Orthopedic knee implant

Abstract

An orthopedic knee implant (10) is disclosed that includes a femoral component (12) having a metal substrate (60) and a metal coating (58).

Description

[0001] This application claims priority to U.S. Provisional Application Serial No. 62 / 978,539, filed February 19, 2020, the contents of which are incorporated herein by reference.

[0002] Cross-reference section

[0003] Cross-reference is made to co-pending U.S. Application Serial No. 17 / 179827 (Agent's File No. 265280-333150, DSP6174USNP1) and International Application Serial No. PCT / IB2021 / 051430 (Agent's File No. DSP6174USPCT1), entitled “COATED IMPLANT AND METHOD OF MAKING THE SAME”, each of which is incorporated herein by reference. Technical Field

[0004] This disclosure relates generally to an implantable orthopedic prosthesis, and more specifically to the femoral component of an implantable orthopedic prosthesis. Background Technology

[0005] Arthroplasty is a well-known surgical procedure that replaces diseased and / or damaged natural joints with prosthetic joints. A typical knee prosthesis consists of a patellar prosthesis component, a tibial support, a femoral component, and a tibial support positioned between the tibial support and the femoral component. The femoral component is designed to attach to the surgically prepared distal end of the patient's femur. The tibial support is designed to attach to the surgically prepared proximal end of the patient's tibia.

[0006] The femoral component and tibial support can be made of biocompatible materials, such as cobalt-chromium metal alloys. The tibial support component positioned between the femoral component and the tibial support can be formed from a plastic material, such as polyethylene. However, cobalt alloys are often expensive, thus necessitating a component made of a non-cobalt metallic material and a method for its manufacture. For example, there is a need for a femoral component of a knee prosthesis made of a non-cobalt metallic material and a method for its manufacture. Summary of the Invention

[0007] According to one aspect of this disclosure, an orthopedic implant includes a femoral component. The femoral component may be configured to attach to the distal end of a patient's femur. The femoral component may include a base comprising a titanium alloy. Exemplarily, the base may have a condylar surface curved in a bisecting plane and a bone-facing surface positioned relative to the condylar surface. An articular layer may be disposed on the condylar surface. The articular layer may include a first layer comprising niobium, zirconium, titanium, tantalum, platinum, molybdenum, or combinations thereof; a second layer comprising an alloy or ceramic; and a third layer comprising titanium zirconium nitride, zirconium oxide, niobium oxide, zirconium oxynitride, niobium oxynitride, or combinations thereof. The first layer may extend between the second layer and the condylar surface and interconnect the second layer with the condylar surface. The second layer may extend between the first and third layers and interconnect the first and third layers. The third layer may form the lateral articular surface of the femoral component.

[0008] In some implementations, the first layer may have approximately 7.1 × 10⁻⁶ in at least one direction. -6 / °K to approximately 7.5×10 -6 Coefficient of thermal expansion / °K.

[0009] In some embodiments, the third layer may comprise at least about 90% monoclinic zirconium oxide. In some embodiments, the third layer may have a thickness of about 100 nm to about 5 μm.

[0010] In some embodiments, the second layer may comprise at least about 95% zirconium-niobium alloy. In some embodiments, the second layer may have a thickness of about 3 μm to about 8 μm.

[0011] In some embodiments, the first layer may contain at least about 95% niobium. In some embodiments, the first layer may have a thickness of about 0.5 μm to about 2 μm.

[0012] Examplely, the femoral component may include a bone-joint layer disposed on a bone-facing surface. In some embodiments, the bone-joint layer may be porous.

[0013] According to another aspect, a process for forming a femoral component of an orthopedic knee implant includes depositing a first layer comprising niobium, zirconium, titanium, tantalum, platinum, molybdenum, combinations thereof, or a ceramic thereof on a condylar surface comprising a substrate. The substrate may comprise titanium. The condylar surface may be curved in a longitudinal bisecting plane. In some embodiments, the process includes depositing a second layer on the first layer, which may comprise an alloy of zirconium and niobium.

[0014] In some embodiments, the first layer may contain at least about 90% niobium. In some embodiments, the first layer may have a thickness of about 0.5 μm to about 2.5 μm.

