Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	OPT-13	The lateral condylar articulation surface 2405 may engage with the lateral articulation surface 2421 at a lateral dwell point 2436 (shown in subsequent figures). The medial articulation surface 2420 may include a medial ramp 2419, which may have no counterpart on the lateral articulation surface 2421 and may create at least part of the asymmetry between the medial tibial compartment 2413 and the lateral tibial compartment 2414.	117	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	The femoral component 2401 may be posterior stabilizing or cruciate retaining. In FIG. 24A, the femoral component 2401, the tibial insert 2410, and the tibial baseplate component 2440 are shown in flexion. The femoral component 2401 may include medial condyle 2402 and lateral condyle 2403, similar to femoral component 114 in FIG. 9. The femoral component 2401 having a medial femoral compartment that includes the medial condylar articulation surface 2404 and a lateral femoral compartment that includes the lateral condylar articulation surface 2405. In certain embodiments, the medial condylar articulation surface 2404 defines the medial femoral compartment and the lateral condylar articulation surface 2405 defines the lateral femoral compartment.	109	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	The resultant tibiofemoral rotation as a result of the asymmetry of the insert 2410 may provide additional joint stability in the patient. As the medial dwell point 1540 migrates medially, toward the sagittal plane, the medial collateral ligaments of the knee may maintain tension as the knee moves from extension to flexion. The tibiofemoral rotation and maintenance of tension of the medial ligaments may more accurately mimic the movement of a healthy knee. Assembly 2400 may allow a more natural biomechanical range of motion of the knee compared to knee prosthetics with symmetric medial and lateral articulation sides.	127	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	Referring to FIG. 24A, the exploded assembly 2400 is shown from a lateral side configured for placement in a left knee and shown in approximately 90 degree extension, or “flexion.” The tibial articulation surface 2412 may include a medial tibial compartment 2413 (indicated generally by the letter “M”) and a lateral tibial compartment 2414 (indicated generally by the letter “L”). In particular, the tibial insert 2410 may be configured and designed specifically for use with a left knee of a patient and may be configured to fit within a tibial baseplate component 2440. Furthermore, the tibial articulation surface 2412 may be configured to contact and interface with a femoral component 2401, which may be specifically configured for a left knee.	128	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	The tapered sides 1032, 1034 of the post 1030 may permit natural articulation of the CR femoral component 2114 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 1038 of the post 1030 may interfere with the medial and lateral portions 2170, 2172 of the internal articulation surface 2154 of the condyles 2160, 2164. When the PS femoral component 1014 is coupled with the PS insert 1012 to form assembly 1010, as in FIGS. 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 2114, the resultant assembly 2110 may provide the native articulation and rotation of a cruciate retaining implant.	99	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
View Edit Delete	OPT-13	Referring to FIGS. 14 and 15, another assembly 1010 of the disclosure for an implantable knee prosthesis is shown in various exploded rear views. The assembly 1010 may include a femoral component 1014 and a tibial insert 1012. The tibial insert 1012 may be further coupled to a tibial baseplate component (not shown) which may also be implanted in a prepared tibia of a patient (not shown). The femoral component 1014 and tibial insert 1012 illustrated in FIGS. 14 and 15 are right side femoral and tibial insert components. Left side femoral and tibial insert components would be mirror images of the right side femoral and tibial insert components that are shown in FIGS. 14 and 15. The femoral component 1014 may also be referred to as a posterior stabilizing femoral component 1014 (or “PS femoral component”) and the tibial insert 1012 may also be referred to as a posterior stabilizing tibial insert (or “PS insert”).	91	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	FIGS. 16A-16D show the PS insert 1012 of FIGS. 15 and 14 in isolation. The PS insert 1012 may include a fixation side 1020, which may be an inferior side, opposite an articulation side 1022, which may be a superior side. The articulation side 1022 may include a medial tibial compartment 1024 having a medial condylar articulation surface 1025 and a lateral tibial compartment 1026 having a lateral condylar articulation surface 1027. A central portion 1028 may separate the medial tibial compartment 1024 from the lateral tibial compartment 1026. A post 1030 may protrude superiorly from the central portion 1028 and extend from a post base 1038 to a post top 1040 or post superior end. From the anterior perspective (shown in FIG. 16B) and/or the posterior perspective (shown in FIG. 16A), the post 1030 may have its maximum medial-lateral or horizontal width toward the top 1040 of the post 1030, and its minimum medial-lateral or horizontal width toward the base 1038 of the post 1030. The post 1030 may also be bilaterally symmetrical from the anterior and/or posterior perspectives. A recess 1045 may be formed posterior to the central portion 1028, between the medial and lateral tibial compartments 1024, 1026, and may provide room for a posterior cruciate ligament (not shown). The PS insert 1012 may further include an insert base 1046, which may further include an engagement feature 1048 for engagement with a tibial baseplate component.	