Knee prosthesis system

Information

  • Patent Grant
  • 9011547
  • Patent Number
    9,011,547
  • Date Filed
    Thursday, January 21, 2010
    14 years ago
  • Date Issued
    Tuesday, April 21, 2015
    9 years ago
Abstract
A knee prosthesis system for total knee replacement procedures includes a plurality of distinctly-sized femoral components, a plurality of distinctly-sized fixed tibial components, a plurality of distinctly-sized mobile tibial components, a plurality of fixed inserts, and a plurality of mobile inserts. Each of the mobile inserts is sized and shaped such that each may be optimally matched to one of the femoral components and may be used with any one of the mobile tibial components. Each of the fixed inserts is sized and shaped such that each may be optimally matched to one of the femoral components and may be used with any one of the fixed tibial components.
Description
BACKGROUND

This disclosure relates generally to surgical devices and procedures, and more particularly, to implantable, total knee replacement prostheses.


The most widely-used type of knee prosthesis for implantation into a patient during a total knee replacement (TKR) procedure includes three components: a metallic, femoral component that attaches to the distal femur; a metallic, tibial component (or tray) that attaches to the proximal tibia; and a polymeric (UHMWPE), insert (also called a bearing or an inlay) that fits between the femoral and tibial components. Various types of patella replacements are also available for use in combination with some of these knee prostheses. Two types of knee prostheses are a posterior-stabilized (PS) prosthesis, for when the posterior cruciate ligament is no longer viable, and a (posterior) cruciate-retaining (CR) knee prosthesis. Each of these two types of knee prostheses may be provided as a fixed bearing knee prosthesis, in which the insert does not move relative to the tibial component, or a mobile bearing knee prosthesis, in which the insert rotates upon a smooth platform of the tibial component. Whether to use a mobile insert or a fixed insert depends largely on the condition of the patient's knee ligaments and other soft tissues.


A knee prosthesis system may include numerous sizes of femoral, tibial and insert components to accommodate the variation of patient anatomies in the worldwide TKR patient population. The design of a knee prosthesis system requires trade-offs among many important factors related to kinematic performance, clinical outcomes, implant longevity, cost, and ease of use, to name just a few. An important consideration relative to both the kinematic performance and the life of the knee prosthesis is the degree of conformity between the femoral component bearing surfaces and the insert bearing surfaces.


Investigators typically characterize conformity in either the coronal plane or sagittal plane as the ratio of the convex radius of a femoral condyle of the femoral component to the concave radius of the interfacing insert surface. A conformity ratio of zero represents a flat insert surface, corresponding to very high contact stress at high loads. A conformity ratio of 0.99 represents high conformity, corresponding, in general, to high contact area, relatively low contact stress and, subsequently, reduced wear rate of the polyethylene surface of the insert.


Investigators have found that conformity in the coronal plane may affect prosthesis life more than conformity in the sagittal plane. For example, in an article by Kuster, et al, “The effects of conformity and load in total knee replacement” (Clinical Orthopaedics and Related Research, Number 375, pp. 302-12, June 2000), the authors found that the compressive surface stress, the shear stress and the von Mises stress were affected by changes to the conformity ratio and to a lesser extent by load changes. In a more recent article by Berend, et al, “Effects of coronal plane conformity on tibial loading in TKA: a comparison of AGC flat versus conforming articulations” (Surgical Technology Int., Number 18, pp. 207-212, 2009), the authors studied the effect of conformity on loading of the proximal tibia of the patient. Improper loading of the proximal tibia may lead to aseptic loosening of the tibial component in the tibia and eventually prosthesis failure requiring revision surgery. The authors found that coronally dished components created a strain increase in the anterior medial tibia while creating a significant strain decrease in the posterior tibia. They also found that proximal tibial strains were decreased and centralized in conforming versus flat articulations.


It is known in the art, however, that very high conformity may also lead, for example, to undesirable loading conditions on the insert surface or to excessive constraint of the femoral component, thereby inhibiting joint motions important to joint performance and patient comfort. Therefore, designs with intermediate values of contact area may be optimal as long as the stresses are below the yield strength of the insert material, in order to provide the optimal combination of joint laxity and conformity.


Complicating the challenge faced by knee prosthesis designers is the variability of patient anatomies in the worldwide, TKR patient population. Smaller patients with smaller femurs require, obviously, smaller knee prostheses. Each of the medial and lateral condyles of a femoral component of a small femoral component has a smaller coronal radius than a large femoral component for a large patient. To maintain the appropriate comformity ratio, as well as other geometrical relationships including condylar spacing, the small femoral component must be matched to a properly sized insert. In addition to the wide range of patient sizes, however, the dimensional proportionality between the femur and tibia bones also varies widely. For example, some patients, have a larger distal femur than other patients for a given size of the proximal tibia. In such cases when using currently available knee prosthesis systems, the surgeon may need to choose to implant a femoral component that is slightly mismatched with the femur and matched with the insert, or a femoral component that is matched with the femur and slightly mismatched with the insert.


Therefore, in view of the foregoing considerations, there is a need for a knee prosthesis system that allows the surgeon to select a femoral component that is sized to fit the femur of a particular patient, a tibial component that is sized to fit the tibia, and an insert that optimally matches the femoral component and is compatible with the tibial component. Such a knee prosthesis system should include both fixed and mobile types of prostheses and provide for both CR and PS procedures. Furthermore, the system should accommodate the wide variety of patient anatomies in the worldwide population.


In addition to providing optimally matched knee prosthesis components, there is an ongoing need to maintain or lower the costs and complexity of knee prosthesis systems. A knee prosthesis system may include femoral, tibial and insert components in a number of sizes, for each of the right and left knees, to accommodate variations in patient anatomies and conditions. In addition, each of inserts may be provided in a number of thicknesses so that the surgeon may select the one that results in the appropriate joint tension. Consequently, knee prosthesis manufacturers must provide a very large inventory of components representing a large number of different size combinations to accommodate the worldwide patient population. What is needed, therefore, is an improved, knee prosthesis system that allows component interchangeability to provide the necessary size combinations with a minimal number of components.


Another consideration during the design of knee prosthesis systems is bone preparation for implantation of the PS femoral component. Both the PS and the CR femoral components have a pair of spaced-apart condyles that are somewhat similar to the natural condyles of the distal femur. For the PS femoral component, a box (or intracondylar notch) positioned between the condyles includes features for interaction with a spine on the PS insert. Implantation of the PS femoral component requires cutting a recess into the distal femur to receive the box. In some current, knee prosthesis systems, the size of the box is the same for all of the PS femoral component sizes, thereby requiring cutting the same size recess into the distal femur, even for smaller femurs. It is desirable, however, to conserve natural bone, if possible, during preparation of the femur for attachment of the femoral component. There is a further need, therefore, for a knee prosthesis system in which each of the PS femoral components has a box that is sized proportionately to the femur size, while also addressing the previously described needs.


Yet another consideration during the design of knee prosthesis systems is bone preparation for implantation of the tibial component. Currently available, mobile and fixed TKR prosthesis systems include tibial components for a range of anatomical sizes. For some of these systems, the tibial component for a mobile TKR prosthesis of a particular size has a different configuration than that of a fixed TKR prosthesis of the same size. Specifically, the platform that supports the fixed bearing insert may have a different shape than the platform that supports the mobile bearing insert. This may result in a small, but possibly significant, difference in coverage of the resected, tibial plateau surface. Although less than ideal, one way surgeons may obtain the desired, tibial bone coverage is to select a larger size tibial component. What is more desirable is a TKR system that has mobile and fixed tibial components with a common platform profile shape that is optimized for interaction with surrounding tissues, kinematic performance, etc.


Also, currently available TKR systems have tibial components with stems of variable lengths to accommodate different tibial bone conditions. Furthermore, the stems for mobile tibial components may have a different configuration than the stems for fixed tibial components. Subsequently, such systems require that a number of different reaming instruments be available for each surgical procedure. A preferable TKR system would have mobile and fixed tibial components with stems of different lengths, but not requiring several different reaming instruments for preparing the tibia. This would also provide the surgeon with the intraoperative flexibility to select the appropriate type of tibial component, while reducing the number of instruments that would need to be available during the surgical procedure.





BRIEF DESCRIPTION OF FIGURES

While this specification concludes with claims that particularly point out and distinctly claim the invention, the following description and the accompanying figures further illustrate some non-limiting examples of the claimed invention. Unless otherwise indicated, like reference numerals identify the same elements.



FIG. 1 is a perspective view of a fixed CR prosthesis 110.



FIG. 2 is a perspective view of a CR femoral component 20, which is part of fixed CR prosthesis 110 shown in FIG. 1 and mobile CR prosthesis 130 shown in FIG. 9.



