Tibial implants with improved anterior load transfer

Abstract

This invention discloses a tibial implant (100). In one embodiment, the tibial implant includes a tibial support (120) and a support member (140), the support member being arranged and configured to be at least partially positioned within the intramedullary canal of a patient's bone. In some embodiments, the tibial implant may further include one or more pins (180) located anteriorly on the bottom surface of the support and one or more bridging members (190) for engaging the pins to the support member such that loads received by the pins are transferred to the support member via bridging members. Additionally and / or alternatively, the tibial implant may include one or more chamfered or load-bearing areas (200) for elongating the transition region between the support member and the bottom surface of the tibial support to extend the area where the load is transferred.

Description

[0001] Cross-references to related applications

[0002] This application is a non-provisional application filed on July 30, 2020, entitled “Tibial Implant with Improved Anterior Load Transfer”, U.S. Provisional Patent Application No. 63 / 058,928, and claims the benefit of the application as of its filing date, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to orthopedic implants, and more specifically to orthopedic knee prostheses for the proximal tibia, such as improved tibial implants for handling anterior loads. Background Technology

[0004] Knee arthroplasty or knee replacement surgery typically involves the implantation, mounting, etc. (these terms are used interchangeably but are not intended to be limiting) of orthopedic implants, such as knee prostheses, onto a patient's knee. For example, in the case of total knee replacement, orthopedic implants (such as knee prostheses) may include femoral implants and tibial implants. In use, the femoral implant is attached to the patient's femur, while the tibial implant is attached to the patient's tibia. Generally, both femoral and tibial implants may include support members (e.g., intramedullary stems), support members, load-bearing members, etc., that can be attached to the joint components (these terms are used interchangeably herein but are not intended to be limiting). In use, the support member is arranged and configured to insert into the intramedullary canal of the patient's bone, while the support member is mounted on a prepared surface on the patient's bone. The load-bearing member or insert is typically mounted on the support member of the tibial component.

[0005] Several factors may be relevant to the design and performance of orthopedic implants. For example, in the case of orthopedic tibial implants, a non-exhaustive list of these factors includes implant flexibility (or the flexibility of certain portions of the implant or its flexibility toward certain axes or other structures), which can indicate the degree of fit of the implant to the potentially uneven resection surface of the proximal tibia; implant stiffness (or the stiffness of certain portions of the implant or its stiffness around certain axes or other structures), which can indicate the extent to which stress or other forces exerted by bone and other anatomical structures associated with the knee joint are transmitted to the peripheral cortical shell of the proximal tibia; rotational resistance of the implant; amount of bone preserved; and / or other potentially relevant factors. In some cases, accommodating these or other factors may require trade-offs to balance competing factors. In some cases, one or more of these factors may not be considered or may be given high importance for the design of orthopedic implants.

[0006] One known knee prosthesis is the Journey II, manufactured and distributed by Smith Nephere, Inc. In use, the Journey II knee prosthesis attempts to substantially mimic the kinematics of a patient's natural knee. Specifically, for example, the Journey II knee prosthesis includes a convex lateral aspect that substantially mimics the convex lateral aspect of the natural tibia. This allows the patient's femur to lock anteriorly at a screw-starting position that mimics the screw-starting position of the natural knee. One consequence of mimicking the natural screw-starting position is that the tibial implant of the knee prosthesis experiences load anteriorly on the tibial support.

[0007] This disclosure is made with this in mind. Summary of the Invention

[0008] This invention is provided to introduce a series of concepts in a simplified form, which will be further described in the detailed description section below. This invention is not intended to identify key or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter.

[0009] In one embodiment, a knee prosthesis (e.g., a tibial implant or component) is disclosed. The tibial implant includes a tibial support and a support member. The tibial support includes a top surface and a bottom surface. The support member extends from the bottom surface of the tibial support and is arranged and configured to be at least partially positioned within the intramedullary canal of a patient's bone for engagement of the tibial implant to the patient's bone during use. The support member includes a stem portion, one or more keels extending from the stem portion, one or more screws located anteriorly on the bottom surface of the tibial support, and one or more bridging members respectively engaging the one or more screws to the one or more keels, the one or more bridging members being arranged and configured to transfer load from the one or more screws to the one or more keels.

[0010] In one embodiment, the tibial implant includes: a tibial support member including a top surface and a bottom surface; and a support member extending from the bottom surface of the tibial support member. The support member is arranged and configured to be at least partially positioned within the intramedullary canal of a patient's bone for attaching the tibial implant to the patient's bone during use. The support member includes a stem portion and one or more keels extending from the stem portion. The tibial implant also includes a chamfered load-bearing region between the bottom surface of the tibial support member and the support member, the chamfered load-bearing region providing a variable thickness transition region between the bottom surface of the tibial support member and the support member to transfer load between the tibial support member and the support member.

[0011] In one embodiment, the one or more keels include a first keel and a second keel, the one or more nails include a first nail and a second nail, and the one or more bridging members include a first bridging member and a second bridging member, wherein the first nail is connected to the first keel via the first bridging member, and the second nail is connected to the second keel via the second bridging member.

[0012] In one embodiment, the first keel extends from the inside of the handle portion toward the inside of the tibia support, and the second keel extends from the outside of the handle portion toward the outside of the tibia support.

[0013] In one embodiment, the first keel and the second keel extend rearward from the handle portion.

[0014] In one embodiment, the first and second nails are positioned closer to the peripheral edge of the tibial support than the handle portion.

[0015] In one embodiment, the first nail and the second nail are positioned on the front side relative to the handle portion.

[0016] In one embodiment, the tibia support and the support member including the handle portion, the one or more keels, the one or more nails and the one or more bridging members are formed as a single piece or integrally.

[0017] In one embodiment, the bottom surface of the tibial support also includes a porous layer mounted thereon.

[0018] In one embodiment, the support member includes one or more protrusions coupled to the handle portion, the one or more protrusions extending along the longitudinal length of the handle portion.