92	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	Continuing with FIGS. 14-16D, the post 1030 may have an articulation surface 1031 extending around the post 1030 on the medial, posterior, lateral, and anterior aspects of the post 1030. The articulation surface 1031 may include a medial articulation surface 1032, a lateral articulation surface 1034, an anterior post surface 1036, and a posterior articulation surface 1042. The medial and lateral articulation surfaces 1032, 1034 may be non-parallel to one another and taper inward from the post superior end 1040 to the post base 1038 relative to an insert midline vertical axis 1002, as shown in FIGS. 16A and 16B. As shown in FIG. 16A, an angle θ between the vertical axis 1002 and each tapered surface 1032, 1034 may be about 6.5°, in at least one embodiment. Since the post 1030 may be bilaterally symmetrical, the angle θ may be the same on both the medial and lateral sides 1032, 1034 of the post 1030. In other embodiments of the disclosure, angle θ may range from about 6° to 11° degrees. The medial articulation surface 1032 may be continuous with the medial condylar articulation surface 1025, and the lateral articulation surface 1034 may be continuous with the lateral condylar articulation surface 1027. The anterior post surface 1036 may extend between the medial and lateral surfaces 1032, 1034 and may be convexly rounded. The anterior post surface 1036 may also taper outward from the post superior end 1040 to the post base 38 relative to the insert midline vertical axis 1002, as best seen in FIG. 16D. In other embodiments of the PS insert 1012, the anterior post surface 1036 may include less taper, more taper, and/or no taper. A midline medial-lateral axis 1004 and a mid-line anterior-posterior axis 1006 are also shown.	93	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	Referring to FIG. 16C, the boundary of the superior end 1040 may define a rounded rim 1044 shaped as a portion of a circle defined by a circular envelope 1047, as seen from a superior perspective. The superior end 1040 and rim 1044 may have a convex protrusion 1041 toward a posterior end of the post 1030 as shown and may permit passage of the posterior cruciate ligament. The circular superior end 1040 with rim 1044 may provide increased rotational range of motion and surface contact against the femoral component 1014 in comparison to traditional posts with a more square or rectangular shape and no rim. Thus, the rounded superior end 1040 and rim 1044 may allow for greater surface contact with the femoral component 1014 in contrast to the mere point or edge contact that is achieved by traditional posts that do not have these features.	94	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	The PS femoral component 1014 depicted in FIGS. 14-15 may include augment fixation apertures 1080, impact driver apertures 1090, a cam element or cam bar 1050, and a box structure 1052 for providing posterior stabilization in place of absent ligaments. The cam bar 1050 may include a cam articulating surface 1051 which may contact the posterior articulation surface 1042 of the post 1030 during flexion. An internal articulation surface 1054 may reside on the inside of the box structure 1052 and may contact the post 1030 during articulation and rotation of the knee joint. The internal articulating surface 1054 may be concavely curved and may contact the rim 1044 of the post 1030 during axial rotation of the knee joint about the post 1030. The PS femoral component 1014 may further include a medial condyle 1060 having a medial condylar articulation surface 1062, and a lateral condyle 1064 having a lateral condylar articulation surface 1066. The medial and lateral condylar articulation surfaces 1062, 1066 may articulate against the PS insert 1012 medial and lateral articulation surfaces 1025, 1027, respectively. A gap 1068 may be formed between the medial and lateral condyles 1060, 1064, with the cam bar 1050 extending medial-laterally across the gap 1068. The internal articulation surface 1054 may include a medial portion 1070 continuous with a lateral portion 1072. In the embodiment depicted, a fixation post 1074 may protrude superiorly from the PS femoral component 1014. However, in other embodiments of the PS femoral component 1014, the fixation post 1074 may be absent and/or other fixation features such as posts, spikes, pegs, webs, keels, or teeth may be present to affix the PS femoral component 1014 to a prepared femur (not shown).	95	Added by DJM 1 2022	1/25/22, 12:00 AM
View Edit Delete	OPT-13	Referring to FIGS. 17 and 18, another assembly 1110 embodiment of the disclosure may include the PS insert 1012 of FIGS. 14-16D coupled with a cruciate retaining femoral component 1114 (or “CR femoral component”). The CR femoral component 1114 may include a keel 1120, fixation members 1130, impact driver apertures 1190, and medial and lateral condyles 1160, 1164 with a gap 1168 formed between the condyles 1160, 1164. As a CR femoral component 1114, no cam bar or box may be present. The condyles 1160, 1164 may include medial and lateral condylar articulation surfaces 1162, 1166, and an internal articulation surface 1154 with medial and lateral portions 1170, 1172.	96	Added by DJM 1 2022	1/25/22, 12:00 AM

Page 9 of 13, showing 20 record(s) out of 256 total