FIG. 3 is a perspective view of a fixed CR insert 50, which is part of fixed CR prosthesis 110 shown in FIG. 1.



FIG. 4 is a perspective view of a fixed tibial component 70, which is part of fixed CR prosthesis 110 shown in FIG. 1 and a fixed PS prosthesis 120 shown in FIG. 5.



FIG. 5 is a perspective view of fixed PS prosthesis 120.



FIG. 6 is a perspective view of a PS femoral component 10, which is part of fixed PS prosthesis 120 shown in FIG. 5 and a mobile PS prosthesis 140 shown in FIG. 13.



FIG. 7 is a perspective view of a fixed PS insert 30, which is part of fixed PS prosthesis 120 shown in FIG. 5.



FIG. 8 is a perspective view of fixed tibial component 70, which is also shown in FIG. 4.



FIG. 9 is a perspective view of a mobile CR prosthesis 130.



FIG. 10 is a perspective view of CR femoral component 20, which is also shown in FIG. 2.



FIG. 11 is a perspective view of a mobile CR insert 60, which is part of mobile CR prosthesis 130 shown in FIG. 9.



FIG. 12 is a perspective view of a mobile tibial component 80, which is part of mobile CR prosthesis 130 and a mobile PS prosthesis 140 shown in FIG. 13.



FIG. 13 is a perspective view of mobile PS prosthesis 140.



FIG. 14 is a perspective view of PS femoral component 10, which is also shown in FIG. 10.



FIG. 15 is a perspective view of a mobile PS insert 40, which is part of mobile PS prosthesis 140 shown in FIG. 13.



FIG. 16 is a perspective view of mobile tibial component 80, which is also shown in FIG. 12.



FIG. 17 is a chart representing knee prosthesis system 100 for configuring, in a plurality of size combinations, each of the prostheses shown in FIGS. 1, 5, 9 and 13.



FIG. 18 is an anterior view of a size one, mobile tibial component.



FIG. 19 is an anterior view of a size three, mobile tibial component.



FIG. 20 is an anterior view of a size seven, mobile tibial component.



FIG. 21 is an anterior view of a size nine, mobile tibial component.



FIG. 22A is a superior view of the size one, mobile tibial component of FIG. 18.



FIG. 22B is a superior view of a size one, fixed tibial component.



FIG. 23A is a superior view of the size three, mobile tibial component of FIG. 19.



FIG. 23B is a superior view of a size three, fixed tibial component.



FIG. 24A is a superior view of the size seven, mobile tibial component of FIG. 20.



FIG. 24B is a superior view of a size seven, fixed tibial component.



FIG. 25A is a superior view of the size nine, mobile tibial component of FIG. 21.



FIG. 25B is a superior view of a size nine, fixed tibial component.





DETAILED DESCRIPTION

In this disclosure, the terms “anterior, posterior, lateral, medial” generally refer to the front, back, outside and midline of the surgical patient, respectively, although we also use these terms in reference to the devices. FIG. 1 shows directional arrows for these terms and the terms “inferior, superior”. Also, we intend references to “surgeon” and “user” to include also any person who may assist the surgeon during the surgical procedure.


The following are incorporated herein by reference in their entirety:

    • U.S. Pat. No. 7,628,818, titled “Fixed-Bearing Knee Prosthesis Having Interchangeable Components”, filed on Sep. 28, 2007 by Hazebrouck, et al, (hereinafter “Hazebrouck”) and published on Apr. 2, 2009.
    • U.S. patent application Ser. No. 12/165,582, titled “Posterior-Stabilized Orthopaedic Prosthesis”, filed on Jun. 30, 2008 by Wyss, et al, (hereinafter “Wyss”).


Hazebrouck discloses a fixed bearing, knee prosthesis system in which each of differently sized inserts are compatible with each size of tibial component, so that it is possible for a surgeon to select a tibial component that is properly sized for a patient's tibia, and an insert that is matched with the femoral component.


Hazebrouck also discloses that the femoral components have medial condyle surfaces and lateral condyle surfaces and that the bearing inserts have upper surfaces including medial and lateral bearing surfaces. Each medial bearing surface is configured to articulate with the medial condyle surface of a femoral component, and each lateral bearing surface is configured to articulate with the lateral condyle surface of a femoral component. Lower surfaces of the fixed bearing inserts have recesses defined therein to receive posterior and anterior buttresses of the fixed tibial components. Each of the plurality of bearings also includes a pair of posterior tabs arranged to be respectively received in the undercuts defined in the pair of arms of the posterior buttress.


Hazebrouck also discloses that the fixed bearing inserts may be made of a polymeric material such as ultrahigh molecular weight polyethylene (UHMWPE) and that the bearing inserts may be of different sizes, particularly different widths. However, each of such differently-sized bearing inserts may include mating features that are commonly-sized and commonly-located with the commonly-sized and commonly-located features of the fixed tibial components. In particular, each of the fixed bearing inserts across a range of different sizes may include posterior and anterior recesses that are positioned and sized to tightly fit against the edges of the buttresses of components differently-sized tibial components.


Wyss discloses a knee prosthesis system having a plurality of distinctly-sized PS inserts (fixed or mobile) having a spine extending superiorly from an inferior surface. The spine has a posterior side that has a concave cam surface and a convex cam surface. Each of the PS femoral components has a pair of spaced-apart condyles defining an intracondylar notch that has a posterior cam. The posterior cam includes a concave cam surface and a convex cam surface. The concave cam surface of the posterior cam contacts the convex cam surface of the spine during a first range of flexion and the convex cam surface of the posterior cam contacts the concave cam surface of the spine during a second range of flexion.



FIGS. 1-16 show components of a knee prosthesis system 100 that is shown in FIG. 17. Each of these components may be provided in a plurality of sizes and may be matched together as described next, thereby providing the surgeon with a large plurality of size combinations. Using knee prosthesis system 100, the surgeon may select, for each patient in a large patient population, a size combination that correctly matches both the femur and the tibia of the patient. That is, the femoral component is distinctly-sized to fit the femur and the tibial component is distinctly-sized to fit the tibia, and the components of the knee prosthesis are optimally match to avoid compromising joint performance.


One characteristic of the distinctly-sized femoral and tibial components of knee prosthesis system 100 is proportionality of each component to the particular size of bone to which the component is to be attached. In general, the dimensional scale of the component varies, but not the shape. For example, the femoral component may have a proportionally-sized, intercondylar distance, such that a large femoral component has a proportionally longer intercondylar distance than that of a small femoral component. Similarly, a large tibial component may have a proportionally wider and deeper, posterior notch than that of a small tibial component.



FIG. 1 is a perspective view of a cruciate-retaining, fixed bearing, knee prosthesis 110, also referred to as a fixed CR prosthesis 110, which includes a CR femoral component 20 (FIGS. 2 and 10), a fixed CR insert 50 (FIG. 3) and a fixed tibial component 70 (FIGS. 4 and 8). Fixed CR prosthesis 110 may be identical to or similar to the knee prosthesis shown in FIG. 1 of Hazebrouck. As disclosed in Hazebrouck, any one of a plurality of differently-sized inserts (or bearings) may be secured to any one of a plurality of differently-sized tibial components (or trays). As a result, articulation surface geometries and other features of the insert may be enhanced for each size of femoral component. Such interchangeability also allows for smaller size increments in the design of a range of femoral components. CR femoral component 20 includes a medial condyle 24 and a lateral condyle 26, both of which articulate upon a superior surface 56 of fixed CR bearing 50. An anterior buttress 75 and a posterior buttress 76 of fixed tibial component 70 (see FIG. 4) fixedly retain CR insert 50 to fixed tibial component 70, such that an inferior surface 54 of CR insert 50 rests on a platform 72 of fixed tibial component 70. These mounting features are commonly-sized and commonly-located across different sizes of fixed tibial components 70. Fixed tibial component 70 also includes a stem 74 that inserts into the surgically prepared proximal tibia. Fixed CR insert 50 may be provided in any of a plurality of thicknesses, designated as “T” in FIG. 3.



FIG. 5 is a perspective view of a posterior-stabilized, fixed bearing, knee prosthesis 120, also referred to as a fixed PS prosthesis 120, which includes a PS femoral component 10 (FIG. 6), a fixed PS insert 30 (FIG. 7) and fixed tibial component 70 (FIGS. 4 and 8). PS femoral component 10 may be identical to or similar to the femoral component shown in FIG. 1 of Wyss. PS femoral component 10 includes a medial condyle 14 and a lateral condyle 16, both of which articulate upon a superior surface 36 of fixed PS insert 30. PS femoral component 10 also includes a box 32 positioned between medial condyle 14 and lateral condyle 16. Box 32 encases a posterior cam and an anterior cam (both hidden) that operationally engage with a spine 32 of fixed PS insert 30 as described in Wyss. Anterior buttress 75 and posterior buttress 76 of fixed tibial component 70 (see FIGS. 4 and 8) retain PS insert 30, such that an inferior surface 34 of PS insert 30 rests on a platform 72 of fixed tibial component 70.