[0019] In one embodiment, the support member includes one or more protrusions coupled to the one or more keels, the one or more protrusions extending along the longitudinal length of the keels.

[0020] In one embodiment, the tibial implant further includes a chamfered load region between the bottom surface of the tibial support and the support member, the chamfered load region providing a variable thickness transition area between the bottom surface of the tibial support and the support member to transfer load between the tibial support and the support member.

[0021] In one embodiment, the chamfered load zone is located between the radial surface associated with the support member and the bottom surface of the tibial support member.

[0022] In one embodiment, each of the handle portion, the one or more keels, the one or more nails, and the one or more bridging members includes a chamfered load zone extending therefrom.

[0023] In one embodiment, the chamfered load zone is arranged and configured to provide a variable thickness to the tibial support so that the bottom surface of the tibial support transitions to the support member, while the total combined thickness of the tibial support and the porous coating applied thereto remains constant.

[0024] In one embodiment, each of the chamfered load zones comprises a circular shape extending outward from the support member.

[0025] In an alternative embodiment, a tibial implant is disclosed. The tibial implant includes a tibial support and a support member. The tibial support includes a top surface and a bottom surface, and the support member extends from the bottom surface. The support member is arranged and configured to be at least partially positioned within the intramedullary canal of a patient's bone for attachment of the implant to the patient's bone during use. The tibial implant also includes a chamfered load region between the bottom surface of the tibial support and the support member, the chamfered load region providing a variable thickness transition area between the bottom surface of the tibial support and the support member to guide load distribution between the tibial support and the support member.

[0026] In one embodiment, the chamfered load zone is located between the radial surface associated with the support member and the bottom surface of the tibial support member.

[0027] In one embodiment, the support member includes a handle portion, one or more keels extending from the handle portion, and one or more nails located on the front side of the bottom surface of the tibia support member, each of the handle portion, the one or more keels, and the one or more nails including a chamfered load zone extending therefrom.

[0028] In one embodiment, each of the chamfered load zones comprises a circular shape extending outward from the handle portion, the one or more keels, and the one or more nails.

[0029] In one embodiment, the chamfered load zone is arranged and configured to provide a variable thickness to the tibial support so that the bottom surface of the tibial support transitions to the support member, while the total combined thickness of the tibial support and the porous coating applied thereto remains constant.

[0030] In one embodiment, the one or more nails are respectively connected to the one or more keels via one or more bridging members, such that the front load on the nail is transferred to the keel via the bridging member.

[0031] In one embodiment, at least a portion of the porous layer includes a non-faceted bottom surface arranged and configured to provide a variable thickness transition region between the bottom surface of the tibial support and the support member to guide load distribution between the tibial support and the support member.

[0032] In an alternative embodiment, a tibial implant is disclosed. The tibial implant includes a tibial support and a support member. The tibial support includes a top surface and a bottom surface, and the support member extends from the bottom surface. The support member is arranged and configured to be at least partially positioned within the intramedullary canal of a patient's bone for attachment of the tibial implant to the patient's bone during use. The tibial support also includes a porous surface, including a non-faceted bottom surface. In one embodiment, the non-faceted bottom surface of the porous surface conceals a chamfered load region arranged and configured to provide a variable thickness transition region between the bottom surface of the tibial support and the support member to guide load distribution between the tibial support and the support member.

[0033] In one embodiment, the non-faceted porous structure is nested within a precisely prepared proximal tibia. The proximal tibia is prepared, for example, by precision grinding using a grinding wheel. Strategic chamfered areas and added material can be embedded within the non-faceted porous structure to provide optimal support for in vivo loads.

[0034] The embodiments disclosed herein offer numerous advantages. For example, by providing a bridging member between the nail and the keel, the tibial implant can better handle and distribute the load borne by the anterior portion of the tibial support. Similarly, by including a chamfered load zone between the tibial support and the support member, the tibial implant can better distribute the load borne during use while minimizing the overall thickness of the tibial support.

[0035] The following describes in detail, with reference to the accompanying drawings, at least some of the additional features and advantages of embodiments of the invention, as well as the structure and operation of various embodiments of the invention. Attached Figure Description

[0036] The specific embodiments of the disclosed apparatus will now be described by way of example with reference to the accompanying drawings, in which:

[0037] Figure 1 This is a bottom perspective view of an example embodiment of an orthopedic tibial implant according to one or more features of this disclosure;

[0038] Figure 2 yes Figure 1 The image shows a bottom view of the tibial implant.

[0039] Figure 3 yes Figure 1 The bottom perspective view of the tibial implant shown indicates that the porous layer of the tibial implant has been removed.

[0040] Figure 4 yes Figure 1 The bottom view of the tibial implant shown illustrates the tibial implant with the porous layer removed;

[0041] Figure 5 The following is a bottom perspective view of an alternative example of an embodiment of a tibial implant according to one or more features of the present disclosure, showing a tibial implant with the porous layer removed.

[0042] Figure 6 The following is a bottom perspective view of an alternative example of an embodiment of a tibial implant according to one or more features of the present disclosure, showing a tibial implant with the porous layer removed.

[0043] Figure 7 The following is a bottom perspective view of an alternative example of an embodiment of a tibial implant according to one or more features of the present disclosure, showing a tibial implant with the porous layer removed.

[0044] Figure 8 A cross-sectional view illustrating the thickness variation in the tibial support piece caused by including one or more chamfers or load zones according to one or more features of this disclosure is shown.

[0045] Figure 9 A bottom perspective view shows an alternative example of an embodiment of a tibial implant according to one or more features of this disclosure, the tibial implant including a non-faceted porous bottom surface;

[0046] Figure 10-12 It shows Figure 9 Various alternative views of the tibial implant shown; and

[0047] Figure 13 A perspective view showing an example of a prepared tibia, which is arranged and configured to receive... Figure 9 The tibial implant shown.

