Knee Prosthesis
Knee Prosthesis
Knee Prosthesis
E U R O P E A N PATENT A P P L I C A T I O N
(57) A knee joint prosthesis includes a femoral com- the prosthesis. This is achieved by increasing the coro-
ponent, a tibial plateau, and a tibial bearing member. nal radius of the bearing surfaces of the femoral com-
The design and geometry of the articulation surfaces of ponent in the anterior to posterior direction along the
the condylar elements of the femoral component and tib- bearing surface, i.e., increasing the coronal radius of the
ial bearing member is such that contact area between bearing surfaces of the femoral component as the fem-
the articulation surfaces is maximized during flexion of oral component transitions from extension to flexion.
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Description
5 This invention relates to implantable bone prostheses, and more particularly to knee joint prostheses.
Joint replacement surgery is quite common and enables many individuals to function normally when otherwise it
would not be possible to do so. Artificial joints are normally composed of metallic, ceramic and/or plastic components
that are fixed to existing bone.
Knee arthroplasty is a well known surgical procedure by which a diseased and/or damaged natural knee joint is
10 replaced with a prosthetic knee joint. Typical knee prostheses include a femoral component, a patella component, a
tibial tray or plateau, and a tibial bearing member. The femoral component generally includes a pair of laterally spaced
apart condylar portions, the distal surfaces of which articulate with complementary condylar elements formed in a tibial
bearing component.
In a properly functioning artificial knee joint, the condylar portions of the femoral component must slide and roll
is freely over the articulation surface formed by the condylar elements of the tibial bearing member. Natural friction within
a replaced, artificial joint can lead to the development of wear debris in which minute particles of debris (e.g., metal or
plastic from the prosthesis) become dislodged and migrate within the joint. The phenomenon of wear debris within
artificial joints is a serious problem that can inhibit the proper mechanical functioning of the joint. Moreover, wear debris
can lead to osteolysis and bone deterioration. When wear debris develops within an artificial joint, surgical removal of
20 the debris or subsequent replacement of the artificial joint is often necessary.
During normal usage of a properly implanted prosthetic knee joint, load and stress are placed on the tibial bearing
member. The tibial bearing member is typically made of an ultrahigh molecular weight polyethylene (UHMWPE). Fric-
tion, continuous cycling and stress can cause some erosion and/or fracture of the tibial bearing member, thus leading
to wear debris. The risk of wear debris can be even greater during malalignment of an artificial knee joint, which can
25 result from normal usage or from imperfect and/or inaccurate implantation of the prosthesis within a patient. As a result
of malalignment, the load upon the tibial bearing member is not evenly distributed. Instead, excess load is placed on
certain areas of the tibial bearing member. This uneven distribution of load (or edge loading) can accelerate the de-
velopment of wear debris. Contact stresses on the tibial bearing member increase substantially with malalignment of
the joint, thus increasing the risk that wear debris will develop when a prosthetic knee joint is subjected to malalignment
30 conditions.
Contact stresses on the tibial bearing member also tend to increase when the prosthetic knee joint is rotated into
flexion. This increased contact stress results from a corresponding decrease in tibio-femoral contact area.
There is thus a need for knee joint prostheses that have reduced tendency to develop wear debris due to the
maintenance of good contact area and low contact stress between femoral and tibial components, even during the
35 dynamics of daily activity and in various conditions of flexion and malalignment.
Accordingly, it is an object of the present invention to provide knee joint prostheses with improved performance
and a longer use for life. It is also an object of the invention to provide knee joint prostheses having reduced tendency
to develop wear debris. A further object of the invention is to provide knee joint prostheses which are able to maintain
relatively high contact area and low contact stress between femoral and tibial components throughout the normal range
40 of motion and in conditions at malalignment. Another object of the invention is to provide knee joint prostheses that
exhibit acceptable levels of laxity despite maintaining good tibio-femoral contact area in conditions of flexion. These
and other objects will be apparent from the description that follows.
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Figure 1 is an exploded, perspective view of an artificial knee joint illustrating the femoral component, the patella
30 component, the tibial bearing member and the tibial plateau.
Figure 2 is a side view from the medial side, with cross-section, of an artificial knee femoral component positioned
adjacent a prosthetic tibial bearing member in perfect alignment and at 0° flexion.
Figure 3 is an anterior view, with cross-section at lines 3-3, of the artificial knee femoral component shown in Figure
2 positioned adjacent a prosthetic tibial bearing member in a condition of perfect alignment and at 0° flexion.