FIG. 9 is a perspective view of a cruciate-retaining, mobile bearing, knee prosthesis 130, also referred to as a mobile CR prosthesis 130, which includes CR femoral component 20 (previously described for FIG. 2), a mobile CR bearing insert 60 and a mobile tibial component 80. Medial condyle 24 and lateral condyle 26 of CR femoral component 20 articulate on a superior surface 66 of mobile CR insert 60. An inferior surface 64 of mobile CR insert 60 articulates against platform 82 of mobile tibial component 80. A post 68 extends inferiorly from inferior surface 64 and rotatably inserts into a hollow stem 84 of mobile tibial component 80.



FIG. 13 is a perspective view of a posterior-stabilized, mobile bearing, knee prosthesis 140, also referred to as a mobile PS prosthesis 140, which includes PS femoral component 10 (previously described for FIG. 6 and shown in FIGS. 6 and 14), a mobile PS insert 40 (FIG. 15) and mobile tibial component 80 (previously described for FIG. 12 and shown in FIGS. 12 and 16). Mobile PS insert 40 includes a superior surface 46 and a spine 42 that may be identical to superior surface 36 and spine 32 of fixed PS insert 30 shown in FIG. 7. Mobile PS insert 40 also includes an inferior surface 44 that may be identical to inferior surface 64 of mobile CR insert 60 shown in FIG. 11. An inferior surface 44 of mobile PS insert 40 articulates against platform 82 of mobile tibial component 80. A post 48 extends inferiorly from inferior surface 44 and rotatably inserts into hollow stem of mobile tibial component 80.



FIG. 17 is a chart representing an integrated, knee prosthesis system 40 that includes each of the knee prostheses shown in FIGS. 1, 5, 9 and 13. Each of components 10, 20, 30, 40, 50, 60, 70 and 80 may be provided in a plurality of sizes (for example, ten sizes) to accommodate the wide variation of anatomies of the patient population. These components may be matched together as follows:

    • Any one size of PS femoral component 10 may be matched with any one size of either fixed PS insert 30 or mobile insert 40.
    • Any one size of CR femoral component 20 may be matched with any one size of either fixed CR insert 50 or mobile CR insert 60.
    • Any one size of fixed tibial component 70 may be matched with any one size of either fixed PS insert 30 or fixed CR insert 50.
    • Any one size of mobile tibial component 80 may be matched with any one size of either mobile PS insert 40 or mobile CR insert 60.


In addition, each size of each of inserts 30, 40, 50 and 60 may be provided in a plurality of thicknesses.


As noted earlier, the anatomies of patients vary not only in size, but also in femur/tibia, size proportionality. Using historical data for TKR procedures, it is possible to determine the size combinations that would be needed for the majority of patients in the worldwide population. For example, each of practically all patients may be accommodated with a knee prosthesis distinctly-sized to fit both the femur and the tibia by pairing a femoral component that is sized either up two sizes or down two sizes from a tibial component. A “size 3” CR femoral component may be used with any one of a “size 1, 2, 3, 4 or 5” tibial components (fixed or mobile), whereas a “size 1” CR femoral component may be used with any one of a “size 1, 2 or 3” tibial components (fixed or mobile). Similarly, a “size 5” fixed tibial component may be used with any one of a “size 3, 4, 5, 6 or 7” fixed insert (CR or PS). Using knee prosthesis system 100, each of these pairings allows optimally matching the femoral component to the insert to maintain desirable geometrical relationships.


Tables 1 lists the components of an exemplary embodiment of knee prosthesis system 100. Table 2 lists the femoral component sizes provided for each femoral component listed in Table 1. Table 2 also shows for each femoral component size the compatible insert size for each insert listed in Table 1 and the compatible tibial component sizes for each tibial component listed in Table 1.









TABLE 1







Knee Prosthesis System Components













No. of
No. of
No. of



Component
sizes
Thicknesses
components
















PS femoral (right)
14

14



PS femoral (left)
14

14



CR femoral (right)
14

14



CR femoral (left)
14

14



PS insert, mobile
10
9
90



PS insert, fixed
10
9
90



CR insert, mobile
10
8
80



CR insert, fixed
10
8
80



Tibial, mobile
10

10



Tibial, fixed
10

10



TOTAL


416

















TABLE 2







Compatible Sizes











Femoral Component Size
Insert Size
Tibial Component Size















1
1
1, 2, 3



2
2
1, 2, 3, 4



3
3
1, 2, 3, 4, 5




3N

3
1, 2, 3, 4, 5



4
4
2, 3, 4, 5, 6




4N

4
2, 3, 4, 5, 6



5
5
3, 4, 5, 6, 7




5N

5
3, 4, 5, 6, 7



6
6
4, 5, 6, 7, 8




6N

6
4, 5, 6, 7, 8



7
7
5, 6, 7, 8, 9



8
8
6, 7, 8, 9, 10



9
9
7, 8, 9, 10



10 
10
8, 9, 10










The embodiment of knee prosthesis system 100 shown in Table 1 and Table 2 provides 2176 unique combinations of prosthesis components. In each of these combinations, the femoral component is distinctly-sized to fit the patient's femur while optimally matched to the insert, and the tibial component is distinctly-sized to fit the patient's tibia while compatible with the insert. As a result, knee prosthesis system 100 may allow surgeons to avoid compromising kinematic performance and life of the implanted joint for each patient of the worldwide patient population.


As previously noted, patella components may also be provided for implantation in combination with the knee prosthesis. The patella components may be provided in a plurality of sizes. Examples of patella implants that may be adapted for use in knee prosthesis system 100 are the “P.F.C. Sigma Patellar Implants” available from DePuy Orthopaedics, Inc., Warsaw, Ind. Another embodiment of knee prosthesis system 100 may also include two unique types of patella components, each type having five sizes, thereby allowing the surgeon to select from 21,760 unique combinations of components. In each of these combinations, the femoral component is distinctly-sized to match the patient's femur while optimally matched to the insert, and the tibial component is distinctly-sized to fit the patient's tibia while compatible with the insert.


Knee prosthesis system 100 allows the surgeon to select a combination of knee prosthesis components for implantation into the patient, wherein the components are distinctly-sized to fit the femur and tibia of the patient, while also optimally matched to avoid compromising performance of the reconstructed joint. Knee prosthesis system 100 further provides PS femoral components that are proportionally sized to the femur since the PS insert (fixed or mobile) is matched to each PS femoral component. Knee prosthesis system 100 also may lower the cost and complexity of the necessary inventory of implant components to accommodate the worldwide patient population, due primarily to the interchangeability of the components.


As previously explained, there is a need for a knee prosthesis system that has mobile and fixed tibial components with stems of different lengths, but that does not require several different reaming instruments for preparing the tibia. As shown in FIG. 17, mobile tibial component 80 and fixed tibial component 70 may have an approximately similar or identical external size and configuration for each anatomical size, enabling the surgeon to prepare the proximal tibia in approximately the same way using the same instrumentation. This also allows the surgeon to implant either type of tibial component even after the proximal tibial has been surgically prepared.



FIGS. 18, 19, 20 and 21 show four representative sizes of mobile tibial component 80 of knee prosthesis system 100. Knee prosthesis system 100, for example, may have ten sizes of each of fixed tibial component 70 and mobile tibial component 80, as shown in Table 2. FIG. 18 is an anterior view of a size one, mobile tibial component 150 having a size one platform 152, a size one stem 154 and a pair of opposing keels 151, 153 extending between stem 154 and platform 152. Stem 154 has a distal portion 156 with a length “E” and a proximal portion 158 with a length “A”.



FIG. 19 is an anterior view of a size three, mobile tibial component 160 having a size three platform 162, a size three stem 164 and a pair of opposing keels 161, 163. Stem 164 has a distal portion 166, also with length “E”, and a proximal portion 168 with a length “B”.



FIG. 20 is an anterior view of a size seven, mobile tibial component 170 having a size seven platform 172, a size three stem 174 and a pair of opposing keels 171, 173. Stem 174 has a distal portion 176, also with length “E”, and a proximal portion 178 with a length “C”.



FIG. 21 is an anterior view of a size nine, mobile tibial component 180 having a size nine platform 182, a size nine stem 184 and a pair of opposing keels 181, 182. Stem 184 has a distal portion 186, also with length “E”, and a proximal portion 188 with a length “D”.


