Systems and methods for stable tibial implantation

Abstract

Systems, methods, devices, and apparatuses are described herein for handling, positioning, and potentially implanting a tibial implant. Various embodiments may comprise a tibial implant holder featuring stabilization tracks, along with a tibial implant and a male impaction guide which may both possess corresponding stabilization flanges configured to slidably engage the holder's tracks. A potentially cannulated male impaction guide positioning screw, seated within the holder, may be adjustable to control the abutment of the male impaction guide against the tibial implant. An implant fixation screw might pass through the positioning screw and male impaction guide to engage a threaded hole within the tibial implant, thereby securing the components. Furthermore, the male impaction guide may include a vertical stem configured to mate with a vertical recess in a separate female impaction guide, which can be affixed to bone, providing stable external referencing for the assembly during implantation procedures.

Description

SYSTEMS AND METHODS FOR STABLE TIBIAL IMPLANTATIONPRIORITY

[0001] This application claims the benefit of and priority to U.S. Provisional Application filed on April 15, 2024 and having application serial number 63 / 634,373, and U.S. Provisional Application filed on April 15, 2024 and having application serial number 63 / 634,382 the entirety of each of said applications being incorporated herein by reference.FIELD

[0002] Embodiments of the present disclosure generally relate to the field of surgical implants. More specifically, embodiments of the disclosure relate to apparatuses and methods for implanting a tibia implant in a more stable fashion for treating tibial defects or revisioning previous implants.BACKGROUND

[0003] The tibia, or shinbone, is the larger bone of the lower leg, extending down towards the foot. At its lower end, it forms the upper and inner part of the ankle joint. The talus is a crucial bone in the foot, situated directly below the tibia, connecting the leg bones to the rest of the foot. The primary joint articulation between these two bones, the tibiotalar joint, is a component of the ankle joint, allowing for the up-and-down motion (dorsiflexion and plantarflexion) essential for walking and movement. Implants in this area typically resurface or replace parts of the lower tibia and the upper talus within the ankle joint.

[0004] Damage or degeneration of the tibiotalar joint is the main reason for needing an ankle implant, often as part of a total ankle replacement or sometimes an ankle fusion procedure. Severe arthritis, particularly osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis resulting from previous ankle fractures or injuries, commonly leads to cartilage loss, pain, and stiffness in this joint. Significant ankle instability, deformity, bone defects, or the failure of previous ankle surgeries (necessitating revision) can also necessitate implants to restore function and alleviate pain by replacing the damaged joint surfaces of the lower tibia and upper talus.

[0005] During the surgical procedure, challenges can arise with the precise physical placement and insertion of tibial and talar implants. Accurately preparing the bone surfaces of the tibia andtalus to accurately match the implant shapes is critical but can be difficult. Inserting and aligning the implant components requires careful alignment; incorrect positioning, even by small amounts, can affect joint mechanics. If the implants are not securely fixed or optimally positioned from the start, this poor initial attachment can lead to significant problems over time, such as micromotion at the implant-bone interface, uneven load distribution causing accelerated wear or implant breakage, eventual loosening from the bone, subsidence (sinking) of the components, joint instability, and ultimately, the potential need for complex revision surgery.SUMMARY

[0006] Embodiments related to an apparatus, system, and / or method are provided for implanting a tibia implant in a more stable fashion. In some embodiments, a tibial shaping system includes a tibial implant holder, including a left stabilization track, and a right stabilization track, a male impaction guide positioning screw, an implant fixation screw, including a fixation screw threaded portion, and a male impaction guide, including, a vertical stem configured to mate with a female impaction guide, a male impaction posterior side, and a tibial implant, including a tibial implant anterior side, wherein the male impaction guide positioning screw is configured to engage with the male impaction guide such that the male impaction guide posterior side abuts the tibial implant anterior side.

[0007] In some embodiments, at least a male impaction anterior side includes at least tibial implant fixation threaded hole, a male impaction guide left stabilization flange, and a male impaction guide right stabilization flange, wherein the male impaction guide left stabilization flange is configured to mate with the left stabilization track, and the male impaction guide right stabilization track is configured to mate with the right stabilization track,

[0008] In some embodiments, the implant anterior side includes at least a tibial implant left stabilization flange, and a tibial implant right stabilization flange, wherein the male tibial implant left stabilization flange is configured to mate with the left stabilization track, and the tibial implant right stabilization track is configured to mate with the right stabilization track.

[0009] In some embodiments, the vertical stem is configured to mate with a vertical recess of a female impaction guide.

[0010] In some embodiments, the vertical recess is dimensioned to mate with the vertical stem such that at least one motion is reduced during the implantation process.

[0011] In some embodiments, the female impaction guide is affixed to a tibia bone via one or more fixation pins such that the mating of the vertical stem and the vertical recess reduces one or more directional motions during the tibial implant process.

[0012] In some embodiments, the one or more fixation pins include at least two parallel pins.

[0013] In some embodiments, the one or more fixation pins include at least one oblique pin.

[0014] In some embodiments, the tibial implant includes at least sone blade.

[0015] In some embodiments, the implant fixation screw further includes an implant fixation screw handle. The tibial shaping system, wherein the male impaction guide positioning screw, includes a positioning screw threaded portion, a positioning screw handle, and a positioning screw anterior access hole.

[0016] In some embodiments, the tibial implantation holder further includes a vertical access void, an intermediate screw hole, and an intermediate access void.

[0017] In some embodiments, the male impaction guide positioning screw is seated within the tibial implantation holder by inserting the male impaction guide positioning screw through the vertical access void and through the intermediate screw hole.

[0018] In some embodiments the tibial implant is configured to cooperate with a flat impactor during the implantation process.

[0019] In some embodiments, the flat impactor is configured to cooperate with an impactor frame such that force may be transferred to the tibial implant.

[0020] In some embodiments, a method of stabilizing a tibial implant includes inserting a male impaction guide positioning screw into a tibial implant holder, inserting an implant fixation screw through a rear screw hole of the tibial implant holder, and through a positioning screw through hole of the male impaction guide positioning screw, engaging a male impaction guide on the tibialimplant holder, engaging a tibial implant on the tibial implant holder, inserting a threaded portion of the implant fixation screw through a through hole encompassing the tibial implant holder, male impaction guide positioning screw, and male impaction guide such that the implant fixation screw traverses along the through hole to engage a tibial implant fixation threaded hole, positioning the tibial implant by adjusting the implant fixation screw, and abutting the male impaction guide against the tibial implant by engaging the male impaction guide positioning screw.

[0021] In some embodiments, the method further includes mating a vertical stem of the male impaction guide with a vertical recess of a female impaction guide.

[0022] In some embodiments, the female impaction guide is affixed to a tibia bone.

[0023] In some embodiments, the female impaction guide is affixed to the tibia bone by a plurality of fixation pins.

[0024] In some embodiments, the fixation of the female impaction guide cooperates with the mating of the male impaction guide to reduce a motion of the tibia implant during an impaction procedure.

[0025] In some embodiments, the tibial implant is configured to cooperate with a flat impactor during the implantation process such that force received from an impactor frame is transferred to the tibia implant through the flat impactor.