[0048] The accompanying drawings are not necessarily drawn to scale. The drawings are merely illustrative and not intended to depict specific parameters of this disclosure. The drawings are intended to depict exemplary embodiments of this disclosure and are therefore not to be considered as limiting the scope. In the drawings, the same reference numerals denote the same elements. Detailed Implementation

[0049] Various features of orthopedic implants, such as knee prostheses (e.g., tibial implants or components), will now be described more fully below with reference to the accompanying drawings, in which one or more features of the knee prosthesis will be shown and described. It should be understood that various features, etc., can be used independently or in combination with each other. It should be understood that the knee prosthesis disclosed herein can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will convey certain features of the knee prosthesis to those skilled in the art. In the drawings, unless otherwise stated, the same numerals refer to the same elements.

[0050] As will be described herein, knee prostheses, such as tibial implants, components, etc. (which are used interchangeably herein but are not intended to be limiting), are disclosed according to one or more features of this disclosure. In one embodiment, the knee prosthesis includes a tibial support or load-bearing component (the terms are used interchangeably herein but are not intended to be limiting) and a support member including an intramedullary stem arranged and configured for implantation into the intramedullary canal of a patient's bone (e.g., the patient's tibia). Additionally, according to one feature of this disclosure, the tibial support includes one or more screws located anteriorly on the bottom surface of the support and one or more bridging members for engaging the screws to the support member, such that load received by the screws is transferred to the support member. Furthermore, according to another feature of this disclosure, which can be used in combination with or separately from other features of this disclosure, the tibial implant may include one or more chamfers or load-bearing areas to elongate the transition region between the support member and the bottom surface of the tibial support to elongate the area where load is transferred.

[0051] refer to Figure 1-4 An example of an embodiment of the tibial implant 100 is shown. Figure 1 and 2 A bottom view of a tibial implant 100 is shown, to which a porous layer 110 is attached or mounted. Figure 3 and Figure 4 A bottom view of the tibial implant 100 with the porous layer 110 removed is shown.

[0052] As shown in the figure, the tibial implant 100 includes a tibial support 120 connected to a support member 140. The support member 140 can be connected to the tibial support 120 using any technology now known or developed hereafter, including, for example, threaded connections, press fits, adhesives, cement, or other techniques. In one embodiment, the support member 140 and the tibial support 120 are formed monolithically or integrally. For example, in one embodiment, the tibial support 120 and the support member 140 can be formed monolithically or integrally using any technology or method now known or developed hereafter, including, for example, additive manufacturing techniques. Examples of non-limiting additive manufacturing techniques include selective laser sintering (SLS), direct metal laser sintering (DMLS), electron beam melting (EBM), selective laser melting (SLM), 3D printing, etc.

[0053] As shown in the figure, the tibial support includes a top surface or upper surface 122 and a bottom surface or lower surface 124. For example... Figure 1 and Figure 2 As shown, the bottom surface 124 of the tibial support 120 includes a porous layer or coating 110 applied thereto. For example, in one embodiment, the porous coating or layer 110 is a titanium layer that can be applied to the bottom surface 124 of the tibial support 120. The porous coating or layer 110 can be applied to the bottom surface 124 of the tibial support 120 by any now-known or hereafter developed technique or method. For example, the porous coating or layer 110 can be applied to the bottom surface 124 of the tibial support 120 via additive manufacturing techniques. For example, some non-limiting additive manufacturing techniques include selective laser sintering (SLS), direct metal laser sintering (DMLS), electron beam melting (EBM), selective laser melting (SLM), 3D printing, etc.

[0054] In use, the top surface 122 of the tibial support 120 may include a lip or lock (not shown) for receiving and / or securing one or more inserts (not shown) to the tibial support 120, such inserts being designed to contact and hinge with a femoral orthopedic implant (not shown) during use. Alternatively, the tibial support 120 itself may include an articular surface that does not require a separate articular insert. In one embodiment, as shown, the tibial support 120 may include a posterior notch 126, which may be designed to allow retention of the attachment site of the posterior cruciate ligament; however, in other embodiments, the tibial support 120 may or may not include this notch or gap, or other notches or gaps, for retaining one or both cruciate ligaments. In other words, in some embodiments, the tibial support 120 may be used in cross-compass sacrifice procedures, posterior cruciate ligament preservation procedures, or double cruciate ligament preservation procedures. In some embodiments, the tibial support 120 may be used in a movable-bearing knee joint or a fixed-bearing knee joint. It should be understood that, according to various embodiments, various top surface and peripheral shapes are possible, and such shapes may be at least partially affected by the strength requirements of the support 120.

[0055] As shown, a support member 140 extends from the bottom surface 124 of the tibial support 120. In use, the support member 140 is at least partially positioned within the intramedullary canal of the patient's tibia to attach the tibial implant 100 to the patient's tibia. In one embodiment, as shown, the support member 140 includes a handle portion 150 extending along a longitudinal axis L away from the bottom surface 124 of the tibial support 120. In the illustrated embodiment, the longitudinal axis L is substantially perpendicular to the bottom surface 124 of the tibial support 120 in the medial-lateral direction, but other angles may be used. Additionally, in some embodiments, the tibial support 120 may have a slope in the anterior-posterior direction. For example, the tibial support 120 may have a posterior slope of 3 to 7 degrees. Alternatively, the tibial support 120 may have a zero-degree slope. The handle portion 150 may be positioned offset from the center of the tibial support 120 (e.g., positioned more medially than lateral). For example, in one embodiment, the handle portion 150 may be slightly inward from the center of the tibial support 120. For example, the handle portion 150 may be 1 to 3 mm inward from the center of the tibial support 120. In other embodiments, the handle portion 150 may be centered on the tibial support 120.

