Tibial implant shapers and shaper guides

Abstract

A tibial shaping guide and associated shaper are disclosed. More specifically, a tibial shaper guide and a tibial shaper used to prepare a tibia bone for an implant are shown. The shaper guide includes a body with an anterior guide recess and multiple fixation pin holes configured to accept parallel and potentially oblique pins for secure fixation to the tibia. The tibial shaper features a distal interlocking portion, potentially for engaging an impactor tool, and a proximal shaping body. The shaping body includes a vertical shaping portion terminating in a proximal shaping cavity (e.g., hollow rectangular) designed to shape bone via impaction. In use, the guide is fixed to the tibia. The shaper may be inserted into the guide's anterior recess at an angle, possibly using an elbow feature as a fulcrum, then oriented upright for impaction. The guide restricts side motion, ensuring the shaper creates an accurately placed cavity.

Description

TIBIAL IMPLANT SHAPERS AND SHAPER GUIDESPRIORITY

[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 tibial implant shapers and shaper guides 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] An apparatus, systems, and methods are provided for an improved tibia implant with a tapered stem and dual fixation holes for treating tibial defects. In some embodiments, a tibial shaping system, includes a tibial shaper, including an interlocking portion, and a shaping body, wherein the shaping body includes a vertical shaping portion with a proximal shaping cavity configured for shaping a tibia bone via impaction, and a tibial shaping guide, including a body with an anterior side, wherein the anterior side includes at least a plurality of fixation pin holes, and an anterior guide recess, wherein the anterior guide recess is dimensioned to mate with a tibial shaper such that the tibial shaping guide restricts the side motions of the tibial shaper during tibia bone shaping.

[0007] In some embodiments, the proximal shaping cavity is a hollow rectangular shape.

[0008] In some embodiments, the plurality of fixation pin holes includes at least two fixation pin holes configured for engaging with two parallel pins.

[0009] In some embodiments, the plurality of fixation pin holes further includes one fixation pin hole configured for engaging with an oblique pin.

[0010] In some embodiments, the two parallel pins are impacted into a tibia bone.

[0011] In some embodiments, the oblique pin is impacted into a tibia bone at an angle oblique to the two parallel pins such that the tibial shaper is affixed to the tibia bone upon engaging with the two parallel pins and oblique pin.

[0012] In some embodiments, the interlocking portion is configured to engage with an impactor frame configured to receive impaction strikes.

[0013] In some embodiments, the tibial shaper is configured to transfer the force received from the interlocking portion to the shaping body during a tibia bone shaping.

[0014] In some embodiments, the tibial shaper is configured to engage with the tibial shaping guide during impaction in an upright position such that the vertical shaping portion extends in a generally perpendicular direction from the base of the tibial shaping guide.

[0015] In some embodiments, the anterior guide recess has a height shorter than the height of the vertical shaping portion.

[0016] In some embodiments, the tibial shaper is inserted into the anterior guide recess at an angle such that the vertical shaping portion is inserted first before changing the angle of the tibial shaper into the orientation necessary for impaction.

[0017] In some embodiments, changing the angle is achieved by pivoting around the proximal elbow as a fulcrum point.

[0018] In some embodiments, a tibial shaper includes an interlocking portion, and a shaping body, wherein the shaping body includes a vertical shaping portion with a proximal shaping cavity configured for shaping a tibia bone via compaction.

[0019] In some embodiments, the proximal shaping cavity is a hollow rectangular shape.

[0020] In some embodiments, the interlocking portion is configured to engage with an impactor frame configured to receive impaction strikes.

[0021] In some embodiments, a tibial shaping guide includes a body with an anterior side, wherein the anterior side includes at least, a plurality of fixation pin holes, and an anterior guide recess, wherein the anterior guide recess is dimensioned to mate with a tibial shaper such that the tibial shaping guide restricts the side motions of the tibial shaper during a tibia bone shaping process.

[0022] In some embodiments, the plurality of fixation pin holes includes at least two fixation pin holes configured for engaging with two parallel pins.

[0023] In some embodiments, the plurality of fixation pin holes further includes one fixation pin hole configured for engaging with an oblique pin.

[0024] In some embodiments, the two parallel pins are impacted into a tibia bone.

[0025] In some embodiments, the oblique pin is impacted into a tibia bone at an angle oblique to the two parallel pins such that the tibial shaper is affixed to the tibia bone upon engaging with the two parallel pins and oblique pin.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The drawings refer to embodiments of the present disclosure in which:

[0027] FIG. 1 illustrates a perspective view of a tibial shaper guide affixed to a tibial bone, in accordance with various embodiments of the disclosure;

[0028] FIG. 2 illustrates a perspective view of a tibial shaper guide with an oblique pin inserted, in accordance with various embodiments of the disclosure;

[0029] FIG. 3 illustrates a perspective view of a tibial shaper guide, in accordance with various embodiments of the disclosure;

[0030] FIG. 4 A illustrates a top-down view of a tibial shaper guide, in accordance with various embodiments of the disclosure;

[0031] FIG. 4B illustrates a bottom-up view of a tibial shaper guide, in accordance with various embodiments of the disclosure;

[0032] FIG. 4C illustrates a front view of a tibial shaper guide, in accordance with various embodiments of the disclosure;

[0033] FIG. 4D illustrates a rear view of a tibial shaper guide, in accordance with various embodiments of the disclosure;

[0034] FIG. 4E illustrates a left side view of a tibial shaper guide, in accordance with various embodiments of the disclosure;

[0035] FIG. 5 illustrates a perspective view of a tibial shaper, in accordance with various embodiments of the disclosure;

[0036] FIG. 6A illustrates a top-down view of a tibial shaper in accordance with various embodiments of the disclosure;

[0037] FIG. 6B illustrates a bottom-up view of a tibial shaper, in accordance with various embodiments of the disclosure;

[0038] FIG. 6C illustrates a front view of a tibial shaper, in accordance with various embodiments of the disclosure;

[0039] FIG. 6D illustrates a rear view of a tibial shaper, in accordance with various embodiments of the disclosure;

[0040] FIG. 6E illustrates a left side view of a tibial shaper, in accordance with various embodiments of the disclosure;

[0041] FIG. 7 A illustrates a perspective view of the insertion of a tibial shaper into the tibial shaper guide in accordance with various embodiments of the disclosure;

[0042] FIG. 7B illustrates a right side view of the insertion of a tibial shaper into the tibial shaper guide in accordance with various embodiments of the disclosure;

[0043] FIG. 7C illustrates a perspective view of a tibial shaper put into a final pre-shaping position within the tibial shaper guide in accordance with various embodiments of the disclosure;

[0044] FIG. 7D illustrates a right side view of a tibial shaper put into a final pre-shaping position within the tibial shaper guide in accordance with various embodiments of the disclosure;

[0045] FIG. 7E illustrates a perspective view of a tibial shaper in a post-shaping position within the tibial shaper guide in accordance with various embodiments of the disclosure; and

[0046] FIG. 7F illustrates a right side view of a tibial shaper in a post-shaping position within the tibial shaper guide in accordance with various embodiments of the disclosure.

