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Dave's PCF WIP: Paragraphs
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OPT-13 The tapered sides 1032, 1034 of the post 1030 may permit natural articulation of the CR femoral component 1114 with the PS insert 1012, which may not be achievable if the post 1030 were not tapered. For example, if the post 1030 had straight sides instead of tapered sides, the wider width of the post 1030 at the base of the post 1030 may interfere with the internal articulating surfaces 1170, 1172 of the condyles 1160, 1164. When the PS femoral component 1014 is coupled with the PS insert 1012 to form assembly 1010, as in FIG. 14 and 15, the circular shape of the post superior end 1040 in combination with the tapered medial and lateral surfaces 1032, 1034 of the post 1030, may permit the PS femoral component 1014 to articulate relative to the PS insert 1012 in the manner of a posterior stabilized femoral component. However, when the PS insert 1012 is paired and implanted with the CR femoral component 1114, the resultant assembly 1110 may provide the native articulation and rotation of a cruciate retaining implant. 97 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 Referring to FIGS. 19 and 20, another assembly 2110 embodiment of the disclosure may include the PS insert 1012 of FIGS. 14-16D coupled with a cruciate retaining femoral component 2114 (or “CR femoral component”). The CR femoral component 2114 may not include a keel, as opposed to the CR femoral component 1114 shown in FIGS. 17 and 18, and the CR femoral component 2114 may be configured for cemented and/or cementless fixation to a femoral bone. The CR femoral component 2114 may include fixation members 2130, impact driver apertures 2190, and medial and lateral condyles 2160, 2164 with a gap 2168 formed between the condyles 2160, 2164. As a CR femoral component 2114, no cam bar or box may be present. The condyles 2160, 2164 may include medial and lateral condylar articulation surfaces 2162, 2166, and an internal articulation surface 2154 with medial and lateral portions 2170, 2172. 98 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 Referring to FIG. 12B, the boundary of the post superior end 340 may define a rounded rim 344 shaped as a portion of a circle, from a superior perspective. The post superior end 340 and rim 344 may be semi-circular as shown, however the rim 344 may define a circular envelope 347. The post superior end 340 may be circular and rim 344 may provide increased surface contact and rotational range of motion when coupled and implanted with the PS femoral component 14 in comparison to traditionally shaped posts with a more square or rectangular shaped post. Thus, the rounded post superior end 340 and rim 344 may allow for surface contact with the femoral component 14 in contrast to the mere point or edge contact that is achieved by traditional posts that do not have these features. The CCK insert 312 may be coupled with the PS femoral component 14 to form a constrained condylar knee assembly, and this assembly may be implanted with a suitable tibial baseplate as a constrained condylar knee prosthesis. The CCK insert 312 may also be coupled with the CR femoral component 114 and implanted with a suitable tibial baseplate. Thus, all of the tibial inserts 12, 212, and 312 disclosed herein are interchangeable with both the CR femoral component 114 and the PS femoral component 14. FIG. 13 is a chart showing the potential combinations of components. 89 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 Referring to FIGS. 21A-21E, an alternative embodiment of a tibial insert 1212 is shown. The tibial insert 1212 may be referred to as a cruciate retaining tibial insert 1212 (or “CR insert”). In a system of the disclosure, the CR insert 1212 may be implanted with the CR femoral components 114, 1114, 2114 and a tibial baseplate component (See FIG. 24A) to form a cruciate retaining knee prosthesis system. The CR insert 1212 may include a fixation side 1220, which may be an inferior side, opposite an articulation side 1222, which may be a superior side. The articulation side 1222 may include a medial tibial compartment 1224 having a medial condylar articulation surface 1225 and a lateral tibial compartment 1226 having a lateral condylar articulation surface 1227. A central portion 1228 may separate the medial tibial compartment 1224 from the lateral tibial compartment 1226. A recess 1245 may be formed posterior to the central portion 1228, between the medial and lateral tibial compartments 1224, 1226, and may provide room for a posterior cruciate ligament. The CR insert 1212 may further include an insert base 1246 and an engagement feature 1248 for engagement with a tibial baseplate component. 