[0026] In some embodiments, a tibial shaping system includes a tibial implant holder, including a vertical access void, an intermediate screw hole, an intermediate access void, a left stabilization track, and a right stabilization track, a male impaction guide positioning screw, including a positioning screw threaded portion, a positioning screw handle, and a positioning screw anterior access hole, an implant fixation screw, including a fixation screw threaded portion, and an implant fixation screw handle, a male impaction guide, including, a vertical stem, wherein the vertical stem is configured to mate with a female impaction guide, a male impaction posterior side, and a male impaction anterior side including at least tibial implant fixation threaded hole, a male impaction guide left stabilization flange, and a male impaction guide right stabilization flange, wherein the male impaction guide left stabilization flange is configured to mate with the left stabilization track, and the male impaction guide right stabilization track is configured to matewith the right stabilization track, a tibial implant, including at least one tibial implant blade, a tibial implant anterior side, including at least a tibial implant left stabilization flange, a tibial implant right stabilization flange, wherein the male tibial implant left stabilization flange is configured to mate with the left stabilization track, and the tibial implant right stabilization track is configured to mate with the right stabilization track, wherein the tibial implant holder, male impaction guide positioning screw, and male impaction guide provide an implant fixation screw through hole such that the implant fixation screw traverses along the through hole to engage the tibial implant fixation threaded hole, wherein the male impaction guide positioning screw is configured to engage with the male impaction guide such that the male impaction guide posterior side abuts the tibial implant anterior side, and wherein the vertical stem is configured to mate with a vertical recess of a female impaction guide, wherein the female impaction guide is affixed to a tibia bone via one or more fixation pins such that the mating of the vertical stem and the vertical recess reduces one or more directional motions during the tibial implant process.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The drawings refer to embodiments of the present disclosure in which:

[0028] FIG. 1A illustrates a first perspective view of a tibial implant holder, in accordance with various embodiments of the disclosure;

[0029] FIG. IB illustrates a bottom-up view of a tibial implant holder, in accordance with various embodiments of the disclosure;

[0030] FIG. 1 C illustrates a second perspective view of a tibial implant holder, in accordance with various embodiments of the disclosure;

[0031] FIG. 2 A illustrates a first perspective view of a male impaction guide positioning screw, in accordance with various embodiments of the disclosure;

[0032] FIG. 2B illustrates a second perspective view of a male impaction guide positioning screw, in accordance with various embodiments of the disclosure;

[0033] FIG. 3 A illustrates a perspective view of a male impaction guide positioning screw being initially inserted into a tibial implant holder in accordance with various embodiments of the disclosure;

[0034] FIG. 3B illustrates a perspective view of a male impaction guide positioning screw being fully inserted into a tibial implant holder in accordance with various embodiments of the disclosure;

[0035] FIG. 3C illustrates a perspective view of a male impaction guide positioning screw being seated into a tibial implant holder in accordance with various embodiments of the disclosure;

[0036] FIG. 4 illustrates a perspective view of an implant fixation screw, in accordance with various embodiments of the disclosure;

[0037] FIG. 5 illustrates a perspective view of an implant fixation screw being inserted into a seated male impaction guide positioning screw, in accordance with various embodiments of the disclosure;

[0038] FIG. 6 illustrates a perspective view of a male impaction guide, in accordance with various embodiments of the disclosure;

[0039] FIG. 7 illustrates a perspective view of a male impaction guide being inserted onto a tibial implant holder, in accordance with various embodiments of the disclosure;

[0040] FIG. 8 illustrates a perspective view of a tibia implant in accordance with various embodiments of the disclosure;

[0041] FIG. 9A illustrates a perspective view of a tibia implant being inserted onto a tibial implant holder, in accordance with various embodiments of the disclosure;

[0042] FIG. 9B illustrates a perspective view of a male impaction guide being abutted against the tibial implant, in accordance with various embodiments of the disclosure;

[0043] FIG. 10A illustrates a perspective view of a female impaction guide, in accordance with various embodiments of the disclosure;

[0044] FIG. 10B illustrates a top-down view of a female impaction guide, in accordance with various embodiments of the disclosure; and

[0045] FIG. 11 illustrates a perspective view of the flat impactor cooperating with the tibial implant during an impaction process, in accordance with various embodiments of the disclosure.

[0046] While the present disclosure is subject to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. The invention should be understood to not be limited to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.DETAILED DESCRIPTION

[0047] Embodiments of the present disclosure relate generally to systems, apparatuses, and methods used in orthopedic surgery, particularly for handling, positioning, and potentially implanting tibial implants or similar prosthetic devices. The disclosed system might involve several interacting components, potentially including a tibial implant holder, a tibial implant intended for implantation, a male impaction guide, a female impaction guide, a specialized male impaction guide positioning screw, and an implant fixation screw. These components might be designed to assemble into a construct that could facilitate precise manipulation and placement of the tibial implant relative to a patient's anatomy, such as a prepared tibia bone or talar bone.

[0048] In various embodiments, the tibial implant holder could serve as a base or handle, potentially featuring longitudinal stabilization tracks. Both the tibial implant and the male impaction guide might possess corresponding stabilization flanges configured to slidably engage these tracks, thereby providing guided alignment as they are mounted onto the holder. The system might further utilize a cannulated positioning screw, seated within the holder, and a fixation screw passing through the positioning screw and potentially the male impaction guide, to engage and secure the tibial implant. Adjusting the positioning screw could allow the male impaction guide to be controllably abutted against the tibial implant, potentially stabilizing it securely within the holder assembly.

[0049] Furthermore, the system might incorporate features for external referencing and stability during the implantation process. For instance, the male impaction guide could include a vertical stem designed to mate with a corresponding vertical recess in a female impaction guide. This female impaction guide might be independently affixed to the patient's bone (e.g., the tibia bone) using fixation pins. The interlocking engagement between the male guide's stem and the female guide's recess could provide enhanced stability and positional control for the entire implant holder assembly relative to the bone, potentially reducing unwanted motion during critical steps like impaction, which might be performed using a flat impactor possibly driven by an impactor frame.

[0050] A method for stabilizing a tibial implant prior to or during implantation may be performed using various disclosed embodiments. Such a method could commence with inserting a male impaction guide positioning screw into a tibial implant holder, potentially seating it via threaded engagement. An implant fixation screw might then be inserted through appropriate access holes and through the cannulated positioning screw. A male impaction guide could subsequently be engaged onto the tibial implant holder, possibly guided by stabilization flanges engaging stabilization tracks on the holder. Similarly, a tibial implant could be engaged onto the holder, potentially guided by its own stabilization flanges mating with the holder's tracks, positioning it adjacent to the male impaction guide. The implant fixation screw might then be advanced through the assembly, including potentially passing through the male impaction guide, to threadedly engage a corresponding fixation hole in the tibial implant, thereby initially securing the implant. Finally, the male impaction guide positioning screw could be adjusted (e.g., rotated) to controllably move the male impaction guide until its posterior side firmly abuts the anterior side of the now-secured tibial implant, creating a stabilized assembly within the holder. This stabilized assembly could then potentially be further referenced by mating the male impaction guide to a bone-fixed female impaction guide for subsequent implantation steps.

