The present invention relates to prosthetic joints (e.g., orthopedic total knee arthroplasty (TKA) devices) and more particularly, to a constrained condylar knee (CCK) implant system for primary and revision surgery that offers improved stability of the joint during rotation (varus/valgus).
Joint replacement surgery is quite common and it enables many individuals to function normally when they otherwise would not be possible to do so. Typically, an artificial joint includes metallic, ceramic and/or plastic components that are fixed to existing bone. One of the more common joints that undergoes replacement surgery is the knee. Knee arthroplasty is a well known surgical procedure by which a diseased and/or damaged natural knee joint is replaced with a prosthetic knee joint.
Artificial knee joints consist of essentially four components. The first component is a metallic tibia implant. The second component is a metallic femoral implant. The third component is a high-density polyethylene insert positioned between the two metal components. The fourth component, not part of the present invention, is a polyethylene patellar component. Together they form a joint that can provide a total replacement for a diseased native knee joint.
Traditionally the joint surfaces associated with the implant components are approximated by toroidal or donut shaped surfaces on both the insert and the condylar surfaces of the femoral component which transfer load from the femur to the tibia through the polyethylene insert. The total joint, once implanted, is stabilized and controlled in part by these surfaces and in part by the soft tissues surrounding and encapsulating the knee.
TKA devices can fail for reasons such as aseptic loosening, instability, or infection. Failure usually requires revision surgery. Revision implants have been developed that include a post on the polyethylene tibial component that articulates within a recess (intercondylar box) in the femoral component. The objective of this so called constrained condylar knee (CCK) implant is to rely on contact between the box and the post within the joint itself to restrain and limit rotation of the knee (varus/valgus rotations). This constraint is also beneficial in primary TKA if the soft tissues cannot be balanced to achieve an adequately stabilized and controlled joint.
In contrast to conventional constrained condylar knee implants, the knee implants of the present invention includes nontoroidal surface geometry on the joint bearing surfaces to provide improved stability and performance of the joint during rotation (varus/valgus).
Additional features of the device tend to reduce contact stress on the post improving longevity and functionality of the joint.
There are several implementations of the improved geometry disclosed, but in general each condylar surface has at least two distinct radii in the coronal plane. During varus or valgus rotation, the point of contact between the femoral component and the tibial component moves laterally (outwardly). This point of contact migration alters the moment arm associated with soft tissue so that a much larger restoring moment is generated by muscles and ligaments, increasing the stability of the joint. The magnitude of this effect depends on the rotational angle of the joint. Additionally contact between a constraint post of the insert component (tibial) and an intercondylar box of the femoral component occurs gradually as a function of varus/valgus rotation and flexion-extension rotation (in a manner that reduces stress and wear on the post).
In one embodiment of the present invention, a knee joint prosthesis includes a femoral component having a first condylar bearing surface and a second condylar bearing surface. Each of the first and second condylar bearing surfaces has a cross-section in a coronal plane that exhibits at least two different radii. The prosthesis also includes a tibial component and an insert component associated with the tibial component. The insert component has bearing surfaces that are complementary to the first and second condylar bearing surfaces, wherein a contact point is established between the bearing surfaces of the insert component and the first and second condylar bearing surface. In accordance with the present invention and as a result of the above construction, varus and valgus rotation of the femoral component relative to the insert component causes the contact point to move laterally/outwardly as the knee is rotated. By shifting the contact pointy laterally (outwardly), the knee stability (i.e., stiffness) gradually increased.
In one embodiment, a femoral component for use in a knee joint prosthesis includes a body having a pair of laterally spaced condylar portions. A cross-section of each of the condylar portions is defined by at least two radii in a coronal plane, wherein a medial radius of each condylar portion is less than a lateral radius of the respective condylar portion.
Similarly, in one embodiment, a tibial component for a knee joint prosthesis includes a platform having an upper surface that includes first and second laterally spaced concavities. Each concavity is adapted for receiving one condylar portion of the femoral component and the tibial component includes a constraint post for reception in an intercondylar recess of the femoral component. Each of the first and second laterally spaced concavities includes a bearing surface that is defined by at least two different radii in a coronal plane.
