 210 in the same manner as the trial 100 engages with the corresponding implant component (e.g., an intermediate implant component may include the same / similar features to couple with the tibial component 200 in the same / similar manner). When engaging (e.g., removably coupling) with the tibial component 200, the trial 100 is shown to be positioned substantially below (e.g., below, distal, etc.) the tibial component.

[0035] The talus component 210 is shown to be arranged such that the trial 100 is located substantially above (e.g., above, proximal, etc.) the talus component 210. The talus component 210 is shown to include a top surface 212 that is located substantially opposite the bottom surface 214 of the talus component 210. The top surface 212 is configured to engage / interface with the trial 100, and the bottom surface 214 includes at least one engagement feature 218 configured to facilitate attachment to the resected bone surface of the patient's talus. The top surface 212 of the talus component 210 is shown to include an articulation 216. The articulation 216 may be the same as and / or similar to that shown and described in the above-mentioned published patents / pending applications incorporated herein by reference. For example, the articulation 216 may include corresponding articular surfaces that are divided into four regions for reference. The regions are anteromedial, anterolateral, posteromedial, and posterolateral (the anterior portion of the talus component 210 is the portion that includes the engagement feature 218), and each region has at least one sagittal radius. In some embodiments, the anterolateral sagittal radius may be larger than the anteromedial sagittal radius. And, the posteromedial sagittal radius may be larger than the posterolateral sagittal radius. The recess 138 of the trial 100 is configured to interface with the articulation 216 and, accordingly, may have a shape complementary to (e.g., a negative of) the articulation 216 and may have a shape that is substantially the same as and / or similar to the recess of the implant component represented by the trial 100.

[0036] As shown in FIGS. 8 - 12, the trial 100 is shown with its front surface 122 facing outward and adjacent to the front (e.g., anterior) portions of the tibial component 200 and the talar component 210 (see at least the front view of FIG. 12). “A” of the trial 100 indicates that the recess 138 is biased forward (e.g., closer to the front / anterior surface 122). Thus, by using the trial / sizing process performed with the trial 100 configured in such a manner, a physician can determine the desired implant size (based on the fit of various different sized trials 100 having the same / similar features as those shown and described herein) for a forwardly biased implant (e.g., an implant having a recess 138 configured to interface with the articulation 216 of the talar component 210 and disposed at a position closer to the front / front surface 122 than the rear / rear surface 132).

[0037] Referring now to FIGS. 13 - 17, the same components as those shown in FIGS. 8 - 12 are shown in an alternative configuration. The trial 100 is shown with its rear surface 132 facing outward and adjacent to the front (e.g., anterior) portions of the tibial component 200 and the talar component 210 (see at least the front view of FIG. 17). “P” of the trial 100 indicates that the recess 138 is biased rearward (e.g., closer to the rear / rear surface 132). Thus, by using the trial / sizing process performed with the trial 100 configured in such a manner, a physician can determine the desired implant size (based on the fit of various different sized trials 100 having the same / similar features as those shown and described herein) for a rearwardly biased implant (e.g., an implant having a recess 138 configured to interface with the articulation 216 of the talar component 210 and disposed at a position closer to the rear / rear surface 132 than the front / front surface 122).

[0038] When performing the trial 100 as previously shown and described herein with reference to FIGS. 8-12 (forward deflection configuration) and FIGS. 13-17 (rearward deflection configuration), a physician can perform a trial process for both the forward deflection implant component and the rearward deflection implant component using the trial 100 (or a plurality of sizes of the trial 100 provided in the system / kit, where each size of the trial 100 has the same / similar characteristics as those shown and described herein). For example, a physician may desire a forward deflection implant for a patient and, accordingly, may perform a trial process using the trial 100 in the position as shown in FIGS. 8-12. However, during the trial process for the forward deflection implant, if the physician determines that the rearward deflection implant is more suitable for the patient, the physician may perform the trial process for the corresponding rearward deflection implant using the same trial 100 but in the reverse (e.g., "flipped") configuration (e.g., a transition from an arrangement where the forward / front surface 122 of the trial 100 is visible and the physician is facing forward to an arrangement where the rearward / rear surface 132 of the trial 100 is visible and the physician is facing forward).

