AU2013242862B2 - Patellar components - Google Patents

Abstract

H:\txblntceovcn\NRPortbIDCC\TXB\5624445_.DOC-9/102013 Embodiments of the present invention provide patellar component designs that are optimally shaped to help reduce shear force and accommodate slight implantation error. Further, they help lessen anterior knee pain, particularly during deep-flexion activities and help ease the transition during the range of knee movement in a controlled way.

Description

PATELLAR COMPONENTS This is a divisional of Australian Patent Application No. 2007222102, the entire contents of which are incorporated herein by reference. This application claims the benefit of U.S. Provisional Application Serial No. 60/761.296, filed 5 January 23, 2006 titled Low Shear Force Patella, U.S. Provisional Application Serial No. 60/761,297, filed January 23,2006 titled Controlled Constraint Anatomic Patella, and U.S. Provisional Application Serial No. 60/761,298, filed January 23, 2006 titled Convex Oval Patella. the entire contents ofeach of which are hereby incorporated by reference. The present invention relates generally to patellar components that are designed to form a 10 patella portion (or knee cap) that replaces a part of a natural patella or knee cap, and particularly to patellar components that are designed to cooperate and articulate against a femoral component ofa total knee prosthesis. Also provided are methods for implanting the described patellar components. Joint replacement, and particularly knee replacement, has become increasingly widespread. Various knee prostheses and procedures have been developed to treat the debilitating effects of knee 15 joint deterioration (e.g.. such as that caused by arthritis, injury, or disease). A fairly common procedure used to repair a patient's knee is total knee replacement, in which the tibia is resected and replaced with a tibial component, and the femur is resected and replaced with a femoral component. In some instances, the surgeon will also replace the articulating surface on the posterior aspect of the patella where it interfaces with the femoral component, which can help improve the results of total or 20 partial knee replacements. The primary function of the patella is to increase the efficiency of the quadriceps muscles and to serve as a connection between the quadriceps tendon and the patellar tendon. The patella has a ridge on its posterior side which slides in a groove between the femoral condyles, referred to as the patellar track. The patella, patellar track, and condyles act together as a low friction pulley and lever for the 25 quadriceps tendon. As shown in FIG. I, during knee replacement surgery, a prosthetic patellar component 2 can be affixed to the natural patella 4 so that its posterior side 6 contacts the femoral component 8 during flexion and extension of the knee. The patellar component 2 then tracks the trochlear groove 9 of the femoral component (the line that separates the femoral condyles) during flexion and extension of the 30 knee. 1 in order to implant the patellar component 2 a part ofi the natural pateila bone is rIoved and an implant is secured thereto. Some implants are inset. meaning that a shallow hoe Is drilled ino the bone using a conterborc SO that the implant has about flush w\ith the bon'gI' Other'l ypcs are "onset w i .. cans, that the back of the patella is paned Of ad the i m pi a, s placcd on top otf th tft bne, 5 Embodinents ofthe invention described in tis applicati tanscends these types of plants arId can be used For both, Te maximum range ofinotion fr a natural knee is about 150-160 degrees, By contrast, most knee replacements achieve only about i1120 degrees of flexion. Soni of ihis gap can be attributed to scarring within the knee join and other physical conditions, but the remainder can be attributed 10 primarily to failure of current implants to provide toh ptoer prostheric componet geometrics that take into consideration the natua kinenatics ofi the knee. Despite tl elstiuccess ofsom s e products on the market. many patellar teld to fail after about fiv to fifteen years. Part of the reason they all is due to excessive wear at certain regions of the component or loosening at the bone/component intrfce For enpi ith a 15 dome patelar component, one reason fOr failure is ite downard forces -f th moral component acting 0 the paLar component during flexion can cause the pegs iat extend front the patellar component and-tach the component to the natural patella to weaken ind break, Shear Orces that are appld direct to the inplant change during knee motion, and ihey increase as the knee is moved deeper into flexion For exampl'e, a 1 different ngles of flexion, the contact stresses across the 20 patelem~rai in-terface m->ove outward tmVards the rtrpriphcri o the itee and increase as knee flexion increases. During knee fiexion the patea itseiffflexes and the contact point moves superiorly on te consponent artic ar surface t A this location, the contact force nomnal to the articular surface of the component) creates backside conipressive forces and backside shear forces. 2 For example, when a person Is standing upright, the normal line of pressure that the femoral component 8 exerts on a button or dome patellar component 2 points at or near the center of the component dome. An example of the line of pressure is shown In FIG. 2, by arrow A. During flexion (e.g., as a person squats), 5 the flexion of the knee Increases and causes the contact point between the femoral component and the patellar component to roll deeper in the trochlear groove and into the condyles. The line of pressure also swings up from the center of the dome toward the upper part of the component. In full flexion, the line of pressure is no longer normal to the natural patella, but is directed downward, pointing down toward 10 an upper portion of the patellar component, as shown by arrow B In FIG. 3. In full flexion, the force vector applies pressure at an upper portion of the patella. It essentially tries to "push" the button patella component off of the patellar bone surface. This force will be referred to as shear force. Part of the reason this occurs is because of the button patella's axis-symmetric dome-like shape. 