Composite orthopedic prosthesis and method of manufacturing the same

Abstract

An orthopaedic prosthesis includes a femoral component (12) comprising a polymeric material. The polymeric material can include a poly(arylene ether) or a poly(oxymethylene). The orthopaedic prosthesis can include a component having an articular layer (58) and a support layer (60) adjacent the articular layer. The support layer can comprise a reinforcing fiber. The orthopaedic prosthesis can be a knee prosthesis.

Description

[0001] This patent application claims priority to U.S. Provisional Patent Application 62 / 934,278, filed November 12, 2019, and U.S. Provisional Patent Application 63 / 070,963, filed August 27, 2020, the entire disclosures of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates generally to plastic surgery prostheses, and more specifically to composite plastic surgery prostheses. Background Technology

[0003] 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 support component 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.

[0004] The femoral and tibial components are typically made of biocompatible materials, such as metal alloys of cobalt-chromium or titanium. The supporting components housed between them are usually formed of plastic materials, such as polyethylene. Summary of the Invention

[0005] An orthopedic implant includes a femoral component configured to engage the distal end of a patient's femur. The femoral component includes a femoral condyle having (i) an articular layer including a hinge surface curved in a bisecting plane and configured to engage a tibial component, and (ii) a support layer including an osteophyte surface positioned relative to the hinge surface and configured to engage the distal end of the patient's femur. In some embodiments, the implant includes a tibial component configured to engage the proximal end of a patient's tibia, the tibial component including a concave surface shaped to engage the hinge surface of the femoral component.

[0006] In some embodiments, the articular layer of the femoral component is constructed of a material comprising a homopolymer or copolymer, or a composite material comprising a blend of polymers.

[0007] In some embodiments, the support layer is constructed of a composite material comprising (i) homopolymers, copolymers, or mixtures thereof and (ii) reinforcing fibers.

[0008] Additional embodiments, features, and advantages of this disclosure will become apparent from the following detailed description and by practicing this disclosure. The compositions and materials of this disclosure can be described as embodiments of any of the following listed items. It should be understood that any of the embodiments described herein can be used in combination with any other embodiments described herein, to a degree that the embodiments do not contradict each other.

[0009] 1. A surgical knee prosthesis system, comprising:

[0010] A tibial component, configured for implantation on the proximal end of a patient's tibia, the tibial component including a concave bearing surface, and

[0011] A femoral component, configured to be implanted on the distal end of a patient's femur, the femoral component including a femoral condyle having: (i) an articular layer including a hinged surface that is curved in a longitudinal plane and configured to hinge with the concave bearing surface of the tibial component; and (ii) a support layer including an osteophyte surface positioned opposite the hinged surface and configured to engage the distal end of the patient's femur.

[0012] The articular layer of the femoral component comprises a polyetheretherketone (PEEK) homopolymer, and

[0013] The support layer comprises (i) reinforcing fibers and (ii) homopolymers, copolymers, or mixtures thereof.

[0014] 2. The orthopedic prosthesis system according to Clause 1, wherein the joint layer further comprises polysulfone, polyimide, or a mixture thereof.

[0015] 3. The orthopedic prosthesis system according to Clause 1 or 2, wherein the PEEK is approximately 75% to approximately 95% by weight of the joint layer.

[0016] 4. The orthopedic prosthesis system according to any one of clauses 1 to 3, wherein the support layer comprises a polyarylether homopolymer.

[0017] 5. The orthopedic prosthesis system according to any one of clauses 1 to 3, wherein the support layer comprises a polyacetal copolymer.

[0018] 6. The orthopedic prosthesis system according to Clause 5, wherein the polyacetal copolymer is a polyoxymethylene copolymer.

[0019] 7. The orthopedic prosthesis system according to any one of clauses 1 to 3, 5 or 6, wherein the support layer comprises at least about 80% polyoxymethylene.

[0020] 8. The orthopedic prosthesis system according to any one of Clauses 1 to 7, wherein the reinforcing fiber is glass fiber or carbon fiber.

[0021] 9. A knee joint prosthesis for orthopedic surgery, comprising:

[0022] A femoral component, comprising a femoral condyle having: (i) an articular layer including a hinge surface that is curved in a longitudinal bisecting plane and configured to engage a tibial component; and (ii) a support layer including an osteophyte surface positioned opposite the hinge surface and configured to engage the distal end of a patient's femur.

[0023] The joint layer is constructed of a composite material comprising a blend of polyetheretherketone (PEEK) homopolymer and polysulfone, polyimide, or mixtures thereof.

[0024] The joint layer has a yield strength of at least about 100 MPa.

[0025] 10. The orthopedic knee prosthesis as described in Clause 9, wherein the joint layer is substantially free of fibers.

[0026] 11. The orthopedic knee prosthesis according to Clause 9 or 10, wherein the joint layer has a tensile modulus of at least about 4,000 MPa.

[0027] 12. The orthopedic knee prosthesis according to any one of clauses 9 to 11, wherein the articular layer has a strength of at least 5 J / m². 2 IZOD toughness.

[0028] 13. The orthopedic knee prosthesis according to any one of clauses 9 to 12, wherein the PEEK is about 75% to about 95% by weight of the joint layer.

[0029] 14. A knee joint prosthesis for orthopedic surgery, comprising:

[0030] A femoral component, comprising a femoral condyle having: (i) an articular layer including a hinge surface that is curved in a longitudinal bisecting plane and configured to engage a tibial component; and (ii) a support layer including an osteophyte surface positioned opposite the hinge surface and configured to engage the distal end of a patient's femur.

[0031] The support layer comprises (i) a homopolymer, copolymer, or mixture thereof and (ii) reinforcing fibers.

[0032] The support layer has a tensile modulus of about 3,000 MPa to about 30,000 MPa.

[0033] 15. The orthopedic knee prosthesis as described in Clause 14, wherein the support layer comprises a polyoxymethylene copolymer.

[0034] 16. The orthopedic knee prosthesis as described in Clause 14, wherein the support layer comprises polyarylether.

[0035] 17. A knee joint prosthesis for orthopedic surgery, comprising:

[0036] A femoral component, comprising a femoral condyle having: (i) an articular layer including a hinge surface that is curved in a longitudinal bisecting plane and configured to engage a tibial component; and (ii) a support layer including an osteophyte surface positioned opposite the hinge surface and configured to engage the distal end of a patient's femur.

[0037] The articular layer of the femoral component comprises a homopolymer, and

[0038] The support layer comprises copolymers and reinforcing fibers.

[0039] 18. The orthopedic knee prosthesis as described in Clause 17, wherein the homopolymer of the joint layer is a polyarylether or a polyacetal.

[0040] 19. The orthopedic knee prosthesis as described in Clause 17 or 18, wherein the joint layer comprises a polyacetal copolymer.