[0039] Next, referring to FIGS. 18 - 26, the instrument 300 is shown to be removably coupled to the trial 100. As shown, the instrument 300 can be a tibial trial instrument that may include one or more of the same / similar features and / or shapes of the tibial component 200. The instrument 300 is shown to include an engagement portion 302 configured to removably couple to one or more other instruments that facilitate the operation, placement, and / or re - placement of the instrument 300 and any components (e.g., trial 100) removably coupled thereto. In some embodiments, the engagement portion 302 may include one or more holes or openings configured to receive at least a portion of one or more protrusions of the instrument to facilitate a removable connection. The instrument 300 is further shown to include a trial portion 304. The trial portion 304 may have various geometric features and / or other components that are the same and / or similar to corresponding tibial implant components (e.g., tibial component 200). In some embodiments, a physician can manipulate the instrument 300 such that the trial portion 304 is disposed within or in the vicinity of a region where the physician can place the tibial implant component. Further, the physician can perform such manipulation of the instrument 300 using the trial 100 removably coupled to the trial portion 304 via a slot 306 disposed on the bottom surface of the trial portion 304. In some embodiments, the slot 306 may be the same and / or similar to the recess 206 of the tibial component 210. Further, the trial 100 can be removably coupled to it in the same and / or similar manner (in a forward - deflected configuration and / or a rearward - deflected configuration). The instrument 300 may also be detached from the trial 100 and / or removably coupled to other trials of various sizes (in a forward - deflected configuration and / or a rearward - deflected configuration). Similarly, the trial 100 can be removably coupled to / from instruments 300 of various sizes.

[0040] Next, referring to FIGS. 27-33, an instrument 400 according to an exemplary embodiment is shown. The instrument 400 is shown to include a handle 402 and an actuator 404 disposed adjacent to the handle 402. The instrument 400 further includes an elastic member 406 disposed adjacent to the handle 402 and between two portions of the handle 402 as shown. The elastic member 406 can urge the portions of the handle 402 away from each other. The actuator 404 can be actuated to hold the aforementioned portions of the handle 402 in a desired position despite the force applied by the elastic member 406. The instrument 400 is further shown to include a four-bar mechanism 410 (referred to herein as four-bar 410) shown coupled to the handle 402. The four-bar 410 includes one or more bars (or up to four bars) configured to expand and / or contract in response to movement / actuation of the handle 402, in response to operation of the handle 402 by the elastic member 406 and / or in response to a force applied to the handle 402.

[0041] Apparatus 400 is further shown to include a punch 420 removably coupled to a portion of the four bars 410 opposite the handle 402. The punch is shown to include an upper portion 424 configured to receive at least a portion of the four bars 410 and facilitate a removable coupling therewith. The punch 420 also includes a platform 426 located on the opposite side of the upper portion 424 from the four bars 410. The platform 426 is integral with the upper portion 424. The punch further includes a pair of protrusions 428 disposed at the end of the platform 426. In some embodiments, the platform 426 may include a pair of protuberances at its end. The protrusions 428 extend upwardly in a direction substantially perpendicular to the platform 426. Apparatus 400 is also shown to include a paddle 422 configured to couple to the four bars 410 below the point of attachment of the four bars 410 and the punch 420. The paddle 422 may be configured to contact a first surface on the opposite side of a second surface that a user desires to form a volume / hole complementary to the shape of the protrusions 428. Thus, by operating the apparatus 400, the paddle can contact the first surface and provide this leverage when the punch 420 and protrusions 428 are operated upwardly to contact the second surface and form the aforementioned volume / hole.

[0042] Next, referring to FIGS. 34 - 35, an instrument 500 (shown as an impacting instrument, or "impactor") according to an exemplary embodiment is shown. The instrument 500 is shown to include a body 504 that separates an upper portion 502 and a lower portion 506. The upper portion 502 is configured to include a rectangular shape (which may have alternative shapes in some aspects) at its end. That shape is configured to receive an impact force and mechanically convert the impact force to the instrument 500. For example, the instrument 500 may be positioned at a desired location, and the lower portion 506 (and / or its components, such as the protrusion 508 extending from the lower portion 506) contacts or is adjacent to the surface where the user desires to apply a force / impact. Thus, an impact force can be applied in a plane substantially parallel to the protrusion 508 of the lower portion 506 such that the impact force is applied to a surface adjacent to or in contact with the protrusion 508. As shown, the body 504 is substantially perpendicular to and integral with the upper portion 502 and the lower portion 506, which are substantially parallel to each other.

