Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Matter	Content	Para #	Notes	Modified
View Edit Delete	OPT-13	The femoral component 2401 includes a femoral articulation surface that includes a medial condylar articulation surface 2404 and lateral condylar articulation surface 2405. In certain embodiments, the femoral articulation surface may include one of the medial condylar articulation surface 2404 and the lateral condylar articulation surface 2405. In other embodiments, the femoral articulation surface may include both of the medial condylar articulation surface 2404 and the lateral condylar articulation surface 2405.	110	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	The medial 2402 and lateral 2403 condyles may include the medial condylar articulation surface 2404 and the lateral condylar articulation surface 2405. The femoral component 2401 may include elements to secure the femoral component 2401 in the femur of the patient. For example, the femoral component 2401 may include at least one keel 2406 and at least one post 2407 that penetrate the bone of the associated femur (not shown) to secure the femoral component 2401 to the femur. The at least one post 2407 may be placed on the femoral side of the medial condyle 2402 and/or the lateral condyle 2403. The femoral component 2401 may include surface texturing on the bone-facing side to encourage bone in-growth and securement.	111	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	The tibial baseplate component 2440 may be configured to be secured to the tibia of the patient. As used herein, “baseplate" refers to a structure, component, apparatus, or device that serves as a foundation or frame for other structures, components, apparatuses, or devices that may be coupled or connected to the baseplate. In certain embodiments, a baseplate may have a generally planar structure.	112	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	The tibial baseplate component 2440 may include an insert interface 2441 configured for the placement and securement of the insert 2410, with one or more tibial posts 2442, which may be inserted and secured into a patient’s tibia. The tibial baseplate component 2440 may further have a base 2443, which may also be designed to penetrate the tibial plateau and may receive a separate keel (not shown) that penetrates more deeply into the intramedullary canal of the tibia. As used herein, a "base" refers to a main or central structure, component, or part of a structure. A base is often a structure, component, or part upon which, or from which other structures extend, are coupled to, or connect to. A base may have a variety of geometric shapes and configurations. A base may be rigid or pliable. A base may be solid or hollow. In one embodiment, a base may include a housing, frame, or framework for a larger system, component, structure, or device. In certain embodiments, a base can be a part at the bottom or underneath a structure designed to extend vertically when the structure is in a desired configuration or position.	113	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	FIG. 24A shows the exploded assembly 2400 from a lateral side configured for placement in a left knee and shown in approximately 90 degree extension, or “flexion.” While the tibial baseplate component 2440 and the femoral component 2401 may be medially and laterally symmetric across an anterior-posterior plane, the insert 2410 may be medially-laterally asymmetric. The insert 2410 may include a fixation side or insert interface 2411 configured to mate or engage with the insert interface 2441 of the tibial baseplate component 2440. The insert interface 2411 may have features complementary to features on the insert interface 2441. The complementary features may allow for a removable fit for the insert 2410. The removable fit may allow for a modular assembly 2400, benefitting the surgeon and the patient.	114	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	In some embodiments, the tibial baseplate component 2440 and the femoral component 2401 may be symmetric, as mentioned previously, enabling them to be used for either left or right knee replacements. Only the insert 2410 may be specific to one side or the other. An assembly for either left or right knee arthroplasty may include only one femoral component 2401, one tibial baseplate component 2440, and two (e.g., left and right) inserts 2410. This may greatly reduce the inventory requirements for the system.	115	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	Opposite the insert interface 2411, the insert 2410 has a tibial articulation surface 2412 configured for engagement with the medial 2402 and lateral 2403 condyles on the femoral component 2401. The tibial articulation surface 2412 may include a medial tibial compartment 2413 and a lateral tibial compartment 2414. The medial tibial compartment 2413 may include a medial articulation surface 2420 for direct engagement with the medial condylar articulation surface 2404. The lateral tibial compartment 2414 may include a lateral articulation surface 2421 for direct engagement with the lateral condylar articulation surface 2405. The medial condylar articulation surface 2404 may engage with the medial articulation surface 2420 at a medial dwell point 2435. As used herein, "dwell point" refers to a point or an area where two articular surfaces contact each other during flexion and/or extension of a joint.	116	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	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