100 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 The CR insert 1212 may be coupled with CR femoral components 114, 1114, 2114 to form a cruciate retaining assembly. This cruciate retaining assembly may be implanted with a suitable tibial baseplate as a complete cruciate retaining knee prosthesis. The CR insert 1212 may also be coupled with PS femoral components 14, 1014 to form a posterior stabilizing assembly and implanted with a suitable tibial baseplate as a complete posterior stabilizing knee prosthesis. 101 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 Referring to FIGS. 22A-22F, another alternative embodiment of a tibial insert 1312 is shown. The tibial insert 1312 may be referred to as a constrained condylar knee (CCK) tibial insert 1312 (or “CCK insert”). The CCK insert 1312 may include a fixation side 1320, which may be an inferior side, opposite an articulation side 1322, which may be a superior side. The articulation side 1322 may include a medial tibial compartment 1324 having a medial condylar articulation surface 1325 and a lateral tibial compartment 1326 having a lateral condylar articulation surface 1327. A central portion 1328 may separate the medial tibial compartment 1324 from the lateral tibial compartment 1326. A post 1330 may protrude superiorly from the central portion 1328 and extend from a post base 1338 to a top, or post superior end 1340. From the anterior perspective, as shown in FIG. 22E, and the posterior perspective, as shown in FIG. 22D, the post 1330 may have its maximum medial-lateral or horizontal width at the post superior end 1340 of the post 1330, and its minimum medial-lateral or horizontal width at the post base 1338 of the post 1330. The post 1330 may be bilaterally symmetrical from the anterior and posterior perspectives. The CCK insert 1312 may further include a posterior recess 1345, an insert base 1346, and an engagement feature 1348 for engagement with a tibial tray (not shown). An opening 1350 may be present in the superior surface of the post 1330. 102 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 The post 1330 may have an articulation surface 1331 extending around the post 1330 on the medial, posterior, lateral, and anterior aspects of the post 1330. The articulation surface 1331 may include a medial articulation surface 1332, a lateral articulation surface 1334, an anterior post surface 1336, and a posterior articulation surface 1342. The medial and lateral articulation surfaces 1332, 1334 may taper slightly inward from the post superior end 1340 to the post base 1338 of the post 1330 relative to an insert midline vertical axis 1302. However, some embodiments of CCK insert 1312 may include less taper, more taper, and/or no taper of the medial and lateral articulation surfaces 1332, 1334. The medial articulation surface 1332 may be continuous with the medial condylar articulation surface 1325, and the lateral articulation surface 1334 may be continuous with the lateral condylar articulation surface 1327. The anterior post surface 1336 may extend between the medial and lateral articulation surfaces 1332, 1334 and may be convexly rounded. The anterior post surface 1336 may taper outward from the post superior end 1340 to the post base 1338 relative to the midline axis 1302, as best seen in FIG. 22F. In other embodiments of the CCK insert 1312, the anterior post surface 1336 may include less taper, more taper, and/or no taper. The post 1330 of the CCK insert 1312 may be wider and bigger in diameter than the post 30 of PS insert 12, for example to provide increased stability in the case of removal of the collateral ligaments. A midline medial-lateral axis 1304 and a mid-line anterior-posterior axis 1306 are also shown in FIGS. 22D through 22F. 103 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 Referring to FIG. 22B, the boundary of the post superior end 1340 may define a rounded rim 1344 shaped as a portion of a circle, from a superior perspective, and may have a convex protrusion toward a posterior end of the post 1330. The post superior end 1340 and rim 1344 may be semi-circular as shown, however the rim 1344 may define a circular envelope 1347. The post superior end 1340 may be circular and the rim 1344 may provide increased surface contact and rotational range of motion when coupled and implanted with the PS femoral components disclosed herein in comparison to traditionally shaped posts with a more square or rectangular shaped post. Thus, the rounded post superior end 1340 and rim 1344 may allow for greater surface contact with the femoral components 14, 1014 in contrast to the mere point or edge contact that is achieved by traditional posts that do not include these features. 