As shown in FIGS. 18, 19, 20 and 21, length “D” is greater than length “C”, which is greater than length “B”, which is greater than length “A”. In general, increasing stem length corresponds to increasing length of the proximal portion of the stem, while the length of the distal portion remains constant.


Distal portions 156, 166, 176 and 186 of the stems 154, 164, 174, 184 may also have the same general shape. Proximal portions 158, 168, 178 and 188 may have approximately the same shape and vary primarily in length. The distal portions 156, 166, 176, 186 may have a generally conical or frustoconical shape. Keels 151, 153, 161, 163, 171, 173, 181, 183 may have approximately similar configurations and orientations. As would be apparent to those skilled in the art, a surgeon may use the same reaming instrument to form a cavity to the desired depth in the proximal tibia to receive any one of the various sizes of stems 154, 164, 174 and 184. Because the external sizes and configurations of each of the plurality of distinctly-sized fixed tibial components may be approximately similar or identical to the corresponding one of the plurality of distinctly-sized mobile tibial components, the surgical preparation of the proximal tibia may be the same for a given size of either the fixed or mobile tibial components, and the required instrumentation may be the same for all sizes of both the fixed and mobile tibial components.


As previously explained, it is also desirable that the total knee replacement system have mobile and fixed tibial components with a common, platform profile or “footprint” that is optimized for coverage of the tibial plateau, interaction with surrounding tissues, kinematic performance and other factors. FIGS. 22A, 22B, 23A, 23B, 24A, 24B, 25A and 25B show superior (plan) views of four representative sizes of fixed and mobile tibial components of knee prosthesis system 100. As noted previously, knee prosthesis system 100 may have ten sizes of each of fixed tibial component 70 and mobile tibial component 80, as shown in Table 2.



FIG. 22A shows size one mobile tibial component 150 to have a platform 152 that has a similar “footprint” or profile as a platform 252 of a size one fixed tibial component 250 shown in FIG. 22B.



FIG. 23A shows size three mobile tibial component 160 to have a platform 162 that has a similar profile as a platform 262 of a size one fixed tibial component 260 shown in FIG. 23B.



FIG. 24A shows size seven mobile tibial component 170 to have a platform 172 that has a similar profile as a platform 272 of a size one fixed tibial component 270 shown in FIG. 24B.



FIG. 25A shows size nine mobile tibial component 180 to have a platform 182 that has a similar profile as a platform 282 of a size one fixed tibial component 280 shown in FIG. 25B.


For each size of tibial component, the platform profile (as viewed from the top, in the direction of the stem axis) is the same for both mobile and fixed tibial components for a particular anatomical size. There is no need to change tibial component size to get the same, tibial plateau coverage when choosing between a mobile and a fixed prosthesis. Another benefit of the common platform shape is that the same casting tool or a portion of the tool may be used in the manufacture of both tibial components, enabling reduced component cost.


We have shown and described various embodiments and examples. However, a person having ordinary skill in the art may modify the methods and devices described herein without departing from the overall concept. For instance, the specific materials, dimensions and the scale of drawings should be understood to be non-limiting examples. Accordingly, we do not intend the scope of the following claims to be understood as limited to the details of structure, materials or acts shown and described in the specification and drawings.