35 Figure 4 is a top view of the prosthetic tibial bearing member shown in Figure 1.
Figure 5 is a sectional view, in the sagittal plane, of a femoral component and tibial bearing member constructed
according to the present invention.
Figure 6 is a partial sectional view at lines 6-6, in the coronal plane, of the femoral component illustrated in Figure 2.
Figure 7 is a side view (from the medial side) of the femoral component of the present invention mounted adjacent
40 to a tibial bearing member at 90° flexion.
Figure 8 is a bar graph comparing contact area at high and low flexion angles for knee joint prostheses according
to the present invention and prior art knee joint prostheses.
Figure 9 is a graph comparing the ratio of contact area through the range of motion to contact area at 15° flexion
plotted against flexion angle for knee joint prostheses according to the present invention and prior art knee joint pros-
es theses.
Figure 10 is a graph comparing the ratio of contact stress through the range of motion to contact stress at 15°
flexion plotted against flexion angle for knee joint prosthesis according to the present invention and prior art knee joint
prostheses.
The present invention provides an improved construction for knee joint prostheses, especially as the femoral com-
ponent rotates into flexion. The design and geometry of the knee joint prosthesis of the invention facilitate greater
contact between the femoral and tibial components of the knee joint prosthesis during flexion than that which is typically
55 associated with knee prostheses.
Figure 1 illustrates four components found in a knee joint prosthesis 10 constructed according to the present
invention. A patella component 11 is adapted to seat against an anterior portion of the femoral component 12. The
femoral component 12 includes an inferior surface 16 which is mountable within the distal end of a patient's femur and
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a superior articulation surface 18. The articulation surface 18 includes adjacent lateral 20 and medial 22 condyles. The
knee prosthesis 10 also includes a tibial tray or plateau 24, the distal end 26 of which includes a distally extending
stem 25 which is mountable within the tibia of a patient. The proximal end 30 of the tibial plateau includes a recessed
region 32 within which a tibial bearing member 34 is mounted in a mechanical fit.
5 Tibial bearing member 34 includes a distal surface 36 mountable within a recessed region 32 of proximal end 30
of tibial plateau 24. The proximal surface 38 of tibial bearing member 34 forms an articulation surface 40 that engages
and articulates with the articulation surface 18 of femoral component 12. The articulation surface 40 of the tibial bearing
member 34 includes adjacent lateral 42 and medial 44 condyles. As shown in Figure 3, the lateral and medial condyles
20, 22 of the femoral component 12 mount in engagement with the lateral and medial condyles 42, 44 of tibial bearing
10 member 34.
Although not illustrated, it is understood that a tibial component of an artificial knee joint can be formed as a single
piece which includes portions that correspond to tibial tray component 24 and tibial bearing member 34. Typically, such
single piece units are manufactured of ultrahigh molecular weight polyethylene.
The condyles 20, 22 of femoral component 12 and the condyles 42, 44 of tibial bearing member 34 are configured
is such that a relatively large contact area is achieved when the condyles of the femoral component and the condyles of
the tibial bearing member engage each other. Greatest contact area is achieved in conditions of perfect alignment,
throughout the range of motion of the knee joint. In conditions of malalignment, including varus-valgus lift and internal-
external rotation, contact area of existing knee prostheses typically decreases substantially. The term "perfect align-
ment", as used herein refers to a condition where the knee joint is subjected to 0° varus-valgus lift, and 0° internal-
20 external rotation throughout the anatomic range of flexion-extension (i.e., about -10° to 120°).
Figures 2 through 7 illustrate the femoral component 12 of the invention, including condyles 20, 22. Each condyle
20, 22 is generally ellipsoid in shape and is of a curved, convex shape in both the anterior-posterior direction and in
the medial-lateral direction. In a preferred embodiment, the curvature of the articulation surface 23 of each condyle
20, 22 lying in the sagittal plane, in contact with the condyles 42, 44 tibial bearing member, and extending in theanterior-
25 posterior direction is defined by at least two semi-parallel radii wherein a first sagittal radius is more anterior than a
second sagittal radius. The first, more anterior sagittal radius (R-,) is offset from the second sagittal radius (R2) by the
distance between their respective centers of curvature (C-,, C2). As shown in Figure 5, the curvature of the articulation
surface 23 lying in the sagittal plane for each condyle 20, 22 can be defined by approximately 4 radii. However, the
critical surface geometry is that which relates to the portion of the condyles 20, 22 which contact the condyles 42, 44
30 of the tibial bearing member 34. A first sagittal radius (R-,) covers an intermediate portion of the articulation surface 23
of each condyle 20, 22 in the sagittal plane and extending in the anterior-posterior direction. Typically, the articulation
surface 23 of condyles 20, 22 defined by the first sagittal radius (R-, ) contacts the articulation surface 40 of tibial bearing
member 34 during flexion of the knee between approximately 0° and 40°. The first sagittal radius (R-,) is in the range
of approximately 1.020 to 1.885 inches.