[0047] 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

[0048] This disclosure relates to a tibial shaping system, which may be used in orthopedic surgery, particularly for preparing the tibia bone to receive an implant component, such as during ankle arthroplasty. The system primarily comprises two main components: a tibial shaper guide and a tibial shaper. These components may be designed to work together to allow a surgeon to accurately create a precisely shaped cavity within the tibia.

[0049] The tibial shaper guide can serve as a positioning and guiding fixture. It typically includes a body with features allowing it to be securely affixed to the target bone, such as a plurality of fixation pin holes configured to receive fixation pins inserted into the bone. The guide also defines an anterior guide recess, potentially with interlocking guide recesses, which is dimensioned to receive the shaper and constrain its movement, particularly restricting side-to-side motion during the shaping process. Additional features like a posterior stop may limit the shaper's travel depth.

[0050] The tibial shaper is the instrument used to actively shape the bone. It may comprise a distal interlocking portion adapted for connection to an impacting tool or handle, and a proximal shaping body or body. This shaping body typically includes a shaft (potentially with elbows) leading to a vertical shaping portion that terminates in a proximal shaping cavity, which might be hollow and rectangular, for example. When force is applied via the interlocking portion, the shaper, guided by the shaper guide, uses its proximal shaping cavity to create a cavity in the bone through impaction or compaction.

[0051] As those skilled in the art will recognize, preparing a bone, such as the tibia, to precisely accept an orthopedic implant often presents surgical challenges. Achieving the correct size, shape, depth, location, and orientation for the bone cavity using freehand techniques or less constrained instrumentation can be difficult and may lead to inaccuracies. Such inaccuracies might result in suboptimal implant fit, poor initial stability, malalignment, or uneven stress distribution, potentially compromising the long-term success of the joint replacement. Furthermore, maintaining the stability of guiding instruments during the application of significant forces, such as during impaction or shaping, is crucial; any movement of the guide during the procedure could lead to errors in the final preparation. There may also be challenges related to inserting and correctly orienting the shaping instrument itself within the surgical site and relative to the guide, especially in minimally invasive approaches.

[0052] Therefore, there is a need for systems and methods that provide stable fixation for guidance instrumentation and precisely control the trajectory and depth of the bone shaping tool to ensure accurate and reproducible preparation of the tibial implant site which various embodiments described herein address. Specifically, the disclosed tibial shaping system, potentially incorporating features like multi-pin guide fixation, a constraining guide recess, specific shaper insertion mechanics possibly involving fulcrums, and integrated depth stops, address these challenges by enhancing stability, control, and accuracy during tibial preparation.

[0053] In many embodiments, methods for preparing a tibia for implantation using the disclosed system may involve various steps. Initially, the tibial shaper guide can be positioned accurately on the target area of the tibia bone. It may then be securely affixed using multiple fixation pins inserted through the plurality of fixation pin holes into the bone, potentially utilizing both parallel and oblique pinning configurations for enhanced stability. Once the guide is fixed, the tibial shaper can be introduced into the anterior guide recess of the guide, possibly at an initial insertion angle. The shaper might then be pivoted, potentially using its proximal elbow as a fulcrum against the guide, to achieve a final, typically upright, pre-shaping orientation relative to the bone. An external impacting force may then be applied to the shaper's interlocking portion, driving the proximal shaping cavity into the tibia bone, constrained by the guide and potentially limited in depth by the posterior stop. After the desired cavity is formed, the shaper andsubsequently the shaper guide may be removed, leaving the tibia prepared for the next surgical step, such as implant insertion.

[0054] 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.

[0055] 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.

[0056] 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 otherwise specified 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.

[0057] 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.

[0058] Referring to FIG. 1 , a perspective view of a tibial shaper guide 100 affixed to a tibial bone, in accordance with various embodiments of the disclosure is shown. The shaper guide 100 may be employed during a surgical procedure, such as preparing a bone, specifically the tibia bone (300, implied), to receive an implant. As depicted in the embodiment shown in FIG. 1, the shaper guide 100 can be positioned adjacent to the target bone surface and may be temporarily secured using one or more fixation elements. These fixation elements can include pins, such as a left fixation pin 171 and a right fixation pin 172, which may pass through corresponding fixation pin holes (170, implied by pins) located on the body of the shaper guide 100 and into the tibia bone. This fixation can serve to stabilize the guide during the subsequent bone shaping process, which involves guiding a separate shaper tool (200, not shown in FIG. 1).

[0059] The body of the shaper guide 100 includes features intended to guide the shaper tool. An anterior side 140 of the guide body may include an anterior guide recess (120). This anterior guide recess (120) can be dimensioned and configured to mate with the tibial shaper (200), potentially restricting motions such as, but not limited to, side-to-side motions of the shaper during the bone shaping. Additionally, a superior anterior window 110 might be present above or adjacent to the anterior guide recess (120), which can in certain embodiments be configured to provide visual access or further guiding surfaces. The overall structure includes the anterior side 140 and an opposing posterior side 130.

[0060] Secure positioning of the shaper guide 100 on the tibia bone can be utilized for accuracy. The body of the shaper guide 100 may include a plurality of fixation pin holes (170, implied by pins). Some of these fixation pin holes (170) may be configured to receive parallelpins, such as the left fixation pin 171 and right fixation pin 172 shown. These parallel pins may be impacted or inserted into the tibia bone prior to placing the guide. The plurality of fixation pin holes (170) might also include the ability for receiving an oblique fixation pin (173, FIG. 2), which could provide additional stability by engaging the bone at an oblique angle relative to the parallel pins.

[0061] Further structural aspects of the shaper guide 100 are visible in the embodiment depicted in FIG. 1. A shaper top protrusion 160 may extend from the main body, offering a surface for handling, applying force, interfacing with other instruments, or serving as an alignment reference. The shaper top portion may also provide additional pin holes for affixing pins in situations where the tibia is malformed or has other defects that make traditional pin settings impossible or at least less than ideal. The combination of the guide’s body structure, the anterior guide recess 120, the superior anterior window 110, and the stable fixation provided by the fixation pins (171, 172) can create a reliable framework for guiding the shaper tool (200) accurately during the bone preparation procedure.

[0062] Although a specific embodiment for a shaper guide 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 1 , any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the fixation pin holes (170) could be configured to accept pins of different diameters. The elements depicted in FIG. 1 may also be interchangeable with other elements of FIGS. 2-7F as required to realize a particularly desired embodiment.