Based on the foregoing, the present invention also includes a method for providing increasing stability in a knee joint prosthesis that includes a femoral component and a tibial component comprising the step of: moving in a lateral direction a point of contact between a condylar bearing surface of the femoral component and a complementary bearing surface of the tibial component as the knee undergoes varus or valgus rotation.
These and other aspects, features and advantages shall be apparent from the accompanying Drawings and description of certain embodiments of the invention.
A few exemplary embodiments of the invention are depicted in the following figures, in which:
Failed primary TKA is not common but it is problematic for the patient. Revision knee arthroplasty is a significant percentage (˜10%) of all TKA. TKA patients needing revision often have compromised collateral ligaments and subsequent varus/valgus instability. The common device used to treat these cases is a constrained condylar knee (CCK) implant. A CCK device includes a central post on the tibial insert that articulates with a recess in the femoral component (the intercondylar box). Contact between these structures limit rotation of the joint and prevent excessive varus/valgus rotation of the knee. The post has a relatively tight fit into the box of the femoral component allowing minimal rotation before contact. The post is in the center of the implant and made of a relatively soft material (ultra-high molecular weight polyethylene), so the post tends to fail via local deformation due to high contact stresses on the edges of the post, and thus the stability provided by the post is lost.
In conventional CCK devices, the varus/valgus stability is constant regardless of the flexion angle of the knee. However, a patient needs more stability in mid-flexion than at full extension. As a result, therein is a need to for an improved design where the implant device has variable varus/valgus stability matched to the functional requirements throughout the range of motion of the implant.
Current CCK implants primarily address varus/valgus stability. Motion analysis data during gait show that some patients experience anterior translation of the femur near full extension. Therefore, a CCK device that limits anterior translation is desirable and there is a need for such a device.
In view of the foregoing deficiencies associated with conventional CCK devices, the present invention is directed to an improved CCK device that overcomes the above noted deficiencies and provides improved stability over a range of different motions.
The prosthesis 100 generally includes a femoral component 110 (
As described in detail in commonly assigned U.S. patent application Ser. No. 11/860,423 (U.S. patent publication No. 2008/0097615) (which is hereby incorporated by reference in its entirety), the design of the intercondylar portion 130 has been modified so that the amount of bone that has to be removed is reduced.
The intercondylar portion 130 is defined by an arcuate shaped wall 131 that likewise defines the roof 132 of the portion 130. The roof 132 can thus be thought of as the apex region of the arcuate shaped wall 131. The illustrated arcuate shaped wall 131 has a semi-circular shape or “rounded shape” that is designed to be received within a complementary rounded bone notch or opening. The present intercondylar design thus does not include a well defined roof that is generally horizontal (parallel to a nominal base plane). Significantly less bone is removed in the design of the present invention since the hard squared edges of the conventional femoral box notch are absent in the rounded femoral box notch made according to the present invention. The cylindrical shape of the femoral box notch made in the femur can be cut with a rotating cutter, such as a drill or reamer, which eliminates the additional stress concentrations created by the overcut slots that are created when cutting the box geometry with a sagittal saw. In other words, the cylindrical box geometry can be cut without creating stress concentrations in the corners where a sagittal saw would extend the cut past the edge of the box.
An opening 160 is preferably formed in the roof 132 of the intercondylar portion 130 and in particular, the opening 160 is formed in the arcuate shaped wall 131. Since the roof in the prior art intercondylar portion is a flat, planar surface, the opening was contained in the same plane; however, the arcuate shape of the wall 131 causes the opening 160 to lie not in a single plane, but instead, the opening 160 lies in an arcuate shaped surface. The opening 160 allows for placement of an intramedullary nail in the event of a distal femoral fracture after total knee replacement.
An underside of the femoral component 110 includes a surface 170 (which can be an arcuate surface—e.g., a curved saddle shaped surface as described in the '615 publication). This surface 170 is located adjacent the opening 160 and faces the tibial component 200 when the two components 110, 200 are assembled. The arcuate surface 170 is proximate the patella portion 120. According to the present invention, this surface 170 is configured and dimensioned so as to mate with a complementary surface of the tibial component 200 when the components 110, 200 mate together as described below.
The femoral component 110 can include a cam follower surface (not shown) that is located adjacent the opening 160 at the posterior side of the femoral component 110. In particular, the cam follower surface is positioned between the condylar portions 114, 116 and is described in more detail in the '615 publication.