[0051] The process of positioning and securing tibial implants during orthopedic surgery can encounter challenges related to maintaining precise control, orientation, and stability of the implant throughout the surgical workflow, particularly during transfer to the surgical site and potential final impaction. Handling the implant securely while simultaneously allowing for fine adjustments and applying fixation forces might prove difficult with traditional instrumentation, potentiallyleading to implant malpositioning or instability prior to final fixation. Furthermore, ensuring the implant remains stable relative to the patient's anatomy or external surgical guides, especially if impaction forces are applied, may require complex or cumbersome setups that could impede surgical access or efficiency. Various embodiments disclosed herein may address such problems by providing an integrated system comprising, for example, a tibial implant holder with stabilization tracks, specialized positioning and fixation screws, and potentially mating male and female impaction guides; this system could allow for the tibial implant to be securely yet adjustably held, precisely positioned relative to the holder and potentially an external bone-fixed guide, and stably maintained during subsequent surgical manipulations or impaction steps, thereby potentially improving accuracy and control during implantation.

[0052] The embodiments depicted in the figures are provided by way of example only. The drawings are not necessarily to scale, and relative proportions or specific dimensions shown are illustrative and may be modified. Various features depicted in the figures may be combined, omitted, or rearranged in different ways, and equivalents of the depicted structures and configurations are intended to be encompassed within the scope of this disclosure. The description accompanying the figures is intended to be illustrative and not limiting; the scope of the invention is defined by the appended claims.

[0053] Materials suitable for constructing the components described herein, such as the tibial implant base and the tibial implant cover, may include various biocompatible materials known in the art for orthopedic implants. Examples can include, but are not limited to, metals such as titanium, titanium alloys, cobalt-chromium alloys, stainless steel; polymers; ceramics; or combinations thereof. The selection of a specific material may depend on factors like structural requirements, desired biocompatibility, wear characteristics, manufacturing methods (e.g., additive manufacturing for lattice structures, machining for solid components), and interfacing properties, and the examples provided are not intended to be exhaustive.

[0054] Positional and directional terms such as "anterior," "posterior," "superior," "inferior," "medial," "lateral," "top," "bottom," "upward," "downward," and the like are used herein for convenience to describe the embodiments as typically oriented or viewed, often with reference to standard anatomical positioning or the implant's orientation as depicted. Unless otherwisespecified or required by the context, these terms are not intended to be strictly limiting or absolute. For instance, "superior" may refer to a direction generally towards the head in anatomical terms or away from the bone interface surface of the base component, but the implant could potentially be oriented differently during use or analysis.

[0055] In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present disclosure. It will be apparent, however, to one of ordinary skill in the art that the invention disclosed herein may be practiced without these specific details. In other instances, specific numeric references such as “first implant,” may be made. However, the specific numeric reference should not be interpreted as a literal sequential order but rather interpreted that the “first implant” is different than a “second implant.” Thus, the specific details set forth are merely exemplary. The specific details may be varied from and still be contemplated to be within the spirit and scope of the present disclosure. The term “coupled” is defined as meaning connected either directly to the component or indirectly to the component through another component. Further, as used herein, the terms “about,” “approximately,” or “substantially” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.

[0056] Referring to FIG. 1A, a first perspective view of a tibial implant holder 100, in accordance with various embodiments of the disclosure is shown. This view illustrates an elongated instrument body, configured for holding or manipulating components of a tibial implant system. The tibial implant holder 100 may serve as a base or handle onto which other elements, such as a tibial implant (800) or a male impaction guide (600), can be mounted or stabilized.

[0057] As depicted in the embodiment shown in FIG. 1A, the tibial implant holder 100 can include features along its length possibly intended for guiding or stabilizing associated components. A right stabilization track 150 and a left stabilization track 155 might be present, potentially configured as longitudinal channels or rails. These tracks (150, 155) could be dimensioned to slidably receive corresponding features, such as stabilization flanges, on other parts of the surgical system.

[0058] In some embodiments, the tibial implant holder 100 may define openings or voids. A vertical access void 120 might provide an opening through the body, possibly allowing passage orvisualization of underlying structures or instruments. An intermediate access void 140 could be located further along the body, potentially serving a similar or different access function. Additionally, an inferior access notch 125 may be present on the underside, possibly providing clearance or access from below.

[0059] Furthermore, in certain embodiments visible in FIG. 1A, the tibial implant holder 100 might incorporate apertures for receiving fixation or positioning elements. A rear screw hole 110 may be located towards the proximal end of the holder, while an intermediate screw hole 130 could be situated more distally. These screw holes (110, 130) might be configured to accept screws, such as a male impaction guide positioning screw (200) or an implant fixation screw (400), used in assembling or operating the system.

[0060] Although a specific embodiment for a tibial implant holder 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 1A, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the right stabilization track 150 and left stabilization track 155 could have different cross-sectional profiles in alternative embodiments. The elements depicted in FIG. 1 A may also be interchangeable with other elements of FIGS. IB-11 as required to realize a particularly desired embodiment.

[0061] Referring to FIG. IB, a bottom-up view of a tibial implant holder 100, in accordance with various embodiments of the disclosure is shown. This view presents the underside of the tibial implant holder 100, revealing features that might interface with other components or provide access from an inferior perspective. The overall elongated shape of the tibial implant holder 100 is also apparent from this viewpoint.

[0062] As depicted in the embodiment shown in FIG. IB, the underside of the tibial implant holder 100 can prominently feature guiding or stabilizing structures. Specifically, the right stabilization track 150 and the left stabilization track 155 may extend longitudinally along the holder. These tracks (150, 155) might be configured as channels or grooves designed to receive corresponding flanges or rails from other system components, potentially guiding their insertion or limiting their movement relative to the tibial implant holder 100.

[0063] In some embodiments, apertures or notches providing access through the tibial implant holder 100 may be visible from the bottom. The vertical access void 120 can be seen penetrating the body of the holder. Additionally, an inferior access notch 125 might be present, potentially offering clearance or specific access for instruments or portions of other components from the underside of the tibial implant holder 100.

[0064] The features visible in this bottom-up view illustrate aspects potentially related to the assembly and function of the overall tibial implant system. The right stabilization track 150 and left stabilization track 155 might cooperate with elements like a male impaction guide (600) or a tibial implant (800), while the vertical access void 120 and inferior access notch 125 could facilitate the passage or interaction of positioning or fixation screws, such as the male impaction guide positioning screw (200) or the implant fixation screw (400).

[0065] Although a specific embodiment for a tibial implant holder 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. IB, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the surfaces defining the right stabilization track 150 and left stabilization track 155 might incorporate different textures or coatings in alternative embodiments. The elements depicted in FIG. IB may also be interchangeable with other elements of FIGS. 1A, and 1C-11 as required to realize a particularly desired embodiment.

[0066] Referring to FIG. 1C, a second perspective view of a tibial implant holder 100, in accordance with various embodiments of the disclosure is shown. This perspective offers another view of the elongated instrument body, potentially highlighting internal features or passages not as clearly visible in FIG. 1A or FIG. IB. The tibial implant holder 100 is presented as potentially suitable for manipulating or stabilizing other surgical components.

[0067] As depicted in the embodiment shown in FIG. 1C, the tibial implant holder 100 again displays the right stabilization track 150 and the left stabilization track 155 extending longitudinally. This view reinforces their potential function as guide channels for mating components. The perspective also provides clarity on the openings along the holder, such as the vertical access void 120 and the intermediate access void 140, suggesting pathways through the holder body.

[0068] In some embodiments, FIG. 1C particularly illustrates internal passages or recesses. A rear through hole 115 might be associated with the rear screw hole 110, potentially forming a continuous passage. Similarly, an intermediate through hole 135 could be associated with the intermediate screw hole (130), suggesting another path for a screw or instrument. A positioning screw recess 145 is also shown, perhaps configured to seat or align a portion of a male impaction guide positioning screw (200).