[0063] Referring to FIG. 2, a perspective view of a tibial shaper guide 100 with an oblique pin 173 inserted, in accordance with various embodiments of the disclosure is shown. Similar to FIG. 1, the shaper guide 100 is depicted as being secured to the bone via fixation elements. This view specifically highlights the potential use of multiple types of fixation pins simultaneously, including a left fixation pin 171, a right fixation pin 172, and additionally, an oblique fixation pin 173. The body of the shaper guide 100 may comprise a plurality of fixation pin holes (170, implied by pins), some of different sizes and / or geometries. In some embodiments, a number of these holes can be configured to receive fixation pins inserted in a generally parallel orientation relative to each other, such as the left fixation pin 171 and right fixation pin 172. These may be inserted into the tibiabone prior to use of the shaper guide 100. FIG. 2 further illustrates the engagement of an oblique fixation pin 173 through one of the fixation pin holes.

[0064] The use of the oblique fixation pin 173, potentially inserted into the tibia bone at an angle oblique to the parallel pins (171, 172), may serve to further secure or affix the shaper guide 100 onto the bone. This enhanced fixation can prevent undesired movement or shifting of the shaper guide 100 during the potentially high-force process of bone shaping using a shaper tool (200, FIG. 5), thereby contributing to the accuracy of the bone preparation. The oblique pin 173 may provide stability in a different plane or direction compared to the parallel pins (171, 172) as well.

[0065] With the shaper guide 100 affixed by the pins (171, 172, 173), other features remain oriented for guiding the shaper tool. These features can include the anterior guide recess (represented generally by 120), which may be dimensioned to mate with a shaper and restrict its various motions, (such as side-to-side motions), and the superior anterior window 110. The anterior side 140, posterior side 130, and shaper top protrusion 160 define the general structure that provides the guided pathway. The stable platform created by the guide and pins can ensure the subsequent shaping action is performed at the correct location and orientation.

[0066] Although a specific embodiment for a shaper guide 100 showing engagement with multiple fixation pins for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 2, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, alternative locking mechanisms besides an oblique pin could be used to secure the guide. The elements depicted in FIG. 2 may also be interchangeable with other elements of FIGS. 1 and 3-7F as required to realize a particularly desired embodiment.

[0067] Referring to FIG. 3, a perspective view of a tibial shaper guide, in accordance with various embodiments of the disclosure is shown. The shaper guide 100 may be configured as a component of a tibial shaping system, designed to guide a shaper tool (200, FIG. 5) during bone preparation. The shaper guide 100 generally comprises a body having features configured for both guiding the shaper tool and for fixation to a bone, such as a tibia. This perspective view shows aspects of the anterior side (140, implied), posterior side 130, and superior surfaces.

[0068] Certain features of the shaper guide 100 may be prominently located on or accessible from the anterior side. An anterior guide recess 120 can be formed within the body, potentially dimensioned to closely receive and mate with a portion of a shaper. In many embodiments, the anterior guide recess 120 may serve to restrict lateral or side-to-side motion of the shaper tool during operation, thereby enhancing the precision of the bone shaping process. A superior anterior window 110 may also be present in various embodiments, located potentially above or adjacent to the anterior guide recess 120, which can be configured to provide additional guidance, reduced material costs, visual access, and / or clearance.

[0069] For securing the shaper guide 100 to the patient's bone, the body may incorporate a plurality of fixation pin holes 170, as previously discussed, visible on various surfaces in FIG. 3. These fixation pin holes 170 can be configured to receive pins (such as 171, 172, 173 shown in the embodiments depicted in FIGS. 1-2). Specific holes may be designed for engagement with parallel pins, while others might be oriented to accept one or more oblique pins, allowing for stable multi-point fixation onto the bone surface.

[0070] The embodiment depicted in FIG. 3 also illustrates other structural elements of the shaper guide 100. A posterior stop 180 may be located on a superior surface of the body, potentially towards the posterior side 130. In some embodiments, this posterior stop 180 could function to limit the proximal or posterior movement of the shaper 200 within the guide, providing a defined endpoint for the shaping action and / or ensuring correct initial positioning. Additionally, a shaper top protrusion 160 may extend upward from the body, possibly serving as a structural reinforcement, a point for handling or manipulation, or an interface for other instrumentation.

[0071] Although a specific embodiment for a shaper guide 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 3, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the posterior stop 180 could be adjustable or removable. The elements depicted in FIG. 3 may also be interchangeable with other elements of FIGS. 1-2 and 4A-7F as required to realize a particularly desired embodiment.

[0072] Referring to FIG. 4A, a top-down view of a tibial shaper guide 100, in accordance with various embodiments of the disclosure is shown. This view illustrates the overall shape and layoutof the shaper guide 100 as seen from directly above. The general boundaries of the guide’s body can be observed, including the anterior side 140 and the posterior side 130, defining the primary axis of the guide. The shaper top protrusion 160 is also visible along the anterior side 140.

[0073] Centrally located within the body of the shaper guide 100, the anterior guide recess 120 is shown from the top. This anterior guide recess 120 may define a channel or pathway configured to receive and guide a corresponding shaper 200. Visible within or adjacent to the anterior guide recess 120 are features designated as interlocking guide recesses 125. These recesses 125 may be shaped to specifically engage with complementary features on the shaper (200), potentially aiding in alignment, stability, or restricting undesired motion, such as the side-to-side motion.

[0074] Towards the posterior side 130 of the shaper guide 100, the posterior stop 180 can be seen positioned relative to the anterior guide recess 120. The posterior stop 180 may serve as a physical limit to the travel of the shaper tool (200) within the guide, ensuring the shaping process occurs within defined boundaries or facilitating correct positioning before operation. The top surface profile of the posterior stop 180 is visible in this view. Also visible in this top-down perspective are the lateral extensions or portions of the shaper guide 100 body where fixation pin holes (170, implied) may be located. While the holes themselves might not be detailed, their placement on these lateral aspects allows for the insertion of fixation pins (such as parallel pins 171, 172, or an oblique pin 173) to secure the guide 100 firmly to the underlying bone structure during use.

[0075] Although a specific embodiment for a shaper guide 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 4A, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the shape or number of interlocking guide recesses 125 could be modified depending on the geometry of the shaper tool being utilized. The elements depicted in FIG. 4A may also be interchangeable with other elements of FIGS. 1-3 and 4B-7F as required to realize a particularly desired embodiment.

[0076] Referring to FIG. 4B, a bottom-up view of a tibial shaper guide 100, in accordance with various embodiments of the disclosure is shown. The embodiment depicted in FIG. 4B illustrates the underside features and the overall peripheral shape of the shaper guide’s body as seen frombelow. The posterior side 130 is indicated, and the opposing anterior side 140 defines the general boundaries along the primary axis. The structure visible may be configured to rest adjacent to or upon the prepared bone surface during use. From this bottom-up perspective, the internal configuration of the guiding channel is partially visible. The area corresponding generally to the anterior guide recess 120 can be seen extending along the longitudinal axis of the guide. The shape of this recess 120 as defined by the surrounding walls of the guide body determines the path along which a shaper tool (200) may travel.