[0015] In some embodiments, the second layer may comprise an alloy of at least about 95% zirconium and niobium. In some embodiments, the second layer may have a thickness of about 3 μm to about 8 μm.

[0016] In some embodiments, the process may include oxidizing a portion of the second layer to form a third layer. In some embodiments, the third layer may comprise zirconium oxide, niobium oxide, zirconium oxynitride, niobium oxynitride, or combinations thereof.

[0017] In some embodiments, the third layer may contain at least about 95% zirconium oxide. In some embodiments, the third layer may have a thickness of about 4 μm to about 5 μm.

[0018] In some implementations, the oxidation step can be performed in an environment containing about 97.5% argon and about 2.5% oxygen.

[0019] In some implementations, the oxidation step can be performed at a temperature of about 500°C to about 600°C.

[0020] In some implementations, the process may include depositing a third layer on top of the second layer.

[0021] According to another aspect of this disclosure, the orthopedic implant includes a femoral component. The femoral component may be configured to attach to the distal end of a patient's femur. The femoral component may include a base comprising a titanium alloy. Exemplarily, the base may have a condylar surface curved in a longitudinal bisecting plane and a bone-facing surface positioned relative to the condylar surface. An articular layer may be disposed on the condylar surface. The articular layer may include an inner layer comprising niobium, zirconium, titanium, tantalum, platinum, molybdenum, or combinations thereof; and an outer layer comprising titanium zirconium nitride, zirconium oxide, niobium oxide, zirconium oxynitride, niobium oxynitride, or combinations thereof. The inner layer may extend from the condylar surface. The outer layer may form the lateral articular surface of the femoral component.

[0022] In some implementations, the joint layer may include an intermediate layer comprising an alloy or ceramic.

[0023] In some embodiments, the atomic percentage of zirconium in the outer layer can be from 50 At% to 80 At%. In some embodiments, the atomic percentage of zirconium in the outer layer is from 30 At% to 85 At%. Attached Figure Description

[0024] The specific implementation method refers to the following figures, in which:

[0025] Figure 1 This is an exploded perspective view of an orthopedic knee prosthesis, showing the femoral component, tibial support, and tibial support from top to bottom;

[0026] Figure 2 yes Figure 1 The femoral component and tibial support are generally along the upper edge Figure 1 The cross-sectional view of the longitudinal bisecting plane intercepted by line 2-2, as observed in the direction of the arrow. Note that, for clarity, in... Figure 2 The porous metal coating is not shown in the cross-section of the image.

[0027] Figure 3 From Figure 2 An enlarged cross-sectional view, as indicated by the surrounding area. Detailed Implementation

[0028] While the concepts of this disclosure are readily available in various modifications and alternatives, specific exemplary embodiments thereof have been shown by way of example in the accompanying drawings and will be described in detail herein. However, it should be understood that the concepts of this disclosure are not intended to be limited to the specific forms disclosed, but rather are intended to cover all modifications, equivalents, and alternatives within the spirit and scope of the invention as defined by the appended claims.

[0029] Throughout this specification, when referring to the orthopedic implants or prostheses described herein, and when referring to the natural anatomy of a patient, terms indicating anatomical reference, such as anterior, posterior, medial, lateral, superior, inferior, etc., may be used. These terms have well-known meanings in the fields of anatomical studies and orthopedic surgery. Unless otherwise stated, these anatomical reference terms used in the written details and claims are intended to be consistent with their well-known meanings.

[0030] Now for reference Figure 1 In one embodiment, the orthopedic knee prosthesis 10 includes a femoral component 12, a tibial support 14, and a tibial support 16. The femoral component 12 is configured to hinge to the tibial support 14, which is configured to connect to the tibial support 16. Figure 1 In an exemplary embodiment, the tibial support 14 is embodied as a rotatable or movable tibial support and is configured to rotate relative to the tibial support 16 during use. However, in other embodiments, the tibial support 14 may be embodied as a fixed tibial support, which may be restricted or limited to rotation relative to the tibial support 16.