The femoral component 110 can be made of a number of different materials, including a surgical grade, durable metal, such as a 316L stainless steel or a chrome-cobalt-molybdenum meeting ASTM Standard #F75. All surfaces which are external to the bone are preferably highly polished.
Straight Box Femoral Component
In yet another aspect of the present invention and as described herein, in the present invention, the shape of the femoral component 110 (as well as the tibial component 200) so that the geometry is no longer a swept circular shape (i.e., a toroid). Instead, the swept geometry consists of two tangent radii, for which the medial radius of the condyle is smaller than the lateral radius. More specifically, an underside of the femoral component 110 includes a first condylar bearing surface 111 and a second condylar bearing surface 113.
In yet another embodiment, each of the condylar bearing surfaces 111, 113 can be formed by a surface that is created with a multiple radius curve (spline) where the medial part of the curve has smaller radii than the lateral part. Thus, the surface can be defined by more than two radii.
Stepped Box Femoral Component
In one embodiment as shown in
In the illustrated embodiment, the anterior portion of the box is wider than the posterior portion and accordingly, the distance between the first sections 190 is greater than the second sections 192 as shown in
In another embodiment shown in
Tibial Component
Now referring to
As shown in the figures, the tibial component 200 includes an oblong, rounded, disc-like plateau portion 210 that has an upper surface that can be flat or have some other predetermined contour. A pair of laterally spaced-apart, oblong concavities 212, 214 is formed along the upper surface for receiving femoral condylar portions 114, 116 of the femoral component 110 as described below. The “nested” support of the femoral component 110 stabilizes the prosthetic joint, but still permits antero-posterior translation, lateral angulation and rotation, all of which are involved in normal function of the anatomical knee joint.
The tibial insert 220 also preferably includes a base-like fixation portion that extends from a bottom surface of the plateau portion 210 to allow the tibial insert 220 to be attached to the tibial tray using conventional techniques and methods.
The tibial insert 220 also includes a stabilizing post 230 that extends upward from the plateau portion 210 between the concavities 212, 214 and is positioned to be received in an intercondylar recess of the femoral component 110. The stabilizing post 230 is generally triangular in a lateral profile and is defined by side surfaces 232, an anterior face 240, and an opposite posterior face 250. The side surfaces 232 of the stabilizing post 230 are in sufficient clearance from the lateral walls of the femoral intercondylar recess to allow for normal lateral angulation and rotation when assembled with the femoral component 110 of the prosthetic knee joint. Exemplary constructions of the posterior face 250 and anterior face 240 of the stabilizing post 230 are described in the '615 publication.
As mentioned above, the pair of laterally spaced-apart, oblong concavities 212, 214 is formed along the upper surface for receiving femoral condylar portions 114, 116 of the femoral component 110 and therefore, have complementary shapes relative to the condylar portions 114, 116. Accordingly and similar to the femoral component 110, the contact bearing surfaces 212, 214 of the tibial component 200 do not have swept circular shape (i.e., a toroid) but instead, the swept geometry consists of at least two tangent radii (curved articular geometry).
In one embodiment, the ratio femoral to tibial radii is approximately 0.85 to 0.95.
Tapered Stabilizing Post
With reference to
In the illustrated embodiment, the faces 237, 239 have a radius of about 189 mm; however, it will be appreciated that this value is merely exemplary in nature and the faces can be formed to have a curvature defined by a radius having a different value.
As a result of the curved nature of the post 230 and as the femoral component 110 rotates, contact with the post 230 occurs over a broader surface than if the post 230 were flat as in the case of conventional posts.
Also, as shown in
As mentioned above, in one embodiment (
Improved Varus/Valgus and Anterior-Posterior Stability
As described herein, the prosthesis 100 according to the present invention consists of a modified femoral component 110 of either a straight box configuration (
A primary stabilizer of the knee to varus/valgus rotation is the ability of the knee to transfer more load from one condyle to the other and, under more extreme loads, to lift off and load a single condyle when rotated in the coronal plane. This stabilization occurs with the natural knee as well as any bicondylar knee implant. However, in a typical bicondylar implant, where the femoral component has toroidal geometry, the contact point between the femoral component and tibial component tends to stay at the center of the condyle, especially when the joint is under compressive axial load.