35 The second sagittal radius (R2) covers a more posterior portion of the articulation surface 23 of condyles 20, 22
lying in the sagittal plane and extending in the anterior-posterior direction. The articulation surface 23 of condyles 20,
22 defined by R2 typically contacts the articulation surface 40 of tibial bearing member 34 during flexion of the knee
greater than about 40°. The second sagittal radius (R2) preferably has a value of approximately 0.6 to 1.2 inches, and
more preferably due to anatomic constraints, a value of about 0.7 to 1.1 inches.
40 As illustrated in Figure 5, the first and second sagittal radii (R-,, R2) originate from their respective centers of
curvature (C-,, C2). The centers of curvature C1 and C2 are collinear and the center of curvature for R2 (C2) is more
posterior than the center of curvature for R1 (C-,).
The values of the first and second sagittal radii (R-, , R2) are, to some extent, dependent upon the size of the femoral
component. Typically, femoral components are available in different sizes to accommodate the anatomies of different
45 patients. Femoral components can have dimensions in which the largest width (in the anterior-posterior dimension)
ranges from about 50 to 74 mm, and in which the largest width (in the medial-lateral dimension) ranges from about 54
to 78 mm. Table 1 illustrates approximate values for the first and second sagittal radii with varying femoral component
sizes.
so Table 1
Femoral Component Size A-P Width (mm) M-L Width (mm) R1 Value (inches) R2 Value (inches)
2 56 60 1.194 0.743
3 61 66 1.321 0.794
4 65 71 1.405 0.828
5 69 73 1.511 0.860
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Table 1 (continued)
Femoral Component Size A-P Width (mm) M-L Width (mm) R1 Value (inches) R2 Value (inches)
6 74 78 1.750 0.950
Usually, as a prosthetic knee joint goes into flexion the tibio-femoral contact area decreases and hence contact
stress increases. Tibio-femoral conformity is the ratio of the femoral radius to the tibial radius in the medial-lateral plane
and in the anterior-posterior plane. Thus, medial-lateral conformity can be expressed as
RMIL
R,MIL
where RfM/L is the femoral radius in the medial-lateral plane and RiM/L is the tibial insert radius measured in the medial-
lateral plane. Similarly, conformity in the anterior-posterior plane, or anterior-posterior conformity, can be expressed as
RfA/P
RiA/P
Where RWP is the femoral radius in the anterior-posterior plane and RiA/p is the tibial radius in the anterior-posterior
plane. A decrease in conformity between the two components results in a decrease in contact area and an increase
in contact stress.
Conformity can be measured at any flexion angle. Generally, the anterior-posterior conformity of existing knee
prostheses decreases as the femoral component rotates into flexion. This results from a decrease in the femoral radius
in the sagittal plane at higher flexion angles, due to anatomic constraints. In the present invention, the decrease in
anterior-posterior conformity is offset by an increase in medial-lateral conformity. This is accomplished by gradually
increasing the coronal radii of the bearing surface 23 of condyles 20, 22 from anterior to posterior portions of the bearing
surface 23 of condyles 20, 22. The increasing coronal radius (in the anterior-posterior direction) results in an increase
in medial-lateral conformity. This increase in medial-lateral conformity causes the tibio-femoral contact area to remain
more stable (i.e., to remain constant or to decrease to a lesser extent) as compared to representative existing knee
joint prostheses.
Figure 3 illustrates the curvature of bearing surface 23 of condyles 20, 22 lying in the coronal plane and extending
in the medial-lateral direction at a point on the bearing surface corresponding to approximately 0° flexion. The curvature
at this point on the bearing surface is defined by the initial coronal radius (R^). Preferably, the initial coronal radius
is in the range of about 0.70 to 1.1 inches. The value of the coronal radius, as noted above, increases gradually from
the initial coronal radius as one moves along the bearing surface 23 from this anterior portion of the articulation surface
to posterior portions of the articulation surface. Generally, the coronal radius increases by approximately 4 to 7% from
the RC(|) to a point on the bearing surface corresponding to flexion of approximately 90°.