[0041] 20. The orthopedic knee prosthesis as described in Clause 19, wherein the polyacetal copolymer is a polyoxymethylene copolymer.

[0042] 21. The orthopedic knee prosthesis as described in Clause 20, wherein the joint layer comprises at least about 80% polyoxymethylene copolymer.

[0043] 22. The orthopedic knee prosthesis as described in Clause 18, wherein the polyarylether is polyetheretherketone (PEEK).

[0044] 23. The orthopedic knee prosthesis as described in Clause 22, wherein the PEEK is approximately 75% to approximately 95% by weight of the joint layer.

[0045] 24. A method of manufacturing an implantable component for use in orthopedic prostheses, comprising:

[0046] A first polymer material layer is molded onto a second polymer material layer to form a composite material, and

[0047] The composite material is formed into a predetermined shape of the implantable component, wherein the implantable component has a joint layer and a support layer.

[0048] The joint layer comprises a homopolymer, and the support layer comprises a polymer and reinforcing fibers.

[0049] 25. The method according to Clause 24, wherein the implantable component is formed as an acetabular support suitable for implantation in the acetabulum of the patient.

[0050] 26. The method according to Clause 24, wherein the implantable component is a glenoid support adapted for implantation in the glenoid cavity of a patient.

[0051] 27. The method according to Clause 24, wherein the implantable component is a tibial support suitable for implantation in the tibia of a patient.

[0052] 28. The method according to any one of clauses 24 to 27, wherein the joint layer comprises a polyether ether ketone (PEEK) homopolymer.

[0053] 29. The method according to Clause 28, wherein the joint layer further comprises polysulfone, polyimide, or a mixture thereof.

[0054] 30. The method according to Clause 28 or 29, wherein the PEEK is about 75% to about 95% by weight of the joint layer.

[0055] 31. A method for manufacturing a femoral component of a knee joint prosthesis, comprising:

[0056] A first polymer material layer is molded onto a second polymer material layer to form a composite material, and

[0057] The composite material is formed into a predetermined shape of the femoral component, wherein the femoral component has a joint layer and a support layer.

[0058] The joint layer comprises a homopolymer, and the support layer comprises a polymer and reinforcing fibers.

[0059] 32. A method for forming a femoral component of a knee joint prosthesis, the method comprising:

[0060] The joint layer and the support layer are molded together to form a composite material, and

[0061] The composite material is formed into a predetermined shape of the femoral component, wherein the joint layer is constructed of a first polymer material comprising a blend of homopolymers, and the support layer comprises a second polymer material different from the first polymer material and includes reinforcing fibers.

[0062] 33. The method according to clause 32, wherein the first polymeric material comprises polysulfone, polyimide, or a mixture thereof.

[0063] 34. The method according to clause 32 or 33, wherein the homopolymer of the joint layer is a polyarylether or a polyacetal.

[0064] 35. The method according to Clause 34, wherein the polyaromatic ether is polyether ether ketone (PEEK).

[0065] 36. The method according to any one of clauses 32 to 35, wherein the support layer comprises a copolymer and reinforcing fibers.

[0066] 37. The method according to Clause 36, wherein the copolymer of the support layer is a polyacetal.

[0067] 38. The method according to Clause 37, wherein the polyacetal is polyoxymethylene.

[0068] 39. A method for forming a first component for an orthopedic implant, the method comprising:

[0069] A composite material comprising a first polymer material containing polyaromatic ethers and a second polymer material containing polymers and reinforcing fibers is molded together, and

[0070] The composite material is formed into a predetermined shape of the first component, wherein the first polymer material is configured to engage a second component of the orthopedic implant, and the second polymer material is configured to engage bone.

[0071] 40. The method according to clause 39, wherein the first polymeric material comprises a homopolymer, a copolymer, or a mixture thereof.

[0072] 41. The method according to Clause 40, wherein the homopolymer of the first polymer material is a polyaromatic ether.

[0073] 42. The method according to any one of clauses 39 to 41, wherein the first polymer material further comprises polysulfone, polyimide, or a mixture thereof.

[0074] 43. The method according to any one of clauses 39 to 42, wherein the polyaromatic ether is polyether ether ketone (PEEK).

[0075] 44. The method according to any one of clauses 39 to 43, wherein the polymer of the second polymer material comprises a copolymer.

[0076] 45. The method according to Clause 44, wherein the copolymer of the second polymer material is a polyacetal.

[0077] 46. ​​The method according to Clause 45, wherein the polyacetal is polyoxymethylene.

[0078] 47. The method according to any one of clauses 39 to 46, wherein forming the composite material includes molding the composite material into an acetabular support suitable for implantation in a patient's acetabulum.

[0079] 48. The method according to any one of clauses 39 to 46, wherein forming the composite material comprises molding the composite material into a glenoid support suitable for implantation in a patient's glenoid cavity.

[0080] 49. The method according to any one of clauses 39 to 46, wherein forming the composite material comprises molding the composite material into a tibial support suitable for implantation in the tibia of a patient.

[0081] 50. A knee joint prosthesis for orthopedic surgery, comprising:

[0082] A femoral component, comprising a femoral condyle having a hinged surface that is curved in the bisecting plane and configured to engage a tibial component, and an osteophyte surface positioned opposite the hinged surface and configured to engage the distal end of a patient's femur.

[0083] The femoral component comprises at least about 50% by weight of a homopolymer or a blend of a homopolymer with polysulfone, polyimide, or a mixture thereof, and

[0084] The femoral component described therein has a yield strength of at least about 100 MPa.

[0085] 51. The orthopedic knee prosthesis as described in Clause 50, wherein the homopolymer is a polyarylether or a polyacetal.

[0086] 52. The orthopedic knee prosthesis as described in Clause 51, wherein the polyarylether is polyetheretherketone (PEEK).

[0087] 53. The orthopedic knee prosthesis as described in Clause 52, wherein the PEEK is approximately 75% to approximately 95% by weight of the femoral component.

[0088] 54. The orthopedic knee prosthesis as described in Clause 51, wherein the polyacetal is polyoxymethylene.

[0089] 55. A plastic surgery prosthesis, comprising:

[0090] A first component, comprising a joint layer and a support layer, the joint layer being configured to engage with a second component of the prosthesis, and the support layer being configured to engage with the patient's bone.

[0091] The joint layer is constructed from a blend of polyaryletherketone and a second polymer, and the support layer is constructed from a polymer material.

[0092] 56. The orthopedic prosthesis according to Clause 55, wherein the second polymer of the joint layer is polysulfone or polyimide.

[0093] 57. The orthopedic prosthesis as described in Clause 56, wherein the polysulfone is PPSU.

[0094] 58. The orthopedic prosthesis as described in Clause 56, wherein the polyimide is PEI.