15 A useful analogy for illustrating shear force is to consider a dome-shaped paperweight on a desk top. If someone applies pressure at the center of the dome, the paperweight stays in place. This is analogous to a person standing upright, with the force (i.e., compressive force) of the femoral component being directed at the center of the patellar dome. Referring back to the paperweight example, If a person 20 swings the pressure point normal to the surface and toward an upper part of the paperweight (e.g., toward one of the edges), the paperweight wll slide along the surface of the desk. This Is analogous to the knee in flexion, where the force of the femoral component Is directed toward an upper part of the patellar component. In this position, the pegs that attach the patellar component to the patellaare 25 particularly stressed. In fact, a number of artificial patella failures are due to peg failures, and these types of forces can be painful for the patient. This force is referred to as shear force, and embodiments of this Invention seek to avoid or decrease shear force. Part of the reason that shear force causes a problem with artificial patellar 30 components and not with a natural patella is because artificial patellar components tend to be shaped like an arc or a dome, whereas the natural patella Is more linear shaped. Because a natural patella Is flatter, as the patella rotates during flexion and 3 the contact vector(s) travel up the patella (note that when contact is with the condyles, there are two contact vectors, one from each condyle, and when contact is with the trochlear groove, there Is a single contact vector), the force vector(s) from the femoral component still remain somewhat normal (or perpendicular) to the 5 patella, as opposed to pointing down at an angle at the dome of a patellar component. Under Ideal conditions, anatomically-shaped patella components exhibit lower interface shear forces due to their contact condition and shape. However, they can be particularly sensitive to high contact stress edge loading due to mal-rotation or 10 positioning during surgical implantation. For example, many of the highly-conforming "anatomic" patella designs offered have different levels of constraint between the trochlear groove articulation area and the intracondylar articulation area. The constraint difference Is magnified in the anatomic design compared to a button (or dome) design because the anatomic design interfaces with more of the femoral 15 surface. This magnified constraint difference causes the anatomic patellar components to shift their alignment (equilibrium) with respect to the femoral component (particularly in rotational degrees of freedom) when moving from one area to the other, which can be perceived as an instability, pain, or a clunk to the patient. The shift seems to be more aggressive during ascent, when the patella is 20 moving from the Intracondylar area into the trochlear groove. The design challenge faced is to design surfaces of patellar components that minimize the shift in constraint, while still reducing the component/bone shear forces. Such designs will hopefully reduce patient pain and prolong the life of components. Accordingly, embodiments of the invention minimize shear force load between 25 a patella component and the patella bone, but still provide a component that Is not as sensitive to surgical mal-implantation or functional kinematics as highly-conforming "anatomically-shaped" patellas are. Another challenge experienced by patellar component manufacturers Is to design a component that lessens the shear force issues described, but that also 30 accommodates variations introduced by surgical inaccuracy and patient anatomical variation. For example, It is difficult to position a patellar component so that it precisely matches the orientation of the patello-femoral groove geometry on the 4 femoral component Accordingly, most designs on the market use an axis symmetric configuration for the bearing surface of the patellar component (as shown in FIGS. 1-3), which results in a low conformity between the patellar component part and the femoral component. With such a design, the surgeon does not need to 5 exactly and precisely position the component in order for it to function. However, such components cause the above-described shear force problems due to their shape. Other designs have attempted to make patellar components flatter or more concave, so that they more closely approximate a natural patella, but as the components are made flatter, they are more to sensitive positioning error. Due to a 10 lack of precise instruments, data, and information, it can be difficult to surgically arrange for the rotational positioning of an anatomic patellar component so that it precisely matches the orientation of the patello-femoral groove geometry on the femoral component. In other words, flatter components are more sensitive to mal rotation. When non-axis-symmetric patellar components are not implanted at the 15 proper position, it can cause ever greater wear concerns than the axis-symmetric designs discussed above. For example, some designs provide components having saddle shaped articulating areas separated by a flat ridge. While these components theoretically allow for a larger surface contact area between the patellar component and the 20 femoral component, they are also extremely sensitive to alignment (particularly rotational alignment and the inclination of the patellar component to the natural patellar bone). When surgical accuracy is not absolute, the error in alignment can cause edge loading and excessive fixation loading of the patellar component. Another problem experienced by conforming, anatomically-shaped patellas 25 (such as saddle-shaped patellas) is that they have different constraint pattems with the femoral componentthroughout the range of flexion. Specifically, the constraint of the patella riding in the trochlear groove is different from the constraint of the patella riding in the Intracondylar area. As a consequence, the patella seeks different equilibrium positions while articulating in each zone. During the transition of the 30 patella from the trochlear groove to the intracondylar area, there is often a readjustment translation and/or rotation movement caused by the patella arriving at a new equilibrium condition with the different constraint pattern. This movement is 5 H Iicmo cnRPonhi DCCGW X91' i1 dx 'U referred to as dunk, and it is especially apparent during extension from deep flexion. As previously mentioned, it can cause pain and may also be perceived by the patient as instability as the transition may be non-linear and possibly inconsistent from one area to another. Accordingly, there is a need for a patellar component design that is more optimally shaped so 5 that it can help reduce shear force. but that is also shaped to accommodate slight implantation error. There is also a need for a patellar component that can help lessen anterior knee pain, particularly during deep-flexion activities because the component/bone interface shear force is so h igh during these activities. There is also a need for a patellar component that can transition during the range of knee movement in