[0056] In some embodiments, the handle portion 150 may include a first portion 152 adjacent to the bottom surface 124 of the tibial support 120 and a second portion 154 extending away from the first portion 152. The first portion 152 may have a first cross-sectional area, and the second portion 154 may have a second cross-sectional area, wherein the first cross-sectional area is larger than the second cross-sectional area. In other embodiments, the second portion 154 may have the same cross-sectional area and shape as the first portion 152. In use, the length of the handle portion 150 is dimensionally set to promote varus-valgus stability and resistance to tibial support 120 lifting from the patient's bone.

[0057] In one embodiment, as shown, the support member 140 may include one or more fins 160 spaced apart around the handle portion 150. For example, as shown, the handle portion 150 may include four fins 160 spaced apart therearound, but this is only one configuration and more or fewer fins 160 may be used. Furthermore, in one embodiment, the fins 160 may be equally spaced apart from each other or in another arrangement as needed. In one embodiment, the fins 160 may have a tapered configuration extending along the support member 140 toward the second portion 154. In use, the fins 160 help provide rotational stability during implantation and aid in the placement and alignment of the tibial support 120 into the bone. Any or all of the fins 160 may also be sized to the maximum implantable size based on the patient's anatomy.

[0058] Additionally, as shown in the figure, the support member 140 may also include one or more posterior keels or arms 170 (the terms are used interchangeably herein and are not intended to be limiting). As shown, the support member 140 may include a first posterior keel 170a and a second posterior keel 170b, which are mounted on the bottom surface 124 of the tibial support 120 and extend posteriorly from either side of the handle portion 150 toward the posterior side P of the tibial support 120. However, this is merely one configuration, and more or less of the keels 170 and / or different configurations of the keels 170 may be used. In use, the keels 170 can increase the strength of the implant 100 while also helping to prevent rotation of the tibial implant 100 relative to the patient's bone (e.g., the keels 170 assist in the rotational stability of the tibial support 120 in the bone during implantation).

[0059] As shown in the figure, in one embodiment, the first keel 170a may be angled relative to the second keel 170b, but in other embodiments, the first keel 170a and the second keel 170b may be substantially aligned with each other. In one embodiment, the first keel 170a and the second keel 170b may be separated from each other by an angle ranging from about 10 degrees to about 180 degrees. As shown in the figure, in one embodiment, the first keel 170a and the second keel 170b may have similar shapes and sizes; however, in other embodiments, the first keel 170a and the second keel 170b may be provided with different shapes and sizes. In one embodiment, the first keel 170a and the second keel 170b are bent or curled toward the inner side M and the outer side L of the support member 120, respectively.

[0060] The first keel 170a and the second keel 170b extend longitudinally along the support member 140 toward the second portion 154; however, as shown, the first keel 170a and the second keel 170b may be shorter or smaller than the fin 160, and therefore do not extend as far longitudinally along the support member 140 as the fin 160. Each of the first keel 170a and the second keel 170b may have a horizontal length extending toward the edge or peripheral edge 128 of the tibia support member 120. The first keel 170a and the second keel 170b may each have a sharp edge.

[0061] As shown in the figure, the first keel 170a and the second keel 170b, as well as other components of the support member 140, may include a plurality of track protrusions or ridges 175 (the terms are used interchangeably herein but are not intended to be limiting), which extend along or a portion of the height of the keel 170 as measured along the longitudinal axis L. In one embodiment, the plurality of ridges 175 may have a square or semi-square cross-sectional shape; however, in other forms, the shape may be rectangular or semi-circular. The plurality of ridges 175 may have variable height and variable width, such that one or more of the plurality of ridges 175 have a unique height and width. For example, in some forms, the height and width of the plurality of ridges 175 may be in the range of 1 mm to 3 mm. The plurality of ridges 175 may be evenly or non-evenly spaced along the keel 170. The plurality of ridges 175 assist the tibial implant 100 in increasing bone compression and fixation strength in the patient's bone.

[0062] Advantageously, during implantation, the fins 160 and keel 170 provide increased rotational resistance and strength for the tibial implant 100. The construction of the support member 140, including the shank portion 150, fins 160, and keel 170, provides improved fixation between the tibial support 120 and the patient's bone postoperatively. Furthermore, the fins 160 positioned on the anterior side A of the tibial support 120 are more sensitive to the anatomical dimensions of the patient's bone than the fins 160 positioned on the posterior side P, thus the size, positioning, and location of the anterior fins 160 on the tibial support 1120 are more sensitive than those of the posterior fins 160.

[0063] Additionally, as shown in the figures, in one example of the embodiment, the tibial support 120 may also include one or more nails 180. For example, as shown, the tibial implant 100 may include a first nail 180a and a second nail 180b, but this is only one configuration and more or fewer nails may be used. As shown, the first nail 180a and the second nail 180b may be mounted on the bottom surface 124 of the tibial support 120. The nails 180 may be attached to the tibial support 120 using any technology now known or developed hereafter, including, for example, threaded connections, press fits, adhesives, cement, or other techniques. In one embodiment, the nails 180 are formed monolithically or integrally with the tibial support 120.

[0064] In one embodiment, as shown, the first nail 180a and the second nail 180b are positioned near the rim or peripheral edge 128 of the tibial support 120. The first nail 180a and the second nail 180b are close to the tibial plateau upon implantation to increase the stability of the tibial support 120 and penetrate into denser bone than in the central tube. Additional nails 180 may be installed as needed. The nails 180 can have any suitable size and shape that are arranged and configured to engage the patient's bone to provide increased stability. For example, as shown, the nail 180 can be a basic cylinder with a pointed tip, but other shapes, such as arrowhead shapes, are conceivable.