[0095] 59. The orthopedic prosthesis according to any one of clauses 55 to 58, wherein the polyaryletherketone is at least about 80% by weight, preferably at least about 85% by weight.

[0096] 60. The orthopedic prosthesis according to any one of clauses 55 to 59, wherein the second polymer is present in less than about 20%, preferably less than about 15% by weight.

[0097] 61. The orthopedic prosthesis according to any one of clauses 55 to 60, wherein the second polymer is present in about 5% to about 20% by weight.

[0098] 62. The orthopedic prosthesis according to any one of clauses 55 to 61, wherein the support layer comprises reinforcing fibers or reinforcing particles.

[0099] 63. The orthopedic prosthesis according to any one of clauses 55 to 62, wherein the support layer comprises reinforcing fibers, preferably glass fibers or carbon fibers.

[0100] 64. The orthopedic prosthesis according to any one of clauses 55 to 62, wherein the support layer comprises reinforcing particles, preferably barium sulfate.

[0101] 65. The orthopedic prosthesis according to any one of clauses 55 to 62, wherein the support layer does not contain reinforcing fibers or reinforcing particles.

[0102] 66. The orthopedic prosthesis according to any one of clauses 55 to 65, wherein the joint layer does not contain reinforcing fibers or reinforcing particles.

[0103] 67. The orthopedic prosthesis according to any one of clauses 55 to 66, wherein the joint layer has a yield strength of at least about 100 MPa, preferably at least about 102 MPa.

[0104] 68. The orthopedic prosthesis according to any one of clauses 55 to 67, wherein the joint layer has a tensile modulus of at least 3,000 MPa, preferably at least 4,000 MPa.

[0105] 69. The orthopedic prosthesis according to any one of clauses 55 to 68, wherein the joint layer has a compressive yield of at least about 100 MPa, preferably at least about 105 MPa, or more preferably at least about 110 MPa.

[0106] 70. The orthopedic prosthesis according to any one of clauses 55 to 69, wherein the joint layer has a strength of at least 5 J / m². 2 or approximately 5.3 J / m 2 Approximately 8J / m 2 IZOD toughness.

[0107] 71. The orthopedic prosthesis according to any one of clauses 55 to 70, wherein the wear rate of the joint layer is less than about 10, preferably less than about 6, or preferably less than about 4 mg / million cycles (MC).

[0108] 72. The orthopedic prosthesis according to any one of clauses 55 to 71, wherein the first component is an acetabular component adapted for implantation in the acetabulum of a patient.

[0109] 73. The orthopedic prosthesis according to any one of clauses 55 to 71, wherein the first component is a glenoid component adapted for implantation into the glenoid cavity of a patient.

[0110] 74. The orthopedic prosthesis according to any one of clauses 55 to 71, wherein the first component is a tibial component adapted for implantation in the tibia of a patient.

[0111] 75. The orthopedic prosthesis according to any one of clauses 55 to 71, wherein the first component is a femoral component adapted for implantation in the femur of a patient. Attached Figure Description

[0112] The specific implementation method refers to the following figures, in which:

[0113] Figure 1 This is an exploded perspective view of an orthopedic knee joint prosthesis;

[0114] Figure 2 For roughly along Figure 1 Line 2-2 is intercepted as observed in the direction of the arrow. Figure 1Cross-sectional views of the femoral component and tibial support;

[0115] Figure 3 This is a graph showing the tensile strength of the various compositions disclosed herein;

[0116] Figure 4 This is a graph showing the tensile modulus of the various compositions disclosed herein;

[0117] Figure 5 This is a graph showing the compressive strength of the various compositions disclosed herein;

[0118] Figure 6 This is a graph showing the IZOD impact toughness of the various compositions disclosed herein;

[0119] Figure 7 This is a graph showing the average wear rate of the pins and discs after stage 1 (“receiving state”) and stage 2 (“scraping”);

[0120] Figure 8 This is a graph showing the average roughness Sa (μm) of sample blocks containing different polymers at each interval of stage 1 (0.0-1.98 million cycles (MC)) and stage 2 (2.31-4.29 MC);

[0121] Figure 9 It is a graph showing the average cumulative pin wear per interval of pins including POM, PEEK, PEEK / 20% PEI or PEEK / 10% PPSU;

[0122] Figure 10 It is a graph showing the cumulative disk wear for each interval of disks including POM, PEEK, PEEK / 20% PEI, or PEEK / 10% PPSU;

[0123] Figure 11 It is a diagram showing the surface roughness of the mating end faces of various discs including POM, PEEK, PEEK / 20% PEI or PEEK / 10% PPSU;

[0124] Figure 12 This is a graph showing the average cumulative pin wear per interval when the pin interacts with a disc containing POM, PEEK, PEEK / 20% PEI, or PEEK / 10% PPSU;

[0125] Figure 13 It is a graph showing the average cumulative disc wear per interval as each disc interacts with the pin;

[0126] Figure 14 This is a graph showing the wear rates of the combined pins and discs;

[0127] Figure 15 This is a diagram showing the surface roughness of the mating end face of the disk after subsequent cyclic counting using the interferometer;

[0128] Figure 16 It is a graph showing fatigue tests of discs including PEEK, PEEK / 10% PEI, or PEEK / 10% PPSU;

[0129] Figure 17 A perspective view of the glenoid component of a shoulder prosthesis;

[0130] Figure 18 For along Figure 17 A cross-sectional view taken from line 18-18 as viewed in the direction of the arrow;

[0131] Figure 19 A perspective view of the acetabular component of a hip joint prosthesis;

[0132] Figure 20 For along Figure 19 A cross-sectional view taken from line 20-20 as viewed in the direction of the arrow;

[0133] Figure 21 for Figure 1 A perspective view of another embodiment of the tibial component;

[0134] Figure 22 For along Figure 21 The sectional view taken by line 22-22 as viewed in the direction of the arrow;

[0135] Figure 23 It is a perspective view of the head component of a hip or shoulder prosthesis; and

[0136] Figure 24 For along Figure 23 The sectional view taken from line 24-24 as viewed in the direction of the arrow. Attached Figure Description

[0138] While the concepts of this disclosure are readily available in various modifications and alternatives, specific embodiments thereof have been illustrated by way of example in the accompanying drawings and will be described in detail herein. However, it should be understood that this disclosure is not intended to limit the concepts to the specific forms disclosed; rather, the object of the invention is to cover all modifications, equivalents, and alternatives consistent with this disclosure and the appended claims.

[0139] Throughout this specification, when referring to orthopedic implants or prostheses and the surgical instruments described herein, as well as 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.

[0140] 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.

[0141] The tibial support 16 is configured to be fixed to the proximal end of a surgically prepared portion of a 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 of the tibial insert 14, as discussed in more detail below.