[0077] Within or adjacent to the main guiding channel or anterior guide recess 120, features designated as interlocking guide recesses 125 are visible. FIG. 4B shows the shape and position of these recesses 125 from the underside in certain embodiments. These interlocking guide recesses 125 may be configured to engage with corresponding features on the shaper (200), potentially providing enhanced stability, alignment, and restriction of unwanted side-to-side motion during the impaction or shaping process.

[0078] This bottom view also reveals aspects of the construction of the shaper guide 100, such as the relative thickness of the walls forming the anterior guide recess (120) and the interlocking guide recesses 125. The overall structure shown may be designed to provide rigidity and maintain dimensional accuracy during the surgical procedure. While this view primarily shows the features intended to interact with the shaper tool and potentially the bone surface, features such as the fixation pin holes (170) located elsewhere on the body are not typically detailed from this perspective.

[0079] Although a specific embodiment for a shaper guide 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 4B, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the underside surface could incorporate features to prevent slippage on bone or other implant-related components. The elements depicted in FIG. 4B may also be interchangeable with other elements of FIGS. 1-4A and 4C-7F as required to realize a particularly desired embodiment.

[0080] Referring to FIG. 4C, a front view of a tibial shaper guide 100, in accordance with various embodiments of the disclosure is shown. The embodiment shown in FIG. 4C illustratesthe profile of the shaper guide 100 as observed when facing its anterior side (140, implied). The overall width and height dimensions of the guide body may be appreciated from this perspective. The view includes the main structural body, features for guiding a shaper tool, and provisions for fixation.

[0081] In many embodiments, the opening corresponding to the anterior guide recess 120 can be seen. This anterior guide recess 120 may define a primary channel through the body of the shaper guide 100, which can be configured to receive and guide a shaper (200) along a defined path. The shape of the anterior guide recess 120, as seen from the front, may be generally rectangular or otherwise contoured to closely match a portion of the shaper tool, thereby potentially restricting lateral movement during the bone shaping process.

[0082] Located on the lateral portions or flanges of the shaper guide 100 body, a plurality of fixation pin holes 170 are visible in FIG. 4C. In various embodiments, these fixation pin holes 170, can be configured to receive fixation elements such as pins (e.g., 171, 172, 173 in FIG. 2) for securing the guide to the target bone. The arrangement provided in some embodiments may include holes suitable for receiving parallel pins and potentially others configured for one or more oblique pins, allowing for stable fixation during use.

[0083] Other structural aspects are also visible in this anterior view. The shaper top protrusion 160 can be seen extending superiorly from the main body, potentially providing a handling point or interface. The posterior side 130 can define the rear extent of the guide as viewed from the front. Features such as the posterior stop (180) might be located within or behind the anterior guide recess 120 from this specific vantage point. The overall structure can provide a framework for guiding the shaper tool accurately relative to the bone.

[0084] Although a specific embodiment for a shaper guide 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 4C, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the dimensions of the anterior guide recess 120 could be varied to accommodate different shaper tools. The elements depicted in FIG. 4C may also be interchangeable with other elements of FIGS. 1-4B and 4D-7F as required to realize a particularly desired embodiment.

[0085] Referring to FIG. 4D, a rear view of a tibial shaper guide 100, in accordance with various embodiments of the disclosure is shown. In many embodiments, this perspective can illustrate the shaper guide 100 as observed from its posterior side (130, implied). The overall profile width and height of the guide body can be appreciated from this viewpoint. Visible features may include the main body structure, the posterior stop 180, the shaper top protrusion 160, and fixation pin holes 170. In additional embodiments, the view also featured in this posterior view is the posterior stop 180, located on a superior aspect of the guide body. The posterior stop 180 may function as a physical limit or registration surface for a shaper tool (200) when it is fully inserted or positioned within the guide, preventing over-insertion or defining a specific operational endpoint. Also visible from the posterior is the profile of the shaper top protrusion 160, extending superiorly from the main body.

[0086] This view also shows the location of fixation pin holes 170 on the lateral aspects or flanges of the shaper guide 100 body. These fixation pin holes 170 can be configured to receive fixation pins (e.g., 171, 172, 173) for securing the guide 100 to the patient's tibia. The arrangement suggests provisions for stable multi-point fixation. While the guiding features, such as the anterior guide recess (120), are internal to the body structure and thus not visible from this posterior perspective, FIG. 4D illustrates the external envelope and posterior features of the shaper guide 100. The overall construction depicted provides a robust structure capable of maintaining its position via the fixation pin holes 170 and providing reaction surfaces like the posterior stop 180 during the bone shaping procedure.

[0087] Although a specific embodiment for a shaper guide 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 4D, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the posterior stop 180 could be integrated or shaped differently on the guide body. The elements depicted in FIG. 4D may also be interchangeable with other elements of FIGS. 1-4C and 4E-7F as required to realize a particularly desired embodiment.

[0088] Referring to FIG. 4E, a left side view of a tibial shaping guide, in accordance with various embodiments of the disclosure is shown. This view illustrated in this embodiments depicts the profile of the shaper guide 100 when observed from its left side. The overall length, height,and contour of the guide body along this aspect can be appreciated but may vary in other embodiments based on the anatomy or application desired. The view shows the main body, including the posterior side 130 and the implied anterior side (140), along with features extending superiorly and laterally.

[0089] From this left-side perspective, the profile of features related to guiding and stopping a shaper (200) may be visible. The opening or side profile corresponding to the anterior guide recess (120) can be discerned within the main body structure. Positioned potentially towards the posterior side 130 and superiorly on the body is the posterior stop 180, shown here in profile, illustrating its height and location relative to the guiding path defined by the anterior guide recess (120). The posterior stop 180 may function to limit the travel of a shaper tool.

[0090] Other structural aspects are presented in the profile view of FIG. 4E. The shaper top protrusion 160 is visible extending superiorly from the anterior portion of the guide body, displaying its height and shape as seen from the left side. The overall structure depicted suggests a design intended to provide stable and accurate guidance, with robust features for both tool interaction (via recess 120 and stop 180) and bone fixation (via pin holes 170).

[0091] Although a specific embodiment for a shaper guide 100 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 4E, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the relative height of the posterior stop 180 could be different in other embodiments, which may be related to the size and / or shape of the shaper tool. The elements depicted in FIG. 4E may also be interchangeable with other elements of FIGS. 1-4D and 5-7F as required to realize a particularly desired embodiment.

[0092] Referring to FIG. 5, a perspective view of a tibial shaper 200, in accordance with various embodiments of the disclosure is shown. FIG. 5 provides a perspective view of a shaper 200, also referred to as a tibial shaper or bone shaper, according to various embodiments. The shaper 200 may be utilized in conjunction with a shaper guide (e.g., 100 in FIG. 1) to prepare a bone, such as the tibia bone (300), for receiving an implant. The shaper 200 may generally comprise a distal interlocking portion 210 and a shaping body or shaping body 230 extending proximally therefrom.