View Edit Delete	OPT-13	FIGS 24B-24D show details of the shape of the insert 2410. FIG. 24B is a posterior view of the insert 2410. FIG. 24C is an anterior view of the insert 2410. The lateral tibial compartment 2414 may include a lateral posterior side 2416 and a lateral anterior side 2418. The lateral articulation surface 2421 may include a lateral posterior section 2424 and a lateral anterior section 2425 surrounded by a lateral perimeter 2429. The medial tibial compartment 2413 may include a medial posterior side 2415 and a medial anterior side 2417. The medial articulation surface 2420 may include a medial posterior section 2422 and a medial anterior section 2423 surrounded by a medial perimeter 2426.	118	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	FIGS 24D and 24E show lateral and medial views of the insert 2410, respectively. In 24D, the lateral tibial compartment 2414 with lateral perimeter 2429 is shown. The lateral articulation surface 2421 may meet the lateral perimeter 2429 at a lateral high point 2430. The lateral low point 2431 may be toward the center of the lateral articulation surface 2421. In 24E, the medial tibial compartment 2413 with medial perimeter 2426 is shown. The medial articulation surface 2420 may meet the medial perimeter 2426 at a medial high point 2427 at or adjacent the medial posterior section 2422. The medial low point 2428 may be closer to the medial anterior section 2423 and toward the medial perimeter 2426. The high points 2427 2430 and low points 2428 2431 on both the medial tibial compartment 2413 and lateral tibial compartment 2414 are in relation to the insert interface 2411. The difference between the medial high point 2427 and the medial low point 2428 may be greater than the difference between the lateral high point 2430 and the lateral low point 2431 The greater difference in height on the medial articulation side may be represented by the medial ramp 2419.	119	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	The medial posterior section 2422 may include the medial ramp 2419, which may begin at the medial high point 2427 and extend away from the medial high point 2427 anteriorly toward the medial low point 2428. Following the surface topography of the medial ramp 2419, the medial articulation surface 2420 tends to have a gradient from the medial high point 2427 toward the medial low point 2428 near the medial anterior section 2423 and to the medial perimeter 2426. The gradient of the lateral articulation surface 2421 flows to the lateral low point 2431. Therefore, movement down gradients on the medial articulation surface 2420 and lateral articulation surface 2421 may be asymmetric. The lateral articulation surface 2421 may be generally concave toward the lateral low point 2431. The location of the medial low point 2428 may cause the directionality of the gradient from the medial ramp 2419 along the medial articulation surface 2420, which causes an object or a mass to move down the gradient in the direction created by the medial ramp 2419. The medial ramp 2419 and the different heights along the medial perimeter 2426 and the medial articulation surface 2420 may create a medial dwell point 2435 that is transient along the gradient. The approximate gradient is represented by dashed lines in FIG. 24F.	120	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	The medial posterior side 2415, of the medial tibial compartment 2413, may have a medial thickness defined by the medial high point 2427 at the medial perimeter 2426, which may correspond to the medial ramp 2419, and or the insert interface 2411. The lateral posterior side 2416, of the lateral tibial compartment 2414, may have a lateral thickness defined by the lateral high point 2430 at the lateral perimeter 2429 and the insert interface 2411. Because of the medial ramp 2419, the medial tibial compartment 2413 may have a greater thickness than the lateral tibial compartment 2414.	121	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	The medial ramp 2419 and the gradient it creates along the medial articulation surface 2420 towards the medial low point 2428 and may cause a translation or movement of the medial condyle 2402 greater than a translation or movement of the lateral condyle 2403, as the knee and assembly 2400 range from 0 degree of flexion, or extension, to 90 degrees of flexion. The medial condyle 2402 may move down the medial ramp 2419 such that the medial dwell point 2435 migrates anteriorly and outwardly toward the medial perimeter 2426 as the degree of flexion increases. The lateral condyle 2403 may remain in generally the same location near the lateral low point 2431 so the lateral dwell point 2436 may remain in generally the same location. The lateral condyle 2403 may also migrate as the knee moves into flexion, so that the lateral dwell point 2436 migrates posteriorly and outwardly concurrently as the medial dwell point 2435 migrates anteriorly and outwardly. The asymmetric translation of the medial dwell point 2435 and lateral dwell point 2436 may create a tibiofemoral rotation between extension and flexion. As used herein, "tibiofemoral rotation" refers to rotation of a tibia bone and/or part of a patient's leg that includes the tibia bone about a longitudinal axis that is parallel to a center axis of a leg of the patient.	