[0031] The tibial support 16 is configured to be fixed to the proximal end of a surgically prepared portion of the patient's tibia (not shown). The tibial support 16 can be fixed to the patient's tibia using bone adhesive or other attachment methods. The tibial support 16 includes a platform 18 having a top surface 20 and a bottom surface 22. Inventively, the top surface 20 is generally planar. The tibial support 16 also includes a rod 24 extending downward from the bottom surface 22 of the platform 18. A cavity or orifice 26 is defined in the top surface 20 of the platform 18 and extends downward into the rod 24. The orifice 26 is formed to receive a complementary rod 36 of the tibial support 14, as discussed in more detail below.

[0032] As described above, the tibial support 14 is configured to be coupled to the tibial support 16. The tibial support 14 includes a platform 30 having an upper support surface 32 and a lower support surface 34. In an exemplary embodiment where the tibial support 14 is embodied as a rotatable or movable tibial support, the support 14 includes a rod 36 extending downward from the lower surface 34 of the platform 30. When the tibial support 14 is coupled to the tibial support 16, the rod 36 is received in an aperture 26 of the tibial support 16. In use, the tibial support 14 is configured to rotate relative to the tibial support 16 about an axis defined by the rod 36. In an embodiment where the tibial support 14 is embodied as a fixed tibial support, the support 14 may or may not include the rod 36 and / or may include other means or features to secure the tibial support 14 to the tibial support 16 in a non-rotational configuration.

[0033] The upper support surface 32 of the tibial support member 14 includes an inner support surface 42 and an outer support surface 44. The inner support surface 42 and the outer support surface 44 are configured to receive or otherwise contact the corresponding medial condyle 52 and lateral condyle 54 of the femoral member 12, as discussed in more detail below. Thus, each of the support surfaces 42, 44 has a concave profile.

[0034] The femoral component 12 is configured to attach to a surgical preparation surface (not shown) at the distal end of the patient's femur. The femoral component 12 can be secured to the patient's femur using bone adhesive or other attachment methods. The femoral component 12 includes a pair of medial condyles 52 and lateral condyles 54. The condyles 52, 54 are spaced apart to define a condylar notch 56 between the two condyles. In use, the condyles 52, 54 replace the natural condyles of the patient's femur and are configured to allow joint movement on corresponding support surfaces 42, 44 of the platform 30 of the tibial support 14.

[0035] Figure 1 The exemplary orthotic knee prosthesis 10 (sometimes referred to as the "implant") is embodied as a posterior cruciate knee prosthesis. That is, the femoral component 12 is embodied as a posterior cruciate knee prosthesis, and the tibial support 14 is embodied as a posterior cruciate tibial support 14. However, in other embodiments, the orthotic knee prosthesis 10 may be embodied as a posterior cruciate sacrificial knee prosthesis.

[0036] Now for reference Figure 1 and Figure 2 The femoral component 12 is configured to perform joint movement on the tibial support 14 during use. Each condyle 52, 54 of the femoral component 12 includes an external articular surface 50 that is convexly curved in the longitudinal bisecting plane and configured to face the tibial support 14.

[0037] like Figure 2As shown, the femoral component 12 includes a base 60 and an articular layer 58. Inventively, the articular layer 58 is disposed on the base 60 and configured to interact with the tibial support 14. In some embodiments, the femoral component 12 includes a bone-joint layer 62 positioned opposite the articular layer 58 to position the base 60 between the bone-joint layer and the articular layer. The bone-joint layer 62 is configured to interact with the surgically prepared femur of the patient.

[0038] The base 60 includes a condylar surface 66 and a bone-facing surface 64, such as Figure 2 As shown. The condylar surface 66 is curved in the bisecting plane and configured to position the articular layer 58 on the base 60. The bone-facing surface 64 is positioned opposite the condylar surface 66 and arranged to face the distal end of the surgically prepared femur of the patient.

[0039] Figure 1 and Figure 2 An adhesive-free embodiment of the femoral component 12 is shown, wherein the bone-bonding layer 62 is configured for implantation without the presence of adhesive between the femoral component 12 and the surgically prepared distal end of the patient's femur. In some embodiments, the bone-bonding layer 62 comprises titanium. It should be understood that the bone-bonding layer 62 may be a separately applied coating, such as those commercially available from DePuy Synthes (Warsaw, Indiana). Porous coating.