[0142] As described above, the tibial support 14 is configured to engage with the tibial support 16. The tibial support 14 includes a platform 30 having an upper bearing surface 32 and a bottom 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 bottom surface 32 of the platform 30. When the tibial support 14 is engaged with 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 embodiments where the tibial support 14 is embodied as a fixed tibial support, the support 14 may or may not include the rod 22 and / or may include other means or features to secure the tibial support 14 to the tibial support 16 in a non-rotational configuration.

[0143] The upper bearing surface 32 of the tibial support member 14 includes a medial bearing surface 42 and a lateral bearing surface 44. The medial bearing surface 42 and the lateral bearing surface 44 are configured to receive or otherwise contact the corresponding medial and lateral condyles of the femoral member 12, as discussed in more detail below. Thus, each of the bearing surfaces 42, 44 has a concave profile.

[0144] 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 an external hinge surface 50 having a pair of medial and lateral condyles 52, 54. The condyles 52, 54 are spaced apart to define an intracondylar opening 56 therebetween. In use, the condyles 52, 54 replace the natural condyles of the patient's femur and are configured to allow articular movement on corresponding bearing surfaces 42, 44 of the platform 30 of the tibial support 14.

[0145] Figure 1 The exemplary orthopedic knee prosthesis 10 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 orthopedic knee prosthesis 10 may be embodied as a posterior cruciate sacrificial knee prosthesis.

[0146] Now for reference 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 a condylar surface that is convexly curved in the bisecting plane and is configured to contact the condylar surface of the respective bearing surface 42, 44.

[0147] Femoral component 12 includes an articular layer 58 and a supporting layer 60, such as Figure 2 As shown. Joint layer 58 is configured to form all or part of hinge surface 50. Support layer 60 is configured to form all or part of bone surface 62. Support layer 60 is configured to attach to a surgical preparation surface (not shown) at the distal end of the patient's femur. Joint layer 58 is fixed to support layer 60.

[0148] Polymers or blends of polymers are preferably used in constructing layers 58 and 60. As used herein, the term "polymer" is intended to refer to any polymeric material that can be implanted into a patient. Specific examples of such polymers are the polyaryletherketone (PAEK) family, the polysulfone family, the polyimide family, and the polyacetal family. The term "polyaryletherketone" as defined herein includes polyetheretherketone (PEEK), polyetherketone, and polyetherketone etherketone ketone, or any other type of polyaryletherketone used to construct prosthetic implants. The term "polymer" is also intended to include both homopolymers and copolymers.

[0149] It should be understood that, as used herein, the term "layer" is not intended to be limited to a certain "thickness" of material located 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 located near another portion, region, or structure of a different material. For instance, a joint surface may define a first "layer" of material, while a support layer contacting the joint layer may define a second "layer" of material.

[0150] In an exemplary embodiment, the joint layer 58 and the support layer 60 are molded together. In an exemplary embodiment, the joint layer 58 and the support layer 60 together are about 3 mm to about 8 mm thick. In an exemplary embodiment, the joint layer 58 and the support layer 60 together are about 5 mm thick. In an exemplary embodiment, the joint layer 58 has a thickness of about 0.1 mm to 2 mm.

[0151] In exemplary embodiments, the joint layer 58, the support layer 60, or both the joint layer 58 and the support layer 60 are constructed of polymeric materials. In some embodiments, the joint layer 58 comprises a homopolymer, a copolymer, or a mixture thereof. In some embodiments, the joint layer 58 comprises more than one homopolymer. In some embodiments, the joint layer 58 is composed of or substantially composed of homopolymers. In some embodiments, the joint layer 58 is composed of homopolymers and copolymers, or substantially composed of homopolymers and copolymers.

[0152] In some embodiments, the joint layer 58 is constructed of a composite material comprising a first polymer and a second polymer. In some embodiments, the first polymer is a homopolymer. In some embodiments, the second polymer is a homopolymer. In some embodiments, the joint layer 58 consists of or is substantially composed of the first homopolymer and the second homopolymer. In an exemplary embodiment, the joint layer 58 is free of barium sulfate.

[0153] In some embodiments, the homopolymer of joint layer 58 is a polyaromatic ether, a polyacetal, or a mixture thereof. An exemplary polyaromatic ether includes polyetheretherketone or more commonly referred to as "PEEK". In some examples, joint layer 58 comprises KETASPIRE KT-880, purchased from SOLVAY SPECIALTY POLYMERS. In some embodiments, the polyacetal is polyoxymethylene or more commonly referred to as "POM". An exemplary polyoxymethylene homopolymer includes KEP H100, purchased from KEP Americas. In some embodiments, the polyacetal or polyaromatic ether is the first homopolymer.

[0154] In some embodiments, the joint layer 58 comprises a homopolymer present in a specific weight percentage. In exemplary embodiments, the joint layer 58 comprises at least about 50 wt%, at least about 60 wt%, at least about 70 wt%, at least about 75 wt%, at least about 80 wt%, at least 85 wt%, at least about 90 wt%, or at least about 95 wt% of a first homopolymer. In some embodiments, the homopolymer is about 100 wt% of the joint layer 58. In exemplary embodiments, the homopolymer is POM. In exemplary embodiments, the homopolymer is PEEK.

[0155] In some embodiments, the homopolymer of joint layer 58 is a polyimide or a polysulfone. In some embodiments, the polyimide may be a polyetherimide, commonly referred to as "PEI". Exemplary PEIs include Ultem HU1000 from Sabic and COLORRX PEI-1600RX from LTL COLORCOMPOUNDERS, LLC. In some embodiments, the polysulfone may be polyphenylsulfone, commonly referred to as "PPSU". Exemplary PPSUs include RADEL R-5800NT from SOLVAY SPECIALTY POLYMERS. In some embodiments, the polyimide or polysulfone is a second homopolymer.

[0156] In some embodiments, the joint layer 58 is constructed of a composite material comprising a homopolymer blend containing at least two or three homopolymers. In some embodiments, the homopolymer blend comprises a polyaromatic ether and a polyimide. In some embodiments, the homopolymer blend consists of or is substantially composed of polyaromatic ethers (such as PEEK and PEI). In some embodiments, the homopolymer blend comprises a polyaromatic ether and a polysulfone. In some embodiments, the homopolymer blend consists of or is substantially composed of polyaromatic ethers (such as PEEK and PPSU).