Figure 6 illustrates the curvature of the bearing surface 23 of condyles 20, 22 lying in the coronal plane and ex-
tending in the medial-lateral direction at a point on the bearing surface 23 corresponding to approximately 45° flexion.
The value of the coronal radius at this point on the articulation surface preferably is in the range of about 0.74 to about
1.17 inches, and most preferably is about 0.848 inch. In a preferred embodiment, the coronal radius is independent of
the size of the femoral component or tibial bearing member used in the joint prosthesis.
Referring again to Figures 1 through 7, tibial bearing member 34 includes adjacent lateral 42 and medial 44 tibial
condylar elements that are generally ellipsoid and are configured to seat and articulate with condyles 20, 22 of femoral
component 12. The tibial condylar elements 42, 44 preferably are of a curved, concave shape. The articulation surface
46 of tibial condylar elements 42, 44 is characterized by a curved, concave surface in both the medial-lateral and
anterior-posterior directions. The curvature of the tibial condylar elements 42, 44 lying in the sagittal plane and extending
in the anterior-posterior direction is defined by a sagittal radius (Rs). Preferably, this radius is approximately 104% to
120% of the first sagittal radius (R-,) of the condylar elements 20, 22 of femoral component 12.
The curvature of the condyles 42, 44 of the tibial bearing member 34 lying in the coronal plane and extending in
the medial-lateral direction is defined by a coronal radius (Rc). The coronal radius of the condyles 42, 44 of the tibial
bearing member preferably is approximately 120% to 152% of the initial coronal radius Rc^ of the condyles 20, 22 of
the femoral component 12.
The knee joint prosthesis 10 of the present invention provides many advantages. As noted above, the tibial-femoral
contact area is improved and contact stress is reduced. A major improvement in contact area is evident during flexion.
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While many knee joint prostheses experience dramatic decrease in tibio-femoral contact area during flexion (on the
order of about 40%), the present knee prosthesis is less susceptible to dramatic decreases in tibio-femoral contact area.
Figure 8 compares predicted contact area for knee joint prostheses made according to a representative existing
design and the present invention (varying coronal radius condyle design) at low flexion (about 15°) through high flexion
5 (about 90°).
The data was generated using as a sample a medium size representative existing design (i.e., RFC. Knee System
available from Johnson &Johnson Professional. Inc.) and a knee joint prosthesis constructed according to the present
invention. The knee joint prosthesis constructed according to the present invention was a medium size prosthesis
having a minimum and maximum femoral condyle radii of 0.800 to 0.832 inches, respectively.
10 Data was generated both through theoretical and experimental methods as follows. Contact stress and contact
area were calculated using an approximate elasticity solution to the rigid indenter (femoral condyles) on an elastic
bearing surface (tibial insert) problem. This method was adapted from that developed and used by Bartel and his
coworkers to investigate the effects of geometry and material properties on contact stress in joint arthroplasty compo-
nents. (See, Bartel et al., J. Biomech. Eng., Vol. 107, Aug. 1985, pp. 193-199; Bartel, et al., JBJS, Vol. 68-A, No. 7,
is Sept. 1986, pp. 1041 -1 051 .) Bartel et al. concluded from their investigation that the elasticity solution was valid for use
in parameter studies. The load applied during this procedure was 450 pounds. The method has also been shown to
be valid for comparative purposes using Tekscan measurement of stress and area as a baseline. The ratio of peak
stress to average stress of 1.5 (i.e., peak stress = 1.5 times average stress) as given by Hertzian contact theory has
also been shown to agree well with measured and calculated force, area and stress data. (See, Timoshenko et al.,
20 Theory of Elasticity, 3rd Edition, McGraw-Hill, New York, 1970, Reissue, 1987.) The experimental data are illustrated
in Figure 8.
As shown in Figure 8 the current femoral condyle design with multiple, increasing coronal radii achieves substan-
tially constant contact area at low and high flexion. In contrast, conventional designs exhibit a dramatic decrease in
contact area from low to high flexion conditions.
25 Figures 9 and 10 illustrate data obtained by plotting the ratio of contact area to contact area at 15° flexion versus
flexion angle (Figure 9) and contact stress to contact area at 15° flexion versus flexion angle (Figure 10) for both the
current design and a conventional design.
The data were developed using the knee joint prostheses described above with respect to Figure 8, and the pro-
cedure for obtaining the data is similar to that described for Figure 8.