104 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 The CCK insert 1312 may be coupled with the PS femoral components 14, 1014 to form a constrained condylar knee assembly, and this assembly may be implanted with a suitable tibial baseplate as a constrained condylar knee prosthesis. The CCK insert 1312 may also be coupled with any of the CR femoral components disclosed herein and implanted with a suitable tibial baseplate. Thus, all of the tibial inserts disclosed herein are interchangeable with all of the CR and PS femoral components disclosed herein. 105 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 Any of the tibial inserts, CR femoral components, and/or PS femoral components disclosed herein may be grouped together in any number or combination as one or more modular knee replacement systems or kits. A particular kit may include a CR femoral component, a PS insert, and a CR insert. Yet another particular kit may include a PS femoral component, a PS insert, a CR insert, and a CCK insert. Suitable tibial baseplate components may also be included with any kit. Moreover, any of the tibial inserts disclosed herein may be formed of vitamin E polyethylene, highly cross linked polyethylene, ultra-high molecular weight polyethylene (UHMWPE), and/or the like. 106 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 Referring now to FIGS. 23A-B, FIG. 23A is a perspective front view of the femoral component 1014 of FIG. 14 coupled to one or more augments 1082, 1084 of the present disclosure and FIG. 23B is a medial side view of the femoral component 1014 of FIG. 23A. As briefly mentioned above with reference to FIGS. 14 and 15, the femoral component 1014 may include augment fixation apertures 1080 that may be configured to secure the one or more augments 1082, 1084 to the femoral component 1014, as well as impact driver apertures 1090 configured to receive a femoral component impact driver tool (not shown) to allow a surgeon to press fit the femoral component 1014 to the end of a prepared femur. The augments 1082, 1084 may be secured to the femoral component 1014 with fixation members 1086 and the augments 1082, 1084 may generally act to replace missing and/or compromised femoral bone and allow the femoral component 1014 to be adequately secured to a femoral bone under such conditions. 107 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 Referring to FIGS 24A to 24F, an assembly 2400 for an implantable knee prosthesis is shown, according to another embodiment. Assembly 2400 may include a femoral component 2401, an insert 2410, and a tibial baseplate component 2440. FIG. 24A is an exploded view of the assembly 2400 approaching the assembly 2400 from a posterior-lateral side, in reference to the anatomy of a patient. The assembly 2400 is generally asymmetric across the medial and lateral sides, in other words the left side is asymmetric compared to the right side. In FIGS. 24 to 27, a left knee design is shown, and FIGS. 28A-28F illustrate a right knee design. In either a left or right configuration, medial will be proximal to the sagittal plane, or on the inside of the knee, and lateral is distal from the sagittal plane, or outside of the knee. 108 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 In one embodiment, the femoral component 2801 is configured for a first side of a patient and the tibial insert 2910b is configured for the second side of the patient. In the illustrated embodiment, the first side may be a right side of a patient and the second side may be a left side of a patient. Alternatively, or in addition, the first side may be a left side of a patient and the second side may be a right side of a patient. 177 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 With the tibial insert 2910a deployed in the knee joint, the medial tibial compartment 2813 engages the lateral femoral compartment at a lateral dwell point (shown in later figures) during flexion and the lateral tibial compartment 2814 engages the medial femoral compartment at a medial dwell point (shown in later figures) during flexion. Those of skill in the art will recognize that this is different from the arrangement should the tibial insert 2910b be deployed between the femoral component 2401 and the tibial baseplate component 2440. Said another way, if the left tibial insert 2910b were deployed in a left knee joint, the medial compartments of each of the femoral component 2401 and the tibial baseplate component 2440 would engage with each other and the lateral compartments of each of the femoral component 2401 and the tibial baseplate component 2440 would engage with each other. 