[0043] Next, referring to FIG. 36, another surgical instrument 600 according to an exemplary embodiment is shown. The instrument 600 is shown to include an upper portion 602 integral with a lower portion 606. The upper portion 602 is shown to include an opening 604 that at least partially extends into the upper portion 602 and is configured to receive components at least partially within the opening 604 such that they are cross-sectionally disposed at its end and facilitate a detachable coupling. The lower portion 606 is shown to include a protrusion 608 that extends substantially perpendicular to the lower portion 606. The protrusion 608 may include one or more features (such as threading, flutes, etc.) thereon that are configured to facilitate punching a volume / hole into a part of an anatomical structure where the volume / hole is complementary to the shape of the protrusion 608.

[0044] Next, referring to FIGS. 37 - 38, another surgical instrument 700 according to an exemplary embodiment is shown. The instrument 700 is shown as including an upper portion 702 integral with a lower portion 707. The upper portion 702 is shown as including an opening 704 that at least partially extends into the upper portion 702 and that is configured to receive components within the opening 704 such that they are disposed cross-sectionally at its terminus and facilitate a detachable connection. The lower portion 706 is shown as including at least one projection 708 that extends substantially vertically from the lower portion 706. The at least one projection 708 may include one or more features (e.g., threading, fluting, etc.) configured to facilitate punching a volume / aperture into a portion of an anatomical structure where the volume / aperture is complementary to the shape of the at least one projection 708. As shown, the at least one projection 708 includes a pair of projections having the same and / or similar shape. However, in some aspects, the instrument 700 may include one or more projections 708 of various sizes, shapes, and positions with respect to the instrument 700.

[0045] Next, referring to FIGS. 39 - 59, an implant 800 according to one aspect of the present disclosure is shown. The implant 800 is shown to include a body 810 having an upper surface 812 facing a lower surface 836, a pair of outer surfaces 826 facing each other, and a front surface 822 facing a back surface 832. As shown, the body 810 has a substantially rectangular parallelepiped-based configuration. The upper surface 812 and the lower surface 836, the outer surfaces 826, and the front surface 822 and the back surface 832 are each substantially perpendicular to each other. The body 810 is shown to include a protrusion 816 extending upwardly from the upper surface 812. The protrusion includes a ledge 818 that at least partially extends around the outer periphery of the protrusion 816 between the upper surface 812 of the body 810 and the top surface of the protrusion 816 that is substantially parallel to the upper surface 812. In some aspects, the protrusion 816 may abut the front surface 812 of the implant 800. In some aspects, the protrusion 816 and its ledge 818 can collectively form coupling means for facilitating a detachable coupling with, for example, one or more other instruments and / or implant components. In some aspects, the implant 800 may be configured to detachably couple in a dovetail configuration with a surgical instrument and / or implant via the protrusion 816 and the ledge 818. The protrusion 816 and the ledge 818 form a male dovetail component and are received by a corresponding female dovetail component in an instrument and / or implant. The male / female dovetail coupling is one example, and other coupling mechanisms are also contemplated. As shown, the protrusion 816 includes a notch 820 located on the upper surface of the protrusion 816 and adjacent to the front surface 822 of the implant 800. The notch 820 is centered with respect to the side surface 826 of the implant 800 (the protrusion 816 is also laterally centered with respect to the top surface 812 of the implant 800). The notch 820 may be configured to facilitate the coupling of the implant 800 with yet one other component as a coupling function and / or as a function intended to limit the insertion of the protrusion 816 / ledge 818 into a corresponding volume of the instrument / implant component.

[0046] The front 822 (at least one of "A" or "P" is attached to indicate a bias of "anterior" and / or "posterior" with respect to the implant, and the front surface 822 may be referred to as the anterior surface 822) is each shown to include a pair of openings 824 that are disposed on the surface and extend into the body 810 of the implant 800 in a direction substantially perpendicular to the plane in which the front 822 is disposed. In some embodiments, the openings 824 may be configured to facilitate placement of the implant 800 in a desired position, for example, as part of an implant trial / sizing process, with an insertion instrument or other component of an implant / instrument kit / system, and may be configured to removably couple with a trial 800. For example, one or more of the openings 824 may be configured to receive a protrusion of an instrument and hold at least a portion of the protrusion therein while the implant 800 is being manipulated, positioned, and / or repositioned.