[0093] In many embodiments, the shaping body or shaping body 230 constitutes the main working part of the tool that ultimately shapes the bone. This shaping body 230 may include a straight shaft section 237, which can be configured as having a defined superior shaft surface 234 and inferior shaft surface 236. The shaping body 230 can also incorporate bends, such as an anterior elbow 232 and a proximal elbow 233, which may facilitate insertion and positioning relative to the bone and shaper guide (100). In a number of embodiments, the shaping body 230 may comprise a vertical shaping portion (represented by 239) which can include a proximal shaping cavity 231 at its terminal end. This proximal shaping cavity 231 may be configured for shaping the tibia bone via impaction or compaction and can be, for example, a hollow rectangular shape (however, other shapes may be realized based on the desired application).

[0094] In additional embodiments, located at the distal end (relative to the shaping cavity 231) of the shaper 200 is the interlocking portion 210. In various embodiments, this interlocking portion 210 may be specifically configured to engage with an impactor frame or handle (not shown). This engagement allows for the application and transfer of force, such as from impaction strikes delivered to the impactor frame, through the shaper 200. Visible features of the interlocking portion 210 in FIG. 5 may include a leading edge 211, an interlocking stop 216, a side surface feature 214, an interlocking channel recess 215, and an internal step or left interlocking side 217, which collectively form the interface for the impacting tool.

[0095] In operation, force received via the interlocking portion 210 from the impactor frame can be transferred through the shaping body 230 (including the straight shaft section 237 and elbows 232, 233) to the vertical shaping portion (239). This transmitted force can enable the proximal shaping cavity 231 to perform the bone shaping action via impaction or compaction. While the interlocking portion 210 primarily serves the impactor interface function, other features of the shaper 200 (such as left and right transition sides 222, 223 shown in FIG. 6D) may engage with the shaper guide (100) to control the tool's trajectory.

[0096] Although a specific embodiment for a shaper 200 for carrying out the various steps, processes, methods, and operations described herein is discussed with 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 shaping body 230 could have a different curvature or length. Theelements depicted in FIG. 5 may also be interchangeable with other elements of FIGS. 1-4E and 6A-7F as required to realize a particularly desired embodiment.

[0097] Referring to FIG. 6A, a top-down view of a tibial shaper in accordance with various embodiments of the disclosure is shown. The embodiment shown in FIG. 6A illustrates the overall shape and layout of the shaper 200 as observed from directly above. The elongated structure may comprise distinct sections, including a distal interlocking portion (generally 210) and a more proximal shaping body (generally 230), consistent with FIG. 5.

[0098] Focusing on the distal end (left side in FIG. 6A), features associated with the interlocking portion (210) are visible. These may include the leading edge 211, an interlocking notch 212, and potentially aspects of the interlocking channel recess 215 and side surface feature 214. This interlocking portion (210) can be configured to engage with an impactor frame or handle, allowing for the application of force to the shaper 200.

[0099] Moving proximally (right side in FIG. 6 A), features of the shaping body (230) are shown. A straight shaft section 237 defines a portion of the length, displaying a superior shaft surface 234 in this top view. An anterior elbow 232 transitions the shaft towards the more proximal features. At the proximal-most end of the tool shown, the opening corresponding to the proximal shaping cavity 231. In many embodiments, this cavity 231 can form part of the vertical shaping portion (239) and may be configured for shaping bone via impaction, potentially having a hollow rectangular shape.

[0100] In more embodiments, this top-down view can further illustrate the linear arrangement and relative widths of the different sections of the shaper 200. It can show the path through which force, applied potentially via the interlocking portion (210), might be transmitted along the straight shaft section 237 and through the anterior elbow 232 to the proximal shaping cavity 231 at the vertical shaping portion (239) to perform the bone shaping action. The overall geometry viewed from the top can relate to how the shaper 200 may fit within and be guided by a corresponding shaper guide (100).

[0101] Although a specific embodiment for a shaper 200 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 6A, any ofa variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the length and / or angle of the straight shaft section 237 could be varied. The elements depicted in FIG. 6A may also be interchangeable with other elements of FIGS. 1-5 and 6B-7F as required to realize a particularly desired embodiment.

[0102] Referring to FIG. 6B, a bottom-up view of a tibial shaper, in accordance with various embodiments of the disclosure is shown. This view can illustrate the underside surfaces and features of the shaper 200. The overall elongated form may generally be divisible into a distal interlocking portion (area corresponding generally to 210) and a proximal shaping body (area corresponding generally to 230), consistent with the embodiments depicted herein.

[0103] Looking at the distal interlocking portion (210) from underneath, the bottom interlocking side 219 is primarily shown. The outline defining the leading edge 211 and the trailing edge 218 may also be discerned from this perspective. Features such as the interlocking notch 212 might also have aspects visible from the underside. This interlocking portion (210) is generally configured for engagement with an external tool, such as an impactor frame.

[0104] The shaping body (230) is also viewed from the bottom in FIG. 6B. The inferior shaft surface 236 of the straight shaft section 237 is visible, along with aspects of the side shaft surface 235. This view also shows the width and extent of the shaft section from underneath relative to the other elements. The more proximal features related to bone shaping, such as the vertical shaping portion (239) and proximal shaping cavity (231), are located further proximally and are generally not visible from this bottom-up perspective.

[0105] In additional embodiments, the bottom view helps illustrate the planar relationships and widths of the various underside surfaces of the shaper 200. The bottom interlocking side 219 and the inferior shaft surface 236 may potentially interact with features of the shaper guide (100) or glide relative to the talar bone (400) during different phases of insertion or operation. The overall construction shown relates to the tool's ability to transmit force while being guided.

[0106] Although a specific embodiment for a shaper 200 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 6B, any of a variety of systems and / or devices may be utilized in accordance with embodiments of thedisclosure. For example, the bottom interlocking side 219 could incorporate different textures or features suitable for aiding in insertion and / or guiding. The elements depicted in FIG. 6B may also be interchangeable with other elements of FIGS. 1-6A and 6C-7F as required to realize a particularly desired embodiment.

[0107] Referring to FIG. 6C, a front view of a tibial shaper, in accordance with various embodiments of the disclosure is shown. This view depicted in the embodiment shown in FIG. 6C specifically details the features of the interlocking portion 210. The overall cross-sectional shape and the arrangement of various surfaces and recesses that may constitute the interface for an impactor tool can be observed from this perspective.

[0108] Visible at the superior aspect in this view is the interlocking stop 216, which may define an upper boundary or contact surface within the interlocking portion 210. The leading edge 211, forming the anterior-most extent of this distal portion, is also clearly depicted. The arrangement suggests a specific profile designed for initial engagement or alignment within either the shaper guide (100) or an associated instrument.