[0157] In some embodiments, the joint layer 58 is constructed of a composite material comprising a homopolymer blend including a first homopolymer and a second homopolymer. In exemplary embodiments, the joint layer 58 comprises (by weight) about 50% of the first homopolymer and about 50% of the second homopolymer, about 60% of the first homopolymer and about 40% of the second homopolymer, about 70% of the first homopolymer and about 30% of the second homopolymer, about 75% of the first homopolymer and about 25% of the second homopolymer, about 80% of the first homopolymer and about 20% of the second homopolymer, about 85% of the first homopolymer and about 15% of the second homopolymer, about 88% of the first homopolymer and about 12% of the second homopolymer, about 90% of the first homopolymer and about 10% of the second homopolymer, or about 95% of the first homopolymer and about 5% of the second homopolymer. In exemplary embodiments, the first homopolymer may be a polyaromatic ether, and the second homopolymer may be a polysulfone or a polyimide. In an exemplary embodiment, the first homopolymer is PEEK. In an exemplary embodiment, the second homopolymer is PPSU or PEI. In some embodiments, the first homopolymer is PEEK and the second homopolymer is PPSU. In some embodiments, the first homopolymer is PEEK and the second homopolymer is PEI.

[0158] In some embodiments, the homopolymer is a blend of PEI and PEEK. This can be represented as PEI / PEEK. In some embodiments, the PEI / PEEK homopolymer blend contains at least about 5% by weight or at least about 10% by weight of PEI. In some embodiments, the PEI / PEEK homopolymer blend contains up to about 90% by weight or up to about 95% by weight of PEEK. Some embodiments contain about 5% PEI and about 95% PEEK, about 10% PEI and about 90% PEEK, about 12% PEI and about 88% PEEK, about 15% PEI and about 85% PEEK, and about 20% PEI and about 80% PEEK.

[0159] In some embodiments, the homopolymer blend is a combination of PPSU and PEEK. This can be represented as PPSU / PEEK. In some embodiments, the PPSU / PEEK homopolymer blend contains at least about 5% by weight or at least about 10% by weight of PPSU. In some embodiments, the PPSU / PEEK homopolymer blend contains less than about 20% by weight or less than about 15% by weight of PPSU. In some embodiments, the PPSU / PEEK homopolymer blend contains up to about 85% by weight, up to about 90% by weight, or up to about 95% by weight of PEEK. Some embodiments include about 5% PPSU and about 95% PEEK, about 10% PPSU and about 90% PEEK, about 12% PPSU and about 88% PEEK, about 15% PPSU and about 85% PEEK, and about 20% PPSU and about 80% PEEK.

[0160] In some embodiments, the articulated layer 58 has a yield strength measured according to ASTM D638. In exemplary embodiments, the yield strength of the articulated layer 58 is in the range of about 100 MPa to about 220 MPa. In some embodiments, the yield strength of the articulated layer 58 is at least about 100 MPa, at least about 102 MPa, or at least about 103 MPa. In some embodiments, the yield strength of the articulated layer 58 is at least about 100 MPa or at least about 125 MPa. In some embodiments, the yield strength is about 100 MPa to about 150 MPa or about 102 MPa to about 150 MPa. In some embodiments, the yield strength is about 115 MPa to about 220 MPa, about 150 MPa to about 220 MPa, or about 175 MPa to about 220 MPa. In some embodiments, the articulated layer 58 has a yield strength of about 99 MPa to about 104.5 MPa, about 100 MPa to about 103.5 MPa, or about 102 MPa to about 104 MPa. In some embodiments, the articulated layer 58 has a yield strength of about 189 MPa to about 191.5 MPa, about 189.5 MPa to about 191 MPa, or about 189.5 MPa to about 190.5 MPa. In some embodiments, the articulated layer 58 has a yield strength of about 199 MPa to about 201 MPa, about 199.5 MPa to about 200.5 MPa, or about 200 MPa.

[0161] In some embodiments, the articulated layer 58 has a tensile modulus measured according to ASTM D638. In exemplary embodiments, the tensile modulus of the articulated layer 58 is in the range of about 3,000 MPa to about 30,000 MPa or about 3,500 MPa to about 30,000 MPa. In some embodiments, the tensile modulus of the articulated layer 58 is at least about 3,000 MPa, at least about 4,000 MPa, at least about 4,100 MPa, or at least about 4,300 MPa. In some embodiments, the joint layer 58 has a tensile modulus of about 3,000 MPa to about 30,000 MPa, about 3,000 MPa to about 10,000 MPa, about 4,000 MPa to about 10,000 MPa, about 4,100 MPa to about 10,000 MPa, about 4,200 MPa to about 10,000 MPa, or about 4,500 MPa to about 6,000 MPa. In some embodiments, the joint layer 58 has a tensile modulus of about 5,500 MPa to about 24,000 MPa, about 5,500 MPa to about 18,000 MPa, about 5,500 MPa to about 13,000 MPa, or about 5,500 MPa to about 10,800 MPa. In some embodiments, the joint layer 58 has a tensile modulus of about 6,800 MPa to about 10,500 MPa, about 6,900 MPa to about 7,900 MPa, or about 6,900 MPa to about 7,700 MPa.

[0162] In some embodiments, articulated layer 58 has an IZOD impact toughness measured according to ASTM D4812. Examplely, articulated layer 58 has a minimum J / m² impact toughness. 2 The IZOD impact toughness. In an exemplary embodiment, the toughness of the articulated layer 58 is approximately 5 J / m. 2 Approximately 10 J / m 2 Approximately 5.2 J / m 2 Approximately 10 J / m 2 Approximately 5.2 J / m 2 Approximately 8J / m 2 or approximately 5.3 J / m 2 Approximately 8J / m 2 Within the range.

[0163] In some embodiments, the articulated layer 58 has a compressive yield measured according to ASTM D695. Exemplarily, the articulated layer 58 has a compressive yield of at least about 50 MPa, at least about 110 MPa, at least about 115 MPa, or at least about 120 MPa. In some embodiments, the compressive yield is about 50 MPa to about 150 MPa or about 110 MPa to about 150 MPa.

[0164] In some embodiments, the articulated layer 58 exhibits fatigue behavior as measured by using an ASTM D3479 / D3479M tension-tension fatigue test. In some embodiments, each cycle of the fatigue test at a given stress level is performed at 2 Hz and up to 5 million cycles. In some embodiments, an articulated layer 58 constructed from a blend of homopolymers or a blend of PEEK with another polymer is preferred over an articulated layer 58 constructed from a single homopolymer. In some embodiments, the fatigue strength is at least about 60 MPa or at least about 70 MPa.

[0165] The wear rate of the articulated layer 58 can be measured by contacting it with a material. In an exemplary embodiment, the wear rate of the articulated layer 58 is measured by contacting it with polyethylene (such as cross-linked ultra-high molecular weight polyethylene, which is available as XLK ultra-high molecular weight polyethylene). In some embodiments, the articulated layer 58 has a wear rate of less than about 10, less than about 8, less than about 6, or less than about 4 mg / million cycles (MC). In some embodiments, the wear rate of the articulated layer 58 is in the range of about 0.5 mg / MC to about 10 mg / MC. In some embodiments, the wear rate is about 1.5 mg / MC to about 7 mg / MC or about 1.5 mg / MC to about 4 mg / MC.