a controlled way. There is a further need for a patellar component that has an increased 10 volume of material in certain regions that strengthen the component and help reduce failures. The invention provides a patellar component, comprising: a patella component body having (a) a first surface that engages natural patellar bone in use: and (b) a second surface that bears against a femoral component in use, the second surface having superior, inferior, medial, and lateral edge surfaces, the second surface further comprising: 15 (i) a substantially axis-symmetric portion extending from the medial edge surface to the lateral edge surface that contacts a femoral component in use; and (ii) one or more facet surfaces extending from the substantially axis-symmetric portion, the one or more facet surfaces contacting a femoral component in use. Embodiments of the present invention provide patellar components that are shaped to reduce or 20 minimize shear force and accommodate slight implantation error. Further, embodiments may lessen anterior knee pain, particularly during deep flexion activities and ease the transition during the range of knee movement in a controlled way. Disclosed herein is a patellar component, comprising: a patella component body having (a) a first surface that engages natural patellar bone in tise: 25 and (b) a second surface that bears against a femoral component in usC. the second surface having superior, inferior, medial, and lateral edge surfaces. the second surface further comprising: (i) a substantially axis-symmetric portion extending from the medial edge surface to the lateral edge surface that contacts a femoral component in use: 30 (ii) one or more facet surfaces extending from the substantially axis symmetric section, the one or more facet surfaces contacting a femoral component in use. 6 According to one embodiment the patellar may further comprise one or more reduced portions at the superior edge surface, the Inferior edge surface, or both, to allow a smooth transition over a femoral component during flexion and extension. According to a further embodiment the substantially axis-symmetric portion 5 contacts a femoral component in a fixed range of motion in use, and the one or more facet surfaces contacts a femoral component outside a fixed range of motion. According to an even further embodiment, the one or more facet surfaces scoop or extend concavely away from the substantially axis-symmetric portion. According to another embodiment, the substantially axis-symmetric section 10 comprises pie-shaped slivers that have wider curved portions at the medial and lateral edges, with the slivers meeting at an apex of the substantially axis-symmetric section. A further embodiment provides a substantially axis-symmetric section that facilitates mal-rotation tolerance in use. 15 According to a further embodiment, the first surface that engages patellar bone at a patellar bone/patellar component interface, and the second surface provides contact vectors throughout a range of motion that are close to normal to the patellar bonelpatella component Interface. According to further embodiments, the contact vectors are from about 0-30 20 degrees in one embodiment, or 0-20 degrees in another embodiment, or 0-10 degrees in a further embodiment, or 0-5 degrees in an even further embodiment, from one of: (a) a line that Is about perpendicular to the patellar bone/patella component Interface for an onset component; 25 (b) a line that is about parallel to an axis prepared in the patellar bone for an Inset component; or (c) a line that is about perpendicular to a reference line defined as a line between where a quadriceps muscle tendon attaches to a superior pole of the patella and where a patella tendon attaches to an inferior pole of the patella. 30 According to a further embodiment, the one or more reduced portions comprise an edge radius. 7 Ii Ii ,Ii ciNRPor DCC.GWJ . 1'p3e ' 2T)It, According to a further embodiment. the one or more facets extend concavely from the substantially axis-symmetric portion. According to a further embodiment, the relieved portion separates the substantially axis-symmetric portion into a first substantially axis-symmetric portion and a second substantially 5 axis-symmetric portion, wherein the first substantially axis-symmetric portion extends from the medial edge surface of the component to a medial central portion, and the second substantially axis-symmetric portion extends from the lateral edge surface of the component to a lateral central portion. In another embodiment, the relieved portion creates separate contact patches in the facets that contact the femoral component, even in deep flexion in use. 10 Disclosed herein is a patellar component, comprising: a patella component body having a first surface that engages patellar bone in use: and a second surface that bears against a femoral component, the second surface having superior and inferior edge surfaces, the second surface further comprising: a convex articular surface formed by sweeping a profile about one or more axes, none of which 15 intersect the second surface. Another embodiment of this aspect may comprise the one or more axes substantially aligned in the medial to lateral direction. According to a further embodiment, this aspect may also have one or more reduced portions at the superior edge surface, the inferior edge surface, or both, to allow a smooth transition over the 20 femoral component during flexion and extension. According to a further embodiment. the first surface engages patellar bone at a patellar bone/patellar component interface, and the second surface provides contact vectors throughout a range of motion that are close to normal to the patellar bone/patella component interface. According to further embodiments, the contact vectors are from about 0-30 decrees in one 25 embodiment. or 0-20 degrees in another embodiment, or 0-10 degrees in a further embodiment, or 0-5 degrees in an even further embodiment, from one of: 8 (a) a line that is about perpendicular to the patellar bone/patella component interface for an onset component: (b) a line that is about parallel to an axis prepared in the patellar bone for an inset component or 5 (c) a line that is about perpendicular to a reference line defined as a line between where a quadriceps muscle tendon attaches to a superior pole of the patella and where a patella tendon attaches to an inferior pole of the patella. In another embodiment 25, the convex articular surface has a radius of curvature between about 50-250 mm. 10 Disclosed herein is a patellar component characterized that, when in use at angles of knee flexion greater than about 90 degrees. a contact vector angle between the component and