[0040] In some embodiments, the bone bonding layer 62 may be defined by a porous three-dimensional structure formed by a plurality of interconnecting struts. In one example, the plurality of interconnecting struts form a plurality of geometries, which in an exemplary embodiment are rhombic triangular facets. It should be understood that such geometries can be varied to suit the needs of a given design. Furthermore, it should be understood that the bone bonding layer 62 may be formed by any other alternative geometries suitable for adapting to the needs of a given design.

[0041] In some embodiments, the bone bonding layer 62 is formed of metal powder. Exemplarily, the metal powder may include, but is not limited to, titanium, titanium alloys, stainless steel, cobalt-chromium alloys, tantalum, niobium, or combinations thereof. The bone bonding layer 62 has a porosity suitable for promoting inward bone growth into the bone bonding layer 62 of the femoral component 12 when implanted into a surgically prepared surface at the distal end of the femur in a patient.

[0042] In the exemplary embodiments described herein, the bone bonding layer 62 is additively manufactured directly onto the bone-facing surface 64 of the femoral component 12. In such embodiments, both structures (i.e., the femoral component 12 and the bone bonding layer 62) can be manufactured simultaneously during common additive manufacturing methods. For example, the two structures can be manufactured simultaneously in a single 3D printing operation that produces a common monolithic metal assembly comprising both structures. Alternatively, the bone bonding layer 62 can be manufactured as a separate component attached to the bone-facing surface 64 of the femoral component 12.

[0043] In an alternative embodiment, the femoral component 12 is configured to be attached to the surgically prepared distal end of the patient's femur using an adhesive. In some embodiments, the femoral component 12 includes an adhesive reservoir (not shown) disposed on a bone-facing surface 64. In some embodiments, bone adhesive is disposed on the bone-facing surface 64. In some embodiments, the bone adhesive comprises a bone cement. In some embodiments, the bone-facing surface 64 is configured to receive the bone adhesive.

[0044] In some embodiments, the substrate 60 is metallic. In some embodiments, the substrate 60 comprises a metallic alloy. In some embodiments, the substrate 60 comprises a titanium alloy. In some embodiments, the substrate 60 comprises titanium and vanadium. In some embodiments, the substrate 60 comprises titanium, aluminum, and vanadium. In some embodiments, the substrate 60 comprises Ti-6Al-4V. In some embodiments, the substrate 60 is substantially composed of Ti-6Al-4V. In some embodiments, the substrate 60 has a surface area of ​​approximately 8.2 × 10⁻⁶. -6 / °K to approximately 9×10 -6 The coefficient of thermal expansion (CTE) is approximately 8.2 × 10⁻⁶ °K. In some embodiments, substrate 60 comprises Ti-6Al-4V and has a coefficient of thermal expansion of approximately 8.2 × 10⁻⁶ °K. -6 / °K to approximately 9×10 -6 Coefficient of thermal expansion (CTE) per °K.

[0045] Now for reference Figure 2 and Figure 3 The articular layer 58 is disposed on the condylar surface 66. The articular layer 58 is positioned relative to the bone-facing surface 64 to position the base 60 between the articular layer and the bone-facing surface. The articular layer 58 is configured to interact with the support surfaces 42, 44 and to articulate with the tibial support 14.

[0046] The joint layer 58 may have multiple layers as described herein. Each layer of the joint layer 58 may have a material composition that is advantageous for use in the construction of the joint layer 58 (e.g., enhanced wear resistance and / or corrosion resistance).

[0047] In some embodiments, the articular layer 58 cooperates with the base 60 to minimize scratching of the outer articular surface 50. In some embodiments, the articular layer 58 cooperates with the base 60 to minimize cohesive fragmentation of the femoral component 12. In some embodiments, the articular layer 58 cooperates with the base 60 to provide sufficient toughness to minimize or avoid fracture.