[0109] In some embodiments, one or more internal features of the interlocking portion 210 are highlighted in FIG. 6C. An internal channel recess 215 is shown, potentially configured to receive a corresponding feature of an impactor tool. A side surface feature 214 may define a side boundary of the interlocking portion 210. Another feature designated as left interlocking side 217 can be an internal step or ledge within the structure. The posterior face or trailing edge 218 can define the rear boundary of the interlocking portion 210 in this view. An interlocking notch recess 213 is also visible on the inferior aspect.

[0110] The specific geometry comprising the interlocking stop 216, interlocking channel recess 215, side surface feature 214, left interlocking side 217, and other surfaces (211, 213, 218) may collectively form a unique interface. This interface can be designed to securely and accurately engage with a complementary impactor frame or handle. This secure engagement can facilitate the effective transfer of impaction forces applied to the shaper 200 during the bone preparation procedure. As those skilled in the art can appreciate, the specific layout and geometry of the interlocking portion (210) can be configured to allow for a better transfer of force when engaged with an impactor device.

[0111] Although a specific embodiment for a shaper 200 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 6C, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the geometry of the interlocking portion 210 could be adapted to mate with different types of impactor tools. The elements depicted in FIG. 6C may also be interchangeable with other elements of FIGS. 1-6B and 6D-7F as required to realize a particularly desired embodiment.

[0112] Referring to FIG. 6D, a rear view of a tibial shaper, in accordance with various embodiments of the disclosure is shown. In various embodiments this view shown in the embodiment of FIG. 6D can highlight the features of the interlocking portion 210. The overall cross-sectional shape and the arrangement of various surfaces and recesses that may constitute the interface for an impactor tool can be observed from this perspective.

[0113] Visible extending laterally from the main shaft structure near the transition section (220) are features designated as the right transition section side 222 and the left transition section side 223. These features (222, 223) may function as guide wings or alignment rails. In a number of embodiments, they could be configured to mate with corresponding features, such as the interlocking guide recesses (125), within the shaper guide (100) to provide stability and restrict unwanted side-to-side movement during operation, ensuring the shaping occurs along the desired axis.

[0114] Also visible in this posterior view is the profile of the proximal elbow 233, connecting the vertical shaping portion (239) to the more distal parts of the shaping body (230). The relative positioning and geometry of the shaping cavity (231), the guide wings / transition sides (222, 223), and the elbow 233 contribute to the overall function of accurately preparing the bone cavity while being precisely guided by the shaper guide (100). This view emphasizes the features responsible for guidance and bone interaction at the proximal end.

[0115] Although a specific embodiment for a shaper 200 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 6D, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the shape of the proximal shaping cavity could be adapted for differentimplant stem geometries, necessitating a need to adjust other components and their shapes such as the proximal elbow 233, etc. The elements depicted in FIG. 6D may also be interchangeable with other elements of FIGS. 1-6C and 6E-7F as required to realize a particularly desired embodiment.

[0116] Referring to FIG. 6E, a left side view of a tibial shaper, in accordance with various embodiments of the disclosure is shown. In many embodiments, the profile of the shaper 200 along its longitudinal axis can show the relationship between its main functional sections. In the embodiment depicted in FIG. 6E, visible components can include the distal interlocking portion 210, a transition section 220, the main shaping body 230 comprising various shaft portions and elbows, and the proximal vertical shaping portion 239.

[0117] The distal interlocking portion 210 is shown in profile at the left end of the figure. Its length and external profile as viewed from the side are depicted. As those skilled in the art will recognize, this interlocking portion 210 may be configured to interface with an impactor tool or handle, serving as the point where force is applied to the shaper 200. The transition section 220 can connect the interlocking portion 210 to the main shaft, with the bottom transition section side 221 being visible.

[0118] Extending proximally from the transition section 220 is the shaping body 230. This section includes a straight shaft section 237, which then curves or angles through an anterior elbow 232 and a proximal elbow 233. This configuration creates an offset between the main shaft axis and the proximal-most part of the tool. The shaping body 230 may constitute part of the shaping body, responsible for transmitting force and positioning the working end.

[0119] In various embodiments, the shaping body 230 can terminate proximally in the vertical shaping portion 239, shown extending generally upward in this orientation. This vertical shaping portion 239 may contain the proximal shaping cavity (231, not visible in profile) which can perform the bone shaping via impaction or compaction. The elbows (232, 233) may allow this vertical shaping portion 239 to be offset from the interlocking portion 210, potentially facilitating access or visibility during the surgical procedure. Force applied distally may be transmitted through this entire structure to the shaping cavity.

[0120] Although a specific embodiment for a shaper 200 for carrying out the various steps, processes, methods, and operations described herein is discussed with respect to FIG. 6E, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the angles of the interlocking portion 210 may vary in angles based on a change in the length of the transition section portions. The elements depicted in FIG. 6E may also be interchangeable with other elements of FIGS. 1-6D and 7A-7F as required to realize a particularly desired embodiment.

[0121] Referring to FIG. 7A, a perspective view of the insertion of a tibial shaper 200 into the tibial shaper guide 100 in accordance with various embodiments of the disclosure is shown. The shaper guide 100 is shown affixed to the tibia bone 300 via multiple fixation pins, including left fixation pin 171, right fixation pin 172, and oblique fixation pin 173. The underlying talar bone 400 is also indicated for anatomical context. This figure depicts the shaper 200 beginning its engagement with the guide 100 prior to the bone shaping operation.

[0122] Consistent with the method previously described, the shaper 200 may be introduced into the anterior guide recess (120) of the shaper guide 100 at an initial insertion angle. As shown in this perspective view, the longitudinal axis of the main shaping body (230) of the shaper 200 may not yet be aligned with the final shaping axis defined by the guide 100. The distal interlocking portion (210) may be oriented superiorly relative to the proximal shaping cavity (231), which is directed towards the tibia bone 300.

[0123] During this insertion phase, the proximal elbow 233 of the shaper 200 can be seen approaching or making initial contact with a portion of the shaper guide 100, potentially near the anterior guide recess (120). This contact area may be configured to subsequently act as a fulcrum point, allowing the angle of the shaper 200 to be adjusted into its final operative position. The initial angled approach may facilitate easier entry of the shaper's features into the guide.

[0124] In various embodiments, the shaper guide 100, being firmly secured to the tibia bone 300 by the fixation pins (171, 172, 173) via the plurality of fixation pin holes (170) can provide a stable entry portal via the anterior guide recess (120). Even during this initial angled insertion, the guide 100 may begin to constrain the movement of the shaper 200, directing it towards the intendedtarget area on the tibia bone 300 and restricting gross side-to-side motion, consistent with a directed guiding function.