a femoral component is from about 0-30 degrees in one embodiment, or 0-20 degrees in another embodiment, or 0-10 degrees in a further embodiment, or 0-5 degrees in an even further embodiment, from one of: (a) a line that is about perpendicular to a patellar bone/patellar component interface for an 15 onset component; (b) a line that is about parallel to an axis prepared in the patellar bone for an inset component or (c) a line that is about perpendicular to a reference line defined as a line between where a quadriceps muscle tendon attaches to a superior pole of the patella and where a patella tendon attaches 20 to an inferior pole of the patella. Disclosed herein is a method for implanting a patella component comprising: (a) providing a femoral component: (b) providing a patellar component, comprising: a patella component body having (1) a first surface that engages natural patellar bone in use; 25 and (ii) a second surface that bears against the femoral component in use, the second surface having superior, inferior, medial, and lateral edge surfaces, the second surface further comprising: (1) a substantially axis-symmetric portion extending from the medial edge surface to the lateral edge surface that contacts a femoral component in use; and (2) one or more facet surfaces extending from the substantially axis-symmetric section, 30 the one or more facet surfaces contacting a femoral component in use; (c) preparing a recipient's natural patella to receive the implant; 9 H DCC fl I dac-l4 n221116. (d) implanting the implant on a portion of the natural patella. The present invention will now be described, by way of non-limiting example only, with reference to the accompanying drawings as briefly described below. FIG. I shows a side perspective view of how a patellar component may be secured to a portion 5 of a natural patella. FIG. 2 shows an example of the compressive force that a femoral component exerts on a button or domed patellar component when a knee is in extension. FIG. 3 shows an example of the shear force that a femoral component exerts on a button or domed patellar component when a knee is in flexion, 10 FIG. 4 shows a top plan view of a patellar component according to an embodiment of the invention. FIG. 5 shows a top perspective view of the patellar component of FIG. 4. FIG. 6 shows a side plan view in the medial to lateral direction of the patellar component of FIG. 4. 15 FIG, 7 shows a side plan view in the superior to inferiordirection of an alternate embodiment of a patellar component with a medialized apex. FIG. 8 shows a superior to inferior view of a component when implanted on a patella bone in full extension. This component has a design similar to that shown in FIG. 7, although this implant is attached by an inlay (insert) method. 20 FIG. 9 shows a side perspective view of a component having an increased edge radius. FIG. 10 shows a top plan view of a pate I lar component according to another embodiment of the invention. FIG. I I shows a top perspective view of the patellar component of FIG. 10. FIG. 12 shows a side plan view in the medial to lateral direction of the patellar component of 25 FIG. 10. 10 Hi vig mernecNRPiIbi I)C-OW941i17 I I dcc-Int ul22EI6 FIG. 13 shows a side plan view in the superior to inferior direction of the patellar component of FIG. 10. FIG. 14 shows an alternate embodiment of a component having an increased surface area on the articulation surface. 5 FIG. 15 shows a top plan view of an alternate embodiment of a component having an enlarged relieved portion. FIG. 16 shows a top plan view of a patellar component according to a further embodiment of the invention. FIG. 17 shows a side plan view in the medial to lateral direction of the patellar component of 10 FIG, 16. FIG. I8 shows an example of shear forces experienced by a button or dome patellar component. FIG. 19 shows an example of shear forces experienced by the patellar component of FIG. 16. FIG. 20 shows an example of a component geometry construction that may be used to design 15 the component of FIG. 16. FIG. 21 shows an example of a geometry construction that is used to design a dome or button patellar component of the prior art. FIG. 22 shows an example of a geometry construction that may be used to design the component of FIGS. 4-8. 20 FIG. 23 shows an example of an alternate reference frame that can be used to measure the normal force component, contact force vectors, and shear force components. Embodiments of the present invention provide patel tar prostheses that are designed to form a patella portion that replaces a part of a natural patella. The embodiments may decrease the shear force that is experienced by traditional dome 11 shaped patellar components, while also providing ease of implantation and accommodating a range of surgical error. In order to reduce component/bone Interface shear forces, which can be a source of pain and component failure, the ideal articular surface for a patellar 5 component has a substantially flat profile. However, In order to increase contact area for better durability, the Ideal articular surface substantially matches the coronal and sagittal profile of the trochlear groove of the femoral component. Finally, in order to allow for rotational laxity (surgical error), the ideal articular surface is axis symmetric (like the button or circular patellar components discussed above). 10 Embodiments of the patellar components described are an appropriate and optimal mix of these concepts. More specifically, the closer that the design is to a button design, the less the constraint differences between the trochlear groove articulation area and the intracondylar articulation area will affect rotational problems of the component, but the bonelpatella interface shear forces will almost likely be Increased 15 in undesirable ways. However, the closer the geometry is to an "anatomic" design, the interface forces can be reduced (or oriented in a more desirable direction), but the design can be sensitive to the constraint difference and the inevitable surgical mal-rotations. Embodiments of the described designs are intended to arrange the articular surfaces of the patella such that, even with certain amounts of rotation, the 20 contact vectors remain generally normal to the component/bone interface, thus causing the shear forces to be low. For example, at 90 degrees of flexion or greater, embodiments may reduce the contact vectors to 0-50 degrees in one embodiment, 0-45 degrees In another embodiment, 0-40 degrees in a further embodiment 0-35 degrees in another embodiment, 0-30 degrees in another embodiment, 0-25 degrees 25 in another embodiment, 0-20 degrees In a further embodiment, 0-15 degrees in another embodiment, 0-10 degrees In another embodiment, and about 0-5 degrees in a further embodiment, from one of either (a) a line that is about perpendicular to the patellar bonelpatella component Interface for an onset component or (b) a line that is about parallel to an axis prepared In the patellar bone for an inset component, 30 or (c) the alternate reference frames described below. 