In accordance with the present invention, the modified shape of the femoral component 110 and tibial component 200 so that the geometry is no longer a swept circular shape (i.e., a toroid). Instead, the swept geometry consists of the two tangent radii described above, for which the medial radius of the condyle is smaller than the lateral radius. It will therefore be appreciated that both the femoral component 110 and the tibial component 200 have this complementary geometry. As the knee rotates into varus or valgus, the contact point between the two components 110, 200 shifts away from the center of the knee, and thus the restoring moment generated by contraction of the quadriceps and/or hamstring muscles increases.
In addition, as shown in
Based on the geometry of a standard size knee, the contact point can be lateralized by approximately 15 mm. However, it will be appreciated that this value is merely exemplary in nature and other values are equally possible depending upon the construction of the device. Shifting the contact force location laterally can increase the restoring moment of the knee by approximately 70%.
By shifting the contact point laterally (see
While there are existing knee systems that have articular geometry that is not toroidal, these systems employ a nearly flat on flat configuration in the coronal plane. These designs will lateralize the contact point upon varus/valgus loading. The difference between these conventional designs and the present design is that with the curved articular geometry of the present prosthesis 100, the contact point shifts laterally in a gradual manner. In this way, the stiffness of the knee increases gradually, rather than increasing in a step-wise fashion after liftoff. In addition, a design that immediately lateralizes the contact point, as in the conventional devices, is at a greater risk for extreme edge loading of the tibial insert, putting the polyethylene implant, the fixation to the underlying bone, and the bone itself at risk.
Varus/Valgus Stability in Mid-Flexion
As described herein, in the embodiment shown in
The wider box configuration, due to the stepped wall or tapered wall construction, permits greater rotation until contact is made between the post 230 and the box 130 (in this embodiment, approximately 5° of rotation as shown in
To reduce the amount of anterior translation of the knee at near full extension, the proximal posterior surface, as indicated at 250, of the post 230 has been extended posteriorly as shown in
It will be appreciated that the present invention is suitable for revision knee replacement or primary knee replacement for patients with poor collateral ligaments (e.g., extreme valgus deformity). The improved designs of the bearing surfaces of the implant components provide improved stability and performance of the joint during rotation (varus/valgus). The modified surface geometry of the present components provides a better match to patient anatomic requirements through a full range of motion (flexion-extension and rotations).
It will be appreciated that any numerals set forth in the drawings represent exemplary dimensions and only unless otherwise mentioned, in the metric unit of millimeters.
While the invention has been described in connection with certain embodiments thereof, the invention is capable of being practiced in other forms and using other materials and structures. Accordingly, the invention is defined by the recitations in the claims appended hereto and equivalents thereof.
The present application claims the benefit of U.S. patent application Ser. No. 61/281,362, filed Nov. 16, 2009, which is hereby incorporated by reference in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
3748662 | Helfet | Jul 1973 | A |