[0069] The features visible in this second perspective view can further elaborate on the potential functionality of the tibial implant holder 100. The combination of external stabilization tracks (150, 155) with internal voids (120, 140), recesses (145), and through holes (115, 135) suggests a structure designed for complex assembly and interaction with screws and guided components within a surgical implant system.

[0070] Although a specific embodiment for a tibial implant holder 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 1C, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the positioning screw recess 145 could be shaped differently to accommodate alternative screw designs in other embodiments. The elements depicted in FIG. 1C may also be interchangeable with other elements of FIGS. 1 A-1B, and 2A- 11 as required to realize a particularly desired embodiment.

[0071] Referring to FIG. 2A, a first perspective view of a male impaction guide positioning screw 200, in accordance with various embodiments of the disclosure is shown. This component may function as an adjustable element within a tibial implant system, potentially used for positioning or securing other components relative to each other or to a tibial implant holder (100). The male impaction guide positioning screw 200 can be generally cylindrical with distinct sections along its length.

[0072] As depicted in the embodiment shown in FIG. 2A, the proximal end (relative to the likely user interaction point) of the male impaction guide positioning screw 200 may feature a positioning screw handle 230. This positioning screw handle 230 might be configured with facets or a specific shape to facilitate manual rotation or gripping, potentially allowing a user to advanceor retract the screw. An opening, identified as the positioning screw anterior access hole 235, might be present on the proximal face of the positioning screw handle 230.

[0073] In some embodiments, extending distally from the positioning screw handle 230, the male impaction guide positioning screw 200 can include different shaft portions. A positioning screw threaded portion 220 may be located adjacent to the positioning screw handle 230, potentially designed to engage with corresponding threads in another component, such as the intermediate screw hole (130) of the tibial implant holder (100). Distal to the positioning screw threaded portion 220, a positioning screw smooth portion 210 might form the remainder of the shaft.

[0074] Furthermore, in certain embodiments, the male impaction guide positioning screw 200 may possess an internal lumen or channel extending partially or fully along its length, potentially represented by the positioning screw through hole 240 designation. This positioning screw through hole 240 could allow passage for other instruments or fixation elements, such as an implant fixation screw (400), possibly accessed via the positioning screw anterior access hole 235 and potentially a corresponding posterior access hole (215) shown in FIG. 2B.

[0075] Although a specific embodiment for a male impaction guide positioning screw 200 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 2A, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the positioning screw handle 230 could incorporate different gripping surfaces or shapes for enhanced ergonomics in alternative embodiments. The elements depicted in FIG. 2A may also be interchangeable with other elements of FIGS. 1A-1C, and 2B-11 as required to realize a particularly desired embodiment.

[0076] Referring to FIG. 2B, a second perspective view of a male impaction guide positioning screw 200, in accordance with various embodiments of the disclosure is shown. This view presents the male impaction guide positioning screw 200 from an orientation generally opposite to that shown in FIG. 2A, providing additional visual information about its structure, particularly its distal end. As depicted in the embodiment shown in FIG. 2B, the male impaction guide positioning screw 200 includes a positioning screw handle 230 at its proximal end, which might facilitate rotation. An opening, the positioning screw anterior access hole 235, may be visible on theproximal face of the handle. Adjacent to the positioning screw handle 230 is the positioning screw threaded portion 220, followed by the positioning screw smooth portion 210 extending distally.

[0077] In some embodiments, FIG. 2B illustrates the distal end of the male impaction guide positioning screw 200. An opening, identified as the positioning screw posterior access hole 215, may be present at the terminal end of the positioning screw smooth portion 210. This positioning screw posterior access hole 215 could provide access to an internal lumen or through hole (240) running within the screw.

[0078] Furthermore, in certain embodiments, the presence of both the positioning screw anterior access hole 235 and the positioning screw posterior access hole 215 might suggest a cannulated design. This cannulation, potentially extending through the positioning screw through hole (240), could allow the male impaction guide positioning screw 200 to be placed over a guidewire or permit another instrument or fixation element, such as an implant fixation screw (400), to pass entirely through it.

[0079] Although a specific embodiment for a male impaction guide positioning screw 200 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 2B, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the positioning screw posterior access hole 215 and anterior access hole 235 could be shaped to accept specific instrument tips in different embodiments. The elements depicted in FIG. 2B may also be interchangeable with other elements of FIGS. 1A-2A, and 3A-11 as required to realize a particularly desired embodiment.

[0080] Referring to FIG. 3 A, a perspective view of a male impaction guide positioning screw 200 being initially inserted into a tibial implant holder 100, in accordance with various embodiments of the disclosure is shown. This view illustrates a potential step in assembling components of a tibial implant system, where the male impaction guide positioning screw 200 is being introduced into the tibial implant holder 100. As depicted in the embodiment shown in FIG. 3A, the male impaction guide positioning screw 200, comprising features like the positioning screw handle 230, positioning screw threaded portion 220, and positioning screw smooth portion 210, is shown aligned with the tibial implant holder 100. The distal end of the screw, potentiallythe positioning screw smooth portion 210, appears oriented towards openings in the holder, such as the intermediate access void 140 or the intermediate screw hole 130.

[0081] In some embodiments, the insertion process might involve aligning the male impaction guide positioning screw 200 with specific features of the tibial implant holder 100. The screw 200 might be passed through the vertical access void 120 or potentially engage initially with the intermediate screw hole 130 or rear screw hole 110. The positioning screw anterior access hole 235 visible on the positioning screw handle 230 may provide in certain embodiments, access for other tools or elements even during insertion.

[0082] Furthermore, in certain embodiments, this initial insertion step sets the stage for further engagement between the male impaction guide positioning screw 200 and the tibial implant holder 100. Subsequent rotation of the positioning screw handle 230 might cause the positioning screw threaded portion 220 to engage corresponding threads within the intermediate screw hole 130 or other features of the holder, thereby advancing the screw into its seated position as potentially shown in later figures.

[0083] Although a specific embodiment illustrating the initial insertion of a male impaction guide positioning screw 200 into a tibial implant holder 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 3A, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the male impaction guide positioning screw 200 could incorporate a selfguiding tip in alternative embodiments to facilitate initial insertion. The elements depicted in FIG. 3 A may also be interchangeable with other elements of FIGS. 1 A-2B, and 3B-11 as required to realize a particularly desired embodiment.

[0084] Referring to FIG. 3B, a perspective view of a male impaction guide positioning screw 200 being fully inserted into a tibial implant holder 100, in accordance with various embodiments of the disclosure is shown. This view illustrates a state subsequent to the initial insertion shown in FIG. 3 A, potentially depicting the male impaction guide positioning screw 200 as it is advanced or rotated towards a fully seated position within the tibial implant holder 100. As depicted in the embodiment shown in FIG. 3B, the male impaction guide positioning screw 200 has progressed further into the tibial implant holder 100. The positioning screw threaded portion (220) may incertain embodiments, engage corresponding threads within the holder, possibly within the intermediate screw hole 130 or rear screw hole 110. Rotation of the positioning screw handle 230, potentially indicated by the curved arrow, may cause the screw 200 to advance along its axis relative to the holder 100 and into a seated position.