[0048] Now for reference Figure 3 The joint layer 58 includes an inner layer 68, an intermediate layer 70, and an outer layer 72. The outer layer 72 of the joint layer 58 is constructed of a material having mechanical properties (e.g., enhanced wear resistance and / or corrosion resistance) that are advantageous for use in the construction of the joint layer 58. On the other hand, the inner layer 68 is constructed of a material having mechanical properties that are advantageous for use in securing the joint layer 58 to the substrate 60. In some embodiments, the joint layer 58 may consist of only the inner and outer layers.

[0049] It should be understood that, as used herein, the term "layer" is not intended to be limited to a certain "thickness" of material positioned near another material of similar size, but rather to encompass a variety of structures, configurations, and constructions of material. For example, the term "layer" can include portions, regions, or other structures of material positioned near another portion, region, or structure of a different material. For example, although in Figure 3 The diagram shows a uniform interface between the intermediate layer 70 and the outer layer 72; however, in some embodiments, the interface is irregular, resulting in the intermediate layer 70 and the outer layer 72 not having a uniform thickness. In some embodiments, the "layer" is formed by modifying a surface or a portion of an existing layer. For example, in some embodiments, the outer layer 72 is formed by oxidizing the outer portion of the intermediate layer 70. In alternative embodiments, the "layer" is formed by providing additional material to an existing surface. For example, in some embodiments, the inner layer 68 is formed by depositing material onto the condyle surface 66.

[0050] Figure 3 The articular layer 58 in the illustrated exemplary embodiment includes an inner layer 68, an intermediate layer 70, and an outer layer 72. The inner layer 68 is disposed on the condylar surface 66. The outer layer 72 is arranged to form the outer articular surface 50 of the femoral component 12. The intermediate layer 70 extends between the inner layer 68 and the outer layer 72 and interconnects the inner and outer layers.

[0051] The inner layer 68 extends between the intermediate layer 70 and the condylar surface 66 and interconnects the intermediate layer and the condylar surface. The inner layer 68 includes an inner surface 74 and an outer surface 76. The inner surface 74 is located between the outer surface 76 and the condylar surface 66. The outer surface 76 of the inner layer 68 is located between the inner surface 74 of the inner layer 68 and the intermediate layer 70. In some embodiments, the inner layer 68 is configured to minimize the delamination between the articular layer 58 and the femoral component 12.

[0052] The inner layer 68 may have a specific thickness as measured from the condyle surface 66. In some embodiments, the inner layer 68 may be present in thicknesses ranging from nanometers to micrometers. In some embodiments, the inner layer 68 is about 0.5 nm to about 10 nm or about 0.5 nm to about 3 nm. In some embodiments, the inner layer 68 has a thickness of about 0.10 μm to about 2 μm. In some embodiments, the inner layer 68 has a thickness of about 200 nm to about 1 μm. In some embodiments, the inner layer 68 has a thickness of at least about 0.10 μm, at least about 0.20 μm, at least about 0.30 μm, at least about 0.5 μm, at least about 1 μm, at least about 1.5 μm, or at least about 2 μm.

[0053] The inner layer 68 may comprise a metal, alloy, ceramic, or other suitable material to provide mechanical properties favorable for use in securing the articulated layer 58 to the substrate 60. For example, the composition of the inner layer 68 may be selected to minimize cohesive breakage of the articulated layer 58 following the oxidation step of the intermediate layer 70. In exemplary embodiments, the inner layer 68 comprises niobium, zirconium, titanium, tantalum, molybdenum, platinum, hafnium, combinations thereof, or any other suitable metal. Exemplarily, the ceramic may comprise a metal and nitrides, carbides, oxides, or combinations thereof. In some embodiments, the inner layer 68 comprises niobium. In some embodiments, the inner layer 68 comprises at least about 90% niobium. In some embodiments, the inner layer 68 comprises at least about 95% niobium. In some embodiments, the inner layer 68 comprises at least about 90% zirconium, titanium, tantalum, molybdenum, platinum, or combinations thereof. In some embodiments, the inner layer 68 comprises at least about 95% zirconium, titanium, tantalum, molybdenum, platinum, or combinations thereof.