30 The design and geometry of the articulation surfaces of the femoral component and tibial bearing member of the
knee prostheses made according to the present invention lends itself to use with a variety of different constructions
for a knee joint prosthesis. That is, the articulation surface design and geometry described herein may be incorporated
to knee joint prostheses such as cruciate retaining knee prostheses, cruciate sacrificing knee prostheses, meniscal
bearing prostheses, revision prostheses, hinge prostheses, and unicondylar prostheses.
35 It will be appreciated by those of ordinary skill in art that the knee prostheses of the invention can be made from
a variety of biocompatible materials having high strength, durability and resistance to wear debris. Examples of such
materials include metal alloys such as cobalt-chromium alloy, titanium-aluminum-vanadium alloy, stainless steel, ce-
ramics, and other materials that are well known for use in the manufacture of implantable bone prostheses. Typically,
the femoral component and tibial plateau are made from metal alloys such as cobalt-chromium alloy while the tibial
40 bearing member is made from polymers such as ultra-high molecular weight polyethylene.
The foregoing description of the invention is presented to indicate the range of constructions to which the invention
applies. Variations in the physical architecture and dimensions of the knee prostheses will be apparent to those having
ordinary skill in the art based upon the disclosure herein and such variations are considered to be within the scope of
the invention in which patent rights are asserted, as set forth in the claims appended hereto. The entirety of all references
45 cited herein is expressly incorporated by reference.
Claims
a femoral component having an inferior surface mountable on a distal end of the femur of a patient and a
superior articulation surface including two adjacent, semi-parallel bearing surfaces, each bearing surface being
of a curved, convex shape in both the anterior-posterior direction and in the medial-lateral direction, wherein
55 the curvature of each bearing surface lying in the coronal plane and extending in the medial-lateral direction
is defined by multiple coronal radii, wherein the coronal radii increase in value along the bearing surface from
an anterior portion of the bearing surface to a posterior portion of the bearing surface;
a tibial component having a proximal end and a distal end mountable on the tibia of a patient; and
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a tibial bearing member having a distal surface mountable within the proximal end of the tibial component and
a proximal articulation surface, the proximal articulation surface including adjacent tibial condylar elements
that seat adjacent, semi-parallel bearing surfaces of the femoral component.
5 2. The prosthesis of claim 1 wherein the tibial condylar elements of the tibial bearing member are each of a curved,
concave shape in both the anterior-posterior and medial-lateral directions and the curvature of the tibial condylar
elements lying in the coronal plane and extending in a medial-lateral direction is defined by a tibial coronal radius.
3. The prosthesis of claim 2 wherein the curvature of each bearing surface lying in the sagittal plane, in contact with
10 a tibial condylar element, and extending in the anterior-posterior direction is defined by at least two semi-parallel
radii wherein a first sagittal radius is more anterior than a second sagittal radius, with the first and second sagittal
radii being offset from one another by the distance between their respective centers of curvature.
4. The prosthesis of claim 2 wherein the coronal radii increase from a minimum value at an anterior-most point on
is the bearing surface in contact with the condylar elements of the tibial bearing member at about 0° flexion to a
maximum value at a posterior-most point on the bearing surface in contact with the condylar elements of the tibial
bearing member corresponding to about 90° flexion.
5. The prosthesis of claim 4 wherein the coronal radius remains substantially constant beyond the maximum value
20 at a posterior-most point on the bearing surface in contact with the condylar elements of the tibial bearing member
corresponding to about 90° flexion.
6. The prosthesis of claim 4 wherein the coronal radii increase by approximately 4 to 7 percent from the minimum
radius value to the maximum radius value.
25
7. The prosthesis of claim 4 wherein the minimum radius value is about 0.7 to 1. 1 inches.
8. The prosthesis of claim 4 wherein the maximum radius value is about 0.74 to about 1.17.
30 9. The prosthesis of claim 4 wherein the maximum radius value is less than or equal to the tibial coronal radius value.
10. The prosthesis of claim 4 wherein the maximum radius value is approximately 2% less than the value of the tibial
coronal radius.
35 11. The prosthesis of claim 4 wherein the coronal radii range from a minimum value of about 0.80 inch to a maximum
value of about 0.85 inch.
12. The prosthesis of claim 3 wherein the tibio-femoral contact area of the prosthesis remains substantially the same
throughout a range of motion of the prosthesis from 0° flexion to about 90° flexion.
40
13. The prosthesis of claim 12 wherein the tibio-femoral contact area is in the range of about 200 to 400 mm2 throughout
the range of motion of the knee joint prosthesis from 0° flexion to about 90° flexion.
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