4209861 | Walker et al. | Jul 1980 | A |
4309778 | Buechel et al. | Jan 1982 | A |
4634444 | Noiles | Jan 1987 | A |
5007933 | Sidebotham et al. | Apr 1991 | A |
5116375 | Hofmann | May 1992 | A |
5133758 | Hollister | Jul 1992 | A |
5147405 | Van Zile et al. | Sep 1992 | A |
5282869 | Miyajima et al. | Feb 1994 | A |
5282870 | Moser et al. | Feb 1994 | A |
5326361 | Hollister | Jul 1994 | A |
5330534 | Herrington et al. | Jul 1994 | A |
5370699 | Hood et al. | Dec 1994 | A |
5549686 | Johnson et al. | Aug 1996 | A |
5609643 | Colleran et al. | Mar 1997 | A |
5782921 | Colleran et al. | Jul 1998 | A |
5824100 | Kester et al. | Oct 1998 | A |
5871539 | Pappas | Feb 1999 | A |
5871546 | Colleran et al. | Feb 1999 | A |
5935173 | Roger et al. | Aug 1999 | A |
6152960 | Pappas | Nov 2000 | A |
6165223 | Metzger et al. | Dec 2000 | A |
6168629 | Timoteo | Jan 2001 | B1 |
6203576 | Afriat et al. | Mar 2001 | B1 |
6206926 | Pappas | Mar 2001 | B1 |
6235060 | Kubein-Meesenburg et al. | May 2001 | B1 |
6406497 | Takei | Jun 2002 | B2 |
6413279 | Metzger et al. | Jul 2002 | B1 |
6416552 | Hoeppner et al. | Jul 2002 | B1 |
6443991 | Running | Sep 2002 | B1 |
6458160 | Biegun et al. | Oct 2002 | B2 |
6491726 | Pappas | Dec 2002 | B2 |
6558427 | Leclercq et al. | May 2003 | B2 |
6699291 | Augoyard et al. | Mar 2004 | B1 |
6726723 | Running | Apr 2004 | B2 |
6730128 | Burstein | May 2004 | B2 |
6764516 | Pappas | Jul 2004 | B2 |
6770097 | Leclercq | Aug 2004 | B2 |
6797005 | Pappas | Sep 2004 | B2 |
6902582 | Kubein-Meesenburg et al. | Jun 2005 | B2 |
6972039 | Metzger et al. | Dec 2005 | B2 |
7081137 | Servidio | Jul 2006 | B1 |
7160330 | Axelson et al. | Jan 2007 | B2 |
7261740 | Tuttle et al. | Aug 2007 | B2 |
7326252 | Otto et al. | Feb 2008 | B2 |
7413577 | Servidio | Aug 2008 | B1 |
7422605 | Burstein et al. | Sep 2008 | B2 |
7678152 | Suguro et al. | Mar 2010 | B2 |
7837737 | Hedley et al. | Nov 2010 | B2 |
7875081 | Lipman et al. | Jan 2011 | B2 |
7896924 | Servidio | Mar 2011 | B1 |
7922771 | Otto et al. | Apr 2011 | B2 |
7938862 | Naegerl | May 2011 | B2 |
7955394 | Hotokebuchi et al. | Jun 2011 | B2 |
7981159 | Williams et al. | Jul 2011 | B2 |
8075626 | Dun | Dec 2011 | B2 |
8211181 | Walker | Jul 2012 | B2 |
8382845 | Metzger et al. | Feb 2013 | B2 |
8409293 | Howard et al. | Apr 2013 | B1 |
8721733 | Bonitati | May 2014 | B2 |
20010034555 | Pappas | Oct 2001 | A1 |
20020010512 | Takei | Jan 2002 | A1 |
20030004577 | Running | Jan 2003 | A1 |
20030009232 | Metzger et al. | Jan 2003 | A1 |
20040122522 | Kubein-Meesenburg et al. | Jun 2004 | A1 |
20040143339 | Axelson et al. | Jul 2004 | A1 |
20050055102 | Tornier et al. | Mar 2005 | A1 |
20070162143 | Wasielewski | Jul 2007 | A1 |
20070239281 | Gotte et al. | Oct 2007 | A1 |
20080097615 | Lipman et al. | Apr 2008 | A1 |
20090043395 | Hotokebuchi et al. | Feb 2009 | A1 |
20090048680 | Naegerl | Feb 2009 | A1 |
20090204221 | Walker | Aug 2009 | A1 |
20090319047 | Walker | Dec 2009 | A1 |
20090326663 | Dun | Dec 2009 | A1 |
20090326666 | Wyss et al. | Dec 2009 | A1 |
20100016979 | Wyss et al. | Jan 2010 | A1 |
20100042224 | Otto et al. | Feb 2010 | A1 |
20100161067 | Saleh et al. | Jun 2010 | A1 |
20100249940 | Sanford | Sep 2010 | A1 |
20110066246 | Ries et al. | Mar 2011 | A1 |
20110118847 | Lipman et al. | May 2011 | A1 |
20110125275 | Lipman et al. | May 2011 | A1 |
20110125279 | Lipman et al. | May 2011 | A1 |
20110125280 | Otto et al. | May 2011 | A1 |
20110190897 | Guidera et al. | Aug 2011 | A1 |
20120029649 | Collazo et al. | Feb 2012 | A1 |
20120059483 | Greenhalgh et al. | Mar 2012 | A1 |
20120095564 | Mihalko et al. | Apr 2012 | A1 |
Number | Date | Country | |
---|---|---|---|
20110125279 A1 | May 2011 | US |
Number | Date | Country | |
---|---|---|---|
61281362 | Nov 2009 | US |