[0054] In some embodiments, the inner layer 68 has a specific coefficient of thermal expansion (CTE). In some embodiments, the CTE of the inner layer 68 is between that of the substrate 60 and the intermediate layer 70. In some embodiments, the CTE of the inner layer 68 is approximately 6 × 10⁻⁶. -6 / °K to approximately 8×10 -6 / °K or approximately 7.1×10 -6 / °K to approximately 7.5×10 -6 / °K. In some embodiments, the inner layer 68 has approximately 7.1 × 10⁻⁶ K. -6 / °K, approximately 7.2×10 -6 / °K, approximately 7.3×10 -6 / °K, approximately 7.4×10 -6 / °K or approximately 7.5×10 -6 / °K of CTE.

[0055] In an exemplary embodiment, an intermediate layer 70 extends between an inner layer 68 and an outer layer 72 and interconnects the inner and outer layers. The intermediate layer 70 includes an inner surface 78 and an outer surface 80. The inner surface 78 of the intermediate layer 70 lies between the inner layer 68 and the outer surface 80 of the intermediate layer 70. The outer surface 80 of the intermediate layer 70 lies between the inner surface 78 and the outer layer 72. In other embodiments, the outer articular surface 50 does not have an outer layer 72, and the outer surface 80 of the intermediate layer 70 forms the outer articular surface 50.

[0056] In some embodiments, the intermediate layer 70 has a thickness of about 1 μm to about 8 μm. In some embodiments, the intermediate layer 70 has a thickness of at least about 1 μm, at least about 2 μm, at least about 3 μm, at least about 5 μm, at least about 6 μm, at least about 7 μm, or at least about 8 μm.

[0057] Intermediate layer 70 may comprise a metal, alloy, ceramic, or other suitable material to enhance wear resistance and oxidation resistance. For example, intermediate layer 70 may comprise niobium, zirconium, titanium, tantalum, molybdenum, combinations thereof, or any other suitable metal. In some embodiments, intermediate layer 70 comprises a ceramic comprising niobium, zirconium, titanium, tantalum, molybdenum, combinations thereof, or any other suitable metal. Exemplarily, the ceramic may comprise a metal and nitrides, carbides, oxides, or combinations thereof. For example, intermediate layer 70 may comprise a ceramic such as niobium nitride, zirconium nitride, or combinations thereof.

[0058] In some embodiments, the interlayer 70 comprises a zirconium alloy. In some embodiments, the interlayer 70 comprises an alloy of zirconium and niobium. In some embodiments, the interlayer 70 comprises at least about 97.5% zirconium. In some embodiments, the interlayer 70 comprises at least about 2.5% niobium. In some embodiments, the interlayer 70 comprises at least about 95% an alloy of zirconium and niobium. In some embodiments, the interlayer 70 comprises Zr-2.5Nb. In some embodiments, the interlayer 70 is substantially composed of Zr-2.5Nb. In some embodiments, the CTE of the interlayer 70 in each direction can be about 5 × 10⁻⁶. -6 / °K to approximately 5.9×10 -6 Within the range of / °K. In some embodiments, the intermediate layer 70 comprises an alloy of zirconium and niobium, and may have approximately 5 × 10 in each direction. -6 / °K to approximately 5.9×10 -6 / °K of CTE.

[0059] In some exemplary embodiments, the outer layer 72 is configured to form the external articular surface 50 of the femoral component 12. The outer layer 72 includes an inner surface 82 and an outer surface 84. The inner surface 82 of the outer layer 72 is located between the intermediate layer 70 and the outer surface 84 of the outer layer 72. The outer surface 84 of the outer layer 72 forms the external surface 84 of the femoral component 12. Exemplarily, the outer surface 84 of the outer layer 72 forms the external articular surface 50 of the femoral component 12 and is configured to interact and rotate about the tibial support 14, such as... Figure 2 As shown.

[0060] In some examples, the outer layer 72 can be formed by deposition or by thermal growth via a portion of the oxidized intermediate layer 70. In some embodiments, the outer layer 72 has a thickness of at least about 0.2 μm, at least about 0.5 μm, at least about 1 μm, at least about 2 μm, at least about 3 μm, at least about 4 μm, at least about 5 μm, or at least about 6 μm.