[0047] The implant 800 is further shown to include a recess 838 disposed on / within at least a portion of the lower surface 836. The recess 838 may have the same and / or similar shape as the recess 138 of the trial 100, just as the implant 800 may have one or more various geometric features / sizes / articularions that are the same and / or similar to those of the trial 100. In some aspects, the recess 838 may include a ridge along its central portion that separates two smaller sub-recesses. Further, in some aspects, the recess 838 may correspond to the shape of one or more implants and / or a portion thereof configured to interface with the implant 800 in a trial / sizing process. For example, the recess 838 may correspond to the convex surface / curvature of the upper surface of a talus implant configured to interface with the implant 800. As shown in FIGS. 42 - 43, the recess 838 is offset toward the front face 822 of the implant 800. The implant 800 can be inserted such that the front face 822 faces the user, and correspondingly, the recess 838 may be disposed closer to the front face 822 than the back face 832.

[0048] Next, referring to FIGS. 46-49, the implant 800 is shown in combination with the previously described implant system including the tibial component 200 and the talar component 210. The tibial component 200 and the talar component 210 may be the same and / or similar to other similar tibial and talar components of an ankle arthroplasty system, including but not limited to those incorporated herein by reference. The recess 206 is configured to include an engagement feature 208 disposed therein. This engagement feature 208 includes a female dovetail configuration configured to interface and removably couple with the protrusion 816 and the ledge 818 of the implant 800, at least as shown in FIGS. 46-49, and thus removably couple the implant 800 to the tibial component 200 (such that the tibial component 200 is disposed adjacent to the notch 820). In some aspects, the implant 800 may be configured to engage / removably couple with the talar component 210 in the same manner as the implant 800 engages with a corresponding trial component (e.g., trial 100) (e.g., an intermediate trial component that may include the same / similar features for coupling with the tibial component 200 in the same / similar manner). When engaging (e.g., removably coupling) with the tibial component 200, the implant 800 is shown to be located substantially downward (e.g., downward, distal, etc.) relative to the talar component 210.

[0049] The talus component 210 is shown to be arranged such that the implant 800 is located substantially above (e.g., superior, proximal, etc.) the talus component 210. The top surface 212 and its corresponding joint 216 are configured to engage / interface with the implant 800. The joint 216 may be the same as and / or similar to that shown and described in the above-mentioned published patents / pending applications incorporated herein by reference. For example, the joint 216 may include a corresponding articular surface that is divided into four regions for reference. The regions are anteromedial, anterolateral, posteromedial, and posterolateral (the anterior portion of the talus component 210 is the portion that includes the engagement feature 218), and each region has at least one sagittal radius. In some aspects, the anterolateral sagittal radius may be larger than the anteromedial sagittal radius. And, the posteromedial sagittal radius may be larger than the posterolateral sagittal radius. The recess 838 of the implant 800 is configured to interface with the joint 216 and, accordingly, may have a complementary (e.g., opposite) shape to the joint 216 and may have a shape that is substantially the same as and / or similar to the recess of the implant component represented by the implant 800.

[0050] As shown in FIGS. 46-49, the implant 800 is shown with its front surface 822 facing outward and adjacent to the front (e.g., anterior) portion of the tibial component 200 and the talar component 210 (see at least the front view of FIG. 47). “A” of the implant 800 indicates that the recess 838 of the implant 800 is biased forward (e.g., closer to the front / anterior surface 822). Contrary to the trial 100, if the physician determines that a switch from the forward-biased implant 800 to a rearward-biased implant 800 is necessary, a separate implant 800 is required because the implant 800 does not have the reversibility of the trial 100. The implant 800 as shown in FIGS. 46-49 can be selected from a plurality of implants having the same configuration as the implant 800 as shown, but at various sizes, a trial such as the trial 100 is implemented to determine the desired implant size in the trial process, and the physician selects the implant 800 corresponding to the desired size.