[0166] In an exemplary embodiment, the articular layer 58 is fixed to the support layer 60. The support layer 60 is configured to extend between the articular layer 58 and the patient's surgically repaired femur.

[0167] In an exemplary embodiment, the support layer 60 is constructed of a composite material comprising (i) homopolymers, copolymers, or mixtures thereof and (ii) reinforcing fibers.

[0168] In some embodiments, the support layer 60 comprises a homopolymer, a copolymer, or a mixture thereof. In some embodiments, the support layer 60 comprises a homopolymer. In some embodiments, the support layer 60 comprises a copolymer. In some embodiments, the support layer 60 is constructed of a composite material comprising a homopolymer and reinforcing fibers. In some embodiments, the support layer 60 is constructed of a composite material comprising a copolymer and reinforcing fibers. In some embodiments, the support layer 60 is constructed of a composite material consisting of or substantially consisting of a homopolymer and reinforcing fibers. In some embodiments, the support layer 60 is constructed of a composite material consisting of or substantially consisting of a copolymer and reinforcing fibers. In some embodiments, the support layer 60 comprises reinforcing particles, such as barium sulfate. In some embodiments, the support layer 60 does not contain reinforcing fibers or reinforcing particles.

[0169] In some embodiments, the support layer 60 comprises a copolymer. In some embodiments, the support layer 60 comprises a polyacetal. In some embodiments, the support layer 60 comprises a polyacetal copolymer. In some embodiments, the copolymer polyacetal is a polyoxymethylene copolymer or commonly referred to as "POM". Exemplary POM copolymers include Hostaform, MT12U03, or MT2U06, available from CELANCES.

[0170] In exemplary embodiments, the support layer 60 comprises at least about 50 wt%, at least about 60 wt%, at least about 70 wt%, at least about 75 wt%, at least about 80 wt%, at least about 85 wt%, at least about 90 wt%, or at least about 95 wt% of a copolymer. In these exemplary embodiments, the copolymer may be a polyacetal, such as POM.

[0171] In some embodiments, the support layer 60 comprises a homopolymer. In some embodiments, the support layer 60 comprises a polyaromatic ether. In some embodiments, the support layer 60 comprises PEEK.

[0172] In exemplary embodiments, the support layer 60 comprises at least about 50 wt%, at least about 60 wt%, at least about 70 wt%, at least about 75 wt%, at least about 80 wt%, at least about 85 wt%, at least about 90 wt%, or at least about 95 wt% of a homopolymer. In these exemplary embodiments, the homopolymer may be a polyaromatic ether, such as PEEK.

[0173] In some embodiments, the support layer 60 comprises reinforcing fibers. The reinforcing fibers may be distributed throughout the support layer 60. Exemplary reinforcing fibers include glass fiber or carbon fiber. In some embodiments, the support layer 60 comprises carbon fiber reinforced (CFR) PEEK. Exemplary CFR PEEK is available from SOLVAY SPECIALTY POLYMERS. In some embodiments, the support layer 60 comprises glass fiber reinforced (GFR) polyacetal. In other embodiments, the support layer 60 does not contain reinforcing fibers.

[0174] In some embodiments, the support layer 60 has a yield strength measured according to ASTM D638. In exemplary embodiments, the yield strength of the support layer 60 is in the range of about 50 MPa to about 150 MPa. In some embodiments, the yield strength of the support layer 60 is at least about 50 MPa or at least about 75 MPa. In some embodiments, the yield strength is about 50 MPa to about 200 MPa, about 50 MPa to about 150 MPa, or about 50 MPa to about 125 MPa.

[0175] In some embodiments, the support layer 60 has a Young's modulus measured according to ASTM D638. In exemplary embodiments, the Young's modulus of the support layer 60 is in the range of about 3,500 MPa to about 30,000 MPa. In some embodiments, the Young's modulus of the support layer 60 is at least about 3,000 MPa, at least about 5,000 MPa, at least about 10,000 MPa, or at least about 15,000 MPa. In some embodiments, the support layer 60 has a Young's modulus of about 3,500 MPa to about 30,000 MPa, about 5,500 MPa to about 25,000 MPa, or about 5,500 MPa to about 23,000 MPa.

[0176] In other embodiments, the femoral component 12 is constructed from a single composition, such that the femoral component 12 is monolithic. In exemplary embodiments, the femoral component 12 is constructed from a single composition comprising a homopolymer, copolymer, or mixture thereof. In some embodiments, the femoral component 12 is constructed from a single composition comprising a blend of at least two homopolymers. In some embodiments, the homopolymer is a polyaromatic ether, preferably PEEK. In some embodiments, the homopolymer is a polyacetal, preferably POM. In some embodiments, the femoral component 12 is constructed from a single composition comprising a polyaromatic ether, preferably PEEK, and a second homopolymer, preferably PPSU, PEI, or mixture thereof. Exemplarily, the femoral component constructed from a single composition does not include reinforcing fibers.

[0177] In an exemplary method, the femoral component 12 can be constructed by molding the articular layer 58 and the support layer 60 together. In some embodiments, the articular layer 58 is overmolded onto the support layer 60. The method can be injection molding or compression molding. During the method, interfacial adhesion between layers can be enhanced by physical interlocking design and / or by chemically utilizing the chemical miscibility between polymers (e.g., between PEEK and PEI).

[0178] In some embodiments, the method for forming an orthopedic implant includes molding material to form a support layer 60. In an exemplary embodiment, the method further includes stacking molding material to form an articular layer 58 onto the support layer 60 to form a molded blank. In an exemplary embodiment, the method further includes shaping the molded blank into an orthopedic implant. In an exemplary embodiment, the method forms a femoral component of a knee implant. In some embodiments, the composite material forms an acetabular support suitable for implantation in the acetabulum of a patient. In other exemplary embodiments, the composite material forms a glenoid support suitable for implantation in the glenoid cavity of a patient. In other exemplary embodiments, the composite material forms a tibial support suitable for implantation in the tibia of a patient.