Claims
  • 1. A knee prosthesis system for cruciate-retaining (CR) and posterior-stabilized (PS), total knee replacement procedures comprising: a. a plurality of differently-sized CR femoral components, each CR femoral component having a medial condyle surface and a lateral condyle;b. a plurality of differently-sized PS femoral components, each PS femoral component having a medial condyle surface and a lateral condyle surface;c. a plurality of differently-sized metal fixed tibial components;d. a plurality of differently-sized mobile tibial components;e. a plurality of differently-sized CR mobile inserts, each CR mobile insert having a medial bearing surface configured to articulate with the medial condyle surface of one size of CR femoral components and a lateral bearing surface configured to articulate with the lateral condyle surface of the same size of CR femoral components, wherein each size of CR mobile inserts may be mounted on at least two different sizes of the mobile tibial components;f. a plurality of differently-sized polymeric CR fixed inserts, each CR fixed insert having a medial bearing surface configured to articulate with the medial condyle surface of one size of CR femoral components and a lateral bearing surface configured to articulate with the lateral condyle surface of the same size of CR femoral components, wherein each size of CR fixed inserts has a different width and may be mounted in a secure fixed relationship with at least two different sizes of the fixed tibial components;g. a plurality of differently-sized polymeric PS fixed inserts, each PS fixed insert having a medial bearing surface configured to articulate with the medial condyle surface of one size of PS femoral components and a lateral bearing surface configured to articulate with the lateral condyle surface of the same size of PS femoral components, wherein each size of PS fixed inserts has a different width and may be mounted in a secure fixed relationship with at least two different sizes of the fixed tibial components; andh. a plurality of PS mobile inserts, each PS mobile insert having a medial bearing surface configured to articulate with the medial condyle surface of one size of PS femoral components and a lateral bearing surface configured to articulate with the lateral condyle surface of the same size of PS femoral components, wherein each size of PS mobile inserts may be mounted on at least two different sizes of the mobile tibial components;i. wherein each tibial component has a platform and a stem extending distally from the platform, each stem having a distal portion and a proximal portion, the distal portion and the proximal portion having different shapes, the distal portion of the stem of each size of tibial component having the same length and the same generally conical shape and the proximal portion of the stem of each size of tibial component having a different length.
  • 2. The knee prosthesis system of claim 1, wherein: each of the plurality of differently-sized fixed tibial components has a platform from which extends an anterior buttress and a posterior buttress for retaining any one of the plurality of PS fixed inserts and any one of the plurality of CR fixed inserts; the anterior buttresses and posterior buttresses of at least two sizes of fixed tibial components are commonly-sized and commonly-located; and each PS fixed insert has a lower surface with recesses defined therein to receive the anterior buttress and posterior buttress of at least two sizes of fixed tibial components and each CR fixed insert has a lower surface with recesses defined therein to receive the anterior buttress and posterior buttress of at least two sizes of fixed tibial components.
  • 3. The knee prosthesis system of claim 1, wherein each of the plurality of PS fixed inserts and each of the plurality of PS mobile inserts have a surface and a spine extending superiorly therefrom, the spine having a posterior side including a concave cam surface and a convex cam surface, and the posterior cam of each PS femoral component includes a concave cam surface and a convex cam surface, wherein the concave cam surface of the posterior cam contacts the convex cam surface of the spine during a first range of flexion and the convex cam surface of the posterior cam contacts the concave cam surface of the spine during a second range of flexion.
  • 4. The knee prosthesis system of claim 3, wherein each of the plurality of differently-sized PS femoral components includes an intracondylar notch and wherein the intracondylar notch of each of the differently-sized PS femoral components is proportionately sized and shaped to fit a particular anatomical size and shape of a patient's femur.
  • 5. The knee prosthesis system of claim 1, further including a plurality of patella components, any one of which may be used in combination with any one of the plurality of differently-sized CR femoral components and in combination with any one of the plurality of differently-sized PS femoral components.
  • 6. The knee prosthesis system of claim 1, wherein each of the plurality of CR fixed inserts, each of the plurality of CR mobile inserts, each of the plurality of PS fixed inserts and each of the plurality of PS mobile inserts, have a thickness different from the others within that plurality.
  • 7. The knee prosthesis system of claim 1, wherein the stems for a particular anatomical size of the fixed and mobile tibial components have approximately the same external size and configuration, such that approximately the same surgical preparation of the proximal tibia is required for each of the fixed and the mobile tibial components for the particular anatomical size.
  • 8. A knee prosthesis system for cruciate-retaining (CR) and posterior-stabilized (PS), total knee replacement procedures comprising: a. a plurality of differently-sized CR femoral components;b. a plurality of differently-sized PS femoral components;c. a plurality of differently-sized fixed tibial components;d. a plurality of differently-sized mobile tibial components;e. a plurality of CR mobile inserts, each of which is sized and shaped such that each may be optimally matched to one of the CR femoral components;f. a plurality of differently-sized polymeric CR fixed inserts, each of which has an articulation surface that is sized and shaped such that each may be optimally matched to one of the CR femoral components and each of which has an opposite surface with a different width;g. a plurality of differently-sized polymeric PS fixed inserts, each of which has an articulation surface that is sized and shaped such that each may be optimally matched to one of the PS femoral components and each of which has an opposite surface with a different width;h. a plurality of PS mobile inserts, each of which is sized and shaped such that each may be optimally matched to one of the PS femoral components;wherein: the fixed tibial components have mounting structures for securing a selected PS fixed insert or CR fixed insert and a selected one of the fixed tibial components together;the mounting structures of at least two sizes of fixed tibial components are commonly-sized and commonly-located so that at least one size of CR fixed insert and at least one size of PS fixed insert may be selectively secured to at least two sizes of fixed tibial components; andeach tibial component has a platform and a stem extending distally from the platform, each stem having a distal portion and a proximal portion, the distal portion and the proximal portion having different shapes, the distal portion of the stem of each size of tibial component having the same length and the same generally conical shape and the proximal portion of the stem of each size of tibial component having a different length.
  • 9. The knee prosthesis system of claim 8, further including a plurality of patella components, any one of which may be used in combination with any one of the plurality of differently-sized CR femoral components and in combination with any one of the plurality of differently-sized PS femoral components.
  • 10. The knee prosthesis system of claim 8, wherein each of the differently-sized PS femoral components includes an intracondylar notch that is proportionately sized and shaped to fit a particular anatomical size and shape of a patient's femur.
  • 11. The knee prosthesis system of claim 8, wherein the stems for a particular anatomical size of fixed and mobile tibial components have approximately the same external size and configuration, such that approximately the same surgical preparation of the proximal tibia is required for each of the fixed and the mobile tibial components for the particular anatomical size.