[0061] In exemplary embodiments, the outer layer 72 is formed by oxidizing at least a portion of the intermediate layer 70. For example, the outer surface 80 of the intermediate layer 70 may be oxidized to thermally grow the outer layer 72. Exemplarily, thermal growth can occur by inserting oxygen into the lattice of a portion (e.g., the outer portion) of the intermediate layer 70 to form an oxide. In some embodiments, the outer layer 72 comprises ceramic. In exemplary embodiments, the ceramic of the outer layer 72 is an oxide of the composition of the intermediate layer 70. In some embodiments, the outer layer 72 comprises an oxide of a niobium and zirconium alloy. In some embodiments, the outer layer 72 comprises zirconium oxide. In some embodiments, the outer layer 72 comprises titanium zirconium nitride. In some embodiments, the outer layer 72 comprises niobium oxide. In some embodiments, the outer layer 72 comprises both zirconium oxide and niobium oxide. In some embodiments, the outer layer 72 comprises monoclinic zirconium oxide. In some embodiments, the outer layer 72 comprises at least about 90% zirconium oxide. In some embodiments, the atomic percentage of zirconium in the outer layer may be from 50 At% to 80 At%. In some embodiments, the atomic percentage of zirconium in the outer layer is 30 At% to 85 At%. In some embodiments, the outer layer 72 comprises at least about 90% monoclinic zirconium oxide. In some embodiments, the outer layer 72 may comprise zirconium oxynitride and niobium oxynitride.

[0062] In some embodiments, the inner layer 68 comprises niobium, the middle layer 70 comprises an alloy of zirconium and niobium, and the outer layer 72 comprises zirconium oxide.

[0063] The femoral component 12 of the orthopedic knee prosthesis 10 can be formed through a process. In some embodiments, the process includes a first deposition step of depositing an inner layer 68, a second deposition step of depositing an intermediate layer 70, and an oxidation step. In some embodiments, the process includes a first deposition step of depositing an inner layer comprising a metal (such as, for example, titanium), and a second deposition step of depositing an outer layer comprising a ceramic (such as, for example, titanium zirconium nitride). In some embodiments, the process does not include an oxidation step after the second deposition step. In exemplary embodiments, the process includes a step of preparing a substrate 60 for the deposition step. In some embodiments, the process includes a finishing step, such as polishing, after the oxidation step. In some exemplary embodiments, the process includes preparing a substrate 60 for depositing the aforementioned layers.

[0064] In some embodiments, the first deposition step deposits an inner layer 68 and forms the inner layer 68 on the condylar surface 66 of the substrate 60. In some embodiments, the first deposition step is performed by physical vapor deposition (PVD), which can be performed using a magnetron sputtering system. In other embodiments, the PVD can be performed using HiPIMS, ion beam assisted deposition (IBAD), or ion beam emission deposition (IBED), or other deposition systems. In other embodiments, when depositing, for example, zirconium, niobium, tantalum, or ceramics thereof, the first deposition step can be performed by chemical vapor deposition (CVD).

[0065] In some embodiments, the second deposition step forms an intermediate layer 70 on the outer surface 76 of the inner layer 68. In some embodiments, the second deposition step is performed by physical vapor deposition (PVD). In some embodiments, the deposition step is performed by a magnetron sputtering system. In other embodiments, the second deposition step can be performed by chemical vapor deposition (CVD).

[0066] In some embodiments, the oxidation step oxidizes at least a portion of the interlayer 70. In some embodiments, the oxidation step is performed as described in U.S. Patent 6,447,550 and U.S. Patent 5,324,009, the entirety of each of these U.S. Patents being expressly incorporated herein by reference. In some embodiments, the oxidation step oxidizes at least a portion of the outer surface 80 of the interlayer 70. In some embodiments, the oxidation step oxidizes at least a portion of the zirconium alloy of the interlayer 70 to zirconium oxide. In some embodiments, the oxidation step oxidizes at least a portion of the zirconium-niobium alloy of the interlayer 70 to zirconium oxide. In some embodiments, the oxidation step oxidizes the zirconium-niobium alloy of the interlayer 70 to monoclinic zirconium oxide.