[0065] According to one or more features of this disclosure, in use, for example, the nails 180 of the first nail 180a and the second nail 180b can be respectively connected to the support member 140 via, for example, via a support rib, a bridging member or bridging component, a radial portion, material, etc. 190 (the terms are used interchangeably herein but are not intended to be limiting) to, for example, to the first keel 170a and the second keel 170b. As shown, in one embodiment, during use, the bridging member 190 is arranged and configured to connect the first nail 180a and the second nail 180b to the first keel 170a and the second keel 170b respectively, such that any load received by the first nail 180a and the second nail 180b can be transferred to the support member 140 via the first keel 170a and the second keel 170b. With this arrangement, any anterior load can be transferred rearward from the nail 180, which is positioned anteriorly on the support 120 to capture the anterior load, to the keel 170, and subsequently to the support member 140, thereby providing increased strength to the tibial support 120 to prevent fracture due to associated anterior load conditions. In other words, compared to known implants, by connecting the nail 180 to the support member 140 via, for example, the keel 170, the anterior load is transferred from the nail 180 to the keel 170 and to the shank portion 150 of the support member 140, rather than to the support 120, thus providing increased strength to prevent damage such as support fracture.

[0066] In use, the bridging member 190 can have any configuration now known or developed hereafter, arranged and configured to transfer load from the nail 180 to the keel 170, and to the handle portion 150 of the support member 140. That is, the bridging member 190 can have any configuration arranged to protect the front load area and transfer stress rearward to the support member 140. For example, as shown, the bridging member 190 can be made of forged material and formed monolithically or integrally with the bracket 120 and / or the support member 140. Alternatively, the bridging member is envisioned to include, for example, an open space (e.g., a window) which may be filled with a mesh and / or a porous structure. Alternatively, the bridging member can include a reduced cross-sectional area or be connected by struts.

[0067] Although the nail 180 and bridging member 190 have been shown and illustrated with specific tibial support members and bracing elements, it should be understood that this disclosure is not limited thereto, and the nail 180 and bridging member 190 can be used with any tibial implant now known or hereafter developed, unless specifically claimed.

[0068] refer to Figure 3 and Figure 4According to one or more features of this disclosure that allow for use in combination with or separately from the nail 180 and bridging member 190 disclosed above, the tibial support member 120 may include one or more chamfers 200 formed in its bottom or lower surface 124. Additionally, as Figure 3 and Figure 4 As shown, the support member 140, including the handle portion 150, keel 170, pin 180, and bridging member 190, may include a radial surface 210 at the bottom surface 124 that connects to or forms the tibial support member 120. In use, the radial surface 210 facilitates load transfer between the support member 140, including the handle portion 150, keel 170, pin 180, and bridging member 190, and the support member 120 by preventing or at least minimizing stress concentration (e.g., the radial surface 210 helps to facilitate better rearward load transfer towards the support member). As shown, and in conjunction with one or more features of this disclosure, the bottom surface 124 of the support member 120 may also include one or more chamfers 200 formed between the radial surface 210 and the bottom surface 124 of the tibial support member 120. Reference Figure 8 An example embodiment of an embodiment utilizing a cross-sectional area of ​​the support member 120 with one or more chamfers 200 is shown. The chamfers 200 elongate the load-bearing area to increase the area on which the load is transferred between the support member 140, which includes the handle portion 150, the keel 170, the nail 180, and the bridging member 190, and the support member 120. In use, the chamfers or load-bearing areas 200 are used to provide variable thickness to guide the transfer of load between the support member 140, which includes the handle portion 150, the keel 170, the nail 180, and the bridging member 190, and the support member 120. That is, the chamfers or load-bearing areas 200 are used to increase the thickness of the tibial support member 120 adjacent to the support member 140, which includes the handle portion 150, the keel 170, the nail 180, and the bridging member 190. At the same time, the chamfers or load-bearing areas 200 help maintain a constant overall combined thickness of the tibial components (e.g., the combined thickness of the tibial support member 120 and the porous layer 110). That is, the chamfer or load area 200 allows the thickness of the support 120 to be increased, while the total combined thickness of the tibial component remains constant over the surface area of ​​the tibial component (e.g., during the application of the porous layer 110, the thickness of the porous layer 110 can be minimized above the chamfer or load area 200, so that the total combined thickness of the tibial component (e.g., the combined thickness of the support and the porous layer) remains constant).

[0069] In use, the chamfer or load area 200 can have any size and shape arranged and configured to facilitate the transfer of load between the support member 140, including the handle portion 150, the keel 170, the nail 180, and the bridging member 190, and the bracket 120. As shown, in one embodiment, the chamfer or load area 200 can have a substantially circular shape extending from and around the support member 140, including the handle portion 150, the keel 170, the nail 180, and the bridging member 190. As shown, in one embodiment, adjacent chamfers 200 can merge with each other, overlap, etc. In use, the chamfer or load area 200 transitions from a first height adjacent to the radial surface 210 to a second height extending away from the support member 140, including the handle portion 150, the keel 170, the nail 180, and the bridging member 190, the first height being greater than the second height. In one embodiment, the height of the chamfer or load area 200 may extend from approximately 0 to approximately 10 mm or taper, preferably in one embodiment, the height of the chamfer or load area 200 may extend from approximately 0 to approximately 1,000 micrometers. Additionally, in one embodiment, the chamfer or load area 200 may extend outward or taper in a length from approximately 0 to approximately 20 mm or more, preferably in one embodiment, the chamfer or load area 200 may extend outward or taper in a length from approximately 0 to approximately 8,000 micrometers (e.g., the outward extent of the chamfer or load area 200 is limited only by the overall size of the implant).

[0070] Alternatively, refer to Figure 5 In an alternative example of the embodiment, the chamfer or load area 200 may be incorporated (e.g., combined) into a radial surface 210 that transitions between the support member 140, which includes the handle portion 150, the keel 170, the nail 180, and the bridging member 190, and the bottom surface 124 of the bracket 120. With this arrangement, the load area 200 includes an increased thickness that merges with the radius.

[0071] Alternatively, refer to Figure 6 In an alternative example of the embodiment, the bridging element 190 and the chamfer / load zone 200 can be combined to create a reduced profile transition between the nail 180 and the support member 140 (e.g., the keel 170). In this way, the bridging element 190 is essentially hidden and invisible when the porous layer is applied.