[0051] Referring now to FIGS. 50-55, an implant 800 is shown in an alternative rearward-biased configuration. “P” of the implant 800 indicates that the recess 138 is biased rearward (e.g., closer to the rear / posterior surface 832). The implant 800 of FIGS. 50-55 may include some and / or all of the same features as the implant 800 of FIGS. 39-45, with the exception that the recess 838 is biased such that it is closer to the rear / posterior surface 832 than the front / anterior surface 822. The trial process for the implant 800 of FIGS. 50-55 may be the same as and / or similar to that previously described herein with reference to the implant 800 of FIGS. 39-45, although the trial 100 may be performed in the reverse configuration (e.g., a rearward-biased trial configuration).

[0052] Next, referring to FIGS. 56 - 59, the implant 800 is shown with its front surface 822 facing outward and the adjacent front (e.g., forward) portions of the tibial component 200 and the talar component 210 being biased rearward (see at least the front view of FIG. 57). The "P" on the implant 800 indicates that the recess 838 of the implant 800 is biased rearward (e.g., closer to the rear / rearward surface 832). Contrary to the trial 100, if a physician determines that a switch from the rearward - biased implant 800 to the forward - biased implant 800 is necessary, since the implant 800 does not have the reversibility of the trial 100, a different implant 800 is required. The implant 800 as shown in FIGS. 56 - 59 can be selected from a plurality of implants having the same configuration as the implant 800 as shown. However, at various sizes, a trial such as the trial 100 is performed to determine the desired implant size in the trial process, and the physician selects the implant 800 corresponding to that desired size.

[0053] Next, referring to FIGS. 60 - 62, an instrument 900 (shown as an impact instrument, or "impactor") according to an exemplary embodiment is shown. The instrument 900 is shown to include a body 904 that separates an upper portion 902 from a lower portion 906. The upper portion 902 is configured to include a rectangular shape (which may have alternative shapes in some aspects) at its terminus. That shape is configured to receive an impact force and mechanically convert the impact force to the instrument 900. For example, the instrument 900 may be positioned at a desired location, and the lower portion 906 (and / or components coupled thereto, e.g., via coupling element 908) contacts or is adjacent to a surface where a user desires to apply a force / impact. The coupling element 908 extends through a portion of the lower portion 906 and may include engagement features (e.g., threading, ball detent, etc.) operable to facilitate detachable coupling / separation from the instrument 900. Thus, an impact force can be applied in a rectangular shape in a plane substantially parallel to the protrusion of the lower portion 906, and the impact force is applied to a surface adjacent to or contacting the aforementioned protrusion. As shown, the body 904 is substantially perpendicular to and integral with the upper portion 902 and the lower portion 906, which are substantially parallel to each other.

[0054] Next, referring to FIGS. 63 - 65, an instrument 950 (shown as an impact instrument, or "impactor") according to an exemplary embodiment is shown. The instrument 950 is shown to include a body 954 that separates an upper portion 952 and a lower portion 958. The upper portion 952 is configured to include a rectangular shape (which may have alternative shapes in some aspects) at its terminus. The shape is configured to receive an impact force and mechanically convert the impact force with respect to the instrument 950. For example, the instrument 950 may be positioned at a desired location, and the lower portion 958 (and / or components coupled thereto, e.g., via a coupling element 956) contacts or is adjacent to a surface where a user desires to apply a force / impact. The coupling element 956 extends through a portion of the lower portion 958 and may include engagement features (e.g., threads, ball detents, one or more laterally projecting pegs, etc.) that may be operable to facilitate a detachable coupling / separation with the instrument 950. Thus, an impact force can be applied in a plane substantially parallel to the protrusion of the lower portion 958 in a rectangular shape, and the impact force is applied to a surface adjacent to or in contact with the protrusion described above. As shown, the body 954 is substantially perpendicular to and integral with the upper portion 952 and the lower portion 958, which are substantially parallel to each other.

[0055] The terms used in this specification are for the purpose of describing particular embodiments only and are not intended to limit the present invention. In this specification, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. Further, the terms "comprise" (and any form of "comprise" such as "comprises" and "comprising"), "have" (and any form of "have" such as "has" and "having"), "include" (and any form of "include" such as "includes" and "including"), and "contain" (and any form of "contain" such as "contains" and "containing") will be further understood to be open-ended conjunctive verbs. As a result, a method or apparatus that "comprises", "has", "includes", or "contains" one or more steps or elements has those one or more steps or elements but is not limited to having only those one or more steps or elements. Similarly, a step of a method or an element of an apparatus that "comprises", "has", "includes", or "contains" one or more features has those one or more features but is not limited to having only those one or more features. Further, an apparatus or structure configured in a certain way is at least configured in that way but may also be configured in ways not recited.