122	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	FIGS 25-27 demonstrate the movement of the medial dwell point 2435 relative to the lateral dwell point 2436 during flexion of the assembly 2400. FIGS. 25A-25E show a posterior view of the composed assembly 2400 in 0 degree flexion, or “straight leg,” in a left knee. FIG. 25A is a medial-lateral cross-section perspective view of the assembly 2400. Generally, the femoral component 2401 contacts the insert 2410 at dwell points. Dwell points are the points of contact between two surfaces. The medial condylar articulation surface 2404 meets the medial articulation surface 2420 at a medial dwell point 2435. The lateral condylar articulation surface 2405 meets the lateral articulation surface 2421 at a lateral dwell point 2436. FIGS. 25B and 25C show the medial dwell point 2435 and the lateral dwell point 2436 at what may be considered a starting position, in 0 degrees flexion. FIG. 25D is an anterior-posterior cross-section through the lateral tibial compartment 2414 of the insert 2410. The medial ramp 2419 is visible (in the background) and shows the height difference between the medial posterior side 2415 and the lateral posterior side 2416. FIG. 25E is an anterior-posterior cross-section through the medial tibial compartment 2413 of the insert 2410; the medial ramp 2419 is visible and is occluding the lower lateral posterior side 2416.	123	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	FIGS. 26A-26E show a posterior view of the composed assembly 2400 in 45 degree flexion, in a left knee. FIG. 26A is a medial-lateral cross-section perspective view of the assembly 2400. The medial condylar articulation surface 2404 meets the medial articulation surface 2420 at a medial dwell point 2435. The lateral condylar articulation surface 2405 meets the lateral articulation surface 2421 at a lateral dwell point 2436. FIGS. 26B and 26C show the medial dwell point 2435 and the lateral dwell point 2436 at what may be considered a starting position, in 45 degrees flexion. FIG. 26D is an anterior-posterior cross-section through the lateral tibial compartment 2414 of the insert 2410. The medial ramp 2419 is visible (in the background) and shows the height difference between the medial posterior side 2415 and the lateral posterior side 2416. FIG. 26E is an anterior-posterior cross-section through the medial tibial compartment 2413 of the insert 2410; the medial ramp 2419 is visible and is occluding the lower lateral posterior side 2416. Relative to 0 degrees flexion, the medial dwell point 2435 has moved slightly and the lateral dwell point 2436 has not moved significantly.	124	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	FIGS. 27A-27E show a posterior view of the composed assembly 2400 in 90 degree flexion, in a left knee. FIG. 27A is a medial-lateral cross-section perspective view of the assembly 2400. The medial condylar articulation surface 2404 meets the medial articulation surface 2420 at a medial dwell point 2435. The lateral condylar articulation surface 2405 meets the lateral articulation surface 2421 at a lateral dwell point 2436. FIGS. 27B and 27C show the medial dwell point 2435 and the lateral dwell point 2436 at what may be considered a starting position, in 90 degrees flexion. FIG. 27D is an anterior-posterior cross-section through the lateral tibial compartment 2414 of the insert 2410. The medial ramp 2419 is visible (in the background) and shows the height difference between the medial posterior side 2415 and the lateral posterior side 2416. FIG. 27E is an anterior-posterior cross-section through the medial tibial compartment 2413 of the insert 2410; the medial ramp 2419 is visible and is occluding the lower lateral posterior side 2416. Relative to 0 degrees flexion, the medial dwell point 2435 has moved substantially anteriorly and outwardly toward the medial perimeter 2426 and the lateral dwell point 2436 has not moved significantly. During the transition from extension to flexion, the medial dwell point 2435 has moved anteriorly from the medial ramp 2419 toward the medial low point 2428. The lateral dwell point 2436 has not substantially moved along the lateral articulation surface 2421.	125	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	The asymmetry of the insert 2410, and particularly the medial ramp 2419, may cause greater translation of the medial dwell point 2435 compared to the lateral dwell point 2436. The medial dwell point 2436 translation, alone or in conjunction with lateral dwell point 2435 translation, causes or allows tibiofemoral rotation similar to that of a natural knee. Tibiofemoral rotation in a natural knee is the outward rotation of the tibia and lower leg relative to the femur in flexion. In natural tibiofemoral rotation, the toes point outward in flexion compared to extension. The degree of medial dwell point 2435 translation may correspond to rotation of the tibial baseplate component 2440 and insert 2410 relative to the femoral component 2401.	126	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	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
View Edit Delete	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
View Edit Delete	OPT-13	The tibial inserts 12, 212, 312, PS femoral component 14 and CR femoral component 114 may be grouped together as a modular knee replacement system and provided as a kit in one or more packages, in one non-limiting example. Another kit may include a CR femoral component 114, a PS insert 12 and a CR insert 212, in one or more packages in another non-limiting example. Yet another kit may include a PS femoral component 14, a PS insert 12, a CR insert 212, and a CCK insert 312, in one or more packages in yet another non-limiting example. However, it will also be understood that other kit embodiments may utilize any of the tibial inserts and/or femoral components described herein in any number or combination, in one or more packages. Furthermore, other components may also be including in any kit described herein, such as suitable tibial baseplate components, patellar components, etc., in one or more packages. It will also be understood that any of the tibial inserts disclosed herein may be formed of vitamin E polyethylene, highly cross linked polyethylene, ultra-high molecular weight polyethylene (UHMWPE), or any other suitable material.	90	Added by DJM 1 2022	1/25/22, 12:00 AM

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