[0085] In some embodiments, the positioning screw smooth portion 210 of the male impaction guide positioning screw 200 now extends through a significant portion of the tibial implant holder 100. Its distal end might be situated within or near the intermediate access void 140 or potentially closer to the distal end of the holder. The positioning screw handle 230 can remain accessible at the proximal end, potentially adjacent to the rear screw hole 110 or vertical access void 120.

[0086] Furthermore, in certain embodiments, this view demonstrates the mechanism by which the male impaction guide positioning screw 200 might be secured within the tibial implant holder 100. The threaded engagement allows for controlled advancement and potentially locking the screw 200 at a desired position within the holder 100, which may be relevant for subsequent steps involving other components like the male impaction guide (600) or tibial implant (800). The positioning screw anterior access hole 235 remains visible, maintaining potential cannulation access.

[0087] Although a specific embodiment illustrating a male impaction guide positioning screw 200 being fully inserted into a tibial implant holder 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 3B, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, markings on the tibial implant holder 100 or positioning screw handle 230 could indicate full insertion in other embodiments. The elements depicted in FIG. 3B may also be interchangeable with other elements of FIGS. 1A-3A, and 3C-11 as required to realize a particularly desired embodiment.

[0088] Referring to FIG. 3C, a perspective view of a male impaction guide positioning screw 200 being seated into a tibial implant holder 100, forming an intermediate tibial preparation arrangement 300, in accordance with various embodiments of the disclosure is shown. This view illustrates the male impaction guide positioning screw 200 in its potentially final, secured position within the tibial implant holder 100, subsequent to the insertion steps depicted in FIGS. 3 A and3B. As depicted in the embodiment shown in FIG. 3C, the male impaction guide positioning screw 200 is depicted as fully engaged and / or seated within the tibial implant holder 100. The positioning screw handle 230 may now be proximate to or abut the proximal end of the tibial implant holder 100, indicating that the screw 200 has been advanced, potentially via its threaded portion (220) engaging the intermediate screw hole 130 or other threaded features within the holder.

[0089] In some embodiments, the seated configuration shown as the intermediate tibial preparation arrangement 300 highlights the coaxial alignment of features within the assembled components. An implant fixation screw through hole 350 may now be established, potentially running through both the tibial implant holder 100 and the cannulated male impaction guide positioning screw 200 (via its anterior access hole 235 and posterior access hole 215). Furthermore, in certain embodiments, this assembled intermediate tibial preparation arrangement 300 can provide in various embodiments, a stable construct ready for subsequent steps. The implant fixation screw through hole 350 might be configured in some embodiments, to receive an implant fixation screw (400) for securing other components, such as a tibial implant (800), relative to the holder 100 and positioning screw 200 assembly. The positioning screw 200, being seated, may now serve its function in defining the position for other elements within the system.

[0090] Although a specific embodiment illustrating a male impaction guide positioning screw 200 seated in a tibial implant holder 100, forming an intermediate tibial preparation arrangement 300 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 3C, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the implant fixation screw through hole 350 could be sized to accommodate different diameters of fixation screws in other embodiments. The elements depicted in FIG. 3C may also be interchangeable with other elements of FIGS. 1A-3B, and 4-11 as required to realize a particularly desired embodiment.

[0091] Referring to FIG. 4, a perspective view of an implant fixation screw 400, in accordance with various embodiments of the disclosure is shown. This component appears as an elongated screw and can be configured for securing a tibial implant (800) or other elements within thesurgical assembly. The implant fixation screw 400 exhibits distinct sections along its length, suggesting specific functions for each region during its use in a surgical procedure.

[0092] As depicted in the embodiment shown in FIG. 4, the proximal end of the implant fixation screw 400 features an implant fixation screw handle 430. This handle 430 may be shaped with multiple facets or gripping surfaces to allow for secure engagement by a driving instrument or manual manipulation by a surgeon. Such a configuration could facilitate the controlled insertion, rotation, and tightening of the implant fixation screw 400.

[0093] In some embodiments, extending distally from the implant fixation screw handle 430, the shaft of the implant fixation screw 400 includes different portions. A fixation screw smooth portion 420 might be located immediately distal to the handle 430, potentially acting as a nonthreaded shank. Further distally, a fixation screw threaded portion 410 is present, designed in certain embodiments to engage with a corresponding threaded hole, such as the tibial implant fixation threaded hole (855) in a tibial implant (800).

[0094] Furthermore, in certain embodiments, the implant fixation screw 400 might be cannulated, although an internal through hole is not explicitly labeled in this view. Such cannulation could allow the screw to be passed over a guidewire for precise placement or could permit the passage of other substances. The combination of the handle 430, smooth portion 420, and threaded portion 410 suggests a design intended for securely fixing components within the tibial implant system, and passing through elements like the tibial implant holder (100) and the male impaction guide positioning screw (200).

[0095] Although a specific embodiment for an implant fixation screw 400 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 4, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the implant fixation screw 400 might be fabricated from titanium alloy, stainless steel, or another biocompatible material suitable for temporary or permanent fixation. The elements depicted in FIG. 4 may also be interchangeable with other elements of FIGS. 1 A-3C, and 5-11 as required to realize a particularly desired embodiment.

[0096] Referring to FIG. 5, a perspective view of an implant fixation screw 400 being inserted into a seated male impaction guide positioning screw 200, which is within a tibial implant holder 100, in accordance with various embodiments of the disclosure is shown. This view illustrates a potential step in the surgical workflow involving the assembly previously shown in FIG. 3C. The implant fixation screw 400 is depicted being introduced into the cannulated passage formed by the aligned holder 100 and positioning screw 200.

[0097] As depicted in the embodiment shown in FIG. 5, the implant fixation screw 400, characterized by its fixation screw smooth portion 420 and distal fixation screw threaded portion 410, is aligned coaxially with the male impaction guide positioning screw 200. The fixation screw 400 appears to be passing through the positioning screw anterior access hole 235 located in the positioning screw handle 230. This action suggests the utilization of the cannulation feature of the positioning screw 200 in various embodiments, which can correspond to the implant fixation screw through hole (350).

[0098] In some embodiments, the insertion trajectory can indicate that the implant fixation screw 400 is intended to pass through the male impaction guide positioning screw 200 and potentially through apertures within the tibial implant holder 100, such as the intermediate screw hole 130 or others along the path. The positioning screw smooth portion 210 can be visible extending distally within the holder 100, providing context for the path of the implant fixation screw 400. This configuration may allow for fixation of components located distal to the positioning screw 200 while it remains seated in the holder 100.

[0099] Furthermore, in certain embodiments, this step can facilitate the secure attachment of a tibial implant (800) or other components to the assembly. The fixation screw threaded portion 410 may be positioned to advance through the assembly and engage with a corresponding threaded feature, perhaps the tibial implant fixation threaded hole (855), located distally. The precise positioning and secure fixation afforded by this arrangement may be utilized for the stability and success of the subsequent implantation steps.

[0100] Although a specific embodiment illustrating an implant fixation screw 400 being inserted into a seated male impaction guide positioning screw 200 and tibial implant holder 100 for carrying out the various steps, processes, methods, and operations described herein is discussedwith respect to FIG. 5, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the fixation screw threaded portion 410 could utilize different thread pitches or profiles depending on the intended application or implant material. The elements depicted in FIG. 5 may also be interchangeable with other elements of FIGS. 1 A-4, and 6-11 as required to realize a particularly desired embodiment.