[0179] In one embodiment, the orthopedic implant includes a joint layer 58 and a support layer 60 disposed in contact with the joint layer 58. The joint layer 58 is constructed of a blend of polyaryletherketone (PAGEK) and polyimide (preferably PEEK and PEI). The PAGEK, preferably PEEK, is at least 80% by weight, and preferably at least 85% by weight, and the polyimide (preferably PEI) is present in an amount of less than 20% by weight, preferably less than 15% by weight. The joint layer 58 has a yield strength of at least about 100 MPa and at least about 102 MPa. The joint layer 58 has a tensile modulus of at least 3,000 MPa, preferably at least 4,000 MPa, and preferably at least 4,100 MPa. The joint layer 58 has a compressive yield strength of at least about 110 MPa, preferably at least about 115 MPa, or more preferably at least about 120 MPa. The IZOD toughness is at least 5 J / m. 2 or approximately 5.3 J / m 2 Approximately 8J / m 2 The wear rate is less than about 10, preferably less than about 6, or preferably less than about 4 mg / million cycles (MC). The support layer 60 is constructed of a polymer, such as polyacetal or polyaryletherketone, and optionally contains reinforcing fibers, such as carbon fibers or glass fibers, or reinforcing particles, such as barium sulfate.

[0180] In one embodiment, the orthopedic implant includes a joint layer 58 and a support layer 60 disposed in contact with the joint layer 58. The joint layer 58 is constructed of a blend of polyaryletherketone (PAGEK) and polysulfone (preferably PEEK and PPSU). The PAGEK, preferably PEEK, is at least 80% by weight, and preferably at least 85% by weight, and the polysulfone (preferably PPSU) is present in less than 20% by weight, and preferably less than 15% by weight. The joint layer 58 has a tensile modulus of at least 3,000 MPa, preferably at least 3,500 MPa. The joint layer 58 has a compressive yield of at least about 100 MPa, preferably at least about 105 MPa, or more preferably at least about 110 MPa. The IZOD toughness is at least 5 J / m. 2 or approximately 5.3 J / m 2 Approximately 8J / m 2 The wear rate is less than about 10, preferably less than about 6, or preferably less than about 4 mg / million cycles (MC). The support layer 60 is constructed of a polymer, such as polyacetal or polyaryletherketone, and optionally contains reinforcing fibers, such as carbon fibers or glass fibers, or reinforcing particles, such as barium sulfate. Example

[0181] Example 1

[0182] Tensile properties

[0183] Five different types of test specimens were prepared and their tensile properties were tested. The results are shown in... Figures 3 to 6 The formulations are shown below. Percentages are by weight when present. Prepare and test 10 specimens for each type of formulation. Perform tensile tests according to the method specified for Type 1 dog bone specimens in ASTM D638. The displacement rate is 5 mm / min until the displacement reaches 0.5 mm, and then the specimens are tested at a rate of 50.5 mm / min until failure.

[0184] The PEEK specimen block was formed by molding Ketaspire KT-880NT.

[0185] POM sample blocks are formed from molded Hostaform MT12U03.

[0186] 90PEEK / 10PEI specimen blocks were formed by blending 10% ColorRX PEI 1600RX with 90% Ketaspire KT-880NT.

[0187] The 80PEEK / 20PEI sample block was formed by blending 20% ​​ColorRX PEI 1600RX with 80% Ketaspire KT-880NT.

[0188] The 90PEEK / 10PPSU sample block was formed by blending 90% Ketaspire KT-880NT with 10% Radel R5800 NT.

[0189] The 95PEEK / 5PEI sample block was formed by blending 5% ColorRX PEI 1600RX and molding 95% KetaspireKT-880NT.

[0190] The tensile strength of the specimen was measured according to ASTM D638. The results are shown below. Figure 3 middle.

[0191] The tensile modulus of the specimen was measured according to ASTM D638. The results are shown below. Figure 4 middle.

[0192] The compressive strength of the specimen was measured according to ASTM D695. The loading rate was 1.3 mm / min, and the test was conducted until 20% strain was reached. The results are shown below. Figure 5 middle.

[0193] IZOD impact toughness was measured according to ASTM D4812. A pendulum weight was set to generate an impact energy of 11 joules. The results are shown below. Figure 6 middle.

[0194] Example 2

[0195] The test specimens were injection molded and their wear properties were tested. This test evaluated the wear properties of XLK pins on PEEK, PEEK / PPSU, PEEK / PEI, and POM test specimens under scratched test specimens (Phase 1) and unscraped test specimens (Phase 2). The wear rates of the pins and test specimens from Phase 1 and Phase 2 are summarized in... Figure 7 In the middle, the wear rate of the XLK pins or specimen blocks was not significantly different before (stage 1) and after (stage 2) the specimen blocks were scratched within each sample type (i.e., POM stage 1 vs stage 2). Figure 8 The average roughness Sa for the four groups over the duration of the study was summarized. Data points for test phase 2 were obtained after a 1.98 MC interval. Data points at a 2.31 MC interval represent roughness measurements taken after scraping the specimen and before test phase 2.

[0196] Hostaform POM, KT-880-NT pure PEEK (Solvay), PEEK / 10% PPSU, and PEEK / 20% PEI specimen blocks were injection molded. These specimen blocks were used in their molded state, except for the elimination of gates and flashes and the addition of two through-holes for alignment with the testing apparatus, and these specimen blocks were not sterilized. The specimen blocks were approximately 1.38 inches in diameter and approximately 0.17 inches thick, and were mounted into custom-made POD fixtures.

[0197] XLK polyethylene pins were used for abrasion testing. The articulated end of each pin was machined with a fly-cut surface profile. All pins had a diameter of 0.39 inches and a length of 0.9 inches. Eleven XLK pins were used for abrasion testing, and three were used for (no-load) immersion control.

[0198] Tests were performed in calf serum lubricant using a Paul-type load with a maximum load of 330 N for 1.98 million cycles (MC). The samples were assessed for weight using an immersion control according to WI-6071, and wear was calculated at each interval.

[0199] The pins move in a 10mm × 10mm (XY) square pattern. The Paul load cycle (J. Paul, Proc. Inst. Mech. Eng., 181, 8-15, 1967) applies a peak of 330N and a frequency of 1.6Hz.

[0200] Each data collection interval consists of 0.33 million cycles (MC). At the end of each interval, the used lubricant is discarded and new lubricant is added.

[0201] For each interval, each sample pair (multiple pins + disc) is rotated to a new station.

[0202] Following WI-0536, bovine serum (HyClone Laboratories Inc., Logan UT, batch number AC10256479) was diluted to 90% (total protein concentration 62.1 mg / mL). The serum contained 0.2% sodium azide and 20 mM EDTA as preservatives and calcium phosphate stabilizers, respectively.

[0203] Clean the polyethylene pins before starting the test and between each interval.

[0204] The pins and discs were not pre-soaked prior to testing. The pins and discs were stored in RO water at room temperature between test phase 1 and section 2.

[0205] Data is collected after each test interval:

[0206] The pins were weighed using an XPE205 balance (Mettler Toledo, Columbus OH; Gage#9009170060000) according to standard procedure 103499701. The pans were weighed using an XPE205 balance (Mettler Toledo, Columbus OH; Gage#9009140060000) according to standard procedure WI-6071.