[0067] In some embodiments, the oxidation step is performed by heating an environment containing oxygen. In some embodiments, the environment is at a temperature of at least 500°C or about 540°C. In some embodiments, the environment is at a temperature of about 500°C to about 600°C. In exemplary embodiments, the environment contains about 2.5% oxygen in argon. In some embodiments, the oxidation step is performed for about 5 hours. In some embodiments, the environment may include a partial vacuum and a temperature up to about 1,000°C.

[0068] In an alternative embodiment, the process includes a step of depositing an outer layer 72 (not shown) instead of an oxidation step. The step of depositing the outer layer 72 can be performed by physical vapor deposition (PVD), which can be performed using a magnetron sputtering system. In other embodiments, PVD can be performed using HiPIMS, IBAD, or other deposition systems. In some embodiments, the step of depositing the outer layer 72 deposits a ceramic layer (e.g., a layer of zirconium oxide). In some embodiments, the step of depositing the outer layer 72 deposits a ceramic layer (e.g., a layer of titanium zirconium nitride) onto an inner layer of titanium.

[0069] Although the present disclosure has been illustrated and described in detail in the accompanying drawings and the foregoing description, such illustrations and descriptions should be regarded as exemplary rather than limiting in nature. It should be understood that only exemplary embodiments have been shown and described, and all changes and modifications made within the substance of the present disclosure should be protected.

[0070] The methods, apparatus, and systems described herein possess numerous advantages due to their various features. It should be noted that alternative embodiments of the methods, apparatus, and systems of this disclosure may exclude all described features, but may still benefit from at least some of the advantages of such features. Those skilled in the art will readily conceive of their own implementations of the methods, apparatus, and systems described above, which may incorporate one or more features of the invention and fall within the spirit and scope of this disclosure as defined by the appended claims.

Claims

1. An orthopedic knee implant, characterized in that, The orthopedic knee implant includes: A femoral component configured to connect to the distal end of a patient's femur, the femoral component comprising: (i) a substrate comprising a metal alloy, the substrate having (a) a condylar surface curved in a longitudinal bisecting plane and (b) a bone-facing surface positioned relative to the condylar surface; and (ii) a joint layer disposed on the surface of the condyle, the joint layer comprising (a) a first layer comprising a metal, (b) a second layer comprising an alloy or ceramic, and (c) a third layer comprising ceramic. Wherein (i) the first layer extends between the second layer and the condylar surface and interconnects the second layer with the condylar surface, (ii) the second layer extends between the first layer and the third layer and interconnects the first layer with the third layer, and (iii) the third layer forms the external articular surface of the femoral component.

2. The implant according to claim 1, wherein, The first layer has a surface area of ​​approximately 7.1 × 10⁻⁶ in at least one direction. -6 / °K to approximately 7.5×10 -6 Coefficient of thermal expansion / °K.

3. The implant according to claim 1, wherein, The third layer has a thickness of approximately 100 nm to approximately 5 μm.

4. The implant according to claim 1, wherein, The second layer has a thickness of approximately 3 μm to approximately 8 μm.

5. The implant according to claim 1, wherein, The first layer has a thickness of about 0.5 μm to about 2 μm.

6. The implant according to claim 1, wherein, The femoral component includes a bone-bonding layer disposed on the bone-facing surface.

7. The implant according to claim 6, wherein, The bone junction layer is porous.

8. An orthopedic knee implant, characterized in that, The orthopedic knee implant includes: A femoral component configured to connect to the distal end of a patient's femur, the femoral component comprising: (i) a substrate comprising a metal alloy, the substrate having (a) a condylar surface curved in a longitudinal bisecting plane and (b) a bone-facing surface positioned relative to the condylar surface; and (ii) a joint layer disposed on the surface of the condyle, the joint layer comprising (a) an inner layer comprising metal, and (b) an outer layer comprising ceramic. Wherein (i) the inner layer extends from the condyle surface, and (ii) the outer layer forms the external articular surface of the femoral component.

9. The orthopedic knee implant according to claim 8, wherein, The joint layer further includes an intermediate layer comprising an alloy or ceramic, the intermediate layer being positioned between the inner layer and the outer layer.

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