[0101] Referring to FIG. 6, a perspective view of a male impaction guide 600, in accordance with various embodiments of the disclosure is shown. This component may serve in some embodiments, as an interface or guide element within the tibial implant system. The male impaction guide 600 may comprise a base portion from which other features extend, potentially facilitating alignment or connection with other instruments or implants.

[0102] As depicted in the embodiment shown in FIG. 6, the base of the male impaction guide 600 may include features for stabilization and positioning relative to another component, such as a tibial implant holder (100). A male impaction guide left stabilization flange 651 and a male impaction guide right stabilization flange 652 can extend laterally from the base portion, near the male impaction guide base top 610. These flanges (651, 652) might be dimensioned to slidably engage corresponding tracks, like the left stabilization track (155) and right stabilization track (150) on the tibial implant holder (100).

[0103] In some embodiments, a vertical stem 620 projects upwardly (relative to the orientation shown) from the male impaction guide base top 610. This vertical stem 620 may be configured with a specific cross-sectional shape or features designed to mate precisely with a corresponding recess, such as the vertical recess (1010) of a female impaction guide (1000). Such mating could provide stability and restrict relative motion between the male and female impaction guides during a surgical procedure.

[0104] Furthermore, in certain embodiments, the male impaction guide 600 can define distinct surfaces, including a male impaction guide anterior side 630 and a male impaction guide posterior side 640. The male impaction guide anterior side 630, in the depicted embodiment, features a male impaction guide fixation threaded hole 650. This threaded hole 650 might be configured to receive a fixation screw, possibly the implant fixation screw (400), potentially passing through other components to secure a tibial implant (800) against the male impaction guide posterior side 640.

[0105] Although a specific embodiment for a male impaction guide 600 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 6, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the vertical stem 620 could feature different cross-sectional shapes or locking mechanisms for mating with a female impaction guide (1000) in various embodiments. The elements depicted in FIG. 6 may also be interchangeable with other elements of FIGS. 1 A-5, and 7-11 as required to realize a particularly desired embodiment.

[0106] Referring to FIG. 7, a perspective view of a male impaction guide 600 being inserted onto a tibial implant holder 100, in accordance with various embodiments of the disclosure is shown. This view may illustrate a step where the male impaction guide 600 is assembled onto the tibial implant holder 100, which might already contain previously seated components like the male impaction guide positioning screw (200) and the implant fixation screw 400. The arrow indicates the direction of insertion or sliding motion involved in this assembly step.

[0107] As depicted in the embodiment shown in FIG. 7, the male impaction guide 600 might engage with the tibial implant holder 100 via specific guiding features. The male impaction guide left stabilization flange 651 and male impaction guide right stabilization flange 652, located on the base of the guide 600 near the male impaction guide base top 610, could be configured to align with and slide into the corresponding left stabilization track 155 and right stabilization track 150 on the tibial implant holder 100. This interaction may serve to constrain the relative positioning of the guide 600 onto the holder 100.

[0108] In some embodiments, the male impaction guide 600, featuring its vertical stem 620, male impaction guide anterior side 630, and male impaction guide posterior side 640, could be configured to slide along the holder 100 until it reaches a predetermined position. The male impaction guide fixation threaded hole 650 on the anterior side 630 might align with the path of the previously inserted implant fixation screw 400. The assembly shown also includes the positioning screw handle 230 and its positioning screw anterior access hole 235, indicating the prior seating of the positioning screw (200).

[0109] Furthermore, in certain embodiments, this engagement process could prepare the assembly for subsequent interaction with a tibial implant (800) or a female impaction guide (1000).The stabilization provided by the mating flanges (651, 652) and tracks (155, 150) can ensure that the male impaction guide 600 is correctly oriented relative to the holder 100 and any components held within it. The vertical stem 620 could also be positioned ready for potential engagement with the female guide (1000).

[0110] Although a specific embodiment illustrating a male impaction guide 600 being inserted onto a tibial implant holder 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 7, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the male impaction guide stabilization flanges (651, 652) and corresponding stabilization tracks (155, 150) could incorporate features to provide tactile feedback during engagement in some embodiments. The elements depicted in FIG. 7 may also be interchangeable with other elements of FIGS. 1 A-6, and 8-11 as required to realize a particularly desired embodiment.

[0111] Referring to FIG. 8, a perspective view of a tibial implant 800, in accordance with various embodiments of the disclosure is shown. This component might represent an implantable device intended for placement onto or into a prepared bone surface, such as a tibia bone (1120) or the like. The tibial implant 800 could potentially provide a new articular surface or structural support.

[0112] As depicted in the embodiment shown in FIG. 8, the tibial implant 800 may feature structures designed for fixation or engagement with bone. For instance, one or more tibial implant blades 820 could project from the tibial implant top 810, potentially configured to penetrate bone and provide initial stability upon implantation. The tibial implant top 810 might present a surface intended to articulate with another implant component or natural anatomy.

[0113] In some embodiments, the tibial implant 800 may incorporate features for alignment or stabilization relative to other instrumentation or the implant site itself. A tibial implant left stabilization flange 851 and a tibial implant right stabilization flange 852 could extend from the tibial implant left side 860 and tibial implant right side 850, respectively. These flanges (851, 852) might be configured to mate with corresponding tracks, such as the left stabilization track (155) and right stabilization track (150) of a tibial implant holder (100), during insertion or positioning.

[0114] Furthermore, in certain embodiments, the tibial implant 800 defines a tibial implant anterior side 830 and a tibial implant posterior side 840. While not explicitly labeled in this view, the tibial implant anterior side 830 could potentially include features such as a tibial implant fixation threaded hole (855), which might be configured to receive an implant fixation screw (400) for securing the implant 800, which can be configured to interact with a male impaction guide (600) during the process. The overall geometry may indicate that a component in various embodiments can be designed for precise placement and secure fixation within a joint space.

[0115] Although a specific embodiment for a tibial implant 800 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 8, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the tibial implant blades 820 could have different shapes, sizes, or surface treatments to enhance bone ingrowth or initial stability in various embodiments. The elements depicted in FIG. 8 may also be interchangeable with other elements of FIGS. 1 A-7, and 9A-11 as required to realize a particularly desired embodiment.

[0116] Referring to FIG. 9A, a perspective view of a tibial implant 800 being inserted onto a tibial implant holder 100, in accordance with various embodiments of the disclosure is shown. This view may illustrate a further step in the assembly process, where the tibial implant 800 is being introduced onto the holder 100, engaging with previously assembled components like the male impaction guide 600 and implant fixation screw 400. The direction of insertion might be guided in certain embodiments, by the interaction between the implant 800 and the holder 100.

[0117] As depicted in the embodiment shown in FIG. 9A, the tibial implant 800, characterized by features such as tibial implant blades 820, tibial implant top 810, and tibial implant anterior side 830, might be slid onto the tibial implant holder 100. This engagement could be facilitated by alignment features, such as the tibial implant right stabilization flange 852 on the tibial implant right side 850 mating with the corresponding right stabilization track 150 on the holder 100. A similar engagement might occur between the left stabilization flange (851) and left track (155), although not fully visible in this view.