[0207] Non-contact interferometry measurements of the disc were performed at the start of the test and after each interval using a Zygo NewView 8300 (Middlefield CT, Gage#2077520050000). Feedback data were collected and stored at each interval. Wear rates were calculated from the data using best-fit linear regression, excluding data points with zero cycles and zero wear. Any data in this analysis accompanied by evidence supporting an attributable cause was excluded. Statistical comparisons of the mean wear rates of the XLK pins and disc were performed using a one-way ANOVA with the Tukey comparison test (α = 0.2).

[0208] Phase 1 Results

[0209] Figure 9 and Figure 10 Summarize the average cumulative wear data. Figure 9 The wear rate of the pin is shown. Figure 10 The wear rate of the disk is shown. The surface roughness of the mating end faces of the disk, as summarized using a Zygo interferometer, is... Figure 11 middle.

[0210] Phase 2 Results :

[0211] Figure 12 and Figure 13 Summarize the average cumulative wear data. Figure 12 This shows the wear on the pins on the disc. Figure 13 This shows the wear on the disc. Figure 14 The combined losses from the disk and pin sample blocks are shown. The surface roughness of the mating end faces of the disk, obtained using a Zygo interferometer, is summarized in... Figure 15 middle.

[0212] Table 1 provides wear rates and statistical results in mg / MC (MC = million cycles) (±80% CI) for four sample groups (mean ± 80% CI) (shared letters = statistically equivalent).

[0213] Table 1. Wear rate (±80% CI) :

[0214]

[0215] Example 3

[0216] fatigue test

[0217] According to ASTM D3479 / D3479M, as follows Figure 1 Tension-tension fatigue testing of dog bone samples as described in [the paper / document] was performed. Each cycle at a given stress level was conducted at 2 Hz and continued for up to 5 million cycles. Discs formed from PEEK, PEEK with 10% PEI, and PEEK with 10% PPSU were analyzed. The results are shown in [the paper / document ... Figure 16 middle.

[0218] As described above, other orthopedic components can be designed and manufactured in a similar manner to femoral component 12. For example, such as Figure 17 and Figure 18 As shown, the glenoid component 70 of the shoulder prosthesis may include a joint layer 58 and a support layer 60. Although not shown, the humeral component of a reverse shoulder prosthesis may also be designed and manufactured with a joint layer 58 and a support layer 60.

[0219] In addition, such as Figure 19 and Figure 20 As shown, the acetabular component 72 of the hip prosthesis may include an articular layer 58 and a support layer 60. It should be understood that such an acetabular cup 72 can be configured for implantation in a patient's acetabulum with or without the use of a separate acetabular shell.

[0220] like Figure 21 and Figure 22As shown, the tibial component 14 can be designed and manufactured with an articular layer 58 and a support layer 60. It should be understood that such embodiments of the tibial component 12 can be configured for implantation into a patient's tibia with or without the use of a tibial support 16.

[0221] Furthermore, such as Figure 23 and Figure 24 As shown, the head component 74 of a hip or shoulder prosthesis can be designed and manufactured with a joint layer 58 and a support layer 60. Although not shown, the pyloric bulb component of a reverse shoulder prosthesis can also be designed and manufactured with a joint layer 58 and a support layer 60.

[0222] although Figures 17 to 24 The illustration shows another embodiment of an orthopedic component that can be designed and manufactured with joint layer 58 and support layer 60, but other orthopedic components can also be designed and manufactured in this manner, including hip rods, humeral components of shoulder prostheses, components of ankle prostheses, components of limb prostheses, etc.

[0223] 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.

[0224] This disclosure offers numerous advantages arising from the various features of the devices, systems, and methods described herein. It should be noted that alternative embodiments of the devices, systems, and methods of this disclosure may not include all of the described features, but may still benefit from at least some of the advantages of these features. Those skilled in the art can readily devise their own implementations of the devices, systems, and methods, incorporating one or more of the features of the invention, and falling within the spirit and scope of this disclosure.

Claims

1. A surgical knee prosthesis system, comprising: A tibial component, configured for implantation on the proximal end of a patient's tibia, the tibial component including a concave bearing surface, and A femoral component, configured to be implanted on the distal end of a patient's femur, the femoral component including a femoral condyle having: (i) an articular layer including a hinged surface that is curved in a longitudinal plane and configured to hinge with the concave bearing surface of the tibial component; and (ii) a support layer including an osteophyte surface positioned opposite the hinged surface and configured to engage the distal end of the patient's femur. The articular layer of the femoral component comprises 75% of a first homopolymer and 25% of a second homopolymer to 95% of the first homopolymer and 5% of the second homopolymer, wherein the first homopolymer is polyetheretherketone (PEEK) and the second homopolymer is polyetherimide (PEI) or polyphenylsulfone (PPS). The support layer comprises (i) reinforcing fibers and (ii) homopolymers, copolymers, or mixtures thereof.

2. The orthopedic knee prosthesis system according to claim 1, wherein the polyetheretherketone is 75% to 95% by weight of the joint layer.

3. The orthopedic knee prosthesis system according to claim 1, wherein the support layer comprises a polyarylether homopolymer.

4. The orthopedic knee prosthesis system of claim 1, wherein the support layer comprises a polyacetal copolymer.

5. The orthopedic knee prosthesis system according to claim 4, wherein the polyacetal copolymer is a polyoxymethylene copolymer.

6. The orthopedic knee prosthesis system of claim 5, wherein the support layer comprises at least 80% polyoxymethylene.

7. The orthopedic knee prosthesis system of claim 5, wherein the reinforcing fiber is glass fiber or carbon fiber.

8. A knee joint prosthesis for orthopedic surgery, comprising: A femoral component, comprising a femoral condyle having: (i) an articular layer including a hinge surface that is curved in a longitudinal bisecting plane and configured to engage a tibial component; and (ii) a support layer including an osteophyte surface positioned opposite the hinge surface and configured to engage the distal end of a patient's femur. The joint layer is constructed of a composite material comprising 75% of a first homopolymer and 25% of a second homopolymer to 95% of the first homopolymer and 5% of the second homopolymer, wherein the first homopolymer is polyetheretherketone (PEEK), and the second homopolymer is polyetherimide (PEI) or polyphenylsulfone (PPS). The joint layer has a yield strength of at least 100 MPa.

9. The orthopedic knee prosthesis of claim 8, wherein the joint layer is substantially free of fibers.

10. The orthopedic knee prosthesis of claim 9, wherein the joint layer has a tensile modulus of at least 4,000 MPa.

11. The orthopedic knee prosthesis of claim 10, wherein the joint layer has a concentration of at least 5 J / m². 2 IZOD toughness.

12. The orthopedic knee prosthesis according to claim 8, wherein the polyetheretherketone is 75% to 95% by weight of the joint layer.

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