12 For (a): the line that is perpendicular to the patellar bone/patella component interface, an example for one embodiment is shown in FIGS. 18 and 19. A perpendicular line is shown by N, which represents the "normal farce component." (N1 Is shown is In FiG. 18 and N2 is shown in FIG. 19.) For (b): the line that is 5 about parallel to an axis prepared in the patellar bone, an example is the axis formed by a drill when preparing a recess in the bone to receive an inset patellar component The axis of the drill is also the axis prepared In the patellar bone. An alternate way to measure the angle between the contact vector and a normal direction on the patella is shown In FIG. 23. This alternate way uses a 10 different reference line - one that Is not defined by the placement of the patellar component, but Is Instead defined by an anatomic reference frame. In this option, the two areas of interest are (1) the attachment area 107 where the quadriceps muscle tendon 100 attaches to the superior pole of the patella 101 (first attachment area) and (2) the attachment area 108 where the patella tendon 104 attaches to the 15 inferior pole of the patella (second attachment area). These are the areas where forces extend through the patella. If a line 102 is drawn from an area within each attachment area 107 and 108 (preferably the center area of each area, but that is not required), line 102 can be used as a reference line. When viewed from the medial/lateral direction, this 20 reference line can be used to define a reference from which the contact forces acting on the patella can be measured. For example, a contact force angle can be measured from line 103, which is perpendicular to reference line 102. Referring now to the patellar components themselves, in a first embodiment, shown In FIGS. 4-6, the patellar component 10 has an component body 12, a first 25 surface 14 that engages patellar bone, and a second surface 16 that bears against a femoral component. The first surface 14 is typically flat with one or more pegs (not shown) that secure the component 10 to a patients natural patella that has been prepared to receive the component 10. As discussed above, embodiments of the Invention may be inset or onset components. Any appropriate number of pegs and 30 orientation of pegs may be used, and any other appropriate securing mechanism may be used instead of, or in addition to, pegs. 13 Second surface 16 is the surface that articulates with a femoral component and determines to what extent forces will act on the first surface 14/bone interface. Second surface 16 is formed from a set of articular surfaces that are divided into substantially axis-symmetric regions, faceted regions, and blended regions. The 5 combination of these surfaces lessens shear forces at the component/bone interface, as well as allows for mal-rotation Implantation tolerance. Second surface 16 is shown having a substantially axis-symmetric portIon 18 that extends from a medial edge surface 20 to a lateral edge surface 22 of component 10. The substantially axis-symmetric portion 18 has a curved radius over 10 a portion of the component 10. In one embodiment, curved portions 24 near the medial 20 and lateral edges 22 are somewhat wider than the curved portion at the apex 26 of the component. This creates, In essence, two thins slivers 28 (or "pie shaped" slivers) that form the sides of substantially axis-symmetric portion 18. These slivers 28 articulate against a femoral component in a fixed range of motion, 15 and help provide the benefits that are obtained when using a completely axis symmetric (i.e., button) patella. (Note: axis-symmetric portion 18 is referred to as "substantially" axis-symmetric, because, as discussed below, the portion need not be exactly symmetric in order to function. Alternate surface geometries, such a free forming surfaces, may achieve a similar effect and are discussed below.) 20 Within a fixed range of rotation, the patellar component 10 contacts the femoral component on the -substantially axis-symmetric portions 18. After a threshold value of rotation Is reached (which may be any threshold level, examples of which may be between 5-30 degrees, 5-15 degrees, or even more specifically 5 10 degrees, or any other appropriate range), the contact between component 10 and 25 femorai component typically moves into faceted surfaces 30, where a more conforming contact condition exists. For example, as the knee flexes and the patella transitions between the trochiear groove and the intracondylar area, the contact may move from the slivers 28 to the facet surfaces 30. As shown in FIG. 5, facet surfaces 30 are provided on the sides of 30 substantially axis-symmetric portion 18, Facet surfaces 30 define Indentations that "scoop" or extend down and concavely away from slivers 28 of substantially axis symmetric portion 18. In the embodiment shown, there are four facet surfaces 30, 14 one In each quadrant defined by the medial to lateral substantially axis-symmetric portion 18. For perspective and comparison to the button (dome-shaped) implants described above, consider a dome-shaped component that has been shaved to maintain a silver of a substantially axis-symmetric portion in the medial to lateral 5 direction. Facet surfaces 30 may be any depth that allows facet surfaces 30 to cooperate with the profile of the femoral component condyles. One way In which the geometry of facet surfaces 30 may be defined is shown in FIG. 22. The edge of a substantially axis-symmetric portion can be Identified and "extruded" about an axis in space above the articulating surface. This "extruded" surface or "swept sheet" can 10 define a depth range for facet surfaces 30. Surfaces 30 typically contact the femoral component outside a fixed range of motion, I.e., when the contact moves from the substantially axis-symmetric portions 18 to the more conforming facet surfaces 30. When a person In whom patellar component 10 is positioned Is standing upright, the normal line of pressure is directed at or near the apex 26 of the 15 substantially axis-symmetric portion 18. As the person flexes the knee (e.g., begins to initiate a squatting position), the patellar component rotates in relation to the femoral component such that the facet surfaces 30 are now the area upon which contact Is made. Facet surfaces 30 may provide a platform that cooperates with the femoral component and more closely approximates a natural patella: Facets 30 20 provide an increased level of conformity with the femoral component at Increased levels of mal-rotation. As shown In FIG. 6, the shear force component is lessened when the contact surface is a facet surface 30. The transition between the substantially axis-symmetric sliver 28 and the facet surface 30 on each side of sliver 28 is preferably smooth or blended, in order to 25 prevent a shift or clunk during the flexion transition. Also shown In FIGS. 4-6, component 10 may be provided with reduced portions 32 at the superior edge surface 34 and the inferior edge surface 36. Reduced portions 32 are provided in order to avoid "clunk"l or other interference in the trochlear groove that occurs during transition between flexion and extension. 