[0072] Alternatively, refer to Figure 7 In an alternative embodiment, the bridging member 190 may be disposed between adjacent keels 170 and connect adjacent keels in the form of a guide rail 192. That is, as shown, the nail 180 may be positioned on the track 190 extending between adjacent keels 170.

[0073] refer to Figure 9-13An alternative example of an embodiment of the tibial implant 100 is shown. In use, the tibial implant 100 is substantially similar to the previous embodiments described herein. Therefore, for the sake of brevity, a discussion of certain components is omitted here.

[0074] Figure 9-12 Various views of the tibial implant 100 are shown. Figure 13 A perspective view of the patient's tibia is shown, indicating that the tibia is ready to receive [the treatment]. Figure 9-12 The tibial implant 100 is shown in the image. (Reference) Figure 9-12 The image shows a tibial implant 100, to which a porous layer 110 is attached or mounted.

[0075] Similar to the embodiments previously described herein, the tibial implant 100 includes a tibial support 120 connected to a support member 140. Additionally, the tibial support includes a top or upper surface 122 and a bottom or lower surface 124. As previously described and as shown, the bottom surface 124 of the tibial support 120 includes a porous layer or coating 110 applied thereon.

[0076] Similar to the embodiments previously described herein, the support member 140 extends from the bottom surface 124 of the tibial support member 120. In use, the support member 140 is at least partially positioned within the intramedullary canal of the patient's tibial T1 ( Figure 13 The tibial implant 100 is attached to the patient's tibia T. The support member 140 includes a handle portion 150 extending along a longitudinal axis L away from the bottom surface 124 of the tibial support member 120. The longitudinal axis L may be substantially perpendicular to the bottom surface 124 of the tibial support member 120 in a medial-lateral direction. The handle portion 150 may be positioned offset from the center of the tibial support member 120 (e.g., more medial than lateral). For example, in one embodiment, the handle portion 150 may be slightly medial to the center of the tibial support member 120. The tibial support member 120 may include a slope in an anterior-posterior direction. In some embodiments, the handle portion 150 may include a first portion 152 adjacent to the bottom surface 124 of the tibial support member 120 and a second portion 154 extending away from the first portion 152. The first portion 152 may have a first cross-sectional area, and the second portion 154 may have a second cross-sectional area, wherein the first cross-sectional area is larger than the second cross-sectional area. In other embodiments, the second portion 154 may have the same cross-sectional area and shape as the first portion 152. In use, the length of the handle portion 150 is dimensionally set to promote varus-valgus stability and resistance to tibial support 120 lifting from the patient's bone.

[0077] Additionally, in one embodiment, as previously mentioned and as shown, the support member 140 may include one or more fins 160 spaced apart around the handle portion 150. In use, the fins 160 help provide rotational stability during implantation and aid in the placement and alignment of the tibial support 120 into the bone. Any or all of the fins 160 may also be sized to the maximum implantable size based on the patient's anatomy.

[0078] Additionally, as previously mentioned and as shown in the figures, the support member 140 may also include one or more posterior keels 170. As shown, the support member 140 may include a first posterior keel 170a and a second posterior keel 170b, which are mounted on the bottom surface 124 of the tibial support 120 and extend posteriorly from either side of the handle portion 150 toward the posterior side P of the tibial support 120. However, this is merely one configuration, and more or fewer keels 170 and / or different configurations of the keels 170 may be used. In use, the keels 170 can increase the strength of the implant 100 while also helping to prevent rotation of the tibial implant 100 relative to the patient's bone (e.g., the keels 170 assist in the rotational stability of the tibial support 120 in the bone during implantation).

[0079] In use, and as previously described, the first keel 170a and the second keel 170b, as well as other components of the support member 140, may include a plurality of ridges 175 extending along or partially along the height of the keel 170 as measured along the longitudinal axis L. In one embodiment, the plurality of ridges 175 may have a square or semi-square cross-sectional shape; however, in other forms, the shape may be rectangular or semi-circular. In use, the plurality of ridges 175 assist the tibial implant 100 in increasing bone compression and fixation strength in the patient's bone.

[0080] Advantageously, during implantation, the fins 160 and keel 170 provide increased rotational resistance and strength for the tibial implant 100. The construction of the support member 140, including the shank portion 150, fins 160, and keel 170, provides improved fixation between the tibial support 120 and the patient's bone postoperatively. Furthermore, the fins 160 positioned on the anterior side A of the tibial support 120 are more sensitive to the anatomical dimensions of the patient's bone than the fins 160 positioned on the posterior side P, thus the size, positioning, and location of the anterior fins 160 on the tibial support 1120 are more sensitive than those of the posterior fins 160.

[0081] Additionally, as shown in the figures, in one example of the embodiment, the tibial support 120 may also include one or more screws 180. For example, as shown, the tibial implant 100 may include a first screw 180a and a second screw 180b, but this is only one configuration and more or fewer screws may be used. As shown, the first screw 180a and the second screw 180b may be mounted on the bottom surface 124 of the tibial support 120. In one embodiment, as shown, the first screw 180a and the second screw 180b may be positioned closer to the rim or peripheral edge 128 of the tibial support 120. The first screw 180a and the second screw 180b approach the tibial plateau upon implantation to increase the stability of the tibial support 120 and penetrate into denser bone than in the central tube. Additional screws 180 may be installed as needed. The screws 180 may have any suitable size and shape that are arranged and configured to engage the patient's bone to provide increased stability. For example, as shown in the figure, nail 180 can be a basic cylinder with a pointed tip, but other shapes can be envisioned, such as an arrow shape.