  • 12. A knee prosthesis system for cruciate-retaining (CR) and posterior-stabilized (PS), total knee replacement procedures comprising: a. a plurality of fixed CR knee prostheses;b. a plurality of mobile CR knee prostheses;c. a plurality of fixed PS knee prostheses; andd. a plurality of mobile PS knee prostheses;wherein each fixed prosthesis represents a size combination and includes one of a plurality of differently-sized femoral components, one of a plurality of differently-sized tibial components, and one of a plurality of differently-sized inserts, and each prosthesis is optimally matched for performance with the size of the insert matching the size of the femoral component and the size of the tibial component being independent of the size of the femoral component, whereby the knee prosthesis system may be used for a variety of anatomies within a patient population; andwherein: the tibial components of the fixed CR knee prostheses and the fixed PS knee prostheses include platforms with buttresses;the buttresses of at least two sizes of tibial components of the fixed CR knee prostheses and the fixed PS knee prostheses are commonly sized and commonly located;each size of tibial component has a different width;the inserts of the fixed CR knee prostheses and the fixed PS knee prostheses comprise a polymeric material and include lower surfaces with recesses defined therein to receive the buttresses of the tibial components of the fixed CR knee prostheses and the fixed PS knee prostheses;each size of insert of the fixed CR knee prostheses and fixed PS knee prostheses has a different width;each insert of the fixed CR knee prostheses and the fixed PS knee prostheses may be mounted in a secure fixed relationship with at least two different sizes of the tibial components of the fixed CR knee prostheses and the fixed PS knee prostheses; andeach tibial component has a platform and a stem extending distally from the platform, each stem having a distal portion and a proximal portion, the distal portion and the proximal portion having different shapes, the distal portion of the stem of each size of tibial component having the same length and the same generally conical shape and the proximal portion of the stem of each size of tibial component having a different length.
  • 13. A knee prosthesis system for cruciate-retaining (CR) and posterior-stabilized (PS), total knee replacement procedures comprising: a. a plurality of differently-sized CR femoral components;b. a plurality of differently-sized PS femoral components;c. a plurality of differently-sized fixed tibial components and a plurality of differently-sized mobile tibial components;d. a plurality of differently-sized polymeric CR fixed inserts;e. a plurality of differently-sized polymeric PS fixed inserts;f. a plurality of differently-sized CR mobile inserts; andg. a plurality of differently-sized PS mobile inserts;wherein: each size CR femoral component is compatible with a single size of CR fixed insert;each size CR femoral component is compatible with a single size of CR mobile insert;each size of PS femoral component is compatible with a single size of PS fixed insert;each size of PS femoral component is compatible with a single size of PS mobile insert;each size of fixed tibial component has a different width;each size of CR fixed insert has a different width;each size of PS fixed insert has a different width;the tibial components and inserts have complementary mounting structures so that each size of CR fixed insert can be mounted in a secure fixed relationship on a plurality of sizes of fixed tibial components, each size of CR mobile insert is compatible with a plurality of sizes of mobile tibial components, each size of PS fixed insert can be mounted in a secure fixed relationship on a plurality of sizes of fixed tibial components and each size of PS mobile insert is compatible with a plurality of sizes of mobile tibial components; andeach tibial component has a platform and a stem extending distally from the platform, each stem having a distal portion and a proximal portion, the distal portion and the proximal portion having different shapes, the distal portion of the stem of each size of tibial component having the same length and the same generally conical shape and the proximal portion of the stem of each size of tibial component having a different length.
  • 14. The knee prosthesis system of claim 13, wherein the stems for a particular anatomical size of fixed and mobile tibial components have approximately the same external size and configuration, such that approximately the same surgical preparation of the proximal tibia is required for each of the fixed and the mobile tibial components for the particular anatomical size.
  • 15. The knee prosthesis system of claim 13, wherein each of the plurality of differently-sized fixed tibial components has a platform from which extends an anterior buttress and a posterior buttress for retaining any one of the plurality of PS fixed inserts and any one of the plurality of CR fixed inserts.
  • 16. The knee prosthesis system of claim 13, wherein each of the plurality of PS fixed inserts and each of the plurality of PS mobile inserts has a surface and a spine extending superiorly therefrom, the spine having a posterior side including a concave cam surface and a convex cam, and wherein each of the plurality of differently-sized PS femoral components includes a pair of spaced-apart condyles defining an intracondylar notch therebetween and a posterior cam positioned in the intracondylar notch, the posterior cam including a concave cam surface and a convex cam surface, wherein the concave cam surface of the posterior cam contacts the convex cam surface of the spine during a first range of flexion and the convex cam surface of the posterior cam contacts the concave cam surface of the spine during a second range of flexion.
  • 17. The knee prosthesis system of claim 16, wherein the intracondylar notch of each of the differently-sized PS femoral components is proportionately sized and shaped to fit a particular anatomical size and shape of a patient's femur.
  • 18. The knee prosthesis system of claim 13, wherein each of the plurality of CR fixed inserts, each of the plurality of CR mobile inserts, each of the plurality of PS fixed inserts and each of the plurality of PS mobile inserts, have a thickness different from the others within that plurality.
  • 19. The knee prosthesis system of claim 13, further including a plurality of patella components, any one of which may be used in combination with any one of the plurality of differently-sized CR femoral components and in combination with any one of the plurality of differently-sized PS femoral components.
US Referenced Citations (391)
Number Name Date Kind
3852045 Wheeler Dec 1974 A
3855638 Pilliar Dec 1974 A
3953899 Charnley May 1976 A
4156943 Collier Jun 1979 A
4206516 Pilliar Jun 1980 A
4224696 Murray Sep 1980 A
4224697 Murray Sep 1980 A
4257129 Volz Mar 1981 A
4612160 Donlevy Sep 1986 A
4673407 Martin Jun 1987 A
4714474 Brooks, Jr. Dec 1987 A
4795468 Hodorek Jan 1989 A
4808185 Penenberg Feb 1989 A
4822362 Walker Apr 1989 A
4838891 Branemark Jun 1989 A
4938769 Shaw Jul 1990 A
4944757 Martinez Jul 1990 A
4944760 Kenna Jul 1990 A
4950298 Gustilo Aug 1990 A
4963152 Hofmann Oct 1990 A
4990163 Ducheyne Feb 1991 A
5019103 Van Zile May 1991 A
5037423 Kenna Aug 1991 A
5080675 Lawes Jan 1992 A
5104410 Chowdhary Apr 1992 A
5108442 Smith Apr 1992 A
5171283 Pappas Dec 1992 A
5194066 Van Zile Mar 1993 A
5198308 Shetty Mar 1993 A
5201766 Georgette Apr 1993 A
5251468 Lin Oct 1993 A
5258044 Lee Nov 1993 A
5263987 Shah Nov 1993 A
5271737 Baldwin Dec 1993 A
5282861 Kaplan Feb 1994 A
5308556 Bagley May 1994 A
5309639 Lee May 1994 A
5326361 Hollister Jul 1994 A
5326365 Alvine Jul 1994 A
5330534 Herrington Jul 1994 A
5344460 Turanyi Sep 1994 A
5344461 Phlipot Sep 1994 A
5344494 Davidson Sep 1994 A
5358531 Goodfellow et al. Oct 1994 A
5368881 Kelman Nov 1994 A
5370699 Hood Dec 1994 A
5387240 Pottenger Feb 1995 A
5405396 Heldreth Apr 1995 A
5413604 Hodge May 1995 A
5414049 Sun May 1995 A
5443510 Shetty et al. Aug 1995 A
5449745 Sun Sep 1995 A
5458637 Hayes Oct 1995 A
5480446 Goodfellow Jan 1996 A
5543471 Sun Aug 1996 A
5571187 Devanathan Nov 1996 A
5609639 Walker Mar 1997 A
5609641 Johnson et al. Mar 1997 A
5632745 Schwartz May 1997 A
5650485 Sun Jul 1997 A
5658333 Kelman Aug 1997 A
5658342 Draganich Aug 1997 A
5658344 Hurlburt Aug 1997 A
5683472 O'Neil Nov 1997 A
5690636 Wildgoose Nov 1997 A
5702447 Walch Dec 1997 A
5702458 Burstein Dec 1997 A
5702463 Pothier Dec 1997 A
5702464 Lackey Dec 1997 A
5728748 Sun Mar 1998 A
5732469 Hamamoto Mar 1998 A
5749874 Schwartz May 1998 A
5755800 O'Neil May 1998 A
5755801 Walker May 1998 A
5755803 Haines May 1998 A
5755808 DeCarlo May 1998 A
5759190 Vibe Hansen Jun 1998 A
5765095 Flak Jun 1998 A