30 FIG. 7 shows an alternate component 10 from the superior/inferior direction. In this embodiment, It can be seen that substantially axis-symmetric portion 18 may be positioned more to the medial edge 20 of the component (or medially biased). 16 FIG. 8 shows the Implant of FIG. 7 In an inferior to superior direction when implanted on a patient's left knee. This figure also shows how a component may be designed as an inlay design (e.g., so that it can be inset, as opposed to onset). Again, the apex of implant (or In this case, the substantially axis-symmetric portion) may be 5 medialized to provide rotational laxity axes that are not centered on the patella, such as the medial biased axis shown in FIG. 8. As discussed briefly above, it should be understood that other articular surface geometries can be used in order to achieve similar effects as those provided by the substantially axis-symmetric portion 18 and facet surfaces 30. For example, 10 component 10 could be provided with free-form shapes that approximate a geometry that is similar to the discrete surfaces that have been described. The free-form shapes need not be precise. For example, an axis-symmetric portion or substantially axis-symmetric portion need not be perfectly symmetric or a faceted surface could be more or less indented than other faceted surfaces or designed so that other 15 contact conditions exist. FIG. 9 shows a component that has a greater edge radius than that shown by reduced portions 32 of FIGS. 4-6. Edge radius 38 in FIG. 9 has even more material removed from reduced portion 32, which again, may help avoid clunk or other Interference in the trochlear groove that occurs during transition between flexion and 20 extension. This example Is shown to illustrate that reduced portions 32 may be slight or they may have a pronounced edge radius 38. Another embodiment of a patellar component 50 is shown In FIGS. 10-13. This embodiment has many of the above-described features, but it also Includes a relieved portion 52 in the superior to inferior direction (in some embodiments, it 25 extends from the superior edge surface 34 to the inferior edge surface 36). As shown in FIG. 11, relieved portion 52 divides central area 56 of surface 16 into two portions (e.g.. into medial and lateral sides). Relieved portion 52 may be concave, flat, substantially flat, or slightly convex. Its general purpose is to provide a divider with reduced contact area such that minimal to no contact between the relieved 30 portion 52 and the patellar groove of the femoral component occurs. This design provides an arrangement of the articular surfaces such that a constant constraint pattern exists with the femoral component throughout the available range of motion. 16 Relieved portion 52 is, in essence, material removed in the apex region of component 10 in order to provide two contact patches 60 all the way through flexion (or substantially all the way through flexions). The manufacture of relieved portion 52 can be referred to as apex-relief. (This concept is similar to a tiblal insert that has 5 two patches that maintain contact with a femoral component during flexion.) The patches 60 preferably remain at a relatively constant medial-lateral distance from each other during flexion so that the constraint patterns stay similar. This helps maintain a constant constraint throughout the flexion range on the anterior flange and intracondylar areas of the femoral component. The relieved portion 52 rides 10 along the trochlear groove without making contact. The amount of apex relief provided on component 50 can vary, depending upon the desired design. An increased portion of apex relief may also be provided at the superior-most and inferior-most surfaces (34 and 36) in order to help prevent the "clunk" problems described above. These increased apex relief portions are essentially the above 15 described reduced portions 32, they are just optionally provided in a more pronounced fashion.. Also shown in FIGS. 10-13 are substantially axis-symmetric portion 18, facet surfaces 30, and reduced portions 32 (which may have a slight or a large edge radius). These surfaces may be formed as previously described. In other embodiments, these surfaces may not be present as the dual contact patches 20 may allow for proper force balancing to reduce shear forces and controlled transition. In the alternate embodiment shown in FIG. 14, the profile of the component 50 may be modified to maximize contact area in deeper flexion. Facet surfaces are articulated similar to the implant of FIGS. 4-6, and similar to those implants, the articulate facet surfaces help to reduce shear stresses. Additionally, the medial apex 25 relief edge may be modified to Increase the medial contact area in early flexion. For example, as shown in FIG. 14, all axes and dimensions may remain the same as the design shown in FIG. 10, but the contact patches at the upper parts 62 of implant 50 can be slightly modified so that there is a greater articulation surface. In other words, If FIG. 10 is superimposed over FIG. 14, it would be seen that the upper parts 30 62 provide larger corners or have an extended profile that provide more articulation surface at upper parts 62. 17 In a further embodiment shown in FIG. 15, the relieved portion 52 may be widened and extend more to the medial 20 and lateral edges 22 (although it extends more to the medial edge side 20 In the embodiment shown). This embodiment does not have a relieved portion 52 that is flat or substantially flat, but is instead slight 5 convex. As discussed, this can still be considered a relieved portion 52 within the scope of this Invention. This design may find particular use in connection with a cruciate retaining procedure. The width of relieved portion 52 may be the same as the distance between the condyles of the femoral component. Providing an increased relieved portion minimizes the contact area, but may be necessary in 10 some instances. Although not shown, the relieved portion 52 may also be narrower than in the examples shown: This can maximize contact area, but may sacrifice sensItivity to mal-implantation. An appropriate balance for the necessary procedure can be achieved by combining various aspects of the designs described, depending upon the needs of the patient. 