[0082] As previously mentioned and illustrated, according to one or more features of this disclosure, in use, for example, the nails 180 of the first nail 180a and the second nail 180b can be connected to the support members 140, such as the first keel 170a and the second keel 170b, respectively, via the bridging member 190. Figure 1-4 In use, the bridging member 190 is arranged and configured to connect the first nail 180a and the second nail 180b to the first keel 170a and the second keel 170b, respectively, such that any load received by the first nail 180a and the second nail 180b can be transferred via the first keel 170a and the second keel 170b to the support member 140. With this arrangement, any anterior load can be transferred rearward from the nail 180, which is located anteriorly on the support member 120 to capture the anterior load, to the keel 170, and subsequently to the support member 140, thereby providing increased strength to the tibial support member 120 to prevent breakage due to associated anterior load conditions. That is, compared to known implants, by connecting the nail 180 to the support member 140 via, for example, the keel 170, the anterior load is transferred from the nail 180 to the keel 170 and to the shank portion 150 of the support member 140, rather than to the support member 120, thereby providing increased strength to prevent damage such as support breakage.

[0083] Additionally, and as previously mentioned, according to one or more features of this disclosure that allow for use in combination with or alone with the nail 180 and bridging member 190 disclosed above, the tibial support member 120 may include one or more chamfers 200 formed in its bottom or lower surface 124. Figure 3 and Figure 4Additionally, the support member 140, including the handle portion 150, keel 170, nail 180, and bridging member 190, may include a radial surface 210 at the bottom surface 124 that connects to or forms the tibial support member 120. In use, the radial surface 210 facilitates load transfer between the support member 140, including the handle portion 150, keel 170, nail 180, and bridging member 190, and the support member 120 by preventing or at least minimizing stress concentration (e.g., the radial surface 210 helps to facilitate better rearward load transfer toward the support member). One or more chamfers 200 may be formed between the radial surface 210 and the bottom surface 124 of the tibial support member 120.

[0084] In use, the chamfer or load-bearing area 200 is used to provide a variable thickness to guide the transfer of load between the support member 140, which includes the handle portion 150, the keel 170, the nail 180, and the bridging member 190, and the tibia support member 120. That is, the chamfer or load-bearing area 200 is used to increase the thickness of the tibia support member 120 adjacent to the support member 140, which includes the handle portion 150, the keel 170, the nail 180, and the bridging member 190.

[0085] refer to Figure 9-13 According to one or more features of this disclosure, the porous coating 110 may include a non-faceted bottom surface 220 (e.g., a non-planar surface). In one embodiment, as shown, the porous coating 110 may include a planar surface along an internal region or area of ​​the tibial support 120 adjacent to the support member 140, and the non-faceted bottom surface 220 may be disposed adjacent to the peripheral surface 128 of the tibial support 120.

[0086] In use, the non-faceted bottom surface 220 of the porous coating 110 can be arranged and configured to conceal, for example, one or more bridging elements 190, chamfers or load areas 200, and / or radial surfaces 210. Additionally, the non-faceted bottom surface 220 of the porous coating 110 can be arranged and configured such that the tibial support 120 provides increased thickness adjacent to the support member 140. In one embodiment, the non-faceted bottom surface can begin at a distance from the peripheral surface 128 of the tibial support 120 and can provide radial or transitional regions or surfaces 225 arranged and configured along the periphery of the non-faceted bottom surface 220, said radial or transitional regions or surfaces 225 being arranged and configured to transition from the non-faceted bottom surface 220 to the tibial support 120. With this arrangement, the tibial support 120 includes a region of increased thickness (e.g., a non-faceted bottom surface 220) that merges with the tibial support 120 via a radial or transitional region or surface 225 (e.g., a radial transition is provided between the non-faceted bottom surface 220 and the tibial support 120) to guide load distribution between the support member 140 and the tibial support 120.

[0087] In use, such as Figure 13 As shown, the non-faceted bottom surface 220 of the tibial support 110 is arranged and configured to be positioned within or nested within a precisely prepared proximal tibial T in the patient. In use, the patient's proximal tibial T can be prepared using precision grinding, for example, by means of a grinding tool associated with a robotic surgical system, but any other mechanism for preparing the patient's proximal tibial T can be used.

[0088] As previously mentioned herein, tibial implants can be manufactured from any suitable biocompatible material now known or hereafter developed for the manufacture of orthopedic implants, including, for example, titanium, cobalt-chromium, stainless steel, ceramics, or other biocompatible materials. Additionally and / or alternatively, tibial implants can be formed using any desired or suitable method or technique now known or hereafter developed. For example, in one embodiment, any additive manufacturing technique now known or hereafter developed can be used to manufacture the tibial implant. Using some non-limiting known techniques, tibial implants can be manufactured by selective laser sintering (SLS), direct metal laser sintering (DMLS), electron beam melting (EBM), selective laser melting (SLM), 3D printing, etc. For example, in some embodiments, the entire tibial implant can be formed as a single piece or a monolithic implant (including any porous or other in-growth-promoting surfaces or materials). In some embodiments, portions of the tibial implant can be formed, and then additional in-growth materials, surfaces, and / or treatments can be added to or applied to the implant. In other embodiments, additive manufacturing techniques, such as electron beam melting or methods using lasers to subtract or remove selected portions of material from an initial solid material, may be used. In other embodiments, casting or other techniques or methods may be used to form part or all of the tibial implant. In some embodiments, additive manufacturing techniques such as SLS may be used to form non-porous implants such as tibial implants, and the implants may subsequently undergo acid etching, sandblasting, plasma spraying (e.g., titanium dioxide or another metal to promote internal growth), or other treatments.

[0089] In use, tibial implants can be part of a set of tibial implants in various standard sizes, or they can be patient-matched tibial implants with certain geometries and / or other features of the implants customized for the specific patient's anatomy.

[0090] This document uses terms such as top, bottom, above, below, inside, outside, front, back, proximal, and distal. However, such terms are not limited to specific coordinate orientations, distances, or dimensions, but are used to describe relative positions with reference to specific embodiments. Such terms are generally not limited to the scope of the claims set forth herein. Any embodiment or feature of any segment, portion, or any other component shown or specifically described with respect to various embodiments of similar sections, portions, or components herein may be interchangeably applied to any other similar embodiments or features shown or described herein.