5766257 Goodman Jun 1998 A
5769899 Schwartz Jun 1998 A
5800546 Marik Sep 1998 A
5824100 Kester Oct 1998 A
5824103 Williams Oct 1998 A
5871545 Goodfellow Feb 1999 A
5871546 Colleran Feb 1999 A
5879387 Jones Mar 1999 A
5879394 Ashby Mar 1999 A
5879400 Merrill Mar 1999 A
5906577 Beane May 1999 A
5906596 Tallarida May 1999 A
5906644 Powell May 1999 A
5951603 O'Neil Sep 1999 A
5954564 Ganz Sep 1999 A
5957979 Beckman Sep 1999 A
5964808 Blaha Oct 1999 A
5976147 LaSalle Nov 1999 A
5984969 Matthews Nov 1999 A
5989027 Wagner Nov 1999 A
5997577 Herrington Dec 1999 A
6004351 Tomita Dec 1999 A
6005018 Cicierega Dec 1999 A
6010534 O'Neil Jan 2000 A
6017975 Saum Jan 2000 A
6039764 Pottenger Mar 2000 A
6042780 Huang Mar 2000 A
6053945 O'Neil Apr 2000 A
6059949 Gal Or May 2000 A
6068658 Insall May 2000 A
6090144 Letot Jul 2000 A
6123728 Brosnahan Sep 2000 A
6123896 Meeks, III Sep 2000 A
6126692 Robie Oct 2000 A
6132468 Mansmann Oct 2000 A
6135857 Shaw Oct 2000 A
6139581 Engh Oct 2000 A
6142936 Beane Nov 2000 A
6162254 Timoteo Dec 2000 A
6171340 McDowell Jan 2001 B1
6174934 Sun Jan 2001 B1
6179876 Stamper Jan 2001 B1
6210444 Webster Apr 2001 B1
6210445 Zawadzki Apr 2001 B1
6217618 Hileman Apr 2001 B1
6228900 Shen May 2001 B1
6238434 Pappas May 2001 B1
6242507 Saum Jun 2001 B1
6245276 McNulty Jun 2001 B1
6251143 Schwartz Jun 2001 B1
6258127 Schmotzer Jul 2001 B1
6280476 Metzger Aug 2001 B1
6281264 Salovey Aug 2001 B1
6299646 Chambat Oct 2001 B1
6316158 Saum Nov 2001 B1
6319283 Insall Nov 2001 B1
6344059 Krakovits Feb 2002 B1
6352558 Spector Mar 2002 B1
6361564 Marceaux Mar 2002 B1
6372814 Sun Apr 2002 B1
6379388 Ensign Apr 2002 B1
6428577 Evans Aug 2002 B1
6440063 Beane Aug 2002 B1
6443991 Running Sep 2002 B1
6468314 Schwartz Oct 2002 B2
6485519 Meyers Nov 2002 B2
6494914 Brown Dec 2002 B2
6503280 Repicci Jan 2003 B2
6506215 Letot Jan 2003 B1
6506216 McCue Jan 2003 B1
6520964 Tallarida Feb 2003 B2
6524522 Vaidyanathan Feb 2003 B2
6527754 Tallarida Mar 2003 B1
6569202 Whiteside May 2003 B2
6582470 Lee Jun 2003 B1
6589283 Metzger et al. Jul 2003 B1
6592787 Pickrell Jul 2003 B2
6620198 Burstein Sep 2003 B2
6623526 Lloyd Sep 2003 B1
6626950 Brown Sep 2003 B2
6645251 Salehi Nov 2003 B2
6652592 Grooms Nov 2003 B1
6660039 Evans et al. Dec 2003 B1
6660224 Lefebvre Dec 2003 B2
6664308 Sun Dec 2003 B2
6679917 Ek Jan 2004 B2
6699291 Augoyard et al. Mar 2004 B1
6702821 Bonutti Mar 2004 B2
6716249 Hyde Apr 2004 B2
6719800 Meyers Apr 2004 B2
6726724 Repicci Apr 2004 B2
6755864 Brack et al. Jun 2004 B1
6773461 Meyers Aug 2004 B2
6783548 Hyde, Jr. Aug 2004 B2
6818020 Sun Nov 2004 B2
6846327 Khandkar Jan 2005 B2
6849230 Feichtinger Feb 2005 B1
6852272 Artz Feb 2005 B2
6869448 Tuke Mar 2005 B2
6875235 Ferree Apr 2005 B2
6923832 Sharkey Aug 2005 B1
6942670 Heldreth Sep 2005 B2
6945448 Medlin Sep 2005 B2
6953479 Carson Oct 2005 B2
6972039 Metzger Dec 2005 B2
6984248 Hyde, Jr. Jan 2006 B2
6986791 Metzger Jan 2006 B1
6994730 Posner Feb 2006 B2
7025788 Metzger Apr 2006 B2
7048741 Swanson May 2006 B2
7070622 Brown Jul 2006 B1
7077867 Pope Jul 2006 B1
7087082 Paul Aug 2006 B2
7094259 Tarabichi Aug 2006 B2
7101401 Brack Sep 2006 B2
7108720 Hanes Sep 2006 B2
7147819 Bram Dec 2006 B2
7175665 German Feb 2007 B2
7208013 Bonutti Apr 2007 B1
7255715 Metzger Aug 2007 B2
7278997 Mueller Oct 2007 B1
7294149 Hozack Nov 2007 B2
7297164 Johnson Nov 2007 B2
7338529 Higgins Mar 2008 B1
7341602 Fell et al. Mar 2008 B2
7344460 Gait Mar 2008 B2
7357817 D'Alessio, II Apr 2008 B2
7445639 Metzger Nov 2008 B2
7494507 Dixon Feb 2009 B2
7497874 Metzger Mar 2009 B1
7527631 Maroney et al. May 2009 B2
7527650 Johnson May 2009 B2
7563286 Gerber Jul 2009 B2
7572295 Steinberg Aug 2009 B2
7578850 Kuczynski Aug 2009 B2
7608079 Blackwell Oct 2009 B1
7611519 Lefevre Nov 2009 B2
7618462 Ek Nov 2009 B2
7628817 Axelson, Jr. Dec 2009 B1
7628818 Hazebrouck Dec 2009 B2
7635390 Bonutti Dec 2009 B1
7695519 Collazo Apr 2010 B2
7740662 Barnett Jun 2010 B2
7748984 McAllister Jul 2010 B2
7749229 Bonutti Jul 2010 B1
7753960 Cipolletti Jul 2010 B2
7758653 Steinberg Jul 2010 B2
7766911 Navarro Aug 2010 B1
7771484 Campbell Aug 2010 B2
7776044 Pendleton Aug 2010 B2
7780666 Navarro Aug 2010 B1
7780674 Medley et al. Aug 2010 B2
7785327 Navarro Aug 2010 B1
7790779 Muratoglu Sep 2010 B2
7803193 Steinberg Sep 2010 B2
7833245 Kaes Nov 2010 B2
7951204 Chambat et al. May 2011 B2
7978151 Taira Jul 2011 B2
7978152 Huang Jul 2011 B2
7981159 Williams et al. Jul 2011 B2
8066770 Rivard Nov 2011 B2
8128703 Hazebrouck et al. Mar 2012 B2
8187335 Wyss May 2012 B2
8192498 Wagner Jun 2012 B2
8206451 Wyss Jun 2012 B2
8236061 Heldreth Aug 2012 B2
8366782 Wright Feb 2013 B2
8470047 Hazebrouck Jun 2013 B2
8545570 Crabtree et al. Oct 2013 B2
8591594 Parisi et al. Nov 2013 B2
8603101 Claypool et al. Dec 2013 B2
8617250 Metzger Dec 2013 B2
8632600 Zannis Jan 2014 B2
8658710 McKellop Feb 2014 B2
8715359 Deffenbaugh May 2014 B2
8715362 Reiley May 2014 B2
8727203 Wang May 2014 B2
20010010023 Schwartz Jul 2001 A1
20020120274 Overaker Aug 2002 A1
20020173855 Mansmann Nov 2002 A1
20030004578 Brown Jan 2003 A1
20030014122 Whiteside Jan 2003 A1
20030035747 Anderson Feb 2003 A1
20030036801 Schwartz Feb 2003 A1
20030044301 Lefebvre Mar 2003 A1
20030075013 Grohowski Apr 2003 A1
20030139817 Tuke Jul 2003 A1
20030153981 Wang Aug 2003 A1
20030171820 Wilshaw Sep 2003 A1
20030212161 McKellop Nov 2003 A1
20030220700 Hammer Nov 2003 A1
20030225456 Ek Dec 2003 A1
20040015770 Kimoto Jan 2004 A1
20040019384 Kirking Jan 2004 A1
20040039450 Griner Feb 2004 A1
20040167633 Wen Aug 2004 A1
20040186583 Keller Sep 2004 A1
20040215345 Perrone Oct 2004 A1
20050015153 Goble Jan 2005 A1
20050021147 Tarabichi Jan 2005 A1
20050055102 Tornier Mar 2005 A1
20050059750 Sun Mar 2005 A1
20050064042 Vunjak Novakovic Mar 2005 A1
20050069629 Becker Mar 2005 A1
20050100578 Schmid May 2005 A1
20050123672 Justin Jun 2005 A1
20050125068 Hozack Jun 2005 A1
20050192672 Wyss et al. Sep 2005 A1
20050203631 Daniels Sep 2005 A1
20050209702 Todd Sep 2005 A1
20050249625 Bram Nov 2005 A1
20060002810 Grohowski Jan 2006 A1
20060015185 Chambat et al. Jan 2006 A1
20060030945 Wright Feb 2006 A1
20060036329 Webster Feb 2006 A1
20060047283 Evans Mar 2006 A1
20060052875 Bernero Mar 2006 A1
20060100714 Ensign May 2006 A1
20060111790 Dietz May 2006 A1
20060195195 Burstein Aug 2006 A1
20060228247 Grohowski Oct 2006 A1
20060231402 Clasen Oct 2006 A1
20060241781 Brown Oct 2006 A1
20060257358 Wen Nov 2006 A1
20060271191 Hermansson Nov 2006 A1
20060289388 Yang Dec 2006 A1
20070061014 Naegerl Mar 2007 A1
20070073409 Cooney Mar 2007 A1
20070078521 Overholser Apr 2007 A1
20070100463 Aram May 2007 A1
20070129809 Meridew Jun 2007 A1
20070162143 Wasielewski Jul 2007 A1
20070162144 Wasielewski Jul 2007 A1
20070173948 Meridew Jul 2007 A1
20070196230 Hamman Aug 2007 A1
20070203582 Campbell Aug 2007 A1
20070219639 Otto Sep 2007 A1
20070293647 McKellop Dec 2007 A1
20080004708 Wyss Jan 2008 A1
20080021567 Meulink Jan 2008 A1
20080051908 Angibaud et al. Feb 2008 A1
20080058945 Hajaj et al. Mar 2008 A1
20080091272 Aram Apr 2008 A1
20080097616 Meyers Apr 2008 A1
20080114462 Guidera May 2008 A1
20080114464 Barnett May 2008 A1
20080119940 Otto May 2008 A1
20080133019 Andrysek Jun 2008 A1
20080161927 Savage Jul 2008 A1
20080195108 Bhatnagar Aug 2008 A1
20080199720 Liu Aug 2008 A1
20080206297 Roeder Aug 2008 A1
20090048680 Naegerl Feb 2009 A1
20090082873 Hazebrouck Mar 2009 A1
20090084491 Uthgenannt Apr 2009 A1
20090088859 Hazebrouck Apr 2009 A1
20090125114 May May 2009 A1
20090125115 Popoola May 2009 A1
20090149964 May Jun 2009 A1
20090182433 Reiley et al. Jul 2009 A1
20090192610 Case Jul 2009 A1
20090264894 Wasielewski Oct 2009 A1
20090265012 Engh Oct 2009 A1
20090265013 Mandell Oct 2009 A1
20090292365 Smith Nov 2009 A1
20090295035 Evans Dec 2009 A1
20090326663 Dun Dec 2009 A1
20090326664 Wagner Dec 2009 A1
20090326665 Wyss Dec 2009 A1
20090326666 Wyss Dec 2009 A1
20090326667 Williams Dec 2009 A1
20090326674 Liu Dec 2009 A1
20100016979 Wyss Jan 2010 A1
20100036499 Pinskerova Feb 2010 A1
20100036500 Heldreth Feb 2010 A1
20100042224 Otto Feb 2010 A1
20100042225 Shur Feb 2010 A1
20100063594 Hazebrouck Mar 2010 A1
20100070045 Ek Mar 2010 A1
20100076563 Otto Mar 2010 A1
20100076564 Schilling Mar 2010 A1
20100076569 Langhorn Mar 2010 A1
20100094429 Otto Apr 2010 A1
20100098574 Liu Apr 2010 A1
20100100189 Metzger Apr 2010 A1
20100100190 May Apr 2010 A1
20100100191 May Apr 2010 A1
20100114322 Clifford May 2010 A1
20100125337 Grecco May 2010 A1
20100161067 Saleh Jun 2010 A1
20100191341 Byrd Jul 2010 A1
20100222890 Barnett Sep 2010 A1
20100262144 Kelman Oct 2010 A1
20100262253 Cipolletti et al. Oct 2010 A1
20100286788 Komistek Nov 2010 A1
20100292804 Samuelson Nov 2010 A1
20100305710 Metzger Dec 2010 A1
20100312350 Bonutti Dec 2010 A1
20110029090 Zannis Feb 2011 A1
20110029092 Deruntz Feb 2011 A1