[0125] Referring to FIG. 7B, a right-side view of the insertion of a tibial shaper 200 into the tibial shaper guide 100 in accordance with various embodiments of the disclosure is shown. FIG. 7B offers a right-side elevational view corresponding to the insertion step shown in FIG. 7A, further clarifying the angular relationship between the shaper 200, the shaper guide 100, and the underlying anatomy, in accordance with many embodiments. The shaper guide 100 is shown fixed to the tibia bone 300 with fixation pins (e.g., right fixation pin 172, oblique fixation pin 173) visible. In a number of embodiments, the shaper 200 can enter the guide 100 at an angle relative to the talar bone 400.

[0126] This side view emphasizes the initial angled orientation of the shaper 200 as it engages the shaper guide 100. This may be due to the anterior guide recess having a height shorter than the height of the vertical shaping portion. The proximal elbow 233 of the shaper 200 is clearly shown interacting with the lower aspect of the anterior guide recess (120) area within the shaper guide 100. The distal portion of the shaper 200, including the interlocking portion (210), is elevated relative to the proximal elbow 233 in this initial insertion phase.

[0127] The interaction between the proximal elbow 233 and the shaper guide 100, highlighted in this view, strongly suggests a fulcrum-type mechanism such as an proximal elbow 233. By pivoting around this contact point at the proximal elbow 233, the user can subsequently change the angle of the shaper 200, bringing the vertical shaping portion (239) into the desired orientation for impaction, likely perpendicular to the base of the guide.

[0128] FIG. 7B further illustrates how the shaper guide 100 may control the trajectory of the shaper 200 during insertion. The guide dictates the entry point and initial angular constraints, utilizing features like the proximal elbow 233 acting as a fulcrum to transition the shaper 200 from an angled insertion position towards the final, properly oriented pre-shaping position shown in subsequent figures (e.g., FIG. 7D).

[0129] Although specific embodiments for a shaper 200 and shaper guide 100 interaction for carrying out the various steps, processes, methods, and operations described herein are discussedwith respect to FIGS. 7A and 7B, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the initial insertion angle of the shaper 200 might vary depending on surgical approach. The elements depicted in FIGS. 7A and 7B may also be interchangeable with other elements of FIGS. 1-6E and 7C-7F as required to realize a particularly desired embodiment.

[0130] Referring to FIG. 7C, a perspective view of a tibial shaper 200 put into a final preshaping position within the tibial shaper guide 100 in accordance with various embodiments of the disclosure is shown. FIG. 7C illustrates a perspective view of the tibial shaper 200 positioned within the tibial shaper guide 100 in what may be, in certain embodiments, considered a final preshaping position, according to various embodiments of the disclosure. The shaper guide 100 remains affixed to the tibia bone 300 via fixation pins (e.g., left fixation pin 171, right fixation pin 172, oblique fixation pin 173). The talar bone 400 provides anatomical context below. This view depicts the orientation of the shaper 200 immediately prior to the commencement of the bone shaping operation.

[0131] Having potentially pivoted from the initial insertion angle shown in FIG. 7A (potentially facilitated pivoting around the proximal elbow as a fulcrum point), the shaper 200 is now shown in the embodiment depicted in FIG. 7C as seated within the guide 100. In this final pre-shaping position, the vertical shaping portion (239, implied) containing the proximal shaping cavity (231) may be oriented in an upright position relative to the guide 100 and the target bone surface. This orientation could be generally perpendicular to the base of the shaper guide 100, positioning the cavity 231 appropriately for creating the desired bone recess via impaction.

[0132] The engagement between the shaper 200 and the shaper guide 100 in this final position is typically desired for stability. The body of the shaper 200, possibly including features like guide wings (222, 223), may reside within the anterior guide recess (120) and potentially interact with interlocking guide recesses (125). This interaction can serve to restrict side motions of the shaper 200 during the subsequent impaction phase, ensuring accuracy. The proximal elbow (233) might now be fully seated against its fulcrum contact point within the guide 100.

[0133] With the shaper 200 securely guided and oriented by the shaper guide 100, as shown in FIG. 7C, the proximal shaping cavity (231) is precisely located relative to the tibia bone 300.This setup ensures that the subsequent application of force, likely via an impactor tool connected to the interlocking portion (210), can result in the creation of a bone cavity at the desired location and with the intended geometry. The posterior stop (180) on the guide 100 might also be engaged or serve as a reference in this final position.

[0134] Referring to FIG. 7D, a right-side view of a tibial shaper 200 put into a final pre-shaping position within the tibial shaper guide 100 in accordance with various embodiments of the disclosure is shown. This side view can further clarify the orientation of the shaper 200 relative to the shaper guide 100 and the underlying bones (tibia bone 300, talar bone 400) just before shaping begins. The guide 100 can remain fixed via pins (e.g., right fixation pin 172, oblique fixation pin 173) or other fixation devices.

[0135] This view contrasts with the angled insertion shown in FIG. 7B. Here, the shaper 200, particularly the vertical shaping portion (239), is shown in an upright orientation. This orientation may be generally perpendicular to the base of the shaper guide 100 or the targeted bone surface, consistent with the positioning required for effective impaction. The transition from the angled insertion to this upright position may be facilitated by the fulcrum action involving the proximal elbow 233.

[0136] The seating of the shaper 200 within the shaper guide 100 is shown in profile. The proximal elbow (233) appears fully seated or positioned at its lowest point within the guide's constraints. The main shaping body (230) can be oriented along the path defined by the anterior guide recess (120). The relative heights of the anterior guide recess (120) and the vertical shaping portion (239) may contribute to achieving and maintaining this final position.

[0137] From this right-side perspective, the proximal shaping cavity (231) at the end of the vertical shaping portion (239) can positioned directly adjacent to the target region on the tibia bone 300. The distal interlocking portion (210) can remain oriented away from the talar bone 400. This configuration represents the state immediately before force is applied to the shaper 200 (via the interlocking portion 210) to drive the proximal shaping cavity (231) into the tibia bone 300.

[0138] Although specific embodiments for a shaper 200 and shaper guide 100 interaction for carrying out the various steps, processes, methods, and operations described herein are discussedwith respect to FIGS. 7C and 7D, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the final pre-shaping position could incorporate adjustable depth stops. The elements depicted in FIGS. 7C and 7D may also be interchangeable with other elements of FIGS. 1-7B and 7E-7F as required to realize a particularly desired embodiment.

[0139] Referring to FIG. 7E, a perspective view of a tibial shaper 200 in a post-shaping position within the tibial shaper guide 100 in accordance with various embodiments of the disclosure is shown. The shaper guide 100 remains depicted as affixed to the tibia bone 300 via fixation pins (e.g., left fixation pin 171, right fixation pin 172, oblique fixation pin 173). The talar bone 400 provides anatomical reference below. This view represents the state after the shaping operation (e.g., impaction) has potentially been completed, with the shaper 200 fully advanced relative to the guide 100.