[0118] In some embodiments, the tibial implant 800 may be advanced until its tibial implant anterior side 830 is proximate to the male impaction guide 600, which is already positioned on thetibial implant holder 100. The implant fixation screw 400, with its fixation screw smooth portion 420 and fixation screw threaded portion 410, could be disposed at least such that its threaded portion 410 aligns with or passes through the male impaction guide 600 towards a potential fixation hole (855) in the tibial implant 800. The positioning screw handle 230 and its anterior access hole 235 remain visible, indicating the presence of the seated positioning screw (200).

[0119] Furthermore, in certain embodiments, this assembly step places the tibial implant 800 in a controlled position relative to the male impaction guide 600 and the tibial implant holder 100. Subsequent tightening of the implant fixation screw 400 could then potentially secure the tibial implant 800 firmly against the male impaction guide 600. This entire assembly, held by the tibial implant holder 100, might then be ready for further steps in the implantation procedure.

[0120] Although a specific embodiment illustrating a tibial implant 800 being inserted onto a tibial implant holder 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 9A, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, features on the tibial implant 800 or tibial implant holder 100 could provide tactile or audible feedback upon correct seating in some embodiments. The elements depicted in FIG. 9A may also be interchangeable with other elements of FIGS . 1 A-8, and 9B-11 as required to realize a particularly desired embodiment.

[0121] Referring to FIG. 9B, a perspective view of a male impaction guide 600 being abutted against the tibial implant 800, while both may be held by a tibial implant holder 100, in accordance with various embodiments of the disclosure is shown. This view could illustrate a state subsequent to FIG. 9A, where the relative positions of the male impaction guide 600 and tibial implant 800 have been adjusted, potentially using the male impaction guide positioning screw (200). The arrow can indicate the direction of force or adjustment that resulted in this abutted configuration.

[0122] As depicted in the embodiment shown in FIG. 9B, the male impaction guide 600 appears to be positioned immediately adjacent to, and potentially in firm contact with, the tibial implant 800. Specifically, the male impaction guide posterior side (640) might be abutted against the tibial implant anterior side 830. This abutment could serve to stabilize the tibial implant 800 relative to the guide 600 and the holder 100, perhaps prior to or during implantation.

[0123] In some embodiments, this abutted state might be achieved or maintained by the action of the male impaction guide positioning screw (200), whose positioning screw handle 230 and positioning screw anterior access hole 235 remain visible. In many embodiments, adjusting this screw can draw the male impaction guide 600 proximally along the tibial implant holder 100 until it contacts the tibial implant 800, which may also be engaged with the holder via features like the tibial implant right stabilization flange 852 mating with the right stabilization track 150. The implant fixation screw 400, represented by its handle and fixation screw smooth portion 420, might be securing the implant 800 axially during this process.

[0124] Furthermore, in certain embodiments, this fully assembled and abutted configuration on the tibial implant holder 100 may represent the state where the implant 800, featuring its tibial implant top 810 and tibial implant blades 820, is ready for engagement with other instruments or for transfer to the surgical site. The stable association between the male impaction guide 600 and the tibial implant 800, maintained by the holder 100 and screws (200, 400), may facilitate precise handling and positioning.

[0125] Although a specific embodiment illustrating a male impaction guide 600 abutted against a tibial implant 800 on a tibial implant holder 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 9B, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the abutting surfaces between the male impaction guide posterior side (640) and the tibial implant anterior side 830 could include complementary textures to prevent rotation in some embodiments. The elements depicted in FIG. 9B may also be interchangeable with other elements of FIGS. 1A-9A, and 10A-11 as required to realize a particularly desired embodiment.

[0126] Referring to FIG. 10A, a perspective view of a female impaction guide 1000, in accordance with various embodiments of the disclosure is shown. In many embodiments, this component can serve as a guide or reference structure that could be affixed to bone during a surgical procedure. The female impaction guide 1000 can be configured to interact with other components, such as the male impaction guide (600), and / or to provide stable guidance during implant preparation or placement.

[0127] As depicted in the embodiment shown in FIG. 10A, the female impaction guide 1000 may define a prominent vertical recess 1010. This vertical recess 1010 can be shaped and dimensioned to receive a mating feature from another component, such as the vertical stem (620) of the male impaction guide (600). The sides of this recess might incorporate male impaction guide rails 1020, which can further constrain or guide the engagement with the mating component, potentially reducing unwanted motion during the procedure.

[0128] In some embodiments, the female impaction guide 1000 might include features for securing it to bone or other structures. Several fixation pin holes 1070 may be present, possibly located on extending flange portions. Additionally, an oblique fixation hole 1073 may be provided, allowing for fixation using pins (1071, 1072) inserted at multiple angles (e.g., parallel and oblique) for enhanced stability relative to a tibia bone (1120) or the like.

[0129] Furthermore, in certain embodiments, the female impaction guide 1000 can define a female impaction guide anterior side 1030 and may include other structural features like a raised portion 1090. The overall configuration suggests a component designed to be stably fixed near the surgical site, providing a precise reference point and potentially a guided pathway, via the vertical recess 1010 and associated male impaction guide rails 1020, for other instruments or guides used in the tibial implant process.

[0130] Although a specific embodiment for a female impaction guide 1000 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 10A, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the number and arrangement of fixation pin holes 1070 and the oblique fixation hole 1073 could be modified in different embodiments. The elements depicted in FIG. 10A may also be interchangeable with other elements of FIGS. 1 A-9B, and 10B-11 as required to realize a particularly desired embodiment.

[0131] Referring to FIG. 10B, a top-down view of a female impaction guide 1000, in accordance with various embodiments of the disclosure is shown. This view can provide an overhead perspective of the female impaction guide 1000, clarifying the shape and relationship of its various surfaces and internal features. The overall footprint and symmetry of the component can also be appreciated from this angle.

[0132] As depicted in the embodiment shown in FIG. 10B, the female impaction guide 1000 may present distinct external boundaries. These could include a female impaction guide anterior side 1030, a female impaction guide posterior side 1040, a female impaction guide right side 1050, and a female impaction guide left side 1060. The relative dimensions of these sides could define the overall size and shape of the guide 1000.

[0133] In some embodiments, internal features might be visible from this top-down perspective. The vertical recess 1010 can be clearly seen, potentially configured as a cavity or channel extending into the body of the female impaction guide 1000. This vertical recess 1010 could be shaped to receive the vertical stem (620) of a male impaction guide (600), thereby providing guided alignment between the two components.

[0134] Furthermore, in certain embodiments, the top surface topography of the female impaction guide 1000 is seen from both elevations. A generally flat base portion top 1080 might surround a raised portion top side 1015, which itself could define the upper boundary of the vertical recess 1010. This configuration can vary based manufacturing considerations or functional interactions with other instruments or the surgical environment.

[0135] Although a specific embodiment for a female impaction guide 1000 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 10B, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the vertical recess 1010 might have a different geometric profile to accommodate variations in male impaction guide stems (620) in alternative embodiments. The elements depicted in FIG. 10B may also be interchangeable with other elements of FIGS. 1A-10A, and 11 as required to realize a particularly desired embodiment.

[0136] Referring to FIG. 11, a perspective view illustrating components of a tibial implant system 1100 during a potential impaction process, showing a flat impactor 1110 cooperating with a tibial implant 800, in accordance with various embodiments of the disclosure is shown. This view may depict the culmination of the assembly and positioning steps, illustrating how force might be applied to seat the tibial implant 800 onto or into target anatomy, represented by tibia bone 1120 and talar bone 1130. The figure shows multiple components of the system interacting simultaneously.