20110035017 Deffenbaugh Feb 2011 A1
20110035018 Deffenbaugh Feb 2011 A1
20110046735 Metzger et al. Feb 2011 A1
20110106268 Deffenbaugh May 2011 A1
20110178606 Deffenbaugh et al. Jul 2011 A1
20110190897 Guidera et al. Aug 2011 A1
20120067853 Wang et al. Mar 2012 A1
20120296438 Metzger et al. Nov 2012 A1
20120323333 Metzger Dec 2012 A1
20130079885 Meier et al. Mar 2013 A1
20130173009 Hershberger Jul 2013 A1
20130184829 Wyss et al. Jul 2013 A1
20130184830 Hazebrouck et al. Jul 2013 A1
Foreign Referenced Citations (50)
Number Date Country
4308563 Sep 1994 DE
495340 Jul 1992 EP
634156 Jan 1995 EP
636352 Feb 1995 EP
634156 Apr 1995 EP
732092 Sep 1996 EP
732092 Jan 1997 EP
765645 Apr 1997 EP
765645 Nov 1997 EP
634156 May 1999 EP
636352 Jan 2002 EP
732092 Feb 2002 EP
1186277 Mar 2002 EP
1226799 Jul 2002 EP
765645 Aug 2003 EP
1186277 Oct 2003 EP
1421918 May 2004 EP
1226799 May 2005 EP
1186277 Oct 2005 EP
1779812 May 2007 EP
1923079 May 2008 EP
2653992 May 1991 FR
2780636 Jan 2000 FR
2837093 Sep 2003 FR
1065354 Apr 1967 GB
2293109 Mar 1996 GB
62205201 Sep 1987 JP
10137271 May 1998 JP
02272756 Sep 2002 JP
02315757 Oct 2002 JP
WO 9014806 Dec 1990 WO
WO 9524874 Sep 1995 WO
WO 9530388 Nov 1995 WO
WO 9624302 Aug 1996 WO
WO 9624304 Aug 1996 WO
WO 9725942 Jul 1997 WO
WO 9966864 Dec 1999 WO
WO 03039609 May 2003 WO
WO 03101647 Dec 2003 WO
WO 2005009489 Feb 2005 WO
WO 2005009729 Feb 2005 WO
WO 2006014294 Feb 2006 WO
WO 2006130350 Dec 2006 WO
WO 2008048820 Apr 2008 WO
WO 2008048820 Jul 2008 WO
WO 2008100784 Aug 2008 WO
WO 2009046212 Apr 2009 WO
WO 2009128943 Oct 2009 WO
WO 2010056962 May 2010 WO
WO 2010056962 Jul 2010 WO
Non-Patent Literature Citations (54)
Entry
Restoration® Modular Revision Hip System Surgical Protocol, Restoration® Modular Cone Body/Conical Distal Stem Femoral Components Using the Restoration® Modular Instrument System, brochure, (2005) Stryker, pp. 1-21.
Restoration® Modular Revision Hip System, Product. Reference Guide for Cone/Conical and Broached/Fluted & Plasma Implants and Instruments, brochure, 2004 St ker, a es 1-12.
The Effects of Conformity and Load in Total Knee Replacement, Kuster, et al, Clinical Orthopaedics and Related Research, No. 375, Jun. 2000.
Effects of Coronal Plane Conformity on Tibial Loading in TKA: A Comparison of AGC Flat Versus Conforming Articulations, Brent, et al, Orthopaedic Surgery, Surgical Technology International, XVIII.
ASTM Standard D4518-91, “Standard Test Methods for Measuring Static Friction of Coating Surfaces,” ASTM International, West Conshohocken, PA, 1991 DOI: 10.1520-D4518-91, www.astm.org., 5 pages.
ASTM Standard E9-89a(2000), “Standard Test Methods of Compression Testing of Metallic Materials at Room Temperature,” ASTM International, West Conshohocken, PA, 2000 DOI: 10.1520-E0009-89AR00, www.astm.org, 9 pages.
ASTM Standard F1580-01, “Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants,” ASTM International, West Conshohocken, PA, 2001 DOI: 10.1520-F1580-01, www.astm.org, 4 pages.
International Organization for Standardization, “ISO 3274:1996,” 1996, 20 pages.
International Organization for Standardization, “ISO 4287:1997,” 1997, 36 pages.
Alconox, Inc., “Liquinox Technical Bulletin,” 2006 , 2 pages.
Biomet, Vanguard® Mono-Lock™ Tibial System, Patented Convertible Tibial Bearing Technology, 2009, 2 Pages.
C.E. Wen et al., “Novel Titanium Foam for Bone Tissue Engineering,” Journal of Materials Research, vol. 17, No. 10, pp. 2633-2639, 7 pages.
Carl Zeiss, Zeiss Surfcomm 5000—“Contour and Surface Measuring Machines,” 2005, 16 pages.
DePuy Inc., “AMK Total Knee System Product Brochure”, 1996, 8 pages.
DePuy Knees International, “Sigma CR Porocoat®,” 1 page.
DePuy Orthopaedics, Inc., “AMK Total Knee System Legend II Surgical Technique”, 1998, 30 pages.
Depuy PFC Sigma RP, “PFC Sigma Knee System with Rotating Platform Technical Monograph”, 1999, 0611-29-050 (Rev. 3), 70 Pages.
General Plastics Manufacturing Company, “LAST-A-FOAM@ Products Guide to Tooling Applications, Bonding, Filling and Sealing,” FR-6700 Tooling Apps Product Sheet, 2010, 16 pages.
General Plastics Manufacturing Company, “LAST-A-FOAM@,” FR-6700 Series Product Sheet, 2000, 6 pages.
General Plastics Manufacturing Company, “Tooling Board Specifications,” FR-4500® Series Specification Sheet, 2002, 2 pages.
General Plastics Manufacturing Company, “Tooling Boards,” FR-4500® Series Product Data Sheet, 2002, 4 pages.
Johnson & Johnson Orthopaedics, “Primary Cruciate-Retaining & Cruciate-Substituting Procedure,” Reference Guide for Use with P.F.C. Sigma Knee Systems, 1998, 8 pages.
Maca, et al., “Electrophorectic Deposition of Alumina and Zirconia I. Single-Component Systems”, Ceramics International, vol. 20, pp. 843-852.
Media Cybernetics, Inc., “Image-Pro Plus: Powerful and Customizable Image Processing and Analysis Software for Industrial Applications,” 2009, 8 pages.
Micro Powders, Inc., “Technical Data Sheet—Propyltex Waxes,” 1999, 1 page.
Phelly Materials, Inc., “Hydride and dehydride CP Ti and Ti—6Al—4V Powders,” 2007, 1 page.
Phelly Materials, Inc., “Pure Metal Powder,” 2007, 1 page.
DePuy Orthopaedics, Inc., “Sigma Fixed Bearing Knees—Function with Wear Resistance”, 2010, 0612-65-508 (Rev. 1), 20 pages.
Signus Medizintechnik, “PEEK-OPTIMA®, The Polymer for Implants, Technical Information for the Medical Professional”, 7 pages.
Kinbrum, A., “Taking a Peek at Material Options for Orthopedics,” Advantage Business Media, 2008, 6 pages.
Zimmer Nexgen Trabecular Metal Tibial Tray, The Best Thing Next to Bone, 97-5954-001-00, 2007, 4 Pages.
Zimmer, Trabecular Metal Monoblock Tibial Components, An Optimal Combination of Material and Design, www.zimmer.com, 2009, 3 pages.
Zimmer, Trabecular Metal™ Technology, www.zimmer.com, 2009, 4 pages.
European Search Report for European Patent Application No. 08164944.4-2310-2042131, Mar. 16, 2009, 12 pgs.
European Search Report for European Patent Application No. 08253140.1-2310, Dec. 23, 2008, 8 pgs.
Specification As Filed in U.S. Appl. No. 12/691,280, filed Jan. 21, 2010, 35 Pages (Including Drawings).
IDS for U.S. Appl. No. 12/691,280, Submitted on Jan. 21, 2010, 57 Pages.
Non-Final Office Action in U.S. Appl. No. 12/691,280, Dated Mar. 29, 2011, 10 Pages.
Specificiation As Filed in U.S. Appl. No. 12/894,651, filed Sep. 30, 2010, 29 Pages (Including Drawings).
European Search Report From Corresponding EPO Search Report, EPO Application No. 11150577.2-2310, Dated Apr. 16, 2011, 9 Pages.
Coordinate Ultra Revision Knee System, Surgical Technique, Depuy, A Johnson & Johnson Company, 24 Pages, 1.5M1102, 0601-82-000 (Rev. 3), 1997.
PFC Sigma RP-F Product Rationale, Depuy, A Johnson & Johnson Company, 12 Pages, 3M0106, 0612-27-503, 2006.
LCS Complete, LCS RPS Flexion Product Rationale, Depuy, A Johnson & Johnson Company, 24 Pages, Cat. No. 9075-16-000, Ver. 1, 2008.
What Design Factors Influence Wear Behavior in Total Knee Replacement? American Academy of Orthopaedic Surgeons, pp. 156-169, Material & Design Considerations—Implant Wear in Total Joint Replacement, 2001.
Galvin, A., et al, “The Influence of Tibial Tray Design on the Wear of Fixed-Bearing Total Knee Replacements”, Proc. IMECHE vol. 222, Part H: J. Engineering in Medicine, pp. 1289-1293, 2008.
Jayabalan, Prakash et al., “Backside Wear in Modern Total Knee Designs”, HSSJ (2007) 3: 30-34, DOI 10.1007/S11420-006-9033-0, Published Online: Dec. 14, 2006—Hospital for Special Surgery 2006.
APEX Knee System, Exhibit A 510(K) Summary, K060192, Submitter: Omni Life Science, Inc., 5 Pages, 2006.
Akisue, Toshihiro, M.D., et al, “Backside” Polyethylene Deformation in Total Knee Arthroplasty, The Journal of Arthroplasty, vol. 18, No. 6, pp. 784-791, 2003.
Parks, Nancy L., M.S., et al., The Coventry Award, “Modular Tibial Insert Micromotion, A Concern With Contemporary Knee Implants”, pp. 10-15, Clinical Orthopaedics and Related Research, No. 356, Nov. 1998.
Azzam, Michael G., M.D., et al, Second-Generation Locking Mechanisms and Ethylene Oxide Sterilization Reduce Tibial Insert Backside Damage in Total Knee Arthroplasty, The Journal of Arthroplasty vol. 26, No. 4, pp. 523-530, 2011.
Kuster, et al “The Effects of Conformity and Load in Total Knee Replacement”, Clinical Orthopaedics and Related Research, No. 375, pp. 302-312 (2000) 11 Pgs.
Berend, et al “Effects of Coronal Plane Conformity on Tibial Loading in TKA: A Comparison of AGC Flat Versus Conforming Articulations”, Orthopaedic Surgery, Surgical Technology International XVIII, pp. 207-212 (2009) 6 Pgs.
European Search Report for Corresponding EPO Patent App. No. 11150577.2-2310, Dated Apr. 26, 2011 (9 pages).
Japanese Notification of Reasons for Refusal for Patent Application No. 2011-009548 Dated Oct. 27, 2014 With a Mail Date of Nov. 4, 2014, 4 Pages.
Related Publications (1)
Number Date Country
20110178605 A1 Jul 2011 US