[0140] In this post-shaping position, the shaper 200 can typically remain oriented within the shaper guide 100, maintaining the upright position. The vertical shaping portion (239) containing the proximal shaping cavity (231) has been driven into the tibia bone 300 to create the desired cavity. In many embodiments, the depth of insertion may be limited by features of the guide 100 or the shaper 200 itself.

[0141] In the embodiment depicted in FIG. 7E, the engagement between the shaper 200 and the shaper guide 100 continues to provide stability and maintain alignment even at the completion of the shaping stroke. The anterior guide recess (120) and associated features within the guide 100 can constrain the shaper 200, ensuring the created bone cavity is accurately shaped and located, fulfilling the guiding role. In some embodiments, the shaper 200 might be in contact with the posterior stop (180) of the guide 100 in this final position.

[0142] FIG. 7E thus represents the potential culmination of the guided shaping process for this step. The shaper 200, having been accurately guided and potentially impacted, resides at the final intended depth within the constraints set by the shaper guide 100, which is securely fixed to the tibia bone 300. This position signifies the typical completion of the cavity creation process before the shaper 200 is withdrawn.

[0143] Referring to FIG. 7F, a right-side view of a tibial shaper in a post-shaping position within the tibial shaper guide in accordance with various embodiments of the disclosure is shown. As those skilled in the art will recognize, this side view can further clarify the final depth and orientation of the shaper 200 relative to the shaper guide 100 and the underlying bones (tibia bone 300, talar bone 400) after the shaping action is complete. The guide 100 can remain fixed via pins (e.g., 171, 172, 173). The posterior stop 180 of the guide is also visible.

[0144] This view confirms the shaper 200 maintains its upright orientation upon reaching the final depth. The vertical shaping portion (239) is shown fully advanced relative to the guide 100, indicating the completion of the impaction or shaping stroke intended to create a cavity of a specific depth within the tibia bone 300. The relationship between the achieved depth and the surrounding anatomical structures (tibia bone 300, talar bone 400) is illustrated.

[0145] The final seating position of the shaper 200 relative to specific guide features can be observed in FIG. 7F. The shaper 200, particularly a proximal aspect near the shaping body (230), may be shown abutting or immediately adjacent to the posterior stop 180 of the shaper guide 100. In some embodiments, this contact can serve as the definitive end point for the shaping depth controlled by the system. The shaper 200 may also remain constrained within the anterior guide recess (120) path.

[0146] The embodiment depicted in FIG. 7F further illustrates the mechanical state at the conclusion of the bone preparation step using the shaper 200 and shaper guide 100. The controlled depth, orientation, and location of the created cavity (implied) are established by the interaction between the guided shaper 200 and the stably affixed shaper guide 100, potentially contacting the posterior stop 180. This can prepare the tibia bone 300 for subsequent steps, such as receiving a tibial implant component.

[0147] Although specific embodiments for a shaper 200 and shaper guide 100 interaction for carrying out the various steps, processes, methods, and operations described herein are discussed with respect to FIGS. 7E and 7F, any of a variety of systems and / or devices may be utilized in accordance with embodiments of the disclosure. For example, the shaper 200 could incorporate markings to indicate the achieved depth. The elements depicted in FIGS. 7E and 7F may also beinterchangeable with other elements of FIGS. 1-7D as required to realize a particularly desired embodiment.

[0148] 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 more appropriate 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.

[0149] 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.

[0150] 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 thespirit 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 shaper, comprising: an interlocking portion; and a shaping body, wherein the shaping body comprises a vertical shaping portion with a proximal shaping cavity configured for shaping a tibia bone via impaction; and a tibial shaping guide, comprising a body with an anterior side, wherein the anterior side includes at least: a plurality of fixation pin holes; and an anterior guide recess; wherein the anterior guide recess is dimensioned to mate with a tibial shaper such that the tibial shaping guide restricts a side motion of the tibial shaper during tibia bone shaping.

2. The tibial shaping system of claim 1, wherein the proximal shaping cavity is a hollow rectangular shape.

3. The tibial shaping system of claim 1, wherein the plurality of fixation pin holes includes at least two fixation pin holes configured for engaging with two parallel pins.

4. The tibial shaping system of claim 3, wherein the plurality of fixation pin holes further includes one fixation pin hole configured for engaging with an oblique pin.

5. The tibial shaping system of claim 3, wherein the two parallel pins are impacted into a tibia bone.

6. The tibial shaping system of claim 4, wherein the oblique pin is impacted into a tibia bone at an angle oblique to the two parallel pins such that the tibial shaper is affixed to the tibia bone upon engaging with the two parallel pins and oblique pin.

7. The tibial shaping system of claim 1, wherein the interlocking portion is configured to engage with an impactor frame configured to receive impaction strikes.

8. The tibial shaping system of claim 7, wherein the tibial shaper is configured to transfer a force received from the interlocking portion to the shaping body during a tibia bone shaping.

9. The tibial shaping system of claim 1, wherein the tibial shaper is configured to engage with the tibial shaping guide during impaction in an upright position such that the vertical shaping portion extends in a generally perpendicular direction from a base of the tibial shaping guide.

10. The tibial shaping system of claim 9, wherein the anterior guide recess has a height shorter than the height of the vertical shaping portion.

11. The tibial shaping system of claim 10, wherein the tibial shaper is inserted into the anterior guide recess at an angle such that the vertical shaping portion is inserted first before changing the angle of the tibial shaper into an orientation for impaction.

12. The tibial shaping system of claim 11, wherein changing the angle is achieved by pivoting around a proximal elbow as a fulcrum point.

13. A tibial shaper, comprising: an interlocking portion; and a shaping body; wherein the shaping body comprises a vertical shaping portion with a proximal shaping cavity configured for shaping a tibia bone via compaction.

14. The tibial shaper of claim 13, wherein the proximal shaping cavity is a hollow rectangular shape.

15. The tibial shaper of claim 13, wherein the interlocking portion is configured to engage with an impactor frame configured to receive impaction strikes.

16. A tibial shaping guide, comprising: a body with an anterior side, wherein the anterior side includes at least; a plurality of fixation pin holes; and an anterior guide recess; wherein the anterior guide recess is dimensioned to mate with a tibial shaper such that the tibial shaping guide restricts a side motion of the tibial shaper during a tibia bone shaping process.

17. The tibial shaping guide of claim 16, wherein the plurality of fixation pin holes includes at least two fixation pin holes configured for engaging with two parallel pins.

18. The tibial shaping guide of claim 17, wherein the plurality of fixation pin holes further includes one fixation pin hole configured for engaging with an oblique pin.

19. The tibial shaping guide of claim 17, wherein the two parallel pins are impacted into a tibia bone.

20. The tibial shaping guide of claim 19, wherein an oblique pin is impacted into a tibia bone at an angle oblique to the two parallel pins such that the tibial shaper is affixed to the tibia bone upon engaging with the two parallel pins and oblique pin.

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