[0137] As depicted in the embodiment shown in FIG. 11 , a female impaction guide 1000 could be affixed to the tibia bone 1120, potentially via fixation elements such as left fixation pin 1071 and right fixation pin 1072. The female impaction guide 1000, with its vertical recess 1010 and possibly male impaction guide rails 1020, can be engaged with the vertical stem (620) of the male impaction guide 600. This engagement could provide stability and precise alignment for the instruments relative to the fixed anatomical reference point.

[0138] In some embodiments, the male impaction guide 600 might be assembled onto the tibial implant holder 100, which also carries the tibial implant 800 and associated screws like the male impaction guide positioning screw 200 (with its positioning screw smooth portion 210 visible) and the implant fixation screw (400, implied). The tibial implant holder 100 might be manipulated by the surgeon to position the tibial implant 800 correctly relative to the talar bone 1130, guided by the stable connection to the female impaction guide 1000.

[0139] Furthermore, in certain embodiments, FIG. 11 shows a flat impactor 1110 positioned potentially to contact the tibial implant 800. An impactor frame 1150 might cooperate with the flat impactor 1110, possibly serving as a conduit or guide for delivering impaction force (e.g., from a mallet strike, not shown) through the flat impactor 1110 onto the tibial implant 800. This coordinated action, guided by the female impaction guide 1000 and male impaction guide 600 assembly, could drive the tibial implant 800 into its final prepared position on the tibia bone 1120.

[0140] Although a specific embodiment illustrating a tibial implant system 1100 in use during an impaction process for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 11, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the impactor frame 1150 could be integrated with the flat impactor 1110 or replaced by a different force delivery mechanism in other embodiments. The elements depicted in FIG. 11 may also be interchangeable with other elements of FIGS. 1A-10B as required to realize a particularly desired embodiment.

[0141] Although the present disclosure has been described in certain specific aspects, many additional modifications and variations would be apparent to those skilled in the art. In particular, any of the various processes described above can be performed in alternative sequences and / or in parallel in order to achieve similar results in a manner that is moreappropriate to the requirements of a specific application. It is therefore to be understood that the present disclosure can be practiced other than specifically described without departing from the scope and spirit of the present disclosure. Thus, embodiments of the present disclosure should be considered in all respects as illustrative and not restrictive. It will be evident to the person skilled in the art to freely combine several or all of the embodiments discussed here as deemed suitable for a specific application of the disclosure. Throughout this disclosure, terms like “advantageous”, “exemplary” or “example” indicate elements or dimensions which are particularly suitable (but not essential) to the disclosure or an embodiment thereof and may be modified wherever deemed suitable by the skilled person, except where expressly required. Accordingly, the scope of the disclosure should be determined not by the embodiments illustrated, but by the appended claims and their equivalents.

[0142] Any reference to an element being made in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” All structural and functional equivalents to the elements of the above-described preferred embodiment and additional embodiments as regarded by those of ordinary skill in the art are hereby expressly incorporated by reference and are intended to be encompassed by the present claims.

[0143] Moreover, no requirement exists for a system or method to address each and every problem sought to be resolved by the present disclosure, for solutions to such problems to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. Various changes and modifications in form, material, workpiece, and fabrication material detail can be made, without departing from the spirit and scope of the present disclosure, as set forth in the appended claims, as might be apparent to those of ordinary skill in the art, are also encompassed by the present disclosure.

Claims

CLAIMSWhat is claimed is:

1. A tibial shaping system, comprising: a tibial implant holder, comprising: a left stabilization track; and a right stabilization track; a male impaction guide positioning screw; an implant fixation screw, comprising a fixation screw threaded portion; a male impaction guide, comprising; a vertical stem configured to mate with a female impaction guide; and a male impaction posterior side; and a tibial implant, comprising a tibial implant anterior side; wherein the male impaction guide positioning screw is configured to engage with the male impaction guide such that the male impaction guide posterior side abuts the tibial implant anterior side.

2. The tibial shaping system of claim 1, comprising at least: a male impaction anterior side comprising at least: tibial implant fixation threaded hole; a male impaction guide left stabilization flange; and a male impaction guide right stabilization flange; wherein the male impaction guide left stabilization flange is configured to mate with the left stabilization track; and the male impaction guide right stabilization track is configured to mate with the right stabilization track.

3. The tibial shaping system of claim 1, comprising at least: a tibial implant left stabilization flange; and a tibial implant right stabilization flange;wherein a male tibial implant left stabilization flange is configured to mate with the left stabilization track; and the tibial implant right stabilization track is configured to mate with the right stabilization track.

4. The tibial shaping system of claim 1, wherein the vertical stem is configured to mate with a vertical recess of a female impaction guide.

5. The tibial shaping system of claim 4, wherein the vertical recess is dimensioned to mate with the vertical stem such that at least one motion is reduced during an implantation process.

6. The tibial shaping system of claim 4, wherein the female impaction guide is affixed to a tibia bone via one or more fixation pins such that the mating of the vertical stem and the vertical recess reduces one or more directional motions during a tibial implant process.

7. The tibial shaping system of claim 6, wherein the one or more fixation pins include at least two parallel pins.

8. The tibial shaping system of claim 7, wherein the one or more fixation pins include at least one oblique pin.

9. The tibial shaping system of claim 1, wherein the tibial implant comprises at least one blade.

10. The tibial shaping system of claim 1 , wherein the implant fixation screw further comprises an implant fixation screw handle.

11. The tibial shaping system of claim 1, wherein the male impaction guide positioning screw, comprises: a positioning screw threaded portion; a positioning screw handle; anda positioning screw anterior access hole.

12. The tibial shaping system of claim 1, wherein the tibial implantation holder further comprises: a vertical access void; an intermediate screw hole; and an intermediate access void.

13. The tibial shaping system of claim 12, wherein the male impaction guide positioning screw is seated within the tibial implantation holder by inserting the male impaction guide positioning screw through the vertical access void and through the intermediate screw hole.

14. The tibial shaping system of claim 1, wherein the tibial implant is configured to cooperate with a flat impactor during an implantation process.

15. The tibial shaping system of claim 1 , wherein a flat impactor is configured to cooperate with an impactor frame such that force may be transferred to the tibial implant.

16. A method of stabilizing a tibial implant, the method comprising: inserting a male impaction guide positioning screw into a tibial implant holder; inserting an implant fixation screw through a rear screw hole of the tibial implant holder, and through a positioning screw through hole of the male impaction guide positioning screw; engaging a male impaction guide on the tibial implant holder; engaging a tibial implant on the tibial implant holder; inserting a threaded portion of the implant fixation screw through a through hole encompassing the tibial implant holder, male impaction guide positioning screw, and male impaction guide such that the implant fixation screw is disposed along the through hole to engage a tibial implant fixation threaded hole; positioning the tibial implant by adjusting the implant fixation screw; andabutting the male impaction guide against the tibial implant by engaging the male impaction guide positioning screw.

17. The method of claim 16, wherein the method further comprises mating a vertical stem of the male impaction guide with a vertical recess of a female impaction guide.

18. The method of claim 17, wherein, the female impaction guide is affixed to a tibia bone.

19. The method of claim 18, wherein the female impaction guide is affixed to the tibia bone by a plurality of fixation pins.

20. The method of claim 19, wherein the fixation of the female impaction guide cooperates with the mating of the male impaction guide to reduce a motion of a tibia implant during an impaction procedure.

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