162 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 FIG. 30 is a perspective anterior view of knee prosthesis system according to another embodiment of the present disclosure. FIG. 30 includes similar components, parts, devices, apparatus, features, and aspects as those disclosed and described in relation to FIG. 29, however the difference in FIG. 30 is that the knee prosthesis system 2900 is to be deployed in a knee joint having a different condition than a knee joint in relation to the knee prosthesis system 2900 of FIG. 29. In FIG. 30, the example knee prosthesis system 2900 is to be deployed in a knee joint having a valgus condition 163 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 As used herein, a "valgus condition" refers to a state of a bone or joint having an undesired outward angulation (angled laterally, away from the body's midline) of the distal segment of a bone or joint. For example in a valgus condition of the knee, the distal part of the leg below the knee is deviated outward, in relation to the femur, resulting in a knock-kneed appearance. The opposite of varus is called valgus. A varus condition at the knee results in a bowlegged appearance with the distal part of the leg deviated inward, in relation to the femur. (Search "valgus deformity" on Wikipedia.com Oct 20, 2020. Modified. Accessed Jan. 6, 2020.) A valgus condition can be experienced in a variety of joints, including but not limited to, ankle joints, elbow joints, foot joints, hand joints, hip joints, knee joints, toe joints, wrist joints, and the like. A knee that has a valgus condition may also be referred to as a valgus knee. 164 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 A patient knee with a valgus condition may cause one or more problems or challenges in the kinematics of the knee as the knee transitions through various angles of flexion and/or extension. For example, a valgus knee may have impeded, or unnatural, tibiofemoral rotation within the medial tibial compartment during flexion of the knee joint. The impeded, or unnatural, tibiofemoral rotation may cause premature wear on components of the knee prosthesis system 2900, interfere with a patient’s balance, interfere with the patient’s gait or mobility, or the like. 165 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 Advantageously, the knee prosthesis system 3000 can remediate an undesirable or unacceptable tibiofemoral rotation within the medial tibial compartment during flexion of the knee joint. Specifically, the tibial articulation surface 2812 facilitates tibiofemoral rotation within the medial tibial compartment 2813 during flexion of a first knee joint where the condition is a valgus knee joint. In the illustrated embodiment, the surgeon may choose, either pre-operatively and/or intraoperatively, to use tibial insert 2910b with the tibial baseplate component 2840 and the femoral component 2801 for a right knee. The tibial insert 2910b is positioned between the tibial baseplate component 2840 and the femoral component 2801 when deployed, see arrow 3012. The tibial insert 2910b may be used instead of the tibial insert 2910a because the right knee presents a valgus condition. 166 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 The tibial insert 2910b includes a tibial articulation surface 2412 having a medial tibial compartment 2413 and a lateral tibial compartment 2414. The compatible interfaces 2411, 2841 enable the surgeon to deploy the tibial insert 2910b with the tibial baseplate component 2840 and the femoral component 2801 for a right knee to adapt, adjust, refine, or modify kinematics of a patient’s right knee joint having a valgus condition. 167 Added by DJM 1 2022 1/25/22, 12:00 AM
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OPT-13 It should be noted that in the illustrated embodiment a surgeon may deploy the tibial insert 2910b in a right knee because the knee has a valgus condition. However, the tibial insert 2910b may also be deployed (e.g., is suitable for implantation) in a patient’s left knee joint that lacks the valgus condition. While the tibial insert 2910b may be designed for deployment in a left knee joint that lacks a condition, or has a balanced condition, the tibial insert 2910b is illustrated in FIG. 32 being deployed in a right knee joint that has a valgus condition of about eight degrees. Referring still to FIG. 30, with a knee joint having a valgus condition, a surgeon may decide to couple, or connect, the tibial insert 2910a to the tibial baseplate component 2440. 168 Added by DJM 1 2022 1/25/22, 12:00 AM

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