[0056] The present invention has been described with reference to preferred embodiments. It will be understood that the embodiments of the architecture and operation described herein are illustrative of several possible arrangements for providing the same general features, characteristics, and general system operation. Others may make modifications and changes after reading and understanding the foregoing detailed description. The present invention is intended to cover all such modifications and changes.

Claims

1. 1. An orthopedic implant comprising a body, The body includes: a top surface opposite the bottom surface; The back and the front opposite, a pair of side surfaces located on opposite sides of the main body; Including, At least a portion of the bottom surface includes a concave shape extending from one of the side surfaces to the other of the side surfaces; the concave shape is biased toward either the front or back side of the body of the implant; Orthopedic implants.

2. further comprising at least one opening located on the front surface of the body of the implant.

10. The orthopedic implant of claim 1.

3. the at least one opening includes a pair of openings located on either side of a midline of the implant; 3. The orthopedic implant of claim 2.

4. the concave shape is biased toward the anterior surface of the body of the implant; 10. The orthopedic implant of claim 1.

5. the concave shape is biased toward the back surface of the body of the implant; 10. The orthopedic implant of claim 1.

6. further comprising a protrusion extending upward from the top surface of the body; 10. The orthopedic implant of claim 1.

7. the protrusion comprises a substantially rectangular shape; 7. The orthopedic implant of claim 6.

8. the protrusion includes a top surface that is vertically spaced from the top surface of the body of the implant and that lies in a plane substantially parallel to the top surface of the body of the implant.

8. The orthopedic implant of claim 7.

9. the protrusion has a lateral dimension that increases along its height from adjacent the top surface of the body of the implant to the top surface of the protrusion.

9. The orthopedic implant of claim 8.

10. the protrusion includes a male dovetail component; 10. The orthopedic implant of claim 9.

11. the protrusion includes a notch extending upward from a top surface of the protrusion; the notch is laterally centered relative to the protrusion; 11. The orthopedic implant of claim 10.

12. The implant is connectable to another implant via the protrusion and the notch.

12. The orthopedic implant of claim 11.

13. 1. An orthopaedic implant component comprising a body, The body includes: a top surface opposite the bottom surface; The back and the front opposite, a pair of side surfaces located on opposite sides of the main body; Including, At least a portion of the bottom surface includes a concave shape extending from one of the side surfaces to the other of the side surfaces and is located between the front surface and the back surface of the main body. Orthopedic implant components.

14. The concave shape is located closer to the front surface of the main body than to the back surface of the main body. The orthopaedic implant component of claim 13 .

15. The concave shape is located closer to the back surface of the main body than to the front surface of the main body. The orthopaedic implant component of claim 13 .

16. the implant component includes a protrusion extending upwardly from the top surface of the body of the implant component; The orthopaedic implant component of claim 13 .

17. the protrusion includes a top surface that is perpendicularly spaced from the top surface of the body of the implant component and extends in a plane substantially parallel to the top surface of the body of the implant component. The orthopaedic implant component of claim 16.

18. the protrusion has a lateral dimension that increases along its height from adjacent the top surface of the body of the implant component to the top surface of the protrusion. The orthopaedic implant component of claim 16.

19. the protrusion includes a male dovetail component; The orthopaedic implant component of claim 16.

20. 1. An orthopedic implant comprising: The main body is a top surface opposite the bottom surface; The back and the front opposite, a pair of side surfaces located on opposite sides of the main body; Including, At least a portion of the bottom surface includes a concave shape extending from one of the side surfaces to the other of the side surfaces; a body, the concave shape being biased toward either the front or back side of the body of the implant; a plane extending upward from the top surface of the body and substantially parallel to the top surface of the body; a protrusion having a top surface, the protrusion having a lateral dimension that increases along the height of the protrusion from a portion of the body adjacent the top surface to the top surface of the protrusion; Equipped with Orthopedic implants.

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