15 A further embodiment according to further aspects of the invention provides a convex oval patella component 70. Convex patella component 70 is shown in FIGS. 16 and 17 as having an oval shape, although any appropriate shape is within the scope of this invention. Component 70 of this embodiment has a first surface 72 that engages patellar bone and a second surface 74 that articulates against a femoral 20 component. First surface 72 may have features that are similar to the first surface embodiments described above. Second surface 74 is formed having a convex articular surface 76. Surface 76 defines a line with an arc that has been swept about an axis, i.e., a swept arc. An example of the geometry that can be used to construct a convex oval patella component is shown In FIG. 20. In this example, a sweep axis 25 is defined in one plane, and an articular surface profile Is swept or "extruded" about the sweep axis. This "extruded surface" or "swept sheet" can be used to define an articular surface 76 of component 70. The articular surface 76 may be formed by sweeping a profile about one or more axes, none of which intersect the second surface. (This Is distinguished from the typical methods that are used to design a 30 button or dome patella, illustrated in FIG. 21.) The radius of the convex arc or swept profile can range from about 50-250 mm, with a particularly useful radius at 100 mm. Moreover, the convex articular surface 76 may be made up of multiple 18 axes; for example, the center region could be a different radius than the superior and inferior regions to alter the amount of mal-rotation sensitivity for different flexion angles. Because a certain trochlear geometry is needed, component 70 may be 5 designed by taking a transverse section of the femoral trochlear groove and sweeping or extruding it about a substantially medial-lateral axis anterior to (opposite the side of) the articular surface of the patella, creating a convex articular surface when sectioned about sagittal planes. When a large convex radius is used, the backside interface shear forces/stresses can be greatly reduced. Since the articular 10 surface is not concave or flat, the sensitivity to mal-rotation (spin) Is reduced. An example comparing the shear forces experienced by a dome or button component to the shear forces experienced by a convex oval patella component 70 is shown in FIGS. 18 and 19. A contact vector for each design is shown with arrows "A" and "B". This is the direction at which forces from a femoral component extend. 15 The normal force component (measured either from the bone/component interface or using the anatomical reference frame defined by FIG. 23) is represented by N (N1 for FIG. 18 and N2 for FIG. 19). The distance between the ends of the contact force vector (A or B) and the normal force component (NI or N2) is the shear force component, represented by S1 and S2. FIG. 18 shows the shear force "SI" on a 20 dome/button component, and FIG. 19 shows the shear force "S2" on a convex oval component 70. The contact force "B" on the convex oval component is much closer to normal to the first surface, which means that shear forces are greatly reduced with this design. In short, by changing the convex radius, shear force reduction and ma rotation sensitivity can be balanced. This design is also more optimal than concave 25 or flat designs for femoral trochlear grooves that are not straight or that are slightly arcuate. Referring back to FIG. 17, a superior edge surface 78 and inferior edge surface 80 may also have reduced portions 32. As discussed above, reduced portions 32 can help the transition of the component 70 between the trochlear 30 groove and the condyles, preventing a catch or a clunk that may occur when transitioning between flexion and extension. This example also shows that reduced portions may be rounded or angular. The basic purpose in all embodiments 19 discussed is simply to remove material from the edges of the componen 'The convex component T) design may also include a greater volume of matei whan the dome/button paWluI dint s described. as shown in the comparison between FIGS. 18 and 19 The portion at which arrow 1 oints in FI0 I9 has more material, and is thus more durable in that region. than the portion at which arrow A" in 5 F6I . poiNts in short, the convex oval patella desMn can be useful to prV t excessive wear or fracture in certain regions. ie patellar component enbodhnents described herent may be unplanted using traditimal surgical tec unique& For example, the patelIas iraditionauy prepared after the tibial and fmorai eras have been inade, but prior to trial placement Once the appropriate patellar component is selected the 10 patella should be roamed at the appropriate depth mad location, (Difcrent reaming equiprment and techniques will be used depending upon whether the implant wil b onet or inst, asis understood in the art') The overall thickness of the patella should by measured in order to determine he amount of bone that remains after cutting, and then the paella is resected or resurfaced A patela peg drill can then be used to drill peg holes, Then once a portion of thenatural patella is prepared, the appropriate 15 patellar component is iniplanted. While varous embodiments o h present invention have been described above, it should be understood that they have been presented by way ot exainrile only, and not by way of limitation, It wil be apparent to a person skiled in the relevant art that various changes in form and detail can be made therein without departing from th spirit and scope of thin 'thus, the present invenon Should 20 not be limited by any of the above described exemnplary e iments, Throughout this specification and the claimns which low, unless the context requires otherwise. the wvord cOmprise, and variations such as "coTprises" and "comprising" will be understood to imply the inclusion of a stated or step or ro)up of integers or steps but not the exclusion of any other integer or step or grup of integea or steps. 25 The inference in thisspecification to any prior publication (or innnaton derived from it), or to any matter wh ich is known, is not, and should not be taken as an acknowedgment or admission or any foim of suggestion that that prior publication (or irdormation derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates. 30 20