[0091] While this disclosure refers to certain embodiments, numerous modifications, alterations, and variations of the described embodiments are possible without departing from the field and scope of this disclosure as defined in the appended claims. Therefore, this disclosure is not intended to be limited to the described embodiments. Rather, these embodiments should be considered illustrative rather than restrictive. All changes and modifications falling within the spirit of this invention will be considered to be within the scope of this disclosure. This disclosure should be given the full scope defined by the language of the appended claims and their equivalents.

[0092] The above description has broad applications. The discussion of any embodiments is intended to be illustrative only and is not intended to imply that the scope of this disclosure (including the claims) is limited to these embodiments. In other words, while illustrative embodiments of this disclosure have been described in detail herein, it should be understood that the inventive concept can be implemented and employed in other ways differently, and the appended claims are intended to be interpreted as including such variations, in addition to being limited by the prior art.

[0093] It should be understood that, as described herein, "implementation" (as illustrated in the accompanying drawings) may refer to an illustrative representation of an environment or article of manufacture or component that provides or implements the disclosed concept or feature, or a representation of a manner in which only the concept or feature is provided or implemented. However, such illustrated embodiments are to be understood as examples (unless otherwise stated), and other ways of embodying the described concepts or features, such as those that a person of ordinary skill in the art would understand upon learning the concepts or features from this disclosure, are all within the scope of this disclosure. Furthermore, it should be appreciated that although the drawings may show one or more embodiments of a concept or feature together in a single embodiment of an environment, article of manufacture, or component incorporating such a concept or feature, it should be understood that such concepts or features (unless otherwise specified) are independent and separate from each other, shown together for convenience, but not intended to limit their co-existence or use. For example, a feature illustrated or described as part of an embodiment may be used alone or together with another embodiment to produce yet another embodiment. Therefore, this subject matter is intended to cover such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0094] As used herein, an element or step described in the singular and preceded by the word "a / an" should be understood to not exclude a plurality of elements or steps, unless such exclusion is explicitly stated.

[0095] As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions for combining and separating in operation. The terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein. Unless otherwise stated, connection references (e.g., engagement, attachment, linking, joining, and joining) should be interpreted broadly and may include intermediate members between sets of elements as well as intermediate members that move relative to the elements. Thus, a connection reference does not necessarily infer that two elements are directly connected and have a fixed relationship with each other. Identifying references (e.g., first, second, first, third, fourth, etc.) are not intended to imply importance or priority but are used to distinguish one feature from another. The figures are for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the figures accompanying this document may vary.

[0096] The foregoing discussion has been presented for illustrative and descriptive purposes and is not intended to limit this disclosure to one or more of the forms disclosed herein. For example, for the purpose of simplifying this disclosure, various features of this disclosure have been grouped together in one or more embodiments or constructions. However, it should be understood that various features of certain embodiments or constructions of this disclosure may be combined in alternative embodiments or constructions. Furthermore, the following claims are hereby incorporated into this detailed description by reference, wherein each claim is an independent embodiment of this disclosure.

Claims

1. A tibial implant, comprising: A tibial support, the tibial support comprising a top surface and a bottom surface; as well as A support member extending from the bottom surface of the tibial support, the support member being arranged and configured to be at least partially positioned within the intramedullary canal of the patient's bone for attaching the tibial implant to the patient's bone during use, the support member comprising: Handle portion; and One or more keels extending from the handle portion; The tibial implant further includes a chamfered load-bearing region between the bottom surface of the tibial support and the support member, the chamfered load-bearing region providing a variable thickness transition area between the bottom surface of the tibial support and the support member to transfer load between the tibial support and the support member. The bottom surface of the tibial support also includes a porous layer mounted thereon. At least a portion of the porous layer includes a non-faceted bottom surface arranged and configured to provide a variable thickness transition region between the bottom surface of the tibial support and the support member to guide load distribution between the tibial support and the support member.

2. The tibial implant of claim 1, wherein the chamfered load area is located between the radial surface associated with the support member and the bottom surface of the tibial support member.

3. The tibial implant of claim 1, wherein each of the stem portion and the one or more keels includes a chamfered load zone extending therefrom.

4. The tibial implant of claim 3, wherein each of the chamfered load regions comprises a circular shape extending outward from the support member.

5. The tibial implant of claim 1, wherein the support member further comprises one or more pins located anteriorly on the bottom surface of the tibial support and one or more bridging members respectively connecting the one or more pins to the one or more keels, the one or more bridging members being arranged and configured to transfer load from the one or more pins to the one or more keels.

6. The tibial implant of claim 5, wherein the one or more keels include a first keel and a second keel, the one or more nails include a first nail and a second nail, and the one or more bridging members include a first bridging member and a second bridging member, wherein the first nail is connected to the first keel via the first bridging member, and the second nail is connected to the second keel via the second bridging member.

7. The tibial implant of claim 6, wherein the first keel extends from the inside of the handle portion toward the inside of the support, and the second keel extends from the outside of the handle portion toward the outside of the support.

8. The tibial implant of claim 7, wherein the first keel and the second keel extend posteriorly from the stem portion.

9. The tibial implant of claim 6, wherein the first nail and the second nail are positioned closer to the peripheral edge of the tibial support than the handle portion, and the first nail and the second nail are positioned anteriorly relative to the handle portion.

10. The tibial implant of claim 1, wherein the support member includes one or more protrusions coupled to the handle portion, the one or more protrusions extending along the longitudinal length of the handle portion.

11. The tibial implant of claim 10, wherein the support member further comprises one or more protrusions coupled to the one or more keels, the one or more protrusions extending along the longitudinal length of the keels.

12. The tibial implant according to any one of the preceding claims, wherein the support member and the support member including the handle portion and the one or more keels are formed as a single piece or integrally.

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