Claims (16)

1. A patellar component, comprising: a patella component body having (a) a first surface that engages natural patellar bone inl use: and (b) a second surface that bears against a femoral component in use, the second surface having superior. inferior, medial, and lateral edge surfaces, the second surface further comprising: (i) a substantially axis-symmetric portion extending from the medial edge surface to the lateral edge surface that contacts a femoral component in use: and (ii) one or more facet surfaces extending from the substantially axis-symmetric portion, the one or more facet surfaces contacting a femoral component in use.

2. The patellar component according to claim 1, further comprising: one or more reduced portions at the superior edge surface. the inferior edge surface. or both, to allow a smooth transition over a femoral component during flexion and extension.

3. The patellar component according to any one of the preceding claims, wherein the substantially axis-symmetric portion contacts a femoral component ini a fixed range of motion in use, and wherein the one or more facet surfaces contacts a femoral component outside a fixed range of motion.

4. The patellar component according to any one of the preceding claims, wherein the one or more facet surfaces scoop or extend concavely away from the substantially axis-symmetric portion.

5. The patellar component according to any one of the preceding claims, wherein the substantially axis-symmetric section comprises pie-shaped slivers that have wider curved portions at the medial and lateral edges, with the slivers meeting at an apex of the substantially axis-symmetric section.

6. The patel lar component according to any one of the preceding claims, wherein the substantially axis-symmetric section facilitates mal-rotation tolerance in use.

7. The patel lar component according to any one ofthe preced ing claims, wherein the first surface engages patellar bone at a patellar bone/patellar component interface, and the second surface provides contact vectors throughout a range of motion that are close to normal to the patellar bone/patella component interface.

8. The pateIlar component according to any one ofthe preceding claims, wherein the one or more reduced portions comprise an edge radius. 21

9. The patellar component according to any one of the preceding claims, funher coiprising a relieved portion located where an apex of the suhanar l isetic portion would otherwise be, wnerein the one or ioe facets extend on outer sides of the substantial xissymne'tric portion.. 10, The patelar compsonem accord ing to e-aiml (), whoereon the one or more facets extend concavely 5 fhon the sutantial axis ymrnetric portion. I 1. The pate!lar componen t according to claim 9 or 10, whereinthe re Ieved portion separaies the substantial) axissymmetne porihon indo a firsr substantially axis-syimetric portion and a second substantially axsmetric portn wherein the first a a aisynmetric parti extends front the medial edge surface of the component to a rmed al central portion and the second substantialy 10 axissymetric portion extends from the lateral edge surface of ihe component to a lateral central ponion,

12. The patelar component according to any one of claims 9 to I n Wherein the re eved portion creates separate contact patches in the facets that contact the femoral component, even in deep flexioi in use. 15 13. The patelar component according to any one of the peceding claims, wherein the second surface further comprisS a convex articular surface tonned by sweeping a profit le about one or more axesI none of which intersect the second surt'ee,

14. The patellar component according to claim I wherein the one or moare ns are sutantil aligned i the medial to lterl directon. 20 15. The paellar component according to claim 13 or 1 4, further com prising: one or more reduced poritions at the Superior edge surface., the in ferior edge surface, or both, to allow a smooth transition over the femoral component during flexion ia tension

16. The patellar component according to any one of e 1ainc i3 to I5 werein :the first surface engages pateIilar bone at a pateiaar bone/patelar component mntertace a: nd th second d surtace piovids 25 contact vectors throughout a range of motion that are close to normal to the patelha hne/;patela component interface, Q The paeslam component accord-ing to myv one olf the precedhi g claim, wheres the conta vectors are from abott 0 to 30 degrees from one of; (a) a line that is about perpend icular to the paelar bone/patella component interface for an 22' H 1innioeiNRPentbI-DCCCww4919 AI doryx2112:2,M onset component; (b) a line that is about parallel to an axis of a recess prepared in the patellar bone for an inset component; or (c) a line that is about perpendicular to a reference line defined as a line between where a 5 quadriceps muscle tendon attaches to a superior pole of the patella and where a patella tendon attaches to an inferior pole of the patella.

18. The patellar component according to any one of the preceding claims, wherein the contact vectors are from about 0 to 30 degrees from one of: (a) a line that is about perpendicular to the patellar bone/patella component interface for 10 an onset component; (b) a line that is about parallel to an axis prepared in the patellar bone for an inset component or (c) a line that is about perpendicular to a reference line defined as a line between where a quadriceps muscle tendon attaches to a superior pole of the patella and where a patella tendon 15 attaches to an inferior pole of the patella.

19. The patellar component according to any one of the preceding claims. wherein the contact vectors are from about 0 to 20 degrees from one of: (a) a line that is about perpendicular to the patellar bone/patella component interface for an onset component; 20 (b) a line that is about parallel to an axis prepared in the patellar bone for an inset component or (c) a line that is about perpendicular to a reference line defined as a line between where a quadriceps muscle tendon attaches to a superior pole of the patella and where a patella tendon attaches to an inferior pole of the patella. 25 20. The patellar component according to any one of the preceding claims, wherein the contact vectors are from about 0 to 10 degrees from one of: (a) a line that is about perpendicular to the patellar bone/patella component interface for an onset component; (b) a line that is about parallel to an axis prepared in the patellar bone for an inset component 30 or (c) a line that is about perpendicular to a reference line defined as a line between where a quadriceps muscle tendon attaches to a superior pole of the patella and where a patella tendon 23 attaches to an inferior pole of the patella.

21. The patellar component according to any one of the preceding claims, wherein the contact vectors are from about 0 to 5 degrees from one of: (a) a line that is about perpendicular to the patellar bone/patella component interface for an 5 onset component: (b) a line that is about parallel to an axis prepared in the patel lar bone for an inset component or (c) a line that is about perpendicular to a reference line defined as a line between where a quadriceps muscle tendon attaches to a superior pole of the patella and where a patella tendon 10 attaches to an inferior pole of the patella.

22. The patellar component according to any one ofelaims 13 to 21, wherein the convex articular surface has a radius of curvature between about 50 to 250 mm. 24